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Getting recovery right after neck dissection for head and neck cancer (GRRAND): trial protocol for a multicentre, pragmatic randomised controlled trial with health economic evaluation and process evaluation

Por: Evans · C. · Greene · L. · Hossain · A. · Klear · P. · Ratna · M. · Bradley · H. · Lall · R. · Mistry · H. · Naghdi · S. · Reategui · M. · Stevens · T. · Bruce · J. · Price · R. · Schache · A. · Dean · S. G. · Lamb · S. E. · Smith · T. · Winter · S. C.
Introduction

Head and neck cancer (HNC) affects the mouth, throat, salivary glands, voice box, nose or sinuses. Every year, over 12 000 people in the UK are diagnosed with HNC. Neck dissection is a key, surgical component of patient care. However, many people experience postoperative restriction in shoulder and neck movements, pain, fatigue and low mood, with only half ever returning to work.

Methods and analysis

Getting Recovery Right After Neck Dissection (GRRAND) is a two-arm, multicentre, pragmatic randomised controlled trial. The trial aims to compare clinical and cost-effectiveness of a personalised physiotherapy programme (GRRAND programme) versus usual practice, National Health Service (NHS), postdischarge care.

The planned sample size is 390 participants. Participants will be recruited from across UK sites and followed up for 12 months. The primary outcome is the shoulder pain and disability index at 12 months. Economic evaluation will be conducted from a healthcare system and personal social services perspective. Secondary outcome data, including pain, function, health-related quality of life, mental well-being, health resource use and adverse events, will be collected at 6 weeks, 3, 6 and 12 months, with exercise adherence at 6 weeks. A process evaluation will determine how GRRAND is implemented, delivered and received across clinical settings, exploring what works, for whom and under what conditions. Analysis will be on an intention-to-treat basis and reported inline with the Consolidated Standards of Reporting Trials statement.

Ethics and dissemination

The trial was approved by the London-Brent Research Ethics Committee (ref: 24/LO/0722) on 15 October 2024. Trial results will be disseminated via peer-reviewed publications, presentations at national and international conferences, in lay summaries and social media. This protocol adheres to the recommended Standard Protocol Items: Recommendations for Interventional Trials checklist.

Trial registration number

ISRCTN13855775.

Gestational diabetes mellitus and its associated factors among women of advanced maternal age in Malaysia: Findings from a national survey

by Chean Tat Chong, Lalitha Palaniveloo, Sulhariza Husni Zain, Muhamad Khairul Nazrin Khalil, Kishwen Kanna Yoga Ratnam

Gestational diabetes mellitus (GDM) is a growing public health concern, particularly among women with advanced maternal age. Understanding the prevalence and associated sociodemographic factors is crucial for targeted interventions. This study aimed to determine the prevalence of GDM and its association with sociodemographic factors among Malaysian women with advanced maternal age. This study utilized data from the National Health and Morbidity Survey 2022: Maternal and Child Health, a nationwide cross-sectional survey employing a two-stage stratified cluster sampling design. GDM was identified based on the result of a modified oral glucose tolerance test (MOGTT) recorded in the mother’s antenatal book. The 75-g MOGTT was performed according to the Clinical Practice Guidelines for the Management of Diabetes in Pregnancy in Malaysia. Sociodemographic variables, including ethnicity, locality, education, employment, and household income, were analysed. Multiple logistic regression was performed to identify factors associated with GDM. The prevalence of GDM among women with advanced maternal age in Malaysia was 33.7% (95% CI: 30.9%−36.5%). Ethnicity was significantly associated with GDM, with Indian women showing the highest prevalence (48.8%) and odds (AOR: 7.31, 95% CI: 2.58–20.72; P 

Effect of a multidisciplinary team approach on the management of diabetic foot ulcers on the Central Coast: A review of the Gosford Hospital High‐Risk Foot Clinic

Abstract

This retrospective cohort study aims to assess whether the implementation of a multidisciplinary approach in the Gosford Hospital High-Risk Foot Clinic improved outcomes of diabetic foot ulcers. Ulceration is a common foot complication of diabetes mellitus and greatly increases patient morbidity and mortality. Patients who attended at least one appointment at the Gosford Hospital High-Risk Foot Clinic in 2017 or 2019 were identified through the Gosford Hospital Podiatry department's records. The 2017 and 2019 cohorts were compared on measures of ulcer healing, incidence of amputation, incidence of vascular intervention and surgical debridement, percentage of patients admitted to hospital due to complications and use of systemic antibiotic therapy. Sixty-one patients in 2017 and 59 patients in 2019 met inclusion criteria, and from them, 207 ulcers were included. Between 2017 and 2019, there was a 6.2-week reduction in time to 100% ulcer healing in 2019 (p = 0.021), and 10.1% more ulcers healed within 52 weeks (p = 0.22, 95% confidence interval [CI] [−5.9%, 25.5%]). Whilst there was no significant difference in incidence of patients receiving amputation, there was an increased absolute number of amputations in 2019. Implementation of a multidisciplinary approach at the Gosford Hospital High-Risk Foot Clinic led to improvements in diabetic foot ulcer healing.

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