METHODS AND DESIGN: This is a single-center, randomized, controlled, two-arm parallel design clinical trial that will be carried out in a tertiary hospital in Malaysia. In this study, 100 patients diagnosed with type 2 diabetes will be enrolled. Diabetic patients who meet the eligibility criteria will be randomly allocated to two groups, which are diabetic C. caudatus treated(U) group and diabetic control (C) group. Primary and secondary outcomes will be measured at baseline, 4, 8, and 12 weeks. The serum and urine metabolome of both groups will be examined using proton NMR spectroscopy.
DISCUSSION: The study will be the first randomized controlled trial to assess whether C. caudatus can confer beneficial effect in patients with type 2 diabetes. The results of this trial will provide clinical evidence on the effectiveness and safety of C. caudatus in patients with type 2 diabetes.
TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02322268.
METHODS: The Norfolk (UK) based European Prospective Investigation into Cancer (EPIC-Norfolk) recruited 25,639 participants between 1993 and 1997. FEV1 measured by portable spirometry, was categorized into sex-specific quintiles. Mortality and morbidity from all causes, cardiovascular disease (CVD) and respiratory disease were collected from 1997 up to 2015. Cox proportional hazard regression analysis was used with adjustment for socio-economic factors, physical activity and co-morbidities.
RESULTS: Mean age of the population was 58.7 ± 9.3 years, mean FEV1 for men was 294± 74 cL/s and 214± 52 cL/s for women. The adjusted hazard ratios for all-cause mortality for participants in the highest fifth of the FEV1 category was 0.63 (0.52, 0.76) for men and 0.62 (0.51, 0.76) for women compared to the lowest quintile. Adjusted HRs for every 70 cL/s increase in FEV1 among men and women were 0.77 (p < 0.001) and 0.68 (p < 0.001) for total mortality, 0.85 (p<0.001) and 0.77 (p<0.001) for CVD and 0.52 (p <0.001) and 0.42 (p <0.001) for respiratory disease.
CONCLUSIONS: Participants with higher FEV1 levels had a lower risk of CVD and all-cause mortality. Measuring the FEV1 with a portable handheld spirometry measurement may be used as a surrogate marker for cardiovascular risk. Every effort should be made to identify those with poorer lung function even in the absence of cardiovascular disease as they are at greater risk of total and CV mortality.
METHODS AND ANALYSIS: This is a community-based prospective cohort study using randomly selected households from the national census. A multistage sampling method was employed to obtain a total of 2496 older adults living in the rural Kuala Pilah district. The study is divided into two phases: cross-sectional study (baseline), and a longitudinal follow-up study at the third and fifth years. Elder mistreatment was measured using instrument derived from the previous literature and modified Conflict Tactic Scales. Outcomes of elder mistreatment include mortality, physical function, mental health, quality of life and health utilisation. Logistic regression models are used to examine the relationship between risk factors and abuse estimates. Cox proportional hazard regression will be used to estimate risk of mortality associated with abuse. Associated annual rate of hospitalisation and health visit frequency, and reporting of abuse, will be estimated using Poisson regression.
ETHICS AND DISSEMINATION: The study has been approved by the Medical Ethics Committee of the University of Malaya Medical Center (MEC Ref 902.2) and the Malaysian National Medical Research Register (NMRR-12-1444-11726). Written consent was obtained from all respondents prior to baseline assessment and subsequent follow-up. Findings will be disseminated to local stakeholders via forums with community leaders, and health and social welfare departments, and published in appropriate scientific journals and presented at conferences.
OBJECTIVES: To review the literature on trials conducted among older adults residing in care homes within the UK and collate evidence on their methodological characteristics and outcomes.
METHODS: A systematic rapid review methodology was employed. MEDLINE, EMBASE and CENTRAL were searched in two incremental stages: stage 1 searched for oral health-related trials conducted within the UK care homes up to July 2021, whereas stage 2 sought for general health-related trials in the same setting from 2011 to 2021. The quality of included studies was assessed using Cochrane's RoB 2 and ROBINS-I tools. Findings were summarised descriptively.
RESULTS: Five oral health and 33 general health-related trials involving care home residents were included for analysis. The most common trial design was parallel group with two arms (n = 25) involving individual randomisation (n = 21). Consent was mainly obtained from residents and/or their proxies (n = 24), followed by residents only (n = 13) and care homes only (n = 1). Based on available data, the number needed to screen to recruit one participant ranged from 2 to 40 (median: 3; Q1-Q3: 2-9). Attrition rates ranged from 0% to 73% (median: 21%; Q1-Q3: 13%-32%) for follow-up periods between 1 and 52 weeks. The studies were of mixed methodological quality.
CONCLUSION: This rapid review outlines the methodological characteristics and outcomes of trials conducted among older adults in UK care homes. The findings of this review provide valuable information to assist in navigating and designing future research in this complex setting.
METHODS AND ANALYSIS: This multiphase observational study will employ embedded mixed methods with a qualitative/quantitative priority: corating functional vision and O&M during social inquiry. Australian O&M agencies (n=15) provide the sampling frame. O&M specialists will use quota sampling to generate cross-sectional assessment data (n=400) before investigating selected cohorts in outcome studies. Cultural relevance of the VROOM and OMO tools will be investigated in Malaysia, where the tools will inform the design of assistive devices and evaluate prototypes. Exploratory and confirmatory factor analysis, Rasch modelling, cluster analysis and analysis of variance will be undertaken along with descriptive analysis of measurement data. Qualitative findings will be used to interpret VROOM and OMO scores, filter statistically significant results, warrant their generalisability and identify additional relevant constructs that could also be measured.
ETHICS AND DISSEMINATION: Ethical approval has been granted by the Human Research Ethics Committee at Swinburne University (SHR Project 2016/316). Dissemination of results will be via agency reports, journal articles and conference presentations.
DESIGN: MRI substudy nested within the double-blind randomised controlled Tranexamic Acid for Hyperacute Primary Intracerebral Haemorrhage (TICH)-2 trial (ISRCTN93732214).
SETTING: International multicentre hospital-based study.
PARTICIPANTS: Eligible adults consented and randomised in the TICH-2 trial who were also able to undergo MRI scanning. To address the primary hypothesis, a sample size of n=280 will allow detection of a 10% relative increase in prevalence of diffusion-weighted imaging (DWI) hyperintense lesions in the TXA group with 5% significance, 80% power and 5% imaging data rejection.
INTERVENTIONS: TICH-2 MRI substudy participants will undergo MRI scanning using a standardised protocol at day ~5 and day ~90 after randomisation. Clinical assessments, randomisation to TXA or placebo and participant follow-up will be performed as per the TICH-2 trial protocol.
CONCLUSION: The TICH-2 MRI substudy will test whether TXA increases the incidence of new DWI-defined ischaemic lesions or reduces perihaematomal oedema or final ICH lesion volume in the context of SICH.
ETHICS AND DISSEMINATION: The TICH-2 trial obtained ethical approval from East Midlands - Nottingham 2 Research Ethics Committee (12/EM/0369) and an amendment to allow the TICH-2 MRI sub study was approved in April 2015 (amendment number SA02/15). All findings will be published in peer-reviewed journals. The primary outcome results will also be presented at a relevant scientific meeting.
TRIAL REGISTRATION NUMBER: ISRCTN93732214; Pre-results.