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Feasibility of a cluster randomised trial on the effect of trauma life support training: a pilot study in India

Por: Gerdin Wärnberg · M. · Basak · D. · Berg · J. · Chatterjee · S. · Felländer-Tsai · L. · Ghag · G. · Juillard · C. · Khajanchi · M. · Khan · T. · Mishra · A. · Nandu · V. V. · Roy · N. · Singh · R. · Soni · K. D. · Strömmer · L.
Objective

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.

Design

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.

Setting

Tertiary care hospitals across metropolitan areas in India.

Participants

Adult trauma patients and residents managing these patients were included.

Interventions

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

Main outcomes and measures

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.

Results

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.

Conclusions

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.

Trial registration number

NCT05417243.

Telerehabilitation for people with Parkinsons disease: protocol of a randomised clinical trial of mixed methods

Por: Taveira · R. S. · Vasconcellos · L. S. d. · Bezerra · C. F. · Aires · D. N. · Dias de Oliveira · A. K. · da Silva · K. d. O. C. · Melo · L. P. d. · Ribeiro · T. S.
Introduction

Telerehabilitation (TR) programmes are increasingly recognised for their feasibility and potential benefits, such as eliminating travel time, reducing costs and providing a more comfortable rehabilitation experience at home. However, the comparative efficacy of remote physiotherapy compared with traditional in-person sessions for individuals with Parkinson’s disease (PD) remains uncertain. This study aims to evaluate the effects of TR compared with in-person physiotherapy in individuals with PD, focusing on both motor and non-motor outcomes.

Methods and analysis

This is a randomised, single-blind clinical trial with a mixed-methods approach. A total of 22 individuals diagnosed with PD will be randomly assigned to one of two groups. The experimental group will receive TR, consisting of remote physiotherapy sessions conducted once a week for 1 hour over a 4-month period. The control group will receive the same interventions in person. Interventions will include global muscle strengthening exercises, balance training, gait and motor coordination exercises, and cognitive training. The primary outcome will be motor function, measured using part III of the Movement Disorder Society–Unified Parkinson’s Disease Rating Scale. Secondary outcomes will include cognition (Montreal Cognitive Assessment), gait (Functional Gait Assessment), mobility (Timed Up and Go Test) and quality of life (Parkinson’s Disease Questionnaire). Data will be analysed using repeated measures analysis of variance to compare outcomes between groups across four assessment points (baseline, midpoint, postintervention and 2 months follow-up). Additionally, a qualitative phase will explore participants’ perceptions and experiences regarding TR and in-person interventions, with assessments carried out 2 months after the completion of the 24-week interventions, through semistructured interviews that will be analysed using Bardin’s Content Analysis technique.

Ethics and dissemination

This protocol was approved by the Research Ethics Committee of the Federal University of Rio Grande do Norte (approval number: 5.553.701). All participants will provide written informed consent before inclusion. Results will be disseminated through peer-reviewed publications, scientific conferences and communication with participants and healthcare professionals.

Trial registration number

RBR-6h5knrj.

DIABASE: an automatically filled single-centre registry of diabetes mellitus in the Netherlands, combining clinical data with real-world longitudinal wearable device data-a study protocol

Por: Urgert · T. · Kappert · K. D. R. · Veldhuis · A. · Geerdink · J. · van Beijnum · B. J. F. · Laverman · G. D.
Introduction

Advancements in technology for treating diabetes mellitus (DM) are progressing rapidly. With the growing availability and use of continuous glucose monitoring (CGM) systems and continuous subcutaneous insulin infusion (CSII), glucose regulation is improved in individuals with DM, which will lead to less long-term complications and reduce the overall disease burden on patients with DM. Collecting vast amount of biomedical data, these devices combined with clinical outcome data provide more insight into the development and treatment of the disease. The objective of the DIABASE initiative is to collect and examine real-world data from medical devices and clinical practice in a registry.

Methods and analysis

The ongoing study is structured as an observational study registry. Clinical data and real-world data from diabetes wearable devices, such as CGM and CSII, are aggregated in the database. Clinical data is automatically extracted from the hospital’s electronic health record. Data from wearables is periodically collected manually from the various online data platforms for sharing and automatically added to the database.

Ethics and dissemination

This study is exempted from ethics approval by the Medical Research Ethics Committees United (MEC-U) since participants are not subject to procedures and are not required to follow rules of behaviour (approval ID: AW23.009/W20.197). The execution of this study has been approved by the board of the study site Hospital Group Twente (ZGT) (ZGT20-40). Results will be shared through scientific meetings and publications and through articles for the general public.

Trial registration number

NCT05584293; Pre-results.

Incidence and predictors of delirium in patients admitted to intensive care unit at comprehensive specialised hospitals in Amhara region, northwest Ethiopia: a multicentre prospective observational study

Por: Asmare · T. B. · Wubet · H. B. · Gobezie · N. Z. · Deress · G. M. · Belete · K. G. · Tadesse · M. A. · Abuhay · A. G. · Demissie · B. · Melesew · A. A. · Afework · W. A. · Alle · Y. F. · Demite · D. G. · Teshome · D. · Mossie · K. D. · Kassa · B. D. · Gedefaw · G. D.
Objective

To assess the incidence of delirium and its predictors among adult patients admitted to the intensive care units of comprehensive specialised hospitals in the Amhara region of northwest Ethiopia from 18 October 2024 to 20 February 2025.

Design

A multicentre prospective observational study was conducted.

Setting

Four comprehensive specialised hospitals in the Amhara region of northwest Ethiopia, from 18 October 2024 to 20 February 2025.

Participants

A total of 351 patients were included in the final analysis during the study period.

Outcome measures

The primary outcome measure of this study was the incidence of delirium. Additionally, the study investigated the factors associated with delirium incidence among adult patients admitted to intensive care units.

Results

The incidence of delirium among adult patients in intensive care units was 42.17% (95% CI: 37.08 to 47.42). Pain (adjusted HR (AHR) = 4.74; 95% CI: 2.38 to 9.44), mechanical ventilation (AHR = 2.96; 95% CI: 1.56 to 5.63), age 65 years or older (AHR = 2.18; 95% CI: 1.48 to 3.21) and agitation (Richmond Agitation-Sedation Scale (RASS) ≥1) (AHR = 3.26; 95% CI: 2.09 to 5.09) were statistically significant factors associated with delirium.

Conclusion and recommendation

In the present study, more than one-third of patients developed delirium. Pain, mechanical ventilation, age 65 or older and agitation (RASS≥1) were significantly associated with delirium occurrence. To reduce the incidence of delirium, the current study recommends treating or preventing pain and agitation. Additionally, special attention should be given to patients receiving mechanical ventilation and those aged 65 or older during care.

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