Methods to improve recruitment to randomised controlled trials : Cochrane systematic review and meta-analysis

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Primary care research network progress in Scotland

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Networking Four years of TayRen, a primary care research and development network

Tayside's Primary Care Research and Development Network (TayRen) was awarded £140K per annum for 4 years from 1998 by the Scottish Office Department of Health. The operating model of TayRen is described and the outcomes highlighted. A multi-professional, multidisciplinary, methodologically rigorous and locally responsive approach has contributed to the outcomes achieved. The network has enabled practitioners to gain research experience by working with more experienced colleagues. The research culture of Tayside has matured since the formation of TayRen as evidenced by the increased number of research practices (six), training fellowships (three), registration for higher degrees (18), grants (£3.9m) and publications (96). In conclusion, TayRen has increased research activity in primary care in Tayside.</p

Networking Four years of TayRen, a primary care research and development network

Tayside's Primary Care Research and Development Network (TayRen) was awarded £140K per annum for 4 years from 1998 by the Scottish Office Department of Health. The operating model of TayRen is described and the outcomes highlighted. A multi-professional, multidisciplinary, methodologically rigorous and locally responsive approach has contributed to the outcomes achieved. The network has enabled practitioners to gain research experience by working with more experienced colleagues. The research culture of Tayside has matured since the formation of TayRen as evidenced by the increased number of research practices (six), training fellowships (three), registration for higher degrees (18), grants (£3.9m) and publications (96). In conclusion, TayRen has increased research activity in primary care in Tayside.</p

Primary care research network progress in Scotland

Many developed industrialized countries perceive considerable value in developing practice based research networks. In this paper, the development of the Scottish Primary Care Research Network (SPCRN) from 1924–2013 is described. After a false start in the early twentieth century and some local developments 10–15 years ago, the Scottish Primary Care Research Network was finally built upon existing networks of teaching and training practices centred on research active departments of general practice and primary care. This meant that a climate already favourable to research existed and several of the necessary skills were available. Long-term funding commitment to the network by the National Health Service meant that the infrastructure could be developed in the knowledge that it would be likely to become incorporated into wider Scottish and UK systems. Two-thirds of Scottish practices regularly participate in research at a rate of 50–60 studies each year, which result in a range of publications that influence clinical decisions and health policy. As the success of the network grows, greater demands are placed upon it, and the capacity of practices to continue to engage in research may be tested

Strategies to improve recruitment to randomised trials

BackgroundRecruiting participants to trials can be extremely difficult. Identifying strategies that improve trial recruitment would benefit both trialists and health research.ObjectivesTo quantify the effects of strategies for improving recruitment of participants to randomised trials. A secondary objective is to assess the evidence for the effect of the research setting (e.g. primary care versus secondary care) on recruitment.Search methodsWe searched the Cochrane Methodology Review Group Specialised Register (CMR) in the Cochrane Library (July 2012, searched 11 February 2015); MEDLINE and MEDLINE In Process (OVID) (1946 to 10 February 2015); Embase (OVID) (1996 to 2015 Week 06); Science Citation Index &amp; Social Science Citation Index (ISI) (2009 to 11 February 2015) and ERIC (EBSCO) (2009 to 11 February 2015).Selection criteriaRandomised and quasi-randomised trials of methods to increase recruitment to randomised trials. This includes non-healthcare studies and studies recruiting to hypothetical trials. We excluded studies aiming to increase response rates to questionnaires or trial retention and those evaluating incentives and disincentives for clinicians to recruit participants.Data collection and analysisWe extracted data on: the method evaluated; country in which the study was carried out; nature of the population; nature of the study setting; nature of the study to be recruited into; randomisation or quasi-randomisation method; and numbers and proportions in each intervention group. We used a risk difference to estimate the absolute improvement and the 95% confidence interval (CI) to describe the effect in individual trials. We assessed heterogeneity between trial results. We used GRADE to judge the certainty we had in the evidence coming from each comparison.Main resultsWe identified 68 eligible trials (24 new to this update) with more than 74,000 participants. There were 63 studies involving interventions aimed directly at trial participants, while five evaluated interventions aimed at people recruiting participants. All studies were in health care.We found 72 comparisons, but just three are supported by high-certainty evidence according to GRADE.1. Open trials rather than blinded, placebo trials. The absolute improvement was 10% (95% CI 7% to 13%).2. Telephone reminders to people who do not respond to a postal invitation. The absolute improvement was 6% (95% CI 3% to 9%). This result applies to trials that have low underlying recruitment. We are less certain for trials that start out with moderately good recruitment (i.e. over 10%).3. Using a particular, bespoke, user-testing approach to develop participant information leaflets. This method involved spending a lot of time working with the target population for recruitment to decide on the content, format and appearance of the participant information leaflet. This made little or no difference to recruitment: absolute improvement was 1% (95% CI −1% to 3%).We had moderate-certainty evidence for eight other comparisons; our confidence was reduced for most of these because the results came from a single study. Three of the methods were changes to trial management, three were changes to how potential participants received information, one was aimed at recruiters, and the last was a test of financial incentives. All of these comparisons would benefit from other researchers replicating the evaluation. There were no evaluations in paediatric trials.We had much less confidence in the other 61 comparisons because the studies had design flaws, were single studies, had very uncertain results or were hypothetical (mock) trials rather than real ones.Authors' conclusionsThe literature on interventions to improve recruitment to trials has plenty of variety but little depth. Only 3 of 72 comparisons are supported by high-certainty evidence according to GRADE: having an open trial and using telephone reminders to non-responders to postal interventions both increase recruitment; a specialised way of developing participant information leaflets had little or no effect. The methodology research community should improve the evidence base by replicating evaluations of existing strategies, rather than developing and testing new ones

Strategies to improve recruitment to randomised controlled trials

Background: Recruiting participants to trials can be extremely difficult. Identifying strategies that improve trial recruitment would benefit both trialists and health research. Objectives: To quantify the effects of strategies to improve recruitment of participants to randomised controlled trials. Search strategy: We searched the Cochrane Methodology Review Group Specialised Register - CMR (The Cochrane Library (online) Issue 1 2008) (searched 20 February 2008); MEDLINE, Ovid (1950 to date of search) (searched 06 May 2008); EMBASE, Ovid (1980 to date of search) (searched 16 May 2008); ERIC, CSA (1966 to date of search) (searched 19 March 2008); Science Citation Index Expanded, ISI Web of Science (1975 to date of search) (searched 19 March 2008); Social Sciences Citation Index, ISI Web of Science (1975 to date of search) (searched 19 March 2008); and National Research Register (online) (Issue 3 2007) (searched 03 September 2007); C2-SPECTR (searched 09 April 2008). We also searched PubMed (25 March 2008) to retrieve "related articles" for 15 studies included in a previous version of this review. Selection criteria: Randomised and quasi-randomised controlled trials of methods to increase recruitment to randomised controlled trials. This includes non-healthcare studies and studies recruiting to hypothetical trials. Studies aiming to increase response rates to questionnaires or trial retention, or which evaluated incentives and disincentives for clinicians to recruit patients were excluded. Data collection and analysis: Data were extracted on the method evaluated; country in which the study was carried out; nature of the population; nature of the study setting; nature of the study to be recruited into; randomisation or quasi-randomisation method; and numbers and proportions in each intervention group. We used risk ratios and their 95% confidence intervals to describe the effects in individual trials, and assessed heterogeneity of these ratios between trials. Main results: We identified 27 eligible trials with more than 26,604 participants. There were 24 studies involving interventions aimed directly at trial participants, while three evaluated interventions aimed at people recruiting participants. All studies were in health care. Some interventions were effective in increasing recruitment: telephone reminders to non-respondents (RR 2.66, 95% CI 1.37 to 5.18), use of opt-out, rather than opt-in, procedures for contacting potential trial participants (RR 1.39, 95% CI 1.06 to 1.84) and open designs where participants know which treatment they are receiving in the trial (RR 1.25, 95% CI 1.18 to 1.34). However, some of these strategies have disadvantages, which may limit their widespread use. For example, opt-out procedures are controversial and open designs are by definition unblinded. The effects of many other recruitment strategies are unclear; examples include the use of video to provide trial information to potential participants and modifying the training of recruiters. Many studies looked at recruitment to hypothetical trials and it is unclear how applicable these results are to real trials. Authors' conclusions: Trialists can increase recruitment to their trials by using the strategies shown to be effective in this review: telephone reminders; use of opt-out, rather than opt-in; procedures for contacting potential trial participants and open designs. Some strategies (e. g. open trial designs) need to be considered carefully before use because they also have disadvantages. For example, opt-out procedures are controversial and open designs are by definition unblinded.</p