Bmc Med Res Methodol
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Bmc Med Res Methodol · May 2016
Multicenter Study Clinical TrialImplementing a complex rehabilitation intervention in a stroke trial: a qualitative process evaluation of AVERT.
The implementation of multidisciplinary stroke rehabilitation interventions is challenging, even when the intervention is evidence-based. Very little is known about the implementation of complex interventions in rehabilitation clinical trials. The aim of study was to better understand how the implementation of a rehabilitation intervention in a clinical trial within acute stroke units is experienced by the staff involved. This qualitative process evaluation was part of a large Phase III stroke rehabilitation trial (AVERT). ⋯ The AVERT stroke rehabilitation trial required commitment to deliver an intervention that needed strong collaboration between nurses and physiotherapists and was different to current care models. This qualitative process evaluation contributes unique insights into factors that may be critical to successful trials teams, and as AVERT was a pragmatic trial, success factors to delivering complex intervention in clinical practice.
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Bmc Med Res Methodol · Apr 2016
Review Comparative StudyA scoping review of indirect comparison methods and applications using individual patient data.
Several indirect comparison methods, including network meta-analyses (NMAs), using individual patient data (IPD) have been developed to synthesize evidence from a network of trials. Although IPD indirect comparisons are published with increasing frequency in health care literature, there is no guidance on selecting the appropriate methodology and on reporting the methods and results. ⋯ One in three indirect comparison methods modeling IPD adjusted results from different trials to estimate effects as if they had come from the same, randomized, population. Key methodological and reporting elements (e.g., evaluation of consistency, existence of study protocol) were often missing from an indirect comparison paper.
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Bmc Med Res Methodol · Apr 2016
Comparative StudyExploring how individuals complete the choice tasks in a discrete choice experiment: an interview study.
To be able to make valid inferences on stated preference data from a Discrete Choice Experiment (DCE) it is essential that researchers know if participants were actively involved, understood and interpreted the provided information correctly and whether they used complex decision strategies to make their choices and thereby acted in accordance with the continuity axiom. ⋯ The majority of the participants seemed to have understood the provided information about the choice tasks, the attributes, and the levels. They used complex decision strategies (continuity axiom) and are therefore capable to adequately complete a DCE. However, based on the participants' age, educational level and health literacy additional, actions should be undertaken to ensure that participants understand the choice tasks and complete the DCE as presumed.
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Bmc Med Res Methodol · Apr 2016
Comparative StudySingle time point comparisons in longitudinal randomized controlled trials: power and bias in the presence of missing data.
The primary analysis in a longitudinal randomized controlled trial is sometimes a comparison of arms at a single time point. While a two-sample t-test is often used, missing data are common in longitudinal studies and decreases power by reducing sample size. Mixed models for repeated measures (MMRM) can test treatment effects at specific time points, have been shown to give unbiased estimates in certain missing data contexts, and may be more powerful than a two sample t-test. ⋯ Investigators interested in single time point comparisons should use a MMRM with a contrast to gain power and unbiased estimation of treatment effects instead of a complete-case two sample t-test.
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Bmc Med Res Methodol · Apr 2016
Comparative StudyValidation and reliability of a guideline appraisal mini-checklist for daily practice use.
The use of comprehensive instruments for guideline appraisal is time-consuming and requires highly qualified personnel. Since practicing physicians are generally busy, the rapid-assessment Mini-Checklist (MiChe) tool was developed to help them evaluate the quality and utility of guidelines quickly. The aim of this study was to validate the MiChe in comparison to the AGREE II instrument and to determine its reliability as a tool for guideline appraisal. ⋯ The MiChe performed well in comparison to AGREE II and is suitable for the rapid evaluation of guideline quality and utility in practice.