Johnston Bradley C, Ebrahim Shanil, Carrasco-Labra Alonso, Furukawa Toshi A, Patrick Donald L, Crawford Mark W, Hemmelgarn Brenda R, Schunemann Holger J, Guyatt Gordon H, Nesrallah Gihad
Department of Anaesthesia and Pain Medicine, The Hospital for Sick Children, Toronto, Ontario, Canada Child Health Evaluative Sciences, The Research Institute, The Hospital For Sick Children, Hospital for Sick Children, Toronto, Ontario, Canada Institute of Health Policy, Management and Evaluation, Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, Ontario, Canada.
Department of Anaesthesia and Pain Medicine, The Hospital for Sick Children, Toronto, Ontario, Canada Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, Ontario, Canada Department of Anesthesia, McMaster University, Hamilton, Ontario, Canada Department of Medicine, Stanford Prevention Research Center, Stanford University, Stanford, California, USA Meta-Research Innovation Center at Stanford (METRICS), Stanford University, Stanford, California, USA.
BMJ Open. 2015 Oct 1;5(10):e007953. doi: 10.1136/bmjopen-2015-007953.
Patient-reported outcomes (PROs) are often the outcomes of greatest importance to patients. The minimally important difference (MID) provides a measure of the smallest change in the PRO that patients perceive as important. An anchor-based approach is the most appropriate method for MID determination. No study or database currently exists that provides all anchor-based MIDs associated with PRO instruments; nor are there any accepted standards for appraising the credibility of MID estimates. Our objectives are to complete a systematic survey of the literature to collect and characterise published anchor-based MIDs associated with PRO instruments used in evaluating the effects of interventions on chronic medical and psychiatric conditions and to assess their credibility.
We will search MEDLINE, EMBASE and PsycINFO (1989 to present) to identify studies addressing methods to estimate anchor-based MIDs of target PRO instruments or reporting empirical ascertainment of anchor-based MIDs. Teams of two reviewers will screen titles and abstracts, review full texts of citations, and extract relevant data. On the basis of findings from studies addressing methods to estimate anchor-based MIDs, we will summarise the available methods and develop an instrument addressing the credibility of empirically ascertained MIDs. We will evaluate the credibility of all studies reporting on the empirical ascertainment of anchor-based MIDs using the credibility instrument, and assess the instrument's inter-rater reliability. We will separately present reports for adult and paediatric populations.
No research ethics approval was required as we will be using aggregate data from published studies. Our work will summarise anchor-based methods available to establish MIDs, provide an instrument to assess the credibility of available MIDs, determine the reliability of that instrument, and provide a comprehensive compendium of published anchor-based MIDs associated with PRO instruments which will help improve the interpretability of outcome effects in systematic reviews and practice guidelines.
患者报告结局（PROs）通常是对患者最重要的结局。最小重要差异（MID）提供了一种衡量患者认为重要的PRO中最小变化的方法。基于锚定的方法是确定MID最合适的方法。目前不存在提供与PRO工具相关的所有基于锚定的MID的研究或数据库；也没有评估MID估计可信度的公认标准。我们的目标是对文献进行系统调查，以收集和描述与用于评估干预措施对慢性医学和精神疾病影响的PRO工具相关的已发表的基于锚定的MID，并评估其可信度。
我们将检索MEDLINE、EMBASE和PsycINFO（1989年至今），以识别涉及估计目标PRO工具基于锚定的MID的方法或报告基于锚定的MID的实证确定的研究。由两名评审员组成的团队将筛选标题和摘要，审查引文全文，并提取相关数据。根据关于估计基于锚定的MID的方法的研究结果，我们将总结可用方法，并开发一种评估实证确定的MID可信度的工具。我们将使用该可信度工具评估所有报告基于锚定的MID实证确定的研究的可信度，并评估该工具的评分者间信度。我们将分别为成人和儿科人群提供报告。
由于我们将使用已发表研究的汇总数据，因此无需研究伦理批准。我们的工作将总结用于建立MID的基于锚定的方法，提供一种评估可用MID可信度的工具，确定该工具的可靠性，并提供与PRO工具相关的已发表的基于锚定的MID的综合汇编，这将有助于提高系统评价和实践指南中结局效应的可解释性。
