GRADE guidelines 17: assessing the risk of bias associated with missing participant outcome data in a body of evidence

Guyatt, Gordon; Ebrahim, Shanil; Alonso‐Coello, Pablo; Johnston, Bradley C.; Mathioudakis, Alexander G.; Briel, Matthias; Mustafa, Reem A.; Sun, Xin; Walter, Stephen D.; Heels‐Ansdell, Diane; Neumann, Ignacio; Kahale, Lara A; Iorio, Alfonso; Meerpohl, Joerg J; Schünemann, Holger J.; Akl, Elie A.

doi:10.1016/j.jclinepi.2017.05.005

Cited by 130 publications

(68 citation statements)

References 35 publications

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“…Quality assessment of the trials was not performed, as no quality assessment for RPPTs has yet been developed and current criteria predominantly relate to concealment of randomisation (eg, Risk of Bias in Non-Randomized Studies-I and Cochrane Risk of Bias); consequently quality assessment and variability between trials were not applicable 9 10. Since the outcomes of each trial greatly differed, also the risk of bias assessment for systematic reviews (eg, Grading of Recommendations, Assessment, Development and Evaluations) was not applicable 11…”

Section: Methodsmentioning

confidence: 99%

Partially randomised patient preference trials as an alternative design to randomised controlled trials: systematic review and meta-analyses

et al. 2019

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ObjectiveRandomised controlled trials (RCT) are the gold standard to provide unbiased data. However, when patients have a treatment preference, randomisation may influence participation and outcomes (eg, external and internal validity). The aim of this study was to assess the influence of patients’ preference in RCTs by analysing partially randomised patient preference trials (RPPT); an RCT and preference cohort combined.DesignSystematic review and meta-analyses.Data sourcesMEDLINE, Embase, PsycINFO and the Cochrane Library.Eligibility criteria for selecting studiesRPPTs published between January 2005 and October 2018 reporting on allocation of patients to randomised and preference cohorts were included.Data extraction and synthesisTwo independent reviewers extracted data. The main outcomes were the difference in external validity (participation and baseline characteristics) and internal validity (lost to follow-up, crossover and the primary outcome) between the randomised and the preference cohort within each RPPT, compared in a meta-regression using a Wald test. Risk of bias was not assessed, as no quality assessment for RPPTs has yet been developed.ResultsIn total, 117 of 3734 identified articles met screening criteria and 44 were eligible (24 873 patients). The participation rate in RPPTs was >95% in 14 trials (range: 48%–100%) and the randomisation refusal rate was >50% in 26 trials (range: 19%–99%). Higher education, female, older age, race and prior experience with one treatment arm were characteristics of patients declining randomisation. The lost to follow-up and cross-over rate were significantly higher in the randomised cohort compared with the preference cohort. Following the meta-analysis, the reported primary outcomes were comparable between both cohorts of the RPPTs, mean difference 0.093 (95% CI −0.178 to 0.364, p=0.502).ConclusionsPatients’ preference led to a substantial proportion of a specific patient group refusing randomisation, while it did not influence the primary outcome within an RPPT. Therefore, RPPTs could increase external validity without compromising the internal validity compared with RCTs.PROSPERO registration numberCRD42019094438.

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Section: Methodsmentioning

confidence: 99%

Partially randomised patient preference trials as an alternative design to randomised controlled trials: systematic review and meta-analyses

et al. 2019

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“…Differences were resolved by consensus. The methodological quality of each study was assessed using the Cochrane Risk of Bias Tool (Table S3; see Supporting Information) and quality of evidence for each outcome was assessed by the Grading of Recommendations Assessment, Development and Evaluation (GRADE) criteria (Table S4; see Supporting Information) …”

Section: Methodsmentioning

confidence: 99%

Conventional and combination topical photodynamic therapy for basal cell carcinoma: systematic review and meta-analysis

et al. 2018

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“…Assessment will be conducted on an outcome-by-outcome basis by two lead members of the synthesis team (JF and CEK) working independently 52. Specific guidelines will be followed to improve reliability 53–74. Disagreements will be resolved by consensus or by consulting an adjudicator (LF).…”

Section: Methods and Analysismentioning

confidence: 99%

Opioid versus opioid-free analgesia after surgical discharge: protocol for a systematic review and meta-analysis

et al. 2020

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IntroductionExcessive prescribing after surgery has contributed to a public health crisis of opioid addiction and overdose in North America. However, the value of prescribing opioids to manage postoperative pain after surgical discharge remains unclear. We propose a systematic review and meta-analysis to assess the extent to which opioid analgesia impact postoperative pain intensity and adverse events in comparison to opioid-free analgesia in patients discharged after surgery.Methods and analysisMajor electronic databases (MEDLINE, Embase, Cochrane Library, Scopus, AMED, BIOSIS, CINAHL and PsycINFO) will be searched for multi-dose randomised-trials examining the comparative effectiveness of opioid versus opioid-free analgesia after surgical discharge. Studies published from January 1990 to July 2019 will be targeted, with no language restrictions. The search will be re-run before manuscript submission to include most recent literature. We will consider studies involving patients undergoing minor and major surgery. Teams of reviewers will, independently and in duplicate, assess eligibility, extract data and evaluate risk of bias. Our main outcomes of interest are pain intensity and postoperative vomiting. Study results will be pooled using random effects models. When trials report outcomes for a common domain (eg, pain intensity) using different scales, we will convert effect sizes to a common standard metric (eg, Visual Analogue Scale). Minimally important clinical differences reported in previous literature will be considered when interpreting results. Subgroup analyses defined a priori will be conducted to explore heterogeneity. Risk of bias will be assessed according to the Cochrane Collaboration's Risk of Bias Tool 2.0. The quality of evidence for all outcomes will be evaluated using the GRADE rating system.Ethics and disseminationEthical approval is not required since this is a systematic review of published studies. Our results will be published in a peer-reviewed journal and presented at relevant conferences. Further knowledge dissemination will be sought via public and patient organisations focussed on pain and opioid-related harms.

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GRADE guidelines 17: assessing the risk of bias associated with missing participant outcome data in a body of evidence

Cited by 130 publications

References 35 publications

Partially randomised patient preference trials as an alternative design to randomised controlled trials: systematic review and meta-analyses

Partially randomised patient preference trials as an alternative design to randomised controlled trials: systematic review and meta-analyses

Conventional and combination topical photodynamic therapy for basal cell carcinoma: systematic review and meta-analysis

Opioid versus opioid-free analgesia after surgical discharge: protocol for a systematic review and meta-analysis

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