Dataset Information

Use of strategies to improve retention in primary care randomised trials: a qualitative study with in-depth interviews.

ABSTRACT:

Objective

To explore the strategies used to improve retention in primary care randomised trials.

Design

Qualitative in-depth interviews and thematic analysis.

Participants

29 UK primary care chief and principal investigators, trial managers and research nurses.

Methods

In-depth face-to-face interviews.

Results

Primary care researchers use incentive and communication strategies to improve retention in trials, but were unsure of their effect. Small monetary incentives were used to increase response to postal questionnaires. Non-monetary incentives were used although there was scepticism about the impact of these on retention. Nurses routinely used telephone communication to encourage participants to return for trial follow-up. Trial managers used first class post, shorter questionnaires and improved questionnaire designs with the aim of improving questionnaire response. Interviewees thought an open trial design could lead to biased results and were negative about using behavioural strategies to improve retention. There was consensus among the interviewees that effective communication and rapport with participants, participant altruism, respect for participant's time, flexibility of trial personnel and appointment schedules and trial information improve retention. Interviewees noted particular challenges with retention in mental health trials and those involving teenagers.

Conclusions

The findings of this qualitative study have allowed us to reflect on research practice around retention and highlight a gap between such practice and current evidence. Interviewees describe acting from experience without evidence from the literature, which supports the use of small monetary incentives to improve the questionnaire response. No such evidence exists for non-monetary incentives or first class post, use of which may need reconsideration. An exploration of barriers and facilitators to retention in other research contexts may be justified.

SUBMITTER: Brueton VC

PROVIDER: S-EPMC3902408 | biostudies-literature | 2014 Jan

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Use of strategies to improve retention in primary care randomised trials: a qualitative study with in-depth interviews.

Brueton V C VC Stevenson F F Vale C L CL Stenning S P SP Tierney J F JF Harding S S Nazareth I I Meredith S S Rait G G

BMJ open 20140124 1

<h4>Objective</h4>To explore the strategies used to improve retention in primary care randomised trials.<h4>Design</h4>Qualitative in-depth interviews and thematic analysis.<h4>Participants</h4>29 UK primary care chief and principal investigators, trial managers and research nurses.<h4>Methods</h4>In-depth face-to-face interviews.<h4>Results</h4>Primary care researchers use incentive and communication strategies to improve retention in trials, but were unsure of their effect. Small monetary ince ...[more]

PMID: 24464427

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Project description:ObjectiveTo quantify the effect of strategies to improve retention in randomised trials.DesignSystematic review and meta-analysis.Data sourcesSources searched: MEDLINE, EMBASE, PsycINFO, DARE, CENTRAL, CINAHL, C2-SPECTR, ERIC, PreMEDLINE, Cochrane Methodology Register, Current Controlled Trials metaRegister, WHO trials platform, Society for Clinical Trials (SCT) conference proceedings and a survey of all UK clinical trial research units.Review methodsIncluded trials were randomised evaluations of strategies to improve retention embedded within host randomised trials. The primary outcome was retention of trial participants. Data from trials were pooled using the fixed-effect model. Subgroup analyses were used to explore the heterogeneity and to determine whether there were any differences in effect by the type of strategy.Results38 retention trials were identified. Six broad types of strategies were evaluated. Strategies that increased postal questionnaire responses were: adding, that is, giving a monetary incentive (RR 1.18; 95% CI 1.09 to 1.28) and higher valued incentives (RR 1.12; 95% CI 1.04 to 1.22). Offering a monetary incentive, that is, an incentive given on receipt of a completed questionnaire, also increased electronic questionnaire response (RR 1.25; 95% CI 1.14 to 1.38). The evidence for shorter questionnaires (RR 1.04; 95% CI 1.00 to 1.08) and questionnaires relevant to the disease/condition (RR 1.07; 95% CI 1.01 to 1.14) is less clear. On the basis of the results of single trials, the following strategies appeared effective at increasing questionnaire response: recorded delivery of questionnaires (RR 2.08; 95% CI 1.11 to 3.87); a 'package' of postal communication strategies (RR 1.43; 95% CI 1.22 to 1.67) and an open trial design (RR 1.37; 95% CI 1.16 to 1.63). There is no good evidence that the following strategies impact on trial response/retention: adding a non-monetary incentive (RR=1.00; 95% CI 0.98 to 1.02); offering a non-monetary incentive (RR=0.99; 95% CI 0.95 to 1.03); 'enhanced' letters (RR=1.01; 95% CI 0.97 to 1.05); monetary incentives compared with offering prize draw entry (RR=1.04; 95% CI 0.91 to 1.19); priority postal delivery (RR=1.02; 95% CI 0.95 to 1.09); behavioural motivational strategies (RR=1.08; 95% CI 0.93 to 1.24); additional reminders to participants (RR=1.03; 95% CI 0.99 to 1.06) and questionnaire question order (RR=1.00, 0.97 to 1.02). Also based on single trials, these strategies do not appear effective: a telephone survey compared with a monetary incentive plus questionnaire (RR=1.08; 95% CI 0.94 to 1.24); offering a charity donation (RR=1.02, 95% CI 0.78 to 1.32); sending sites reminders (RR=0.96; 95% CI 0.83 to 1.11); sending questionnaires early (RR=1.10; 95% CI 0.96 to 1.26); longer and clearer questionnaires (RR=1.01, 0.95 to 1.07) and participant case management by trial assistants (RR=1.00; 95% CI 0.97 to 1.04).ConclusionsMost of the trials evaluated questionnaire response rather than ways to improve participants return to site for follow-up. Monetary incentives and offers of monetary incentives increase postal and electronic questionnaire response. Some strategies need further evaluation. Application of these results would depend on trial context and follow-up procedures.

Project description:OBJECTIVES:To develop best practice guidance for the use of retention strategies in randomized clinical trials (RCTs). STUDY DESIGN AND SETTING:Consensus development workshops conducted at two UK Clinical Trials Units. Sixty-six statisticians, clinicians, RCT coordinators, research scientists, research assistants, and data managers associated with RCTs participated. The consensus development workshops were based on the consensus development conference method used to develop best practice for treatment of medical conditions. Workshops commenced with a presentation of the evidence for incentives, communication, questionnaire format, behavioral, case management, and methodological retention strategies identified by a Cochrane review and associated qualitative study. Three simultaneous group discussions followed focused on (1) how convinced the workshop participants were by the evidence for retention strategies, (2) barriers to the use of effective retention strategies, (3) types of RCT follow-up that retention strategies could be used for, and (4) strategies for future research. Summaries of each group discussion were fed back to the workshop. Coded content for both workshops was compared for agreement and disagreement. Agreed consensus on best practice guidance for retention was identified. RESULTS:Workshop participants agreed best practice guidance for the use of small financial incentives to improve response to postal questionnaires in RCTs. Use of second-class post was thought to be adequate for postal communication with RCT participants. The most relevant validated questionnaire was considered best practice for collecting RCT data. Barriers identified for the use of effective retention strategies were: the small improvements seen in questionnaire response for the addition of monetary incentives, and perceptions among trialists that some communication strategies are outdated. Furthermore, there was resistance to change existing retention practices thought to be effective. Face-to-face and electronic follow-up technologies were identified as retention strategies for further research. CONCLUSIONS:We developed best practice guidance for the use of retention strategies in RCTs and identified potential barriers to the use of effective strategies. The extent of agreement on best practice is limited by the variability in the currently available evidence. This guidance will need updating as new retention strategies are developed and evaluated.

Project description:Background Retention of participants is essential to ensure the statistical power and internal validity of clinical trials. Poor participant retention reduces power and can bias the estimates of intervention effect. There is sparse evidence from randomised comparisons of effective strategies to retain participants in randomised trials. Currently, non-randomised evaluations of trial retention interventions embedded in host clinical trials are rejected from the Cochrane review of strategies to improve retention because it only included randomised evaluations. However, the systematic assessment of non-randomised evaluations may inform trialists’ decision-making about retention methods that have been evaluated in a trial context.Therefore, we performed a systematic review to synthesise evidence from non-randomised evaluations of retention strategies in order to supplement existing randomised trial evidence. Methods We searched MEDLINE, EMBASE, and Cochrane CENTRAL from 2007 to October 2017. Two reviewers independently screened abstracts and full-text articles for non-randomised studies that compared two or more strategies to increase participant retention in randomised trials. The retention trials had to be nested in real ‘host’ trials ( including feasibility studies) but not hypothetical trials. Two investigators independently rated the risk of bias of included studies using the ROBINS-I tool and determined the certainty of evidence using GRADE (Grading of Recommendations Assessment, Development and Evaluation) framework. Results Fourteen non-randomised studies of retention were included in this review. Most retention strategies (in 10 studies) aimed to increase questionnaire response rate. Favourable strategies for increasing questionnaire response rate were telephone follow-up compared to postal questionnaire completion, online questionnaire follow-up compared to postal questionnaire, shortened version of questionnaires versus longer questionnaires, electronically transferred monetary incentives compared to cash incentives, cash compared with no incentive and reminders to non-responders (telephone or text messaging). However, each retention strategy was evaluated in a single observational study. This, together with risk of bias concerns, meant that the overall GRADE certainty was low or very low for all included studies. Conclusions This systematic review provides low or very low certainty evidence on the effectiveness of retention strategies evaluated in non-randomised studies. Some strategies need further evaluation to provide confidence around the size and direction of the underlying effect.

Project description:Randomised control trials are regarded as the gold standard for evaluating the effectiveness and efficacy of healthcare interventions with thousands of trials published every year. Despite significant investment in infrastructure, a staggering number of clinical trials continue to face challenges with retention. Dropouts could lead to negative consequences-from lengthy delays to missing data that can undermine the results and integrity of the trial. Summarising evidence from non-randomised evaluations of retention strategies could provide complementary information to randomised evaluations that could guide trialists to the most effective ways of increasing retention of participants in clinical trials.The following electronic databases will be searched for relevant studies: EMBASE, MEDLINE, the Cochrane Controlled Trials Register, and Cochrane Methodology Register and the search will be limited to English-published studies during the last 10 years to increase relevance to current trials. Non-randomised studies (observational studies) including a comparison of two or more strategies to increase participant retention in randomised trials or comparing one or more strategies with no strategy will be included. The primary outcome will be the proportion of participants remained at the primary analysis as determined in each retention study.This review aims to gather and evaluate evidence on the effect of retention strategies examined in non-randomised studies. It is imperative to collect evidence from obseravational studies to infer whether or not these studies could be considered a practical way to complement or even replace a broadly favourable randomised design. If we find that non-randomised studies to be included in this review are of high quality with adequate control of biases, we will recommend to trialists and others not to rely exclusively on randomised studies and to give meticulous attention to the plentiful evidence that can be obtained from non-randomised studies. Should the results of this review suggest that evaluating retention strategies in observational studies provides insufficient evidence to trialists planning their retention strategies, we will be able to say that there is little point in conducting non-randomised studies and that they would do better to invest their time and resources in a randomised evaluation if possible. Where a non-randomised study design is chosen, the review authors will offer recommendations to trialists and others regarding how to ensure that these studies are conducted in a way that can minimise the risk of bias and increase confidence in the findings.PROSPERO 2017: CRD42017072775 .

Project description:ObjectivesTo systematically review published pretrial qualitative research studies and explore how their findings were used to inform recruitment and retention processes in full-scale trials.DesignQualitative evidence synthesis using thematic analysis.Data sources and eligibility criteriaWe conducted a comprehensive search of databases; Dissertation Abstracts International, CINAHL, Embase, MEDLINE, Sociological Abstracts and PsycINFO. We included all reports of pretrial qualitative data on recruitment and retention in clinical trials up to March 2018.Data extraction and synthesisTwo authors independently extracted data using a predefined data extraction form that captured study aims, design, methodological approach and main findings, including barriers and facilitators to recruitment and or retention. The synthesis was undertaken using Thomas and Harden's thematic synthesis method and reported following the Enhancing Transparency in Reporting the Synthesis of Qualitative Research guidelines. Confidence was assessed using Grading of Recommendations Assessment, Development and Evaluation-Confidence in the Evidence from Reviews of Qualitative research approach.ResultsThirty-five papers (connected to 31 feasibility studies) from three different countries, published between 2010 and 2017 were included. All studies were embedded in pilot or feasibility studies to inform design aspects in preparation for a subsequent full-scale trial. Twelve themes were identified as recruitment barriers and three as recruitment facilitators. Two themes were identified as barriers for retention and none as retention facilitators. The findings from qualitative research in feasibility or pilot trials are often not explicitly linked to proposed changes to the recruitment and retention strategies to be used in the future or planned full-scale trial.ConclusionsMany trial teams do pretrial qualitative work with the aim of improving recruitment and retention in future full-scale trials. Just over half of all reports of such work do not clearly show how their findings will change the recruitment and retention strategy of the future trial. The scope of pretrial work needs to expand beyond looking for problems and also look for what might help and spend more time on retention.

Project description:Search strategies for systematic reviews aim to identify all evidence relevant to the research question posed. Reports of methodological research can be difficult to find leading to biased results in systematic reviews of research methodology. Evidence suggests that contact with investigators can help to identify unpublished research. To identify additional eligible randomised controlled trials (RCTs) for a Cochrane systematic review of strategies to improve retention in RCTs, we conducted a survey of UK clinical trials units (CTUs) and made contact with RCT methodologists.Key contacts for all UK CTUs were sent a personalised email with a short questionnaire and summary protocol of the Cochrane methodology review. The questionnaire asked whether a RCT evaluating strategies to improve retention embedded in a RCT had ever been conducted by the CTU. Questions about the stage of completion and publication of such RCTs were included. The summary protocol outlined the aims, eligibility criteria, examples of types of retention strategies, and the primary outcome for the systematic review. Personal communication with RCT methodologists and presentations of preliminary results of the review at conferences were also used to identify additional eligible RCTs. We checked the results of our standard searches to see if eligible studies identified through these additional methods were also found using our standard searches.We identified 14 of the 38 RCTs included in the Cochrane methodology review by contacting trials units and methodologists. Eleven of the 14 RCTs identified by these methods were either published in grey literature, in press or unpublished. Three remaining RCTs were fully published at the time. Six of the RCTs identified were not found through any other searches. The RCTs identified represented data for 6 of 14 RCTs of incentive strategies (52% of randomised participants included in the review), and 6 of 14 RCTs of communication strategies (52% of randomised participants included in the Cochrane review). Data were unavailable for two of the RCTs identified.Methodological evaluations embedded in RCTs may be unpublished, published in the grey literature or where published, poorly indexed in bibliographic databases. To identify such studies and minimise selection bias in systematic reviews of methodological evaluations, reviewers should consider contacting CTUs and trial methodologists.

Project description:BackgroundRacial and ethnic minority groups are underrepresented in health research, contributing to persistent health disparities in the United States. Identifying effective recruitment and retention strategies among minority groups and their subpopulations is an important research agenda. Web-based intervention approaches are becoming increasingly popular with the ubiquitous use of the internet. However, it is not completely clear which recruitment and retention strategies have been successful in web-based intervention trials targeting racial and ethnic minorities.ObjectiveThis study aims to describe lessons learned in recruiting and retaining one of the understudied ethnic minority women-Korean Americans-enrolled in a web-based intervention trial and to compare our findings with the strategies reported in relevant published web-based intervention trials.MethodsMultiple sources of data were used to address the objectives of this study, including the study team's meeting minutes, participant tracking and contact logs, survey reports, and postintervention interviews. In addition, an electronic search involving 2 databases (PubMed and CINAHL) was performed to identify published studies using web-based interventions. Qualitative analysis was then performed to identify common themes addressing recruitment and retention strategies across the trials using web-based intervention modalities.ResultsA total of 9 categories of recruitment and retention strategies emerged: authentic care; accommodation of time, place, and transportation; financial incentives; diversity among the study team; multiple, yet standardized modes of communication; mobilizing existing community relationships with efforts to build trust; prioritizing features of web-based intervention; combined use of web-based and direct recruitment; and self-directed web-based intervention with human support. Although all the studies included in the analysis combined multiple strategies, prioritizing features of web-based intervention or use of human support were particularly relevant for promoting recruitment and retention of racial and ethnic minorities in web-based intervention trials.ConclusionsThe growing prevalence of internet use among racial and ethnic minority populations represents an excellent opportunity to design and deliver intervention programs via the internet. Future research should explore and compare successful recruitment and retention methods among race and ethnic groups for web-based interventions.Trial registrationClinicalTrials.gov NCT03726619; https://clinicaltrials.gov/ct2/show/NCT03726619.

Dataset Information

Use of strategies to improve retention in primary care randomised trials: a qualitative study with in-depth interviews.

Objective

Design

Participants

Methods

Results

Conclusions

Publications

Use of strategies to improve retention in primary care randomised trials: a qualitative study with in-depth interviews.

Similar Datasets

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