METHODS AND DESIGN: A randomised, single blind controlled trial will be conducted. Twenty-eight patients aged 18 years and above with a recent grade-2 hamstring injury will be invited to take part. Participants will be randomised to receive either autologous PRP injection with rehabilitation programme, or rehabilitation programme only. Participants will be followed up at day three of study and then weekly for 16 weeks. At each follow up visit, participants will be assessed on readiness to return-to-play using a set of criteria. The primary end-point is when participants have fulfilled the return-to-play criteria or end of 16 weeks.The main outcome measure of this study is the duration to return-to-play after injury.
CONCLUSION: This study protocol proposes a rigorous and potential significant evaluation of PRP use for grade-2 hamstring injury. If proven effective such findings could be of great benefit for patients with similar injuries.
TRIAL REGISTRATION: Current Controlled Trials ISCRTN66528592.
METHODS: This study is a single blind, randomized controlled trial with two parallel arms in which participants will be allocated to VRET or IP with a ratio of 1:1. Thirty participants (18-50 years) meeting the Phobia Checklist criteria of dental phobia will undergo block randomization with allocation concealment. The primary outcome measures include participants' dental trait anxiety (Modified Dental Anxiety Scale and Dental Fear Survey) and state anxiety (Visual Analogue Scale) measured at baseline (T0), at intervention (T1), 1-week (T2), 3 months (T3) and 6 months (T4) follow-up. A behavior test will be conducted before and after the intervention. The secondary outcome measures are real-time evaluation of HR and VR (Virtual Reality) experience (presence, realism, nausea) during and following the VRET intervention respectively. The data will be analyzed using intention-to-treat and per-protocol analysis.
DISCUSSION: This study uses novel non-invasive VRET, which may provide a possible alternative treatment for dental anxiety and phobia.
TRIAL REGISTRATION NUMBER: ISRCTN25824611 , Date of registration: 26 October 2015.
METHODS: The development of the RAPID guidelines was based on the Guidance for Developers of Health Research Reporting Guidelines. Following a comprehensive search of the literature, the Executive Group identified ten themes in Pediatric Dentistry and compiled a draft checklist of items under each theme. The themes were categorized as: General, Oral Medicine, Pathology and Radiology, Children with Special Health Care Needs, Sedation and Hospital Dentistry, Behavior Guidance, Dental Caries, Preventive and Restorative Dentistry, Pulp Therapy, Traumatology, and Interceptive Orthodontics. A RAPID Delphi Group (RDG) was formed comprising of 69 members from 15 countries across six continents. Items were scored using a 9-point rating Likert scale. Items achieving a score of seven and above, marked by at least 70% of RDG members were accepted into the RAPID checklist items. Weighted mean scores were calculated for each item. Statistical significance was set at p researchers, authors, reviewers and editors, to ensure that all elements relevant to particular studies are adequately reported.
METHOD: This study employed an experimental design and involved a total of 122 nurses, with 59 in the experimental group and 63 in the control group. Participants were selected from palliative care wards associated with Hospital Universiti Sains Malaysia. Nurses in the experimental group underwent a two-week educational module on nursing spiritual care, while nurses in the control group attended a single lecture on spiritual care provided by the hospital.
RESULTS: The results indicated no significant differences in sociodemographic characteristics between the two groups. A significant difference in spiritual care competence within the intervention group and the control group over time (p-value = 0.001), between the two groups (p-value = 0.038), and in the interaction between time and group (p-value = 0.001).
CONCLUSION: The Nursing Spiritual Care Module is crucial in aiding nurses and healthcare professionals in cultivating the appropriate and wholesome attitudes and practices necessary to address the spiritual needs of patients.
METHODS: Ten government maternal and child health clinics in Kuala Lumpur, Malaysia will be randomly selected. Sample size of 438 first-trimester pregnant women will be followed-up until the birth of their infant. Salivary melatonin and cortisol concentration among subsample will be determined using enzyme-linked immunosorbent assay. Data on sleep quality, psychological distress and morningness/eveningness chronotype of pregnant women will be collected using validated questionnaires. Pedometer will be used to measure 5-day physical activity data. Total gestational weight gain will be determined at the end of pregnancy. Utilization of 3-day food record is to capture meal timing and nutrient intake. All measurements will be done in 2nd and 3rd trimester. Birth outcomes will be collected through clinic records and Centers for Disease Control and Prevention (CDC) Neonatal questionnaire. Infants will be followed-up at 6 and 12 months old to obtain anthropometric measurements.
DISCUSSION: There is a growing recognition of the role of maternal circadian rhythm, which entrains fetal circadian rhythms that may subsequently have long-term health consequences. The present study will identify the effect of circadian rhythm on pregnancy outcomes and infant growth in the first year of life.
METHODS: This study uses a quantitative approach through a questionnaire survey method involving 340 Kota Kinabalu City Hall employees who were selected through simple random sampling.
RESULTS: The results of linear regression analysis found that organisation participation has a positive significant relationship with job satisfaction. Organisational communication also showed a negative and significant relationship with job satisfaction. Meanwhile, both management commitment and management priority are statistically insignificant. When the organisational climate is included in the relationship as a mediator through Structural Equation Modelling (SEM) to reinforce the role of psychological safety climate in increasing job satisfaction, such mediating role can only strengthen the relationship between management commitment and organisational participation with job satisfaction.
CONCLUSION: Despite the study being cross-sectional, it contributes to knowledge on the resources facilitating PSC, which is important for employees' psychological health. From a practical viewpoint, this study contributes to the literature showing that organizations with good PSC should have policies and practices directed towards employee well-being. The implications of the study for DBKK management are to providing knowledge on the types of psychosocial safety climate domains that plays a crucial role in improving the job satisfaction of DBKK employees.
METHODS/DESIGN: This quasi-experimental study aimed to evaluate the effectiveness of the SNP between intervention and comparison groups before and after the SNP, and after a 3-month follow-up. The SNP consisted of two main components, whereby three nutrition education sessions were implemented by trained teachers using three standardised modules, and healthy school food environment was implemented by the canteen food handlers with the provision of healthy menu to children during school recess times. Children from intervention group participated in the SNP, in addition to the standard Physical and Health Curriculum. The comparison group attended only the standardised Physical and Health Curriculum and the school canteen food handlers were reminded to follow the standard canteen guidelines from the Ministry of Education Malaysia. The assessment parameters in evaluating the effectiveness of the programme were knowledge, attitude and practice on nutrition, eating behaviours, physical activity, body composition, psychological distress, cognitive performance and health-related quality of life. Assessments were conducted at three time points: pre-intervention, post-intervention and 3-month follow-up.
DISCUSSION: It was hypothesised that the SNP would be effective in promoting healthy lifestyle among school children, and further contributes in preventing malnutrition problem, enhancing cognitive performance and improving health-related quality of life among school children. Findings of the present study can be expanded to other schools in future on ways to improve nutrition education and healthy school food environment.
TRIAL REGISTRATION: UMIN Clinical Trial Registration UMIN000032914 (Date of registration: 7th June 2018, retrospectively registered).
PROTOCOL VERSION: 16th September 2019 & Version 4.
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: The scoping review was conducted based on the framework by Arksey and O'Malley. The Preferred Reporting Items for Systematic Reviews and Meta Analysis (PRISMA) diagram was used as a guide to record the review process. Articles from year 2008 until 2017 on overweight and obesity among adults aged 18 years and above were retrieved based on the keywords using electronic databases (Embase/Ovid, Pubmed, Cochrane library and Google Scholar). Local journals, Nutrition Research in Malaysia Biblography (2011 and 2016), online local theses databases, virtual library databases were also included in the searches. Consultations with relevant key informants from the National Institutes of Health and local universities were also conducted. Search activities were managed using Endnote software and MS Excelsheet.
RESULTS: The characteristics of the results were described based on the objectives of the review. A total of 2004 articles and reports were retrieved, and 188 articles related to obesity in Malaysia were included in the final review. Scopes and topics of obesity research based on the Nutrition Research Priorities in Malaysia (NRPM) for 11th Malaysia Plan were obesity prevalence, weight loss intervention, association of physical activities and dietary factors with obesity. The majority of obesity research among adults in Malaysia was cross sectional studies and only a small number of intervention studies, qualitative studies and systematic review were indentified. Research gaps were identified in order to make useful recommendations to the stakeholders.
CONCLUSIONS: In the past decade, there has been an emerging evidence on obesity research among adults in Malaysia. More obesity research needs to be conducted particularly on obesity intervention among specific gender, qualitative studies, economic cost and genetic factors of obesity.
METHODS AND ANALYSIS: ACT KNOW, the first randomised controlled trial ever performed in knowlesi malaria, is a two-arm open-label trial with enrolments over a 2-year period at three district sites in Sabah, powered to show a difference in proportion of patients negative for malaria by microscopy at 24 h between treatment arms (clinicaltrials.gov #NCT01708876). Enrolments started in December 2012, with completion expected by September 2014. A total sample size of 228 is required to give 90% power (α 0.05) to determine the primary end point using intention-to-treat analysis. Secondary end points include parasite clearance time, rates of recurrent infection/treatment failure to day 42, gametocyte carriage throughout follow-up and rates of anaemia at day 28, as determined by survival analysis.
ETHICS AND DISSEMINATION: This study has been approved by relevant institutional ethics committees in Malaysia and Australia. Results will be disseminated to inform knowlesi malaria treatment policy in this region through peer-reviewed publications and academic presentations.
TRIAL REGISTRATION NUMBER: NCT01708876.
METHODS AND ANALYSIS: A population-based case-control study will be conducted over a 2-year period at two adjacent districts in north-west Sabah, Malaysia. Confirmed malaria cases presenting to the district hospital sites meeting relevant inclusion criteria will be requested to enrol. Three community controls matched to the same village as the case will be selected randomly. Study procedures will include blood sampling and administration of household and individual questionnaires to evaluate potential exposure risks associated with acquisition of P. knowlesi malaria. Secondary outcomes will include differences in exposure variables between P. knowlesi and other Plasmodium spp, risk of severe P. knowlesi malaria, and evaluation of P. knowlesi case clustering. Primary analysis will be per protocol, with adjusted ORs for exposure risks between cases and controls calculated using conditional multiple logistic regression models.
ETHICS: This study has been approved by the human research ethics committees of Malaysia, the Menzies School of Health Research, Australia, and the London School of Hygiene and Tropical Medicine, UK.
METHODS AND ANALYSIS: The NeST Registry is designed as a product registry that would provide information on the use and safety of NeuroAiD in clinical practice. An online NeST Registry was set up to allow easy entry and retrieval of essential information including demographics, medical conditions, clinical assessments of neurological, functional and cognitive state, compliance, concomitant medications, and side effects, if any, among patients on NeuroAiD. Patients who are taking or have been prescribed NeuroAiD may be included. Participation is voluntary. Data collected are similar to information obtained during standard care and are prospectively entered by the participating physicians at baseline (before initialisation of NeuroAiD) and during subsequent visits. The primary outcome assessed is safety (ie, non-serious and serious adverse event), while compliance and neurological status over time are secondary outcomes. The in-person follow-up assessments are timed with clinical appointments. Anonymised data will be extracted and collectively analysed. Initial target sample size for the registry is 2000. Analysis will be performed after every 500 participants entered with completed follow-up information.
ETHICS AND DISSEMINATION: Doctors who prescribe NeuroAiD will be introduced to the registry by local partners. The central coordinator of the registry will discuss the protocol and requirements for implementation with doctors who show interest. Currently, the registry has been approved by the Ethics Committees of Universiti Kebangsaan Malaysia (Malaysia) and National Brain Center (Indonesia). In addition, for other countries, Ethics Committee approval will be obtained in accordance with local requirements.
TRIAL REGISTRATION NUMBER: NCT02536079.
METHODS: This hospital-based prospective cohort study will comprise patients with breast cancer (18 years and above), managed in the University Malaya Medical Centre (UMMC). We aim to recruit 1000 cancer survivors over a 6-year period. Data collection will occur at baseline (within 3 months of diagnosis), 6 months, and 1, 3 and 5 years following diagnosis. The primary outcomes are disease-free survival and overall survival, and secondary outcome is QoL. Factors measured are demographic and socioeconomic factors, lifestyle factors (eg, dietary intake, physical activity), anthropometry measurements (eg, height, weight, waist, hip circumference, body fat analysis), psychosocial aspects, and complementary and alternative medicine (CAM) usage.
ETHICS AND DISSEMINATION: This protocol was approved by the UMMC Ethical Committee in January 2012. All participants are required to provide written informed consent. The findings from our cohort study will be disseminated via scientific publication as well as presentation to stakeholders including the patients, clinicians, the public and policymakers, via appropriate avenues.
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.
DESIGN: AVERT is a prospective, parallel group, assessor-blinded randomised clinical trial. This paper presents data assessing the generalisability of AVERT.
SETTING: Acute stroke units at 44 hospitals in 8 countries.
PARTICIPANTS: The first 20,000 patients screened for AVERT, of whom 1158 were recruited and randomised.
MODEL: We use the Proximal Similarity Model, which considers the person, place, and setting and practice, as a framework for considering generalisability. As well as comparing the recruited patients with the target population, we also performed an exploratory analysis of the demographic, clinical, site and process factors associated with recruitment.
RESULTS: The demographics and stroke characteristics of the included patients in the trial were broadly similar to population-based norms, with the exception that AVERT had a greater proportion of men. The most common reason for non-recruitment was late arrival to hospital (ie, >24 h). Overall, being older and female reduced the odds of recruitment to the trial. More women than men were excluded for most of the reasons, including refusal. The odds of exclusion due to early deterioration were particularly high for those with severe stroke (OR=10.4, p<0.001, 95% CI 9.27 to 11.65).
CONCLUSIONS: A model which explores person, place, and setting and practice factors can provide important information about the external validity of a trial, and could be applied to other clinical trials.
TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (ACTRN12606000185561) and Clinicaltrials.gov (NCT01846247).
METHODS AND ANALYSIS: A feasibility study to test the practicality of running a multicentre, randomised clinical trial of surgery for UVFP, including: (1) a qualitative study to understand the recruitment process and how it operates in clinical centres and (2) a small randomised trial of 30 participants recruited at 3 UK sites comparing non-selective laryngeal reinnervation to type I thyroplasty. Participants will be followed up for 12 months. The primary outcome focuses on recruitment and retention, with secondary outcomes covering voice, swallowing and quality of life.
ETHICS AND DISSEMINATION: Ethical approval was received from National Research Ethics Service-Committee Bromley (reference 11/LO/0583). In addition to dissemination of results through presentation and publication of peer-reviewed articles, results will be shared with key clinician and patient groups required to develop the future large-scale randomised controlled trial.
TRIAL REGISTRATION NUMBER: ISRCTN90201732; 16 December 2015.
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.
METHODS AND ANALYSIS: HIP ATTACK is a multicentre, international, parallel group randomised controlled trial (RCT) that will include patients ≥45 years of age and diagnosed with a hip fracture from a low-energy mechanism requiring surgery. Patients are randomised to accelerated medical assessment and surgical repair (goal within 6 h) or standard care. The co-primary outcomes are (1) all-cause mortality and (2) a composite of major perioperative complications (ie, mortality and non-fatal myocardial infarction, pulmonary embolism, pneumonia, sepsis, stroke, and life-threatening and major bleeding) at 90 days after randomisation. All patients will be followed up for a period of 1 year. We will enrol 3000 patients.
ETHICS AND DISSEMINATION: All centres had ethics approval before randomising patients. Written informed consent is required for all patients before randomisation. HIP ATTACK is the first large international trial designed to examine whether accelerated surgery can improve outcomes in patients with a hip fracture. The dissemination plan includes publishing the results in a policy-influencing journal, conference presentations, engagement of influential medical organisations, and providing public awareness through multimedia resources.
TRIAL REGISTRATION NUMBER: NCT02027896; Pre-results.