GRADE Guidelines: 16. GRADE evidence to decision frameworks for tests in clinical practice and public health

Schünemann, Holger J.; Mustafa, Reem A.; Brožek, Jan; Santesso, Nancy; Alonso‐Coello, Pablo; Scholten, R. J. P. M.; Langendam, Miranda; Bossuyt, Patrick M.; Leeflang, Mariska; Akl, Elie A.; Singh, Jasvinder A; Meerpohl, Joerg J; Hultcrantz, Monica; Guyatt, Gordon; Oxman, Andrew D; Lange, Stefan; Parmelli, Elena; Moberg, Jenny; Rosenbaum, Sarah; Brignardello‐Petersen, Romina; Wiercioch, Wojtek; Davoli, Marina; Nowak, Artur; Dietl, Bart

doi:10.1016/j.jclinepi.2016.01.032

Cited by 355 publications

(403 citation statements)

References 33 publications

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“…97 The same is true for GRADE (Grading of Recommendations Assessment, Development and Evaluation) guidelines. [98][99][100] Unless a clinical practice guideline working group specifically asks a question about evidence-based sex and gender differences, it is unlikely that the correct search terms will be used to query the literature.…”

Section: Discussionmentioning

confidence: 99%

Sex and gender considerations in Canadian clinical practice guidelines: a systematic review

et al. 2017

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Background:The importance of sex and gender in the diagnosis and management of health conditions is well established, but the extent to which this evidence is integrated into clinical practice guidelines remains unknown. We aimed to determine the proportion of Canadian clinical practice guidelines that integrate evidence on sex and gender considerations. Methods:We searched the Canadian Medical Association's CPG Infobase, PubMed, all provincial/territorial websites and websites of professional organizations for English-and French-language Canadian clinical practice guidelines published between January 2013 and June 2015 on selected conditions identified as priorities by policy-makers and practitioners. Citations and text were searched electronically using keyword terms related to sex and gender. Three investigators independently analyzed and categorized the content of text-positive clinical practice guidelines based on clinical relevance for practitioners. Results:Of the 118 clinical practice guidelines that met the inclusion criteria, 79 (66.9%) were text-positive for sex and/or gender keywords; 8 (10%) of the 79 used the keywords only in relation to pregnancy. Of the remaining 71 guidelines, 25 (35%) contained sex-related diagnostic or management recommendations. An additional 5 (7%) contained recommendations for sex-specific laboratory reference values, 29 (41%) referred to differences in epidemiologic features or risk factors only, and 12 (17%) contained nonrelevant mentions of search keywords. Twenty-five (35%) of the text-positive guidelines used the terms "sex" and/or "gender" correctly. higher in women than in men, with increased risk of driving impairment. 19 Rochon and colleagues 20 discovered that, in Ontario, men with dementia who were prescribed antipsychotic drugs had significantly higher risks for hospital admission and death than did women with dementia. Similarly, social risk factors are associated with higher rates of suicide in older men, which suggests that more aggressive screening and treatment may be required. [21][22][23] The extent to which evidence about sex and gender is integrated into clinical practice guidelines for diagnosis and management of diseases remains unknown. We conducted a systematic review to investigate the integration of sex and gender evidence into Canadian clinical practice guidelines published between 2013 and 2015 for noncommunicable health conditions. Methods Data sources and inclusion criteriaProtocols for this review are posted on Open Science Framework and follow PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) reporting guidelines (www.prisma-statement.org/). The review search focused on selected health conditions identified as priorities by policymakers and practitioners [24][25][26][27][28][29][30] (Box 1). We considered only 2 cancers, lung and colorectal, because they are among the leading causes of death from cancer for both females and males, 31 and important sex and/or gender differences in prevalence, risk and screening, path...

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Section: Discussionmentioning

confidence: 99%

Sex and gender considerations in Canadian clinical practice guidelines: a systematic review

et al. 2017

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“…In the development of clinical guidelines, evidence-to-decision frameworks have been developed to guide decision-making 22 , 23 . Explicit guidance on the inclusion of fairness in the decision-making needed to achieve universal health coverage has been published 24 .…”

Section: From Evidence To Decision-makingmentioning

confidence: 99%

Cost–effectiveness thresholds: pros and cons

Bertram

Lauer

Joncheere

et al. 2016

Bull. World Health Organ.

585

509

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Cost–effectiveness analysis is used to compare the costs and outcomes of alternative policy options. Each resulting cost–effectiveness ratio represents the magnitude of additional health gained per additional unit of resources spent. Cost–effectiveness thresholds allow cost–effectiveness ratios that represent good or very good value for money to be identified. In 2001, the World Health Organization’s Commission on Macroeconomics in Health suggested cost–effectiveness thresholds based on multiples of a country’s per-capita gross domestic product (GDP). In some contexts, in choosing which health interventions to fund and which not to fund, these thresholds have been used as decision rules. However, experience with the use of such GDP-based thresholds in decision-making processes at country level shows them to lack country specificity and this – in addition to uncertainty in the modelled cost–effectiveness ratios – can lead to the wrong decision on how to spend health-care resources. Cost–effectiveness information should be used alongside other considerations – e.g. budget impact and feasibility considerations – in a transparent decision-making process, rather than in isolation based on a single threshold value. Although cost–effectiveness ratios are undoubtedly informative in assessing value for money, countries should be encouraged to develop a context-specific process for decision-making that is supported by legislation, has stakeholder buy-in, for example the involvement of civil society organizations and patient groups, and is transparent, consistent and fair.

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“…“Disagreement” will occur when 33% or more score 1–3 and 33% or more score 7–9 for a particular item. All other combinations will be considered “Equivocal,” which means that these items are open to more than one interpretation [23]. …”

Section: Methodsmentioning

confidence: 99%

Protocol for the development of a Core Outcome Set (COS) for hemorrhoidal disease: an international Delphi study

Tol

Melenhorst

Dirksen

et al. 2017

Int J Colorectal Dis

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PurposeOver the last decade, many studies were performed regarding treatment options for hemorrhoidal disease. Randomised controlled trials (RCTs) should have well-defined primary and secondary outcomes. However, the reported outcome measures are numerous and diverse. The heterogeneity of outcome definition in clinical trials limits transparency and paves the way for bias. The development of a core outcome set (COS) helps minimizing this problem. A COS is an agreed minimum set of outcomes that should be measured and reported in all clinical trials of a specific disease. The aim of this project is to generate a COS regarding the outcome of treatment after hemorrhoidal disease.MethodsA Delphi study will be performed by an international steering group healthcare professionals and patients with the intention to create a standard outcome set for future clinical trials for the treatment of hemorrhoidal disease. First, a literature review will be conducted to establish which outcomes are used in clinical trials for hemorrhoidal disease. Secondly, both healthcare professionals and patients will participate in several consecutive rounds of online questionnaires and a face-to-face meeting to refine the content of the COS.DiscussionDevelopment of a COS for hemorrhoidal disease defines a minimum outcome-reporting standard and will improve the quality of research in the future.Electronic supplementary materialThe online version of this article (doi:10.1007/s00384-017-2833-5) contains supplementary material, which is available to authorized users.

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GRADE Guidelines: 16. GRADE evidence to decision frameworks for tests in clinical practice and public health

Cited by 355 publications

References 33 publications

Sex and gender considerations in Canadian clinical practice guidelines: a systematic review

Sex and gender considerations in Canadian clinical practice guidelines: a systematic review

Cost–effectiveness thresholds: pros and cons

Protocol for the development of a Core Outcome Set (COS) for hemorrhoidal disease: an international Delphi study

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