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A literature review: efficacy of online learning courses for higher education institution using meta-analysis

• Published: 04 November 2019
• Volume 26 , pages 1367–1385, ( 2021 )

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• Mayleen Dorcas B. Castro   ORCID: orcid.org/0000-0002-6618-6958 1 , 2 &
• Gilbert M. Tumibay 3  

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The Internet has made online learning possible, and many educators and researchers are interested in online learning courses to enhance and improve the student learning outcomes while battling the shortage in resources, facilities and equipment particularly in higher education institution. Online learning has become popular because of its potential for providing more flexible access to content and instruction at any time, from any place. It is imperative that the researchers consider, and examine the efficacy of online learning in educating students. For this study, the researchers reviewed literature through meta-analysis as the method of research concerning the use of ADDIE (Analysis, Design, Development, Implementation and Evaluation) framework for designing and developing instructional materials that can provide wider access to quality higher education. This framework can be used to list generic processes that instructional designers and training developers use (Morrison et al., 2010 ). It represents a descriptive guideline for building effective training and performance support tools in five phases, as follows: 1.) Analysis, 2.) Design, 3.) Development, 4.) Implementation, and 5.) Evaluation. The researchers collected papers relating to online learning courses efficacy studies to provide a synthesis of scientifically rigorous knowledge in online learning courses, the researchers searched on ERIC (Education Resources Information Center), ProQuest databases, PubMed, Crossref, Scribd EBSCO, and Scopus. The researchers also conducted a manual search using Google Scholar. Based on the analysis, three main themes developed: 1.) comparison of online learning and traditional face-to-face setting, 2.) identification of important factors of online learning delivery, and 3.) factors of institutional adoption of online learning. Based on the results obtained 50 articles. The researchers examine each paper and found 30 articles that met the efficacy of online learning courses through having well-planned, well-designed courses and programs for higher education institution. Also, it highlights the importance of instructional design and the active role of institutions play in providing support structures for educators and students. Identification of different processes and activities in designing and developing an Online Learning Courses for Higher Education Institution will be the second phase of this study for which the researchers will consider using the theoretical aspect of the ADDIE framework.

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Castro, M.D.B., Tumibay, G.M. A literature review: efficacy of online learning courses for higher education institution using meta-analysis. Educ Inf Technol 26 , 1367–1385 (2021). https://doi.org/10.1007/s10639-019-10027-z

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Received : 16 April 2019

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A systematic review of research on online teaching and learning from 2009 to 2018

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Systematic reviews were conducted in the nineties and early 2000's on online learning research. However, there is no review examining the broader aspect of research themes in online learning in the last decade. This systematic review addresses this gap by examining 619 research articles on online learning published in twelve journals in the last decade. These studies were examined for publication trends and patterns, research themes, research methods, and research settings and compared with the research themes from the previous decades. While there has been a slight decrease in the number of studies on online learning in 2015 and 2016, it has then continued to increase in 2017 and 2018. The majority of the studies were quantitative in nature and were examined in higher education. Online learning research was categorized into twelve themes and a framework across learner, course and instructor, and organizational levels was developed. Online learner characteristics and online engagement were examined in a high number of studies and were consistent with three of the prior systematic reviews. However, there is still a need for more research on organization level topics such as leadership, policy, and management and access, culture, equity, inclusion, and ethics and also on online instructor characteristics.

• • Twelve online learning research themes were identified in 2009–2018.
• • A framework with learner, course and instructor, and organizational levels was used.
• • Online learner characteristics and engagement were the mostly examined themes.
• • The majority of the studies used quantitative research methods and in higher education.
• • There is a need for more research on organization level topics.

1. Introduction

Online learning has been on the increase in the last two decades. In the United States, though higher education enrollment has declined, online learning enrollment in public institutions has continued to increase ( Allen & Seaman, 2017 ), and so has the research on online learning. There have been review studies conducted on specific areas on online learning such as innovations in online learning strategies ( Davis et al., 2018 ), empirical MOOC literature ( Liyanagunawardena et al., 2013 ; Veletsianos & Shepherdson, 2016 ; Zhu et al., 2018 ), quality in online education ( Esfijani, 2018 ), accessibility in online higher education ( Lee, 2017 ), synchronous online learning ( Martin et al., 2017 ), K-12 preparation for online teaching ( Moore-Adams et al., 2016 ), polychronicity in online learning ( Capdeferro et al., 2014 ), meaningful learning research in elearning and online learning environments ( Tsai, Shen, & Chiang, 2013 ), problem-based learning in elearning and online learning environments ( Tsai & Chiang, 2013 ), asynchronous online discussions ( Thomas, 2013 ), self-regulated learning in online learning environments ( Tsai, Shen, & Fan, 2013 ), game-based learning in online learning environments ( Tsai & Fan, 2013 ), and online course dropout ( Lee & Choi, 2011 ). While there have been review studies conducted on specific online learning topics, very few studies have been conducted on the broader aspect of online learning examining research themes.

2. Systematic Reviews of Distance Education and Online Learning Research

Distance education has evolved from offline to online settings with the access to internet and COVID-19 has made online learning the common delivery method across the world. Tallent-Runnels et al. (2006) reviewed research late 1990's to early 2000's, Berge and Mrozowski (2001) reviewed research 1990 to 1999, and Zawacki-Richter et al. (2009) reviewed research in 2000–2008 on distance education and online learning. Table 1 shows the research themes from previous systematic reviews on online learning research. There are some themes that re-occur in the various reviews, and there are also new themes that emerge. Though there have been reviews conducted in the nineties and early 2000's, there is no review examining the broader aspect of research themes in online learning in the last decade. Hence, the need for this systematic review which informs the research themes in online learning from 2009 to 2018. In the following sections, we review these systematic review studies in detail.

Comparison of online learning research themes from previous studies.

2.1. Distance education research themes, 1990 to 1999 ( Berge & Mrozowski, 2001 )

Berge and Mrozowski (2001) reviewed 890 research articles and dissertation abstracts on distance education from 1990 to 1999. The four distance education journals chosen by the authors to represent distance education included, American Journal of Distance Education, Distance Education, Open Learning, and the Journal of Distance Education. This review overlapped in the dates of the Tallent-Runnels et al. (2006) study. Berge and Mrozowski (2001) categorized the articles according to Sherry's (1996) ten themes of research issues in distance education: redefining roles of instructor and students, technologies used, issues of design, strategies to stimulate learning, learner characteristics and support, issues related to operating and policies and administration, access and equity, and costs and benefits.

In the Berge and Mrozowski (2001) study, more than 100 studies focused on each of the three themes: (1) design issues, (2) learner characteristics, and (3) strategies to increase interactivity and active learning. By design issues, the authors focused on instructional systems design and focused on topics such as content requirement, technical constraints, interactivity, and feedback. The next theme, strategies to increase interactivity and active learning, were closely related to design issues and focused on students’ modes of learning. Learner characteristics focused on accommodating various learning styles through customized instructional theory. Less than 50 studies focused on the three least examined themes: (1) cost-benefit tradeoffs, (2) equity and accessibility, and (3) learner support. Cost-benefit trade-offs focused on the implementation costs of distance education based on school characteristics. Equity and accessibility focused on the equity of access to distance education systems. Learner support included topics such as teacher to teacher support as well as teacher to student support.

2.2. Online learning research themes, 1993 to 2004 ( Tallent-Runnels et al., 2006 )

Tallent-Runnels et al. (2006) reviewed research on online instruction from 1993 to 2004. They reviewed 76 articles focused on online learning by searching five databases, ERIC, PsycINFO, ContentFirst, Education Abstracts, and WilsonSelect. Tallent-Runnels et al. (2006) categorized research into four themes, (1) course environment, (2) learners' outcomes, (3) learners’ characteristics, and (4) institutional and administrative factors. The first theme that the authors describe as course environment ( n  = 41, 53.9%) is an overarching theme that includes classroom culture, structural assistance, success factors, online interaction, and evaluation.

Tallent-Runnels et al. (2006) for their second theme found that studies focused on questions involving the process of teaching and learning and methods to explore cognitive and affective learner outcomes ( n  = 29, 38.2%). The authors stated that they found the research designs flawed and lacked rigor. However, the literature comparing traditional and online classrooms found both delivery systems to be adequate. Another research theme focused on learners’ characteristics ( n  = 12, 15.8%) and the synergy of learners, design of the online course, and system of delivery. Research findings revealed that online learners were mainly non-traditional, Caucasian, had different learning styles, and were highly motivated to learn. The final theme that they reported was institutional and administrative factors (n  = 13, 17.1%) on online learning. Their findings revealed that there was a lack of scholarly research in this area and most institutions did not have formal policies in place for course development as well as faculty and student support in training and evaluation. Their research confirmed that when universities offered online courses, it improved student enrollment numbers.

2.3. Distance education research themes 2000 to 2008 ( Zawacki-Richter et al., 2009 )

Zawacki-Richter et al. (2009) reviewed 695 articles on distance education from 2000 to 2008 using the Delphi method for consensus in identifying areas and classified the literature from five prominent journals. The five journals selected due to their wide scope in research in distance education included Open Learning, Distance Education, American Journal of Distance Education, the Journal of Distance Education, and the International Review of Research in Open and Distributed Learning. The reviewers examined the main focus of research and identified gaps in distance education research in this review.

Zawacki-Richter et al. (2009) classified the studies into macro, meso and micro levels focusing on 15 areas of research. The five areas of the macro-level addressed: (1) access, equity and ethics to deliver distance education for developing nations and the role of various technologies to narrow the digital divide, (2) teaching and learning drivers, markets, and professional development in the global context, (3) distance delivery systems and institutional partnerships and programs and impact of hybrid modes of delivery, (4) theoretical frameworks and models for instruction, knowledge building, and learner interactions in distance education practice, and (5) the types of preferred research methodologies. The meso-level focused on seven areas that involve: (1) management and organization for sustaining distance education programs, (2) examining financial aspects of developing and implementing online programs, (3) the challenges and benefits of new technologies for teaching and learning, (4) incentives to innovate, (5) professional development and support for faculty, (6) learner support services, and (7) issues involving quality standards and the impact on student enrollment and retention. The micro-level focused on three areas: (1) instructional design and pedagogical approaches, (2) culturally appropriate materials, interaction, communication, and collaboration among a community of learners, and (3) focus on characteristics of adult learners, socio-economic backgrounds, learning preferences, and dispositions.

The top three research themes in this review by Zawacki-Richter et al. (2009) were interaction and communities of learning ( n  = 122, 17.6%), instructional design ( n  = 121, 17.4%) and learner characteristics ( n  = 113, 16.3%). The lowest number of studies (less than 3%) were found in studies examining the following research themes, management and organization ( n  = 18), research methods in DE and knowledge transfer ( n  = 13), globalization of education and cross-cultural aspects ( n  = 13), innovation and change ( n  = 13), and costs and benefits ( n  = 12).

2.4. Online learning research themes

These three systematic reviews provide a broad understanding of distance education and online learning research themes from 1990 to 2008. However, there is an increase in the number of research studies on online learning in this decade and there is a need to identify recent research themes examined. Based on the previous systematic reviews ( Berge & Mrozowski, 2001 ; Hung, 2012 ; Tallent-Runnels et al., 2006 ; Zawacki-Richter et al., 2009 ), online learning research in this study is grouped into twelve different research themes which include Learner characteristics, Instructor characteristics, Course or program design and development, Course Facilitation, Engagement, Course Assessment, Course Technologies, Access, Culture, Equity, Inclusion, and Ethics, Leadership, Policy and Management, Instructor and Learner Support, and Learner Outcomes. Table 2 below describes each of the research themes and using these themes, a framework is derived in Fig. 1 .

Research themes in online learning.

Online learning research themes framework.

The collection of research themes is presented as a framework in Fig. 1 . The themes are organized by domain or level to underscore the nested relationship that exists. As evidenced by the assortment of themes, research can focus on any domain of delivery or associated context. The “Learner” domain captures characteristics and outcomes related to learners and their interaction within the courses. The “Course and Instructor” domain captures elements about the broader design of the course and facilitation by the instructor, and the “Organizational” domain acknowledges the contextual influences on the course. It is important to note as well that due to the nesting, research themes can cross domains. For example, the broader cultural context may be studied as it pertains to course design and development, and institutional support can include both learner support and instructor support. Likewise, engagement research can involve instructors as well as learners.

In this introduction section, we have reviewed three systematic reviews on online learning research ( Berge & Mrozowski, 2001 ; Tallent-Runnels et al., 2006 ; Zawacki-Richter et al., 2009 ). Based on these reviews and other research, we have derived twelve themes to develop an online learning research framework which is nested in three levels: learner, course and instructor, and organization.

2.5. Purpose of this research

In two out of the three previous reviews, design, learner characteristics and interaction were examined in the highest number of studies. On the other hand, cost-benefit tradeoffs, equity and accessibility, institutional and administrative factors, and globalization and cross-cultural aspects were examined in the least number of studies. One explanation for this may be that it is a function of nesting, noting that studies falling in the Organizational and Course levels may encompass several courses or many more participants within courses. However, while some research themes re-occur, there are also variations in some themes across time, suggesting the importance of research themes rise and fall over time. Thus, a critical examination of the trends in themes is helpful for understanding where research is needed most. Also, since there is no recent study examining online learning research themes in the last decade, this study strives to address that gap by focusing on recent research themes found in the literature, and also reviewing research methods and settings. Notably, one goal is to also compare findings from this decade to the previous review studies. Overall, the purpose of this study is to examine publication trends in online learning research taking place during the last ten years and compare it with the previous themes identified in other review studies. Due to the continued growth of online learning research into new contexts and among new researchers, we also examine the research methods and settings found in the studies of this review.

The following research questions are addressed in this study.

• 1. What percentage of the population of articles published in the journals reviewed from 2009 to 2018 were related to online learning and empirical?
• 2. What is the frequency of online learning research themes in the empirical online learning articles of journals reviewed from 2009 to 2018?
• 3. What is the frequency of research methods and settings that researchers employed in the empirical online learning articles of the journals reviewed from 2009 to 2018?

This five-step systematic review process described in the U.S. Department of Education, Institute of Education Sciences, What Works Clearinghouse Procedures and Standards Handbook, Version 4.0 ( 2017 ) was used in this systematic review: (a) developing the review protocol, (b) identifying relevant literature, (c) screening studies, (d) reviewing articles, and (e) reporting findings.

3.1. Data sources and search strategies

The Education Research Complete database was searched using the keywords below for published articles between the years 2009 and 2018 using both the Title and Keyword function for the following search terms.

“online learning" OR "online teaching" OR "online program" OR "online course" OR “online education”

3.2. Inclusion/exclusion criteria

The initial search of online learning research among journals in the database resulted in more than 3000 possible articles. Therefore, we limited our search to select journals that focus on publishing peer-reviewed online learning and educational research. Our aim was to capture the journals that published the most articles in online learning. However, we also wanted to incorporate the concept of rigor, so we used expert perception to identify 12 peer-reviewed journals that publish high-quality online learning research. Dissertations and conference proceedings were excluded. To be included in this systematic review, each study had to meet the screening criteria as described in Table 3 . A research study was excluded if it did not meet all of the criteria to be included.

Inclusion/Exclusion criteria.

3.3. Process flow selection of articles

Fig. 2 shows the process flow involved in the selection of articles. The search in the database Education Research Complete yielded an initial sample of 3332 articles. Targeting the 12 journals removed 2579 articles. After reviewing the abstracts, we removed 134 articles based on the inclusion/exclusion criteria. The final sample, consisting of 619 articles, was entered into the computer software MAXQDA ( VERBI Software, 2019 ) for coding.

Flowchart of online learning research selection.

3.4. Developing review protocol

A review protocol was designed as a codebook in MAXQDA ( VERBI Software, 2019 ) by the three researchers. The codebook was developed based on findings from the previous review studies and from the initial screening of the articles in this review. The codebook included 12 research themes listed earlier in Table 2 (Learner characteristics, Instructor characteristics, Course or program design and development, Course Facilitation, Engagement, Course Assessment, Course Technologies, Access, Culture, Equity, Inclusion, and Ethics, Leadership, Policy and Management, Instructor and Learner Support, and Learner Outcomes), four research settings (higher education, continuing education, K-12, corporate/military), and three research designs (quantitative, qualitative and mixed methods). Fig. 3 below is a screenshot of MAXQDA used for the coding process.

Codebook from MAXQDA.

3.5. Data coding

Research articles were coded by two researchers in MAXQDA. Two researchers independently coded 10% of the articles and then discussed and updated the coding framework. The second author who was a doctoral student coded the remaining studies. The researchers met bi-weekly to address coding questions that emerged. After the first phase of coding, we found that more than 100 studies fell into each of the categories of Learner Characteristics or Engagement, so we decided to pursue a second phase of coding and reexamine the two themes. Learner Characteristics were classified into the subthemes of Academic, Affective, Motivational, Self-regulation, Cognitive, and Demographic Characteristics. Engagement was classified into the subthemes of Collaborating, Communication, Community, Involvement, Interaction, Participation, and Presence.

3.6. Data analysis

Frequency tables were generated for each of the variables so that outliers could be examined and narrative data could be collapsed into categories. Once cleaned and collapsed into a reasonable number of categories, descriptive statistics were used to describe each of the coded elements. We first present the frequencies of publications related to online learning in the 12 journals. The total number of articles for each journal (collectively, the population) was hand-counted from journal websites, excluding editorials and book reviews. The publication trend of online learning research was also depicted from 2009 to 2018. Then, the descriptive information of the 12 themes, including the subthemes of Learner Characteristics and Engagement were provided. Finally, research themes by research settings and methodology were elaborated.

4.1. Publication trends on online learning

Publication patterns of the 619 articles reviewed from the 12 journals are presented in Table 4 . International Review of Research in Open and Distributed Learning had the highest number of publications in this review. Overall, about 8% of the articles appearing in these twelve journals consisted of online learning publications; however, several journals had concentrations of online learning articles totaling more than 20%.

Empirical online learning research articles by journal, 2009–2018.

Note . Journal's Total Article count excludes reviews and editorials.

The publication trend of online learning research is depicted in Fig. 4 . When disaggregated by year, the total frequency of publications shows an increasing trend. Online learning articles increased throughout the decade and hit a relative maximum in 2014. The greatest number of online learning articles ( n  = 86) occurred most recently, in 2018.

Online learning publication trends by year.

4.2. Online learning research themes that appeared in the selected articles

The publications were categorized into the twelve research themes identified in Fig. 1 . The frequency counts and percentages of the research themes are provided in Table 5 below. A majority of the research is categorized into the Learner domain. The fewest number of articles appears in the Organization domain.

Research themes in the online learning publications from 2009 to 2018.

The specific themes of Engagement ( n  = 179, 28.92%) and Learner Characteristics ( n  = 134, 21.65%) were most often examined in publications. These two themes were further coded to identify sub-themes, which are described in the next two sections. Publications focusing on Instructor Characteristics ( n  = 21, 3.39%) were least common in the dataset.

4.2.1. Research on engagement

The largest number of studies was on engagement in online learning, which in the online learning literature is referred to and examined through different terms. Hence, we explore this category in more detail. In this review, we categorized the articles into seven different sub-themes as examined through different lenses including presence, interaction, community, participation, collaboration, involvement, and communication. We use the term “involvement” as one of the terms since researchers sometimes broadly used the term engagement to describe their work without further description. Table 6 below provides the description, frequency, and percentages of the various studies related to engagement.

Research sub-themes on engagement.

In the sections below, we provide several examples of the different engagement sub-themes that were studied within the larger engagement theme.

Presence. This sub-theme was the most researched in engagement. With the development of the community of inquiry framework most of the studies in this subtheme examined social presence ( Akcaoglu & Lee, 2016 ; Phirangee & Malec, 2017 ; Wei et al., 2012 ), teaching presence ( Orcutt & Dringus, 2017 ; Preisman, 2014 ; Wisneski et al., 2015 ) and cognitive presence ( Archibald, 2010 ; Olesova et al., 2016 ).

Interaction . This was the second most studied theme under engagement. Researchers examined increasing interpersonal interactions ( Cung et al., 2018 ), learner-learner interactions ( Phirangee, 2016 ; Shackelford & Maxwell, 2012 ; Tawfik et al., 2018 ), peer-peer interaction ( Comer et al., 2014 ), learner-instructor interaction ( Kuo et al., 2014 ), learner-content interaction ( Zimmerman, 2012 ), interaction through peer mentoring ( Ruane & Koku, 2014 ), interaction and community building ( Thormann & Fidalgo, 2014 ), and interaction in discussions ( Ruane & Lee, 2016 ; Tibi, 2018 ).

Community. Researchers examined building community in online courses ( Berry, 2017 ), supporting a sense of community ( Jiang, 2017 ), building an online learning community of practice ( Cho, 2016 ), building an academic community ( Glazer & Wanstreet, 2011 ; Nye, 2015 ; Overbaugh & Nickel, 2011 ), and examining connectedness and rapport in an online community ( Bolliger & Inan, 2012 ; Murphy & Rodríguez-Manzanares, 2012 ; Slagter van Tryon & Bishop, 2012 ).

Participation. Researchers examined engagement through participation in a number of studies. Some of the topics include, participation patterns in online discussion ( Marbouti & Wise, 2016 ; Wise et al., 2012 ), participation in MOOCs ( Ahn et al., 2013 ; Saadatmand & Kumpulainen, 2014 ), features that influence students’ online participation ( Rye & Støkken, 2012 ) and active participation.

Collaboration. Researchers examined engagement through collaborative learning. Specific studies focused on cross-cultural collaboration ( Kumi-Yeboah, 2018 ; Yang et al., 2014 ), how virtual teams collaborate ( Verstegen et al., 2018 ), types of collaboration teams ( Wicks et al., 2015 ), tools for collaboration ( Boling et al., 2014 ), and support for collaboration ( Kopp et al., 2012 ).

Involvement. Researchers examined engaging learners through involvement in various learning activities ( Cundell & Sheepy, 2018 ), student engagement through various measures ( Dixson, 2015 ), how instructors included engagement to involve students in learning ( O'Shea et al., 2015 ), different strategies to engage the learner ( Amador & Mederer, 2013 ), and designed emotionally engaging online environments ( Koseoglu & Doering, 2011 ).

Communication. Researchers examined communication in online learning in studies using social network analysis ( Ergün & Usluel, 2016 ), using informal communication tools such as Facebook for class discussion ( Kent, 2013 ), and using various modes of communication ( Cunningham et al., 2010 ; Rowe, 2016 ). Studies have also focused on both asynchronous and synchronous aspects of communication ( Swaggerty & Broemmel, 2017 ; Yamagata-Lynch, 2014 ).

4.2.2. Research on learner characteristics

The second largest theme was learner characteristics. In this review, we explore this further to identify several aspects of learner characteristics. In this review, we categorized the learner characteristics into self-regulation characteristics, motivational characteristics, academic characteristics, affective characteristics, cognitive characteristics, and demographic characteristics. Table 7 provides the number of studies and percentages examining the various learner characteristics.

Research sub-themes on learner characteristics.

Online learning has elements that are different from the traditional face-to-face classroom and so the characteristics of the online learners are also different. Yukselturk and Top (2013) categorized online learner profile into ten aspects: gender, age, work status, self-efficacy, online readiness, self-regulation, participation in discussion list, participation in chat sessions, satisfaction, and achievement. Their categorization shows that there are differences in online learner characteristics in these aspects when compared to learners in other settings. Some of the other aspects such as participation and achievement as discussed by Yukselturk and Top (2013) are discussed in different research themes in this study. The sections below provide examples of the learner characteristics sub-themes that were studied.

Self-regulation. Several researchers have examined self-regulation in online learning. They found that successful online learners are academically motivated ( Artino & Stephens, 2009 ), have academic self-efficacy ( Cho & Shen, 2013 ), have grit and intention to succeed ( Wang & Baker, 2018 ), have time management and elaboration strategies ( Broadbent, 2017 ), set goals and revisit course content ( Kizilcec et al., 2017 ), and persist ( Glazer & Murphy, 2015 ). Researchers found a positive relationship between learner's self-regulation and interaction ( Delen et al., 2014 ) and self-regulation and communication and collaboration ( Barnard et al., 2009 ).

Motivation. Researchers focused on motivation of online learners including different motivation levels of online learners ( Li & Tsai, 2017 ), what motivated online learners ( Chaiprasurt & Esichaikul, 2013 ), differences in motivation of online learners ( Hartnett et al., 2011 ), and motivation when compared to face to face learners ( Paechter & Maier, 2010 ). Harnett et al. (2011) found that online learner motivation was complex, multifaceted, and sensitive to situational conditions.

Academic. Several researchers have focused on academic aspects for online learner characteristics. Readiness for online learning has been examined as an academic factor by several researchers ( Buzdar et al., 2016 ; Dray et al., 2011 ; Wladis & Samuels, 2016 ; Yu, 2018 ) specifically focusing on creating and validating measures to examine online learner readiness including examining students emotional intelligence as a measure of student readiness for online learning. Researchers have also examined other academic factors such as academic standing ( Bradford & Wyatt, 2010 ), course level factors ( Wladis et al., 2014 ) and academic skills in online courses ( Shea & Bidjerano, 2014 ).

Affective. Anderson and Bourke (2013) describe affective characteristics through which learners express feelings or emotions. Several research studies focused on the affective characteristics of online learners. Learner satisfaction for online learning has been examined by several researchers ( Cole et al., 2014 ; Dziuban et al., 2015 ; Kuo et al., 2013 ; Lee, 2014a ) along with examining student emotions towards online assessment ( Kim et al., 2014 ).

Cognitive. Researchers have also examined cognitive aspects of learner characteristics including meta-cognitive skills, cognitive variables, higher-order thinking, cognitive density, and critical thinking ( Chen & Wu, 2012 ; Lee, 2014b ). Lee (2014b) examined the relationship between cognitive presence density and higher-order thinking skills. Chen and Wu (2012) examined the relationship between cognitive and motivational variables in an online system for secondary physical education.

Demographic. Researchers have examined various demographic factors in online learning. Several researchers have examined gender differences in online learning ( Bayeck et al., 2018 ; Lowes et al., 2016 ; Yukselturk & Bulut, 2009 ), ethnicity, age ( Ke & Kwak, 2013 ), and minority status ( Yeboah & Smith, 2016 ) of online learners.

4.2.3. Less frequently studied research themes

While engagement and learner characteristics were studied the most, other themes were less often studied in the literature and are presented here, according to size, with general descriptions of the types of research examined for each.

Evaluation and Quality Assurance. There were 38 studies (6.14%) published in the theme of evaluation and quality assurance. Some of the studies in this theme focused on course quality standards, using quality matters to evaluate quality, using the CIPP model for evaluation, online learning system evaluation, and course and program evaluations.

Course Technologies. There were 35 studies (5.65%) published in the course technologies theme. Some of the studies examined specific technologies such as Edmodo, YouTube, Web 2.0 tools, wikis, Twitter, WebCT, Screencasts, and Web conferencing systems in the online learning context.

Course Facilitation. There were 34 studies (5.49%) published in the course facilitation theme. Some of the studies in this theme examined facilitation strategies and methods, experiences of online facilitators, and online teaching methods.

Institutional Support. There were 33 studies (5.33%) published in the institutional support theme which included support for both the instructor and learner. Some of the studies on instructor support focused on training new online instructors, mentoring programs for faculty, professional development resources for faculty, online adjunct faculty training, and institutional support for online instructors. Studies on learner support focused on learning resources for online students, cognitive and social support for online learners, and help systems for online learner support.

Learner Outcome. There were 32 studies (5.17%) published in the learner outcome theme. Some of the studies that were examined in this theme focused on online learner enrollment, completion, learner dropout, retention, and learner success.

Course Assessment. There were 30 studies (4.85%) published in the course assessment theme. Some of the studies in the course assessment theme examined online exams, peer assessment and peer feedback, proctoring in online exams, and alternative assessments such as eportfolio.

Access, Culture, Equity, Inclusion, and Ethics. There were 29 studies (4.68%) published in the access, culture, equity, inclusion, and ethics theme. Some of the studies in this theme examined online learning across cultures, multi-cultural effectiveness, multi-access, and cultural diversity in online learning.

Leadership, Policy, and Management. There were 27 studies (4.36%) published in the leadership, policy, and management theme. Some of the studies on leadership, policy, and management focused on online learning leaders, stakeholders, strategies for online learning leadership, resource requirements, university policies for online course policies, governance, course ownership, and faculty incentives for online teaching.

Course Design and Development. There were 27 studies (4.36%) published in the course design and development theme. Some of the studies examined in this theme focused on design elements, design issues, design process, design competencies, design considerations, and instructional design in online courses.

Instructor Characteristics. There were 21 studies (3.39%) published in the instructor characteristics theme. Some of the studies in this theme were on motivation and experiences of online instructors, ability to perform online teaching duties, roles of online instructors, and adjunct versus full-time online instructors.

4.3. Research settings and methodology used in the studies

The research methods used in the studies were classified into quantitative, qualitative, and mixed methods ( Harwell, 2012 , pp. 147–163). The research setting was categorized into higher education, continuing education, K-12, and corporate/military. As shown in Table A in the appendix, the vast majority of the publications used higher education as the research setting ( n  = 509, 67.6%). Table B in the appendix shows that approximately half of the studies adopted the quantitative method ( n  = 324, 43.03%), followed by the qualitative method ( n  = 200, 26.56%). Mixed methods account for the smallest portion ( n  = 95, 12.62%).

Table A shows that the patterns of the four research settings were approximately consistent across the 12 themes except for the theme of Leaner Outcome and Institutional Support. Continuing education had a higher relative frequency in Learner Outcome (0.28) and K-12 had a higher relative frequency in Institutional Support (0.33) compared to the frequencies they had in the total themes (0.09 and 0.08 respectively). Table B in the appendix shows that the distribution of the three methods were not consistent across the 12 themes. While quantitative studies and qualitative studies were roughly evenly distributed in Engagement, they had a large discrepancy in Learner Characteristics. There were 100 quantitative studies; however, only 18 qualitative studies published in the theme of Learner Characteristics.

In summary, around 8% of the articles published in the 12 journals focus on online learning. Online learning publications showed a tendency of increase on the whole in the past decade, albeit fluctuated, with the greatest number occurring in 2018. Among the 12 research themes related to online learning, the themes of Engagement and Learner Characteristics were studied the most and the theme of Instructor Characteristics was studied the least. Most studies were conducted in the higher education setting and approximately half of the studies used the quantitative method. Looking at the 12 themes by setting and method, we found that the patterns of the themes by setting or by method were not consistent across the 12 themes.

The quality of our findings was ensured by scientific and thorough searches and coding consistency. The selection of the 12 journals provides evidence of the representativeness and quality of primary studies. In the coding process, any difficulties and questions were resolved by consultations with the research team at bi-weekly meetings, which ensures the intra-rater and interrater reliability of coding. All these approaches guarantee the transparency and replicability of the process and the quality of our results.

5. Discussion

This review enabled us to identify the online learning research themes examined from 2009 to 2018. In the section below, we review the most studied research themes, engagement and learner characteristics along with implications, limitations, and directions for future research.

5.1. Most studied research themes

Three out of the four systematic reviews informing the design of the present study found that online learner characteristics and online engagement were examined in a high number of studies. In this review, about half of the studies reviewed (50.57%) focused on online learner characteristics or online engagement. This shows the continued importance of these two themes. In the Tallent-Runnels et al.’s (2006) study, the learner characteristics theme was identified as least studied for which they state that researchers are beginning to investigate learner characteristics in the early days of online learning.

One of the differences found in this review is that course design and development was examined in the least number of studies in this review compared to two prior systematic reviews ( Berge & Mrozowski, 2001 ; Zawacki-Richter et al., 2009 ). Zawacki-Richter et al. did not use a keyword search but reviewed all the articles in five different distance education journals. Berge and Mrozowski (2001) included a research theme called design issues to include all aspects of instructional systems design in distance education journals. In our study, in addition to course design and development, we also had focused themes on learner outcomes, course facilitation, course assessment and course evaluation. These are all instructional design focused topics and since we had multiple themes focusing on instructional design topics, the course design and development category might have resulted in fewer studies. There is still a need for more studies to focus on online course design and development.

5.2. Least frequently studied research themes

Three out of the four systematic reviews discussed in the opening of this study found management and organization factors to be least studied. In this review, Leadership, Policy, and Management was studied among 4.36% of the studies and Access, Culture, Equity, Inclusion, and Ethics was studied among 4.68% of the studies in the organizational level. The theme on Equity and accessibility was also found to be the least studied theme in the Berge and Mrozowski (2001) study. In addition, instructor characteristics was the least examined research theme among the twelve themes studied in this review. Only 3.39% of the studies were on instructor characteristics. While there were some studies examining instructor motivation and experiences, instructor ability to teach online, online instructor roles, and adjunct versus full-time online instructors, there is still a need to examine topics focused on instructors and online teaching. This theme was not included in the prior reviews as the focus was more on the learner and the course but not on the instructor. While it is helpful to see research evolving on instructor focused topics, there is still a need for more research on the online instructor.

5.3. Comparing research themes from current study to previous studies

The research themes from this review were compared with research themes from previous systematic reviews, which targeted prior decades. Table 8 shows the comparison.

Comparison of most and least studied online learning research themes from current to previous reviews.

L = Learner, C=Course O=Organization.

5.4. Need for more studies on organizational level themes of online learning

In this review there is a greater concentration of studies focused on Learner domain topics, and reduced attention to broader more encompassing research themes that fall into the Course and Organization domains. There is a need for organizational level topics such as Access, Culture, Equity, Inclusion and Ethics, and Leadership, Policy and Management to be researched on within the context of online learning. Examination of access, culture, equity, inclusion and ethics is very important to support diverse online learners, particularly with the rapid expansion of online learning across all educational levels. This was also least studied based on Berge and Mrozowski (2001) systematic review.

The topics on leadership, policy and management were least studied both in this review and also in the Tallent-Runnels et al. (2006) and Zawacki-Richter et al. (2009) study. Tallent-Runnels categorized institutional and administrative aspects into institutional policies, institutional support, and enrollment effects. While we included support as a separate category, in this study leadership, policy and management were combined. There is still a need for research on leadership of those who manage online learning, policies for online education, and managing online programs. In the Zawacki-Richter et al. (2009) study, only a few studies examined management and organization focused topics. They also found management and organization to be strongly correlated with costs and benefits. In our study, costs and benefits were collectively included as an aspect of management and organization and not as a theme by itself. These studies will provide research-based evidence for online education administrators.

6. Limitations

As with any systematic review, there are limitations to the scope of the review. The search is limited to twelve journals in the field that typically include research on online learning. These manuscripts were identified by searching the Education Research Complete database which focuses on education students, professionals, and policymakers. Other discipline-specific journals as well as dissertations and proceedings were not included due to the volume of articles. Also, the search was performed using five search terms “online learning" OR "online teaching" OR "online program" OR "online course" OR “online education” in title and keyword. If authors did not include these terms, their respective work may have been excluded from this review even if it focused on online learning. While these terms are commonly used in North America, it may not be commonly used in other parts of the world. Additional studies may exist outside this scope.

The search strategy also affected how we presented results and introduced limitations regarding generalization. We identified that only 8% of the articles published in these journals were related to online learning; however, given the use of search terms to identify articles within select journals it was not feasible to identify the total number of research-based articles in the population. Furthermore, our review focused on the topics and general methods of research and did not systematically consider the quality of the published research. Lastly, some journals may have preferences for publishing studies on a particular topic or that use a particular method (e.g., quantitative methods), which introduces possible selection and publication biases which may skew the interpretation of results due to over/under representation. Future studies are recommended to include more journals to minimize the selection bias and obtain a more representative sample.

Certain limitations can be attributed to the coding process. Overall, the coding process for this review worked well for most articles, as each tended to have an individual or dominant focus as described in the abstracts, though several did mention other categories which likely were simultaneously considered to a lesser degree. However, in some cases, a dominant theme was not as apparent and an effort to create mutually exclusive groups for clearer interpretation the coders were occasionally forced to choose between two categories. To facilitate this coding, the full-texts were used to identify a study focus through a consensus seeking discussion among all authors. Likewise, some studies focused on topics that we have associated with a particular domain, but the design of the study may have promoted an aggregated examination or integrated factors from multiple domains (e.g., engagement). Due to our reliance on author descriptions, the impact of construct validity is likely a concern that requires additional exploration. Our final grouping of codes may not have aligned with the original author's description in the abstract. Additionally, coding of broader constructs which disproportionately occur in the Learner domain, such as learner outcomes, learner characteristics, and engagement, likely introduced bias towards these codes when considering studies that involved multiple domains. Additional refinement to explore the intersection of domains within studies is needed.

7. Implications and future research

One of the strengths of this review is the research categories we have identified. We hope these categories will support future researchers and identify areas and levels of need for future research. Overall, there is some agreement on research themes on online learning research among previous reviews and this one, at the same time there are some contradicting findings. We hope the most-researched themes and least-researched themes provide authors a direction on the importance of research and areas of need to focus on.

The leading themes found in this review is online engagement research. However, presentation of this research was inconsistent, and often lacked specificity. This is not unique to online environments, but the nuances of defining engagement in an online environment are unique and therefore need further investigation and clarification. This review points to seven distinct classifications of online engagement. Further research on engagement should indicate which type of engagement is sought. This level of specificity is necessary to establish instruments for measuring engagement and ultimately testing frameworks for classifying engagement and promoting it in online environments. Also, it might be of importance to examine the relationship between these seven sub-themes of engagement.

Additionally, this review highlights growing attention to learner characteristics, which constitutes a shift in focus away from instructional characteristics and course design. Although this is consistent with the focus on engagement, the role of the instructor, and course design with respect to these outcomes remains important. Results of the learner characteristics and engagement research paired with course design will have important ramifications for the use of teaching and learning professionals who support instruction. Additionally, the review also points to a concentration of research in the area of higher education. With an immediate and growing emphasis on online learning in K-12 and corporate settings, there is a critical need for further investigation in these settings.

Lastly, because the present review did not focus on the overall effect of interventions, opportunities exist for dedicated meta-analyses. Particular attention to research on engagement and learner characteristics as well as how these vary by study design and outcomes would be logical additions to the research literature.

8. Conclusion

This systematic review builds upon three previous reviews which tackled the topic of online learning between 1990 and 2010 by extending the timeframe to consider the most recent set of published research. Covering the most recent decade, our review of 619 articles from 12 leading online learning journal points to a more concentrated focus on the learner domain including engagement and learner characteristics, with more limited attention to topics pertaining to the classroom or organizational level. The review highlights an opportunity for the field to clarify terminology concerning online learning research, particularly in the areas of learner outcomes where there is a tendency to classify research more generally (e.g., engagement). Using this sample of published literature, we provide a possible taxonomy for categorizing this research using subcategories. The field could benefit from a broader conversation about how these categories can shape a comprehensive framework for online learning research. Such efforts will enable the field to effectively prioritize research aims over time and synthesize effects.

Credit author statement

Florence Martin: Conceptualization; Writing - original draft, Writing - review & editing Preparation, Supervision, Project administration. Ting Sun: Methodology, Formal analysis, Writing - original draft, Writing - review & editing. Carl Westine: Methodology, Formal analysis, Writing - original draft, Writing - review & editing, Supervision

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

1 Includes articles that are cited in this manuscript and also included in the systematic review. The entire list of 619 articles used in the systematic review can be obtained by emailing the authors.*

Appendix B Supplementary data to this article can be found online at https://doi.org/10.1016/j.compedu.2020.104009 .

Appendix A. 

Research Themes by the Settings in the Online Learning Publications

Research Themes by the Methodology in the Online Learning Publications

Appendix B. Supplementary data

The following are the Supplementary data to this article:

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• Intrathecal baclofen pump in pregnancy: case report, literature review, and management considerations
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• http://orcid.org/0000-0002-1030-2729 Kevin Yang ,
• Porus D Mistry and
• Steven H Richeimer
• USC Keck School of Medicine , Los Angeles , California , USA
• Correspondence to Kevin Yang, USC Keck School of Medicine, Los Angeles, CA 90089, USA; kjyang{at}usc.edu

Background Baclofen, a gamma-aminobutyric acid receptor type B agonist in the central nervous system, is the first-line medication among central nervous system modulating agents for the treatment of neurogenic muscle spasticity. While baclofen is most often administered enterally, patients with severe spasticity may be candidates for baclofen delivered by intrathecal pump. Currently, there are only nine studies reporting on the use of intrathecal baclofen (ITB) during pregnancy and childbirth.

Case presentation We described a female patient with a history of childhood idiopathic spasticity of the bilateral lower extremities that was controlled by ITB pump who became pregnant in her late third decade of life and delivered a healthy infant. The patient required multiple increases of her baclofen course over the course of her pregnancy.

Discussion Our case, alongside the existing literature on ITB during pregnancy, suggests that ITB therapy in pregnancy poses a low risk of teratogenicity and infant withdrawal seizures; however, larger, controlled studies are necessary to make those conclusions with confidence. Healthcare providers caring for pregnant ITB patients should be cognizant of the potential for such patients to require increased doses of ITB during pregnancy to achieve adequate symptom control.

• CHRONIC PAIN
• Drug-Related Side Effects and Adverse Reactions
• Neurologic Manifestations
• Neurotoxicity Syndromes

https://doi.org/10.1136/rapm-2024-105569

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Introduction

Baclofen, a gamma-aminobutyric acid receptor type B (GABA B receptor) agonist in the central nervous system, is the first-line medication among central nervous system modulating agents for the treatment of neurogenic muscle spasticity. 1 By binding the GABA B receptors in the spinal cord, baclofen reduces the release of excitatory neurotransmitters such as glutamate. This action decreases motor neuron firing thus decreasing muscle spasms, resulting in muscle relaxation.

Patients who do not find adequate relief with enteral baclofen may be candidates for baclofen delivered by intrathecal pump. 1 Intrathecal baclofen (ITB) administration occurs via subcutaneously implanted pump which delivers the medication from within a reservoir through a catheter placed directly into the intrathecal space. 2 ITB is at least 100 times as potent as enteral baclofen; as such, ITB pump administers medication in microgram amounts, using just a fraction of the enteral milligram dosage while achieving a comparable therapeutic impact. 3 ITB therapy has been shown to decrease spasticity and spasms and improve the patient’s ability to perform activities of daily living. 4 The diminished total dosage of baclofen administered via pump compared with enteral dosing also minimizes the drowsiness and other systemic side effects associated with the medication. 3 5 Recent estimates suggest that there are approximately 40 000 patients with ITB pumps in the USA. 6

There is limited existing literature reporting on the use of ITB during pregnancy and childbirth. This report describes the antenatal and postnatal course of a female patient who underwent ITB pump placement in adolescence and became pregnant in her late third decade of life. We discuss this case alongside the existing literature on ITB during pregnancy.

Case report

We report a case of a woman in her late third decade of life with idiopathic spasticity of the bilateral lower extremities since childhood. Our patient reported that she did not have spasticity at birth and had no history of cerebral palsy. However, at age 9, she developed an abnormal gait due to spasticity of the lower extremities. No dystonia was noted per neurology workup. The patient never had motor function problems with her upper extremities. To manage her symptoms, the patient eventually underwent ITB pump implantation in adolescence.

Prior to pregnancy, our patient was stable on an ITB dose of 92–93 µg/day for many years. On pregnancy, the patient elected to decrease her ITB dose to 83 µg/day in June 2022 to minimize her dosage early in pregnancy. However, over the course of the prepartum period, the patient required numerous increases in her ITB dose due to severe, uncontrolled spasticity. Her spasticity during pregnancy was worse during nighttime and prevented the patient from sleeping. No nighttime bolus or change of infusion rate was programmed in the patient’s device. The timeline of the patient’s ITB dose increases is presented in table 1 . The patient reached her maximum ITB dose, 122.1 µg/day (~32% increase), in November 2022; the patient reported that her symptoms were finally well controlled at that dose. She was followed closely by her obstetrician throughout the prepartum period and was not found to have any acute illness or complications.

• View inline

Timeline of our patient’s ITB dose increases

The patient underwent delivery in January 2023 by caesarian section under general anesthesia. The neonate demonstrated no complications; the neonate’s motor function was intact and did not demonstrate any evidence of baclofen toxicity. Per the patient, the neonate’s muscular tone was intact and had appearance, pulse, grimace, activity, and respiration (APGAR) Scores within normal limits. In April 2023, the patient reported that her spasticity remained well controlled but felt that her muscles were excessively loose. It was then decided to reduce the ITB dose from 122.1 to 110 µg/day.

There is limited existing literature reporting on the use of ITB during pregnancy and childbirth. Our review of the literature through PubMed ( https://pubmed.ncbi.nlm.nih.gov ) uncovered nine articles that report a total of 13 cases of ITB pumps in pregnancy. Those cases, in addition to our case, are summarized in table 2 . 7–15 One article uncovered by our literature search was omitted from analysis, as it failed to specify ITB dose and pregnancy outcome. 16 A second article uncovered by our literature search was omitted from analysis because it discussed ITB administered by bolus via external catheter, not implantable pump. 17

Our review of the literature uncovered nine articles which report a total of 13 cases of ITB pumps in pregnancy

The potential teratogenic effects of baclofen, both enteral and intrathecal, on the developing fetus are not well studied. Baclofen currently belongs to the U.S. Food and Drug Administration pregnancy category C, meaning that there are no adequate controlled studies of baclofen use in pregnant women. Studies of enteral baclofen in pregnant animal models have demonstrated teratogenicity doses many times higher than the recommended enteral human dosage. 13 In contrast, ITB allows for therapeutic cerebrospinal fluid (CSF) concentrations to be achieved with plasma concentrations 100 times less than that associated with enteral administration, 18 reducing fetal exposure to the drug and theoretically reducing potential for teratogenicity. That hypothesis is corroborated by our case and the existing cases reported in the literature, none of which reported any teratogenic side effects. However, controlled studies with sizeable cohorts are necessary to make a definitive conclusion.

Convulsive withdrawal seizures in an infant born to a mother who took enteral baclofen during pregnancy have been previously reported. 19 While that case describes infant seizures in the context of enteral baclofen, neither our case nor any of the cases of ITB in the literature observed evidence of infant seizures. This finding may be attributable to the substantially lower doses of baclofen required for therapeutic effect via intrathecal administration.

Four of the 13 total cases of ITB use during pregnancy reported in the literature noted neonatal complications. Morton et al 10 report three infants who experienced neonatal complications (cases 5a, 5b, and 6; table 2 ), but the nature of these complications is unlikely related to fetal exposure to baclofen. Tandon et al 9 report polyhydramnios at 31 weeks gestation, which the authors state was possibly caused by impaired fetal swallowing secondary to the muscle relaxant effect of baclofen. Our case and the remaining reports did not observe any complications in their respective infants. Healthcare providers should be aware of the potential for fetal complications related to the muscle relaxant effect of baclofen.

Therapeutic doses of enteral baclofen are recognized to transfer into breast milk, but whether measurable concentrations are transmitted into the breast milk of mothers on ITB is not known. The guidelines from the American Academy of Pediatrics categorize baclofen as “usually compatible with breastfeeding.” 20 The patient described by DeVries-Rizzo et al 11 and one patient reported by Morton et al 10 (case 4) both breast fed their respective infants and both reported no adverse effects. While the patient reported by Hara et al 7 did not breast feed, the investigators measured baclofen concentration in the patient’s breast milk using high-performance liquid chromatography/tandem mass spectrometry. They found the total baclofen secreted into the breast milk of their ITB patient was about 1.1% of that found in a previous study that investigated the total baclofen secreted in breast milk of a patient on enteral baclofen.

Seven of 15 cases, including our case, required at least one dose increase of ITB due to increased pain and/or spasticity during pregnancy. The increase in such symptoms may be explained by multiple factors. Estrogen may contribute to increased muscle tone and spasticity by influencing the excitability of neurons in the central nervous system. Furthermore, increased weight and pressure on the spine and peripheral nerves due to the growing fetus can impact nerve signaling and potentially lead to heightened spasticity and pain. Another possible contributing factor is increased blood volume, circulation, and fluid retention during pregnancy. Changes in blood flow and blood pressure may affect the delivery of oxygen and nutrients to nerve cells and muscles, leading to altered nerve excitability and muscle tone. Fluid retention and peripheral edema may compress nerves and interfere with nerve conduction. The increased pressure from edema could contribute to heightened muscle tone and exacerbate spasticity. The inflammatory response associated with fluid retention might further contribute to nerve and muscle irritability. Interestingly, a study by Onuki et al , which investigated the spread of neuraxial anesthesia in 18 pregnant women by MRI, found a significant reduction in lumbar CSF volumes, which the authors concluded may explain the increase in the sensory level of neuraxial block observed in pregnant women. 21 However, the patients discussed in our review who required changes to their ITB dose required increases, not decreases, of their baclofen dose, which seems to contradict the findings of Onuki et al . While individual reactions to pregnancy are likely to vary widely, healthcare providers caring for pregnant ITB patients should be cognizant of the potential for ITB patients to require increased doses of ITB during pregnancy to achieve adequate symptom control.

Conclusions

Our case, alongside the existing literature, suggests that ITB therapy in pregnancy helps to continue to manage spasticity and poses a low risk of teratogenicity and infant withdrawal seizures, likely due to the low baclofen dosage afforded by intrathecal administration. Existing literature also suggests that the breast milk of mothers on ITB therapy contains baclofen levels subtoxic to infants. However, we make those conclusions with caution, as larger, controlled studies are necessary to make those conclusions with confidence. Both this patient and previous case studies showed patients required an increased dose of ITB during pregnancy to maintain a therapeutic level. Healthcare providers caring for pregnant ITB patients should be cognizant of the potential for ITB patients to require increased doses of ITB during pregnancy to achieve adequate symptom control. Further investigation is required to elucidate potential short-term and long-term adverse effects of this practice. Further study is also required to establish a maximum dose of ITB during pregnancy. Additional investigation into potential effects of various baclofen doses during each trimester of pregnancy is merited.

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Contributors KY: Conceptualization, Project administration, Writing—original draft, Writing—review and editing; PDM: Conceptualization, Supervision, Writing—review and editing; SHR: Supervision, Writing—review and editing.

Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

Competing interests None declared.

Provenance and peer review Not commissioned; externally peer reviewed.

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