Which attributes within target product profiles for tuberculosis diagnostics are the most important to focus on?

Adepoyibi, T.; Lilis, L; Greb, H.; Boyle, D.

doi:10.5588/ijtld.17.0312

Cited by 7 publications

(2 citation statements)

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“…Country stakeholders of 14 countries ranked sensitivity the most important element in the TPPs for TB diagnostics. 33 Yet, a TB test developer argues that in order to optimise accessibility at POC, a developer might have to compromise accuracy (test developer 20). Regulatory approval processes should be cognizant of this trade-off and require evidence accordingly.…”

Section: Research and Developmentmentioning

confidence: 99%

Aligning diagnostics to the point-of-care: lessons for innovators, evaluators and decision-makers from tuberculosis and HIV

Engel

Wolffs

2020

BMJ Glob Health

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Diagnostics, including those that work at point-of-care, are an essential part of successful public health responses to infectious diseases and pandemics. Yet, they are not always used or fit intended use settings. This paper reports on key insights from a qualitative study on how those engaged with developing and implementing new point-of-care (POC) diagnostics for tuberculosis (TB) and HIV ensure these technologies work at POC. Ethnographic fieldwork between 2015 and 2017 consisting of 53 semistructured interviews with global stakeholders and visits to workshops, companies, and conferences was combined with 15 semistructured interviews with stakeholders in India including providers, decision-makers, scientists and developers and visits to companies, clinics and laboratories. Our results show how developers and implementer of HIV and TB POC diagnostics aim to know and align their diagnostics to elements in more settings than just intended use, but also the setting of the developer, the global intermediaries, the bug/disease and the competitor. Actors and elements across these five settings define what a good diagnostic is, yet their needs might conflict or change and they are difficult to access. Aligning diagnostics to the POC requires continuous needs assessment throughout development and implementation phases as well as substantive, ongoing investment in relationships with users. The flexibility required for such continuous realigning and iteration clashes with established evaluation procedures and business models in global health and risks favouring certain products over others. The paper concludes with suggestions to strengthen this alignment work and applies this framework to research needs in the wake of COVID-19.

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Section: Research and Developmentmentioning

confidence: 99%

Aligning diagnostics to the point-of-care: lessons for innovators, evaluators and decision-makers from tuberculosis and HIV

Engel

Wolffs

2020

BMJ Glob Health

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“…A high-level guideline [ 16 ] and a roadmap [ 17 ] have been published recently. Adepoyibi et al [ 18 ] conducted a survey among laboratory personnel, national tuberculosis control program managers, donors, technical experts, patients and researchers, and asked them to rank the items in a TPP for tuberculosis diagnostic tools by their perceived importance. Denkinger et al [ 19 ] included patients among stakeholders in the prioritization of TPP items for tuberculosis diagnostic tools.…”

Section: Introductionmentioning

confidence: 99%

Involving patients in drug development for Neglected Tropical Diseases (NTDs): A qualitative study exploring and incorporating preferences of patients with cutaneous leishmaniasis into Target Product Profile development

Castro,

Erber,

Arana

et al. 2024

PLoS Negl Trop Dis

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Background Target Product Profiles (TPPs) are instrumental to help optimise the design and development of therapeutics, vaccines, and diagnostics–these products, in order to achieve the intended impact, should be aligned with users’ preferences and needs. However, patients are rarely involved as key stakeholders in building a TPP. Methodology Thirty-three cutaneous leishmaniasis (CL) patients from Brazil, Colombia, and Austria, infected with New-World Leishmania species, were recruited using a maximum variation approach along geographic, sociodemographic and clinical criteria. Semi-structured interviews were conducted in the respective patient’s mother tongue. Transcripts, translated into English, were analysed using a framework approach. We matched disease experiences, preferences, and expectations of CL patients to a TPP developed by DNDi (Drug for Neglected Diseases initiative) for CL treatment. Principal findings Patients’ preferences regarding treatments ranged from specific efficacy and safety endpoints to direct and significant indirect costs. Respondents expressed views about trade-offs between efficacy and experienced discomfort/adverse events caused by treatment. Reasons for non-compliance, such as adverse events or geographical and availability barriers, were discussed. Considerations related to accessibility and affordability were relevant from the patients’ perspective. Conclusions/Significance NTDs affect disadvantaged populations, often with little access to health systems. Engaging patients in designing adapted therapies could significantly contribute to the suitability of an intervention to a specific context and to compliance, by tailoring the product to the end-users’ needs. This exploratory study identified preferences in a broad international patient spectrum. It provides methodological guidance on how patients can be meaningfully involved as stakeholders in the construction of a TPP of therapeutics for NTDs. CL is used as an exemplar, but the approach can be adapted for other NTDs.

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Rapid molecular tests for tuberculosis and tuberculosis drug resistance: a qualitative evidence synthesis of recipient and provider views

Engel

Ochodo

Karanja

et al. 2022

Cochrane Database of Systematic Reviews

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Background Programmes that introduce rapid molecular tests for tuberculosis and tuberculosis drug resistance aim to bring tests closer to the community, and thereby cut delay in diagnosis, ensure early treatment, and improve health outcomes, as well as overcome problems with poor laboratory infrastructure and inadequately trained personnel. Yet, diagnostic technologies only have an impact if they are put to use in a correct and timely manner. Views of the intended beneficiaries are important in uptake of diagnostics, and their effective use also depends on those implementing testing programmes, including providers, laboratory professionals, and staff in health ministries. Otherwise, there is a risk these technologies will not fit their intended use and setting, cannot be made to work and scale up, and are not used by, or not accessible to, those in need. Objectives To synthesize end‐user and professional user perspectives and experiences with low‐complexity nucleic acid amplification tests (NAATs) for detection of tuberculosis and tuberculosis drug resistance; and to identify implications for effective implementation and health equity. Search methods We searched MEDLINE, Embase, CINAHL, PsycInfo and Science Citation Index Expanded databases for eligible studies from 1 January 2007 up to 20 October 2021. We limited all searches to 2007 onward because the development of Xpert MTB/RIF, the first rapid molecular test in this review, was completed in 2009. Selection criteria We included studies that used qualitative methods for data collection and analysis, and were focused on perspectives and experiences of users and potential users of low‐complexity NAATs to diagnose tuberculosis and drug‐resistant tuberculosis. NAATs included Xpert MTB/RIF, Xpert MTB/RIF Ultra, Xpert MTB/XDR, and the Truenat assays. Users were people with presumptive or confirmed tuberculosis and drug‐resistant tuberculosis (including multidrug‐resistant (MDR‐TB)) and their caregivers, healthcare providers, laboratory technicians and managers, and programme officers and staff; and were from any type of health facility and setting globally. MDR‐TB is tuberculosis caused by resistance to at least rifampicin and isoniazid, the two most effective first‐line drugs used to treat tuberculosis. Data collection and analysis We used a thematic analysis approach for data extraction and synthesis, and assessed confidence in the findings using GRADE CERQual approach. We developed a conceptual framework to illustrate how the findings relate. Main results We found 32 studies. All studies were conducted in low‐ and middle‐income countries. Twenty‐seven studies were conducted in high‐tuberculosis burden countries and 21 studies in high‐MDR‐TB burden countries. Only one study was from an Eastern European country. While the studies covered a diverse use of low‐complexity NAATs, in only a m...

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Which attributes within target product profiles for tuberculosis diagnostics are the most important to focus on?

Abstract: Consulting widely regarding which TPP attributes are valued most by users and decision-makers involved in introducing TB diagnostics can assist TB test developers to prioritize their investments, and guide decision making if trade-offs are necessary.

Cited by 7 publications

References 0 publications

Aligning diagnostics to the point-of-care: lessons for innovators, evaluators and decision-makers from tuberculosis and HIV

Aligning diagnostics to the point-of-care: lessons for innovators, evaluators and decision-makers from tuberculosis and HIV

Involving patients in drug development for Neglected Tropical Diseases (NTDs): A qualitative study exploring and incorporating preferences of patients with cutaneous leishmaniasis into Target Product Profile development

Rapid molecular tests for tuberculosis and tuberculosis drug resistance: a qualitative evidence synthesis of recipient and provider views

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