AHRQ Series Paper 5: Grading the strength of a body of evidence when comparing medical interventions—Agency for Healthcare Research and Quality and the Effective Health-Care Program

Owens, Douglas K; Lohr, Kathleen N; Atkins, David C.; Treadwell, Jonathan; Reston, James; Bass, Eric B.; Chang, Stephanie; Helfand, Mark

doi:10.1016/j.jclinepi.2009.03.009

Cited by 422 publications

(314 citation statements)

References 14 publications

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“…40 To avoid the spurious increase in precision in multiarm trials, we divided placebo arms approximately evenly among the comparisons according to the randomization ratio. 39,52 We tested consistency of the results by comparing the direction and strength of the association, 53 assessed heterogeneity in results with the chi-squared and I-squared tests, 54,55 and explored it with meta-regression and sensitivity analysis, reporting only the results from random effects models, 56 which incorporate inevitable differences between trials in patient populations, baseline rates of the outcomes, dosages of drugs, and other factors. 47 We examined whether the definition of migraine could contribute to differences in trial results.…”

Section: Methodsmentioning

confidence: 99%

“…We assessed strength of evidence according to risk of bias, consistency, directness, and precision for clinical response and treatment discontinuation due to harms. 53 We based our criteria on published guidelines acknowledging inevitable subjectivity of the assessment. 40,69 We assigned a medium or high risk of bias in the body of evidence when at least one individual RCT had a medium or high risk of bias, respectively.…”

Section: Methodsmentioning

confidence: 99%

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Preventive Pharmacologic Treatments for Episodic Migraine in Adults

et al. 2013

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ELIGIBILITY CRITERIA: English-language randomized controlled trials (RCTs) of preventive drugs compared to placebo or active treatments examining rates of ≥50 % reduction in monthly migraine frequency or improvement in quality of life. STUDY APPRAISAL AND SYNTHESIS METHODS:We assessed risk of bias and strength of evidence and conducted random effects meta-analyses of absolute risk differences and Bayesian network meta-analysis. RESULTS: Of 5,244 retrieved references, 215 publications of RCTs provided mostly low-strength evidence because of the risk of bias and imprecision. RCTs examined 59 drugs from 14 drug classes. All approved drugs, including topiramate (9 RCTs), divalproex (3 RCTs), timolol (3 RCTs), and propranolol (4 RCTs); offlabel beta blockers metoprolol (4 RCTs), atenolol (1 RCT), nadolol (1 RCT), and acebutolol (1 RCT); angiotensin-converting enzyme inhibitors captopril (1 RCT) and lisinopril (1 RCT); and angiotensin II receptor blocker candesartan (1 RCT), outperformed placebo in reducing monthly migraine frequency by ≥50 % in 200-400 patients per 1,000 treated. Adverse effects leading to treatment discontinuation (68 RCTs) were greater with topiramate, off-label antiepileptics, and antidepressants than with placebo. Limited direct evidence as well as frequentist and exploratory network Bayesian meta-analysis showed no statistically significant differences in benefits between approved drugs. Off-label angiotensin-inhibiting drugs and beta-blockers were most effective and tolerable for episodic migraine prevention. LIMITATIONS:We did not quantify reporting bias or contact principal investigators regarding unpublished trials. CONCLUSIONS: Approved drugs prevented episodic migraine frequency by ≥50 % with no statistically significant difference between them. Exploratory network meta-analysis suggested that off-label angiotensin-inhibiting drugs and beta-blockers had favorable benefit-to-harm ratios. Evidence is lacking for longterm effects of drug treatments (i.e., trials of more than 3 months duration), especially for quality of life.KEY WORDS: migraine; evidence based medicine; adverse drug effects.

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Preventive Pharmacologic Treatments for Episodic Migraine in Adults

et al. 2013

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“…18 We organized our work by the generic CPG development steps extracted from the review of leading, collaborative CPG initiatives. [19][20][21][22][23][24][25][26][27] Next, we iteratively drafted and refined a list of issues and existing approaches relevant for addressing multimorbidity in each step of CPG development, based on review of key literature and investigators' experience. An expert panel (see acknowledgements, also co-authors) with clinical and methods expertise in CPG development, methods of evidence synthesis, epidemiology, and multimorbidity provided feedback on the list of issues identified by CB, KU, BL, and were asked to identify examples of how existing CPGs currently address or do not address multimorbidity.…”

Section: Methodsmentioning

confidence: 99%

“…23,24,46,47 Their goal in assessing applicability separately is to enable decision-makers to take into account how well the evidence maps to the populations, settings, diseases or conditions, interventions, comparators, and outcomes that are most relevant to their decisions. Thus, for "applicability," Evidence-based Practice Centers typically highlight noteworthy features of included studies and identify potential limitations to applicability.…”

Section: Steps 1 and 2: Topic Nomination And Topic Scopingmentioning

confidence: 99%

A Framework for Crafting Clinical Practice Guidelines that are Relevant to the Care and Management of People with Multimorbidity

et al. 2014

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Many patients of all ages have multiple conditions, yet clinicians often lack explicit guidance on how to approach clinical decision-making for such people. Most recommendations from clinical practice guidelines (CPGs) focus on the management of single diseases, and may be harmful or impractical for patients with multimorbidity. A major barrier to the development of guidance for people with multimorbidity stems from the fact that the evidence underlying CPGs derives from studies predominantly focused on the management of a single disease. In this paper, the investigators from the Improving Guidelines for Multimorbid Patients Study Group present consensusbased recommendations for guideline developers to make guidelines more useful for the care of people with multimorbidity. In an iterative process informed by review of key literature and experience, we drafted a list of issues and possible approaches for addressing important coexisting conditions in each step of the guideline development process, with a focus on considering relevant interactions between the conditions, their treatments and their outcomes. The recommended approaches address consideration of coexisting conditions at all major steps in CPG development, from nominating and scoping the topic, commissioning the work group, refining key questions, ranking importance of outcomes, conducting systematic reviews, assessing quality of evidence and applicability, summarizing benefits and harms, to formulating recommendations and grading their strength. The list of issues and recommendations was reviewed and refined iteratively by stakeholders. This framework acknowledges the challenges faced by CPG developers who must make complex judgments in the absence of high-quality or direct evidence. These recommendations require validation through implementation, evaluation and refinement.

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“…This resulted in assigned grades of "insufficient" for all six comparisons of PCA3 with tPSA, free PSA, PSA velocity, PSA density, complexed PSA, and externally validated nomograms. Furthermore, strength of evidence 31 was considered insufficient to derive any conclusions about relative performance or about the combination of PCA3 and one or more of the comparators. This included all intermediate and long-term outcomes of interest.…”

Section: Clinical Validitymentioning

confidence: 99%

Recommendations from the EGAPP Working Group: does PCA3 testing for the diagnosis and management of prostate cancer improve patient health outcomes?

Calonge

Klein

Berg

et al. 2014

Genetics in Medicine

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Summary of recommendations:The Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Working Group found insufficient evidence to recommend prostate cancer antigen 3 (PCA3) testing to inform decisions for when to rebiopsy previously biopsy-negative patients for prostate cancer or to inform decisions to conduct initial biopsies for prostate cancer in at-risk men (e.g., previous elevated prostate-specific antigen test or suspicious digital rectal examination).The EGAPP Working Group found insufficient evidence to recommend PCA3 testing in men with cancer-positive biopsies to determine if the disease is indolent or aggressive in order to develop an optimal treatment plan.Based on the available evidence, the overall certainty of clinical validity to predict the diagnosis of prostate cancer using PCA3 is deemed "low. " The EGAPP Working Group discourages clinical use for diagnosis unless further evidence supports improved clinical validity.Based on the available evidence, the overall certainty of net health benefit is deemed "low. " The EGAPP Working Group discourages clinical use unless further evidence supports improved clinical outcomes.Rationale: It has been suggested that PCA3 testing in the general male population might lead to earlier diagnosis and management changes (e.g., earlier detection and earlier initiation or higher rates of medical interventions) that improve outcomes. EGAPP Working Group found no direct evidence to support this possibility, so we sought indirect evidence aimed at documenting the extent to which PCA3 testing alters prostate cancer diagnosis or management, alone and in combination with traditional clinical management factors, and the extent to which this testing improves health outcomes.Analytic validity: Assay-related evidence was deemed adequate for the PROGENSA PCA3 assay approved by the US Food and Drug Administration, available from Gen-Probe. Very few studies were available that investigated preanalytical effects, analytical performance, and diagnostic accuracy of other quantitative assays for PCA3.Clinical validity: Evidence on clinical validity was rated inadequate to derive any conclusions about performance of PCA3 testing to inform decisions for when to rebiopsy previously biopsy-negative patients for prostate cancer, or to inform decisions to conduct initial biopsies for prostate cancer in at-risk men (e.g., previous elevated prostate-specific antigen test or suspicious digital rectal examination). Furthermore, there was little evidence to derive any conclusions about performance of PCA3 testing in men with cancer-positive biopsies to determine if the disease is indolent or aggressive in order to develop an optimal treatment plan. Clinical utility:No studies were available to provide direct evidence on the balance of benefits and harms related to PCA3 testing for diagnosis and management in the general male population. Evidence for other populations (e.g., high risk) was not evaluated in the review.

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AHRQ Series Paper 5: Grading the strength of a body of evidence when comparing medical interventions—Agency for Healthcare Research and Quality and the Effective Health-Care Program

Cited by 422 publications

References 14 publications

Preventive Pharmacologic Treatments for Episodic Migraine in Adults

Preventive Pharmacologic Treatments for Episodic Migraine in Adults

A Framework for Crafting Clinical Practice Guidelines that are Relevant to the Care and Management of People with Multimorbidity

Recommendations from the EGAPP Working Group: does PCA3 testing for the diagnosis and management of prostate cancer improve patient health outcomes?

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