Buyinza Nasur, Nkhoma Kennedy, Namisango Eve, Maddocks Matthew, Downing Julia, Prevost A Toby, Chukwusa Emeka, Harding Richard
Hospice Africa Uganda, Makindye, Kampala, Uganda.
Florence Nightingale Faculty of Nursing Midwifery & Palliative Care, King's College London, London, UK.
Lancet Glob Health. 2025 Aug;13(8):e1448-e1457. doi: 10.1016/S2214-109X(25)00173-1. Epub 2025 May 21.
People with multidrug-resistant tuberculosis experience burdensome symptoms, clinical uncertainty, and high mortality. Palliative care is a designated essential health service under Universal Health Coverage. We aimed to test the hypothesis that receipt of additional nurse-led palliative care would improve patient-reported outcomes for patients with multidrug-resistant tuberculosis, compared with usual care.
This single-masked, parallel pragmatic randomised controlled trial recruited adults from three public hospitals in Uganda (Mulago National Referral Hospital Kampala, Gulu Regional Referral Hospital, and Mbale Regional Referral Hospital). Inclusion criteria for the study were adults aged 18 years and older with a confirmed bacteriological diagnosis of multidrug-resistant tuberculosis (not responsive to isoniazid or rifampicin) who were registered at the respective study site clinics and who were able to give informed consent. Participants were randomly assigned (1:1) to the intervention (additional nurse-led care) or the standard care control group using randomly permuted blocks stratified by treatment centre. Intervention group participants received nurse-led person-centred holistic assessment, care planning, symptom control, and psychosocial support delivered on inpatient wards or at home. Fortnightly appointments alternated between face-to-face visits and telephone follow-up. Researchers were masked to participant group allocation. The primary outcome was multidimensional palliative care-related symptoms and concerns measured using the African Palliative Care Association Integrated Palliative Outcome Scale, measured monthly from baseline to the primary 4-month endpoint, analysed using a linear mixed-effect model, applying the intention-to-treat principle to analyse participants by allocated group. The trial was registered on the ISRCTN registry (ISRCTN13664346) and is complete.
Between Dec 18, 2019, and Sept 10, 2020, 178 individuals were initially assessed for eligibility, 24 were excluded for not meeting inclusion criteria, declining to participate, or being too ill to participate, and 154 participants were recruited and randomly assigned to the intervention group or the control group. 76 were assigned to the nurse-led palliative care group and 78 were assigned to the control group. 52 (34%) participants were female and 102 (66%) were male and participants had an overall median age of 38 years (IQR 31-46). From the linear mixed-effects model the intervention had a significant positive effect compared with standard care (5·12 scale-points [95% CI 2·89-7·21], p<0·0001) at the 4-month follow-up. The standardised effect size was 0·61 (95% CI 0·35-0·86).
Additional nurse-led palliative care for patients with multidrug-resistant tuberculosis improved self-reported outcomes spanning physical, psychological, social, and spiritual domains, and increased medication adherence. Person-centred assessment and holistic care with pain and symptom control should be task-shifted into routine tuberculosis care.
Open Society Foundations.
耐多药结核病患者承受着沉重的症状负担、临床不确定性和高死亡率。姑息治疗是全民健康覆盖下指定的基本卫生服务。我们旨在检验这一假设：与常规治疗相比，额外接受护士主导的姑息治疗能改善耐多药结核病患者的患者报告结局。
这项单盲、平行实用随机对照试验从乌干达的三家公立医院（坎帕拉穆拉戈国家转诊医院、古卢地区转诊医院和姆巴莱地区转诊医院）招募成年人。研究的纳入标准为年龄在18岁及以上、经细菌学确诊为耐多药结核病（对异烟肼或利福平无反应）、在各自研究地点诊所登记且能够给予知情同意的成年人。参与者使用按治疗中心分层的随机排列块以1:1的比例随机分配至干预组（额外的护士主导护理）或标准护理对照组。干预组参与者在住院病房或家中接受护士主导的以患者为中心的全面评估、护理计划、症状控制和心理社会支持。每两周的预约在面对面访视和电话随访之间交替进行。研究人员对参与者的分组分配情况不知情。主要结局是使用非洲姑息治疗协会综合姑息结局量表测量的多维度姑息治疗相关症状和担忧，从基线到主要的4个月终点每月测量一次，使用线性混合效应模型进行分析，采用意向性分析原则按分配组分析参与者。该试验已在国际标准随机对照试验编号注册库（ISRCTN13664346）注册且已完成。
在2019年12月18日至2020年9月10日期间，最初评估了178人是否符合资格，24人因不符合纳入标准、拒绝参与或病情太重无法参与而被排除，154名参与者被招募并随机分配至干预组或对照组。76人被分配至护士主导的姑息治疗组，78人被分配至对照组。52名（34%）参与者为女性，102名（66%）为男性，参与者的总体中位年龄为38岁（四分位间距31 - 46岁）。在线性混合效应模型中，与标准护理相比，干预在4个月随访时有显著的正向效应（5.12个量表点[95%置信区间2.89 - 7.21]，p<0.0001）。标准化效应大小为0.61（95%置信区间0.35 - 0.86）。
为耐多药结核病患者额外提供护士主导 的姑息治疗可改善自我报告的结局，涵盖身体、心理、社会和精神领域，并提高药物依从性。应以患者为中心进行评估并提供包括疼痛和症状控制在内的全面护理，可将其任务转移至常规结核病护理中。
开放社会基金会。
