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Quantitative Methods for Second Language Research: A Problem-Solving Approach

Carsten Roever, Aek Phakiti

Routledge | Published : 2018

DOI: 10.4324/9780203067659

Practical and lucid, this book is the ideal resource for data analysis for graduate students and researchers in applied linguistics.

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A Practical Guide to Writing Quantitative and Qualitative Research Questions and Hypotheses in Scholarly Articles

Edward barroga.

1 Department of General Education, Graduate School of Nursing Science, St. Luke’s International University, Tokyo, Japan.

Glafera Janet Matanguihan

2 Department of Biological Sciences, Messiah University, Mechanicsburg, PA, USA.

The development of research questions and the subsequent hypotheses are prerequisites to defining the main research purpose and specific objectives of a study. Consequently, these objectives determine the study design and research outcome. The development of research questions is a process based on knowledge of current trends, cutting-edge studies, and technological advances in the research field. Excellent research questions are focused and require a comprehensive literature search and in-depth understanding of the problem being investigated. Initially, research questions may be written as descriptive questions which could be developed into inferential questions. These questions must be specific and concise to provide a clear foundation for developing hypotheses. Hypotheses are more formal predictions about the research outcomes. These specify the possible results that may or may not be expected regarding the relationship between groups. Thus, research questions and hypotheses clarify the main purpose and specific objectives of the study, which in turn dictate the design of the study, its direction, and outcome. Studies developed from good research questions and hypotheses will have trustworthy outcomes with wide-ranging social and health implications.

INTRODUCTION

Scientific research is usually initiated by posing evidenced-based research questions which are then explicitly restated as hypotheses. 1 , 2 The hypotheses provide directions to guide the study, solutions, explanations, and expected results. 3 , 4 Both research questions and hypotheses are essentially formulated based on conventional theories and real-world processes, which allow the inception of novel studies and the ethical testing of ideas. 5 , 6

It is crucial to have knowledge of both quantitative and qualitative research 2 as both types of research involve writing research questions and hypotheses. 7 However, these crucial elements of research are sometimes overlooked; if not overlooked, then framed without the forethought and meticulous attention it needs. Planning and careful consideration are needed when developing quantitative or qualitative research, particularly when conceptualizing research questions and hypotheses. 4

There is a continuing need to support researchers in the creation of innovative research questions and hypotheses, as well as for journal articles that carefully review these elements. 1 When research questions and hypotheses are not carefully thought of, unethical studies and poor outcomes usually ensue. Carefully formulated research questions and hypotheses define well-founded objectives, which in turn determine the appropriate design, course, and outcome of the study. This article then aims to discuss in detail the various aspects of crafting research questions and hypotheses, with the goal of guiding researchers as they develop their own. Examples from the authors and peer-reviewed scientific articles in the healthcare field are provided to illustrate key points.

DEFINITIONS AND RELATIONSHIP OF RESEARCH QUESTIONS AND HYPOTHESES

A research question is what a study aims to answer after data analysis and interpretation. The answer is written in length in the discussion section of the paper. Thus, the research question gives a preview of the different parts and variables of the study meant to address the problem posed in the research question. 1 An excellent research question clarifies the research writing while facilitating understanding of the research topic, objective, scope, and limitations of the study. 5

On the other hand, a research hypothesis is an educated statement of an expected outcome. This statement is based on background research and current knowledge. 8 , 9 The research hypothesis makes a specific prediction about a new phenomenon 10 or a formal statement on the expected relationship between an independent variable and a dependent variable. 3 , 11 It provides a tentative answer to the research question to be tested or explored. 4

Hypotheses employ reasoning to predict a theory-based outcome. 10 These can also be developed from theories by focusing on components of theories that have not yet been observed. 10 The validity of hypotheses is often based on the testability of the prediction made in a reproducible experiment. 8

Conversely, hypotheses can also be rephrased as research questions. Several hypotheses based on existing theories and knowledge may be needed to answer a research question. Developing ethical research questions and hypotheses creates a research design that has logical relationships among variables. These relationships serve as a solid foundation for the conduct of the study. 4 , 11 Haphazardly constructed research questions can result in poorly formulated hypotheses and improper study designs, leading to unreliable results. Thus, the formulations of relevant research questions and verifiable hypotheses are crucial when beginning research. 12

CHARACTERISTICS OF GOOD RESEARCH QUESTIONS AND HYPOTHESES

Excellent research questions are specific and focused. These integrate collective data and observations to confirm or refute the subsequent hypotheses. Well-constructed hypotheses are based on previous reports and verify the research context. These are realistic, in-depth, sufficiently complex, and reproducible. More importantly, these hypotheses can be addressed and tested. 13

There are several characteristics of well-developed hypotheses. Good hypotheses are 1) empirically testable 7 , 10 , 11 , 13 ; 2) backed by preliminary evidence 9 ; 3) testable by ethical research 7 , 9 ; 4) based on original ideas 9 ; 5) have evidenced-based logical reasoning 10 ; and 6) can be predicted. 11 Good hypotheses can infer ethical and positive implications, indicating the presence of a relationship or effect relevant to the research theme. 7 , 11 These are initially developed from a general theory and branch into specific hypotheses by deductive reasoning. In the absence of a theory to base the hypotheses, inductive reasoning based on specific observations or findings form more general hypotheses. 10

TYPES OF RESEARCH QUESTIONS AND HYPOTHESES

Research questions and hypotheses are developed according to the type of research, which can be broadly classified into quantitative and qualitative research. We provide a summary of the types of research questions and hypotheses under quantitative and qualitative research categories in Table 1 .

Research questions in quantitative research

In quantitative research, research questions inquire about the relationships among variables being investigated and are usually framed at the start of the study. These are precise and typically linked to the subject population, dependent and independent variables, and research design. 1 Research questions may also attempt to describe the behavior of a population in relation to one or more variables, or describe the characteristics of variables to be measured ( descriptive research questions ). 1 , 5 , 14 These questions may also aim to discover differences between groups within the context of an outcome variable ( comparative research questions ), 1 , 5 , 14 or elucidate trends and interactions among variables ( relationship research questions ). 1 , 5 We provide examples of descriptive, comparative, and relationship research questions in quantitative research in Table 2 .

Hypotheses in quantitative research

In quantitative research, hypotheses predict the expected relationships among variables. 15 Relationships among variables that can be predicted include 1) between a single dependent variable and a single independent variable ( simple hypothesis ) or 2) between two or more independent and dependent variables ( complex hypothesis ). 4 , 11 Hypotheses may also specify the expected direction to be followed and imply an intellectual commitment to a particular outcome ( directional hypothesis ) 4 . On the other hand, hypotheses may not predict the exact direction and are used in the absence of a theory, or when findings contradict previous studies ( non-directional hypothesis ). 4 In addition, hypotheses can 1) define interdependency between variables ( associative hypothesis ), 4 2) propose an effect on the dependent variable from manipulation of the independent variable ( causal hypothesis ), 4 3) state a negative relationship between two variables ( null hypothesis ), 4 , 11 , 15 4) replace the working hypothesis if rejected ( alternative hypothesis ), 15 explain the relationship of phenomena to possibly generate a theory ( working hypothesis ), 11 5) involve quantifiable variables that can be tested statistically ( statistical hypothesis ), 11 6) or express a relationship whose interlinks can be verified logically ( logical hypothesis ). 11 We provide examples of simple, complex, directional, non-directional, associative, causal, null, alternative, working, statistical, and logical hypotheses in quantitative research, as well as the definition of quantitative hypothesis-testing research in Table 3 .

Research questions in qualitative research

Unlike research questions in quantitative research, research questions in qualitative research are usually continuously reviewed and reformulated. The central question and associated subquestions are stated more than the hypotheses. 15 The central question broadly explores a complex set of factors surrounding the central phenomenon, aiming to present the varied perspectives of participants. 15

There are varied goals for which qualitative research questions are developed. These questions can function in several ways, such as to 1) identify and describe existing conditions ( contextual research question s); 2) describe a phenomenon ( descriptive research questions ); 3) assess the effectiveness of existing methods, protocols, theories, or procedures ( evaluation research questions ); 4) examine a phenomenon or analyze the reasons or relationships between subjects or phenomena ( explanatory research questions ); or 5) focus on unknown aspects of a particular topic ( exploratory research questions ). 5 In addition, some qualitative research questions provide new ideas for the development of theories and actions ( generative research questions ) or advance specific ideologies of a position ( ideological research questions ). 1 Other qualitative research questions may build on a body of existing literature and become working guidelines ( ethnographic research questions ). Research questions may also be broadly stated without specific reference to the existing literature or a typology of questions ( phenomenological research questions ), may be directed towards generating a theory of some process ( grounded theory questions ), or may address a description of the case and the emerging themes ( qualitative case study questions ). 15 We provide examples of contextual, descriptive, evaluation, explanatory, exploratory, generative, ideological, ethnographic, phenomenological, grounded theory, and qualitative case study research questions in qualitative research in Table 4 , and the definition of qualitative hypothesis-generating research in Table 5 .

Qualitative studies usually pose at least one central research question and several subquestions starting with How or What . These research questions use exploratory verbs such as explore or describe . These also focus on one central phenomenon of interest, and may mention the participants and research site. 15

Hypotheses in qualitative research

Hypotheses in qualitative research are stated in the form of a clear statement concerning the problem to be investigated. Unlike in quantitative research where hypotheses are usually developed to be tested, qualitative research can lead to both hypothesis-testing and hypothesis-generating outcomes. 2 When studies require both quantitative and qualitative research questions, this suggests an integrative process between both research methods wherein a single mixed-methods research question can be developed. 1

FRAMEWORKS FOR DEVELOPING RESEARCH QUESTIONS AND HYPOTHESES

Research questions followed by hypotheses should be developed before the start of the study. 1 , 12 , 14 It is crucial to develop feasible research questions on a topic that is interesting to both the researcher and the scientific community. This can be achieved by a meticulous review of previous and current studies to establish a novel topic. Specific areas are subsequently focused on to generate ethical research questions. The relevance of the research questions is evaluated in terms of clarity of the resulting data, specificity of the methodology, objectivity of the outcome, depth of the research, and impact of the study. 1 , 5 These aspects constitute the FINER criteria (i.e., Feasible, Interesting, Novel, Ethical, and Relevant). 1 Clarity and effectiveness are achieved if research questions meet the FINER criteria. In addition to the FINER criteria, Ratan et al. described focus, complexity, novelty, feasibility, and measurability for evaluating the effectiveness of research questions. 14

The PICOT and PEO frameworks are also used when developing research questions. 1 The following elements are addressed in these frameworks, PICOT: P-population/patients/problem, I-intervention or indicator being studied, C-comparison group, O-outcome of interest, and T-timeframe of the study; PEO: P-population being studied, E-exposure to preexisting conditions, and O-outcome of interest. 1 Research questions are also considered good if these meet the “FINERMAPS” framework: Feasible, Interesting, Novel, Ethical, Relevant, Manageable, Appropriate, Potential value/publishable, and Systematic. 14

As we indicated earlier, research questions and hypotheses that are not carefully formulated result in unethical studies or poor outcomes. To illustrate this, we provide some examples of ambiguous research question and hypotheses that result in unclear and weak research objectives in quantitative research ( Table 6 ) 16 and qualitative research ( Table 7 ) 17 , and how to transform these ambiguous research question(s) and hypothesis(es) into clear and good statements.

a These statements were composed for comparison and illustrative purposes only.

b These statements are direct quotes from Higashihara and Horiuchi. 16

a This statement is a direct quote from Shimoda et al. 17

The other statements were composed for comparison and illustrative purposes only.

CONSTRUCTING RESEARCH QUESTIONS AND HYPOTHESES

To construct effective research questions and hypotheses, it is very important to 1) clarify the background and 2) identify the research problem at the outset of the research, within a specific timeframe. 9 Then, 3) review or conduct preliminary research to collect all available knowledge about the possible research questions by studying theories and previous studies. 18 Afterwards, 4) construct research questions to investigate the research problem. Identify variables to be accessed from the research questions 4 and make operational definitions of constructs from the research problem and questions. Thereafter, 5) construct specific deductive or inductive predictions in the form of hypotheses. 4 Finally, 6) state the study aims . This general flow for constructing effective research questions and hypotheses prior to conducting research is shown in Fig. 1 .

Research questions are used more frequently in qualitative research than objectives or hypotheses. 3 These questions seek to discover, understand, explore or describe experiences by asking “What” or “How.” The questions are open-ended to elicit a description rather than to relate variables or compare groups. The questions are continually reviewed, reformulated, and changed during the qualitative study. 3 Research questions are also used more frequently in survey projects than hypotheses in experiments in quantitative research to compare variables and their relationships.

Hypotheses are constructed based on the variables identified and as an if-then statement, following the template, ‘If a specific action is taken, then a certain outcome is expected.’ At this stage, some ideas regarding expectations from the research to be conducted must be drawn. 18 Then, the variables to be manipulated (independent) and influenced (dependent) are defined. 4 Thereafter, the hypothesis is stated and refined, and reproducible data tailored to the hypothesis are identified, collected, and analyzed. 4 The hypotheses must be testable and specific, 18 and should describe the variables and their relationships, the specific group being studied, and the predicted research outcome. 18 Hypotheses construction involves a testable proposition to be deduced from theory, and independent and dependent variables to be separated and measured separately. 3 Therefore, good hypotheses must be based on good research questions constructed at the start of a study or trial. 12

In summary, research questions are constructed after establishing the background of the study. Hypotheses are then developed based on the research questions. Thus, it is crucial to have excellent research questions to generate superior hypotheses. In turn, these would determine the research objectives and the design of the study, and ultimately, the outcome of the research. 12 Algorithms for building research questions and hypotheses are shown in Fig. 2 for quantitative research and in Fig. 3 for qualitative research.

EXAMPLES OF RESEARCH QUESTIONS FROM PUBLISHED ARTICLES

• EXAMPLE 1. Descriptive research question (quantitative research)
• - Presents research variables to be assessed (distinct phenotypes and subphenotypes)
• “BACKGROUND: Since COVID-19 was identified, its clinical and biological heterogeneity has been recognized. Identifying COVID-19 phenotypes might help guide basic, clinical, and translational research efforts.
• RESEARCH QUESTION: Does the clinical spectrum of patients with COVID-19 contain distinct phenotypes and subphenotypes? ” 19
• EXAMPLE 2. Relationship research question (quantitative research)
• - Shows interactions between dependent variable (static postural control) and independent variable (peripheral visual field loss)
• “Background: Integration of visual, vestibular, and proprioceptive sensations contributes to postural control. People with peripheral visual field loss have serious postural instability. However, the directional specificity of postural stability and sensory reweighting caused by gradual peripheral visual field loss remain unclear.
• Research question: What are the effects of peripheral visual field loss on static postural control ?” 20
• EXAMPLE 3. Comparative research question (quantitative research)
• - Clarifies the difference among groups with an outcome variable (patients enrolled in COMPERA with moderate PH or severe PH in COPD) and another group without the outcome variable (patients with idiopathic pulmonary arterial hypertension (IPAH))
• “BACKGROUND: Pulmonary hypertension (PH) in COPD is a poorly investigated clinical condition.
• RESEARCH QUESTION: Which factors determine the outcome of PH in COPD?
• STUDY DESIGN AND METHODS: We analyzed the characteristics and outcome of patients enrolled in the Comparative, Prospective Registry of Newly Initiated Therapies for Pulmonary Hypertension (COMPERA) with moderate or severe PH in COPD as defined during the 6th PH World Symposium who received medical therapy for PH and compared them with patients with idiopathic pulmonary arterial hypertension (IPAH) .” 21
• EXAMPLE 4. Exploratory research question (qualitative research)
• - Explores areas that have not been fully investigated (perspectives of families and children who receive care in clinic-based child obesity treatment) to have a deeper understanding of the research problem
• “Problem: Interventions for children with obesity lead to only modest improvements in BMI and long-term outcomes, and data are limited on the perspectives of families of children with obesity in clinic-based treatment. This scoping review seeks to answer the question: What is known about the perspectives of families and children who receive care in clinic-based child obesity treatment? This review aims to explore the scope of perspectives reported by families of children with obesity who have received individualized outpatient clinic-based obesity treatment.” 22
• EXAMPLE 5. Relationship research question (quantitative research)
• - Defines interactions between dependent variable (use of ankle strategies) and independent variable (changes in muscle tone)
• “Background: To maintain an upright standing posture against external disturbances, the human body mainly employs two types of postural control strategies: “ankle strategy” and “hip strategy.” While it has been reported that the magnitude of the disturbance alters the use of postural control strategies, it has not been elucidated how the level of muscle tone, one of the crucial parameters of bodily function, determines the use of each strategy. We have previously confirmed using forward dynamics simulations of human musculoskeletal models that an increased muscle tone promotes the use of ankle strategies. The objective of the present study was to experimentally evaluate a hypothesis: an increased muscle tone promotes the use of ankle strategies. Research question: Do changes in the muscle tone affect the use of ankle strategies ?” 23

EXAMPLES OF HYPOTHESES IN PUBLISHED ARTICLES

• EXAMPLE 1. Working hypothesis (quantitative research)
• - A hypothesis that is initially accepted for further research to produce a feasible theory
• “As fever may have benefit in shortening the duration of viral illness, it is plausible to hypothesize that the antipyretic efficacy of ibuprofen may be hindering the benefits of a fever response when taken during the early stages of COVID-19 illness .” 24
• “In conclusion, it is plausible to hypothesize that the antipyretic efficacy of ibuprofen may be hindering the benefits of a fever response . The difference in perceived safety of these agents in COVID-19 illness could be related to the more potent efficacy to reduce fever with ibuprofen compared to acetaminophen. Compelling data on the benefit of fever warrant further research and review to determine when to treat or withhold ibuprofen for early stage fever for COVID-19 and other related viral illnesses .” 24
• EXAMPLE 2. Exploratory hypothesis (qualitative research)
• - Explores particular areas deeper to clarify subjective experience and develop a formal hypothesis potentially testable in a future quantitative approach
• “We hypothesized that when thinking about a past experience of help-seeking, a self distancing prompt would cause increased help-seeking intentions and more favorable help-seeking outcome expectations .” 25
• “Conclusion
• Although a priori hypotheses were not supported, further research is warranted as results indicate the potential for using self-distancing approaches to increasing help-seeking among some people with depressive symptomatology.” 25
• EXAMPLE 3. Hypothesis-generating research to establish a framework for hypothesis testing (qualitative research)
• “We hypothesize that compassionate care is beneficial for patients (better outcomes), healthcare systems and payers (lower costs), and healthcare providers (lower burnout). ” 26
• Compassionomics is the branch of knowledge and scientific study of the effects of compassionate healthcare. Our main hypotheses are that compassionate healthcare is beneficial for (1) patients, by improving clinical outcomes, (2) healthcare systems and payers, by supporting financial sustainability, and (3) HCPs, by lowering burnout and promoting resilience and well-being. The purpose of this paper is to establish a scientific framework for testing the hypotheses above . If these hypotheses are confirmed through rigorous research, compassionomics will belong in the science of evidence-based medicine, with major implications for all healthcare domains.” 26
• EXAMPLE 4. Statistical hypothesis (quantitative research)
• - An assumption is made about the relationship among several population characteristics ( gender differences in sociodemographic and clinical characteristics of adults with ADHD ). Validity is tested by statistical experiment or analysis ( chi-square test, Students t-test, and logistic regression analysis)
• “Our research investigated gender differences in sociodemographic and clinical characteristics of adults with ADHD in a Japanese clinical sample. Due to unique Japanese cultural ideals and expectations of women's behavior that are in opposition to ADHD symptoms, we hypothesized that women with ADHD experience more difficulties and present more dysfunctions than men . We tested the following hypotheses: first, women with ADHD have more comorbidities than men with ADHD; second, women with ADHD experience more social hardships than men, such as having less full-time employment and being more likely to be divorced.” 27
• “Statistical Analysis
• ( text omitted ) Between-gender comparisons were made using the chi-squared test for categorical variables and Students t-test for continuous variables…( text omitted ). A logistic regression analysis was performed for employment status, marital status, and comorbidity to evaluate the independent effects of gender on these dependent variables.” 27

EXAMPLES OF HYPOTHESIS AS WRITTEN IN PUBLISHED ARTICLES IN RELATION TO OTHER PARTS

• EXAMPLE 1. Background, hypotheses, and aims are provided
• “Pregnant women need skilled care during pregnancy and childbirth, but that skilled care is often delayed in some countries …( text omitted ). The focused antenatal care (FANC) model of WHO recommends that nurses provide information or counseling to all pregnant women …( text omitted ). Job aids are visual support materials that provide the right kind of information using graphics and words in a simple and yet effective manner. When nurses are not highly trained or have many work details to attend to, these job aids can serve as a content reminder for the nurses and can be used for educating their patients (Jennings, Yebadokpo, Affo, & Agbogbe, 2010) ( text omitted ). Importantly, additional evidence is needed to confirm how job aids can further improve the quality of ANC counseling by health workers in maternal care …( text omitted )” 28
• “ This has led us to hypothesize that the quality of ANC counseling would be better if supported by job aids. Consequently, a better quality of ANC counseling is expected to produce higher levels of awareness concerning the danger signs of pregnancy and a more favorable impression of the caring behavior of nurses .” 28
• “This study aimed to examine the differences in the responses of pregnant women to a job aid-supported intervention during ANC visit in terms of 1) their understanding of the danger signs of pregnancy and 2) their impression of the caring behaviors of nurses to pregnant women in rural Tanzania.” 28
• EXAMPLE 2. Background, hypotheses, and aims are provided
• “We conducted a two-arm randomized controlled trial (RCT) to evaluate and compare changes in salivary cortisol and oxytocin levels of first-time pregnant women between experimental and control groups. The women in the experimental group touched and held an infant for 30 min (experimental intervention protocol), whereas those in the control group watched a DVD movie of an infant (control intervention protocol). The primary outcome was salivary cortisol level and the secondary outcome was salivary oxytocin level.” 29
• “ We hypothesize that at 30 min after touching and holding an infant, the salivary cortisol level will significantly decrease and the salivary oxytocin level will increase in the experimental group compared with the control group .” 29
• EXAMPLE 3. Background, aim, and hypothesis are provided
• “In countries where the maternal mortality ratio remains high, antenatal education to increase Birth Preparedness and Complication Readiness (BPCR) is considered one of the top priorities [1]. BPCR includes birth plans during the antenatal period, such as the birthplace, birth attendant, transportation, health facility for complications, expenses, and birth materials, as well as family coordination to achieve such birth plans. In Tanzania, although increasing, only about half of all pregnant women attend an antenatal clinic more than four times [4]. Moreover, the information provided during antenatal care (ANC) is insufficient. In the resource-poor settings, antenatal group education is a potential approach because of the limited time for individual counseling at antenatal clinics.” 30
• “This study aimed to evaluate an antenatal group education program among pregnant women and their families with respect to birth-preparedness and maternal and infant outcomes in rural villages of Tanzania.” 30
• “ The study hypothesis was if Tanzanian pregnant women and their families received a family-oriented antenatal group education, they would (1) have a higher level of BPCR, (2) attend antenatal clinic four or more times, (3) give birth in a health facility, (4) have less complications of women at birth, and (5) have less complications and deaths of infants than those who did not receive the education .” 30

Research questions and hypotheses are crucial components to any type of research, whether quantitative or qualitative. These questions should be developed at the very beginning of the study. Excellent research questions lead to superior hypotheses, which, like a compass, set the direction of research, and can often determine the successful conduct of the study. Many research studies have floundered because the development of research questions and subsequent hypotheses was not given the thought and meticulous attention needed. The development of research questions and hypotheses is an iterative process based on extensive knowledge of the literature and insightful grasp of the knowledge gap. Focused, concise, and specific research questions provide a strong foundation for constructing hypotheses which serve as formal predictions about the research outcomes. Research questions and hypotheses are crucial elements of research that should not be overlooked. They should be carefully thought of and constructed when planning research. This avoids unethical studies and poor outcomes by defining well-founded objectives that determine the design, course, and outcome of the study.

Disclosure: The authors have no potential conflicts of interest to disclose.

Author Contributions:

• Conceptualization: Barroga E, Matanguihan GJ.
• Methodology: Barroga E, Matanguihan GJ.
• Writing - original draft: Barroga E, Matanguihan GJ.
• Writing - review & editing: Barroga E, Matanguihan GJ.

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Home » Quantitative Research – Methods, Types and Analysis

Quantitative Research – Methods, Types and Analysis

Table of Contents

Quantitative Research

Quantitative research is a type of research that collects and analyzes numerical data to test hypotheses and answer research questions . This research typically involves a large sample size and uses statistical analysis to make inferences about a population based on the data collected. It often involves the use of surveys, experiments, or other structured data collection methods to gather quantitative data.

Quantitative Research Methods

Quantitative Research Methods are as follows:

Descriptive Research Design

Descriptive research design is used to describe the characteristics of a population or phenomenon being studied. This research method is used to answer the questions of what, where, when, and how. Descriptive research designs use a variety of methods such as observation, case studies, and surveys to collect data. The data is then analyzed using statistical tools to identify patterns and relationships.

Correlational Research Design

Correlational research design is used to investigate the relationship between two or more variables. Researchers use correlational research to determine whether a relationship exists between variables and to what extent they are related. This research method involves collecting data from a sample and analyzing it using statistical tools such as correlation coefficients.

Quasi-experimental Research Design

Quasi-experimental research design is used to investigate cause-and-effect relationships between variables. This research method is similar to experimental research design, but it lacks full control over the independent variable. Researchers use quasi-experimental research designs when it is not feasible or ethical to manipulate the independent variable.

Experimental Research Design

Experimental research design is used to investigate cause-and-effect relationships between variables. This research method involves manipulating the independent variable and observing the effects on the dependent variable. Researchers use experimental research designs to test hypotheses and establish cause-and-effect relationships.

Survey Research

Survey research involves collecting data from a sample of individuals using a standardized questionnaire. This research method is used to gather information on attitudes, beliefs, and behaviors of individuals. Researchers use survey research to collect data quickly and efficiently from a large sample size. Survey research can be conducted through various methods such as online, phone, mail, or in-person interviews.

Quantitative Research Analysis Methods

Here are some commonly used quantitative research analysis methods:

Statistical Analysis

Statistical analysis is the most common quantitative research analysis method. It involves using statistical tools and techniques to analyze the numerical data collected during the research process. Statistical analysis can be used to identify patterns, trends, and relationships between variables, and to test hypotheses and theories.

Regression Analysis

Regression analysis is a statistical technique used to analyze the relationship between one dependent variable and one or more independent variables. Researchers use regression analysis to identify and quantify the impact of independent variables on the dependent variable.

Factor Analysis

Factor analysis is a statistical technique used to identify underlying factors that explain the correlations among a set of variables. Researchers use factor analysis to reduce a large number of variables to a smaller set of factors that capture the most important information.

Structural Equation Modeling

Structural equation modeling is a statistical technique used to test complex relationships between variables. It involves specifying a model that includes both observed and unobserved variables, and then using statistical methods to test the fit of the model to the data.

Time Series Analysis

Time series analysis is a statistical technique used to analyze data that is collected over time. It involves identifying patterns and trends in the data, as well as any seasonal or cyclical variations.

Multilevel Modeling

Multilevel modeling is a statistical technique used to analyze data that is nested within multiple levels. For example, researchers might use multilevel modeling to analyze data that is collected from individuals who are nested within groups, such as students nested within schools.

Applications of Quantitative Research

Quantitative research has many applications across a wide range of fields. Here are some common examples:

• Market Research : Quantitative research is used extensively in market research to understand consumer behavior, preferences, and trends. Researchers use surveys, experiments, and other quantitative methods to collect data that can inform marketing strategies, product development, and pricing decisions.
• Health Research: Quantitative research is used in health research to study the effectiveness of medical treatments, identify risk factors for diseases, and track health outcomes over time. Researchers use statistical methods to analyze data from clinical trials, surveys, and other sources to inform medical practice and policy.
• Social Science Research: Quantitative research is used in social science research to study human behavior, attitudes, and social structures. Researchers use surveys, experiments, and other quantitative methods to collect data that can inform social policies, educational programs, and community interventions.
• Education Research: Quantitative research is used in education research to study the effectiveness of teaching methods, assess student learning outcomes, and identify factors that influence student success. Researchers use experimental and quasi-experimental designs, as well as surveys and other quantitative methods, to collect and analyze data.
• Environmental Research: Quantitative research is used in environmental research to study the impact of human activities on the environment, assess the effectiveness of conservation strategies, and identify ways to reduce environmental risks. Researchers use statistical methods to analyze data from field studies, experiments, and other sources.

Characteristics of Quantitative Research

Here are some key characteristics of quantitative research:

• Numerical data : Quantitative research involves collecting numerical data through standardized methods such as surveys, experiments, and observational studies. This data is analyzed using statistical methods to identify patterns and relationships.
• Large sample size: Quantitative research often involves collecting data from a large sample of individuals or groups in order to increase the reliability and generalizability of the findings.
• Objective approach: Quantitative research aims to be objective and impartial in its approach, focusing on the collection and analysis of data rather than personal beliefs, opinions, or experiences.
• Control over variables: Quantitative research often involves manipulating variables to test hypotheses and establish cause-and-effect relationships. Researchers aim to control for extraneous variables that may impact the results.
• Replicable : Quantitative research aims to be replicable, meaning that other researchers should be able to conduct similar studies and obtain similar results using the same methods.
• Statistical analysis: Quantitative research involves using statistical tools and techniques to analyze the numerical data collected during the research process. Statistical analysis allows researchers to identify patterns, trends, and relationships between variables, and to test hypotheses and theories.
• Generalizability: Quantitative research aims to produce findings that can be generalized to larger populations beyond the specific sample studied. This is achieved through the use of random sampling methods and statistical inference.

Examples of Quantitative Research

Here are some examples of quantitative research in different fields:

• Market Research: A company conducts a survey of 1000 consumers to determine their brand awareness and preferences. The data is analyzed using statistical methods to identify trends and patterns that can inform marketing strategies.
• Health Research : A researcher conducts a randomized controlled trial to test the effectiveness of a new drug for treating a particular medical condition. The study involves collecting data from a large sample of patients and analyzing the results using statistical methods.
• Social Science Research : A sociologist conducts a survey of 500 people to study attitudes toward immigration in a particular country. The data is analyzed using statistical methods to identify factors that influence these attitudes.
• Education Research: A researcher conducts an experiment to compare the effectiveness of two different teaching methods for improving student learning outcomes. The study involves randomly assigning students to different groups and collecting data on their performance on standardized tests.
• Environmental Research : A team of researchers conduct a study to investigate the impact of climate change on the distribution and abundance of a particular species of plant or animal. The study involves collecting data on environmental factors and population sizes over time and analyzing the results using statistical methods.
• Psychology : A researcher conducts a survey of 500 college students to investigate the relationship between social media use and mental health. The data is analyzed using statistical methods to identify correlations and potential causal relationships.
• Political Science: A team of researchers conducts a study to investigate voter behavior during an election. They use survey methods to collect data on voting patterns, demographics, and political attitudes, and analyze the results using statistical methods.

How to Conduct Quantitative Research

Here is a general overview of how to conduct quantitative research:

• Develop a research question: The first step in conducting quantitative research is to develop a clear and specific research question. This question should be based on a gap in existing knowledge, and should be answerable using quantitative methods.
• Develop a research design: Once you have a research question, you will need to develop a research design. This involves deciding on the appropriate methods to collect data, such as surveys, experiments, or observational studies. You will also need to determine the appropriate sample size, data collection instruments, and data analysis techniques.
• Collect data: The next step is to collect data. This may involve administering surveys or questionnaires, conducting experiments, or gathering data from existing sources. It is important to use standardized methods to ensure that the data is reliable and valid.
• Analyze data : Once the data has been collected, it is time to analyze it. This involves using statistical methods to identify patterns, trends, and relationships between variables. Common statistical techniques include correlation analysis, regression analysis, and hypothesis testing.
• Interpret results: After analyzing the data, you will need to interpret the results. This involves identifying the key findings, determining their significance, and drawing conclusions based on the data.
• Communicate findings: Finally, you will need to communicate your findings. This may involve writing a research report, presenting at a conference, or publishing in a peer-reviewed journal. It is important to clearly communicate the research question, methods, results, and conclusions to ensure that others can understand and replicate your research.

When to use Quantitative Research

Here are some situations when quantitative research can be appropriate:

• To test a hypothesis: Quantitative research is often used to test a hypothesis or a theory. It involves collecting numerical data and using statistical analysis to determine if the data supports or refutes the hypothesis.
• To generalize findings: If you want to generalize the findings of your study to a larger population, quantitative research can be useful. This is because it allows you to collect numerical data from a representative sample of the population and use statistical analysis to make inferences about the population as a whole.
• To measure relationships between variables: If you want to measure the relationship between two or more variables, such as the relationship between age and income, or between education level and job satisfaction, quantitative research can be useful. It allows you to collect numerical data on both variables and use statistical analysis to determine the strength and direction of the relationship.
• To identify patterns or trends: Quantitative research can be useful for identifying patterns or trends in data. For example, you can use quantitative research to identify trends in consumer behavior or to identify patterns in stock market data.
• To quantify attitudes or opinions : If you want to measure attitudes or opinions on a particular topic, quantitative research can be useful. It allows you to collect numerical data using surveys or questionnaires and analyze the data using statistical methods to determine the prevalence of certain attitudes or opinions.

Purpose of Quantitative Research

The purpose of quantitative research is to systematically investigate and measure the relationships between variables or phenomena using numerical data and statistical analysis. The main objectives of quantitative research include:

• Description : To provide a detailed and accurate description of a particular phenomenon or population.
• Explanation : To explain the reasons for the occurrence of a particular phenomenon, such as identifying the factors that influence a behavior or attitude.
• Prediction : To predict future trends or behaviors based on past patterns and relationships between variables.
• Control : To identify the best strategies for controlling or influencing a particular outcome or behavior.

Quantitative research is used in many different fields, including social sciences, business, engineering, and health sciences. It can be used to investigate a wide range of phenomena, from human behavior and attitudes to physical and biological processes. The purpose of quantitative research is to provide reliable and valid data that can be used to inform decision-making and improve understanding of the world around us.

Advantages of Quantitative Research

There are several advantages of quantitative research, including:

• Objectivity : Quantitative research is based on objective data and statistical analysis, which reduces the potential for bias or subjectivity in the research process.
• Reproducibility : Because quantitative research involves standardized methods and measurements, it is more likely to be reproducible and reliable.
• Generalizability : Quantitative research allows for generalizations to be made about a population based on a representative sample, which can inform decision-making and policy development.
• Precision : Quantitative research allows for precise measurement and analysis of data, which can provide a more accurate understanding of phenomena and relationships between variables.
• Efficiency : Quantitative research can be conducted relatively quickly and efficiently, especially when compared to qualitative research, which may involve lengthy data collection and analysis.
• Large sample sizes : Quantitative research can accommodate large sample sizes, which can increase the representativeness and generalizability of the results.

Limitations of Quantitative Research

There are several limitations of quantitative research, including:

• Limited understanding of context: Quantitative research typically focuses on numerical data and statistical analysis, which may not provide a comprehensive understanding of the context or underlying factors that influence a phenomenon.
• Simplification of complex phenomena: Quantitative research often involves simplifying complex phenomena into measurable variables, which may not capture the full complexity of the phenomenon being studied.
• Potential for researcher bias: Although quantitative research aims to be objective, there is still the potential for researcher bias in areas such as sampling, data collection, and data analysis.
• Limited ability to explore new ideas: Quantitative research is often based on pre-determined research questions and hypotheses, which may limit the ability to explore new ideas or unexpected findings.
• Limited ability to capture subjective experiences : Quantitative research is typically focused on objective data and may not capture the subjective experiences of individuals or groups being studied.
• Ethical concerns : Quantitative research may raise ethical concerns, such as invasion of privacy or the potential for harm to participants.

About the author

Muhammad Hassan

Researcher, Academic Writer, Web developer

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Types Of Quantitative Research Methods: Use And Examples

Quantitative research plays a vital role in the comprehensive user research process. This approach involves numerical data derived exclusively from research findings, revealing numerous hidden aspects of customer behavior. However, many people struggle with finding the ideal ways to conduct such research while gathering the needed information. That’s why, in this article, we want to elaborate on the types of quantitative research methods, their use, and potential benefits. 

By giving you an insight into how the most commonly used quantitative data-collection methods work, you’ll have a better understanding of how to implement them in your next strategy. Furthermore, elaborating on the types of quantitative methods will highlight their significance and showcase their usability. Continue reading to discover the different ways you can conduct quantitative research and the methods behind it!

What is Quantitative Research?

Quantitative research is a data-driven analytical method that can be used to extract key information from a larger audience. Since it’s focused on numerical data, this research methodology may also serve as a robust tool for identifying relevant trends and patterns.

In contrast to qualitative research, quantitative research is most effective when applied to larger study groups. This approach achieves optimal results through the use of questions such as “How many?” and “How much?”. One notable advantage of employing quantitative research is its capacity to address complex issues and shed light on hidden factors often overlooked in qualitative studies. 

Moreover, it facilitates comparing results across various contexts, enhancing the testing process. As a result, this type of research proves highly valuable in many diverse fields, including healthcare, marketing, and economics.

While quantitative research is often considered easily analyzable through the use of specialized software, the real challenge stems from the limited contextual depth in the obtained findings. To address this constraint, many professionals choose a balanced approach by incorporating qualitative information, leading to the adoption of mixed methods.

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Types Of Quantitative Research Methods

If your primary objective is gathering quantitative data, it's essential to specify the type of research you are interested in. Remember that while one of these methods may work great for one business, it doesn’t always mean that you’ll achieve the same results. Thus, before choosing the ideal methodology and techniques, here are some of the most commonly used focus points for quantitative research you should know:

Correlation studies

Descriptive research.

• Experimental design

Quasi-experimental research

Correlation studies are used to evaluate the relationship between variables present during the research. By analyzing these connections, you can gain insights into user behaviors and preferences, aiding in the refinement of user experiences. Furthermore, correlation studies are particularly useful in interface design, by aiding in identifying design elements that significantly impact user satisfaction.

Descriptive research is used to measure variables and establish associations between them. Unlike correlational studies, it can’t establish the relationship between the variables and focuses on the characteristics of a subject without manipulating them. It’s also referred to as an observational study because it’s mostly used during case, cross-sectional, and prospective studies.

Experimental design 

Experimental design utilizes the scientific approach to test cause-and-effect relationships by manipulating variables. In user research, it allows you to actively change elements to observe their impact on user outcomes. This method helps uncover insights into what influences user experiences, providing a controlled approach for designing and refining user-centric solutions.

Quasi-experimental research explores the cause-and-effect relationships but lacks full control over variables as seen in experimental design. While one of the variables in the study is independent, the other is dependent. Furthermore, it compares groups undergoing different circumstances or treatments to draw statistical conclusions.

Quantitative Research Techniques

To successfully gather the needed data, there are different techniques you can try out. Even though some of them are also used for qualitative research, they’re known to drive great results for businesses. That being said, here are the best quantitative data-collection methods you should know:

Surveys and questionnaires

Observation.

The primary use of surveys and questionnaires in quantitative research lies in their ability to quantify opinions, attitudes, and behaviors across a broad spectrum. You can design closed-ended questions to elicit specific responses, making data analysis more efficient. Furthermore, this technique will enable you to conduct comparisons across different demographic groups and variables.

For that reason, many people turn to the use of cross-sectional and longitudinal surveys. The first option provides you with data from a diverse sample at a single point in time. These surveys efficiently capture a wide range of responses, allowing you a quick analysis and comparisons across different groups.

On the other hand, longitudinal surveys capture data from the same subjects over multiple points in time. This approach allows you to track changes, trends, and developments within a specific group. Thus, it offers a comprehensive understanding of how variables evolve over an extended period.

Image by Andreas Breitling from Pixabay

The second quantitative data-collection technique you can try out is user interviews . Similar to the previous option, you’ll have the opportunity to ask carefully crafted questions to the participants. However, this time you’ll be having a one-on-one meeting where you’ll be able to guide the conversation. 

When dealing with this type of research, there are two types of interviews you can implement. The first option is a structured interview, where participants are asked identical questions in a specific order. Employing a standardized set of predefined questions ensures consistency in data collection during the systematic gathering of numerical insights.

The second option is known as an unstructured interview and is used when the questions can be modified based on the participant’s response. Even though you can have a set of predefined questions at hand, most researchers tend to come up with suitable questions on the go. This flexible approach allows more open-ended questioning and in-depth exploration of participants' responses. Although they’re primarily considered a qualitative technique, these interviews can provide valuable insights for researchers seeking a deeper understanding of complex phenomena within a quantitative context.

The last effective data-collection method for this type of research is observation . Even though this technique is most commonly used for qualitative research, it can also be used in specific quantitative research scenarios. By providing a structured and systematic approach to assess user behavior you can derive measurable insights into usability, efficiency, and user interactions with a product or service.

This method allows you to collect objective data about task completion times, error rates, and other performance metrics, contributing to a quantitative understanding of usability. The numerical information obtained from quantitative observation enhances the reliability of findings, helping you make data-driven recommendations for optimizing user experiences. 

How to Choose the Right Quantitative Research Methods

Even after you’ve gathered all the necessary information, you may still be wondering about how to choose the right quantitative research methods for your case. The first thing you need to do is assess your research goals and objectives. This way, you can align the desired outcome with the ideal data-collection method to achieve optimal results.

For this reason, we recommend the use of the SMART framework. This helps you focus on gathering insights that are:

Furthermore, we also advise you to choose the ideal data-collection methods based on the information you want to acquire. Always be mindful of the questions you need to ask the participants by preparing them in advance. 

Lastly, remember that the gathered data has to be analyzed if you want to gain valuable insights from it. Even though the numerical findings may require specific software for detailed analysis, you can also make use of various online tools. If you want to implement the power of AI during the process, check out the features we offer at User Evaluation for fast and efficient user research. 

After learning about the different types of quantitative research methods, we highly advise you to try the ones we’ve mentioned throughout the article. By keeping your research objectives in mind, you should always choose the option that will benefit your business the most. So, take the time to evaluate your circumstances and decide on the type of data you need.

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• Volume 22, Issue 3
• Triangulation in research, with examples
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• Helen Noble 1 ,
• Roberta Heale 2
• 1 School of Nursing and Midwifery , Queens University Belfast , Belfast , UK
• 2 School of Nursing , Laurentian University , Sudbury , Ontario , Canada
• Correspondence to Dr Helen Noble, School of Nursing and Midwifery, Queen’s University Belfast, Belfast BT7 1NN, UK; helen.noble{at}qub.ac.uk

https://doi.org/10.1136/ebnurs-2019-103145

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What is triangulation

Triangulation is a method used to increase the credibility and validity of research findings. 1 Credibility refers to trustworthiness and how believable a study is; validity is concerned with the extent to which a study accurately reflects or evaluates the concept or ideas being investigated. 2 Triangulation, by combining theories, methods or observers in a research study, can help ensure that fundamental biases arising from the use of a single method or a single observer are overcome. Triangulation is also an effort to help explore and explain complex human behaviour using a variety of methods to offer a more balanced explanation to readers. 2 It is a procedure that enables validation of data and can be used in both quantitative and qualitative studies.

Four types of triangulation are proposed by Denzin (p.301): 5 (1) data triangulation, which includes matters such as periods of time, space and people; (2) investigator triangulation, which includes the use of several researchers in a study; (3) theory triangulation, which encourages several theoretical schemes to enable interpretation of a phenomenon and (4) methodological triangulation, which promotes the use of several data collection methods such as interviews and observations.

Examples of studies using triangulation

Below, we offer two examples of triangulation within research studies, providing a context for each study and a description of how triangulation was used and successfully implemented to ensure an in-depth and more unbiased set of findings.

Johnson et al ,s 6 qualitative study aimed to identify system influences on decision making in a pre-hospital setting with paramedics. Several data sets were included and comprised exploratory interviews with ambulance service staff (n=16); document review observations of paramedic shifts (n=34); paramedic accounts (n=10) via audio-recorded ‘digital diaries’; staff focus groups (n=3) and service user focus groups (n=3) to explore a range of experiences and perceptions. The approach followed Denzin’s 5 multiple triangulation approach, which encourages several methods to collect data and multiple investigators with varied expertise.

Phase I of the study focused on understanding the context of the study and included interviews with ambulance service staff and the collection of demographics and local policies. The second phase involved observation of paramedics’ daily work in order to throw light on decisions related to transporting patients. Focus groups with paramedics, followed by focus groups with service users were then completed in order to share personal experiences of the decisions made by the ambulance service in practice. The final phase included workshops to feed back findings.

Data were coded and thematically analysed. The observations of paramedic shifts identified the complexities of the decision-making process related to the context. The observations were supplemented by the interviews and focus groups. Each research method exposed one aspect of reality. 5 This multimethod, multidisciplinary collaborative research was insightful. It permitted cross-validation, and facilitated exploration, of issues that influenced the decision making of paramedics and concerns and experiences of service users.

A study was undertaken to explore the quality of care for patients in a unique model of primary healthcare in Ontario, Canada: the Nurse Practitioner-Led Clinic (NPLC) 7 . The focus was on the care of patients with diabetes and at least one additional chronic condition, with the assumption that this group of patients represents those with the most complex clinical presentations managed in family practice settings. A multiple case study design was chosen for this research because with this approach, analysis of a variety of data arising from several NPLCs allowed for assumptions to be made about the model as a whole. 7 Additionally, both qualitative and quantitative research methods were used in the study. Mixing methods is a form of triangulation in research seen as mitigating the weaknesses found in single methods. 8

The first research method was a chart audit, conducted on randomly selected charts of adult patients in five NPLCs who had diabetes and at least one additional chronic condition. The variables included demographic items as well as clinical data related to the care of patients with diabetes. The data were analysed to determine the completeness of the care of diabetes for the subjects. 9

The second research method was interviews with nurse practitioners (NPs) working at the five NPLCs to determine their perceptions of the quality of care delivered in the NPLC model for patients with diabetes and other chronic conditions. Data from the interviews were analysed using the processes related to an integrative description design. 10 The draft themes arising from the analysis were forwarded to the participants for their feedback and were confirmed through a review of literature. Finally, a detailed document search was undertaken, including but not limited to academic articles, media releases and articles, letters to editor, government policy statements and publications released from the NPLCs. These data were used to confirm and support the findings of the chart review and NP interviews, representing triangulation.

With analysis completed separately for the qualitative and quantitative parts of the study, the final step was analysis of the NPLCs individually and then as a group. An extensive analysis process arising from Stake’s multiple case methodology was implemented. 11 This process included coding and identification of themes for individual NPLCs, then across the NPLC model as a whole. The final product represented triangulation in that each final theme represented analysis of data from at least two data sources, and literature was used to further support these conclusions.

Limitations of triangulation

Triangulation offers richness and clarity to research studies 8 but also has limitations. It adds to the complexity of the research making it more time-consuming. 6 When used as a method for combining research methodologies, triangulation may not be achieved in a uniform or consistent manner. Additionally, researchers may not adequately explain their techniques for blending results. 12 In addition, theremay be times when comparison of the findings of two sources is inconsistent or conflicting. Triangulation does not always adequately mitigate problems in a chosen research methodology. The processes of triangulation are complex and require a skilled analyst. Finally, the value of triangulation may be overestimated in some studies. 13

• Carvalho S ,
• Rothbauer P
• Johnson M ,
• Hirst E , et al
• Wenghofer E ,
• James S , et al
• Wenghofer E , et al
• Thurmond VA

Competing interests None declared.

Provenance and peer review Not commissioned; internally peer reviewed.

Patient consent for publication Not required.

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Open Access

Peer-reviewed

Research Article

Factors influencing the participation of pregnant and lactating women in clinical trials: A mixed-methods systematic review

Contributed equally to this work with: Mridula Shankar, Alya Hazfiarini

Roles Data curation, Formal analysis, Methodology, Project administration, Validation, Visualization, Writing – original draft, Writing – review & editing

* E-mail: [email protected]

Affiliation Gender and Women’s Health Unit, Nossal Institute for Global Health, School of Population and Global Health, University of Melbourne, Carlton, Victoria, Australia

Roles Formal analysis, Methodology, Validation, Visualization, Writing – original draft, Writing – review & editing

Roles Formal analysis, Methodology, Writing – review & editing

Roles Methodology, Writing – review & editing

Affiliation Maternal, Child and Adolescent Health Program, Burnet Institute, Melbourne, Victoria, Australia

Roles Data curation, Methodology, Writing – review & editing

Affiliation University Library, University of Melbourne, Carlton, Victoria, Australia

Affiliation Women’s and Children’s Health Research Unit, KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi, Karnataka, India

Affiliation Concept Foundation, Geneva, Switzerland/Bangkok, Thailand

Roles Conceptualization, Funding acquisition, Methodology, Writing – review & editing

Roles Conceptualization, Data curation, Formal analysis, Funding acquisition, Methodology, Supervision, Validation, Writing – original draft, Writing – review & editing

• Mridula Shankar, 
• Alya Hazfiarini, 
• Rana Islamiah Zahroh, 
• Joshua P. Vogel, 
• Annie R. A. McDougall, 
• Patrick Condron, 
• Shivaprasad S. Goudar, 
• Yeshita V. Pujar, 
• Manjunath S. Somannavar, 

• Published: May 30, 2024
• https://doi.org/10.1371/journal.pmed.1004405
• Peer Review
• Reader Comments

Poor representation of pregnant and lactating women and people in clinical trials has marginalised their health concerns and denied the maternal–fetal/infant dyad benefits of innovation in therapeutic research and development. This mixed-methods systematic review synthesised factors affecting the participation of pregnant and lactating women in clinical trials, across all levels of the research ecosystem.

Methods and findings

We searched 8 databases from inception to 14 February 2024 to identify qualitative, quantitative, and mixed-methods studies that described factors affecting participation of pregnant and lactating women in vaccine and therapeutic clinical trials in any setting. We used thematic synthesis to analyse the qualitative literature and assessed confidence in each qualitative review finding using the GRADE-CERQual approach. We compared quantitative data against the thematic synthesis findings to assess areas of convergence or divergence. We mapped review findings to the Theoretical Domains Framework (TDF) and Capability, Opportunity, and Motivation Model of Behaviour (COM-B) to inform future development of behaviour change strategies.

We included 60 papers from 27 countries. We grouped 24 review findings under 5 overarching themes: (a) interplay between perceived risks and benefits of participation in women’s decision-making; (b) engagement between women and the medical and research ecosystems; (c) gender norms and decision-making autonomy; (d) factors affecting clinical trial recruitment; and (e) upstream factors in the research ecosystem. Women’s willingness to participate in trials was affected by: perceived risk of the health condition weighed against an intervention’s risks and benefits, therapeutic optimism, intervention acceptability, expectations of receiving higher quality care in a trial, altruistic motivations, intimate relationship dynamics, and power and trust in medicine and research. Health workers supported women’s participation in trials when they perceived clinical equipoise, had hope for novel therapeutic applications, and were convinced an intervention was safe. For research staff, developing reciprocal relationships with health workers, having access to resources for trial implementation, ensuring the trial was visible to potential participants and health workers, implementing a woman-centred approach when communicating with potential participants, and emotional orientations towards the trial were factors perceived to affect recruitment. For study investigators and ethics committees, the complexities and subjectivities in risk assessments and trial design, and limited funding of such trials contributed to their reluctance in leading and approving such trials. All included studies focused on factors affecting participation of cisgender pregnant women in clinical trials; future research should consider other pregnancy-capable populations, including transgender and nonbinary people.

Conclusions

This systematic review highlights diverse factors across multiple levels and stakeholders affecting the participation of pregnant and lactating women in clinical trials. By linking identified factors to frameworks of behaviour change, we have developed theoretically informed strategies that can help optimise pregnant and lactating women’s engagement, participation, and trust in such trials.

Author summary

Why was this study done.

• Pregnant and lactating women and people are routinely excluded from participating in drug and vaccine clinical trials, resulting in limited options for prevention and treatment of medical conditions.
• Challenges to including pregnant and lactating women and people in clinical research have been identified at multiple levels of the research and health systems, but the full range of barriers and facilitators to participation are not well known.

What did the researchers do and find?

• We conducted a mixed-methods systematic review and identified 60 research articles from 27 countries on the views and experiences of pregnant and lactating women’s participation in clinical research, from the perspectives of cisgender women, family and community members, health workers, and people involved in the conduct of clinical research.
• Using a thematic synthesis approach, we identified barriers affecting participation including women having a limited appetite for risk during pregnancy and lactation, concerns about women’s bodily autonomy during pregnancy, and challenges in obtaining ethical approval for clinical research with pregnant women.
• We also identified facilitators of participation including the potential for personal health benefits, expectations of higher quality care, trust in the medical and research systems, and strong teamwork between researchers and health workers.

What do these findings mean?

• Our findings demonstrate the need for multipronged strategies to address barriers and reinforce facilitators across the various levels of the research and health systems.
• The actions that are needed to overcome these barriers and reinforce facilitators must be discussed, prioritised, and adapted to specific contexts.
• All included studies focused on factors affecting participation of cisgender pregnant women in clinical trials; future research should consider other pregnancy-capable populations, including transgender and nonbinary people.

Citation: Shankar M, Hazfiarini A, Zahroh RI, Vogel JP, McDougall ARA, Condron P, et al. (2024) Factors influencing the participation of pregnant and lactating women in clinical trials: A mixed-methods systematic review. PLoS Med 21(5): e1004405. https://doi.org/10.1371/journal.pmed.1004405

Received: December 20, 2023; Accepted: April 19, 2024; Published: May 30, 2024

Copyright: © 2024 Shankar et al. This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Data Availability: All relevant data are within the manuscript and its Supporting Information files.

Funding: The research in this publication was supported by funding from MSD (grant MFM-22-159697 to Concept Foundation), through its MSD for Mothers initiative ( https://www.msdformothers.com/ ) and is the sole responsibility of the authors. MSD for Mothers is an initiative of Merck & Co., Inc., Rahway, NJ, U.S.A. MAB’s time is supported by an Australian Research Council Discovery Early Career Researcher Award (DE200100264) and a Dame Kate Campbell Fellowship (University of Melbourne Faculty of Medicine, Dentistry and Health Sciences). JPV is supported by an Australian National Health and Medical Research Council (NHMRC) Investigator grant (GNT1194248). The funders had no role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Competing interests: The authors have declared that no competing interests exist.

Abbreviations: BCW, Behaviour Change Wheel; COM-B, Capability, Opportunity, and Motivation Model of Behaviour; MMAT, Mixed Methods Appraisal Tool; TDF, Theoretical Domains Framework

Introduction

Clinical trials are the foundation for knowledge on the efficacy and safety of biomedical interventions to protect health and treat illness. The fundamental questions of who participates and whose data contributes to trials have implications for understanding the risks and benefits of interventions, and the societal value of such interventions to specific populations. Pregnant and lactating women and people have long been underrepresented or excluded entirely from participating in therapeutic and vaccine clinical trials [ 1 ]. Notwithstanding valid concerns regarding fetal and infant safety, an outright exclusionary response to this complex issue has denied the maternal–fetal/infant dyad the health benefits of biomedical innovation, despite demonstrated public health need [ 2 , 3 ]. As a recent example, during the COVID-19 pandemic, pregnant women and people were excluded from early therapeutic and vaccine trials despite greater severity of infection-related illness [ 4 – 9 ].

Including pregnant and lactating women and people as research participants is vital: pregnancy is a unique physiological state where the body undergoes adaptations that can lead to pregnancy-specific disorders or worsen preexisting conditions [ 10 ]. These changes can influence how effective a drug is, whether and how the body responds to the drug, and the dosages at which the drug is optimally effective and minimally harmful. Most pregnant women take at least 1 medication during pregnancy [ 11 ], yet many of these medications are provided with limited information on efficacy, appropriate dosing, and safety in these populations [ 1 ]. Pregnant and lactating women with preexisting illnesses may also be advised to discontinue medications to minimise potential harms, without full appreciation of the possible consequences of unmedicated disease progression [ 12 ].

The current state of maternal health and the limited therapeutic options available for pregnant and lactating populations illustrates the consequences of these evidence gaps. Each year, complications of pregnancy and childbirth result in approximately 287,000 maternal deaths [ 13 ], 1.9 million stillbirths [ 14 ], and 2.3 million neonatal deaths [ 15 ]. Most of these deaths occur from preventable or treatable obstetric causes (e.g., postpartum haemorrhage, preeclampsia/eclampsia, sepsis) that are generally treated using repurposed medications that were originally developed and approved for use in other non-obstetric conditions [ 16 ]. Over the past 3 decades, only 2 drugs have been registered to specifically treat pregnancy-related complications: Atosiban—a tocolytic to prevent preterm birth, and Carbetocin—an oxytocin analogue for managing postpartum haemorrhage [ 17 ]. Pregnancy-specific medicines rarely progress through the research and development pipeline due to a multitude of factors, including the absence of public stewardship, chronic underinvestment, and regulatory and market barriers [ 18 , 19 ]. Maternal mortality rates have largely remained static in the Sustainable Development Goal era: progress has halted or reversed in 150 countries [ 13 ]. Without significant investments in pharmaceutical development, the 2030 target of a global maternal mortality ratio less than 70 maternal deaths per 100,000 live births [ 20 ] is unlikely to be achieved.

Poor representation of pregnant and lactating women and people in clinical research, and the absence of a pregnancy-focused research and development agenda violates fundamental ethical principles of justice and equity [ 12 , 21 ]. Challenges to equitable inclusion operate across all research stages: “upstream” barriers include a lack of appropriate animal models, pharmaceutical industry risk aversion, and clinical trials and liability insurance challenges [ 12 , 18 , 22 , 23 ]. “Downstream” barriers include perceptions that pregnant and lactating women do not want to take part in clinical trials, or that their inclusion makes research activities too risky or onerous [ 23 ]. Overall, there is a lack of a comprehensive understanding of the full range of these factors from the perspectives of key stakeholder groups. This mixed-methods systematic review seeks to address this gap by synthesising current research evidence on factors (i.e., barriers and facilitators) affecting the participation of pregnant and lactating women in vaccine and therapeutic clinical trials. We use behavioural [ 24 , 25 ] frameworks to provide a theory-informed basis for the development and implementation of appropriate behaviour change intervention strategies to promote their meaningful inclusion.

This review is reported using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines ( S1 Appendix ), Enhancing Transparency in Reporting the Synthesis of Qualitative Research (ENTREQ) statement ( S2 Appendix ), and based on guidance from the Cochrane Effective Practice and Organisation of Care group [ 26 ]. The protocol has been registered (PROSPERO: CRD42023462449).

Types of studies

We included primary qualitative, quantitative, and mixed-methods studies. There were no limitations on publication date, language, or country.

We excluded publications that were not primary research, including conceptual scholarship on the ethics of inclusion/exclusion, case reports, reviews, commentaries, short communications, editorials, news articles, letters to the editor, conference abstracts, workshop summaries, theses or dissertations, book chapters, book reviews, and regulatory or committee guidance or decisions.

Topic of interest

This review focuses on systematically identifying the factors, including barriers and facilitators, influencing the participation of pregnant and lactating women in drug or vaccine trials (i.e., therapeutic or prophylactic trials). We recognise that people who are capable of pregnancy have diverse gender identities. We use the terminology “pregnant and lactating women,” acknowledging that empirical literature on this topic has been focused on the experiences of cisgender women. Extrapolating these data to apply to people with other gender identities may lead to inaccurate or incomplete conclusions.

We included studies that described the attitudes, perspectives, and experiences of multiple stakeholders: women who participated and declined participation in clinical trials during pregnancy and lactation, partners or husbands, family members, community leaders, health workers, research staff, study investigators, ethics committee members, regulators, funders, pharmaceutical representatives, policy makers, and other relevant stakeholders.

We excluded the following types of interventions from this review: (a) lifestyle or behavioural interventions; (b) trials of diagnostics or medical devices; (b) workforce interventions to improve clinical care outcomes; (c) alternative or complementary medicine; (d) trials evaluating health policies or clinical protocols; (e) fetal tissue research, bio-banking, and genetic testing; (f) facilitators and barriers to engaging pregnant women in observational research; (g) supports to clinicians or pregnant or lactating women regarding decision-making on medication; and (h) research solely focused on substance use prevention and treatment, due to the particularly distinct barriers and facilitators given overlapping vulnerabilities among substance-using pregnant women, and unique considerations in relation to fetal health such as in utero exposure to alcohol and other substances. We also excluded clinical trial protocols and publications of randomised controlled trials that did not contain data related to facilitators or barriers to trial participation.

Search methods for identification of relevant studies

We searched 8 databases from inception to 14 February 2024: MEDLINE (Ovid), CINAHL Complete, Family & Society Studies Worldwide, SocINDEX, Scopus, Web of Science Core Collection, Embase (Ovid), and Global Health (Ovid). PC, an Information Specialist developed the final search strategy ( S3 Appendix ), using a combination of terms relevant to pregnant and lactating women, and perspectives and experiences of stakeholders regarding their inclusion/exclusion and participation in drug or vaccine clinical trials. No restrictions were placed on publication year, language, or geographical setting.

Selection of studies

We imported the search results into Covidence [ 27 ] and removed duplicates. Five review authors (MS, AH, MAB, AM, and AA) independently screened titles and abstracts. Titles and abstracts of non-English publications were screened with the assistance of Google Translate. Three reviewers (MS, AH, and AM) independently reviewed full texts. One French publication that met the inclusion criteria was translated to English using ChatGPT [ 28 ], and translation accuracy was subsequently verified with a native French speaker in our research network. At each screening stage, differences in decisions regarding record inclusion were resolved through discussion and final decisions were made through consensus with a third review author (MAB).

Data extraction and assessing methodological limitations

Two review authors (MS and AH) extracted relevant data, including study aims, methodological characteristics, geographical settings, population of interest (pregnant women, lactating women, or both), intervention type (therapy or vaccine), specific areas of research, and study findings (author-generated themes, supporting explanations, participant quotes, survey results, and relevant tables and figures). We developed a data extraction form and refined it by extracting data from a subset of 6 studies. All extracted data was cross-checked for accuracy and completeness, and differences resolved via consensus.

Two reviewers (MS and AH) independently assessed the methodological limitations of each study using an adapted Mixed Methods Appraisal Tool (MMAT) [ 29 ]. For qualitative studies, evaluative criteria included alignment of methodology and data collection with research aims, rigour in data analysis and reporting of study findings, ethical considerations, and researcher reflexivity. We assessed quantitative studies based on the suitability of sampling strategy, reporting on sample representativeness, use of appropriate measures, level of nonresponse bias, ethical considerations, and relevance of statistical analyses conducted. In addition to the aforementioned criteria, we assessed mixed-methods studies to determine whether authors demonstrated sufficient rationale for the use of a mixed-methods approach, effectiveness of integration of study components and outputs, and discussion of data triangulation. All differences in assessments between the 2 review authors were resolved through discussion. The assessment of methodological limitations did not affect the inclusion or exclusion of studies but rather served as a mechanism for determining confidence in the evidence.

Data analysis and synthesis

We used a thematic synthesis approach to analyse qualitative data [ 30 ]. After selecting 6 data-rich studies, 2 reviewers (MS and AH) independently applied line-by-line coding to the textual data to create summative codes. Codes were discussed for consistency in meaning and refined if necessary. The remaining studies were each coded by one of the 2 reviewers, and new codes were added as necessary. Through discussion, we subsumed codes of similar meaning under broader categories, gradually developing “summary layers” in a hierarchical grouping structure. We applied the gender domains of the gender analysis matrix [ 31 ] as a lens to our findings to understand how our data on factors influencing participation were shaped by aspects such as distribution of labour and roles, gender norms and beliefs, access to resources, decision-making power, and institutional policies. We consolidated our results into a set of 5 overarching themes and 24 review findings through an iterative process of identifying, comparing, and discussing conceptual boundaries between and among thematic data outputs.

Two review authors (MS and AH) used the GRADE-CERQual (Confidence in the Evidence from Reviews of Qualitative research) approach [ 32 , 33 ] to assess our confidence in each of the 24 qualitative review findings. GRADE-CERQual assesses confidence in the evidence, based on the following 4 key components [ 26 ]:

• methodological limitations of included studies [ 34 ];
• coherence of the review finding [ 35 ];
• adequacy of the data contributing to the review finding [ 36 ]; and
• relevance of the included studies to the review question [ 37 ].

After assessing each component, we made a judgement via consensus about the overall confidence—rated as high, moderate, low, or very low—in the evidence supporting the review finding [ 32 ]. Detailed descriptions of the GRADE-CERQual assessments are in S4 Appendix .

We then mapped data from the quantitative studies onto the findings of the qualitative evidence synthesis, and determined areas of convergence or divergence, and whether any additional factors arose that had previously not been discussed. We regarded the quantitative data as (a) “supporting” of a qualitative evidence synthesis finding if the information synthesised from the contributory quantitative studies were similar to the finding; (b) “extending” if the data offered additional details in line with a review finding; and (c) “contradictory” if the data conflicted with a review finding. Summaries of the quantitative findings are presented in S5 Appendix .

Finally, we mapped our review findings to the Theoretical Domains Framework (TDF) [ 24 ] and the Capability, Opportunity, and Motivation (COM-B) [ 25 ] models of behavioural determinants and the Behaviour Change Wheel (BCW) to identify and provide a rational basis for the development and implementation of appropriate behaviour change strategies.

Review team and reflexivity

The review author team has diverse personal backgrounds, including gender, personal experiences of pregnancy, countries of origin and residence, and linguistic traditions. Our professional and academic backgrounds and experiences are varied, and include the social, behavioural, and biomedical sciences, medicine, clinical epidemiology, and public health. Some review authors have led and implemented trials in maternal and perinatal health. As an interdisciplinary team with diverse social and professional backgrounds, we maintained a reflexive stance through all stages of the review process by engaging in multiple reflective dialogues to interrogate and interpret the data and findings. Through this process, we named and critiqued assumptions that underpinned the analysis and challenged disciplinary biases. In doing so, we aimed to develop review findings that were inclusive of different disciplinary lenses.

Sixty papers from 53 studies met the inclusion criteria [ 38 – 97 ]. Fig 1 presents the PRISMA flowchart. Table 1 reports the summary characteristics of included papers and S6 Appendix includes more detailed individual characteristics of the included papers.

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Description of papers

Thirty-nine papers used qualitative methodologies [ 39 , 40 , 42 – 48 , 53 , 54 , 56 – 66 , 69 , 70 , 72 – 74 , 78 , 81 , 82 , 84 – 87 , 89 – 92 , 96 ], 18 papers used quantitative methodologies [ 38 , 41 , 50 – 52 , 67 , 68 , 71 , 75 – 77 , 79 , 80 , 88 , 93 – 95 , 97 ], and 3 papers used mixed-methods study designs [ 49 , 55 , 83 ].

The 60 papers present data from 27 countries and 4 geographic regions: 13 countries in Africa [ 44 – 47 , 65 , 73 , 78 , 84 , 85 ], 8 countries in Europe [ 38 , 39 , 41 , 48 – 50 , 53 – 56 , 58 , 59 , 61 , 62 , 64 , 67 – 69 , 72 , 74 , 80 – 83 , 86 , 89 , 90 , 92 , 94 , 96 ], 3 countries in the Americas [ 42 , 43 , 51 , 52 , 57 , 60 , 63 , 66 , 70 , 71 , 75 , 77 , 79 , 85 , 88 , 91 , 93 , 95 ], and 3 countries in the Western Pacific [ 40 , 76 , 87 , 97 ].

Fifty-one papers focused on pregnant women only [ 38 – 41 , 44 , 47 – 50 , 52 , 53 , 55 – 70 , 72 – 94 , 97 ], 2 papers focused on lactating women only [ 46 , 96 ], and 7 papers focused on pregnant and lactating women [ 42 , 43 , 45 , 51 , 54 , 71 , 95 ]. Thirty-seven papers addressed a therapeutic drug-related intervention [ 38 , 40 , 41 , 44 – 49 , 53 , 56 , 59 – 62 , 66 , 69 , 70 , 72 , 73 , 77 , 79 – 90 , 92 , 93 , 96 , 97 ], 11 papers focused on a vaccine-related intervention [ 50 , 51 , 55 , 57 , 58 , 63 , 64 , 67 , 68 , 78 , 94 ], and 12 papers were about pregnant and/or lactating women’s participation in interventional clinical trials generally [ 39 , 42 , 43 , 52 , 54 , 65 , 71 , 74 – 76 , 91 , 95 ].

Twenty-five papers included perspectives of pregnant women [ 38 , 45 , 47 , 48 , 51 , 57 , 58 , 60 , 61 , 64 , 65 , 67 , 71 – 75 , 77 , 85 , 89 – 91 , 94 , 95 , 97 ], 28 papers included perspectives of postpartum women [ 39 – 41 , 44 – 46 , 49 , 51 , 56 , 57 , 59 , 62 , 63 , 69 – 71 , 74 , 79 – 87 , 92 , 95 ], and 14 papers included health workers’ perspectives [ 44 , 47 , 50 , 52 – 54 , 61 , 64 , 65 , 67 , 87 , 88 , 91 , 94 ]. For other stakeholder groups, please refer to Table 1 .

Methodological limitations of included studies

Assessments of methodological limitations of the included studies are available in S7 Appendix . Across qualitative studies, the most common methodological limitations concerned recruitment approaches and strategies, descriptions of analytical methods, ethical considerations, specifically steps or precautions taken to protect from loss of privacy and confidentiality, data security and integrity, and most studies did not include a reflexivity statement. Across quantitative studies, authors rarely reported on indicators of sample representativeness of the target population, most did not report on or were judged at high risk of nonresponse bias, and ethical considerations pertaining to data security and integrity were frequently missing. For the 3 mixed-methods studies, limitations were identified at the level of integrating methodological approaches at the methods, interpretation, and reporting levels.

Themes and findings from the qualitative and quantitative evidence synthesis

We developed 5 overarching themes and 24 review findings in the qualitative evidence synthesis ( Table 2 ):

• interplay between perceived risks and benefits of participation in women’s decision-making (9 review findings);
• engagement between women and the medical and research ecosystems (2 review findings);
• gender norms and decision-making autonomy (3 review findings);
• factors affecting clinical trial recruitment (7 review findings); and
• upstream factors in the research ecosystem (3 review findings).

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We graded 6 review findings as high confidence, 11 as moderate confidence, and 7 as low confidence. An explanation for each GRADE-CERQual assessment is presented in the evidence profile ( S4 Appendix ).

Interplay between perceived risks and benefits of participation in women’s decision-making

Findings 1 to 9 are categorised under this theme with 48 studies exploring women’s perspectives on clinical trial participation and factors influencing their decision-making. These factors include balancing risks and benefits, experiences and expectations of high quality care, understanding of study design features, acceptability and stigma associated with the intervention, altruistic motivations and financial incentives.

Finding 1 : Women have a limited appetite and higher perception of risk during pregnancy or lactation . Perception of risks influenced pregnant and lactating women’s willingness to participate in trials, which varied based on their individual levels of risk tolerance, previous trial experiences, observations of others’ experiences, stage of pregnancy or lactation, existing health conditions, and a sense of responsibility for their health and that of the fetus/infant. Women were more likely to decline participation if the experimental intervention was previously untested and were more confident to participate when convinced of no harm (high confidence) [ 39 , 40 , 47 , 48 , 57 , 58 , 60 , 63 – 65 , 69 , 72 , 74 , 83 , 84 , 87 , 89 , 91 , 92 , 96 ].

The most salient factors affecting perceptions of risk were concerns of potential harm to the fetus or baby, including in the longer term, and fears of side-effects [ 39 , 48 , 57 , 58 , 60 , 63 , 69 , 72 , 74 , 83 , 84 , 87 , 89 , 91 , 92 , 96 ]. The uncertainty of these negative outcomes contributed to women’s reluctance to take medications [ 48 , 64 , 69 , 72 ] or participate in experimental interventions, with some likening the experience to being treated as “guinea pigs” [ 39 , 56 , 58 , 69 , 90 ]. Women willing to consider participation wanted proof of safety from previous research evidence [ 57 , 58 , 84 ], online resources [ 96 ], discussions with research staff and health workers [ 96 ], and knowing the experiences of others who had taken the intervention [ 47 , 96 ].

Quantitative evidence supported the qualitative findings that women were apprehensive about taking an experimental product during pregnancy or lactation [ 79 ] primarily due to concerns of fetal or infant harm [ 38 , 51 , 67 , 71 , 75 , 83 , 94 , 95 ], side-effects [ 77 , 80 ], and the possibility of unknown longer-term negative sequelae [ 67 , 75 , 77 ]. Prior knowledge of the health condition [ 68 ], information about drug safety in pregnant and nonpregnant populations [ 51 ], and information that large numbers of pregnant women had already enrolled in the trial [ 67 ] were factors that increased willingness to participate.

Finding 2 : Making trade-offs between risk and severity of the condition and risk-benefit ratio of intervention . Before participating, women weighed the risk of their medical condition and its impact, especially on the baby, against the risks of an intervention and its potential benefits. Women were less likely to participate if they felt healthy or perceived themselves at low risk of experiencing or being negatively affected by the condition, believed they had nothing to gain from participating, or felt concerned that the intervention risks were too high (moderate confidence) [ 39 , 48 , 57 – 60 , 63 , 64 , 69 , 72 , 74 , 87 , 91 , 96 ].

Women were more willing to participate when they had concerns about their risk factors [ 70 ], had previously experienced the condition [ 48 , 70 ], or personally knew someone who had [ 48 ], were anxious about the baby suffering health problems [ 57 – 60 ], or perceived the intervention to be helpful based on past use [ 87 ], or the only course of action to avoid (further) ill-health [ 57 – 59 , 63 , 91 ]. For some women with preconceived notions that research entailed significant risks, their perceptions did not change in the presence of information, including about intervention safety [ 48 ].

Quantitative evidence supported the qualitative findings that, when coupled with risks that were considered minimal or manageable [ 83 ], women with greater knowledge about [ 83 ] or direct exposure to the condition [ 94 ] were more likely to participate in a vaccine or therapeutic trial. However, prior exposure to the medical condition did not consistently lead to higher participation in trials [ 51 ].

Finding 3 : Benefits to health arising from participation . A key motivating factor for pregnant and lactating women to participate in trials was the expectation of personal health benefits, such as improved knowledge about how the condition affected them, protecting their fetus or infant from harm, and reducing mother-to-child disease transmission. When women saw the potential for these benefits, deciding not to participate was viewed as potentially putting the baby’s life at risk (high confidence) [ 40 , 47 , 55 , 60 , 61 , 63 , 64 , 70 , 73 , 83 , 84 , 87 , 90 – 92 , 96 ].

Quantitative evidence supported this finding that women were more willing to participate in a trial when they were convinced about the potential short and longer-term benefits of the intervention for the health of the fetus [ 38 , 51 , 75 , 77 , 80 ], and their own health [ 38 , 41 , 51 , 75 , 80 , 95 ] and education [ 41 , 95 ].

Finding 4 : Experiences and expectations of high-quality care motivate participation . Pregnant and lactating women were motivated to participate as a token of appreciation to health workers who provided good quality care. Additionally, women were more likely to participate when they perceived that it would result in higher quality clinical care or access to vaccines or therapeutic products that had previously been denied or were otherwise not accessible outside the context of a trial (high confidence) [ 39 , 48 , 49 , 60 , 63 , 70 , 72 , 83 , 84 , 86 , 87 , 92 , 96 ].

In addition to free medications and vaccines, women’s perceptions of higher quality care were linked to greater frequency of diagnostic and monitoring tests [ 72 , 83 , 84 , 92 ], detailed information regarding care provided [ 63 ], and closer and continuous clinical observation [ 49 , 63 , 70 , 92 ]. Occasionally, women perceived care associated with a trial as lower quality due to the “experimental” nature of the intervention [ 39 ].

Quantitative evidence supported the qualitative finding that women expected trial participation to engender more and better quality care through enhanced monitoring [ 38 , 41 , 67 , 68 , 80 ], more tests [ 67 ], better therapeutic treatment [ 38 , 49 ], and the general feeling of being provided a high standard of medical care [ 51 , 75 , 80 ].

Finding 5 : Knowledge of the rationale for study design features . The rationale behind certain trial design features such as randomisation, blinding or inclusion of a placebo arm could be a source of confusion, concern, or reassurance for potential participants, impacting their decisions to participate. These features could be viewed as preferential treatment of one group over another, adding burden with little opportunity for personal benefit, a mechanism to reduce bias or conversely for researchers to avoid accountability for an adverse outcome (moderate confidence) [ 39 , 40 , 45 , 59 , 62 , 63 , 69 , 72 , 74 , 87 , 91 , 92 ].

Quantitative evidence extended understanding of women’s views about participation in placebo-controlled trials. Some women expressed reluctance to participate due to the possibility of being assigned to the control or placebo group [ 67 , 77 , 79 , 83 ]. However, others expressed that the uncertainty of assignment would not affect their decision, and for a minority, the possibility of assignment to the control condition motivated their participation as it could minimise risk but still provide ancillary benefits [ 67 ]. Women were keen to be unblinded regarding the arm to which they were assigned, once the trial was complete [ 80 ].

Finding 6 : Acceptability of the intervention is key to pregnant and lactating women’s willingness to participate in a trial and for research staff to recruit for a trial . Interventions that were most acceptable to women and research staff were those that simplified intervention delivery, were less onerous or painful than usual care, had negligible risk, were noninvasive, placed limited demands on time, did not involve invasive procedures, and where prior knowledge about the condition intersected with positive attitudes towards the therapeutic product (high confidence) [ 40 , 45 , 48 , 53 , 54 , 61 , 64 , 65 , 72 , 73 , 81 , 83 , 86 , 87 , 90 – 92 , 96 ].

For health workers involved in recruitment and trial operations, acceptability of the intervention was closely linked to their perceptions of the safety of the experimental therapy, derived from previous positive experiences administering the drug in a different clinical setting [ 53 ].

Quantitative evidence supported this qualitative finding that some women might be more willing to participate in a trial when they were less likely to be inconvenienced by or experience discomfort from trial procedures, additional and lengthy study visits [ 38 , 41 , 80 ]. Decliners cited blood tests, additional scans, and availability of suitable noninvasive alternatives as reasons for nonparticipation [ 51 , 83 ]. In the case of vaccine trials, quantitative data extended this qualitative finding by suggesting that women indicated greater acceptability of inactivated virus vaccines compared to live-attenuated virus vaccines [ 51 ].

Finding 7 : Fears around data sharing and use . Some women feared that trial participation, including provision of blood samples, could expose them to stigmatisation and judgement due to unwanted diagnoses and disclosure of disease status, data sharing regarding sensitive behaviours, and the threat of their data being used in ways that would compromise confidentiality and safety (low confidence) [ 65 , 85 , 86 ]. In the context of HIV trials, some women discussed concerns that an HIV diagnosis would lead to abandonment by their husbands [ 85 ].

No quantitative evidence was identified in this domain.

Finding 8 : Altruistic motivations . Pregnant women expressed willingness to participate in trials for the purpose of contributing to societal benefits of research, including the potential to improve health and healthcare for pregnant women in the future. Altruistic motivations could act as a stand-alone stimulus, secondary to or alongside beliefs around personal benefit, or conditional on no additional risk for participation (moderate confidence) [ 39 , 40 , 47 , 48 , 55 – 61 , 63 , 64 , 70 , 72 – 74 , 83 , 86 , 87 , 89 , 91 , 92 ].

In addition to helping other women, altruistic sentiments were linked to perceptions that the research effort was worthy [ 48 , 59 , 61 ], well-intentioned [ 61 ], filled an important scientific gap [ 58 , 70 , 72 ], and addressed a pressing need [ 48 , 63 , 73 , 91 ].

Quantitative evidence supported the qualitative finding that altruistic motivations influenced willingness to participate in trials, alongside personal benefits [ 38 , 41 , 49 , 51 , 67 , 77 , 80 , 95 ]. Women expressed having a sense of fulfilment that participation would have a positive impact on women’s health in the future.

Finding 9 : Financial incentives . Pregnant and lactating women had mixed attitudes to financial incentives for research participation. Some viewed financial incentives as acceptable, with higher remuneration as an appropriate strategy to encourage participation, whereas others viewed financial incentives as potentially coercive, especially in the context of poverty. Some women felt that financial reimbursements did not play a substantial role in women’s decision-making (low confidence) [ 39 , 55 , 65 , 83 , 96 ].

Negative views on renumeration arose from concerns that financial incentives would entice women to enrol multiple times [ 65 ], or make it challenging for them to withdraw from the study [ 39 ].

Quantitative evidence extended this qualitative finding by suggesting that attitudes to financial compensation differed based on levels of education attainment [ 97 ]. In one study, less than 1 in 10 women discussed that financial incentives would increase their likelihood of participation in medication or vaccine-based research [ 75 ], whereas in another, 4 in 10 women agreed that they volunteered to participate due to financial compensation [ 41 ].

Engagement between women and the medical and research ecosystems

Findings 10 and 11 are categorised under this theme, with 34 contributing studies examining factors operating at the intersection of women and the medical and research ecosystems. The factors include women’s reliance on health workers’ clinical opinions to assist decision-making, and the role of therapeutic hope and optimism in women’s decisions to participate and health worker and research staffs’ motivations to administer trials.

Finding 10 : Roles of trust and power in the medical and research ecosystem . Pregnant and lactating women’s willingness to participate in trials was driven by trust, confidence, and faith in medicine and research, and women relied on the opinions of the health workers that they consulted with regarding the efficacy and safety of the intervention. Simultaneously, power imbalances between women and health workers, coupled with women’s therapeutic misconceptions, could lead to coercion in participation. This ethical dilemma was recognised by study investigators, ethics committee members, and women, especially in the context of the dual roles of clinician-researchers; however, power and credibility when combined with good rapport and clear communication generated trust to participate or comfort to decline. While rare, some women had larger concerns about the vested interests of pharmaceutical companies (high confidence) [ 39 , 40 , 42 – 45 , 47 – 49 , 56 – 61 , 65 , 69 , 70 , 72 – 74 , 81 , 82 , 86 , 87 , 89 , 91 , 92 ].

Quantitative data supported the qualitative finding that trust (or lack thereof) in health workers, research teams, and pharmaceutical companies affected participation [ 38 , 51 , 75 , 95 ]. Some women felt pressured to participate by health workers and were disappointed by the lack of an individualised approach to recruitment [ 80 ]. Among decliners of a vaccine trial, some noted that recommendations from a health worker could motivate a change of mind [ 51 ].

Finding 11 : The role of therapeutic hope and optimism . Therapeutic hope and optimism played a critical role for health workers and research staff to administer trials, and for pregnant and lactating women to participate in trials. Prior knowledge about and experience with using the intervention, observation of potential beneficial effects, and trust in health workers shaped feelings of therapeutic hope and optimism. However, for some women, a lack of understanding of the differences between research and clinical care when combined with therapeutic hope led to therapeutic misconceptions and unmet expectations about the personal benefits arising from trial participation (moderate confidence) [ 42 , 45 , 47 , 53 , 65 , 70 , 74 , 81 , 82 , 87 ].

Health workers expressed the importance of women and themselves comprehending the differences between research and clinical care to minimise participation arising from therapeutic misconceptions [ 47 ].

Gender norms and decision-making autonomy

Findings 12 to 14 are categorised under this theme with 24 contributing studies discussing women’s roles as mothers and caregivers, mixed perceptions of women’s autonomous decision-making, and intimate male partner involvement in decision-making.

Finding 12 : Expectations of women’s roles as mothers and caregivers . Pregnant and lactating women’s decisions to participate in clinical trials were often influenced by their strong sense of responsibility towards the health and care of their fetus or infant, themselves, and their families. This sense of responsibility was endorsed and reinforced by familial and societal expectations of what it means to be a good mother (low confidence) [ 60 , 61 , 64 , 91 , 96 ].

For some women, this responsibility to protect their baby translated to not engaging in any actions that might risk jeopardising the baby’s health [ 91 ].

Finding 13 : Role of bodily autonomy in decision-making . Some women, health workers, ethics committee members, and regulators perceived that pregnant women might not be able to make decisions by themselves about trial participation due to fetal involvement, inability to make rational choices during pregnancy, hormones, the stressful context of hospitalisation and financial inducements. However, research staff and some women believed in the right to bodily autonomy to make decisions by themselves despite having discussions with partners, family members, support persons, or health workers. Women viewed other people making decisions regarding their participation as a violation of this right, though some women declined participation due to pressure from family members (moderate confidence) [ 39 , 40 , 43 , 47 , 54 , 56 , 72 , 74 , 81 , 82 , 85 , 87 , 90 , 92 ].

Women also believed that research could be an avenue through which women demanded their rights in the healthcare [ 65 ].

Quantitative evidence supported qualitative findings that women believed in their capability to make decisions regarding trial participation, with some doing so autonomously and others receiving support from family members [ 38 , 83 ].

Finding 14 : Relationship dynamics , gender roles , and norms are key to women’s attitudes to partner involvement and paternal consent . Pregnant women often discussed the benefits and risks of trial participation with their partners—especially in the context of fetal involvement—and their final decision may or may not have been influenced by their partners’ own attitudes. In some settings, pregnant women’s trial participation was contingent on partners’ buy-in, and the formality justified in the context of gender norms and roles. These could be the partner being the household head, to allay men’s suspicions about women’s whereabouts and interactions, and to minimise any misunderstanding related to positive tests or disease status that might cast doubt on women’s fidelity to their husbands (moderate confidence) [ 39 , 40 , 42 , 43 , 47 , 60 , 64 , 65 , 69 , 72 , 74 , 81 , 83 , 85 , 87 , 90 , 91 ].

Partner involvement was not preferred when that partner was abusive or uninvolved, or when a woman was unmarried, or the pregnancy had occurred in the context of rape [ 85 ]. Furthermore, imposing a paternal consent rule in these circumstances was a serious barrier to participation [ 85 ]. When research participation violated gender roles and norms, it sometimes resulted in partner violence, marital breakdown, or rejection of the baby [ 85 ].

Factors affecting clinical trial recruitment

Findings 15 through 21 are categorised under this theme with 41 contributing studies exploring the importance of cultural acceptability and safety of intervention procedures, development of reciprocal relationships between research staff and health workers, the importance of resource availability, trial visibility and emotional orientations, and woman-centred approach to recruitment.

Finding 15 : Developing trusting and reciprocal relationships with the community as part of the research process . Designing and embedding research within communities required engaging with community norms, beliefs, and practices. Some community members expressed how they viewed research negatively in the context of historical and ongoing oppressions that people experience due to colonisation, corruption, extractive practices, and civil and political conflict. Central to the acceptability and cultural safety of the research were investments in developing trusting relationships with community representatives and leaders (moderate confidence) [ 44 , 45 , 60 , 65 , 66 , 74 , 78 , 83 , 90 , 92 ].

This was achieved through dialogue and engagement starting at research conceptualisation, collaborating with community representatives and previous research participants to develop communication and mobilisation strategies, providing accurate information about study procedures, and ensuring alignment of these procedures with community norms, beliefs, and practices.

Finding 16 : Increasing visibility and awareness of the trial . Increasing visibility and awareness of the trial to potential participants, health workers, and community representatives influenced trial recruitment. Recommended strategies included paper and electronic promotional materials, regular physical presence of research staff in the areas where recruitment was taking place, and reminders to health workers about recruitment pathways and trial protocols through trainings (low confidence) [ 54 , 62 , 65 , 74 , 87 ].

Quantitative evidence extended the qualitative finding that women preferred to have information about trials through their health workers [ 67 ].

Finding 17 : Inadequate resources . Inadequate physical infrastructure, time, finances, and insufficient quantity and quality of human resources were barriers for research staff to recruit women for clinical trials. For health workers specifically, heavy workloads made it challenging to incorporate trial recruitment into clinical workflows, and the added burden and sometimes insufficient compensation, contributed to poor morale (low confidence) [ 44 , 54 , 55 , 62 , 87 , 89 ].

In terms of competency of human resources, research staff shared that their recruiting capability was built through practice and working alongside more experienced colleagues [ 54 ]. A key limiting factor in the recruitment of women from non-English speaking backgrounds was the unavailability of interpreters [ 87 ].

Quantitative evidence similarly reported that lack of infrastructure and limited time due to heavy workloads for health workers were barriers to including pregnant women in trials [ 50 , 67 , 88 ].

Finding 18 : Engaging health workers in trials . Research staff perceived the importance of building reciprocal and collaborative relationships with health workers because some acted as gatekeepers. Some health workers, however, were reluctant to engage women in clinical trials due to a lack of knowledge about trial design and the research value, varying levels of acceptability of risk, perceived obligation to protect women, and a lack of trust in the research team. Health workers supported inclusion when trial protocols included close monitoring of risks and when there was clinical equipoise alongside therapeutic hope in the trial intervention. These factors were informed by their clinical knowledge, previous clinical experiences using the intervention, and observed outcomes in the current trial (high confidence) [ 47 , 53 – 55 , 60 , 62 , 64 , 65 , 87 , 89 – 91 ].

Quantitative evidence supported qualitative findings that knowledge of the relevance, feasibility, and ethical obligations to include pregnant and lactating women in trials, perceptions that pregnant women were a vulnerable population, lack of interest in trials, and preferences for noninvasive treatment were factors influencing whether health workers encouraged pregnant women’s clinical trial participation [ 50 , 52 , 67 , 88 , 94 , 95 ].

Finding 19 : Research staff’s emotional orientations towards clinical trials . Having a sense of trial ownership, supportive teamwork, a shared sense of team achievement and motivation to achieve recruitment targets could support successful trial recruitment. However, feeling pressured by the recruitment process, seeing it as a procedural activity and needing to implement complex study designs impacted research staffs’ ability to recruit women, leading to frustration and lower enthusiasm (low confidence) [ 53 , 54 , 62 ].

Finding 20 : Women-centred approach encourages participation . Women valued an individualised, humanised, and transparent approach to communication, and adequate time during trial recruitment to discuss details and concerns related to the trial. These helped ensure they had sufficient capacity and opportunity to make informed decisions. Similarly, research staff found that approaching potential participants at the “right time” and in an appropriate manner by considering their physical and mental state, providing adequate information and engaging in discussions increased recruitment success (moderate confidence) [ 39 , 40 , 54 , 56 , 62 , 66 , 69 , 70 , 72 , 74 , 86 , 87 , 92 ].

To support an individualised recruitment approach, research staff reviewed obstetric information from women’s charts [ 54 , 86 ] and had discussions with health workers [ 86 ] to tailor the recruitment information to women’s personal situations. They also discussed using intuition to determine when and whom to approach for trial participation [ 54 ], considering the extent to which women looked sick or unwell at the time of recruitment [ 86 ].

Quantitative data supported this qualitative finding of women noting the significance of having detailed and well-explained trial information, including about risks and benefits, and adequate time to make decisions regarding participation [ 80 , 95 ]. Some women expressed disappointment when they felt they had been ill-informed about study procedures by research staff [ 80 ].

Finding 21 : Recruitment for intrapartum research . Pain, intensity, and duration of labour motivated pregnant women to participate in intrapartum clinical trials. However, women, their partners, and research staff recognised the challenges in ensure women make informed decisions during this sensitive time, as decisions had to be made quickly, and partners were reluctant to make decisions on women’s behalf, even during emergencies, due to fears of negative outcomes. To optimise women making informed decisions, research staff provided information clearly and succinctly during the intrapartum period and tried to offer adequate time for decision-making. Most women recommended having trial information provided in the antenatal period, and revisiting trial details, including having a de-briefing about one’s own experience, prior to discharge (moderate confidence) [ 43 , 49 , 56 , 59 , 61 , 62 , 81 , 82 , 86 , 91 ].

Quantitative data extended this qualitative finding with most ethics committee members considering consent in-labour as ethical. Factors that ethics committee members considered when approving labour trials, included the level of risk involved and women’s ability to provide informed consent [ 76 ]. Most ethics committee members also supported the involvement of partners in the consent process [ 76 ]. Aligned with the qualitative data, women expressed a preference to be approached for a labour trial earlier to have adequate time for discussion and an informed decision [ 79 , 80 ].

Upstream factors affecting the research ecosystem

Findings 22 to 24 are categorised under this theme with 13 studies discussing factors operating at the level of study investigators, ethics committees, and funders. The factors include study investigators’ personal and professional motivations to pursue research with pregnant women, complexities in obtaining ethical approval, and limited interest of funders to support clinical trials with pregnant and lactating women.

Finding 22 : Factors affecting motivation of study investigators . The underlying factors that motivated many study investigators to conduct research with pregnant women were ethical responsibility, passion towards equity, and dedication to improving women’s health status and care, and filling scientific gaps. Additionally, lived experience of being pregnant, having mentors in this area in early careers, and previous research experiences with pregnant women contributed to study investigators’ motivations. However, concerns about risks of teratogenicity demotivated some investigators (moderate confidence) [ 42 , 43 , 66 , 78 , 89 , 91 ].

Finding 23 : Challenges in gaining ethical approvals for trials with pregnant women . While some regulators, ethics committee members, and study investigators strongly support inclusion of pregnant women in clinical trials, most stakeholders start from a presumption of minimal risk to the fetus. This results in women’s exclusion, especially in the context of poor public stewardship, ambiguous guidelines, insufficient data on intervention safety, complexities and subjectivities in risk assessment, poor agreement on appropriate trial design, time-consuming ethical processes, and concerns about reputation (moderate confidence) [ 42 , 43 , 66 , 78 , 82 , 89 – 91 ].

Study investigators and ethics committee members reported that these challenges could be overcome through shared institutional commitment to pregnant women’s inclusion, close collaboration between investigators and ethics committee members from protocol inception, mutual understanding about each other roles, responsibilities, and intentions, development and implementation of practical guidance for consistency in regulatory interpretation and risk assessment, safety monitoring during implementation, and safeguards for injury compensation [ 42 , 66 , 78 , 89 , 91 ].

Quantitative evidence supported qualitative findings that obtaining regulatory approval for clinical trials that include pregnant women was challenging [ 88 ] due to ethics committees’ preference for observational studies over trials [ 93 ], and varied opinions on the inclusion of pregnant women and what constituted minimal risk [ 76 , 93 ]. Most ethics committee members were also aware that they did not have adequate policy or guidance to inform their decisions to ensure equitable subject selection [ 76 , 93 ].

Finding 24 : Role of funders . Limited interest of public and private funders and pharmaceutical companies to financially invest in trials due to the ethical complexities, potential for adverse events, liability, and possibility of political fallout was a barrier to conduct trials with pregnant and lactating women. When funding was available, funders’ requests might facilitate the inclusion of pregnant women or create ethical challenges in conducting trials (low confidence) [ 54 , 62 , 66 , 78 ].

Mapping review findings to TDF, COM-B, and potential implementation strategies

Table 3 presents the mapping of review findings to the applicable TDF [ 24 ] and COM-B model domains [ 25 ], and the BCW intervention types to inform proposed strategies that address these factors. The strategies that we have identified are designed to provide a theoretically informed guide to the types of actions that can be taken to address barriers at various levels associated with different stakeholder groups. Which actions are appropriate for a given context should therefore be discussed, prioritised, and adapted to a particular setting.

https://doi.org/10.1371/journal.pmed.1004405.t003

Some of these strategies may already be in place as part of ethical conduct for trial recruitment, for example, sharing information transparently with potential participants about safety, risks, benefits, and side effects of the trial intervention (BCW intervention type: education). Given pregnant and lactating women’s concerns around risks of the intervention, such strategies can be enhanced through personalised discussions about how the intervention relates to women’s personal and clinical circumstances, for example, using a decision-aid tool (BCW intervention type: enablement). Developing clear and context-specific ways to explain study design features in plain language, and involvement of trusted sources (such as health workers), to communicate trial information can aid the decision-making process. Engaging with patient advocates and women’s groups and conducting formative research with potential participants to receive feedback on acceptability of trial components can streamline trial procedures and enhance acceptability and contextual alignment. Considerations should include how societal and gender norms, and gender roles impact various aspects of participation.

Given potential concerns among health workers regarding safety of interventions during pregnancy, providing access to credible resources on the risks, benefits and potential side-effects of the product being trialled, and elaborating on the trial rationale, potential benefits, and where the trial fits into existing evidence can help address fear and uncertainty regarding intervention safety (BCW intervention type: education, training).

At the health systems-level, strategies include creating a research-friendly environment within health facilities. In addition to promoting buy-in from hospital leadership, this would include infrastructural enhancements such as creating research spaces within health facilities (e.g., offices, meeting rooms, labs, data storage, research information systems), and hiring and training research support staff (e.g., research midwives), among other aspects.

Strategies to promote alignment between study investigators and ethics committee members include: educating ethics committee members about the health consequences of excluding pregnant women from research, and useful approaches for monitoring and managing risks associated with trial inclusion (BCW intervention type: education); developing a shared institutional commitment to inclusion of pregnant women research as the standard, and developing a common understanding of regulatory guidelines and associated documentation such as standard operating procedures, worksheets, and checklists to facilitate consistency in guideline application by institutional ethics committees and researchers.

This review provides a comprehensive overview of the range of factors affecting the participation of pregnant and lactating women in clinical trials across the research ecosystem. At the upstream levels, we identified barriers arising from limited interest of funders to invest in clinical trials with pregnant and lactating women, and reluctance of ethics committees to approve protocols due to potential for risks, particularly to fetal health. Factors at the interface between health systems and communities included developing trusting and reciprocal relationships among community members, research staff, and healthcare workers, and taking a woman-centred approach to recruitment. For women, determining the risk-benefit ratio of participation, trust (or lack thereof) in medicine and research, the potential to access high-quality care through trial participation, and altruistic motivations were key factors. Incorporating a gender lens to the data, we found that participation was impacted by gender relations of power sustained by gender norms, gender role expectations of women as mothers and caregivers, and mixed opinions regarding bodily and decisional autonomy during pregnancy.

Our findings on factors influencing pregnant women’s decisions regarding participation are aligned with those identified by Van der Zande and colleagues [ 98 ] who found that the potential for personal benefits alongside altruistic motivations were crucial drivers, while participation burdens, risks, and mistrust in research were key barriers to participation. Some of these findings, such as the role of altruism and potential for personal benefit, concerns about randomisation and other study design features, burdensome trial procedures, fears associated with taking an experimental therapy, and health worker attitudes towards trials are also consistent with the broader literature on factors associated with trial participation [ 99 – 101 ]. Across the findings, women and research staff emphasised the importance of a woman-centred approach to trial recruitment, with careful consideration of women’s individual clinical and personal circumstances, transparency in information, and support for informed and unhurried decision-making. These aspects were found to be challenging to navigate in intrapartum trials, given the timing of recruitment coinciding with birth, often in the context of impending or ongoing complications. For example, a recent analysis of uterotonic trials for prevention of postpartum haemorrhage found considerable variability between trials in the timing of informed consent—most obtained consent during labour, with a minority in the antenatal period [ 102 ]. Our findings suggest that women prefer consent in the antenatal period to optimise informed and unhurried decision-making. However, there are ethical concerns about seeking antenatal consent as it may exclude participation of women who do not regularly access antenatal care [ 102 ]. Indeed, the informed consent process in intrapartum trials is an issue of current debate and ethical interest [ 103 ], and more empirical work is needed to understand women’s preferences and needs to optimise informed decision-making.

We found that healthcare workers’ engagement was crucial in recruiting women as they play a vital role in bridging communication between potential participants and research staff. Many studies reported that women relied on health workers advice in making decisions about participation. Health workers in turn encouraged or discouraged participation based on their own attitudes towards clinical research in pregnancy and knowledge about or personal experience using the therapy under investigation. Given the roles of trust and power in women’s decision-making processes, it is important to promote transparent and open communication between women and health workers regarding trials, and their associated risks and benefits [ 104 , 105 ]. It is also important to clarify differences between clinical trial and regular clinical care to minimise the potential for therapeutic misconceptions, the consequences of which could lead to the eroding of trust in the medical system, affecting future health-seeking behaviour.

The complicated issue of autonomy in decision-making during pregnancy was raised by multiple stakeholders. Many women discussed trial participation with their partners and other family members but considered the final decision to be their own. In some settings, usually in the context of rigid gender norms, women required partners’ permission to participate; if violated, this could result in the threat of violence or marital discord. Separately, the imposition of a paternal consent requirement was viewed as a significant barrier for women who were in unstable relationships, unmarried, or wanted to exercise fully autonomous decision-making. Widmer and colleagues [ 102 ] argue that it is the role of research staff to guarantee and protect women’s autonomy. We found that women’s decisional autonomy was impacted by intimate partner relationship dynamics, and wider sociocultural and gender norms that required nuanced understandings of the context and multistakeholder engagement to create an enabling environment for women to exercise choice.

We also identified barriers experienced by researchers, ethics committees, and funders of clinical trials. Study investigators had trouble obtaining ethical approval as ethics committees have mixed perspectives on the inclusion of pregnant and lactating women in trials, particularly in the absence of clear guidelines. In line with previously reported upstream barriers [ 16 , 23 ], limited interest in funding clinical trials with pregnant and lactating women due to potential risks, high liability, and reputational consequences also inhibits the implementation of trials. These findings demonstrate a need to develop holistic strategies addressing barriers experienced by stakeholders operating at the upstream levels of clinical research.

The TDF and COM-B mapping in our review (Table 3) can be used by study investigators, research staff, health workers, ethics committees, and funders to inform the development of implementation strategies to address barriers to pregnant and lactating women’s participation in clinical trials. Formative research to identify specific barriers and facilitators in specific settings and contexts is a recommended starting point before developing appropriate strategies.

A limitation is that we did not include grey literature, which may have expanded the types of evidence and/or contexts of the review. However, our search strategies yielded high coverage of published literature. The studies included in the review had good coverage of countries from the African region, but sparse representation of countries from Latin America, and no representation of countries in the Eastern Mediterranean or South-East Asian regions. A growing number of trials addressing maternal and perinatal health are being implemented in these settings [ 106 ], calling for significantly greater focus in formative and process evaluation research with pregnant and lactating women and people, family members, health workers, local researchers, and ethics committee members to understand context-specific motivations for and concerns regarding conduct of and participation in research during pregnancy and lactation. The AIM-Gender project [ 107 ] aims to address this limitation through qualitative research on the topic in India and Nigeria—2 countries that together account for 37% of global maternal deaths [ 13 ]. Future work must also consider inclusion of pregnancy-capable transgender and nonbinary people, as knowledge gaps regarding factors affecting their participation in pregnancy and lactation clinical research are particularly pronounced. We also draw attention to 2 relevant reviews on factors affecting participation of racial and ethnically marginalised populations in pregnancy and lactation research, a related topic that was beyond the scope of this review [ 108 , 109 ].

Our review builds on previous work [ 98 ] by examining the full range of factors and perspectives of multiple stakeholders operating at the upstream and downstream levels of the research ecosystem. We optimised the available data by including qualitative, quantitative, and mixed-methods primary research. We applied the GRADE-CERQual approach to assess confidence in each finding, i.e., the extent to which the finding adequately represented the phenomenon of interest [ 32 , 33 ]. These assessments have important practical implications for increasing the applicability and usability of these findings by stakeholders seeking to enhance research and development in maternal health. This review additionally integrates the use of behavioural frameworks [ 24 , 25 ] to propose a theory-informed set of behaviour change interventions to address factors affecting clinical trial participation among pregnant and lactating women.

Supporting information

S1 appendix. preferred reporting items for systematic reviews and meta-analyses (prisma) reporting checklist..

https://doi.org/10.1371/journal.pmed.1004405.s001

S2 Appendix. Enhancing transparency in reporting the synthesis of qualitative research (ENTREQ) reporting checklist.

https://doi.org/10.1371/journal.pmed.1004405.s002

S3 Appendix. Search strategies.

https://doi.org/10.1371/journal.pmed.1004405.s003

S4 Appendix. GRADE-CERQual evidence profile.

https://doi.org/10.1371/journal.pmed.1004405.s004

S5 Appendix. Summaries of quantitative findings.

https://doi.org/10.1371/journal.pmed.1004405.s005

S6 Appendix. Characteristics of included papers.

https://doi.org/10.1371/journal.pmed.1004405.s006

S7 Appendix. Critical appraisal.

https://doi.org/10.1371/journal.pmed.1004405.s007

Acknowledgments

We are grateful to Alessandra Fleurent at Concept Foundation for her assistance with verifying the accuracy of the translated French paper included in this review.

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• Open access
• Published: 29 May 2024

Exploring the use of body worn cameras in acute mental health wards: a mixed-method evaluation of a pilot intervention

• Una Foye 1 , 2 ,
• Keiran Wilson 1 , 2 ,
• Jessica Jepps 1 , 2 ,
• James Blease 1 ,
• Ellen Thomas 3 ,
• Leroy McAnuff 3 ,
• Sharon McKenzie 3 ,
• Katherine Barrett 3 ,
• Lilli Underwood 3 ,
• Geoff Brennan 1 , 2 &
• Alan Simpson 1 , 2  

BMC Health Services Research volume  24 , Article number:  681 ( 2024 ) Cite this article

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Body worn cameras (BWC) are mobile audio and video capture devices that can be secured to clothing allowing the wearer to record some of what they see and hear. This technology is being introduced in a range of healthcare settings as part of larger violence reduction strategies aimed at reducing incidents of aggression and violence on inpatient wards, however limited evidence exists to understand if this technology achieves such goals.

This study aimed to evaluate the implementation of BWCs on two inpatient mental health wards, including the impact on incidents, the acceptability to staff and patients, the sustainability of the resource use and ability to manage the use of BWCs on these wards.

The study used a mixed-methods design comparing quantitative measures including ward activity and routinely collected incident data at three time-points before during and after the pilot implementation of BWCs on one acute ward and one psychiatric intensive care unit, alongside pre and post pilot qualitative interviews with patients and staff, analysed using a framework based on the Consolidated Framework for Implementation Research.

Results showed no clear relationship between the use of BWCs and rates or severity of incidents on either ward, with limited impact of using BWCs on levels of incidents. Qualitative findings noted mixed perceptions about the use of BWCs and highlighted the complexity of implementing such technology as a violence reduction method within a busy healthcare setting Furthermore, the qualitative data collected during this pilot period highlighted the potential systemic and contextual factors such as low staffing that may impact on the incident data presented.

This study sheds light on the complexities of using such BWCs as a tool for ‘maximising safety’ on mental health settings. The findings suggest that BWCs have a limited impact on levels of incidents on wards, something that is likely to be largely influenced by the process of implementation as well as a range of contextual factors. As a result, it is likely that while BWCs may see successes in one hospital site this is not guaranteed for another site as such factors will have a considerable impact on efficacy, acceptability, and feasibility.

Peer Review reports

Body worn cameras (BWC) are mobile audio and video capture devices that can be secured to clothing allowing the wearer to record some of what they see and hear. In England, these have been introduced in the National Health Service (NHS) as part of a violence reduction strategy [ 1 ] which emphasises the reduction of aggression and violence against staff. The NHS Staff Survey 2022 found that 14.7% of NHS staff had experienced at least one incident of physical violence from patients, relatives or other members of the public in the previous 12 months. Violent attacks on staff were found to contribute to almost half of staff illness [ 2 ]. Levels of violence against staff working in mental health trusts remain much higher than other types of healthcare providers [ 3 ]. Numerous reports internationally highlight the increased risks faced by staff working in psychiatric care [ 4 ], though studies have reported that both ward staff and mental health patients experience violence and feeling unsafe on inpatient wards [ 5 , 6 ].

Body worn cameras have been in use for over a decade within law enforcement, where they hoped to provide transparency and accountability within use-of-force incidents and in the event of citizen complaints against police [ 7 ]. It was believed that video surveillance would help identify integral problems within the organisation, improve documentation of evidence, reduce use-of-force incidents, improve police-community relations, and provide training opportunities for officers [ 8 ]. However, a recent extensive international systematic review by Lum et al. [ 9 ], found that despite the successes noted in early evaluations, the way BWCs are currently used by police may not substantially affect most officer or citizen behaviours. Irrespective of these findings, other public services such as train operators have been implementing BWCs for security purposes, with reductions reported in the number of assaults on railway staff [ 10 ].

A recent systematic review of BWC use in public sector services established that there is a poor evidence base supporting the use of BWCs in the reduction of violence and aggression [ 11 ]. Yet, we are seeing a swift increase in the use of BWCs in mental health settings with that aim, with few studies conducted on the use of BWC technology in inpatient mental health wards, and even fewer studies exploring staff or patients’ views. Two evaluations conducted in England reported mixed results with both increases and decreases in violence and aggression found, and variation between types of wards. There is some suggestion of a reduction in more serious incidents and the use of restraint, but quality of evidence is low [ 12 , 13 ].

The use of BWCs in mental healthcare settings for safety and security remains a contentious topic due to the lack of evidence regarding the influence that such technology has on preventing violence and aggression and the complex philosophical and ethical issues raised, particularly where many patients may lack capacity and/or are detained under mental health legislation [ 14 ]. Additionally, there are concerns that BWCs may be used as a ‘quick fix’ for staff shortages rather than addressing the wider systemic and resourcing issues facing services [ 15 ]. With little independent evaluation of body-worn cameras in mental health settings, many of these concerns remain unanswered. There is also limited understanding of this technology from an implementation perspective. Therefore, in this study we aimed to conduct an independent evaluation of the introduction of BWCs as a violence reduction intervention on two inpatient mental health wards during a six-month pilot period to explore the impact of using the technology, alongside an exploration of the facilitators and barriers to implementation.

Research aim(s)

To evaluate the implementation of BWCs on two inpatient mental health wards, including the impact on incidents, the acceptability to staff and patients, the sustainability of the resource use and ability to manage the use of BWCs on these wards.

Patient and public involvement

The research team included a researcher and independent consultant, each with lived experience of mental health inpatient care. In addition, we recruited and facilitated a six member Lived Experience Advisory Panel (LEAP). This group was made up of patients and carers, some of whom had experienced the use of BWCs. Members were of diverse ethnic backgrounds and included four women and two men. The LEAP provided guidance and support for the research team in developing an understanding of the various potential impacts of the use of BWCs on inpatient mental health wards. Members contributed to the design of the study, development of the interview schedule, practice interviews prior to data collection on the wards, and supported the analysis and interpretation of the data, taking part in coding sessions to identify themes in the interview transcripts. The LEAP met once a month for two hours and was chaired by the Lived Experience Research Assistant and Lived Experience Consultant. Participants in the LEAP were provided with training and paid for their time.

The pilot introduction of the body worn cameras was conducted within a London mental health Trust consisting of four hospital sites with 17 acute wards. The research team were made aware of extensive preparatory work and planning that was conducted at a directorate and senior management level prior to camera implementation, including lived experience involvement and consultation, and the development of relevant policies and protocols inclusive of a human rights assessment and legal consultation.

The pilot period ran from 25th April to 25th October 2022. Reveal (a company who supply BWCs nationally across the UK) provided the Trust with 12 Calla BWCs for a flat fee that covered use of the cameras, cloud-based storage of footage, management software, and any support/maintenance required during the pilot period. Cameras were introduced to two wards based on two hospital sites, with six cameras provided to each of the wards on the same date. Training on using the BWCs was provided by the BWC company to staff working on both wards prior to starting the pilot period. Ward one was a 20-bed male acute inpatient ward, representing the most common ward setting where cameras have been introduced. Ward two was a ten-bed male Psychiatric Intensive Care Unit (PICU), representing smaller and more secure wards in which patients are likely to present as more unwell and where there are higher staff to patient ratios.

To answer our research questions, we used a mixed-methods design [ 16 ]. Using this design allowed us to investigate the impact of implementing BWCs in mental health settings on a range of quantitative and qualitative outcomes. This mixed methods design allows the study to statistically evaluate the effectiveness of using BWCs in these settings on key dependent variables (i.e., rates of violence and aggression, and incidents of conflict and containment) alongside qualitatively exploring the impact that the implementation of such technology has on patients and staff.

To ensure that the study was able to capture the impact and effect of implementation of the cameras, a repeated measures design was utilised to capture data at three phases on these wards:

Pre-pilot data: data prior of the implementation of the BWCs (quantitative and qualitative data).

Pilot period data: data collected during the six-month pilot period when BWCs were implemented on the wards (quantitative and qualitative data).

Post-pilot: data collected after the pilot period ended and cameras had been removed from the wards (quantitative data only).

Quantitative methods

Quantitative data was collected at all three data collection periods:

Pre-period: Data spanning six months prior to the implementation of BWCs (Nov 21 to May 22).

Pilot period: Data spanning the six months of the Trusts pilot period of using BWCs on the wards (June 22 to Nov 22).

Post-pilot: Data spanning the six months following the pilot period, when BWCs had been removed (Dec 22 to May 23).

Quantitative measures

To analyse the impact of BWC implementation, we collected two types of incident data related to violence and aggression and use of containment measures, including BWCs. Combined, these data provide a view of a wide range of incidents and events happening across the wards prior to, during, and after the implementation and removal of the BWCs.

The patient-staff conflict checklist

The Patient-staff Conflict Checklist (PCC-SR) [ 17 ] is an end of shift report that is completed by nurses to collate the frequency of conflict and containment events. This measure has been used successfully in several studies on inpatient wards [ 18 , 19 , 20 ].The checklist consists of 21 conflict behaviour items, including physical and verbal aggression, general rule breaking (e.g., smoking, refusing to attend to personal hygiene), eight containment measures (e.g., special observation, seclusion, physical restraint, time out), and staffing levels. In tests based on use with case note material, the PCC-SR has demonstrated an interrater reliability of 0.69 [ 21 ] and has shown a significant association with rates of officially reported incidents [ 22 ].

The checklist was revised for this study to include questions related to the use of BWCs ( e.g., how many uses of BWCs happened during the shift when a warning was given and the BWC was not used; when a warning was given and the BWC was used; when the BWC was switched on with no warning given ) in order to provide insight into how the cameras were being used on each ward (see appendix 1). Ward staff were asked to complete the checklist online at the end of each shift.

Routinely collected incident data (via datix system)

To supplement the PCC-SR-R, we also used routinely collected incident data from both wards for all three data collection phases. This data is gathered as part of routine practice by ward staff members via the Datix system Datix [ 23 ] is a risk management system used widely across mental health wards and Trusts in the UK to gather information on processes and errors. Previous studies have utilised routinely collect data via this system [ 24 , 25 ]. Incidents recorded in various Datix categories were included in this study (see Table  1 ). Incidents were anonymised before being provided to the research team to ensure confidentiality.

Routinely collected data included:

Recorded incidents of violence and aggression.

Recorded use of restrictive practices including seclusion, restraint, and intra-muscular medication/rapid tranquilisations.

Patient numbers.

Staffing levels.

Numbers of staff attending BWC training.

Quantitative data analysis

Incident reports.

Incident reports retrieved from Datix were binary coded into aggregate variables to examine violence and aggression, self-harm, and other conflict as outlined in Table  1 . Multivariate analyses of variance (MANOVA) were used to identify differences in type of incident (violence against person, violence against object, verbal aggression, self-harm, conflict) for each ward. MANOVA was also used to examine differences in incident outcomes (severity, use of restrictive practice, police involvement) across pre-trial, trial, and post-trial periods for each ward. Incident severity was scored by ward staff on a four-point scale (1 = No adverse outcome, 2 = Low severity, 3 = Moderate severity, 4 = Severe). Use of restrictive practice and police involvement were binary coded for presence or absence. Analyses were conducted using SPSS [ 26 ].

Patient-staff conflict checklist shift-report – revised (PCC-SR-R; )

Data were condensed into weeks for analysis rather than shifts to account for variability in PCC-SR-R submission by shift. Linear regressions assessed the relationship between BWC use and incident outcome (severity, use of restrictive practice, police involvement).

Qualitative methods

We used semi-structured qualitative interviews to explore participants’ experiences of BWCs on the ward to understand the impact of their use as well as to identify any salient issues for patients, staff and visitors that align with the measures utilised within the quantitative aspect of this study. These interviews were conducted at two time points: pre-pilot and at the end of the six-month pilot period.

Sample selection, eligibility, and recruitment

Convenience sampling was used to recruit staff and patients on wards. Researchers approached ward managers to distribute information sheets to staff, who shared that information with patients. Staff self-selected to participate in the study by liaising directly with the research team. Patients that were identified as close to discharge and having capacity to consent were approached by a clinical member of the team who was briefed on the study inclusion criteria (see Table  2 ). The staff member spoke with the patient about the study and provided them with a copy of the information sheet to consider. If patients consented, a member of the research team approached the participant to provide more information on the study and answer questions. After initial contact with the research team, participants were given a 24-hour period to consider whether they wanted to participate before being invited for an interview.

Participants were invited to take part in an interview within a private space on the ward. Interviews were scheduled for one hour with an additional 15 min before and after to obtain informed consent and answer any questions. Participation was voluntary and participants were free to withdraw at any time. To thank patients for their time, we offered a £10 voucher following the interview. Interviews were audio-recorded and saved to an encrypted server. Interview recordings were transcribed by an external company, and the research team checked the transcripts for accuracy and pseudonymised all participants. All transcripts were allocated a unique ID number and imported to MicroSoft Excel [ 27 ] for analysis.

Qualitative data analysis

Qualitative data were analysed using a framework analysis [ 28 ] informed by implementation science frameworks. Our coding framework used the Consolidated Framework for Implementation Research (CFIR) [ 29 ], which is comprised of five major domains including: Intervention Characteristics, Implementation Processes, Outer Setting, Inner Setting, and Characteristics of the Individual. Each domain consists of several constructs that reflect the evidence base of the types of factors that are most likely to influence implementation of interventions. The CFIR is frequently used to design and conduct implementation evaluations and is commonly used for complex health care delivery interventions to understand barriers and facilitators to implementation. Based on its description, the CFIR is an effective model to address our research question, particularly given the complexity of the implementation of surveillance technology such as BWCs in this acute care setting.

The initial analytic stage was undertaken by eight members of the study team with each researcher charting data summaries onto the framework for each of the interviews they had conducted on MicroSoft Excel [ 27 ]. Sub-themes within each broad deductive theme from our initial framework were then derived inductively through further coding and collaborative discussion within the research team, inclusive of Lived Experience Researcher colleagues. Pseudonyms were assigned to each participant during the anonymisation of transcripts along with key identifiers to provide context for illustrative quotes (e.g., P = patient, S = staff, A = acute ward, I = Intensive Care, Pre = pre-BWC implementation interview, Post = Post BWC implementation interview).

All participants gave their informed consent for inclusion before they participated in the study. The study was conducted in accordance with the Declaration of Helsinki, and the protocol was approved by the Health Research Authority: London - Camden & Kings Cross Research Ethics Committee (IRAS Project ID 322,268, REC Reference 23/LO/0337).

Quantitative results

Exploring how body worn cameras were used during the pilot period.

Analysis of the PCC-SR-R provides information about how the BWCs were used on a day-to-day basis during the pilot period. Out of 543 total shift reports completed, BWC use was reported 50 times, indicating that BWCs were used on less than 10% of shifts overall; 78% of those deployments were on the Acute ward (see Figure 1 ). Overall, the majority of deployments happened as activations without a warning being given ( n  = 30, 60% of activations), 19 times the BWC was deployed with a warning but the camera was not activated (38%), and only one was the camera activated without a warning being given (2%).

BWC use by ward per week of pilot (no data available before week 6 on Ward 1)

According to the PCC-SR-R, a total of 227 incidents of aggression occurred during the pilot period across both wards (see Table  3 ). Overall, there were small statistically significant correlations between BWC usage and certain types of conflict, aggression, and restrictive practice. Results found that BWC use was positively correlated with verbal aggression and use of physical restraint. BWC use was moderately positively correlated with verbal aggression ( r  = .37, p  < .001). This indicates that BWCs were more likely to be used in incidents involving verbal aggression, which do not tend to be documented in Datix. Similarly, BWC use was moderately positively correlated with physical restraint ( r  = .31, p  < .001) indicating that they were also more likely to be used alongside physical restraint.

Exploring the impact of BWCs utilising routinely collected ward data

Acute ward results.

Routine data collected via Datix records were used to examine differences in frequency of conflict and aggression, incident severity, and use of containment measures before, during, and after introduction of BWCs on each trial ward (see Table  4 ).

There was no effect of trial period on incident type ( F (10, 592) = 1.703, p  = .077, Wilk’s Λ = 0.945), meaning there was no discernible difference in the type of incidents that occurred (E.g., verbal aggression, physical aggression) before, during, and after the pilot phase.

Incident outcomes

There was an effect of trial period on incident outcomes ( F (6, 596) = 10.900, p  < .001, Wilk’s Λ = 0.812). Incident severity was statistically significantly higher in the trial and post-trial periods compared to the pre-trial period. Use of restrictive practice was significantly lower in the post-trial period compared to the pre-trial and trial period. Police involvement was also lower in the post-trial period compared to the pre-trial and trial periods (see Table  5 ).

Results for the psychiatric intensive care unit

There was an effect of trial period on incident type ( F (10, 490) = 4.252, p  < .001, Wilk’s Λ = 0.847). Verbal aggression was statistically significantly higher in the post-trial period compared to the pre and trial periods. Self-harm was statistically significantly higher in the trial period compared to the pre-trial and post-trial periods. There were no differences in violence against a person ( p  = .162), violence against an object or conflict behaviour (see Table  4 ).

There was a statistically significant difference in incident outcome across the trial periods ( F (6, 494) = 12.907, p  < .001, Wilk’s Λ = 0.747). There was no difference in incident severity or police involvement. However, use of restrictive practice was statistically significantly higher in the pre-trial period, reducing in the test period, and reducing further in the post-trial period (see Table  5 ).

Qualitative findings

A total of 22 participants took part in interviews: five patients and 16 staff members. During the pre-pilot interviews a total of nine staff took part (five in the acute ward, four in the PICU ward) and two patients (both from the acute ward). After the pilot period, a total of eight staff took part (four from each ward) and three patients (all from the acute ward). Table  6 includes a full description of participants.

Below we have presented the key themes aligning to the five core CFIR categories of Intervention Characteristics, Characteristics of Individuals, The Process of Implementation, the Inner Setting, and The Outer Setting (see Table  7 ).

Intervention characteristics

Design and usability of wearing a bwc on the ward.

When discussing the use of the BWCs, staff noted a range of design issues related to the cameras that they said impacted on their use and acceptance of the cameras. This included the nature of the camera pulling on clothing necklines (a particular issue for female staff working on male wards), and overheating causing discomfort and irritation to skin, challenges with infection control, as well as the issue of cameras in a mental health setting where they can be easily grabbed, thrown and broken during an incident. Staff often cited these design issues as related to the lack of proactive use of the cameras on the wards.

There were issues around the devices getting overheated or about it going on your clothing, it pulls down the top… we had one person who was leading on it, whenever he was around, of course, the camera was being used, but if he wasn’t there, people weren’t as proactive in using the camera. Petra (f), Staff, A, Post.

There were also issues with staff forgetting to wear the cameras, forgetting to switch them on during incidents, and forgetting to charge them at the end of the shift, reducing the potential use of the cameras by other staff. These were perceived as key logistical issues prior to the pilot and were reported as issues at the end of the pilot by several staff on the wards.

The practicalities of will they actually turn it on in those sorts of incidents, I don’t know. Just little stuff as well, like if they don’t put it back on the docking station, so you think you’re charging it for next shift but then it’s not charged and the battery is dead, that’s one less camera to use, so little stuff. Jamal (m), Staff, A, Pre.

In relation to usability, staff noted that the cameras were small and easy to use given their simple single switch interface. It was felt that not having to upload and manage the data themselves made cameras more user friendly and usable by staff members. Protocols put into place such as signing the cameras in and out, and allocation for use during shifts were likened to procedures in place for other security measures therefore the implementation of this for the BWCs was viewed as easy for many staff.

It’s just like the ASCOM alarms that we wear. There’s a system to sign in and sign out, and that’s it. Alice (f), Staff, A, Pre.

While staff were generally positive about the usability of the cameras, some were cautious of with concerns for those less confident with technology.

… you have to be conscious that there’s some people – it’s quite easy to use, but I can say that because I’m alright using devices and all that but there’s some that are older age or not that familiar with using devices that may struggle with using it… they’re feeling a bit anxious and a bit scared, if they’re not familiar with it then they won’t use it. Jamal (m), Staff, A, Pre.

Evidence strength and quality: do BWCs change anything?

There were conflicting reports regarding the potential benefits of using BWCs on the wards, with both staff and patients reporting mixed perceptions as to whether the cameras might reduce violence and aggression. In the pre-pilot interviews, some staff reported feeling that the BWCs may have a positive impact on reducing physical violence.

I think it’s going to reduce violence and aggression on the ward…I don’t think they’ll want to punch you…they might be verbally abusive but in terms of physical that might reduce. Sarah (f), Staff, I, Pre.

Patients however noted that the cameras might hold staff to account of their own behaviours and therefore may improve care, however they felt that this impact would wear off after the first few months after which people might forget about the cameras being there.

Now they’ve got the body cams, it’s going to be a lot of changes. They’ll think, ‘Ooh well he’s on tape’. So, it might do something to their conscience, they actually start to listen to patients… until the novelty wears off and it might go back to square one again. Ian (m), Patient, A, Pre.

One staff member suggested that incident rates had reduced following introduction of the BWCs, but they remained unsure as to whether this was due to the cameras, reflecting that violence and aggression on wards can be related to many factors.

I know our violence and aggression has reduced significantly since the start of the cameras pilot… I don’t know, because obviously wearing the camera’s one thing, but if they weren’t in use, I don’t know maybe just the presence of the camera made a difference. But yeah, it’s hard to tell. Petra (f), Staff, A, Post.

In contrast, several staff reported that they had seen limited evidence for such changes.

I used it yesterday. He was aggressive and I used it, but he even when I was using [it] he doesn’t care about the camera… it didn’t make any difference… It doesn’t stop them to do anything, this camera does not stop them to do anything. Abraham (m), Staff, I, Post.

Some staff suggested that in some circumstances the cameras increased patient agitation and created incidents, so there was a need to consider whether the BWCs were going to instigate aggression in some circumstances.

There has been with a few patients because they will threaten you. They will tell you, ‘if you turn it on, I’m gonna smash your head in’. So incidents like that, I will not turn it on… Yeah, or some of them will just tell you, ‘if you come close by, I’m going to pull that off your chest’. So things like that, I just stay back. Ada (f), Staff, A, Post.

One rationale for a potential lack of effectiveness was noted by both staff and patients and was related to the levels of acute illness being experienced by patients which meant that for many they were too unwell to have insight into their own actions or those of staff switching on the cameras.

We’ve had instances where patients are so unwell that they just don’t care. You switch on the camera, whether you switch it on or not, it doesn’t really change the behaviour. ‘All right, okay, whatever switch it on’. They’re so unwell, they’re not really understanding. Petra (f), Staff, A, Post. It might make [staff] feel safer as a placebo effect, but I don’t think it would necessarily make them safer… I think the people that are likely to attack a member of staff are crazy enough that they’re not gonna even consider the camera as a factor. Harry (m), Patient, A, Pre.

This lack of evidence that the cameras were necessarily effective in reducing incident rates or severity of incidents may have had an impact on staff buy-in and the use of the cameras as a result. One staff member reflected that having feedback from senior management about the impact and evidence would have been useful during the pilot period to inform ward staff whether the cameras were influencing things or not.

Staff want feedback. I don’t think we’ve had any since we’ve had the cameras… it would be nice to get feedback from, I don’t know, whoever is watching it, and stuff like that. Ada (f), Staff, A, Post.

Relative advantage: are BWCs effective and efficient for the ward?

Due to a combination of personal beliefs related to BWCs, the lack of evidence of their impact on violence and aggression, and other elements of care and culture on the wards, a number of staff and patients explored alternative interventions and approaches that may be more beneficial than BWCs. Both staff and patients suggested that Closed Circuit Television (CCTV) as an intervention that provided the transparency of using cameras and video footage but with an independent perspective. This was felt by many to remove the bias that could be introduced in BWC use as the video capture didn’t require staff control of the filming.

I feel like [BWCs] puts all the power and trust into the hands of the staff and I feel that it would be better to have CCTV on the ward because CCTV is neutral. Harry (m), Patient, A, Pre. I have control over that [BWC recording] … It kind of gives that split as well between staff and patients. You can tell me or I can tell you when to switch it on. Whereas I feel like a CCTV camera is there all the time. Nobody’s asking to switch it on. It’s there. If you wanted to review the footage you can request it, anyone can request to view the footage for a legitimate reason. Whereas the camera can come across as if you’re threatening. Petra (f), Staff, A, Post.

In addition, some participants reflected that the nature and design of BWCs meant that unless staff were present for an incident it wouldn’t be captured, whereas CCTV has the advantage of being always present.

If there’s CCTV, then it’s the same thing, you get me. Like, if its body worn cameras that people can always do things away from staff. They can always go down to that corridor to have their fight or go to the side where staff ain’t gonna see them to have their fight, but with CCTV you can’t do that. Elijah (m), Patient, A, Post.

In addition to exploring technological and video-based interventions, many staff noted that the key tool to violence reduction had to be the use of de-escalation skills, noting that the use of communication and positive relationships had to be the primary tool before other interventions such as BWCs or CCTV.

We do a lot of verbal de-escalation. So we got our destress room now still open. That has a punch bag, and it’s got sensory tiles, and the aim and hope is that when people do get frustrated, because we’re all human. We all get annoyed at anything or many little things in life. There is the aim that they go into that room and start punching the bag instead of property and damaging furniture. But we also are working really hard on verbal de-escalation and actually trying to listen to patients and talk to them before anything else. And that’s helped a lot. And between this kind of shared, or role modelling, where while we’re showing staff, actually even spending an extra 20 min is okay. If it means you’re not going to end up having to restrain a patient. Petra (f), Staff, A, Post.

By using communication skills and de-escalation techniques skilfully, some staff felt there was no need to utilise the BWCs. One concern with the introduction of the BWCs for staff was that the use of this technology may negatively impact on trust and relationships and the use of de-escalation.

Some situations I feel like it can make a situation worse sometimes… I think a lot of situations can be avoided if you just talk with people…. Trying to find out why they’re angry, trying to just kind of see it from their point of view, understand them… I think maybe additional training for verbal de-escalation is needed first. Patrick (m), Staff, A, Post.

Characteristics of individuals

Staff and patients’ knowledge and beliefs about the intervention.

Overall, there were mixed views among both staff and patients as to whether cameras would reduce incidents, prior to and after the pilot period. When considering the possible impact on violence and aggressive incidents there was a view among staff that there was the need for a nuanced and person-centred view.

All the patients that come in, they’re different you know. They have different perceptions; they like different things… everyone is different. So, it just depends. We might go live, and then we have good feedback because the patients they are open and the understand why we have it, and then as they get discharged and new patients come in it might not go as well. It just depends. Serene (f), Staff, A, Pre.

As a result of the desire to be person-centred in the use of such interventions, one staff member noted that they weighed-up such consequences for the patient before using the BWC and would make decisions not to use the camera where they thought it may have a negative impact.

Actually, with this body worn camera, as I did mention, if a patient is unwell, that doesn’t, the patient will not have the capacity to I mean, say yes, you cannot just put it on like that. Yeah, I know it’s for evidence, but when something happens, you first have to attend to the patient. You first have to attend to the patient before this camera is, for me. Ruby (f), Staff, I, Post.

Some staff questioned the existing evidence and theories as to why BWCs work to reduce incidents, and instead noted that for some people it will instigate an incident, while others may be triggered by a camera.

I’m on the fence of how that is going to work because I know the evidence is that by telling a patient ‘look if you keep escalating I’m gonna have to turn this on’, but I know several of our patients would kind of take that as a dare and escalate just to spite so that you would turn it on. Diana (f), Staff, A, Pre.

In contrast, some staff felt the cameras helped them feel safer on wards due to transparency of footage as evidence for both staff and patients.

They [staff] need to use it for protection, for recording evidence, that type of thing… They can record instances for later evidence. Yeah, for them as well. Safer for them and for patients because you can also have the right to get them to record, because a patient might be in the wrong but sometimes it may be the staff is in the wrong position. And that’s achieving safety for patients as well. Yeah, I think it works both ways. Dylan (m), Patient, A, Post.

Positive buy-in was also related to the potential use of the intervention as a training, learning or reflective tool for staff to improve practice and care and promote positive staff behaviour.

If you know that your actions might be filmed one way or the other, that would make me to step up your behaviour to patients… if you know that your actions can be viewed, if the authority wants to, then you behave properly with patients so I think that will improve the quality of the care to patient. Davide (m), Staff, I, Pre.

While there were some positive attitudes towards the cameras, there remained considerable concerns among participants regarding the transparency of camera use to collate evidence in relation to incidents as it was widely noted that the cameras remain in staff control therefore there is an issue in relation to bias and power.

I do think my gut would say that it wouldn’t necessarily be well received. Because also I think people feel like prisoners in here, that’s how some of the patients have described their experience, so in terms of the power dynamic and also just – I think that can make one feel a bit, even worse, basically, you know? Leslie (m), Staff, A, Pre.

These issues lead to staff reporting they didn’t want to wear the camera.

I’d feel quite uncomfortable wearing one to be honest. Leslie (m), Staff, A, Pre.

The staff control of the cameras had a particular impact on patient acceptability of the intervention as it led to some patients viewing BWCs as being an intervention for staff advantage and staff safety, thus increasing a ‘them and us’ culture and leading to patient resistance to the cameras. This was particularly salient for those with prior negative experiences of police use of cameras or mistrust in staff.

I feel like the fact that the body worn cameras is gonna be similar to how the police use them, if a staff member has negative intent toward a patient, they would be able to instigate an incident and then turn the camera on and use the consequences of what they’ve instigated to expect restraint or injection or whatever else might happen. So, I feel like it would be putting all the power and trust into the hands of the staff and I feel that it would be better to have CCTV on the ward because CCTV is neutral. Whereas, the body worn camera, especially with some of the personality conflicts/bad attitudes, impressions I’ve had from certain members of staff since I’ve been here, I feel like body worn cameras might be abused in that way possible. Harry (m), Patient, A, Pre.

Perceived unintended consequences and impact on care

Prior to the implementation there were concerns from staff that the introduction of BWCs could have consequences beyond the intended use of reducing violence and aggression, unintentionally affecting a range of factors that may impact on the overall delivery of care. There was a key concern regarding the potential negative impact that cameras may have for patients who have paranoia or psychosis as well as for those who may have prior traumatic experiences of being filmed.

It might have negative impacts on these patients because I’m thinking about kind of patients with schizophrenia and things like that who already have paranoid delusions, thinking that people are after them, thinking that people are spying on them, people are watching them, and then seeing kind of cameras around. It might have negative impacts on them. Tayla (f), Staff, I, Pre. When I was admitted I was going through psychosis… I don’t want to be filmed and things like that. So you just see a camera, a guy with a camera on, you are like, are you filming me? Elijah (m), Patient, A, Post.

There was also a considerable concern among both staff and patients that the use of cameras would have a negative impact on the therapeutic relationship between staff and patients. This was felt to be related to the implication that the cameras enhanced a ‘them and us’ dynamic due to the power differential that staff controlling the cameras can create, likened to policing and criminalisation of patients. With the potential of a negative impact on relationships between staff and patients, staff suggested they may be disinclined to use BWCs if it would stop patients speaking to them or approaching them if they needed support.

Yeah, I think it would probably damage [the therapeutic relationship] because I think what’s probably quite helpful is things that maybe create less of a power difference. I think to some extent, [the BWC] might hinder that ability. Like for example imagine going to a therapist and them just like ‘I’ve got this camera in the corner of the room and it’s gonna be filming our session and just in case – or like, just in case I feel that you might get aggressive with me’. Um, I don’t think that’s going to help the therapeutic relationship! Jamal (m), Staff, A, Pre. When you get body worn cameras on there, the relationship as well between staff and patients, is just gonna instantly change because you’re looking like police! Elijah (m), Patient, A, Post.

In contrast, a minority of staff felt that the presence of cameras may improve relationships as they provide transparency of staff behaviour and would encourage staff to behave well and provide high quality care for patients.

It will also help how, improve the way we look at the patients… because if you know that your actions might be filmed one way or the other, that would make me to step up your behaviour you know… you behave properly with patients so I think that will improve the quality of the care to patient. More efficiently, more caring to patient. Davide (m), Staff, I, Pre.

The process of implementation

Planning: top-down implementation.

Staff perceived that BWC implementation directives had been given by senior management or policy stakeholders whom they felt viewed the process from a position of limited understanding due to a lack of ‘frontline’ mental health service experience. This led to a lack of faith amongst staff, and a perception that funds were being misspent.

They sit up there, they just roll it out and see how it works, how it goes. They waste a whole lot of money, millions or whatever, thousands of pounds in it, and then they see that ‘Oh, it’s not gonna work’. They take it back and all of that. Before coming out with it, you need to come speak to us… they just sit up there drinking tea and coffee, and then they’re just like, Oh, yeah, well, let’s do it this way…come stay with these people, work with them, for just I give you a 12 h shift, stay with them. Richard (m), Staff, I, Post.

This was exacerbated when staff felt there was a lack of consultation or explanation.

we don’t always get the ins and outs of certain things…We know that the cameras are coming in and stuff like that, but you know, and obviously it’s gone through every avenue to make sure that it’s fine. But then sometimes we don’t always know the ins and outs to then explain to people why we have the cameras. Patrick (m), Staff, A, Post.

It was also highlighted that due to multiple initiatives being implemented and directives handed down in parallel, staff felt negative towards interventions more widely, with the BWCs being ‘ just another thing to do’ , adding to workload for staff and reducing enthusiasm to use the cameras.

it’s not just to do with the camera, I just think there’s lots of changes happening at once, and there’s loads of new things being constantly introduced that people are just thinking oh it’s another thing. I think that’s what it is more than the camera itself. Alice (f), Staff, A, Pre.

Execution: training, Use and Ward Visibility

Overall, there was a lack of consistency amongst staff in their understanding of the purpose and processes of using the BWCs on the wards.

What do you do, do you record every single thing or, I don’t know. Do you record like, if a patient said, I want to talk to you, confidential, you go sit in a room, do you record things like those or is it just violence and aggression? Ada (f), Staff, A, Post.

The lack of clarity regarding the purpose of the intervention and the appropriate use of the cameras was felt to impact staffs’ attitudes and acceptance of using them and contributed to a lack of transparency or perhaps trust regarding the use of any subsequent video footage.

I think if the importance of the recording was explained a bit more…and how it would improve things, I think people would use it more… that’s why I don’t think it’s always used sometimes… if you’re not sure why some of it’s important, then you’re not going to see the value…I think if you’re gonna keep with them, it’s about updating the training, teaching staff when to use it, then where does that information go? How does that look in terms of improving? Just a bit of transparency, I think. But when you don’t know certain things it’s a bit hard to get behind something or back it, you know? Patrick (m), Staff, A, Post.

The lack of information about the purpose and processes related to the intervention was also seen among patients, with most patients noting that they hadn’t received information about the cameras during their admissions.

No information at all. I don’t think any of the patients know about it. Toby (m), Patient, A, Post.

While training was provided it was widely felt that it was insufficient to provide understanding about the purpose of the cameras or the more in-depth processes beyond operational aspects such as charging and docking. Several staff interviewed were unaware of the training, while others noted that they had an informal run-through by colleagues rather than anything formal.

What training are you talking about?… I wasn’t here, so I was taught by my colleague. I mean, from what I was taught, to operate the camera, and to give a warning to the patient that you’re going to use the camera. Nevis (f), Staff, A, Post.

Longer training with further details beyond operational use was felt to be needed by staff.

I think the training should have to be longer, even if it’s like an hour or something… Like what situations deem the camera to be… more information on the cameras, when to use it, why it’s used, and I think if the importance of the recording was explained a bit more and what it was doing and how that recording would go and how it would improve things. Patrick (m), Staff, A, Post.

Furthermore, there was a need for training to be on a rolling basis given the use of bank staff who were not trained to use the cameras or to understand the proper processes or purpose of using the BWCs, which could leave them vulnerable to misuse or abuse.

We have bank staff [who aren’t trained] so they say ‘I don’t know how to use that camera you are giving me’. Nevis (f), Staff, A, Post.

The inner setting

Ward context: acceptance of violence and aggression is part of the job.

It was widely believed by staff that the nature of working on a mental health ward included accepting that violence and aggression was part of the job. This was not seen as an acceptance of violence but more that the job was providing care for individuals who are mentally unwell, and confusion, fear, frustration and aggression can be part of that. As a result, there was an ambivalence among some staff that the introduction of cameras would change this.

I think like in this line of work, there’s always that potential for like risky behaviours to happen. I’m not sure if putting the camera on will make much difference. Patrick (m), Staff, A, Post.

Staff noted that because of the nature of the job, staff are used to managing these situations and they understood that it was part of the job; therefore, it was unlikely that they would record everything that on paper might be considered an incident.

There’s also enough things that happen here, so I don’t think they would record [the incidents] because it’s just another day here. You know what I’m saying… [staff] can just say, ‘Stop, go back to your room and leave it at that and that kind of be the end of it’. Dylan (m), Patient, A, Post. We are trained for it. Eveline (f), Staff, I, Pre.

This acceptance that incidents are a hazard of mental healthcare was linked to staff’s acknowledgment that many factors make up the complexity of violence and aggression including the nature of individual patients, acuity levels, ward atmosphere, staffing levels, access to activities, leave and outside space. The interplay of multiple factors creates a context in which frustrations and incidents are likely, thus become part of the everyday and ‘normal’ life on the ward for staff and patients alike.

I feel like, you know, how in GP services you say, zero tolerance to abusive language, or any kind of harassment. I don’t think there is that on a psychiatric ward you are kind of expected to take all the abuse and just get on with it. Petra (f), Staff, A, Post.

With staff reported having a higher threshold for these behaviours it was perceived that this was likely to impact on the efficiency of the intervention as staff would be less likely to consider a situation as violent but more ‘ part of the job’ .

Reactive nature of the ward and incidents

Most participants noted that the ward context is always changing with people being admitted and discharged, with daily staff changes and wider turnover of staff, so things are never static and can change at any point. This reflects the dynamic nature of the ward which creates a complex moving picture that staff need to consider and react to.

[the atmosphere] it’s very good at the moment. If you had asked me this two weeks ago, I would say, ‘Oh, my gosh’. But it changes… The type of patient can make your whole ward change… it depends on the client group we have at the time. Nevis (f), Staff, A, Post.

Staff noted that a key limitation of using the cameras to reduce incidents was the reactive nature of the environment and care being provided. This was felt to impact on the feasibility and use of the cameras as staff noted that they often react to what is happening rather than thinking to ‘ put the camera on first ’. It was felt by staff with experience of reacting to incidents that the failure to use BWCs during these processes were linked to staff’s instincts and training to focus on patients as a priority.

Say for instance, you’re in the office, and two patients start fighting, or a patient attacks someone and, all you’re thinking about is to go there to stop the person. You’re not thinking about putting on any camera. You understand? So sometimes it’s halfway through it, somebody might say, ‘Has anybody switched the camera on’? And that’s the time you start recording… If something happens immediately, you’re not thinking about the camera at that time, you’re just thinking to just go, so yeah. Nevis (f), Staff, A, Post.

Incidents happen quickly and often surprise staff, therefore staff react instantly so are not thinking about new processes such as recording on the cameras as this would slow things down or is not in the reactive nature needed by staff during such incidents.

When you’re in the middle of an incident and your adrenaline’s high, you’re focusing on the incident itself. It’s very difficult for you to now remember, remind yourself to switch on the camera because you’re thinking, patient safety, staff safety, who’s coming to relieve you? What’s going on? Who’s at the door? Petra (f), Staff, A, Post.

In addition, the need for an immediate response meant that it was felt that by the time staff remember to, or have the chance to, switch the camera on it was often too late.

Sometimes in the heat of moments and stuff like that, or if the situation’s happening, sometimes you don’t always think to, you know, put your camera on. Patrick (m), Staff, A, Post.

Outer setting

Resources: staffing.

Issues related to staffing were highlighted by several participants as a key problem facing mental health wards thus leading to staff having higher workloads, and higher rates of bank and agency staff being used on shift and feeling burnt-out.

Out of all the wards I’ve been on I’d say this is the worst. It’s primarily because the staff are overworked…it seems like they spend more time doing paperwork than they do interacting with the patients. Harry (m), Patient, A, Pre. We’re in a bit of a crisis at the minute, we’re really, really understaffed. We’re struggling to cover shifts, so the staff are generally quite burnt out. We’ve had a number of people that have just left all at once, so that had an impact… Staff do get frustrated if they’re burnt out from lack of staff and what have you. Alice (f), Staff, A, Pre.

It was noted by one participant that the link of a new intervention with extra workload was likely to have a negative impact on its acceptability due to these increasing demands.

People automatically link the camera to then the additional paperwork that goes alongside it. It’s like, ‘Oh god, if we do this, we’ve got to do that’, and that could play a part. Petra (f), Staff, A, Post.

One staff member noted that the staffing issue meant there were more likely to be bank staff on wards so the care of patients may be affected as temporary staff may be less able to build meaningful therapeutic relationships.

So obviously there is the basic impact on safety of not having adequate staffing, but then there’s the impact of having a lot of bank staff. So obviously when you have permanent staff they get to know the patients more, we’re able to give them the more individualised care that we ideally should be giving them, but we can’t do that with bank staff. Diana (f), Staff, A, Pre.

It was also suggested that staffing levels and mix often made it more difficult to provide activities or facilitate escorted leave which can lead to patients feeling frustrated and becoming more aggressive.

So you know there is enough staff to facilitate the actual shift, so you know when there’s less staff like you say you’ve got people knocking at the door, but then you don’t have staff to take people out on leave straight away, that all has a rippling effect! Serene (f), Staff, A, Pre.

Wider systemic issues

Overall, there was a concern that the introduction of BWCs would not impact on wider, underlying factors that may contribute to frustration, aggression and incidents on wards. Providing a more enhanced level of care and better addressing the needs of patients was felt to be central to helping people but also reducing the frustration that patients feel when on the ward.

… for violence and aggression, [focus on] the mental health side of things like therapy and psychology should be compulsory. It shouldn’t be something you apply for and have to wait three or four weeks for. I think every person should, more than three or four weeks even, months even… we need psychology and therapists. That’s what will stop most violence, because psychologists and a therapist can edit the way that they speak to people because they’ve been given that skill depending on the way the person behaves. So that’s what we need regularly… not like all this dancing therapy, yoga therapy. That’s a person, that you come and you actually sit down and talk through your shit with them. That will help! Elijah (m), Patient, A, Post. There’s a lack of routine and I think there’s a lack of positive interaction between the patient and the staff as well. The only time you interact with a member of staff is if you’re hassling them for something, you have to hassle for every little thing, and it becomes a sort of, frustration inducing and like I’m a very calm person, but I found myself getting very fucking angry, to be honest, on this ward just because out of pure frustration… there’s bigger problems than body worn cameras going on. Harry (m), Patient, A, Pre.

Staff agreed that there was a need to invest in staff and training rather than new technologies or innovations as it is staff and their skills behind the camera.

It’s not the camera that will do all of that. It’s not making the difference. It’s a very good, very beautiful device, probably doing its job in its own way. But it’s more about investing in the staff, giving them that training and making them reflect on every day-to-day shift. Richard (m), Staff, I, Post.

There was felt to be a need to support staff more in delivering care within wards that can be challenging and where patients are unwell to ensure that staff feel safe. While in some circumstances the cameras made some staff feel safer, greater support from management would be more beneficial in making staff feel valued.

In this study exploring the implementation and use of body-worn cameras on mental health wards, we employed two methods for collecting and comparing data on incidents and use of containment measures, including BWCs, on one acute ward and one psychiatric intensive care unit. We found no clear relationship between the use of BWCs and rates or severity of incidents on either ward. While BWCs may be used when there are incidents of both physical and verbal aggression, results indicate that they may also provoke verbal aggression, as was suggested during some interviews within this study. This should be a concern, as strong evidence that being repeatedly subject to verbal aggression and abuse can lead to burnout and withdrawal of care by staff [ 30 ]. These mixed findings reflect results that were reported in two earlier studies of BWCs on mental health wards [ 12 , 13 ]. However, the very low use of the cameras, on just 10 per cent of the shifts where data was obtained, makes it even more difficult to draw any conclusions.

While the data shows limited impact of using BWCs on levels of incidents, we did find that during the pilot period BWC use tended to occur alongside physical restraint, but the direction of relationship is unclear as staff were asked to use BWCs when planning an intervention such as restraint. This relationship with restraint reflected the findings on several wards in a previous study [ 13 ], while contrasting with those reported in a second study that found reductions in incidents involving restraint during the evaluation period [ 12 ]. Such a mix of findings highlights the complexity of using BWCs as a violence reduction method within a busy healthcare setting in which several interacting components and contextual factors, and behaviours by staff and patients can affect outcomes [ 31 ]. The qualitative data collected during this pilot period highlighted the potential systemic and contextual factors such as low staffing that may have a confounding impact on the incident data presented in this simple form.

The findings presented within this evaluation provide some insights into the process of implementing BWCs as a safety intervention in mental health services and highlight some of the challenges and barriers faced. The use of implementation science to evaluate the piloting of BWCs on wards helps to demonstrate how multiple elements including a variety of contextual and systemic factors can have a considerable impact and thus change how a technology may vary not only between hospitals, but even across wards in the same hospital. By understanding the elements that may and do occur during the process of implementing such interventions, we can better understand if and how BWCs might be used in the future.

Within this pilot, extensive preparatory work conducted at a directorate and senior management level did not translate during the process of implementation at a ward level, which appeared to impact on the use of BWCs by individuals on the wards. This highlights that there is a need to utilise implementation science approaches in planning the implementation of new technologies or interventions and to investigate elements related to behavioural change and context rather than just the desired and actual effects of the intervention itself.

While ward staff and patients identified the potential for BWCs to enhance safety on the wards, participants distrusted their deployment and expressed concerns about ethical issues and possible harmful consequences of their use on therapeutic relationships, care provided and patient wellbeing. These themes reflect previous findings from a national interview study of patient and staff perspectives and experiences of BWCs in inpatient mental health wards [ 14 ]. Given these issues, alternatives such as increasing de-escalation skills were identified by staff as possible routes that may be more beneficial in these settings. Furthermore, other approaches such as safety huddles have also been highlighted within the literature as potential means to improve patient safety by looking ahead at what can be attended to or averted [ 32 ].

Furthermore, it is important to consider that the presence of power imbalances and the pre-existing culture on the ward have considerable implications for safety approaches and must be considered, as exemplified by the preferences by both staff and patients in this evaluation for more perceived ‘impartial’ interventions such as CCTV. As identified within previous studies [ 14 ], BWCs can have different implications for psychological safety, particularly for vulnerable patients who already feel criminalised in an environment with asymmetrical power imbalances between staff and patients. This is particularly salient when considering aspects of identity such as race, ethnicity, and gender both in terms of the identities of the patient group but also in terms of the staff/patient relationship.

While preferences in this study note CCTV as more ‘impartial’, work by Desai [ 33 ] draws on the literature about the use of surveillance cameras in other settings (such as public streets) as well as on psychiatric wards and concludes that CCTV monitoring is fraught with difficulties and challenges, and that ‘watching’ patients and staff through the lens of a camera can distort the reality of what is happening within a ward environment. In her recently published book, Desai [ 34 ] develops this theme to explore the impacts of being watched on both patients and staff through her ethnographic research in psychiatric intensive care units. She highlights concerns over the criminalisation of patient behaviour, safeguarding concerns in relation to the way women’s bodies and behaviours are viewed and judged, and the undermining by CCTV of ethical mental health practice by staff who attempt to engage in thoughtful, constructive, therapeutic interactions with patients in face-to-face encounters. Appenzeller et al.’s [ 35 ] review found that whilst the presence of CCTV appeared to increase subjective feelings of safety amongst patients and visitors, there was no objective evidence that video surveillance increases security, and that staff may develop an over-reliance on the technology.

In addition, our findings add to the existing literature which notes that alternative interventions and approaches that address underlying contextual and systemic issues related to improving care on inpatient wards require attention to address the underlying factors related to incidents, e.g., flashpoints [ 36 ]. Evidence suggests that factors leading to incidents can be predicted; therefore, there is a need to enable staff to work in a proactive way to anticipate and prevent incidents rather than view incidents as purely reactive [ 37 , 38 , 39 ]. Such skills-based and relational approaches are likely to impact more on improving safety and reducing incidents by addressing the complex and multi-faceted issue of incidents on inpatient mental health wards [ 40 ].

These findings highlight that interventions such as BWCs are not used within a vacuum, and that hospitals are complex contexts in which there are a range of unique populations, processes, and microsystems that are multi-faceted [ 41 ]. As a result, interventions will encounter both universal, specific, and local barriers that will impact on its functioning in the real world. This is salient because research suggests that camera use inside mental health wards is based on a perception of the violent nature of the mental health patient, a perception that not only influences practice but also impacts how patients experience the ward [ 33 ]. As a result, there needs to be careful consideration of the use of any new and innovative intervention aimed at improving safety within mental health settings that have limited research supporting their efficacy.

Limitations

While the study provides important insights into the efficacy and acceptability of introducing BWCs onto inpatient mental health wards, there were several limitations. Firstly, the analysis of incident data is limited in its nature as it only presents surface level information about incidents without wider contextual information. Results using such data should be cautiously interpreted as they do not account for confounding factors, such as staffing, acuity, ward culture or ward atmosphere, that are likely to contribute to incidents of violence and aggression. For example, while there was a statistically significant decrease in restrictive practice on the PICU across the study period, we know that BWCs were not widely used on that ward, so this is likely due to a confounding variable that was not accounted for in the study design.

Secondly, the study faced limitations in relation to recruitment, particularly with patients. Researchers’ access to wards was challenging due to high staff turnover and high rates of acuity, meaning many patients were not deemed well enough to be able to consent to take part in the study. In addition, the low use of the cameras on wards meant that many patients, and some staff, had not seen the BWCs in use. Similarly, patients had been provided limited information about the pilot, so their ability to engage in the research and describe their own experiences with BWCs was restricted.

Thirdly, analysis captures the active use of the BWC, however it does not fully capture the impact of staff wearing the cameras even where they do not actively use them. While our qualitative analysis provides insight into the limitation of such passive use, it is likely that the presence of the cameras being worn by staff, even when turned off, may have an impact on both staff and patient behaviours. This may explain trends in the data that did not reach significance but warrant further investigation in relation to the presence of BWCs, nonetheless.

Finally, researchers had planned to collect quantitative surveys from staff and patients in relation to their experiences of the ward atmosphere and climate, views related to therapeutic relationships on the ward, levels of burnout among staff, views on care, and attitudes to containment measures. Due to issues related to staff time, patient acuity, and poor engagement from staff leading to challenges accessing the wards, the collection of such survey data was unfeasible, and this element of the study was discontinued. As a result, we have not reported this aspect in our paper. This limitation reflects the busy nature of inpatient mental health wards with pressures on staff and high levels of ill health among patients. As such, traditional methodologies for evaluation are unlikely to elicit data that is comprehensive and meaningful. Alternative approaches may need to be considered.

Future directions

With BWCs being increasingly used across inpatient mental health services [ 14 ], it is important that further research and evaluation is conducted. To date, there is limited data regarding the effectiveness of this technology in relation to violence reduction; however, there may be other beneficial uses in relation to safeguarding and training [ 13 ]. Future research should consider alternative methods that ensure contextual factors are accounted for and that patient voices can be maximised. For example, focus groups with patients currently admitted to a mental health ward or interviews with those who have recently been on a ward that has used the cameras, would bypass problems encountered with capacity to consent in the present study. Furthermore, ethnographic approaches may provide a deeper understanding of the implementation, deployment and impact that BWCs have on wards.

Overall, this research sheds light on the complexities of using BWCs as a tool for ‘maximising safety’ in mental health settings. The findings suggest that BWCs have a limited impact on levels of incidents on wards, something that is likely to be largely influenced by the process of implementation as well as a range of contextual factors, including the staff and patient populations on the wards. As a result, it is likely that while BWCs may see successes in one hospital site this is not guaranteed for another site as such factors will have a considerable impact on efficacy, acceptability, and feasibility. Furthermore, the findings point towards the need for more consideration to be placed on processes of implementation and the complex ethical discussions regarding BWC use from both a patient and a staff perspective.

In conclusion, while there have been advances in digital applications and immersive technologies showing promise of therapeutic benefits for patients and staff more widely, whether BWCs and other surveillance approaches are to be part of that picture remains to be seen and needs to be informed by high-quality, co-produced research that focuses on wider therapeutic aspects of mental healthcare.

Data availability

The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions.

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Acknowledgements

We would like to thank The Burdett Trust for Nursing for funding this work. We would also like to acknowledge our wider Lived Experience Advisory Panel and Project Advisory Panel for their contributions and support and would like to thank the staff and service users on the wards we attended for their warmth and participation.

Funding was provided by The Burdett Trust of Nursing. Funders were independent of the research and did not impact findings.

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All authors have read and approved the manuscript. Authors AS, UF, KW, GB created the protocol for the study. KW, JJ, UF conducted the recruitment for the study, and conducted the interviews. UF, JJ, JB, LMA, LU, SMK, KB, ET coded data, and contributed to the analysis. All authors supported drafting and development of the manuscript.

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Foye, U., Wilson, K., Jepps, J. et al. Exploring the use of body worn cameras in acute mental health wards: a mixed-method evaluation of a pilot intervention. BMC Health Serv Res 24 , 681 (2024). https://doi.org/10.1186/s12913-024-11085-x

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About the University of Melbourne We’re tightly connected with the community, both at home and abroad. We take pride in our people, who all contribute to our mission to benefit society through the transformative impact of education and research. Discover more via  our website  and stay connected with our stories and people on  LinkedIn .   

Be Yourself The University of Melbourne values the unique backgrounds, experiences and contributions that each person brings to our community and welcomes and celebrates diversity.  First Nations people, those identifying as LGBTQIA+, parents, carers, people of all ages, abilities and genders, and people of diverse ethnicity, nationality and faith are encouraged to apply. Our aim is to create a workforce that reflects the diversity of the community in which we live. For more information please visit our Diversity and Inclusion page.

We are dedicated to ensuring barrier free and inclusive practices to recruit the most talented candidates. If you require reasonable adjustments, please contact the employee listed on the first page of the Position Description found below, with an email containing your name and contact details for a confidential discussion. Please ensure your email is titled "Reasonable Adjustments Request".

Aboriginal and Torres Strait Islander Applicants We aspire to be the University of choice for Indigenous Australians, with unprecedented investment to attract, nurture and retain Aboriginal and Torres Strait Islander students and staff. Tangible support through a range of programs and initiatives will ensure that you personally succeed and flourish while at the University of Melbourne.

For further information, including our 2023-2027 Indigenous strategy please visit - https://about.unimelb.edu.au/reconciliation/murmuk-djerring

Join Us! If you feel this role is right for you, please apply with the following documents: 

• Cover Letter outlining your interest and experience
• The responses against the Selection Criteria^ (found in the Position Description)

^For information to help you with compiling short statements to answer the selection criteria and competencies, please go to  http://about.unimelb.edu.au/careers/selection-criteria

If you have any questions regarding the recruitment process, please feel free to contact Nick Petersen via email at [email protected] , ensuring that you include the Position Number and the Job Title as the subject. Please do not share your application to this email address.

If you have any particular questions regarding the job please follow the details listed on the Position Description.

Advertised: 04 Jun 2024 12:05 AM AUS Eastern Standard Time

Applications close: 18 Jun 2024 11:55 PM AUS Eastern Standard Time

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