Methodological review to develop a list of bias items used to assess reviews incorporating network meta-analysis: protocol and rationale.
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ABSTRACT: Introduction
Systematic reviews with network meta-analysis (NMA; ie, multiple treatment comparisons, indirect comparisons) have gained popularity and grown in number due to their ability to provide comparative effectiveness of multiple treatments for the same condition. The methodological review aims to develop a list of items relating to biases in reviews with NMA. Such a list will inform a new tool to assess the risk of bias in NMAs, and potentially other reporting or quality checklists for NMAs which are being updated.Methods and analysis
We will include articles that present items related to bias, reporting or methodological quality, articles assessing the methodological quality of reviews with NMA, or papers presenting methods for NMAs. We will search Ovid MEDLINE, the Cochrane library and difficult to locate/unpublished literature. Once all items have been extracted, we will combine conceptually similar items, classifying them as referring to bias or to other aspects of quality (eg, reporting). When relevant, reporting items will be reworded into items related to bias in NMA review conclusions, and then reworded as signalling questions.Ethics and dissemination
No ethics approval was required. We plan to publish the full study open access in a peer-reviewed journal, and disseminate the findings via social media (Twitter, Facebook and author affiliated websites). Patients, healthcare providers and policy-makers need the highest quality evidence to make decisions about which treatments should be used in healthcare practice. Being able to critically appraise the findings of systematic reviews that include NMA is central to informed decision-making in patient care.
SUBMITTER: Lunny C
PROVIDER: S-EPMC8231030 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BACKGROUND:A crucial element in the systematic review (SR) methodology is the appraisal of included primary studies, using tools for assessment of methodological quality or risk of bias (RoB). SR authors can conduct sensitivity analyses to explore whether their results are sensitive to exclusion of low quality studies or a high RoB. However, it is unknown which tools do SR authors use for assessing quality/RoB, and how they set threshold for quality/RoB in sensitivity analyses. The aim of this study was to assess quality/RoB assessment tools, the types of sensitivity analyses and quality/RoB thresholds for sensitivity analyses used within SRs published in high-impact pain/anesthesiology journals. METHODS:This was a methodological study. We analyzed SRs published from January 2005 to June 2018 in the 25% highest-ranking journals within the Journal Citation Reports (JCR) "Anesthesiology" category. We retrieved the SRs from PubMed. Two authors independently screened records, full texts, and extracted data on quality/RoB tools and sensitivity analyses. We extracted data about quality/RoB tools, types of sensitivity analyses and the thresholds for quality/RoB used in them. RESULTS:Out of 678 analyzed SRs, 513 (76%) reported the use of quality/RoB assessments. The most commonly reported tools for assessing quality/RoB in the studies were the Cochrane tool for risk of bias assessment (N?=?251; 37%) and Jadad scale (N?=?99; 15%). Meta-analysis was conducted in 451 (66%) of SRs and sensitivity analysis in 219/451 (49%). Most commonly, sensitivity analysis was conducted to explore the influence of study quality/RoB (90/219; 41%) on the results. Quality/RoB thresholds used for sensitivity analysis for those studies were clearly reported in 47 (52%) articles that used them. The quality/RoB thresholds used for sensitivity analyses were highly heterogeneous and inconsistent, even when the same tool was used. CONCLUSIONS:A quarter of SRs reported using quality/RoB assessments, and some of them cited tools that are not meant for assessing quality/RoB. Authors who use quality/RoB to explore the robustness of their results in meta-analyses use highly heterogeneous quality/RoB thresholds in sensitivity analyses. Better methodological consistency for quality/RoB sensitivity analyses is needed.
| S-EPMC7236513 | biostudies-literature
Project description:BackgroundOverviews of reviews (overviews) compile information from multiple systematic reviews (SRs) to provide a single synthesis of relevant evidence for decision-making. It is recommended that authors assess and report the methodological quality of SRs in overviews-for example, using A MeaSurement Tool to Assess systematic Reviews (AMSTAR). Currently, there is variation in whether and how overview authors assess and report SR quality, and limited guidance is available. Our objectives were to: examine methodological considerations involved in using AMSTAR to assess the quality of Cochrane and non-Cochrane SRs in overviews of healthcare interventions; identify challenges (and develop potential decision rules) when using AMSTAR in overviews; and examine the potential impact of considering methodological quality when making inclusion decisions in overviews.MethodsWe selected seven overviews of healthcare interventions and included all SRs meeting each overview's inclusion criteria. For each SR, two reviewers independently conducted AMSTAR assessments with consensus and discussed challenges encountered. We also examined the correlation between AMSTAR assessments and SR results/conclusions.ResultsNinety-five SRs were included (30 Cochrane, 65 non-Cochrane). Mean AMSTAR assessments (9.6/11 vs. 5.5/11; p < 0.001) and inter-rater reliability (AC1 statistic: 0.84 vs. 0.69; "almost perfect" vs. "substantial" using the Landis & Koch criteria) were higher for Cochrane compared to non-Cochrane SRs. Four challenges were identified when applying AMSTAR in overviews: the scope of the SRs and overviews often differed; SRs examining similar topics sometimes made different methodological decisions; reporting of non-Cochrane SRs was sometimes poor; and some non-Cochrane SRs included other SRs as well as primary studies. Decision rules were developed to address each challenge. We found no evidence that AMSTAR assessments were correlated with SR results/conclusions.ConclusionsResults indicate that the AMSTAR tool can be used successfully in overviews that include Cochrane and non-Cochrane SRs, though decision rules may be useful to circumvent common challenges. Findings support existing recommendations that quality assessments of SRs in overviews be conducted independently, in duplicate, with a process for consensus. Results also suggest that using methodological quality to guide inclusion decisions (e.g., to exclude poorly conducted and reported SRs) may not introduce bias into the overview process.
| S-EPMC5364717 | biostudies-literature
Project description:BackgroundOur objective was to develop an instrument to assess the methodological quality of systematic reviews, building upon previous tools, empirical evidence and expert consensus.MethodsA 37-item assessment tool was formed by combining 1) the enhanced Overview Quality Assessment Questionnaire (OQAQ), 2) a checklist created by Sacks, and 3) three additional items recently judged to be of methodological importance. This tool was applied to 99 paper-based and 52 electronic systematic reviews. Exploratory factor analysis was used to identify underlying components. The results were considered by methodological experts using a nominal group technique aimed at item reduction and design of an assessment tool with face and content validity.ResultsThe factor analysis identified 11 components. From each component, one item was selected by the nominal group. The resulting instrument was judged to have face and content validity.ConclusionA measurement tool for the 'assessment of multiple systematic reviews' (AMSTAR) was developed. The tool consists of 11 items and has good face and content validity for measuring the methodological quality of systematic reviews. Additional studies are needed with a focus on the reproducibility and construct validity of AMSTAR, before strong recommendations can be made on its use.
| S-EPMC1810543 | biostudies-literature
Project description:IntroductionThe Haemophilia Activities List (HAL) was developed to measure activities and participation in persons with haemophilia (PWH). Shortening the questionnaire may facilitate use of the HAL.AimThe aim of this study was to determine which items of the HAL are redundant, to construct a shorter version of the HAL, and to determine the construct validity of the HALshort .MethodsA secondary analysis was performed on pooled data of two published studies using the HAL (seven domains, 42 items, optimum score: 100) in adults with haemophilia A/B. Data were divided into a derivation (62%) and a validation set (38%). Redundant items were identified by evaluation of: floor and ceiling effects, proportions of missing and 'not applicable' responses, inter-item correlations, component loadings in an exploratory factor analysis, internal consistency, and item-total correlations. Correlations with the SF-36 and EQ-5D-5L were used to determine construct validity of the HALshort .ResultsData on 680 PWH were evaluated. In the derivation dataset (n = 420), median age was 30 years (range 18-80), 43% had severe haemophilia and 61% received prophylaxis. Median (IQR) HAL sum score was 65.0 (55.7-88.8). The stepwise procedure resulted in a HALshort of 18 items with a median sum score of 63.3 (54.4-86.7). Construct validity was similar for the HAL and HALshort in the validation dataset (n = 260).ConclusionThis clinimetric study resulted in a >50% shortening of the HAL. The 18-item HALshort reduces patient burden and is expected to capture the information on activities and participation. The HALshort needs further validation.
| S-EPMC9293145 | biostudies-literature
Project description:BACKGROUND:A strong need exists for a validated tool that clearly defines peer review report quality in biomedical research, as it will allow evaluating interventions aimed at improving the peer review process in well-performed trials. We aim to identify and describe existing tools for assessing the quality of peer review reports in biomedical research. METHODS:We conducted a methodological systematic review by searching PubMed, EMBASE (via Ovid) and The Cochrane Methodology Register (via The Cochrane Library) as well as Google® for all reports in English describing a tool for assessing the quality of a peer review report in biomedical research. Data extraction was performed in duplicate using a standardized data extraction form. We extracted information on the structure, development and validation of each tool. We also identified quality components across tools using a systematic multi-step approach and we investigated quality domain similarities among tools by performing hierarchical, complete-linkage clustering analysis. RESULTS:We identified a total number of 24 tools: 23 scales and 1 checklist. Six tools consisted of a single item and 18 had several items ranging from 4 to 26. None of the tools reported a definition of 'quality'. Only 1 tool described the scale development and 10 provided measures of validity and reliability. Five tools were used as an outcome in a randomized controlled trial (RCT). Moreover, we classified the quality components of the 18 tools with more than one item into 9 main quality domains and 11 subdomains. The tools contained from two to seven quality domains. Some domains and subdomains were considered in most tools such as the detailed/thorough (11/18) nature of reviewer's comments. Others were rarely considered, such as whether or not the reviewer made comments on the statistical methods (1/18). CONCLUSION:Several tools are available to assess the quality of peer review reports; however, the development and validation process is questionable and the concepts evaluated by these tools vary widely. The results from this study and from further investigations will inform the development of a new tool for assessing the quality of peer review reports in biomedical research.
| S-EPMC6402095 | biostudies-literature
Project description:ObjectiveTo develop ROBIS, a new tool for assessing the risk of bias in systematic reviews (rather than in primary studies).Study design and settingWe used four-stage approach to develop ROBIS: define the scope, review the evidence base, hold a face-to-face meeting, and refine the tool through piloting.ResultsROBIS is currently aimed at four broad categories of reviews mainly within health care settings: interventions, diagnosis, prognosis, and etiology. The target audience of ROBIS is primarily guideline developers, authors of overviews of systematic reviews ("reviews of reviews"), and review authors who might want to assess or avoid risk of bias in their reviews. The tool is completed in three phases: (1) assess relevance (optional), (2) identify concerns with the review process, and (3) judge risk of bias. Phase 2 covers four domains through which bias may be introduced into a systematic review: study eligibility criteria; identification and selection of studies; data collection and study appraisal; and synthesis and findings. Phase 3 assesses the overall risk of bias in the interpretation of review findings and whether this considered limitations identified in any of the phase 2 domains. Signaling questions are included to help judge concerns with the review process (phase 2) and the overall risk of bias in the review (phase 3); these questions flag aspects of review design related to the potential for bias and aim to help assessors judge risk of bias in the review process, results, and conclusions.ConclusionsROBIS is the first rigorously developed tool designed specifically to assess the risk of bias in systematic reviews.
| S-EPMC4687950 | biostudies-literature
Project description:BackgroundSystematic reviews (SRs) are expected to critically appraise included studies and privilege those at lowest risk of bias (RoB) in the synthesis. This study examines if and how critical appraisals inform the synthesis and interpretation of evidence in SRs.MethodsAll SRs published in March-May 2012 in 14 high-ranked medical journals and a sample from the Cochrane library were systematically assessed by two reviewers to determine if and how: critical appraisal was conducted; RoB was summarised at study, domain and review levels; and RoB appraisals informed the synthesis process.ResultsOf the 59 SRs studied, all except six (90%) conducted a critical appraisal of the included studies, with most using or adapting existing tools. Almost half of the SRs reported critical appraisal in a manner that did not allow readers to determine which studies included in a review were most robust. RoB assessments were not incorporated into synthesis in one-third (20) of the SRs, with their consideration more likely when reviews focused on randomised controlled trials. Common methods for incorporating critical appraisals into the synthesis process were sensitivity analysis, narrative discussion and exclusion of studies at high RoB. Nearly half of the reviews which investigated multiple outcomes and carried out study-level RoB summaries did not consider the potential for RoB to vary across outcomes.ConclusionsThe conclusions of the SRs, published in major journals, are frequently uninformed by the critical appraisal process, even when conducted. This may be particularly problematic for SRs of public health topics that often draw on diverse study designs.
| S-EPMC4316857 | biostudies-literature
Project description:BackgroundArticle summaries' information and structure may influence researchers/clinicians' decisions to conduct deeper full-text analyses. Specifically, abstracts of systematic reviews (SRs) and meta-analyses (MA) should provide structured summaries for quick assessment. This study explored a method for determining the methodological quality and bias risk of full-text reviews using abstract information alone.MethodsSystematic literature searches for SRs and/or MA about psoriasis were undertaken on MEDLINE, EMBASE, and Cochrane database. For each review, quality, abstract-reporting completeness, full-text methodological quality, and bias risk were evaluated using Preferred Reporting Items for Systematic Reviews and Meta-analyses for abstracts (PRISMA-A), Assessing the Methodological Quality of Systematic Reviews (AMSTAR), and ROBIS tools, respectively. Article-, author-, and journal-derived metadata were systematically extracted from eligible studies using a piloted template, and explanatory variables concerning abstract-reporting quality were assessed using univariate and multivariate-regression models. Two classification models concerning SRs' methodological quality and bias risk were developed based on per-item and total PRISMA-A scores and decision-tree algorithms. This work was supported, in part, by project ICI1400136 (JR). No funding was received from any pharmaceutical company.ResultsThis study analysed 139 SRs on psoriasis interventions. On average, they featured 56.7% of PRISMA-A items. The mean total PRISMA-A score was significantly higher for high-methodological-quality SRs than for moderate- and low-methodological-quality reviews. SRs with low-bias risk showed higher total PRISMA-A values than reviews with high-bias risk. In the final model, only 'authors per review > 6' (OR: 1.098; 95%CI: 1.012-1.194), 'academic source of funding' (OR: 3.630; 95%CI: 1.788-7.542), and 'PRISMA-endorsed journal' (OR: 4.370; 95%CI: 1.785-10.98) predicted PRISMA-A variability. Reviews with a total PRISMA-A score < 6, lacking identification as SR or MA in the title, and lacking explanation concerning bias risk assessment methods were classified as low-methodological quality. Abstracts with a total PRISMA-A score ≥ 9, including main outcomes results and explanation bias risk assessment method were classified as having low-bias risk.ConclusionsThe methodological quality and bias risk of SRs may be determined by abstract's quality and completeness analyses. Our proposal aimed to facilitate synthesis of evidence evaluation by clinical professionals lacking methodological skills. External validation is necessary.
| S-EPMC5747101 | biostudies-literature
Project description:BackgroundObstetrics and gynaecology have seen rapid growth in the development of new tests with research on these tests presented as diagnostic accuracy studies. To avoid errors in judgement it is important that the methodology of these studies is such that bias is minimised. Our objective was to determine the methodological quality of test accuracy studies in obstetrics and gynaecology using the Quality Assessment of Diagnostic Accuracy Studies (QUADAS) checklist and to assess sources of bias.MethodsA prospective protocol was developed to assess the impact of QUADAS on ten systematic reviews performed over the period 2004-2007.We investigated whether there was an improvement in study quality since the introduction of QUADAS, whether a correlation existed between study sample size, country of origin of study and its quality. We also investigated whether there was a correlation between reporting and methodological quality and by the use of meta-regression analyses explored for items of quality that were associated with bias.ResultsA total of 300 studies were included. The overall quality of included studies was poor (> 50% compliance with 57.1% of quality items). However, the mean compliance with QUADAS showed an improvement post-publication of QUADAS (54.9% versus 61.4% p = 0.002). There was no correlation with study sample size. Gynaecology studies published from the United States of America showed higher quality (USA versus Western Europe p = 0.002; USA versus Asia p = 0.004). Meta-regression analysis showed that no individual quality item had a significant impact on accuracy. There was an association between reporting and methodological quality (r = 0.51 p < 0.0001 for obstetrics and r = 0.56 p < 0.0001 for gynaecology).ConclusionsA combination of poor methodological quality and poor reporting affects the inferences that can be drawn from test accuracy studies. Further compliance with quality checklists is required to ensure that bias is minimised.
| S-EPMC3072918 | biostudies-literature
Project description:BackgroundBias in randomized controlled trials (RCTs) can lead to underestimation or overestimation of the true effects of interventions. Surgical RCTs may suffer from the risk of bias (RoB) that is avoidable in trials of other interventions, and vice versa. We aimed to compare the adequacy of RoB assessments in surgical versus non-surgical RCTs included in Cochrane reviews and to assess the most common differences in those RoB assessments. Due to specificities of surgical trials, i.e. difficulties associated with blinding of surgical interventions, we hypothesized that assessments of surgical trials may be more adequate, compared to RCTs of non-surgical interventions.MethodsThis was a methodological study, analyzing methods of published Cochrane systematic reviews. Data were extracted from RoB tables in Cochrane reviews (judgments and accompanying explanatory comment) for the following four RoB domains used in the 2011 Cochrane RoB tool: randomization, allocation concealment, blinding of participants and personnel, and blinding of outcome assessors. We defined adequate assessments as those that were in line with instructions from the Cochrane Handbook for Systematic Reviews of Interventions. The prevalence of adequate assessments was compared in surgical versus non-surgical trials. The most common differences in both groups of reviews were presented.ResultsIn 729 analyzed Cochrane reviews, there were 10,537 included trials. The prevalence of adequate RoB judgments made by Cochrane authors ranged from 87.9, 95%CI (87.3 to 88.6%) for randomization to 70.7, 95%CI (69.8 to 71.5%) for blinding of participants and personnel. For all analyzed RoB domains, the prevalence of adequate RoB domains was higher in surgical trials than in non-surgical trials. For two RoB domains assessing blinding, this difference between surgical and non-surgical trials was statistically significant (P < 0.001), while the difference was not significant for the RoB domain regarding randomization (P = 0.124) and allocation concealment (P = 0.039, β < 0.8).ConclusionsRoB judgments were more in line with instructions from the Cochrane Handbook when Cochrane reviews assessed surgical trials, compared to those that analyzed non-surgical interventions. However, further steps are warranted to scrutinize RoB assessment in trials of both surgical and non-surgical interventions.
| S-EPMC7526117 | biostudies-literature