Guidelines were developed for data collection from medical records for use in retrospective analyses.

OBJECTIVE To construct a set of guidelines for data collection from medical records. STUDY DESIGN AND SETTING Retrospective analysis of clinical data is often performed by physician-scientists. In such research, the source of clinical data is the patient's medical record; however, medical records are intended for patient care and the data are not systematically recorded for research purposes. We drew on recommendations in the literature and our own experience with a retrospective cohort study that uses a DNA bank to construct guidelines for data collection from medical records. RESULTS The guidelines incorporate a number of strategies for accurate data collection, which are discussed and illustrated by application. CONCLUSION With guidelines for data collection, the quality of research data is enhanced. A well-designed case record form and a handbook for standardized data collection are essential for training the data collectors and for ensuring fastidious searching of the record; however, certain kinds of information are not always well documented in patient records. Consequently, it is essential to perform a pilot study to assess the study design and to use additional questionnaires. Correct interpretation of clinical outcomes documented in the medical records often necessitates an independent adjudication committee to prevent bias in outcome definition.