Matching Development of Point-of-Care Diagnostic Tests to the Local Context: A Case Study of Visceral Leishmaniasis in Kenya and Uganda

Bengtson, Michel; Bharadwaj, Mitasha; Bosch, Astrid ten; Nyakundi, Hellen; Matoke-Muhia, Damaris; Dekker, Cees; Diehl, Jan Carel

doi:10.9745/ghsp-d-20-00028

Cited by 6 publications

(6 citation statements)

References 27 publications

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“…With the onset of symptoms of VL, many patients avoid or delay seeking healthcare due to confusing symptoms with those of other diseases, gaps in VL awareness, disbelief in the severity of the condition, 67 , 68 fear of loss of productivity, 69 particularly if the afflicted family member is male, 67 , 68 and cultural barriers where the decision to seek care for women and children has to be granted by the male head. 70 Poor diet and low levels of education, all associated with poverty, are compounding risk factors for leishmaniasis. 13 Lack of public health education on VL contributes to the morbidity of the disease.…”

Section: Vulnerability To and Risk Factors For Leishmaniasesmentioning

confidence: 99%

“… 88 The general deficiency of healthcare for women is also considered an important factor contributing to their vulnerability to leishmaniasis. 88 Compared to men, women are less likely to seek healthcare in a timely manner when they have sought permission from their husbands, 70 leading to more severe complications and, in the case of CL, a greater likelihood of life-long, disfiguring scarring. 89 Late clinical presentations of women primarily stem from financial limitations and inadequate knowledge about the disease.…”

Section: Vulnerability To and Risk Factors For Leishmaniasesmentioning

confidence: 99%

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Vulnerabilities to and the Socioeconomic and Psychosocial Impacts of the Leishmaniases: A Review

Grifferty¹,

Shirley²,

McGloin

et al. 2021

RRTM

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The leishmaniases are a group of four vector-borne neglected tropical diseases (NTDs) with 1.6 billion people in some 100 countries at risk. They occur in certain eco-epidemiological foci that reflect manipulation by human activities, such as migration, urbanization and deforestation, of which poverty, conflict and climate change are key drivers. Given their synergistic impacts, risk factors and the vulnerabilities of poor populations and the launch of a new 2030 roadmap for NTDs in the context of the global sustainability agenda, it is warranted to update the state of knowledge of the leishmaniases and their effects. Using existing literature, we review socioeconomic and psychosocial impacts of leishmaniasis within a framework of risk factors and vulnerabilities to help inform policy interventions. Studies show that poverty is an overarching primary risk factor. Low-income status fosters inadequate housing, malnutrition and lack of sanitation, which create and exacerbate complexities in access to care and treatment outcomes as well as education and awareness. The co-occurrence of the leishmaniases with malnutrition and HIV infection further complicate diagnosis and treatment, leading to poor diagnostic outcomes and therapeutic response. Even with free treatment, households may suffer catastrophic health expenditure from direct and indirect medical costs, which compounds existing financial strain in low-income communities for households and healthcare systems. The dermatological presentations of the leishmaniases may result in long-term severe disfigurement, leading to stigmatization, reduced quality of life, discrimination and mental health issues. A substantial amount of recent literature points to the vulnerability pathways and burden of leishmaniasis on women, in particular, who disproportionately suffer from these impacts. These emerging foci demonstrate a need for continued international efforts to address key risk factors and population vulnerabilities if leishmaniasis control, and ultimately elimination, is to be achieved by 2030.

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Section: Vulnerability To and Risk Factors For Leishmaniasesmentioning

confidence: 99%

Section: Vulnerability To and Risk Factors For Leishmaniasesmentioning

confidence: 99%

Vulnerabilities to and the Socioeconomic and Psychosocial Impacts of the Leishmaniases: A Review

Grifferty¹,

Shirley²,

McGloin

et al. 2021

RRTM

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“…When: What is/are the appropriate use case scenario(s) of the technology? When in a workflow, healthcare continuum, or disease stage is a device to be used (33)(34)(35)? A clear understanding of the use case scenario is necessary to inform requirements and later implementation stages.…”

Section: Takeawaymentioning

confidence: 99%

“…When available, a TPP is an ideal starting blueprint for technology designers. When a TPP does not yet exist and the use case is not yet well defined, the development of a concept target product profile (CTPP) can be a useful tool to help engineers identify key contextual factors and specific needs earlier in a design process (33,34). A CTPP defines the context-specific need via the Five Ws and How of the use-case scenario that the medical device solution should address, and informs the technical requirements of the solution.…”

Section: Concept Target Product Profilesmentioning

confidence: 99%

Thinking Beyond the Device: An Overview of Human- and Equity-Centered Approaches for Health Technology Design

Rodríguez

Burleson

Linnes

et al. 2023

Annu. Rev. Biomed. Eng.

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A shift in the traditional technocentric view of medical device design to a human-centered one is needed to bridge existing translational gaps and improve health equity. To ensure the successful and equitable adoption of health technology innovations, engineers must think beyond the device and the direct end user and must seek a more holistic understanding of broader stakeholder needs and the intended context of use early in a design process. The objectives of this review article are ( a) to provide rationale for the need to incorporate meaningful stakeholder analysis and contextual investigation in health technology development and biomedical engineering pedagogy, ( b) to review existing frameworks and human- and equity-centered approaches to stakeholder engagement and contextual investigation for improved adoption of innovative technologies, and ( c) to present case study examples of medical device design that apply these approaches to bridge the gap between biomedical engineers and the contexts for which they are designing. Expected final online publication date for the Annual Review of Biomedical Engineering, Volume 25 is June 2023. Please see http://www.annualreviews.org/page/journal/pubdates for revised estimates.

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“…21,22,23,24,25,26,27,28 Point-of-care tests are medical devices, designed to meet the World Health Organization (WHO) ASSURED (affordable, sensitive, specific, user-friendly, rapid and robust, equipment-free, and deliverable to end user) http://www.phcfm.org Open Access quality standard. 12,27,29,30,31,32,33,34,35,36,37,38,39 The introduction of the WHO Model List of an Essential In-Vitro Diagnostic (EDL) has been a remarkable strategy to reach and speed up a life-saving diagnosis, informing treatment and referral decisions and eliminating symptomatic treatment, particularly in health facilities without laboratories. 28,40,41,42 The WHO EDL is additionally contributing to improving access to healthcare services and health outcomes in resourcelimited settings.…”

Section: Introductionmentioning

confidence: 99%

Availability, stock levels and usage of In-vitro diagnostics in the Bono region, Ghana: A cross-sectional study

Ansu-Mensah,

Kuupiel,

Bawontuo

et al. 2023

African Journal of Primary Health Care & Family Medicine

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Background: Point-of-care (POC) diagnostic tests play essential roles in diagnosis, surveillance, and disease management in health settings. Nevertheless, implementation challenges may hamper POC test accessibility. This study evaluated the availability and stock levels of the World Health Organization (WHO) prequalified existing in-vitro diagnostics (IVDs) for use in health facilities without laboratories.Aim: To evaluate the availability, stock levels, and usage of POC diagnostic tests.Setting: Bono Region, Ghana.Methods: This cross-sectional survey involved 102 randomly selected Community Health-based and Planning Services (CHPS), 12 district health depots, and a regional medical depot. Using a survey tool, data were collected on clinic staffing, availability and stock levels of tests, and funding sources. STATA 17 was employed for data analysis.Results: Majority (37.3%) of the respondents were community health nurses, with 4.4 mean years of work experience and 38 working hours per week. Of the 18 existing WHO prequalified POC tests for use at facilities without laboratories, 10 (56%), 2 (11%) and 0 (0%) were found at CHPS, regional, and district depots, respectively. Majority (183 out of 301) stock levels were low. Of the 10 available tests found, 7 scored 111 (36%) of ‘high use’. Supply chain management compliance was 5 (31%) out of 16. All CHPS received government funding with 25.5% of them receiving additional donor or internally generated funding.Conclusion: This study found poor supply chain management compliance, and low availability of POC tests in the Bono Region of Ghana.Contribution: The study outlines POC tests availability and usage in low-resourced setting.

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Matching Development of Point-of-Care Diagnostic Tests to the Local Context: A Case Study of Visceral Leishmaniasis in Kenya and Uganda

Cited by 6 publications

References 27 publications

Vulnerabilities to and the Socioeconomic and Psychosocial Impacts of the Leishmaniases: A Review

Vulnerabilities to and the Socioeconomic and Psychosocial Impacts of the Leishmaniases: A Review

Thinking Beyond the Device: An Overview of Human- and Equity-Centered Approaches for Health Technology Design

Availability, stock levels and usage of In-vitro diagnostics in the Bono region, Ghana: A cross-sectional study

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