METHOD AND ANALYSIS: A single center, prospective, randomized, parallel design, single-blind trial will be conducted in the Malaysian state of Kelantan among postdialysis euvolemic hypertensive patients that are on regular dialysis at least 3 times a week. The primary outcome of the trial will be to note the effectiveness of losartan (RAAS inhibitor) in reducing systolic BP 140 mm Hg will be randomized using Covariate Adaptive Randomization to standard or treatment arm. Participants in the treatment arm will be given 50 mg of losartan once daily except on dialysis days, whereas the standard arm patients will be prescribed non-RAAS antihypertensive agents. The study participants will be followed for a period of 12 months. A Wilcoxon statistical test will be performed to note the difference in BP from baseline up to 12 months using Statistical Package for the Social Sciences (SPSS) 20.
ETHICAL AND TRIAL REGISTRATION: The study protocols are approved from the Ethical and Research Committee of the Universiti Sains Malaysia (USM/JEPeM/15050173). The trial is registered under the Australia New Zealand Clinical Trial Registry (ACTRN12615001322527). The trial was registered on 2/12/2015 and the 1st patient was enrolled on 10/12/2015. The trial was formally initiated on 16/02/2016.
CONCLUSION: Management of HTN among HD patients requires understanding the primary cause of HTN and treating accordingly. The current trial is an attempt to reduce BP among postdialysis euvolemic but hypertensive patients.
METHODS AND ANALYSIS: Arksey and O'Malley's scoping review methodology framework will guide the conduct of this scoping review. The search strategy will involve electronic databases including PubMed, Excerpta Medica Database, Cumulative Index of Nursing and Allied Health Literature, Cochrane Library, Google Scholar and ScienceDirect, in addition to grey literature sources and hand-searching of reference lists. Two reviewers will independently screen all abstracts and full-text studies for inclusion. Data will be charted and sorted through an iterative process by the research team. The extracted data will undergo a descriptive analysis and simple quantitative analysis will be conducted using descriptive statistics. Engagement with relevant stakeholders will be carried out to gain more insights into our data from different perspectives.
ETHICS AND DISSEMINATION: Since the data used are from publicly available sources, this study does not require ethical approval. Results will be disseminated through academic journals, conferences and seminars. We anticipate that our findings will aid technology developers and health professionals working in the area of ageing and rehabilitation.
METHOD: This is a behavioral randomized controlled trial of patient education intervention with video narratives for patients with stroke lacking medication understanding and use self-efficacy. The study will recruit up to 200 eligible stroke patients at the neurology tertiary outpatient clinic, whereby they will be requested to return for follow-up approximately 3 months once for up to 12 months. Consenting patients will be randomized to either standard patient education care or intervention with video narratives. The researchers will ensure control of potential confounding factors, as well as unbiased treatment review with prescribed medications only obtained onsite.
RESULTS: The primary analysis outcomes will reflect the variances in medication understanding and use self-efficacy scores, as well as the associated factors, such as retention of knowledge, belief and perception changes, whereas stroke risk factor control, for example, self-monitoring and quality of life, will be the secondary outcomes.
DISCUSSION AND CONCLUSION: The study should be able to determine if video narrative can induce a positive behavioral change towards stroke risk factor control via enhanced medication understanding and use self-efficacy. This intervention is innovative as it combines health belief, motivation, and role model concept to trigger self-efficacy in maintaining healthy behaviors and better disease management.
TRIAL REGISTRATION: ACTRN (12618000174280).
Objective: To investigate medication adherence among patients with and without medication subsidies and to identify factors that may influence patients' adherence to medication. Setting: Government healthcare institutions in Kuala Lumpur, Selangor, and Negeri Sembilan and private healthcare institutions in Selangor and Negeri Sembilan, Malaysia.
Methods: This cross-sectional study sampled patients with and without medication subsidies (self-paying patients). Only one of the patient's medications was re-packed into Medication Event Monitoring Systems (MEMS) bottles, which were returned after four weeks. Adherence was defined as the dose regimen being executed as prescribed on 80% or more of the days. The factors that may influence patients' adherence were modelled using binary logistic regression. Main outcome measure: Percentage of medication adherence.
Results: A total of 97 patients, 50 subsidized and 47 self-paying, were included in the study. Medication adherence was observed in 50% of the subsidized patients and 63.8% of the self-paying patients (χ2=1.887, df=1, p=0.219). None of the evaluated variables had a significant influence on patients' medication adherence, with the exception of attending drug counselling. Patients who attended drug counselling were found to be 3.3 times more likely to adhere to medication than those who did not (adjusted odds ratio of 3.29, 95% CI was 1.42 to 7.62, p = 0.006).
Conclusion: There is no significant difference in terms of medication adherence between subsidized and self-paying patients. Future studies may wish to consider evaluating modifiable risk factors in the examination of non-adherence among subsidized and self-paying patients in Malaysia.
METHODS AND ANALYSIS: A multicentre, open-label randomised trial. Patients with MPE will be randomised 1:1 to daily or symptom-guided drainage regimes after IPC insertion. Patient allocation to groups will be stratified for the cancer type (mesothelioma vs others), performance status (Eastern Cooperative Oncology Group status 0-1 vs ≥2), presence of trapped lung (vs not) and prior pleurodesis (vs not). The primary outcome is the mean daily dyspnoea score, measured by a 100 mm visual analogue scale (VAS) over the first 60 days. Secondary outcomes include benefits on physical activity levels, rate of spontaneous pleurodesis, complications, hospital admission days, healthcare costs and QoL measures. Enrolment of 86 participants will detect a mean difference of VAS score of 14 mm between the treatment arms (5% significance, 90% power) assuming a common between-group SD of 18.9 mm and a 10% lost to follow-up rate.
ETHICS AND DISSEMINATION: The Sir Charles Gairdner Group Human Research Ethics Committee has approved the study (number 2015-043). Results will be published in peer-reviewed journals and presented at scientific meetings.
TRIAL REGISTRATION NUMBER: ACTRN12615000963527; Pre-results.
METHODS AND DESIGN: This is a single-center, randomized, controlled, two-arm parallel design clinical trial that will be carried out in a tertiary hospital in Malaysia. In this study, 100 patients diagnosed with type 2 diabetes will be enrolled. Diabetic patients who meet the eligibility criteria will be randomly allocated to two groups, which are diabetic C. caudatus treated(U) group and diabetic control (C) group. Primary and secondary outcomes will be measured at baseline, 4, 8, and 12 weeks. The serum and urine metabolome of both groups will be examined using proton NMR spectroscopy.
DISCUSSION: The study will be the first randomized controlled trial to assess whether C. caudatus can confer beneficial effect in patients with type 2 diabetes. The results of this trial will provide clinical evidence on the effectiveness and safety of C. caudatus in patients with type 2 diabetes.
TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02322268.
METHODS: An online REDCap questionnaire was circulated to surgeons in the Asia-Pacific region during the period of July 2019 to September 2019 to inquire about various components of nonoperative treatment for AIS. Aspects under study included access to screening, when MRIs were obtained, quality-of-life assessments used, role of scoliosis-specific exercises, bracing criteria, type of brace used, maturity parameters used, brace wear regimen, follow-up criteria, and how braces were weaned. Comparisons were made between middle-high income and low-income countries, and experience with nonoperative treatment.
RESULTS: A total of 103 responses were collected. About half (52.4%) of the responders had scoliosis screening programs and were particularly situated in middle-high income countries. Up to 34% obtained MRIs for all cases, while most would obtain MRIs for neurological problems. The brace criteria were highly variable and was usually based on menarche status (74.7%), age (59%), and Risser staging (92.8%). Up to 52.4% of surgeons elected to brace patients with large curves before offering surgery. Only 28% of responders utilized CAD-CAM techniques for brace fabrication and most (76.8%) still utilized negative molds. There were no standardized criteria for brace weaning.
CONCLUSION: There are highly variable practices related to nonoperative treatment for AIS and may be related to availability of resources in certain countries. Relative consensus was achieved for when MRI should be obtained and an acceptable brace compliance should be more than 16 hours a day.
METHODS AND ANALYSIS: The measurement challenge has been established as an international resource to offer a common set of anonymised mammogram images for measurement and analysis. To date, full field digital mammogram images and core data from 1650 cases and 1929 controls from five countries have been collated. The measurement challenge is an ongoing collaboration and we are continuing to expand the resource to include additional image sets across different populations (from contributors) and to compare additional measurement methods (by challengers). The intended use of the measurement challenge resource is for refinement and validation of new and existing mammographic measurement methods. The measurement challenge resource provides a standardised dataset of mammographic images and core data that enables investigators to directly compare methods of measuring mammographic density or other mammographic features in case/control sets of both raw and processed images, for the purposes of the comparing their predictions of breast cancer risk.
ETHICS AND DISSEMINATION: Challengers and contributors are required to enter a Research Collaboration Agreement with the University of Melbourne prior to participation in the measurement challenge. The Challenge database of collated data and images are stored in a secure data repository at the University of Melbourne. Ethics approval for the measurement challenge is held at University of Melbourne (HREC ID 0931343.3).
METHODS AND DESIGN: TICH-2 is a pragmatic, phase III, prospective, double-blind, randomised placebo-controlled trial. Two thousand adult (aged ≥ 18 years) patients with an acute SICH, within 8 h of stroke onset, will be randomised to receive TXA or the placebo control. The primary outcome is ordinal shift of modified Rankin Scale score at day 90. Analyses will be performed using intention-to-treat.
RESULTS: This paper and its attached appendices describe the statistical analysis plan (SAP) for the trial and were developed and published prior to database lock and unblinding to treatment allocation. The SAP includes details of analyses to be undertaken and unpopulated tables which will be reported in the primary and key secondary publications. The database will be locked in early 2018, ready for publication of the results later in the same year.
DISCUSSION: The SAP details the analyses that will be done to avoid bias arising from prior knowledge of the study findings. The trial will determine whether TXA can improve outcome after SICH, which currently has no definitive therapy.
TRIAL REGISTRATION: ISRCTN registry, ID: ISRCTN93732214 . Registered on 17 January 2013.
METHODS: The Federation of International Societies of Pediatric Gastroenterology, Hepatology, and Nutrition (FISPGHAN) Working Group (WG) selected care protocols on the management of acute diarrhea in infants and children aged between 1 month and 18 years. The WG used a 3-step approach consisting of: systematic review and comparison of published guidelines, agreement on draft recommendations using Delphi methodology, and external peer-review and validation of recommendations.
RESULTS: A core of recommendations including definition, diagnosis, nutritional management, and active treatment of AGE was developed with an overall agreement of 91% (range 80%-96%). A total of 28 world experts in pediatric gastroenterology and emergency medicine successively validated the set of 23 recommendations with an agreement of 87% (range 83%-95%). Recommendations on the use of antidiarrheal drugs and antiemetics received the lowest level of agreement and need to be tailored at local level. Oral rehydration and probiotics were the only treatments recommended.
CONCLUSIONS: Universal recommendations to assist health care practitioners in managing children with AGE may improve practitioners' compliance with guidelines, reduce inappropriate interventions, and significantly impact clinical outcome and health care-associated costs.