LARGE-SCALE, PROSPECTIVE, OBSERVATIONAL STUDIES IN PATIENTS WITH PSORIASIS AND PSORIATIC ARTHRITIS- A SYSTEMATIC AND CRITICAL REVIEW.
Author(s)
Langham S1, Langham J2, Goertz HP3, Ratcliffe M11PHMR Consulting, London, United Kingdom, 2London School of Hygiene and Tropical Medicine, London, United Kingdom, 3Novartis Pharma AG, Basel, Switzerland
Background: Observational studies, if conducted appropriately, play an important role in the decision-making process providing invaluable information on effectiveness, patient-reported outcomes and costs in a real-world environment. Objective: A systematic review of large-scale, prospective, cohort studies with the aim of (a) summarising design characteristics, the interventions or aspects of the disease studied and the outcomes measured and (b) investigating methodological quality. Methods: We included prospective, cohort studies which included at least 100 adults with psoriasis or psoriatic arthritis. Studies were identified through searches in electronic databases (Pubmed, Medline, Cochrane library, Centre for Reviews and Dissemination). Information on study characteristics were extracted and tabulated and quality assessment, using a checklist of 18 questions, was conducted.Results: Thirty five papers covering 16 cohorts met the inclusion criteria. There were 10 treatment-related studies, only 2 of which provided a comparison between treatments, and 6 non-treatment studies which examined a number of characteristics of the disease including mortality, morbidity, cost of illness and health-related quality of life. All studies included a clinical outcome measure and 11 included patient-reported outcomes, however only two studies reported information on patient utilities and two on costs. Quality ranged from 41% to 89%. Studies did well on a number of quality assessment questions including having clear objectives, documenting selection criteria, providing a representative sample, defining interventions/characteristics under study, defining and using appropriate outcomes, describing results clearly and using appropriate statistical tests. The quality assessment criteria least adhered to involved questions regarding sample size calculations, describing potential selection bias, defining and adjusting for confounders and losses to follow-up, and defining and describing a comparison group. Conclusion: The review highlights the need for well designed prospective observational studies on the effectiveness, patient-reported outcomes and economic impact of treatment regimes for patients with psoriasis and psoriatic arthritis in a real-world environment.
Conference/Value in Health Info
2010-05, ISPOR 2010, Atlanta, GA, USA
Value in Health, Vol. 13, No. 3 (May 2010)
Code
PSY60
Topic
Methodological & Statistical Research
Topic Subcategory
Modeling and simulation
Disease
Sensory System Disorders, Systemic Disorders/Conditions