Applying behavioural frameworks to contextualise reported influences on clinical trial recruitment and retention: A secondary analysis of three qualitative evidence syntheses

Applying behavioural frameworks to contextualise reported influences on clinical trial recruitment and retention: A secondary analysis of three qualitative evidence syntheses | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Applying behavioural frameworks to contextualise reported influences on clinical trial recruitment and retention: A secondary analysis of three qualitative evidence syntheses Lya-Solange Doidge-Harrison, Taylor Coffey, Katie Gillies This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-4431879/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background Recruitment and retention to clinical trials are key processes underlying their success. Methodological work in this area has identified a number of influences, from both participant and trial staff perspectives, on what drives recruitment and retention. Collation of this evidence is crucial for these findings to be translated into actionable changes in how trials are conducted. Initial efforts to do so have resulted in qualitative evidence syntheses that summarise recurrent themes in recruitment and retention. However, many of these primary studies, and the evidence syntheses themselves, lack a theoretical basis to understand the reported influences. The objective of this paper was to apply theoretical frameworks to these evidence syntheses and assess whether they captured reported influences in their theoretical domains. Methods Two behavioural theoretical frameworks were used to code reported influences on recruitment and retention from three qualitative evidence syntheses. The syntheses summarised participant and trial staff-reported influences on recruitment and participant-reported influences on retention. These influences were coded into the relevant behavioural domains of the two frameworks. Each behavioural domains’ relative coverage of influences across the papers were calculated. The most and least often coded domains were identified, with potential interventions targeting the most frequent domains suggested. Results Both frameworks were able to categorise influences from all three papers. The most-often coded domains were “reflective motivation” and “beliefs about consequences”. The least-often coded were “physical capability” and “behavioural regulation”. These findings are largely consistent with other work using behavioural frameworks to categorise influences on recruitment and retention. Conclusions The selected frameworks demonstrated their utility in contextualising reported influences on recruitment and retention. These frameworks offer advantages in collation of evidence and for their integration in intervention development to target problem areas. Future work could continue their application, producing a significant and accessible evidence base on what drives recruitment and retention to trials. clinical trials secondary analysis behavioural science trials methodology recruitment and retention Figures Figure 1 Figure 2 Figure 3 Introduction Clinical trials remain a key component informing evidence-based healthcare. If conducted rigorously, trials can provide unbiased estimates of the benefits and risks of treatment. However, trials routinely take longer (and so cost more) than originally proposed, often due to challenges with recruitment (including participants in a trial) and/or retention (keeping participants in a trial) [ 1 ]. Recruitment and retention continue to be amongst the most challenging aspects of trial conduct and remain the top methods research priority areas amongst the UK clinical trials community [ 2 ]. A significant amount of previous research has explored the influences on recruitment from perspectives of both trial participants (those who have consented and those who have not) and health care professionals involved in recruiting patients to trials [ 3 – 7 ]. More recently studies exploring participant-reported reasons impacting on trial retention have also been published in the literature [ 6 , 8 ]. This body of work has highlighted the range of complex, multi-faceted, contextually-determined challenges that impact on recruitment and retention. Many of these challenges involve behaviours, in other words, they rely on people (patients, clinicians, trial staff) performing, or not performing, an action (such as approaching eligible participants or returning a questionnaire). These actions are behaviours, yet trialists do not conceptualise them as such. Behaviours are pervasive, contextually-determined, and, importantly, amenable to change. Indeed, a failure to recognise the behavioural influences (and change them where appropriate) could contribute to the overall success or failure of the trial. Thus, behaviours are at the heart of clinical trial delivery and the scientific discipline of behavioural science (that is, the study of behaviour and behaviour change) can provide critical insights for the clinical trials community. Reframing the influences on trial processes as behaviours has the potential for developing more effective evidence-based strategies for improvement. There are a few emerging examples in the literature of how applying behavioural science can improve various aspects of trials. For example, early work in this space has offered valuable insights on behavioural barriers and enablers of trial recruitment and retention [ 9 – 17 ]. The application of theory through behavioural science could offer potential benefits to (re) examine these trial conduct challenges. Exploring how behavioural approaches can be applied to better understand existing evidence on reported influences on trial conduct, namely recruitment and retention, is an important next step to explore the application of behavioural science to trial conduct challenges. The majority of studies included in existing trial conduct qualitative evidence syntheses (QES) have been conducted without consideration of behavioural theory. Therefore, this study aimed to apply a behavioural lens to existing QESs on recruitment and retention to identify generalisable behavioural barriers and enablers that are relevant across trials. Methods Data collection: A secondary analysis was performed on data from three existing qualitative evidence syntheses. The first QES, conducted by Farrar et al., reported influences on recruitment from the perspective of trial staff [ 3 ]. The second QES, conducted by Houghton et al., focused on patient-reported influences that impact on recruitment [ 4 ]. Finally, the third QES by Skea et al., similarly reported patient influences but to retention [ 8 ]. Further summary characteristics of the studies included in these QESs are discussed below in the results section. Data extraction: Themes reported in the QESs were extracted verbatim and collated into an Excel spreadsheet for each QES. Secondary analysis items informed by the QES authors narrative descriptions were generated by the team (LDH, TC) and annotated with excerpts from their source theme to provide evidence and justification for their further breakdown. These secondary analysis items represented discrete concepts within the source theme. This process was completed by one author (LDH) with a select sample assessed for clarity and fit by another author (TC). A consensus on the content of each secondary analysis item was reached through discussion with these two members, with a third (KG) acting to resolve any disagreement. Data coding: Following extraction, the data were then coded against two behavioural frameworks that have been previously used to understand trial-relevant behaviours. These frameworks were: The Capability, Opportunity, and Motivation – Behaviour (COM-B) model [ 18 ] The Theoretical Domains Framework (TDF) [ 19 ] Briefly, both frameworks were selected due to their potential utility in categorising the influences on trial recruitment and retention reported in the QESs. Both the COM-B and the TDF have been developed to synthesise a large number of behavioural constructs into concise, yet comprehensive, models to investigate influences on behaviour and how those influences might be leveraged for behaviour change [ 18 , 19 ]. The COM-B model posits that any behaviour is comprised of the three domains of capability, opportunity, and motivation, and that these domains interact with one another to produce the final observed behaviour [ 18 ]. The TDF can be seen as a more granular version of the COM-B, defining 14 component domains to behaviour, although without reference to how they interact with each other in producing behaviour [ 19 ]. The COM-B domains, and their equivalent TDF domains, can be seen in Fig. 1. FIGURE 1 PLACEHOLDER Figure 1 The COM-B domains (inner rings) and how they are mapped to TDF domains (outer ring); Adapted from Michie et al. 2014 [ 20 ] These frameworks were applied to understand the overarching trial behaviours of recruitment and retention in the three selected QESs. The themes of each QES were deductively coded to the relevant domains of each of the behavioural frameworks. Coding was undertaken by one author (LDH) and a select sample was double coded by another (TC). Any discrepancies in coding were resolved through discussion, with a third member (KG) resolving any disagreements. Data analysis: Frequency counts were generated for the number of occurrences of each behavioural frameworks’ domains against the secondary analysis items of the themes within each of the QESs. Summary counts of domains by framework are presented by ‘multi-trial’ influences to reflect the multiple, and varied, host trials included in the QES for analysis. Mapping of Intervention Functions and Behaviour Change Techniques (BCTs): We applied the intervention design method known as the Behaviour Change Wheel (BCW) [ 20 ]. This method links the behavioural domains of the COM-B and TDF to potential categories of solutions, known as “intervention functions” [ 20 ]. For example, the intervention function, “Education”, is defined as “Increasing knowledge or understanding” [ 20 ]. In this study, we chose to map the most frequent TDF domains to intervention functions, and then to behaviour change techniques (BCTs). BCTs are known as the “active ingredients” of behaviour change interventions, representing the means through which an intervention endeavours to act on the targeted behavioural domains [ 21 ]. The BCTs linked to the intervention functions of the BCW have been agreed through expert consensus, generating a list of those most frequently used within a category and assigning a level of evidence to their link [ 20 ]. There is either evidence from past applications that a BCT has a known link, has a known absence of a link (non-link), or does not have evidence of a link [ 22 ]. Results Characteristics of included studies Farrar et al., the QES of recruitment from recruiters’ perspectives, included 30 papers with a total of 605 individual participants [ 3 ]. The majority of studies were based in the UK (n = 23) and were typically in primary or secondary care settings. The studies included a number of different roles that acted as ‘recruiters’, predominantly health care professionals (HCPs) and will be referred to as such from herein. Their analysis produced five themes: recruiting to randomised clinical trials (RCTs) in a clinical environment enthusiasm for the RCT making judgements about whether to approach a patient communication challenges interplay between recruiter and professional roles These five themes were further separated in our coding into 20 secondary analysis items (available in Supplementary Table 1). Houghton et al., the QES of participant factors of recruitment, included 30 papers with a total of 847 individual participants [ 4 ]. Studies were mainly conducted within the UK and Europe (n = 22) and involved host trials within a range of clinical specialties and intervention types. Their analysis resulted in three broad themes (and six subthemes), with 22 “key findings” presented within these themes. The three broad themes were: Trial influences on decision to participate Personal influences on decision to participate The impact of potential outcomes on decision to participate The 22 key findings presented were further coded into 46 secondary analysis items (available in Supplementary Table 2) as part of our analysis. Finally, the QES on participant reasons for non-retention by Skea et al. included eleven papers with a total of 168 individual participants [ 8 ]. Studies were mainly conducted within the UK and Europe (n = 9) and involved host trials within a range of clinical specialties and intervention types. Their analysis resulted in five key themes, which were: perceptions of current health state in relation to specific aspects of the trial the ‘fit’ of aspects of the trial with individual preferences for care and support the compatibility of aspects of trial processes with individual capabilities concerns about or experiences of trial medication considerations around the extent to which trial participation could be appropriately accommodated into individuals’ broader lives During our analysis, these five themes were further coded into 19 secondary analysis items (available in Supplementary Table 3). Coding of multi-trial influences on recruitment and retention to the COM-B model of behaviour: Frequencies of the six sub-domains of the COM-B coded for each of the secondary items within each QES, are presented in Table 1 . Overall, reflective motivation (the motivations involving conscious planning and evaluation) was the sub-domain most frequently coded across all three QESs. Coding into this sub-domain also reflected the majority of coding within each QES, accounting for 42% within HCP-focused recruitment factors, 37% in participant-reported recruitment factors, and 41% in participant-reported retention factors. Specific items that were relevant to this domain were: personal interest and belief of research benefit improved recruitment (HCP recruitment); a perceived lack of further benefits/relevance was a barrier (participant recruitment); and trial design/requirements being too demanding (participant retention). The most infrequently coded sub-domain was physical capability (which involves the physical skills and ability of an individual), with only two coded instances across the QESs. Items coded to physical capability were from the participant retention QES and included: the intervention challenging sense of self or didn’t match their perceived mental and/or physical state; and perception of current health state made participants feel unable to complete trial tasks. Neither of the QESs on recruitment had instances of physical capability, only retention, with those two coded instances representing only 7% of its total coding. The percent coverage of each sub-domain is illustrated further in Fig. 2, demonstrating the relative fit of each. Further details on the content of QES themes and items coded to COM-B domains is provided in Supplementary Tables 1–3. Table 1 Themes from QESs coded to COM-B QES COM-B Sub-domains Capability Opportunity Motivation Totals Psychological Physical Social Physical Reflective Automatic Recruitment (HCP) 7 (18%) 0 5 (13%) 6(16%) 16 (42%) 4 (11%) 38 Recruitment (participant) 9 (12%) 0 12 (16%) 15 (20%) 28 (37%) 11 (15%) 75 Retention (participant) 5 (17%) 2 (7%) 1 (3%) 3 (10%) 12 (41%) 6 (21%) 29 Total count 21 2 18 24 56 21 FIGURE 2 PLACEHOLDER Figure 2 COM-B coverage of QESs by sub-domain. Coding of multi-trial influences on recruitment and retention to the Theoretical Domains Framework: Frequency counts for each of the 14 domains for the TDF, by QES, are presented in Table 2 . These counts are not directly equivalent to the COM-B counts as, due to the further granularity of the TDF, COM-B domains typically cover more than one TDF domain. This resulted in more overall instances of TDF domains being coded due to more domains being available to code to. Overall, the TDF domain “beliefs about consequences” was the most frequently coded domain across the QESs. It accounted for 19% and 20% of the coding with the HCP and participant-focused recruitment QESs, respectively, and 9% within the retention QES. Specific items that were relevant to this domain were: personal interest and belief in research benefit improved recruitment (HCP recruitment); acceptability of randomisation influenced by motivations to participate and beliefs about clinical uncertainty (participant recruitment); and individuals who believed they had recovered, assumed they could no longer effectively contribute to the goals of the trial (participant retention). The most infrequently coded domain was “behavioural regulation”, which is related to strategies employed by individuals to promote performance of the target behaviour. This domain was only coded once across the three QESs, within the HCP QES, which was only 2% of that QES’s total coding. Specific content related to the domain was the perception that integrating research into care was effortful and was proactively enforced. The percent coverage of each domain is illustrated further in Fig. 3. Further details on the content of QES themes and items coded to TDF domains is provided in Table 3 and Supplementary Tables 1–3 (in Additional File 1). Linking COM-B/TDF coding to potential solutions Coding of the trial recruitment and retention QESs into the COM-B and TDF allowed us to explore potential solutions through the intervention design method of the Behaviour Change Wheel [ 20 ]. The intervention functions, and their linked BCTs, for the three most frequent TDF domains identified in our analysis are presented in Table 3 . Intervention functions are presented on the far left, with their linked BCTs in the following column. Some intervention functions are repeated/grouped together when they share BCTs. This mapping identifies potential targets for future intervention development. Table 2 Themes from QESs coded to TDF QES TDF domains Social influences Environmental context and resources Behavioural regulation Memory, attention, & decision processes Skills Knowledge Beliefs about consequences Goals Intentions Optimism Beliefs about capabilities Social Professional role and identity Emotion Reinforcement Total codes/QES Recruitment (HCP) 5 (9%) 6 (11%) 1 (2%) 1 (2%) 1 (2%) 4 (8%) 10 (19%) 2 (4%) 9 (17%) 3 (6%) 1 (2%) 6 (11%) 4 (8%) 0 53 Recruitment (participant) 12 (12%) 15 (15%) 0 5 (5%) 0 6 (6%) 19 (20%) 7 (7%) 3 (3%) 12 (12%) 4 (4%) 3 (3%) 5 (5%) 6 (6%) 97 Retention (participant) 1 (3%) 3 (9%) 0 2 (6%) 3 (9%) 2 (6%) 3 (9%) 1 (3%) 1 (3%) 3 (9%) 7 (22%) 0 5 (16%) 1 (3%) 32 Totals per TDF domain 18 24 1 8 4 12 32 10 13 18 12 9 14 7 FIGURE 3 PLACEHOLDER Figure 3 TDF coverage of evidence sources by domain Discussion We have presented our secondary analysis of three qualitative evidence syntheses within recruitment and retention, applying two behaviourally focussed theoretical frameworks to categorise the respective findings of each QES. Both the COM-B and TDF were able to accommodate findings from all three QESs, demonstrating their utility in categorising multi-trial influences on behaviours that are relevant to recruitment and retention in clinical trials. Some theoretical domains proved to be more applicable than others across the trials included within the QESs and some more applicable within particular populations (participants versus staff). For instance, the TDF domain “environmental context and resources” was coded fairly consistently across each QES, from 9–15% of total coding, demonstrating that resources and external factors are likely contributing factors to both recruitment and retention from both participant and staff perspectives. Similarly, the TDF domain “behavioural Regulation” was only coded once across the three QESs, entirely absent in the participant context. Other notable domains, unrepresented in one population, included “skills”, “social professional role/identity”, and “reinforcement”. Table 3 Intervention function and potential BCTs Intervention Function BCT ( most frequently used) TDF domains (context) Beliefs about capabilities (high for retention) Intentions (high for recruiters) Beliefs about consequences (high for recruitment & recruiters) Enablement 1.1 Goal setting (Behaviour) - - - 1.2 Problem solving ✓ - - 1.3 Goal setting (Outcome) - - - 1.4 Action planning - - - 1.5 Review behaviour goal(S) - - - 1.7 Review outcome goal(S) - - - 3.1 Social Support (unspecified) - - - 3.2 Social support (practical) - - - 12.1 Restructuring the physical environment - - - 12.5 Adding objects to the environment - - X Incentivisation Coercion 2.1. Monitoring of behaviour by others without feedback - - - 2.5. Monitoring of outcome(s) of behaviour without feedback X - - Education Persuasion Incentivisation Coercion 2.2 Feedback on behaviour - - - 2.7 Feedback on outcome(s) of behaviour - - - Education Enablement Incentivisation Coercion 2.3 Self-monitoring of behaviour - - - Education Persuasion 5.1 Information about health consequences - ✓ ✓ 5.3 Information about social and environmental consequences X - ✓ Modelling 6.1 Demonstration of the behaviour ✓ - - Education 7.1 Prompts /cues X - X Persuasion 9.1 Credible source - - - Legend: “check” = evidence of link; “-” = no evidence; “X” = evidence of non-link It is important to consider whether this lack of data that could be coded against some TDF domains was due to a lack of relevance or due to a limitation of the included data. For example, four domains (behavioural regulation, skills, social professional role/identity, and reinforcement) were not identified as relevant within at least one population. However, given the majority of studies included in these QESs did not use a behavioural theory or framework to understand recruitment or retention, nor did any use the TDF, it may be a limitation of the data set rather than a lack of relevance. There are a number of primary studies published after the publication of the included QESs that support the hypothesis that this is a limitation of the included data. A TDF-guided interview study by Lalu et al. queried both patients and clinicians on the potential barriers and facilitators to participation in a planned stem cell trial [ 15 ]. In contrast to the “skills” domain being absent in our participant recruitment sample, Lalu et al. identified skills relevant to participants enrolling in about half of their sample. These skills included identification of trial opportunities through media resources or through conversations with their personal clinicians [ 15 ]. Secondly, a TDF-guided interview study by Hanrahan et al. identified barriers and enablers to healthcare providers recruiting to maternity trials [ 13 ]. In contrast to our findings, the domain of “reinforcement” was found relevant to recruiting staff. In particular, social support received during the recruitment process acted as an incentive for recruiters to perform, as did recruitment targets that put them in competition with other sites (although this was not universal) [ 13 ]. Lastly, two papers report on participant-centred instances of “behavioural regulation” within recruitment and retention. The first by Guillot et al. identified that parents seek information about enrolment in a hypothetical trial through specific communication strategies [ 23 ]. The second, a TDF-guided interview study on retention by Newlands et al., queried participants about their perspectives on the barriers and enablers to returning questionnaires and/or attending follow-up clinic visits. Participants in this study highlighted the strategies they employ to make the return of questionnaires or attendance at follow-up visits easier for them to engage in [ 12 ]. However, in line with our findings, they did not identify any instances of “social professional role/identity” within their sample. This may point to a lack of “buy-in” from participants who may not fully appreciate their contribution to the trial’s success through their continued involvement. The identification of relevance of several of these TDF domains in the cited empirical work highlights that, whilst our analysis has identified potential “big ticket” items that could be amenable to change and have benefit across a number of trials, there are still trial-specific, contextually-determined, domains of relevance. These domains will thus require a behavioural diagnostic approach to identify and target support for recruitment and retention in trials. Our behavioural analysis had identified over-arching influences on HCP and participants behaviours when considering trial recruitment and retention and could hold promise in identifying generalisable intervention targets for future research. When considering potential strategies to address issues within recruitment and retention, theoretically-informed investigations present opportunities to link behavioural factors to mechanisms known to mediate change [ 9 , 19 , 20 ]. Within this study, the behavioural domains identified can serve as targets for further investigation or for intervention development. In the former, for instance, domains that are low in occurrence, but likely amenable to change (i.e., "skills” and “behavioural regulation”) could be more systematically explored to confirm whether they are, indeed, not relevant, or if potential strategies are deemed missing but possibly needed. The latter case, of using these findings to inform intervention target selection and development, is also feasible. In addition, the intervention design method using the BCW has identified potential intervention functions and BCTs that could be used to develop interventions that target our populations of interest to improve recruitment and/or retention. Specifically, BCT ‘5.1 Information about health consequences’ was identified as having evidence of effectiveness that is linked to the TDF domains of “intentions” and “beliefs about consequences” [ 22 ], which were high for recruitment influences of patients and health care professionals across the QES data. Developing this BCT content through the intervention functions of education, persuasion and modelling would be an obvious next step based on the findings of our study. However, the design of wholly new interventions may not be necessary. Behavioural frameworks have also shown utility in identifying BCTs in existing interventions [ 24 – 26 ]. One such example assessed interventions effective for improving trial retention to see if they contained implicit BCTs, even though they were not designed with them in mind [ 10 ]. In that study, eleven BCTs were identified across eight interventions. Some of these BCTs (Social support, Credible source, Adding objects to the environment) are also able to address the “beliefs about capabilities” domain that we have found to be important to retention within our sample. As such, adapting the effective interventions identified in Duncan et al. to address the retention-related factors in our sample could be a fruitful next step without the need for building an intervention from scratch. Strengths and limitations Our secondary analysis of QESs has demonstrated the utility of applying behavioural frameworks in categorising the influences on recruitment and retention to clinical trials. These findings, along with the findings of others who have similarly applied these frameworks retrospectively [ 10 ], lends evidence to the theoretical fit of these frameworks in accounting for the diverse and complex factors that are found to underlie trial recruitment and retention. Collation of these factors under a common theoretical language then allows a more meaningful synthesis of previously disparate findings [ 9 , 20 ]. Accordingly, this establishes a more coherent evidence base that trialists and intervention designers can reference with greater confidence. Placing findings within these theoretical domains then also facilitates the translation of findings into actionable targets for strategy development, as we have given an example of above in proposed intervention functions of the BCW. Additionally, our analysis adds a further layer of scrutiny and summary of the findings within the QESs, which can aid those seeking to identify, from amongst many publications, the generalisable factors most relevant to recruitment and retention, even if they do not take a theoretical approach. However, this further analysis of already synthesised findings is also a potential limitation. As we did not analyse the primary studies included in the QESs, we cannot speak to the quality of their findings. Our further breakdown of their thematic findings into secondary analysis items could also be viewed as introducing our own interpretations of their content. To best ameliorate this, we have attempted to remain as close to the original findings as possible and linking our secondary analysis items explicitly to text within the original papers. Finally, we have chosen two behavioural frameworks to apply here, but do not have reason to discount frameworks from other disciplines, such as implementation science. The TDF and COM-B were chosen for their comprehensibility in understanding behavioural influences on recruitment and retention, but an implementation framework may interrogate operationalisation of these behaviours, or strategies to change them [ 27 ]. Within the scope of this paper, we believe the chosen frameworks have demonstrated their utility, satisfying our research aim. Conclusion Our application of the TDF and COM-B to evidence syntheses of influences on recruitment and retention has demonstrated that these behavioural frameworks can be meaningfully applied to categorise the multi-trial findings and propose potential intervention functions that could be generalisable across trials. This alignment with theory serves to further combine these influences, bringing findings from different methodological and ontological perspectives together under a shared descriptive and mechanistic umbrella. Not only does this then allow more fluid synthesis of findings, but it connects those findings to strategies of intervention development. Whether these same frameworks are applicable to the behaviours associated with the wide-ranging phenomena under investigation in trials methodology, that go beyond recruitment and retention, is still to be explored. However, the results presented here demonstrate an important proof-of-concept and engender a degree of optimism in such future pursuits. Abbreviations behaviour change techniques (BCTs) Behaviour Change Wheel (BCW) Capability, Opportunity, and Motivation – Behaviour (COM-B) model health care professionals (HCPs) qualitative evidence syntheses (QES) randomised clinical trials (RCTs) Theoretical Domains Framework (TDF) Declarations Ethics approval and consent to participate Not applicable Consent for publication Not applicable Availability of data and materials The dataset(s) supporting the conclusions of this article is(are) included within the article (and its additional file(s)). Competing interests The authors declare that they have no competing interests. Funding This work is delivered as part of an MRC-funded Non-Clinical research fellowship (MR/X007464/1). Authors’ contributions KG was responsible for the conceptualisation, design, conduct, and manuscript feedback of this study. LD was responsible for data collection and analysis and assisted in the writing of the manuscript. 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Behaviour change techniques: the development and evaluation of a taxonomic method for reporting and describing behaviour change interventions (a suite of five studies involving consensus methods, randomised controlled trials and analysis of qualitative data). 2015;19:1–188. http://ovidsp.ovid.com/ovidweb.cgi?T=JS&PAGE=reference&D=med12&NEWS=N&AN=26616119 Johnston M, Carey RN, Connell Bohlen LE, Johnston DW, Rothman AJ, de Bruin M, Kelly MP, Groarke H, Michie S. Development of an online tool for linking behavior change techniques and mechanisms of action based on triangulation of findings from literature synthesis and expert consensus. Transl Behav Med. 2021;11(5):1049–65. 10.1093/tbm/ibaa050 . PMID: 32749460; PMCID: PMC8158171. Guillot M, Asad S, Lalu MM, Lemyre B, Castillo G, Thébaud B et al. So You Want to Give Stem Cells to Babies? Neonatologists and Parents’ Views to Optimize Clinical Trials. United States: Elsevier Inc; 2019;210:41–47.e1. https://dx.doi.org/10.1016/j.jpeds.2019.03.005 . Bishop FL, Fenge-Davies A, Kirby S, Geraghty AWA. Context effects and behaviour change techniques in randomised trials: a systematic review using the example of trials to increase adherence to physical activity in musculoskeletal pain. 2015;30:104–21. http://ovidsp.ovid.com/ovidweb.cgi?T=JS&PAGE=reference&D=med12&NEWS=N&AN=25109300 Room J, Hannink E, Dawes H, Barker K. What interventions are used to improve exercise adherence in older people and what behavioural techniques are they based on? A systematic review. 2017;7:e019221. http://ovidsp.ovid.com/ovidweb.cgi?T=JS&PAGE=reference&D=med14&NEWS=N&AN=29247111 Steinmo SH, Michie S, Fuller C, Stanley S, Stapleton C, Stone SP. Bridging the gap between pragmatic intervention design and theory: using behavioural science tools to modify an existing quality improvement programme to implement Sepsis Six. 2016;11:14. http://ovidsp.ovid.com/ovidweb.cgi?T=JS&PAGE=reference&D=med13&NEWS=N&AN=26841877 Birken SA, Powell BJ, Presseau J, Kirk MA, Lorencatto F, Gould NJ et al. Combined use of the Consolidated Framework for Implementation Research (CFIR) and the Theoretical Domains Framework (TDF): a systematic review. England: BioMed Central; 2017;12:2. https://www.ncbi.nlm.nih.gov/pubmed/28057049 . Supplementary Files AdditionalFile1SupplTables13131223.docx Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-4431879","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":338242098,"identity":"cace3f91-587a-4ea0-8aa4-525b4458f049","order_by":0,"name":"Lya-Solange Doidge-Harrison","email":"","orcid":"","institution":"University of Aberdeen School of Psychology","correspondingAuthor":false,"prefix":"","firstName":"Lya-Solange","middleName":"","lastName":"Doidge-Harrison","suffix":""},{"id":338242099,"identity":"99338480-1f6c-43ed-ad59-2f50734bb298","order_by":1,"name":"Taylor Coffey","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAABDklEQVRIiWNgGAWjYHACxgNgivngAwYGAxsGA4YEiLgEDvU8QAzRwpZswMBQkEaylg+HCWuxZz9jcODjHgZ5fjZmxsc8BuflzdlzDzD8qGFInNmAwxaeHIODM54xGM5sY2Y25jG4bbiz510CY88xhsTZOB2WY3CY5wBDgsH9/mPSQC2MG27kGDDwNjAkzsOlhf8NVMsxZvbfPAbn7EFaGP/i0yKRA9fCxsxjcCARpIUZZAtOh914VnBwxgEJsF8k5xgkJ+/sAdorc0zCGJf32fuTNz74cMAGHGIf3vyxs93OnmP48E2NjeyMAzisYeAARgc0Dph4oGIHcMcK2J4HcCbjDzzqRsEoGAWjYOQCAOkiWfnOzwSxAAAAAElFTkSuQmCC","orcid":"https://orcid.org/0000-0002-6921-8230","institution":"University of Aberdeen Health Services Research Unit","correspondingAuthor":true,"prefix":"","firstName":"Taylor","middleName":"","lastName":"Coffey","suffix":""},{"id":338242100,"identity":"542addb6-a110-4745-b12d-2955c55c231e","order_by":2,"name":"Katie Gillies","email":"","orcid":"","institution":"University of Aberdeen Health Services Research Unit","correspondingAuthor":false,"prefix":"","firstName":"Katie","middleName":"","lastName":"Gillies","suffix":""}],"badges":[],"createdAt":"2024-05-16 14:54:20","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-4431879/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-4431879/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":74436567,"identity":"7bcad840-1799-402c-aa6a-14f50598dca8","added_by":"auto","created_at":"2025-01-22 09:27:32","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":114736,"visible":true,"origin":"","legend":"\u003cp\u003eThe COM-B domains (inner rings) and how they are mapped to TDF domains (outer ring); Adapted from Michie et al. 2014 [20]\u003c/p\u003e","description":"","filename":"Figure1.png","url":"https://assets-eu.researchsquare.com/files/rs-4431879/v1/e0d825bcf031eda3f2d766e9.png"},{"id":74436568,"identity":"c47ea5c0-878c-4078-a0e1-8125779557c1","added_by":"auto","created_at":"2025-01-22 09:27:32","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":66845,"visible":true,"origin":"","legend":"\u003cp\u003eCOM-B coverage of QESs by sub-domain.\u003c/p\u003e","description":"","filename":"Figure2.png","url":"https://assets-eu.researchsquare.com/files/rs-4431879/v1/8b3c9b304c4a7e992ccaf255.png"},{"id":74436569,"identity":"29749c1d-8812-40e8-ae8b-808d9c56603f","added_by":"auto","created_at":"2025-01-22 09:27:32","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":118427,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cem\u003eTDF coverage of evidence sources by domain\u003c/em\u003e\u003c/p\u003e","description":"","filename":"Figure3.png","url":"https://assets-eu.researchsquare.com/files/rs-4431879/v1/a69a2ca3390c81b4a56e355c.png"},{"id":79240669,"identity":"4da88871-5b68-4306-b3d6-2e36b92f7e33","added_by":"auto","created_at":"2025-03-26 05:41:39","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1199863,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4431879/v1/185612ed-e0e6-4f60-afcf-4f1c9ebd7c4a.pdf"},{"id":74436570,"identity":"fc3c8f2c-86ed-445c-9cf7-862a1cb30426","added_by":"auto","created_at":"2025-01-22 09:27:32","extension":"docx","order_by":9,"title":"","display":"","copyAsset":false,"role":"supplement","size":51836,"visible":true,"origin":"","legend":"","description":"","filename":"AdditionalFile1SupplTables13131223.docx","url":"https://assets-eu.researchsquare.com/files/rs-4431879/v1/a870b7d1fd7e89f78a457814.docx"}],"financialInterests":"","formattedTitle":"Applying behavioural frameworks to contextualise reported influences on clinical trial recruitment and retention: A secondary analysis of three qualitative evidence syntheses","fulltext":[{"header":"Introduction","content":"\u003cp\u003eClinical trials remain a key component informing evidence-based healthcare. If conducted rigorously, trials can provide unbiased estimates of the benefits and risks of treatment. However, trials routinely take longer (and so cost more) than originally proposed, often due to challenges with recruitment (including participants in a trial) and/or retention (keeping participants in a trial) [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. Recruitment and retention continue to be amongst the most challenging aspects of trial conduct and remain the top methods research priority areas amongst the UK clinical trials community [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eA significant amount of previous research has explored the influences on recruitment from perspectives of both trial participants (those who have consented and those who have not) and health care professionals involved in recruiting patients to trials [\u003cspan additionalcitationids=\"CR4 CR5 CR6\" citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e]. More recently studies exploring participant-reported reasons impacting on trial retention have also been published in the literature [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e, \u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]. This body of work has highlighted the range of complex, multi-faceted, contextually-determined challenges that impact on recruitment and retention. Many of these challenges involve behaviours, in other words, they rely on people (patients, clinicians, trial staff) performing, or not performing, an action (such as approaching eligible participants or returning a questionnaire). These actions are behaviours, yet trialists do not conceptualise them as such. Behaviours are pervasive, contextually-determined, and, importantly, amenable to change. Indeed, a failure to recognise the behavioural influences (and change them where appropriate) could contribute to the overall success or failure of the trial. Thus, behaviours are at the heart of clinical trial delivery and the scientific discipline of behavioural science (that is, the study of behaviour and behaviour change) can provide critical insights for the clinical trials community.\u003c/p\u003e \u003cp\u003eReframing the influences on trial processes as behaviours has the potential for developing more effective evidence-based strategies for improvement. There are a few emerging examples in the literature of how applying behavioural science can improve various aspects of trials. For example, early work in this space has offered valuable insights on behavioural barriers and enablers of trial recruitment and retention [\u003cspan additionalcitationids=\"CR10 CR11 CR12 CR13 CR14 CR15 CR16\" citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e]. The application of theory through behavioural science could offer potential benefits to (re) examine these trial conduct challenges.\u003c/p\u003e \u003cp\u003eExploring how behavioural approaches can be applied to better understand existing evidence on reported influences on trial conduct, namely recruitment and retention, is an important next step to explore the application of behavioural science to trial conduct challenges. The majority of studies included in existing trial conduct qualitative evidence syntheses (QES) have been conducted without consideration of behavioural theory. Therefore, this study aimed to apply a behavioural lens to existing QESs on recruitment and retention to identify generalisable behavioural barriers and enablers that are relevant across trials.\u003c/p\u003e"},{"header":"Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eData collection:\u003c/h2\u003e \u003cp\u003eA secondary analysis was performed on data from three existing qualitative evidence syntheses. The first QES, conducted by Farrar et al., reported influences on recruitment from the perspective of trial staff [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]. The second QES, conducted by Houghton et al., focused on patient-reported influences that impact on recruitment [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]. Finally, the third QES by Skea et al., similarly reported patient influences but to retention [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]. Further summary characteristics of the studies included in these QESs are discussed below in the \u003cspan refid=\"Sec8\" class=\"InternalRef\"\u003eresults\u003c/span\u003e section.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003eData extraction:\u003c/h2\u003e \u003cp\u003eThemes reported in the QESs were extracted verbatim and collated into an Excel spreadsheet for each QES. Secondary analysis items informed by the QES authors narrative descriptions were generated by the team (LDH, TC) and annotated with excerpts from their source theme to provide evidence and justification for their further breakdown. These secondary analysis items represented discrete concepts within the source theme. This process was completed by one author (LDH) with a select sample assessed for clarity and fit by another author (TC). A consensus on the content of each secondary analysis item was reached through discussion with these two members, with a third (KG) acting to resolve any disagreement.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003eData coding:\u003c/h2\u003e \u003cp\u003eFollowing extraction, the data were then coded against two behavioural frameworks that have been previously used to understand trial-relevant behaviours. These frameworks were:\u003c/p\u003e \u003cp\u003e \u003col\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eThe Capability, Opportunity, and Motivation \u0026ndash; Behaviour (COM-B) model [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eThe Theoretical Domains Framework (TDF) [\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e]\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003c/ol\u003e \u003c/p\u003e \u003cp\u003eBriefly, both frameworks were selected due to their potential utility in categorising the influences on trial recruitment and retention reported in the QESs. Both the COM-B and the TDF have been developed to synthesise a large number of behavioural constructs into concise, yet comprehensive, models to investigate influences on behaviour and how those influences might be leveraged for behaviour change [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e, \u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e]. The COM-B model posits that any behaviour is comprised of the three domains of capability, opportunity, and motivation, and that these domains interact with one another to produce the final observed behaviour [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]. The TDF can be seen as a more granular version of the COM-B, defining 14 component domains to behaviour, although without reference to how they interact with each other in producing behaviour [\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e]. The COM-B domains, and their equivalent TDF domains, can be seen in Fig.\u0026nbsp;1.\u003c/p\u003e \u003cp\u003eFIGURE 1 PLACEHOLDER\u003c/p\u003e \u003cp\u003e \u003cem\u003eFigure 1 The COM-B domains (inner rings) and how they are mapped to TDF domains (outer ring); Adapted from Michie et al. 2014\u003c/em\u003e [\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e]\u003c/p\u003e \u003cp\u003eThese frameworks were applied to understand the overarching trial behaviours of recruitment and retention in the three selected QESs. The themes of each QES were deductively coded to the relevant domains of each of the behavioural frameworks. Coding was undertaken by one author (LDH) and a select sample was double coded by another (TC). Any discrepancies in coding were resolved through discussion, with a third member (KG) resolving any disagreements.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec6\" class=\"Section2\"\u003e \u003ch2\u003eData analysis:\u003c/h2\u003e \u003cp\u003eFrequency counts were generated for the number of occurrences of each behavioural frameworks\u0026rsquo; domains against the secondary analysis items of the themes within each of the QESs. Summary counts of domains by framework are presented by \u0026lsquo;multi-trial\u0026rsquo; influences to reflect the multiple, and varied, host trials included in the QES for analysis.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec7\" class=\"Section2\"\u003e \u003ch2\u003eMapping of Intervention Functions and Behaviour Change Techniques (BCTs):\u003c/h2\u003e \u003cp\u003eWe applied the intervention design method known as the Behaviour Change Wheel (BCW) [\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e]. This method links the behavioural domains of the COM-B and TDF to potential categories of solutions, known as \u0026ldquo;intervention functions\u0026rdquo; [\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e]. For example, the intervention function, \u0026ldquo;Education\u0026rdquo;, is defined as \u0026ldquo;Increasing knowledge or understanding\u0026rdquo; [\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e]. In this study, we chose to map the most frequent TDF domains to intervention functions, and then to behaviour change techniques (BCTs). BCTs are known as the \u0026ldquo;active ingredients\u0026rdquo; of behaviour change interventions, representing the means through which an intervention endeavours to act on the targeted behavioural domains [\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e]. The BCTs linked to the intervention functions of the BCW have been agreed through expert consensus, generating a list of those most frequently used within a category and assigning a level of evidence to their link [\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e]. There is either evidence from past applications that a BCT has a known link, has a known absence of a link (non-link), or does not have evidence of a link [\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e].\u003c/p\u003e \u003c/div\u003e"},{"header":"Results","content":"\u003cdiv id=\"Sec9\" class=\"Section2\"\u003e \u003ch2\u003eCharacteristics of included studies\u003c/h2\u003e \u003cp\u003eFarrar et al., the QES of recruitment from recruiters\u0026rsquo; perspectives, included 30 papers with a total of 605 individual participants [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]. The majority of studies were based in the UK (n\u0026thinsp;=\u0026thinsp;23) and were typically in primary or secondary care settings. The studies included a number of different roles that acted as \u0026lsquo;recruiters\u0026rsquo;, predominantly health care professionals (HCPs) and will be referred to as such from herein. Their analysis produced five themes:\u003c/p\u003e \u003cp\u003e \u003col\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003erecruiting to randomised clinical trials (RCTs) in a clinical environment\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eenthusiasm for the RCT\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003emaking judgements about whether to approach a patient\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003ecommunication challenges\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003einterplay between recruiter and professional roles\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003c/ol\u003e \u003c/p\u003e \u003cp\u003eThese five themes were further separated in our coding into 20 secondary analysis items (available in Supplementary Table\u0026nbsp;1).\u003c/p\u003e \u003cp\u003eHoughton et al., the QES of participant factors of recruitment, included 30 papers with a total of 847 individual participants [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]. Studies were mainly conducted within the UK and Europe (n\u0026thinsp;=\u0026thinsp;22) and involved host trials within a range of clinical specialties and intervention types. Their analysis resulted in three broad themes (and six subthemes), with 22 \u0026ldquo;key findings\u0026rdquo; presented within these themes. The three broad themes were:\u003c/p\u003e \u003cp\u003e \u003col\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eTrial influences on decision to participate\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003ePersonal influences on decision to participate\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eThe impact of potential outcomes on decision to participate\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003c/ol\u003e \u003c/p\u003e \u003cp\u003eThe 22 key findings presented were further coded into 46 secondary analysis items (available in Supplementary Table\u0026nbsp;2) as part of our analysis.\u003c/p\u003e \u003cp\u003eFinally, the QES on participant reasons for non-retention by Skea et al. included eleven papers with a total of 168 individual participants [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]. Studies were mainly conducted within the UK and Europe (n\u0026thinsp;=\u0026thinsp;9) and involved host trials within a range of clinical specialties and intervention types. Their analysis resulted in five key themes, which were:\u003c/p\u003e \u003cp\u003e \u003col\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eperceptions of current health state in relation to specific aspects of the trial\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003ethe \u0026lsquo;fit\u0026rsquo; of aspects of the trial with individual preferences for care and support\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003ethe compatibility of aspects of trial processes with individual capabilities\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003econcerns about or experiences of trial medication\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003econsiderations around the extent to which trial participation could be appropriately accommodated into individuals\u0026rsquo; broader lives\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003c/ol\u003e \u003c/p\u003e \u003cp\u003eDuring our analysis, these five themes were further coded into 19 secondary analysis items (available in Supplementary Table\u0026nbsp;3).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec10\" class=\"Section2\"\u003e \u003ch2\u003eCoding of multi-trial influences on recruitment and retention to the COM-B model of behaviour:\u003c/h2\u003e \u003cp\u003eFrequencies of the six sub-domains of the COM-B coded for each of the secondary items within each QES, are presented in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e. Overall, reflective motivation (the motivations involving conscious planning and evaluation) was the sub-domain most frequently coded across all three QESs. Coding into this sub-domain also reflected the majority of coding within each QES, accounting for 42% within HCP-focused recruitment factors, 37% in participant-reported recruitment factors, and 41% in participant-reported retention factors. Specific items that were relevant to this domain were: personal interest and belief of research benefit improved recruitment (HCP recruitment); a perceived lack of further benefits/relevance was a barrier (participant recruitment); and trial design/requirements being too demanding (participant retention). The most infrequently coded sub-domain was physical capability (which involves the physical skills and ability of an individual), with only two coded instances across the QESs. Items coded to physical capability were from the participant retention QES and included: the intervention challenging sense of self or didn\u0026rsquo;t match their perceived mental and/or physical state; and perception of current health state made participants feel unable to complete trial tasks. Neither of the QESs on recruitment had instances of physical capability, only retention, with those two coded instances representing only 7% of its total coding. The percent coverage of each sub-domain is illustrated further in Fig.\u0026nbsp;2, demonstrating the relative fit of each. Further details on the content of QES themes and items coded to COM-B domains is provided in Supplementary Tables\u0026nbsp;1\u0026ndash;3.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eThemes from QESs coded to COM-B\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"8\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c8\" colnum=\"8\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\" morerows=\"2\" rowspan=\"3\"\u003e \u003cp\u003eQES\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"7\" nameend=\"c8\" namest=\"c2\"\u003e \u003cp\u003eCOM-B Sub-domains\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e \u003cp\u003e\u003cem\u003eCapability\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c5\" namest=\"c4\"\u003e \u003cp\u003e\u003cem\u003eOpportunity\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c7\" namest=\"c6\"\u003e \u003cp\u003e\u003cem\u003eMotivation\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c8\"\u003e \u003cp\u003e\u003cb\u003eTotals\u003c/b\u003e\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cem\u003ePsychological\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cem\u003ePhysical\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u003cem\u003eSocial\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u003cem\u003ePhysical\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003e\u003cem\u003eReflective\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c7\"\u003e \u003cp\u003e\u003cem\u003eAutomatic\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eRecruitment (HCP)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e7 (18%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e5 (13%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e6(16%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e16 (42%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e4 (11%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c8\"\u003e \u003cp\u003e38\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eRecruitment (participant)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e9 (12%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e12 (16%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e15 (20%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e28 (37%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e11 (15%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c8\"\u003e \u003cp\u003e75\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eRetention (participant)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e5 (17%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2 (7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1 (3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e3 (10%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e12 (41%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e6 (21%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c8\"\u003e \u003cp\u003e29\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTotal count\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e21\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e18\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e24\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e56\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e21\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eFIGURE 2 PLACEHOLDER\u003c/p\u003e \u003cp\u003e \u003cem\u003eFigure 2 COM-B coverage of QESs by sub-domain.\u003c/em\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003eCoding of multi-trial influences on recruitment and retention to the Theoretical Domains Framework:\u003c/h2\u003e \u003cp\u003eFrequency counts for each of the 14 domains for the TDF, by QES, are presented in Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e. These counts are not directly equivalent to the COM-B counts as, due to the further granularity of the TDF, COM-B domains typically cover more than one TDF domain. This resulted in more overall instances of TDF domains being coded due to more domains being available to code to. Overall, the TDF domain \u0026ldquo;beliefs about consequences\u0026rdquo; was the most frequently coded domain across the QESs. It accounted for 19% and 20% of the coding with the HCP and participant-focused recruitment QESs, respectively, and 9% within the retention QES. Specific items that were relevant to this domain were: personal interest and belief in research benefit improved recruitment (HCP recruitment); acceptability of randomisation influenced by motivations to participate and beliefs about clinical uncertainty (participant recruitment); and individuals who believed they had recovered, assumed they could no longer effectively contribute to the goals of the trial (participant retention). The most infrequently coded domain was \u0026ldquo;behavioural regulation\u0026rdquo;, which is related to strategies employed by individuals to promote performance of the target behaviour. This domain was only coded once across the three QESs, within the HCP QES, which was only 2% of that QES\u0026rsquo;s total coding. Specific content related to the domain was the perception that integrating research into care was effortful and was proactively enforced. The percent coverage of each domain is illustrated further in Fig.\u0026nbsp;3. Further details on the content of QES themes and items coded to TDF domains is provided in Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e and Supplementary Tables\u0026nbsp;1\u0026ndash;3 (in Additional File 1).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec12\" class=\"Section2\"\u003e \u003ch2\u003eLinking COM-B/TDF coding to potential solutions\u003c/h2\u003e \u003cp\u003eCoding of the trial recruitment and retention QESs into the COM-B and TDF allowed us to explore potential solutions through the intervention design method of the Behaviour Change Wheel [\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e]. The intervention functions, and their linked BCTs, for the three most frequent TDF domains identified in our analysis are presented in Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e. Intervention functions are presented on the far left, with their linked BCTs in the following column. Some intervention functions are repeated/grouped together when they share BCTs. This mapping identifies potential targets for future intervention development.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eThemes from QESs coded to TDF\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"16\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c8\" colnum=\"8\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c9\" colnum=\"9\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c10\" colnum=\"10\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c11\" colnum=\"11\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c12\" colnum=\"12\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c13\" colnum=\"13\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c14\" colnum=\"14\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c15\" colnum=\"15\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c16\" colnum=\"16\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eQES\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"15\" nameend=\"c16\" namest=\"c2\"\u003e \u003cp\u003eTDF domains\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cem\u003eSocial influences\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cem\u003eEnvironmental context and resources\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u003cem\u003eBehavioural regulation\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u003cem\u003eMemory, attention, \u0026amp; decision processes\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003e\u003cem\u003eSkills\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c7\"\u003e \u003cp\u003e\u003cem\u003eKnowledge\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c8\"\u003e \u003cp\u003e\u003cem\u003eBeliefs about consequences\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c9\"\u003e \u003cp\u003e\u003cem\u003eGoals\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c10\"\u003e \u003cp\u003e\u003cem\u003eIntentions\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c11\"\u003e \u003cp\u003e\u003cem\u003eOptimism\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c12\"\u003e \u003cp\u003e\u003cem\u003eBeliefs about capabilities\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c13\"\u003e \u003cp\u003e\u003cem\u003eSocial Professional role and identity\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c14\"\u003e \u003cp\u003e\u003cem\u003eEmotion\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c15\"\u003e \u003cp\u003e\u003cem\u003eReinforcement\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c16\"\u003e \u003cp\u003e\u003cb\u003eTotal codes/QES\u003c/b\u003e\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eRecruitment (HCP)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e5 (9%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e6 (11%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1 (2%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e1 (2%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e1 (2%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e4 (8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e10 (19%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e2 (4%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e9 (17%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e \u003cp\u003e3 (6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c12\"\u003e \u003cp\u003e1 (2%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c13\"\u003e \u003cp\u003e6 (11%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c14\"\u003e \u003cp\u003e4 (8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c15\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c16\"\u003e \u003cp\u003e\u003cb\u003e53\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eRecruitment (participant)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e12 (12%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e15 (15%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e5 (5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e6 (6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e19 (20%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e7 (7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e3 (3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e \u003cp\u003e12 (12%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c12\"\u003e \u003cp\u003e4 (4%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c13\"\u003e \u003cp\u003e3 (3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c14\"\u003e \u003cp\u003e5 (5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c15\"\u003e \u003cp\u003e6 (6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c16\"\u003e \u003cp\u003e\u003cb\u003e97\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eRetention (participant)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3 (9%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e2 (6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e3 (9%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e2 (6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e3 (9%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e1 (3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e1 (3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e \u003cp\u003e3 (9%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c12\"\u003e \u003cp\u003e7 (22%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c13\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c14\"\u003e \u003cp\u003e5 (16%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c15\"\u003e \u003cp\u003e1 (3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c16\"\u003e \u003cp\u003e\u003cb\u003e32\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTotals per TDF domain\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003e18\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003e24\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u003cb\u003e1\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u003cb\u003e8\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e\u003cb\u003e4\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e\u003cb\u003e12\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e\u003cb\u003e32\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e\u003cb\u003e10\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e\u003cb\u003e13\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e \u003cp\u003e\u003cb\u003e18\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c12\"\u003e \u003cp\u003e\u003cb\u003e12\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c13\"\u003e \u003cp\u003e\u003cb\u003e9\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c14\"\u003e \u003cp\u003e\u003cb\u003e14\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c15\"\u003e \u003cp\u003e\u003cb\u003e7\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c16\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eFIGURE 3 PLACEHOLDER\u003c/p\u003e \u003cp\u003e \u003cem\u003eFigure 3 TDF coverage of evidence sources by domain\u003c/em\u003e \u003c/p\u003e \u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eWe have presented our secondary analysis of three qualitative evidence syntheses within recruitment and retention, applying two behaviourally focussed theoretical frameworks to categorise the respective findings of each QES. Both the COM-B and TDF were able to accommodate findings from all three QESs, demonstrating their utility in categorising multi-trial influences on behaviours that are relevant to recruitment and retention in clinical trials. Some theoretical domains proved to be more applicable than others across the trials included within the QESs and some more applicable within particular populations (participants versus staff). For instance, the TDF domain \u0026ldquo;environmental context and resources\u0026rdquo; was coded fairly consistently across each QES, from 9\u0026ndash;15% of total coding, demonstrating that resources and external factors are likely contributing factors to both recruitment and retention from both participant and staff perspectives. Similarly, the TDF domain \u0026ldquo;behavioural Regulation\u0026rdquo; was only coded once across the three QESs, entirely absent in the participant context. Other notable domains, unrepresented in one population, included \u0026ldquo;skills\u0026rdquo;, \u0026ldquo;social professional role/identity\u0026rdquo;, and \u0026ldquo;reinforcement\u0026rdquo;.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eIntervention function and potential BCTs\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"5\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eIntervention Function\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eBCT (\u003cem\u003emost frequently used)\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"3\" nameend=\"c5\" namest=\"c3\"\u003e \u003cp\u003eTDF domains\u003c/p\u003e \u003cp\u003e(context)\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eBeliefs about capabilities\u003c/p\u003e \u003cp\u003e(high for retention)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eIntentions\u003c/p\u003e \u003cp\u003e(high for recruiters)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eBeliefs about consequences\u003c/p\u003e \u003cp\u003e(high for recruitment \u0026amp; recruiters)\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"9\" rowspan=\"10\"\u003e \u003cp\u003eEnablement\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1.1 Goal setting (Behaviour)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1.2 Problem solving\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e✓\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1.3 Goal setting (Outcome)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1.4 Action planning\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1.5 Review behaviour goal(S)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1.7 Review outcome goal(S)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3.1 Social Support (unspecified)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3.2 Social support (practical)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e12.1 Restructuring the physical environment\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e12.5 Adding objects to the environment\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eX\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eIncentivisation\u003c/p\u003e \u003cp\u003eCoercion\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2.1. Monitoring of behaviour by others without feedback\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2.5. Monitoring of outcome(s) of behaviour without feedback\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eX\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eEducation\u003c/p\u003e \u003cp\u003ePersuasion\u003c/p\u003e \u003cp\u003eIncentivisation\u003c/p\u003e \u003cp\u003eCoercion\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2.2 Feedback on behaviour\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2.7 Feedback on outcome(s) of behaviour\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eEducation\u003c/p\u003e \u003cp\u003eEnablement\u003c/p\u003e \u003cp\u003eIncentivisation\u003c/p\u003e \u003cp\u003eCoercion\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2.3 Self-monitoring of behaviour\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eEducation\u003c/p\u003e \u003cp\u003ePersuasion\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e5.1 Information about health consequences\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e✓\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e✓\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e5.3 Information about social and environmental consequences\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eX\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e✓\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eModelling\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e6.1 Demonstration of the behaviour\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e✓\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eEducation\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e7.1 Prompts /cues\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eX\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eX\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePersuasion\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e9.1 Credible source\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cdiv id=\"Sec14\" class=\"Section2\"\u003e \u003ch2\u003eLegend: \u0026ldquo;check\u0026rdquo; = evidence of link; \u0026ldquo;-\u0026rdquo; = no evidence; \u0026ldquo;X\u0026rdquo; = evidence of non-link\u003c/h2\u003e \u003cp\u003eIt is important to consider whether this lack of data that could be coded against some TDF domains was due to a lack of relevance or due to a limitation of the included data. For example, four domains (behavioural regulation, skills, social professional role/identity, and reinforcement) were not identified as relevant within at least one population. However, given the majority of studies included in these QESs did not use a behavioural theory or framework to understand recruitment or retention, nor did any use the TDF, it may be a limitation of the data set rather than a lack of relevance. There are a number of primary studies published after the publication of the included QESs that support the hypothesis that this is a limitation of the included data. A TDF-guided interview study by Lalu et al. queried both patients and clinicians on the potential barriers and facilitators to participation in a planned stem cell trial [\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]. In contrast to the \u0026ldquo;skills\u0026rdquo; domain being absent in our participant recruitment sample, Lalu et al. identified skills relevant to participants enrolling in about half of their sample. These skills included identification of trial opportunities through media resources or through conversations with their personal clinicians [\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]. Secondly, a TDF-guided interview study by Hanrahan et al. identified barriers and enablers to healthcare providers recruiting to maternity trials [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]. In contrast to our findings, the domain of \u0026ldquo;reinforcement\u0026rdquo; was found relevant to recruiting staff. In particular, social support received during the recruitment process acted as an incentive for recruiters to perform, as did recruitment targets that put them in competition with other sites (although this was not universal) [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]. Lastly, two papers report on participant-centred instances of \u0026ldquo;behavioural regulation\u0026rdquo; within recruitment and retention. The first by Guillot et al. identified that parents seek information about enrolment in a hypothetical trial through specific communication strategies [\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e]. The second, a TDF-guided interview study on retention by Newlands et al., queried participants about their perspectives on the barriers and enablers to returning questionnaires and/or attending follow-up clinic visits. Participants in this study highlighted the strategies they employ to make the return of questionnaires or attendance at follow-up visits easier for them to engage in [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e]. However, in line with our findings, they did not identify any instances of \u0026ldquo;social professional role/identity\u0026rdquo; within their sample. This may point to a lack of \u0026ldquo;buy-in\u0026rdquo; from participants who may not fully appreciate their contribution to the trial\u0026rsquo;s success through their continued involvement. The identification of relevance of several of these TDF domains in the cited empirical work highlights that, whilst our analysis has identified potential \u0026ldquo;big ticket\u0026rdquo; items that could be amenable to change and have benefit across a number of trials, there are still trial-specific, contextually-determined, domains of relevance. These domains will thus require a behavioural diagnostic approach to identify and target support for recruitment and retention in trials.\u003c/p\u003e \u003cp\u003eOur behavioural analysis had identified over-arching influences on HCP and participants behaviours when considering trial recruitment and retention and could hold promise in identifying generalisable intervention targets for future research. When considering potential strategies to address issues within recruitment and retention, theoretically-informed investigations present opportunities to link behavioural factors to mechanisms known to mediate change [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e, \u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e, \u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e]. Within this study, the behavioural domains identified can serve as targets for further investigation or for intervention development. In the former, for instance, domains that are low in occurrence, but likely amenable to change (i.e., \"skills\u0026rdquo; and \u0026ldquo;behavioural regulation\u0026rdquo;) could be more systematically explored to confirm whether they are, indeed, not relevant, or if potential strategies are deemed missing but possibly needed. The latter case, of using these findings to inform intervention target selection and development, is also feasible. In addition, the intervention design method using the BCW has identified potential intervention functions and BCTs that could be used to develop interventions that target our populations of interest to improve recruitment and/or retention. Specifically, BCT \u0026lsquo;5.1 Information about health consequences\u0026rsquo; was identified as having evidence of effectiveness that is linked to the TDF domains of \u0026ldquo;intentions\u0026rdquo; and \u0026ldquo;beliefs about consequences\u0026rdquo; [\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e], which were high for recruitment influences of patients and health care professionals across the QES data. Developing this BCT content through the intervention functions of education, persuasion and modelling would be an obvious next step based on the findings of our study. However, the design of wholly new interventions may not be necessary. Behavioural frameworks have also shown utility in identifying BCTs in existing interventions [\u003cspan additionalcitationids=\"CR25\" citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e]. One such example assessed interventions effective for improving trial retention to see if they contained implicit BCTs, even though they were not designed with them in mind [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]. In that study, eleven BCTs were identified across eight interventions. Some of these BCTs (Social support, Credible source, Adding objects to the environment) are also able to address the \u0026ldquo;beliefs about capabilities\u0026rdquo; domain that we have found to be important to retention within our sample. As such, adapting the effective interventions identified in Duncan et al. to address the retention-related factors in our sample could be a fruitful next step without the need for building an intervention from scratch.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec15\" class=\"Section2\"\u003e \u003ch2\u003eStrengths and limitations\u003c/h2\u003e \u003cp\u003eOur secondary analysis of QESs has demonstrated the utility of applying behavioural frameworks in categorising the influences on recruitment and retention to clinical trials. These findings, along with the findings of others who have similarly applied these frameworks retrospectively [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e], lends evidence to the theoretical fit of these frameworks in accounting for the diverse and complex factors that are found to underlie trial recruitment and retention. Collation of these factors under a common theoretical language then allows a more meaningful synthesis of previously disparate findings [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e, \u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e]. Accordingly, this establishes a more coherent evidence base that trialists and intervention designers can reference with greater confidence. Placing findings within these theoretical domains then also facilitates the translation of findings into actionable targets for strategy development, as we have given an example of above in proposed intervention functions of the BCW. Additionally, our analysis adds a further layer of scrutiny and summary of the findings within the QESs, which can aid those seeking to identify, from amongst many publications, the generalisable factors most relevant to recruitment and retention, even if they do not take a theoretical approach. However, this further analysis of already synthesised findings is also a potential limitation. As we did not analyse the primary studies included in the QESs, we cannot speak to the quality of their findings. Our further breakdown of their thematic findings into secondary analysis items could also be viewed as introducing our own interpretations of their content. To best ameliorate this, we have attempted to remain as close to the original findings as possible and linking our secondary analysis items explicitly to text within the original papers. Finally, we have chosen two behavioural frameworks to apply here, but do not have reason to discount frameworks from other disciplines, such as implementation science. The TDF and COM-B were chosen for their comprehensibility in understanding behavioural influences on recruitment and retention, but an implementation framework may interrogate operationalisation of these behaviours, or strategies to change them [\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e]. Within the scope of this paper, we believe the chosen frameworks have demonstrated their utility, satisfying our research aim.\u003c/p\u003e \u003c/div\u003e"},{"header":"Conclusion","content":"\u003cp\u003eOur application of the TDF and COM-B to evidence syntheses of influences on recruitment and retention has demonstrated that these behavioural frameworks can be meaningfully applied to categorise the multi-trial findings and propose potential intervention functions that could be generalisable across trials. This alignment with theory serves to further combine these influences, bringing findings from different methodological and ontological perspectives together under a shared descriptive and mechanistic umbrella. Not only does this then allow more fluid synthesis of findings, but it connects those findings to strategies of intervention development. Whether these same frameworks are applicable to the behaviours associated with the wide-ranging phenomena under investigation in trials methodology, that go beyond recruitment and retention, is still to be explored. However, the results presented here demonstrate an important proof-of-concept and engender a degree of optimism in such future pursuits.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cul\u003e\n \u003cli\u003ebehaviour change techniques (BCTs)\u003c/li\u003e\n \u003cli\u003eBehaviour Change Wheel (BCW)\u003c/li\u003e\n \u003cli\u003eCapability, Opportunity, and Motivation \u0026ndash; Behaviour (COM-B) model\u0026nbsp;\u003c/li\u003e\n \u003cli\u003ehealth care professionals (HCPs)\u003c/li\u003e\n \u003cli\u003equalitative evidence syntheses (QES)\u003c/li\u003e\n \u003cli\u003erandomised clinical trials (RCTs)\u003c/li\u003e\n \u003cli\u003eTheoretical Domains Framework (TDF)\u003c/li\u003e\n\u003c/ul\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cem\u003eEthics approval and consent to participate\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eConsent for publication\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eAvailability of data and materials\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe dataset(s) supporting the conclusions of this article is(are) included within the article (and its additional file(s)).\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eCompeting interests\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare that they have no competing interests.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eFunding\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThis work is delivered as part of an MRC-funded Non-Clinical research fellowship (MR/X007464/1).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eAuthors’ contributions\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eKG was responsible for the conceptualisation, design, conduct, and manuscript feedback of this study. LD was responsible for data collection and analysis and assisted in the writing of the manuscript. TC was responsible for quality assurance within data collection and analysis and was the primary author of the manuscript. \u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eAcknowledgements\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable\u0026nbsp;\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eWalters SJ, Henriques-Cadby BdosA, Bortolami I, Flight O, Hind L, Jacques D et al. RM,. Recruitment and retention of participants in randomised controlled trials: a review of trials funded and published by the United Kingdom Health Technology Assessment Programme. 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England: BioMed Central; 2017;12:2. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.ncbi.nlm.nih.gov/pubmed/28057049\u003c/span\u003e\u003cspan address=\"https://www.ncbi.nlm.nih.gov/pubmed/28057049\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"clinical trials, secondary analysis, behavioural science, trials methodology, recruitment and retention","lastPublishedDoi":"10.21203/rs.3.rs-4431879/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4431879/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e \u003cp\u003eRecruitment and retention to clinical trials are key processes underlying their success. Methodological work in this area has identified a number of influences, from both participant and trial staff perspectives, on what drives recruitment and retention. Collation of this evidence is crucial for these findings to be translated into actionable changes in how trials are conducted. Initial efforts to do so have resulted in qualitative evidence syntheses that summarise recurrent themes in recruitment and retention. However, many of these primary studies, and the evidence syntheses themselves, lack a theoretical basis to understand the reported influences. The objective of this paper was to apply theoretical frameworks to these evidence syntheses and assess whether they captured reported influences in their theoretical domains.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eTwo behavioural theoretical frameworks were used to code reported influences on recruitment and retention from three qualitative evidence syntheses. The syntheses summarised participant and trial staff-reported influences on recruitment and participant-reported influences on retention. These influences were coded into the relevant behavioural domains of the two frameworks. Each behavioural domains\u0026rsquo; relative coverage of influences across the papers were calculated. The most and least often coded domains were identified, with potential interventions targeting the most frequent domains suggested.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eBoth frameworks were able to categorise influences from all three papers. The most-often coded domains were \u0026ldquo;reflective motivation\u0026rdquo; and \u0026ldquo;beliefs about consequences\u0026rdquo;. The least-often coded were \u0026ldquo;physical capability\u0026rdquo; and \u0026ldquo;behavioural regulation\u0026rdquo;. These findings are largely consistent with other work using behavioural frameworks to categorise influences on recruitment and retention.\u003c/p\u003e\u003ch2\u003eConclusions\u003c/h2\u003e \u003cp\u003eThe selected frameworks demonstrated their utility in contextualising reported influences on recruitment and retention. These frameworks offer advantages in collation of evidence and for their integration in intervention development to target problem areas. Future work could continue their application, producing a significant and accessible evidence base on what drives recruitment and retention to trials.\u003c/p\u003e","manuscriptTitle":"Applying behavioural frameworks to contextualise reported influences on clinical trial recruitment and retention: A secondary analysis of three qualitative evidence syntheses","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-01-22 09:27:28","doi":"10.21203/rs.3.rs-4431879/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"531db021-1a6e-47f9-ab2f-f417a9cede5b","owner":[],"postedDate":"January 22nd, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2025-03-26T05:17:32+00:00","versionOfRecord":[],"versionCreatedAt":"2025-01-22 09:27:28","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-4431879","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-4431879","identity":"rs-4431879","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}