Journal of clinical epidemiology
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Lack of standardization of outcome measures limits the usefulness of clinical trial evidence to inform health care decisions. This can be addressed by agreeing on a minimum core set of outcome measures per health condition, containing measures relevant to patients and decision makers. Since 1992, the Outcome Measures in Rheumatology (OMERACT) consensus initiative has successfully developed core sets for many rheumatologic conditions, actively involving patients since 2002. Its expanding scope required an explicit formulation of its underlying conceptual framework and process. ⋯ The OMERACT Filter 2.0 explicitly describes a comprehensive conceptual framework and a recommended process to develop core outcome measurement sets for rheumatology likely to be useful as a template in other areas of health care.
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This is the first reported study to determine the minimal clinically important difference (MCID) of Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog), a validated subjective neuropsychological instrument designed to evaluate cancer patients' perceived cognitive deterioration. ⋯ The estimates of 6.9-10.6 points as MCID can facilitate the interpretation of patient-reported cognitive deterioration and sample size estimates in future studies.
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The Grading of Recommendations Assessment, Development and Evaluation (GRADE) Working Group developed an approach to assess the quality of evidence of diagnostic tests. Its use in Cochrane diagnostic test accuracy reviews is new. We applied this approach to three Cochrane reviews with the aim of better understanding the application of the GRADE criteria to such reviews. ⋯ The perspective from which evidence is graded can influence judgments about quality. Guidance on application of GRADE to comparative test reviews and on the GRADE criteria of inconsistency, imprecision, and publication bias will facilitate the operationalization of GRADE for diagnostics.
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Nonrandomized studies (NRSs) are considered to provide less reliable evidence for intervention effects. However, these are included in Cochrane reviews, despite discouragement. There has been no evaluation of when and how these designs are used. Therefore, we conducted an overview of current practice. ⋯ Most Cochrane reviews do not justify including NRS. When they do, most are not in line with Cochrane recommendations. Risk of bias assessment varies across reviews and needs improvement.
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Expert guideline panelists are sometimes reluctant to offer weak/conditional/contingent recommendations. Grading of Recommendations Assessment, Development and Evaluation (GRADE) guidance warns against strong recommendations when confidence in effect estimates is low or very low, suggesting that such recommendations may seldom be justified. We aim to characterize the classification of strength of recommendations and confidence in estimates in World Health Organization (WHO) guidelines that used the GRADE approach and graded both strength and confidence (GRADEd). ⋯ Strong recommendations based on low or very low confidence estimates are very frequently made in WHO guidelines. Further study to determine the reasons for such high uncertainty recommendations is warranted.