SynthesisPloS one2011
Applying the risk of bias tool in a systematic review of combination long-acting beta-agonists and inhaled corticosteroids for persistent asthma.
Synthesis in PloS one, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers, 6 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
28 citing papers in PubMed, 6 syntheses or guidelines pooled it.
- Pooled it
- Pooled it
- Tools for assessing risk of reporting biases in studies and syntheses of studies: a systematic review.BMJ open · 2018Pooled it
- Industry sponsorship and research outcome.The Cochrane database of systematic reviews · 2017Pooled it
- Non-pharmacological cancer pain interventions in populations with social disparities: a systematic review and meta-analysis.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2016Pooled it
- Complaints of micturition, defecation and sexual function in cauda equina syndrome due to lumbar disk herniation: a systematic review.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2013Pooled it
- Unified tools for assessing the methodological quality of intervention effects in rapid reviews: a scoping review.Systematic reviews · 2026Article
- Assessment of Selective Reporting Biases in Studies Included in Campbell Systematic Reviews: A Systematic Review.Campbell systematic reviews · 2026Review
- RoBuster-Corpus Annotated With Risk of Bias Text Spans in Randomized Controlled Trials in Physiotherapy and Rehabilitation: Corpus Development and Annotation Study.JMIR formative research · 2026Article
- Enhancing antioxidant capacity and reducing asthma risk: the impact of zinc and iron on molecular pathways.Clinical and experimental medicine · 2025Article
- Efficacy and Safety of Laser Therapy and Phototherapy in Cicatricial and NonCicatricial Alopecia: A Systematic Review Study.Health science reports · 2024Review
- Enhancing study quality assessment: an in-depth review of risk of bias tools for meta-analysis-a comprehensive guide for anesthesiologists.Journal of anesthesia, analgesia and critical care · 2023Review
- Risk of Bias in Iranian Randomized Trials Included in Cochrane Reviews.Archives of Iranian medicine · 2022Article
- The Composite Quality Score (CQS) as a trial appraisal tool: inter-rater reliability and rating time.Clinical oral investigations · 2021Article
- Antidiabetic Medicinal Plants Used in Democratic Republic of Congo: A Critical Review of Ethnopharmacology and Bioactivity Data.Frontiers in pharmacology · 2021Review
- Article
- Inter-rater reliability of AMSTAR is dependent on the pair of reviewers.BMC medical research methodology · 2017Article
- Article
- Evaluation of the Cochrane tool for assessing risk of bias in randomized clinical trials: overview of published comments and analysis of user practice in Cochrane and non-Cochrane reviews.Systematic reviews · 2016Review
- Machine learning to assist risk-of-bias assessments in systematic reviews.International journal of epidemiology · 2016Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe Risk of Bias (RoB) tool is used to assess internal validity of randomized controlled trials (RCTs). Our objectives were to: 1) evaluate inter-rater agreement of the RoB tool; 2) determine the time to access supplemental study information; 3) compare the RoB tool with the Jadad scale and Schulz allocation concealment (AC); and 4) examine the relationship between RoB and effect estimates.
methodsWe conducted a systematic review of long-acting beta agonists (LABA) combined with inhaled corticosteroids (ICS) for adults with persistent asthma. Two reviewers independently assessed 107 trials using RoB, Jadad, and AC. One reviewer searched for study protocols. We assessed inter-rater agreement using weighted Kappa (κ) and the correlation between tools using Kendall's Tau (τ). Mean differences in effect sizes for RCTs with different RoB were calculated using inverse variance method and random effects model.
resultsTrials had good Jadad scores (median 4, IQR 3-4); however, 85% had unclear AC and 87% high RoB. The factor that most influenced RoB was the potential inappropriate influence of study sponsors (95% industry funded). Agreement on RoB domains was fair (κ = 0.40) to almost perfect (κ = 0.86), and moderate for overall RoB (κ = 0.41). Median time to complete RoB assessments was 21 minutes (IQR 14-27) and 12 minutes (IQR 9-16) to search for protocols. Protocols were identified for 5/42 studies (12%); in 3 cases the assessment of selective outcome reporting changed. There was low correlation between overall RoB vs. Jadad (τ = 0.04, p = 0.3) and AC (τ = -0.02, p = 0.7). Analyses comparing effect estimates and risk showed no important patterns.
conclusionsInter-rater agreement on RoB assessments was better than previously reported suggesting that review-specific guidelines are important. The correlation between RoB and Jadad was low suggesting measurement of different constructs (risk of bias vs. quality of reporting). The extensive involvement of the pharmaceutical industry in this LABA/ICS research should raise concerns about potential overestimates of treatment effects.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.