One lesson of COVID-19: Conduct more health policy trials

Bain, Luchuo Engelbert; Berner-Rodoreda, Astrid; McMahon, Shannon A.; Sarker, Malabika; Tanser, Frank; Bärnighausen, Till; Wikler, Daniel; Eyal, Nir

doi:10.1073/pnas.2119887119

Cited by 4 publications

(3 citation statements)

References 9 publications

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“…Similarly, there is an ethical imperative to collect data regarding the benefits and harms of non-pharmaceutical interventions, as this may help to refine public health control strategies over time by improving the balance of benefits and harms as well as determining which measures are most acceptable to local communities. More broadly, there is increasing awareness of the ethical case for trials of policy, 49 and the rationale for such research may be particularly compelling for high-consequence pathogens such as Nipah virus. In addition to the kinds of research described above, social and behavioural research is increasingly recognised as vital to effective epidemic prevention, preparedness and response.…”

Section: Therapeutics and Non-pharmaceutical Interventionsmentioning

confidence: 99%

Ethical issues in Nipah virus control and research: addressing a neglected disease

Johnson,

Jamrozik,

Hurst

et al. 2023

J Med Ethics

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Nipah virus is a priority pathogen that is receiving increasing attention among scientists and in work on epidemic preparedness. Despite this trend, there has been almost no bioethical work examining ethical considerations surrounding the epidemiology, prevention, and treatment of Nipah virus or research that has already begun into animal and human vaccines. In this paper, we advance the case for further work on Nipah virus disease in public health ethics due to the distinct issues it raises concerning communication about the modes of transmission, the burdens of public health surveillance, the recent use of stringent public health measures during epidemics, and social or religious norms intersecting with preventive measures. We also advance the case for further work on Nipah virus disease in research ethics, given ethical issues surrounding potential vaccine trials for a high-fatality disease with sporadic spillover events, the different local contexts where trials may occur, and the potential use of unproven therapeutics during outbreaks. Further bioethics work may help to ensure that research and public health interventions for Nipah virus disease are ethically acceptable and more likely to be effective.

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Section: Therapeutics and Non-pharmaceutical Interventionsmentioning

confidence: 99%

Ethical issues in Nipah virus control and research: addressing a neglected disease

Johnson,

Jamrozik,

Hurst

et al. 2023

J Med Ethics

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“…Although there have been efforts to evaluate COVID-19’s impact on child mental health, most have not adequately accounted for many simultaneously implemented COVID-19 policies . COVID-19 stringency and restrictive policies (eg, closures of schools and businesses) reduced viral spread and saved lives, but they also disrupted family finances (eg, via parental job losses or fewer working hours) and children’s schooling .…”

Section: Introductionmentioning

confidence: 99%

“…Although there have been efforts to evaluate COVID-19's impact on child mental health, [22][23][24][25] most have not adequately accounted for many simultaneously implemented COVID-19 policies. 26,27 COVID-19 stringency and restrictive policies (eg, closures of schools and businesses) reduced viral spread and saved lives, but they also disrupted family finances (eg, via parental job losses or fewer working hours) [28][29][30][31] and children's schooling. 32,33 Conversely, COVID-19 support-and-flexibility policies provided economic support (eg, income support, debt relief) to mitigate pandemic-related disruptions.…”

Section: Introductionmentioning

confidence: 99%

COVID-19 Policies, Pandemic Disruptions, and Changes in Child Mental Health and Sleep in the United States

et al. 2023

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ImportanceThe adverse effects of COVID-19 containment policies disrupting child mental health and sleep have been debated. However, few current estimates correct biases of these potential effects.ObjectivesTo determine whether financial and school disruptions related to COVID-19 containment policies and unemployment rates were separately associated with perceived stress, sadness, positive affect, COVID-19–related worry, and sleep.Design, Setting, and ParticipantsThis cohort study was based on the Adolescent Brain Cognitive Development Study COVID-19 Rapid Response Release and used data collected 5 times between May and December 2020. Indexes of state-level COVID-19 policies (restrictive, supportive) and county-level unemployment rates were used to plausibly address confounding biases through 2-stage limited information maximum likelihood instrumental variables analyses. Data from 6030 US children aged 10 to 13 years were included. Data analysis was conducted from May 2021 to January 2023.ExposuresPolicy-induced financial disruptions (lost wages or work due to COVID-19 economic impact); policy-induced school disruptions (switches to online or partial in-person schooling).Main Outcomes and MeasuresPerceived stress scale, National Institutes of Health (NIH)–Toolbox sadness, NIH-Toolbox positive affect, COVID-19–related worry, and sleep (latency, inertia, duration).ResultsIn this study, 6030 children were included in the mental health sample (weighted median [IQR] age, 13 [12-13] years; 2947 [48.9%] females, 273 [4.5%] Asian children, 461 [7.6%] Black children, 1167 [19.4%] Hispanic children, 3783 [62.7%] White children, 347 [5.7%] children of other or multiracial ethnicity). After imputing missing data, experiencing financial disruption was associated with a 205.2% [95% CI, 52.9%-509.0%] increase in stress, a 112.1% [95% CI, 22.2%-268.1%] increase in sadness, 32.9% [95% CI, 3.5%-53.4%] decrease in positive affect, and a 73.9 [95% CI, 13.2-134.7] percentage-point increase in moderate-to-extreme COVID-19–related worry. There was no association between school disruption and mental health. Neither school disruption nor financial disruption were associated with sleep.Conclusions and RelevanceTo our knowledge, this study presents the first bias-corrected estimates linking COVID-19 policy-related financial disruptions with child mental health outcomes. School disruptions did not affect indices of children’s mental health. These findings suggest public policy should consider the economic impact on families due to pandemic containment measures, in part to protect child mental health until vaccines and antiviral drugs become available.

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The Ethical Obligation for Research During Public Health Emergencies: Insights From the COVID-19 Pandemic

Barosa,

Jamrozik,

Prasad

2023

Med Health Care and Philos

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In times of crises, public health leaders may claim that trials of public health interventions are unethical. One reason for this claim can be that equipoise—i.e. a situation of uncertainty and/or disagreement among experts about the evidence regarding an intervention—has been disturbed by a change of collective expert views. Some might claim that equipoise is disturbed if the majority of experts believe that emergency public health interventions are likely to be more beneficial than harmful. However, such beliefs are not always justified: where high quality research has not been conducted, there is often considerable residual uncertainty about whether interventions offer net benefits. In this essay we argue that high-quality research, namely by means of well-designed randomized trials, is ethically obligatory before, during, and after implementing policies in public health emergencies (PHEs). We contend that this standard applies to both pharmaceutical and non-pharmaceutical interventions, and we elaborate an account of equipoise that captures key features of debates in the recent pandemic. We build our case by analyzing research strategies employed during the COVID-19 pandemic regarding drugs, vaccines, and non-pharmaceutical interventions; and by providing responses to possible objections. Finally, we propose a public health policy reform: whenever a policy implemented during a PHE is not grounded in high-quality evidence that expected benefits outweigh harms, there should be a planned approach to generate high-quality evidence, with review of emerging data at preset time points. These preset timepoints guarantee that policymakers pause to review emerging evidence and consider ceasing ineffective or even harmful policies, thereby improving transparency and accountability, as well as permitting the redirection of resources to more effective or beneficial interventions.

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One lesson of COVID-19: Conduct more health policy trials

Cited by 4 publications

References 9 publications

Ethical issues in Nipah virus control and research: addressing a neglected disease

Ethical issues in Nipah virus control and research: addressing a neglected disease

COVID-19 Policies, Pandemic Disruptions, and Changes in Child Mental Health and Sleep in the United States

The Ethical Obligation for Research During Public Health Emergencies: Insights From the COVID-19 Pandemic

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