Losses of functional reserve across multiple physiological systems have been identified in frail patients, yet the exact aetiology of frailty remains unclear. Although strongly associated with chronological age, frailty often develops at a younger age in patients with organ failure. Frailty is prevalent in patients with kidney failure; however, individuals experience improvements in physical frailty measures following kidney transplantation. This makes younger patients with kidney failure a unique population for studying both the accelerated onset of frailty and its reversal. This research project aims to test the hypothesis that frailty secondary to organ failure and age-related frailty are associated with similar molecular and physiological measures.

This longitudinal study will recruit 150 patients in three groups. Group A (kidney transplant recipients aged ≥40 years; n=50) and Group B (patients aged ≥40 years active on the kidney transplant waitlist; n=50) will comprise younger adults with frailty from organ failure. Group C (adults aged ≥65 years (or ≥55 years for Aboriginal and Torres Strait Islander patients); n=50) will comprise older community dwellers. The primary outcome is the Frailty Index (FI). Secondary outcomes include the change in FI over time, and at baseline when considering various clinical metadata, immune parameters, kidney function and nutrition intake which will be measured at baseline and 12-month time points. Longitudinal changes in frailty will be analysed using linear mixed models with multiple testing corrections for false discovery rates.

Endocrine profiles and metabolomics, measures of immune function and microcirculatory dysfunction, will be measured by liquid chromatography-mass spectrometry and/or gas chromatography-mass spectrometry. The gut microbiome will be sequenced via shotgun metagenomics (Illumina NextSeq500, 150 bp paired-end, ³Gbp/sample). Circulating cell-free DNA/mitochondrial DNA will be quantified through droplet digital PCR. Microcirculation will be assessed via sublingual dark field videomicroscopy with glycocalyx markers measured by ELISA.

This study will be conducted with all stipulations of this protocol, and the conditions of the ethics committee approval. Ethical principles have their origin in the Declaration of Helsinki, all Australian and local regulations and in the spirit of the standard of Good Clinical Practice (as defined by the International Conference on Harmonisation). Organs/tissues will be sourced ethically and will not be sourced from executed prisoners or prisoners of conscience or other vulnerable groups.

Ethics approval was received by the Metro South Health Research Ethics Committee (HREC/2023/QMS/95392) and ratified by the University of Queensland.

Results will be disseminated through peer-reviewed publications, academic conferences, participant newsletters and health organisation collaboration.

Sympathetic activation is the hallmark of cardiac disease, driving disease progression and triggering ventricular arrhythmia (VA). Despite optimal medical therapy, many patients experience recurrent VAs refractory to medical therapy, leading to repetitive implantable cardioverter defibrillator (ICD) therapy, worse quality of life and adverse outcomes. Cardiac sympathetic denervation (CSD) through surgical removal of the stellate ganglia is an effective treatment for refractory VAs but carries a high complication rate. We hypothesise that high precision image guided radiotherapy can be used to target the stellate ganglia to achieve CSD non-invasively.

RADIO-STAR (hypofractionated radiotherapy to the stellate ganglia for ventricular arrhythmia) is a first-in-human, phase 1 safety and dose finding study of radiotherapy to the stellate ganglia in patients with recurrent VAs. Patients with structural heart disease requiring recurrent ICD therapy for VAs are invited to undergo radiotherapy bilaterally to their stellate ganglia with a predetermined sample size of n=13. Radiotherapy dose will be determined by a prespecified dose escalation protocol. The primary outcome is safety defined as any treatment-related grade 3–5 toxicity occurring within 6 months of radiotherapy treatment, as defined by the Common Terminology Criteria for Adverse Events or any treatment-related side effects detected on patient symptom questionnaires and clinical examination during study visits. Secondary outcome measures to evaluate feasibility and efficacy include ability to safely deliver radiotherapy and consequent changes in circulating catecholamines and neuropeptide-Y, heart rate variability, structural changes in the stellate ganglia on MRI imaging and ICD therapy burden.

This study has received ethical approval by the South Central—Oxford B Research Ethics Committee (REC/SC/0005). Study findings will be submitted for publication in peer-reviewed scientific journals and presented at national and/or international scientific conferences.

ISRCTN49861434.

India had an estimated three to five million excess deaths from causes attributable to SARS-CoV-2 during 2020–2021, far exceeding official government statistics. Most deaths in India occur in rural areas, where medical certification of deaths is limited. Yet, the effects of the pandemic in rural settings remain largely undocumented. We estimated the cause-specific excess mortality in rural areas of selected states of India.

Longitudinal analyses of hospital mortality data.

India’s Health Management Information System (HMIS) reports the number of deaths by cause for adolescents or adults aged 10 years or more. We examined eight states with high coverage of the expected number of deaths in rural areas.

We analysed monthly death reports from the HMIS, which covered approximately 0.2 million health facilities during 2018–2023. We compared excess deaths during the peak COVID-19 months in rural health facilities to pre-COVID-19 and non-peak periods of 2021, and categorised reported causes by their probable association with COVID-19.

Excesses of cause-specific and total mortality.

During the April–June 2021 SARS-CoV-2 wave, predominantly driven by the Delta variant, monthly deaths in rural health facilities across India surged from approximately 200 000 to 500 000. In eight states with high-quality reporting, rural facility deaths increased by 270% (95% CI 267% to 272%) compared with the same months in 2018–2019, prior to the COVID-19 pandemic. Notably, this surge occurred despite a sharp decline in hospital admissions following the national lockdown in March 2020. The largest relative increase was for fever-related and respiratory diseases, and these deaths were markedly elevated even when compared to non-peak months of 2021. Generalising these findings from eight states to all of rural India yields an estimate of approximately 2.6 million excess rural deaths in April–June 2021. In contrast, there were few excess deaths during the Omicron viral waves in 2022–2023.

COVID-19 substantially increased deaths in rural India during April–June 2021, but reassuringly, no significant excess mortality was observed in subsequent years. The HMIS provides an important opportunity to strengthen routine mortality surveillance in rural India.

Palliative care supports the physical, emotional, social and spiritual needs of people with serious life-limiting illness. Future research must align with the priorities of people approaching the end of their lives, and those close to them.

To undertake a refresh of the James Lind Alliance Palliative and End of Life Care Priority Setting Partnership, to identify and prioritise areas for future research.

The James Lind Alliance process was applied, between May 2023 and February 2025. An initial online survey collected areas for future research from participants. These were synthesised into a long list of questions and shortlisted through a second online survey. Final ranking of priorities was achieved using an adapted Nominal Group Technique within a prioritisation workshop.

People living with serious life-limiting illnesses, carers, friends and family members supporting them, bereaved people, health and social care professionals, volunteers working in palliative and end-of-life care and members of the public.

1032 and 626 responses were received to survey 1 and 2, respectively. 20 people with lived and professional experience attended the prioritisation workshop. An updated list of 24 priorities for palliative and end-of-life care research was produced.

The priorities reflect the range of issues shaping end-of-life experiences and serve as a call to action for researchers and funders.

This study assessed the associations between asthma, gastro-oesophageal reflux disease (GORD) and health-related quality-of-life (HRQoL) among adolescents.

A cross-sectional survey.

Six randomly selected schools across all five educational zones of the Anuradhapura district in Sri Lanka.

A total of 1127 adolescents aged 13–14 years were included from six randomly selected schools representing all five educational zones in the Anuradhapura district, Sri Lanka.

Prevalence of asthma and GORD, the associations between asthma, GORD and HRQoL among adolescents in Sri Lanka.

This study of 1127 adolescents (44.8% male, mean age 13.66±0.56 years) found that 16.1% (n=181) had current asthma and 17.9% (n=202) exhibited symptoms of GORD. A significant association was observed between current asthma and GORD (OR 2.30, 95% CI 1.59 to 3.31, p=0.0005). Comorbidity of asthma and GORD was observed in 4.8% of participants (n=54). The total HRQoL score was not associated with asthma, GORD or those having both asthma and GORD. However, the presence of GORD was associated with poor emotional functioning (unstandardized regression coefficient ± standard error = -4.7±1.7, p=0.008).

Asthma and GORD were significantly associated among early adolescents in Sri Lanka. While overall HRQoL did not differ by disease status, the presence of GORD was associated with poorer emotional functioning.

Malaria remains a major public health challenge in India, with transmission dynamics varying widely across ecological, epidemiological, sociobehavioural and health system contexts. Achieving the national malaria elimination target by 2030 requires integrated, context-specific evidence to design effective interventions. This study aims to generate a comprehensive understanding of malaria transmission and factors surrounding it across diverse eco-epidemiological settings in India by assessing malaria burden, identifying determinants of transmission, evaluating health system performance and equity, characterising vector bionomics and insecticide resistance, and examining the influence of environmental drivers.

This longitudinal, multicentric study will be conducted in collaboration with the national programme in 12 districts spanning 10 states in India, covering a population of around 25 000 individuals representing varied ecological contexts (urban, periurban, rural, forest-foothill and coastal) and malaria endemicity levels. In each district, two clusters (villages) with a population of 1000 individuals will be included. A baseline mass survey will estimate malaria prevalence using bivalent rapid diagnostic tests (RDTs) and blood smear microscopy, with low-density parasitaemia detected by PCR in a subset of RDT-negative samples. Participants will be followed for 1 year, with monthly screening of symptomatic individuals using RDT and microscopy, and testing a subset of asymptomatic individuals to detect subclinical infections. Sociobehavioural data will be collected through structured interviews and household observations, with purposive inclusion of vulnerable groups, pregnant women, migrants, elderly persons, individuals with disabilities and tribal populations to assess equity dimensions through mixed-methods approaches. Health system performance will be evaluated through key informant interviews with programme officials, health workers, patients, private practitioners and traditional healers. Entomological surveillance will document vector species composition, density, infection rates and assessment of susceptibility status and intensity of insecticide resistance to commonly used public health insecticides. Environmental variables, including temperature, rainfall and humidity, will be linked with entomological and epidemiological data to explore spatiotemporal relationships.

The protocol was approved by the Institute Human Ethics Committee of ICMR-Vector Control Research Centre (IHEC 03-0125/N/F). All standard ethical practices will be adhered to. The findings will be shared with stakeholders and published in reputed open-access journals.

The objective of this study is to co-produce a care bundle for women with multiple long-term health conditions (MLTC) that could be pilot tested and implemented in UK maternity services.

Online co-production workshops each attended by 20–30 key interest holders.

United Kingdom, October 2023-February 2024.

Women with experience of pregnancy with MLTC, healthcare professionals and other interest holders involved in commissioning, planning and delivering care for pregnant women with MLTC.

This study followed a three-step process: (1) a consolidated list of key components of care for pregnant women with MLTC was created through secondary analysis of prior collected qualitative data; (2) the list of care components was explored during four co-production workshops; and (3) findings from (1) and (2) were synthesised to develop a maternity care bundle of 4–5 key care components for pregnant women with MLTC.

A maternity care bundle of five key care components for pregnant women with MLTC.

A list of 25 care components was refined to develop a proposed care bundle of five components. These were provisions of early and reliable medication advice and decision support; creation of a ‘goals of care summary’ accessible to women and the care team; provision of continuity of midwifery care throughout pregnancy and postnatal care; provision of a named care coordinator; and a formal postnatal handover of care from the multidisciplinary care team to the General Practitioner (GP) and secondary care team involving the woman.

This study coproduced an evidence-based care bundle for pregnant women with MLTC to enhance communication and ensure individualised care and support. Further collaborative work with women and professionals is required to refine, implement and evaluate its impact on outcomes.

To evaluate the impact of digital supportive supervision (DiSS) for maternal and child healthcare on utilisation of services in Rajasthan state of India, as well as exploring the perceived enablers and barriers to the implementation of DiSS.

We employed a sequential mixed-method study design. Routine monthly service data from April 2016 to March 2023 were analysed using an interrupted time-series (ITS) analysis with a control group, followed by qualitative in-depth key-informant interviews.

The study is set at the primary healthcare level in Rajasthan state in India, where maternal health, child health and nutrition (MCHN) sessions are conducted at village level to deliver essential maternal and child health services.

Based on the proportion of MCHN sessions supervised digitally, two districts demonstrating high DiSS uptake were selected as intervention districts, and two matched districts were identified as comparator districts, creating a quasi-experimental design. Using routine data extracted from the pregnancy, child tracking and health services database, a segmented regression analysis using ITS was undertaken to assess temporal changes in service utilisation. For the qualitative component, we purposively sampled supervisors in intervention districts (ranked by DiSS supervisory volume) and conducted interviews until thematic saturation (n=18).

The intervention involved digitising the traditional paper-based supportive supervision of MCHN sessions in Rajasthan through a DiSS tool. Supervisors across state, district, block and sector levels used smartphones or tablets to record MCHN session data offline, which was automatically analysed and reported on dashboards on submission.

The study aims to measure the change in the monthly rate of MCHN service uptake following the rollout of DiSS in Rajasthan state.

Pentavalent and inactivated-polio vaccine uptake significantly improved in the intervention group, while no change was observed in the comparator group. Both groups showed significant improvement in the iron and folic acid supplementation among pregnant women and uptake of BCG, Hepatitis B birth dose and Measles vaccines among children, with greater increase in the intervention group. Notably, pneumococcal-conjugate-vaccine uptake declined significantly in the comparator group, whereas no significant change occurred in the intervention group. Limited digital literacy during the initial rollout and compatibility restriction of the digital application to Android devices were chief barriers. Among the enablers, its user-friendly interface, offline functionality, GIS-based monitoring and automated report generation were reported to enhance the timeliness, accountability and efficiency of supportive supervision. This, in turn, strengthened the feedback loop, empowering programme managers to promptly identify and address any shortcomings.

DiSS has the potential to strengthen the healthcare system and significantly improve the utilisation of MCHN services.

Waiting for cardiac surgery is a stressful life event for most patients. Exploring what people experience while waiting and understanding their preferences and views on how waiting time could be improved will help to inform new strategies for more efficacious waiting list management. In this study, we explored experiences and views of people waiting for elective cardiac surgery across four major London hospitals.

Mixed-methods cross-sectional survey, with explanatory concurrent design.

Four cardiac surgery services across two National Health Service Trusts in London.

Patients on waiting lists for elective cardiac surgery at Royal Brompton, Harefield, St Thomas and King’s College hospitals between October 2023 and March 2024.

Experience of waiting for surgery, and preferences about how waiting time could be improved.

554 out of 1041 invited participants agreed to participate (recruitment rate 53.2%). Among them, 274 fully completed the survey (completion rate 49.5%). Most participants (from 52.2% to 70.9%) reported their daily and social activities were impacted by their cardiac condition, and worrying was an ubiquitous feeling (reported by 86%). Psychological distress was reported differently across women and men (higher in women). Eight themes were identified: worrying, daily activities, family/friends and social activities, sexual life, waiting list experience and feelings, communication, most important factors for surgery and suggested improvements. Communication with the surgeon and clinical team, and regular updates on waiting list progress are suggested as crucial factors to alleviate stress, thus potentially improving the experience of waiting for the surgery.

This study highlights the importance of emotional support, clear communication, regular updates on waiting list progress and building trust with the clinical team to improve patient-centred care while waiting for elective cardiac surgery. This finding can offer valuable insights for managing waiting lists in other surgery waiting list contexts.

NCT05996640.

Values and preferences are key determinants of optimal care, and variability in patient values and preferences often dictates differences in patient management. Clinicians’ views of patients’ values and preferences may differ across cultural aspects and stage of training, but the extent to which this is the case remains uncertain. One key value and preference issue is the trade-off between quantity and quality of life, and this issue is particularly prominent among patients with dementia. We therefore propose to investigate the extent to which physicians’ perceptions of optimal management for patients living with advanced dementia may differ due to cross-cultural factors and stage of medical training.

We will conduct a sequential explanatory mixed-methods study (QUAN -> qual). First, we will administer paper-based or electronic surveys during educational sessions, conferences and rounds to medical students, residents and physicians in ten countries, either in person or online. Following that, a qualitative inquiry, guided by the findings of the quantitative study and the principles of the interpretive description design, will inform an in-depth exploration of the predictive factors identified in the quantitative data analysis.

The Hamilton Integrated Research Ethics Board at McMaster University has approved this study (approval number 2024-17651). We will disseminate our findings in peer-reviewed publications and present results at conferences as oral and poster presentations.

There is limited research exploring the age-related difference in communication when describing pain experiences. This project aimed to identify key differences between adolescents’, young adults’ and adults’ (i) preferred communication method, (ii) language content and (iii) lexical amount and variety when discussing their persistent pain experience using chatbot technology.

An exploratory concurrent nested mixed-methods design using a comparative analysis.

Participants were recruited through a convenience sampling strategy from two tertiary multidisciplinary pain centres in Australia.

20 adolescents, 20 young adults and 20 adults completed a pain history assessment using the Dolores application. The inclusion criteria for this study were (i) persistent non-cancer pain for at least 3 months, (ii) 10 years of age and over and (iii) adequate expressive and receptive language skills to complete the required tasks in English, as determined by clinicians in the treating team.

Drawn, voice and typed responses provided by participants during the chatbot interaction were analysed using content analysis. Fisher’s exact tests and ² tests were used to examine differences between age groups. Strong effect size estimates generated from comparative analyses suggested that adolescents were the most likely age group to utilise drawing (p=0.153, Cramer’s V=0.268), preferred typing over speaking (p==0.007, Cramer’s V=0.433). Young adults used the greatest number and variety of words in response to chatbot questions including evaluative language (p=0.097, Cramer’s V=0.296). Adults tended to use more metaphors (p=0.085, Cramer’s V=0.305) and had a strong preference for speaking over typing (p=

The results of this study provide insights into age-related differences in communication and preferences when using technology to communicate about persistent pain. Future research exploring individualised age-related approaches to pain assessment, supported by the findings of this study, in comparison to current standardised assessments administered by clinicians are warranted.

Global migration has steadily risen, with 16% of the UK population born abroad. Migrants (defined here as foreign-born individuals) face unique health risks, including potential higher rates and delays in diagnosis of infectious and non-communicable diseases, compounded by significant barriers to healthcare. UK Public Health guidelines recommend screening at-risk migrants, but primary care often faces significant challenges in achieving this, exacerbating health disparities. The Health Catch-UP! tool was developed as a novel digital, multidisease screening and catch-up vaccination solution to support primary care to identify at-risk adult migrants and offer individualised care. The tool has been shown to be acceptable and feasible and to increase migrant health screening in previous studies, but to facilitate use in routine care requires the development of an implementation package. This protocol describes the development and optimisation of an implementation package for Health Catch-UP! following the person-based approach (PBA), a participatory intervention development methodology, and evaluates our use of this methodological approach for migrant participants.

Through engagement with both migrants and primary healthcare professionals (approximately 80–100 participants) via participatory workshops, focus groups and think-aloud interviews, the study aims to cocreate a comprehensive Health Catch-UP! implementation package. This package will encompass healthcare professional support materials, patient resources and potential Health Catch-UP! care pathways (delivery models), developed through iterative refinement based on user feedback and behavioural theory. The study will involve three linked phases (1) planning: formation of an academic–community coalition and cocreation of guiding principles, logic model and intervention planning table, (2) intervention development: focus groups and participatory workshops to coproduce prototype implementation materials and (3) intervention optimisation: think-aloud interviews to iteratively refine the final implementation package. An embedded mixed-methods evaluation of how we used the PBA will allow shared learning from the use of this methodology within the migrant health context.

Ethics approval granted by the St George’s University Research Ethics Committee (REC reference: 2024.0191). A community celebration event will be held to recognise contributions and to demonstrate impact.

The objective of this study was to explore medical practitioners’ understanding of antimicrobial resistance (AMR) and its aspects, such as its causes, possible outcomes and how doctors can contribute to its prevention.

This qualitative study was conducted in Sri Lankan healthcare settings.

Using convenience sampling, the study included allopathic medical practitioners aged 18–60 years, excluding intern-medical officers, until data saturation.

One-on-one interviews were conducted online or in person, depending on each participant’s preference. A structured questionnaire was used to triangulate the information.

Data were categorised into four: (1) understanding, awareness and identifying AMR as an issue among medical practitioners, (2) knowledge and understanding of factors that contribute to AMR development among medical practitioners, (3) knowledge and understanding of the outcome of AMR and (4) knowledge and understanding of preventive measures against AMR among medical officers. Interviewees showed an awareness of AMR; however, their knowledge was not up to date. Key reasons for inappropriate antibiotic use included unavailability and poor quality of antibiotics and unawareness of updated guidelines, especially in the government sector. In the private sector, patient pressure, the need to attract patients and the high cost of investigations contributed to misuse. Additionally, low patient literacy about AMR was a significant factor.

This study revealed that although medical practitioners in Sri Lanka are aware of AMR, their knowledge remains limited in certain areas. Several challenges contributed to inappropriate antibiotic use, including the availability and quality of antibiotics, external pressures from patients and financial constraints. The findings of this study highlight the urgent need for continuous medical education and public awareness campaigns to improve both practitioner and patient understanding of AMR. Addressing these issues is essential for effectively preventing and managing AMR in healthcare settings in Sri Lanka.

To estimate the treatment outcomes among individuals treated for hypertension in the public sector in 89 districts across 15 states in India and to identify the risk factors for uncontrolled blood pressure (BP).

An analysis of a cohort of people with hypertension from 2018 to 2022 from public sector health facilities.

All India Hypertension Control Initiative (IHCI) implementing districts using digital information systems across 15 states of India, namely Andhra Pradesh, Bihar, Goa, Gujarat, Jharkhand, Karnataka, Maharashtra, Nagaland, Puducherry, Punjab, Rajasthan, Sikkim, Tamil Nadu, Uttar Pradesh and West Bengal.

Individuals aged 30 years or older, who were diagnosed with hypertension or on medication at the time of registration between 1 January 2018 and 31 December 2021 were included in the study.

Treatment outcomes were controlled BP, uncontrolled BP and missed visits in the reporting quarter (1 January 2022–31 March 2022). We analysed the risk factors for uncontrolled BP.

Out of 1, 235, 453 hypertensive individuals enrolled in the IHCI project across 15 states, 1, 046, 512 remained under care, with 44% BP control. The control varied from 26% to 57% in various types of facilities. The states of Maharashtra, Punjab and Rajasthan had above 50% control, while Nagaland, Jharkhand and Bihar had below 25%. BP control declined from 68% when defined using a single recent reading to 52% when defined using the two-visit readings. Younger individuals (

We documented the implementation of IHCI strategies at scale and measured treatment outcomes in a large cohort. Overall, BP control improved with variations across states. We need focused strategies to improve control in higher-level facilities, among males and people with diabetes. Using two BP readings may support consistent treatment adherence.

To assess maternal medical conditions, physical and surgical ailments, contraceptive use and barriers to its use, maternal mental health, neonatal health, breastfeeding practices and available social support in the postpartum period.

A prospective cohort study.

A large tertiary care centre.

12 245 women who delivered after 22 weeks gestation in the year 2022.

Three pre-specified exposures, namely mode of delivery, presence of significant risk factors and preterm delivery within the cohort, were used to identify potential groups of women who would need additional support.

The primary outcome was the number of unscheduled visits by the mother or child and the indications for these visits.

The secondary outcomes in mothers included unhealed wound sites, anaemia, increase in body mass index (BMI) by >3, persistent high blood pressure, pain in the abdomen or pelvis, urinary or bowel problems, musculoskeletal pain, abnormal maternal mental health, breast-related issues and barriers to breastfeeding, contraceptive use and sexual activity.

Only 2% of women and children were lost to follow-up. Nine women and 75 babies died. The majority of infant deaths were related to serious congenital diseases. Unscheduled visits to the health facility were seen in 44% of the cohort, most commonly for upper respiratory infections and fever in the mother and baby. 41 mothers and 741 infants needed admission to hospital. Hospitalisation was more common in those with risk factors or preterm delivery. High blood pressure was seen in 3 to 4% and anaemia in 4% of the cohort. Wound infection was seen in 3 to 4% and urinary incontinence in 2% of women. Wound infection was more common with instrumental delivery. Bowel incontinence was rare. A fourth of the cohort had musculoskeletal pain, especially back pain, which was more common after caesarean delivery. Only 5.5% of the cohort had unsatisfactory mental health, and these women were more likely to have abnormal mental health scores with the NICE Questionnaire at screening. The family APGAR of the cohort was 9/10, and 95% belonged to the middle-income group. 2.6% of neonates had delayed milestones, and this was more common in the group with risk factors and preterm delivery.

Healthcare utilisation was mainly for minor complaints. Re-admissions were rare, as intrapartum and immediate postpartum care were optimal. Women who delivered by caesarean section or delivered a preterm child needed additional support in the postpartum phase. NICE Questionnaire is a quick and easy screening tool to identify unsatisfactory mental health and should be used before discharge, postnatally, even in busy settings. The implementation of formal telephonic support 24 hours a day in birthing facilities should be explored in the future. Holistic postnatal care of mother and child during the immunisation of the baby would be the best opportunity to improve the quality and coverage of care in the postnatal phase.

CTRI/2022/03/041343.

Monitoring physical rehabilitation is an essential component of patient recovery after knee arthroplasty. Monitoring can be remote, or clinic based. In India, unsupervised home-based physical rehabilitation is a common practice, but there is a lack of evidence to demonstrate the effectiveness of remote monitoring. Therefore, we developed and piloted a mobile application (TeleREhabilitation after knee ArThroplasty app) based on behaviour design thinking to support the recovery period. This trial aims to compare the effectiveness, acceptability, cost and safety of this app-supported home-based intervention against usual care using an open label, 1:1 individual randomised superiority trial at two tertiary care hospitals in India.

Consecutive adults undergoing partial or total, unilateral or bilateral knee arthroplasty who can use a smart phone will be invited to participate in this trial. Consenting individuals will be randomised to either an app-supported intervention or a usual home-based rehabilitation which typically consists of provision of oral or written instructions at discharge and follow-up check-up with the surgeon or physiotherapist at their discretion or as per individual need. We aim to recruit 300 individuals over a period of eighteen months. The primary objective is to compare patient-reported knee function between the two groups at 3 and 6 months postsurgery. Secondary objectives are to compare patient-reported outcomes (pain and activity), performance-based outcomes (lower limb strength and knee function), resource utilisation and quality of life. Fidelity of implementation, end-user experiences and challenges in implementing this intervention will be measured using both quantitative and qualitative methods. Quantitative data will be analysed in Stata, and group comparisons will be done using mixed effect linear regression. A mixed-methods approach will be used to analyse and interpret the process evaluation data. A modified intention-to-treat approach will be taken, which includes all those who were randomised irrespective of their adherence to trial protocol if they had at least one follow-up visit after enrolment.

The protocol has been approved by the ethics committees of the sponsor institute (The George Institute for Global Health) and the two clinical sites (All India Institute for Medical Sciences, Delhi & Indraprastha Apollo Hospitals, Delhi). The results will be disseminated via peer-reviewed publications, conference presentations and via plain language newsletters to the trial participants.

CTRI/2024/06/068838.