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提高临床医生参与随机对照试验的招募活动:一项系统评价。

Improving the recruitment activity of clinicians in randomised controlled trials: a systematic review.

作者信息

Fletcher Ben, Gheorghe Adrian, Moore David, Wilson Sue, Damery Sarah

机构信息

School of Health and Population Sciences, The University of Birmingham, Edgbaston, Birmingham, UK.

出版信息

BMJ Open. 2012 Jan 6;2(1):e000496. doi: 10.1136/bmjopen-2011-000496. Print 2012.

Abstract

Background Poor recruitment to randomised controlled trials (RCTs) is a widespread problem. Provision of interventions aimed at supporting or incentivising clinicians may improve recruitment to RCTs. Objectives To quantify the effects of strategies aimed at improving the recruitment activity of clinicians in RCTs, complemented with a synthesis of qualitative evidence related to clinicians' attitudes towards recruiting to RCTs. Data sources A systematic review of English and non-English articles identified from: The Cochrane Library, Ovid MEDLINE, Ovid EMBASE, Ovid PsycINFO, Ebsco CINAHL, Index to Theses and Open SIGLE from 2001 to March 2011. Additional reports were identified through citation searches of included articles. Study eligibility criteria Quantitative studies were included if they evaluated interventions aimed at improving the recruitment activity of clinicians or compared recruitment by different groups of clinicians. Information about host trial, study design, participants, interventions, outcomes and host RCT was extracted by one researcher and checked by another. Studies that met the inclusion criteria were assessed for quality using a standardised tool, the Effective Public Health Practice Project tool. Qualitative studies were included if they investigated clinicians' attitudes to recruiting patients to RCTs. All results/findings were extracted, and content analysis was carried out. Overarching themes were abstracted, followed by a metasummary analysis. Studies that met the inclusion criteria were assessed for quality using the Critical Appraisal Skills Programme qualitative checklist. Data extraction Data extraction was carried out by one researcher using predefined data fields, including study quality indicators, and verified by another. Results Eight quantitative studies were included describing four interventions and a comparison of recruiting clinicians. One study was rated as strong, one as moderate and the remaining six as weak when assessed for quality using the Effective Public Health Practice Project tool. Effective interventions included the use of qualitative research to identify and overcome barriers to recruitment, reduction of the clinical workload associated with participation in RCTs and the provision of extra training and protected research time. Eleven qualitative studies were identified, and eight themes were abstracted from the data: understanding of research, communication, perceived patient barriers, patient-clinician relationship, effect on patients, effect on clinical practice, individual benefits for clinicians and methods associated with successful recruitment. Metasummary analysis identified the most frequently reported subthemes to be: difficulty communicating trial methods, poor understanding of research and priority given to patient well-being. Overall, the qualitative studies were found to be of good quality when assessed using the Critical Appraisal Skills Programme checklist. Conclusions There were few high-quality trials that tested interventions to improve clinicians' recruitment activity in RCTs. The most promising intervention was the use of qualitative methods to identify and overcome barriers to clinician recruitment activity. More good quality studies of interventions are needed to add to the evidence base. The metasummary of qualitative findings identified understanding and communicating RCT methods as a key target for future interventions to improve recruitment. Reinforcement of the potential benefits, both for clinicians and for their patients, could also be a successful factor in improving recruitment. A bias was found towards investigating barriers to recruitment, so future work should also encompass a focus on successfully recruiting trials.

摘要

背景

随机对照试验(RCT)的受试者招募不佳是一个普遍存在的问题。提供旨在支持或激励临床医生的干预措施可能会改善RCT的受试者招募情况。

目的

量化旨在提高临床医生在RCT中招募活动的策略的效果,并综合与临床医生对RCT招募态度相关的定性证据。

数据来源

对2001年至2011年3月期间从以下数据库中识别出的英文和非英文文章进行系统综述:考克兰图书馆、Ovid MEDLINE、Ovid EMBASE、Ovid PsycINFO、Ebsco CINAHL、学位论文索引和Open SIGLE。通过对纳入文章的引文检索识别其他报告。

研究入选标准

如果定量研究评估了旨在改善临床医生招募活动的干预措施,或比较了不同临床医生群体的招募情况,则纳入该研究。由一名研究人员提取有关主办试验、研究设计、参与者、干预措施、结局和主办RCT的信息,并由另一名研究人员进行核对。使用标准化工具“有效公共卫生实践项目工具”对符合纳入标准的研究进行质量评估。如果定性研究调查了临床医生对将患者招募到RCT中的态度,则纳入该研究。提取所有结果/发现,并进行内容分析。提取总体主题,然后进行元总结分析。使用批判性评估技能计划定性清单对符合纳入标准的研究进行质量评估。

数据提取

由一名研究人员使用预定义的数据字段进行数据提取,包括研究质量指标,并由另一名研究人员进行核实。

结果

纳入了八项定量研究,描述了四种干预措施以及对招募临床医生的比较。使用“有效公共卫生实践项目工具”评估质量时,一项研究被评为强,一项为中等,其余六项为弱。有效的干预措施包括使用定性研究来识别和克服招募障碍、减少与参与RCT相关的临床工作量以及提供额外培训和受保护的研究时间。识别出十一项定性研究,并从数据中提取了八个主题:对研究的理解、沟通、感知到的患者障碍、患者-临床医生关系、对患者 的影响、对临床实践的影响、临床医生的个人利益以及与成功招募相关 的方法。元总结分析确定最常报告的子主题为:试验方法沟通困难、对研究理解不足以及优先考虑患者福祉。总体而言,使用批判性评估技能计划清单评估时,定性研究质量良好。

结论

很少有高质量的试验测试改善临床医生在RCT中招募活动的干预措施。最有前景的干预措施是使用定性方法来识别和克服临床医生招募活动的障碍。需要更多高质量的干预措施研究来增加证据基础。定性研究结果的元总结将对RCT方法的理解和沟通确定为未来改善招募干预措施的关键目标。强化对临床医生及其患者的潜在益处也可能是改善招募的一个成功因素。发现存在偏向于调查招募障碍的情况,因此未来的工作还应包括关注成功招募试验。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ba74/3253423/982307ff3590/bmjopen-2011-000496fig1.jpg

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