Data from: Improving the recruitment activity of clinicians in randomised controlled trials - a systematic review

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 (EPHPP) 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 (CASP) 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 EPHPP 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 sub-themes to be: difficulty communicating trial methods; poor understanding of research; and priority given to patient wellbeing. Overall, the qualitative studies were found to be of good quality when assessed using the CASP 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 their patients, could also be a successful factor in improving recruitment. A bias was found toward investigating barriers to recruitment, so future work should also encompass a focus on successfully recruiting trials.背景：随机对照试验（randomised controlled trials, RCTs）的受试者招募困境是一个普遍存在的问题。为临床医生提供支持或激励类干预措施，或可提升RCT的受试者招募效率。 研究目标：本研究旨在量化旨在提升临床医生RCT招募工作效能的各类策略的效果，并综合分析与临床医生参与RCT招募的态度相关的定性研究证据。 数据来源：本研究对2001年至2011年3月期间，从考克兰图书馆（Cochrane Library）、Ovid MEDLINE、Ovid EMBASE、Ovid PsycINFO、Ebsco CINAHL、《学位论文索引》（Index to Theses）以及Open SIGLE数据库中检索到的英文与非英文文献开展系统综述；此外通过对纳入文献的参考文献进行检索，补充获取了相关研究报告。 研究纳入排除标准：对于定量研究，若其评估了旨在提升临床医生RCT招募效能的干预措施，或比较了不同临床医生群体的招募效果，则予以纳入。由一名研究人员提取有关纳入试验、研究设计、研究对象、干预措施、结局指标以及所纳入RCT的相关信息，并由另一名研究人员进行核查。采用标准化工具——公共卫生实践效果项目（Effective Public Health Practice Project, EPHPP）量表，对符合纳入标准的定量研究开展质量评价。对于定性研究，若其探讨了临床医生招募受试者参与RCT的相关态度，则予以纳入。提取所有研究结果/发现并开展内容分析，提炼核心主题后进行元汇总分析。采用关键评价技能项目（Critical Appraisal Skills Programme, CASP）定性研究清单，对符合纳入标准的定性研究开展质量评价。 数据提取：数据提取工作由一名研究人员基于预先设定的数据字段（包括研究质量评价指标）开展，并由另一名研究人员进行复核验证。 研究结果：共纳入8项定量研究，涵盖4种干预措施以及不同临床医生招募群体的对比分析。采用EPHPP量表进行质量评价后，1项研究被评为高质量，1项为中等质量，剩余6项为低质量。经证实有效的干预措施包括：利用定性研究识别并克服招募障碍；降低临床医生参与RCT所需承担的临床工作负荷；为临床医生提供额外培训以及受保护的研究时间。 共检索到11项定性研究，从数据中提炼出8个核心主题：对研究的认知、沟通交流、患者层面的招募障碍、医患关系、对患者的影响、对临床实践的影响、临床医生的个人收益以及与成功招募相关的方法。元汇总分析显示，最常被报道的子主题包括：试验方法沟通困难、对研究的认知不足以及优先考量患者福祉。总体而言，采用CASP清单进行质量评价后，纳入的定性研究整体质量良好。 结论：目前针对提升临床医生RCT招募效能的干预措施开展的高质量研究较为匮乏。最具应用前景的干预措施为采用定性方法识别并克服临床医生的招募障碍。未来仍需开展更多高质量的干预措施相关研究，以充实相关证据基础。定性研究结果的元汇总分析显示，提升对RCT方法的认知与沟通能力是未来改善招募工作的核心目标。强化干预措施对临床医生及其患者的潜在收益，也可成为提升招募效率的有效助力。现有研究存在仅关注招募障碍的偏倚，因此未来的研究应同时聚焦于成功开展招募的相关实践。