Objective: To determine whether the adoption of the CONSORT checklist is associated with improvement in the quality of reporting of randomised controlled trials (RCTs). Data sources: MEDLINE, EMBASE, Cochrane CENTRAL, and reference lists of included studies and of experts were searched to identify eligible studies published between 1996 and 2005. Study selection: Studies were eligible if they (a) compared CONSORT‐adopting and non‐adopting journals after the publication of CONSORT, (b) compared CONSORT adopters before and after publication of CONSORT, or (c) a combination of (a) and (b). Outcomes examined included reports for any of the 22 items on the CONSORT checklist or overall trial quality. Data synthesis: 1128 studies were retrieved, of which 248 were considered possibly relevant. Eight studies were included in the review. CONSORT adopters had significantly better reporting of the method of sequence generation (risk ratio [RR], 1.67; 95% CI, 1.19–2.33), allocation concealment (RR, 1.66; 95% CI, 1.37–2.00) and overall number of CONSORT items than non‐adopters (standardised mean difference, 0.83; 95% CI, 0.46–1.19). CONSORT adoption had less effect on reporting of participant flow (RR, 1.14; 95% CI, 0.89–1.46) and blinding of participants (RR, 1.09; 95% CI, 0.84–1.43) or data analysts (RR, 5.44; 95% CI, 0.73–36.87). In studies examining CONSORT‐adopting journals before and after the publication of CONSORT, description of the method of sequence generation (RR, 2.78; 95% CI, 1.78–4.33), participant flow (RR, 8.06; 95% CI, 4.10–15.83), and total CONSORT items (standardised mean difference, 3.67 items; 95% CI, 2.09–5.25) were improved after adoption of CONSORT by the journal. Conclusions: Journal adoption of CONSORT is associated with improved reporting of RCTs.
BackgroundSearch filters or hedges play an important role in evidence-based medicine but their development depends on the availability of a "gold standard" – a reference standard against which to establish the performance of the filter. We demonstrate the feasibility of using relative recall of included studies from multiple systematic reviews to validate methodological search filters as an alternative to validation against a gold standard formed through hand searching.MethodsWe identified 105 Cochrane reviews that used the Highly Sensitive Search Strategy (HSSS), included randomized or quasi-randomized controlled trials, and reported their included studies. We measured the ability of two published and one novel variant of the HSSS to retrieve the MEDLINE-index studies included in these reviews.ResultsThe systematic reviews were comprehensive in their searches. 72% of included primary studies were indexed in MEDLINE. Relative recall of the three strategies ranged from .98 to .91 across all reviews and more comprehensive strategies showed higher recall.ConclusionAn approach using relative recall instead of a hand searching gold standard proved feasible and produced recall figures that were congruent with previously published figures for the HSSS. This technique would permit validation of a methodological filter using a collection of approximately 100 studies of the chosen design drawn from the included studies of multiple systematic reviews that used comprehensive search strategies.
Spinal anaesthesia is the primary anaesthetic technique for many types of surgery. Adjuncts to the local anaesthetics (LA) used in spinal anaesthesia can exhibit undesirable side-effects, limiting their use, but magnesium may have advantages in this respect. We sought randomized control trials (RCTs) in patients undergoing all types of surgery and in women in labour to compare the effect of intrathecal magnesium sulphate ± LA ± lipophilic opioid (experimental group) with the use of either intrathecal lipophilic opioids ± LA or LA only (control group). The primary outcome was the duration of spinal anaesthesia. Secondary outcomes were: onset and time to maximal sensory blockade, onset of motor block, and duration of sensory and motor blockade. We found 15 RCTs comprising 980 patients. The duration of spinal anaesthesia was significantly increased in the experimental group [standardized mean difference (SMD) -1.05 (-1.70, -0.41) (P = 0.001)], compared with the control group. This increased duration of spinal anaesthesia was seen in non-obstetric studies, SMD -1.38 (-2.11, -0.66) (P = 0.0002), but not in obstetric studies, SMD -0.55 (-1.87, 0.77) (P = 0.41). There was no delay in the onset of sensory or motor blockade. The incidence of hypotension and pruritus was similar in both groups. Heterogeneity was high in all outcome measures. The duration of spinal anaesthesia may be increased by the addition of magnesium to lipophilic opioids ± LA.
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