Research Ethics Committee Research Articles

Impact of Eating Habits on Academic Performance among 4th year Medical Students of a Private College Faisalabad

Objective: This study was designed to determine the relationship between eating habits and academic performance among medical students of Aziz Fatimah Medical and Dental College. Study design & Setting: A comparative cross-sectional study was being conducted Methodology: After the permission of the Ethical Research Committee of the institution. Students of 4th year MBBS was recruited by simple convenient sampling. A validated questionnaire consisting of 14 questions in reference to eating habits was used. Statistical analysis was done by SPSS version 24 and a one-way ANOVA test was used and p value of = 0.05 was considered statistically significant. Results: Study was conducted on 100 medical students with mean age of 22.67±.554. Out of 100 participants 51 (51%) were male and 49 (49%) were female students. It was observed that good eating habit score was associated with high academic achievements. While, a bad eating habit score was associated with low academic achievements. Conclusion: It was concluded from our study that there was a significant association between good eating habits and academic performance.

Supercharged end-to-side anterior interosseous nerve transfer to restore intrinsic function in high ulnar nerve injury: a prospective cohort study

BackgroundHigh ulnar nerve injuries is known to have unfavorable motor outcomes compared to other peripheral nerve injuries in the upper extremity. Functional muscle recovery after peripheral nerve injury depends on the time to motor end plate reinnervation and the number of motor axons that successfully reach the target muscle. The purpose of this study is to assess the functional recovery, and complications following performing supercharge end-to-side (SETS) anastomosis for proximal ulnar nerve injuries. Our study focuses on the role of SETS in the recovery process of high ulnar nerve injury.Patient and methodsThis study is a prospective, single-arm, open-label, case series. The original proximal nerve pathology was dealt with according to the cause of injury, then SETS was performed distally. The follow-up period was 18 months. We compared the neurological findings before and after the procedure. A new test was used to show the effect of SETS on recovery by performing a Lidocaine proximal ulnar nerve block test.ResultsRecovery of the motor function of the ulnar nerve was evident in 33 (86.8%) patients. The mean time to intrinsic muscle recovery was 6.85 months ± 1.3, only 11.14% of patients restored protective sensation to the palm and finger and 86.8% showed sensory level at the wrist level at the end of the follow-up period. Lidocaine block test was performed on 35 recovered patients and showed no change in intrinsic hand function in 31 patients.ConclusionSETS exhibit a remarkable role in the treatment of high ulnar nerve damage. SETS transfer can act as a nerve transfer that can supply intrinsic muscles by its fibers and allows for proximal nerve regeneration. We believe that this technique improves recovery of hand motor function and allows recovery of sensory fibers when combined with treating the proximal lesion.Trial registrationApproved by Research Ethics Committee of Faculty of Medicine- Cairo University on 01/09/2021 with code number: MD-215–2021.

Switching from Dose-Intensified intravenous to SubCutaneoUS infliximab in Inflammatory Bowel Disease (DISCUS-IBD): protocol for a multicentre randomised controlled trial

IntroductionA substantial proportion of patients with inflammatory bowel disease (IBD) on intravenous infliximab require dose intensification. Accessing additional intravenous infliximab is labour-intensive and expensive, depending on insurance and pharmaceutical reimbursement....

Nature-engagement and wellbeing in Brazil: Understanding the dose-effect relationship for designing urban green spaces

Statement of problemIn the face of increasing urbanization, the pursuit of healthy and sustainable cities promoting a high quality of life intertwined with nature is paramount. PurposeThis research endeavors to assess the impact of variations in nature interaction styles on health, with the objective of generating evidence to inform the design of urban green spaces. MethodEthically approved by the Human Research Ethics Committee (CAAE 58149622.3.0000.0077), a survey involving 2136 respondents was conducted. Participants reported their nature engagement frequency, duration, and intensity, alongside mental health assessments using the Depression, Anxiety, and Stress Scale (DASS-21). Welch's ANOVA and Cohen’s d were employed to derive meaningful effect size. ConclusionsThis research provided empirical insights into the relationship between nature interaction and public health, thus offering evidence to inform urban green space design. Practical implicationsThe findings are expected to empower urban planners and policymakers with evidence-based strategies for creating urban green spaces conducive to physical activities, leisure events, and nature-based recreation, promoting public health through appropriately timed and frequented activities. Future directionsFurther research avenues may include longitudinal studies to assess the long-term impact of nature interaction on mental health and the implementation of evidence-based design strategies in urban green space development.

Atosiban versus placebo in the treatment of threatened preterm birth between 30 and 34 weeks gestation: study protocol of the 4-year APOSTEL 8 follow-up

IntroductionCurrently, the majority of women worldwide with threatened preterm birth are treated with tocolytics. Although tocolytics can effectively delay birth for 48 hours, no tocolytic drug has convincingly been shown...

Barriers to maintaining dignity for patients with schizophrenia: A qualitative study.

Since dignity is one of the fundamental rights of each patient, maintaining patients' dignity is essential. Unfortunately, in many cases, particularly among patients with schizophrenia (SCZ), dignity is not fully respected. Nonetheless, there is limited knowledge regarding this matter in Middle Eastern Nations. This study aimed to identify the barriers to maintaining dignity for patients with schizophrenia from the perspective of patients with schizophrenia, their family caregivers, and healthcare personnel. This qualitative study was conducted with patients (n = 16), family caregivers (n = 4), and healthcare personnel (n = 6) who were selected using a purposeful sampling method. The data were collected through semi-structured, in-depth face-to-face interviews until the data reached saturation. Data were analyzed using the Graneheim and Lundman method. The Research Ethics Committee of Urmia University of Medical Sciences (IR.UMSU.REC.1401.099). Analysis of the interviews revealed two main themes and five subthemes as the barriers to maintaining dignity for patients with schizophrenia. The main themes included "Black shadow of stigma" (three subthemes: "Facing the fear and discrimination of others," "Misconceptions in society," and "Social rejection") and "Facing violations" (two subthemes: "Basic human rights violation" and "Negative emotional responses"). Patients' dignity with schizophrenia was at a low level due to the negative attitude of society toward these patients. In this respect, the basic human rights violations, social rejection, and misconceptions were abundant in society and care centers. An in-depth comprehension of the threatening factors affecting dignity can assist policymakers in safeguarding their dignity through effective programs.

Costs and cost drivers of comprehensive sexual reproductive health services to female sex workers in Kenya

BackgroundComprehensive sexual reproductive health (SRH) programs for female sex workers (FSW) offering clinical, behavioural, and structural interventions have contributed to declining rates of HIV in this population. However, data on costs and cost drivers is needed to support programs and their donors to better allocate resources, make an investment case for continued funding, and to identify areas of improvement in program design and implementation. We aimed to estimate the annual per-FSW costs of comprehensive services for a standalone FSW program in Kenya.MethodsWe implemented a top–bottom and activity-based costing study of comprehensive FSW services at two drop-in centres (DICs), Mtwapa and Kilifi town, in Kilifi County, Kenya. Service costs were obtained from routinely collected patient data during FSW scheduled and unscheduled visits using Kenyan Ministry of Health records. Costing data were from the program and organization’s expenditure reports, cross checked against bank documents and supported by information from in-depth interviews. Data were collected retrospectively for the fiscal year 2019. We obtained approval from the AMREF Research Ethics Committee (AMREF-ESRC P862/2020).ResultsIn 2019, the unit cost of comprehensive services was 105.93 USD per FSW per year, roughly equivalent to 10,593 Kenya shillings. Costs were higher at Mtwapa DICs compared to Kilifi town DIC; 121.90 USD and 89.90 USD respectively. HIV counselling and testing cost 63.90 USD per person, PrEP was 34.20 USD and family planning was 9.93 USD. Of the total costs, staff salaries accounted for about 60%. Adjusted for inflation, costs in 2024 would be approximately 146.60.ConclusionPrograms should strive to maximize the number of FSW served to benefit from economies of scale. Given that personnel costs contribute most to the unit costs, programs should consider alternative designs which reduce personnel and other costs.

American registry of ambulatory and acute decompensated heart failure (AMERICCAASS registry): Rationale and design.

Heart failure (HF) is a highly prevalent and progressive condition associated with significant morbidity and mortality rates. Acute decompensated HF precipitates millions of hospitalizations each year. Despite therapeutic advances, the overall prognosis of HF is poor. The varying clinical courses and outcomes of patients with this disease may be due to region-specific gaps and since most HF studies are conducted in developed countries, the participation of Latin American and Caribbean countries is low. Considering this, the American Registry of Ambulatory and Acute Decompensated Heart Failure (AMERICCAASS) aims to characterize the population with ambulatory and acute decompensated HF in the American continent and to determine rehospitalization and survival outcomes during the 12months of follow-up. AMERICCAASS Registry is an observational, prospective, and hospital-based registry recruiting patients with ambulatory or acute decompensated HF. The registry plans to include between two and four institutions per country from at least 20 countries in the Americas, and at least 60 patients recruited from each participant institution regardless of their ambulatory or acutely decompensated condition. Ambulatory patients with confirmed HF diagnosis or inpatients presenting with acute decompensated HF will be included. Follow-up will be performed at 12months in ambulatory patients or 1, 6, and 12months after hospital discharge in acutely decompensated HF patients. This ongoing study began on 1 April 2022, with recruitment scheduled to end on 30 November 2023, and follow-up on 31 January 2025. Ethics approval was obtained from the Biomedical Research Ethics Committee of Fundación Valle del Lili. Data collected in the AMERICCAASS registry is being stored on the electronic platform REDCap (Research Electronic Data Capture), which allows different forms for patient groups to enable unbiased analyses. For quantitative variables comparison, we will use the Student's t-test or non-parametric tests accordingly. Categorical variables will be presented as proportions, and groups will be compared with Fisher's exact test. The significance level will be <0.05 for comparisons. Readmissions and post-discharge mortality will be calculated as proportions at 1, 6, and 12months, with a survival analysis by conditional probability and the Kaplan-Meier method. AMERICCAASS Registry is intended to be the most important registry of the continent for obtaining important information about demographics, aetiology, co-morbidities, and treatment received, either ambulatory or hospitalized. This registry may contribute to the optimization of national and regional evidence and public policies for the diagnosis and treatment of HF disease.

Effect of lung volume preservation during spontaneous breathing trial on successful extubation in patients receiving mechanical ventilation: protocol for a multicenter clinical trial

BackgroundIn standard weaning from mechanical ventilation, a successful spontaneous breathing test (SBT) consisting of 30 min 8 cmH2O pressure-support ventilation (PSV8) without positive end-expiratory pressure (PEEP) is followed by extubation with continuous suctioning; however, these practices might promote derecruitment. Evidence supports the feasibility and safety of extubation without suctioning. Ultrasound can assess lung aeration and respiratory muscles. We hypothesize that weaning aiming to preserve lung volume can yield higher rates of successful extubation.MethodsThis multicenter superiority trial will randomly assign eligible patients to receive either standard weaning [SBT: 30-min PSV8 without PEEP followed by extubation with continuous suctioning] or lung-volume-preservation weaning [SBT: 30-min PSV8 + 5 cmH2O PEEP followed by extubation with positive pressure without suctioning]. We will compare the rates of successful extubation and reintubation, ICU and hospital stays, and ultrasound measurements of the volume of aerated lung (modified lung ultrasound score), diaphragm and intercostal muscle thickness, and thickening fraction before and after successful or failed SBT. Patients will be followed for 90 days after randomization.DiscussionWe aim to recruit a large sample of representative patients (N = 1600). Our study cannot elucidate the specific effects of PEEP during SBT and of positive pressure during extubation; the results will show the joint effects derived from the synergy of these two factors. Although universal ultrasound monitoring of lungs, diaphragm, and intercostal muscles throughout weaning is unfeasible, if derecruitment is a major cause of weaning failure, ultrasound may help clinicians decide about extubation in high-risk and borderline patients.Trial registrationThe Research Ethics Committee (CEIm) of the Fundació Unió Catalana d’Hospitals approved the study (CEI 22/67 and 23/26). Registered at ClinicalTrials.gov in August 2023. Identifier: NCT05526053.

An Assessment of the Knowledge, Attitude, and Practice of Probiotics and Prebiotics among the Population of the United Arab Emirates.

Probiotics and prebiotics offer a range of advantageous effects on human health. The knowledge, attitudes, and practices (KAP) of individuals can impact their inclination to consume probiotics and prebiotics. The main objective of this study was to examine the KAP of the people in the United Arab Emirates (UAE) about probiotics and prebiotics consumption. Additionally, the study aimed to assess the impact of KAP and sociodemographic factors on the use of probiotics and prebiotics. In order to accomplish this objective, a verified online questionnaire was used with a five-point Likert scale and distributed using an online platform (Google Forms). A cross-sectional research, non-probability sampling was implemented, and G*Power statistical power analysis was used to estimate a sample size of 385 participants. A total of 408 replies were gathered. The population under study consisted of residents in the UAE between the ages of 18 to 64 years old, excluding populations under the age of 18 and those living outside the UAE. A total of 392 participants met the criteria for inclusion in this study. The research ethics committees of UAE University granted the study approval (ERSC_2024_4359), and the validity of the findings was confirmed through face-to-face interviews with around 50 individuals and a Cronbach's alpha test with result of 0.84. The statistical software SPSS version 29.0 for Mac OS was utilized to examine the relationships between KAP variables, including Chi-square tests and Pearson's correlation coefficients. The tests were selected based on their capacity to handle categorical and continuous data, respectively. The female population was 85.2% of the total, while the male population accounts for 14.8%. The age distribution of participants shows that the largest proportion, 68.4%, falls within the 18-24 age range. Out of the participants, 61.5% held a bachelor's degree. Most of the participants, 56.4%, were students, while 29.1% were employees. The average results indicate a significant inclination towards probiotics and prebiotics, as demonstrated by the scores above the midpoint for the six knowledge questions (M = 2.70), six attitude questions (M = 3.10), and six practice questions (M = 3.04). Several studies have examined this phenomenon; however, additional research comparing individuals in the UAE is necessary to fully comprehend the influence of KAP on the consumption of probiotics and prebiotics in the UAE.

Sepsis call emergency department pharmacist service: a single healthcare network cohort study

AbstractBackgroundSepsis and septic shock are common emergency department (ED) presentations, with current guidelines recommending early administration of antibiotics to reduce mortality.AimSepsis calls with pharmacist attendance have been introduced at two EDs, and the aim of this study was to evaluate the impact of this service on outcomes of all septic patients.MethodAt a multisite, single healthcare network, located in Victoria, Australia, emergency medicine pharmacists were trained in assisting medical staff in antibiotic selection, dosing, and delivering antibiotics directly to nursing staff. The sepsis call service was introduced in May 2022 at one site and in March 2023 at another site, with time to first antibiotic administration, morbidity, and mortality being compared to the outcomes of patients from the same EDs from January–April 2022 (group 1). Post the sepsis call introduction, two cohorts were compared: sepsis call attended patients without a pharmacist (group 2) and with a pharmacist (group 3). This project was exempt due to the local policy requirements that constitute research by the Monash Health Human Research Ethics Committee (Reference no: RES‐23‐0000‐237Q). The justification for this ethics exemption was as follows: the study was retrospective, included privacy protections for patients' data, and presented no increased risk to patient care.ResultsThe study included 201 patients, with time to first antibiotic administration on average 302.0 min in group 1, 201.3 min (p = 0.007) in group 2, and 89.8 min (p &lt; 0.001) in group 3. Mortality (p = 0.306), rates of acute kidney injury (p = 0.111), intensive care unit (ICU) admission (p = 0.002), and need for dialysis (p = 0.497) were all reduced in group 3. Adherence to antibiotic guidelines was increased in group 3 (p &lt; 0.001).ConclusionEmergency medicine pharmacist contribution led to reduced time to first antibiotic, an improved adherence to antibiotic guidelines, and positive trends in secondary clinical outcomes. Further research is required to determine the significance of improvements in mortality, intensive care unit admissions, and renal impairment.

EPIC-CP pilot trial study protocol: a multicentre, randomised controlled trial investigating the feasibility and acceptability of social prescribing for Australian children with cerebral palsy

IntroductionThe social determinants of health contribute to poorer health outcomes for children with cerebral palsy (CP) and are barriers to families accessing health services. At an individual level, social determinants...

Carvedilol to prevent decompensation of cirrhosis in patients with clinically significant portal hypertension stratified by liver stiffness: study protocol for a randomied, double-blind, placebo-controlled, multicentre trial in China

IntroductionPatients with clinically significant portal hypertension (CSPH) are recommended to be treated with non-selective beta-blockers (ie, carvedilol) to prevent the first hepatic decompensation event by the renewing Baveno VII consensus....

Adapting COVID-19 research infrastructure to capture influenza and respiratory syncytial virus alongside SARS-CoV-2 in UK healthcare workers winter 2022/23 and beyond: protocol for a pragmatic sub-study

Introduction During the COVID-19 pandemic, extensive research was conducted on SARS-CoV-2; however, important questions about other respiratory pathogens remain unanswered. A severe influenza season in 2022–2023 with simultaneous circulation of SARS-CoV2 and respiratory syncytial virus is anticipated. This sub-study aims to determine the incidence and impact of these respiratory viruses on healthcare workers, the symptoms they experienced, the effectiveness of both COVID-19 and influenza vaccination and the burden of these infections on the National Health Service (NHS) workforce. Methods and analysis This is a longitudinal prospective cohort sub-study, utilising the population and infrastructure of the SARS-CoV-2 Immunity &amp; Reinfection Evaluation (SIREN) study, which focuses on hospital staff in the UK. Participants undergo fortnightly nucleic acid amplification testing on a multiplex assay including SARS-CoV-2, influenza A and B and RSV, regardless of symptoms. Questionnaires are completed every two weeks, capturing symptoms, sick days, exposures, and vaccination records. Serum samples are collected monthly or quarterly from participants associated with a SIREN site. This sub-study commenced on 28/11/22 to align with the predicted influenza season and participants’ influenza vaccine status. The SIREN Participant Involvement Panel shaped the aims and methods for the study, highlighting its acceptability. UK devolved administrations were supported to develop local protocols. Analysis plans include incidence of asymptomatic and symptomatic infection, comparisons of vaccination coverage, assessment of sick day burden, and effectiveness of seasonal influenza against infection and time off work. Data are also integrated into UKHSA nosocomial modelling. Ethics and dissemination The protocol was approved by the Berkshire Research Ethics Committee (IRAS ID 284460, REC Reference 20SC0230) on 14/11/2022. Participants were informed in advance. As the frequency and method of sampling remained the same, implied consent processes were approved by the committee. Participants returning to the study give informed consent. Regular reports to advisory groups and peer-reviewed publications are planned to disseminate findings and inform decision making. Clinical trial registration number: ISRCTN11041050; registration date: 12 January 2021. Sub study included in protocol version: v8.0, and amended in v9.0

Protocol for a hybrid effectiveness-implementation clinical trial evaluating video-assisted electronic consent vs standard consent for patients initiating and continuing haemodialysis in Australia (eConsent HD)

IntroductionCommunicating complex information about haemodialysis (HD) and ensuring it is well understood remains a challenge for clinicians. Informed consent is a high-impact checkpoint in augmenting patients’ decision awareness and engagement...

Indigenous governance, ethics and data collection in Australian clinical registries.

To examine Indigenous Governance of Data processes in Australian clinical registries. Audit (via desktop review and interviews) of registries in the Australian Register of Clinical Registries from 17 January 2022 to 30 April 2023. The number of clinical registries collecting ethnicity data, reporting Aboriginal and/or Torres Strait Islander representation on registry governance or steering committees, and reporting human research ethics committee approval. A total of 107 clinical registries were reviewed. Of these registries, 65 (61%) collected ethnicity data; when these were grouped by geographical coverage, those most likely to collect ethnicity data were binational (24/40 [60%]), national (19/26 [73%]) or state based (19/26 [73%]). Of the registries that collected ethnicity data, 29 (45%) classified their ethnicity item as Aboriginal and/or Torres Strait Islander. Only eight clinical registries (7%) reported Aboriginal and/or Torres Strait Islander representation on their governance or steering committees. Human research ethics approval was reported in 94 registries (88%), with only 11 (12%) having Aboriginal human research ethics committee approval. Significant variability is evident in clinical registry recording of Indigenous governance of data, meaning that Aboriginal and Torres Strait Islander communities remain invisible in data which is used to inform policy, clinical models of care, health services and initiatives. Radical change is required to facilitate meaningful change in quality indicators for clinical registries nationally.

"Just a knife wound this week, nothing too painful": An ethnographic exploration of how primary care patients experiencing homelessness view their own health and healthcare.

Community health needs assessments (CHNA) involving qualitative techniques help tailor health services to the specific needs of the population groups for whom they are designed. In light of increasing health disparities amongst people experiencing homelessness (PEH)-and to ensure the integration of their voices into a larger CHNA-this study used an ethnographic approach grounded in a social constructivist research paradigm to explore the perspectives of PEH attending a primary care and addiction service in Ireland on their priority health and healthcare needs. Participant observations and informal interviews were conducted with clients experiencing homelessness attending the service for three hours every Monday morning between October 2022 and April 2023. Field note data from active participant observation and informal conversations were collected, anonymised, and analysed using inductive thematic analysis in accordance with the Declaration of Helsinki and the researchers' institutional Research Ethics Committee. Three main themes emerged from the analysis: self-identified priorities, satisfaction with health services, and migrant health. Clients' priority concerns relate to their mental health and personal safety, strengthening ties with children and families, finding a sense of purpose, and feeling better physically. These challenges differ from those of the general population in terms of their severity observed both prior to and during experiences of homelessness, coupled with disproportionately high levels of loss, fear, pain, fatigue, social stigma and other barriers to accessing satisfactory housing. In terms of services, clients are satisfied with their ability to access primary care and harm reduction in a social environment where positive exchanges with friends and providers take place. Conversely, barriers to accessing mental health and addiction services persist including the internalised belief that one is beyond help, lack of access to information on available services and their entry requirements, and lingering stigma within a health system that treats addiction as separate to health. Moving forward, health practitioners may consider holding more regular and open conversations with clients experiencing homelessness about the care they are receiving, its rationale, and whether or not changes are desired that can be safely made. The health needs of migrants and asylum seekers entering homelessness in Ireland are urgent and should be prioritised in future research.

Frequency of episiotomy practice in an institution in Quito, Ecuador 2009-2022

To determine the prevalence of episiotomy over a 14-year period and to explore its association with maternal, delivery, and neonatal variables using administrative data. This is a cross-sectional study. Women who had a vaginal delivery with a live newborn at a referral hospital for obstetric care in Ecuador were included. Consecutive sampling was employed. ICD-10 records and the perinatal information system (PIS) were utilized. Sociodemographic, gestational, delivery, and neonatal variables were assessed. Descriptive analysis was performed. The overall and yearly prevalence was determined. Exploratory bivariate and multivariate analyses were conducted. The study was approved by the Human Research Ethics Committee of the Universidad Central del Ecuador. A total of 11,862 records were analyzed. The overall prevalence of episiotomy was 36.69 %, with a maximum of 42 % and a minimum of 28 %. There is an implied trend towards a reduction in frequency from 2019 to 2022. A positive association was found between episiotomy and maternal age under 20 years, previous cesarean section, absence of a companion during delivery, term newborns, and large for gestational age newborns. A negative association was found with previous vaginal deliveries. The prevalence of episiotomy exceeds the recommendation of the World Health Organization (WHO). Clinical practice guidelines should consider potentially modifiable maternal and neonatal factors in their recommendations. Prospective studies should be conducted to evaluate the safety of the procedure, confirm these observations, and use robust methodologies to assess if there is a real decrease in its practice.

The effect of body weight-supported Tai Chi Yunshou on upper limb motor function in stroke survivors based on neurobiomechanical analysis: a four-arm, parallel-group, assessors-blind randomized controlled trial protocol.

A series of functional disorders commonly occur after stroke, of which upper limb dysfunction is the most difficult to recover. The upper limb rehabilitation effect of Tai Chi Yunshou(TCY) in the later stage of stroke has been confirmed by research. Body weight support-Tai Chi Yunshou (BWS-TCY) is based on TCY exercise and robotic exoskeletons offers most flexibility in deweighting and control strategy. This study is aimed to explore the effect of BWS-TCY on upper limb motor function in stroke based on neurobiomechanics. A single-blind randomized controlled trial will be conducted on 36 stroke survivors who will be randomly assigned to three groups: experimental group, control group A and control group B. In addition, 12 healthy elderly people will be recruited into the healthy control group. Those in the experimental group will receive 20 min of CRT and 20 min of BWS-TCY training, while participants in the control group A will receive 20 min of CRT and 20 min of Robot-assisted training. Participants in the control group B will undergo 40 min of Conventional rehabilitation training (CRT) daily. All interventions will take place 5 days a week for 12 weeks, with a 12-week follow-up period. No intervention will be carried out for the healthy control group. Upper limb function will be assessed before and after the intervention using various rating scales (Fugl-Meyer Assessment, Wolf Motor Function Test, etc.), as well as neurobiomechanical analyses (surface electromyography, functional near-infrared brain function analysis system, and Xsens maneuver Capture System). Additionally, 10 healthy elderly individuals will be recruited for neurobiomechanical analysis, and the results will be compared with those of stroke survivors. The results of this study will offer initial evidence on the effectiveness and feasibility of BWS-TCY as an early intervention for stroke rehabilitation. Positive findings from this study could contribute to the development of guidelines for the use of BWS-TCY in the early stages of stroke. This study has been approved by the Research Ethics Committees of the seventh People's Hospital Affiliated to Shanghai University of Traditional Chinese Medicine (Study ID: 2022-7th-HIRB-022). The results of the study will be published in a peer-reviewed journal and presented at scientific conferences. https://clinicaltrials.gov/, ChiCTR 2200063150.

Development of Promising Interventions to Improve Human Papillomavirus Vaccination in a School-Based Program in Quebec, Canada: Results From a Formative Evaluation Using a Mixed Methods Design.

Despite the availability of school-based human papillomavirus (HPV) vaccination programs, disparities in vaccine coverage persist. Barriers to HPV vaccine acceptance and uptake include parental attitudes, knowledge, beliefs, and system-level barriers. A total of 3 interventions were developed to address these barriers: an in-person presentation by school nurses, an email reminder with a web-based information and decision aid tool, and a telephone reminder using motivational interviewing (MI) techniques. Here we report on the development and formative evaluation of interventions to improve HPV vaccine acceptance and uptake among grade 4 students' parents in Quebec, Canada. In the summer of 2019, we conducted a formative evaluation of the interventions to assess the interventions' relevance, content, and format and to identify any unmet needs. We conducted 3 focus group discussions with parents of grade 3 students and nurses. Interviews were recorded, transcribed, and analyzed for thematic content using NVivo software (Lumivero). Nurses received training on MI techniques and we evaluated the effect on nurses' knowledge and skills using a pre-post questionnaire. Descriptive quantitative analyses were carried out on data from questionnaires relating to the training. Comparisons were made using the proportions of the results. Finally, we developed a patient decision aid using an iterative, user-centered design process. The iterative refinement process involved feedback from parents, nurses, and experts to ensure the tool's relevance and effectiveness. The evaluation protocol and data collection tools were approved by the CHU (Centre Hospitalier Universitaire) de Québec Research Ethics Committee (MP-20-2019-4655, May 16, 2019). The data collection was conducted from April 2019 to March 2021. Following feedback (n=28) from the 3 focus group discussions in June 2019, several changes were made to the in-person presentation intervention. Experts (n=27) and school nurses (n=29) recruited for the project appreciated the visual and simplified information on vaccination in it. The results of the MI training for school nurses conducted in August 2019 demonstrated an increase in the skills and knowledge of nurses (n=29). School nurses who took the web-based course (n=24) filled out a pretest and posttest questionnaire to evaluate their learning. The rating increased by 19% between the pretest and posttest questionnaires. Several changes were made between the first draft of the web-based decision-aid tool and the final version during the summer of 2019 after an expert consultation of experts (n=3), focus group participants (n=28), and parents in the iterative process (n=5). More information about HPV and vaccines was added, and users could click if more detail is desired. We developed and pilot-tested 3 interventions using an iterative process. The interventions were perceived as potentially effective to increase parents' knowledge and positive attitudes toward HPV vaccination, and ultimately, vaccine acceptance. Future research will assess the effectiveness of these interventions on a larger scale.