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Quality of reporting of randomized clinical trials in implant dentistry. A systematic review on critical aspects in design, outcome assessment and clinical relevance

2012; Wiley; Volume: 39; Issue: s12 Linguagem: Inglês

10.1111/j.1600-051x.2011.01839.x

1600-051X

Francesco Cairo, Ignacio Sanz‐Sánchez, Paula Matesanz, Michele Nieri, Umberto Pagliaro,

Health Systems, Economic Evaluations, Quality of Life

Abstract Background The aim of this systematic review ( SR ) was to assess the quality of reporting randomized clinical trials ( RCT s) in the field of implant dentistry, its evolution over time and the possible relations between quality items and reported outcomes. Material and Methods RCT s in implant dentistry were retrieved through electronic and hand searches. Risk of bias in individual studies was assessed focusing on study design, outcome assessment and clinical relevance. Associations between quality items and year of publication of RCT s or reporting of statistically significant outcomes were tested. Results Among the 495 originally screened manuscripts published from 1989 to April 2011, 276 RCT s were assessed in this SR ; 59% of them were published between 2006 and 2011. RCT s were mainly parallel (65%), with a single centre (83%) and a superiority design (88%). Trials in implant dentistry showed several methodological flaws: only 37% showed a random sequence generation at low risk of bias, 75% did not provide information on allocation concealment, only 12% performed a correct sample size calculation, the examiner was blind solely in 42% of studies where blinding was feasible. In addition, only 21% of RCT s declared operator experience and 31% reported patient‐related outcomes. Many quality items improved over time. Allocation concealment at high risk of bias ( p = 0.0125), no information on drop‐out (p = 0.0318) and lack of CONSORT adherence ( p = 0.0333) were associated with statistically significant reported outcomes. Conclusions The overall quality of reporting of RCT s in implant dentistry is poor and only partially improved in the last years. Caution is suggested when interpreting these RCT s since risk of bias was associated with higher chance of reporting of statistically significant results.