[Outcomes research: definitions, methods and challenges in trauma and orthopaedic surgery].

BACKGROUND: Besides basic, illness- and patient-oriented research, outcomes research is regarded as the fourth pillar of modern health care systems. Outcomes research investigates both the desirable and adverse effects of medical and surgical interventions under day-to-day conditions.
METHOD: Because of rigorous entry criteria and selection of eligible subjects, the efficacy of a certain treatment derived from clinical experiments (i.e. classic randomized trials) may not necessarily be transferred to common patient populations or clinical settings. Apart from efficacy, a valuable (thus reimbursable) diagnostic or therapeutic procedure must prove its effectiveness in clinical practice as well. Demanding study designs are necessary to model effectiveness and to separate the observed intervention-related effects from bias and confounding.
RESULTS: Registries and pragmatic randomized trials may represent the most appropriate modalities to establish outcomes research in trauma and orthopaedic surgery. Good examples for interventions still needing proof of effectiveness are kyphoplasty and vertebroplasty, navigated surgery, damage control, interlocking implants and bone growth factors. Revealing over- and undersupply, generating negative lists (i.e. interventions of questionable or almost nil effectiveness) and integrating patients as co-therapists requires networking between hospitals and private practitioners.
CONCLUSION: Also, since outcomes research is a societal need, its development and funding must be ensured by all providers and payers of health care services.