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Reporting conflicts of interest in randomised trials of patient blood management interventions in patients requiring major surgery: a systematic review and meta-analysis

OBJECTIVE: This study aimed to systematically review the effects of declared and undeclared conflicts of interest on randomised controlled trials (RCTs) of patient blood management (PBM) interventions. DESIGN: We performed a secondary analysis of a recently published meta-analysis of RCTs evaluating...

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Autores principales: Roman, Marius, Fashina, Oluwatomini, Tomassini, Sara, Abbasciano, Riccardo G, Lai, Florence, Richards, Toby, Murphy, Gavin
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9389106/
https://www.ncbi.nlm.nih.gov/pubmed/35977767
http://dx.doi.org/10.1136/bmjopen-2021-054582
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author Roman, Marius
Fashina, Oluwatomini
Tomassini, Sara
Abbasciano, Riccardo G
Lai, Florence
Richards, Toby
Murphy, Gavin
author_facet Roman, Marius
Fashina, Oluwatomini
Tomassini, Sara
Abbasciano, Riccardo G
Lai, Florence
Richards, Toby
Murphy, Gavin
author_sort Roman, Marius
collection PubMed
description OBJECTIVE: This study aimed to systematically review the effects of declared and undeclared conflicts of interest on randomised controlled trials (RCTs) of patient blood management (PBM) interventions. DESIGN: We performed a secondary analysis of a recently published meta-analysis of RCTs evaluating five common PBM interventions in patients undergoing major surgery. DATA SOURCES: The databases searched by the original systematic reviews were searched using subject headings and Medical Subject Headings terms according to search strategies from the final search time-points until 1 June 2019. ELIGIBILITY CRITERIA: RCTs on PBM irrespective of blinding, language, date of publication and sample size were included. Abstracts and unpublished trials were excluded. Conflicts of interest were defined as sponsorship, funding or authorship by industry, professional PBM advocacy groups or blood services. DATA EXTRACTION AND SYNTHESIS: Three independent reviewers extracted the data and assessed the risk of bias. Pooled treatment effect estimates were reported as risk ratios (RRs) or standardised mean difference with 95% CIs. Heterogeneity was quantified using the I(2) statistic. RESULTS: Three hundred and eighty-nine RCTs totalling 53 635 participants were included. Thirty-two trials (8%) were considered free from important sources of bias. There was reporting bias favouring PBM interventions on transfusion across all analyses. In trials with no declared author conflicts of interest, the treatment effect on mortality was RR 1.12 (0.86 to 1.45). In trials where author conflicts of interest were declared, the treatment effect on mortality was RR 0.84 (0.69 to 1.03), with significant reporting bias favouring PBM interventions. Trials with declared conflicts linked to professional PBM advocacy groups (five studies, n=977 patients) reported statistically significant reductions in mortality RR 0.40 (0.17 to 0.92), unlike other groups. CONCLUSIONS: Low certainty of the evidence that guides PBM implementation is confounded by evidence of reporting bias, and the effects of declared and undeclared conflicts of interest, favouring PBM on important trial outcomes.
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spelling pubmed-93891062022-09-06 Reporting conflicts of interest in randomised trials of patient blood management interventions in patients requiring major surgery: a systematic review and meta-analysis Roman, Marius Fashina, Oluwatomini Tomassini, Sara Abbasciano, Riccardo G Lai, Florence Richards, Toby Murphy, Gavin BMJ Open Haematology (Incl Blood Transfusion) OBJECTIVE: This study aimed to systematically review the effects of declared and undeclared conflicts of interest on randomised controlled trials (RCTs) of patient blood management (PBM) interventions. DESIGN: We performed a secondary analysis of a recently published meta-analysis of RCTs evaluating five common PBM interventions in patients undergoing major surgery. DATA SOURCES: The databases searched by the original systematic reviews were searched using subject headings and Medical Subject Headings terms according to search strategies from the final search time-points until 1 June 2019. ELIGIBILITY CRITERIA: RCTs on PBM irrespective of blinding, language, date of publication and sample size were included. Abstracts and unpublished trials were excluded. Conflicts of interest were defined as sponsorship, funding or authorship by industry, professional PBM advocacy groups or blood services. DATA EXTRACTION AND SYNTHESIS: Three independent reviewers extracted the data and assessed the risk of bias. Pooled treatment effect estimates were reported as risk ratios (RRs) or standardised mean difference with 95% CIs. Heterogeneity was quantified using the I(2) statistic. RESULTS: Three hundred and eighty-nine RCTs totalling 53 635 participants were included. Thirty-two trials (8%) were considered free from important sources of bias. There was reporting bias favouring PBM interventions on transfusion across all analyses. In trials with no declared author conflicts of interest, the treatment effect on mortality was RR 1.12 (0.86 to 1.45). In trials where author conflicts of interest were declared, the treatment effect on mortality was RR 0.84 (0.69 to 1.03), with significant reporting bias favouring PBM interventions. Trials with declared conflicts linked to professional PBM advocacy groups (five studies, n=977 patients) reported statistically significant reductions in mortality RR 0.40 (0.17 to 0.92), unlike other groups. CONCLUSIONS: Low certainty of the evidence that guides PBM implementation is confounded by evidence of reporting bias, and the effects of declared and undeclared conflicts of interest, favouring PBM on important trial outcomes. BMJ Publishing Group 2022-08-17 /pmc/articles/PMC9389106/ /pubmed/35977767 http://dx.doi.org/10.1136/bmjopen-2021-054582 Text en © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ. https://creativecommons.org/licenses/by/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.
spellingShingle Haematology (Incl Blood Transfusion)
Roman, Marius
Fashina, Oluwatomini
Tomassini, Sara
Abbasciano, Riccardo G
Lai, Florence
Richards, Toby
Murphy, Gavin
Reporting conflicts of interest in randomised trials of patient blood management interventions in patients requiring major surgery: a systematic review and meta-analysis
title Reporting conflicts of interest in randomised trials of patient blood management interventions in patients requiring major surgery: a systematic review and meta-analysis
title_full Reporting conflicts of interest in randomised trials of patient blood management interventions in patients requiring major surgery: a systematic review and meta-analysis
title_fullStr Reporting conflicts of interest in randomised trials of patient blood management interventions in patients requiring major surgery: a systematic review and meta-analysis
title_full_unstemmed Reporting conflicts of interest in randomised trials of patient blood management interventions in patients requiring major surgery: a systematic review and meta-analysis
title_short Reporting conflicts of interest in randomised trials of patient blood management interventions in patients requiring major surgery: a systematic review and meta-analysis
title_sort reporting conflicts of interest in randomised trials of patient blood management interventions in patients requiring major surgery: a systematic review and meta-analysis
topic Haematology (Incl Blood Transfusion)
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9389106/
https://www.ncbi.nlm.nih.gov/pubmed/35977767
http://dx.doi.org/10.1136/bmjopen-2021-054582
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