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Risk factors for COVID-19 symptom severity across clinical categories among hospitalised patients in Kuala Lumpur, Malaysia: a prospective cohort study

Por: Johdi · N. A. · Abdullah · N. · Goh · Y.-X. · Min · J. O. S. · Muhammad Azami · N. A. · Abdul Jalal · M. I. · Mohammed Nawi · A. · Ahmad · N. · Hassan · M. R. · Sulong · A. · Kori · N. · Periyasamy · P. · Hamid · F. · Sapuan · N. M. · Selvam · S. B. P. · Hajib · N. · Mustafa · N. · Rashi
Objectives

This study aimed to quantify how patient risk factors relate to COVID-19 severity across categories 1–5 in a prospective, hospital-based cohort. We hypothesised that greater severity would be associated with higher odds of intensive care unit (ICU) admission and in-hospital mortality. Secondary aims were to assess associations with age, viral variants, symptom clusters, lymphocyte count, fasting blood glucose and cytokine profiles.

Design

Prospective cohort study.

Setting

A secondary-care/tertiary-care hospital and linked community settings in Cheras, Kuala Lumpur, Malaysia.

Participants

This study was nested within the COVGEN project, a prospective COVID-19 cohort conducted at Hospital Canselor Tuanku Muhriz UKM (HCTM), Cheras Health Clinic and the Bandar Tun Razak COVID-19 Assessment Centre in Cheras, Kuala Lumpur, Malaysia, from 1 August 2021 to 31 October 2022. 2532 participants were enrolled at baseline. Eligible participants were Malaysian citizens aged 12–18 years (paediatric/adolescent) or ≥18 years who had reverse transcription-polymerase chain reaction–confirmed COVID-19 at recruitment and resided in Kuala Lumpur or Selangor. Patients who had a clinically unstable condition and those who declined participation (personally or via a next-of-kin or legal representative) were excluded. This analysis included 559 patients hospitalised at HCTM; after excluding five with incomplete questionnaires, 554 remained for analysis (413 admitted to general wards and 141 to ICUs). Categories 3–5 comprised hospitalised patients, whereas categories 1–2 included hospitalised individuals and a subset recruited from community settings.

Primary and secondary outcome measures

Primary outcomes included disease severity (categories 4–5 vs 1–3), ICU admission and in-hospital mortality. Secondary outcomes included associations with age strata, viral variant (delta vs omicron), symptom clusters, lymphocyte count, fasting blood glucose and cytokines: interferon gamma-inducible protein 10, interferon gamma, interleukins 8, 10, 2, 6 and 7 and tumour necrosis factor alpha.

Results

141 of 554 (25.5%) patients required ICU care. Compared with milder categories, category 5 was associated with markedly higher odds of ICU admission (OR 204.50; 95% CI 37.54 to 1114.18; p55 versus

Conclusions

An increasing clinical severity category was strongly associated with ICU admission and mortality. Age, delta infection, specific symptom clusters, lymphopenia, hyperglycaemia and pro-inflammatory cytokines identified higher-risk patients, supporting risk-stratified management and prioritisation for enhanced monitoring.

Randomised, double-blind, parallel group, placebo-controlled, trial of Bactek for the prevention of lower respiratory tract infections in preterm infants in the UK: BALLOON study - study protocol

Por: Kotecha · S. J. · Lowe · J. · Gillespie · D. · Perez-Alijas · M. · Aboklaish · A. F. · Mahachi · T. L. · Cumming · O. S. · Harris · D. · Hubbard · M. · Thomas-Jones · E. · Jones · T. · Ladell · K. · Moore · C. · Humpreys · I. · Grigg · J. · Berrington · J. · Kotecha · S.
Introduction

A significant proportion of infants born at ≤29+6 weeks’ gestation develop lung disease during the neonatal period, thus putting them at risk of developing prematurity-associated lung disease in childhood and adulthood. After discharge from the neonatal unit, pre-existing lung disease in preterm-born infants is exacerbated by (often frequent) respiratory viral infections requiring greater health utilisation, including hospital admissions, than their term-born equivalents. Opportunities to prevent viral infections in infancy are largely limited to anti-respiratory syncytial virus (RSV) antibody prophylaxis and recently maternal RSV immunisation, but in term-born infants, trained immunity-based vaccines such as Bactek (MV130, Inmunotek, Spain) are increasingly used. Bactek provides a promising therapeutic avenue for preterm-born infants to target postdischarge respiratory viral infection in this vulnerable group of infants. The BALLOON study aims to assess this treatment in a very/extremely preterm-born population and determine if treatment with the trained immunity-based vaccine Bactek decreases the risk of unscheduled visits to healthcare professionals for lower respiratory tract infections, when compared with placebo. Included infants are born at ≤29+6 weeks’ gestation and treated daily from term-equivalent (37–43 weeks’ postmenstrual age, PMA) or from discharge, if earlier, up to 1 year of corrected age.

Methods and analysis

542 infants are being recruited prior to discharge by neonatal units in the UK. They are being randomised to receive Bactek or placebo, once daily dose of 2 sprays (each 0.1 mL) of IMP (300 Formazin Turbidity Units), from 37 to 43 weeks’ PMA or discharge if earlier up to 1 year of corrected age. The primary objective is to assess if sublingual Bactek spray decreases the risk of health professional diagnosed lower respiratory tract infections (LRTIs) (unscheduled visits to general practitioners, accident and emergency departments and hospital admissions) between enrolment and 1 year of corrected age. Secondary outcomes include the number of parent-reported, health professional-confirmed unscheduled visits for LRTIs, the time to first parent-reported, health professional-confirmed unscheduled visit for LRTI, parent-reported wheeze episodes (identification aided by WheezeScan (Omron, Japan)), parent-reported use of respiratory medications, growth (weight, length and head circumference), parent(s)/guardian(s) reported time missed from work and/or nursery time missed for the infant and volume of adverse reactions. Viruses associated with LRTIs will also be identified.

Ethics and dissemination

Ethics permission has been granted by the Wales Research Ethics Committee 3 (Ref 24/WA/0181), and regulatory permission by the Medicines and Healthcare Products Regulatory Agency (CTA reference 21323/0063/001-0004). The study is registered on ISRCTN (ISRCTN14019493). Findings will be disseminated via national and international peer-reviewed journals, and conferences. Oversight of the study is being provided by an Independent Data Monitoring Committee and an independent Trial Steering Committee (TSC). The Trial Management Group (TMG) meets every month.

Trial registration number

ISRCTN14019493.

Assessing the clinical utility of composite outcomes in studies examining outcomes of implantable neuromodulation therapies for pain: a systematic review

Por: Chung · O. S. · Gabriel · G. M. · Alomari · A. · Bhatia · A.
Background

Implantable neuromodulation therapies are offered to patients with certain refractory pain syndromes. These therapies are resource-intensive and effort-intensive and may be associated with significant adverse effects. Change in pain intensity score, an unidimensional measurement tool, is currently the most used eligibility criteria for patients to receive implanted neuromodulation devices. However, pain is a biopsychosocial phenomenon, and assessment of effectiveness of neuromodulation therapies using tools that incorporate multiple pain-related domains may be more relevant and accurate. Composite measures integrate multiple domains of patient well-being, enabling a clinically relevant assessment of treatment effects. This systematic review aims to evaluate the literature on the clinical utility and reliability of composite outcomes as a means to assess efficacy of implantable neuromodulation therapies for refractory pain.

Methods and analysis

We will search Embase, MEDLINE, Cochrane Central Register of Controlled Trials and the WHO’s International Clinical Trials Registry Platform. Searches will be limited to from inception of each database to 31 December 2025. Studies published in English will be considered eligible if they used composite outcomes to evaluate the efficacy and/or effectiveness of implantable neuromodulation therapies for treating refractory pain. The studies should investigate adult populations (aged ≥18 years) undergoing implantation for chronic refractory pain of moderate-to-severe intensity. Two reviewers will independently screen articles, extract data and review the risk of bias and the grade of evidence provided in the studies. Extracted data will include study details (author, year, country of origin), participant demographics (age, sex), sample sizes and intervention details. Outcome measures include pain intensity, physical health, mental health, quality of life, medication use and neuromodulation device explantation rates. Data will be collected at baseline, 3 months, 6 months and 12 months post-implantation where available. A meta-analysis will be formed if there is sufficient homogeneity in the studies and their data.

Ethics and dissemination

As this study is a systematic review using data that has already been published in scientific literature or is publicly available, ethics approval is not required. For dissemination, we plan to share the findings of our review through multiple academic and clinical channels. The completed review will be submitted for publication in a peer-reviewed journal relevant to pain medicine or neuromodulation.

PROSPERO registration number

CRD42025631488.

A mixed-methods evaluation of a peer-led, co-produced, asset-based intervention for early diagnosis of prostate cancer for Black men: the PROCAN-B study

Por: Christie-de Jong · F. · Eberhardt · J. · Oyeniyi · O. S. · Ratcliffe · E. · Kabuye · J. · Kalemba · M. · Nnyanzi · L. A. · Murphy · M. K. · Robb · K. A.
Objective

To pilot a culturally tailored, peer-led, co-produced asset-based intervention workshop to encourage early diagnosis of prostate cancer for Black men.

Design

Mixed-methods pilot study.

Setting

Community centres in the North-East of England and Scotland.

Participants

The intervention was delivered in November 2023 with Black African and Caribbean men (n=21), and again in February 2024 (n=41). Participants were highly educated and aged between 42 and 63 years. The intervention was qualitatively evaluated with 40 of the intervention participants.

Intervention

Underpinned by the Integrated Screening Action Model (I-SAM), we co-produced a culturally tailored, peer-led 2-hour workshop consisting of multiple components, including small group discussions about barriers to accessing prostate cancer care, general practitioner (GP) health education, activities to facilitate effective communication with the GP and reception staff and videos with testimonials from survivors, women and religious leaders.

Primary outcomes

Knowledge, attitudes and intention to engage in prostate cancer testing were examined through a pre- and post-survey design. Intervention acceptability was qualitatively explored through focus groups.

Results

Participants (n=41) reported that the workshop increased their confidence in engaging with healthcare providers to discuss prostate cancer testing (I-SAM component: psychological capability). Knowledge (I-SAM component: psychological capability: Z=4.939, p

Conclusion

Asset-based strategies, focusing on community strengths, including faith-based health promotion, can promote health behaviours in a culturally and spiritually meaningful way. The PROCAN-B intervention effectively targeted components within the I-SAM and shows potential to increase prostate cancer awareness and build confidence to engage in behaviours conducive to early diagnosis. However, the sample was small, and more robust effectiveness testing is needed.

High-Intensity Statin versus Upfront Equivalent-Dose Combination of Moderate-Intensity Statin with Ezetimibe Following Acute Myocardial Infarction (ROSUZET-AMI): protocol of a multicentre, open-label, randomised non-inferiority trial

Por: Choo · E. H. · Kim · C. J. · Hwang · B.-H. · Lee · K. Y. · Oh · G. C. · Lim · S. · Choi · I. J. · Kim · D.-B. · Kwon · O. S. · Lee · S. · Choi · Y. · Park · C.-S. · Park · M.-W. · Kim · H.-Y. · Lee · H. C. · Kang · T. S. · Sung · J. K. · Woo · S.-I. · Park · H. S. · Yun · K. H. · Chang · K. · On
Introduction

High-intensity statin therapy is recommended as a first-line strategy for lowering low-density lipoprotein cholesterol (LDL-C) levels in patients with acute myocardial infarction (AMI). A combination of moderate-intensity statin and ezetimibe at an equivalent dose to high-intensity statin may achieve similar LDL-C reduction with fewer side effects. This study evaluates the long-term efficacy and safety of this approach, initiated following AMI, compared with high-intensity statin monotherapy.

Methods and analysis

The ROSUZET-AMI trial is a multicentre, prospective, open-label, randomised, non-inferiority trial. Patients with AMI who underwent percutaneous coronary intervention were randomised 1:1 to receive either moderate-intensity statin with ezetimibe (rosuvastatin 5 mg with ezetimibe 10 mg) or high-intensity statin monotherapy (rosuvastatin 20 mg). The primary endpoint is the composite of cardiovascular death, major coronary events (non-fatal myocardial infarction, documented unstable angina requiring hospitalisation and all coronary revascularisation events occurring at least 30 days after randomisation), or non-fatal stroke.

Ethics and dissemination

Ethics approval for this study was obtained from the Institutional Review Board of Seoul St. Mary’s Hospital (No. 2020-0424-0003). Informed consent is obtained from every participant before randomisation. The results of this study will be submitted for publication in international peer-reviewed journals, and the key findings will be presented at international scientific conferences.

Trial registration number

NCT04499859.

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