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Assessing the clinical utility of composite outcomes in studies examining outcomes of implantable neuromodulation therapies for pain: a systematic review

Por: Chung · O. S. · Gabriel · G. M. · Alomari · A. · Bhatia · A.
Background

Implantable neuromodulation therapies are offered to patients with certain refractory pain syndromes. These therapies are resource-intensive and effort-intensive and may be associated with significant adverse effects. Change in pain intensity score, an unidimensional measurement tool, is currently the most used eligibility criteria for patients to receive implanted neuromodulation devices. However, pain is a biopsychosocial phenomenon, and assessment of effectiveness of neuromodulation therapies using tools that incorporate multiple pain-related domains may be more relevant and accurate. Composite measures integrate multiple domains of patient well-being, enabling a clinically relevant assessment of treatment effects. This systematic review aims to evaluate the literature on the clinical utility and reliability of composite outcomes as a means to assess efficacy of implantable neuromodulation therapies for refractory pain.

Methods and analysis

We will search Embase, MEDLINE, Cochrane Central Register of Controlled Trials and the WHO’s International Clinical Trials Registry Platform. Searches will be limited to from inception of each database to 31 December 2025. Studies published in English will be considered eligible if they used composite outcomes to evaluate the efficacy and/or effectiveness of implantable neuromodulation therapies for treating refractory pain. The studies should investigate adult populations (aged ≥18 years) undergoing implantation for chronic refractory pain of moderate-to-severe intensity. Two reviewers will independently screen articles, extract data and review the risk of bias and the grade of evidence provided in the studies. Extracted data will include study details (author, year, country of origin), participant demographics (age, sex), sample sizes and intervention details. Outcome measures include pain intensity, physical health, mental health, quality of life, medication use and neuromodulation device explantation rates. Data will be collected at baseline, 3 months, 6 months and 12 months post-implantation where available. A meta-analysis will be formed if there is sufficient homogeneity in the studies and their data.

Ethics and dissemination

As this study is a systematic review using data that has already been published in scientific literature or is publicly available, ethics approval is not required. For dissemination, we plan to share the findings of our review through multiple academic and clinical channels. The completed review will be submitted for publication in a peer-reviewed journal relevant to pain medicine or neuromodulation.

PROSPERO registration number

CRD42025631488.

Who gets counted? Understanding low female death registration in India

by Sheetal Verma, Ritul Kamal, Laxmi Kant Dwivedi, Mrigesh Bhatia

Background

Civil Registration and Vital Statistics (CRVS) systems are essential for governance, public health, and achieving SDGs however, gender gaps limit women’s access to rights and services, with under-registration of female vital events reinforcing their invisibility and distorting gender-responsive policies.

Objectives

This study examines the drivers of low female death registration across India’s States and Union Territories, focusing on the roles of age, gender and wealth, with an aim to inform policies to strengthen CRVS systems and reduce gender disparities in vital statistics.

Methods

The study utilizes data from NFHS-5 (2019–2021 for examining the factors associated with female death registration. Multivariable logistic regression models have been used to examine the impact of socio-economic and demographic factors on female death registration in India.

Findings

The results highlight a significant gender gap in death registration (73% male vs. 64% female). The gap is widest in states like Bihar and Uttar Pradesh, while states like Kerala and Goa report near universal registration for both sexes. Gender gaps in housing and land ownership align with gaps in death registration, suggesting a strong association between asset ownership and registration. The results highlight association between wealth and death registration, with rates rising across quintiles for both sexes; however males consistently have higher registration rates. Among the poorest, the gap is widest which narrows down in the richest group. A gender gap in death registration persists across all age groups in India, beginning early, widening during working ages, and continuing into old age; while registration rates improve with age and wealth, women especially among the poorest remain under-registered, particularly in early and later life stages.

Conclusions

Women in India encounter barriers to civil registration, and improving death registration demands systemic reforms, digital advancements, and community engagement Strengthening political commitment, collaboration, and public awareness will ensure inclusive, accurate records, enhancing CRVS for governance and policy.

What is the experience of healthcare professionals managing Achilles tendon ruptures in the National Health Service (NHS)?--a qualitative interview study in the United Kingdom

Por: Briggs-Price · S. · Yates · T. · Mangwani · J. · Bhatia · M. · ONeill · S.
Objective

To explore National Health Service (NHS) healthcare professionals’ experiences of delivering rehabilitation for patients with Achilles tendon rupture (ATR).

Design

Qualitative study using semistructured interviews and reflexive thematic analysis.

Setting

NHS hospital sites in the United Kingdom, providing non-surgical ATR management using the Leicester Achilles Management Protocol (LAMP).

Participants

Twenty-one NHS healthcare professionals, including physiotherapists and orthopaedic consultants with a mean of 10.8 years of clinical experience, purposively sampled based on profession and experience managing ATR.

Results

Three main themes were identified: (1) clinical training on Achilles tendon ruptures, (2) rehabilitation following ATR and (3) the NHS service delivering rehabilitation. Participants reported limited training on ATR, leading to reduced confidence and slower rehabilitation progressions. Fear of re-injury influenced clinical decision-making, while discharge decisions were goal-oriented but constrained by service limitations.

Conclusions

This study highlights limited clinical training, inconsistent rehabilitation practices and NHS service constraints that collectively slow rehabilitation progress and affect return to sport following ATR. Enhanced training, service development and greater standardisation of ATR rehabilitation pathways are recommended to improve patient outcomes.

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