A practical educational tool for teaching child‐care hospital professionals attending evidence‐based practice courses for continuing medical education to appraise internal validity in systematic reviews

Rosati, Paola; Porzsolt, Franz

doi:10.1111/j.1365-2753.2012.01889.x

Cited by 4 publications

(7 citation statements)

References 30 publications

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“…In addition, students who are not native English speakers are supported to overcome their well known language problems (Letelier et al, 2007). This expected benefit of our approach could meanwhile be confirmed in cooperation with an Italian Group (Rosati et al, 2009;Rosati et al, 2012).…”

Section: Discussionmentioning

confidence: 53%

Medical Students Can Help Avoid the Expert Bias in Medicine

Porzsolt¹,

Braubach²,

Flurschütz³

et al. 2012

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Background: Applying the principles of Evidence Based Health Care (EBHC) in an academic environment we became aware of important differences between medical students and the users of clinical research. The latter may be clinicians, educators, guideline developers, or industry managers. These users are adapted to the system and have some kind of conflict of interest: they are either biased by patients’ demands, by main stream thinking, by medical standards and/or by economic interests. All are under time pressure, want to avoid conflicts with their employer and the analysis of scientific reports may not really be their main focus. Medical students were not exposed to these confounders. Methods: Medical students under professional supervision completed critical assessments of more than 100 published studies. Their analyses were limited to identification of mistakes, bias and errors using a check list of potential weaknesses in design and conduct but included the feedback to the academic supervisors. Results: Medical students trained in Evidence Based Medicine are capable of identifying problems in clinical trials by the systematic application of an assessment checklist. Conclusion: In our approach we demonstrate that students can assist health care professionals and academic teachers with the assessment of clinical evidence. The premise of the approach is that the final appraisals, which involve consideration of clinical, practical and value issues, necessarily reside with the academic teachers, writers of guidelines or industry managers who constitute the active users of research

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Section: Discussionmentioning

confidence: 53%

Medical Students Can Help Avoid the Expert Bias in Medicine

Porzsolt¹,

Braubach²,

Flurschütz³

et al. 2012

Self Cite

View full text Add to dashboard Cite

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“…In a study conducted from November 2012 to January 2016, to seek possible discrepancies between what CTRs record and paediatric RCTs actually publish, two reviewers, an experienced clinical paediatrician and an experienced researcher (PR and RD), identified six major reporting domains: five based on their long experience in critically appraising well-conducted clinical trials (reported funding and conflict of interest incompletely declared; discrepant or unclear sample size; inclusion and exclusion criteria not being respected or selective crossover; primary outcome downgraded and secondary outcomes upgraded and reported as primary outcomes in the publication; early study completion unjustified), and one domain (main outcome selectively reported or unreported) based on the Cochrane risk of bias tool [ 23 , 24 ]. Over the first year they developed, assessed, and graded CTR-RCT discrepancy scores.…”

Section: Methodsmentioning

confidence: 99%

“…Apart from the Critical Appraisal Skills Programme (CASP) checklist [ 18 ], nor do paediatricians and clinical researchers have tools for assessing discrepancies and risk of bias that compare what clinical researchers record in the registered study hypothesis and protocol, and what they then publish in RCTs [ 19 – 23 ]. Knowing more about trial discrepancies should alert paediatricians, clinical researchers, peer-reviewers, editors, and policymakers to possible dissemination or reporting bias undermining paediatric trials whose results provide the best information for medical care [ 24 ].…”

Section: Introductionmentioning

confidence: 99%

Major discrepancies between what clinical trial registries record and paediatric randomised controlled trials publish

Rosati

Porzsolt

Ricciotti

et al. 2016

Trials

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BackgroundWhether information from clinical trial registries (CTRs) and published randomised controlled trial (RCTs) differs remains unknown. Knowing more about discrepancies should alert those who rely on RCTs for medical decision-making to possible dissemination or reporting bias. To provide help in critically appraising research relevant for clinical practice we sought possible discrepancies between what CTRs record and paediatric RCTs actually publish. For this purpose, after identifying six reporting domains including funding, design, and outcomes, we collected data from 20 consecutive RCTs published in a widely read peer-reviewed paediatric journal and cross-checked reported features with those in the corresponding CTRs.MethodsWe collected data for 20 unselected, consecutive paediatric RCTs published in a widely read peer-reviewed journal from July to November 2013. To assess discrepancies, two reviewers identified and scored six reporting domains: funding and conflict of interests; sample size, inclusion and exclusion criteria or crossover; primary and secondary outcomes, early study completion, and main outcome reporting. After applying the Critical Appraisal Skills Programme (CASP) checklist, five reviewer pairs cross-checked CTRs and matching RCTs, then mapped and coded the reporting domains and scored combined discrepancy as low, medium and high.ResultsThe 20 RCTs were registered in five different CTRs. Even though the 20 RCTs fulfilled the CASP general criteria for assessing internal validity, 19 clinical trials had medium or high combined discrepancy scores for what the 20 RCTs reported and the matched five CTRs stated. All 20 RCTs selectively reported or failed to report main outcomes, 9 had discrepancies in declaring sponsorship, 8 discrepancies in the sample size, 9 failed to respect inclusion or exclusion criteria, 11 downgraded or modified primary outcome or upgraded secondary outcomes, and 13 completed early without justification. The CTRs for seven trials failed to index automatically the URL address or the RCT reference, and for 12 recorded RCT details, but the authors failed to report the results.ConclusionsMajor discrepancies between what CTRs record and paediatric RCTs publish raise concern about what clinical trials conclude. Our findings should make clinicians, who rely on RCT results for medical decision-making, aware of dissemination or reporting bias. Trialists need to bring CTR data and reported protocols into line with published data.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1551-6) contains supplementary material, which is available to authorized users.

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“…Die Mortalität wird durch vorgezogene Diagnosen oder Überdiagnosen 1 im Gegensatz zur Überlebenszeit kaum beeinflusst [8]. Die Validität der ausgewählten Publikationen wurden mithilfe einer publizierten Strategie [9,10] analysiert. Diese Methode umfasst 9 Kriterien und 2 Werturteile (l " Tab.…”

Section: Materials Und Methodenunclassified