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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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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Public Library of Science
2014
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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. |
format | Online Article Text |
id | pubmed-3961288 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2014 |
publisher | Public Library of Science |
record_format | MEDLINE/PubMed |
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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