Randomised Controlled Trials Recruitment Research Articles

A qualitative exploration of advantages and disadvantages to using technology in the process of randomised controlled trial recruitment.

Despite its importance, recruiting a sufficient sample size for randomised controlled trials (RCTs) can pose a significant challenge, which has real-world impact on reliability of evidence, trial completion and ultimately, patient care. Technology has potential to enhance the recruitment process, but there is a lack of evidence regarding its current use and effectiveness. Consistent with findings from the PRioRiTy I study, the current research aims to explore the advantages and disadvantages to using technology during the recruitment process for RCTs. Semi-structured interviews (n=7) were conducted with researchers involved in RCT recruitment in Ireland. Subsequently, a Public & Patient Involvement (PPI) panel focus group (n=3) was conducted to add further depth to these findings. The data were qualitatively analysed through 'Reflexive Thematic Analysis' to extract prominent themes. A superordinate theme arose: 'Tech is just a medium so that you can reach more people', along with two themes, which were corroborated by the PPI focus group: 'Technology is used if and when the benefits outweigh the costs' and 'Success of recruitment through technology depends on the nature of the study.' This study provided a deeper understanding of the factors which influence researchers to employ technology in recruitment for RCTs. Implications suggest that future researchers should aim to adapt their recruitment approaches to meet digital tool preferences of their target cohort; and engage with patient groups in the community to allow networking opportunities for future studies. This research may contribute towards maximising efficiency in RCT recruitment.

A qualitative exploration of advantages and disadvantages to using technology in the process of randomised controlled trial recruitment

Background: Despite its importance, recruiting a sufficient sample size for randomised controlled trials (RCTs) can pose a significant challenge, which has real-world impact on reliability of evidence, trial completion and ultimately, patient care. Technology has potential to enhance the recruitment process, but there is a lack of evidence regarding its current use and effectiveness. Consistent with findings from the PRioRiTy I study, the current research aims to explore the advantages and disadvantages to using technology during the recruitment process for RCTs. Methods: Semi-structured interviews (n=7) were conducted with researchers involved in RCT recruitment in Ireland. Subsequently, a Public & Patient Involvement (PPI) panel focus group (n=3) was conducted to add further depth to these findings. The data were qualitatively analysed through ‘Reflexive Thematic Analysis’ to extract prominent themes. Results: A superordinate theme arose: ‘Tech is just a medium so that you can reach more people’, along with two themes, which were corroborated by the PPI focus group: ‘Technology is used if and when the benefits outweigh the costs’ and ‘Success of recruitment through technology depends on the nature of the study.’ Conclusions: This study provided a deeper understanding of the factors which influence researchers to employ technology in recruitment for RCTs. Implications suggest that future researchers should aim to adapt their recruitment approaches to meet digital tool preferences of their target cohort; and engage with patient groups in the community to allow networking opportunities for future studies. This research may contribute towards maximising efficiency in RCT recruitment.

Understanding the perspectives of recruiters is key to improving randomised controlled trial enrolment: a qualitative evidence synthesis

BackgroundRecruiting patients to randomised controlled trials (RCTs) is often reported to be challenging, and the evidence base for effective interventions that could be used by staff (recruiters) undertaking recruitment is lacking. Although the experiences and perspectives of recruiters have been widely reported, an evidence synthesis is required in order to inform the development of future interventions. This paper aims to address this by systematically searching and synthesising the evidence on recruiters’ perspectives and experiences of recruiting patients into RCTs. MethodsA qualitative evidence synthesis (QES) following Thomas and Harden’s approach to thematic synthesis was conducted. The Ovid MEDLINE, CINAHL, EMBASE, PsycInfo, Cochrane Central Register of Controlled Trials, ORRCA and Web of Science electronic databases were searched. Studies were sampled to ensure that the focus of the research was aligned with the phenomena of interest of the QES, their methodological relevance to the QES question, and to include variation across the clinical areas of the studies. The GRADE CERQual framework was used to assess confidence in the review findings.ResultsIn total, 9316 studies were identified for screening, which resulted in 128 eligible papers. The application of the QES sampling strategy resulted in 30 papers being included in the final analysis. Five overlapping themes were identified which highlighted the complex manner in which recruiters experience RCT recruitment: (1) recruiting to RCTs in a clinical environment, (2) enthusiasm for the RCT, (3) making judgements about whether to approach a patient, (4) communication challenges, (5) interplay between recruiter and professional roles.ConclusionsThis QES identified factors which contribute to the complexities that recruiters can face in day-to-day clinical settings, and the influence recruiters and non-recruiting healthcare professionals have on opportunities afforded to patients for RCT participation. It has reinforced the importance of considering the clinical setting in its entirety when planning future RCTs and indicated the need to better normalise and support research if it is to become part of day-to-day practice.Trial registrationPROSPERO CRD42020141297 (registered 11/02/2020).

Using a qualitative sub-study to inform the design and delivery of randomised controlled trials on medicinal cannabis for symptom relief in patients with advanced cancer

BackgroundRecruitment for randomised controlled trials in palliative care can be challenging; disease progression and terminal illness underpin high rates of attrition. Research into participant decision-making in medicinal cannabis randomised controlled trials (RCTs) is very limited. Nesting qualitative sub-studies within RCTs can identify further challenges to participation, informing revisions to study designs and recruitment practices. This paper reports on findings from a qualitative sub-study supporting RCTs of medicinal cannabis for symptom burden relief in patients with advanced cancer in one Australian city.MethodsSemi-structured qualitative interviews were conducted with 48 patients with advanced cancer, eligible to participate in a medicinal cannabis RCT (n=28 who consented to participate in an RCT; n=20 who declined). An iterative and abductive approach to thematic analysis and data collection fostered exploration of barriers and enablers to participation.ResultsKey enablers included participants’ enthusiasm and expectations of medicinal cannabis as beneficial (to themselves and future patients) for symptom management, especially after exhausting currently approved options, and a safer alternative to opioids. Some believed medicinal cannabis to have anti-cancer effects. Barriers to participation were the logistical challenges of participating (especially due to driving restrictions and fatigue), reluctance to interfere with an existing care plan, cost, and concerns about receiving the placebo and the uncertainty of the benefit. Some declined due to concerns about side-effects or a desire to continue accessing cannabis independent of the study.ConclusionsThe findings support revisions to subsequent medicinal cannabis RCT study designs, namely, omitting a requirement that participants attend weekly hospital appointments. These findings highlight the value of embedding qualitative sub-studies into RCTs. While some challenges to RCT recruitment are universal, others are context (population, intervention, location) specific. A barrier to participation found in research conducted elsewhere—stigma—was not identified in the current study. Thus, findings have important implications for those undertaking RCTs in the rapidly developing context of medical cannabis.

Using a theory-informed approach to explore patient and staff perspectives on factors that influence clinical trial recruitment for patients with cirrhosis and small oesophageal varices.

The success of pharmacological randomised controlled trials (RCTs) depends on the recruitment of the required number of participants. Recruitment to RCTs for patients with cirrhosis and small oesophageal varices raises specific additional challenges. The objectives of the study were 1) to explore patient perspectives on factors that influence RCT recruitment, 2) to understand factors that influence the success of recruitment from a staff perspective, and 3) to identify opportunities for tailored interventions to improve trial recruitment in this context. The qualitative study was embedded in a multi-centre blinded RCT (BOPPP trial) and was conducted alongside site opening. Semi-structured interviews were conducted with patients who enrolled to participate in the trial (n = 13), patients who declined to take part (n = 5), and staff who were responsible for recruiting participants to the trial (n = 18). An open approach to data collection and analysis was adopted and the Theoretical Domains Framework (TDF) was used to provide a theoretical lens through which to view influences on behaviour. Data was analysed using thematic analysis. The findings consist of 5 overarching themes that outline trial recruitment influences at the patient, staff, team, organisational and trial levels: i) patient risks and benefits ii) staff attitudes, knowledge and capacity, iii) team-based approach, iv) organisational context and v) Trial collective. Patient-generated themes map onto thirteen of the fourteen TDF domains and staff-generated themes map onto all TDF domains. The overarching themes are not mutually exclusive; with evidence of direct interactions between patient and staff-level themes that influence recruitment behaviours. This study uses a theory-informed approach to gain new insights into improving clinical trial recruitment for patients with cirrhosis and small oesophageal varices. Although people with cirrhosis often display decreased healthcare-seeking behaviours, we found that patients used research to empower themselves to improve their health. Pragmatic trials involving unpredictable populations require staff expertise in building trust, and a deep knowledge of the patient group and their vulnerabilities. RCT recruitment is also more successful when research visits align with what staff identified as the natural rhythm of care. ISRCTN10324656; https://clinicaltrials.gov/.

Trust in research physicians as a key dimension of randomized controlled trial participation in clinical addictions research

Background: In the development of pharmacotherapies for substance use disorders, willingness to participate in randomized controlled trials (RCTs) among people who use drugs (PWUD) is influenced by numerous social and structural factors. Considering the criminalization and stigma experienced by PWUD and range of experiences in healthcare and research, PWUD may vary in their trust of health providers, health research physicians, or medical research processes. We therefore examine associations between trust in these three domains and willingness to participate in a hypothetical RCT for a novel pharmacotherapy for stimulant use among PWUD. Methods: Data were derived from a cross-sectional questionnaire administered to participants using crack and/or cocaine from three cohort studies of PWUD in Vancouver (N = 229). Results: A majority of participants were “definitely” or “probably” willing to participate in an RCT. In multivariable ordinal regression, trust in research physicians was positively associated with willingness to participate, while trust in primary care providers or medical research processes were not significantly associated. Conclusions: This data suggests trust in research physicians plays a role in RCT decision-making among PWUD, while trust in healthcare providers and research processes appears less relevant. These findings highlight opportunities for supporting RCT recruitment by building trust in research physicians.

Recruitment and adherence of randomized controlled trials for mild cognitive impairment: A systematic review and meta-analysis.

The recruitment and adherence status of randomized controlled trials (RCTs) for population with mild cognitive impairment (MCI) are little known. We aimed to explore the RCT recruitment and adherence status and factors associated with these among MCI patients. We searched MEDLINE, EMBASE, Cochrane Library, CINAHL, PsycINFO, and PsycARTICLES from inception to 8th July 2019. Included studies were RCTs conducted among MCI patients with available data of invitation rate, eligibility rate, randomization rate, recruitment rate, adherence rate, satisfaction rate, or potential barrier for recruitment and compliance. Two authors screened the studies and extracted the data independently. We calculated pooled proportions of each rate and their 95% confidence intervals (CIs) using random-effects meta-analysis. Meta-regression and subgroup analysis was conducted. Hundred and ten articles were judged to meet the study inclusion criteria from 10 387 articles. The invitation rates ranged from 9% to96% but were not pooled together due to high heterogeneity. The pooled overall eligibility, randomization, recruitment, intervention adherence, and follow-up adherence rates were 55% (95% CI: 48%-62%), 86% (95% CI: 81%-91%), 44% (95% CI: 37%-50%), 88% (95% CI: 86%-90%), and 85% (95% CI: 83%-87%), respectively. Non-MCI (47.5%), disease or medical problems (13.8%), and loss of interest (8.5%) were the most frequent reasons for screen failure. Refusal without reason (36.6%), adverse events (30.9%), and health issues (7.7%) were the most frequent reasons for drop-out. This study provided important information for future RCTs targeting at MCI patients. Strategies designed to improve participant recruitment and RCT adherence should be developed among this population.

Recruitment strategies in randomised controlled trials of men aged 50 years and older: a systematic review

ObjectivesTo identify and review evaluations of strategies to recruit men aged 50 years and over to randomised controlled trials (RCTs).DesignSystematic review and narrative synthesis.Data sourcesMEDLINE, EMBASE, CINAHL and ORRCA databases...

Intensive Triangulation of Qualitative Research and Quantitative Data to Improve Recruitment to Randomized Trials: The QuinteT Approach.

Randomized controlled trials (RCTs) can provide high quality evidence about the comparative effectiveness of health care interventions, but many RCTs struggle with or fail to complete recruitment. RCTs are built on the principles of the experimental method, but their planning, conduct, and interpretation can depend on complex social, behavioral, and cultural factors that may be best understood through qualitative research. Most qualitative studies undertaken alongside RCTs involve interviews that produce data that are used in a supportive or supplicatory role, but there is potential for qualitative research to be more influential. In this article, we describe the research methods underpinning the "QuinteT" (Qualitative Research Integrated Within Trials) approach to understand and address RCT recruitment difficulties. The QuinteT Recruitment Intervention (QRI) brings together multiple qualitative strategies and quantitative data and uses triangulation to understand recruitment issues rapidly. These nuanced understandings are used to inform the implementation of collaborative actions to improve recruitment.

Treatment preference and recruitment to pediatric RCTs: A systematic review.

BackgroundRecruitment to pediatric randomised controlled trials (RCTs) can be a challenge, with ethical issues surrounding assent and consent. Pediatric RCTs frequently recruit from a smaller pool of patients making adequate recruitment difficult. One factor which influences recruitment and retention in pediatric trials is patient and parent preferences for treatment.PurposeTo systematically review pediatric RCTs reporting treatment preference.MethodsDatabase searches included: MEDLINE, CINAHL, EMBASE, and COCHRANE.Qualitative or quantitative papers were eligible if they reported: pediatric population, (0–17 years) recruited to an RCT and reported treatment preference for all or some of the participants/parents in any clinical area. Data extraction included: Number of eligible participants consenting to randomisation arms, number of eligible patients not randomised because of treatment preference, and any further information reported on preferences (e.g., if parent preference was different from child).ResultsFifty-two studies were included. The number of eligible families declining participation in an RCT because of preference for treatment varied widely (between 2 and 70%) in feasibility, conventional and preference trial designs. Some families consented to trial involvement despite having preferences for a specific treatment. Data relating to ‘participant flow and recruitment’ was not always reported consistently, therefore numbers who were lost to follow-up or withdrew due to preference could not be extracted.ConclusionsFamilies often have treatment preferences which may affect trial recruitment. Whilst children appear to hold treatment preferences, this is rarely reported. Further investigation is needed to understand the reasons for preference and the impact preference has on RCT recruitment, retention and outcome.

How can we successfully recruit depressed people? Lessons learned in recruiting depressed participants to a multi-site trial of a brief depression intervention (the \u2018CLASSIC\u2019 trial)

BackgroundThere are enormous problems in recruiting depressed people into randomised controlled trials (RCTs), with numerous studies consistently failing to recruit to target (Sully et al., Trials 14:166, 2013). Given the high prevalence of—and disability associated with—depression, it is important to find ways of effectively recruiting to RCTs evaluating interventions. This study aimed to test the feasibility of using a self-referral system to recruit to a brief intervention in a multi-site trial, the CLASSIC trial of self-confidence workshops for depression. In that trial, participants referred themselves to a depression intervention with a positive non-diagnostic title of ‘self-confidence’, given the close relationship of depression and self-esteem (Horrell et al., Br J Psychiatry 204:222–233, 2014).MethodWe analysed uptake and retention rates by recruitment to the study, attendance at the workshops and follow-up rates. However, because of the rapid rate of recruitment, we decided to pause the trial and revise our original single-site research protocol in months 5–6. We report findings under three main headings: recruitment rates for the 12 months of the project before and after the pause; data regarding attendance at the workshops before and after the pause; and the follow-up rates before and after the pause.ResultsWe recruited 459 participants within 12 months, representing 38 participants recruited per month. Improved uptake of the intervention and retention after the development of multi-site research protocols are reported.DiscussionBased on previous evidence from RCT recruitment among depressed participants, our recruitment rate demonstrates that a self-referral system using a non-diagnostic title of self-confidence is a successful recruitment method. The implications of rapid recruitment using a self-referral system are described, including the impact on uptake of the intervention as well as participant retention. Because of the potential for recruiting many participants quickly, research teams need to be adequately resourced and the oversight committees prepared to meet at shorter intervals with RCTs of brief interventions.Short conclusionSelf-referral to a brief intervention for depression with a non-diagnostic title can be a very effective way of recruiting depressed people into trials. However, there are also some challenges.Trial registrationISRCTN, ISRCTN26634837. Registered on 10 June 2010.

Randomised controlled trials as part of clinical care: A seven-step routinisation framework proposal.

Evidence translation in wound care relies on the need for evidence generation. Clinical practice may generate evidence only if evidence-generating research projects, such as randomised controlled trials (RCTs), became routinised in clinical settings. The aim of this study was to identify optimal trial-related practices to routinise trial-related activities in Melbourne-located wound clinics as reported by clinicians and researchers. We conducted a secondary analysis of the available data on how to routinise RCTs in clinical care, with a focus on enablers and suggestions provided by the participants during face-to-face and telephone interviews. Data were obtained from a qualitative observational study nested within a randomised, double-blinded, placebo-controlled trial on clinical effectiveness of aspirin as an adjunct to compression therapy in healing chronic venous leg ulcers (ASPiVLU). We developed a seven-step Routinisation of Trials in Clinical Care Framework. These steps include: (1) pre-trial clinical site assessment, (2) optimising pre-recruitment arrangements, (3) developing and updating trial-related skills, (4) embedding RCT recruitment as part of routine clinical care, (5) promoting teamwork and trial-related collaboration, (6) addressing trial-related financial issues, and (7) communicating trial results to clinicians.

Recruitment Strategies for Cluster Randomized Controlled Trials Targeting Workplace Sedentary Behavior- a Retrospective Review

Increased demand for sedentary behavior reduction in workplace environments has led to the planning of large-scale interventions implemented at the group level in the form of cluster randomized controlled trials (RCTs). To date, limited evidence is available regarding cluster RCT recruitment strategies. PURPOSE: The purpose of this paper is to provide a review of recruitment strategies employed in a large cluster RCT targeting a reduction in workplace sedentary behavior. METHODS: Recruitment yields ([N enrolled/N screened] x 100) were calculated. Mean (±SD) and median worksite sizes were calculated at each recruitment step. The percentage of participants who progressed to each recruitment step (of the total N screened per worksite) was calculated to determine the mean percentage of a worksite successfully randomized. Recruitment barriers and modifications were recorded by the research team. A survey was completed by a subset of non-participants (N = 57) and thematic analyses conducted to examine reasons for non-participation, positive impacts and negative experiences. RESULTS: Cluster recruitment yield was 43% (24 worksites enrolled/56 screened). Individual recruitment yield was 49% (641 employees enrolled/1317 screened). On average, 52 ± 16% of the worksite was successfully randomized. Eighteen modifications were developed to overcome participant-related, context-related and research-related barriers. CONCLUSIONS: Researchers should plan to screen at least 200% of the intended number of worksites and they should target worksites that are approximately double the size of the intended cluster size to avoid loss of statistical power or timeline extensions. Acknowledging temporal fluctuations in worksite-specific workloads, providing options throughout the recruitment process, and adopting a participant-centered approach may facilitate cluster RCT success.

Detailed systematic analysis of recruitment strategies in randomised controlled trials in patients with an unscheduled admission to hospital

ObjectivesTo examine the design and findings of recruitment studies in randomised controlled trials (RCTs) involving patients with an unscheduled hospital admission (UHA), to consider how to optimise recruitment in future...

Training health professionals to recruit into challenging randomized controlled trials improved confidence: the development of the QuinteT randomized controlled trial recruitment training intervention

ObjectivesThe objective of this study was to describe and evaluate a training intervention for recruiting patients to randomized controlled trials (RCTs), particularly for those anticipated to be difficult for recruitment. Study Design and SettingOne of three training workshops was offered to surgeons and one to research nurses. Self-confidence in recruitment was measured through questionnaires before and up to 3 months after training; perceived impact of training on practice was assessed after. Data were analyzed using two-sample t-tests and supplemented with findings from the content analysis of free-text comments. ResultsSixty-seven surgeons and 32 nurses attended. Self-confidence scores for all 10 questions increased after training [range of mean scores before 5.1–6.9 and after 6.9–8.2 (scale 0–10, all 95% confidence intervals are above 0 and all P-values <0.05)]. Awareness of hidden challenges of recruitment following training was high—surgeons' mean score 8.8 [standard deviation (SD), 1.2] and nurses' 8.4 (SD, 1.3) (scale 0–10); 50% (19/38) of surgeons and 40% (10/25) of nurses reported on a 4-point Likert scale that training had made “a lot” of difference to their RCT discussions. Analysis of free text revealed this was mostly in relation to how to convey equipoise, explain randomization, and manage treatment preferences. ConclusionSurgeons and research nurses reported increased self-confidence in discussing RCTs with patients, a raised awareness of hidden challenges and a positive impact on recruitment practice following QuinteT RCT Recruitment Training. Training will be made more available and evaluated in relation to recruitment rates and informed consent.

Evidence for strategies that improve recruitment and retention of adults aged 65 years and over in randomised trials and observational studies: a systematic review.

adults aged ≥65 years are often excluded from health research studies. Lack of representation reduces generalisability of treatments for this age group. to evaluate the effectiveness of strategies that improve recruitment and retention of adults aged ≥65 in observational studies and randomised controlled trials (RCTs). searches conducted in 10 databases for RCTs of recruitment and retention strategies in RCTs or observational studies. Two reviewers screened abstracts and full-text articles for eligibility and extracted data. Studies without separate data for adults aged ≥65 were discarded. Risk of bias assessed using the Cochrane Risk of Bias tool. Results were synthesised narratively. thirty-two studies were included in the review (n = 75,444). Twelve studies had low risk of bias, of which 10 had successful strategies including: Opt-out versus opt-in increased recruitment (13.6% (n = 261)-18.7% (n = 36) difference; two studies); Advance notification increased retention (1.6% difference, OR 1.45; 95% CI 1.01, 2.10, one study (n = 2,686); 9.1% difference at 4 months, 1.44; 1.08, 1.92, one study (n = 753)); Hand-delivered versus postal surveys increased response (25.1% difference; X2 = 11.40, P < 0.01; one study (n = 139)); Open randomised design versus blinded RCT increased recruitment (1.56; 1.05, 2.33) and retention (13.9% difference; 3.1%, 24.6%) in one study (n = 538). Risk of bias was high/unclear for studies in which incentives or shorter length questionnaires increased response. in low risk of bias studies, few of the strategies that improved participation in older adults had been tested in ≥1 study. Opt-out and advance notification strategies improved recruitment and retention, respectively, although an opt-out approach may have ethical limitations. Evidence from single studies limits the generalisability of other strategies.

Identifying the participant characteristics that predict recruitment and retention of participants to randomised controlled trials involving children: a systematic review.

BackgroundRandomised controlled trials (RCTs) are recommended as the ‘gold standard’ in evaluating health care interventions. The conduct of RCTs is often impacted by difficulties surrounding recruitment and retention of participants in both adult and child populations. Factors influencing recruitment and retention of children to RCTs can be more complex than in adults. There is little synthesised evidence of what influences participation in research involving parents and children.AimTo identify predictors of recruitment and retention in RCTs involving children.MethodsA systematic review of RCTs was conducted to synthesise the available evidence. An electronic search strategy was applied to four databases and restricted to English language publications. Quantitative studies reporting participant predictors of recruitment and retention in RCTs involving children aged 0–12 were identified. Data was extracted and synthesised narratively. Quality assessment of articles was conducted using a structured tool developed from two existing quality evaluation checklists.ResultsTwenty-eight studies were included in the review. Of the 154 participant factors reported, 66 were found to be significant predictors of recruitment and retention in at least one study. These were classified as parent, child, family and neighbourhood characteristics. Parent characteristics (e.g. ethnicity, age, education, socioeconomic status (SES)) were the most commonly reported predictors of participation for both recruitment and retention. Being young, less educated, of an ethnic minority and having low SES appear to be barriers to participation in RCTs although there was little agreement between studies. When analysed according to setting and severity of the child’s illness there appeared to be little variation between groups. The quality of the studies varied. Articles adhered well to reporting guidelines around provision of a scientific rationale for the study and background information as well as displaying good internal consistency of results. However, few studies discussed the external validity of the results or provided recommendations for future research.ConclusionParent characteristics may predict participation of children and their families to RCTs; however, there was a lack of consensus. Whilst sociodemographic variables may be useful in identifying which groups are least likely to participate they do not provide insight into the processes and barriers to participation for children and families. Further studies that explore variables that can be influenced are warranted. Reporting of studies in this field need greater clarity as well as agreed definitions of what is meant by retention.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1415-0) contains supplementary material, which is available to authorized users.

What does a good RCT recruitment consultation look like? A new simple six-step model to promote information sharing and recruitment to RCTs

Objective: The mode of delivery of trial information is a key determinant of recruitment to randomised controlled trials (RCTs), which can be modified in order to encourage patients to participate. This paper presents the development and initial validation of a simple six-step model to support recruitment. Study design and setting: 92 recruitment consultations with 60 new patients were recorded and analysed during a pilot RCT comparing surgical and non-surgical interventions for hip impingement. Recordings were analysed using techniques of thematic analysis and focused conversation analysis pioneered in previous studies. Analysis of recordings continued during the full-scale trial. Results: The pilot study was successful, with 70% of patients approached across 9 centres agreeing to take part in the RCT, and the full-scale trial has achieved 75% recruitment in 19 centres. A simple six-step model providing a framework for good recruitment practice was developed at the pilot phase and then validated, and tested in the main trial. The model enabled recruiters to explain the design and conduct of the RCT and provide reassuring information for patients in the context of consultations very different from routine practice. Conclusion: The six-step model provides a useful framework for recruitment to RCTs. It encourages the implementation of good RCT recruitment practice and provides strategies to support recruiters. The model requires further testing in a wide range of RCTs and clinical contexts.

A systematic review of training programmes for recruiters to randomised controlled trials

BackgroundRecruitment to randomised controlled trials (RCTs) is often difficult. Clinician related factors have been implicated as important reasons for low rates of recruitment. Clinicians (doctors and other health professionals) can experience discomfort with some underlying principles of RCTs and experience difficulties in conveying them positively to potential trial participants. Recruiter training has been suggested to address identified problems but a synthesis of this research is lacking. The aim of our study was to systematically review the available evidence on training interventions for recruiters to randomised trials.MethodsStudies that evaluated training programmes for trial recruiters were included. Those that provided only general communication training not linked to RCT recruitment were excluded. Data extraction and quality assessment were completed by two reviewers independently, with a third author where necessary.ResultsSeventeen studies of 9615 potentially eligible titles and abstracts were included in the review: three randomised controlled studies, two non-randomised controlled studies, nine uncontrolled pre-test/post-test studies, two qualitative studies, and a post-training questionnaire survey. Most studies were of moderate or weak quality. Training programmes were mostly set within cancer trials, and usually consisted of workshops with a mix of health professionals over one or two consecutive days covering generic and trial specific issues. Recruiter training programmes were well received and some increased recruiters’ self-confidence in communicating key RCT concepts to patients. There was, however, little evidence that this training increased actual recruitment rates or patient understanding, satisfaction, or levels of informed consent.ConclusionsThere is a need to develop recruiter training programmes that can lead to improved recruitment and informed consent in randomised trials.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-015-0908-6) contains supplementary material, which is available to authorized users.

Training recruiters to randomized trials to facilitate recruitment and informed consent by exploring patients' treatment preferences.

BackgroundPatients’ treatment preferences are often cited as barriers to recruitment in randomized controlled trials (RCTs). We investigated how RCT recruiters reacted to patients’ treatment preferences and identified key strategies to improve informed decision-making and trial recruitment.MethodsAudio-recordings of 103 RCT recruitment appointments with 96 participants in three UK multicenter pragmatic RCTs were analyzed using content and thematic analysis. Recruiters’ responses to expressed treatment preferences were assessed in one RCT (ProtecT - Prostate testing for cancer and Treatment) in which training on exploring preferences had been given, and compared with two other RCTs where this specific training had not been given.ResultsRecruiters elicited treatment preferences similarly in all RCTs but responses to expressed preferences differed substantially. In the ProtecT RCT, patients’ preferences were not accepted at face value but were explored and discussed at length in three key ways: eliciting and acknowledging the preference rationale, balancing treatment views, and emphasizing the need to keep an open mind and consider all treatments. By exploring preferences, recruiters enabled participants to become clearer about whether their views were robust enough to be sustained or were sufficiently weak that participation in the RCT became possible. Conversely, in the other RCTs, treatment preferences were often readily accepted without further discussion or understanding the reasoning behind them, suggesting that patients were not given the opportunity to fully consider all treatments and trial participation.ConclusionsRecruiters can be trained to elicit and address patients’ treatment preferences, enabling those who may not have considered trial participation to do so. Without specific guidance, some RCT recruiters are likely to accept initial preferences at face value, missing opportunities to promote more informed decision-making. Training interventions for recruiters that incorporate key strategies to manage treatment preferences, as in the ProtecT study, are required to facilitate recruitment and informed consent.Trial registrationProtecT RCT: Current Controlled Trials ISRCTN20141297. The other two trials are registered but have asked to be anonymized.