一项关节炎工作残疾预防随机临床试验的招募成本与结果：“努力工作”研究
Recruitment cost and outcomes for an arthritis work disability prevention randomized clinical trial: The Work It study.
作者信息
AlHeresh Rawan, Vaughan Molly W, Brenner Inbar Hanouna, Keysor Julie
机构信息
MGH Institute of Health Professions, Boston, MA, USA.
RTI International, Boston, MA, USA.
出版信息
Contemp Clin Trials Commun. 2021 Nov 12;24:100862. doi: 10.1016/j.conctc.2021.100862. eCollection 2021 Dec.
BACKGROUND
Despite the recommendations to increase recruitment of participants into clinical trials, investigators face costly challenges in trials investigating work disability interventions for people with arthritis and rheumatological conditions. This study aims to evaluate the recruitment costs and outcomes from a randomized controlled trial of an arthritis work disability prevention program conducted between 2011 and 2015, to inform planning and monitoring recruitment in similar studies.
METHODS
Data were obtained from enrollment and financial records pertaining to recruitment costs for each recruitment approach employed. The cost for each recruitment method was calculated for total cost and cost per number of participants screened, eligible, and enrolled in the trial. Then the yield of each possible recruitment method was also determined based on the ratio of the number of randomized participants divided by the number of people contacted through each recruitment method. Finally, the.
RESULTS
Recruitment rate was lower than projected. Community advertising, specifically newspapers, was the most successful method of recruitment in terms of numbers, but social media, specifically Craigslist, was the least costly method used to recruit. Some social media approaches, including Facebook and LinkedIn, yielded few if any participants. Recruitment efforts used successfully in the past are not always effective.
CONCLUSIONS
Costs to recruit large numbers of people with arthritis into clinical trials are high. Investigators are encouraged to monitor recruitment efforts and evaluate the costs and outcomes of their strategies throughout the study period. Close consideration to recruitment costs should be considered as part of the research fiscal resources prior to and during the study period for long-term outcomes like work disability.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT01387100, date: 06/01/2011.
背景
尽管有增加临床试验参与者招募人数的建议，但在针对关节炎和风湿病患者的工作残疾干预措施的试验中，研究人员面临着成本高昂的挑战。本研究旨在评估2011年至2015年进行的一项关节炎工作残疾预防计划随机对照试验的招募成本和结果，为类似研究的招募计划和监测提供参考。
方法
从与所采用的每种招募方法的招募成本相关的登记和财务记录中获取数据。计算每种招募方法的总成本以及每筛选、符合条件并纳入试验的参与者人数的成本。然后，还根据随机分组参与者人数与通过每种招募方法联系的人数之比确定每种可能的招募方法的成功率。最后，……
结果
招募率低于预期。就人数而言，社区广告，特别是报纸广告，是最成功的招募方法，但社交媒体，特别是克雷格列表网站，是用于招募的成本最低的方法。包括脸书和领英在内的一些社交媒体方法招募到的参与者寥寥无几。过去成功使用的招募方法并不总是有效。
结论
将大量关节炎患者招募到临床试验中的成本很高。鼓励研究人员在整个研究期间监测招募工作，并评估其策略的成本和结果。在研究期间之前和期间，对于像工作残疾这样的长期结果，应密切考虑招募成本，并将其作为研究财政资源的一部分。
试验注册
ClinicalTrials.gov标识符：NCT01387100，日期：2011年1月6日。
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