METHODS: CINAHL, Cochran Library, Clinical trial.gov, OpenGrey, PubMed, ScienceDirect, and Scopus were systematically searched from the inception up to October 2021 without language restriction. Studies comparing the safety of low-dose vitamin K1 treatment in patients with placebo or other anticoagulant reversal agents were included. We used a random-effect model for the meta-analysis. Publication bias was determined by a funnel plot with subsequent Begg's test and Egger's test.
RESULTS: From 7529 retrieved studies, 3 randomized control trials were included in the meta-analysis. Pooled data demonstrated that low-dose vitamin K was not associated with thromboembolism rate (risk ratio [RR] = 0.94; 95% CI: 0.19-4.55) major bleeding rate (RR = 0.58; 95% CI: 0.07-4.82), and minor bleeding rate (RR = 0.60; 95% CI: 0.07-5.09). Subgroup and sensitivity analysis demonstrated the nonsignificant effect of low-dose vitamin K on the risk of thromboembolism. Publication bias was not apparent, according to Begg's test and Egger's test (P = .090 and 0.134, respectively).
CONCLUSION: The current evidence does not support the role of low-dose vitamin K as a trigger of thromboembolism in supratherapeutic INR patients with mechanical heart valves. Nevertheless, more well-designed studies with larger sample sizes are required to justify this research question.
METHODS: We will perform comprehensive searches of published studies in electronic databases such as Medline (via Ovid), EBSCOhost, PubMed, Scopus, and Web of Science by using the following search terms: "quality of life"; "breast cancer"; "upper limb"; "lymphedema"; "questionnaire"; and "measurement properties." Only full-text articles in English language are included. Two reviewers will independently conduct the article selection, data extraction, and quality assessment. Any possible conflict between the 2 reviewers is going to be solved with the help of a third reviewer. The Consensus-based Standards for the Selection of Health Measurement Instrument (COSMIN) checklist and manual will be used to assess the selected study quality.
RESULTS: This review will provide an updated overview of available lymphedema-specific questionnaires used in BCRL population and then recommend the most valid and reliable QoL questionnaire for clinical and research use in patients with BCRL.
CONCLUSION: This review may help the clinician and researcher to find an updated overview of various questionnaires used to assess BCRL patients' QoL.
ETHICS AND DISSEMINATION: This review will use data from published studies. Therefore, ethical approval is not required prior to this review. The results of this review will be published in a peer-reviewed journal or presented at conferences.
STUDY REGISTRATION: OSF osf.io/8xwym.
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.