Background: Follow-up for diagnostic research studies might be facilitated if medical record review (MRR) could be used instead of telephone calls.
Objectives: The authors hypothesized that MRR would yield similar accuracy to telephone follow-up.
Methods: This was a secondary analysis of 2,178 initially disease-free patients who were followed after enrollment in a diagnostic study of either acute coronary syndrome (45 days) or pulmonary embolism (90 days) conducted in an urban teaching emergency department (ED). Disease status (positive or negative) was defined explicitly. Using structured data forms, trained researchers performed MRR using a comprehensive electronic database, and formulated an opinion about disease status. Trained researchers, blinded to the MRR, then dialed telephone numbers, asked questions from a script, and categorized disease status. The criterion standard was adjudication by consensus of two of three physicians who independently determined disease status based on explicit criteria and access to all follow-up data.
Results: Adjudicators found that 13 of 2,178 patients developed disease during follow-up; all 13 true positives occurred among the 2,054 (94.3%) of patients who acknowledged intent to return to the study hospital. Telephone follow-up was successful in 81% of patients, and found all 13 true positives (sensitivity 100%) but with three additional false-positive cases. MRR disclosed 12 of 13 cases of disease (sensitivity 92%) with no false-positive cases. Further review of the one false-negative case from MRR revealed that it occurred after the prescribed time limit for follow-up.
Conclusions: Under limited circumstances, accurate clinical follow-up for diagnostic studies conducted in the ED can be obtained by medical record review.