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      Factors Associated With High-Quality Guidelines for the Pharmacologic Management of Chronic Diseases in Primary Care : A Systematic Review

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          Abstract

          As the rate of publication of new and sometimes conflicting medical research increases, clinicians rely heavily on clinical practice guidelines (CPGs) to inform practice. However, CPGs are of widely variable quality, and there are no existing objective measures to rate the quality of CPGs.

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          Most cited references38

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          AGREE II: advancing guideline development, reporting and evaluation in health care.

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            Is Open Access

            A literature review on the representativeness of randomized controlled trial samples and implications for the external validity of trial results

            Randomized controlled trials (RCTs) are conducted under idealized and rigorously controlled conditions that may compromise their external validity. A literature review was conducted of published English language articles that reported the findings of studies assessing external validity by a comparison of the patient sample included in RCTs reporting on pharmaceutical interventions with patients from everyday clinical practice. The review focused on publications in the fields of cardiology, mental health, and oncology. A range of databases were interrogated (MEDLINE; EMBASE; Science Citation Index; Cochrane Methodology Register). Double-abstract review and data extraction were performed as per protocol specifications. Out of 5,456 de-duplicated abstracts, 52 studies met the inclusion criteria (cardiology, n = 20; mental health, n = 17; oncology, n = 15). Studies either performed an analysis of the baseline characteristics (demographic, socioeconomic, and clinical parameters) of RCT-enrolled patients compared with a real-world population, or assessed the proportion of real-world patients who would have been eligible for RCT inclusion following the application of RCT inclusion/exclusion criteria. Many of the included studies concluded that RCT samples are highly selected and have a lower risk profile than real-world populations, with the frequent exclusion of elderly patients and patients with co-morbidities. Calculation of ineligibility rates in individual studies showed that a high proportion of the general disease population was often excluded from trials. The majority of studies (n = 37 [71.2 %]) explicitly concluded that RCT samples were not broadly representative of real-world patients and that this may limit the external validity of the RCT. Authors made a number of recommendations to improve external validity. Findings from this review indicate that there is a need to improve the external validity of RCTs such that physicians treating patients in real-world settings have the appropriate evidence on which to base their clinical decisions. This goal could be achieved by trial design modification to include a more representative patient sample and by supplementing RCT evidence with data generated from observational studies. In general, a thoughtful approach to clinical evidence generation is required in which the trade-offs between internal and external validity are considered in a holistic and balanced manner. Electronic supplementary material The online version of this article (doi:10.1186/s13063-015-1023-4) contains supplementary material, which is available to authorized users.
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              The AGREE Reporting Checklist: a tool to improve reporting of clinical practice guidelines

              AGREE II is a widely used standard for assessing the methodological quality of practice guidelines. This article describes the development of the AGREE Reporting Checklist, which was designed to improve the quality of practice guideline reporting and aligns with AGREE II in its structure and content.
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                Author and article information

                Journal
                JAMA Internal Medicine
                JAMA Intern Med
                American Medical Association (AMA)
                2168-6106
                February 18 2019
                Affiliations
                [1 ]Departamento de Farmácia, Faculdade de Ciências Farmacêuticas, Universidade de São Paulo, São Paulo, Brazil
                [2 ]Departamento de Medicina Preventiva, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil
                [3 ]Departamento de Ciências Farmacêuticas, Instituto de Ciências Ambientais, Químicas e Farmacêuticas, Universidade Federal de São Paulo, Diadema, São Paulo, Brazil
                [4 ]Departamento de Políticas e Gestão e Saúde, Faculdade de Saúde Pública Universidade de São Paulo, São Paulo, Brazil
                [5 ]Departamento de Saúde Pública, Universidade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre, Brazil
                Article
                10.1001/jamainternmed.2018.7529
                30776060
                4b406867-5fff-4b4e-be06-d8e24b5a0276
                © 2019
                History

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