Ethical Issues Related to Early Screening Programs in Low Resource Settings.
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ABSTRACT:
SUBMITTER: Yadla M
PROVIDER: S-EPMC11328672 | biostudies-literature | 2024 Aug
REPOSITORIES: biostudies-literature
Publications
Ethical Issues Related to Early Screening Programs in Low Resource Settings.
Yadla Manjusha M John Priyadarshini P Fong Voon Ken VK Anandh Urmila U
Kidney international reports 20240624 8
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Project description:BackgroundStepped-wedge cluster randomized trials (SW-CRTs) are increasingly popular in health-related research in both high- and low-resource settings. There may be specific ethical issues that researchers face when designing and conducting SW-CRTs in low-resource settings. Knowledge of these issues can help to improve the ethical conduct of SW-CRTs in a global health context.MethodsWe performed an ethical analysis of two studies using SW-CRT designs in low-resource settings: the Que Vivan Las Madres study conducted from 2014 to 2017 in Guatemala and the Atmiyata study conducted from 2017 to 2018 in rural parts of India. For both case studies, we identified and evaluated the classification of the study as research or nonresearch and the ethical issues regarding the justification of the design, including the delayed rollout of an intervention that had a promising effect.ResultsIn our case studies, some minor ethical issues surfaced about the registration and stakeholder pressure on the order of randomization, but both included good justification for the design and delayed rollout. Our analysis did, however, demonstrate that careful consideration of the role of randomization and registration of the trials is important.DiscussionSW-CRTs can provide an opportunity for rigorous evaluation of interventions destined to be rolled out on the basis of limited evidence. Furthermore, in SW-CRTs, the underlying objective is often to provide a robust evaluation of the effectiveness for generalized dissemination, and this makes the SW-CRT no less a research study than any other form of cluster randomized trial.ConclusionThe design and conduct of stepped-wedge cluster randomized trials raises at least two ethical issues that need special consideration in both high- and low-resource settings: the justification for using the design, specifically the delayed rollout of the intervention to the control group, and the classification of the study as research or nonresearch. In our case studies, these issues did not seem to raise special ethical scrutiny in low-resource settings. Further ethical evaluation will hopefully result in specific ethical guidelines for the use of SW-CRTs in both high- and low-resource settings to contribute to responsible functioning of these trials and adequate protection of participants.
| S-EPMC6921381 | biostudies-literature
Project description:Women in developing countries disproportionately bear the burden of cervical cancer. The availability of prophylactic vaccines against human papillomavirus (HPV) types 16 and 18, which cause approximately 70% of cervical cancers, provides reason for optimism as roll-out begins with support from Gavi, the Vaccine Alliance. However, for the hundreds of millions of women beyond the target age for HPV vaccination, cervical cancer screening to detect and treat precancerous lesions remains the only form of prevention. Here we describe the challenges that confront screening programs in low-resource settings, including (1) optimizing screening test effectiveness; (2) achieving high screening coverage of the target population; and (3) managing screen-positive women. For each of these challenges, we summarize the tradeoffs between resource utilization and programmatic attributes. We then highlight opportunities for efficient and equitable programming, with supporting evidence from recent mathematical modeling analyses informed by data from the PATH demonstration projects in India, Nicaragua, and Uganda.
| S-EPMC5548874 | biostudies-other
Project description:Smaller, more affordable, and more portable MRI brain scanners offer exciting opportunities to address unmet research needs and long-standing health inequities in remote and resource-limited international settings. Field-based neuroimaging research in low- and middle-income countries (LMICs) can improve local capacity to conduct both structural and functional neuroscience studies, expand knowledge of brain injury and neuropsychiatric and neurodevelopmental disorders, and ultimately improve the timeliness and quality of clinical diagnosis and treatment around the globe. Facilitating MRI research in remote settings can also diversify reference databases in neuroscience, improve understanding of brain development and degeneration across the lifespan in diverse populations, and help to create reliable measurements of infant and child development. These deeper understandings can lead to new strategies for collaborating with communities to mitigate and hopefully overcome challenges that negatively impact brain development and quality of life. Despite the potential importance of research using highly portable MRI in remote and resource-limited settings, there is little analysis of the attendant ethical, legal, and social issues (ELSI). To begin addressing this gap, this paper presents findings from the first phase of an envisioned multi-staged and iterative approach for creating ethical and legal guidance in a complex global landscape. Section 1 provides a brief introduction to the emerging technology for field-based MRI research. Section 2 presents our methodology for generating plausible use cases for MRI research in remote and resource-limited settings and identifying associated ELSI issues. Section 3 analyzes core ELSI issues in designing and conducting field-based MRI research in remote, resource-limited settings and offers recommendations. We argue that a guiding principle for field-based MRI research in these contexts should be including local communities and research participants throughout the research process in order to create sustained local value. Section 4 presents a recommended path for the next phase of work that could further adapt these use cases, address ethical and legal issues, and co-develop guidance in partnership with local communities.
| S-EPMC8382487 | biostudies-literature
Project description:PurposeCervical cancer disproportionately burdens low-resource populations where access to quality screening services is limited. A greater understanding of sustainable approaches to implement cervical cancer screening services is needed.MethodsWe conducted a systematized literature review of evaluations from cervical cancer screening programs implemented in resource-limited settings globally that included a formal evaluation and intention of program sustainment over time. We categorized the included studies using the continuum of implementation research framework which categorizes studies progressively from "implementation light" to more implementation intensive.ResultsFifty-one of 13,330 initially identified papers were reviewed with most study sites in low-resource settings of middle-income countries (94.1%) ,while 9.8% were in low-income countries. Across all studies, visual inspection of the cervix with acetic acid (58.8%) was the most prevalent screening method followed by cytology testing (39.2%). Demand-side (client and community) considerations were reported in 86.3% of the articles, while 68.6% focused scientific inquiry on the supply side (health service). Eighteen articles (35.3%) were categorized as "Informing Scale-up" along the continuum of implementation research.ConclusionsThe number of cervical cancer screening implementation reports is limited globally, especially in low-income countries. The 18 papers we classified as Informing Scale-up provide critical insights for developing programs relevant to implementation outcomes. We recommend that program managers report lessons learnt to build collective implementation knowledge for cervical cancer screening services, globally.
| S-EPMC7105425 | biostudies-literature
Project description:Cervical cancer is a leading cause of cancer death worldwide, with 85% of the disease burden residing in less developed regions. To inform evidence-based decision-making as cervical cancer screening programs are planned, implemented, and scaled in low- and middle-income countries, we used cost and test performance data from the START-UP demonstration project in Uganda and a microsimulation model of HPV infection and cervical carcinogenesis to quantify the health benefits, distributional equity, cost-effectiveness, and financial impact of either (1) improving access to cervical cancer screening or (2) increasing the number of lifetime screening opportunities for women who already have access. We found that when baseline screening coverage was low (i.e., 30%), expanding coverage of screening once in a lifetime to 50% can yield comparable reductions in cancer risk to screening two or three times in a lifetime at 30% coverage, lead to greater reductions in health disparities, and cost 150 international dollars (I$) per year of life saved (YLS). At higher baseline screening coverage levels (i.e., 70%), screening three times in a lifetime yielded greater health benefits than expanding screening once in a lifetime to 90% coverage, and would have a cost-effectiveness ratio (I$590 per YLS) below Uganda's per capita GDP. Given very low baseline coverage at present, we conclude that a policy focus on increasing access for previously unscreened women appears to be more compatible with improving both equity and efficiency than a focus on increasing frequency for a small subset of women.
| S-EPMC5516173 | biostudies-literature
Project description:The road to malaria elimination for low- and middle-income countries is paved with obstacles, including the complexity and high costs of advanced molecular methods for genomic analysis. The usefulness of PCR-RFLP as less complex and affordable molecular surveillance tool in low-endemic malaria regions was assessed in a cross-sectional study conducted in Suriname, currently striving for malaria elimination, but plagued by recent P. vivax outbreaks. Molecular analysis of two highly polymorphic genes Pvmsp-1 F2 and Pvmsp-3α was performed for 49 samples, collected during October 2019 through September 2021 from four different regions with varying malaria transmission risks. RFLP-profiling revealed that outbreak samples from three indigenous villages, almost exclusively, harbored a single clonal type, matching the "Palumeu" lineage previously described in 2019, despite multiple relapses and drug pressure exerted by mass drug administration events, suggesting a limited P. vivax hypnozoite reservoir in Suriname. In contrast, isolates originating from Sophie, a mining area in neighboring French Guiana displayed a highly heterogeneous parasite population consistent with its endemic malaria status, demonstrating the differentiating capacity and thus the usefulness of PCR-RFLP for P. vivax genetic diversity studies. Outbreak reconstruction emphasized the impact of undetected human movement and relapses on reintroduction and resurgence of P. vivax malaria and PCR-RFLP monitoring of circulating parasites guided the roll-out of targeted interventions. PCR-RFLP seems a suitable molecular alternative in low-endemic areas with restricted resources for outbreak analysis, for monitoring the spread or containment of circulating strains and for identification of imported cases or potential foci.
| S-EPMC10659184 | biostudies-literature
Project description:Highlights • Low-to-middle income countries (LMICs) face disparities in cervical cancer due to low rates of screening and early treatment.• Despite advanced testing for human papillomavirus (HPV), the need for visual inspection with acetic acid (VIA) will remain.• Digital cervicography (DC) is an adjunct to VIA in LMICs to address disparities in cervical cancer screening programs.• Screening programs can use DC to support task sharing, same day screen-and-treat, mentoring, and quality improvement. Introduction Digital cervicography (DC) is a method of capturing images for analysis during visual inspection with acetic acid (VIA) for cervical cancer screening. Cervical cancer is the 3rd leading cause of female cancer in the world with approximately 90 % of deaths due to cervical cancer occurring in low and middle income countries (LMICs). The need for cost-effective and sustainable methods for screening is vital in these settings. This scoping review systematically synthesizes published data illustrating the use of DC in screening programs. We aim to understand how digital cervicography is used, implemented, and impacted on programs. Methods Search of eight online databases identified 53 studies published between 1993 and 2021. Inclusion of articles were English language, cervical cancer screening program located in an LMIC, and DC as an intervention. Results All studies were cross-sectional studies (n = 53), with variation in terminology, uses, and device methods. Devices were grouped as either smartphones (n = 14), commercially available digital cameras (n = 17), or other (EVA®, n = 4; Cerviscope, n = 12; custom device, n = 4; or not specified, n = 2). Nineteen studies found acceptability and feasibility for DC in their screening programs. Various programs using DC found benefits such as task sharing, healthcare worker training, patient education and using images for review from a remote specialist or mentor. Conclusion The use of DC in LMICs is beneficial for support of healthcare workers, enhances quality improvement and demonstrates overall acceptability in screening programs. Advancing technologies for human papillomavirus (HPV) testing and cytology are common methods for cervical cancer screening, although are limited in LMICs. This scoping review demonstrates the different methods, uses, and benefit of digital cervicography in cervical cancer screening programs.
| S-EPMC9845952 | biostudies-literature
Project description:Differences in definitions of acute pediatric diarrhea result in variable estimates of morbidity and mortality, treatment coverage, and associations with risk factors and outcomes. We reviewed published literature and guidelines focused on acute pediatric diarrhea in low- and middle-income countries. Clinical guidelines most commonly defined diarrhea in terms of quantity of loose or watery stool with consideration of normal stool patterns, whereas research studies often relied exclusively on a quantitative definition. The most commonly used quantitative definition, ≥3 loose or watery stools in a 24-hour period, has been compared to gold standards of caregiver perception and visual inspection of stool, with variable agreement. Age, breast-feeding status, and setting (facility vs household-based) influence the performance of quantitative diarrhea definitions in children. Universal adoption of a set of valid gold standard definitions specifically aligned with various programmatic and research goals will lead to more accurate coverage estimates and better-informed resource prioritization.
| S-EPMC5907861 | biostudies-literature
Project description:The field of public health includes a wide scope of activities and professional disciplines, ranging from sanitation, health protection, epidemiology, environmental health, financing, health promotion, including supervision, or the provision of clinical care. Each of these disciplines works in systems that face ethical dilemmas, making it important that public health workers have motivation to understand and practice within the ethical guidelines of their profession, thus making ethics an important component of training and practice. The dangers of ethical lapses are overwhelmingly apparent in the case of the Eugenics movement of the early 20th century which metamorphosed from forced sterilizations in many liberal democratic countries into mass murder of physically and mentally handicapped children and adults in Nazi Germany. Between 1939 and 1941, 180 thousand psychiatric patients along with an equivalent number of handicapped children and adults were killed in an organized extermination program in Germany by lethal gassing. This method was then applied to the industrialized murder or Holocaust of six million Jews and millions of other “untermenschen” (sub human) in the greatest genocide in human history. Shortly after World War II ended the Nuremberg Trials of Nazi war criminals were conducted including medical doctors, and some were executed for crimes against humanity. This was followed by the 1948 United Nations Declaration on Human Rights and by the World Medical Association’s Helsinki Declaration. Both are widely accepted as cornerstone documents—the latter specifically governing ethical standards related to human experimentation—and are revised regularly since being issued in 1964. But genocide has not disappeared, nor has unscrupulous experimentation such as the Tuskegee experiment on black Americans infected with syphilis and left untreated even after the availability of a cure, penicillin. Ethical standards are now required by “Helsinki Committees”—ethical review boards—in most medical facilities worldwide. Ethical frameworks have evolved in part due to bitter experience of ethical failures later recognized and affecting public health standards of practice. Future generations of public health leaders and staff will face many ethical issues such as mandatory immunization of health workers and school children, and assisted death of terminally ill patients.
| S-EPMC7149338 | biostudies-literature
Project description:ENT professionals are facing the heat of raised number of malpractice complaints against them. Some of them have a direct impact on surgeon's career & life progression. Lawsuits are not new to otology, but with evolution of education, social media & media trials etc., negativity is being generated against doctors each day. This article considers the causes, types & prevention of medicolegal malpractice claims/lawsuits against the doctors with incorporation of recent NMC guidelines for the same.Supplementary informationThe online version contains supplementary material available at 10.1007/s12070-023-04078-5.
| S-EPMC10645664 | biostudies-literature