We thank Noah A. Haber, Sarah E. Wieten and Emily R. Smith[1] for their interest, questions and c... more We thank Noah A. Haber, Sarah E. Wieten and Emily R. Smith[1] for their interest, questions and comments on the design article published in DMJ entitled “Face masks for the prevention of COVID-19 Rationale and design of the randomised controlled trial DANMASK-19” [2]. In order to increase the use of evidence-based practices at hospitals and in the community, it is crucial to conduct properly designed randomised controlled trials (RCT). We welcome these questions as proper understanding is crucial to support the interpretation of trial findings by decision-makers, media and other academics without a medical background.
Directed acyclic graphs (DAGs) are frequently used in epidemiology as a guide to encode causal in... more Directed acyclic graphs (DAGs) are frequently used in epidemiology as a guide to encode causal inference assumptions. We propose the DAGWOOD framework to bring many of those encoded assumptions to the forefront. DAGWOOD combines a root DAG (the DAG in the proposed analysis) and a set of branch DAGs (alternative hidden assumptions to the root DAG). All branch DAGs share a common ruleset, and must 1) change the root DAG, 2) be a valid DAG, and either 3a) change the minimally sufficient adjustment set or 3b) change the number of frontdoor paths. Branch DAGs comprise a list of assumptions which must be justified as negligible. We define two types of branch DAGs: exclusion restriction branch DAGs add a single- or bidirectional pathway between two nodes in the root DAG (e.g. direct pathways and colliders), while misdirection restriction branch DAGs represent alternative pathways that could be drawn between objects (e.g., creating a collider by reversing the direction of causation for a co...
Non-pharmaceutical interventions (NPI) for infectious diseases such as COVID-19 are particularly ... more Non-pharmaceutical interventions (NPI) for infectious diseases such as COVID-19 are particularly challenging given the complexities of what is both practical and ethical to randomize. We are often faced with the difficult decision between having weak trials or not having a trial at all. In a recent article, Dr. Atle Fretheim argues that statistically underpowered studies are still valuable, particularly in conjunction with other similar studies in meta-analysis in the context of the DANMASK-19 trial, asking “Surely, some trial evidence must be better than no trial evidence?” However, informative trials are not always feasible, and feasible trials are not always informative. In some cases, even a well-conducted but weakly designed and/or underpowered trial such as DANMASK-19 may be uninformative or worse, both individually and in a body of literature. Meta-analysis, for example, can only resolve issues of statistical power if there is a reasonable expectation of compatible well-desig...
BackgroundUS hospitals typically provide a set of code status options that includes Full Code and... more BackgroundUS hospitals typically provide a set of code status options that includes Full Code and Do Not Resuscitate (DNR) but often includes additional options. Although US hospitals differ in the design of code status options, this variation and its impacts have not been empirically studied.Design and methodsMulti-institutional qualitative study at 7 US hospitals selected for variability in geographical location, type of institution and design of code status options. We triangulated across three data sources (policy documents, code status ordering menus and in-depth physician interviews) to characterise the code status options available at each hospital. Using inductive qualitative methods, we investigated design differences in hospital code status options and the perceived impacts of these differences.ResultsThe code status options at each hospital varied widely with regard to the number of code status options, the names and definitions of code status options, and the formatting ...
IntroductionAssessing the impact of COVID-19 policy is critical for informing future policies. Ho... more IntroductionAssessing the impact of COVID-19 policy is critical for informing future policies. However, there are concerns about the overall strength of COVID-19 impact evaluation studies given the circumstances for evaluation and concerns about the publication environment. This study systematically reviewed the strength of evidence in the published COVID-19 policy impact evaluation literature.MethodsWe included studies that were primarily designed to estimate the quantitative impact of one or more implemented COVID-19 policies on direct SARS-CoV-2 and COVID-19 outcomes. After searching PubMed for peer-reviewed articles published on November 26, 2020 or earlier and screening, all studies were reviewed by three reviewers first independently and then to consensus. The review tool was based on previously developed and released review guidance for COVID-19 policy impact evaluation, assessing what impact evaluation method was used, graphical display of outcomes data, functional form for ...
BackgroundAvoiding “causal” language with observational study designs is common publication pract... more BackgroundAvoiding “causal” language with observational study designs is common publication practice, often justified as being a more cautious approach to interpretation.ObjectivesWe aimed to i) estimate the degree to which causality was implied by both the language linking exposures to outcomes and by action recommendations in the high-profile health literature, ii) examine disconnects between language and recommendations, iii) identify which linking phrases were most common, and iv) generate estimates by which these phrases imply causality.MethodsWe identified 18 of the most prominent general medical/public health/epidemiology journals, and searched and screened for articles published from 2010 to 2019 that investigated exposure/outcome pairs until we reached 65 non-RCT articles per journal (n=1,170). Two independent reviewers and an arbitrating reviewer rated the degree to which they believed causality had been implied by the language in abstracts based on written guidance. Revie...
While a shift from Evidence-Based Medicine (EBM) to Precision Medicine has not yet taken place, I... more While a shift from Evidence-Based Medicine (EBM) to Precision Medicine has not yet taken place, I here argue that precision medicine has familiar problems with expertise, causes and values that we can see in Evidence-Based Medicine. Some of these similarities suggest we should be cautious in thinking of precision medicine as more person-centered than EBM.
The ethics of invertebrate research have largely been ignored compared to the consideration of hi... more The ethics of invertebrate research have largely been ignored compared to the consideration of higher order animals, but more recent focus has questioned this trend. Using biohybrid robotic jellyfish as a case study, we examine the ethical considerations of invertebrate work and provide recommendations for future guidelines. This paper starts with an overview of philosophical views of animal ethics, the current state of knowledge for invertebrate pain and nociception, and current ethical guidelines. Next, we delve into the case study and analogous precedents. Specifically, in prior studies, we developed biohybrid robotic jellyfish, which modified live moon jellyfish with microelectronic swim controllers for future applications in ocean monitoring. Although jellyfish possess no central nervous system, pain receptors, or nociceptors, we closely monitored their stress responses, using the precautionary and minimization principles in consideration of the 4Rs: reduction, replacement, ref...
Abstract Digital contact tracing, in combination with widespread testing, has been a focal point ... more Abstract Digital contact tracing, in combination with widespread testing, has been a focal point for many plans to “reopen” economies while containing the spread of Covid‐19. Most digital contact tracing projects in the United States and Europe have prioritized privacy protections in the form of local storage of data on smartphones and the deidentification of information. However, in the prioritization of privacy in this narrow form, there is not sufficient attention given to weighing ethical trade‐offs within the context of a public health pandemic or to the need to evaluate safety and effectiveness of software‐based technology applied to public health.
Background: The coronavirus disease 2019 pandemic has or threatens to overwhelm health care syste... more Background: The coronavirus disease 2019 pandemic has or threatens to overwhelm health care systems. Many institutions are developing ventilator triage policies. Objective: To characterize the development of ventilator triage policies and compare policy content. Design: Survey and mixed-methods content analysis. Setting: North American hospitals associated with members of the Association of Bioethics Program Directors. Participants: Program directors. Measurements: Characteristics of institutions and policies, including triage criteria and triage committee membership. Results: Sixty-seven program directors responded (response rate, 91.8%); 36 (53.7%) hospitals did not yet have a policy, and 7 (10.4%) hospitals' policies could not be shared. The 29 institutions providing policies were relatively evenly distributed among the 4 U.S. geographic regions (range, 5 to 9 policies per region). Among the 26 unique policies analyzed, 3 (11.3%) were produced by state health departments. The most frequently cited triage criteria were benefit (25 policies [96.2%]), need (14 [53.8%]), age (13 [50.0%]), conservation of resources (10 [38.5%]), and lottery (9 [34.6%]). Twenty-one (80.8%) policies use scoring systems, and 20 of these (95.2%) use a version of the Sequential Organ Failure Assessment score. Among the policies that specify the triage team's composition (23 [88.5%]), all require or recommend a physician member, 20 (87.0%) a nurse, 16 (69.6%) an ethicist, 8 (34.8%) a chaplain, and 8 (34.8%) a respiratory therapist. Thirteen (50.0% of all policies) require or recommend those making triage decisions not be involved in direct patient care, but only 2 (7.7%) require that their decisions be blinded to ethically irrelevant considerations. Limitation: The results may not be generalizable to institutions without academic bioethics programs. Conclusion: Over one half of respondents did not have ventilator triage policies. Policies have substantial heterogeneity, and many omit guidance on fair implementation.
Philosophy, ethics, and humanities in medicine : PEHM, Feb 2, 2018
Expertise has been a contentious concept in Evidence-Based Medicine (EBM). Especially in the earl... more Expertise has been a contentious concept in Evidence-Based Medicine (EBM). Especially in the early days of the movement, expertise was taken to be exactly what EBM was rebelling against-the authoritarian pronouncements about "best" interventions dutifully learned in medical schools, sometimes with dire consequences. Since then, some proponents of EBM have tried various ways of reincorporating the idea of expertise into EBM, with mixed results. However, questions remain. Is expertise evidence? If not, what is it good for, if anything? In this article, I describe and analyze the three historical models of expertise integration in EBM and discuss the difficulties in putting each into practice. I also examine accounts of expertise from disciplines outside of medicine, including philosophy, sociology, psychology, and science and technology studies to see if these accounts can strengthen and clarify what EBM has to say about expertise. Of the accounts of expertise discussed here...
We developed and validated a new parsimonious scale to measure stoic beliefs. Key domains of stoi... more We developed and validated a new parsimonious scale to measure stoic beliefs. Key domains of stoicism are imperviousness to strong emotions, indifference to death, taciturnity and self-sufficiency. In the context of illness and disease, a personal ideology of stoicism may create an internal resistance to objective needs, which can lead to negative consequences. Stoicism has been linked to help-seeking delays, inadequate pain treatment, caregiver strain and suicide after economic stress. During 2013-2014, 390 adults aged 18+ years completed a brief anonymous paper questionnaire containing the preliminary 24-item Pathak-Wieten Stoicism Ideology Scale (PW-SIS). Confirmatory factor analysis (CFA) was used to test an a priori multidomain theoretical model. Content validity and response distributions were examined. Sociodemographic predictors of strong endorsement of stoicism were explored with logistic regression. The final PW-SIS contains four conceptual domains and 12 items. CFA showed...
We developed and validated a new parsimonious scale to measure stoic beliefs. Key domains of stoi... more We developed and validated a new parsimonious scale to measure stoic beliefs. Key domains of stoicism are imperviousness to strong emotions, indifference to death, taciturnity and self-sufficiency. In the context of illness and disease, a personal ideology of stoicism may create an internal resistance to objective needs, which can lead to negative consequences. Stoicism has been linked to help-seeking delays, inadequate pain treatment, caregiver strain and suicide after economic stress. METHODS: During 2013-2014, 390 adults aged 18+ years completed a brief anonymous paper questionnaire containing the preliminary 24-item Pathak-Wieten Stoicism Ideology Scale (PW-SIS). Confirmatory factor analysis (CFA) was used to test an a priori multidomain theoretical model. Content validity and response distributions were examined. Sociodemographic predictors of strong endorsement of stoicism were explored with logistic regression. RESULTS: The final PW-SIS contains four conceptual domains and 12...
Expertise has been a contentious concept in Evidence-Based Medicine (EBM). Especially in the earl... more Expertise has been a contentious concept in Evidence-Based Medicine (EBM). Especially in the early days of the movement, expertise was taken to be exactly what EBM was rebelling against—the authoritarian pronouncements about " best " interventions dutifully learned in medical schools, sometimes with dire consequences. Since then, some proponents of EBM have tried various ways of reincorporating the idea of expertise into EBM, with mixed results. However, questions remain. Is expertise evidence? If not, what is it good for, if anything? There have historically been three main models of expertise in EBM. Differences between these models, uncertainty about the difference between expertise as evidence and expertise as a force for amalgamating evidence, and a lack of consensus over whether the older models should be abandoned and replaced by the new, or used in concert, mean that the EBM conception of expertise remains impoverished. There is, however, a wealth of theoretical re...
We thank Noah A. Haber, Sarah E. Wieten and Emily R. Smith[1] for their interest, questions and c... more We thank Noah A. Haber, Sarah E. Wieten and Emily R. Smith[1] for their interest, questions and comments on the design article published in DMJ entitled “Face masks for the prevention of COVID-19 Rationale and design of the randomised controlled trial DANMASK-19” [2]. In order to increase the use of evidence-based practices at hospitals and in the community, it is crucial to conduct properly designed randomised controlled trials (RCT). We welcome these questions as proper understanding is crucial to support the interpretation of trial findings by decision-makers, media and other academics without a medical background.
Directed acyclic graphs (DAGs) are frequently used in epidemiology as a guide to encode causal in... more Directed acyclic graphs (DAGs) are frequently used in epidemiology as a guide to encode causal inference assumptions. We propose the DAGWOOD framework to bring many of those encoded assumptions to the forefront. DAGWOOD combines a root DAG (the DAG in the proposed analysis) and a set of branch DAGs (alternative hidden assumptions to the root DAG). All branch DAGs share a common ruleset, and must 1) change the root DAG, 2) be a valid DAG, and either 3a) change the minimally sufficient adjustment set or 3b) change the number of frontdoor paths. Branch DAGs comprise a list of assumptions which must be justified as negligible. We define two types of branch DAGs: exclusion restriction branch DAGs add a single- or bidirectional pathway between two nodes in the root DAG (e.g. direct pathways and colliders), while misdirection restriction branch DAGs represent alternative pathways that could be drawn between objects (e.g., creating a collider by reversing the direction of causation for a co...
Non-pharmaceutical interventions (NPI) for infectious diseases such as COVID-19 are particularly ... more Non-pharmaceutical interventions (NPI) for infectious diseases such as COVID-19 are particularly challenging given the complexities of what is both practical and ethical to randomize. We are often faced with the difficult decision between having weak trials or not having a trial at all. In a recent article, Dr. Atle Fretheim argues that statistically underpowered studies are still valuable, particularly in conjunction with other similar studies in meta-analysis in the context of the DANMASK-19 trial, asking “Surely, some trial evidence must be better than no trial evidence?” However, informative trials are not always feasible, and feasible trials are not always informative. In some cases, even a well-conducted but weakly designed and/or underpowered trial such as DANMASK-19 may be uninformative or worse, both individually and in a body of literature. Meta-analysis, for example, can only resolve issues of statistical power if there is a reasonable expectation of compatible well-desig...
BackgroundUS hospitals typically provide a set of code status options that includes Full Code and... more BackgroundUS hospitals typically provide a set of code status options that includes Full Code and Do Not Resuscitate (DNR) but often includes additional options. Although US hospitals differ in the design of code status options, this variation and its impacts have not been empirically studied.Design and methodsMulti-institutional qualitative study at 7 US hospitals selected for variability in geographical location, type of institution and design of code status options. We triangulated across three data sources (policy documents, code status ordering menus and in-depth physician interviews) to characterise the code status options available at each hospital. Using inductive qualitative methods, we investigated design differences in hospital code status options and the perceived impacts of these differences.ResultsThe code status options at each hospital varied widely with regard to the number of code status options, the names and definitions of code status options, and the formatting ...
IntroductionAssessing the impact of COVID-19 policy is critical for informing future policies. Ho... more IntroductionAssessing the impact of COVID-19 policy is critical for informing future policies. However, there are concerns about the overall strength of COVID-19 impact evaluation studies given the circumstances for evaluation and concerns about the publication environment. This study systematically reviewed the strength of evidence in the published COVID-19 policy impact evaluation literature.MethodsWe included studies that were primarily designed to estimate the quantitative impact of one or more implemented COVID-19 policies on direct SARS-CoV-2 and COVID-19 outcomes. After searching PubMed for peer-reviewed articles published on November 26, 2020 or earlier and screening, all studies were reviewed by three reviewers first independently and then to consensus. The review tool was based on previously developed and released review guidance for COVID-19 policy impact evaluation, assessing what impact evaluation method was used, graphical display of outcomes data, functional form for ...
BackgroundAvoiding “causal” language with observational study designs is common publication pract... more BackgroundAvoiding “causal” language with observational study designs is common publication practice, often justified as being a more cautious approach to interpretation.ObjectivesWe aimed to i) estimate the degree to which causality was implied by both the language linking exposures to outcomes and by action recommendations in the high-profile health literature, ii) examine disconnects between language and recommendations, iii) identify which linking phrases were most common, and iv) generate estimates by which these phrases imply causality.MethodsWe identified 18 of the most prominent general medical/public health/epidemiology journals, and searched and screened for articles published from 2010 to 2019 that investigated exposure/outcome pairs until we reached 65 non-RCT articles per journal (n=1,170). Two independent reviewers and an arbitrating reviewer rated the degree to which they believed causality had been implied by the language in abstracts based on written guidance. Revie...
While a shift from Evidence-Based Medicine (EBM) to Precision Medicine has not yet taken place, I... more While a shift from Evidence-Based Medicine (EBM) to Precision Medicine has not yet taken place, I here argue that precision medicine has familiar problems with expertise, causes and values that we can see in Evidence-Based Medicine. Some of these similarities suggest we should be cautious in thinking of precision medicine as more person-centered than EBM.
The ethics of invertebrate research have largely been ignored compared to the consideration of hi... more The ethics of invertebrate research have largely been ignored compared to the consideration of higher order animals, but more recent focus has questioned this trend. Using biohybrid robotic jellyfish as a case study, we examine the ethical considerations of invertebrate work and provide recommendations for future guidelines. This paper starts with an overview of philosophical views of animal ethics, the current state of knowledge for invertebrate pain and nociception, and current ethical guidelines. Next, we delve into the case study and analogous precedents. Specifically, in prior studies, we developed biohybrid robotic jellyfish, which modified live moon jellyfish with microelectronic swim controllers for future applications in ocean monitoring. Although jellyfish possess no central nervous system, pain receptors, or nociceptors, we closely monitored their stress responses, using the precautionary and minimization principles in consideration of the 4Rs: reduction, replacement, ref...
Abstract Digital contact tracing, in combination with widespread testing, has been a focal point ... more Abstract Digital contact tracing, in combination with widespread testing, has been a focal point for many plans to “reopen” economies while containing the spread of Covid‐19. Most digital contact tracing projects in the United States and Europe have prioritized privacy protections in the form of local storage of data on smartphones and the deidentification of information. However, in the prioritization of privacy in this narrow form, there is not sufficient attention given to weighing ethical trade‐offs within the context of a public health pandemic or to the need to evaluate safety and effectiveness of software‐based technology applied to public health.
Background: The coronavirus disease 2019 pandemic has or threatens to overwhelm health care syste... more Background: The coronavirus disease 2019 pandemic has or threatens to overwhelm health care systems. Many institutions are developing ventilator triage policies. Objective: To characterize the development of ventilator triage policies and compare policy content. Design: Survey and mixed-methods content analysis. Setting: North American hospitals associated with members of the Association of Bioethics Program Directors. Participants: Program directors. Measurements: Characteristics of institutions and policies, including triage criteria and triage committee membership. Results: Sixty-seven program directors responded (response rate, 91.8%); 36 (53.7%) hospitals did not yet have a policy, and 7 (10.4%) hospitals' policies could not be shared. The 29 institutions providing policies were relatively evenly distributed among the 4 U.S. geographic regions (range, 5 to 9 policies per region). Among the 26 unique policies analyzed, 3 (11.3%) were produced by state health departments. The most frequently cited triage criteria were benefit (25 policies [96.2%]), need (14 [53.8%]), age (13 [50.0%]), conservation of resources (10 [38.5%]), and lottery (9 [34.6%]). Twenty-one (80.8%) policies use scoring systems, and 20 of these (95.2%) use a version of the Sequential Organ Failure Assessment score. Among the policies that specify the triage team's composition (23 [88.5%]), all require or recommend a physician member, 20 (87.0%) a nurse, 16 (69.6%) an ethicist, 8 (34.8%) a chaplain, and 8 (34.8%) a respiratory therapist. Thirteen (50.0% of all policies) require or recommend those making triage decisions not be involved in direct patient care, but only 2 (7.7%) require that their decisions be blinded to ethically irrelevant considerations. Limitation: The results may not be generalizable to institutions without academic bioethics programs. Conclusion: Over one half of respondents did not have ventilator triage policies. Policies have substantial heterogeneity, and many omit guidance on fair implementation.
Philosophy, ethics, and humanities in medicine : PEHM, Feb 2, 2018
Expertise has been a contentious concept in Evidence-Based Medicine (EBM). Especially in the earl... more Expertise has been a contentious concept in Evidence-Based Medicine (EBM). Especially in the early days of the movement, expertise was taken to be exactly what EBM was rebelling against-the authoritarian pronouncements about "best" interventions dutifully learned in medical schools, sometimes with dire consequences. Since then, some proponents of EBM have tried various ways of reincorporating the idea of expertise into EBM, with mixed results. However, questions remain. Is expertise evidence? If not, what is it good for, if anything? In this article, I describe and analyze the three historical models of expertise integration in EBM and discuss the difficulties in putting each into practice. I also examine accounts of expertise from disciplines outside of medicine, including philosophy, sociology, psychology, and science and technology studies to see if these accounts can strengthen and clarify what EBM has to say about expertise. Of the accounts of expertise discussed here...
We developed and validated a new parsimonious scale to measure stoic beliefs. Key domains of stoi... more We developed and validated a new parsimonious scale to measure stoic beliefs. Key domains of stoicism are imperviousness to strong emotions, indifference to death, taciturnity and self-sufficiency. In the context of illness and disease, a personal ideology of stoicism may create an internal resistance to objective needs, which can lead to negative consequences. Stoicism has been linked to help-seeking delays, inadequate pain treatment, caregiver strain and suicide after economic stress. During 2013-2014, 390 adults aged 18+ years completed a brief anonymous paper questionnaire containing the preliminary 24-item Pathak-Wieten Stoicism Ideology Scale (PW-SIS). Confirmatory factor analysis (CFA) was used to test an a priori multidomain theoretical model. Content validity and response distributions were examined. Sociodemographic predictors of strong endorsement of stoicism were explored with logistic regression. The final PW-SIS contains four conceptual domains and 12 items. CFA showed...
We developed and validated a new parsimonious scale to measure stoic beliefs. Key domains of stoi... more We developed and validated a new parsimonious scale to measure stoic beliefs. Key domains of stoicism are imperviousness to strong emotions, indifference to death, taciturnity and self-sufficiency. In the context of illness and disease, a personal ideology of stoicism may create an internal resistance to objective needs, which can lead to negative consequences. Stoicism has been linked to help-seeking delays, inadequate pain treatment, caregiver strain and suicide after economic stress. METHODS: During 2013-2014, 390 adults aged 18+ years completed a brief anonymous paper questionnaire containing the preliminary 24-item Pathak-Wieten Stoicism Ideology Scale (PW-SIS). Confirmatory factor analysis (CFA) was used to test an a priori multidomain theoretical model. Content validity and response distributions were examined. Sociodemographic predictors of strong endorsement of stoicism were explored with logistic regression. RESULTS: The final PW-SIS contains four conceptual domains and 12...
Expertise has been a contentious concept in Evidence-Based Medicine (EBM). Especially in the earl... more Expertise has been a contentious concept in Evidence-Based Medicine (EBM). Especially in the early days of the movement, expertise was taken to be exactly what EBM was rebelling against—the authoritarian pronouncements about " best " interventions dutifully learned in medical schools, sometimes with dire consequences. Since then, some proponents of EBM have tried various ways of reincorporating the idea of expertise into EBM, with mixed results. However, questions remain. Is expertise evidence? If not, what is it good for, if anything? There have historically been three main models of expertise in EBM. Differences between these models, uncertainty about the difference between expertise as evidence and expertise as a force for amalgamating evidence, and a lack of consensus over whether the older models should be abandoned and replaced by the new, or used in concert, mean that the EBM conception of expertise remains impoverished. There is, however, a wealth of theoretical re...
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