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Effects of multimodal nutritional intervention on nutritional status and clinical outcomes in patients with systemic sclerosis: study protocol for a randomised controlled trial

Por: Shahmohammadi · F. · Kavosi · H. · Naeini · F. · Imani · H. · Mohammadi · H.
Introduction

Systemic sclerosis (SSc) is an autoimmune disorder causing progressive fibrosis of internal organs and skin, leading to increased thickness and rigidity. It frequently results in malnutrition, which can decrease survival rates and physical performance, while also imposing financial burdens on healthcare systems and society. Multimodal nutritional interventions may encompass various approaches, including nutritional counselling, consumption of oral nutritional supplements and disease-specific dietary regimens based on nutritional needs. The present clinical trial is designed to examine the effectiveness of multimodal nutritional intervention on nutritional status, quality of life, food intake, body composition and fatigue in patients with SSc.

Methods and analysis

This is a parallel, randomised, placebo-controlled clinical trial that will investigate the impacts of multimodal nutritional interventions in SSc patients. 46 qualified SSc participants will be chosen at random and given multimodal nutritional intervention or dietary recommendations for a period of 8 weeks. The primary outcomes of this study are changes in nutritional status and quality of life. The secondary outcomes include changes in body composition, fatigue, body weight, body mass index and calf circumference. Statistical analysis will be conducted using the SPSS software (Version 24).

Ethics and dissemination

The current trial received approval from the Medical Ethics Committee of Tehran University of Medical Sciences, Tehran, Iran (IR.TUMS.MEDICINE.REC.1403.345). The findings will be submitted to international, peer-reviewed publications and presented at national and international conferences.

Trial registration number

IRCT20220208053971N4.

Mixed methods implementation research of oral antiviral treatment for COVID-19 in low- and middle-income countries: a study protocol

Por: Narayanasamy · S. · Gambanga · F. · Boeke · C. E. · Udayakumar · K. · Brothers · L. · Wolfe · C. R. · Agwuocha · C. · Asamoa-Amoakohene · M. N. · Detleuxay · K. · Griffith · B. C. · Hamza · N. · Joseph · J. · Kimani · P. · Kirungi · R. · Lufesi · N. · Mbewe · N. · McCarthy · E. · Mulenga
Introduction

There is an absence of real-world evidence, especially from low- and middle-income countries (LMICs), on the implementation successes and challenges of COVID-19 Test and Treat (T&T) programmes. In 2022, nirmatrelvir/ritonavir was provided as standard of care for mild to moderate COVID-19 treatment in eight LMICs (Ghana, Kenya, Laos, Malawi, Nigeria, Rwanda, Uganda and Zambia). This manuscript describes a research protocol to study novel drug introduction during the COVID-19 health emergency, with implications and learnings for future pandemic preparedness. The goal of the study is to provide simultaneous programme learnings and improvements with programme rollout, to fill a gap in real-world implementation data on T&T programmes of oral antiviral treatment for COVID-19 and inform programme implementation and scale-up in other LMICs.

Methods and analysis

This multiple methods implementation research study is divided into three components to address key operational research objectives: (1) programme learnings, monitoring and evaluation; (2) patient-level programme impact; and (3) key stakeholder perspectives. Data collection will occur for a minimum of 6 months in each country up to the end of grant. Quantitative data will be analysed using descriptive statistics for each country and then aggregated across the programme countries. Stakeholder perspectives will be examined using the Consolidated Framework for Implementation Research implementation science framework and semistructured interviews.

Ethics and dissemination

This study was approved by the Duke University Institutional Review Board (Pro00111388). The study was also approved by the local institutional review boards in each country participating in individual-level data collection (objectives 2 and 3): Ghana, Malawi, Rwanda, Nigeria and Zambia. The study’s findings will be published in peer-reviewed journals and disseminated through dialogue events, national and international conferences and through social media.

Trial registration number

NCT06360783.

A time‐motion study on impact of spatial separation for empiric airborne precautions in emergency department length of stay

Abstract

Aims

To evaluate the impact of spatial separation on patient flow in the emergency department.

Design

This was a retrospective, time-and-motion analysis conducted from 15 to 22 August, 2022 at the emergency department of a tertiary hospital in Kuala Lumpur, Malaysia. During this duration, spatial separation was implemented in critical and semi-critical zones to separate patients with symptoms of respiratory infections into respiratory area, and patients without into non-respiratory area. This study adhered to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines.

Methods

Patients triaged to critical and semi-critical zones were included in this study. Timestamps of patient processes in emergency department until patient departure were documented.

Results

The emergency department length-of-stay was longer in respiratory area compared to non-respiratory area; 527 min (381–698) versus 390 min (285–595) in critical zone and 477 min (312–739) versus 393 min (264–595) in semi-critical zone. In critical zone, time intervals of critical flow processes and compliance to hospital benchmarks were similar in both areas. More patients in respiratory area were managed within the arrival-to-contact ≤30 min benchmark and more patients in non-respiratory area had emergency department length-of-stay ≤8 h.

Conclusions

The implementation of spatial separation in infection control should address decision-to-departure delays to minimise emergency department length of stay.

Impact

The study evaluated the impact of spatial separation on patient flow in the emergency department. Emergency department length-of-stay was significantly prolonged in the respiratory area. Hospital administrators and policymakers can optimise infection control protocols measures in emergency departments, balancing infection control measures with efficient patient care delivery.

Reporting Method

STROBE guidelines.

No Patient or Public Contribution

None.

Trial and Protocol Registration

The study obtained ethics approval from the institution's Medical Ethics Committee (MREC ID NO: 20221113–11727).

Statistical Analysis

The author has checked and make sure our submission has conformed to the Journal's statistical guideline. There is a statistician on the author team (Noor Azhar).

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