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为以患者为中心的结核病诊断目标产品简介提供信息:一项多国定性研究。

Informing People-Centered Target Product Profiles for TB Diagnostics: A Multi-Country Qualitative Study.

作者信息

Castro Maria Del Mar, Le Hien, Manoj Kumar Kingsley, Mamani-Mategula Elisabeth, Nakaweesa Annet, Dalay Victoria, Shah Kinari, Venter Rouxjeane, Christopher Devasahayam J, Yu Charles, Theron Grant, Worodria William, Nahid Payam, Cattamanchi Adithya, Denkinger Claudia M, Kerkhoff Andrew D, West Nora, Phan Ha

机构信息

Division of Infectious Disease and Tropical Medicine, University Hospital Heidelberg, Germany.

German Center for Infection Research (DZIF), partner site Heidelberg, Germany.

出版信息

medRxiv. 2025 Jul 14:2025.07.11.25331385. doi: 10.1101/2025.07.11.25331385.

Abstract

BACKGROUND

Timely and accurate tuberculosis (TB) diagnosis remains a key challenge in high-burden settings. The World Health Organization (WHO) has developed Target Product Profiles (TPPs) to guide diagnostic development, which have largely reflected the perspectives of experts, with limited input from people affected by TB. This qualitative study explored preferences and experiences to inform people-centered TB diagnostic strategies.

METHODS

We conducted 75 semi-structured interviews with adults undergoing TB evaluation at outpatient clinics in India, the Philippines, South Africa, Uganda, and Vietnam. Participants were purposively sampled to ensure diversity in sex, TB status, age and treatment. Thematic analysis was utilized.

FINDINGS

Preferences were shaped by five interrelated domains: perceived diagnostic accuracy, sample collection experience, time-to-results, affordability, and testing location. Diagnostic accuracy was consistently prioritized, with many expressing willingness to trade comfort and convenience for more trustworthy results. Sputum and blood were widely trusted despite collection challenges, whereas tongue swabs and urine were easier to provide but perceived as less accurate. Rapid, same-day turnaround was valued for minimizing emotional distress, financial and logistical burdens. Although testing was typically free, indirect costs such as transport and lost income, remained barriers. Hospital-based testing was preferred due to trust in staff and infrastructure, though some acknowledged the appeal of community-based approaches if reliability and privacy were ensured.

CONCLUSION

People seeking TB care prioritize accuracy and trustworthiness, even at the expense of comfort or convenience. These preferences can inform WHO policy updates, especially regarding the adoption of novel sample types and testing strategies, to support uptake and equitable access to novel diagnostics.

摘要

背景

在结核病高负担地区,及时、准确的结核病诊断仍然是一项关键挑战。世界卫生组织(WHO)制定了目标产品简介(TPPs)来指导诊断方法的研发,这些简介在很大程度上反映了专家的观点,而受结核病影响的人群提供的意见有限。这项定性研究探讨了相关偏好和经历,以为以患者为中心的结核病诊断策略提供信息。

方法

我们在印度、菲律宾、南非、乌干达和越南的门诊诊所,对正在接受结核病评估的成年人进行了75次半结构化访谈。通过目的抽样确保参与者在性别、结核病状况、年龄和治疗情况方面具有多样性。采用了主题分析法。

结果

偏好受到五个相互关联的领域影响:感知到的诊断准确性、样本采集体验、获得结果的时间、可承受性和检测地点。诊断准确性始终被列为优先考虑因素,许多人表示愿意为了更可靠的结果而牺牲舒适度和便利性。尽管痰液和血液样本采集存在困难,但仍被广泛信任,而咽拭子和尿液样本采集更容易,但被认为准确性较低。快速、当天出结果受到重视,因为这可以将情绪困扰、经济和后勤负担降至最低。尽管检测通常是免费的,但交通和收入损失等间接成本仍然是障碍。由于对医院工作人员和基础设施的信任,基于医院的检测更受青睐,不过一些人也承认,如果能确保可靠性和隐私性,基于社区的检测方法也有吸引力。

结论

寻求结核病治疗的人将准确性和可靠性放在首位,即使以牺牲舒适度或便利性为代价。这些偏好可为WHO的政策更新提供参考,特别是在采用新型样本类型和检测策略方面,以支持新型诊断方法的推广和公平获取。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff3e/12338892/90368db6c362/nihpp-2025.07.11.25331385v1-f0001.jpg

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