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      Trials need participants but not their feedback? A scoping review of published papers on the measurement of participant experience of taking part in clinical trials

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          Abstract

          Background

          Participant recruitment and retention are long-standing problems in clinical trials. Although there are a large number of factors impacting on recruitment and retention, some of the problems may reflect the fact that trial design and delivery is not sufficiently ‘patient-centred’ (i.e., sensitive to patient needs and preferences). Most trials collect process and outcome measures, but it is unclear whether patient experience of trial participation itself is routinely measured. We conducted a structured scoping review of studies reporting standardised assessment of patient experience of participation in a trial.

          Methods

          A structured search of Medline, PsycINFO, Embase and CINAHL (Cumulative Index to Nursing and Allied Health Literature) and hand searching of included studies were conducted in 2016. Additional sources included policy documents, relevant websites and experts. We extracted data on trial context (type, date and location) and measure type (number of items and mode of administration), patient experience domains measured, and the results reported. We conducted a narrative synthesis.

          Results

          We identified 22 journal articles reporting on 21 different structured measures of participant experience in trials. None of the studies used a formal definition of patient experience. Overall, patients reported relatively high levels of global satisfaction with the trial process as well as positive outcomes (such as the likelihood of future participation or recommendation of the trial to others).

          Conclusions

          Current published evidence is sparse. Standardised assessment of patient experience of trial participation may provide opportunities for researchers to enhance trial design and delivery. This could complement other methods of enhancing the patient-centredness of trials and might improve recruitment, retention, and long-term patient engagement with trials.

          Electronic supplementary material

          The online version of this article (10.1186/s13063-019-3444-y) contains supplementary material, which is available to authorized users.

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          Most cited references37

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          What influences recruitment to randomised controlled trials? A review of trials funded by two UK funding agencies

          Background A commonly reported problem with the conduct of multicentre randomised controlled trials (RCTs) is that recruitment is often slower or more difficult than expected, with many trials failing to reach their planned sample size within the timescale and funding originally envisaged. The aim of this study was to explore factors that may have been associated with good and poor recruitment in a cohort of multicentre trials funded by two public bodies: the UK Medical Research Council (MRC) and the Health Technology Assessment (HTA) Programme. Methods The cohort of trials was identified from the administrative databases held by the two funding bodies. 114 trials that recruited participants between 1994 and 2002 met the inclusion criteria. The full scientific applications and subsequent trial reports submitted by the trial teams to the funders provided the principal data sources. Associations between trial characteristics and recruitment success were tested using the Chi-squared test, or Fisher's exact test where appropriate. Results Less than a third (31%) of the trials achieved their original recruitment target and half (53%) were awarded an extension. The proportion achieving targets did not appear to improve over time. The overall start to recruitment was delayed in 47 (41%) trials and early recruitment problems were identified in 77 (63%) trials. The inter-relationship between trial features and recruitment success was complex. A variety of strategies were employed to try to increase recruitment, but their success could not be assessed. Conclusion Recruitment problems are complex and challenging. Many of the trials in the cohort experienced recruitment difficulties. Trials often required extended recruitment periods (sometimes supported by additional funds). While this is of continuing concern, success in addressing the trial question may be more important than recruitment alone.
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            Increasing response rates to postal questionnaires: systematic review.

            To identify methods to increase response to postal questionnaires. Systematic review of randomised controlled trials of any method to influence response to postal questionnaires. 292 randomised controlled trials including 258 315 participants INTERVENTION REVIEWED: 75 strategies for influencing response to postal questionnaires. The proportion of completed or partially completed questionnaires returned. The odds of response were more than doubled when a monetary incentive was used (odds ratio 2.02; 95% confidence interval 1.79 to 2.27) and almost doubled when incentives were not conditional on response (1.71; 1.29 to 2.26). Response was more likely when short questionnaires were used (1.86; 1.55 to 2.24). Personalised questionnaires and letters increased response (1.16; 1.06 to 1.28), as did the use of coloured ink (1.39; 1.16 to 1.67). The odds of response were more than doubled when the questionnaires were sent by recorded delivery (2.21; 1.51 to 3.25) and increased when stamped return envelopes were used (1.26; 1.13 to 1.41) and questionnaires were sent by first class post (1.12; 1.02 to 1.23). Contacting participants before sending questionnaires increased response (1.54; 1.24 to 1.92), as did follow up contact (1.44; 1.22 to 1.70) and providing non-respondents with a second copy of the questionnaire (1.41; 1.02 to 1.94). Questionnaires designed to be of more interest to participants were more likely to be returned (2.44; 1.99 to 3.01), but questionnaires containing questions of a sensitive nature were less likely to be returned (0.92; 0.87 to 0.98). Questionnaires originating from universities were more likely to be returned than were questionnaires from other sources, such as commercial organisations (1.31; 1.11 to 1.54). Health researchers using postal questionnaires can improve the quality of their research by using the strategies shown to be effective in this systematic review.
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              A reinvestigation of recruitment to randomised, controlled, multicenter trials: a review of trials funded by two UK funding agencies

              Background Randomised controlled trials (RCTs) are the gold standard assessment for health technologies. A key aspect of the design of any clinical trial is the target sample size. However, many publicly-funded trials fail to reach their target sample size. This study seeks to assess the current state of recruitment success and grant extensions in trials funded by the Health Technology Assessment (HTA) program and the UK Medical Research Council (MRC). Methods Data were gathered from two sources: the National Institute for Health Research (NIHR) HTA Journal Archive and the MRC subset of the International Standard Randomised Controlled Trial Number (ISRCTN) register. A total of 440 trials recruiting between 2002 and 2008 were assessed for eligibility, of which 73 met the inclusion criteria. Where data were unavailable from the reports, members of the trial team were contacted to ensure completeness. Results Over half (55%) of trials recruited their originally specified target sample size, with over three-quarters (78%) recruiting 80% of their target. There was no evidence of this improving over the time of the assessment. Nearly half (45%) of trials received an extension of some kind. Those that did were no more likely to successfully recruit. Trials with 80% power were less likely to successfully recruit compared to studies with 90% power. Conclusions While recruitment appears to have improved since 1994 to 2002, publicly-funded trials in the UK still struggle to recruit to their target sample size, and both time and financial extensions are often requested. Strategies to cope with such problems should be more widely applied. It is recommended that where possible studies are planned with 90% power.
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                Author and article information

                Contributors
                claire.planner@manchester.ac.uk
                peter.bower@manchester.ac.uk
                ailsadonnelly@gmail.com
                k.gillies@abdn.ac.uk
                katrina.turner@bristol.ac.uk
                bridget.young@liverpool.ac.uk
                Journal
                Trials
                Trials
                Trials
                BioMed Central (London )
                1745-6215
                24 June 2019
                24 June 2019
                2019
                : 20
                Affiliations
                [1 ]ISNI 0000000121662407, GRID grid.5379.8, NIHR School for Primary Care Research, Centre for Primary Care and Health Services Research, , University of Manchester, ; 5th Floor Williamson Building, Manchester, M13 9PL UK
                [2 ]ISNI 0000 0004 1936 8470, GRID grid.10025.36, North West Hub for Trials Methodology Research, Block F Waterhouse Building, , University of Liverpool, ; 1-5 Brownlow Street, Liverpool, L69 3GL UK
                [3 ]ISNI 0000 0004 1936 7291, GRID grid.7107.1, Health Services Research Unit, , University of Aberdeen, ; 3rd Floor, Health Sciences Building, Aberdeen, AB25 2ZD UK
                [4 ]ISNI 0000 0004 1936 7603, GRID grid.5337.2, Population Health Sciences, , University of Bristol, ; Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS UK
                [5 ]ISNI 0000 0004 1936 8470, GRID grid.10025.36, Department of Health Services Research, Institute of Population Health Sciences, , University of Liverpool, ; Liverpool, L69 3GL UK
                Article
                3444
                10.1186/s13063-019-3444-y
                6591815
                31234945
                36c2c429-91a3-463c-8707-dd9a4aca6e42
                © The Author(s). 2019

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                Funding
                Funded by: School for Primary Care Research
                Funded by: MRC Hub for Trials Methodology
                Categories
                Review
                Custom metadata
                © The Author(s) 2019

                Medicine

                trial, participation, patient experience, patient satisfaction, patient-centred trials

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