User-only design to assess drug effectiveness in clinical practice: application to bisphosphonates and secondary prevention of fractures

Autori: Corrao G, Ghirardi A, Segafredo G, Zambon A, Della Vedova G, Lapi F, Cipriani F, Caputi A, Vaccheri A, Gregori D, Gesuita R, Vestri A, Staniscia T, Mazzaglia G, Di Bari M; BEST investigators
Rivista: Pharmacoepidemiol Drug Saf. 2014 Aug;23(8):859-67


PURPOSE: Different strategies applicable to control for confounding by indication in observational studies were compared in a large population-based study regarding the effect of bisphosphonates (BPs) for secondary prevention of fractures.

METHODS: The cohort was drawn from healthcare utilization databases of 13 Italian territorial units. Patients aged 55 years or more who were hospitalized for fracture during 2003-2005 entered into the cohort. A nested case-control design was used to compare BPs use in cohort members who did (cases) and who did not
experience (controls) a new fracture until 2007 (outcome). Three designs were employed: conventional-matching (D1 ), propensity score-matching (D2 ), and user-only (D3 ) designs. They differed for (i) cohort composition, restricted to patients who received BPs straight after cohort entry (D3 ); (ii) using propensity score for case-control matching (D2 ); and (iii) compared groups of BPs users versus no users (D1 and D2 ) and long-term versus short-term users (D3)...


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