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Variability and completeness of outcome reporting in studies for low back pain rehabilitation interventions: a survey of trials included in Cochrane reviews

Date and Location




Sunday 22 September 2013 - 10:30 - 12:00


Presenting author and contact person

Presenting author

Silvia Gianola

Contact person

Silvia Gianola
Abstract text
Background: The selection of appropriate outcomes or domains is crucial when designing clinical trials in order to compare directly the effects of different interventions in ways that minimize bias. Objectives: We aimed to assess the frequency and completeness of outcome measures in randomized controlled trials (RCTs) included in Cochrane systematic reviews (SRs) focused on rehabilitation interventions for low back pain. Methods: We performed a cross-sectional study of all RCTs included in 11 Cochrane SRs. Data extraction exploring frequency and completeness (full, partial or incomplete) was independently evaluated by two raters. Our outcomes were: the cumulative frequency of outcomes across RCTs and the proportion of outcomes rated as fully replicable. Results: The provisional results are derived from a random sampled of one-third (n=60) of the 190 RCTs. Overall forty-two outcomes were investigated. The outcomes most commonly reported were pain [in 52 RCTs (86,7%)] and disability [in 49 RCTs (81,7%)] measured respectively by 34 and 15 different measurement instruments. An half of RCTs described the methodological procedure to assess the outcome as blinded (50 %), in a few less the procedure was unclear (43,3%) and few reported not blinded (6,7%). For 50% of the RCTs the outcome description was considered sufficient to allow replication. Conclusions: In our preliminary results, we reported a large number of outcome measures and a myriad of measurement instruments used with better opportunities to the standardization of approaches. Most times the outcomes reporting was complete. In other cases was partial or incomplete. Initiatives to ensure quality assurance of outcomes in rehabilitation trials should be encouraged.