MATERIALS AND METHODS: Overall methods were guided by the Core Outcome Set Measures in Effectiveness Trials (COMET) initiative. Initial outcome identification was achieved from focus groups with PWLE employing calibrated methods across two low-middle-income countries (China and Malaysia) and two high-income countries (Spain and the United Kingdom). Following consolidation of the results, the outcomes were incorporated into a three-stage Delphi process with PWLE participation. Finally, consensus between PWLE and DPs was achieved using a mixed live and recorded platform. The experiences of PWLE involvement in the process was also evaluated.
RESULTS: Thirty-one PWLE participated in four focus groups. Thirty-four outcomes were suggested across the focus groups. Evaluation of the focus groups revealed a high level of satisfaction with the engagement process and some new learning. Seventeen PWLE contributed to the first 2 Delphi rounds and 7 to the third round. The final consensus included 17 PWLE (47%) and 19 DPs (53%). Out of the total of 11 final consensus outcomes considered essential by both PWLE and health professionals, 7 (64%) outcomes mapped across to ones that PWLE initially identified, broadening their definition. One outcome (PWLE effort required for treatment and maintenance) was entirely novel.
CONCLUSIONS: We conclude that engaging PWLE in COS development can be achieved across widely different communities. Furthermore, the process both broadened and enriched overall outcome consensus, yielding important and novel perspectives for health-related research.
MATERIALS AND METHODS: Overall methods were guided by the Core Outcome Set Measures in Effectiveness Trials (COMET) initiative. Initial outcome identification was achieved from focus groups with PWLE employing calibrated methods across two low-middle-income countries (China and Malaysia) and two high-income countries (Spain and the United Kingdom). Following consolidation of the results, the outcomes were incorporated into a three-stage Delphi process with PWLE participation. Finally, consensus between PWLE and DPs was achieved using a mixed live and recorded platform. The experiences of PWLE involvement in the process was also evaluated.
RESULTS: Thirty-one PWLE participated in four focus groups. Thirty-four outcomes were suggested across the focus groups. Evaluation of the focus groups revealed a high level of satisfaction with the engagement process and some new learning. Seventeen PWLE contributed to the first 2 Delphi rounds and 7 to the third round. The final consensus included 17 PWLE (47%) and 19 DPs (53%). Out of the total of 11 final consensus outcomes considered essential by both PWLE and health professionals, 7 (64%) outcomes mapped across to ones that PWLE initially identified, broadening their definition. One outcome (PWLE effort required for treatment and maintenance) was entirely novel.
CONCLUSIONS: We conclude that engaging PWLE in COS development can be achieved across widely different communities. Furthermore, the process both broadened and enriched overall outcome consensus, yielding important and novel perspectives for health-related research.
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.
MATERIALS AND METHODS: A cross-sectional study was conducted among the healthcare workers in the paediatric department at three public specialist hospitals in Negeri Sembilan between 15 and 21 April 2022. Data were collected through a self-administered questionnaire.
RESULTS: Out of the 504 eligible healthcare workers, 493 participated in this study (response rate 97.8%). The overall prevalence of COVID-19 (11 March 2020-15 April 2022) among healthcare workers was 50.9%. The majority (80.1%) were infected during the Omicron wave two months before the survey. Household contacts accounted for 35.9% of infection sources. The proportion of non-doctors in the COVID-19-infected group was significantly higher compared to the non-infected group (74.1% vs 64.0%, p=0.016). The COVID-19-infected group had a higher proportion of schoolgoing children (44.6% vs 30.6%, p=0.001) and children who attended pre-school/sent to the babysitter (49.0% vs 24.4%, p<0.001). There were no significant differences between infection rates among the healthcare workers working in the tertiary hospital and the district hospitals. There were also no significant differences in the proportion of COVID-19- infected doctors and nurses when analysed by seniority.
CONCLUSION: Our study provided an estimate on the prevalence of COVID-19 among paediatric healthcare workers in Negeri Sembilan and the factors associated with infection, which captures the extent and magnitude of this pandemic on the state's paediatric department. Most infections resulted from household contact, with a higher proportion of infected healthcare workers having young children.
OBJECTIVE: The objective of this research is to develop and implement the Change and Health Evaluation and Response System (CHEERS) as a methodological framework, designed to facilitate the generation and ongoing monitoring of climate change and health-related data within existing Health and Demographic Surveillance Sites (HDSSs) and comparable research infrastructures.
METHODS: CHEERS uses a multi-tiered approach to assess health and environmental exposures at the individual, household, and community levels, utilizing digital tools such as wearable devices, indoor temperature and humidity measurements, remotely sensed satellite data, and 3D-printed weather stations. The CHEERS framework utilizes a graph database to efficiently manage and analyze diverse data types, leveraging graph algorithms to understand the complex interplay between health and environmental exposures.
RESULTS: The Nouna CHEERS site, established in 2022, has yielded significant preliminary findings. By using remotely-sensed data, the site has been able to predict crop yield at a household level in Nouna and explore the relationships between yield, socioeconomic factors, and health outcomes. The feasibility and acceptability of wearable technology have been confirmed in rural Burkina Faso for obtaining individual-level data, despite the presence of technical challenges. The use of wearables to study the impact of extreme weather on health has shown significant effects of heat exposure on sleep and daily activity, highlighting the urgent need for interventions to mitigate adverse health consequences.
CONCLUSION: Implementing the CHEERS in research infrastructures can advance climate change and health research, as large and longitudinal datasets have been scarce for LMICs. This data can inform health priorities, guide resource allocation to address climate change and health exposures, and protect vulnerable communities in LMICs from these exposures.
METHODS: The guidance document was developed over two face-to-face workshops, in addition to an online survey, a face-to-face interview and pragmatic search of literature. The specific focus was on what, where and how to collect RWD/ RWE.
RESULTS: All 11 REALISE member jurisdictions participated in the online survey and the first in-person workshop, 10 participated in the second in-person workshop, and 8 participated in the in-depth face-to-face interviews. The guidance document was iteratively reviewed by all working group members and the International Advisory Panel. There was substantial variation in: (a) sources and types of RWD being used in HTA, and (b) the relative importance and prioritization of RWE being used for policy-making. A list of national-level databases and other sources of RWD available in each country was compiled. A list of useful guidance on data collection, quality assurance and study design were also compiled.
CONCLUSION: The REALISE guidance document serves to align the collection of better quality RWD and generation of reliable RWE to ultimately inform HTA in Asia.
METHODS: A two-round online survey will be conducted, followed by a stakeholder consensus meeting to identify a Core Domain Set. Participants will belong to one of two stakeholder groups: healthcare users with lived experience of tinnitus, and professionals with relevant clinical, commercial, or research experience.
DISCUSSION: This study will establish a Core Domain Set for the evaluation of electrical stimulation-based interventions for tinnitus via an e-Delphi study. The resulting Core Domain Set will act as a minimum standard for reporting in future clinical trials of electrical stimulation interventions for tinnitus. Standardisation will facilitate comparability of research findings.
METHODS AND ANALYSIS: The methodology draws on Arksey and O'Malley's seminal framework for the scoping review. The literature search will be conducted by using keywords to find suitable published literature. The existing literature will be searched using selected electronic databases such as PubMed/MEDLINE, CINAHL, Scopus, ProQuest and Web of Science from the years 2011 and 2021. The selected publications will focus on 10 Southeast Asian countries: Malaysia, Indonesia, Singapore, Thailand, Brunei, Philippines, Laos, Vietnam, Cambodia and Myanmar. Two reviewers will be performing title and abstract screening for the criteria of each publication, in which they will be working independently of each other. The included publication will undergo a full-text review and references cited will be examined for relevance using the same inclusion criteria. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses flow diagram will guide throughout the process. Data will be extracted, analysed and charted within each category from the selected publications for each Southeast Asian country.
ETHICS AND DISSEMINATION: The results of this scoping review will illustrate an overview of the 3D printing healthcare research in the Southeast Asian context, which can be a guide for the advancement of 3D printing that can be accentuated in future research. The results will undergo dissemination which will be submitted for publication in a scientific journal.
METHODS: Data was obtained from the Malaysian Elders Longitudinal Research (MELoR) study, which employed random stratified sampling from three parliamentary constituencies within the Klang Valley. Beat-to-beat blood pressure (BP) was recorded using non-invasive BP monitoring (TaskforceTM, CNSystems). Low frequency (LF), high frequency (HF) and low-to-high frequency (LF:HF) ratio for BPV were derived using fast Fourier transformation. Cognition was evaluated using the Montreal Cognitive Assessment (MoCA) test, and categorized into normal aging, mild impairment and moderate-to-severe impairment.
RESULTS: Data from 1,140 individuals, mean age (SD) 68.48 (7.23) years, were included. Individuals with moderate-to-severe impairment had higher HF-BPV for systolic (SBP) and diastolic (DBP) blood pressure compared to individuals within the normal aging group [OR (95% CI) = 2.29 (1.62-3.24)] and [OR (95% CI) = 1.80 (1.32-2.45)], while HF-SBPV [OR (95% CI) = 1.41 (1.03-1.93)] but not HF-DBPV was significantly higher with mild impairment compared to normal aging after adjustments for potential confounders. Moderate-to-severe impairment was associated with significantly lower LF:HF-SBPV [OR (95% CI) = 0.29 (0.18-0.47)] and LF:HF-DBPV [OR (95% CI) = 0.49 (0.34-0.72)], while mild impairment was associated with significantly lower LF:HF-SBPV [OR (95% CI) = 0.52 (0.34-0.80)] but not LF:HF-DBPV [OR (95% CI) = 0.81 (0.57-1.17)], compared to normal aging with similar adjustments.
CONCLUSION: Higher HF-BPV, which indicates parasympathetic activation, and lower LF:HF-BPV, which addresses sympathovagal balance, were observed among individuals with moderate-to-severe cognitive impairment. Future studies should determine whether BPV could be a physiological marker or modifiable risk factor for cognitive decline.
SUMMARY OF BACKGROUND DATA: A previous systematic review identified 115 outcomes in 60 trials and systematic reviews evaluating treatments for children with appendicitis, suggesting the need for a COS.
METHODS: The development process consisted of 4 phases: (1) an updated systematic review identifying all previously reported outcomes, (2) a 2-stage international Delphi study in which parents with their children and surgeons rated these outcomes for inclusion in the COS, (3) focus groups with young people to identify missing outcomes, and (4) international expert meetings to ratify the final COS.
RESULTS: The systematic review identified 129 outcomes which were mapped to 43 unique outcome terms for the Delphi survey. The first-round included 137 parents (8 countries) and 245 surgeons (10 countries), the second-round response rates were 61% and 85% respectively, with 10 outcomes emerging with consensus. After 2 young peoples' focus groups, 2 additional outcomes were added to the final COS (12): mortality, bowel obstruction, intraabdominal abscess, recurrent appendicitis, complicated appendicitis, return to baseline health, readmission, reoperation, unplanned appendectomy, adverse events related to treatment, major and minor complications.
CONCLUSION: An evidence-informed COS based on international consensus, including patients and parents has been developed. This COS is recommended for all future studies evaluating treatment ofsimple appendicitis in children, to reduce heterogeneity between studies and facilitate data synthesis and evidence-based decision-making.
METHODS: Patients with T2D and HbA1c ≥ 8 % and body mass index (BMI) ≥ 27 kg/m2 and/or waist circumference ≥ 80 cm in women and ≥90 cm in men were recruited. The intervention in Diabetes Centre included 1) nurse-led, group-based workshops; 2) review by endocrinologists; 3) telephone reminders by healthcare assistants and 4) peer support during visits. The usual care (UC) group received consultations at outpatient clinic without workshops or peer support. The MIC group received UC after 1-year of intervention. The primary outcome was change of HbA1c from baseline at 1- and 3-year.
RESULTS: Of 207 eligible patients [age (mean ± standard deviation): 56.9 ± 8.8 years, 47.4 % men, disease duration: 13.5 ± 8.2 years, HbA1c: 9.6 ± 1.3 %, BMI: 28.8 ± 4.3 kg/m2, waist circumference: 101.5 ± 9.9 cm (men), 95.3 ± 9.8 cm (women)], 104 received MIC and 103 received UC. 95 % patients had repeat assessments at 1- and 3-year. After adjustment for confounders, MIC had greater HbA1c reduction (β -0.51, 95 % confidence interval [CI] -1.00 to -0.01; P = 0.045) than UC at 1-year, with sustained improvement at 3-year (β -0.56, CI -1.10 to -0.02; P = 0.044).
CONCLUSION: Team-based MIC for 1 year improved glycemic control in obese T2D which was sustained at 3-year.