Pub Date : 2024-10-09DOI: 10.1016/j.jclinepi.2024.111553
Julian F. Daza , Aya A. Mitani , Shabbir M.H. Alibhai , Peter M. Smith , Erin D. Kennedy , Mark A. Shulman , Paul S. Myles , Duminda N. Wijeysundera
<div><h3>Objectives</h3><div>Evaluate the utility of a joint model when analysing a patient-reported endpoint as part of a randomized controlled trial (RCT) in which censoring occurs when patients die during follow-up.</div></div><div><h3>Study Design and Setting</h3><div>The present study comprises two parts as follows: first we reanalyzed data from a previously published RCT comparing two fluid regimens in the first 24 hours of major abdomino-pelvic surgery ('Restrictive versus Liberal Fluid Therapy for Major Abdominal Surgery [RELIEF]' trial). In this trial, patient-reported disability was measured at multiple timepoints before and after surgery. Next, we conducted a simulation study to jointly emulate patient-reported disability and survival, similar to the RELIEF trial, under nine treatment-outcome scenarios. In both parts, we compared a joint model analysis to a linear mixed-effect model combined with one of the several traditional methods of handling longitudinal missingness as follows: available data analysis, complete case analysis, last observation carried forward, and worst-case assumption.</div></div><div><h3>Results</h3><div>In part one, the joint model revealed no between-group differences in patient-reported disability at 1, 3, 6, and 12 months after surgery. The worst-case approach consistently resulted in the largest deviation from the joint model estimates, although in this particular setting none of the approaches materially changed the study's conclusions. In part two, the simulations revealed that across all treatment-outcome scenarios, the joint model expectedly produced unbiased estimates of patient-reported disability. Similarly, employing an approach based on all available data (ie, relying on the maximum likelihood estimator for handling missingness) yielded disability estimates close to the simulated values, albeit with slight bias across some scenarios. The last observation carried forward approach that mirrored the joint model's estimates except when the treatment had a nonnull effect on patient-reported disability. The worst-case analysis resulted in high bias, which was particularly evident when the treatment had a large effect on survival. The complete case analysis resulted in high bias across all scenarios.</div></div><div><h3>Conclusion</h3><div>In randomized trials that employ a patient-reported outcome as one of their endpoints, a joint model can address bias arising from informative missingness related to death. Methods for handling missingness based on all available data appear to be a reasonable alternative to joint models, with only slight bias across some simulated scenarios.</div></div><div><h3>Plain Language Summary</h3><div>‘Patient-centered research’ focuses on outcomes that are prioritized by patients. This approach often involves asking patients to complete questionnaires about their health experiences. However, if a patient does not finish a study, dealing with their missing answers can pose signif
{"title":"Joint models inform the longitudinal assessment of patient-reported outcomes in clinical trials: a simulation study and secondary analysis of the restrictive Vs. liberal fluid therapy for major abdominal surgery (RELIEF) randomized controlled trial","authors":"Julian F. Daza , Aya A. Mitani , Shabbir M.H. Alibhai , Peter M. Smith , Erin D. Kennedy , Mark A. Shulman , Paul S. Myles , Duminda N. Wijeysundera","doi":"10.1016/j.jclinepi.2024.111553","DOIUrl":"10.1016/j.jclinepi.2024.111553","url":null,"abstract":"<div><h3>Objectives</h3><div>Evaluate the utility of a joint model when analysing a patient-reported endpoint as part of a randomized controlled trial (RCT) in which censoring occurs when patients die during follow-up.</div></div><div><h3>Study Design and Setting</h3><div>The present study comprises two parts as follows: first we reanalyzed data from a previously published RCT comparing two fluid regimens in the first 24 hours of major abdomino-pelvic surgery ('Restrictive versus Liberal Fluid Therapy for Major Abdominal Surgery [RELIEF]' trial). In this trial, patient-reported disability was measured at multiple timepoints before and after surgery. Next, we conducted a simulation study to jointly emulate patient-reported disability and survival, similar to the RELIEF trial, under nine treatment-outcome scenarios. In both parts, we compared a joint model analysis to a linear mixed-effect model combined with one of the several traditional methods of handling longitudinal missingness as follows: available data analysis, complete case analysis, last observation carried forward, and worst-case assumption.</div></div><div><h3>Results</h3><div>In part one, the joint model revealed no between-group differences in patient-reported disability at 1, 3, 6, and 12 months after surgery. The worst-case approach consistently resulted in the largest deviation from the joint model estimates, although in this particular setting none of the approaches materially changed the study's conclusions. In part two, the simulations revealed that across all treatment-outcome scenarios, the joint model expectedly produced unbiased estimates of patient-reported disability. Similarly, employing an approach based on all available data (ie, relying on the maximum likelihood estimator for handling missingness) yielded disability estimates close to the simulated values, albeit with slight bias across some scenarios. The last observation carried forward approach that mirrored the joint model's estimates except when the treatment had a nonnull effect on patient-reported disability. The worst-case analysis resulted in high bias, which was particularly evident when the treatment had a large effect on survival. The complete case analysis resulted in high bias across all scenarios.</div></div><div><h3>Conclusion</h3><div>In randomized trials that employ a patient-reported outcome as one of their endpoints, a joint model can address bias arising from informative missingness related to death. Methods for handling missingness based on all available data appear to be a reasonable alternative to joint models, with only slight bias across some simulated scenarios.</div></div><div><h3>Plain Language Summary</h3><div>‘Patient-centered research’ focuses on outcomes that are prioritized by patients. This approach often involves asking patients to complete questionnaires about their health experiences. However, if a patient does not finish a study, dealing with their missing answers can pose signif","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"176 ","pages":"Article 111553"},"PeriodicalIF":7.3,"publicationDate":"2024-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142401888","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-09DOI: 10.1016/j.jclinepi.2024.111565
Nicola F Tavella, Sara R Wetzler, Chelsea A DeBolt, Angela T Bianco
{"title":"Towards mixed-methods analyses of social vulnerability and perinatal risk: comment on murphy et al 2024.","authors":"Nicola F Tavella, Sara R Wetzler, Chelsea A DeBolt, Angela T Bianco","doi":"10.1016/j.jclinepi.2024.111565","DOIUrl":"10.1016/j.jclinepi.2024.111565","url":null,"abstract":"","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":" ","pages":"111565"},"PeriodicalIF":7.3,"publicationDate":"2024-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142401891","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
We examined the ethnic origin of authors who published research articles in leading medical journals over the past 2 decades.
Study Design and Setting
We carried out a serial cross-sectional analysis of first and last authors who published original research articles in the British Medical Journal, Lancet, Journal of the American Medical Association, and New England Journal of Medicine in 2002, 2012, and 2022. The main outcome was the change in proportion of authors over time according to ethnic origin (Anglo, North/West European, South/West European, Asian, Arab and Middle Eastern, African), gender (male, female), and institutional affiliation in percentage points.
Results
Most authors were of Anglo descent (44%), although the proportion of non-European authors grew between 2002 and 2022. East Asian, South Asian, and Arab and Middle Eastern last authors accounted for a greater proportion of authors over time, gaining between 3 and 6 percentage points, while African authors made no gains. Gains were gender-specific, with non-European men gaining 8 points as first and last authors, but non-European women gaining 5 points as last authors only. Most non-European authors were affiliated with North American (42.9%) or European (22.4%) institutions, while non-European authors from other institutions did not make meaningful gains over time.
Conclusion
Ethnic diversity of authors in leading medical journals has increased somewhat over time, but non-European men account for most of the gains. Non-European women have yet to make comparable advancement as authors.
{"title":"Persistent ethnic disparities in authorship within top European and North American medical journals: a serial cross-sectional analysis","authors":"Sarit Kang-Auger , U. Vivian Ukah , Jessica Healy-Profitós , Aimina Ayoub , Nathalie Auger","doi":"10.1016/j.jclinepi.2024.111552","DOIUrl":"10.1016/j.jclinepi.2024.111552","url":null,"abstract":"<div><h3>Objectives</h3><div>We examined the ethnic origin of authors who published research articles in leading medical journals over the past 2 decades.</div></div><div><h3>Study Design and Setting</h3><div>We carried out a serial cross-sectional analysis of first and last authors who published original research articles in the <em>British Medical Journal</em>, <em>Lancet</em>, <em>Journal of the American Medical Association</em>, and <em>New England Journal of Medicine</em> in 2002, 2012, and 2022. The main outcome was the change in proportion of authors over time according to ethnic origin (Anglo, North/West European, South/West European, Asian, Arab and Middle Eastern, African), gender (male, female), and institutional affiliation in percentage points.</div></div><div><h3>Results</h3><div>Most authors were of Anglo descent (44%), although the proportion of non-European authors grew between 2002 and 2022. East Asian, South Asian, and Arab and Middle Eastern last authors accounted for a greater proportion of authors over time, gaining between 3 and 6 percentage points, while African authors made no gains. Gains were gender-specific, with non-European men gaining 8 points as first and last authors, but non-European women gaining 5 points as last authors only. Most non-European authors were affiliated with North American (42.9%) or European (22.4%) institutions, while non-European authors from other institutions did not make meaningful gains over time.</div></div><div><h3>Conclusion</h3><div>Ethnic diversity of authors in leading medical journals has increased somewhat over time, but non-European men account for most of the gains. Non-European women have yet to make comparable advancement as authors.</div></div>","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"176 ","pages":"Article 111552"},"PeriodicalIF":7.3,"publicationDate":"2024-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142401890","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-09DOI: 10.1016/j.jclinepi.2024.111551
Yana Qi , Kai Zhao , Ningsu Chen , Xinyu Xue , Jiajie Yu , Xin Sun
Objectives
To provide an overview of the existing guides for real-world study (RWS).
Study Design and Setting
Scoping review: a systematic and snowball search of PubMed, Web of Science, Chinese National Knowledge Infrastructure (CNKI), Wan Fang, and nine other official websites was conducted to identify guides for RWS published between January 1, 1990, and December 31, 2023. Two reviewers independently screened and extracted the data using a predefined form. Descriptive, quantitative, and qualitative summaries were also obtained.
Results
A total of 61 guides from PubMed (26, 42.6%), CNKI (9, 14.8%), and other websites (26, 42.6%) were included. Of these, 20 guides (32.8%) were developed through international collaboration, and 49 (80.3%) were published after 2016. Fifty-three (86.9%), 6 (9.8%), and 4 (6.6%) were methodological guides, reporting guidelines, and evaluation tools, respectively. These guides addressed observational studies (24, 39.3%), interventional studies (5, 8.2%), or both (22, 36.1%) that covered design (46, 75.4%), conduct (24, 39.3%), analysis (15, 24.6%), reporting (13, 21.3%), and evaluation (3, 4.9%). Only ten guides (16.4%) used both evidence-based and consensus-driven methods in their development.
Conclusion
Existing RWS guides vary significantly in purpose, format, and content and are often tailored to specific contexts. However, improved guide development methods remain to be established. Researchers should carefully assess the scope, classification, and applicability of these guides, particularly at the beginning of the study, to ensure that they meet the needs of their specific research objectives.
{"title":"Understanding the landscape and promoting the use of guides for real-world study: a scoping review","authors":"Yana Qi , Kai Zhao , Ningsu Chen , Xinyu Xue , Jiajie Yu , Xin Sun","doi":"10.1016/j.jclinepi.2024.111551","DOIUrl":"10.1016/j.jclinepi.2024.111551","url":null,"abstract":"<div><h3>Objectives</h3><div>To provide an overview of the existing guides for real-world study (RWS).</div></div><div><h3>Study Design and Setting</h3><div>Scoping review: a systematic and snowball search of PubMed, Web of Science, Chinese National Knowledge Infrastructure (CNKI), Wan Fang, and nine other official websites was conducted to identify guides for RWS published between January 1, 1990, and December 31, 2023. Two reviewers independently screened and extracted the data using a predefined form. Descriptive, quantitative, and qualitative summaries were also obtained.</div></div><div><h3>Results</h3><div>A total of 61 guides from PubMed (26, 42.6%), CNKI (9, 14.8%), and other websites (26, 42.6%) were included. Of these, 20 guides (32.8%) were developed through international collaboration, and 49 (80.3%) were published after 2016. Fifty-three (86.9%), 6 (9.8%), and 4 (6.6%) were methodological guides, reporting guidelines, and evaluation tools, respectively. These guides addressed observational studies (24, 39.3%), interventional studies (5, 8.2%), or both (22, 36.1%) that covered design (46, 75.4%), conduct (24, 39.3%), analysis (15, 24.6%), reporting (13, 21.3%), and evaluation (3, 4.9%). Only ten guides (16.4%) used both evidence-based and consensus-driven methods in their development.</div></div><div><h3>Conclusion</h3><div>Existing RWS guides vary significantly in purpose, format, and content and are often tailored to specific contexts. However, improved guide development methods remain to be established. Researchers should carefully assess the scope, classification, and applicability of these guides, particularly at the beginning of the study, to ensure that they meet the needs of their specific research objectives.</div></div>","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"176 ","pages":"Article 111551"},"PeriodicalIF":7.3,"publicationDate":"2024-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142401892","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
To investigate the impact of early intensive in-hospital rehabilitation, initiated within 2 days of surgery and lasting up to 7 days, on the recovery of activities of daily living in patients with and without dementia.
Study Design and Setting
Medical claims data from 925 hospitals in Japan were analyzed. We enrolled patients aged ≥50 years who underwent hip fracture surgery within 2 days of admission between April 1, 2018, and December 31, 2019. Low- (20 minutes per day starting on day 2), highest- (60 minutes per day starting on day 1), and gradually increasing (20 minutes on day 1, 40 minutes on days 2–4, and 60 minutes per day thereafter) intensity regimens were used as exposures. The outcomes were Barthel Index (BI) scores at 14 and 30 days postoperatively. For per-protocol analysis, a target trial emulation framework with the sequential doubly robust estimator was used.
Results
Among patients without dementia (N = 11,461), no significant differences in BI scores were observed at 14 days postoperatively across regimens. At 30 days postoperatively, significant differences in BI scores were noted between highest- and low-intensity regimens and between gradually increasing intensity and low-intensity regimens, with additive BI scores of 15.2 (95% CI, 10.7–19.7) and 14.7 (95% CI, 9.2–20.2), respectively. In patients with dementia (N = 14,302), significant differences in BI scores were noted at 14 days postoperatively between highest- and low-intensity regimens and between gradually increasing intensity and low-intensity regimens, with additive BI scores of 8.7 (95% CI, 5.2–12.2) and 10.7 (95% CI, 5.8–15.6), respectively. At 30 days postoperatively, a significant difference in BI scores was observed between gradually increasing intensity and low-intensity regimens, with an additive BI score of 17.9 (95% CI, 11.3–24.5).
Conclusion
Early intensive in-hospital rehabilitation is highly relevant and beneficial for dementia patients.
{"title":"Associations of hypothetical early intensive in-hospital rehabilitation with activities of daily living after hip fracture surgery in patients with and without dementia: emulating a randomized controlled trial using medical claims data","authors":"Takaaki Ikeda , Upul Cooray , Ryutaro Matsugaki , Yuta Suzuki , Michiaki Takagi , Keiji Muramatsu , Kiyohide Fushimi , Masayasu Murakami , Ken Osaka , Shinya Matsuda","doi":"10.1016/j.jclinepi.2024.111550","DOIUrl":"10.1016/j.jclinepi.2024.111550","url":null,"abstract":"<div><h3>Objectives</h3><div>To investigate the impact of early intensive in-hospital rehabilitation, initiated within 2 days of surgery and lasting up to 7 days, on the recovery of activities of daily living in patients with and without dementia.</div></div><div><h3>Study Design and Setting</h3><div>Medical claims data from 925 hospitals in Japan were analyzed. We enrolled patients aged ≥50 years who underwent hip fracture surgery within 2 days of admission between April 1, 2018, and December 31, 2019. Low- (20 minutes per day starting on day 2), highest- (60 minutes per day starting on day 1), and gradually increasing (20 minutes on day 1, 40 minutes on days 2–4, and 60 minutes per day thereafter) intensity regimens were used as exposures. The outcomes were Barthel Index (BI) scores at 14 and 30 days postoperatively. For per-protocol analysis, a target trial emulation framework with the sequential doubly robust estimator was used.</div></div><div><h3>Results</h3><div>Among patients without dementia (<em>N</em> = 11,461), no significant differences in BI scores were observed at 14 days postoperatively across regimens. At 30 days postoperatively, significant differences in BI scores were noted between highest- and low-intensity regimens and between gradually increasing intensity and low-intensity regimens, with additive BI scores of 15.2 (95% CI, 10.7–19.7) and 14.7 (95% CI, 9.2–20.2), respectively. In patients with dementia (<em>N</em> = 14,302), significant differences in BI scores were noted at 14 days postoperatively between highest- and low-intensity regimens and between gradually increasing intensity and low-intensity regimens, with additive BI scores of 8.7 (95% CI, 5.2–12.2) and 10.7 (95% CI, 5.8–15.6), respectively. At 30 days postoperatively, a significant difference in BI scores was observed between gradually increasing intensity and low-intensity regimens, with an additive BI score of 17.9 (95% CI, 11.3–24.5).</div></div><div><h3>Conclusion</h3><div>Early intensive in-hospital rehabilitation is highly relevant and beneficial for dementia patients.</div></div>","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"176 ","pages":"Article 111550"},"PeriodicalIF":7.3,"publicationDate":"2024-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142395027","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-01DOI: 10.1016/j.jclinepi.2024.111493
KM Saif-Ur-Rahman
{"title":"What should journals do to prevent the publication of methodologically flawed systematic reviews?","authors":"KM Saif-Ur-Rahman","doi":"10.1016/j.jclinepi.2024.111493","DOIUrl":"10.1016/j.jclinepi.2024.111493","url":null,"abstract":"","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"174 ","pages":"Article 111493"},"PeriodicalIF":7.3,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141890820","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-01DOI: 10.1016/j.jclinepi.2024.111491
Sophie Leducq, Richard Barlow, Arabella Baker, Mikolaj Swiderski, Hywel C. Williams
{"title":"Long list of conflicts of interest in industry-funded drug trials are counterproductive and opaque for readers","authors":"Sophie Leducq, Richard Barlow, Arabella Baker, Mikolaj Swiderski, Hywel C. Williams","doi":"10.1016/j.jclinepi.2024.111491","DOIUrl":"10.1016/j.jclinepi.2024.111491","url":null,"abstract":"","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"174 ","pages":"Article 111491"},"PeriodicalIF":7.3,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141890818","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-01DOI: 10.1016/j.jclinepi.2024.111460
Kat Kolaski , Mike Clarke , Lynne Romeiser Logan
<div><h3>Objectives</h3><div>Risk of bias (RoB) assessment is a critical part of any systematic review (SR). There are multiple tools available for assessing RoB of the studies included in a SR. The conduct of these assessments in intervention SRs are addressed by three items in AMSTAR-2, considered the preferred tool for critically appraising an intervention SR. This study focuses attention on item 9, which assesses the ability of a RoB tool to adequately address sources of bias, particularly in randomized trials (RCTs) and nonrandomized studies of interventions (NRSI). Our main objective is to report the detailed results of our examination of both Cochrane and non-Cochrane RoB tools and distinguish those that meet AMSTAR-2 item 9 appraisal standards.</div></div><div><h3>Study Design and Setting</h3><div>We identified critical appraisal tools reported in a sample of 126 SRs reporting on interventions for persons with cerebral palsy published from 2014 to 2021. Eligible tools were those that had been used to assess the primary studies included in these SRs and for which assessment results were reported in enough detail to allow appraisal of the tool. We identified the version of the tool applied as original, modified, or novel and established the applicable study designs as intended by the tools’ developers. We then evaluated the potential ability of these tools to assess the four sources of bias specified in AMSTAR-2 item 9 for RCTs and NRSI. We adapted item 9 to appraise tools applied to single-case experimental designs, which we also encountered in this sample of SRs.</div></div><div><h3>Results</h3><div>Most of the eligible tools are recognized by name in the published literature and were applied in the original or modified form. Modifications were applied with considerable variability across the sample. Of the 37 tools we examined, those judged to fully meet the appraisal standards for RCTs included all the Cochrane tools, the original and modified Downs and Black Checklist, and the quality assessment standard for a cross-over study by Ding et al; for NRSI, these included all the Cochrane tools, the original and modified Downs and Black Checklist, and the Research Triangle Institute item bank on Risk of Bias and Precision of Observational Studies for NRSI. In general, tools developed for a specific study design were judged to meet the appraisal standards fully or partially for that design. These results suggest it is unlikely that a single tool will be adequate by AMSTAR-2 item 9 appraisal standards for an intervention SR that includes studies of various designs.</div></div><div><h3>Conclusion</h3><div>To our knowledge, this is the first resource providing SR authors with practical information about the appropriateness and adequacy of RoB tools by the appraisal standards specified in AMSTAR-2 item 9 for RCTs and NRSI. We propose similar methods for appraisal of tools applied to single-case experimental design. We encourage authors to seek co
目的：偏倚风险（RoB）评估是任何系统综述（SR）的关键部分。有多种工具可用于评估纳入系统综述的研究的偏倚风险。AMSTAR-2 被认为是对干预性系统综述进行批判性评估的首选工具，其中有三个项目涉及干预性系统综述中进行这些评估的问题。本研究重点关注项目 9，该项目评估 RoB 工具充分解决偏倚来源的能力，尤其是随机试验 (RCT) 和非随机干预研究 (NRSI) 中的偏倚来源。我们的主要目的是报告对 Cochrane 和非 Cochrane RoB 工具的详细检查结果，并区分那些符合 AMSTAR-2 第 9 项评估标准的工具：我们在2014年至2021年发表的126篇报告中抽样调查了对脑瘫患者干预措施的关键评估工具。符合条件的工具是那些用于评估这些SR中包含的主要研究的工具，并且评估结果有足够详细的报告，以便对工具进行评估。我们确定了所应用工具的原始版本、修改版本或新型版本，并按照工具开发者的意图确定了适用的研究设计。然后，我们评估了这些工具评估 AMSTAR-2 第 9 项针对 RCT 和 NRSI 规定的四种偏倚来源的潜在能力。我们对第 9 项进行了调整，以评估适用于单例实验设计的工具，我们在 SR 样本中也遇到了这种情况：结果：大多数符合条件的工具在已发表的文献中都有名称，并以原始或修改后的形式应用。修改后的工具在样本中的应用具有相当大的差异性。在我们检查的 37 种工具中，被判定完全符合 RCT 评估标准的工具包括所有 Cochrane 工具、原始和修改后的 Downs 和 Black 检查表，以及 Ding 等人的交叉研究质量评估标准；对于 NRSI，这些工具包括所有 Cochrane 工具、原始和修改后的 Downs 和 Black 检查表，以及三角研究所的 NRSI 观察性研究偏倚风险和精确性项目库。一般来说，为特定研究设计开发的工具被判定为完全或部分符合该设计的鉴定标准。这些结果表明，根据 AMSTAR-2 第 9 项评估标准，单一工具不太可能满足包括各种设计研究在内的干预 SR 的要求：据我们所知，这是第一份为SR作者提供实用信息的资料，介绍了RoB工具在AMSTAR-2第9项规定的RCT和NRSI评估标准下的适宜性和充分性。我们建议采用类似的方法来评估适用于单例实验设计的工具。我们鼓励作者寻找为医疗相关干预性研究开发的、旨在评估相关研究设计特征的当代 RoB 工具。这些工具应针对综述主题和研究问题的独特属性，但不应进行不合理的过度修改。我们提倡认识到 Cochrane 和非 Cochrane RoB 工具的潜在缺陷，即使是那些在 AMSTAR-2 第 9 项评估标准中表现良好的工具。
{"title":"Analysis of risk of bias assessments in a sample of intervention systematic reviews, Part II: focus on risk of bias tools reveals few meet current appraisal standards","authors":"Kat Kolaski , Mike Clarke , Lynne Romeiser Logan","doi":"10.1016/j.jclinepi.2024.111460","DOIUrl":"10.1016/j.jclinepi.2024.111460","url":null,"abstract":"<div><h3>Objectives</h3><div>Risk of bias (RoB) assessment is a critical part of any systematic review (SR). There are multiple tools available for assessing RoB of the studies included in a SR. The conduct of these assessments in intervention SRs are addressed by three items in AMSTAR-2, considered the preferred tool for critically appraising an intervention SR. This study focuses attention on item 9, which assesses the ability of a RoB tool to adequately address sources of bias, particularly in randomized trials (RCTs) and nonrandomized studies of interventions (NRSI). Our main objective is to report the detailed results of our examination of both Cochrane and non-Cochrane RoB tools and distinguish those that meet AMSTAR-2 item 9 appraisal standards.</div></div><div><h3>Study Design and Setting</h3><div>We identified critical appraisal tools reported in a sample of 126 SRs reporting on interventions for persons with cerebral palsy published from 2014 to 2021. Eligible tools were those that had been used to assess the primary studies included in these SRs and for which assessment results were reported in enough detail to allow appraisal of the tool. We identified the version of the tool applied as original, modified, or novel and established the applicable study designs as intended by the tools’ developers. We then evaluated the potential ability of these tools to assess the four sources of bias specified in AMSTAR-2 item 9 for RCTs and NRSI. We adapted item 9 to appraise tools applied to single-case experimental designs, which we also encountered in this sample of SRs.</div></div><div><h3>Results</h3><div>Most of the eligible tools are recognized by name in the published literature and were applied in the original or modified form. Modifications were applied with considerable variability across the sample. Of the 37 tools we examined, those judged to fully meet the appraisal standards for RCTs included all the Cochrane tools, the original and modified Downs and Black Checklist, and the quality assessment standard for a cross-over study by Ding et al; for NRSI, these included all the Cochrane tools, the original and modified Downs and Black Checklist, and the Research Triangle Institute item bank on Risk of Bias and Precision of Observational Studies for NRSI. In general, tools developed for a specific study design were judged to meet the appraisal standards fully or partially for that design. These results suggest it is unlikely that a single tool will be adequate by AMSTAR-2 item 9 appraisal standards for an intervention SR that includes studies of various designs.</div></div><div><h3>Conclusion</h3><div>To our knowledge, this is the first resource providing SR authors with practical information about the appropriateness and adequacy of RoB tools by the appraisal standards specified in AMSTAR-2 item 9 for RCTs and NRSI. We propose similar methods for appraisal of tools applied to single-case experimental design. We encourage authors to seek co","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"174 ","pages":"Article 111460"},"PeriodicalIF":7.3,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141724954","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-01DOI: 10.1016/j.jclinepi.2024.111554
Andrea C. Tricco, David Tovey
{"title":"Editors’ Choice: October 2024","authors":"Andrea C. Tricco, David Tovey","doi":"10.1016/j.jclinepi.2024.111554","DOIUrl":"10.1016/j.jclinepi.2024.111554","url":null,"abstract":"","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"174 ","pages":"Article 111554"},"PeriodicalIF":7.3,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142433648","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-01DOI: 10.1016/j.jclinepi.2024.111547
Vivienne C. Bachelet , Francisca J. Lizana , Catalina O. Andrades , Belén Carroza , Leandro R.A. González , Paula Munita , Luana Wosiack , Nicolás Meza
Objectives
To evaluate the design, conduct, and analysis of systematic reviews on the diagnostic accuracy of rapid antigen tests for SARS-CoV-2 during the COVID-19 pandemic.
Study Design and Setting
We did a methodological overview of systematic reviews on diagnostic test accuracy, exploring methodological rigor, risk of bias and potential factors of between-review variability.
Results
Of the 31 included reviews, 30 provided summary statistics for sensitivity and 29 for specificity. Summary sensitivities ranged from 56.2% to 91.1%, with a median of 71.5% (IQR 68.3%–76.6%) and a mean of 72.7% with a 7.2 SD. Reported summary specificity estimates were consistently high: median 99.5% (IQR 99%–99.9%) and a mean of 99.3% with a 0.9 SD. We found methodological shortcomings in the systematic reviews, with a majority showing critically low confidence in quality and a high risk of bias.
Conclusion
Despite significant methodological flaws in the reviews, the diagnostic accuracy estimates for rapid antigen tests were characterized by a strong central tendency, highlighting the importance of large sample sizes and broad participant representation. This study suggests the need for further research in diagnostic test accuracy assessments of rigor and risk of bias in systematic reviews.
{"title":"Estimates for diagnostic accuracy of rapid antigen tests for SARS-CoV-2 in systematic reviews are consistently similar despite poor methodological rigor: a methodological overview","authors":"Vivienne C. Bachelet , Francisca J. Lizana , Catalina O. Andrades , Belén Carroza , Leandro R.A. González , Paula Munita , Luana Wosiack , Nicolás Meza","doi":"10.1016/j.jclinepi.2024.111547","DOIUrl":"10.1016/j.jclinepi.2024.111547","url":null,"abstract":"<div><h3>Objectives</h3><div>To evaluate the design, conduct, and analysis of systematic reviews on the diagnostic accuracy of rapid antigen tests for SARS-CoV-2 during the COVID-19 pandemic.</div></div><div><h3>Study Design and Setting</h3><div>We did a methodological overview of systematic reviews on diagnostic test accuracy, exploring methodological rigor, risk of bias and potential factors of between-review variability.</div></div><div><h3>Results</h3><div>Of the 31 included reviews, 30 provided summary statistics for sensitivity and 29 for specificity. Summary sensitivities ranged from 56.2% to 91.1%, with a median of 71.5% (IQR 68.3%–76.6%) and a mean of 72.7% with a 7.2 SD. Reported summary specificity estimates were consistently high: median 99.5% (IQR 99%–99.9%) and a mean of 99.3% with a 0.9 SD. We found methodological shortcomings in the systematic reviews, with a majority showing critically low confidence in quality and a high risk of bias.</div></div><div><h3>Conclusion</h3><div>Despite significant methodological flaws in the reviews, the diagnostic accuracy estimates for rapid antigen tests were characterized by a strong central tendency, highlighting the importance of large sample sizes and broad participant representation. This study suggests the need for further research in diagnostic test accuracy assessments of rigor and risk of bias in systematic reviews.</div></div>","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"176 ","pages":"Article 111547"},"PeriodicalIF":7.3,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142367241","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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