Reporting and interpretation of effects in non-randomized nutritional and environmental epidemiology: a methods study.

PURPOSE: The presentation of absolute effects, in addition to relative effects, is critical to the optimal interpretation of effect estimates. Failure to present and interpret absolute effects may obscure the magnitude of the effect of an intervention or exposure and mislead evidence users. OBJECTIVE: In this study, we estimate the proportion of systematic reviews and meta-analyses (SRMAs) addressing the health effects of nutritional and environmental exposures that report absolute effects. METHODS: We searched MEDLINE and EMBASE from 2019 through 2021 for SRMAs addressing the health effects of nutritional and environmental exposures and patient-important health outcomes. We included a sample of 200 SRMAs. Pairs of reviewers, working independently and in duplicate, reviewed search records for eligibility and collected data from SRMAs. RESULTS: More than two-thirds (153/200; 76.5%) of eligible systematic reviews reported on one or more dichotomous outcomes that could be translated to absolute effects. Only eight (8/153, 5.2%)5.2%), however, reported absolute effects. A similar proportion of reviews published in high-impact journals and in other journals reported absolute effects (4/131; 3.1% vs. 4/69; 5.9%). Among reviews that reported absolute effects, six reviews (6/8; 75%) reported absolute risk differences as fractions (e.g., 2 fewer cases per 1000 people) and two reviews (2/8; 25%) presented the number of cases prevented by modifying the exposure (e.g., 2000 cases prevented in United States annually). CONCLUSIONS: Reviews addressing the effects of nutritional and environmental exposures on health outcomes rarely report absolute effects, which precludes effective interpretation of magnitudes of effects and their importance. We present guidance for review authors, editors, peer reviewers, and evidence users to calculate and interpret absolute effects.

GRADE guidance 35: update on rating imprecision for assessing contextualized certainty of evidence and making decisions.

OBJECTIVES: Grading of Recommendations Assessment, Development and Evaluation (GRADE) guidance to rate the certainty domain of imprecision is presently not fully operationalized for rating down by two levels and when different baseline risk or uncertainty in these risks are considered. In addition, there are scenarios in which lowering the certainty of evidence by three levels for imprecision is more appropriate than lowering it by two levels. In this article, we conceptualize and operationalize rating down for imprecision by one, two and three levels for imprecision using the contextualized GRADE approaches and making decisions. METHODS: Through iterative discussions and refinement in online meetings and through email communication, we developed draft guidance to rating the certainty of evidence down by up to three levels based on examples. The lead authors revised the approach according to the feedback and the comments received during these meetings and developed GRADE guidance for how to apply it. We presented a summary of the results to all attendees of the GRADE Working Group meeting for feedback in October 2021 (approximately 80 people) where the approach was formally approved. RESULTS: This guidance provides GRADE's novel approach for the considerations about rating down for imprecision by one, two and three levels based on serious, very serious and extremely serious concerns. The approach includes identifying or defining thresholds for health outcomes that correspond to trivial or none, small, moderate or large effects and using them to rate imprecision. It facilitates the use of evidence to decision frameworks and also provides guidance for how to address imprecision about implausible large effects and trivial or no effects using the concept of the 'review information size' and for varying baseline risks. The approach is illustrated using practical examples, an online calculator and graphical displays and can be applied to dichotomous and continuous outcomes. CONCLUSION: In this GRADE guidance article, we provide updated guidance for how to rate imprecision using the partially and fully contextualized GRADE approaches for making recommendations or decisions, considering alternate baseline risks and for both dichotomous and continuous outcomes.

Standardized wording to improve efficiency and clarity of GRADE EtD frameworks in health guidelines.

BACKGROUND: Grading of Recommendations Assessment, Development and Evaluation (GRADE) Evidence-to-Decision (EtDs) frameworks are increasingly applied by health guideline developers to improve the use of evidence and transparency of health recommendations. Typically, EtDs include 12 criteria but these are flexible and EtDs have been adapted to different types of health decisions. However, developers of health recommendations struggle with the content that they should include in the EtD. The goal of this work was to provide a standardized template that facilitate the development of GRADE EtDs in health guidelines and examples for practical training. METHODS: We began by establishing the need for standardized wording templates in 10 American Society of Hematology guidelines with over 250 recommendations. We drafted template wording, and examples, and sought iterative feedback from methodologists and guideline panels in this guideline and two additional guidelines. RESULTS: We generated templates for all EtD criteria describing the type of research evidence considered, ideally based on systematic reviews, using standardized reporting of effect size, integrating the certainty of evidence and additional considerations. We also produced templates to inform the completion of the EtD conclusions section that includes recommendations, justification, implementation considerations, monitoring and evaluation and research priorities. CONCLUSION: We developed a pragmatic and useful tool to support clarity, transparency, and efficiency of the guideline EtD process.

[Preventive activities in women's care]. / Actividades preventivas en la mujer. Actualización PAPPS 2020.

A review is presented of the scientific evidence on preventive activities in women's care in relation to pregnancy follow-up, preventive activities in the planning and follow-up of contraceptive methods, preventive activities in menopause, and the prevention of osteoporotic fractures.

GRADE guidelines: 20. Assessing the certainty of evidence in the importance of outcomes or values and preferences-inconsistency, imprecision, and other domains.

OBJECTIVE: To provide Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) guidance for assessing inconsistency, imprecision, and other domains for the certainty of evidence about the relative importance of outcomes. STUDY DESIGN AND SETTING: We applied the GRADE domains to rate the certainty of evidence in the importance of outcomes to several systematic reviews, iteratively reviewed draft guidance, and consulted GRADE members and other stakeholders for feedback. RESULTS: We describe the rationale for considering the remaining GRADE domains when rating the certainty in a body of evidence for the relative importance of outcomes. As meta-analyses are not common in this context, inconsistency and imprecision assessments are challenging. Furthermore, confusion exists about inconsistency, imprecision, and true variability in the relative importance of outcomes. To clarify this issue, we suggest that the true variability is neither equivalent to inconsistency nor imprecision. Specifically, inconsistency arises from population, intervention, comparison and outcome and methodological elements that should be explored and, if possible, explained. The width of the confidence interval and sample size inform judgments about imprecision. We also provide suggestions on how to detect publication bias and discuss the domains to rate up the certainty. CONCLUSION: We provide guidance and examples for rating inconsistency, imprecision, and other domains for a body of evidence describing the relative importance of outcomes.

Using patient values and preferences to inform the importance of health outcomes in practice guideline development following the GRADE approach.

BACKGROUND: There are diverse opinions and confusion about defining and including patient values and preferences (i.e. the importance people place on the health outcomes) in the guideline development processes. This article aims to provide an overview of a process for systematically incorporating values and preferences in guideline development. METHODS: In 2013 and 2014, we followed the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to adopt, adapt and develop 226 recommendations in 22 guidelines for the Ministry of Health of the Kingdom of Saudi Arabia. To collect context-specific values and preferences for each recommendation, we performed systematic reviews, asked clinical experts to provide feedback according to their clinical experience, and consulted patient representatives. RESULTS: We found several types of studies addressing the importance of outcomes, including those reporting utilities, non-utility measures of health states based on structured questionnaires or scales, and qualitative studies. Guideline panels used the relative importance of outcomes based on values and preferences to weigh the balance of desirable and undesirable consequences of alternative intervention options. However, we found few studies addressing local values and preferences. CONCLUSIONS: Currently there are different but no firmly established processes for integrating patient values and preferences in healthcare decision-making of practice guideline development. With GRADE Evidence-to-Decision (EtD) frameworks, we provide an empirical strategy to find and incorporate values and preferences in guidelines by performing systematic reviews and eliciting information from guideline panel members and patient representatives. However, more research and practical guidance are needed on how to search for relevant studies and grey literature, assess the certainty of this evidence, and best summarize and present the findings.

Initiation and continuation of randomized trials after the publication of a trial stopped early for benefit asking the same study question: STOPIT-3 study design.

BACKGROUND: Randomized control trials (RCTs) stopped early for benefit (truncated RCTs) are increasingly common and, on average, overestimate the relative magnitude of benefit by approximately 30%. Investigators stop trials early when they consider it is no longer ethical to enroll patients in a control group. The goal of this systematic review is to determine how investigators of ongoing or planned RCTs respond to the publication of a truncated RCT addressing a similar question. METHODS/DESIGN: We will conduct systematic reviews to update the searches of 210 truncated RCTs to identify similar trials ongoing at the time of publication, or started subsequently, to the truncated trials ('subsequent RCTs'). Reviewers will determine in duplicate the similarity between the truncated and subsequent trials. We will analyze the epidemiology, distribution, and predictors of subsequent RCTs. We will also contact authors of subsequent trials to determine reasons for beginning, continuing, or prematurely discontinuing their own trials, and the extent to which they rely on the estimates from truncated trials. DISCUSSION: To the extent that investigators begin or continue subsequent trials they implicitly disagree with the decision to stop the truncated RCT because of an ethical mandate to administer the experimental treatment. The results of this study will help guide future decisions about when to stop RCTs early for benefit.

GRADE guidelines: 15. Going from evidence to recommendation-determinants of a recommendation's direction and strength.

In the GRADE approach, the strength of a recommendation reflects the extent to which we can be confident that the composite desirable effects of a management strategy outweigh the composite undesirable effects. This article addresses GRADE's approach to determining the direction and strength of a recommendation. The GRADE describes the balance of desirable and undesirable outcomes of interest among alternative management strategies depending on four domains, namely estimates of effect for desirable and undesirable outcomes of interest, confidence in the estimates of effect, estimates of values and preferences, and resource use. Ultimately, guideline panels must use judgment in integrating these factors to make a strong or weak recommendation for or against an intervention.

La formulación de recomendaciones en salud: el sistema GRADE / Formulating health care recommendations: The GRADE system

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Medical students' perceptions and attitudes about family practice: a qualitative research synthesis.

BACKGROUND: During the last decade medical students from most Western countries have shown little interest in family practice. Understanding the factors that influence medical students to choose family medicine is crucial. OBJECTIVE: To systematically review and synthesize published evidence about medical students' attitudes and perceptions towards family practice. METHODS: A qualitative systematic review. The literature search was undertaken in July 2010 in PubMed, EMBASE, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Social Science Citation Index (SSCI), and ProQuest Dissertations & Theses. Two authors independently selected the studies for their inclusion and assessed their quality. The selected studies were thoroughly read. Key themes and categories were identified. A matrix was created for allowing the comparison of each theme across studies. RESULTS: Ten studies were finally included. Seven broad themes were identified across them: 1) Scope and context of practice was a broad theme comprising linked sub-themes: perception of a varied specialty, broad practice, holistic perspective and flexibility that allows having a family; 2) Lower interest or intellectually less challenging: treating common disease, repetitive, quasi administrative job; 3) Influence of role models, either positive and negative, and society: negative comments from other professionals, peers and family; 4) Lower prestige; 5) Poor remuneration; 6) Medical school influences, being important both the length and quality of the exposure; 7) Post graduate training, where the shorter duration and the lower intensity were perceived as positive aspects. After identifying these seven key themes, were also looked into patterns in the distribution of these themes among studies. CONCLUSIONS: Our qualitative review provides a comprehensive picture of medical students' attitudes towards family practice in the available literature. In general, although some students find family medicine appealing, it is regarded as a career of low interest and prestige. More research is needed on the influence of role models, medical school and post graduate training.