Problems with prognosis research

Prognosis research has been defined as the study of relations between occurrences of outcomes and predictors in defined populations of people with disease.1 It encompasses (ideally) prospective, observational research evaluating three broad questions—causes of disease progression, prediction of risk in individuals, and individual response to treatment. High quality prognosis research results in better understanding of disease progression, offers improved opportunities for mitigating that progression, and allows more reliable communication of outcome risk to patients.1 2 Prognosis research should be a basic science in translational medicine.

Analysing 168 reports, Malats and colleagues concluded that “after 10 years of research [including over 10 000 patients], evidence is not sufficient to conclude whether changes in P53 act as markers of outcome in patients with bladder cancer.”3 This is not an isolated example. Such concerns have been identified in systematic reviews of different types of prognostic biomarkers4 5 and across different clinical specialties and major global burdens of disease including cancer,6 coronary disease,7 stroke,8 trauma,9 and musculoskeletal disorders.10 11 Although some systematic reviews and meta-analyses of prognostic studies …