Benbaba Stella, Isaakidis Petros, Das Mrinalini, Jadhav Sonakshi, Reid Tony, Furin Jennifer
Médecins Sans Frontières, Mumbai, India.
Médecins Sans Frontières, Operational Research Unit, Luxembourg City, Luxembourg.
PLoS One. 2015 Dec 29;10(12):e0144936. doi: 10.1371/journal.pone.0144936. eCollection 2015.
Directly-observed therapy (DOT) is recommended for drug-resistant tuberculosis (DR-TB) patients during their entire treatment duration. However, there is limited published evidence on implementation of direct observation (DO) in the field. This study aims to detail whether DO was followed with DR-TB patients in a Médecins Sans Frontières (MSF) tuberculosis program in Mumbai, India.
This was a cross-sectional, mixed-methods study. Existing qualitative data from a purposively-selected subset of 12 patients, 5 DOT-providers and 5 family members, were assessed in order to determine how DO was implemented. A questionnaire-based survey of DR-TB patients, their DOT-providers and MSF staff was completed between June and August 2014. Patients were defined as"following Strict DO" and "following DO" if a DOT-provider had seen the patient swallow his/her medications "every day" or "most of the days" respectively. If DO was not followed, reasons were also recorded. The qualitative data were analysed for theme and content and used to supplement the questionnaire-based data.
A total of 70 DR-TB patients, 65 DOT-providers and 21 MSF health staff were included. Fifty-five per cent of the patients were HIV-co-infected and 41% had multidrug-resistant-TB plus additional resistance to a fluoroquinolone. Among all patients, only 14% (10/70) and 20% (14/70) self-reported "following Strict DO" and "following DO" respectively. Among DOT-providers, 46% (30/65) reported that their patients "followed DO". MSF health staff reported none of the patients "followed DO". Reasons for not implementing DO included the unavailability of DOT-provider, time spent, stigma and treatment adverse events. The qualitative data also revealed that "Strict DO" was rarely followed and noted the same reasons for lack of implementation.
This mixed-methods study has found that a majority of patients with DR-TB in Mumbai did not follow DO, and this was reported by patients and care-providers. These data likely reflect the reality of DO implementation in many high-burden settings, since this relatively small cohort was supported and closely monitored by a skilled team with access to multiple resources. The findings raise important concerns about the necessity of DO as a "pillar" of DR-TB treatment which need further validation in other settings. They also suggest that patient-centred adherence strategies might be better approaches for supporting patients on treatment.
对于耐多药结核病（DR-TB）患者，建议在整个治疗期间采用直接观察治疗（DOT）。然而，关于实地实施直接观察（DO）的已发表证据有限。本研究旨在详细了解在印度孟买无国界医生组织（MSF）的结核病项目中，耐多药结核病患者是否接受了直接观察。
这是一项横断面混合方法研究。对从12名患者、5名DOT提供者和5名家庭成员中特意挑选出的子集的现有定性数据进行评估，以确定直接观察是如何实施的。2014年6月至8月期间，对耐多药结核病患者、他们的DOT提供者和无国界医生组织工作人员进行了基于问卷的调查。如果DOT提供者分别看到患者“每天”或“大多数日子”吞咽其药物，则患者被定义为“严格遵循直接观察”和“遵循直接观察”。如果未遵循直接观察，也记录了原因。对定性数据进行主题和内容分析，并用于补充基于问卷的数据。
共纳入70名耐多药结核病患者、65名DOT提供者和21名无国界医生组织卫生工作人员。55%的患者合并感染艾滋病毒，4......余下全文。41%的患者患有耐多药结核病并对氟喹诺酮类药物有额外耐药性。在所有患者中，分别只有14%（10/70）和20%（14/70）自我报告“严格遵循直接观察”和“遵循直接观察”。在DOT提供者中，46%（30/65）报告他们的患者“遵循直接观察”。无国界医生组织卫生工作人员报告没有患者“遵循直接观察”。未实施直接观察的原因包括DOT提供者不可用、花费的时间、耻辱感和治疗不良事件。定性数据还显示“严格直接观察”很少被遵循，并指出了缺乏实施的相同原因。
这项混合方法研究发现，孟买的大多数耐多药结核病患者没有遵循直接观察，患者和护理提供者均报告了这一情况。这些数据可能反映了许多高负担环境中直接观察实施的现实情况，因为这个相对较小的队列得到了一个有能力获取多种资源的专业团队的支持和密切监测。这些发现引发了对直接观察作为耐多药结核病治疗“支柱”必要性的重要担忧，这需要在其他环境中进一步验证。它们还表明，以患者为中心的依从性策略可能是支持患者接受治疗的更好方法。
