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Quality and Quantity of Information in Summary Basis of Decision Documents Issued by Health Canada

BACKGROUND: Health Canada’s Summary Basis of Decision (SBD) documents outline the clinical trial information that was considered in approving a new drug. We examined the ability of SBDs to inform clinician decision-making. We asked if SBDs answered three questions that clinicians might have prior to...

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Autores principales: Habibi, Roojin, Lexchin, Joel
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3961288/
https://www.ncbi.nlm.nih.gov/pubmed/24651766
http://dx.doi.org/10.1371/journal.pone.0092038
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author Habibi, Roojin
Lexchin, Joel
author_facet Habibi, Roojin
Lexchin, Joel
author_sort Habibi, Roojin
collection PubMed
description BACKGROUND: Health Canada’s Summary Basis of Decision (SBD) documents outline the clinical trial information that was considered in approving a new drug. We examined the ability of SBDs to inform clinician decision-making. We asked if SBDs answered three questions that clinicians might have prior to prescribing a new drug: 1) Do the characteristics of patients enrolled in trials match those of patients in their practice? 2) What are the details concerning the drug’s risks and benefits? 3) What are the basic characteristics of trials? METHODS: 14 items of clinical trial information were identified from all SBDs published on or before April 2012. Each item received a score of 2 (present), 1 (unclear) or 0 (absent). The unit of analysis was the individual SBD, and an overall SBD score was derived based on the sum of points for each item. Scores were expressed as a percentage of the maximum possible points, and then classified into five descriptive categories based on that score. Additionally, three overall ‘component’ scores were tallied for each SBD: “patient characteristics”, “benefit/risk information” and “basic trial characteristics”. RESULTS: 161 documents, spanning 456 trials, were analyzed. The majority (126/161) were rated as having information sometimes present (score of >33 to 66%). No SBDs had either no information on any item, or 100% of the information. Items in the patient characteristics component scored poorest (mean component score of 40.4%), while items corresponding to basic trial information were most frequently provided (mean component score of 71%). CONCLUSION: The significant omissions in the level of clinical trial information in SBDs provide little to aid clinicians in their decision-making. Clinicians’ preferred source of information is scientific knowledge, but in Canada, access to such information is limited. Consequently, we believe that clinicians are being denied crucial tools for decision-making.
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spelling pubmed-39612882014-03-27 Quality and Quantity of Information in Summary Basis of Decision Documents Issued by Health Canada Habibi, Roojin Lexchin, Joel PLoS One Research Article BACKGROUND: Health Canada’s Summary Basis of Decision (SBD) documents outline the clinical trial information that was considered in approving a new drug. We examined the ability of SBDs to inform clinician decision-making. We asked if SBDs answered three questions that clinicians might have prior to prescribing a new drug: 1) Do the characteristics of patients enrolled in trials match those of patients in their practice? 2) What are the details concerning the drug’s risks and benefits? 3) What are the basic characteristics of trials? METHODS: 14 items of clinical trial information were identified from all SBDs published on or before April 2012. Each item received a score of 2 (present), 1 (unclear) or 0 (absent). The unit of analysis was the individual SBD, and an overall SBD score was derived based on the sum of points for each item. Scores were expressed as a percentage of the maximum possible points, and then classified into five descriptive categories based on that score. Additionally, three overall ‘component’ scores were tallied for each SBD: “patient characteristics”, “benefit/risk information” and “basic trial characteristics”. RESULTS: 161 documents, spanning 456 trials, were analyzed. The majority (126/161) were rated as having information sometimes present (score of >33 to 66%). No SBDs had either no information on any item, or 100% of the information. Items in the patient characteristics component scored poorest (mean component score of 40.4%), while items corresponding to basic trial information were most frequently provided (mean component score of 71%). CONCLUSION: The significant omissions in the level of clinical trial information in SBDs provide little to aid clinicians in their decision-making. Clinicians’ preferred source of information is scientific knowledge, but in Canada, access to such information is limited. Consequently, we believe that clinicians are being denied crucial tools for decision-making. Public Library of Science 2014-03-20 /pmc/articles/PMC3961288/ /pubmed/24651766 http://dx.doi.org/10.1371/journal.pone.0092038 Text en © 2014 Habibi, Lexchin http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are properly credited.
spellingShingle Research Article
Habibi, Roojin
Lexchin, Joel
Quality and Quantity of Information in Summary Basis of Decision Documents Issued by Health Canada
title Quality and Quantity of Information in Summary Basis of Decision Documents Issued by Health Canada
title_full Quality and Quantity of Information in Summary Basis of Decision Documents Issued by Health Canada
title_fullStr Quality and Quantity of Information in Summary Basis of Decision Documents Issued by Health Canada
title_full_unstemmed Quality and Quantity of Information in Summary Basis of Decision Documents Issued by Health Canada
title_short Quality and Quantity of Information in Summary Basis of Decision Documents Issued by Health Canada
title_sort quality and quantity of information in summary basis of decision documents issued by health canada
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3961288/
https://www.ncbi.nlm.nih.gov/pubmed/24651766
http://dx.doi.org/10.1371/journal.pone.0092038
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