Classifying the diagnosis of study participants in clinical trials: a structured and efficient approach.

European Radiology Experimental
Tjitske S R van EngelenOPTIMACT Study Group

Abstract

A challenge in imaging research is a diagnostic classification of study participants. We hypothesised that a structured approach would be efficient and that classification by medical students, residents, and an expert panel whenever necessary would be as valid as classification of all patients by experts. OPTIMACT is a randomised trial designed to evaluate the effectiveness of replacing chest x-ray for ultra-low-dose chest computed tomography (CT) at the emergency department. We developed a handbook with diagnostic guidelines and randomly selected 240 cases from 2,418 participants enrolled in OPTIMACT. Each case was independently classified by two medical students and, if they disagreed, by the students and a resident in a consensus meeting. Cases without consensus and cases classified as complex were assessed by a panel of medical specialists. To evaluate the validity, 60 randomly selected cases not referred to the panel by the students and the residents were reassessed by the specialists. Overall, the students and, if necessary, residents were able to assign a diagnosis in 183 of the 240 cases (76% concordance; 95% confidence interval [CI] 71-82%). We observed agreement between students and residents versus medical specialist...Continue Reading

References

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Jun 30, 2009·BMJ : British Medical Journal·Wytze LamérisUNKNOWN OPTIMA study group
Sep 21, 2010·Radiology·Alexander A BankierHerbert Y Kressel

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Methods Mentioned

BETA
x-ray

Software Mentioned

OPTIMACT
SPSS

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