Journal of clinical epidemiology
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To describe the inaugural comparative effectiveness research (CER) cohort study of Washington State's Comparative Effectiveness Research Translation Network (CERTAIN), which compares invasive with noninvasive treatments for peripheral artery disease, and to focus on the patient centeredness of this cohort study by describing it within the context of a newly published conceptual framework for patient-centered outcomes research (PCOR). ⋯ The CERTAIN's inaugural cohort study may serve as a useful model for conducting PCOR and creating a learning health care network.
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To raise awareness among clinicians and epidemiologists that single-patient (n-of-1) trials are potentially useful for informing personalized treatment decisions for patients with chronic conditions. ⋯ Single-patient trials may be poised to emerge as an important part of the methodological armamentarium for comparative effectiveness research and patient-centered outcomes research. By permitting direct estimation of individual treatment effects, they can facilitate finely graded individualized care, enhance therapeutic precision, improve patient outcomes, and reduce costs.
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As psychopathology and social functioning can worsen with repeated psychotic episodes in schizophrenia, relapse prevention is critical. Because high nonadherence rates limit the efficacy of pharmacotherapy, the use of long-acting injectable (LAI) antipsychotics is considered an important treatment option. To date, many studies comparing LAIs and oral antipsychotics have been conducted; however, the results are mixed, and careful interpretation of the data is required. ⋯ Divergent results from studies using different methodologies create a dilemma for comparative effectiveness research, and LAI studies may serve as an example of a situation in which a conventional RCT is not the gold standard. Traditional RCTs generally increase adherence compared with clinical practice and, therefore, might not be well suited to detect differences between LAIs and oral medications, because any increase in adherence affects patients on oral medications more than those on LAIs and thus leads to an underestimation of any potential difference in effectiveness. A possible solution would be the implementation of a true effectiveness trial in which post-randomization involvement would be kept to a minimum to better reflect routine practice.
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Comparative Study
Impact of immortal person-time and time scale in comparative effectiveness research for medical devices: a case for implantable cardioverter-defibrillators.
To assess the extent of immortal time bias in estimating the clinical effectiveness of implantable cardioverter-defibrillators (ICDs) and the impact of methods of handling immortal time bias. ⋯ Immortal time bias was detected in the ICD clinical effectiveness study, which might have led to substantial bias overestimating the treatment effect if handled by exclusion. When an appropriate landmark was selected, that method yielded similar hazard ratios to those obtained by the Mantel-Byar method, supporting the validity of the landmark method.
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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.