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Identifying actionable statements in Chinese health guidelines: a cross-sectional study.
IF 9 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-03-14 DOI: 10.1136/bmjebm-2024-113050
Xiangying Ren, Tamara Lotfi, Jiyu Chen, Yuling Lei, Chenyibei Zhou, Wei Zhang, Qiao Huang, Yongbo Wang, Siyu Yan, Shichun Wang, Siyuan Ruan, Wanru Wang, Qiyi Zhang, Xiaomei Yao, Yinghui Jin, Holger J Schuenemann

Objective: The purpose of this study is to validate the taxonomy and framework using Chinese guidelines and identify actionable statements.

Design and setting: We searched five databases, to identify the health guidelines from 1 January 2020 to 1 May 2023. Five researchers categorised statements into six types: formal recommendations (Type I) with clear direction and strength, with explicit and direct evidence; good practice statements (GPS) (Type II), actionable in isolation with a significant benefit; remarks (Type III), an inseparable unit belonging to a formal recommendation or GPS that provides additional clarification; research only recommendations (Type IV) for specific populations; implementation considerations, tools and tips (Type V), that describe the how, who, where, what and when, in relation to implementing a recommendation and lacking a direct evidence link; and informal recommendations (Type VI), unrelated to evidence and not meeting GPS criteria.

Results: We included 116 guidelines, including 74 Western medicine guidelines, 12 traditional Chinese medicine guidelines and 30 integrated Chinese and Western medicine guidelines. 99 guidelines (85.3%) used the Grading of Recommendations Assessment, Development and Evaluation criteria. Medical specialty societies developed the highest number of guidelines (53.4%). Of all the statements, 4422 statements were extracted from the guidelines. Among them, 2154 (48.7%) were formal recommendations, 197 (4.4%) were GPS, 394 (8.9%) were remarks, 16 (0.4%) were research only recommendations, 1106 (25.0%) were implementation considerations, tools and tips, and 555 (12.6%) were informal recommendations.

Conclusions: Up to date, the Chinese guideline developers tend to overestimate the number of formal recommendations and underestimate the number of GPS, remarks, research only recommendations, implementation considerations, tools and tips, and informal recommendations. Thus the current quality of actionable statements in Chinese health guidelines requires further enhancement.

{"title":"Identifying actionable statements in Chinese health guidelines: a cross-sectional study.","authors":"Xiangying Ren, Tamara Lotfi, Jiyu Chen, Yuling Lei, Chenyibei Zhou, Wei Zhang, Qiao Huang, Yongbo Wang, Siyu Yan, Shichun Wang, Siyuan Ruan, Wanru Wang, Qiyi Zhang, Xiaomei Yao, Yinghui Jin, Holger J Schuenemann","doi":"10.1136/bmjebm-2024-113050","DOIUrl":"https://doi.org/10.1136/bmjebm-2024-113050","url":null,"abstract":"<p><strong>Objective: </strong>The purpose of this study is to validate the taxonomy and framework using Chinese guidelines and identify actionable statements.</p><p><strong>Design and setting: </strong>We searched five databases, to identify the health guidelines from 1 January 2020 to 1 May 2023. Five researchers categorised statements into six types: formal recommendations (Type I) with clear direction and strength, with explicit and direct evidence; good practice statements (GPS) (Type II), actionable in isolation with a significant benefit; remarks (Type III), an inseparable unit belonging to a formal recommendation or GPS that provides additional clarification; research only recommendations (Type IV) for specific populations; implementation considerations, tools and tips (Type V), that describe the how, who, where, what and when, in relation to implementing a recommendation and lacking a direct evidence link; and informal recommendations (Type VI), unrelated to evidence and not meeting GPS criteria.</p><p><strong>Results: </strong>We included 116 guidelines, including 74 Western medicine guidelines, 12 traditional Chinese medicine guidelines and 30 integrated Chinese and Western medicine guidelines. 99 guidelines (85.3%) used the Grading of Recommendations Assessment, Development and Evaluation criteria. Medical specialty societies developed the highest number of guidelines (53.4%). Of all the statements, 4422 statements were extracted from the guidelines. Among them, 2154 (48.7%) were formal recommendations, 197 (4.4%) were GPS, 394 (8.9%) were remarks, 16 (0.4%) were research only recommendations, 1106 (25.0%) were implementation considerations, tools and tips, and 555 (12.6%) were informal recommendations.</p><p><strong>Conclusions: </strong>Up to date, the Chinese guideline developers tend to overestimate the number of formal recommendations and underestimate the number of GPS, remarks, research only recommendations, implementation considerations, tools and tips, and informal recommendations. Thus the current quality of actionable statements in Chinese health guidelines requires further enhancement.</p>","PeriodicalId":9059,"journal":{"name":"BMJ Evidence-Based Medicine","volume":" ","pages":""},"PeriodicalIF":9.0,"publicationDate":"2025-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143630009","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Therapeutic quality of exercise interventions for chronic low back pain: a meta-research study using i-CONTENT tool.
IF 9 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-03-11 DOI: 10.1136/bmjebm-2024-113235
Ignazio Geraci, Silvia Bargeri, Giacomo Basso, Greta Castellini, Alessandro Chiarotto, Silvia Gianola, Raymond Ostelo, Marco Testa, Tiziano Innocenti

Objective: To assess the therapeutic quality of exercise interventions delivered in chronic low back pain (cLBP) trials using the international Consensus on Therapeutic Exercise aNd Training (i-CONTENT) tool and its inter-rater agreement.

Methods: We performed a meta-research study, starting from the trials' arms included in the published Cochrane review (2021) 'Exercise therapy for chronic low back pain'. Two pairs of independent reviewers applied the i-CONTENT tool, a standardised tool designed to ensure the quality of exercise therapy intervention, in a random sample of 100 different exercise arms. We assessed the inter-rater agreement of each category calculating the specific agreement. A percentage of 70% was considered satisfactory.

Results: We included 100 arms from 68 randomised controlled trials published between 1991 and 2019. The most assessed exercise types were core strengthening (n=27 arms) and motor control (n=13 arms). Among alternative approaches, yoga (n=11) and Pilates (n=7) were the most representative. Overall, most exercise interventions were rated as having a low risk of ineffectiveness for patient selection (100%), exercise type (92%), outcome type and timing (89%) and qualified supervisor (84%). Conversely, some items showed more uncertainty: the safety of exercise programmes was rated as 'probably low risk' in 58% of cases, exercise dosage in 34% and adherence to exercise in 44%. The items related to exercise dosage (31%) and adherence (29%) had heterogenous judgements, scoring as high risk of ineffectiveness or probably not done. Among all exercise types, Pilates scored best in all domains. A satisfactory specific agreement for 'low risk category' was achieved in all items, except dosage of exercise (60%) and adherence to exercise (54%).

Conclusion: Exercises delivered for patients with cLBP generally demonstrate favourable therapeutic quality, although some exercise modalities may present poor therapeutic quality related to dosage and adherence. While the i-CONTENT judgements generally showed satisfactory specific agreement between raters, disagreements arose in evaluating some crucial items.

{"title":"Therapeutic quality of exercise interventions for chronic low back pain: a meta-research study using i-CONTENT tool.","authors":"Ignazio Geraci, Silvia Bargeri, Giacomo Basso, Greta Castellini, Alessandro Chiarotto, Silvia Gianola, Raymond Ostelo, Marco Testa, Tiziano Innocenti","doi":"10.1136/bmjebm-2024-113235","DOIUrl":"10.1136/bmjebm-2024-113235","url":null,"abstract":"<p><strong>Objective: </strong>To assess the therapeutic quality of exercise interventions delivered in chronic low back pain (cLBP) trials using the international Consensus on Therapeutic Exercise aNd Training (i-CONTENT) tool and its inter-rater agreement.</p><p><strong>Methods: </strong>We performed a meta-research study, starting from the trials' arms included in the published Cochrane review (2021) 'Exercise therapy for chronic low back pain'. Two pairs of independent reviewers applied the i-CONTENT tool, a standardised tool designed to ensure the quality of exercise therapy intervention, in a random sample of 100 different exercise arms. We assessed the inter-rater agreement of each category calculating the specific agreement. A percentage of 70% was considered satisfactory.</p><p><strong>Results: </strong>We included 100 arms from 68 randomised controlled trials published between 1991 and 2019. The most assessed exercise types were core strengthening (n=27 arms) and motor control (n=13 arms). Among alternative approaches, yoga (n=11) and Pilates (n=7) were the most representative. Overall, most exercise interventions were rated as having a low risk of ineffectiveness for patient selection (100%), exercise type (92%), outcome type and timing (89%) and qualified supervisor (84%). Conversely, some items showed more uncertainty: the safety of exercise programmes was rated as 'probably low risk' in 58% of cases, exercise dosage in 34% and adherence to exercise in 44%. The items related to exercise dosage (31%) and adherence (29%) had heterogenous judgements, scoring as high risk of ineffectiveness or probably not done. Among all exercise types, Pilates scored best in all domains. A satisfactory specific agreement for 'low risk category' was achieved in all items, except dosage of exercise (60%) and adherence to exercise (54%).</p><p><strong>Conclusion: </strong>Exercises delivered for patients with cLBP generally demonstrate favourable therapeutic quality, although some exercise modalities may present poor therapeutic quality related to dosage and adherence. While the i-CONTENT judgements generally showed satisfactory specific agreement between raters, disagreements arose in evaluating some crucial items.</p>","PeriodicalId":9059,"journal":{"name":"BMJ Evidence-Based Medicine","volume":" ","pages":""},"PeriodicalIF":9.0,"publicationDate":"2025-03-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143027793","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Improving peer review of systematic reviews and related review types by involving librarians and information specialists as methodological peer reviewers: a randomised controlled trial.
IF 9 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-03-11 DOI: 10.1136/bmjebm-2024-113527
Melissa L Rethlefsen, Sara Schroter, Lex M Bouter, Jamie J Kirkham, David Moher, Ana Patricia Ayala, David Blanco, Tara J Brigham, Holly K Grossetta Nardini, Shona Kirtley, Kate Nyhan, Whitney Townsend, Maurice Zeegers

Objective: To evaluate the impact of adding librarians and information specialists (LIS) as methodological peer reviewers to the formal journal peer review process on the quality of search reporting and risk of bias in systematic review searches in the medical literature.

Design: Pragmatic two-group parallel randomised controlled trial.

Setting: Three biomedical journals.

Participants: Systematic reviews and related evidence synthesis manuscripts submitted to The BMJ, BMJ Open and BMJ Medicine and sent out for peer review from 3 January 2023 to 1 September 2023. Randomisation (allocation ratio, 1:1) was stratified by journal and used permuted blocks (block size=4). Of 2670 manuscripts sent to peer review during study enrollment, 400 met inclusion criteria and were randomised (62 The BMJ, 334 BMJ Open, 4 BMJ Medicine). 76 manuscripts were revised and resubmitted in the intervention group and 90 in the control group by 2 January 2024.

Interventions: All manuscripts followed usual journal practice for peer review, but those in the intervention group had an additional (LIS) peer reviewer invited.

Main outcome measures: The primary outcomes are the differences in first revision manuscripts between intervention and control groups in the quality of reporting and risk of bias. Quality of reporting was measured using four prespecified PRISMA-S items. Risk of bias was measured using ROBIS Domain 2. Assessments were done in duplicate and assessors were blinded to group allocation. Secondary outcomes included differences between groups for each individual PRISMA-S and ROBIS Domain 2 item. The difference in the proportion of manuscripts rejected as the first decision post-peer review between the intervention and control groups was an additional outcome.

Results: Differences in the proportion of adequately reported searches (4.4% difference, 95% CI: -2.0% to 10.7%) and risk of bias in searches (0.5% difference, 95% CI: -13.7% to 14.6%) showed no statistically significant differences between groups. By 4 months post-study, 98 intervention and 70 control group manuscripts had been rejected after peer review (13.8% difference, 95% CI: 3.9% to 23.8%).

Conclusions: Inviting LIS peer reviewers did not impact adequate reporting or risk of bias of searches in first revision manuscripts of biomedical systematic reviews and related review types, though LIS peer reviewers may have contributed to a higher rate of rejection after peer review.

Trial registration number: Open Science Framework: https://doi.org/10.17605/OSF.IO/W4CK2.

{"title":"Improving peer review of systematic reviews and related review types by involving librarians and information specialists as methodological peer reviewers: a randomised controlled trial.","authors":"Melissa L Rethlefsen, Sara Schroter, Lex M Bouter, Jamie J Kirkham, David Moher, Ana Patricia Ayala, David Blanco, Tara J Brigham, Holly K Grossetta Nardini, Shona Kirtley, Kate Nyhan, Whitney Townsend, Maurice Zeegers","doi":"10.1136/bmjebm-2024-113527","DOIUrl":"https://doi.org/10.1136/bmjebm-2024-113527","url":null,"abstract":"<p><strong>Objective: </strong>To evaluate the impact of adding librarians and information specialists (LIS) as methodological peer reviewers to the formal journal peer review process on the quality of search reporting and risk of bias in systematic review searches in the medical literature.</p><p><strong>Design: </strong>Pragmatic two-group parallel randomised controlled trial.</p><p><strong>Setting: </strong>Three biomedical journals.</p><p><strong>Participants: </strong>Systematic reviews and related evidence synthesis manuscripts submitted to <i>The BMJ</i>, <i>BMJ Open</i> and <i>BMJ Medicine</i> and sent out for peer review from 3 January 2023 to 1 September 2023. Randomisation (allocation ratio, 1:1) was stratified by journal and used permuted blocks (block size=4). Of 2670 manuscripts sent to peer review during study enrollment, 400 met inclusion criteria and were randomised (62 <i>The BMJ</i>, 334 <i>BMJ Open</i>, 4 <i>BMJ Medicine</i>). 76 manuscripts were revised and resubmitted in the intervention group and 90 in the control group by 2 January 2024.</p><p><strong>Interventions: </strong>All manuscripts followed usual journal practice for peer review, but those in the intervention group had an additional (LIS) peer reviewer invited.</p><p><strong>Main outcome measures: </strong>The primary outcomes are the differences in first revision manuscripts between intervention and control groups in the quality of reporting and risk of bias. Quality of reporting was measured using four prespecified PRISMA-S items. Risk of bias was measured using ROBIS Domain 2. Assessments were done in duplicate and assessors were blinded to group allocation. Secondary outcomes included differences between groups for each individual PRISMA-S and ROBIS Domain 2 item. The difference in the proportion of manuscripts rejected as the first decision post-peer review between the intervention and control groups was an additional outcome.</p><p><strong>Results: </strong>Differences in the proportion of adequately reported searches (4.4% difference, 95% CI: -2.0% to 10.7%) and risk of bias in searches (0.5% difference, 95% CI: -13.7% to 14.6%) showed no statistically significant differences between groups. By 4 months post-study, 98 intervention and 70 control group manuscripts had been rejected after peer review (13.8% difference, 95% CI: 3.9% to 23.8%).</p><p><strong>Conclusions: </strong>Inviting LIS peer reviewers did not impact adequate reporting or risk of bias of searches in first revision manuscripts of biomedical systematic reviews and related review types, though LIS peer reviewers may have contributed to a higher rate of rejection after peer review.</p><p><strong>Trial registration number: </strong>Open Science Framework: https://doi.org/10.17605/OSF.IO/W4CK2.</p>","PeriodicalId":9059,"journal":{"name":"BMJ Evidence-Based Medicine","volume":" ","pages":""},"PeriodicalIF":9.0,"publicationDate":"2025-03-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143613194","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Rating certainty when the target threshold is the null and the point estimate is close to the null.
IF 9 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-03-05 DOI: 10.1136/bmjebm-2024-113077
Linan Zeng, Monica Hultcrantz, David Tovey, Nancy Santesso, Philipp Dahm, Romina Brignardello-Petersen, Reem A Mustafa, M Hassan Murad, Ariel Izcovich, Hans de Beer, Martin Alberto Ragusa, Bradley Johnston, Lingli Zhang, Alfonso Iorio, Gordon Guyatt

When one initially targets the null effect and the point estimate falls close to the null, two challenges exist in rating certainty of evidence. First, when the point estimate is near the null and the data, therefore, suggests little or no effect, rating certainty in a benefit or harm is misleading. Second, since in general the narrower the confidence interval (CI) the more precise the estimate, if the CI is narrow, rating down for imprecision due simply to crossing the null is inappropriate. This paper addresses these issues and provides a solution: to revise the target of certainty rating from a non-zero effect to a little or no effect. This solution requires estimating a range in which the minimal important difference (MID) for benefit and an MID for harm might lie, and thus establishing a range that represents little or no effect. If GRADE (Grading of Recommendations, Assessment, Development, and Evaluations) users are confident that the point estimate represents an effect less than the smallest plausible MID, they will revise their target and rate certainty to a little or no effect. If the entire CI falls within the range of little or no effect, they will not rate down for imprecision. Otherwise (if the CI includes an important effect), they will rate down. Using the solution provided in this paper GRADE users can make an optimal choice of the target of certainty rating.

{"title":"Rating certainty when the target threshold is the null and the point estimate is close to the null.","authors":"Linan Zeng, Monica Hultcrantz, David Tovey, Nancy Santesso, Philipp Dahm, Romina Brignardello-Petersen, Reem A Mustafa, M Hassan Murad, Ariel Izcovich, Hans de Beer, Martin Alberto Ragusa, Bradley Johnston, Lingli Zhang, Alfonso Iorio, Gordon Guyatt","doi":"10.1136/bmjebm-2024-113077","DOIUrl":"https://doi.org/10.1136/bmjebm-2024-113077","url":null,"abstract":"<p><p>When one initially targets the null effect and the point estimate falls close to the null, two challenges exist in rating certainty of evidence. First, when the point estimate is near the null and the data, therefore, suggests little or no effect, rating certainty in a benefit or harm is misleading. Second, since in general the narrower the confidence interval (CI) the more precise the estimate, if the CI is narrow, rating down for imprecision due simply to crossing the null is inappropriate. This paper addresses these issues and provides a solution: to revise the target of certainty rating from a non-zero effect to a little or no effect. This solution requires estimating a range in which the minimal important difference (MID) for benefit and an MID for harm might lie, and thus establishing a range that represents little or no effect. If GRADE (Grading of Recommendations, Assessment, Development, and Evaluations) users are confident that the point estimate represents an effect less than the smallest plausible MID, they will revise their target and rate certainty to a little or no effect. If the entire CI falls within the range of little or no effect, they will not rate down for imprecision. Otherwise (if the CI includes an important effect), they will rate down. Using the solution provided in this paper GRADE users can make an optimal choice of the target of certainty rating.</p>","PeriodicalId":9059,"journal":{"name":"BMJ Evidence-Based Medicine","volume":" ","pages":""},"PeriodicalIF":9.0,"publicationDate":"2025-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143565930","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Harnessing health technology assessment in India: paving the way for sustainable healthcare solutions in developing countries.
IF 9 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-03-04 DOI: 10.1136/bmjebm-2025-113740
Nicolás Meza, Paula Riganti, Kalipso Chalkidou
{"title":"Harnessing health technology assessment in India: paving the way for sustainable healthcare solutions in developing countries.","authors":"Nicolás Meza, Paula Riganti, Kalipso Chalkidou","doi":"10.1136/bmjebm-2025-113740","DOIUrl":"https://doi.org/10.1136/bmjebm-2025-113740","url":null,"abstract":"","PeriodicalId":9059,"journal":{"name":"BMJ Evidence-Based Medicine","volume":" ","pages":""},"PeriodicalIF":9.0,"publicationDate":"2025-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143555860","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Post-publication peer review and the identification of methodological and reporting issues in COVID-19 trials: a qualitative study.
IF 9 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-03-03 DOI: 10.1136/bmjebm-2024-113068
Mauricia Davidson, Christoffer Bruun Korfitsen, Carolina Riveros, Anna Chaimani, Isabelle Boutron

Objectives: We aimed to determine to what extent systematic reviewers and post-preprint and post-publication peer review identified methodological and reporting issues in COVID-19 trials that could be easily resolved by the authors.

Design: Qualitative study.

Data sources: COVID-NMA living systematic review (covid-nma.com), PubPeer, medRxiv, Research Square, SSRN.

Methods: We considered randomised controlled trials (RCTs) in COVID-NMA that evaluated pharmacological treatments for COVID-19 and retrieved systematic reviewers' assessments of the risk of bias and outcome reporting bias. We also searched for commentary data on PubPeer and preprint servers up to 6 November 2023. We employed qualitative content analysis to develop themes and domains of methodological and reporting issues identified by commenters.

Results: We identified 500 eligible RCTs. Systematic reviewers identified methodological and reporting issues in 446 (89%) RCTs. In 391 (78%) RCTs, the issues could be easily resolved by the trial authors; issues included incomplete reporting (49%), selection of the reported results (52%) and no access to the pre-specified plan (25%). Alternatively, 74 (15%) RCTs had received at least one comment on PubPeer or preprint servers, totalling 348 comments. In 46 (9%) RCTs, the issues identified by post-preprint and post-publication peer review comments could be easily resolved by the trial authors; the issues were related to incomplete reporting (6%), errors (5%), statistical analysis (3%), inconsistent reporting of methods and analyses (2%), spin (2%), selection of the reported results (1%) and no access to the raw data/pre-specified plan (1%).

Conclusions: Without changing their process, systematic reviewers identified issues in most RCTs that could be easily resolved by the trial authors; however, the lack of an established author feedback mechanism represents a wasted opportunity for facilitating improvement and enhancing the overall manuscript quality. On the other hand, despite the existing feedback loop to authors present in post-publication peer review, it demonstrated limited effectiveness in identifying methodological and reporting issues.

{"title":"Post-publication peer review and the identification of methodological and reporting issues in COVID-19 trials: a qualitative study.","authors":"Mauricia Davidson, Christoffer Bruun Korfitsen, Carolina Riveros, Anna Chaimani, Isabelle Boutron","doi":"10.1136/bmjebm-2024-113068","DOIUrl":"10.1136/bmjebm-2024-113068","url":null,"abstract":"<p><strong>Objectives: </strong>We aimed to determine to what extent systematic reviewers and post-preprint and post-publication peer review identified methodological and reporting issues in COVID-19 trials that could be easily resolved by the authors.</p><p><strong>Design: </strong>Qualitative study.</p><p><strong>Data sources: </strong>COVID-NMA living systematic review (covid-nma.com), PubPeer, medRxiv, Research Square, SSRN.</p><p><strong>Methods: </strong>We considered randomised controlled trials (RCTs) in COVID-NMA that evaluated pharmacological treatments for COVID-19 and retrieved systematic reviewers' assessments of the risk of bias and outcome reporting bias. We also searched for commentary data on PubPeer and preprint servers up to 6 November 2023. We employed qualitative content analysis to develop themes and domains of methodological and reporting issues identified by commenters.</p><p><strong>Results: </strong>We identified 500 eligible RCTs. Systematic reviewers identified methodological and reporting issues in 446 (89%) RCTs. In 391 (78%) RCTs, the issues could be easily resolved by the trial authors; issues included incomplete reporting (49%), selection of the reported results (52%) and no access to the pre-specified plan (25%). Alternatively, 74 (15%) RCTs had received at least one comment on PubPeer or preprint servers, totalling 348 comments. In 46 (9%) RCTs, the issues identified by post-preprint and post-publication peer review comments could be easily resolved by the trial authors; the issues were related to incomplete reporting (6%), errors (5%), statistical analysis (3%), inconsistent reporting of methods and analyses (2%), spin (2%), selection of the reported results (1%) and no access to the raw data/pre-specified plan (1%).</p><p><strong>Conclusions: </strong>Without changing their process, systematic reviewers identified issues in most RCTs that could be easily resolved by the trial authors; however, the lack of an established author feedback mechanism represents a wasted opportunity for facilitating improvement and enhancing the overall manuscript quality. On the other hand, despite the existing feedback loop to authors present in post-publication peer review, it demonstrated limited effectiveness in identifying methodological and reporting issues.</p>","PeriodicalId":9059,"journal":{"name":"BMJ Evidence-Based Medicine","volume":" ","pages":""},"PeriodicalIF":9.0,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143466997","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
What makes a 'good' decision with artificial intelligence? A grounded theory study in paediatric care.
IF 9 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-02-12 DOI: 10.1136/bmjebm-2024-112919
Melissa D McCradden, Kelly Thai, Azadeh Assadi, Sana Tonekaboni, Ian Stedman, Shalmali Joshi, Minfan Zhang, Fanny Chevalier, Anna Goldenberg
<p><strong>Objective: </strong>To develop a framework for good clinical decision-making using machine learning (ML) models for interventional, patient-level decisions.</p><p><strong>Design: </strong>Grounded theory qualitative interview study.</p><p><strong>Setting: </strong>Primarily single-site at a major urban academic paediatric hospital, with external sampling.</p><p><strong>Participants: </strong>Sixteen participants representing physicians (n=10), nursing (n=3), respiratory therapists (n=2) and an ML specialist (n=1) with experience working in acute care environments were identified through purposive sampling. Individuals were recruited to represent a spectrum of ML knowledge (three expert, four knowledgeable and nine non-expert) and years of experience (median=12.9 years postgraduation). Recruitment proceeded through snowball sampling, with individuals approached to represent a diversity of fields, levels of experience and attitudes towards artificial intelligence (AI)/ML. A member check step and consultation with patients was undertaken to vet the framework, which resulted in some minor revisions to the wording and framing.</p><p><strong>Interventions: </strong>A semi-structured virtual interview simulating an intensive care unit handover for a hypothetical patient case using a simulated ML model and seven visualisations using known methods addressing interpretability of models in healthcare. Participants were asked to make an initial care plan for the patient, then were presented with a model prediction followed by the seven visualisations to explore their judgement and potential influence and understanding of the visualisations. Two visualisations contained contradicting information to probe participants' resolution process for the contrasting information. The ethical justifiability and clinical reasoning process were explored.</p><p><strong>Main outcome: </strong>A comprehensive framework was developed that is grounded in established medicolegal and ethical standards and accounts for the incorporation of inference from ML models.</p><p><strong>Results: </strong>We found that for making good decisions, participants reflected across six main categories: evidence, facts and medical knowledge relevant to the patient's condition; how that knowledge may be applied to this particular patient; patient-level, family-specific and local factors; facts about the model, its development and testing; the patient-level knowledge sufficiently represented by the model; the model's incorporation of relevant contextual factors. This judgement was centred on and anchored most heavily on the overall balance of benefits and risks to the patient, framed by the goals of care. We found evidence of automation bias, with many participants assuming that if the model's explanation conflicted with their prior knowledge that their judgement was incorrect; others concluded the exact opposite, drawing from their medical knowledge base to reject the incorrect informati
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引用次数: 0
Expanded disease definitions in Alzheimer's disease and the new era of disease-modifying drugs.
IF 9 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-02-12 DOI: 10.1136/bmjebm-2023-112588
Su Jin Yim, Sevil Yasar, Nancy Schoenborn, Eddy Lang
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引用次数: 0
Rapid reviews methods series (paper 7): guidance on rapid scoping, mapping and evidence and gap map ('Big Picture Reviews').
IF 9 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-02-04 DOI: 10.1136/bmjebm-2023-112389
Fiona Campbell, Anthea Sutton, Danielle Pollock, Chantelle Garritty, Andrea C Tricco, Lena Schmidt, Hanan Khalil
{"title":"Rapid reviews methods series (paper 7): guidance on rapid scoping, mapping and evidence and gap map ('Big Picture Reviews').","authors":"Fiona Campbell, Anthea Sutton, Danielle Pollock, Chantelle Garritty, Andrea C Tricco, Lena Schmidt, Hanan Khalil","doi":"10.1136/bmjebm-2023-112389","DOIUrl":"https://doi.org/10.1136/bmjebm-2023-112389","url":null,"abstract":"","PeriodicalId":9059,"journal":{"name":"BMJ Evidence-Based Medicine","volume":" ","pages":""},"PeriodicalIF":9.0,"publicationDate":"2025-02-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143188195","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
AI in healthcare: an introduction for clinicians.
IF 9 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-01-25 DOI: 10.1136/bmjebm-2024-112966
Ahmed Maiter, Samer Alabed, Genevera Allen, Fares Alahdab
{"title":"AI in healthcare: an introduction for clinicians.","authors":"Ahmed Maiter, Samer Alabed, Genevera Allen, Fares Alahdab","doi":"10.1136/bmjebm-2024-112966","DOIUrl":"https://doi.org/10.1136/bmjebm-2024-112966","url":null,"abstract":"","PeriodicalId":9059,"journal":{"name":"BMJ Evidence-Based Medicine","volume":" ","pages":""},"PeriodicalIF":9.0,"publicationDate":"2025-01-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143036402","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
期刊
BMJ Evidence-Based Medicine
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