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2.
PLoS Med ; 18(10): e1003793, 2021 10.
Article in English | MEDLINE | ID: covidwho-1477510

ABSTRACT

BACKGROUND: The importance of infectious disease epidemic forecasting and prediction research is underscored by decades of communicable disease outbreaks, including COVID-19. Unlike other fields of medical research, such as clinical trials and systematic reviews, no reporting guidelines exist for reporting epidemic forecasting and prediction research despite their utility. We therefore developed the EPIFORGE checklist, a guideline for standardized reporting of epidemic forecasting research. METHODS AND FINDINGS: We developed this checklist using a best-practice process for development of reporting guidelines, involving a Delphi process and broad consultation with an international panel of infectious disease modelers and model end users. The objectives of these guidelines are to improve the consistency, reproducibility, comparability, and quality of epidemic forecasting reporting. The guidelines are not designed to advise scientists on how to perform epidemic forecasting and prediction research, but rather to serve as a standard for reporting critical methodological details of such studies. CONCLUSIONS: These guidelines have been submitted to the EQUATOR network, in addition to hosting by other dedicated webpages to facilitate feedback and journal endorsement.


Subject(s)
Biomedical Research/standards , COVID-19/epidemiology , Checklist/standards , Epidemics , Guidelines as Topic/standards , Research Design , Biomedical Research/methods , Checklist/methods , Communicable Diseases/epidemiology , Epidemics/statistics & numerical data , Forecasting/methods , Humans , Reproducibility of Results
5.
Healthc Policy ; 17(1): 17-24, 2021 08.
Article in English | MEDLINE | ID: covidwho-1431157

ABSTRACT

The unequal social and economic burden of the COVID-19 pandemic is evident in racialized and low-income communities across Canada. Importantly, social inequities have not been adequately addressed and current public policies are not reflective of the needs of diverse populations. Public participation in decision-making is crucial and there is, therefore, a pressing need to increase diversity of representation in patient partnerships in order to prevent the further exclusion of socially marginalized groups from research and policy making. Deliberate effort and affirmative action are needed to meaningfully engage and nurture diverse patient partnerships by broadening the scope of the patient community to include excluded or underrepresented individuals or groups. This will help us co-develop ways to enhance access and equity in healthcare and prevent the systematic reproduction of structural inequalities that have already been heightened by the COVID-19 pandemic.


Subject(s)
Biomedical Research/standards , COVID-19/therapy , Delivery of Health Care/standards , Health Equity/standards , Health Policy , Patient Selection , Research Design/standards , Adult , Aged , Aged, 80 and over , Canada , Female , Guidelines as Topic , Humans , Male , Middle Aged , Pandemics , SARS-CoV-2
7.
Diabetes Metab Syndr ; 15(5): 102242, 2021.
Article in English | MEDLINE | ID: covidwho-1397297

ABSTRACT

INTRODUCTION: Emergence of COVID-19 pandemic has led to increased use of telemedicine in health care delivery. Telemedicine facilitates long-term clinical care for monitoring and prevention of complications of diabetes mellitus. GUIDELINES: Precise indications for teleconsultation, clinical care services which can be provided, and good clinical practices to be followed during teleconsultation are explained. Guidance on risk assessment and health education for diabetes risk factors, counselling for blood glucose monitoring, treatment compliance, and prevention of complications are described. CONCLUSION: The guidelines will help physicians in adopting teleconsultation for management of diabetes mellitus, facilitate access to diabetes care and improve health outcomes.


Subject(s)
COVID-19/epidemiology , Diabetes Mellitus, Type 2/therapy , Remote Consultation/standards , Biomedical Research/organization & administration , Biomedical Research/standards , COVID-19/prevention & control , Communicable Disease Control/methods , Communicable Disease Control/organization & administration , Communicable Disease Control/standards , Delivery of Health Care/organization & administration , Delivery of Health Care/standards , Diabetes Mellitus, Type 2/epidemiology , Expert Testimony , Humans , India/epidemiology , Pandemics , Remote Consultation/methods , Remote Consultation/organization & administration , Telemedicine/organization & administration , Telemedicine/standards
8.
Ethics Hum Res ; 43(5): 42-44, 2021 Sep.
Article in English | MEDLINE | ID: covidwho-1396864

ABSTRACT

With the rapid spread of SARS-CoV2 has come a rapid proliferation of clinical research studies, resulting in considerable strain on research ethics committees (RECS), which need to review study proposals. RECs are pressured to move through the review process quickly so that studies can get underway to address the pandemic. These committees are also asked to increase efficiency without relaxing the standards for ethical review. RECs are accustomed to external pressure for approval from investigators; however, in the Covid-19 era, this pressure is coming from not only the sponsors and investigators but also many other stakeholders, including world leaders, the community, the media, and professional organizations. Drawing on the authors' experiences on a central REC reviewing complex multicenter Covid-19 studies, this commentary describes challenges that are inherent to Covid-19 research studies, such as the difficulty of obtaining informed consent from patients ill with the highly infectious virus. The commentary recommends several steps that RECs can take to ensure ethical review of research studies during the Covid-19 pandemic and future infectious disease outbreaks.


Subject(s)
COVID-19 , Ethics Committees, Research/standards , Ethics, Research , Biomedical Research/ethics , Biomedical Research/standards , Humans , Informed Consent
10.
Adv Skin Wound Care ; 33(9): 455-456, 2020 09.
Article in English | MEDLINE | ID: covidwho-1310941
12.
Trends Mol Med ; 27(9): 830-832, 2021 09.
Article in English | MEDLINE | ID: covidwho-1281503

ABSTRACT

Coronavirus disease 2019 (COVID-19) has exacerbated the structural inequities in healthcare and the challenges of translating research into public discourse. This article highlights key antiracist considerations, presents previously noted core challenges, and provides recommendations for writing and reporting. Importantly, this article contributes to combating racialized science in the biomedical community.


Subject(s)
Biomedical Research/methods , Serial Publications , Biomedical Research/standards , COVID-19 , Humans , Racism , Serial Publications/standards , /standards
13.
Indian J Med Ethics ; VI(1): 1-12, 2021.
Article in English | MEDLINE | ID: covidwho-1257359

ABSTRACT

The world currently faces an unprecedented pandemic outbreak of coronavirus disease (Covid-19). The novel nature of the virus and very high infection rates have not only increased the urgency to find a vaccine or cure but have also led to drastic changes in the mode of conduct of research. Thus, the Indian Council of Medical Research has developed the "National Guidelines for Ethics Committees Reviewing Biomedical & Health Research during Covid-19 Pandemic" for guidance during the review of research. Here, we attempt to analyse the strengths and limitations of these guidelines to assess if the unique ethical challenges faced during research in the current situation are adequately identified and addressed and if foundational values and principles of research ethics have been taken into account in these guidelines.


Subject(s)
Biomedical Research/ethics , Biomedical Research/standards , COVID-19/prevention & control , Codes of Ethics , Ethics Committees, Research/standards , Health Policy , Adult , Aged , Aged, 80 and over , COVID-19/epidemiology , Ethics, Research , Female , Humans , India/epidemiology , Male , Middle Aged , Pandemics , SARS-CoV-2
14.
Indian J Med Ethics ; VI(1): 1-5, 2021.
Article in English | MEDLINE | ID: covidwho-1257358

ABSTRACT

The Covid-19 pandemic is raging, taking heavy toll of lives and livelihoods. The need for safe and effective vaccine(s) is urgent. Vaccine research has progressed rapidly and a few vaccine candidates have passed trial Phases 1 and 2, confirming reasonable safety and immunogenicity parameters. They are ready for large scale Phase 3 trials to quantify protective efficacy, if any, and to detect uncommon but serious adverse effects, if any. These developments present unprecedented opportunities and challenges, scientific and ethical. Globally hundreds die every day due to Covid-19, and emergency/compassionate use of vaccine candidates that are ready for Phase 3 trials are likely to save lives. We perceive an ethical imperative to allow such vaccination for those at high risk of death and voluntarily make such informed choice - for them protection delayed will be tantamount to protection denied.


Subject(s)
Biomedical Research/ethics , Biomedical Research/standards , COVID-19 Vaccines/standards , COVID-19/prevention & control , Pandemics/prevention & control , Vaccination/ethics , Vaccination/standards , Humans , India , Practice Guidelines as Topic , SARS-CoV-2 , Time Factors
16.
J Clin Epidemiol ; 138: 219-226, 2021 10.
Article in English | MEDLINE | ID: covidwho-1253151

ABSTRACT

Covid-19 research made it painfully clear that the scandal of poor medical research, as denounced by Altman in 1994, persists today. The overall quality of medical research remains poor, despite longstanding criticisms. The problems are well known, but the research community fails to properly address them. We suggest that most problems stem from an underlying paradox: although methodology is undeniably the backbone of high-quality and responsible research, science consistently undervalues methodology. The focus remains more on the destination (research claims and metrics) than on the journey. Notwithstanding, research should serve society more than the reputation of those involved. While we notice that many initiatives are being established to improve components of the research cycle, these initiatives are too disjointed. The overall system is monolithic and slow to adapt. We assert that top-down action is needed from journals, universities, funders and governments to break the cycle and put methodology first. These actions should involve the widespread adoption of registered reports, balanced research funding between innovative, incremental and methodological research projects, full recognition and demystification of peer review, improved methodological review of reports, adherence to reporting guidelines, and investment in methodological education and research. Currently, the scientific enterprise is doing a major disservice to patients and society.


Subject(s)
Biomedical Research/methods , Biomedical Research/standards , Research Design/standards , COVID-19/epidemiology , COVID-19/prevention & control , Humans
19.
Methods ; 195: 3-14, 2021 11.
Article in English | MEDLINE | ID: covidwho-1240650

ABSTRACT

More than 130,000 peer-reviewed studies have been published within one year after COVID-19 emerged in many countries. This large and rapidly growing field may overwhelm the synthesizing abilities of both researchers and policy-makers. To provide a sinopsis, prevent errors, and detect cognitive gaps that may require interdisciplinary research methods, the literature on COVID-19 is summarized, twice. The overall purpose of this study is to generate a dialogue meant to explain the genesis of and/or find remedies for omissions and contradictions. The first review starts in Biology and ends in Policy. Policy is chosen as a destination because it is the setting where cognitive integration must occur. The second review follows the opposite path: it begins with stated policies on COVID-19 and then their assumptions and disciplinary relationships are identified. The purpose of this interdisciplinary method on methods is to yield a relational and explanatory view of the field -one strategy likely to be incomplete but usable when large bodies of literature need to be rapidly summarized. These reviews identify nine inter-related problems, research needs, or omissions, namely: (1) nation-wide, geo-referenced, epidemiological data collection systems (open to and monitored by the public); (2) metrics meant to detect non-symptomatic cases -e.g., test positivity-; (3) cost-benefit oriented methods, which should demonstrate they detect silent viral spreaders even with limited testing; (4) new personalized tests that inform on biological functions and disease correlates, such as cell-mediated immunity, co-morbidities, and immuno-suppression; (5) factors that influence vaccine effectiveness; (6) economic predictions that consider the long-term consequences likely to follow epidemics that growth exponentially; (7) the errors induced by self-limiting and/or implausible paradigms, such as binary and reductionist approaches; (8) new governance models that emphasize problem-solving skills, social participation, and the use of scientific knowledge; and (9) new educational programs that utilize visual aids and audience-specific communication strategies. The analysis indicates that, to optimally address these problems, disciplinary and social integration is needed. By asking what is/are the potential cause(s) and consequence(s) of each issue, this methodology generates visualizations that reveal possible relationships as well as omissions and contradictions. While inherently limited in scope and likely to become obsolete, these shortcomings are avoided when this 'method on methods' is frequently practiced. Open-ended, inter-/trans-disciplinary perspectives and broad social participation may help researchers and citizens to construct, de-construct, and re-construct COVID-19 related research.


Subject(s)
Biomedical Research/methods , COVID-19/epidemiology , COVID-19/prevention & control , Health Policy , Interdisciplinary Research/methods , Animals , Biomedical Research/standards , Biomedical Research/trends , COVID-19/immunology , Health Policy/trends , Humans , Immunity, Herd/physiology , Interdisciplinary Research/standards , Interdisciplinary Research/trends
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