External validity is also an ethical consideration in cluster-randomised trials of policy changes
In the Statistical Analysis Plan (SAP), which was made available at www.nejm.org, we clearly and prospectively stated, ‘[t]his study is a trial-based evaluation of potential policy effects on patient safety and resident wellbeing… this study is intended to inform real-world policy decision-making wi...
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Published in | BMJ quality & safety Vol. 28; no. 2; p. 167 |
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Abstract | In the Statistical Analysis Plan (SAP), which was made available at www.nejm.org, we clearly and prospectively stated, ‘[t]his study is a trial-based evaluation of potential policy effects on patient safety and resident wellbeing… this study is intended to inform real-world policy decision-making with respect to resident duty hours regulation.’2 The SAP and online supplementary appendix (www.nejm.org) also provide all assumptions for our power calculations and cluster sizes, which were not large in the case of resident outcomes.3 As such, it was important that the trial closely resembles real-world conditions in which residency training occurs and duty hour policies are implemented. A shorter study would pose risks owing to non-standard, multiple policy shifts and would increase administrative/organisational burdens of staff workflow coordination. [...]a shorter period would threaten external validity, rendering evidence from the study potentially uninformative for policy decisions that could affect the lives of millions. [...]a shorter study would be of little social benefit while imposing unjustifiable risks and burden. |
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AbstractList | In the Statistical Analysis Plan (SAP), which was made available at www.nejm.org, we clearly and prospectively stated, ‘[t]his study is a trial-based evaluation of potential policy effects on patient safety and resident wellbeing… this study is intended to inform real-world policy decision-making with respect to resident duty hours regulation.’2 The SAP and online supplementary appendix (www.nejm.org) also provide all assumptions for our power calculations and cluster sizes, which were not large in the case of resident outcomes.3 As such, it was important that the trial closely resembles real-world conditions in which residency training occurs and duty hour policies are implemented. A shorter study would pose risks owing to non-standard, multiple policy shifts and would increase administrative/organisational burdens of staff workflow coordination. [...]a shorter period would threaten external validity, rendering evidence from the study potentially uninformative for policy decisions that could affect the lives of millions. [...]a shorter study would be of little social benefit while imposing unjustifiable risks and burden. |
Author | Bilimoria, Karl Y Chung, Jeanette W Hedges, Larry V |
Author_xml | – sequence: 1 givenname: Karl Y surname: Bilimoria fullname: Bilimoria, Karl Y email: k-bilimoria@northwestern.edu organization: Department of Surgery, Feinberg School of Medicine, Surgical Outcomes and Quality Improvement Center, Northwestern University, Chicago, Illinois, USA – sequence: 2 givenname: Jeanette W surname: Chung fullname: Chung, Jeanette W email: k-bilimoria@northwestern.edu organization: Department of Surgery, Feinberg School of Medicine, Surgical Outcomes and Quality Improvement Center, Northwestern University, Chicago, Illinois, USA – sequence: 3 givenname: Larry V surname: Hedges fullname: Hedges, Larry V email: k-bilimoria@northwestern.edu organization: Department of Statistics, Northwestern University, Chicago, Illinois, USA |
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Cites_doi | 10.1136/bmjqs-2017-007164 10.1097/SLA.0000000000000595 10.1001/jama.2016.17424 10.1227/NEU.0b013e3182245989 10.1056/NEJMp1011413 10.1016/j.amjmed.2015.03.023 10.1056/NEJMp1202848 10.1146/annurev-med-120711-135717 |
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Copyright | Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and permissions. Published by BMJ. 2019 Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and permissions. Published by BMJ. |
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References | Fargen, Chakraborty, Friedman 2011; 69 Drolet, Christopher, Fischer 2012; 366 Hemming, Taljaard, Forbes 2018; 27 Denson, Jensen, Saag 2016; 316 Denson, McCarty, Fang 2015; 128 Philibert, Nasca, Brigham 2013; 64 Ahmed, Devitt, Keshet 2014; 259 Drolet, Spalluto, Fischer 2010; 363 30314976 - BMJ Qual Saf. 2019 Feb;28(2):168 29463768 - BMJ Qual Saf. 2018 Aug;27(8):664-670 2020050723283462000_28.2.167.8 2020050723283462000_28.2.167.7 2020050723283462000_28.2.167.5 Denson (2020050723283462000_28.2.167.6) 2016; 316 2020050723283462000_28.2.167.11 2020050723283462000_28.2.167.10 2020050723283462000_28.2.167.9 2020050723283462000_28.2.167.4 2020050723283462000_28.2.167.3 2020050723283462000_28.2.167.2 2020050723283462000_28.2.167.1 |
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SubjectTerms | Clinical trials Medical ethics Mortality Neurosurgery Patient safety Policy Regulation Research Design Statistical analysis Validity |
Title | External validity is also an ethical consideration in cluster-randomised trials of policy changes |
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