To assess the feasibility of conducting a cluster randomised controlled trial comparing the effects of Advanced Trauma Life Support (ATLS) and Primary Trauma Care (PTC) with standard care on patient outcomes.

This was a pilot pragmatic three-armed parallel, cluster randomised, controlled trial conducted between April 2022 and February 2023. Patients were followed up for 30 days.

Tertiary care hospitals across metropolitan areas in India.

Adult trauma patients and residents managing these patients were included.

ATLS or PTC training was provided for residents in the intervention arms.

The outcomes were the consent rate, loss to follow-up rate, missing data rates, differences in the distribution between observed data and data extracted from medical records, and the resident pass rate.

Two hospitals were randomised to the ATLS arm, two to the PTC arm and three to the standard care arm. We included 376 patients and 22 residents. The percentage of patients who consented to follow-up was 77% and the percentage of residents who consented to receive training was 100%. The loss to follow-up rate was 14%. The pass rate was 100%. Overall, the amount of missing data for key variables was low. The data collected through observations were similar to data extracted from medical records, but there were more missing values in the extracted data.

Conducting a full-scale cluster randomised controlled trial comparing the effects of ATLS, PTC and standard care on patient outcomes appears feasible, especially if such a trial would use data and outcomes available in medical records.

NCT05417243.

Epidemics pose significant challenges for fragile health systems, particularly in humanitarian emergencies. Recent responses to epidemics such as cholera in Yemen and Ebola virus disease in the Democratic Republic of the Congo have highlighted the lack of effective and integrated coordination. We review existing global models for addressing large-scale epidemics in humanitarian emergencies, identify gaps and inefficiencies, and propose operational recommendations to enhance response mechanisms.

A two-pronged approach was used to identify and critically assess current response coordination frameworks. Using the Arksey and O’Malley framework, a scoping review was undertaken, which was complemented by key informant interviews with humanitarian emergency response experts. The interviews focused on identifying the existing challenges and potential strategies to improve epidemic response in humanitarian contexts.

The scoping review included 51 documents (13 peer-reviewed articles and 38 grey literature documents). We conducted in-depth interviews with 28 respondents representing 17 different agencies and donors.

We focused on two major response architectures: the Incident Management System (IMS) and the cluster system. IMS is an important coordination and response instrument increasingly being used to respond to infectious disease threats.

Outcome measures of interest included the gaps in the current mechanisms to address infectious disease threats in complex humanitarian emergencies.

Unlike the cluster system model, which relies on consensus decision-making, IMS has a command-and-control approach, ensuring rapid decision-making. However, it can also lead to vertical responses that neglect the cross-sectoral and complex needs of affected communities. In addition, we found that the absence of context-specific response coordination mechanisms, with clear roles and responsibilities for involved stakeholders, was a common shortcoming. Fragmented response efforts that sidelined national and local stakeholders and a lack of reliable funding were also identified as important weaknesses.

We recommend the integration of coordination mechanisms into a sufficiently flexible framework that can be adapted to local contexts, while empowering national and local actors and ensuring the continuity of essential humanitarian services. We propose a paradigm shift towards mechanisms that respect humanitarian principles, effectively addressing the epidemic threats while remaining focused on deploying community-centric response efforts.

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.