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Digital Transformation in Healthcare: Technology Acceptance and Its Applications

Angelos i. stoumpos.

1 Healthcare Management Postgraduate Program, Open University Cyprus, P.O. Box 12794, Nicosia 2252, Cyprus

Fotis Kitsios

2 Department of Applied Informatics, University of Macedonia, 156 Egnatia Street, GR54636 Thessaloniki, Greece

Michael A. Talias

Associated data.

Not applicable.

Technological innovation has become an integral aspect of our daily life, such as wearable and information technology, virtual reality and the Internet of Things which have contributed to transforming healthcare business and operations. Patients will now have a broader range and more mindful healthcare choices and experience a new era of healthcare with a patient-centric culture. Digital transformation determines personal and institutional health care. This paper aims to analyse the changes taking place in the field of healthcare due to digital transformation. For this purpose, a systematic bibliographic review is performed, utilising Scopus, Science Direct and PubMed databases from 2008 to 2021. Our methodology is based on the approach by Wester and Watson, which classify the related articles based on a concept-centric method and an ad hoc classification system which identify the categories used to describe areas of literature. The search was made during August 2022 and identified 5847 papers, of which 321 fulfilled the inclusion criteria for further process. Finally, by removing and adding additional studies, we ended with 287 articles grouped into five themes: information technology in health, the educational impact of e-health, the acceptance of e-health, telemedicine and security issues.

1. Introduction

Digital transformation refers to the digital technology changes used to benefit society and the healthcare industry. Healthcare systems need to use digital technology for innovative solutions to improve healthcare delivery and to achieve improvement in medical problems. The digital transformation of healthcare includes changes related to the internet, digital technologies, and their relation to new therapies and best practices for better health management procedures. The quality control of massive data collected can help improve patients’ well-being and reduce the cost of services. Digital technologies will also impact medical education, and experts will deceive new ways to train people. Now in this way, practitioners will face new opportunities.

Digital transformation is an ongoing process that can create opportunities in the health sector, provided the necessary infrastructure and training are available. Under Regulation (EU) 2021/694 of the European Parliament and of the Council of 29 April 2021, establishing the Digital Europe Program and repealing Decision (EU) 2015/2240, digital transformation is defined as the use of digital technologies for the transformation of businesses and services. Some technologies that contribute to digital transformation are the digital platform of the Internet of Things, cloud computing and artificial intelligence. At the same time, the sectors of society that are almost affected are telecommunications, financial services and healthcare.

Digital health can play a role in innovation in health, as it facilitates the participation of patients in the process of providing health care [ 1 ]. The patient can overcome his poor state of health when they are no longer in a state of well-being. In this case, the patient is given the to participate in the decision-making regarding their health care. Searching for information through the patient’s internet or using digital health applications (e.g., via mobile phone) is essential for the patient to make the right decision about their health.

In the coming years, health change is expected to focus primarily on the patient, who will take on the “health service consumer” role as the patient seeks control over their health management. The healthcare industry will be shaped based on the needs and expectations of this new “consumer of health services”, which will require upgraded experiences with the main characteristics of personalisation, comfort, speed and immediacy in the provision of services. Gjellebaek C. et al. argue that new digital technologies will shift healthcare towards digitalisation, bringing significant benefits to patients and healthcare infrastructure [ 2 ]. Some of the benefits listed by Gjellebaek C. are the increase in employee productivity, the improvement of the efficiency and effectiveness of the operation of the health units, and the reduction of their operating costs.

On the other hand, in terms of health infrastructure, a typical example is the United States, where 75% of hospitals use electronic health record systems, according to Rebekah E. et al. [ 3 ]. However, clinicians often report side effects using digital technologies, which can be attributed to their misuse [ 3 ]. In addition, some health professionals oppose using these systems and develop solutions that jeopardise patient care. In some countries, such as the United States, the government provides incentives for the “effective use” of e-health technologies, but their results remain uncertain [ 3 ].

Rebekah E. et al. focus more specifically on U.S. hospitals, observing that the remaining countries are relatively in the early stages of transformation [ 4 ]. The United Kingdom, for example, has recently pursued troubled e-health initiatives, and Australian hospitals have only recently participated in investments in the digitalisation of their hospital services [ 4 ]. At the European Union level, digital health is a critical key strategic priority, in line with the European Strategic Plan 2019–2024 (European Commission).

Today, digital transformation in health is spreading and consolidating rapidly [ 5 ]. The purpose of this paper is to provide an assessment of the current literature on digital health transformation, as well as to identify potential vulnerabilities that make its implementation impossible. The ultimate goal is to see how digital technologies facilitate patients’ participation in health and their health.

Due to the rapid development of e-health and digitalisation, data from previous studies are becoming potentially irrelevant. Most studies evaluating digitalisation have relied heavily on quantitative research-based methods. Although quantitative evaluations are required, some of their effects could be omitted.

According to Gopal G. et al., healthcare has the lowest level of digital innovation compared to other industries, such as media, finance, insurance and retail, contributing to limited labour productivity growth [ 6 ]. With this article, we seek to reverse this picture and contribute to the emergence of digitalisation as a factor of health innovation while optimising patient outcomes and the cost of services provided. However, to achieve this innovation, systemic changes are needed in healthcare finances, the education of healthcare staff and healthcare infrastructure.

The following section analyses the methodology and its steps, which then contributed to the emergence of our results.

2. Material and Methods

2.1. search strategy and bibliography reviews.

Our research approach is based on the methodology of Webster and Watson, who developed a concept-centric method and an ad hoc classification system in which categories are used to describe areas of literature [ 7 ]. Initially, the existing bibliographic reviews were searched to select the databases based on keywords. A retrospective search was then performed to examine the reports of the selected works. Finally, the references of selected works were investigated to increase the search sample through the future search. After selecting the articles, they were grouped according to their content.

Systematic reviews were conducted to place this paper on existing knowledge of digital health, as well as to review prior knowledge in this area and to discuss recognised research questions based on the results of previous studies. A comprehensive review of the published literature was reported by Marques, I. C., & Ferreira, J. J. [ 8 ]. The authors explored the potential of existing digital solutions to improve healthcare quality and analysed the emerging trend in digital medicine to evaluate the research question of how stakeholders apply and manage digital technologies for business purposes [ 9 ]. The main question is: How and what could be done sustainably and inclusively through innovation to achieve sustainable development goals by taking advantage of Information and Communication Technologies? Recently, researchers have expressed concern about secure communication and user authentication within providing information to patients. In contrast with data storage, information exchange, and system integration, new approaches and uses of patient care processes are envisaged with the prospect of monitoring not only diagnostic statistics but also in-depth analysis of signs and symptoms before and after treatment, essential sources for new research. Table 1 presents the previous bibliographic reviews on which our study was based.

Previous Bibliographic Reviews.

2.2. Network Analysis

Network analysis is considered a branch of graph theory. Our network analysis is based on the similarity of keywords found in identifying the eligible papers. We used visualisation of similarities (VOS) software, version 1.6.18, to construct graphical networks to understand the clustering of the keywords and their degree of dissimilarity. Our network analysis is based on the similarity of keywords found in identifying the eligible papers.

Initial Search

The search was performed on the following databases: Scopus, Science Direct, and PubMed, using the keywords “digital transformation”, “digitalisation”, “Ehealth or e-health”, “mhealth or m-health”, “healthcare” and “health economics”. We selected publications from the search of international journals and conference proceedings. We collected papers from 2008 until 2021. The documents sought belonged to strategy, management, computer science, medicine, and health professions. Finally, the published works were in English only. The total number of articles collected using the keywords as shown in Table 2 was 5847.

Search Strategy.

We systematically checked the total number of papers 5847 by reading their titles, abstracts, and, whenever necessary, the article’s first page to conclude if each document was relevant as a first step as shown in the Figure 1 .

The diagram for the first phase of the selection process.

Then, we looked at the titles of the 378 articles, and after reading their summary, we accepted 321 articles. Further studies were rejected because their full text was not accessible. As a result, there were 255 articles in our last search. Of the selected 255 articles, 32 more were added based on backward and forward research. The investigation was completed by collecting common standards from all databases using different keyword combinations. According to the systematic literature review, we follow the standards of Webster and Watson (2002) to reject an article. Since then, we have collected the critical mass of the relevant publications, as shown in Figure 2 .

The diagram of the article selection process.

3.1. Chronological Development of the Publications

The categorisation of the articles was based on their content and the concepts discussed within them. As a result, we classify articles into the following categories: information technology in health, the educational impact on e-health, the acceptance of e-health, telemedicine, and e-health security.

Although researchers in Information and Communication Technology and digitalisation conducted studies almost two decades ago, most publications have been published in the last eight years. This exciting finding highlights the importance of this field and its continuous development. Figure 3 shows a clear upward trend in recent years. More specifically, the research field of Information and Communication Technology, in combination with digital transformation, appeared in 2008. However, the most significant number of articles was found in 2019, 2020 and 2021. The number of articles decreased to the lowest in 2009–2011 and 2013–2014. Due to the expansion of the field to new technologies, the researchers studied whether the existing technological solutions are sufficient for implementing digital transformation and what problems they may face.

Number of articles and citations per publication by year.

Figure 3 shows a combination of the articles per year and the number of citations per publication per year.

3.2. Document Type

Of the document types, 59.51 per cent of the articles were categorised as “survey”, while a smaller percentage were in: “case study” (32.53%), “literature review” (5.88%) and “report” (2.08%). However, these documents focused on specific concepts: “information technology in health” (45%), “education impact of e-health” (11%), “acceptance of e-health” (19%), “telemedicine” (7%), “security of e-health” (18%).

As we can see from the following Figure 4 , we used network analysis, where the keywords related to digitalisation and digital transformation were identified in the research study. Network analysis, using keywords, came with VOSviewer software to find more breadth and information on healthcare digitalisation and transformation exploration. It was created by analysing the coexistence of keywords author and index. This analysis’s importance lies in the structure of the specific research field is highlighted. In addition, it helped map the intellectual structure of scientific literature. Keywords were obtained from the title and summary of a document. However, there was a limit to the number of individual words. The figure represents a grid focused on reproducing keywords in the literature on the general dimensions of digitalisation. The digitalisation network analysis showed that e-health, telemedicine, telehealth, mobile health, electronic health/medical record, and information systems were the main relevant backgrounds in the literature we perceived. In the healthcare literature, keywords such as “empowerment” and “multicenter study” usually do not lead to a bibliographic search on digitalisation. Figure 4 shows how e-health and telemedicine have gone beyond the essential and most crucial research framework on how they can affect hospitals and the health sector. The potentially small gaps in network analysis can be filled by utilising data in our research study, contributing to future research.

Bibliometric map of the digital transformation and healthcare.

Figure 5 shows the network analysis with the keywords concerning time publication. The yellow colour indicates keywords for most recent years.

Network visualisation of keywords per year.

Figure 6 presents the density visualisation of keywords.

Heat map of keywords.

Figure 7 shows the number of articles per each method (survey, literature review etc.) for each year.

The map of number of articles per method for each year.

It is evident from Figure 7 that the most used method paper is the survey type and that in the year 2021, we have a high number of surveys compared to previous years.

3.3. Summary of the Included Articles

In Figure 2 , we have explained how we collected the critical mass of the 255 relevant publications. We added another 32 articles based on further research with the backward and research methods, which resulted in a total number of 287 articles.

Then, the articles were categorised according to their content. The concepts discussed in the papers are related to information technology in health, the educational impact of e-health, the acceptance of e-health, telemedicine, and e-health security. For this purpose, the following table was created, called the concept matrix table.

4. Concept Matrix

In this section, we provide the Concept matrix table. Academic resources are classified according to if each article belongs or not to any of the five concepts shown in Table 3 .

Concept Matrix Table.

5. Analysis of Concepts

From the articles included in the present study between 2008 and 2021, they were grouped into five categories identified: (i) information technology in health, (ii) acceptance of e-health, (iii) telemedicine, (iv) security of e-health, and (v) education impact of e-health.

5.1. Information Technology in Health

Researchers have studied several factors to maximise the effectiveness and success of adopting new technology to benefit patients. Hospitals can benefit from information technology when designing or modifying new service procedures. Health units can use information and communication technology applications to analyse and identify patients’ needs and preferences, enhancing their service innovation processes. Previous findings conclude that technological capability positively influences patient service and innovation in the service process [ 301 ]. These results have significant management implications as managers seek to increase technology resources’ efficiency to achieve patient-centred care as the cornerstone of medical practice [ 207 ].

Informatics facilitates the exchange of knowledge necessary for creating ideas and the development process. The internet supports health organisations in developing and distributing their services more efficiently [ 206 ]. Also, Information Technology improves the quality of services, reduces costs, and helps increase patient satisfaction. As new technologies have created opportunities for companies developing high-tech services, healthcare units can increase customer value, personalise services and adapt to their patient’s needs [ 209 ]. To this end, the “smart hospitals” should represent the latest investment frontiers impacting healthcare. Their technological characteristics are so advanced that the public authorities need know-how for their conception, construction, and operation [ 228 ].

A new example is reshaping global healthcare services in their infancy, emphasising the transition from sporadic acute healthcare to continuous and comprehensive healthcare. This approach is further refined by “anytime and everywhere access to safe eHealth services.” Recent developments in eHealth, digital transformation and remote data interchange, mobile communication, and medical technology are driving this new paradigm. Follow-up and timely intervention, comprehensive care, self-care, and social support are four added features in providing health care anywhere and anytime [ 289 ]. However, the healthcare sector’s already precarious security and privacy conditions are expected to be exacerbated in this new example due to the much greater monitoring, collection, storage, exchange, and retrieval of patient information and the cooperation required between different users, institutions, and systems.

The use of mobile telephony technologies to support health goals contributes to the transformation of healthcare benefits worldwide. The same goes for small and medium-sized healthcare companies, such as pharmacies. A potent combination of factors between companies and customers is the reason for creating new relationships. In particular, mobile technology applications represent new opportunities for integrating mobile health into existing services, facilitating the continued growth of quality service management. Service-based, service-focused strategies have changed distribution patterns and the relationship between resellers and consumers in the healthcare industry, resulting in mobile health and significant pharmacy opportunities. It has been an important research topic in the last decade because it has influenced and changed traditional communication between professionals and patients [ 211 ]. An example of a mobile healthcare platform is “Thymun”, designed and developed by Salamah et al. aiming to create intelligent health communities to improve the health and well-being of autoimmune people in Indonesia [ 225 ].

5.2. Acceptance of E-Health

In a long-term project and a population study (1999–2002), Hsu et al. evaluated e-health usage patterns [ 302 ]. The authors conclude that access to and use of e-health services are rapidly increasing. These services are more significant in people with more medical needs. Fang (2015) shows that scientific techniques can be an essential tool for revealing patterns in medical research that could not be apparent with traditional methods of reviewing the medical literature [ 303 ]. Teleradiology and telediagnosis, electronic health records, and Computer-Aided Diagnosis (CAD) are examples of digital medical technology. France is an example of a country that invests and leads in electronic health records, based on what is written by Manard S. et al. [ 243 ]. However, the impact of technological innovation is reflected in the availability of equipment and new technical services in different or specialised healthcare sectors.

On the other hand, Mariusz Duplaga (2013) argues that the expansion of e-health solutions is related to the growing demand for flexible, integrated and cost-effective models of chronic care [ 304 ]. The scope of applications that can support patients with chronic diseases is broad. In addition to accessing educational resources, patients with chronic diseases can use various electronic diaries and systems for long-term disease monitoring. Depending on the disease and the symptoms, the devices used to assess the patient’s condition vary. However, the need to report symptoms and measurements remains the same. According to Duplaga, the success of treatments depends on the patient’s involvement in monitoring and managing the disease. The emphasis on the role of the patient is parallel to the general tendency of people and patients to participate in decisions made about their health. Involving patients in monitoring their symptoms leads to improved awareness and ability to manage diseases. Duplaga argues that the widespread use of e-health systems depends on several factors, including the acceptance and ability to use information technology tools, combined with an understanding of disease and treatment.

Sumedha Chauhan & Mahadeo Jaiswal (2017) are on the same wavelength. They claim that e-health applications provide tools, processes and communication systems to support e-health practices [ 305 ]. These applications enable the transmission and management of information related to health care and thus contribute to improving patient’s health and physicians’ performance. The human element plays a critical role in the use of e-health, according to the authors. In addition, researchers have studied the acceptance of e-health applications among patients and the general public, as they use services such as home care and search for information online. The meta-analysis they use combines and analyzes quantitative findings of multiple empirical studies providing essential knowledge. However, the reason for their research was the study of Holden and Karsh (2010) [ 306 ].

To provide a comprehensive view of the literature acceptance of e-health applications, Holden and Karsh reviewed 16 studies based on healthcare technology acceptance models [ 306 ]. Findings show them that the use and acceptance of technological medical solutions bring improvements but can be adopted by those involved in the medical field.

5.3. Telemedicine

On the other hand, telemedicine is considered one of the most important innovations in health services, not only from a technological but also from a cultural and social point of view. It benefits the accessibility of healthcare services and organisational efficiency [ 215 ]. Its role is to meet the challenges posed by the socio-economic change in the 21st century (higher demands for health care, ageing population, increased mobility of citizens, need to manage large volumes of information, global competitiveness, and improved health care provision) in an environment with limited budgets and costs. Nevertheless, there are significant obstacles to its standardisation and complete consolidation and expansion [ 300 ].

At present, there are Telemedicine centres that mediate between the patient and the hospital or doctor. However, many factors make this communication impossible [ 300 ]. Such factors include equipment costs, connectivity problems, the patient’s trust or belief in the system or centre that applies telemedicine, and resistance to new and modern diagnostics, especially in rural and island areas. Therefore, telemedicine would make it easier to provide healthcare systems in remote areas than having a specialist in all the country’s remote regions [ 300 ]. Analysing the concept further, one can easily argue that the pros outweigh the disadvantages. Therefore, telemedicine must be adopted in a concerted effort to resolve all the obstacles we are currently facing. Telemedicine centres and services such as teleradiology, teledermatology, teleneurology, and telemonitoring will soon be included. This means that a few years from now, the patient will not have to go to a central hospital and can benefit remotely from the increased quality of health services. This will save valuable time, make good use of available resources, save patient costs, and adequately develop existing and new infrastructure.

In 2007, the World Health Organisation adopted the following broad description of telemedicine: “The delivery of health care services, where distance is a critical factor, by all health care professionals using information and communication technologies for the exchange of valid information for the diagnosis, treatment and prevention of disease and injuries, research and evaluation, and for the continuing education of health care providers, all in the interests of advancing the health of individuals and their communities ” [ 307 ]

According to the Wayback Machine, Canadian Telehealth Forum, other terms similar to telemedicine are telehealth and e-health, which are used as broader concepts of remote medical therapy. It is appropriate to clarify that telemedicine refers to providing clinical services. In contrast, telehealth refers to clinical and non-clinical services, including education, management and research in medical science. On the other hand, the term eHealth, most commonly used in the Americas and Europe, consists of telehealth and other elements of medicine that use information technology, according to the American Telemedicine Association [ 308 ].

The American Telemedicine Association divides telemedicine into three categories: storage-promotion, remote monitoring, and interactive services. The first category includes medical data, such as medical photographs, cardiograms, etc., which are transferred through new technologies to the specialist doctor to assess the patient’s condition and suggest the appropriate medication. Remote monitoring allows remote observation of the patient. This method is used mainly for chronic diseases like heart disease, asthma, diabetes, etc. Its interactive services enable direct communication between the patient and the treating doctor [ 309 ].

Telemedicine is a valuable and efficient tool for people living or working in remote areas. Its usefulness lies in the health access it provides to patients. In addition, it can be used as an educational tool for learning students and medical staff [ 310 ].

Telemedicine is an open and constantly evolving science, as it incorporates new technological developments and responds to and adapts to the necessary health changes within societies.

According to J.J. Moffatt, the most common obstacles to the spread of telemedicine are found in the high cost of equipment, the required technical training of staff and the estimated time of a meeting with the doctor, which can often be longer than the use of a standard doctor [ 311 ]. On the other hand, the World Health Organisation states that telemedicine offers excellent potential for reducing the variability of diagnoses and improving clinical management and the provision of health care services worldwide. The World Health Organisation claims, according to Craig et al. and Heinzelmann PJ, that telemedicine improves access, quality, efficiency and cost-effectiveness [ 312 , 313 ]. In particular, telemedicine can help traditionally under-served communities by overcoming barriers to the distance between healthcare providers and patients [ 314 ]. In addition, Jennett PA et al. highlight significant socio-economic benefits for patients, families, health professionals and the health system, including improved patient-provider communication and educational opportunities [ 315 ].

On the other hand, Wootton R. argues that telemedicine applications have achieved different levels of success. In both industrial and developing countries, telemedicine has yet to be used consistently in the healthcare system, and few pilot projects have been able to be maintained after the end of their initial funding [ 316 ].

However, many challenges are regularly mentioned and responsible for the need for more longevity in many efforts to adopt telemedicine. One such challenge is the complexity of human and cultural factors. Some patients and healthcare workers resist adopting healthcare models that differ from traditional approaches or home practices. In contrast, others need to have the appropriate educational background in Information and Communication Technologies to make effective use of telemedicine approaches [ 314 ]. The need for studies documenting telemedicine applications’ economic benefits and cost-effectiveness is also a challenge. Strong business acumen to persuade policymakers to embrace and invest in telemedicine has contributed to a need for more infrastructure and program funding [ 312 ]. Legal issues are also significant obstacles to the adoption of telemedicine. These include the need for an international legal framework that allows health professionals to provide services in different jurisdictions and countries. Furthermore, the lack of policies governing data confidentiality, authentication and the risk of medical liability for health professionals providing telemedicine services [ 314 ]. In any case, the technological challenges are related to legal issues. In addition, the systems used are complex, and there is a possibility of malfunction, which could cause software or hardware failure. The result is an increase in patient morbidity or mortality as well as the liability of healthcare providers [ 317 ].

According to Stanberry B., to overcome these challenges, telemedicine must be regulated by definitive and comprehensive guidelines, which are ideally and widely applied worldwide [ 318 ]. At the same time, legislation must be enacted governing health confidentiality, data access, and providers’ responsibility [ 314 ].

5.4. Security of eHealth

The possibility of the patients looking at the electronic patient folder in a cloud environment, through mobile devices anytime and anywhere, is significant. On the one hand, the advantages of cloud computing are essential, and on the other hand, a security mechanism is critical to ensure the confidentiality of this environment. Five methods are used to protect data in such environments: (1) users must encrypt the information before storing it; (2) users must transmit information through secure channels; (3) the user ID must be verified before accessing data; (4) the information is divided into small portions for handling and storage, retrieved when necessary; (5) digital signatures are added to verify that a suitable person has created the file to which a user has access. On the other hand, users of these environments will implement self-encryption to protect data and reduce over-reliance on providers [ 210 ].

At the same time, Maliha S. et al. [ 227 ] proposed the blockchain to preserve sensitive medical information. This technology ensures data integrity by maintaining a trace of control over each transaction. At the same time, zero trusts provide that medical data is encrypted and that only certified users and devices interact with the network. In this way, this model solves many vulnerabilities related to data security [ 227 ]. Another alternative approach is the KONFIDO project, which aims at the safe cross-border exchange of health data. A European H2020 project aims to address security issues through a holistic example at the system level. The project combines various cutting-edge technologies in its toolbox (such as blockchain, photonic Physical Unclonable Functions, homomorphic encryption, and trusted execution) [ 234 ]. Finally, Coppolino L. et al. [ 271 ] proposed using a SIEM framework for an e-healthcare portal developed under the Italian National eHealth Net Program. This framework allows real-time monitoring of access to the portal to identify potential threats and anomalies that could cause significant security issues [ 271 ].

5.5. Education Impact of E-Health

But all this would only be feasible with the necessary education of both users and patients [ 11 ]. As the volume and quality of evidence in medical education continue to expand, the need for evidence synthesis will increase [ 295 ]. On the other hand, Brockers C. et al. argued that digitalisation changes jobs and significantly impacts medical work. The quality of medical data provided for support depends on telemedicine’s medical specialisation and knowledge. Adjustments to primary and further education are inevitable because physicians are well trained to support their patients satisfactorily and confidently in the increasingly complex digitalisation of healthcare. The ultimate goal of the educational community is the closest approach of students to the issues of telemedicine and e-health, the creation of a spirit of trust, and the acceptance and transmission of essential knowledge [ 268 ].

Noor also moved in this direction, seeking to discover the gaps in Saudi education for digital transformation in health [ 248 ]. The growing complexity of healthcare systems worldwide and the growing reliance of the medical profession on information technology for precise practices and treatments require specific standardised training in Information Technology (IT) health planning. Accreditation of core Information Technology (IT) is advancing internationally. Noor A. examined the state of Information Technology health programmes in the Kingdom of Saudi Arabia (KSA) to determine (1) how well international standards are met and (2) what further development is required in the light of recent initiatives of the Kingdom of Saudi Arabia on e-health [ 248 ]. Of the 109 institutions that participated in his research, only a few offered programmes specifically in Health Information Technology. As part of Saudi Vision 2030, Saudi digital transformation was deemed an urgent need. This initiative calls for applying internationally accepted Information Technology skills in education programmes and healthcare practices, which can only happen through greater collaboration between medical and technology educators and strategic partnerships with companies, medical centres and government agencies.

Another study by Diviani N. et al. adds to the knowledge of e-health education, demonstrating how online health information affects a person’s overall behaviour and enhances patients’ ability to understand, live and prepare for various health challenges. The increasing digitalisation of communication and healthcare requires further research into the digital divide and patients’ relationships with health professionals. Healthcare professionals must recognise the online information they seek and engage with patients to evaluate online health information and support joint healthcare-making [ 235 ].

6. Discussion

The selected studies comprise a conceptual model based on bibliographic research. Using an open-ended technique, we analyse the selected 287 articles, which are grouped into categories based on their context. This methodology provides readers with a good indication of issues concerning the timeliness of health digitalisation. A limitation of the methodology is that selected criteria of the method might be subjective in terms of the search terms and how the papers are selected. The articles indicate that this field is initial, and further research is needed. Although several articles have created a theoretical basis for corporate sustainability and strategic digital management, only limited studies provided guidelines on the strategic digital transformation process and its health implementation stages. However, studies have also developed sustainable models, software or applications in this area. This is also the reason for creating opportunities for future researchers, who will be closed to investigate this gap and improve the viability of digital health strategies. In addition, any work carried out in case studies provides fruitful results by facilitating researchers through deep penetration into sustainable digitalisation. No generalised frameworks are available to guide the wording and implementation of digital action plans. Thus, the need for quantitative or qualitative research is created, providing conclusions on the impact of internal or external factors in the sustainability process, implementation, adoption, planning, and challenges of digital health solutions in general, as well as the impact of digital transformation. Most existing studies explore the issue of digitalisation in a particular part of a nursing institution or a disease rather than the management strategy perspective. In this way, researchers ignore a debate on obstacles and problems that often face in practice during integration. Such an analysis could lead to more profound knowledge.

7. Conclusions

In conclusion, our research observed a timeless analysis of systematised studies focusing on digital health developments. These studies broaden the researchers’ vision and provide vital information for further investigation. This article focuses on understanding digitalisation in healthcare, including, for the most part, the digitalisation of information and adopting appropriate parameters for further development. To build a more holistic view of digital health transformation, there is a great need for research on the management implications of digitalisation by different stakeholders. Finally, the development of telemedicine, the further enhancement of digital security and the strengthening of technological information systems will contribute to the universal acceptance of the digital health transformation by all involved.

Funding Statement

This research received no external funding.

Author Contributions

Conceptualisation, A.I.S., F.K. and M.A.T.; methodology, F.K. and M.A.T.; software, A.I.S.; validation, A.I.S.; data curation, A.I.S.; writing—original draft preparation, A.I.S. and M.A.T.; writing—review and editing, A.I.S. and M.A.T.; visualisation, A.I.S.; supervision, M.A.T.; project administration, M.A.T. All authors have read and agreed to the published version of the manuscript.

Institutional Review Board Statement

Informed consent statement, data availability statement, conflicts of interest.

The authors declare no conflict of interest.

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This paper is in the following e-collection/theme issue:

Published on 16.5.2024 in Vol 26 (2024)

Person-Generated Health Data in Women’s Health: Scoping Review

Authors of this article:

• Jalisa Lynn Karim 1 , BA, BMath   ; 
• Rachel Wan 1 , BSc, BSN, RN   ; 
• Rhea S Tabet 2 , BSc   ; 
• Derek S Chiu 3 , BSc, MSc   ; 
• Aline Talhouk 1 , BA, MSc, PhD  

1 Department of Obstetrics and Gynaecology, University of British Columbia, Vancouver, BC, Canada

2 Department of Pharmacology and Therapeutics, McGill University, Montréal, QC, Canada

3 Department of Molecular Oncology, University of British Columbia, Vancouver, BC, Canada

Corresponding Author:

Aline Talhouk, BA, MSc, PhD

Department of Obstetrics and Gynaecology

University of British Columbia

593 - 828 West 10th Ave

Vancouver, BC, V5Z 1M9

Phone: 1 604 875 3111

Email: [email protected]

Background: The increased pervasiveness of digital health technology is producing large amounts of person-generated health data (PGHD). These data can empower people to monitor their health to promote prevention and management of disease. Women make up one of the largest groups of consumers of digital self-tracking technology.

Objective: In this scoping review, we aimed to (1) identify the different areas of women’s health monitored using PGHD from connected health devices, (2) explore personal metrics collected through these technologies, and (3) synthesize facilitators of and barriers to women’s adoption and use of connected health devices.

Methods: Following the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines for scoping reviews, we searched 5 databases for articles published between January 1, 2015, and February 29, 2020. Papers were included if they targeted women or female individuals and incorporated digital health tools that collected PGHD outside a clinical setting.

Results: We included a total of 406 papers in this review. Articles on the use of PGHD for women steadily increased from 2015 to 2020. The health areas that the articles focused on spanned several topics, with pregnancy and the postpartum period being the most prevalent followed by cancer. Types of digital health used to collect PGHD included mobile apps, wearables, websites, the Internet of Things or smart devices, 2-way messaging, interactive voice response, and implantable devices. A thematic analysis of 41.4% (168/406) of the papers revealed 6 themes regarding facilitators of and barriers to women’s use of digital health technology for collecting PGHD: (1) accessibility and connectivity, (2) design and functionality, (3) accuracy and credibility, (4) audience and adoption, (5) impact on community and health service, and (6) impact on health and behavior.

Conclusions: Leading up to the COVID-19 pandemic, the adoption of digital health tools to address women’s health concerns was on a steady rise. The prominence of tools related to pregnancy and the postpartum period reflects the strong focus on reproductive health in women’s health research and highlights opportunities for digital technology development in other women’s health topics. Digital health technology was most acceptable when it was relevant to the target audience, was seen as user-friendly, and considered women’s personalization preferences while also ensuring accuracy of measurements and credibility of information. The integration of digital technologies into clinical care will continue to evolve, and factors such as liability and health care provider workload need to be considered. While acknowledging the diversity of individual needs, the use of PGHD can positively impact the self-care management of numerous women’s health journeys. The COVID-19 pandemic has ushered in increased adoption and acceptance of digital health technology. This study could serve as a baseline comparison for how this field has evolved as a result.

International Registered Report Identifier (IRRID): RR2-10.2196/26110

Introduction

The practice of keeping notes to monitor one’s health is not a recent phenomenon. Individuals have long recognized the benefits of tracking various health aspects, including the ability to be more active participants in managing their health, gaining a more complete picture of their health, and reducing the frequency of in-person appointments; however, this tracking was previously done through paper logs [ 1 ]. Today, with the proliferation of digital tools, self-tracking has significantly evolved and become more prevalent. The increasing pervasiveness of technology, particularly mobile phones, has seamlessly integrated it into our daily lives, making self-tracking more accessible and convenient than ever before [ 2 ]. Connected digital health technologies such as smartphones, wearables (eg, smartwatches), sensors, the Internet of Things (eg, internet-enabled weight scales), and web-based applications have permeated society and are increasingly adopted to collect and track health data. In 2021, a total of 87% of Canadians owned a smartphone, up by 73% from 2009 [ 3 ]. With >350,000 digital health apps accessible via these smartphones [ 4 ], approximately two-thirds of Canadians digitally track at least one aspect of their health [ 5 ]; similar statistics have been reported in the United States [ 6 ]. Moreover, since the introduction and popularization of fitness trackers in 2010, sensors and wearable devices have increasingly become part of daily life [ 2 ]. During the global COVID-19 pandemic, self-tracking took on even greater significance [ 7 , 8 ]. With the heightened awareness of health and the need for proactive measures, individuals have turned to self-tracking to monitor their well-being and make informed decisions. With this transformation, self-tracking has transcended its previous boundaries, offering individuals new opportunities to optimize their well-being and ushering in a new era of personalized health care [ 9 - 11 ].

Digital health tools have revolutionized the active and passive collection of health data through various applications and wearable devices. These various digital health tools collect and generate an unprecedented amount of data that can be used to glean insights into one’s health. Person-generated health data (PGHD), which are clinically relevant data captured outside traditional care settings [ 12 ], provide valuable insights that empower users to self-monitor and reflect on their health. PGHD can refer to any data collected from wearable and smart devices as well as self-input information into platforms such as mobile apps and websites. By leveraging digital technologies, individuals can collect and store their health data, enabling them to actively manage their own health and monitor chronic conditions. Furthermore, the integration of these data with research presents an opportunity to improve the patients’ experience and enhance personalized medicine. The recognition of this opportunity has started to take shape with patient-reported outcome measures and patient-reported experience measures being increasingly recognized as essential information to assess quality of care and prioritize patient-centered approaches and with mandatory assessment as part of clinical trials [ 13 ]. Seamlessly linking PGHD that are captured outside traditional care settings with clinical data and disease models can unlock new possibilities for tailored treatments and predictive informatics. The integration of digital health tools not only facilitates patient-provider communication but also offers opportunities for education, increased awareness, self-tracking, and self-monitoring without burdening health care resources. By focusing on the individual’s experience, personalization, and prevention, digital health tools contribute to a patient-centered care paradigm that aims to optimize health care outcomes and improve overall well-being while empowering patients to take charge of their health.

In recent years, the emergence of femtech, defined as technology-driven solutions specifically designed to address women’s health needs and concerns, has revolutionized the landscape of self-tracking and health care for women [ 14 ]. Femtech encompasses a wide range of digital tools, such as period-tracking apps, fertility monitors, pregnancy trackers, and menopause management platforms. These innovative solutions empower women to track and manage their reproductive health, menstrual cycles, and overall well-being with greater accuracy and ease. Femtech has not only provided women with personalized insights into their bodies but has also helped break taboos and encouraged open conversations about topics that were once stigmatized or ignored. The rapid growth of femtech has promoted access to women’s health information, greater autonomy in decision-making, and enhanced overall health care experiences for women worldwide. It has become an integral part of the self-tracking movement, demonstrating the transformative power of technology in promoting women’s health and well-being.

In this study, we reviewed the use of digital tools and PGHD in women’s health research, focusing on articles published between January 1, 2015, and February 29, 2020, before the COVID-19 pandemic. Our review encompassed various connected health devices, which included both passive data collection devices such as wearable sensors and active input devices such as smartphone apps and websites. This review sought to accomplish the following:

• Identify the different areas of women’s health and health-related behaviors monitored using PGHD from connected health devices.
• Explore personal metrics collected through these technologies.
• Synthesize facilitators and barriers that impact women’s adoption and use of connected health devices in managing their health.

This scoping review was conducted based on our previously published protocol [ 15 ]. We adopted the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines [ 16 ]. The completed checklist is provided in Multimedia Appendix 1 [ 16 ].

Search Strategy

The search strategy was designed in close collaboration with a reference librarian with input from the authors (JLK and AT). We searched a total of 5 databases: MEDLINE, Embase, APA PsycINFO, CINAHL Complete, and Web of Science Core Collection. Initial searches were completed in early March 2020. Searches were limited to articles published in 2015 or later because publications with the keyword “digital health” started to emerge in the literature around that time [ 17 ], and with the fast evolution of the field, previous articles may not be relevant to the current landscape. Keywords and subject headings were designed to search the literature for the intersection of the following 4 topics: women, health, digital devices, and tracking. The full search strategy, including a full list of search terms, was published with the protocol [ 15 ] and is available in Multimedia Appendix 2 .

Eligibility Criteria

We were interested in digital technologies and interventions targeting women and people assigned female at birth. To be included in the review, studies needed to specifically target women, focus on female-only health topics (eg, menstruation), or only include female participants. We included a variety of publication types but excluded conference abstracts and conference reviews, editorials, letters, and comments due to the limited details in such literature.

We excluded articles that presented digital health tools designed for health care providers as we were primarily interested in devices and apps that women can engage with outside a clinical setting. Articles only discussing the use of real-time consultations, whether through video, phone, or web-based chat, were excluded. We excluded articles that described digital health tools used solely for educational purposes; to maintain the focus of the review on tracking or monitoring one’s data for health, devices must have allowed users to input personal health data.

The complete inclusion and exclusion criteria are presented in Textbox 1 . We decided to retain the original inclusion end date of February 29, 2020, to maintain a focus on the literature before the COVID-19 pandemic and avoid potential complexities caused by pandemic-related disruptions in research and health care practices. Concentrating on prepandemic literature also established a clear baseline for future comparisons and allowed us to maintain feasibility of completion without compromising quality given the broad scope of the review.

Inclusion criteria

• Published between January 1, 2015, and February 29, 2020
• Refers to a health issue that pertains only to women or comprises only female participants of any age
• Includes the use of connected health tools for tracking or monitoring some aspect of health, which could include smartphone apps, wearable devices, the Internet of Things (eg, Bluetooth- or internet-enabled glucometers, blood pressure cuffs, and weight scales), and implantable devices
• Involves data collection from the user of the connected health tool (ie, the user either manually inputs data into the device or they are automatically uploaded)
• The user must be able to interact with the app or device on her own at home (outside a clinical setting)
• Available in English

Exclusion criteria

• Not available in English
• Conference abstracts, conference reviews, editorials, letters, or comments
• Study media releases and user reviews of specific applications
• Research conducted on animals
• Research involving male participants
• Tracking of infants and children unless tracking breastfeeding (because breastfeeding is directly related to the mother’s health and body)
• Devices or apps that are meant for health care provider use or use in a clinical setting only or cannot be used independently without a health care provider present
• Digital health tools that are only for educational or informational purposes and do not allow the user to enter or track her own data (ie, no information exchange)
• Telemedicine services (eg, live video consultations with health care providers)

Study Selection

We imported the results from the database searches to the Covidence systematic review software (Veritas Health Innovation). Covidence detected records believed to be duplicates, and these were manually checked before removing them. In addition, some articles were manually recognized as duplicates during the screening process and were subsequently tagged as duplicates and removed. Screening was conducted independently by at least 2 reviewers (JLK, RST, and AT) at both the abstract screening stage and the full-text screening stage. We attempted to contact the corresponding authors of articles that passed abstract screening when we were unable to locate the full text. Conflicts at either stage were discussed and agreed upon among the 3 authors involved in the screening process.

Data Charting and Deviations From the Protocol

The final list of data charting elements is provided in Textbox 2 . Data charting for all elements except for usability and acceptability was conducted using Google Sheets created by the study team. The categories for different data charting options were initially created based on a small subset of articles and were discussed among the authors involved in the charting process. The team met regularly throughout the data charting process to discuss and refine coding categories that best summarized the data. Starting with more granular categories and later combining them into broader concepts was necessary to summarize the number of articles included in this review. For each article included, data were charted by one reviewer (RW or RST) and verified for accuracy by a second reviewer (JLK). Data were summarized in bar graphs, maps, and tables (JLK, RST, and DSC), as presented in the following sections. For the locations, we recorded the countries from which the participants were recruited (if applicable). If an article did not describe recruiting participants, then the countries of the authors were recorded based on the authors’ affiliations.

Article information

• Year of first publication

Study characteristics

• Country or countries in which the research was conducted
• Research study type

Contexts for women’s connected health

• Health areas of focus

Digital device details

• Types of digital health
• Metrics collected by the devices

Usability and acceptability

• Facilitators of and barriers to the use of the technologies (coded into themes)

For the thematic analysis, articles that mentioned any aspect of usability, acceptability, facilitators, or barriers to the use of digital health tools were imported into NVivo (R1 2020; QSR International). Coding was done independently by 2 reviewers (JLK and RW) and then combined through discussions. As with the data charting process, we initially coded more granularly and then grouped the detailed codes together later in the analytic process. Decisions on how to group the codes into themes and subthemes were made through group consensus (JLK, RW, and AT).

In our protocol, we indicated that we would extract the name of the device or app used in each study. While we did complete this step in our data charting, we have not presented the results in this paper. Several articles either did not specify the brand name (eg, only specified that it was a mobile app) or had digital health tools named after the study, so we did not find this information useful to showcase in our results. There were no other deviations from the published protocol.

The searches identified 14,629 records that were imported into the Covidence software for deduplication and screening. After deduplication, a total of 9102 articles were screened for relevance, and 8545 (93.88%) were excluded based on title and abstract. From reading the full texts of the remaining 557 records, an additional 151 (27.1%) were excluded. The most common reasons for exclusion were the inability of study participants to enter or track their own data (58/151, 38.4%) or because the digital health technology was designed to be used by or with a health care provider (48/151, 31.8%). The remaining 406 publications were included in the scoping review. Some of the included publications reported on the same research project; in those cases, all of them were included. Our search did not encounter any articles that directly addressed or mentioned the inclusion of intersex, transgender, or nonbinary participants. The PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) flow diagram detailing the full study selection process is shown in Figure 1 . The list of included articles sorted by health areas of focus can be found in Multimedia Appendix 3 [ 18 - 58 ].

Year and Country

There was an increasing trend in number of publications per year, with 10.1% (41/406) of the articles published in 2015, a total of 13.3% (54/406) of the articles published in 2016, a total of 18% (73/406) of the articles published in 2017, a total of 26.4% (107/406) of the articles published in 2018, and 29.6% (120/406) of the articles published in 2019. Only 2.7% (11/406) of the publications were from 2020 because our cutoff date for inclusion was February 29, 2020.

Articles included in the review covered worldwide research, including every continent except Antarctica ( Figure 2 ). As we only considered articles written in English, most of the articles were published in Western, English-speaking countries, primarily the United States (169/406, 41.6% of the articles), the United Kingdom (34/406, 8.4% of the articles), Australia (33/406, 8.1% of the articles), and Canada (19/406, 4.7% of the articles). Other countries where several included articles were published were China (13/406, 3.2% of the articles), the Netherlands (13/406, 3.2% of the articles), Spain (13/406, 3.2% of the articles), and Sweden (10/406, 2.5% of the articles).

Interestingly, of the 169 articles from the United States, 26 (15.4%) specifically focused on African American or Black, ethnic minority, or low-income women. One study from Singapore specifically included multiethnic women [ 18 ], and a study from Australia included Indigenous Australian women as their participants [ 19 ]. In addition, one review conducted by researchers in Australia looked specifically at studies with women from culturally and linguistically diverse backgrounds [ 20 ].

Study Types

The types of studies that used digital health tools in women’s health research are reported in Figure 3 by year of publication (note that the articles could fall into more than one study category). The most common study type encountered was feasibility or acceptability studies (197/406, 48.5% of the articles, including 9/197, 4.6% protocols), followed by effectiveness studies (146/406, 36% of the articles, including 36/146, 24.7% protocols) and publications reporting on digital tool prototypes (73/406, 18% of the articles). Effectiveness studies reported on outcome measures of an intervention, including randomized and nonrandomized trials with one or more study arms. Reviews (of published literature, apps, or wearables), viewpoints, manuals, case studies, or analytical methods (56/406, 13.8% of the articles combined) were also encountered. Observational or correlative studies (44/406, 10.8% of the articles, including 3/44, 7% protocols) were studies that observed the health behaviors of individuals through digital health technologies without assessing the effectiveness of an intervention or analyzed associations between variables (eg, associations between heart rate and loss-of-control eating) [ 21 ]. Finally, measurement studies (23/406, 5.7% of the articles) reported on the validity, reliability, or accuracy of a digital health tool.

Health Areas of Focus

The analysis of the reviewed articles highlighted research in several recurring women’s health areas of focus. A full breakdown of the health areas is reported in Table 1 (articles could fall into more than one health area). Pregnancy and the postpartum period emerged as the most prominent health area with 42.6% (173/406) of the articles. Within this category, there was a specific emphasis on general care and monitoring (45/173, 26% of the articles), physical activity and diet (34/173, 19.7% of the articles), and glucose monitoring (31/173, 17.9% of the articles). Cancer was identified as the second most common health area, with 19.5% (79/406) of the articles dedicated to its exploration. Specifically, a significant focus was observed on the relationship between cancer and cardiovascular health, with 47% (37/79) of the articles addressing this aspect. The impact of lifestyle on overall health and well-being was also addressed, with 14.3% (58/406) of the articles delving into physical activity, sedentary behavior, diet, weight, and obesity. Menstrual, sexual, and reproductive health were explored in 12.1% (49/406) of the articles to shed light on various aspects of women’s reproductive health and associated concerns, with 76% (37/49) focusing on menstrual cycle tracking or fertility monitoring. Furthermore, 9.9% (40/406) of the articles were dedicated to chronic conditions (such as urinary incontinence, osteoporosis, and diabetes) with the aim of enhancing understanding and developing interventions for individuals living with chronic health conditions. To accommodate articles that did not fit within the primary health areas, an Other category comprising 6.4% (26/406) of the articles was established. This category included articles on athlete monitoring (10/26, 38% of the articles), such as heart rate monitoring during sports tournaments; mental health and quality of life (9/26, 35% of the articles); gender-based violence (3/26, 12% of the articles); and more. Finally, a small subset of 0.5% (2/406) of the articles did not align with any specific health area; these included a publication reporting results from a survey on African American women’s willingness to participate in eHealth research [ 22 ] and a publication analyzing women’s interactions with digital health technologies [ 23 ]. These articles were included because, although they did not discuss a specific health area, they still focused on women’s use of digital health tools in general.

a PCOS: polycystic ovary syndrome.

b CVD: cardiovascular disease.

c COPD: chronic obstructive pulmonary disease.

d SLE: systemic lupus erythematosus.

e IC: interstitial cystitis.

f BPS: bladder pain syndrome.

g ABL: accidental bowel leakage.

Figure 4 shows how the health areas of focus for women’s use of digital health changed over the years that were included in the review (2015-2019 plus January 2020-February 2020). There was an increasing trend from 2015 to 2020 in the number of publications focusing on pregnancy and the postpartum period, as well as cancer and menstrual, sexual, and reproductive health. However, articles focused on women’s use of digital health for lifestyle-related topics and chronic conditions did not see a notable increase over those years.

Type of Digital Health and Metrics Collected

Within the articles reviewed, smartphone, mobile, or tablet apps emerged as the most prevalent type of digital health (295/406, 72.7% of the articles), followed by wearable devices (165/406, 40.6% of the articles) and websites or patient portals (93/406, 22.9% of the articles). Other types of technology were not investigated as much. For example, 13.5% (55/406) of the articles addressed smart devices or the Internet of Things (referring to objects with sensors that connect to a network, such as Bluetooth-enabled glucometers and blood pressure machines). Finally, 7.4% (30/406) of the articles reported on 2-way messaging, 1% (4/406) of the articles reported on interactive voice response telephone calls, and only 0.5% (2/406) of the articles reported on implantable devices. With respect to the metrics collected, we found >250 metrics, such as heart rate, number of steps, mood, ovulation test results, and days of menstruation. A full list of the metrics is reported in Multimedia Appendix 4 .

Thematic Analysis

Of the 406 articles included in this scoping review, 168 (41.4%) mentioned usability, acceptability, facilitators, or barriers to the use of digital health tools at least once. Our thematic analysis identified 6 themes: (1) accessibility and connectivity, (2) design and functionality, (3) accuracy and credibility, (4) audience and adoption, (5) impact on community and health service, and (6) impact on health and behavior. The themes are described in further detail in the following sections.

The thematic analysis detailed in the following sections is primarily based on the views of the participants in the studies we reviewed to provide a user perspective; however, one subsection in theme 5 focuses on the health care provider perspective.

Theme 1: Accessibility and Connectivity

The accessibility and connectivity of digital technologies emerged as an important theme with two subthemes: (1) cost and convenience and (2) connectivity, compatibility, and software issues.

Cost and Convenience

Our analysis revealed that the cost and convenience of digital tools collecting PGHD are important factors that can impact their adoption and use. On the one hand, digital health technologies can be seen as more affordable compared to traditional health care visits and more accessible to a wider range of people, including those of a lower socioeconomic status. On the other hand, they can also be perceived as too expensive and novelty items, and associated extra costs such as data plans can also be a barrier for some people. Because PGHD can be collected and entered throughout the day in real time, and because most people carry a phone around with them every day, these technologies offer greater convenience than traditional in-person health care encounters by providing anytime, anywhere virtual access and putting information at people’s fingertips through smartphones and web platforms. One user spoke about an in-app treatment program:

That was what was so good about this, I can do this at home myself, no need to book an appointment, find the time and suit others, and you know, that process of booking a time. [ 24 ]

Some inconvenient aspects of digital health technologies include uncomfortable wearables that are too bulky, difficulty of use, or not fitting into the users’ lifestyles, as noted in one article:

Women also mentioned that the comfort of the wearable sensors was a barrier. Comfort became a barrier for some women during exercise and hot weather. [ 25 ]

Devices with a short battery life and wearables that are not water resistant are also considered inconvenient as they require the user to frequently remember to charge the device or put the wearable back on after water-based activities. Certain restrictions, such as not being able to wear a device in a workplace, can also create inconvenient barriers for some users.

Connectivity, Compatibility, and Software Issues

Factors related to connectivity and other issues such as device synchronization, freezing, or disconnection can significantly impact the user experience and engagement with digital health tools. For example, the dependence on mobile and internet access can be a disadvantage. Cellphone and network coverage limitations can pose an important barrier in rural areas or during travel. Where mobile data or Wi-Fi connection are limited, people may struggle to use digital health tools that require internet connection; this can create disparities in access to health care resources, particularly for those of a lower socioeconomic status or living in remote communities with limited infrastructure. Incompatibility between operating systems such as Android and iOS, iPhone and iPad, or various browsers can also be an important barrier to accessing digital health technology.

Software issues can significantly impact the user experience of digital health technologies. Broken links can prevent users from accessing valuable information or features within apps or websites. App crashes can discourage users from engaging with the digital health tool altogether. In addition, slow loading times can negatively impact the user experience, making it challenging for users to access information or features quickly and efficiently.

Theme 2: Design and Functionality

The second theme centered on design and functionality and included four subthemes: (1) appearance and design; (2) functionality and features; (3) personalization; and (4) safety, privacy, and security.

Appearance and Design

Appearance and design play important roles in the success of connected health devices. In terms of app design, the color scheme and layout facilitate user-friendliness. Bad formatting can make it difficult for users to read or understand the content of an app or website. Font size that is too small can be challenging for those with visual impairments, and some color combinations can be difficult to read. The quality of the images used in digital health interventions can also impact user experience, with low-quality images potentially making it difficult for users to interpret the information being presented.

Apps that are visually appealing and easy to use are more likely to be successful. When it comes to wearables, women tend to prefer sleek, understated designs that are esthetically pleasing without being bulky. A sleek design can encourage use of the wearable. For example, some women consider their wearable to be a fashion item that sparks conversation, which encourages their continued use of the device, as illustrated in a participant quote:

Um, that it’s, like, kind of stylish, like, I feel, like, cool that I wear one. A lot of people ask me, they’re like, oh, which one is that, like, is that a Fitbit, is that an Apple watch? It has the interchangeable bands and stuff like that, so, you can, like, change the color of it and everything. It’s like a conversation piece. [ 26 ]

Other women prefer more discretion in the design of wearables and their size or in the app icon on their mobile device because they do not want to reveal the purpose of the device to others. People may feel self-conscious when wearing the device or using the app, especially if it reveals their medical condition. For example, the following quote is from a study that incorporated a sensor band worn on the wrist to help female undergraduate students with problematic drinking:

P310 noted that while in class, “my professor commented on it which made me feel awkward.” [ 27 ]

Functionality and Features

In terms of functionality, the availability of clinical interpretation of user data is deemed essential, and health warnings based on recorded PGHD are noted to be helpful. Moreover, notifications and reminders are also useful for improving adherence to self-tracking and maintaining goals, and users appreciate receiving automated SMS text messages and feedback on progress. Actionable advice is seen as very important, and women expressed a desire for more interaction and the ability to integrate with other apps. For example, users want the ability to access information from their health record and to be able to see graphical summaries of their data over time. Regarding the presentation of information, users appreciate concise information written in simple language. Choice of words is also perceived as especially important to ensure that the information is easy to understand. People enjoy the gamification of content, and the graphical presentation of results is found to be informative.

The ability to upload multimedia and the ability to customize the application’s displays and notifications are noted as features that improve user engagement and satisfaction. The ability to record voice notes and consultations within apps is noted as a desirable feature, as well as having the option to book appointments directly through apps. Women also want the option to sync their desktop or phone calendar with apps to remind them of medical appointments and prescription requests, as some researchers noted:

Women could see the potential usefulness of being reminded to order their next prescription through the electronic alerts system. They found managing the monthly prescription requests challenging long-term and found setting up the reminder easy with the alert popping up on their phone or tablet. [ 28 ]

The application also allows women to set appointment reminders to ensure she is not missing her appointments and developing gaps in her care [...] “It allows me to remain organized for my visits to my OB with concerns, questions, symptoms I have experienced since my last visit.” [ 29 ]

Issues that negatively impact user engagement and outcomes are the inability to edit information or unsubscribe from notifications, which are sometimes thought to be either inconvenient or intrusive, as well as the presence of advertisements within the app. Ease of use is essential as apps or websites that are difficult to navigate can discourage users from engaging with them. For example, a study including the use of a mobile phone app reported the following:

A hindrance and disliked aspect was the difficulty in navigating through the app (eg, no back button, clunkiness, and the inability of participants to edit their inputted daily goals) as well as a lack of color and visuals within the app, giving it a clinical appearance. [ 30 ]

Some women are not comfortable answering questions that they consider intrusive, such as those related to sexual health. They rely on applications to provide trusted information about their condition and want suggestions for additional resources such as website links and local information.

Personalization

Women generally expressed a desire for greater personalization across several features within digital health tools. Messages and notifications that are personalized to the user’s health and self-tracking history and goals are more motivational and less likely to be ignored or perceived as irritating. Even factors such as using a first name in messages from the app make women feel like the messages are more personal and supportive.

Users have individual preferences when it comes to the frequency and timing of notifications, and it is important for digital health apps to allow for the customization of these settings as they can greatly impact user engagement and adherence. Moreover, users expressed a desire for the ability to customize their goals and the metrics they tracked. For example, they may want to change their goals in an app when their life circumstances change (eg, moving, starting a new job, becoming pregnant, or sustaining an injury). The ability to customize the dashboard of an app or website according to the user’s goals was also expressed as a desired feature. The ability to make these customizations will improve their adherence in the long run as their goals evolve.

When it comes to wearables, their placement on the body influences users’ preference and adherence to their use. For example, some women may prefer a wrist-worn device, whereas others may prefer a chest strap, a ring, or a device worn on the waist or ankle. The type of activity being monitored may also influence placement preference. A wrist-worn device may be more appropriate for monitoring steps, whereas a chest strap may be better suited for monitoring heart rate during exercise. Furthermore, placement preference may also be influenced by factors such as comfort, convenience, and visibility. A user may prefer a wrist-worn device because it is more visible and easier to access, whereas another user may prefer a device worn on the waist because it is less obtrusive and more comfortable during exercise or sleep. For instance, one study found the following:

Eight of the participants (40%) reported at some point of the long study period that the smart wristbands were uncomfortable to wear, especially at night. The wristbands irritated the skin, possibly due to pregnancy-related swelling. [ 31 ]

Finally, users have different preferences for how they want information to be presented in an app or website. Some people prefer to read content that is written out with citations and links to external websites. Others enjoy learning content from videos or audio recordings. When looking at their trends and progress, some users like to look at detailed graphs showing their daily progress, whereas others prefer to look at the data occasionally and only receive high-level information. The challenges concerning personalization were articulated by several authors:

It’s a difficult one. Some women want the full picture to fully understand what they are taking. Others want a black and white sketch, but not the details. They just want to know enough. Others do not want to see the picture, they just want to get on with it without knowing too much. Catering for all is a challenge. [ 28 ]

Safety, Privacy, and Security

Women are sometimes concerned about the physical safety of certain devices. For example, some mothers worried about their wearable wristbands scratching their babies [ 31 ]. Others worried about the effects of wearable devices on their skin, as expressed by a participant:

It’s weird because it does have a little laser thing on it, and I wonder if that’s, like, harming my skin (laughing). Like, I’ll sleep in it, and when I wake up I’ll have a red spot on my arm, it’s itchy sometime or sensitive, and I think it’s because of the laser thing, but I don’t really know. [ 26 ]

Some women are concerned about the privacy and security of digital health technologies and expect appropriate safeguards to be implemented in the tools they use. However, privacy and data security are not a concern for all women:

As I said, I’m very critical about patient data in general, especially in terms of data security...If you have a free app, it really depends on what happens to the private data. As a matter of fact, usually the information is stored on the app itself, and so other apps might gain access to the data easily. [ 32 ]

The survey revealed a low level of concern about issues relating to privacy or security of personal data. This suggests that privacy concerns were secondary to the benefits offered by uploading personal details into apps to provide the type of customisation they seek. [ 33 ]

Researchers also shared that some users perceived there to be more privacy when using an app as compared to traditional ways of communicating:

Some participants perceived the storage of their glucose levels on the smartphone as more secure than their current registration in a booklet. [ 34 ]

Women, particularly those who worked outside of the home, also commented that they appreciated the added convenience and privacy of this [text-based] communication method over phone-based communication. [ 34 ]

Theme 3: Accuracy and Credibility

In theme 3, we identified accuracy and credibility as important factors for acceptability considerations in digital health technologies.

The accuracy of digital health can impact user trust and adoption. Digital health tools enable users to keep track of their health, symptoms, and behaviors over time without relying on memory recall, which can be inaccurate or incomplete. Many studies reported that digital tracking can lead to more accurate data collection compared to paper-based methods. For example, at-home measurements of blood pressure and other vital signs have been found to be more accurate than those taken in a hospital or clinic setting. In some cases, apps are even able to accurately predict users’ menstrual cycles and mood changes. In addition, food diaries and activity trackers are often found to be more accurate when tracked within the app compared to using traditional paper-based methods. As the following participant conveyed, digital health may also make it easier for patients to tell the truth about their habits or health concerns:

I like this principle because...I know exactly, that via tablet one would admit things you wouldn’t necessarily tell the doctor or nurse. So, for starters, you can state it in the application. Of course, a conversation shouldn’t be missed afterwards, but this might make it easier for you to overcome yourself. [ 32 ]

However, accuracy can still be an issue in digital health. Different devices can produce different measurements, and some devices may miscount steps, the intensity of workouts, or the quantity and quality of sleep. For example, some women reported devices not tracking their steps while pushing a grocery cart or stroller, whereas others found that their steps were overcounted due to arm movements while they were seated. In addition, some users reported that food tracking options in apps were limited and did not include foods from their culture. Therefore, users may perceive digital health tools as not being representative of their true activity, which may lead them to discontinue the use of the devices. The following participant quote refers to a wrist-worn activity tracker:

Out paddling and we’re huffing and puffing and barely breathing and this isn’t even triggering anything. So it shows [...] that our 150 minute goal is like 60 or half of that. But we’ve actually put in the effort and then you just give up after a while. Like there’s no way I can make this. [ 35 ]

Women often prefer evidence-based health information (eg, explanations of conditions and symptoms and health advice) from a trustworthy source, such as an app curated from up-to-date and evidence-based research, over general internet searches. Users reported that the information provided in some apps was incomplete or inaccurate, with gaps in content or contradictory information that diminished their trustworthiness. In such cases, users may still prefer to talk to a health professional for more trustworthy information. Some women may also find it challenging to trust information that does not disclose sources as they are unsure of its reliability. Devices that are endorsed by, cite, and link to trustworthy health sources are more appealing to users. When sharing results from a web-based survey, the authors of one study reported the following:

Some respondents were specific about from where such advice should come, stating that they wanted expert, credible and up-to-date advice while others noted that they would like to see more Australian-specific or locally-based information in apps or apps that were not linked to the manufacturers of pregnancy or baby products. [ 33 ]

Theme 4: Audience and Adoption

Our fourth theme concerns audience and adoption, which includes two subthemes: (1) demographics and inclusivity and (2) timing and circumstances.

Demographics and Inclusivity

One of the challenges with digital health is to avoid one-size-fits-all interventions and to strive to tailor interventions to address the specific needs of different populations. Digital health that targets specific demographic groups or specific health conditions may increase the adoption of digital tools in those populations. That said, even when targeting people with specific health conditions as the audience, attention must be paid to the language and content in apps and websites. Some researchers noted that women did not want to participate or continue in their study because they did not want to constantly be confronted with their disease. Too much of a focus on disease and ill health can deter women from engaging with the tools, as commented on by some authors:

All but one participant preferred text content that focused on health and physical activity rather than content explicit to cancer. [ 36 ]

The women emphasized that less attention should be paid to chronic disease management and medication as the only treatment option. [...] it was important to explain the implications of the result of the scan and the risk of fractures in a way that will not place the women in a sickness role unnecessarily. [...] The knowledge base of osteoporosis should focus on osteoporosis as a common condition instead of a chronic bone disease. [ 37 ]

Younger women are often more familiar with and more comfortable using digital technology and, therefore, are more likely to use and adhere to a digital health protocol. Users with low technology skills want more training on how to use the digital health tools properly. Little provision is made for those for whom English is not their primary language, which can limit the accessibility and usefulness of digital health interventions. Factors such as language barriers, cultural beliefs, or lack of access to technology may lead to less adoption by some people belonging to ethnic minority groups. The relevance and usefulness of digital health may also vary based on geographic location.

Digital health tools are negatively perceived by some users if not designed to be inclusive of attributes such as body type or gender. For example, users prefer applications that use pictures or models that represent a diverse range of body sizes. Digital health technologies may not be gender inclusive and can conflate sex and gender. It is important to consider the unique health needs and experiences of individuals across the gender spectrum, as several researchers reported:

Participants commented on an exercise demonstration video and recommended that the model should have an “everyday-look” (e.g. plain clothes, jewellery). Also a choice of models of different ages to engage a wider range of patients and help them to relate or identify with the model was proposed. [ 38 ]

[Participant quote]: Maybe the body image it presents...like on a lot of apps, the people doing it looked like they were athletes already. And maybe they should have more people that look normal. [ 39 ]

Two women commented on the gendered design of most FTAs. FTA092 commented that “I chose Clue because it’s the only app that wasn’t pink.” FTA051 also found the gendered design of her previous app insulting; “my last app had a pink flower and was called MyDays or something ...I felt like they were trying to lure me in with this kind of ‘women’s’ approach” (FTA051). She subsequently stopped using that app and downloaded Clue. [ 40 ]

Timing and Circumstances

Individuals are more motivated to use digital health tools during times of illness or when they have a specific health goal in mind. The introduction of technology at the appropriate time impacts the utility and effectiveness of digital health interventions, especially when they are integrated into existing health care systems and routines. Digital health apps need to account for existing medical conditions or medical history to ensure accurate and complete information. For example, technologies that do not provide an option to indicate current pregnancy are perceived as frustrating to users as the in-app goals or notifications can be irrelevant and inconsiderate of their current limitations. In a focus group, one mother shared the following:

I get frustrated with the Garmin [smartwatch] because I wear my watch during the night so it tracks my sleeping as well. Then it gives you like an insight—so a little note will pop up and you know whether your sleep has been really regular or you’ve had irregular sleep. I wish that there was a thing that during pregnancy where that I could put in and say I’m pregnant, because I got those notes that your sleep is really irregular, and I was like, “Because I’m pregnant!” [ 23 ]

Users who are not experiencing symptoms or who perceive their health to be good are less likely to adopt digital health tools as they may not perceive any benefit from using them. Moreover, those who are already tracking their health using other methods (eg, paper-based tracking) are less interested in trying a new digital health tool. Similarly, regarding wearables, some people may already have a wearable and be less interested in having an additional wearable device.

Theme 5: Impact on Community and Health Service

This theme considers the impact of PGHD on community and health service, with three subthemes: (1) communication and community support, (2) clinical integration, and (3) health care provider perspective.

Communication and Community Support

One of the many perceived benefits by users of digital health interventions is the sense of community that these platforms enable. Even though some women reported feeling uncomfortable sharing personal information with strangers in a virtual group, most found that the ability to connect with others who shared similar experiences provided a sense of belonging and support that was motivating and reassuring, as shared by one woman:

What I did love about the apps is the forums. So if you have a weird pain or, you know, you have cramp in your legs at three a.m., you can get on your phone straight away, and you can get support by the women who are going through the same thing. [ 41 ]

Discussion forums and social media platforms associated with digital health interventions are perceived as helpful for connecting with others, sharing personal stories, and receiving support. Digital health interventions can also help women elicit support from friends and family to stay motivated and achieve health goals. For example, researchers who reported on women’s experiences of an app for stress urinary incontinence shared that some participants found it easier to talk to friends about an app for pelvic floor muscle training rather than talk about incontinence [ 24 ]. This can enable increased accountability and further encourage adherence to the intervention. One woman spoke about how her family supported her engagement with a digital health intervention for physical activity maintenance among female cancer survivors:

My husband’s a good motivator. When I say I’m going for a walk, he’ll go with me...with my sister-in-law and her kids, it’s they want to go with me; so it’s how many steps have you got today? Or, are we going to go for a walk. That kind of thing. And with my husband and my daughter it’s, “how many steps did you get today, did you do your workout, let us get it going.” [ 36 ]

In addition to support from family, friends, and community members, these digital platforms can provide an alternative to speaking with a health care provider in person. Asynchronous communication with health care providers is helpful especially for those who may not have easy access to in-person visits or for those who are uncomfortable discussing sensitive information face-to-face. Records of PGHD can also improve the ability to gather and share details with health care providers about symptoms that are difficult to remember during an in-person visit.

Clinical Integration

Women are more willing to participate in digital health interventions if they perceive that they have a direct impact on their clinical care. They appreciate the idea that their health is being monitored and that someone is keeping an eye on their data. Furthermore, women want to see more integration of their clinical test results within their digital health apps and websites. This increases their motivation to adhere to the interventions prescribed through the digital health application.

It was noted that physicians and other health care providers play a crucial role in promoting the use of digital health interventions among patients. As noted in the following participant quote, women enjoy being able to communicate with a health care provider through digital health:

I like it because you can tell the doctor what’s going on and submit it to your doctor, that is the main reason I like it because you can talk directly to your doctor and tell them what is going on without going in or calling. [ 42 ]

Women are more likely to adopt and use technology if it is recommended by their health care providers, family members, or friends. Women reported that digital health interventions were more effective when they were supported by a health care team. For example, having access to a health coach or counselor or receiving feedback from a health care provider on their progress increases their motivation to adhere to the interventions. This support also provides reassurance that they are on the right track toward achieving their health goals. However, some patients become frustrated when they receive conflicting advice from the digital health tool and their health care provider.

Health Care Provider Perspective

Some articles included thoughts from health care providers on digital health tools collecting PGHD [ 20 , 37 , 43 - 55 ]. From the health care provider perspective, digital health can offer several benefits, including the ability to monitor patients’ adherence to treatment and interventions. This can be particularly helpful for patients with chronic conditions that require ongoing management. Providers can use digital health tools to track patients’ progress and identify any potential issues that may require further attention, which can lead to improved clinical outcomes and reduce unnecessary consultations. For instance, one provider learned about their patient’s anxiousness through a mobile health intervention:

I didn’t know my patient was feeling anxious...But when she wrote it down, we could talk about it... [ 43 ]

Some health care providers expressed that digital health tracking could give them a more accurate picture of their patients’ activities and adherence to treatments. In a study about perspectives on a sensor attached to pills that can send data such as date and time of ingestion, a provider commented the following:

A positive would be data and getting a better grip on compliance. (...) I’m making sure the patient is adhering - assuming that the patient is taking everything inside of that blister, you can have confirmation of that. [ 44 ]

In addition, digital health can improve the efficiency of care delivery by providing education and resources directly to patients. This can help patients better understand their condition, treatment options, and self-management strategies, which can lead to better health outcomes.

However, it was also noted that digital health interventions should not replace in-person visits but rather complement them. Some health care providers are concerned about overreliance on digital health tools as well as the potential for misinterpretation of the data they provide. There may be a lack of feedback on the correct use of interventions, such as interpretations of medical advice provided, and health care providers have raised concerns about the safety and trustworthiness of the medical advice generated by the digital health tools. Health care providers especially worry about medico-legal effects of having information from digital health tools taken out of context or without considering the full picture of the user’s history and health, as demonstrated in the following quotes:

As a health care professional, I’m just mindful that if there was a video of me up there talking, if that was taken out of context or shared with another person where that information was not appropriate, that’s a concern to me. [ 45 ]

One anesthesiologist raised, “Who has access to the responses that I provide? Because if a patient receives information from me which they hold onto and is taken out of context, in a medical–legal situation, then that’s a big issue as well.” [ 46 ]

Providers may also find that the abundance of information generated by digital health tools can be overwhelming and time-consuming to manage, adding to an already hectic workflow and blurring professional boundaries. Large volumes of alerts and notifications from digital health tools can be disruptive to health care providers, who expressed the need to set boundaries regarding how and when they engaged with digital health tools. In a study reporting on perspectives about digital health from key informants (health care providers and researchers), one participant shared their thoughts on the potential for digital health to increase workload and liability:

Sometimes the more information that we provide for them (doctors), the more work and liability we give them, right? So if they get so much information that becomes actionable but they are overwhelmed, now they would be obligated to do something with this patient, they are in a chain of distribution, a chain of liability. [ 44 ]

Theme 6: Impact on Health and Behavior

Finally, our sixth theme describes the impact of PGHD on health and health behaviors.

Several studies reported that digital health interventions helped users stay motivated and, in turn, improved their health habits and behaviors, such as adherence to medication, physical activity, and healthy eating. The ability of users to look back at their data helps them identify patterns in their health and behaviors, which increases their awareness of their health and habits. The awareness then allows them to be more mindful of their habits and encourages self-reflection, thus promoting a deeper understanding of their health and well-being. The tracking of patterns in their health, combined with the educational component of some digital health tools, helps users come up with better self-management strategies and feel more confident in their ability to reach their health goals, giving them a greater sense of self-efficacy and control over their health. In a digital health intervention aimed at treating lymphedema following breast cancer treatment, a participant spoke of changes in her awareness of symptoms and improvements:

It helped me realize that I had excess fluid. My arms got lighter each time I did the exercises. My arms began to feel less heavy. It noticed it in my clothes as well. [ 56 ]

Digital health interventions are often reported to positively impact the mental health and well-being of individuals. Women reported improvements in their mood, emotional state, and coping abilities. They also reported a reduction in stress and anxiety levels, which can lead to improvements in overall health outcomes. The digital health tools provide users with a sense of support and accountability as well as feelings of accomplishment when meeting their goals.

However, it is important to note that, while digital health interventions can have many benefits, they may not be suitable for everyone and may even have negative effects on some individuals. For example, some users reported increased anxiety due to excessive monitoring or notifications, and others reported negative effects on their thoughts or worsening of symptoms related to health conditions. Some users found that self-tracking made them more attached to their phones, less likely to engage in social activities, and more isolated overall. Care should be taken to ensure that users do not become obsessive about self-tracking as this can be counterproductive or even harmful. Being hyperfocused on their symptoms or health condition could be distressing and even detrimental to their overall well-being. Therefore, it is important to carefully monitor the use of digital health interventions and adjust them as needed to ensure the best possible outcomes for each individual. One woman spoke about her overreliance on an app used to track breastfeeding:

I stopped using it because um I thought I’m being too anal about this...being too concerned about it, I just need to stress less, and just go with the flow and just be a bit more relaxed about it...so, that’s why I stopped using it completely, and then I think the breastfeeding improved from there ’cause I was worrying about it less. [ 57 ]

Table 2 provides a summary of the thematic analysis grouped into barriers and facilitators. It is worth noting that many things are both a barrier and a facilitator (eg, cost) depending on the individual. In addition, the presence of a specific feature may be a facilitator, whereas the absence of it may be a barrier.

Principal Findings

In this scoping review, we summarized information from 406 articles on digital technologies collecting PGHD and how they have been used in women’s health research. We found a steady increase in articles meeting our inclusion criteria from 2015 to 2020, indicating an increasing trend in the uptake and use of digital health tools in women’s health research before the COVID-19 pandemic. Most included studies (310/406, 76.4%) were feasibility or acceptability studies, effectiveness studies, or reports of digital tool prototypes. Most studies (299/406, 73.6%) focused on tracking conditions related to pregnancy or the postpartum period, cancer survivorship, or menstrual, sexual, and reproductive health. Several types of digital health were represented, with the most common being apps, wearable devices, and websites or patient portals. Through our thematic analysis, we found several considerations of facilitators of and barriers to using digital health tools, including the accessibility and convenience of the tools, visual appearance, device functionality and ability to personalize the user experience, and accuracy of the algorithms and information provided. It is also important to consider the target audience to optimize the adoption of the tools. Engagement with digital health tools may help users improve their health and health-related behaviors and gather support from friends, family, and other digital health users. Women are more likely to use digital health if it is recommended by a health care provider, but there are both benefits and challenges that health care providers may face if considering integrating digital health technology into clinical practice.

A previously published scoping review focused on information and communications technologies as a tool for women’s empowerment [ 59 ]. They reported that the concept of empowerment appeared in various ways with no clear consensus on the definition, with some studies mentioning terms such as self-concept, self-esteem, self-worth, and self-efficacy. Our thematic analysis also found that some women’s use of digital health tools increases their self-efficacy in managing their health. Another systematic review of 13 digital health interventions for midlife women found that many interventions did not use a specific behavior change theory [ 60 ]. Our scoping review did not examine the effectiveness of the interventions described, but those designing digital health tools and interventions may want to carefully consider behavioral theories in the design to increase adoption and retention rates and adherence to interventions.

Overall, digital health technology to collect PGHD has gained popularity over the past several years. The integration of wearables, smartphones, and digital health technologies has enabled the integration of passive data collection. This wealth of data provides valuable insights into various aspects of health, enabling informed decisions and the adoption of proactive measures to improve well-being. The uptake of this technology will usher in a new era in how we manage our health and well-being. This transformation has changed how we engage with our health and shifted our perception of health and the approach we take toward maintaining it.

Femtech, as a subset of digital health technology, has grown in popularity. This was evidenced by the large increase in the number of articles published between 2015 and 2020 that used digital health tools to track metrics during pregnancy and the postpartum period as well as metrics related to menstrual, sexual, and reproductive health. These technologies empower women and people assigned female at birth to take charge of their health. This is particularly relevant for people with conditions that are not diseases or health concerns per se but are nevertheless part of managing their overall health and well-being. In this way, femtech can provide a greater sense of control over reproductive health and choices, which can be precarious in many settings worldwide. However, in a previous scoping review, researchers reported that many mobile health apps do not follow data privacy, sharing, and security standards [ 61 ]. Issues related to the privacy and security of personal health data may be especially important when it comes to tracking reproductive health in settings where sexual and reproductive health rights are not guaranteed. This focus on pregnancy and reproductive health is consistent with the fact that women’s health research has largely focused on reproductive health topics [ 62 ]. Researchers and digital health developers must address gaps in women’s health regarding areas that are not strictly related to reproductive health. Women’s health encompasses much more than obstetrics and gynecology; even for health conditions that affect men and women, there may be sex or gender differences in disease presentation, personal experiences, and treatment plans. While using gendered language and design in femtech has the potential to reinforce stereotypes regarding femininity that could cause harm [ 63 ], there is a need for apps to provide content relevant to female populations while being gender inclusive and conscious of biases in the language and advice presented.

When analyzing themes related to acceptability, personalization emerged as a key aspect influencing the adoption and sustained use of digital health tools. People respond positively and want to engage with tools that cater to their unique needs and preferences. The ability to customize elements such as the frequency of notifications, specific health measures tracked and displayed, goal-setting options, and the amount of health information provided enhanced user engagement and motivation. However, offering too many personalization options might overwhelm users, making apps or devices cumbersome to use and navigate. Simplicity and ease of use should not be compromised in the pursuit of personalization. Creating personalized experiences that are intuitive and user-friendly while integrating multiple functionalities into a given device is an important consideration. Recognizing that a “one-size-fits-all” approach is inadequate, digital intervention designers need to define their target audience clearly. Apps that cater to specific groups, such as those with certain chronic health conditions, may inherently provide a sense of personalization by addressing their unique requirements. We have also learned the importance of ensuring that the design is inclusive and accessible to everyone within the target audience. Our findings that some tools are not sensitive to certain circumstances such as pregnancy are consistent with those of a systematic review of digital health interventions for postpartum women, in which the authors reported that barriers related to postpartum status could make it more difficult to engage with the interventions [ 58 ]. Tools designed with these circumstances in mind may be more engaging for women during pregnancy and the postpartum period, leading to greater adoption and quality of the technologies. Attrition can be high among users of digital health interventions [ 64 , 65 ], but most participants were willing to self-track when motivated by a specific health condition.

An important finding of this review was the growing demand and expectation that PGHD are integrated with clinical care. As digital health continues evolving, patients seek more seamless interactions between digital health data and health care providers. Moreover, services delivered through digital health technologies were not expected to replace the role of health care professionals but rather to be a useful tool to support health care management. Maintaining the human touch during communication for health care delivery was seen as important, with technology complementing clinical care to enhance the overall experience for patients and providers.

One of the critical considerations in clinical integration is the accuracy of PGHD collected from digital health tools. Ensuring the reliability and validity of the data is essential for effective clinical decision-making. Striking a balance between patient empowerment and health care provider oversight is crucial to achieving the best possible outcomes. In general, it is important for health care providers to actively propose digital health during patient visits and encourage its use. While challenges and concerns associated with the use of digital health are noted from health care providers’ perspective, such as concerns about medico-legal effects, maintaining professional boundaries, and not adding an abundance of work, the benefits of these tools in supporting patient care and improving outcomes are perceived as important.

Strengths, Limitations, and Future Directions

There are some limitations to this scoping review. Our inclusion criteria did not cover conference abstracts, conference reviews, editorials, letters, comments, or gray literature. Our review also did not include articles written in languages other than English. Therefore, there may be other uses of PGHD in women’s health that were not captured in this review. The assessments of the quality of included articles, the effectiveness of the interventions, or the accuracy in validating PGHD were outside this review’s scope and were not performed. Our aim was to provide a broad overview of PGHD in published women’s health research literature rather than evaluating the quality of the digital technologies or intervention effectiveness. Another limitation is the rapid growth of digital health and femtech, especially during the COVID-19 pandemic. It is important to note that this scoping review only captures the use of PGHD in women’s health before the emergence of the pandemic. We suggest that this review may provide a baseline for comparison in a future scoping review that captures articles published in March 2020 or later. The strengths of this review include the large number of publications analyzed and the data charting process conducted in duplicate by 2 reviewers. The broad scope of this review also helps provide an overall picture of digital health for women and highlights gaps in the research literature.

Future endeavors in this space should consider digital health tools for women for nonreproductive topics such as chronic health conditions that primarily affect women or conditions that have sex or gender differences in presentation and treatment. Within reproductive health, there was a large focus on pregnancy, but there is an unmet need for research and digital health tools appropriate for women in perimenopause and menopause. A previous literature review found <5 articles published between 2010 and 2020 about digital health technologies that meet the psychosocial needs of women experiencing menopause [ 66 ]. There may also be further opportunities for digital health tools geared toward specific racial or ethnic groups that are culturally sensitive and available in multiple languages. A systematic review found that barriers to the use of digital health among culturally and linguistically diverse populations include lower literacy levels and the use of complex medical terminology in some apps, lack of recognition of cultural concerns, stereotypes, and inaccurate portrayals of cultural groups [ 67 ]. Previous scoping reviews in the space of women’s digital health have identified the need for femtech to pay more attention to cultural appropriateness and consider cultural contexts in their design [ 68 , 69 ].

Conclusions

In conclusion, the integration of wearables, smartphones, and other forms of digital health has revolutionized how we approach and engage with our health. Personalization, inclusivity, and integration with clinical care are vital aspects of developing effective digital health solutions. By understanding the needs of the target audience, providing meaningful personalization, and ensuring data accuracy, digital health can truly transform health care and empower individuals to take charge of their well-being while maintaining a collaborative relationship with health care professionals.

Acknowledgments

Thank you to Shannon Cheng, reference librarian, for her work in developing the search strategy and conducting the database searches. A big thank you to Dr Beth Payne for reviewing the manuscript draft and providing helpful feedback. AT is funded by a Michael Smith Health Research British Columbia Scholar award.

Data Availability

The data sets generated during this study are available in the OSF repository [ 70 ].

Authors' Contributions

JLK and AT conceived the study and designed the study protocol. JLK, RST, and AT conducted the article screening. JLK, RW, and RST conducted the data charting. JLK, RST, and DSC created the visualizations and tables of the charted data. The thematic analysis coding was conducted by JLK and RW, with additional discussions with AT in refining the themes. JLK, RST, and AT wrote the draft of the manuscript. All authors reviewed the manuscript before submission.

Conflicts of Interest

None declared.

PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) checklist.

Full search strategy.

List of included articles by health area.

Metrics collected in the included studies.

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Abbreviations

Edited by T de Azevedo Cardoso; submitted 04.10.23; peer-reviewed by D Liu, M Herron; comments to author 23.02.24; revised version received 15.03.24; accepted 26.03.24; published 16.05.24.

©Jalisa Lynn Karim, Rachel Wan, Rhea S Tabet, Derek S Chiu, Aline Talhouk. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 16.05.2024.

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Buck E , Haslam A , Tuia J , Prasad V. Frequency and Characteristics of Trials Using Medical Writer Support in High-Impact Oncology Journals. JAMA Netw Open. 2023;6(2):e2254405. doi:10.1001/jamanetworkopen.2022.54405

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Frequency and Characteristics of Trials Using Medical Writer Support in High-Impact Oncology Journals

• 1 Department of Epidemiology and Biostatistics, University of California, San Francisco

Question   What are the characteristics of cancer studies that use and do not use medical writer support?

Findings   In this cross-sectional analysis of 270 clinical trials, compared with studies that did not use medical writers, studies with medical writers were more likely to focus on progression-free survival than overall survival and were more likely to report favorable conclusions, but there was no association with favorable conclusions in the adjusted analysis.

Meaning   These findings suggest that the use of medical writers is associated with the end point of progression-free survival.

Importance   The practice of using medical writers to communicate scientific information has gained popularity, but it may affect how and what information is communicated.

Objective   To assess characteristics of oncology trials that use medical writers and whether there is an association between the use of medical writers and trial success or the primary outcome evaluated.

Design, Setting, and Participants   This cross-sectional study included oncology trials testing a tumor-targeting intervention that were published in The Lancet , The Lancet Oncology , JAMA , JAMA Oncology , Journal of Clinical Oncology , and The New England Journal of Medicine between May 1, 2021, and May 1, 2022.

Exposures   Assistance of medical writers or no assistance.

Main Outcomes and Measures   The main outcomes were the percentage of studies with medical writers, the percentage of trial successes reported with medical writers, the association between trial success and medical writer use, and the association between a primary end point and medical writer use.

Results   Among 270 studies, 141 (52.2%) included a medical writer and 129 (47.8%) did not include a medical writer. Of the studies that included a medical writer, 83 (58.9%) were successful. Of the studies that did not include a medical writer, 64 (49.6%) were successful ( P  = .16 for difference). Studies with medical writers were less likely than studies without medical writers to have the end point of overall survival (15 [10.6%] vs 17 [13.2%]) and disease-free or event-free survival (16 [11.3%] vs 29 [22.5%]), whereas studies with a medical writer were more likely to have the end point of progression-free survival (32 [22.7%] vs 17 [13.2%]). Use of medical writer was associated with the conclusions being presented favorably in all studies (113 [80.1%] vs 89 [69.0%]; odds ratio [OR], 1.81 [95% CI, 1.04-3.19]), but when adjusted for other variables, there was no association (OR, 1.84 [95% CI, 0.92-3.72]).

Conclusions and Relevance   In this cross-sectional study, trials using medical writers were more likely to report surrogate end points, such as progression-free survival, and favorable conclusions, but when adjusted for trial phase, randomization, and study funding, there was no association with favorable conclusions. These findings suggest that journals need heightened scrutiny for studies with medical writers and that authorship should be properly acknowledged.

The global medical writing market size was $3.6 billion in 2021 and is projected to rise to the value of $8.4 billion by 2030. 1 Medical writers may be employed by pharmaceutical companies or third-party agencies and work alongside physicians, scientists, and medical professionals to draft and edit articles for publication and to assist with information dissemination and documentation.

Companies and researchers state they rely on medical writers to save time and improve the quality of a manuscript, thereby having a higher chance of having published articles compared with those who do not use a medical writer. 2 However, certain ethical issues arise when using medical writers.

Third-party medical writers may lack accountability for the results and conclusions of publications because they do not qualify for authorship, and when they are listed as authors, they are unlikely to report potential conflicts of interest that might bias study results. 3 Further, because their livelihood depends on getting funding from companies in industry, they may be financially incentivized to present findings in a way that is favorable to the company paying them, as has been shown in other areas of research. 4

Issues around authorship may arise. The International Committee of Medical Journal Editors defines authorship as substantial contributions to the design, data acquisition, analysis, interpretation, and drafting of the manuscript, giving approval for the final version, and accountability for all aspects of the work. 5 Overreliance on medical writers might threaten these standards.

The term medical writer may be considered a rebranding of the term ghostwriter , the former term suggesting a significantly lower contribution to the manuscript. 6 Despite acknowledgment of medical writing and editorial assistance in footnotes, the use of medical writers allows for medical manuscripts to be written without sufficient disclosure of how the manuscript was composed. In the present study, we reviewed original oncology trials to assess whether the declared use of medical writers was associated with trial success and the use of a particular type of end point.

In accordance with 45 CFR §46.102(f), this cross-sectional study was not submitted for institutional review board approval because it involved publicly available data and did not involve individual patient data. This study was not preregistered since our objective was hypothesis generating, rather than confirmatory. Our study adhered to Strengthening the Reporting of Observational Studies in Epidemiology ( STROBE ) guideline.

We searched 6 top medical and oncology journals ( The Lancet , The Lancet Oncology , JAMA , JAMA Oncology , The New England Journal of Medicine , and Journal of Clinical Oncology ) for original cancer trials. We selected these journals because they are high-impact journals for both general medicine and the medical subdiscipline of oncology that publish human randomized clinical trials. Two of us (A.H. and V.P.) have used these journals in a previous study. 7

We searched for studies published between May 1, 2021, and May 1, 2022. Included studies needed to (1) report on a cancer trial, (2) report original research, and (3) evaluate a tumor-targeting treatment. Excluded studies (1) had a primary end point of noninferiority or equivalence, (2) were a meta-analysis or retrospective analysis, (3) were an observational study, (4) were not cancer trials, and/or (5) had a non–tumor targeting intervention. We allowed multiple articles on the same trial, as long as they published or presented different aspects of the trial (eg, different titles, different outcomes). Articles were collected manually from journal websites.

We abstracted data on the journal, trial phase, date, study design, masking, tumor type, and primary end point(s) and/or outcome(s) of both the overall trial and the published manuscript; disclosure of medical writers, name(s) of medical writer(s), number of medical writers, medical writing company name(s), and number of medical writing companies; disclosure of English language editing; whether the intervention included radiotherapy, surgery, or drug(s); name of drug(s) used in the intervention; a statement of adherence to a research checklist (eg, Consolidated Standards of Reporting Trials or Transparent Reporting of Evaluations with Nonrandomized Designs); study funding; and the drug’s manufacturer(s). Medical writers were identified in the Acknowledgments or Funding section of a journal article with the key words medical writing support , editorial support , writing support , medical editing , medical writing assistance , editorial assistance , assisted with preparing the final manuscript , assistance in preparation of the article , and provided drafts .

We coded study success by whether the study met its primary end point of the study publication (met vs nonmet), as reported in the trial publication. This was sometimes different than the primary end point of the trial (eg, quality of life in publication vs overall survival [OS] in the trial) We also coded the tone of the authors’ conclusion (positive vs negative and/or equivocal). For single-arm trials, we determined study success based on the value used for the sample size calculation (eg, the alternate hypothesis). Studies with no clearly defined end point benchmark or studies with multiple outcomes with differential effects were coded as having an equivocal study end point. The coding was done by 2 of 3 reviewers, and disagreements were adjudicated by a third (E.B., A.H., and/or J.T.).

We calculated the number of studies with or without medical writers for each of the following: tumor type (breast, colorectal, non–small cell lung cancer, or other), trial phase (1, 2, 3, 4, or not indicated), randomization (randomized or nonrandomized), blinding status (double-blind, single-blind, open-label, or not indicated), primary end point (progression-free survival [PFS], OS, disease-free survival [DFS], and other), whether the study end point was met (yes vs no or equivocal), intervention type (drug, radiotherapy, or surgery), and journal. We used χ 2 and Wilcoxon rank sum tests to assess statistical differences in categorical and continuous variables between studies that used a medical writer and studies that did not use a medical writer. Specifically, our primary aim was to test whether studies that used medical writers were more likely to be reported as successful than studies that did not use medical writers. Our secondary aim was to test whether studies that used a medical writer were more likely to use a particular type of outcome (eg, PFS rather than OS) than studies that did not use medical writers. To control for an association between medical writers and study success or author conclusion, we performed 2 logistic regression models with success and conclusion as the outcomes. We included study characteristics in the model and removed them 1 at a time if their removal resulted in a lower Akaike information criterion. We forced in the variable indicating the use of a medical writer in both models. We used Excel, version 2022 (Microsoft Corporation) and R statistical software, version 4.2.1 (R Program for Statistical Computing) for all analysis and a 2-sided P value of less than 0.05 as our threshold for statistical significance.

Our search identified 539 articles. After excluding articles not meeting our inclusion criteria, we identified 270 articles ( Figure 1 ). For the 270 unique studies, there were 198 different medical writers and 40 different medical writing companies. Characteristics of these studies, stratified by whether medical writers assisted in the writing of the manuscript or not, are presented in Table 1 .

Of the 270 studies, 141 (52.2%) included a medical writer and 129 (47.8%) did not include a medical writer. The most common tumor types in studies with medical writers were hematologic (16 [11.3%]), lung (17 [12.1%]), breast (13 [9.2%]), and urothelial and/or renal (12 [8.5%]). The most common tumor types in studies without medical writers were breast (22 [17.1%]), hematologic (21 [16.3%]), and lung (15 [11.6%]).

There were differences in blinding status between studies that used a medical writer and studies that did not, with studies using a medical writer being more likely to be blinded than studies that did not use a medical writer (36 [25.5%] vs 10 [7.8%]; P  < .001). Compared with studies without medical writers ( Table 1 and Figure 2 ), the studies with medical writers were more likely to be published in The Lancet Oncology (57 [40.4%] vs 24 [18.6%]; P  < .001). The studies with medical writers were less likely to be published in the Journal of Clinical Oncology (40 [28.4%] vs 71 [55.0%]). Studies with medical writers were less likely to include surgery (3 [2.1%] vs 17 [13.2%]; P  = .001) or radiotherapy (9 [6.4%] vs 34 [26.4%]; P  < .001) as part of the intervention compared with studies without medical writers.

The most common end point for a study using a medical writer was PFS, occurring in 32 studies (22.7%). The most common end point for a study without a medical writer was DFS or event-free survival, occurring in 29 studies (22.5%). Compared with studies that did not use medical writers, studies with medical writers were less likely to have the end point of OS (17 [13.2%] vs 15 [10.6%]) and DFS (29 [22.5%] vs 16 [11.3%]), whereas studies with a medical writer were more likely than studies without medical writers to have the end point of PFS (32 [22.7%] vs 17 [13.2%]; P  = .001 for global differences) ( Figure 3 ).

Of the studies that included a medical writer, 83 (58.9%) were successful (ie, met the primary end point of the study). Of the studies that did not include a medical writer, 64 (49.6%) were successful (odds ratio [OR], 1.45 [95% CI, 0.90-2.36]). Of the studies that included a medical writer, 113 (80.1%) had positive conclusions. Of the studies that did not include a medical writer, 89 (69.0%) had positive conclusions (OR, 1.81 [95% CI, 1.04-3.19]). When adjusted for study funding, randomization, trial phase, and being a primary report of the study, the use of a medical writer was not associated with meeting the study end point (OR, 1.04 [95% CI, 0.60-1.81). Similarly, when adjusted for other study factors, the use of a medical writer was not associated with positive author conclusions (OR, 1.84 [95% CI, 0.92-3.72]). Of the studies that used medical writers, 25 (17.7%) used medical writers who worked for the sponsoring company of the study, 100 (70.9%) included medical writers who worked for a medical writing company, and 8 (5.7%) used medical writers who worked for a hospital or other group.

One-hundred eighty-one of the 202 medical writers (89.6%) appeared in only 1 study, 18 (8.9%) appeared in 2 studies, and 3 (1.5%) appeared in 3 or 4 studies. Of the 82 studies using only 1 medical writer with only 1 appearance overall, 44 (53.6%) were successful. Of the 44 studies that used 2 medical writers, 28 (63.6%) were successful. Of the 13 studies that used 3 medical writers, 9 (69.2%) were successful. Of the 2 studies that used 4 medical writers, 2 (100%) were successful ( P  = .046 for global differences) ( Table 2 ). The rates of success for each company are presented in the eTable in Supplement 1 .

Our analysis of 270 high-impact cancer articles and their use of medical writers revealed several key findings. First, oncology studies with medical writers were more likely to have favorable conclusions than studies without medical writers. However, there was no association when adjusted for study funding. Study and author funding can lead to conflicts of interest, which can also lead to bias in study conclusions. 4 , 8 , 9 Second, we found that studies with medical writers were more likely to have the end point of PFS, while studies without medical writers were more likely to have the end point of OS. These findings suggest that medical writers are recruited for trials that focus on end points of lesser importance.

We found that studies with medical writers were more likely to investigate the end point of PFS and objective response rate, which are common surrogate end points. Surrogate end points often fail to estimate which therapies improve survival. 10 An intervention that achieves improvement in a surrogate end point, with toxic effects and cost, and has yet to show improvement in quality of life or survival may be debated by physicians. Use of a medical writer may help assuage or distract from such concerns.

We found that studies that did not use medical writers were more likely to provide a statement of adherence to a reporting checklist. While it was beyond the scope of our study to assess the completeness of reporting according to established checklists, another study 11 found that use of a medical writer was associated with more complete reporting of checklist components; however, that study did not report declared adherence.

A medical writer may draft a manuscript without a major contribution being shown in the official author list. The International Committee of Medical Journal Editors has clear authorship guidelines. To qualify for authorship, one must have made substantial contributions to the conception or design of the work. They must also draft the work or revise it critically for important intellectual content. 5 , 12 Our analysis is limited as we did not have access to versions of documents with tracked changes and thus could not delineate appropriate authorship criteria.

Medical writers are often cited as assisting in the preparation of the manuscript or first draft. 12 It may be the case that a medical writer has drafted a manuscript predominantly and is acknowledged in a footnote, while the official authors did not contribute as heavily. A concern is that when medical writers are not listed as authors, they are not held accountable for the information presented in the publication. 12 If medical writers are influential in the drafting of a manuscript, including the use of language and even trial outcomes, perhaps they should be listed as authors or restricted from involvement in publications.

In a previous study, 11 47% of medical publications were confirmed as eligible for inclusion in a group of articles with medical writing support, although for ghostwriting, which can have varied definitions, the estimate has varied widely, from 1% to 91%. 13 These estimates may vary depending on study design, year of publication, and biomedical discipline. Our finding of 52.2% is representative of how often medical writers were generally used in contemporary oncology research, but this percentage is projected to increase as the global medical writing market size continues to grow. 1

Our study has several strengths. Our study is the first, to our knowledge, to examine the prevalence of medical writing in oncology studies, and we are the first, to our knowledge, to examine the association of medical writing assistance with whether studies met the primary end point or had favorable conclusions.

This study also has limitations. The determination of favorable conclusions could be subjective and, to an extent, so could meeting the study’s end point since some studies did not indicate the primary end point or were nonrandomized studies without a comparison arm. To minimize these biases, we had these 2 variables double coded and we used the study outcome that was used for the sample size determination. Our results may not be generalizable to the oncology literature at large. We noted differences in outcomes between journals, and because we did not comprehensively examine studies in all journals, we cannot rule out that studies published in different journals would have different results. It may be that some medical writers were not identified in the publications, which may have biased our results toward the null hypothesis. In addition, we were unable to quantify the contribution that each medical writer made to the manuscript, only that they were used in the drafting of the manuscript.

In this cross-sectional study, original oncology trials using medical writers were less likely than trials without medical writers to report OS but were more likely to report PFS as an outcome. They were also more likely to report favorable conclusions, but when adjusted for other factors, there was no association. These findings suggest that journals need to give more scrutiny to studies with medical writers and that authorship needs to be properly acknowledged.

Accepted for Publication: December 15, 2022.

Published: February 1, 2023. doi:10.1001/jamanetworkopen.2022.54405

Open Access: This is an open access article distributed under the terms of the CC-BY License . © 2023 Buck E et al. JAMA Network Open .

Corresponding Author: Alyson Haslam, PhD, Department of Epidemiology and Biostatistics, UCSF Mission Bay Campus, Mission Hall, Global Health & Clinical Sciences Building, 550 16th St, 2nd Floor, San Francisco, CA 94158 ( [email protected] ).

Author Contributions: Ms Buck and Dr Haslam had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Buck, Prasad.

Acquisition, analysis, or interpretation of data: Buck, Haslam, Tuia.

Drafting of the manuscript: Buck.

Critical revision of the manuscript for important intellectual content: All authors.

Statistical analysis: Buck, Haslam.

Administrative, technical, or material support: Tuia.

Supervision: Prasad.

Conflict of Interest Disclosures: Dr Haslam and Ms Tuia reported being employed through funding to their institution from Arnold Ventures LLC. Dr Prasad reported receiving research funding from Arnold Ventures LLC during the conduct of the study; royalties from Johns Hopkins Press, Medscape, and MedPage Today; consulting fees from UnitedHealthcare and OptumRX; and subscriber fees from YouTube, Substack, and Patreon outside the submitted work. No other disclosures were reported.

Funding/Support: This study was supported by Arnold Ventures LLC.

Role of the Funder/Sponsor: The sponsor had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Data Sharing Statement: See Supplement 2 .

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Cultural Relativity and Acceptance of Embryonic Stem Cell Research

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There is a debate about the ethical implications of using human embryos in stem cell research, which can be influenced by cultural, moral, and social values. This paper argues for an adaptable framework to accommodate diverse cultural and religious perspectives. By using an adaptive ethics model, research protections can reflect various populations and foster growth in stem cell research possibilities.

INTRODUCTION

Stem cell research combines biology, medicine, and technology, promising to alter health care and the understanding of human development. Yet, ethical contention exists because of individuals’ perceptions of using human embryos based on their various cultural, moral, and social values. While these disagreements concerning policy, use, and general acceptance have prompted the development of an international ethics policy, such a uniform approach can overlook the nuanced ethical landscapes between cultures. With diverse viewpoints in public health, a single global policy, especially one reflecting Western ethics or the ethics prevalent in high-income countries, is impractical. This paper argues for a culturally sensitive, adaptable framework for the use of embryonic stem cells. Stem cell policy should accommodate varying ethical viewpoints and promote an effective global dialogue. With an extension of an ethics model that can adapt to various cultures, we recommend localized guidelines that reflect the moral views of the people those guidelines serve.

Stem cells, characterized by their unique ability to differentiate into various cell types, enable the repair or replacement of damaged tissues. Two primary types of stem cells are somatic stem cells (adult stem cells) and embryonic stem cells. Adult stem cells exist in developed tissues and maintain the body’s repair processes. [1] Embryonic stem cells (ESC) are remarkably pluripotent or versatile, making them valuable in research. [2] However, the use of ESCs has sparked ethics debates. Considering the potential of embryonic stem cells, research guidelines are essential. The International Society for Stem Cell Research (ISSCR) provides international stem cell research guidelines. They call for “public conversations touching on the scientific significance as well as the societal and ethical issues raised by ESC research.” [3] The ISSCR also publishes updates about culturing human embryos 14 days post fertilization, suggesting local policies and regulations should continue to evolve as ESC research develops. [4]  Like the ISSCR, which calls for local law and policy to adapt to developing stem cell research given cultural acceptance, this paper highlights the importance of local social factors such as religion and culture.

I.     Global Cultural Perspective of Embryonic Stem Cells

Views on ESCs vary throughout the world. Some countries readily embrace stem cell research and therapies, while others have stricter regulations due to ethical concerns surrounding embryonic stem cells and when an embryo becomes entitled to moral consideration. The philosophical issue of when the “someone” begins to be a human after fertilization, in the morally relevant sense, [5] impacts when an embryo becomes not just worthy of protection but morally entitled to it. The process of creating embryonic stem cell lines involves the destruction of the embryos for research. [6] Consequently, global engagement in ESC research depends on social-cultural acceptability.

a.     US and Rights-Based Cultures

In the United States, attitudes toward stem cell therapies are diverse. The ethics and social approaches, which value individualism, [7] trigger debates regarding the destruction of human embryos, creating a complex regulatory environment. For example, the 1996 Dickey-Wicker Amendment prohibited federal funding for the creation of embryos for research and the destruction of embryos for “more than allowed for research on fetuses in utero.” [8] Following suit, in 2001, the Bush Administration heavily restricted stem cell lines for research. However, the Stem Cell Research Enhancement Act of 2005 was proposed to help develop ESC research but was ultimately vetoed. [9] Under the Obama administration, in 2009, an executive order lifted restrictions allowing for more development in this field. [10] The flux of research capacity and funding parallels the different cultural perceptions of human dignity of the embryo and how it is socially presented within the country’s research culture. [11]

b.     Ubuntu and Collective Cultures

African bioethics differs from Western individualism because of the different traditions and values. African traditions, as described by individuals from South Africa and supported by some studies in other African countries, including Ghana and Kenya, follow the African moral philosophies of Ubuntu or Botho and Ukama , which “advocates for a form of wholeness that comes through one’s relationship and connectedness with other people in the society,” [12] making autonomy a socially collective concept. In this context, for the community to act autonomously, individuals would come together to decide what is best for the collective. Thus, stem cell research would require examining the value of the research to society as a whole and the use of the embryos as a collective societal resource. If society views the source as part of the collective whole, and opposes using stem cells, compromising the cultural values to pursue research may cause social detachment and stunt research growth. [13] Based on local culture and moral philosophy, the permissibility of stem cell research depends on how embryo, stem cell, and cell line therapies relate to the community as a whole . Ubuntu is the expression of humanness, with the person’s identity drawn from the “’I am because we are’” value. [14] The decision in a collectivistic culture becomes one born of cultural context, and individual decisions give deference to others in the society.

Consent differs in cultures where thought and moral philosophy are based on a collective paradigm. So, applying Western bioethical concepts is unrealistic. For one, Africa is a diverse continent with many countries with different belief systems, access to health care, and reliance on traditional or Western medicines. Where traditional medicine is the primary treatment, the “’restrictive focus on biomedically-related bioethics’” [is] problematic in African contexts because it neglects bioethical issues raised by traditional systems.” [15] No single approach applies in all areas or contexts. Rather than evaluating the permissibility of ESC research according to Western concepts such as the four principles approach, different ethics approaches should prevail.

Another consideration is the socio-economic standing of countries. In parts of South Africa, researchers have not focused heavily on contributing to the stem cell discourse, either because it is not considered health care or a health science priority or because resources are unavailable. [16] Each country’s priorities differ given different social, political, and economic factors. In South Africa, for instance, areas such as maternal mortality, non-communicable diseases, telemedicine, and the strength of health systems need improvement and require more focus. [17] Stem cell research could benefit the population, but it also could divert resources from basic medical care. Researchers in South Africa adhere to the National Health Act and Medicines Control Act in South Africa and international guidelines; however, the Act is not strictly enforced, and there is no clear legislation for research conduct or ethical guidelines. [18]

Some parts of Africa condemn stem cell research. For example, 98.2 percent of the Tunisian population is Muslim. [19] Tunisia does not permit stem cell research because of moral conflict with a Fatwa. Religion heavily saturates the regulation and direction of research. [20] Stem cell use became permissible for reproductive purposes only recently, with tight restrictions preventing cells from being used in any research other than procedures concerning ART/IVF.  Their use is conditioned on consent, and available only to married couples. [21] The community's receptiveness to stem cell research depends on including communitarian African ethics.

c.     Asia

Some Asian countries also have a collective model of ethics and decision making. [22] In China, the ethics model promotes a sincere respect for life or human dignity, [23] based on protective medicine. This model, influenced by Traditional Chinese Medicine (TCM), [24] recognizes Qi as the vital energy delivered via the meridians of the body; it connects illness to body systems, the body’s entire constitution, and the universe for a holistic bond of nature, health, and quality of life. [25] Following a protective ethics model, and traditional customs of wholeness, investment in stem cell research is heavily desired for its applications in regenerative therapies, disease modeling, and protective medicines. In a survey of medical students and healthcare practitioners, 30.8 percent considered stem cell research morally unacceptable while 63.5 percent accepted medical research using human embryonic stem cells. Of these individuals, 89.9 percent supported increased funding for stem cell research. [26] The scientific community might not reflect the overall population. From 1997 to 2019, China spent a total of $576 million (USD) on stem cell research at 8,050 stem cell programs, increased published presence from 0.6 percent to 14.01 percent of total global stem cell publications as of 2014, and made significant strides in cell-based therapies for various medical conditions. [27] However, while China has made substantial investments in stem cell research and achieved notable progress in clinical applications, concerns linger regarding ethical oversight and transparency. [28] For example, the China Biosecurity Law, promoted by the National Health Commission and China Hospital Association, attempted to mitigate risks by introducing an institutional review board (IRB) in the regulatory bodies. 5800 IRBs registered with the Chinese Clinical Trial Registry since 2021. [29] However, issues still need to be addressed in implementing effective IRB review and approval procedures.

The substantial government funding and focus on scientific advancement have sometimes overshadowed considerations of regional cultures, ethnic minorities, and individual perspectives, particularly evident during the one-child policy era. As government policy adapts to promote public stability, such as the change from the one-child to the two-child policy, [30] research ethics should also adapt to ensure respect for the values of its represented peoples.

Japan is also relatively supportive of stem cell research and therapies. Japan has a more transparent regulatory framework, allowing for faster approval of regenerative medicine products, which has led to several advanced clinical trials and therapies. [31] South Korea is also actively engaged in stem cell research and has a history of breakthroughs in cloning and embryonic stem cells. [32] However, the field is controversial, and there are issues of scientific integrity. For example, the Korean FDA fast-tracked products for approval, [33] and in another instance, the oocyte source was unclear and possibly violated ethical standards. [34] Trust is important in research, as it builds collaborative foundations between colleagues, trial participant comfort, open-mindedness for complicated and sensitive discussions, and supports regulatory procedures for stakeholders. There is a need to respect the culture’s interest, engagement, and for research and clinical trials to be transparent and have ethical oversight to promote global research discourse and trust.

d.     Middle East

Countries in the Middle East have varying degrees of acceptance of or restrictions to policies related to using embryonic stem cells due to cultural and religious influences. Saudi Arabia has made significant contributions to stem cell research, and conducts research based on international guidelines for ethical conduct and under strict adherence to guidelines in accordance with Islamic principles. Specifically, the Saudi government and people require ESC research to adhere to Sharia law. In addition to umbilical and placental stem cells, [35] Saudi Arabia permits the use of embryonic stem cells as long as they come from miscarriages, therapeutic abortions permissible by Sharia law, or are left over from in vitro fertilization and donated to research. [36] Laws and ethical guidelines for stem cell research allow the development of research institutions such as the King Abdullah International Medical Research Center, which has a cord blood bank and a stem cell registry with nearly 10,000 donors. [37] Such volume and acceptance are due to the ethical ‘permissibility’ of the donor sources, which do not conflict with religious pillars. However, some researchers err on the side of caution, choosing not to use embryos or fetal tissue as they feel it is unethical to do so. [38]

Jordan has a positive research ethics culture. [39] However, there is a significant issue of lack of trust in researchers, with 45.23 percent (38.66 percent agreeing and 6.57 percent strongly agreeing) of Jordanians holding a low level of trust in researchers, compared to 81.34 percent of Jordanians agreeing that they feel safe to participate in a research trial. [40] Safety testifies to the feeling of confidence that adequate measures are in place to protect participants from harm, whereas trust in researchers could represent the confidence in researchers to act in the participants’ best interests, adhere to ethical guidelines, provide accurate information, and respect participants’ rights and dignity. One method to improve trust would be to address communication issues relevant to ESC. Legislation surrounding stem cell research has adopted specific language, especially concerning clarification “between ‘stem cells’ and ‘embryonic stem cells’” in translation. [41] Furthermore, legislation “mandates the creation of a national committee… laying out specific regulations for stem-cell banking in accordance with international standards.” [42] This broad regulation opens the door for future global engagement and maintains transparency. However, these regulations may also constrain the influence of research direction, pace, and accessibility of research outcomes.

e.     Europe

In the European Union (EU), ethics is also principle-based, but the principles of autonomy, dignity, integrity, and vulnerability are interconnected. [43] As such, the opportunity for cohesion and concessions between individuals’ thoughts and ideals allows for a more adaptable ethics model due to the flexible principles that relate to the human experience The EU has put forth a framework in its Convention for the Protection of Human Rights and Dignity of the Human Being allowing member states to take different approaches. Each European state applies these principles to its specific conventions, leading to or reflecting different acceptance levels of stem cell research. [44]

For example, in Germany, Lebenzusammenhang , or the coherence of life, references integrity in the unity of human culture. Namely, the personal sphere “should not be subject to external intervention.” [45]  Stem cell interventions could affect this concept of bodily completeness, leading to heavy restrictions. Under the Grundgesetz, human dignity and the right to life with physical integrity are paramount. [46] The Embryo Protection Act of 1991 made producing cell lines illegal. Cell lines can be imported if approved by the Central Ethics Commission for Stem Cell Research only if they were derived before May 2007. [47] Stem cell research respects the integrity of life for the embryo with heavy specifications and intense oversight. This is vastly different in Finland, where the regulatory bodies find research more permissible in IVF excess, but only up to 14 days after fertilization. [48] Spain’s approach differs still, with a comprehensive regulatory framework. [49] Thus, research regulation can be culture-specific due to variations in applied principles. Diverse cultures call for various approaches to ethical permissibility. [50] Only an adaptive-deliberative model can address the cultural constructions of self and achieve positive, culturally sensitive stem cell research practices. [51]

II.     Religious Perspectives on ESC

Embryonic stem cell sources are the main consideration within religious contexts. While individuals may not regard their own religious texts as authoritative or factual, religion can shape their foundations or perspectives.

The Qur'an states:

“And indeed We created man from a quintessence of clay. Then We placed within him a small quantity of nutfa (sperm to fertilize) in a safe place. Then We have fashioned the nutfa into an ‘alaqa (clinging clot or cell cluster), then We developed the ‘alaqa into mudgha (a lump of flesh), and We made mudgha into bones, and clothed the bones with flesh, then We brought it into being as a new creation. So Blessed is Allah, the Best of Creators.” [52]

Many scholars of Islam estimate the time of soul installment, marked by the angel breathing in the soul to bring the individual into creation, as 120 days from conception. [53] Personhood begins at this point, and the value of life would prohibit research or experimentation that could harm the individual. If the fetus is more than 120 days old, the time ensoulment is interpreted to occur according to Islamic law, abortion is no longer permissible. [54] There are a few opposing opinions about early embryos in Islamic traditions. According to some Islamic theologians, there is no ensoulment of the early embryo, which is the source of stem cells for ESC research. [55]

In Buddhism, the stance on stem cell research is not settled. The main tenets, the prohibition against harming or destroying others (ahimsa) and the pursuit of knowledge (prajña) and compassion (karuna), leave Buddhist scholars and communities divided. [56] Some scholars argue stem cell research is in accordance with the Buddhist tenet of seeking knowledge and ending human suffering. Others feel it violates the principle of not harming others. Finding the balance between these two points relies on the karmic burden of Buddhist morality. In trying to prevent ahimsa towards the embryo, Buddhist scholars suggest that to comply with Buddhist tenets, research cannot be done as the embryo has personhood at the moment of conception and would reincarnate immediately, harming the individual's ability to build their karmic burden. [57] On the other hand, the Bodhisattvas, those considered to be on the path to enlightenment or Nirvana, have given organs and flesh to others to help alleviate grieving and to benefit all. [58] Acceptance varies on applied beliefs and interpretations.

Catholicism does not support embryonic stem cell research, as it entails creation or destruction of human embryos. This destruction conflicts with the belief in the sanctity of life. For example, in the Old Testament, Genesis describes humanity as being created in God’s image and multiplying on the Earth, referencing the sacred rights to human conception and the purpose of development and life. In the Ten Commandments, the tenet that one should not kill has numerous interpretations where killing could mean murder or shedding of the sanctity of life, demonstrating the high value of human personhood. In other books, the theological conception of when life begins is interpreted as in utero, [59] highlighting the inviolability of life and its formation in vivo to make a religious point for accepting such research as relatively limited, if at all. [60] The Vatican has released ethical directives to help apply a theological basis to modern-day conflicts. The Magisterium of the Church states that “unless there is a moral certainty of not causing harm,” experimentation on fetuses, fertilized cells, stem cells, or embryos constitutes a crime. [61] Such procedures would not respect the human person who exists at these stages, according to Catholicism. Damages to the embryo are considered gravely immoral and illicit. [62] Although the Catholic Church officially opposes abortion, surveys demonstrate that many Catholic people hold pro-choice views, whether due to the context of conception, stage of pregnancy, threat to the mother’s life, or for other reasons, demonstrating that practicing members can also accept some but not all tenets. [63]

Some major Jewish denominations, such as the Reform, Conservative, and Reconstructionist movements, are open to supporting ESC use or research as long as it is for saving a life. [64] Within Judaism, the Talmud, or study, gives personhood to the child at birth and emphasizes that life does not begin at conception: [65]

“If she is found pregnant, until the fortieth day it is mere fluid,” [66]

Whereas most religions prioritize the status of human embryos, the Halakah (Jewish religious law) states that to save one life, most other religious laws can be ignored because it is in pursuit of preservation. [67] Stem cell research is accepted due to application of these religious laws.

We recognize that all religions contain subsets and sects. The variety of environmental and cultural differences within religious groups requires further analysis to respect the flexibility of religious thoughts and practices. We make no presumptions that all cultures require notions of autonomy or morality as under the common morality theory , which asserts a set of universal moral norms that all individuals share provides moral reasoning and guides ethical decisions. [68] We only wish to show that the interaction with morality varies between cultures and countries.

III.     A Flexible Ethical Approach

The plurality of different moral approaches described above demonstrates that there can be no universally acceptable uniform law for ESC on a global scale. Instead of developing one standard, flexible ethical applications must be continued. We recommend local guidelines that incorporate important cultural and ethical priorities.

While the Declaration of Helsinki is more relevant to people in clinical trials receiving ESC products, in keeping with the tradition of protections for research subjects, consent of the donor is an ethical requirement for ESC donation in many jurisdictions including the US, Canada, and Europe. [69] The Declaration of Helsinki provides a reference point for regulatory standards and could potentially be used as a universal baseline for obtaining consent prior to gamete or embryo donation.

For instance, in Columbia University’s egg donor program for stem cell research, donors followed standard screening protocols and “underwent counseling sessions that included information as to the purpose of oocyte donation for research, what the oocytes would be used for, the risks and benefits of donation, and process of oocyte stimulation” to ensure transparency for consent. [70] The program helped advance stem cell research and provided clear and safe research methods with paid participants. Though paid participation or covering costs of incidental expenses may not be socially acceptable in every culture or context, [71] and creating embryos for ESC research is illegal in many jurisdictions, Columbia’s program was effective because of the clear and honest communications with donors, IRBs, and related stakeholders.  This example demonstrates that cultural acceptance of scientific research and of the idea that an egg or embryo does not have personhood is likely behind societal acceptance of donating eggs for ESC research. As noted, many countries do not permit the creation of embryos for research.

Proper communication and education regarding the process and purpose of stem cell research may bolster comprehension and garner more acceptance. “Given the sensitive subject material, a complete consent process can support voluntary participation through trust, understanding, and ethical norms from the cultures and morals participants value. This can be hard for researchers entering countries of different socioeconomic stability, with different languages and different societal values. [72]

An adequate moral foundation in medical ethics is derived from the cultural and religious basis that informs knowledge and actions. [73] Understanding local cultural and religious values and their impact on research could help researchers develop humility and promote inclusion.

IV.     Concerns

Some may argue that if researchers all adhere to one ethics standard, protection will be satisfied across all borders, and the global public will trust researchers. However, defining what needs to be protected and how to define such research standards is very specific to the people to which standards are applied. We suggest that applying one uniform guide cannot accurately protect each individual because we all possess our own perceptions and interpretations of social values. [74] Therefore, the issue of not adjusting to the moral pluralism between peoples in applying one standard of ethics can be resolved by building out ethics models that can be adapted to different cultures and religions.

Other concerns include medical tourism, which may promote health inequities. [75] Some countries may develop and approve products derived from ESC research before others, compromising research ethics or drug approval processes. There are also concerns about the sale of unauthorized stem cell treatments, for example, those without FDA approval in the United States. Countries with robust research infrastructures may be tempted to attract medical tourists, and some customers will have false hopes based on aggressive publicity of unproven treatments. [76]

For example, in China, stem cell clinics can market to foreign clients who are not protected under the regulatory regimes. Companies employ a marketing strategy of “ethically friendly” therapies. Specifically, in the case of Beike, China’s leading stem cell tourism company and sprouting network, ethical oversight of administrators or health bureaus at one site has “the unintended consequence of shifting questionable activities to another node in Beike's diffuse network.” [77] In contrast, Jordan is aware of stem cell research’s potential abuse and its own status as a “health-care hub.” Jordan’s expanded regulations include preserving the interests of individuals in clinical trials and banning private companies from ESC research to preserve transparency and the integrity of research practices. [78]

The social priorities of the community are also a concern. The ISSCR explicitly states that guidelines “should be periodically revised to accommodate scientific advances, new challenges, and evolving social priorities.” [79] The adaptable ethics model extends this consideration further by addressing whether research is warranted given the varying degrees of socioeconomic conditions, political stability, and healthcare accessibilities and limitations. An ethical approach would require discussion about resource allocation and appropriate distribution of funds. [80]

While some religions emphasize the sanctity of life from conception, which may lead to public opposition to ESC research, others encourage ESC research due to its potential for healing and alleviating human pain. Many countries have special regulations that balance local views on embryonic personhood, the benefits of research as individual or societal goods, and the protection of human research subjects. To foster understanding and constructive dialogue, global policy frameworks should prioritize the protection of universal human rights, transparency, and informed consent. In addition to these foundational global policies, we recommend tailoring local guidelines to reflect the diverse cultural and religious perspectives of the populations they govern. Ethics models should be adapted to local populations to effectively establish research protections, growth, and possibilities of stem cell research.

For example, in countries with strong beliefs in the moral sanctity of embryos or heavy religious restrictions, an adaptive model can allow for discussion instead of immediate rejection. In countries with limited individual rights and voice in science policy, an adaptive model ensures cultural, moral, and religious views are taken into consideration, thereby building social inclusion. While this ethical consideration by the government may not give a complete voice to every individual, it will help balance policies and maintain the diverse perspectives of those it affects. Embracing an adaptive ethics model of ESC research promotes open-minded dialogue and respect for the importance of human belief and tradition. By actively engaging with cultural and religious values, researchers can better handle disagreements and promote ethical research practices that benefit each society.

This brief exploration of the religious and cultural differences that impact ESC research reveals the nuances of relative ethics and highlights a need for local policymakers to apply a more intense adaptive model.

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[5] Concerning the moral philosophies of stem cell research, our paper does not posit a personal moral stance nor delve into the “when” of human life begins. To read further about the philosophical debate, consider the following sources:

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[7] Socially, at its core, the Western approach to ethics is widely principle-based, autonomy being one of the key factors to ensure a fundamental respect for persons within research. For information regarding autonomy in research, see: Department of Health, Education, and Welfare, & National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1978). The Belmont Report. Ethical principles and guidelines for the protection of human subjects of research.; For a more in-depth review of autonomy within the US, see: Beauchamp, T. L., & Childress, J. F. (1994). Principles of Biomedical Ethics . Oxford University Press.

[8] Sherley v. Sebelius , 644 F.3d 388 (D.C. Cir. 2011), citing 45 C.F.R. 46.204(b) and [42 U.S.C. § 289g(b)]. https://www.cadc.uscourts.gov/internet/opinions.nsf/6c690438a9b43dd685257a64004ebf99/$file/11-5241-1391178.pdf

[9] Stem Cell Research Enhancement Act of 2005, H. R. 810, 109 th Cong. (2001). https://www.govtrack.us/congress/bills/109/hr810/text ; Bush, G. W. (2006, July 19). Message to the House of Representatives . National Archives and Records Administration. https://georgewbush-whitehouse.archives.gov/news/releases/2006/07/20060719-5.html

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[13] Source for further reading: Tangwa G. B. (2007). Moral status of embryonic stem cells: perspective of an African villager. Bioethics , 21(8), 449–457. https://doi.org/10.1111/j.1467-8519.2007.00582.x , see also Mnisi, F. M. (2020). An African analysis based on ethics of Ubuntu - are human embryonic stem cell patents morally justifiable? African Insight , 49 (4).

[14] Jecker, N. S., & Atuire, C. (2021). Bioethics in Africa: A contextually enlightened analysis of three cases. Developing World Bioethics , 22 (2), 112–122. https://doi.org/10.1111/dewb.12324

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[18] Oosthuizen, H. (2013). Legal and Ethical Issues in Stem Cell Research in South Africa. In: Beran, R. (eds) Legal and Forensic Medicine. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-32338-6_80 , see also: Gaobotse G (2018) Stem Cell Research in Africa: Legislation and Challenges. J Regen Med 7:1. doi: 10.4172/2325-9620.1000142

[19] United States Bureau of Citizenship and Immigration Services. (1998). Tunisia: Information on the status of Christian conversions in Tunisia . UNHCR Web Archive. https://webarchive.archive.unhcr.org/20230522142618/https://www.refworld.org/docid/3df0be9a2.html

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[21] Kooli, C. Review of assisted reproduction techniques, laws, and regulations in Muslim countries.  Middle East Fertil Soc J   24 , 8 (2020). https://doi.org/10.1186/s43043-019-0011-0 ; Gaobotse, G. (2018) Stem Cell Research in Africa: Legislation and Challenges. J Regen Med 7:1. doi: 10.4172/2325-9620.1000142

[22] Pang M. C. (1999). Protective truthfulness: the Chinese way of safeguarding patients in informed treatment decisions. Journal of medical ethics , 25(3), 247–253. https://doi.org/10.1136/jme.25.3.247

[23] Wang, L., Wang, F., & Zhang, W. (2021). Bioethics in China’s biosecurity law: Forms, effects, and unsettled issues. Journal of law and the biosciences , 8(1).  https://doi.org/10.1093/jlb/lsab019 https://academic.oup.com/jlb/article/8/1/lsab019/6299199

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[30] Chen, H., Wei, T., Wang, H.  et al.  Association of China’s two-child policy with changes in number of births and birth defects rate, 2008–2017.  BMC Public Health   22 , 434 (2022). https://doi.org/10.1186/s12889-022-12839-0

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[34] Resnik, D. B., Shamoo, A. E., & Krimsky, S. (2006). Fraudulent human embryonic stem cell research in South Korea: lessons learned.  Accountability in research ,  13 (1), 101–109. https://doi.org/10.1080/08989620600634193 .

[35] Alahmad, G., Aljohani, S., & Najjar, M. F. (2020). Ethical challenges regarding the use of stem cells: interviews with researchers from Saudi Arabia. BMC medical ethics, 21(1), 35. https://doi.org/10.1186/s12910-020-00482-6

[36] Association for the Advancement of Blood and Biotherapies.  https://www.aabb.org/regulatory-and-advocacy/regulatory-affairs/regulatory-for-cellular-therapies/international-competent-authorities/saudi-arabia

[37] Alahmad, G., Aljohani, S., & Najjar, M. F. (2020). Ethical challenges regarding the use of stem cells: Interviews with researchers from Saudi Arabia.  BMC medical ethics ,  21 (1), 35. https://doi.org/10.1186/s12910-020-00482-6

[38] Alahmad, G., Aljohani, S., & Najjar, M. F. (2020). Ethical challenges regarding the use of stem cells: Interviews with researchers from Saudi Arabia. BMC medical ethics , 21(1), 35. https://doi.org/10.1186/s12910-020-00482-6

Culturally, autonomy practices follow a relational autonomy approach based on a paternalistic deontological health care model. The adherence to strict international research policies and religious pillars within the regulatory environment is a great foundation for research ethics. However, there is a need to develop locally targeted ethics approaches for research (as called for in Alahmad, G., Aljohani, S., & Najjar, M. F. (2020). Ethical challenges regarding the use of stem cells: interviews with researchers from Saudi Arabia. BMC medical ethics, 21(1), 35. https://doi.org/10.1186/s12910-020-00482-6), this decision-making approach may help advise a research decision model. For more on the clinical cultural autonomy approaches, see: Alabdullah, Y. Y., Alzaid, E., Alsaad, S., Alamri, T., Alolayan, S. W., Bah, S., & Aljoudi, A. S. (2022). Autonomy and paternalism in Shared decision‐making in a Saudi Arabian tertiary hospital: A cross‐sectional study. Developing World Bioethics , 23 (3), 260–268. https://doi.org/10.1111/dewb.12355 ; Bukhari, A. A. (2017). Universal Principles of Bioethics and Patient Rights in Saudi Arabia (Doctoral dissertation, Duquesne University). https://dsc.duq.edu/etd/124; Ladha, S., Nakshawani, S. A., Alzaidy, A., & Tarab, B. (2023, October 26). Islam and Bioethics: What We All Need to Know . Columbia University School of Professional Studies. https://sps.columbia.edu/events/islam-and-bioethics-what-we-all-need-know

[39] Ababneh, M. A., Al-Azzam, S. I., Alzoubi, K., Rababa’h, A., & Al Demour, S. (2021). Understanding and attitudes of the Jordanian public about clinical research ethics.  Research Ethics ,  17 (2), 228-241.  https://doi.org/10.1177/1747016120966779

[40] Ababneh, M. A., Al-Azzam, S. I., Alzoubi, K., Rababa’h, A., & Al Demour, S. (2021). Understanding and attitudes of the Jordanian public about clinical research ethics.  Research Ethics ,  17 (2), 228-241.  https://doi.org/10.1177/1747016120966779

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[42] Dajani, R. (2014). Jordan’s stem-cell law can guide the Middle East.  Nature  510, 189. https://doi.org/10.1038/510189a

[43] The EU’s definition of autonomy relates to the capacity for creating ideas, moral insight, decisions, and actions without constraint, personal responsibility, and informed consent. However, the EU views autonomy as not completely able to protect individuals and depends on other principles, such as dignity, which “expresses the intrinsic worth and fundamental equality of all human beings.” Rendtorff, J.D., Kemp, P. (2019). Four Ethical Principles in European Bioethics and Biolaw: Autonomy, Dignity, Integrity and Vulnerability. In: Valdés, E., Lecaros, J. (eds) Biolaw and Policy in the Twenty-First Century. International Library of Ethics, Law, and the New Medicine, vol 78. Springer, Cham. https://doi.org/10.1007/978-3-030-05903-3_3

[44] Council of Europe. Convention for the protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine (ETS No. 164) https://www.coe.int/en/web/conventions/full-list?module=treaty-detail&treatynum=164 (forbidding the creation of embryos for research purposes only, and suggests embryos in vitro have protections.); Also see Drabiak-Syed B. K. (2013). New President, New Human Embryonic Stem Cell Research Policy: Comparative International Perspectives and Embryonic Stem Cell Research Laws in France.  Biotechnology Law Report ,  32 (6), 349–356. https://doi.org/10.1089/blr.2013.9865

[45] Rendtorff, J.D., Kemp, P. (2019). Four Ethical Principles in European Bioethics and Biolaw: Autonomy, Dignity, Integrity and Vulnerability. In: Valdés, E., Lecaros, J. (eds) Biolaw and Policy in the Twenty-First Century. International Library of Ethics, Law, and the New Medicine, vol 78. Springer, Cham. https://doi.org/10.1007/978-3-030-05903-3_3

[46] Tomuschat, C., Currie, D. P., Kommers, D. P., & Kerr, R. (Trans.). (1949, May 23). Basic law for the Federal Republic of Germany. https://www.btg-bestellservice.de/pdf/80201000.pdf

[47] Regulation of Stem Cell Research in Germany . Eurostemcell. (2017, April 26). https://www.eurostemcell.org/regulation-stem-cell-research-germany

[48] Regulation of Stem Cell Research in Finland . Eurostemcell. (2017, April 26). https://www.eurostemcell.org/regulation-stem-cell-research-finland

[49] Regulation of Stem Cell Research in Spain . Eurostemcell. (2017, April 26). https://www.eurostemcell.org/regulation-stem-cell-research-spain

[50] Some sources to consider regarding ethics models or regulatory oversights of other cultures not covered:

Kara MA. Applicability of the principle of respect for autonomy: the perspective of Turkey. J Med Ethics. 2007 Nov;33(11):627-30. doi: 10.1136/jme.2006.017400. PMID: 17971462; PMCID: PMC2598110.

Ugarte, O. N., & Acioly, M. A. (2014). The principle of autonomy in Brazil: one needs to discuss it ...  Revista do Colegio Brasileiro de Cirurgioes ,  41 (5), 374–377. https://doi.org/10.1590/0100-69912014005013

Bharadwaj, A., & Glasner, P. E. (2012). Local cells, global science: The rise of embryonic stem cell research in India . Routledge.

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[59] There is no explicit religious reference to when life begins or how to conduct research that interacts with the concept of life. However, these are relevant verses pertaining to how the fetus is viewed. (( King James Bible . (1999). Oxford University Press. (original work published 1769))

Jerimiah 1: 5 “Before I formed thee in the belly I knew thee; and before thou camest forth out of the womb I sanctified thee…”

In prophet Jerimiah’s insight, God set him apart as a person known before childbirth, a theme carried within the Psalm of David.

Psalm 139: 13-14 “…Thou hast covered me in my mother's womb. I will praise thee; for I am fearfully and wonderfully made…”

These verses demonstrate David’s respect for God as an entity that would know of all man’s thoughts and doings even before birth.

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[75] Pirzada, N. (2022). The Expansion of Turkey’s Medical Tourism Industry.  Voices in Bioethics ,  8 . https://doi.org/10.52214/vib.v8i.9894

[76] Stem Cell Tourism: False Hope for Real Money . Harvard Stem Cell Institute (HSCI). (2023). https://hsci.harvard.edu/stem-cell-tourism , See also: Bissassar, M. (2017). Transnational Stem Cell Tourism: An ethical analysis.  Voices in Bioethics ,  3 . https://doi.org/10.7916/vib.v3i.6027

[77] Song, P. (2011) The proliferation of stem cell therapies in post-Mao China: problematizing ethical regulation,  New Genetics and Society , 30:2, 141-153, DOI:  10.1080/14636778.2011.574375

[78] Dajani, R. (2014). Jordan’s stem-cell law can guide the Middle East.  Nature  510, 189. https://doi.org/10.1038/510189a

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Mifrah Hayath

SM Candidate Harvard Medical School, MS Biotechnology Johns Hopkins University

Olivia Bowers

MS Bioethics Columbia University (Disclosure: affiliated with Voices in Bioethics)

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Published on 26.4.2024 in Vol 10 (2024)

Exploring the Performance of ChatGPT-4 in the Taiwan Audiologist Qualification Examination: Preliminary Observational Study Highlighting the Potential of AI Chatbots in Hearing Care

Authors of this article:

• Shangqiguo Wang 1 , PhD ; 
• Changgeng Mo 2 , PhD ; 
• Yuan Chen 3 , PhD ; 
• Xiaolu Dai 4 , PhD ; 
• Huiyi Wang 5 , MSc ; 
• Xiaoli Shen 6 , MSc

1 Human Communication, Learning, and Development Unit, Faculty of Education, The University of Hong Kong, , Hong Kong, , China (Hong Kong)

2 Department of Otorhinolaryngology, Head and Neck Surgery, Faculty of Medicine, The Chinese University of Hong Kong, , Hong Kong, , China (Hong Kong)

3 Department of Special Education and Counselling, The Education University of Hong Kong, , Hong Kong, , China (Hong Kong)

4 Department of Social Work, Hong Kong Baptist University, , Hong Kong, , China (Hong Kong)

5 Department of Medical Services, Children’s Hospital, Zhejiang University School of Medicine, , Hangzhou, , China

6 Department of Health and Early Childhood Care, Ningbo College of Health School, , Ningbo, , China

Corresponding Author:

Yuan Chen, PhD

Background: Artificial intelligence (AI) chatbots, such as ChatGPT-4, have shown immense potential for application across various aspects of medicine, including medical education, clinical practice, and research.

Objective: This study aimed to evaluate the performance of ChatGPT-4 in the 2023 Taiwan Audiologist Qualification Examination, thereby preliminarily exploring the potential utility of AI chatbots in the fields of audiology and hearing care services.

Methods: ChatGPT-4 was tasked to provide answers and reasoning for the 2023 Taiwan Audiologist Qualification Examination. The examination encompassed six subjects: (1) basic auditory science, (2) behavioral audiology, (3) electrophysiological audiology, (4) principles and practice of hearing devices, (5) health and rehabilitation of the auditory and balance systems, and (6) auditory and speech communication disorders (including professional ethics). Each subject included 50 multiple-choice questions, with the exception of behavioral audiology, which had 49 questions, amounting to a total of 299 questions.

Results: The correct answer rates across the 6 subjects were as follows: 88% for basic auditory science, 63% for behavioral audiology, 58% for electrophysiological audiology, 72% for principles and practice of hearing devices, 80% for health and rehabilitation of the auditory and balance systems, and 86% for auditory and speech communication disorders (including professional ethics). The overall accuracy rate for the 299 questions was 75%, which surpasses the examination’s passing criteria of an average 60% accuracy rate across all subjects. A comprehensive review of ChatGPT-4’s responses indicated that incorrect answers were predominantly due to information errors.

Conclusions: ChatGPT-4 demonstrated a robust performance in the Taiwan Audiologist Qualification Examination, showcasing effective logical reasoning skills. Our results suggest that with enhanced information accuracy, ChatGPT-4’s performance could be further improved. This study indicates significant potential for the application of AI chatbots in audiology and hearing care services.

Introduction

In recent years, the rapid advancement of large language models (LLMs) has significantly expanded their usage in various domains. Among the leading artificial intelligence (AI) chatbots—such as Bard, Bing, and ChatGPT—there has been a notable increase in diverse applications in everyday life. Prominently, ChatGPT, launched by OpenAI in November 2022 [ 1 ], stands out in the realm of AI chatbots. This model, known for its proficiency in generating and comprehending human-like text, showcases remarkable natural language processing skills. It has the capability to grasp complex queries, furnish insightful responses, and participate in meaningful conversations, thus broadening the scope of AI’s practicality in everyday scenarios [ 2 , 3 ].

ChatGPT represents a significant advancement in the field of natural language processing, exemplifying the latest developments in LLMs, particularly within the subset of autoregressive language models. Such generative LLMs, including ChatGPT, are predominantly trained on extensive text corpora. They use the decoder element of a transformer model, a groundbreaking architecture introduced by Vaswani et al [ 4 ] in 2017. This model is adept at predicting subsequent tokens in text sequences, a capability that has been progressively refined in subsequent research [ 5 , 6 ]. The transformer model, upon which ChatGPT is built, has revolutionized natural language processing. Its core strength lies in its ability to process text sequences efficiently, facilitating tasks such as language translation, question answering, and text summarization. One of the key features of this architecture is the self-attention mechanism, which allows it to understand long-range dependencies between words in a sentence without the need for sequential processing. This feature not only enhances efficiency compared to older recurrent neural network architectures but also offers improved interpretability, linking the semantic and syntactic structures of language inputs more effectively [ 4 ]. In addition to these capabilities, ChatGPT has evolved to incorporate real-time and knowledge-based information through various plug-ins. The introduction of GPT-4 by OpenAI in 2023 has expanded ChatGPT’s proficiency to include processing both image and text inputs [ 1 ], marking a new milestone in the versatility and applicability of AI in diverse contexts.

ChatGPT has received considerable attention and exploration in its application within health care. The integration of ChatGPT into health care demonstrates its significant potential in enhancing patient education and handling general inquiries, marking it as a vital informational and supportive tool [ 7 ]. The broad applicability of AI chatbots in health care extends beyond patient interaction, serving clinicians, researchers, and students, with ChatGPT showing effectiveness in personalizing patient interactions and providing consumer health education [ 8 , 9 ]. This trend aligns with the overarching aim in health care AI to increase accessibility to medical knowledge and make care more affordable. Chatbots offer continuous health advice and support, potentially improving patient outcomes by reducing the need for in-person consultations. Additionally, they provide health care professionals with valuable insights for more informed patient care decision-making, though concerns regarding data transparency have been noted [ 10 ]. ChatGPT is capable of generating empathetic, high-quality responses to health-related queries, often comparable to those of physicians, and shows promise in producing emotionally aware responses with potential for continuous improvement [ 11 , 12 ]. In low- and middle-income countries, ChatGPT has great potential as a pivotal tool in public health efforts. Its advantages span various domains such as health literacy, screening, triage, remote support, mental health, multilingual communication, medical training, and professional support, addressing numerous challenges in these health care systems [ 13 ]. Furthermore, ChatGPT’s role as a supplementary educational tool in areas requiring aptitude, problem-solving, critical thinking, and reading comprehension has been highlighted. The ChatGPT-4 version, in particular, shows potential in applications such as discharge summarization and group learning, enhancing human-computer interaction through verbal fluency [ 14 , 15 ]. However, the need for embracing these advancements while ensuring patient safety and recognizing the limitations of AI in intricate clinical cases is emphasized [ 16 ].

The evolution of computational sciences in hearing care services and research has given rise to the field of computational audiology. This approach combines algorithms, machine learning, and data-driven modeling for audiological diagnosis, treatment, and rehabilitation, using biological, clinical, and behavioral theories to augment care for patients and professionals [ 17 ]. The rapid development of AI technologies, especially LLMs such as ChatGPT, has significantly contributed to this field’s growth. ChatGPT’s advanced capabilities position it as a potential tool for patient interaction, education, aural rehabilitation program, and preliminary diagnostics in audiology [ 18 , 19 ]. However, it is crucial to recognize its current limitations. While it can handle complex interactions, it is not a substitute for human expertise in specialized areas such as audiology and is limited in interpreting nuanced medical information or performing physical diagnostics. AI chatbots have shown immense potential in hearing health care, aiding patients, clinicians, and researchers. Their applications range from initial screenings, educational support, and teleaudiology services for patients, to data analysis and decision support for clinicians and researchers [ 19 ]. In countries with vast geographical areas and imbalanced hearing care resources, AI chatbots could significantly enhance the development of hearing care services. Very recently, explorations into the use of AI chatbots for answering questions pertaining audiological knowledge have shown that AI chatbots can serve as a tool to access basic audiological information [ 20 ]. However, the accuracy and reliability of information provided by these tools remain a concern [ 19 ].

Despite the significant potential of AI chatbots to enhance hearing care services, research in this area remains sparse. AI chatbots’ ability to understand questions and provide logical responses based on available information is crucial. This capability suggests promising applications in hearing care, including educational support, patient assistance in clinical settings, and aid for clinical staff. By engaging with AI chatbots, students, teachers, patients, and clinical personnel could significantly improve learning outcomes, patient care, and clinical practice efficiency. Therefore, this study starts from the most fundamental aspects to explore the performance of the current commercial version of ChatGPT-4 in taking an audiologist qualification examination (ie, the Taiwan Audiologist Qualification Examination). This investigation not only assesses the accuracy of responses to test questions but also explores the ability of the current AI chatbot to comprehend and logically respond to examination questions. These capabilities form the cornerstone for future integration of AI chatbots into educational support or clinical service assistance.

This study used the 2023 Taiwan Audiologist Qualification Examination [ 21 ]—a professional licensing examination for audiologists in Taiwan. Candidates of this examination are required to have a bachelor’s or masters’s degree in audiology and at least 6 months or 375 hours of clinical practice. The examination comprises six subjects: (1) basic auditory science, (2) behavioral audiology, (3) electrophysiological audiology, (4) principles and practice of hearing devices, (5) health and rehabilitation of the auditory and balance systems, and (6) auditory and speech communication disorders (including professional ethics). Each subject consists of 50 multiple-choice questions, except for behavioral audiology, which has 49 questions, totaling 299 questions in all. The examination papers featured 7 images, pivotal for answering 13 of the questions. Notably, these images were embedded directly within the PDF version of the examination rather than being provided as separate attachments. However, it is important to highlight that the images’ resolution was relatively low, and they were presented without color. When extracted and saved in JPEG format, the images ranged in size from 12.7 to 27.2 KB and had resolutions spanning from 82 to 150 DPI. All related PDFs are accessible for download from the official source [ 21 ].

Prompt Engineering

Recognizing the significant influence of prompt engineering (where “prompt” refers to the input text provided by the user, which the model responds to) on the outputs of generative LLMs, a standardized prompt format was used in this research: “Please answer the following multiple-choice question as a hearing care professional, providing reasoning and explanation.” This format was chosen to assess the logic and reasoning behind ChatGPT’s responses. The original examination questions, a blend of Traditional Chinese and English, often used bilingual terminology for specialized concepts. For this study, ChatGPT was instructed to respond in English. Additionally, ChatGPT was not informed that these questions were from the Taiwan Audiologist Qualification Examination to prevent it from sourcing specific information to increase the accuracy of its responses. An example of a prompt and response is illustrated in Figure 1 .

All questions and correct answers were downloaded from the official website of the Taiwan Ministry of Examination in PDF format [ 21 ]. Subsequently, all questions were pre-edited in a Word (Microsoft Corp) document to avoid formatting issues. ChatGPT-4, enhanced with DALL-E (Decoder-Only Autoregressive Language and Image Synthesis), browsing, and analysis capabilities, was used for the test from December 10 to 12, 2023. A separate chat was used for each subject of the examination. Despite being within the same subject, the questions essentially had no overlapping content. For questions presented as images, both the image and the text format of the question were provided to leverage ChatGPT-4’s image recognition capabilities. It is important to note that the resolution of the images supplied in the test was relatively poor, which could have potentially impacted the accuracy of image recognition. Following the approach of Gilson et al [ 9 ], the reasons for errors in incorrectly answered questions were categorized as follows: (1) logical errors: the response correctly identifies relevant information but fails to translate this information into an appropriate answer; (2) information errors: ChatGPT either overlooks a key piece of information, whether present in the question stem or from external sources, or shows a lack of expected knowledge; and (3) statistical errors: the error is due to a miscalculation, including explicit arithmetic errors or incorrect estimations of statistical data. Authors SW and CM, both having a PhD in audiology, reviewed the original questions in Chinese and the GPT’s responses in English, and then compared ChatGPT-4’s responses to the official correct answers provided for the examination (all multiple-choice questions) to determine whether each question was answered correctly. They then performed a cross-check to ensure the accuracy of this step. Subsequently, SW and CM classified the incorrect answers into the 3 aforementioned categories and compared their classification results. In case of any discrepancies, they consulted with HW, who has a master’s degree in public health, to reach a consensus and make a final decision together.

Ethical Considerations

This research did not involve human participants or private data and was therefore exempt from ethics approval by the ethics committee of Ningbo College of Health Sciences.

Data Analysis

The data analysis for this study was straightforward and conducted using Excel (Microsoft Corp). Our primary objective was to calculate the accuracy rate of ChatGPT-4 when tasked with taking the Taiwan Audiologist Qualification Examination.

Overall Performance

ChatGPT-4 demonstrated commendable performance in the Taiwan Audiologist Qualification Examination. The accuracy rates for the 6 subjects were as follows: 88% for basic auditory science, 63% for behavioral audiology, 58% for electrophysiological audiology, 72% for principles and practice of hearing devices, 80% for health and rehabilitation of the auditory and balance systems, and 86% for auditory and speech communication disorders (including professional ethics). The overall accuracy rate for the 299 questions was 75% (see Table 1 ). The examination’s passing criteria include an average accuracy rate of 60% across all subjects. Thus, ChatGPT-4 successfully passed this examination. Records of all ChatGPT-4's responses to the test questions can be found in the supplements ( Multimedia Appendices 1 - 6 ). A detailed review of ChatGPT 4’s responses revealed that errors were not caused by logical or statistical errors; instead, all incorrect answers resulted from information errors.

Information Errors Leading to Incorrect Answers

Lack of correct information sources.

Most incorrect answers were due to ChatGPT-4 relying on inaccurate information. For example, in the basic auditory science examination, question 43 involved identifying an incorrect statement about temporal masking among options A, B, C, and D. Option B stated that forward masking occurs when a signal appears after the masking noise, even with a 200-millisecond gap between the 2 stimuli (which is a misconception). The correct answer was that this statement is false, but ChatGPT-4’s explanation suggested otherwise:

Forward Masking with 200 ms Gap (B): This is correct. Forward masking can occur when the signal appears after the masking noise, even with a gap as long as 200 ms.

This response indicates that ChatGPT-4 did not have accurate information to answer this question. As a matter of fact, no masking occurs when the time interval between the masker and the signal equals or exceeds 200 milliseconds [ 22 ]. Similarly, for option D, which stated that forward masking is more effective than backward masking, ChatGPT-4’s choice and explanation were as follows:

Forward Masking More Effective Than Backward Masking (D): This is typically incorrect. Backward masking is often found to be more effective than forward masking.

While this appears correct at first glance, it lacks the clarification that backward masking is more effective than forward masking when the same time interval exists between the masker and signal, with more masking occurring when the masker follows the signal [ 23 ]. However, from the perspective of the information available to ChatGPT-4, option D was the most reasonable choice.

Conflicting Information Sources

Multiple sources of information also led to incorrect responses from ChatGPT-4. For example, question 22 in the electrophysiological audiology examination asked about the most appropriate frequency for tympanometry in newborns, with the correct answer being 1000 Hz. Despite its simplicity and lack of complexity in reasoning, ChatGPT-4 provided an incorrect response:

(A) 112 Hz is typically used for infants and young children. Newborns and young children have a more compliant ear canal than adults, and lower frequencies such as 226 Hz can sometimes overestimate middle ear pressure and compliance. Therefore, a lower frequency probe tone is often recommended.

Considering the straightforward nature of this question, the authors expected an accurate answer from ChatGPT-4. Therefore, after the conclusion of all tests, the question was posed to ChatGPT-4 twice more in separate new dialogues to avoid information cross-over. Two completely different responses were generated by ChatGPT-4:

226 Hz Standard: The 226 Hz probe tone is the standard frequency used in clinical tympanometry for all ages, including newborns. This frequency has been proven to provide reliable and accurate measurements of middle ear function in this age group. It is effective in identifying middle ear fluid, a common issue in newborns, and other conditions that might affect hearing. … In conclusion, 226 Hz (option B) is the most suitable probe tone frequency for tympanometry in newborns, due to its effectiveness in assessing middle ear function accurately in this specific age group.

When performing tympanometry on a newborn, the most appropriate probe tone frequency is typically 1000 Hz (Option C). Let me explain why: Age-Related Differences: The middle ear mechanics in infants, especially newborns, differ significantly from those in older children and adults. These differences are mainly due to the size and composition of the middle ear and ear canal, as well as the compliance of the tympanic membrane.

High-Frequency Probe Tones: A 1000 Hz probe tone is recommended for newborns and infants up to around six months of age. This higher frequency provides more accurate assessments of middle ear function in this age group, as it is less affected by the high compliance of the infant ear canal.

Therefore, the most appropriate option for tympanometry in newborns is 1000 Hz (Option C), as it offers the most reliable assessment of middle ear function in this specific age group.

This indicates that ChatGPT-4 may provide different answers each time based on varying sources of information, particularly when these sources have conflicts or inconsistencies.

Image Information Recognition

In the examination, 13 questions could be answered only through the recognition of images to extract information. ChatGPT-4 correctly answered 8 of these questions. Images 1 to 4 are from the behavioral audiology subject, images 5 and 6 are from the electrophysiological audiology subject, and image 7 is from the principles and practice of hearing devices subject. Out of the 7 images provided in total, ChatGPT-4 successfully recognized 4. The criterion for determining successful recognition was assessing the accuracy of ChatGPT-4’s interpretation of image content and its ability to extract pertinent information for answering questions. Authors SW and CM independently evaluated this aspect and subsequently performed a cross-check of their assessments.

Principal Findings

This study evaluated ChatGPT-4’s performance in the 2023 Taiwan Audiologist Qualification Examination. The eligibility criteria for this examination are having a degree in audiology or a related field and a minimum of 6 months or 375 hours of clinical practice. The minimum required accuracy rate to pass the examination is set at 60%. In the 2023 examination, 88.5% of candidates achieved this accuracy rate or higher, effectively passing the examination. ChatGPT-4 achieved an overall accuracy rate of 75%, meeting the passing criterion necessary for candidates to obtain the basic qualification for practicing as clinical audiologists in Taiwan. It performed notably well in subjects that required more analytical reasoning and contextual decision-making, such as health and rehabilitation of the auditory and balance systems and auditory and speech communication disorders (including professional ethics). The proficiency of LLMs in integrating and interpreting information logically was evident in subjects demanding contextual knowledge. However, in fields such as electrophysiological audiology, which depend more on precise knowledge points, the accuracy of ChatGPT-4 was challenged when confronted with incorrect or insufficient information. In our study, the original questions were in both Chinese and English. We requested ChatGPT to provide responses in English, and the translation between the 2 languages did not negatively impact either the comprehension or the accuracy of the responses. In addition, although this research was a preliminary examination of ChatGPT-4’s capabilities in image recognition within audiology examinations, it is important to note that the number of images used was limited, and their quality and resolution were suboptimal. Nevertheless, despite these constraints, ChatGPT-4 demonstrated a moderately acceptable level of image recognition performance, successfully identifying over half of the content within the images.

Comparative analysis with the existing literature indicates that LLMs such as ChatGPT have shown promising results in medical examinations [ 24 - 26 ], particularly GPT-4 [ 27 ]. The model’s ability to pass examinations that are challenging for many humans has been noted [ 9 , 28 ]. In our study, which involved multiple-choice questions, ChatGPT was tasked with not only selecting answers but also articulating the reasoning behind its choices. Notably, ChatGPT-4 has substantially reduced the incidence of logical and statistical errors that were more prevalent in its predecessors. Its accuracy rate in examinations based on multiple-choice questions has increased from 53.6% with GPT-3 and -3.5 to 75.1% with GPT-4 [ 27 ]. The absence of logical errors, in particular, suggests that ChatGPT-4 has an enhanced ability to understand questions accurately and make decisions that are logically coherent, using the information it has access to [ 9 , 27 ]. This advancement is especially relevant in the context of audiology examinations, especially in the multiple-choice question format, where statistical reasoning has traditionally been less emphasized. In this study, the primary challenge faced by ChatGPT-4 in accurately answering questions was identified as information errors, which primarily manifest in 2 distinct forms: a lack of correct information sources and the presence of conflicting information sources. The former issue directly impacts the ChatGPT’s performance; for several questions, ChatGPT-4 lacked the necessary correct information to either directly answer or logically deduce the correct responses. Despite its training on an extensive database of information [ 29 , 30 ], it became evident that ChatGPT-4 does not possess a comprehensive knowledge base required to flawlessly address specialized queries within the field of audiology, a discipline that demands a high degree of professional expertise. Conversely, the presence of conflicting information sources contributed to erroneous responses from ChatGPT. The model, although equipped with a wealth of information, was not developed with a focus on audiological knowledge or audiology best practices. This abundance of data, however, presents a challenge in verifying the accuracy and reliability of the information, especially when multiple sources offer conflicting viewpoints on widely discussed topics. This was exemplified in this study’s results, where a question on a fundamental concept in audiology—the use of 1000 Hz in tympanometry for children—resulted in ChatGPT-4 providing 3 distinct answers. Additionally, the lowest scores were observed in questions related to electrophysiological audiology. Apart from the issue of inaccurate sources of information, another possible reason is that information about electrophysiological audiology might be more specialized than that in other subjects, thereby restricting the amount of information that ChatGPT has access to. This is unlike the case with hearing aids or auditory rehabilitation, where a vast amount of information is readily available on the internet. Altogether, this highlights the necessity for further refinement of LLMs, emphasizing the integration of more precise and professionally relevant information. This approach will ensure that responses are derived from verified and accurate data sources, pointing to a crucial direction for future research in this area [ 31 ].

AI Chatbots and Audiology

The introduction of advanced AI models such as ChatGPT-4 has significant implications in hearing health care [ 18 ]. ChatGPT’s capacity to process and analyze extensive data makes it a potentially useful tool for patients, clinicians, and researchers [ 19 ]. Our findings suggest that given training with reliable information, even the current iteration of ChatGPT-4 holds considerable promise for application in hearing care services. This potential is likely to increase alongside the continual advancements in LLMs. The results of this study show that when faced with professional-level audiology questions, AI chatbots can provide answers with a high accuracy rate and logical reasoning. Furthermore, their ability to mimic human-like responses suggests that they are capable of assisting in educational learning and hearing care awareness. However, this is contingent upon first building a fine-tuned model with accurate information sources.

In the context of patient care, AI chatbots could act as digital audiologists, providing answers to a range of hearing-related queries. Their easy accessibility may be beneficial for early hearing screenings and prompt intervention or medical attention. AI chatbots also have the potential to educate patients about hearing issues and offer psychological support for conditions such as tinnitus. They have been shown to have potential in managing mental health concerns and demonstrate a level of empathy that can surpass that of human physicians [ 11 , 32 ]. The development of AI chatbots as qualified audiologists could greatly enhance teleaudiology services. For clinicians, AI chatbots could serve as supportive tools, offering rapid references or recommendations based on current research and guidelines, aiding in diagnosis and treatment suggestions [ 33 ], and facilitating the creation of diagnostic or referral reports [ 34 ]. This is especially relevant in regions with limited hearing care resources [ 13 ], where AI chatbots could play a vital role in both the education of hearing care professionals and in augmenting clinical services. This enhancement could lead to improved overall quality and availability of hearing care services, ultimately benefiting individuals with hearing impairments. Similarly, researchers in auditory science could use AI chatbots to streamline their research processes. However, the effectiveness of these proposed applications depends on the thorough and complete validation of the chatbots’ functionality and information accuracy.

Limitations

This study represents a preliminary exploration of an AI chatbot’s performance in an audiologist qualification examination. However, several limitations must be acknowledged. First, the selected examination questions were exclusively multiple-choice, with a subset requiring integrated information for reasoning. This format lacks open-ended questions that typically mirror the complexity of real-world clinical scenarios in hearing care, where audiologists address diverse and intricate issues beyond isolated knowledge points. Future research could extend to evaluating AI chatbots in handling complex audiology cases. Second, while this study included an assessment of ChatGPT-4’s image recognition capabilities, the quality of the images in the original test files was suboptimal. Additionally, the number of questions involving image information was limited, which constrained the ability of this study to draw substantial conclusions about this functionality.

Conclusions

In conclusion, the findings of this study show that ChatGPT 4 achieved a 75% accuracy rate in the 2023 Taiwan Audiologist Qualification Examination, thus successfully passing it. The primary reason for ChatGPT-4’s incorrect responses was identified to be information errors, including both a lack of correct information sources and the presence of conflicting information sources. Therefore, a fine-tuned model containing accurate hearing care information sources has the potential to further enhance the feasibility of AI chatbot applications in hearing care services. However, passing the examination does not imply that ChatGPT-4 can become a qualified clinical audiologist in Taiwan; rather, it only indicates that ChatGPT-4 has some basic knowledge required for the audiology profession. Adequate clinical internship hours are also a crucial requirement for the actual practice of audiology in Taiwan, and its performance in handling real clinical cases remains unknown.

Acknowledgments

The authors wish to express gratitude for the rapid development of large language models, which brings hope for future improvement in hearing care globally. ChatGPT was used to proofread and correct grammatical issues in this article.

Data Availability

The data supporting the findings of this study are available from the corresponding author upon request.

Authors' Contributions

SW led the study's design, managed the data, performed the analysis, and contributed to drafting the manuscript. CM, YC, and XD helped conceptualize the study. HW also participated in the analysis, while XS oversaw the study’s administration.

Conflicts of Interest

None declared.

ChatGPT transcripts: basic auditory science.

ChatGPT transcripts for behavioral audiology.

ChatGPT transcripts for auditory and speech communication disorders (including professional ethics).

ChatGPT transcripts for electrophysiological audiology.

ChatGPT transcripts for principles and practice of hearing devices.

ChatGPT transcripts for health and rehabilitation of the auditory and balance systems.

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Abbreviations

Edited by Gunther Eysenbach, Taiane de Azevedo Cardoso; submitted 18.12.23; peer-reviewed by Helen Cullington, Prasha Sooful, Robert Eikelboom; final revised version received 09.03.24; accepted 22.03.24; published 26.04.24.

© Shangqiguo Wang, Changgeng Mo, Yuan Chen, Xiaolu Dai, Huiyi Wang, Xiaoli Shen. Originally published in JMIR Medical Education (https://mededu.jmir.org), 26.4.2024.

This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/ ), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Medical Education, is properly cited. The complete bibliographic information, a link to the original publication on https://mededu.jmir.org/ , as well as this copyright and license information must be included.

The Use of Minimally Invasive Surgery in the Treatment of Crohn's Disease: A Systematic Review of Evidence

Article sidebar, main article content.

Minimally invasive surgery (MIS) is a groundbreaking approach for treating Crohn's disease (CD), affecting approximately 100-300 per 100,000 people. In 2015, an estimated 3.1 million people were diagnosed with Inflammatory Bowel Disease (IBD). Our research aims to consolidate previous evidence on MIS techniques, including laparoscopic techniques and robotic-assisted surgery, and compare them to traditional surgical techniques in managing CD. The practical benefits of MIS are evident in comparative studies, which consistently show that laparoscopic approaches result in shorter hospital stays and faster recovery than open surgery. MIS also demonstrates significant long-term benefits, particularly in reducing the mortality rate. Even pediatric CD patients have shown improved outcomes with laparoscopic-assisted surgery, experiencing fewer postoperative complications and better recovery. MIS applications include Laparoscopic ileocolic resections, a key MIS technique, offer comparable outcomes to other therapies like open ileocolic resection but with the added advantages of lower costs and long-term disease control. This cost-effectiveness of MIS techniques is a significant advantage. Techniques like intracorporeal anastomosis and trans colonic specimen removal have further improved postoperative recovery and cosmesis. Strictureplasty is another MIS technique, is particularly beneficial for CD patients with strictures due to its ability to preserve intestinal length and function. Lastly, laparoscopic robotic-assisted surgery is a game-changer, offering a significant reduction in postoperative pain and faster recovery compared to manual surgeries.

Article Details

This work is licensed under a Creative Commons Attribution 4.0 International License .

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