MRC Clinical Trials Unit at UCL and Department of Primary Care and Population Health, UCL, ICTM, 2nd Floor, 90 High Holborn, London, WC1V 6LJ, UK.
Department of Primary Care and Public Health, UCL, London, UK.
Syst Rev. 2019 Jun 25;8(1):150. doi: 10.1186/s13643-019-1065-x.
Phase III randomised controlled trials aim not just to increase the sum of human knowledge, but also to improve treatment, care or prevention for future patients through changing policy and practice. To achieve this, the results need to be communicated effectively to several audiences. It is unclear how best to do this while not wasting scarce resources or causing avoidable distress or confusion. The aim of this systematic review is to examine the effectiveness, acceptability and resource implications of different methods of communication of clinical research results to lay or professional audiences, to inform practice.
We will systematically review the published literature from 2000 to 2018 for reports of approaches for communicating clinical study results to lay audiences (patients, participants, carers and the wider public) or professional audiences (clinicians, policymakers, guideline developers, other medical professionals). We will search Embase, MEDLINE, PsycINFO, ASSIA, the Cochrane Database of Systematic Reviews and grey literature sources. One reviewer will screen titles and abstracts for potential eligibility, discarding only those that are clearly irrelevant. Potentially relevant full texts will then be assessed for inclusion by two reviewers. Data extraction will be carried out by one reviewer using EPPI-Reviewer. Risk of bias will be assessed using the relevant Cochrane Risk of Bias 2.0 tool, ROBINS-1, AXIS Appraisal Tool or Critical Appraisals Skills Programme Qualitative Checklist, depending on study design. We will decide whether to meta-analyse data based on whether the included trials are similar enough in terms of participants, settings, intervention, comparison and outcome measures to allow meaningful conclusions from a statistically pooled result. We will present the data in tables and narratively summarise the results. We will use thematic synthesis for qualitative studies.
Developing the search strategy for this review has been challenging as many of the concepts (patients, clinicians, clinical studies, and communication) are widely used in literature that is not relevant for inclusion in our review. We expect there will be limited comparative evidence, spread over a wide range of approaches, comparators and populations and, therefore, do not anticipate being able to carry out meta-analysis.
International Prospective Register of Systematic Reviews PROSPERO ( CRD42019137364 ).
三期随机对照试验的目的不仅在于增加人类知识的总和，还在于通过改变政策和实践，为未来的患者改善治疗、护理或预防效果。要实现这一目标，需要向多个受众有效地传达研究结果。目前尚不清楚如何在不浪费稀缺资源或造成不必要的困扰或混淆的情况下做到这一点。本系统评价的目的是研究向非专业或专业受众传达临床研究结果的不同方法的有效性、可接受性和资源影响，为实践提供信息。
我们将系统地检索 2000 年至 2018 年发表的文献，以报告向非专业受众（患者、参与者、护理人员和广大公众）或专业受众（临床医生、决策者、指南制定者、其他医疗专业人员）传达临床研究结果的方法。我们将检索 Embase、MEDLINE、PsycINFO、ASSIA、Cochrane 系统评价数据库和灰色文献来源。一名评审员将筛选标题和摘要，以确定潜在的合格性，仅排除那些明显不相关的内容。然后，两名评审员将评估潜在的全文是否符合纳入标准。数据提取将由一名评审员使用 EPPI-Reviewer 进行。使用相关的 Cochrane 偏倚风险 2.0 工具、ROBINS-1、AXIS 评估工具或批判性评估技能计划定性检查表来评估偏倚风险，具体取决于研究设计。我们将根据纳入试验在参与者、环境、干预措施、比较和结局测量方面的相似程度，决定是否对数据进行荟萃分析，以得出具有统计学意义的汇总结果。我们将以表格形式呈现数据，并进行叙述性总结。我们将对定性研究进行主题综合分析。
由于许多概念（患者、临床医生、临床研究和沟通）广泛用于与我们的综述不相关的文献中，因此为本次综述制定搜索策略具有挑战性。我们预计比较证据有限，分散在广泛的方法、对照和人群中，因此，我们预计无法进行荟萃分析。
国际前瞻性系统评价注册处（PROSPERO，CRD42019137364）。
