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BMC Medical Research Methodology

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Open Access 01-12-2021 | Research article

Early experience with an opt-in research register - Scottish Health Research Register (SHARE): a multi-method evaluation of participant recruitment performance

Authors: Wen Shi, Shobna Vasishta, Louise Dow, Daniella Cavellini, Colin Palmer, Brian McKinstry, Frank Sullivan

Published in: BMC Medical Research Methodology | Issue 1/2021

Abstract

Background

Recruiting participants to a clinical study is a resource-intensive process with a high failure rate. The Scottish Health Research Register (SHARE) provides recruitment support service which helps researchers recruit participants by searching patients’ Electronic Health Records (EHRs). The current study aims to evaluate the performance of SHARE in participant recruitment.

Methods

Recruitment projects eligible for evaluation were those that were conducted for clinical trials or observational studies and finished before 2020. For analysis of recruitment data, projects with incomplete data were excluded. For each project we calculated, from SHARE records, 1) the fraction of the participants recruited through SHARE as a percentage of the number requested by researchers (percentage fulfilled), 2) the percentage of the potential candidates provided by SHARE to researchers that were actually recruited (percentage provided and recruited), 3) the percentage of the participants recruited through SHARE of all the potentially eligible candidates identified by searching registrants’ EHRs (percentage identified and recruited). Research teams of the eligible projects were invited to participate in an anonymised online survey. Two metrics were derived from research teams’ responses, including a) the fraction of the recruited over the study target number of participants (percentage fulfilled), and b) the percentage of the participants recruited through SHARE among the candidates received from SHARE (percentage provided and recruited).

Results

Forty-four projects were eligible for inclusion. Recruitment data for 24 projects were available (20 excluded because of missingness or incompleteness). Survey invites were sent to all the eligible research teams and received 12 responses. Analysis of recruitment data shows the overall percentage fulfilled was 34.2% (interquartile 13.3–45.1%), the percentage provided and recruited 29.3% (interquartile 20.6–52.4%) and percentage identified and recruited 4.9% (interquartile 2.6–10.2%). Based on the data reported by researchers, percentage fulfilled was 31.7% (interquartile 5.8–59.6%) and percentage provided and recruited was 20.2% (interquartile 8.2–31.0%).

Conclusions

SHARE may be a valuable resource for recruiting participants for some clinical studies. Potential improvements are to expand the registrant base and to incorporate more data generated during patients’ different health care encounters into the candidate-searching step.

Available only for authorised users

Amanda Hunn, Joint Head of Policy, HRA. Survey of the general public: attitudes towards health research 2017. Available from: https://www.hra.nhs.uk/documents/1422/HRA_NIHR_general_public_omnibus_survey_2017_FINAL.pdf. Access date: July 2020.

Prescott R, Counsell C, Gillespie W, Grant A, Russell I. Factors that limit the quality, number and progress of randomised controlled trials. Health Technol Assess. 1999;3(20):78.CrossRef

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.CrossRef

Tudur Smith C, Hickey H, Clarke M, Blazeby J, Williamson P. The trials methodological research agenda: results from a priority setting exercise. Trials. 2014;15:32.CrossRef

Treweek S, Pitkethly M, Cook J, Fraser C, Mitchell E, Sullivan F, et al. Strategies to improve recruitment to randomised trials. Cochrane Database Syst Rev. 2018;2(2):MR000013.PubMed

Cadmus Bertram LA, Chung G, Yu H, Salovey P, Irwin M. Feasibility of institutional registry-based recruitment for enrolling newly diagnosed breast cancer patients in an exercise trial. J Phys Act Health. 2011;8(7):955–63.CrossRef

Hall AE, Sanson-Fisher RW, Lynagh MC, Threlfall T, D'Este CA. Format and readability of an enhanced invitation letter did not affect participation rates in a cancer registry-based study: a randomized controlled trial. J Clin Epidemiol. 2013;66(1):85–94.CrossRef

Burnell M, Gentry-Maharaj A, Ryan A, Apostolidou S, Habib M, Kalsi J, et al. Impact on mortality and cancer incidence rates of using random invitation from population registers for recruitment to trials. Trials. 2011;12:61.CrossRef

Aung T, Haynes R, Barton J, Cox J, Murawska A, Murphy K, et al. Cost-effective recruitment methods for a large randomised trial in people with diabetes: a study of cardiovascular events iN diabetes (ASCEND). Trials. 2016;17(1):286.CrossRef

10.

Researchmatch. Available from: https://www.researchmatch.org/. Access date: Oct, 2020.

11.

All of Us Research Hub. Available from: https://www.researchallofus.org. Access date: Feb, 2021.

12.

Discover-NOW. Available from: https://imperialcollegehealthpartners.com/what-we-do/discover-now/. Access date: Oct, 2020.

13.

SHARE NHS Research Scotland. Available from: https://www.registerforshare.org/. Access date: Oct, 2021.

14.

DIGITRIALS. Available from: https://digital.nhs.uk/services/nhs-digitrials . Access date: Feb, 2021.

15.

McKinstry B, Sullivan FM, Vasishta S, Armstrong R, Hanley J, Haughney J, et al. Cohort profile: the Scottish research register SHARE. A register of people interested in research participation linked to NHS data sets. BMJ Open. 2017;7:e013351.CrossRef

16.

Sullivan F, McKinstry B, Vasishta S. The "all of us" research program. N Engl J Med. 2019;381(19):1883–4.CrossRef

17.

Grant A, Ure J, Nicolson DJ, Hanley J, Sheikh A, McKinstry B, et al. Acceptability and perceived barriers and facilitators to creating a national research register to enable 'direct to patient' enrolment into research: the Scottish Health Research register (SHARE). BMC Health Serv Res. 2013;13:422.CrossRef

18.

Public Health Information for Scotland. The Scottish Burden of Disease Study 2016 overview report. Available from: https://www.scotpho.org.uk/comparative-health/burden-of-disease/overview. Access date: May, 2020.

19.

Estimated population of Scotland, actual and projected, 1951–2039. Scotland's Population 2016 - The Registrar General's Annual Review of Demographic Trends. Available from: https://www.nrscotland.gov.uk/statistics-and-data/statistics/stats-at-a-glance/registrar-generals-annual-review/2016/chapter-1-population. Access date: May, 2020.

20.

HDRUK. Trusted Research Environments (TRE) - A strategy to build public trust and meet changing health data science needs. Available from: https://ukhealthdata.org/wp-content/uploads/2020/04/200430-TRE-Green-Paper-v1.pdf. Access date: Oct, 2021.

21.

NHS Research Scotland. Data Safe Haven. Available from: https://www.nhsresearchscotland.org.uk/research-in-scotland/data/safe-havens. Access date: Oct, 2021.

22.

Harris PA, Scott KW, Lebo L, Hassan N, Lightner C, Pulley J. ResearchMatch: a National Registry to recruit volunteers for clinical research. Acad Med. 2012;87(1):66–73.CrossRef

23.

Denny JC, Rutter JL, Goldstein DB, Philippakis A, Smoller JW, Jenkins G, et al. The "all of us" research program. N Engl J Med. 2019;381(7):668–76.CrossRef

24.

Qualtrics. Available from: https://www.qualtrics.com/uk/core-xm/survey-software/. Access date: July, 2020.

25.

R. Available from: https://www.r-project.org. Access date: Feb, 2021.

26.

Jennings CG, MacDonald TM, Wei L, Brown MJ, McConnachie L, Mackenzie IS. Does offering an incentive payment improve recruitment to clinical trials and increase the proportion of socially deprived and elderly participants? Trials. 2015;16:80.CrossRef

27.

Nystuen P, Hagen KB. Telephone reminders are effective in recruiting nonresponding patients to randomized controlled trials. J Clin Epidemiol. 2004;57(8):773–6.CrossRef

28.

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.CrossRef

29.

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(4):343–51.CrossRef

30.

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(3):265–73.CrossRef

31.

Li L, Chase HS, Patel CO, Friedman C, Weng C. Comparing ICD9-encoded diagnoses and NLP-processed discharge summaries for clinical trials pre-screening: a case study. AMIA Annu Symp Proc. 2008:404–8.

32.

Ni Y, Kennebeck S, Dexheimer JW, McAneney CM, Tang H, Lingren T, et al. Automated clinical trial eligibility prescreening: increasing the efficiency of patient identification for clinical trials in the emergency department. J Am Med Inform Assoc. 2015;22(1):166–78.CrossRef

33.

Miotto R, Weng C. Case-based reasoning using electronic health records efficiently identifies eligible patients for clinical trials. J Am Med Inform Assoc. 2015;22(e1):e141–50.CrossRef

34.

Ni Y, Wright J, Perentesis J, Lingren T, Deleger L, Kaiser M, et al. Increasing the efficiency of trial-patient matching: automated clinical trial eligibility pre-screening for pediatric oncology patients. BMC Med Inform Decis Mak. 2015;15:28.CrossRef

35.

SurveyMonkey. Available from: https://www.surveymonkey.co.uk/curiosity/improve-survey-response-rate/. Access date: Mar, 2021.

Title: Early experience with an opt-in research register - Scottish Health Research Register (SHARE): a multi-method evaluation of participant recruitment performance
Authors: Wen Shi
Shobna Vasishta
Louise Dow
Daniella Cavellini
Colin Palmer
Brian McKinstry
Frank Sullivan
Publication date: 01-12-2021
Publisher: BioMed Central
Published in: BMC Medical Research Methodology / Issue 1/2021
Electronic ISSN: 1471-2288
DOI: https://doi.org/10.1186/s12874-021-01479-4

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Early experience with an opt-in research register - Scottish Health Research Register (SHARE): a multi-method evaluation of participant recruitment performance

Abstract

Background

Methods

Results

Conclusions

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Results

Conclusions

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