Guidelines for reporting embedded recruitment trials

Vichithranie W Madurasinghe, Sandra Eldridge on behalf of MRC START Group and Gordon Forbes on behalf of the START Expert Consensus Group, Vichithranie W Madurasinghe, Sandra Eldridge on behalf of MRC START Group and Gordon Forbes on behalf of the START Expert Consensus Group

Abstract

Background: Recruitment to clinical trials is difficult with many trials failing to recruit to target and within time. Embedding trials of recruitment interventions within host trials may provide a successful way to improve this. There are no guidelines for reporting such embedded methodology trials. As part of the Medical Research Council funded Systematic Techniques for Assisting Recruitment to Trials (MRC START) programme designed to test interventions to improve recruitment to trials, we developed guidelines for reporting embedded trials.

Methods: We followed a three-phase guideline development process: (1) pre-meeting literature review to generate items for the reporting guidelines; (2) face-to-face consensus meetings to draft the reporting guidelines; and (3) post-meeting feedback review, and pilot testing, followed by finalisation of the reporting guidelines.

Results: We developed a reporting checklist based on the Consolidated Standards for Reporting Trials (CONSORT) statement 2010. Embedded trials evaluating recruitment interventions should follow the CONSORT statement 2010 and report all items listed as essential. We used a number of examples to illustrate key issues that arise in embedded trials and how best to report them, including (a) how to deal with description of the host trial; (b) the importance of describing items that may differ in the host and embedded trials (such as the setting and the eligible population); and (c) the importance of identifying clearly the point at which the recruitment interventions were embedded in the host trial.

Conclusions: Implementation of these guidelines will improve the quality of reports of embedded recruitment trials while advancing the science, design and conduct of embedded trials as a whole.

Figures

Fig. 1
Fig. 1
Example abstract for an embedded recruitment trial [17]
Fig. 2
Fig. 2
Flow chart illustrating intervention and control sites and route of additional communication strategy
Fig. 3
Fig. 3
A flow chart illustrating the focal point(s) of the host trial recruitment pathway targeted by embedded recruitment trial interventions
Fig. 4
Fig. 4
Recruitment flowchart
Fig. 5
Fig. 5
Recruitment flowchart
Fig. 6
Fig. 6
Recruitment flowchart
Fig. 7
Fig. 7
CONSORT diagram showing the flow of participants through each stage of the randomised trial (enrolment, intervention allocation, follow-up and data analysis)

References

    1. McDonald AM, Knight RC, Campbell MK, Entwistle VA, Grant AM, Cook JA, et al. What influences recruitment to randomised controlled trials? A review of trials funded by two UK funding agencies. Trials. 2006;7:9. doi: 10.1186/1745-6215-7-9.
    1. Sully BGO, Julious SA, Nicholl J. A reinvestigation of recruitment to randomised, controlled, multicenter trials: a review of trials funded by two UK funding agencies. Trials. 2013;14:166. doi: 10.1186/1745-6215-14-166.
    1. Treweek S, Lockhart P, Pitkethly M, Cook JA, Kjeldstrøm M, Johansen M, et al. Methods to improve recruitment to randomised controlled trials: Cochrane systematic review and meta-analysis. BMJ Open. 2013;3:e002360. doi: 10.1136/bmjopen-2012-002360.
    1. Watson JM, Torgerson DJ. Increasing recruitment to randomised trials: a review of randomised controlled trials. BMC Med Res Methodol. 2006;6:34. doi: 10.1186/1471-2288-6-34.
    1. Bonevski B, Randell M, Paul C, Chapman K, Twyman L, Bryant J, et al. Reaching the hard-to-reach: a systematic review of strategies for improving health and medical research with socially disadvantaged groups. BMC Med Res Methodol. 2014;14:42. doi: 10.1186/1471-2288-14-42.
    1. Campbell MK, Snowdon C, Francis D, Elbourne D, McDonald AM, Knight R, et al. Recruitment to randomised trials: strategies for trial enrolment and participation study. The STEPS study. Health Technol Assess. 2007;11(48):iii. doi: 10.3310/hta11480.
    1. Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c869. doi: 10.1136/bmj.c869.
    1. Caldwell PHY, Hamilton S, Tan A, Craig JC. Strategies for increasing recruitment to randomised controlled trials: systematic review. Boutron I, ed. PLoS Med. 2010;7(11):e1000368. doi: 10.1371/journal.pmed.1000368.
    1. Rick J, Bower P, Collier D, Eldridge S, Graffy J, Kennedy A, et al. Systematic techniques for assisting recruitment to trials (START): developing the science of recruitment. Trials. 2013;14 Suppl 1:O61. doi: 10.1186/1745-6215-14-S1-O61.
    1. Moher D, Schulz KF, Simera I, Altman DG. Guidance for developers of health research reporting guidelines. PLoS Med. 2010;7(2):e1000217. doi: 10.1371/journal.pmed.1000217.
    1. Treweek S, Barnett K, MacLennan G, Bonetti D, Eccles MP, Francis JJ, et al. E-mail invitations to general practitioners were as effective as postal invitations and were more efficient. J Clin Epidemiol. 2012;65(7):793–7. ISSN 0895–4356. . Accessed 16 April 2013.
    1. Schulz KF, Altman DG, Moher D, for the CONSORT Group CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c332. doi: 10.1136/bmj.c332.
    1. Man M-S, on behalf of the Healthlines Study Group. Rick J, Bower P, on behalf of the MRC-START Group Improving recruitment to a study of telehealth management for long-term conditions in primary care: two embedded, randomised controlled trials of optimised patient information materials. Trials. 2015;16:309. doi: 10.1186/s13063-015-0820-0.
    1. Brueton VC, Tierney J, Stenning S, Harding S, Meredith S, Nazareth I, et al. Strategies to improve retention in randomised trials. Cochrane Database of Systematic Reviews. 2013; Issue 12. Art. No.: MR000032. doi:10.1002/14651858.MR000032.pub2.
    1. Edwards PJ, Roberts I, Clarke MJ, DiGuiseppi C, Wentz R, Kwan I, et al. Methods to increase response to postal and electronic questionnaires. Cochrane Database of Systematic Reviews. 2009;Issue 3. Art. No.: MR000008. doi:10.1002/14651858.MR000008.pub4.
    1. Hopewell S, Clarke M, Moher D, Wager E, Middleton P, Altman DG, et al. CONSORT for reporting randomized controlled trials in journal and conference abstracts: explanation and elaboration. PLoS Med. 2008;5:e20. doi: 10.1371/journal.pmed.0050020.
    1. Wong AD, Kirby J, Guyatt GH, Moayyedi P, Vora P, You JJ. Randomized controlled trial comparing telephone and mail follow-up for recruitment of participants into a clinical trial of colorectal cancer screening. Trials. 2013;14:40. doi: 10.1186/1745-6215-14-40.
    1. Altman DG, Schulz KF, Moher D, Egger M, Davidoff F, Elbourne D, et al. The Revised CONSORT Statement for reporting randomized trials: explanation and elaboration. Ann Intern Med. 2001;134:663–94. doi: 10.7326/0003-4819-134-8-200104170-00012.
    1. Ford ME, Havstad SL, Davis SD. A randomized trial of recruitment methods for older African American men in the Prostate, Lung, Colorectal and Ovarian (PLCO) cancer screening trial. Clin Trials. 2004;1:343–51. doi: 10.1191/1740774504cn029oa.
    1. Warren FC, Stych K, Thorogood M, Sharp DJ, Murphy M, Turner KM, et al. Evaluation of different recruitment and randomisation methods in a trial of general practitioner led interventions to increase physical activity: a randomised controlled feasibility study with factorial design. Trials. 2014;15:134. doi: 10.1186/1745-6215-15-134.
    1. Hemminki E, Hovi SL, Veerus P, Sevón T, Tuimala R, Rahu M, et al. Blinding decreased recruitment in a prevention trial of postmenopausal hormone therapy. J Clin Epidemiol. 2004;57(12):1237–43. ISSN 0895–4356. . Accessed 10 October 2013
    1. Hutchison C, Cowan C, McMahon T, Paul J. A randomised controlled study of an audiovisual patient information intervention on informed consent and recruitment to cancer clinical trials. Br J Cancer. 2007;97(6):705–11. doi: 10.1038/sj.bjc.6603943.
    1. Tworoger SS, Yasui Y, Ulrich CM, Nakamura H, LaCroix K, Johnston R, et al. Mailing strategies and recruitment into an intervention trial of the exercise effect on breast cancer biomarkers. Cancer Epidemiol Biomarkers Prev. 2002;11:73–7.
    1. Ives NJ, Troop M, Waters A, Davies S, Higgs C, Easterbrook PJ. Does an HIV clinical trial information booklet improve patient knowledge and understanding of HIV clinical trials? HIV Med. 2001;2(4):241–9. doi: 10.1046/j.1464-2662.2001.00084.x.
    1. Kiernan M, Phillips K, Fair JM, King AC. Using direct mail to recruit hispanic adults into a dietary intervention: an experimental study. Ann Behav Med. 2000;22(1):89–93. doi: 10.1007/BF02895172.
    1. Coyne CA, Xu R, Raich P, Plomer K, Dignan M, Wenzel LB, et al. Randomized controlled trial of an easy-to-read informed consent statement for clinical trial participation: a study of the Eastern Cooperative Oncology Group. JCO. 2003;1:836–42. doi: 10.1200/JCO.2003.07.022.
    1. Geraets JJ, de Groot IJ, Goossens ME, de Bruijn CP, de Bie RA, van den Heuvel WJ, et al. Comparison of two recruitment strategies for patients with chronic shoulder complaints. Br J Gen Pract. 2006;56(523):127–33.
    1. Brewster WR, Anton-Culver H, Ziogas A, Largent J, Howe S, Hubbell FA, et al. Recruitment strategies for cervical cancer prevention study. Gynecol Oncol. 2002;85(2):250–4. ISSN 0090–8258. . Accessed 09 December 2014.
    1. Monaghan H, Richens A, Colman S, Currie R, Girgis S, Jayne K, et al. A randomised trial of the effects of an additional communication strategy on recruitment into a large-scale, multi-centre trial. Contemporary Clinical Trials. 2007;28(1):1–5. ISSN 1551–7144. . Accessed 27 February 2014.
    1. Avenell A, Grant AM, McGee M, McPherson G, Campbell MK, McGee MA, et al. The effects of an open design on trial participant recruitment, compliance and retention – a randomized controlled trial comparison with a blinded, placebo-controlled design. Clin Trials. 2004;1:490–8. doi: 10.1191/1740774504cn053oa.
    1. Free C, Hoile E, Robertson S, Knight R. Three controlled trials of interventions to increase recruitment to a randomized controlled trial of mobile phone based smoking cessation support. Clin Trials. 2010;7:265–73. doi: 10.1177/1740774510367687.
    1. Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, et al. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ. 2014;348:g1687. doi: 10.1136/bmj.g1687.
    1. Simes RJ, Tattersall MHN, Coates AS, Raghavan D, Solomon HJ, Smartt H. Randomised comparison of procedures for obtaining informed consent in clinical trials of treatment for cancer. BMJ (Clinical Research Edition). 1986;293(6554):1065–8. Published by: BMJ Stable URL: . Accessed 06/11/2013.
    1. Weston J, Hannah M, Downes J. Evaluating the benefits of a patient information video during the informed consent process. Patient Educ Couns. 1997;30(3):239–45. ISSN 0738–3991. . Accessed 10 October 2013.
    1. Harris TJ, Carey IM, Victor CR, Adams R, Cook DG. Optimising recruitment into a study of physical activity in older people: a randomised controlled trial of different approaches. Age Ageing. 2008;37(6):659–65. doi: 10.1093/ageing/afn159.
    1. Day SJ, Altman DG. Blinding in clinical trials and other studies. BMJ. 2000;321:504. doi: 10.1136/bmj.321.7259.504.
    1. Liénard JL, Quinaux E, Guillevin EF, Piedbois P, Jouhaud A, Decoster G, et al. Impact of on-site initiation visits on patient recruitment and data quality in a randomized trial of adjuvant chemotherapy for breast cancer. Clin Trials. 2006;3:486–92. doi: 10.1177/1740774506070807.
    1. Fowell A, Johnstone R, Finlay IG, Russell D, Russell IT. Design of trials with dying patients: a feasibility study of cluster randomisation versus randomised consent. Palliat Med. 2006;20:799–804. doi: 10.1177/0269216306072554.
    1. Donovan JL, Peters TJ, Noble S, Powell P, Gillatt D, Oliver SE, et al. for the ProtecT Study Group. Who can best recruit to randomized trials? Randomized trial comparing surgeons and nurses recruiting patients to a trial of treatments for localized prostate cancer (the ProtecT study). J Clin Epidemiol. 2003;56(7):605–9. ISSN 0895–4356. . Accessed 10 December 2014.
    1. Bower P, Wilson S, Mathers N. Short report: how often do UK primary care trials face recruitment delays? Fam Pract. 2007;24:601–3. doi: 10.1093/fampra/cmm051.
    1. Paramasivan S, Huddart R, Hall E, Lewis R, Birtle A, Donovan JL. Key issues in recruitment to randomised controlled trials with very different interventions: a qualitative investigation of recruitment to the SPARE trial (CRUK/07/011) Trials. 2011;12:78. doi: 10.1186/1745-6215-12-78.
    1. Nystuen P, Hagen KB. Telephone reminders are effective in recruiting nonresponding patients to randomized controlled trials. J Clin Epidemiol. 2004;57(8):773–6. ISSN 0895–4356. . Accessed 10 October 2013.
    1. Miller NL, Markowitz JC, Kocsis JH, Leon AC, Brisco ST, Garno JL. Cost effectiveness of screening for clinical trials by research assistants versus senior investigators. J Psychiatr Res. 1999;33(2):81–5. ISSN 0022–3956. . Accessed 10 December 2014.
    1. Kendrick D, Watson M, Dewey M, Woods AJ. Does sending a home safety questionnaire increase recruitment to an injury prevention trial? A randomised controlled trial. J Epidemiol Community Health. 2001;55(11):845–6. doi: 10.1136/jech.55.11.845.
    1. Ioannidis JPA, Evans SJW, Gotzsche PC, O’Neill RT, Altman DG, Schulz K, et al. Better reporting of harms in randomized trials: an extension of the CONSORT Statement. Ann Intern Med. 2004;141(10):781–8. doi: 10.7326/0003-4819-141-10-200411160-00009.
    1. Martinson BC, Lazovich D, Lando HA, Perry CL, McGovern PG, Boyle RG. Effectiveness of monetary incentives for recruiting adolescents to an intervention trial to reduce smoking. Prev Med. 2000;31(6):706–13. ISSN 0091–7435. . Accessed 10 December 2014.
    1. Piaggio G, Elbourne DR, Pocock SJ, Evans SJ, Altman DG, CONSORT Group Reporting of noninferiority and equivalence randomized trials: extension of the CONSORT 2010 statement. JAMA. 2012;308(24):2594–604. doi: 10.1001/jama.2012.87802.
    1. Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, et al. Pragmatic Trials in Healthcare (Practihc) group. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ. 2008;337:a2390. doi: 10.1136/bmj.a2390.
    1. Kimmick GG, Peterson BL, Kornblith AB, Mandelblatt J, Johnson JL, Wheeler J, et al. Improving accrual of older persons to cancer treatment trials: a randomized trial comparing an educational intervention with standard information: CALGB 360001. JCO. 2005;1:2201–7. doi: 10.1200/JCO.2005.01.222.
    1. Jacobsen PB, Wells KJ, Meade CD, Quinn GP, Lee J, Fulp WJ, et al. Effects of a brief multimedia psychoeducational intervention on the attitudes and interest of patients with cancer regarding clinical trial participation: a multicenter randomized controlled trial. JCO. 2012;2516–2521. Published online on 21 May 2012.

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