Abraha Iosief, Serraino Diego, Giovannini Gianni, Stracci Fabrizio, Casucci Paola, Alessandrini Giuliana, Bidoli Ettore, Chiari Rita, Cirocchi Roberto, De Giorgi Marcello, Franchini David, Vitale Maria Francesca, Fusco Mario, Montedori Alessandro
Health Planning Service, Regional Health Authority of Umbria, Perugia, Italy.
Epidemiology and Biostatistic Unit, Centro di Riferimento Oncologico Aviano, Aviano, Italy.
BMJ Open. 2016 Mar 25;6(3):e010547. doi: 10.1136/bmjopen-2015-010547.
Administrative healthcare databases are useful tools to study healthcare outcomes and to monitor the health status of a population. Patients with cancer can be identified through disease-specific codes, prescriptions and physician claims, but prior validation is required to achieve an accurate case definition. The objective of this protocol is to assess the accuracy of International Classification of Diseases Ninth Revision-Clinical Modification (ICD-9-CM) codes for breast, lung and colorectal cancers in identifying patients diagnosed with the relative disease in three Italian administrative databases.
Data from the administrative databases of Umbria Region (910,000 residents), Local Health Unit 3 of Napoli (1,170,000 residents) and Friuli--Venezia Giulia Region (1,227,000 residents) will be considered. In each administrative database, patients with the first occurrence of diagnosis of breast, lung or colorectal cancer between 2012 and 2014 will be identified using the following groups of ICD-9-CM codes in primary position: (1) 233.0 and (2) 174.x for breast cancer; (3) 162.x for lung cancer; (4) 153.x for colon cancer and (5) 154.0-154.1 and 154.8 for rectal cancer. Only incident cases will be considered, that is, excluding cases that have the same diagnosis in the 5 years (2007-2011) before the period of interest. A random sample of cases and non-cases will be selected from each administrative database and the corresponding medical charts will be assessed for validation by pairs of trained, independent reviewers. Case ascertainment within the medical charts will be based on (1) the presence of a primary nodular lesion in the breast, lung or colon-rectum, documented with imaging or endoscopy and (2) a cytological or histological documentation of cancer from a primary or metastatic site. Sensitivity and specificity with 95% CIs will be calculated.
Study results will be disseminated widely through peer-reviewed publications and presentations at national and international conferences.
行政医疗保健数据库是研究医疗保健结果和监测人群健康状况的有用工具。癌症患者可通过特定疾病代码、处方和医生申报来识别，但需要事先进行验证以实现准确的病例定义。本方案的目的是评估国际疾病分类第九版临床修订本（ICD-9-CM）代码在三个意大利行政数据库中识别被诊断患有相关疾病患者时，对乳腺癌、肺癌和结直肠癌的准确性。
将考虑翁布里亚地区（91万居民）、那不勒斯地方卫生单位3（117万居民）和弗留利-威尼斯朱利亚地区（122.7万居民）行政数据库中的数据。在每个行政数据库中，将使用主要位置的以下几组ICD-9-CM代码识别2012年至2014年首次诊断为乳腺癌、肺癌或结直肠癌的患者：（1）233.0和（2）174.x用于乳腺癌；（3）162.x用于肺癌；（4）153.x用于结肠癌；（5）154.0 - 154.1和154.8用于直肠癌。仅考虑新发病例，即排除在感兴趣时间段之前5年（2007 - 2011年）有相同诊断的病例。将从每个行政数据库中随机抽取病例和非病例样本，并由经过培训的独立评审员对相应的病历进行配对评估以进行验证。病历中的病例确诊将基于（1）乳房、肺部或结肠直肠中存在原发性结节性病变，通过影像学或内镜检查记录，以及（2）来自原发性或转移部位的癌症的细胞学或组织学记录。将计算95%置信区间的敏感性和特异性。
研究结果将通过同行评审出版物以及在国内和国际会议上的报告广泛传播。
