scholarly journals Diagnostic Justice

2021 ◽  
Vol 17 (2) ◽  
Author(s):  
Ashley Graham Kennedy ◽  
Bryan Cwik
Keyword(s):  
Public Health ◽  
Clinical Research ◽  
Disease Surveillance ◽  
Ethical Issues ◽  
Clinical Care ◽  
Diagnostic Testing ◽  
Trial Participation ◽  
Ethical Considerations ◽  
Randomized Controlled ◽  
Active Surveillance Testing

Diagnostic testing can be used for many purposes, including testing to facilitate the clinical care of individual patients, testing as an inclusion criterion for clinical trial participation, and both passive and active surveillance testing of the general population in order to facilitate public health outcomes, such as the containment or mitigation of an infectious disease. As such, diagnostic testing presents us with ethical questions that are, in part, already addressed in the literature on clinical care as well as clinical research (such as the rights of patients to refuse testing or treatment in the clinical setting or the rights of participants in randomized controlled trials to withdraw from the trial at any time). However, diagnostic testing, for the purpose of disease surveillance also raises ethical issues that we do not encounter in these settings, and thus have not been much discussed. In this paper we will be concerned with the similarities and differences between the ethical considerations in these three domains: clinical care, clinical research, and public health, as they relate to diagnostic testing specifically. Via an examination of the COVID-19 case we will show how an appeal to the concept of diagnostic justice helps us to make sense of the (at times competing) ethical considerations in these three domains.

The Ethics of AI in Biomedical Research, Patient Care, and Public Health

2020 ◽  
pp. 702-718 ◽  
Author(s):  
Alessandro Blasimme ◽  
Effy Vayena
Keyword(s):  
Public Health ◽  
Patient Care ◽  
Biomedical Research ◽  
Disease Surveillance ◽  
Ethical Issues ◽  
Ethical Review ◽  
Ethical Challenges ◽  
Healthcare Provision ◽  
Social Scientists ◽  
Ethical Frameworks

This chapter explores ethical issues raised by the use of artificial intelligence (AI) in the domain of biomedical research, healthcare provision, and public health. The litany of ethical challenges that AI in medicine raises cannot be addressed sufficiently by current regulatory and ethical frameworks. The chapter then advances the systemic oversight approach as a governance blueprint, which is based on six principles offering guidance as to the desirable features of oversight structures and processes in the domain of data-intense biomedicine: adaptivity, flexibility, inclusiveness, reflexivity, responsiveness, and monitoring (AFIRRM). In the research domain, ethical review committees will have to incorporate reflexive assessment of the scientific and social merits of AI-driven research and, as a consequence, will have to open their ranks to new professional figures such as social scientists. In the domain of patient care, clinical validation is a crucial issue. Hospitals could equip themselves with “clinical AI oversight bodies” charged with the task of advising clinical administrators. Meanwhile, in the public health sphere, the new level of granularity enabled by AI in disease surveillance or health promotion will have to be negotiated at the level of targeted communities.

scholarly journals Scraping the Web for Public Health Gains: Ethical Considerations from a ‘Big Data’ Research Project on HIV and Incarceration

2020 ◽  
Vol 13 (1) ◽  
pp. 111-121 ◽  
Author(s):  
Stuart Rennie ◽  
Mara Buchbinder ◽  
Eric Juengst ◽  
Lauren Brinkley-Rubinstein ◽  
Colleen Blue ◽  
...  
Keyword(s):  
Public Health ◽  
Ethical Issues ◽  
Health Planning ◽  
Public Health Practice ◽  
Public Health Research ◽  
Health Practice ◽  
Ethical Considerations ◽  
Individual Level ◽  
Hiv Surveillance ◽  
The Web

Abstract Web scraping involves using computer programs for automated extraction and organization of data from the Web for the purpose of further data analysis and use. It is frequently used by commercial companies, but also has become a valuable tool in epidemiological research and public health planning. In this paper, we explore ethical issues in a project that “scrapes” public websites of U.S. county jails as part of an effort to develop a comprehensive database (including individual-level jail incarcerations, court records and confidential HIV records) to enhance HIV surveillance and improve continuity of care for incarcerated populations. We argue that the well-known framework of Emanuel et al. (2000) provides only partial ethical guidance for the activities we describe, which lie at a complex intersection of public health research and public health practice. We suggest some ethical considerations from the ethics of public health practice to help fill gaps in this relatively unexplored area.

scholarly journals Pivoting during a pandemic: lessons learned from transitioning a multisite randomized controlled trial to a remote protocol in response to COVID-19

2021 ◽  
Author(s):  
Hailey Inverso ◽  
Fayo Abadula ◽  
Troy Morrow ◽  
Lauren LeStourgeon ◽  
Angelee Parmar ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Research ◽  
Controlled Trial ◽  
Clinical Care ◽  
Lessons Learned ◽  
Diabetes Distress ◽  
Randomized Controlled ◽  
Testing Strategies ◽  
Glycemic Outcomes

Abstract THR1VE! is an ongoing multisite randomized clinical trial of a positive psychology intervention designed to treat diabetes distress and improve glycemic outcomes in teens with type 1 diabetes. Due to the COVID-19 pandemic restrictions on clinical research and changes in diabetes clinical care, THR1VE! was adapted from an in-person enrollment protocol to a remote protocol through a series of development and testing strategies. We discuss the process of transitioning the protocol and the demonstrated feasibility of ongoing recruitment, enrollment, and retention outcomes. These findings offer support for a remotely transitioned protocol that has larger applications for ongoing and future clinical research.

Information systems in support of public health in high-income countries

2021 ◽  
pp. 3-12
Author(s):  
Tjeerd-Pieter van Staa ◽  
Liam Smeeth
Keyword(s):  
Public Health ◽  
Information Systems ◽  
Disease Surveillance ◽  
Point Of Care ◽  
Clinical Care ◽  
Healthcare Providers ◽  
Clinical Information ◽  
Evidence Base ◽  
Healthcare Intervention ◽  
Healthcare Interventions

Public health activities are dependent on the availability of information and ability to disseminate information to clinicians/healthcare providers, individuals, and communities. The increasing computerization of healthcare systems can offer opportunities to improve these activities. Databases of electronic healthcare records are used for disease surveillance and monitoring healthcare interventions. The quality and quantity of reporting of notifiable diseases may be improved by regular review of the electronic healthcare records. Randomized trials that recruit patients at the point of care and use electronic healthcare records for collection of follow-up information can be used to test the effectiveness of healthcare intervention in routine clinical practice. Cluster trials that randomize different clinics or regions can compare different public health policies and improve the evidence base for the pragmatic use of public health interventions. Data generated within clinical information systems can be used to provide feedback and guidance to clinicians and patients as part of clinical care. Better information systems providing data on risks and benefits of healthcare interventions will provide an important impetus to evidence-based public health.

scholarly journals Linking Statistics With Testing Policy to Manage COVID-19 in the Community

2020 ◽  
Vol 154 (2) ◽  
pp. 142-148
Author(s):  
Lee H Hilborne ◽  
Zachary Wagner ◽  
Irineo Cabreros ◽  
Robert H Brook
Keyword(s):  
Public Health ◽  
Disease Surveillance ◽  
Public Health Surveillance ◽  
Clinical Laboratory ◽  
Health Management ◽  
Acute Infection ◽  
Diagnostic Testing ◽  
Health Surveillance ◽  
Testing Strategies ◽  
National Public Health

Abstract Objectives To determine the public health surveillance severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) testing volume needed, both for acute infection and seroprevalence. Methods Required testing volumes were developed using standard statistical methods based on test analytical performance, disease prevalence, desired precision, and population size. Results Widespread testing for individual health management cannot address surveillance needs. The number of people who must be sampled for public health surveillance and decision making, although not trivial, is potentially in the thousands for any given population or subpopulation, not millions. Conclusions While the contributions of diagnostic testing for SARS-CoV-2 have received considerable attention, concerns abound regarding the availability of sufficient testing capacity to meet demand. Different testing goals require different numbers of tests and different testing strategies; testing strategies for national or local disease surveillance, including monitoring of prevalence, receive less attention. Our clinical laboratory and diagnostic infrastructure are capable of incorporating required volumes for many local, regional, and national public health surveillance studies into their current and projected testing capacity. However, testing for surveillance requires careful design and randomization to provide meaningful insights.

scholarly journals Bridging the divide between clinical research and clinical care in oncology: An integrated real-world evidence generation platform

2021 ◽  
Vol 7 ◽  
pp. 205520762110599
Author(s):  
Ariel B. Bourla ◽  
Neal J. Meropol
Keyword(s):  
Clinical Research ◽  
Real World ◽  
Clinical Care ◽  
Routine Care ◽  
Trial Participation ◽  
Real World Data ◽  
Regulatory Decision ◽  
Real World Evidence ◽  
Level Data ◽  
Patient Health

Real world data (RWD) are data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources; real-world evidence (RWE) generated by RWD analyses can become an important component of drug development programs and, potentially, regulatory decision-making. As a RWD source, electronic health records (EHRs) can now provide patient-level data at unparalleled depth and granularity. We propose a RWE generation framework that could maximize the synergy between RWD and prospective clinical trials by capitalizing on an emerging data curation infrastructure that may be applied to both retrospective and prospective research. In this platform, centralized data collection and monitoring could be enabled via routine EHR use, and seamlessly integrated with select intentional data capture during prospective study periods. By bridging the divide between routine care and clinical research, this integrated platform aggregates retrospective and prospective data, collected both routinely and intentionally. This approach makes clinical trial participation more available to patients, increasing the potential depth of data, representativeness and efficiency of clinical research.

Telehealth: technological, legal, and ethical issues

2021 ◽  
pp. 169-178
Author(s):  
Angelina Ivanova ◽  
Keyword(s):  
Public Health ◽  
Healthcare Professionals ◽  
Ethical Issues ◽  
Clinical Care ◽  
Legal Issues ◽  
Health Interventions ◽  
Patient Relationship ◽  
Public Health Interventions ◽  
Ethical And Legal Issues ◽  
Legal And Ethical Issues

The use of telehealth is an increasingly common avenue for providing clinical care, performing research and conducting public health interventions. However, with the growth of telecommunication technologies, healthcare professionals have encountered an emerging new set of ethical and legal issues relating to the doctor-patient relationship, standarts, privacy, cost and liability. This article explores the main benefits and challenges that come with growth of telehealth.

Diagnostic Testing, Screening, and Surveillance

2019 ◽  
pp. 79-104
Author(s):  
Daniel Westreich
Keyword(s):  
Public Health ◽  
Sensitivity Analysis ◽  
Predictive Value ◽  
Disease Surveillance ◽  
Clinical Epidemiology ◽  
Diagnostic Testing ◽  
Screening And Surveillance ◽  
Sensitivity Specificity ◽  
Public Health Epidemiology ◽  
Epidemiology And Public Health

Surveillance, diagnostic testing, and screening are central (and related) concepts in epidemiology, and are all addressed together in this chapter. Both description and prediction are also important goals of epidemiology, and these differ in important ways from causal epidemiology. In Chapter 4, the author discusses concepts in diagnostic testing, screening, and active and passive disease surveillance, including concepts of sensitivity, specificity, and positive and negative predictive value. Also in this chapter, the author briefly touches on differences between clinical epidemiology and public health epidemiology. The chapter also briefly discusses very basic bias, or sensitivity, analysis.

scholarly journals From wealth to health: Evaluating microfinance as a complex intervention

Evaluation ◽  
2017 ◽  
Vol 23 (2) ◽  
pp. 209-225 ◽  
Author(s):  
Neil McHugh ◽  
Olga Biosca ◽  
Cam Donaldson
Keyword(s):  
Public Health ◽  
Randomized Controlled Trials ◽  
Gold Standard ◽  
Impact Evaluation ◽  
Ethical Issues ◽  
Complex Interventions ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Relevant Evidence ◽  
The Social

Innovative interventions that address the social determinants of health are required to help reduce persistent health inequalities. We argue that microcredit can act in this way and develop a conceptual framework from which to examine this. In seeking to evaluate microcredit this way we then examine how randomized controlled trials, currently considered as the ‘gold standard’ in impact evaluations of microcredit, compare with developments in thinking about study design in public health. This leads us to challenge the notion of trials as the apparent gold standard for microcredit evaluations and contend that the pursuit of trial-based evidence alone may be hampering the production of relevant evidence on microcredit’s public health (and other wider) impacts. In doing so, we introduce new insights into the global debate on microfinance impact evaluation, related to ethical issues in staging randomized controlled trials, and propose innovations on complementary methods for use in the evaluation of complex interventions.

scholarly journals Impact of COVID-19 on Public Research Recruitment

2020 ◽  
Author(s):  
Yichuan Grace Hsieh ◽  
Holly Parker ◽  
Greg Estey ◽  
Stephen Lorenz ◽  
Mark Wylie ◽  
...  
Keyword(s):  
Public Health ◽  
Clinical Trials ◽  
Clinical Research ◽  
Clinical Care ◽  
Public Research ◽  
Research Recruitment ◽  
Preliminary Results ◽  
Volunteer Recruitment

The coronavirus disease 2019 (COVID-19) pandemic created a major challenge for clinical trials recruitment as early attention was focused on matters of public health and clinical care, and research--outside of COVID-19-- essentially shut down. Rally with Partners (rally.partners.org), an Internet-based portal for clinical research volunteer recruitment, continued to support studies that continued their recruitment during this period and additionally, implemented several measures to support COVID-19 research. In this paper, we summarize our experiences and preliminary results.

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