Montedori Alessandro, Abraha Iosief, Chiatti Carlos, Cozzolino Francesco, Orso Massimiliano, Luchetta Maria Laura, Rimland Joseph M, Ambrosio Giuseppe
Health Planning Service, Regional Health Authority of Umbria, Perugia, Italy.
Scientific Directorate, Italian National Research Center on Aging, Ancona, Italy.
BMJ Open. 2016 Sep 15;6(9):e011776. doi: 10.1136/bmjopen-2016-011776.
Administrative healthcare databases are useful to investigate the epidemiology, health outcomes, quality indicators and healthcare utilisation concerning peptic ulcers and gastrointestinal bleeding, but the databases need to be validated in order to be a reliable source for research. The aim of this protocol is to perform the first systematic review of studies reporting the validation of International Classification of Diseases, 9th Revision and 10th version (ICD-9 and ICD-10) codes for peptic ulcer and upper gastrointestinal bleeding diagnoses.
MEDLINE, EMBASE, Web of Science and the Cochrane Library databases will be searched, using appropriate search strategies. We will include validation studies that used administrative data to identify peptic ulcer disease and upper gastrointestinal bleeding diagnoses or studies that evaluated the validity of peptic ulcer and upper gastrointestinal bleeding codes in administrative data. The following inclusion criteria will be used: (a) the presence of a reference standard case definition for the diseases of interest; (b) the presence of at least one test measure (eg, sensitivity, etc) and (c) the use of an administrative database as a source of data. Pairs of reviewers will independently abstract data using standardised forms and will evaluate quality using the checklist of the Standards for Reporting of Diagnostic Accuracy (STARD) criteria. This systematic review protocol has been produced in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocol (PRISMA-P) 2015 statement.
Ethics approval is not required given that this is a protocol for a systematic review. We will submit results of this study to a peer-reviewed journal for publication. The results will serve as a guide for researchers validating administrative healthcare databases to determine appropriate case definitions for peptic ulcer disease and upper gastrointestinal bleeding, as well as to perform outcome research using administrative healthcare databases of these conditions.
CRD42015029216.
行政医疗保健数据库对于调查消化性溃疡和胃肠道出血的流行病学、健康结局、质量指标及医疗保健利用情况很有用,但为了成为可靠的研究来源,这些数据库需要进行验证。本方案的目的是对报告国际疾病分类第9版和第10版(ICD - 9和ICD - 10)编码用于消化性溃疡和上消化道出血诊断验证的研究进行首次系统评价。
将使用适当的检索策略检索MEDLINE、EMBASE、科学引文索引和考科蓝图书馆数据库。我们将纳入使用行政数据识别消化性溃疡疾病和上消化道出血诊断的验证研究,或评估行政数据中消化性溃疡和上消化道出血编码有效性的研究。将采用以下纳入标准:(a)存在感兴趣疾病的参考标准病例定义;(b)存在至少一项测试指标(如敏感性等);(c)使用行政数据库作为数据来源。成对的评审员将使用标准化表格独立提取数据,并使用诊断准确性报告标准(STARD)标准清单评估质量。本系统评价方案已按照系统评价和Meta分析方案的首选报告项目(PRISMA - P)2015声明制定。
鉴于这是一项系统评价方案,无需伦理批准。我们将把本研究结果提交给同行评审期刊发表。研究结果将为验证行政医疗保健数据库的研究人员提供指导,以确定消化性溃疡疾病和上消化道出血的适当病例定义,以及使用这些疾病的行政医疗保健数据库进行结局研究。
CRD42015029216。