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Showing papers by "Gordon H. Guyatt published in 2019"




Journal ArticleDOI
TL;DR: The 2018 ACR/NPF guideline as mentioned in this paper provides evidence-based guidelines for the pharmacologic and non-pharmacologic treatment of psoriatic arthritis (PsA) using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) methodology.
Abstract: Objective To develop an evidence-based guideline for the pharmacologic and nonpharmacologic treatment of psoriatic arthritis (PsA), as a collaboration between the American College of Rheumatology (ACR) and the National Psoriasis Foundation (NPF). Methods We identified critical outcomes in PsA and clinically relevant PICO (population/intervention/comparator/outcomes) questions. A Literature Review Team performed a systematic literature review to summarize evidence supporting the benefits and harms of available pharmacologic and nonpharmacologic therapies for PsA. GRADE (Grading of Recommendations Assessment, Development and Evaluation) methodology was used to rate the quality of the evidence. A voting panel, including rheumatologists, dermatologists, other health professionals, and patients, achieved consensus on the direction and the strength of the recommendations. Results The guideline covers the management of active PsA in patients who are treatment-naive and those who continue to have active PsA despite treatment, and addresses the use of oral small molecules, tumor necrosis factor inhibitors, interleukin-12/23 inhibitors (IL-12/23i), IL-17 inhibitors, CTLA4-Ig (abatacept), and a JAK inhibitor (tofacitinib). We also developed recommendations for psoriatic spondylitis, predominant enthesitis, and treatment in the presence of concomitant inflammatory bowel disease, diabetes, or serious infections. We formulated recommendations for a treat-to-target strategy, vaccinations, and nonpharmacologic therapies. Six percent of the recommendations were strong and 94% conditional, indicating the importance of active discussion between the health care provider and the patient to choose the optimal treatment. Conclusion The 2018 ACR/NPF PsA guideline serves as a tool for health care providers and patients in the selection of appropriate therapy in common clinical scenarios. Best treatment decisions consider each individual patient situation. The guideline is not meant to be proscriptive and should not be used to limit treatment options for patients with PsA.

311 citations


Journal ArticleDOI
TL;DR: To develop an evidence‐based guideline for the pharmacologic and nonpharmacologic treatment of psoriatic arthritis (PsA), as a collaboration between the American College of Rheumatology and the National Psoriasis Foundation (NPF).
Abstract: Objective:To develop an evidence-based guideline for the pharmacologic and nonpharmacologic treatment of psoriatic arthritis (PsA), as a collaboration between the American College of Rheumatology (...

282 citations


Journal ArticleDOI
TL;DR: NeuroVISION assessed patients aged 65 years or older who underwent inpatient, elective, non-cardiac surgery and had brain MRI after surgery to investigate the relationship between perioperative covert stroke and cognitive decline 1 year after surgery and the association with an increased risk of cognitive decline.

124 citations


OtherDOI
01 Jan 2019
TL;DR: Summary data on patient-reported outcomes (PROs) are important to ensure healthcare decision makers are informed about the outcomes most meaningful to patients.
Abstract: Authors of systematic reviews that include patient-reported outcomes (PROs) should have a good understanding of how patient-reported outcome measures (PROMs) are developed, including the constructs they are intended to measure, their reliability, validity and responsiveness. This chapter describes the category of outcomes known as PROs and their importance for healthcare decision making, and illustrates the key issues related to reliability, validity and responsiveness that systematic review authors should consider when including PROs. It also addresses the structure and content of PROs and provides guidance for combining information from different PROs. The chapter outlines a step-by-step approach to addressing each of these elements in the systematic review process. The focus is on the use of PROs in randomized trials, and what is crucial in this context when selecting PROs to include in a meta-analysis. The chapter describes PROMs in more detail and discusses some issues to consider when deciding which PROMs to address in a review.

121 citations


Journal ArticleDOI
TL;DR: A Grading of Recommendations, Assessment, Development and Evaluation (GRADE) summary of findings (SoF) table format that displays the critical information from a network meta-analysis (NMA) that facilitates understanding NMA findings and health decision-making is developed.

117 citations


Journal ArticleDOI
02 Oct 2019-BMJ
TL;DR: This guideline looks at the evidence and makes recommendations on screening for four screening options: faecal immunochemical test every year, FIT every two years, a single sigmoidoscopy, or a single colonoscopy and best estimates suggested that all four screenings options resulted in similar colorectal cancer mortality reductions.
Abstract: Clinical question Recent 15-year updates of sigmoidoscopy screening trials provide new evidence on the effectiveness of colorectal cancer screening. Prompted by the new evidence, we asked: “Does colorectal cancer screening make an important difference to health outcomes in individuals initiating screening at age 50 to 79? And which screening option is best?” Current practice Numerous guidelines recommend screening, but vary on recommended test, age and screening frequency. This guideline looks at the evidence and makes recommendations on screening for four screening options: faecal immunochemical test (FIT) every year, FIT every two years, a single sigmoidoscopy, or a single colonoscopy. Recommendations These recommendations apply to adults aged 50-79 years with no prior screening, no symptoms of colorectal cancer, and a life expectancy of at least 15 years. For individuals with an estimated 15-year colorectal cancer risk below 3%, we suggest no screening (weak recommendation). For individuals with an estimated 15-year risk above 3%, we suggest screening with one of the four screening options: FIT every year, FIT every two years, a single sigmoidoscopy, or a single colonoscopy (weak recommendation). With our guidance we publish the linked research, a graphic of the absolute harms and benefits, a clear description of how we reached our value judgments, and linked decision aids. How this guideline was created A guideline panel including patients, clinicians, content experts and methodologists produced these recommendations using GRADE and in adherence with standards for trustworthy guidelines. A linked systematic review of colorectal cancer screening trials and microsimulation modelling were performed to inform the panel of 15-year screening benefits and harms. The panel also reviewed each screening option’s practical issues and burdens. Based on their own experience, the panel estimated the magnitude of benefit typical members of the population would value to opt for screening and used the benefit thresholds to inform their recommendations. The evidence Overall there was substantial uncertainty (low certainty evidence) regarding the 15-year benefits, burdens and harms of screening. Best estimates suggested that all four screening options resulted in similar colorectal cancer mortality reductions. FIT every two years may have little or no effect on cancer incidence over 15 years, while FIT every year, sigmoidoscopy, and colonoscopy may reduce cancer incidence, although for FIT the incidence reduction is small compared with sigmoidoscopy and colonoscopy. Screening related serious gastrointestinal and cardiovascular adverse events are rare. The magnitude of the benefits is dependent on the individual risk, while harms and burdens are less strongly associated with cancer risk. Understanding the recommendation Based on benefits, harms, and burdens of screening, the panel inferred that most informed individuals with a 15-year risk of colorectal cancer of 3% or higher are likely to choose screening, and most individuals with a risk of below 3% are likely to decline screening. Given varying values and preferences, optimal care will require shared decision making.

106 citations


Journal ArticleDOI
TL;DR: Systematic reviewers should be aware of the problem and plan sensitivity analyses that produce intuitively sensible confidence intervals, which may include using informative priors for the between-study heterogeneity parameter in the Bayesian framework and the use of fixed effects models.

90 citations


Journal ArticleDOI
02 Oct 2019-BMJ
TL;DR: Over a 15 year period, all screening strategies may reduce colorectal cancer mortality to a similar extent, and Colonoscopy and sigmoidoscopy may also reduce colorescopy cancer incidence, while FIT shows a smaller incidence reduction.
Abstract: Objective To estimate benefits and harms of different colorectal cancer screening strategies, stratified by (baseline) 15-year colorectal cancer risk. Design Microsimulation modelling study using MIcrosimulation SCreening ANalysis-Colon (MISCAN-Colon). Setting A parallel guideline committee (BMJ Rapid Recommendations) defined the time frame and screening interventions, including selection of outcome measures. Population Norwegian men and women aged 50-79 years with varying 15-year colorectal cancer risk (1-7%). Comparisons Four screening strategies were compared with no screening: biennial or annual faecal immunochemical test (FIT) or single sigmoidoscopy or colonoscopy at 100% adherence. Main outcome measures Colorectal cancer mortality and incidence, burdens, and harms over 15 years of follow-up. The certainty of the evidence was assessed using the GRADE approach. Results Over 15 years of follow-up, screening individuals aged 50-79 at 3% risk of colorectal cancer with annual FIT or single colonoscopy reduced colorectal cancer mortality by 6 per 1000 individuals. Single sigmoidoscopy and biennial FIT reduced it by 5 per 1000 individuals. Colonoscopy, sigmoidoscopy, and annual FIT reduced colorectal cancer incidence by 10, 8, and 4 per 1000 individuals, respectively. The estimated incidence reduction for biennial FIT was 1 per 1000 individuals. Serious harms were estimated to be between 3 per 1000 (biennial FIT) and 5 per 1000 individuals (colonoscopy); harms increased with older age. The absolute benefits of screening increased with increasing colorectal cancer risk, while harms were less affected by baseline risk. Results were sensitive to the setting defined by the guideline panel. Because of uncertainty associated with modelling assumptions, we applied a GRADE rating of low certainty evidence to all estimates. Conclusions Over a 15 year period, all screening strategies may reduce colorectal cancer mortality to a similar extent. Colonoscopy and sigmoidoscopy may also reduce colorectal cancer incidence, while FIT shows a smaller incidence reduction. Harms are rare and of similar magnitude for all screening strategies.

84 citations


Journal ArticleDOI
TL;DR: Convincing associations between DFA and all-cause mortality were restricted to the mid to older-aged population (moderate credibility) and Insomnia disorder, difficulty maintaining sleep, and early morning awakening proved to be unassociated with all- Cause and cardiovascular disease mortality.

Journal ArticleDOI
TL;DR: This article presents official guidance from the Grading of Recommendations Assessments, Development, and Evaluation (GRADE) working group on how to address incoherence when assessing the certainty in the evidence from network meta-analysis.

Journal ArticleDOI
01 Feb 2019-BMJ Open
TL;DR: A review provides anchor-based minimal important differences estimates, as well as a rating of their credibility, for PROMs for patients with shoulder conditions, and identified MIDs of high credibility for pain and function outcomes and of low credibility for HRQoL.
Abstract: Objectives To identify credible anchor-based minimal important differences (MIDs) for patient-reported outcome measures (PROMs) relevant to a BMJ Rapid Recommendations addressing subacromial decompression surgery for shoulder pain. Design Systematic review. Outcome measures Estimates of anchor-based MIDs, and their credibility, for PROMs judged by the parallel BMJ Rapid Recommendations panel as important for informing their recommendation (pain, function and health-related quality of life (HRQoL)). Data sources MEDLINE, EMBASE and PsycINFO up to August 2018. Study selection and review methods We included original studies of any intervention for shoulder conditions reporting estimates of anchor-based MIDs for relevant PROMs. Two reviewers independently evaluated potentially eligible studies according to predefined selection criteria. Six reviewers, working in pairs, independently extracted data from eligible studies using a predesigned, standardised, pilot-tested extraction form and independently assessed the credibility of included studies using an MID credibility tool. Results We identified 22 studies involving 5562 patients that reported 74 empirically estimated anchor-based MIDs for 10 candidate instruments to assess shoulder pain, function and HRQoL. We identified MIDs of high credibility for pain and function outcomes and of low credibility for HRQoL. We offered median estimates for the systematic review team who applied these MIDs in Grading of Recommendations Assessment, Development and Evaluation (GRADE) evidence summaries and in their interpretations of results in the linked systematic review addressing the effectiveness of surgery for shoulder pain. Conclusions Our review provides anchor-based MID estimates, as well as a rating of their credibility, for PROMs for patients with shoulder conditions. The MID estimates inform the interpretation for a linked systematic review and guideline addressing subacromial decompression surgery for shoulder pain, and could also prove useful for authors addressing other interventions for shoulder problems. PROSPERO registration number CRD42018106531.


Journal ArticleDOI
06 Feb 2019-BMJ
TL;DR: Subacromial decompression surgery should not be offered to patients with SAPS, and almost all informed patients would choose to avoid surgery because there is no benefit but there are harms and it is burdensome.
Abstract: Clinical question Do adults with atraumatic shoulder pain for more than 3 months diagnosed as subacromial pain syndrome (SAPS), also labelled as rotator cuff disease, benefit from subacromial decompression surgery? This guideline builds on to two recent high quality trials of shoulder surgery. Current practice SAPS is the common diagnosis for shoulder pain with several first line treatment options, including analgesia, exercises, and injections. Surgeons frequently perform arthroscopic subacromial decompression for prolonged symptoms, with guidelines providing conflicting recommendations. Recommendation The guideline panel makes a strong recommendation against surgery. How this guideline was created A guideline panel including patients, clinicians, and methodologists produced this recommendation in adherence with standards for trustworthy guidelines and the GRADE system. The recommendation is based on two linked systematic reviews on (a) the benefits and harms of subacromial decompression surgery and (b) the minimally important differences for patient reported outcome measures. Recommendations are made actionable for clinicians and their patients through visual overviews. These provide the relative and absolute benefits and harms of surgery in multilayered evidence summaries and decision aids available in MAGIC (www.magicapp.org) to support shared decisions and adaptation. The evidence Surgery did not provide important improvements in pain, function, or quality of life compared with placebo surgery or other options. Frozen shoulder may be more common with surgery. Understanding the recommendation The panel concluded that almost all informed patients would choose to avoid surgery because there is no benefit but there are harms and it is burdensome. Subacromial decompression surgery should not be offered to patients with SAPS. However, there is substantial uncertainty in what alternative treatment is best.

Journal ArticleDOI
TL;DR: Gender disparity existed overall in grant and personnel award success rates, especially for grants directed to selected research communities, over a 15-year period and funding agencies should monitor for gender differences in grant success rates overall and by research content.
Abstract: Background Although women at all career stages are more likely to leave academia than men, early-career women are a particularly high-risk group. Research supports that women are less likely than men to receive research funding; however, whether funding success rates vary based on research content is unknown. We addressed gender differences in funding success rates for applications directed to one or more of 13 institutes, representing research communities, over a 15-year period. Methods and findings We retrospectively reviewed 55,700 grant and 4,087 personnel award applications submitted to the Canadian Institutes of Health Research. We analyzed application success rates according to gender and the primary institute selected by applicants, pooled gender differences in success rates using random effects models, and fitted Poisson regression models to assess the effects of gender, time, and institute. We noted variable success rates among grant applications directed to selected institutes and declining success rates over time. Women submitted 31.1% and 44.7% of grant and personnel award applications, respectively. In the pooled estimate, women had significantly lower grant success (risk ratio [RR] 0.89, 95% confidence interval [CI] 0.84–0.94; p < 0.001; absolute difference 3.2%) compared with men, with substantial heterogeneity (I2 = 58%). Compared with men, women who directed grants to the Institutes of Cancer Research (RR 0.86, 95% CI 0.78–0.96), Circulatory and Respiratory Health (RR 0.74, 95% CI 0.66–0.84), Health Services and Policy Research (RR 0.78, 95% CI 0.68–0.90), and Musculoskeletal Health and Arthritis (RR 0.80, 95% CI 0.69–0.93) were significantly less likely to be funded, and those who directed grants to the Institute of Aboriginal People’s Health (RR 1.67, 95% CI 1.0–2.7) were more likely to be funded. Overall, women also had significantly lower personnel award success (RR 0.75, 95% CI 0.65–0.86; p < 0.001; absolute difference 6.6%). Regression modelling identified that the effect of gender on grant success rates differed by institute and not time. Study limitations include use of institutes as a surrogate identifier, variability in designation of primary institute, and lack of access to metrics reflecting applicants, coapplicants, peer reviewers, and the peer-review process. Conclusions Gender disparity existed overall in grant and personnel award success rates, especially for grants directed to selected research communities. Funding agencies should monitor for gender differences in grant success rates overall and by research content.


Journal ArticleDOI
TL;DR: In this article, the authors conducted a systematic survey addressing current practice and recommendations for patients with open fractures of the extremities and found that the evidence with regard to antibiotic prophylaxis is limited.
Abstract: Background:Evidence with regard to antibiotic prophylaxis for patients with open fractures of the extremities is limited. We therefore conducted a systematic survey addressing current practice and recommendations.Methods:We included publications from January 2007 to June 2017. We searched Embase, ME

Journal ArticleDOI
TL;DR: A systematic review addressing people's health-related values and preferences on meat consumption and developing recommendations for red and processed meat and health outcomes is conducted.
Abstract: People need to choose from a wide range of foods on a daily basis to meet their nutritional requirements (1). Consumption of different foods may yield both desirable and undesirable health effects (2). In light of recent studies showing an association between consumption of unprocessed red meat and processed meat and adverse health consequences, including increased risk for cancer (3), all-cause (4) and cardiovascular mortality (5), and stroke (6), dietary guidelines have generally endorsed limiting meat intake (79). However, these guidelines have neglected to identify and incorporate their target populations' values and preferences on meat consumption (1013), which are major influences on what foods people eat (1416). Understanding people's health-related values and preferences on meat consumption may improve the trustworthiness of dietary recommendations (17). Therefore, we conducted a systematic review addressing people's health-related values and preferences on meat consumption. This review was done as part of Nutritional Recommendations and Accessible Evidence Summaries Composed of Systematic Reviews (NutriRECS), an initiative that aims to develop trustworthy nutritional recommendations (18). We performed 4 parallel systematic reviews addressing the following: experimental (19) and observational evidence (20) on the effect of red and processed meat on cancer and cardiometabolic outcomes, observational studies on the effect of red and processed meat on cancer outcomes (21), and the effect of varying red and processed meat dietary patterns on cardiometabolic and cancer outcomes (22). On the basis of these reviews, we developed recommendations for red and processed meat and health outcomes (23). Methods We registered the protocol with PROSPERO (CRD42018088854) (24) and adhered to the PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses) statement (25). Data Sources and Searches We designed and conducted a search in MEDLINE (via PubMed), EMBASE (via Ovid), Web of Science (Institute for Scientific Information), Centre for Agriculture and Biosciences Abstracts (via CABI), International System for Agricultural Science and Technology, and Food Science and Technology Abstracts from inception to July 2018, and an updated search of MEDLINE and EMBASE through June 2019. We combined search terms related to meat consumption, consumer behavior, and values and preferences with the controlled vocabulary from each database. We did not restrict our search by publication status, language, or date of publication (Supplement Table 1). We also reviewed reference lists of the included articles and relevant systematic reviews. Supplement. Supplementary Material* Study Selection We included studies exploring health-related values and preferences on meat consumption if more than 80% of participants were adults (aged 18 years). We considered quantitative (that is, cross-sectional design), qualitative (that is, participant interviews, focus groups), and mixed-methods studies. If studies did not report the participants' ages, we assumed that more than 80% were aged 18 years or older. We included only studies done in Europe, Australia, Canada, the United States, and New Zealand because we considered them to be homogeneous countries reflecting similar socioeconomic characteristics and values. We excluded studies that focused on meat alternatives (for example, cultured, in vitro, functional products, or genetically modified), types (for example, organic), quality (composition, sensory quality or palatability factors, or origin), safety (for example, food handling, chemical hazards or contamination, or storing or preserving), industry (for example, market research to inform or meet consumers' demands), consumption trends, and specific populations (for example, cancer survivors or pregnant women). Before beginning each aspect of the review process, we conducted calibration exercises in which reviewers assessed the same articles and discussed any disagreement, leading to a clarification and a common understanding of criteria and process. After calibration, teams of 2 reviewers independently screened titles and abstracts of all retrieved references. Subsequently, teams of 2 reviewers independently reviewed the full text of articles deemed potentially eligible during title and abstract screening. In cases of disagreement, reviewers reached consensus with assistance from a third reviewer. Data Extraction and Quality Assessment We used 2 ad hoc data extraction forms for quantitative and qualitative research (Supplement Tables 2 and 3). After calibration exercises similar to the ones described earlier, teams of reviewers independently abstracted information from each study, including study identification, objectives or research questions, population characteristics, design and methods, risk of bias or methodological limitations, and findings. In cases of disagreement, reviewers reached consensus with assistance from a third reviewer. For quantitative studies, we used an adapted version of the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach to assess risk of bias of studies on importance of outcomes or values and preferences (26). We considered 5 items grouped in 3 domains: selection of participants, missing outcome data, and measurement instruments' validity. We rated studies as having high risk of bias if the measurement instrument was not validated or was unclear, and as having moderate risk if it was validated but 2 or more items had high risk of bias. For qualitative studies, we used the Critical Appraisal Skills Programme qualitative research checklist, which consists of the following items: aim of the research, qualitative methodology appropriateness, research design, appropriate recruitment strategy, data collection, investigator and participants' relationship, ethical issues, data analysis, findings, and value of the research (27). We rated studies as having serious methodological limitations if more than 2 items had serious concerns and as having moderate methodological limitations if they had 2 items with serious concerns. Reviewers independently assessed risk of bias or methodological limitations. In cases of disagreement, reviewers reached consensus with assistance from a third reviewer. Data Synthesis and Analysis We synthesized results from studies using a 4-step approach that involved simultaneous quantitative and qualitative data collection and analysis. First, we selected 2 to 3 eligible articles per study design, identified key themes, and coded them in categories. Second, we used these categories to design ad hoc data extraction forms. Third, using an iterative process, we compared the key themes of the categories identified across all studies and developed analytic themes. Fourth, we applied the critical meta-narrative synthesis to transform the quantitative data into qualitative data (28, 29). For the last step, we used 4 systematic profiles and several critical questions to extract the identified narratives and to guide our synthesis of data (Supplement Table 4). We synthesized and narratively reported the findings according to participants' meat consumption. We defined those who consumed meat as omnivores and analyzed them separately from persons who typically avoided meat, whom we defined as vegetarians, including lacto-ovo vegetarians or low-meat consumers. For quantitative studies, we assessed the certainty of evidence for each review finding according to GRADE domains (risk of bias, imprecision, inconsistency, indirectness, and publication bias) (30, 31). For qualitative studies, we assessed the certainty of evidence according to GRADE-CERQual (Confidence in the Evidence from Reviews of Qualitative Research) domains (methodological limitations, relevance, coherence, and adequacy) (32). Findings were initially considered as high certainty and were downgraded (from high to very low) by 1 or more levels if serious or several minor or moderate concerns were detected in 1 or more domains. Role of the Funding Source The study received no funding. Results The search yielded 19172 articles, of which 456 were deemed potentially eligible on the basis of title and abstract. We excluded 402 studies (Supplement Table 5). After full-text appraisal, we included 41 quantitative (3373) and 13 qualitative studies (7486). The Figure presents the flow diagram with the search results and selection of studies. Figure. Evidence search and selection. AGRIS = International System for Agricultural Science and Technology; CAB = Centre for Agriculture and Biosciences; FSTA = Food Science and Technology Abstracts. Study Characteristics Table 1 presents the characteristics of the 54 included studies. Of the 41 quantitative studies, 21 were done in Europe, 11 in the United States, 7 in Australia, 1 in Canada, and 1 in New Zealand. Eighteen studies were done between 1988 and 2009, and 23 were done between 2011 and 2019. Of the 13 qualitative studies, 7 were done in Europe, 3 in the United States, and 3 in Australia. Six were done between 1991 and 2010, and 7 were done between 2011 and 2018. The number of participants ranged from 100 to 22935 (aged 18 to >65 years) in the quantitative studies and from 19 to 460 (aged 16 to >75 years) in the qualitative studies. Among the included studies, 41 reported data on meat in general, 6 reported data on both meat in general and red meat, and 7 reported data on red meat only. Table 1. Characteristics of the Included Studies Table 1Continued Findings We identified 2 main themes: reasons for meat consumption (38 quantitative [62963 participants] and 10 qualitative [419 participants]) and willingness to reduce meat consumption in the face of undesirable health effects (5 quantitative [8983 participants] and 4 qualitative [616 participants]). Table 2 shows the main findings and their certainty (Supplement Tables 6 and 7). Of the quantitative studies, 23 of 38

Journal ArticleDOI
TL;DR: Patients with POAF have a significantly increased risk of stroke, MI, and death at 1 year, and intervention studies are needed to evaluate risk reduction strategies in this high-risk population.
Abstract: AIMS To determine the 1-year risk of stroke and other adverse outcomes in patients with a new diagnosis of perioperative atrial fibrillation (POAF) after non-cardiac surgery. METHODS AND RESULTS The PeriOperative ISchemic Evaluation (POISE)-1 trial evaluated the effects of metoprolol vs. placebo in 8351 patients, and POISE-2 compared the effect of aspirin vs. placebo, and clonidine vs. placebo in 10 010 patients. These trials included patients with, or at risk of, cardiovascular disease who were undergoing non-cardiac surgery. For the purpose of this study, we combined the POISE datasets, excluding 244 patients who were in atrial fibrillation (AF) at the time of randomization. Perioperative atrial fibrillation was defined as new AF that occurred within 30 days after surgery. Our primary outcome was the incidence of stroke at 1 year of follow-up; secondary outcomes were mortality and myocardial infarction (MI). We compared outcomes among patients with and without POAF using multivariable adjusted Cox proportional hazards models. Among 18 117 patients (mean age 69 years, 57.4% male), 404 had POAF (2.2%). The stroke incidence 1 year after surgery was 5.58 vs. 1.54 per 100 patient-years in patients with and without POAF, adjusted hazard ratio (aHR) 3.43, 95% confidence interval (CI) 2.00-5.90; P < 0.001. Patients with POAF also had an increased risk of death (incidence 31.37 vs. 9.34; aHR 2.51, 95% CI 2.01-3.14; P < 0.001) and MI (incidence 26.20 vs. 8.23; aHR 5.10, 95% CI 3.91-6.64; P < 0.001). CONCLUSION Patients with POAF have a significantly increased risk of stroke, MI, and death at 1 year. Intervention studies are needed to evaluate risk reduction strategies in this high-risk population.

Journal ArticleDOI
TL;DR: Recipient age, donor age, standard versus extended criteria donor, living versus deceased donor, HLA mismatch, and delayed graft function all predicted 1-year graft survival and the effect of each risk factor is small.
Abstract: Background and objectives With expansion of the pool of kidney grafts, through the use of higher-risk donors, and increased attention to donor management strategies, the 1-year graft survival rate is subject to change. It is, therefore, useful to elucidate 1-year graft survival rates by dissecting the characteristics of the low-risk and high-risk kidney transplant cases. The objective of our study was to evaluate factors purported to influence the risk of 1-year graft loss in kidney transplant recipients. Design, setting, participants, & measurements We searched bibliographic databases from 2000 to 2017 and included observational studies that measured the association between donor, recipient, the transplant operation, or early postoperative complications, and 1-year death-censored graft loss. Results We identified 35 eligible primary studies, with 20 risk factors amenable to meta-analysis. Six factors were associated with graft loss, with moderate to high degree of certainty: donor age (hazard ratio [HR], 1.11 per 10-year increase; 95% confidence interval [95% CI], 1.04 to 1.18), extended criteria donors (HR, 1.35; 95% CI, 1.28 to 1.42), deceased donors (HR, 1.54; 95% CI, 1.32 to 1.82), number of HLA mismatches (HR, 1.08 per one mismatch increase; 95% CI, 1.07 to 1.09), recipient age (HR, 1.17 per 10-year increase; 95% CI, 1.09 to 1.25), and delayed graft function (HR, 1.89; 95% CI, 1.46 to 2.47) as risk factors for 1-year graft loss. Pooled analyses also excluded, with a high degree of certainty, any associations of cold ischemia time, recipient race, pretransplant body mass index, diabetes, and hypertension with 1-year graft loss. Conclusions Recipient age, donor age, standard versus extended criteria donor, living versus deceased donor, HLA mismatch, and delayed graft function all predicted 1-year graft survival. The effect of each risk factor is small.

Journal ArticleDOI
01 Jun 2019-BMJ Open
TL;DR: Determining certainty of net benefit is introduced, defined as the certainty that the balance between desirable and undesirable health effects is favourable, which requires considering certainty of effect estimates, the expected importance of outcomes and variability in importance, and the interaction of these concepts.
Abstract: Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology is used to assess and report certainty of evidence and strength of recommendations. This GRADE concept article is not GRADE guidance but introduces certainty of net benefit, defined as the certainty that the balance between desirable and undesirable health effects is favourable. Determining certainty of net benefit requires considering certainty of effect estimates, the expected importance of outcomes and variability in importance, and the interaction of these concepts. Certainty of net harm is the certainty that the net effect is unfavourable. Guideline panels using or testing this approach might limit strong recommendations to actions with a high certainty of net benefit or against actions with a moderate or high certainty of net harm. Recommendations may differ in direction or strength from that suggested by the certainty of net benefit or harm when influenced by cost, equity, acceptability or feasibility.

Journal ArticleDOI
TL;DR: Randomized clinical trials have failed to provide compelling evidence for the use of decision aids for men contemplating prostate cancer screening that have, up to now, undergone rigorous testing to determine their outcome.
Abstract: Importance US guidelines recommend that physicians engage in shared decision-making with men considering prostate cancer screening. Objective To estimate the association of decision aids with decisional outcomes in prostate cancer screening. Data Sources MEDLINE, Embase, PsycINFO, CINAHL, and Cochrane CENTRAL were searched from inception through June 19, 2018. Study Selection Randomized trials comparing decision aids for prostate cancer screening with usual care. Data Extraction and Synthesis Independent duplicate assessment of eligibility and risk of bias, rating of quality of the decision aids, random-effects meta-analysis, and Grading of Recommendations, Assessment, Development and Evaluations rating of the quality of evidence. Main Outcomes and Measures Knowledge, decisional conflict, screening discussion, and screening choice. Results Of 19 eligible trials (12 781 men), 9 adequately concealed allocation and 8 blinded outcome assessment. Of 12 decision aids with available information, only 4 reported the likelihood of a true-negative test result, and 3 presented the likelihood of false-negative test results or the next step if the screening test result was negative. Decision aids are possibly associated with improvement in knowledge (risk ratio, 1.38; 95% CI, 1.09-1.73;I2 = 67%; risk difference, 12.1; low quality), are probably associated with a small decrease in decisional conflict (mean difference on a 100-point scale, −4.19; 95% CI, −7.06 to −1.33;I2 = 75%; moderate quality), and are possibly not associated with whether physicians and patients discuss prostate cancer screening (risk ratio, 1.12; 95% CI, 0.90-1.39;I2 = 60%; low quality) or with men’s decision to undergo prostate cancer screening (risk ratio, 0.95; 95% CI, 0.88-1.03;I2 = 36%; low quality). Conclusions and Relevance The results of this study provide moderate-quality evidence that decision aids compared with usual care are associated with a small decrease in decisional conflict and low-quality evidence that they are associated with an increase in knowledge but not with whether physicians and patients discussed prostate cancer screening or with screening choice. Results suggest that further progress in facilitating effective shared decision-making may require decision aids that not only provide education to patients but are specifically targeted to promote shared decision-making in the patient-physician encounter.

Journal ArticleDOI
01 Apr 2019
TL;DR: The approach and the challenges encountered during the development of Anticoagulation Choice, a conversation aid to help patients with atrial fibrillation and their clinicians jointly consider the risk of thromboembolic stroke and decide whether and how to respond to this risk with anticoagulations, are described.
Abstract: Patient-centered care requires that treatments respond to the problematic situation of each patient in a manner that makes intellectual, emotional, and practical sense, an achievement that requires shared decision making (SDM). To implement SDM in practice, tools-sometimes called conversation aids or decision aids-are prepared by collating, curating, and presenting high-quality, comprehensive, and up-to-date evidence. Yet, the literature offers limited guidance for how to make evidence support SDM. Herein, we describe our approach and the challenges encountered during the development of Anticoagulation Choice, a conversation aid to help patients with atrial fibrillation and their clinicians jointly consider the risk of thromboembolic stroke and decide whether and how to respond to this risk with anticoagulation.

Journal ArticleDOI
TL;DR: This is the first work to demonstrate that the existing guidelines in breaking bad news such as SPIKES largely reflect the perspectives of many patient groups, as assessed by quantitative and qualitative measures.
Abstract: Background: Guidelines for breaking bad news are largely directed at and validated in oncology patients, based on expert opinion, and neglect those with other diagnoses. We sought to determine whet...

Journal ArticleDOI
TL;DR: For women aged younger than 50 years, forceps delivery is associated with significant increased long‐term risk of stress urinary incontinence compared with other vaginal deliveries, and there was no association of stress or urgency urinaryincontinence with mode of delivery in women aged 50 years or older.

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TL;DR: Mortality following elective THR/TKR has markedly declined over the past 50 years and is now low irrespective of which prophylactic agent is being used, and improvements in peri-operative care played a major role in the mortality reduction.
Abstract: Background Systematic reviews reporting time trends in mortality following major orthopaedic surgery are few and have limitations. They reported on only a fraction ( Methods We searched PubMed for randomized trials and observational studies, published between 1950 and 2016, reporting on mortality within 3 months of elective total hip and knee replacement (THR/TKR). Mortality risks were estimated for each 5-year interval using a Poisson regression model and presented by study design and mode of prophylaxis. To estimate the mortality reduction unrelated to anti-thrombotic use, we performed a pooled analysis of four thromboprophylaxis strategies for which data spanned five decades. Results We identified 255 eligible studies, which documented 31,604 deaths among 6,293,954 patients, and found a consistent decline in mortality irrespective of study design and mode of prophylaxis. Mortality declined from 1.15% pre-1980 to 0.24% post-2000, a 78.7% relative risk reduction (95% confidence interval [CI]: 74.7–82.1%) in randomized and cohort studies. Furthermore, our data showed a 74.4% (95% CI: 68.7–79.0%) relative reduction in mortality independent of the methods of prophylaxis, thereby indicating that improvements in peri-operative care unrelated to anti-thrombotic prophylaxis played a major role in such reduction. Conclusion Mortality following elective THR/TKR has markedly declined over the past 50 years and is now low irrespective of which prophylactic agent is being used. Although anti-thrombotic prophylaxis may have contributed, other improvements in peri-operative care played a major role in the mortality reduction.

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TL;DR: The practice of evidence-based nutrition involves using the best available nutrition evidence, together with clinical experience, to conscientiously work with patients’ values and preferences to help them prevent, resolve, or cope with problems related to their physical, mental, and social health.

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TL;DR: Improving the methods by which dietary guidelines are produced has considerable potential to substantially improve public policy decision-making.
Abstract: Dietary guidelines and recommendations, usually developed by government bodies or large authoritative organizations, have major downstream effects on public policy. A growing body of evidence supports the notion that there are serious deficiencies in the methods used to develop dietary guidelines. Such deficiencies include the failure to access or conduct comprehensive systematic reviews, a lack of systematic or rigorous evaluation of the quality of the evidence, a failure to acknowledge the limitations of the evidence base underlying recommendations, and insufficiently stringent management of conflicts of interest. These issues may be addressed by adhering to international standards for guideline development, including adopting systematic review methodology and using rigorous systems to evaluate the certainty of the evidence and to move from evidence to recommendations, of which the GRADE approach (Grading of Recommendations Assessment,Development and Evaluation) is the most rigorous and fully developed. Improving the methods by which dietary guidelines are produced has considerable potential to substantially improve public policy decision-making.

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TL;DR: It is argued that incentivizing bottom-up, local QI initiatives would improve health care delivery to a far greater extent than the current top-down initiatives undertaken in a response to various regulatory mandates, and is best done under a Health System Science (HSS) framework.
Abstract: The quality health care around world is suboptimal. To improve the quality of contemporary health care delivery, advocates have proposed a number of scientific and technical initiatives. All these initiatives, however, have arisen and continue to operate in siloes, resulting in confusion and incommensurability among those concerned with health care improvement. Participants in the quality improvement (QI) space typically stress their own, often narrow, perspective, failing to place QI in context or to acknowledge other approaches. In order to improve delivery of health care, the following is required: Provide a unifying framework for improving health care. We argue this is best done under a Health System Science (HSS) framework but with full understanding that the fundamental principles of HSS are rooted in evidence-based medicine (EBM) and decision sciences. Understand that QI initiatives are fundamentally local activities. Hence, incentivizing bottom-up, local QI initiatives would improve health care delivery to a far greater extent than the current top-down initiatives undertaken in a response to various regulatory mandates. Akin to the "Choosing Wisely" initiative, which challenged professional societies, each institution should identify (a) the extent to which its practices are evidence-based and (b) the top 5 health care practices or interventions that, at a given institution, represent overuse, underuse, or misuse/error or undermine clinicians' efforts to deliver kind and empathic care. Providing a framework that can unify the current patchwork of the initiatives would help create a common basis to help align all the existing QI efforts. In addition, thinking small (at local level) may lead to health care quality improvements that national initiatives (thinking big), focused on regulation, competition, or legal requirements, have failed to achieve.