1,721,594 research outputs found

    Diagram of reliability and net gain: a new method for summarizing and displaying the results of controlled trials.

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    Sound evidence-based clinical and policy therapy recommendations depend on a process of acquiring literature, appraising it for study design and quality, and assessing its results in terms of relative benefits and harms. In this article we describe two summary metrics that have been developed to assist guideline developers to assess the importance of the quality/size of trials and the relative benefit and harm of treatments, and a related graphical method for displaying them together. To illustrate this graphic approach, we have used the evidence base for drug therapies for neuropathic pain. "Reliability" is calculated from the sample size and quality of trials, while the second metric, "Net Gain," is calculated from the relative benefit and harm of each trial. The graphical method differentiated the evidence for neuropathic pain drugs. This graphical output provides a simple and relatively easy way to understand summary of information on large amounts of trial data across a number of therapies, which may present an impression of the evidence at a glance even for a non-expert. The usefulness of this graphical approach needs to be tested in the development of future clinical guidelines

    Validation of surrogate end points for overall survival in advanced colorectal cancer: a harmonized approach is needed

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    A letter invited from the Editors as a response to a comment on a previous article published by us in the same journal

    Development of a framework and decision tool for the evaluation of health technologies based on surrogate endpoint evidence

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    In the drive toward faster patient access to treatments, health technology assessment (HTA) agencies and payers are increasingly faced with reliance on evidence based on surrogate endpoints, increasing decision uncertainty. Despite the development of a small number of evaluation frameworks, there remains no consensus on the detailed methodology for handling surrogate endpoints in HTA practice. This research overviews the methods and findings of four empirical studies undertaken as part of COMED (Pushing the Boundaries of Cost and Outcome Analysis of Medical Technologies) program work package 2 with the aim of analyzing international HTA practice of the handling and considerations around the use of surrogate endpoint evidence. We have synthesized the findings of these empirical studies, in context of wider contemporary body of methodological and policy-related literature on surrogate endpoints, to develop a web-based decision tool to support HTA agencies and payers when faced with surrogate endpoint evidence. Our decision tool is intended for use by HTA agencies and their decision-making committees together with the wider community of HTA stakeholders (including clinicians, patient groups, and healthcare manufacturers). Having developed this tool, we will monitor its use and we welcome feedback on its utility
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