171 Classifying study participants in clinical trials writing. If all panel members who were involved on a paper case vignette agreed on the diagnostic label(s), the participant was classified accordingly. If not, three members of the research team (TvE, MK, JP) assessed the case for procedural errors. All remaining disagreements were discussed in a plenary meeting by the internist, pulmonologist, and chest radiologist, until consensus was reached. It was the role of the chest radiologist to reassess images on the spot, when deemed necessary. The meeting was chaired as previously described. To validate the diagnoses assigned by students and residents, we randomly selected 30 cases classified by students and 30 cases classified during the consensus meeting of students and a resident. These 60 cases were reassessed and classified by the expert panel in a similar method as previously described. Outcome variables The primary outcomes of the evaluation were the efficiency of the structured approach and the validity of classifications by the medical students and residents. Efficiency was defined as the percentage of participants to whom a diagnosis could be assigned by the students and residents without evaluation by the expert panel. As the OPTIMACT trial focuses on thoracic pathology, disagreements on extrathoracic pathology were ignored. To illustrate the efficiency of our method we calculated the reduction in working hours needed by medical specialists to classify the entire OPTIMACT study group of 2,418 Step 1 Independent assessment by two medical students per patient Agreement by students Step 2 Plenary consensus meeting including a resident Step 3 Plenary consensus meeting of medical specialists Cohort clinical trial n = 2,418 Random selection of cases n = 240 (100%) Partial agreement Agreement by students/resident Complex case Classification by medical specialists Reassessment by medical specialists of 60 cases Agreement with students/residents n = 50 (83%) Random selection 30 cases Random selection 30 cases Total disagreement Complex case EFFICIENCY VALIDITY n = 25 (10%) n = 33 (14%) n = 75 (31%) n = 107 (45%) n = 76 (32%) n = 32 (13%) n = 57 (24%) Figure 1. Study design and main results 8
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