Journal of clinical epidemiology
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Review Meta Analysis
A systematic review finds that methodological quality is better than its reputation but can be improved in physiotherapy trials in childhood cerebral palsy.
To identify critical issues in performing randomized controlled trials (RCTs) on complex interventions such as physiotherapy in multifaceted disabilities like cerebral palsy (CP); to systematically assess how well trials handled patient characteristics, key components of complex interventions, and outcome assessments; to make suggestions for improving the effectiveness of physiotherapy research. ⋯ We found good to fair methodological quality in a considerable number of RCTs on physiotherapy in CP children. Nevertheless, improvement is indicated for certain areas in design and performance of future studies. This review shows that informative RCTs on complex interventions for multifaceted disabilities are feasible.
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To evaluate the methodological robustness of patient-reported outcomes (PROs) evaluation in complementary and alternative medicine (CAM) randomized controlled trials (RCTs) in oncology. ⋯ To facilitate the interpretation of results from such CAM RCTs, investigators are encouraged to pay greater attention to key methodological issues as identified in this study.
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Controlled trials that use randomized allocation are the best tool to control for bias and confounding in trials testing clinical interventions. Investigators must be sure to include information that is required by the reader to judge the validity and implications of the findings in the reports of these trials. In part, complete reporting of trials will allow clinicians to modify their clinical practice to reflect current evidence toward the improvement of clinical outcomes. ⋯ We expect that these recommendations will lead to more complete and accurate reporting of herbal trials. We wrote this explanatory document to outline the rationale for each recommendation and to assist authors in using them by providing the CONSORT items and the associated elaboration, together with examples of good reporting and empirical evidence, where available, for each. These recommendations for the reporting of herbal medicinal products presented here are open to revision as more evidence accumulates and critical comments are collected.
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To illustrate the effects of different methods for handling missing data--complete case analysis, missing-indicator method, single imputation of unconditional and conditional mean, and multiple imputation (MI)--in the context of multivariable diagnostic research aiming to identify potential predictors (test results) that independently contribute to the prediction of disease presence or absence. ⋯ In multivariable diagnostic research complete case analysis and the use of the missing-indicator method should be avoided, even when data are missing completely at random. MI methods are known to be superior to single imputation methods. For our example study, the single imputation methods performed equally well, but this was most likely because of the low overall number of missing values.
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To propose and test a simple instrument based on seven criteria of study design to distinguish effectiveness (pragmatic) from efficacy (explanatory) trials. ⋯ When applied in a standardized manner, our proposed criteria can provide a valid and simple tool to distinguish effectiveness from efficacy studies. The applicability of systematic reviews can improve when analysts place more emphasis on the generalizability of included studies. In addition, clinicians can also use our criteria to determine the external validity of individual studies, given an appropriate population of interest.