Cluster Clinical Research Ethics Committee Research Articles

Cortical–striatal network functional connectivity markers in poststroke fatigue: a single-centre fMRI case–control study protocol

IntroductionStructural and functional abnormalities in the cortical–striatal network (CSN) are hypothesised to play a key role in the pathogenesis of neurological disease-associated fatigue. Some small-scale functional MRI (fMRI) studies have...

Apathy in subarachnoid hemorrhage: study protocol for a 1-year follow-up study.

Apathy is a frequent and debilitating condition among subarachnoid hemorrhage (SAH) survivors. Few studies have evaluated apathy in SAH, and none have examined the course of the condition, predictors of persistent apathy, or its impact on functional outcomes. The proposed study will examine, for the first time, the 12-month course of apathy and its impact on functional outcomes in the largest cohort of SAH survivors to date. The current study is designed as a prospective cohort study with a duration of 36 months. We will recruit 240 participants. A trained research assistant will assess apathy using the Apathy Evaluation Scale 3 months after SAH. Patients' level of functioning, comorbidity, global cognitive functioning, and depressive symptoms will be assessed. All SAH patients will participate in follow-up assessments of apathy and functioning at 9 (T2) and 15 months (T3) post-SAH or at 6 and 12 months after the first assessment. Predictors of persistent apathy and the impact of apathy on functional outcomes will be examined. This will be the first large-scale 1-year follow-up study of apathy in SAH survivors. The findings will provide valuable data to advance our understanding of the clinical course of apathy in this population. Moreover, the results will have clinical relevance by providing essential information to patients, caregivers, and clinicians; promoting the evaluation of apathy; and facilitating the development of prevention strategies, rehabilitation programs, and therapeutic options. Ethical approval for this study was obtained from the Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee (CREC Ref. No.: 2023.339) on 3 October 2023. The findings of this study will be shared through publication in a peer-reviewed journal, presentations at relevant conferences, and dissemination through social media platforms.

Effects of acceptance and commitment therapy on fatigue interference in patients with advanced lung cancer and caregiving burden: protocol for a pilot randomised controlled trial

IntroductionCancer-related fatigue is common in patients with advanced lung cancer. It not only interferes with patients’ health-related quality of life, but also increases the caregiving burden of their caregivers. Acceptance...

Aspirin versus metformin in pregnancies at high risk of preterm pre-eclampsia in China (AVERT): protocol for a multicentre, double-blind, 3-arm randomised controlled trial

IntroductionPre-eclampsia (PE) affects about 5% of Chinese pregnant women and is a major cause of maternal and perinatal morbidity and mortality. The first trimester screening model developed by the Fetal...

Effects of a structured Tai Chi program on improving physical activity levels, exercise self-efficacy and health outcomes among pregnant women: study protocol for a randomised controlled trial

IntroductionTai Chi is a traditional Chinese martial art developed over 300 years ago. Although studies report that Tai Chi benefits practitioners’ cardiovascular health, respiratory system and psychological outcomes, only limited...

A comparison of sleep-wake patterns among school-age children and adolescents in Hong Kong before and during the COVID-19 pandemic.

The lifestyles change of children and adolescents during the COVID-19 pandemic due to antipandemic measures can affect their sleep health. Existing studies have used convenient samples and focused on the initial months of the pandemic, leaving a knowledge gap on changes in young people's sleep patterns under the "new normal" under COVID-19. As part of a territory-wide epidemiological study in Hong Kong, this cross-sectional study recruited primary and secondary school students by stratified random sampling. Sleep parameters were collected using the structured diagnostic interview for sleep patterns and disorders. We investigated the pandemic's effects on sleep parameters by comparing data of participants recruited pre-COVID and those recruited during COVID using multivariate regression, adjusting for age, sex, household income, seasonality, and presence of mental disorders, and the moderators and mediators of the effects. Between September 1, 2019 and June 2, 2021, 791 primary and 442 secondary school students were recruited and analyzed. Primary school and secondary school participants assessed before COVID had a longer sleep latency on school days (95% confidence interval [CI] = 1.0-5.2 minutes, adjusted P-value = .010; and 95% CI= 3.9-13.0 minutes, adjusted P-value = .004, respectively) and nonschool days (95% CI = 1.7-7.2 minutes, adjusted P-value = .005; 95% CI = 3.4-13.7 minutes, adjusted P-value = .014, respectively). Low household income was a moderator for later bedtime (adjusted P-value = .032) and later sleep onset (adjusted P-value = .043) during nonschool days among secondary school students. Changes associated with COVID have a widespread and enduring effect on the sleep health of school-aged students in Hong Kong. Household income plays a role in adolescent sleep health resilience, and the impact of antiepidemic measures on the health gaps of the youth should be considered. Chau SWH, Hussain S, Chan SSM, etal. A comparison of sleep-wake patterns among school-age children and adolescents in Hong Kong before and during the COVID-19 pandemic. J Clin Sleep Med. 2023;19(4):749-757.

Effects of a nurse-led peer support intervention for stroke survivors: protocol for a randomised controlled trial

IntroductionMany stroke survivors have unmet psychosocial needs during the recovery phase following a stroke. There is emerging evidence that peer support interventions may play a valuable role in managing stroke....

Non-Time Varying and Cumulative Effects of Long-Term Use of Renin-Angiotensin System Inhibitor on All-Site Cancers and Mortality in the Hong Kong Diabetes Surveillance Database (2002-2019)

Background: In many countries, cancer is replacing cardiovascular disease as a leading causes of death. Type 2 diabetes (T2D) is associated with increased risk of cancer. Patients with T2D have activated renin-angiotensin-system (RAS) although the association of RAS inhibitors (RASi) and cancer risk remains inconclusive in T2D. Methods: We conducted a prospective cohort study with new-user design in 253,491 Chinese patients with T2D in 2002-2019. We used longitudinal real-world-data from a territory-wide electronic medical record system and evaluated the associations of time-varying RASi use (angiotensin-converting-enzyme-inhibitor [ACEi] and angiotensin-receptor-blocker [ARBs]) with all-site cancer, diabetes-related cancers, and cancer-specific mortality with or without comparison with new-users of calcium-channel-blockers (CCBs). Findings: After excluding prevalent RASi users, amongst the eligible patients (n=253,491), 133,730 (52·8%) were new-RASi and 119,761 (47·2%) were non-RASi users during 6·5 years follow-up period. Time-varying RASi use was associated with lower risk of all-site cancer (HR=0·76, 95%CI: 0·74-0·79), diabetes-related cancer (HR=0·79, 0·75-0·84), cancer-specific mortality (HR=0·50, 0·47-0·53), and diabetes-related cancer mortality (HR=0·49, 0·45-0·54) versus non-RASi. ARBs use was associated with lower risk of cancer-specific mortality versus ACEi (HR=0·77, 0·66-0·91). Use of RASi was non-time-varying with an estimated prevention of 2·6 (95% CI: 2·3-3·0) all-site cancer events per-1000-person-years and 2·2 (95%CI: 2·0-2·5) cancer-related mortality per-1000-person-years. The reduced risk associations of RASi with all-cause and cancer-specific mortality were most evident in young adults versus new-CCBs users. Interpretation: Long-term RASi use was independently associated with lower cancer risk in T2D, including diabetes-related cancers and cancer-specific mortality, with stronger associations in users of ARBs than ACEi. Funding Information: Dr. Aimin Yang was supported by a CUHK Impact-Research-Fellowship Scheme. Declaration of Interests: JCNC has received research grants and/or honoraria for consultancy or giving lectures, from AstraZeneca, Bayer, Boehringer Ingelheim, Eli-Lilly, Hua Medicine, Lee Powder, Merck Serono, Merck Sharp & Dohme, Pfizer and Sanofi. APSK has received research grants and/or speaker honoraria from Abbott, Astra Zeneca, Bayer, Boehringer Ingelheim, Eli-Lilly, Merck Serono, Nestle, Novo Nordisk, Pfizer and Sanofi. AOYL has served as a member of advisory panel for Amgen, AstraZeneca, Boehringer Ingelheim and Sanofi and received research support from Amgen, Asia Diabetes Foundation, Bayer, Boehringer Ingelheim, Lee’s Pharmaceutical, MSD, Novo Nordisk, Roche, Sanofi, Sugardown Ltd, Takeda. None of these relationships had any influence on the content of the present manuscript. RCWM has received research funding from AstraZeneca, Bayer, Merck Sharp & Dohme, Novo Nordisk, Pfizer and Tricida Inc. for carrying out clinical trials, and has received speaker honorarium or consultancy in advisory boards from AstraZeneca, Bayer and Boehringer Ingelheim. All proceeds have been donated to the Chinese University of Hong Kong to support diabetes research. Other authors have no conflicts of interest to disclose. Ethics Approval Statement: Ethical approval was obtained from the Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee for analysis and reporting of anonymized data.

Seroepidemiology of hepatitis A and B in the general population in Hong Kong: protocol of a cross-sectional survey using spatial sampling in a highly urbanised city

IntroductionDifferences in immunisation policies have significantly reshaped the epidemiology of hepatitis A and B in the population. Assessment of the susceptibility and transmission potential of these two types of vaccine-preventable...

Patient-specific instrumentation (PSI) Referencing High Tibial Osteotomy Technological Transfer and Education: protocol for a double-blind, randomised controlled trial (PROTECTED HTO Trial)

IntroductionHigh tibial osteotomy (HTO) is a treatment of choice for active adult with knee osteoarthritis. With advancement in CT imaging with three-dimensional (3D) model reconstruction, virtual planning and 3D printing,...

Retention of men who have sex with men in a pre-exposure prophylaxis programme: survival analysis from a crossover study

BackgroundAdherence to monitoring and prescription of pre-exposure prophylaxis (PrEP) is important in effectively preventing HIV infection. We aimed to establish the retention rate of men who have sex with men (MSM) who enrolled in a PrEP implementation study in Hong Kong, China. MethodsOur study was a survival analysis of a crossover study. A research clinic was set up in the teaching hospital of the university to recruit participants through community-based organisations or by self-referral. Participants were randomly assigned by block randomisation with a block size of four to two groups during the study period (32 weeks split into two 16-week phases); in the first group, participants were asked to take PrEP every day for the first 16 weeks then on demand for the remaining 16 weeks, and in the second group, participants took PrEP on demand for the first 16 weeks then ever day for the remaining 16 weeks. Eligible participants were adult HIV-negative MSM with a history of high HIV-risk behaviours or sexually transmitted infections in the preceding 6 months and an inclination to practice condomless sex in the coming 6 months. The exclusion criteria were hepatitis B virus infection, creatinine clearance lower than 60 mL per min, with or without mental illnesses. We assessed behavioural factors associated with retention by bivariate analysis. We used cox regression to characterise participants who had dropped out of the study. The study was approved by the Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee (CREC 2016.719). The trial is registered with the Centre for Clinical Research and Biostatistics, The Chinese University of Hong Kong, Hong Kong, China (trial number CUHK_CCRB00606). FindingsBetween Aug 25, 2018, and Mar 23, 2019, we recruited 120 MSM. Of the 120 MSM recruited, one (<1%) tested positive for HIV at baseline and was therefore excluded and referred to HIV services. Of the remaining 119 participants, with a median age of 30 years (interquartile range 26–38 years), 59 (50%) were assigned to the daily-PrEP-first group and 60 (50%) were assigned to the on-demand-PrEP-first group. Some 103 (87%) MSM attended all scheduled visits. Study group was not associated with retention status (p=0·97) with 51 (86%) of 59 MSM completing 32 weeks follow-up in the daily-PrEP-first group and 52 (87%) of 60 MSM completing follow-up in the on-demand-PrEP-first group. Participants who discussed PrEP use with their boyfriends were more likely to drop out (p=0·030). After excluding one participant who defaulted after the first visit, results from cox regression showed that MSM who were on PrEP before joining this study had a dropout hazard of 0·256 and those who had HIV-positive sex partners had a dropout hazard of 9·513. The hazard increased by 10% for each year of age. Discordant results were found in the effect of sexual role. On a scale of 1 to 10 ranking inclination to have insertive condomless anal sex, the hazard decreased by 20% for each increasing point, whereas receptive roles increased by 30%. InterpretationThe retention was high in a trial setting. Defaulters who had receptive anal sex or HIV-positive sex partners might have continued HIV risk, therefore other prevention measures should be made available if PrEP was not sought elsewhere. The role of intimate or sex partners in retention in PrEP programmes should be explored. FundingAIDS Trust Fund (MSS 292 R).

Effects of a multidisciplinary team-led school-based human papillomavirus vaccination health-promotion programme on improving vaccine acceptance and uptake among female adolescents: A cluster randomized controlled trial.

Introduction:Evidence has consistently shown the high efficacy of human papillomavirus (HPV) vaccines in preventing cervical cancers. However, the HPV vaccine uptake rate in Hong Kong is very low. We will develop and evaluate an innovative, theory-based multidisciplinary team-led school-based HPV vaccination health-promotion program (MDL-SHPVP), engaging female adolescents, parents/guardians, and secondary school personnel in multicomponent educational strategies and interactive discussions.Methods and analysis:A cluster randomized controlled trial is proposed. We will recruit 2520 female adolescents and their parents/guardians from 18 secondary day schools. The MDL-SHPVP is underpinned by the Health Belief Model and Precaution Adoption Process Model. Multicomponent interventions will be offered, including education sessions with small group dialogues with a registered nurse and trained healthcare and lay volunteers, and educational computer games. A team of volunteers will be established to raise HPV, cervical cancer, and HPV vaccine awareness. Outcomes include adolescents’ uptake of the HPV vaccine, adolescents’ intention to receive HPV vaccination, vaccine acceptance among parents/guardians, and parents’/guardians’ and adolescents’ HPV knowledge, attitudes, and beliefs. Data will be collected at baseline, 1 month, and 1 year after intervention. The generalized estimating equations analysis will be used for comparing the outcomes between the 2 groups.Ethics and dissemination:Ethical approval was obtained from the Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee (Ref. no.: 2019.055). We will disseminate the study findings via peer-reviewed publications and presentations at relevant events and international and local conferences.Trial registration number:ClinicalTrials.gov NCT04438291

Collateral Effect of Coronavirus Disease 2019 Pandemic on Hospitalizations and Clinical Outcomes in Gastrointestinal and Liver Diseases: A Territory-wide Observational Study in Hong Kong

Background The Coronavirus Disease 2019 (COVID-19) pandemic had a huge impact on healthcare systems globally. Decline in hospital admissions for common medical emergencies was observed. We investigated its collateral effect on hospitalizations and clinical outcomes in patients with gastrointestinal (GI) and liver diseases in Hong Kong. Methods We performed a territory-wide retrospective cohort study in Hong Kong from January 1, 2019, to May 31, 2020. Data were retrieved through Clinical Data Analysis and Reporting System. We included patients admitted to hospitals with top diagnoses of luminal GI cancers, pancreatico-hepatobiliary cancers, benign pancreaticobiliary disorders, liver diseases, non-infective enteritis and colitis, non-variceal and variceal upper gastrointestinal bleeding (UGIB). We excluded patient-based hospital admissions without emergency department attendance and length of stay equal to or shorter than one day. The primary endpoint was the total number of index hospital admissions related to these diagnoses at different time points. The secondary endpoints were in-hospital mortality, intensive care unit admission, elective or emergency operations and endoscopy. The COVID-19 period was defined as the time after the first local case in January 2020, week 4. Results We recorded a total of 195,867 hospital admissions related to GI diseases during the study period, and 125,049 of them were included in the final analysis. Comparing the same pre-COVID19 and COVID-19 periods, we observed a significant decline in the average number of hospitalizations for GI diseases (17.0% reduction, P Conclusions The number of hospitalizations related to GI diseases reduced drastically during the COVID-19 epidemic, yet no excessive in-hospital mortality was observed. More emergency endoscopies and operations were required, particularly for UGIB and benign pancreaticobiliary conditions.

An Exploratory Birth Cohort Study on the Relationship of Early-Life Gut Microbiome and Lifestyle Factors in the Development of Eczema in Hong Kong Infants

Background: Childhood eczema is common but the prevalence is variable in different regions of the world. Therefore, identification of risk factors of eczema in specific region is important to prevent its occurrence. In this study, we aim to explore the association of various risk factors like microbiome, environment, lifestyle, diet and maternal stress, and the development of eczema in early-life of infants in Hong Kong Methods: At enrolment, the infants’ parents provided demographic data by self-reporting. At enrolment and at one year after birth, the allergy condition and lifestyle of the infants were assessed by the modified parent proxy version of the Comprehensive Early Childhood Allergy Questionnaire. The dietary factors were assessed by the eating-habit module of the Behavioural Risk Factor Surveillance System. Maternal stress was assessed by 10-item Perceived Stress Scale. Infants’ gut microbiome was analysed by 16S RNA sequencing and the longitudinal change of various bacterial strains was compared between healthy and eczema group. Findings: In univariate analysis, it was shown that the mode of delivery, abundance change in Clostridia and Hungatella hathewayi were significantly different between healthy and eczema group. Multivariate analysis, after adjustment for other significant factors, further revealed that the abundance change of Hungatella hathewayi in the gut (p=0.005) were associated with the development of eczema in this study. Interpretation: Increased change in abundance of Hungatella hathewayi were associated with increased risk of eczema development in the infants at one year of age. This study explored the potential risk factors for eczema development in the infants in Hong Kong and sheds light on the possible association between early-life gut microbiome and other environmental factors. Trial Registration: This study was registered on the ISRCTN Registry with reference number ISRCTN44080054. Funding Statement: This study was supported by Department Funding from The Nethersole School of Nursing in The Chinese University of Hong Kong. Declaration of Interests: None. Ethics Approval Statement: The study protocol was approved by the Joint Chinese University of Hong Kong – New Territories East Cluster Clinical Research Ethics Committee with reference number 2016.321. Written informed consent were obtained from the participants’ parents prior to data collection.

Factors associated with participation in colorectal cancer screening: a population-based study of 7200 Chinese individuals

BackgroundScreening for colorectal cancer can reduce mortality, yet, participation rate is suboptimal in various countries. We aimed to evaluate the effectiveness of a pilot programme for colorectal cancer screening on increasing the enabling factors of screening in a large Chinese population, and identified factors associated with its participation based on variables pertinent to the Health Belief Model. MethodsWe collected data from 3600 screening participants who were randomly selected using a telephone list for 2016, 2017, and 2018, from the government colorectal cancer screening programme. We also collected data from 3600 non-screening participants through a telephone survey via simple random sampling of telephone numbers in a territory-wide directory for the years 2016, 2017, and 2018. We collected sociodemographic factors, the enabling factors of screening (such as knowledge levels of colorectal cancer, perceptions of colorectal cancer screening, cues to actions), and barriers of screening. We constructed a logistic regression model to identify the association between these factors and participation in colorectal cancer screening adjusted for age, gender, educational level, and household income. The study was approved by the Joint Chinese University of Hong Kong − New Territories East Cluster Clinical Research Ethics Committee (reference number 2016.485). Verbal consent was obtained from the study participants. FindingsThe knowledge level of colorectal cancer screening tools (from 67·9% to 85·4%, p<0·001), perceived severity of having colorectal cancer (from 37·7% to 42·8%, p<0·001), perceived benefits of screening (from 54·9% to 72·1%, p<0·001), and reductions in access barriers of colorectal cancer screening (from 18·5% to 7·5%, p<0·001) significantly improved from 2016 to 2018. People with older age (adjusted odds ratio [AOR] 2·02, 95% CI 1·77–2·30, p<0·001), higher level of knowledge of screening methods (6·70, 4·40–10·20, p<0·001), greater perceived severity (2·03, 1·69–2·43, p<0·001), and coverage of insurance (1·25, 1·09–1·43, p<0·01) were more likely to participate in screening. By contrast, more affluent people (0·68, 0·57–0·80, p<0·001), female individuals (0·64, 0·56–0·72, p<0·001), higher level of perceived psychological barriers (0·54, 0·42–0·69, p<0·001), and access barriers (0·57, 0·44–0·73, p<0·001) were associated with poorer participation. InterpretationThese findings demonstrate the effectiveness of the screening programme on increasing the enabling factors and identify the target groups such as younger individuals, females, and more affluent people among whom more intensive educational initiatives are needed to enhance their participation. FundingHealth and Medical Research Fund (No. 6904168), Food and Health Bureau, Hong Kong, China.

Effectiveness and cost-effectiveness of a virtual multidisciplinary stroke care clinic for community-dwelling stroke survivors and caregivers: a randomised controlled trial protocol

IntroductionThe virtual multidisciplinary stroke care clinic (VMSCC) is the first nurse-led clinic developed to offer support to community-dwelling stroke survivors and caregivers, and to promote poststroke recovery. This two-arm randomised...

Coaching Ongoing Momentum Building On stroKe rEcovery journeY (’COMBO-KEY'): a randomised controlled trial protocol

IntroductionSystematic reviews reporting self-management interventions are associated with significant improvements in stroke survivors’ self-efficacy, health-related quality of life (HRQoL) and independence. However, common barriers such as transportation and availability of...

Effects of a mindfulness-based intervention (MYmind) for children with ADHD and their parents: protocol for a randomised controlled trial

IntroductionMindfulness is one of the potential alternative interventions for children with attention-deficit hyperactivity disorder (ADHD). Some evidence suggests that mindfulness is related to changes in brain regions associated with ADHD....

Acceptability of an incentivised PrEP programme for men who have sex with men at high risk of HIV infection in Hong Kong: an implementation study

BackgroundIn Hong Kong, pre-exposure prophylaxis (PrEP) was first launched as a pilot study for men who have sex with men (MSM) at high risk of HIV infection. However, the community's acceptance of such programme might affect policy making in its implementation as a service. Therefore, we aimed to examine the feasibility of an incentivised mode of PrEP delivery in the MSM community. MethodsWe did a implementation study of daily co-formulated tenofovir disoproxil fumarate 300 mg plus emtricitabine 200 mg (TDF/FTC). We prescribed oral tablets of TDF/FTC to PrEP-naive, HIV-negative, high-risk MSM for 30 weeks through a pilot clinic in Hong Kong. We assessed MSM that self-referred or were referred by collaborating community organisations or HIV services using a survey about their eligibility and, if applicable, reasons for not joining the study. The key inclusion criteria were recent history of condomless anal sex and HIV negative on testing, whereas HBsAg-positive patients and those with impaired renal functions were excluded. The primary measures were acceptance rate and associated socio-behavioural factors. Consenting MSM were required to pay a fixed price at each visit but the follow-up interval was increased over time, such that the unit cost of TDF/FTC became lower for participants who remained on the programme. The actual cost of TDF/FTC was equivalent to HK$25 (US$3·20) per tablet or 13% of the market price upon completion. The study was approved by the Joint Chinese University of Hong Kong–New Territories East Cluster Clinical Research Ethics Committee. This study is registered with the Centre for Clinical Research and Biostatistics Clinical Trials Registry, number CUHK_CCRB00533, and the Chinese Clinical Trial Registry, number ChiCTR-OPC-16009603. FindingsBetween Sep 21, 2017, and May 23, 2018, 292 MSM were assessed. Among 247 MSM who showed interest in the study, 196 (79%) had engaged in high-risk behaviours in the preceding 6 months. Among 229 high risk MSM, 196 (86%) indicated willingness to join the study, of which 71 ultimately enrolled. 49 (98%) of 50 MSM who used drugs during sex were interested in joining the programme (p=0·004). There were no significant associations between risky behaviours, such as the practice of condomless sex, and PrEP acceptance. The most common reason for not being interested in the study was the drug cost (24 [53%] of 45), concern about side-effects (13 [29%]), low perceived risk (ten [22%]), and feeling troublesome about taking daily medications (nine [20%]). InterpretationAn incentivised mode of PrEP delivery was moderately well accepted by high risk MSM in Hong Kong. The gap between awareness and their access to PrEP would need to be addressed in the future if programme expansion is considered, since price can be a major deterrent for some eligible people despite the lowered price. Community education on PrEP together with pre-PrEP counselling is crucial for successful implementation. FundingAIDS Trust Fund (MSS 264 R), Hong Kong.

Time trend and characteristics of prostate cancer diagnosed in Hong Kong (China) in the past two decades.

Time trend and characteristics of prostate cancer diagnosed in Hong Kong (China) in the past two decades.