{"resourceType":"ArtifactAssessment","id":"risk-of-bias-example","identifier":[{"type":{"text":"FEvIR Object Identifier"},"system":"https://fevir.net","value":"27751","assigner":{"display":"Computable Publishing LLC"}}],"artifactCanonical":"http://fevir.net/resources/Evidence/7637","date":"2021-11-02T14:31:30.239Z","copyright":"https://creativecommons.org/licenses/by-nc-sa/4.0/","lastReviewDate":"2021-08-11","content":[{"type":{"coding":[{"system":"http://terminology.hl7.org/CodeSystem/certainty-type","version":"6.0.0","code":"RiskOfBias","display":"Risk of bias","userSelected":true}]},"classifier":[{"coding":[{"system":"http://terminology.hl7.org/CodeSystem/certainty-rating","version":"6.0.0","code":"extremely-serious-concern","display":"extremely serious concern","userSelected":true}]}],"author":[{"display":"COVID-19 Knowledge Accelerator Evidence 7637 Authors (Brian S. Alper, Harold Lehmann, Ahmad Sofi-Mahmudi, Joanne Dehnbostel, Ilkka Kunnamo)"}],"freeToShare":true,"component":[{"summary":"Inclusion of suspected COVID-19 in 1 of 3 trials may introduce selection bias, but the impact appears limited.","type":{"text":"Selection Bias"},"classifier":[{"coding":[{"system":"http://terminology.hl7.org/CodeSystem/certainty-rating","version":"6.0.0","code":"no-concern","display":"no serious concern","userSelected":true}]}],"author":[{"display":"Brian S. Alper"},{"display":"Joanne Dehnbostel"},{"display":"Muhammad Afzal"}],"component":[{"summary":"Definition of Selection Bias \u003d A bias resulting from methods used to select subjects or data, factors that influence initial study participation, or differences between the study sample and the population of interest"}]},{"summary":"The study design used response-adaptive randomization in which group assignment ratios could be modified during the trial on the basis of response-adaptive interim analyses to favor the assignment of patients to the treatment group showing greater benefit. The confounding by time (imbalanced randomization with time period) is not adequately reported to determine the potential influence on results or adequacy of adjusted analyses.","type":{"text":"Confounding Covariate Bias"},"classifier":[{"coding":[{"system":"http://terminology.hl7.org/CodeSystem/certainty-rating","version":"6.0.0","code":"serious-concern","display":"serious concern","userSelected":true}]}],"author":[{"display":"Brian S. Alper"},{"display":"Ilkka Kunnamo"},{"display":"Alfonso Iorio"},{"display":"Joanne Dehnbostel"},{"display":"Harold Lehmann"},{"display":"Kenneth Wilkins"},{"display":"clarifying explanation reviewed by Janice Tufte"}],"component":[{"summary":"Definition of Confounding Covariate Bias \u003d A situation in which the effect or association between an exposure and outcome is distorted by another variable. For confounding covariate bias to occur the distorting variable must be (1) associated with the exposure and the outcome, (2) not in the causal pathway between exposure and outcome, and (3) unequally distributed between the groups being compared."},{"summary":"ATTACC implemented response-adaptive randomization on December 15, 2020, which led to imbalanced randomization. No data reported to determine if intervention-specific outcome rates were similar or different before and after December 15, 2020 in the ATTACC cohort."},{"summary":"Insufficient details reported to judge whether there is an imbalance in outcomes related to the adaptive randomization which in turn could be used to judge the validity of adjustment methods in the statistical model for this concern and the appropriateness of any sensitivity analyses."},{"summary":"Response-adaptive randomization led to imbalanced randomization.","type":{"text":"Allocation Bias"},"classifier":[{"text":"Adaptive randomization is not a concern by itself, only if it results in a confounding difference."}],"author":[{"display":"Brian S. Alper"},{"display":"Joanne Dehnbostel"},{"display":"Harold Lehmann"},{"display":"Kenneth Wilkins"}],"component":[{"summary":"Definition of Allocation Bias \u003d A confounding covariate bias resulting from methods for assignment of the independent variable by the investigator to evaluate a response or outcome."},{"summary":"ATTACC implemented response-adaptive randomization on December 15, 2020, which led to imbalanced randomization."}]},{"summary":"There is an unequal distribution of calendar time between the groups being compared.","type":{"text":"Confounding difference"},"classifier":[{"coding":[{"system":"http://terminology.hl7.org/CodeSystem/certainty-rating","version":"6.0.0","code":"serious-concern","display":"serious concern","userSelected":true}]}],"author":[{"display":"Brian S. Alper"},{"display":"Joanne Dehnbostel"},{"display":"Harold Lehmann"},{"display":"Kenneth Wilkins"}],"component":[{"summary":"Definition of Confounding difference \u003d A confounding covariate bias in which the unequal distribution of a potentially distorting variable is recognized."},{"summary":"Incomplete reporting limits the determination of the potential degree of influence of calendar time."},{"summary":"There is evidence of potential for calendar time to influence the results: In an observational study of 18,508 adults with laboratory-confirmed, COVID-19 associated hospitalization \u0027The percentage of hospitalized patients admitted to the ICU decreased from 37.8% in March to 20.5% in December\u0027 (Ann Intern Med 2021 Aug 10 https://www.acpjournals.org/doi/10.7326/M21-1991)."}]}]},{"summary":"Awareness of treatment assignment may reduce clinical decision to initiate some types of \"organ support\" in patients with higher risk of major bleeding.","type":{"text":"Performance Bias"},"classifier":[{"coding":[{"system":"http://terminology.hl7.org/CodeSystem/certainty-rating","version":"6.0.0","code":"very-serious-concern","display":"very serious concern","userSelected":true}]}],"author":[{"display":"Brian S. Alper"},{"display":"Joanne Dehnbostel"},{"display":"Harold Lehmann"},{"display":"Muhammad Afzal"}],"component":[{"summary":"Definition of Performance Bias \u003d A bias resulting from differences between the received exposure and the intended exposure."},{"summary":"Lack of blinding may explain reported differences in the primary outcome.","type":{"text":"Inadequate blinding of intervention deliverers"},"classifier":[{"coding":[{"system":"http://terminology.hl7.org/CodeSystem/certainty-rating","version":"6.0.0","code":"very-serious-concern","display":"very serious concern","userSelected":true}]}],"author":[{"display":"Brian S. Alper"},{"display":"clarifying explanation reviewed by Janice Tufte"}],"component":[{"summary":"The absolute difference in survival without intubation was 1%, so 3% of the 4% absolute difference in the primary outcome can be considered \"organ support without intubation\"."},{"summary":"The specific \"organ support without intubation\" was not reported. The methods for one of the included trials stated \"Organ Support is defined as receipt of invasive or non-invasive mechanical ventilation, high flow nasal oxygen, vasopressor therapy, or ECMO support\""},{"summary":"Awareness of treatment assignment may reduce clinical decision to initiate \"organ support without intubation\" in patients with higher risk of major bleeding."},{"summary":"Definition of Inadequate blinding of intervention deliverers \u003d A performance bias due to awareness of the allocated intervention by individuals providing or delivering the intervention."}]},{"summary":"Crossover to other intervention in 20%","type":{"text":"Deviation from study intervention protocol"},"classifier":[{"text":"degree of concern unclear"}],"author":[{"display":"Surbhi Shah"},{"display":"Brian S. Alper"}],"component":[{"summary":"Therapeutic dose anticoagulation (in the first 24-48 hours following randomization) was reported in 79.6% of the therapeutic arm and 0.9% of the usual care arm. (Table S3)"},{"summary":"Definition of Deviation from study intervention protocol \u003d A performance bias in which the intervention received differs from the intervention specified in the study protocol."}]},{"summary":"We discussed whether they may be a bias related to limited adherence to anticoagulation. Because this was an inpatient population, we did not expect adherence problems that are more common with outpatient thromboprophylaxis.","type":{"text":"Nonadherence of implementation"},"classifier":[{"text":"limited concern"}],"author":[{"display":"COVID-19 Knowledge Accelerator Working Group discussion with Brian S. Alper, Ilkka Kunnamo, Joanne Dehnbostel; Performance Bias concern initially suggested by Harold Lehmann"}],"component":[{"summary":"Initial adherence to the protocol-assigned anticoagulation dose after randomization was 88.3% in the therapeutic-dose anticoagulation group and 98.3% in the thromboprophylaxis group (Table S3)."},{"summary":"Definition of Nonadherence of implementation \u003d A performance bias in which the intervention deliverers do not completely adhere to the expected intervention."}]}]},{"summary":"The influence of awareness of treatment assignment by the treating clinicians on the initaition of organ support (which is the primary outcome) was already addressed as Performance Bias so is not repeated here as a bias in detecting the outcome.","type":{"text":"Detection Bias"},"classifier":[{"coding":[{"system":"http://terminology.hl7.org/CodeSystem/certainty-rating","version":"6.0.0","code":"no-concern","display":"no serious concern","userSelected":true}]}],"author":[{"display":"Brian S. Alper"},{"display":"Joanne Dehnbostel"},{"display":"Muhammad Afzal"}],"component":[{"summary":"Definition of Detection Bias \u003d A bias due to distortions in how variable values (data) are determined."}]},{"summary":"Only 19 of 1190 (1.6%) therapeutic group and 6 of 1054 (0.6) prophylactic group were excluded after randomization.","type":{"text":"Attrition Bias"},"classifier":[{"coding":[{"system":"http://terminology.hl7.org/CodeSystem/certainty-rating","version":"6.0.0","code":"no-concern","display":"no serious concern","userSelected":true}]}],"author":[{"display":"Brian S. Alper"},{"display":"Joanne Dehnbostel"},{"display":"Muhammad Afzal"}],"component":[{"summary":"Definition of Attrition Bias \u003d A bias due to absence of expected participation or data collection after selection for study inclusion."}]},{"summary":"It is unknown if the results are sensitive to the analytic method, and the stopping criteria were based on statistical significance and not magnitude of effect.","type":{"text":"Analysis Bias"},"classifier":[{"coding":[{"system":"http://terminology.hl7.org/CodeSystem/certainty-rating","version":"6.0.0","code":"very-serious-concern","display":"very serious concern","userSelected":true}]}],"author":[{"display":"Brian S. Alper"},{"display":"Joanne Dehnbostel"},{"display":"Muhammad Afzal"},{"display":"Janice Tufte"}],"component":[{"summary":"Definition of Analysis Bias \u003d A bias related to the analytic process applied to the data."},{"summary":"A frequentist analysis is not reported so we cannot determine if the results are sensitive to the analytic method","type":{"text":"Bias related to selection of the analysis"},"classifier":[{"coding":[{"system":"http://terminology.hl7.org/CodeSystem/certainty-rating","version":"6.0.0","code":"very-serious-concern","display":"very serious concern","userSelected":true}]}],"author":[{"display":"Brian S. Alper"},{"display":"Joanne Dehnbostel"},{"display":"Muhammad Afzal"},{"display":"Janice Tufte"}],"component":[{"summary":"Definition of Bias related to selection of the analysis \u003d An analysis bias due to inappropriate choice of analysis methods before the analysis is applied."},{"summary":"There was no pre-specified frequentist analysis. There was no posthoc frequentist analysis reported."},{"summary":"It is uncertain what a frequentist analysis would show and uncertain whether the choice of Bayesian analysis or frequentist analysis has a substantial influence on the results."}]},{"summary":"The stopping criteria were based on statistical significance and not magnitude of effect.","type":{"text":"Early trial termination"},"classifier":[{"coding":[{"system":"http://terminology.hl7.org/CodeSystem/certainty-rating","version":"6.0.0","code":"very-serious-concern","display":"very serious concern","userSelected":true}]}],"author":[{"display":"Brian S. Alper"},{"display":"Joanne Dehnbostel"},{"display":"Muhammad Afzal"},{"display":"Janice Tufte"}],"component":[{"summary":"There was no “minimally important difference”. So a 99% probability of having an odds ratio \u003e 1 (even if the magnitude of effect is infinitesimal) was used to decide it was time to stop the trial."}]}]}]},{"summary":"Results not consistent with critically ill cohort.","type":{"coding":[{"system":"http://terminology.hl7.org/CodeSystem/certainty-type","version":"6.0.0","code":"Inconsistency","display":"Inconsistency","userSelected":true}]},"author":[{"display":"Ilkka Kunnamo"}]}]}
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A\u003c/td\u003e\u003ctd\u003eundefined\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd\u003eRating System (coded as: rating-system from https://fevir.net/resources/CodeSystem/179423)\u003c/td\u003e\u003ctd\u003eundefined\u003c/td\u003e\u003ctd\u003eADA Level of Evidence\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd\u003eStrength of Recommendation (coded as: RJCS-1000 from https://fevir.net/resources/CodeSystem/27834); Strength of Recommendation (coded as: strength-of-recommendation from https://fevir.net/resources/CodeSystem/179423)\u003c/td\u003e\u003ctd\u003eundefined\u003c/td\u003e\u003ctd\u003eundefined\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd\u003eDirection of Recommendation (coded as: RJCS-1014 from https://fevir.net/resources/CodeSystem/27834); Direction of Recommendation (coded as: direction-of-recommendation from https://fevir.net/resources/CodeSystem/179423)\u003c/td\u003e\u003ctd\u003eundefined\u003c/td\u003e\u003ctd\u003eFavors intervention (coded as: RJCS-2021 from https://fevir.net/resources/CodeSystem/27834)\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd\u003eRatings (coded as: ratings from https://fevir.net/resources/CodeSystem/179423)\u003c/td\u003e\u003ctd\u003eundefined\u003c/td\u003e\u003ctd\u003eA\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd\u003eEvidence (coded as: RJCS-content1 from https://fevir.net/resources/CodeSystem/27834); Evidence (coded as: evidence from https://fevir.net/resources/CodeSystem/179423)\u003c/td\u003e\u003ctd\u003eADA Level of Evidence A. A substantial body of evidence has now been accumulated, including data from numerous randomized controlled (nonblinded) clinical trials, demonstrating that metabolic surgery achieves superior glycemic control and reduction of cardiovascular risk factors in patients with type 2 diabetes and obesity compared with various lifestyle/medical interventions.\u003c/td\u003e\u003ctd\u003eundefined\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd\u003eSummary of Findings (coded as: summary-of-findings from https://fevir.net/resources/CodeSystem/179423)\u003c/td\u003e\u003ctd\u003eADA Level of Evidence A. A substantial body of evidence has now been accumulated, including data from numerous randomized controlled (nonblinded) clinical trials, demonstrating that metabolic surgery achieves superior glycemic control and reduction of cardiovascular risk factors in patients with type 2 diabetes and obesity compared with various lifestyle/medical interventions.\u003c/td\u003e\u003ctd\u003eundefined\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd\u003eDesirable Effects (coded as: RJCS-1004 from https://fevir.net/resources/CodeSystem/27834); Desirable Effects (coded as: desirable-effects from https://fevir.net/resources/CodeSystem/179423)\u003c/td\u003e\u003ctd\u003eundefined\u003c/td\u003e\u003ctd\u003eundefined\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd\u003eUndesirable Effects (coded as: RJCS-1005 from https://fevir.net/resources/CodeSystem/27834); Undesirable Effects (coded as: undesirable-effects from https://fevir.net/resources/CodeSystem/179423)\u003c/td\u003e\u003ctd\u003eundefined\u003c/td\u003e\u003ctd\u003eundefined\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd\u003eDiscussion (coded as: discussion from https://fevir.net/resources/CodeSystem/179423)\u003c/td\u003e\u003ctd\u003eA substantial body of evidence has now been accumulated, including data from numerous randomized controlled (nonblinded) clinical trials, demonstrating that metabolic surgery achieves superior glycemic control and reduction of cardiovascular risk factors in patients with type 2 diabetes and obesity compared with various lifestyle/medical interventions.\u003cbr/\u003eIn extended follow-up of obese adults with type 2 diabetes randomized to adding gastric bypass compared with lifestyle and intensive medical management alone, there remained a significantly better composite triple end point in the surgical group at 5 years. However, because the effect size diminished over 5 years, further follow-up is needed to understand the durability of the improvement.\u003c/td\u003e\u003ctd\u003eundefined\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd\u003eNet Effect (coded as: RJCS-1007 from https://fevir.net/resources/CodeSystem/27834); Net Effect (coded as: net-effect from https://fevir.net/resources/CodeSystem/179423)\u003c/td\u003e\u003ctd\u003eundefined\u003c/td\u003e\u003ctd\u003eundefined\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd\u003eValues/Preferences (coded as: RJCS-1006 from https://fevir.net/resources/CodeSystem/27834); Preferences (coded as: preferences from https://fevir.net/resources/CodeSystem/179423)\u003c/td\u003e\u003ctd\u003eundefined\u003c/td\u003e\u003ctd\u003eundefined\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd\u003eDiscussion (coded as: discussion from https://fevir.net/resources/CodeSystem/179423)\u003c/td\u003e\u003ctd\u003eundefined\u003c/td\u003e\u003ctd\u003eundefined\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd\u003eJudgments (coded as: RJCS-content2 from https://fevir.net/resources/CodeSystem/27834); Judgments (coded as: judgments from https://fevir.net/resources/CodeSystem/179423)\u003c/td\u003e\u003ctd\u003eundefined\u003c/td\u003e\u003ctd\u003eundefined\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd\u003eJustification (coded as: justification from https://fevir.net/resources/CodeSystem/179423)\u003c/td\u003e\u003ctd\u003eundefined\u003c/td\u003e\u003ctd\u003eundefined\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd\u003eProblem Importance (coded as: RJCS-1003 from https://fevir.net/resources/CodeSystem/27834); Problem Importance (coded as: problem-importance from https://fevir.net/resources/CodeSystem/179423)\u003c/td\u003e\u003ctd\u003eundefined\u003c/td\u003e\u003ctd\u003eundefined\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd\u003eResources/Costs (coded as: RJCS-1008 from https://fevir.net/resources/CodeSystem/27834); Costs (coded as: costs from https://fevir.net/resources/CodeSystem/179423)\u003c/td\u003e\u003ctd\u003eundefined\u003c/td\u003e\u003ctd\u003eundefined\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd\u003eCost-effectiveness (coded as: RJCS-1009 from https://fevir.net/resources/CodeSystem/27834); Cost-effectiveness (coded as: cost-effectiveness from https://fevir.net/resources/CodeSystem/179423)\u003c/td\u003e\u003ctd\u003eundefined\u003c/td\u003e\u003ctd\u003eundefined\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd\u003eEquity (coded as: RJCS-1010 from https://fevir.net/resources/CodeSystem/27834); Equity (coded as: equity from https://fevir.net/resources/CodeSystem/179423)\u003c/td\u003e\u003ctd\u003eundefined\u003c/td\u003e\u003ctd\u003eundefined\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd\u003eAcceptability (coded as: RJCS-1011 from https://fevir.net/resources/CodeSystem/27834); Acceptability (coded as: acceptability from https://fevir.net/resources/CodeSystem/179423)\u003c/td\u003e\u003ctd\u003eundefined\u003c/td\u003e\u003ctd\u003eundefined\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd\u003eFeasibility (coded as: RJCS-1012 from https://fevir.net/resources/CodeSystem/27834); Feasibility (coded as: feasibility from https://fevir.net/resources/CodeSystem/179423)\u003c/td\u003e\u003ctd\u003eundefined\u003c/td\u003e\u003ctd\u003eundefined\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd\u003eCompeting Interests (coded as: RJCS-1002 from https://fevir.net/resources/CodeSystem/27834); Competing Interests (coded as: competing-interests from https://fevir.net/resources/CodeSystem/179423)\u003c/td\u003e\u003ctd\u003eAll members of the PPC are required to disclose potential conflicts of interest with industry and other relevant organizations. These disclosures are discussed at the outset of each Standards of Care revision meeting. Members of the committee, their employers, and their disclosed conflicts of interest are listed in \u0027Disclosures: Standards of Medical Care in Diabetes—2021\u0027 (https://doi.org/10.2337/dc21-SPPC). The ADA funds development of the Standards of Care out of its general revenues and does not use industry support for this purpose. NOTE: The disclosed conflicts of interest was not found at the suggested URL\u003c/td\u003e\u003ctd\u003eundefined\u003c/td\u003e\u003c/tr\u003e\u003c/table\u003e\u003cbr/\u003e\u003c/div\u003e"},"identifier":[{"type":{"coding":[{"system":"http://terminology.hl7.org/CodeSystem/v2-0203","code":"ACSN","display":"Accession ID"}],"text":"FEvIR Object Identifier"},"system":"urn:ietf:rfc:3986","value":"https://fevir.net/FOI/179469","assigner":{"display":"Computable Publishing LLC"}}],"title":"Justification for Recommendation: ADA Obesity Management Recommendation 8.16","artifactReference":{"reference":"Composition/179466","type":"Composition","display":"Recommendation: ADA Obesity Management Recommendation 8.16"},"content":[{"summary":"8.16 Metabolic surgery should be a recommended option to treat type 2 diabetes in screened surgical candidates with BMI ≥40 kg/m2 (BMI ≥37.5 kg/m2 in Asian Americans) and in adults with BMI 35.0–39.9 kg/m2 (32.5–37.4 kg/m2 in Asian Americans) who do not achieve durable weight loss and improvement in comorbidities (including hyperglycemia) with nonsurgical methods. 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A substantial body of evidence has now been accumulated, including data from numerous randomized controlled (nonblinded) clinical trials, demonstrating that metabolic surgery achieves superior glycemic control and reduction of cardiovascular risk factors in patients with type 2 diabetes and obesity compared with various lifestyle/medical interventions.","type":{"coding":[{"system":"https://fevir.net/resources/CodeSystem/27834","code":"RJCS-content1","display":"Evidence"},{"system":"https://fevir.net/resources/CodeSystem/179423","code":"evidence","display":"Evidence"}]},"relatesTo":[{"type":{"coding":[{"system":"http://terminology.hl7.org/CodeSystem/artifact-relationship-type","code":"justification","display":"Justification"}]},"targetReference":{"reference":"DocumentReference/33089","type":"DocumentReference","display":"JournalArticleCitation: Metabolic Surgery in the Treatment Algorithm for Type 2 Diabetes: A Joint Statement by International Diabetes Organizations"}},{"type":{"coding":[{"system":"http://terminology.hl7.org/CodeSystem/artifact-relationship-type","code":"justification","display":"Justification"}]},"targetReference":{"reference":"Evidence/33244","type":"Evidence","display":"ComparativeEvidence: Mean difference in HbA1c effect of bariatric surgery in 2016 meta-analysis"}}],"freeToShare":true,"component":[{"summary":"ADA Level of Evidence A. A substantial body of evidence has now been accumulated, including data from numerous randomized controlled (nonblinded) clinical trials, demonstrating that metabolic surgery achieves superior glycemic control and reduction of cardiovascular risk factors in patients with type 2 diabetes and obesity compared with various lifestyle/medical interventions.","type":{"coding":[{"system":"https://fevir.net/resources/CodeSystem/179423","code":"summary-of-findings","display":"Summary of Findings"}]},"freeToShare":true},{"type":{"coding":[{"system":"https://fevir.net/resources/CodeSystem/27834","code":"RJCS-1004","display":"Desirable Effects"},{"system":"https://fevir.net/resources/CodeSystem/179423","code":"desirable-effects","display":"Desirable Effects"}]},"freeToShare":true},{"type":{"coding":[{"system":"https://fevir.net/resources/CodeSystem/27834","code":"RJCS-1005","display":"Undesirable Effects"},{"system":"https://fevir.net/resources/CodeSystem/179423","code":"undesirable-effects","display":"Undesirable Effects"}]},"freeToShare":true},{"summary":"A substantial body of evidence has now been accumulated, including data from numerous randomized controlled (nonblinded) clinical trials, demonstrating that metabolic surgery achieves superior glycemic control and reduction of cardiovascular risk factors in patients with type 2 diabetes and obesity compared with various lifestyle/medical interventions.\u003cbr/\u003eIn extended follow-up of obese adults with type 2 diabetes randomized to adding gastric bypass compared with lifestyle and intensive medical management alone, there remained a significantly better composite triple end point in the surgical group at 5 years. However, because the effect size diminished over 5 years, further follow-up is needed to understand the durability of the improvement.","type":{"coding":[{"system":"https://fevir.net/resources/CodeSystem/179423","code":"discussion","display":"Discussion"}]},"relatesTo":[{"type":{"coding":[{"system":"http://terminology.hl7.org/CodeSystem/artifact-relationship-type","code":"justification","display":"Justification"}]},"targetMarkdown":"Sjöström L, Peltonen M, Jacobson P, et al. Association of bariatric surgery with long-term remission of type 2 diabetes and with microvascular and macrovascular complications. JAMA 2014;311:2297–2304"},{"type":{"coding":[{"system":"http://terminology.hl7.org/CodeSystem/artifact-relationship-type","code":"justification","display":"Justification"}]},"targetReference":{"reference":"Evidence/32144","type":"Evidence","display":"ComparativeEvidence: Bariatric Surgery effect for ADA triple outcome at 5 years (Diabetes Surgery Study)"}}],"freeToShare":true}]},{"type":{"coding":[{"system":"https://fevir.net/resources/CodeSystem/27834","code":"RJCS-1007","display":"Net Effect"},{"system":"https://fevir.net/resources/CodeSystem/179423","code":"net-effect","display":"Net Effect"}]},"freeToShare":true,"component":[{"type":{"coding":[{"system":"https://fevir.net/resources/CodeSystem/27834","code":"RJCS-1006","display":"Values/Preferences"},{"system":"https://fevir.net/resources/CodeSystem/179423","code":"preferences","display":"Preferences"}]},"freeToShare":true},{"type":{"coding":[{"system":"https://fevir.net/resources/CodeSystem/179423","code":"discussion","display":"Discussion"}]},"freeToShare":true}]},{"type":{"coding":[{"system":"https://fevir.net/resources/CodeSystem/27834","code":"RJCS-content2","display":"Judgments"},{"system":"https://fevir.net/resources/CodeSystem/179423","code":"judgments","display":"Judgments"}]},"freeToShare":true,"component":[{"type":{"coding":[{"system":"https://fevir.net/resources/CodeSystem/179423","code":"justification","display":"Justification"}]},"freeToShare":true},{"type":{"coding":[{"system":"https://fevir.net/resources/CodeSystem/27834","code":"RJCS-1003","display":"Problem Importance"},{"system":"https://fevir.net/resources/CodeSystem/179423","code":"problem-importance","display":"Problem Importance"}]},"freeToShare":true},{"type":{"coding":[{"system":"https://fevir.net/resources/CodeSystem/27834","code":"RJCS-1008","display":"Resources/Costs"},{"system":"https://fevir.net/resources/CodeSystem/179423","code":"costs","display":"Costs"}]},"freeToShare":true},{"type":{"coding":[{"system":"https://fevir.net/resources/CodeSystem/27834","code":"RJCS-1009","display":"Cost-effectiveness"},{"system":"https://fevir.net/resources/CodeSystem/179423","code":"cost-effectiveness","display":"Cost-effectiveness"}]},"freeToShare":true},{"type":{"coding":[{"system":"https://fevir.net/resources/CodeSystem/27834","code":"RJCS-1010","display":"Equity"},{"system":"https://fevir.net/resources/CodeSystem/179423","code":"equity","display":"Equity"}]},"freeToShare":true},{"type":{"coding":[{"system":"https://fevir.net/resources/CodeSystem/27834","code":"RJCS-1011","display":"Acceptability"},{"system":"https://fevir.net/resources/CodeSystem/179423","code":"acceptability","display":"Acceptability"}]},"freeToShare":true},{"type":{"coding":[{"system":"https://fevir.net/resources/CodeSystem/27834","code":"RJCS-1012","display":"Feasibility"},{"system":"https://fevir.net/resources/CodeSystem/179423","code":"feasibility","display":"Feasibility"}]},"freeToShare":true}]},{"summary":"All members of the PPC are required to disclose potential conflicts of interest with industry and other relevant organizations. These disclosures are discussed at the outset of each Standards of Care revision meeting. Members of the committee, their employers, and their disclosed conflicts of interest are listed in \u0027Disclosures: Standards of Medical Care in Diabetes—2021\u0027 (https://doi.org/10.2337/dc21-SPPC). The ADA funds development of the Standards of Care out of its general revenues and does not use industry support for this purpose. NOTE: The disclosed conflicts of interest was not found at the suggested URL","type":{"coding":[{"system":"https://fevir.net/resources/CodeSystem/27834","code":"RJCS-1002","display":"Competing Interests"},{"system":"https://fevir.net/resources/CodeSystem/179423","code":"competing-interests","display":"Competing Interests"}]},"freeToShare":true}]}
{"resourceType":"ArtifactAssessment","id":"example-risk-of-bias-assessment-of-parachute-trial","meta":{"versionId":"4","lastUpdated":"2025-02-25T20:01:47.665Z","profile":["http://hl7.org/fhir/uv/ebm/StructureDefinition/risk-of-bias"]},"identifier":[{"type":{"text":"FEvIR Object Identifier"},"system":"urn:ietf:rfc:3986","value":"https://fevir.net/FOI/307449","assigner":{"display":"Computable Publishing LLC"}}],"title":"Risk of Bias Assessment of PARACHUTE trial","artifactReference":{"type":"Citation","display":"30545967 Parachute use to prevent death and major trauma when jumping from aircraft: randomized controlled trial."},"copyright":"https://creativecommons.org/licenses/by-nc-sa/4.0/","content":[{"type":{"coding":[{"system":"https://fevir.net/resources/CodeSystem/27270","code":"SEVCO:00001","display":"Bias"}]},"freeToShare":true,"component":[{"summary":"Assignment was done by order of enrollment. ","type":{"coding":[{"system":"https://fevir.net/resources/CodeSystem/27270","code":"SEVCO:00278","display":"Inadequate random sequence generation"}]},"classifier":[{"coding":[{"system":"https://fevir.net/resources/CodeSystem/27270","code":"SEVCO:00194","display":"Factor present"}]},{"coding":[{"system":"https://fevir.net/resources/CodeSystem/27270","code":"SEVCO:00208","display":"Factor likely has potential to impact results"}]},{"coding":[{"system":"https://fevir.net/resources/CodeSystem/27270","code":"SEVCO:00205","display":"Risk of bias direction unpredictable"}]},{"coding":[{"system":"https://fevir.net/resources/CodeSystem/27270","code":"SEVCO:00187","display":"Moderate risk of bias"}]}]},{"summary":"The investigator who assigned the treatment was aware of the assignment which was reported verbally to the participant. ","type":{"coding":[{"system":"https://fevir.net/resources/CodeSystem/27270","code":"SEVCO:00031","display":"Inadequate allocation concealment"}]},"classifier":[{"coding":[{"system":"https://fevir.net/resources/CodeSystem/27270","code":"SEVCO:00194","display":"Factor present"}]},{"coding":[{"system":"https://fevir.net/resources/CodeSystem/27270","code":"SEVCO:00208","display":"Factor likely has potential to impact results"}]},{"coding":[{"system":"https://fevir.net/resources/CodeSystem/27270","code":"SEVCO:00205","display":"Risk of bias direction unpredictable"}]},{"coding":[{"system":"https://fevir.net/resources/CodeSystem/27270","code":"SEVCO:00187","display":"Moderate risk of bias"}]}]},{"summary":"Participants could discern the difference between a parachute and an empty backpack. Knowing that they have only an empty backpack might change jumping behavior which would have an unpredictable effect on the outcome. ","type":{"coding":[{"system":"https://fevir.net/resources/CodeSystem/27270","code":"SEVCO:00035","display":"Inadequate blinding of participants"}]},"classifier":[{"coding":[{"system":"https://fevir.net/resources/CodeSystem/27270","code":"SEVCO:00195","display":"Factor likely present"}]},{"coding":[{"system":"https://fevir.net/resources/CodeSystem/27270","code":"SEVCO:00208","display":"Factor likely has potential to impact results"}]},{"coding":[{"system":"https://fevir.net/resources/CodeSystem/27270","code":"SEVCO:00205","display":"Risk of bias direction unpredictable"}]},{"coding":[{"system":"https://fevir.net/resources/CodeSystem/27270","code":"SEVCO:00187","display":"Moderate risk of bias"}]}]},{"summary":"Intervention deliverers could discern the difference between the parachute and the empty backback. This likely made no difference in the outcome.","type":{"coding":[{"system":"https://fevir.net/resources/CodeSystem/27270","code":"SEVCO:00036","display":"Inadequate blinding of intervention deliverers"}]},"classifier":[{"coding":[{"system":"https://fevir.net/resources/CodeSystem/27270","code":"SEVCO:00195","display":"Factor likely present"}]},{"coding":[{"system":"https://fevir.net/resources/CodeSystem/27270","code":"SEVCO:00209","display":"Factor likely does not have potential to impact results"}]},{"coding":[{"system":"https://fevir.net/resources/CodeSystem/27270","code":"SEVCO:00205","display":"Risk of bias direction unpredictable"}]},{"coding":[{"system":"https://fevir.net/resources/CodeSystem/27270","code":"SEVCO:00186","display":"Low risk of bias"}]}]},{"summary":"Although outcome determination was done with full knowledge of exposure status, it was not likely that this changed the determination of death or injury","type":{"coding":[{"system":"https://fevir.net/resources/CodeSystem/27270","code":"SEVCO:00048","display":"Bias due to lack of masking for outcome determination"}]},"classifier":[{"coding":[{"system":"https://fevir.net/resources/CodeSystem/27270","code":"SEVCO:00195","display":"Factor likely present"}]},{"coding":[{"system":"https://fevir.net/resources/CodeSystem/27270","code":"SEVCO:00209","display":"Factor likely does not have potential to impact results"}]},{"coding":[{"system":"https://fevir.net/resources/CodeSystem/27270","code":"SEVCO:00205","display":"Risk of bias direction unpredictable"}]},{"coding":[{"system":"https://fevir.net/resources/CodeSystem/27270","code":"SEVCO:00186","display":"Low risk of bias"}]}]},{"summary":"Attrition was much higher in the intervention group.","type":{"coding":[{"system":"https://fevir.net/resources/CodeSystem/27270","code":"SEVCO:00019","display":"Attrition Bias"}]},"classifier":[{"coding":[{"system":"https://fevir.net/resources/CodeSystem/27270","code":"SEVCO:00195","display":"Factor likely present"}]},{"coding":[{"system":"https://fevir.net/resources/CodeSystem/27270","code":"SEVCO:00208","display":"Factor likely has potential to impact results"}]},{"coding":[{"system":"https://fevir.net/resources/CodeSystem/27270","code":"SEVCO:00205","display":"Risk of bias direction unpredictable"}]},{"coding":[{"system":"https://fevir.net/resources/CodeSystem/27270","code":"SEVCO:00187","display":"Moderate risk of bias"}]}]},{"summary":"Study was only published in a satirical journal issue.","type":{"coding":[{"system":"https://fevir.net/resources/CodeSystem/27270","code":"SEVCO:00023","display":"Reporting Bias"}]},"classifier":[{"coding":[{"system":"https://fevir.net/resources/CodeSystem/27270","code":"SEVCO:00194","display":"Factor present"}]},{"coding":[{"system":"https://fevir.net/resources/CodeSystem/27270","code":"SEVCO:00208","display":"Factor likely has potential to impact results"}]},{"coding":[{"system":"https://fevir.net/resources/CodeSystem/27270","code":"SEVCO:00205","display":"Risk of bias direction unpredictable"}]},{"coding":[{"system":"https://fevir.net/resources/CodeSystem/27270","code":"SEVCO:00187","display":"Moderate risk of bias"}]}]}]},{"type":{"text":"Profile"},"classifier":[{"text":"ROB1"}]}]}
{"resourceType":"ArtifactAssessment","id":"example-certainty-rating","identifier":[{"type":{"text":"FEvIR Object Identifier"},"system":"https://fevir.net","value":"27756","assigner":{"display":"Computable Publishing LLC"}}],"artifactReference":{"reference":"Evidence/example-stroke-alteplase-fatalICH","type":"Evidence","display":"Critically appraised summary of all-cause mortality in meta-analysis of RCTs of heparin for moderately ill patients with COVID-19"},"date":"2021-11-02T14:48:59.890Z","copyright":"https://creativecommons.org/licenses/by-nc-sa/4.0/","content":[{"summary":"serious concerns with risk of bias, inconsistency, and imprecision","type":{"coding":[{"system":"http://hl7.org/fhir/certainty-type","code":"Overall","display":"Overall certainty"}]},"classifier":[{"coding":[{"system":"http://terminology.hl7.org/CodeSystem/certainty-rating","code":"very-low","display":"Very low quality"}]}],"author":[{"display":"Brian S. Alper"}],"freeToShare":true,"component":[{"summary":"risk of bias in both included trials","type":{"coding":[{"system":"http://terminology.hl7.org/CodeSystem/certainty-type","code":"RiskOfBias","display":"Risk of bias"}]},"classifier":[{"coding":[{"system":"http://terminology.hl7.org/CodeSystem/certainty-rating","code":"serious-concern","display":"serious concern"}]}],"author":[{"display":"Brian S. Alper"}]},{"summary":"high degree of heterogeneity (I-squared 80.7%) with confidence intervals of 2 trial effect estimates barely overlapping","type":{"coding":[{"system":"http://terminology.hl7.org/CodeSystem/certainty-type","code":"Inconsistency","display":"Inconsistency"}]},"classifier":[{"coding":[{"system":"http://terminology.hl7.org/CodeSystem/certainty-rating","code":"serious-concern","display":"serious concern"}]}],"author":[{"display":"Brian S. Alper"}]},{"type":{"coding":[{"system":"http://terminology.hl7.org/CodeSystem/certainty-type","code":"Indirectness","display":"Indirectness"}]},"classifier":[{"coding":[{"system":"http://terminology.hl7.org/CodeSystem/certainty-rating","code":"no-concern","display":"no serious concern"}]}],"author":[{"display":"Brian S. Alper"}]},{"summary":"95% confidence interval includes both large effects and no effects","type":{"coding":[{"system":"http://terminology.hl7.org/CodeSystem/certainty-type","code":"Imprecision","display":"Imprecision"}]},"classifier":[{"coding":[{"system":"http://terminology.hl7.org/CodeSystem/certainty-rating","code":"serious-concern","display":"serious concern"}]}],"author":[{"display":"Brian S. Alper"}]},{"type":{"coding":[{"system":"http://terminology.hl7.org/CodeSystem/certainty-type","code":"PublicationBias","display":"Publication bias"}]},"classifier":[{"coding":[{"system":"http://terminology.hl7.org/CodeSystem/certainty-rating","code":"no-concern","display":"no serious concern"}]}],"author":[{"display":"Brian S. Alper"}]}]}]}