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1.
Ann Intern Med ; 2019 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-31569213

RESUMO

Background: Dietary guidelines generally recommend limiting intake of red and processed meat. However, the quality of evidence implicating red and processed meat in adverse health outcomes remains unclear. Purpose: To evaluate the association between red and processed meat consumption and all-cause mortality, cardiometabolic outcomes, quality of life, and satisfaction with diet among adults. Data Sources: EMBASE (Elsevier), Cochrane Central Register of Controlled Trials (Wiley), Web of Science (Clarivate Analytics), CINAHL (EBSCO), and ProQuest from inception until July 2018 and MEDLINE from inception until April 2019, without language restrictions, as well as bibliographies of relevant articles. Study Selection: Cohort studies with at least 1000 participants that reported an association between unprocessed red or processed meat intake and outcomes of interest. Data Extraction: Teams of 2 reviewers independently extracted data and assessed risk of bias. One investigator assessed certainty of evidence, and the senior investigator confirmed the assessments. Data Synthesis: Of 61 articles reporting on 55 cohorts with more than 4 million participants, none addressed quality of life or satisfaction with diet. Low-certainty evidence was found that a reduction in unprocessed red meat intake of 3 servings per week is associated with a very small reduction in risk for cardiovascular mortality, stroke, myocardial infarction (MI), and type 2 diabetes. Likewise, low-certainty evidence was found that a reduction in processed meat intake of 3 servings per week is associated with a very small decrease in risk for all-cause mortality, cardiovascular mortality, stroke, MI, and type 2 diabetes. Limitation: Inadequate adjustment for known confounders, residual confounding due to observational design, and recall bias associated with dietary measurement. Conclusion: The magnitude of association between red and processed meat consumption and all-cause mortality and adverse cardiometabolic outcomes is very small, and the evidence is of low certainty. Primary Funding Source: None. (PROSPERO: CRD42017074074).

2.
Ann Intern Med ; 2019 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-31569214

RESUMO

Background: Cancer incidence has continuously increased over the past few centuries and represents a major health burden worldwide. Purpose: To evaluate the possible causal relationship between intake of red and processed meat and cancer mortality and incidence. Data Sources: Embase, Cochrane Central Register of Controlled Trials, Web of Science, CINAHL, and ProQuest from inception until July 2018 and MEDLINE from inception until April 2019 without language restrictions. Study Selection: Cohort studies that included more than 1000 adults and reported the association between consumption of unprocessed red and processed meat and cancer mortality and incidence. Data Extraction: Teams of 2 reviewers independently extracted data and assessed risk of bias; 1 reviewer evaluated the certainty of evidence, which was confirmed or revised by the senior reviewer. Data Synthesis: Of 118 articles (56 cohorts) with more than 6 million participants, 73 articles were eligible for the dose-response meta-analyses, 30 addressed cancer mortality, and 80 reported cancer incidence. Low-certainty evidence suggested that an intake reduction of 3 servings of unprocessed meat per week was associated with a very small reduction in overall cancer mortality over a lifetime. Evidence of low to very low certainty suggested that each intake reduction of 3 servings of processed meat per week was associated with very small decreases in overall cancer mortality over a lifetime; prostate cancer mortality; and incidence of esophageal, colorectal, and breast cancer. Limitation: Limited causal inferences due to residual confounding in observational studies, risk of bias due to limitations in diet assessment and adjustment for confounders, recall bias in dietary assessment, and insufficient data for planned subgroup analyses. Conclusion: The possible absolute effects of red and processed meat consumption on cancer mortality and incidence are very small, and the certainty of evidence is low to very low. Primary Funding Source: None. (PROSPERO: CRD42017074074).

3.
Ann Intern Med ; 2019 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-31569217

RESUMO

Background: Studying dietary patterns may provide insights into the potential effects of red and processed meat on health outcomes. Purpose: To evaluate the effect of dietary patterns, including different amounts of red or processed meat, on all-cause mortality, cardiometabolic outcomes, and cancer incidence and mortality. Data Sources: Systematic search of MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, CINAHL, Web of Science, and ProQuest Dissertations & Theses Global from inception to April 2019 with no restrictions on year or language. Study Selection: Teams of 2 reviewers independently screened search results and included prospective cohort studies with 1000 or more participants that reported on the association between dietary patterns and health outcomes. Data Extraction: Two reviewers independently extracted data, assessed risk of bias, and evaluated the certainty of evidence using GRADE (Grading of Recommendations Assessment, Development and Evaluation) criteria. Data Synthesis: Eligible studies that followed patients for 2 to 34 years revealed low- to very-low-certainty evidence that dietary patterns lower in red and processed meat intake result in very small or possibly small decreases in all-cause mortality, cancer mortality and incidence, cardiovascular mortality, nonfatal coronary heart disease, fatal and nonfatal myocardial infarction, and type 2 diabetes. For all-cause, cancer, and cardiovascular mortality and incidence of some types of cancer, the total sample included more than 400 000 patients; for other outcomes, total samples included 4000 to more than 300 000 patients. Limitation: Observational studies are prone to residual confounding, and these studies provide low- or very-low-certainty evidence according to the GRADE criteria. Conclusion: Low- or very-low-certainty evidence suggests that dietary patterns with less red and processed meat intake may result in very small reductions in adverse cardiometabolic and cancer outcomes. Primary Funding Source: None. (PROSPERO: CRD42017074074).

4.
Ann Intern Med ; 2019 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-31569219

RESUMO

Background: A person's meat consumption is often determined by their values and preferences. Purpose: To identify and evaluate evidence addressing health-related values and preferences regarding meat consumption. Data Sources: MEDLINE, EMBASE, Web of Science, Centre for Agriculture and Biosciences Abstracts, International System for Agricultural Science and Technology, and Food Science and Technology Abstracts were searched from inception to July 2018 without language restrictions. Study Selection: Pairs of reviewers independently screened search results and included quantitative and qualitative studies reporting adults' health-related values and preferences regarding meat consumption. Data Extraction: Pairs of reviewers independently extracted data and assessed risk of bias. Data Synthesis: Data were synthesized into narrative form, and summaries were tabulated and certainty of evidence was assessed using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach. Of 19 172 initial citations, 41 quantitative studies (38 addressed reasons for meat consumption and 5 addressed willingness to reduce meat consumption) and 13 qualitative studies (10 addressed reasons for meat consumption and 4 addressed willingness to reduce meat consumption) were eligible for inclusion. Thirteen studies reported that omnivores enjoy eating meat, 18 reported that these persons consider meat an essential component of a healthy diet, and 7 reported that they believe they lack the skills needed to prepare satisfactory meals without meat. Omnivores are generally unwilling to change their meat consumption. The certainty of evidence was low for both "reasons for meat consumption" and "willingness to reduce meat consumption in the face of undesirable health effects." Limitation: Limited generalizability of findings to lower-income countries, low-certainty evidence for willingness to reduce meat consumption, and limited applicability to specific types of meat (red and processed meat). Conclusion: Low-certainty evidence suggests that omnivores are attached to meat and are unwilling to change this behavior when faced with potentially undesirable health effects. Primary Funding Source: None. (PROSPERO: CRD42018088854).

5.
Ann Intern Med ; 2019 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-31569235

RESUMO

Description: Dietary guideline recommendations require consideration of the certainty in the evidence, the magnitude of potential benefits and harms, and explicit consideration of people's values and preferences. A set of recommendations on red meat and processed meat consumption was developed on the basis of 5 de novo systematic reviews that considered all of these issues. Methods: The recommendations were developed by using the Nutritional Recommendations (NutriRECS) guideline development process, which includes rigorous systematic review methodology, and GRADE methods to rate the certainty of evidence for each outcome and to move from evidence to recommendations. A panel of 14 members, including 3 community members, from 7 countries voted on the final recommendations. Strict criteria limited the conflicts of interest among panel members. Considerations of environmental impact or animal welfare did not bear on the recommendations. Four systematic reviews addressed the health effects associated with red meat and processed meat consumption, and 1 systematic review addressed people's health-related values and preferences regarding meat consumption. Recommendations: The panel suggests that adults continue current unprocessed red meat consumption (weak recommendation, low-certainty evidence). Similarly, the panel suggests adults continue current processed meat consumption (weak recommendation, low-certainty evidence). Primary Funding Source: None. (PROSPERO 2017: CRD42017074074; PROSPERO 2018: CRD42018088854).

6.
Medicine (Baltimore) ; 98(39): e17064, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31574805

RESUMO

BACKGROUND: Most systematic reviews have explored the efficacy of treatments on symptoms associated with post-traumatic stress disorder (PTSD), which is a chronic and often disabling condition. Previous network meta-analysis (NMA) had limitations such as focusing on pharmacological or psychotherapies. Our review is aims to explore the relative effectiveness of both pharmacological and psychotherapies and we will establish the differential efficacy of interventions for PTSD in consideration of both symptom reduction and functional recovery. METHODS: We will conduct a network meta-analysis of randomized controlled trials evaluating treatment interventions for PTSD. We will systematically search Medline, PILOT, Embase, CINHAL, AMED, Psychinfo, Health Star, DARE and CENTRAL to identify trials that: (1) enroll adult patients with PTSD, and (2) randomize them to alternative interventions or an intervention and a placebo/sham arm. Independent reviewers will screen trials for eligibility, assess risk of bias using a modified Cochrane instrument, and extract data. Our outcomes of interest include PTSD symptom reduction, quality of life, functional recovery, social and occupational impairment, return to work and all-cause drop outs. RESULTS: We will conduct frequentist random-effects network meta-analysis to assess relative effects of competing interventions. We will use a priori hypotheses to explore heterogeneity between studies, and assess the certainty of evidence using the GRADE approach. CONCLUSION: This network meta-analysis will determine the comparative effectiveness of therapeutic options for PTSD on both symptom reduction and functional recovery. Our results will be helpful to clinicians and patients with PTSD, by providing a high-quality evidence synthesis to guide shared-care decision making.

7.
Ann Intern Med ; 2019 10 01.
Artigo em Inglês | MEDLINE | ID: mdl-31569236

RESUMO

Background: Few randomized trials have evaluated the effect of reducing red meat intake on clinically important outcomes. Purpose: To summarize the effect of lower versus higher red meat intake on the incidence of cardiometabolic and cancer outcomes in adults. Data Sources: EMBASE, CENTRAL, CINAHL, Web of Science, and ProQuest from inception to July 2018 and MEDLINE from inception to April 2019, without language restrictions. Study Selection: Randomized trials (published in any language) comparing diets lower in red meat with diets higher in red meat that differed by a gradient of at least 1 serving per week for 6 months or more. Data Extraction: Teams of 2 reviewers independently extracted data and assessed the risk of bias and the certainty of the evidence. Data Synthesis: Of 12 eligible trials, a single trial enrolling 48 835 women provided the most credible, though still low-certainty, evidence that diets lower in red meat may have little or no effect on all-cause mortality (hazard ratio [HR], 0.99 [95% CI, 0.95 to 1.03], cardiovascular mortality (HR, 0.98 [CI, 0.91 to 1.06]), and cardiovascular disease (HR, 0.99 [CI, 0.94 to 1.05]). That trial also provided low- to very-low-certainty evidence that diets lower in red meat may have little or no effect on total cancer mortality (HR, 0.95 [CI, 0.89 to 1.01]) and the incidence of cancer, including colorectal cancer (HR, 1.04 [CI, 0.90 to 1.20]) and breast cancer (HR, 0.97 [0.90 to 1.04]). Limitations: There were few trials, most addressing only surrogate outcomes, with heterogeneous comparators and small gradients in red meat consumption between lower versus higher intake groups. Conclusion: Low- to very-low-certainty evidence suggests that diets restricted in red meat may have little or no effect on major cardiometabolic outcomes and cancer mortality and incidence. Primary Funding Source: None (PROSPERO: CRD42017074074).

8.
J Urol ; : 101097JU0000000000000463, 2019 Jul 31.
Artigo em Inglês | MEDLINE | ID: mdl-31364920

RESUMO

PURPOSE: Nocturia (waking from sleep at night to void) is a common cause of sleep disruption and associated with increased comorbidity and impaired quality of life. However, its impact on mortality remains unclear. We performed a systematic review and meta-analysis to evaluate the association of nocturia with mortality, both as a prognostic and causal risk factor. MATERIALS AND METHODS: We searched PubMed, Scopus, CINAHL and major conference abstracts up to December 31, 2018. Random effects meta-analyses addressed adjusted relative risks (RR) of mortality for people with nocturia and a meta-regression explored potential determinants of heterogeneity, including risk of bias. We applied the GRADE framework to rate the quality of evidence for nocturia as a prognostic risk factor for mortality and, separately, as a cause of mortality. RESULTS: Of 5230 identified reports, 11 observational studies proved eligible. For the assessment of nocturia, ten studies used symptom questionnaires and one frequency-volume charts. Nocturia was defined as ≥2 episodes/night in six (55%), and as ≥3 episodes/night in five (45%) studies. Pooled estimates demonstrated a risk ratio of 1.27 (95% confidence interval 1.16-1.40; I2=48%; absolute 5-year mortality difference 1.6% and 4.0% in people aged 60 and 75 years, respectively). The pooled estimates of relative risk did not differ significantly across varying age, gender, follow-up time, nocturia case definition, risk of bias, or study region. We rated the quality of evidence for nocturia as a prognostic factor as moderate and as a cause of mortality as very low. CONCLUSIONS: Nocturia is probably associated with an approximately 1.3-fold increased risk of death.

9.
J Urol ; : 101097JU0000000000000459, 2019 Jul 26.
Artigo em Inglês | MEDLINE | ID: mdl-31347956

RESUMO

PURPOSE: Although nocturia is associated with various comorbidities, its impact on falls and fractures remains unclear. We performed a systematic review and meta-analysis to evaluate the association between nocturia with falls and fractures, both as a prognostic and causal risk factor. MATERIALS AND METHODS: We searched PubMed, Scopus and CINAHL and abstracts of major urologic meetings up to December 31, 2018. We conducted random effects meta-analyses of adjusted relative risks (RR) of falls and fractures. We applied the GRADE approach to rate the quality of evidence for nocturia as a prognostic and causal factor of falls and fractures. RESULTS: Of 5230 potential reports, nine observational longitudinal studies provided data on the association between nocturia and falls or fractures (1 for both, 4 for falls, 4 for fractures). Pooled estimates demonstrated a risk ratio of 1.20 (95% confidence interval 1.05-1.37; I2=51.7%; annual risk difference 7.5% among the elderly) for association between nocturia and falls and 1.32 (95% confidence interval 0.99-1.76; I2=57.5%; annual risk difference 1.2%) for association between nocturia and fractures. Subgroup analyses showed no significant effect modification by age, gender, follow-up time, nocturia case definition or risk of bias. We rated the quality of evidence for nocturia as a prognostic factor as moderate for falls and low for fractures, and as very low as a cause of falls/fractures. CONCLUSIONS: Nocturia is probably associated with an approximately 1.2-fold increased risk of falls and possibly with an approximately 1.3-fold increased risk of fractures.

10.
J Clin Epidemiol ; 115: 25-34, 2019 Jul 02.
Artigo em Inglês | MEDLINE | ID: mdl-31276781

RESUMO

OBJECTIVES: The objective of the study was to investigate time-lag bias based on statistical significance in findings in non-Cochrane systematic reviews (SRs) and explore barriers to publication for review authors. STUDY DESIGN AND SETTING: We included SRs of randomized controlled trials with completed analyses for protocols registered in the international prospective register of systematic reviews (PROSPERO) by the end of 2014. To obtain unpublished information, we sent questionnaires regarding barriers to publication of SRs to all authors between May and November 2018 and examined the association between the statistical significance of SR findings and time to acceptance. RESULTS: Among the 241 SR authors contacted, 141 (58%) responded, of whom 103 met the eligibility criteria and agreed to participate. Ninety-three (90%) of the protocols had been published as journal articles and 11 (11%) remained unpublished. Statistical significance was not significantly associated with time to acceptance (adjusted hazard ratio, 1.36; 95% confidence interval, 0.84 to 2.19). The authors reported lack of time (52%), rejection by journals (42%), duplication of similar topics (42%), and nonsignificant results (29%) as barriers to publication of SRs. CONCLUSION: We found no convincing evidence of time-lag bias based on statistical significance in the findings among non-Cochrane SRs registered in the PROSPERO.

11.
J Clin Epidemiol ; 115: 55-63, 2019 Jul 09.
Artigo em Inglês | MEDLINE | ID: mdl-31299357

RESUMO

BACKGROUND AND OBJECTIVES: In order for authors of systematic reviews to address missing data in randomized controlled trials (RCTs), they need to first identify the number of trial participants with missing data. The objective of this study was to provide guidance for authors of systematic reviews on how to identify participants with missing outcome data in reports of RCTs. METHODS: Guidance statements were informed by a review of studies addressing the topic of missing data and an iterative process of feedback and refinement, through meetings involving experts in health research methodology and authors of systematic reviews. RESULTS: The proposed guidance includes (1) definitions of key terms, (2) 19 categories of participants described in RCT reports and who might have missing data, and (3) a flowchart on how to judge the outcome data missingness for each category. The judgment of missingness relies on how trial authors report on the categories and handle them in their analyses. Practically, for their primary analysis, systematic review authors should choose how to identify participants with missing outcome data (i.e., use either "definitely missing data" or "total possible missing data"), then select a method for handling missing data in meta-analysis. Sensitivity analyses should be undertaken to explore consistency with competing options for classifying patients as having missing data. CONCLUSION: Adopting the proposed guidance will help promote transparency and consistency regarding how missing data are managed in systematic reviews.

12.
BMJ Open ; 9(6): e024265, 2019 Jun 04.
Artigo em Inglês | MEDLINE | ID: mdl-31167856

RESUMO

OBJECTIVE: To assess which mental health-related states of being are perceived as diseases by psychiatrists, non-psychiatric physicians, nurses, parliament members and laypeople. DESIGN AND SETTING: A population-based, mailed survey in Finland. PARTICIPANTS: Respondents from a random sample of 3000 laypeople, 1500 physicians, 1500 nurses and all 200 members of the parliament (MPs) of Finland. PRIMARY OUTCOME MEASURES: Respondents' perspectives on 20 mental health-related states of being as diseases, measuring the extent of agreement with the claim: '[This state of being] is a disease'. RESULTS: Of the 6200 people approached, we received 3259 eligible responses (53%). Two conditions (schizophrenia and autism) were considered to be diseases by at least 75% and two states (grief and homosexuality) were considered not to be diseases by at least 75% in each group. A majority (at least 50% in each group) considered seven states as diseases (anorexia, attention deficit hyperactivity disorder, bulimia, depression, generalised anxiety disorder, panic disorder and personality disorder) and three not to be diseases (absence of sexual desire, premature ejaculation and transsexualism). In six states, there was a wide divergence of opinion (alcoholism, drug addiction, gambling addiction, insomnia, social anxiety disorder and work exhaustion). Psychiatrists were significantly more inclined to considering states of being as diseases relative to other groups, followed by non-psychiatric physicians, nurses, MPs and laypeople. CONCLUSIONS: Respondents agreed that some conditions, such as schizophrenia and autism, are diseases and other states, such as grief and homosexuality, are not; for others, there was considerable disagreement. Psychiatrists are more inclined to consider mental health-related states of being as diseases compared with other physicians, who, in turn, are more inclined than other constituencies. Understanding notions of disease may underlie important debates in public policy and practice in areas of mental health and behaviour, and have implications for resource allocation and stigma.

13.
JAMA Intern Med ; 2019 Jun 24.
Artigo em Inglês | MEDLINE | ID: mdl-31233091

RESUMO

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.

15.
CMAJ ; 191(20): E565, 2019 May 21.
Artigo em Inglês | MEDLINE | ID: mdl-31113788
16.
J Clin Epidemiol ; 113: 159-167, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31132471

RESUMO

OBJECTIVE: The objective of the study was to systematically survey the methodological literature and collect suggested criteria for assessing the credibility of effect modification and associated rationales. STUDY DESIGN AND SETTING: We searched MEDLINE, Embase, and WorldCat up to March 2018 for publications providing guidance for assessing the credibility of effect modification identified in randomized trials or meta-analyses. Teams of two investigators independently identified eligible publications and extracted credibility criteria and authors' rationale, reaching consensus through discussion. We created a taxonomy of criteria that we iteratively refined during data abstraction. RESULTS: We identified 150 eligible publications that provided 36 criteria and associated rationales. Frequent criteria included significant test for interaction (n = 54), a priori hypothesis (n = 49), providing a causal explanation (n = 47), accounting for multiplicity (n = 45), testing a small number of effect modifiers (n = 38), and prespecification of analytic details (n = 39). For some criteria, we found more than one rationale; some criteria were connected through a common rationale. For some criteria, experts disagreed regarding their suitability (e.g., added value of stratified randomization; trustworthiness of biologic rationales). CONCLUSION: Methodologists have expended substantial intellectual energy providing criteria for critical appraisal of apparent effect modification. Our survey highlights popular criteria, expert agreement and disagreement, and where more work is needed, including testing criteria in practice.

17.
BMJ Open ; 9(4): e024441, 2019 Apr 03.
Artigo em Inglês | MEDLINE | ID: mdl-30948570

RESUMO

INTRODUCTION: Acute, non-low back-related musculoskeletal pain is common and associated with significant socioeconomic costs. No review has evaluated all interventional studies for acute musculoskeletal pain, which limits attempts to make inferences regarding the relative effectiveness of treatments. METHODS AND ANALYSIS: We will conduct a systematic review of all randomised controlled trials evaluating therapies for acute musculoskeletal pain (excluding low back pain). We will identify eligible, English-language, trials by a systematic search of the Cumulative Index to Nursing and Allied Health Literature (CINAHL), Embase, Medline, Physiotherapy Evidence Database (PEDro) and the Cochrane Central Register of Controlled Trials (CENTRAL) from inception to February 2018. Eligible trials will: (1) enrol patients presenting with acute, non-low back-related musculoskeletal pain (duration of pain ≤4 weeks), and (2) randomise patients to alternative interventions or an intervention and a placebo/sham arm. Fractures will be considered ineligible, unless they are non-surgical and therapy is directed at pain relief. Pairs of reviewers will, independently and in duplicate, screen titles and abstracts of identified citations, review the full texts of potentially eligible trials and extract information from eligible trials. We will use a modified Cochrane instrument to evaluate risk of bias. Disagreements will be resolved through discussion to achieve consensus. We will use the Grading of Recommendations Assessment, Development and Evaluation approach to evaluate the quality of evidence supporting treatment effects. When possible, we will conduct: (1) in direct comparisons, a random-effect meta-analysis to establish the effectiveness of therapeutic interventions on patient-important outcomes; and (2) multiple treatment comparison meta-analysis to assess the relative effects of treatments. We will use a priori hypotheses to explain heterogeneity between studies. We will use STATA V.14.2 for all analyses. ETHICS AND DISSEMINATION: No research ethics approval is required for this systematic review, as no confidential patient data will be used. The results of this systematic review will be disseminated through publication in a peer-reviewed journal, conference presentations and will inform a clinical practice guideline. PROSPERO REGISTRATION NUMBER: CRD42018094412.

19.
J Clin Epidemiol ; 111: 69-82, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-30738926

RESUMO

OBJECTIVES: This article describes the Grading of Recommendations Assessment, Development and Evaluation (GRADE) Working Group's framework of moving from test accuracy to patient or population-important outcomes. We focus on the common scenario when studies directly evaluating the effect of diagnostic and other tests or strategies on health outcomes are not available or are not providing the best available evidence. STUDY DESIGN AND SETTING: Using practical examples, we explored how guideline developers and other decision makers can use information from test accuracy to develop a recommendation by linking evidence that addresses downstream consequences. Guideline panels should develop an analytic framework that summarizes the actions that follow from applying a test and the consequences. RESULTS: We describe GRADE's current thinking about the overall certainty of the evidence (also known as quality of the evidence or confidence in the estimates) arising from consideration of the often complex pathways that involve multiple tests and management options. Each link in the evidence can-and often does-lower the overall certainty of the evidence required to formulate recommendations and make decisions about tests. The frequency with which an outcome occurs and its importance will influence whether or not a particular step in the linked evidence is critical to decision-making. CONCLUSIONS: Overall certainty may be expressed by the weakest critical step in the linked evidence. The linked approach to addressing optimal testing will often require the use of decision analytic approaches. We present an example that involves decision modeling in a GRADE Evidence to Decision framework for cervical cancer screening. However, because resources and time of guideline developers may be limited, we describe alternative, pragmatic strategies for developing recommendations addressing test use.

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