Ignacio Neumann, Federico Bottaro, Ariel Izcovich, Agustín Bengolea, Camila Agnoletti, Martin Alberto Ragusa, Fernando Tortosa, Lorena Karzulovic, Luz María Letelier, Hugo Catalano, Holger Schünemann
{"title":"Encouraging the use of the best available evidence in journal clubs for practising clinicians.","authors":"Ignacio Neumann, Federico Bottaro, Ariel Izcovich, Agustín Bengolea, Camila Agnoletti, Martin Alberto Ragusa, Fernando Tortosa, Lorena Karzulovic, Luz María Letelier, Hugo Catalano, Holger Schünemann","doi":"10.1136/bmjebm-2024-113448","DOIUrl":"https://doi.org/10.1136/bmjebm-2024-113448","url":null,"abstract":"","PeriodicalId":9059,"journal":{"name":"BMJ Evidence-Based Medicine","volume":" ","pages":""},"PeriodicalIF":9.0,"publicationDate":"2025-06-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144494546","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}
Ruobing Lei, Janne Estill, Haiyun Wang, Jin Xiong, Qiu Li, Yaolong Chen, Paula Williamson
{"title":"Children's and caregivers' participation in the development of paediatric core outcome sets: a cross-sectional analysis.","authors":"Ruobing Lei, Janne Estill, Haiyun Wang, Jin Xiong, Qiu Li, Yaolong Chen, Paula Williamson","doi":"10.1136/bmjebm-2024-113521","DOIUrl":"https://doi.org/10.1136/bmjebm-2024-113521","url":null,"abstract":"<p><strong>Objectives: </strong>This study aims to address the status of children's and caregivers' participation in the development of paediatric core outcome sets (COS).</p><p><strong>Methods: </strong>We included all paediatric COS from a previous systematic review and searched the Core Outcome Measures in Effectiveness Trials database to 26 February 2024 for recent paediatric COS. We used descriptive and thematic analysis methods to present the characteristics of the included COS and to describe children's and caregivers' participation in the development, including any facilitators and barriers. We assessed the degree of participation of children and caregivers in two steps: by rating whether their views were considered in forming the outcome list (yes/no) and then whether their views were integrated in determining the most important outcomes (fully integrated/partially integrated/not integrated).</p><p><strong>Results: </strong>A total of 114 paediatric COS were included. 60 (53%) COS involved children and caregivers in the development process. 29 (48%) of the 60 COS considered children's and caregivers' views in forming the initial outcome list, which was most often conducted by interview (n=12 of 29, 41%). Regarding determining the most important outcomes, 35 (58%) of the 60 COS fully integrated children's and caregivers' views, and the most common method was the Delphi survey with consensus meeting (n=29 of 35, 83%); the youngest child participants were aged 7 years. The most frequently mentioned facilitator of children's and caregivers' participation was the engagement of patient groups or organisations.</p><p><strong>Conclusion and relevance: </strong>We evaluated the degree of children's and caregivers' participation in the development of COS and found that strategies to promote children's and caregivers' participation should be constructed.</p>","PeriodicalId":9059,"journal":{"name":"BMJ Evidence-Based Medicine","volume":" ","pages":""},"PeriodicalIF":9.0,"publicationDate":"2025-06-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144483121","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}
Lum Kastrati, Sara Farina, Angelica Valz Gris, Hamidreza Raeisi-Dehkordi, Erand Llanaj, Hugo G Quezada-Pinedo, Lia Bally, Taulant Muka, John P A Ioannidis
{"title":"Evaluation of reported claims of sex-based differences in treatment effects across meta-analyses: a meta-research study.","authors":"Lum Kastrati, Sara Farina, Angelica Valz Gris, Hamidreza Raeisi-Dehkordi, Erand Llanaj, Hugo G Quezada-Pinedo, Lia Bally, Taulant Muka, John P A Ioannidis","doi":"10.1136/bmjebm-2024-113359","DOIUrl":"10.1136/bmjebm-2024-113359","url":null,"abstract":"<p><strong>Importance: </strong>Differences in treatment effects between men and women may have important implications across diverse interventions and diseases.</p><p><strong>Objectives: </strong>We aimed to evaluate claims of sex-based differences in treatment effects across published meta-analyses.</p><p><strong>Eligibility criteria: </strong>Published meta-analyses of randomised controlled trials (RCTs) that had any mention of sex (male/female) subgroup or related analysis in their abstract INFORMATION SOURCES: PubMed (searched up to 17 January 2024).</p><p><strong>Synthesis: </strong>We determined how many meta-analyses had made claims of sex-based differences in treatment effects. These meta-analyses were examined in depth to determine whether the claims reflected sex-treatment interactions with statistical support or fallacious claims, and we categorised the frequency of different fallacies or genuine interactions. We also investigated how many of the genuine and fallacious claims were considered and discussed in Up-To-Date. Whenever possible, we reanalysed the p value for sex-treatment interaction.</p><p><strong>Main outcomes and measures: </strong>Number of claims with statistical support and fallacious claims; clinical implications of subgroup differences as well as the credibility of subgroup analyses assessed by the Instrument to assess the Credibility of Effect Modification Analyses criteria.</p><p><strong>Results: </strong>216 meta-analysis articles fulfilled the eligibility criteria. Of them, 99 stated in the abstract that there was no sex-based difference, and 20 mentioned a sex-based subgroup analysis but without reporting results in the abstract. The other 97 meta-analyses made 115 claims of sex-based differences. 27 of the 115 positive claims for subgroup differences made across 21 articles had statistical support at p<0.05, of which 4 were mentioned in Up-To-Date, with none leading to different recommendations for men and women. 39 of the 115 positive claims made across 35 articles were fallacious, where the sex-treatment interaction was not statistically significant. The most common form of fallacy (29/115) was made in instances where there was a significant effect in one sex, but not in the other, with no true difference between the two groups. In 7/115 other claims, there were larger effects in one sex, again, with no true difference between the two groups, and 3/115 other claims had various forms of fallacies.Another 44 articles made 49 claims based on potentially fallacious methods (44 based on meta-regression, and 5 provided the results of only one group), but proper data were unavailable to assess statistical significance.</p><p><strong>Conclusions and relevance: </strong>Few meta-analyses of RCTs make claims of sex-based differences in treatment effects, and most of these claims lack formal statistical support. In the present sample, statistically significant and clinically actionable sex-treatment interactions were ra","PeriodicalId":9059,"journal":{"name":"BMJ Evidence-Based Medicine","volume":" ","pages":""},"PeriodicalIF":9.0,"publicationDate":"2025-06-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144332350","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}
Melissa D McCradden, Kelly Thai, Azadeh Assadi, Sana Tonekaboni, Ian Stedman, Shalmali Joshi, Minfan Zhang, Fanny Chevalier, Anna Goldenberg
{"title":"What makes a 'good' decision with artificial intelligence? A grounded theory study in paediatric care.","authors":"Melissa D McCradden, Kelly Thai, Azadeh Assadi, Sana Tonekaboni, Ian Stedman, Shalmali Joshi, Minfan Zhang, Fanny Chevalier, Anna Goldenberg","doi":"10.1136/bmjebm-2024-112919","DOIUrl":"10.1136/bmjebm-2024-112919","url":null,"abstract":"<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","PeriodicalId":9059,"journal":{"name":"BMJ Evidence-Based Medicine","volume":" ","pages":"183-193"},"PeriodicalIF":9.0,"publicationDate":"2025-05-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12171473/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143405686","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ignazio Geraci, Silvia Bargeri, Giacomo Basso, Greta Castellini, Alessandro Chiarotto, Silvia Gianola, Raymond Ostelo, Marco Testa, Tiziano Innocenti
{"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":"194-201"},"PeriodicalIF":9.0,"publicationDate":"2025-05-20","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}