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Addressing standards of care in resource-limited settings.

ABSTRACT: : The choice between "best-known" standards of care (SOC) or "best available" standards as the control arm in a clinical trial is a fundamental dilemma in clinical research in resource-limited settings (RLS). When the health system is delivering less than an optimal level of care, using highest standard of care in a clinical trial may produce results that cannot be implemented or sustained locally. On the other hand, using interventions that are more feasible in the local setting may involve suboptimal care, and clinical outcomes may be affected. The need for improved standards in health systems in RLS, and the difficulty in securing them, has led many researchers advocate for policy changes at the national or international level to improve clinical care more systemically. SOC decisions in a clinical trial affect the level of benefit provided to study participants and the policy implications of the trial findings. SOC choices should provide high-quality care to help advance the health care system in host countries participating in the trial, but balancing the scientific and ethical objectives of SOC choices is difficult, and there is no single formula for selecting the appropriate SOC. Despite the challenges, well-designed and conducted clinical trials can and should make significant contributions to health systems in RLS.

SUBMITTER: Dawson L

PROVIDER: S-EPMC4169284 | biostudies-literature | 2014 Jan

REPOSITORIES: biostudies-literature

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Addressing standards of care in resource-limited settings.

Dawson Liza L Klingman Karin L KL Marrazzo Jeanne J

Journal of acquired immune deficiency syndromes (1999) 20140101

: The choice between "best-known" standards of care (SOC) or "best available" standards as the control arm in a clinical trial is a fundamental dilemma in clinical research in resource-limited settings (RLS). When the health system is delivering less than an optimal level of care, using highest standard of care in a clinical trial may produce results that cannot be implemented or sustained locally. On the other hand, using interventions that are more feasible in the local setting may involve sub ...[more]

PMID: 24321977

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Project description:ObjectiveThe objective of this narrative review is to outline the current epidemiology and interventional research within the context of sepsis recovery, and to provide a summary of key priorities for future work in this area.BackgroundMorbidity and mortality secondary to sepsis disproportionately affects children, especially those in low- and middle-income countries (LMICs), where over 85% of global cases and deaths occur. These regions are plagued by poorly resilient health systems, widespread socio-economic deprivation and unique vulnerabilities such as malnutrition. Reducing the overall burden of sepsis will require a multi-pronged strategy that addresses all three important periods along the sepsis care continuum - pre-facility, facility and post-facility. Of these aspects, post-facility issues have been largely neglected in research, practice and policy, and are thus the focus of this review.MethodsRelevant data for this review was identified through a literature search using PubMed, through a review of the citations of select systematic reviews and from the personal repositories of articles collected by the authors. Data is presented within three sections. The first two sections on the short and long-term outcomes among sepsis survivors each outline the epidemiology as well as review relevant interventional research done. Where clear gaps exist, these are stated. The third section focuses on priorities for future research. This section highlights the importance of data (and data systems) and of innovative interventional approaches, as key areas to improve research of post-sepsis outcomes in children.ConclusionsDuring the initial post-facility period, mortality is high with as many children dying during this period as during the acute period of hospitalization, mostly due to recurrent illness (including infections) which are associated with malnutrition and severe acute disease. Long-term outcomes, often labelled as post-sepsis syndrome (PSS), are characterized by a lag in developmental milestones and suboptimal quality of life (QoL). While long-term outcomes have not been well characterized in resource limited settings, they are well described in high-income countries (HICs), and likely are important contributors to long-term morbidity in resource limited settings. The paucity of interventional research to improve post-discharge outcomes (short- or long-term) is a clear gap in addressing its burden. A focus on the development of improved data systems for collecting routine data, standardized definitions and terminology and a health-systems approach in research need to be prioritized during any efforts to improve outcomes during the post-sepsis phase.

Project description:BackgroundMultinational clinical trials are logistically complex and require close coordination between various stakeholders. They must comply with global clinical standards and are accountable to multiple regulatory and ethical bodies. In resource-limited settings, it is challenging to understand how to apply global clinical standards to international, national, and local factors in clinical trials, making multiple-level stakeholder engagement an important element in the successful conduct of these clinical trials.Main bodyDuring the planning and implementation of a large multinational clinical trial for intermittent preventive treatment of malaria in pregnancy in resource-limited areas of sub-Saharan Africa, we encountered numerous challenges, which required implementation of a range of engagement measures to ensure compliance with global clinical and regulatory standards. These challenges included coordination with ongoing global malaria efforts, heterogeneity in national regulatory structures, sub-optimal healthcare infrastructure, local practices and beliefs, and perspectives that view healthcare providers with undue trust or suspicion. In addition to engagement with international bodies, such as the World Health Organization, the Malaria in Pregnancy Consortium, the Steve Biko Centre for Bioethics, and the London School of Hygiene and Tropical Medicine, in order to address the challenges just described, Pfizer Inc. and Medicines for Malaria Venture (the "Sponsoring Entities" for these studies) and investigators liaised with national- and district-level stakeholders such as health ministers and regional/local community health workers. Community engagement measures undertaken by investigators included local meetings with community leaders to explain the research aims and answer questions and concerns voiced by the community. The investigators also engaged with family members of prospective trial participants in order to be sensitive to local practices and beliefs.ConclusionEngagement with key stakeholders at international and national levels enabled the Sponsoring Entities to address challenges by aligning the study design with the requirements of health and regulatory agencies and to understand and address healthcare infrastructure needs prior to trial initiation. Local stakeholder engagement, including community members, study participants, and family enabled the investigators to address challenges by ensuring that study design and conduct were adapted to local considerations and ensuring accurate information about the study aims was shared with the public.Trial registrationClinicalTrials.gov, ID: NCT01103063 . Registered on 7 April 2010.

Project description:BackgroundThe early identification of individuals at high risk for adverse outcomes by a Comprehensive Geriatric Assessment (CGA) in resource-limited primary care settings enables tailored treatments, however, the evidence concerning its benefits are still controversial. The main objective of this study was to examine the validity and reliability of the "Multidimensional Assessment of Older People in Primary Care (AMPI-AB)", a CGA for primary care in resource-limited settings.MethodsLongitudinal study, with median follow-up time of 16 months. Older adults from a public primary care unit in São Paulo, Brazil, were consecutively admitted. Reliability was tested in a sample from a public geriatric outpatient clinic. Participants were classified by the AMPI-AB score as requiring a low, intermediate or high complexity of care. The Physical Frailty Phenotype was used to explore the AMPI-AB's concurrent validity. Predictive validity was assessed with mortality, worsening of the functional status, hospitalizations, emergency room (ER) visits and falls. The area under the ROC curve and logistic regression were calculated for binary outcomes, and a Cox proportional hazards model was used for survival analysis.ResultsOlder adults (n = 317) with a median age of 80 (74-86) years, 67% female, were consecutively admitted. At the follow-up, 7.1% of participants had died, and increased dependency on basic and instrumental activities of daily living was detected in 8.9 and 41.1% of the participants, respectively. The AMPI-AB score was accurate in detecting frailty (area under the ROC curve = 0.851), predicted mortality (HR = 1.25, 95%CI = 1.13-1.39) and increased dependency on basic (OR = 1.26, 95%CI = 1.10-1.46) and instrumental (OR = 1.22, 95%CI = 1.12-1.34) activities of daily living, hospitalizations (OR = 2.05, 95%CI = 1.04-1.26), ER visits (OR = 1.20, 95%CI = 1.10-1.31) and falls (OR = 1.10, 95%CI = 1.01-1.20), all models adjusted for sex and years of schooling. Reliability was tested in a sample of 52 older adults with a median age of 72 (85-64) years, 63.5% female. The AMPI-AB also had good interrater (ICC = 0.87, 95%CI = 0.78-0.92), test-retest (ICC = 0.86, 95%CI = 0.76-0.93) and proxy reliability (ICC = 0.84, 95%CI = 0.67-0.93). The Cronbach's alpha was 0.69, and the mean AMPI-AB administration time was 05:44 ± 02:42 min.ConclusionThe AMPI-AB is a valid and reliable tool for managing older adults in resource-limited primary care settings.

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Addressing standards of care in resource-limited settings.

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Addressing standards of care in resource-limited settings.

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