Journal of clinical epidemiology
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This article presents a new tool that helps systematic reviewers to extract and compare implementation data across primary trials. Currently, systematic review guidance does not provide guidelines for the identification and extraction of data related to the implementation of the underlying interventions. ⋯ The Oxford Implementation Index provides a framework to help reviewers assess implementation data across trials. Reviewers can use this tool to identify implementation data, extract relevant information, and compare features of implementation across primary trials in a systematic review. The index is a work-in-progress, and future efforts will focus on refining the index, improving usability, and integrating the index with other guidance on systematic reviewing.
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This article presents the current state of patient-reported outcome measures and explains new opportunities for leveraging the recent adoption of electronic health records to expand the application of patient-reported outcomes in both clinical care and comparative effectiveness research. ⋯ The science of patient-reported outcome measurement has matured sufficiently to be integrated routinely into electronic health records and other electronic health solutions to collect data on an ongoing basis for clinical care and comparative effectiveness research. Further efforts and ideally coordinated efforts from various stakeholders are needed to refine the details of the proposed framework for standardization.
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Comparative Study
Stepped wedge designs could reduce the required sample size in cluster randomized trials.
The stepped wedge design is increasingly being used in cluster randomized trials (CRTs). However, there is not much information available about the design and analysis strategies for these kinds of trials. Approaches to sample size and power calculations have been provided, but a simple sample size formula is lacking. Therefore, our aim is to provide a sample size formula for cluster randomized stepped wedge designs. ⋯ For CRTs, the stepped wedge design is far more efficient than the parallel group and ANCOVA design in terms of sample size.
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We evaluated the inter-rater reliability (IRR) of assessing the quality of evidence (QoE) using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach. ⋯ Our findings suggest that trained individuals using the GRADE approach improves reliability in comparison to intuitive judgments about the QoE and that two individual raters can reliably assess the QoE using the GRADE system.
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Competing risks endpoints are frequently encountered in hematopoietic stem cell transplantation where patients are exposed to relapse and treatment-related mortality. Both cause-specific hazards and direct models for the cumulative incidence functions have been used for analyzing such competing risks endpoints. For both approaches, the popular models are of a proportional hazards type. ⋯ We argue that a complete understanding of the event dynamics requires that both hazards and cumulative incidence be analyzed side by side, and that this is generally the most rigorous scientific approach to analyzing competing risks data. That is, understanding the effects of covariates on cause-specific hazards and cumulative incidence functions go hand in hand. A case study illustrates our proposal.