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Economic evaluation of integrating nutritional support intervention in Indias National Tuberculosis Elimination Programme: implications for low-income and middle-income countries

Por: Jyani · G. · Prinja · S. · Nadipally · S. · Shankar · M. · Rao · N. · Rao · V. · Singh · R. R. · Shah · A. · Chugh · Y. · Monga · D. · Sharma · A. · Aggarwal · A.
Objectives

This study aimed to evaluate the cost-effectiveness of integrating nutritional support into India’s National Tuberculosis Elimination Programme (NTEP) using the MUKTI initiative.

Design

Economic evaluation.

Setting

Primary data on the cost of delivering healthcare services, out-of-pocket expenditure and health-related quality of life among patients with tuberculosis (TB) were collected from Dhar district of Madhya Pradesh, India.

Intervention

Integration of nutritional support (MUKTI initiative) into the NTEP of India.

Control

Routine standard of care in the NTEP of India.

Primary outcome measure

Incremental cost per quality-adjusted life year (QALY) gained.

Methods

A mathematical model, combining a Markov model and a compartmental susceptible–infected–recovered model, was used to simulate outcomes for patients with pulmonary TB under NTEP and MUKTI protocols. Primary data collected from 2615 patients with TB, supplemented with estimates from published literature, were used to model progression of disease, treatment outcomes and community transmission dynamics over a 2-year time horizon. Health-related quality of life was assessed using the EuroQol 5-Dimension 5-Level scale. Costs to the health system and out-of-pocket expenditures were included. A multivariable probabilistic sensitivity analysis was undertaken to estimate the effect of joint parameter uncertainty. A scenario analysis explored outcomes without considering community transmission. Results are presented based on health-system and abridged societal perspectives.

Results

Over 2 years, patients in the NTEP plus MUKTI programme had higher life years (1.693 vs 1.622) and QALYs (1.357 vs 1.294) than those in NTEP alone, with increased health system costs (11 538 vs 6807 (US$139 vs US$82)). Incremental cost per life year gained and QALY gained were 67 164 (US$809) and 76 306 (US$919), respectively. At the per capita gross domestic product threshold of 161 500 (US$1946) for India, the MUKTI programme had a 99.9% probability of being cost-effective but exceeded the threshold when excluding community transmission.

Conclusion

The findings highlight the potential benefits of a cost-effective, holistic approach that addresses socio-economic determinants such as nutrition. Reduction in community transmission is the driver of cost-effectiveness of nutritional interventions in patients with TB.

Surgery or radiotherapy for early-stage cancer study (SORT) target trial protocol: stereotactic ablative radiotherapy (SABR) with curative intent versus surgical resection for early-stage non-small cell lung cancer (NSCLC)

Por: Kagenaar · E. · Lugo-Palacios · D. G. · Hutchings · A. · Aggarwal · A. · ONeill · S. · Rachet · B. · Edwards · J. · Faivre-Finn · C. · Grieve · R. · Surgery or Radiotherapy Study (SORT) group · Choudhury · Vohra · Cresswell · Charlton · Chuter · Nolte · Gravenhorst · Alencar · Mon
Introduction

Randomised controlled trials have aimed to assess the effectiveness of stereotactic ablative radiotherapy (SABR) with curative intent versus surgical resection for individuals diagnosed with early-stage non-small cell lung cancer (NSCLC) but have failed to recruit sufficient numbers of patients. Non-randomised studies for early-stage NSCLC have reported mixed outcomes following curative SABR versus surgical resection, but did not fully address confounding by indication. The Surgery Or RadioTherapy for early-stage cancer study (SORT) will assess the comparative effectiveness of SABR with curative intent versus surgical resection for NSCLC with a target trial emulation approach, as this can reduce biases in observational studies that aim to estimate the causal effect of interventions.

Methods and analysis

The SORT study will use the National Cancer Registry for individuals diagnosed with early-stage NSCLC in England during 2015–2020 (inclusive) who received SABR with curative intent or surgical resection. These data will be linked to Hospital Episode Statistics, National Radiotherapy Data Set and the Systemic Anti-Cancer Therapy dataset to obtain information on clinical and sociodemographic characteristics and the treatment received. This target trial emulation will define study population eligibility criteria and regimens for SABR with curative intent and surgical resection. We will reduce the risk of residual confounding with instrumental variable analyses that will exploit geographical variation across the National Health Service in England in the use of SABR with curative intent versus surgical resection for early-stage NSCLC. The primary outcome will be 3-year all-cause mortality after treatment initiation. Secondary outcomes will include 3-month, 6-month, 12-month and 24-month all-cause and lung-cancer mortality, time to death, numbers of hospitalisations, incremental costs and incremental cost-effectiveness.

Ethics and dissemination

Ethical approval was obtained from the London School of Hygiene and Tropical Medicine Research Ethics Committee (reference number 29 717–1). Results will be disseminated to clinicians, patients, policy-makers and researchers.

Statins improve antidepressant adherence and tolerability compared to antidepressants alone

Por: Aggarwal · N.

Commentary on: De Giorgi R, De Crescenzo F, Cowen PJ, Harmer CJ, Cipriani A. Real-world outcomes of concomitant antidepressant and statin use in primary care patients with depression: a population-based cohort study. BMC Med. 2023 Nov 7;21(1):424. doi: 10.1186/s12916-023-03138-5.

Implications for practice and research

  • Providers should encourage antidepressant use with statins for depression that is comorbid with physical conditions.

  • Research can clarify which population subgroups taking both medications demonstrate improved outcomes.

  • Context

    Depression affects more than 350 million people worldwide.1 Even though guidelines support using antidepressants to treat moderate and severe depression, nearly 50% of people do not respond to antidepressants2 and 25% discontinue them.3 Studies suggest that adding statins to antidepressants can improve antidepressant adherence, but these studies have been underpowered to test outcomes.4

    Methods

    De Giorgi and colleagues used the largest UK-based...

    Strategic multimodal intervention in at-risk elderly Indians for prevention of dementia (SMRUTHI INDIA): a cohort multiple randomised controlled trial (cmRCT) protocol

    Por: Gupta · A. · Sinha · A. · Sharma · V. · Raina · S. K. · Roy · S. · Baidya · S. · Anand · P. K. · Nehra · A. · Nilima · N. · Khan · M. A. · Vishnu · V. Y. · Srivastava · P. · SMRUTHI INDIA Collaborators · Patil · Aggarwal · Gupta · Sharma · Sharma · Dubey · Narzari · Sneha · Kashyap · Kau
    Introduction

    Treating modifiable risk factors of dementia may prevent or delay dementia cases by up to 40%. The ‘Strategic Multimodal Intervention in at-risk Elderly Indians for Prevention of Dementia (SMRUTHI INDIA)’ study will be conducted to establish a trial-ready cohort of elderly Indians who are at high risk of developing dementia.

    Methods and analysis

    The main aim of the study is to create and study a cohort of individuals at high risk of dementia in rural India, where we can do multiple intervention trials. The study uses the ‘Cohort Multiple Randomised Controlled Trial’ (cmRCT) design, which combines a cohort study with in-built provisions to do multiple randomised controlled trials. A large rural cohort of size 10 000 (four zones of India, through established Indian Council of Medical Research - Model Rural Health Research Units) will be followed systematically with yearly neuropsychological evaluation for 5 years (the current funding supports first 3000 participants). The study also proposes to design a multimodal ‘care bundle’ for the prevention of dementia, which is culturally tailored and context-specific to the Indian population. This intervention will undergo testing for feasibility in the hospital setting at the central coordinating site through a pilot randomised controlled trial (6 months, 30 participants). In parallel, the care bundle will be culturally and linguistically adapted and pilot-tested in 20 participants in each zone. The final curated care bundle (first intervention that is planned) will then be tested for efficacy in phase 2 of the SMRUTHI INDIA cmRCT cohort.

    Ethics and dissemination

    The study has received ethical clearance at the central coordinating site and at each of the four clinical sites by the Institute Research Committee of each site. The outcomes of the study will be disseminated to various target audiences, including research participants, general public, scientific community and policy makers through national and international conferences and events, social media, various community engagement activities and publication in peer-reviewed journals.

    Trial registration number

    The study protocol is registered in the Clinical Trial Registry of India (CTRI/2024/01/061172).

    Youth, caregiver and healthcare professional perspectives on planning the implementation of a trauma‐informed care programme: A qualitative study

    Abstract

    Aims

    To explore youth, caregiver and staff perspectives on their vision of trauma-informed care, and to identify and understand potential considerations for the implementation of a trauma-informed care programme in an inpatient mental health unit within a paediatric hospital.

    Design and Methods

    We applied the Interpretive Description approach, guided by complexity theory and the Implementation Roadmap, and used Applied Thematic Analysis methods.

    Findings

    Twenty-five individuals participated in individual or group interviews between March and June 2022, including 21 healthcare professionals, 3 youth and 1 caregiver. We identified two overarching themes. The first theme, ‘Understanding and addressing the underlying reasons for distress’, related to participants’ understanding and vision of TIC in the current setting comprising: (a) ‘Participants’ understanding of TIC’; (b) ‘Trauma screening and trauma processing within TIC’; (c) ‘Taking “a more individualized approach”’; (d) ‘Unit programming’; and (e) “Connecting to the community”. The second theme, ‘Factors that support or limit successful TIC implementation’ comprises: (a) ‘The need for a broad “cultural shift”’; (b) ‘The physical environment on the unit’; and (c) ‘Factors that may limit successful implementation’.

    Conclusion

    We identified five key domains to consider within trauma-informed care implementation: (a) the centrality of engagement with youth, caregivers and staff in trauma-informed care delivery and implementation, (b) trauma-informed care core programme components, (c) factors that may support or limit success in implementing trauma-informed care within the mental health unit and (d) hospital-wide and (e) the importance of intersectoral collaboration (partnering with external organizations and sectors).

    Impact

    When implementing TIC, there is an ongoing need to increase clarity regarding TIC interventions and implementation initiatives. Youth, caregiver and healthcare professional participants shared considerations important for planning the delivery and implementation of trauma-informed care in their setting. We identified five key domains to consider within trauma-informed care implementation: (a) the centrality of relational engagement, (b) trauma-informed care programme components, (c) factors that may support or limit successful implementation of trauma-informed care within the mental health unit and (d) hospital-wide and (e) the importance of intersectoral collaboration. Organizations wishing to implement trauma-informed care should consider ongoing engagement with all relevant knowledge user groups throughout the process.

    Reporting Method

    Standards for Reporting Qualitative Research (SRQR).

    Patient or Public Contribution

    The local hospital research institute's Patient and Family Advisory Committee reviewed the draft study methods and provided feedback.

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