Embracing Uncertainty: The Value of Partial Identification in Public Health and Clinical Research

Author(s):  
John Mullahy ◽  
Atheendar Venkataramani ◽  
Daniel L. Millimet ◽  
Charles F. Manski
2020 ◽  
Vol 15 (1) ◽  
Author(s):  
Brittany N. Rudd ◽  
Molly Davis ◽  
Rinad S. Beidas

Abstract Background Although comprehensive reporting guidelines for implementation strategy use within implementation research exist, they are rarely used by clinical (i.e., efficacy and effectiveness) researchers. In this debate, we argue that the lack of comprehensive reporting of implementation strategy use and alignment of those strategies with implementation outcomes within clinical research is a missed opportunity to efficiently narrow research-to-practice gaps. Main body We review ways that comprehensively specifying implementation strategy use can advance science, including enhancing replicability of clinical trials and reducing the time from clinical research to public health impact. We then propose that revisions to frequently used reporting guidelines in clinical research (e.g., CONSORT, TIDieR) are needed, review current methods for reporting implementation strategy use (e.g., utilizing StaRI), provide pragmatic suggestions on how to both prospectively and retrospectively specify implementation strategy use and align these strategies with implementation outcomes within clinical research, and offer a case study of using these methods. Conclusions The approaches recommended in this article will not only contribute to shared knowledge and language among clinical and implementation researchers but also facilitate the replication of efficacy and effectiveness research. Ultimately, we hope to accelerate translation from clinical to implementation research in order to expedite improvements in public health.


2019 ◽  
Vol 9 (9) ◽  
pp. 235 ◽  
Author(s):  
Creeley ◽  
Denton

This paper reviews the findings from preclinical animal and human clinical research investigating maternal/fetal, neonatal, and child neurodevelopmental outcomes following prenatal exposure to psychotropic drugs. Evidence for the risks associated with prenatal exposure was examined, including teratogenicity, neurodevelopmental effects, neonatal toxicity, and long-term neurobehavioral consequences (i.e., behavioral teratogenicity). We conducted a comprehensive review of the recent results and conclusions of original research and reviews, respectively, which have investigated the short- and long-term impact of drugs commonly prescribed to pregnant women for psychological disorders, including mood, anxiety, and sleep disorders. Because mental illness in the mother is not a benign event, and may itself pose significant risks to both mother and child, simply discontinuing or avoiding medication use during pregnancy may not be possible. Therefore, prenatal exposure to psychotropic drugs is a major public health concern. Decisions regarding drug choice, dose, and duration should be made carefully, by balancing severity, chronicity, and co-morbidity of the mental illness, disorder, or condition against the potential risk for adverse outcomes due to drug exposure. Globally, maternal mental health problems are considered as a major public health challenge, which requires a stronger focus on mental health services that will benefit both mother and child. More preclinical and clinical research is needed in order to make well-informed decisions, understanding the risks associated with the use of psychotropic medications during pregnancy.


2020 ◽  
Vol 18 (1) ◽  
Author(s):  
Seydou Doumbia ◽  
Ydrissa Sow ◽  
Mahamadou Diakite ◽  
Chuen-Yen Lau

Abstract Mali, like the rest of the world, has seen a rapid spread of COVID-19 since the first report of imported cases. Despite being a low-income country, Mali has leveraged scientific research resources via coordinated approaches to enable public health emergency planning and response to the COVID-19 pandemic. Mali’s approach includes the harmonization of research activities; leveraging of research laboratory capacity of the University Clinical Research Center, Mali International Center for Excellence and three other in-country laboratories for community COVID-19 testing; strengthening relationships amongst local and international stakeholders; and collaboration with the Ministry of Health to integrate scientific evidence into public policy and emergency management of COVID-19 through a platform of consultation and open communication. The country has implemented national coordination of its COVID-19 response by establishing a COVID-19 Scientific Advisory Committee and a COVID-19 Technical Coordination Committee, both within the Ministry of Health and working collaboratively with other stakeholders. Members of Mali’s COVID-19 Scientific Advisory Committee also serve as leaders of its principal academic and government clinical and public health research entities. This centralised approach has enabled the prioritisation of COVID-19 control activities, informed allocation of resources, evidence-based public health practices and timely decision-making in the pandemic setting. Though challenges remain, lessons learned from Mali’s harnessing of clinical research capacity to guide and support its COVID-19 response can be applied to future global health research challenges and illustrate the power of building public health-responsive research capacity in resource-limited settings through international collaboration.


2019 ◽  
Vol 9 (2) ◽  
pp. 22-25
Author(s):  
Zoheb Rafique

This article talks about both clinical research ethics and public health research ethics. Clinical research ethics are defined as set of relevant ethics considered necessary for the conduct of clinical trials in field of the clinical research. While public health research ethics is mainly aimed at finding out what is best for the communities and the populations rather than the individuals. Research ethics is mainly focused on the protection of individual participants and some of the research norms and accepted principles may be challenging when applying in some of the research contexts.  


2021 ◽  
Vol 14 (11) ◽  
Author(s):  
Kirsty M. Hooper

ABSTRACT It has been 100 years since the discovery of insulin. This revolutionary treatment saves the lives of millions of people living with diabetes, but much remains to be understood of its mechanisms and roles in homeostasis and disease. To celebrate this centenary, we explore areas of ongoing insulin research in diabetes, metabolic syndrome and beyond. Disease Models & Mechanisms aims to publish high-quality basic and pre-clinical research that advances our understanding of these conditions to facilitate clinical and public health impact.


2016 ◽  
Vol 7 (2) ◽  
Author(s):  
Tahera Ahmed Ahmed

Hello readers! Hope everyone is fine especially in this season where we often are prone to attacks of cold or flu. The holiday season is at our threshold, and we wish everyone to be in the best of health and happiness.This issue of the BJB is very interesting with topics stretching from Non Communicable Diseases to the ethical issues related to the habitation of the planet Mars, and proves how forward looking are our readers and authors.Mohammad Rashedul Islam et al discuss the application of the SARA method in a district in Bangladesh. The method is based on the principle of Service Availability and Readiness Assessment of WHO. The study in a district in Bangladesh found that about 62% of all the facilities were ready to provide general services like basic amenities with basic equipment, standard precautions for infection prevention, diagnostic capacity and essential medicines. However in case of Non-Communicable Diseases (NCD), only 40% of the health facilities had chronic respiratory disease and cardiovascular diseases diagnosis/management and only 32% had availability of diabetes diagnosis/management. Therefore, service availability and readiness of the health facilities to provide NCD related health services were not satisfactory. The authors emphasize that SARA which is a tool to monitor facilities to be ready for provision of services including NCD, should be used by all clinic managers.The very scientific and forward looking article titled “SCNT Method and the Application for Patent Eligibility on Cloned Animals” by Norman K. Swazo reviews US federal court decisions regarding applications for patent in the case of live-born animal clones. A decision issued from the United States Court of Appeals for the Federal Circuit established an earlier decision of the Patent Trial and Appeal Board that live-born animals cloned by the somatic cell nuclear transfer method (SCNT) like cattle, sheep, pigs, and goats are not patentable, so a scientist using the method is not eligible for a patent claim on the animals. The author feels that this decision has ethical implications related to the moral status of cloned animals. The author argues whether the end product of a SCNT (somatic cell nuclear transfer) application is same as an invention or   only a revelation of nature at the cellular level. The author quotes Article 11 of Universal Declaration on the Human Genome and Human Rights UNDHGR “Practices which are contrary to human dignity, such as reproductive cloning of human beings, shall not be permitted.” He concludes that the judicial assessments in the USA deciding on the question of patenting of animal clones provide important barriers to human reproductive cloning research, safeguarding moral and legal commitment to human dignity.  The article on Ethics in Public Health Research and Clinical Research by Muhammad Waseem Khanet al discusses on the need to continue to focus on ethical values in conducting any research. Tha authors stress the importance, either in public health research or clinical research, of the need to  recognize an ethical standard that respects individual’s autonomy and community’s wellbeing. This can be achieved through collective collaboration for the protection of individual’s autonomy, dignity and wellbeing. Research ethics is a fundamental criterion to be complied with throughout a research study. The very interesting article on Planetary Protection for Mars: Time for Reconsideration by Svetoslav Alexandrov looks into the ethical questions beyond mother earth but which could be affected by people from our planet. In this manuscript the author discusses the ethics of the protection of hypothetical organisms on Mars in terms of planned manned space missions and subsequent colonization. The author discusses the possible problems related to a process called terraformation where the planet is converted to make it suitable for Earth life. He argues that terraformation will change the whole condition of the planet. The author quotes Carl Sagan, of The Planetary Society: “If there is life, then I believe we should do nothing to disturb that life. Mars then, belongs to the Martians, even if they are microbes” . I think we all agree with this brilliant recommendation.The article ‘We Still Need to Improve Our Research Writing Ethics’ by Sheikh Arslan Sehgal looks into the value of maintaining professional integrity of research work. Particularly with issues like plagiarism, ethics, authorship and data fabrication. He argues that the scientific community must obey the scientific ethical norms and rules. He feels that ethical problems must be resolved for the advancement of research in countries including Pakistan. The author recommends teaching students the international, institutional and professional standards regarding research and authorship issue. Thus from the beginning researchers will know the key components of ethics in conducting research and the end product will be research work of quality and acceptability.Dear Readers, we look forward to your articles, commentaries, observations on different issues which touch our lives and will help in broadening our knowledge and understanding of Bioethics.


2019 ◽  
Vol 184 (Supplement_2) ◽  
pp. 66-70
Author(s):  
Christian Coles ◽  
Martin G Ottolini

ABSTRACT The role of physicians in the U.S. Armed Forces is diverse, encompassing a wide array of skills and responsibilities to provide superior healthcare to their patients and to advance military medicine. In addition to healthcare delivery and medical education, military physicians are engaged in public health, operational medicine, and cutting-edge medical research. Thus, clinical research is a crucial component of Graduate Medical Education (GME) and supports critical thinking (knowledge, skills, and abilities) and the development of leadership skills among U.S. military physicians. The Infectious Disease Clinical Research Program (IDCRP) education mission was established in 2005 with the overall goal of supporting the development and training of the next generation of clinical researchers in infectious diseases and related public health disciplines in the Armed Forces using several strategies, including didactic learning, mentored research, and research engagement. Through involvement in the IDCRP, infectious disease fellows, residents (e.g., surgical, internal medicine, and pediatrics), and Master of Public Health (MPH) students have continued their education and gained valuable skills related to clinical research. Trainees either conduct research with IDCRP mentors or participate in IDCRP-led practicum experiences, with research projects ranging from epidemiologic studies to microbiological assessments. Consistent with the needs of the Military Health System (MHS), and in accordance with Accreditation Council for Graduate Medical Education goals, the IDCRP provides opportunities for medical and graduate students, residents, and infectious disease fellows to conduct mentored research within the MHS, as well as gain important leadership skills in the conduct of clinical research. Overall, IDCRP continues to further infectious disease research through the support and education of the next generation of active-duty infectious disease researchers in the MHS.


Author(s):  
Anne Brice ◽  
Amanda Burls ◽  
Alison Hill

Making good public health decisions requires integrating relevant local knowledge about your population with national guidance and best research evidence. However, public health research evidence is more diverse than clinical research and needs to be sought in a much wider range of information sources. Furthermore, evidence comes from a range of different study types, which adds a further challenge when assessing the quality of the research. This chapter has two aims. The first is to help you find research evidence efficiently, so that you can access the best, most relevant research evidence for your research query. The second is to help you make sense of research through the technique of critical appraisal, which is the systematic assessment of research evidence. Finding and appraising evidence is an essential skill in the process of improving the health of the population.


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