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      Increasing recruitment to randomised trials: a review of randomised controlled trials

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      1 , , 1
      BMC Medical Research Methodology
      BioMed Central

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          Abstract

          Background

          Poor recruitment to randomised controlled trials (RCTs) is a widespread and important problem. With poor recruitment being such an important issue with respect to the conduct of randomised trials, a systematic review of controlled trials on recruitment methods was undertaken in order to identify strategies that are effective.

          Methods

          We searched the register of trials in Cochrane library from 1996 to end of 2004. We also searched Web of Science for 2004. Additional trials were identified from personal knowledge. Included studies had to use random allocation and participants had to be allocated to different methods of recruitment to a 'real' randomised trial. Trials that randomised participants to 'mock' trials and trials of recruitment to non-randomised studies (e.g., case control studies) were excluded. Information on the study design, intervention and control, and number of patients recruited was extracted by the 2 authors.

          Results

          We identified 14 papers describing 20 different interventions. Effective interventions included: telephone reminders; questionnaire inclusion; monetary incentives; using an 'open' rather than placebo design; and making trial materials culturally sensitive.

          Conclusion

          Few trials have been undertaken to test interventions to improve trial recruitment. There is an urgent need for more RCTs of recruitment strategies.

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          Most cited references25

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          Understanding controlled trials: What is a patient preference trial?

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            Understanding controlled trials. What is a patient preference trial?

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              Patient preferences in randomised trials: threat or opportunity?

              To assess whether it is feasible to elicit patients' preferences for treatments and then to proceed with randomisation which may allocate those with preferences to their less preferred treatment; and to describe which prognostic variables were associated with such preferences within the context of a randomised trial of an exercise programme for back pain. The first 97 patients enrolled in a randomised controlled trial (RCT) for the treatment of back pain were asked about their preferences, health characteristics and other prognostic variables. Fifty-eight (60%) patients preferred to be allocated to the exercise programme whilst 38 (39%) were indifferent; one patient preferred conventional general practitioner (GP) management. No patient refused randomisation. Comparing patients preferring the exercise programme with indifferent patients showed that the former had a higher belief in the effectiveness of the new treatment (P < 0.01), tended to have worse back pain (P = 0.09), had back pain for a shorter duration (P = 0.04), and tended to have had more GP home visits (P = 0.06). For many randomised trials preference may be an important prognostic variable. In such circumstances, preference should be taken into account in the final analysis. This study demonstrates it is sometimes feasible to randomise patients to their less preferred treatment, thus allowing more robust statistical comparisons between randomised groups. This modification may make RCTs more rigorous and improve their external validity.
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                Author and article information

                Journal
                BMC Med Res Methodol
                BMC Medical Research Methodology
                BioMed Central (London )
                1471-2288
                2006
                19 July 2006
                : 6
                : 34
                Affiliations
                [1 ]York Trials Unit, Department of Health Sciences, University of York, York, YO10 5DD, UK
                Article
                1471-2288-6-34
                10.1186/1471-2288-6-34
                1559709
                16854229
                e5a83be4-3a09-4cc2-9b4d-74a2aa7c8a94
                Copyright © 2006 Watson and Torgerson; licensee BioMed Central Ltd.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 31 March 2006
                : 19 July 2006
                Categories
                Research Article

                Medicine
                Medicine

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