Abstract
BackgroundRandomized controlled trials (RCTs) are not always well reported, especially in terms of their methodological descriptions. This study aimed to investigate the adherence of methodological reporting complying with CONSORT and explore associated trial level variables in the Chinese nursing care field.MethodsIn June 2012, we identified RCTs published in five leading Chinese nursing journals and included trials with details of randomized methods. The quality of methodological reporting was measured through the methods section of the CONSORT checklist and the overall CONSORT methodological items score was calculated and expressed as a percentage. Meanwhile, we hypothesized that some general and methodological characteristics were associated with reporting quality and conducted a regression with these data to explore the correlation. The descriptive and regression statistics were calculated via SPSS 13.0.ResultsIn total, 680 RCTs were included. The overall CONSORT methodological items score was 6.34±0.97 (Mean ± SD). No RCT reported descriptions and changes in “trial design,” changes in “outcomes” and “implementation,” or descriptions of the similarity of interventions for “blinding.” Poor reporting was found in detailing the “settings of participants” (13.1%), “type of randomization sequence generation” (1.8%), calculation methods of “sample size” (0.4%), explanation of any interim analyses and stopping guidelines for “sample size” (0.3%), “allocation concealment mechanism” (0.3%), additional analyses in “statistical methods” (2.1%), and targeted subjects and methods of “blinding” (5.9%). More than 50% of trials described randomization sequence generation, the eligibility criteria of “participants,” “interventions,” and definitions of the “outcomes” and “statistical methods.” The regression analysis found that publication year and ITT analysis were weakly associated with CONSORT score.ConclusionsThe completeness of methodological reporting of RCTs in the Chinese nursing care field is poor, especially with regard to the reporting of trial design, changes in outcomes, sample size calculation, allocation concealment, blinding, and statistical methods.
Highlights
The randomized controlled trial (RCT) is the most appropriate design for evaluating the effectiveness of a nursing intervention among eligible primary study designs for evidence-based practice [1]
The extraction form included (1) general characteristics [5] and a description of the interventions [19], including length of descriptions of interventions and controls in words and the reproducibility of the interventions, which authors evaluated by assessing whether the intervention was described in enough detail to be reproducible; (2) Consolidated Standards of Reporting Trials (CONSORT) methodological items; and (3) methodological quality measurements [20], including allocation concealment and intention-to-treat (ITT) analysis
We explored the association of predictors, including general characteristics and methodological quality measurements, with CONSORT methodological score with a linear regression and found that publication year and ITT analysis were weakly associated with CONSORT score
Summary
The randomized controlled trial (RCT) is the most appropriate design for evaluating the effectiveness of a nursing intervention among eligible primary study designs for evidence-based practice [1]. Evidence-based nursing practitioners believe that randomization and unbiased allocation of interventions assure methodological quality and the subsequent findings of RCTs [2,3]. The CONSORT guidelines have been associated with improving the quality of RCT reporting [7]. Randomized controlled trials (RCTs) are not always well reported, especially in terms of their methodological descriptions. This study aimed to investigate the adherence of methodological reporting complying with CONSORT and explore associated trial level variables in the Chinese nursing care field
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