Merzenich Hiltrud, Blettner Maria, Niehoff Dorothea, Schwentner Lukas, Schmidt Marcus, Schmitt Margit, Wollschläger Daniel
Institute of Medical Biostatistics, Epidemiology and Informatics, University Medical Center Mainz, Obere Zahlbacher Str. 69, 55131, Mainz, Germany.
Department of Gynecology and Obstetrics, University Hospital Ulm, Prittwitzstr. 43, 89075, Ulm, Germany.
BMC Cardiovasc Disord. 2018 Nov 29;18(1):218. doi: 10.1186/s12872-018-0961-7.
Self-administered health-status questionnaires are important tools in epidemiology. The objective of the presented validation study is to measure the agreement between breast cancer patients' self-reports and their physicians' information on late cardiac events, and to investigate determinants of agreement. To estimate possible misclassification is an important requirement for observational studies on cardiovascular endpoints.
A retrospective, multi-center cohort study included 11,982 women diagnosed with breast cancer in Germany in 1998-2008. In 2014, a questionnaire survey assessed cardiovascular risk factors and incident cardiac events after therapy. A validation study was conducted, based on a sample of 3091 breast cancer patients from two university hospitals. Among them, 2261 women (73%) sent back the questionnaire on cardiovascular events, and 1316 women gave consent to request medical records from their general practitioners. A total of 1212/1316 (92.1%) medical records could be obtained for validation. Cohen's kappa coefficient was calculated, and multivariate regression was applied to study the influence of patient characteristics on agreement between both data sources.
Overall agreement for the composite endpoint of any cardiac event was 84.5% (kappa 0.35). Of 1055 breast cancer patients reporting no cardiac event, 950 (90%) had no such diagnosis in physicians' medical records. A total of 157 breast cancer survivors indicated a cardiac event, and the same diagnosis was confirmed by GPs for 74 (47%) women. For specific diagnoses, moderate to substantial agreement of self-reports was found for myocardial infarction (kappa 0.54) and stroke (kappa 0.61). Poor to fair agreement was present for angina pectoris, valvular heart disease, arrhythmia, and congestive heart failure. Younger age, higher education and a more recent cancer diagnosis were found to be associated with greater total agreement.
For the composite endpoint, survivors of breast cancer report the absence of cardiac disease accurately. However, for specific diagnoses, self-reported morbidity data from breast cancer patients may not fully agree with information from physicians. The agreement is moderate for acute events like myocardial infarction and stroke, but poor to fair for chronic diseases.
自我管理的健康状况问卷是流行病学中的重要工具。本验证研究的目的是衡量乳腺癌患者自我报告与医生关于晚期心脏事件信息之间的一致性，并调查一致性的决定因素。估计可能的错误分类是心血管终点观察性研究的一项重要要求。
一项回顾性多中心队列研究纳入了1998年至2008年在德国被诊断为乳腺癌的11982名女性。2014年，一项问卷调查评估了心血管危险因素和治疗后的心脏事件发生率。基于两所大学医院的3091名乳腺癌患者样本进行了一项验证研究。其中，2261名女性（73%）寄回了心血管事件问卷，1316名女性同意向其全科医生索取病历。总共获得了1212/1316（92.1%）份病历用于验证。计算了科恩kappa系数，并应用多变量回归研究患者特征对两个数据源之间一致性的影响。
任何心脏事件综合终点的总体一致性为84.5%（kappa值为0.35）。在1055名报告无心脏事件的乳腺癌患者中，950名（90%）在医生病历中无此类诊断。共有157名乳腺癌幸存者表示发生了心脏事件，全科医生对74名（47%）女性确诊了相同诊断。对于特定诊断，自我报告在心肌梗死（kappa值为0.54）和中风（kappa值为0.61）方面存在中度至高度一致性。心绞痛、心脏瓣膜病、心律失常和充血性心力衰竭的一致性较差至一般。发现年龄较小、教育程度较高和癌症诊断较新与总体一致性较高相关。
对于综合终点，乳腺癌幸存者能准确报告无心脏病情况。然而，对于特定诊断，乳腺癌患者自我报告的发病数据可能与医生的信息不完全一致。对于心肌梗死和中风等急性事件，一致性为中度，但对于慢性病则较差至一般。
