OBJECTIVE: To examine the psychometric properties of the Malay version of SF-36 (Malay SF-36) summated rating scales and validate the scale among post-coronary artery bypass grafting surgery (CABG) patients at the National Heart Institute (IJN), Kuala Lumpur.
METHODS: Five hundred and nine post-CABG patients at the IJN, Malaysia completed the questionnaires between 1 July and 31 December 2017. Psychometric tests endorsed by the "International Quality of Life Assessment Project" were utilised.
RESULTS: The data quality was excellent with a high questionnaire completion rate (100%). As hypothesized, the ordering of item means within scales was clustered. In unison, scaling assumptions were satisfied. Good discriminant validity was shown between subsets of patients with various levels of health status. Notwithstanding, there were probably translation issues of the Physical Functioning scale which showed small ceiling effects. We clearly observed high ceiling and floor effects in both Role Physical and Role Emotional scale most probably attributed to the dichotomous style of their choice of responses. Cronbach alpha values of the eight scales ranged from 0.73 to 0.90, showing good internal consistency reliability. Confirmatory Factor Analysis (CFA) confirmed the 8-factor solution and Composite Reliability revealed internal consistency reliability except for Vitality and Social Functioning. Based on the Average Variance Extracted (AVE), convergent validity was adequate except for two domains. Discriminant Validity is good for the eight constructs as the √AVE are generally higher than the correlation coefficients between the latent constructs.
CONCLUSION: The scoring for the Malay SF-36 based on the summated ratings method was proven to be valid to be applied in our local clinical population. The CFA, fitness estimates, reliability and validity assessments suggest that the Malay version of SF36 is a valid and reliable instrument. However, further work is warranted to further refine the convergent validity and reliability of some scales.
AIMS: The aim of this study is to determine whether a potent antioxidative and anti-inflammatory agent, Tocovid, a tocotrienol-rich capsule, could reduce the incidence of POAF and affect the mortality and morbidity as well as the duration of ICU, HDU and hospital stay.
METHODS: This study was planned as a prospective, randomised, controlled trial with parallel groups. The control group received placebo containing palm superolein while the treatment group received Tocovid capsules. We investigated the incidence of POAF, the length of hospital stay after surgery and the health-related quality of life.
RESULTS: Recruitment commenced in January 2019 but the preliminary results were unblinded as the study is still ongoing. Two-hundred and two patients have been recruited out of a target sample size of 250 as of January 2021. About 75% have completed the study and 6.4% were either lost during follow-up or withdrew; 4% of participants died. The mean age group was 61.44 ± 7.30 years with no statistical difference between the groups, with males having a preponderance for AF. The incidence of POAF was 24.36% and the mean time for developing POAF was 55.38 ± 29.9 h post-CABG. Obesity was not a predictive factor. No statistically significant difference was observed when comparing left atrial size, NYHA class, ejection fraction and the premorbid history. The mean cross-clamp time was 71 ± 34 min and the mean bypass time was 95 ± 46 min, with no difference between groups. There was a threefold increase in death among patients with POAF (p = 0.008) and an increase in the duration of ICU stay (p = 0.01), the total duration of hospital stay (p = 0.04) and reintubation (p = 0.045).
CONCLUSION: A relatively low incidence rate of POAF was noted although the study is still ongoing. It remains to be seen if our prophylactic intervention using Tocovid would effectively reduce the incidence of POAF. Clinical Registration Number: US National Library of Medicine. Clinical Trials - NCT03807037. Registered on 16th January 2019. Link: https://clinicaltrials.gov/ct2/show/NCT03807037.
METHODS: Prospective observational study of sixty human saphenous vein grafts was performed to evaluate endothelial preservation by haematoxylin-eosin and Cluster of Differentiation 31 (CD 31) staining. Saphenous vein was harvested endoscopically either by closed CO2 (carbon dioxide) ESVH, open CO2 ESVH or OSVH harvesting technique. Demographic data and intra-operative data were collected. Two saphenous vein samples were collected from each patient to compare differences before and after distension of the veins. Both haematoxylin-eosin and immunohistochemistry slides were imaged by a high-resolution slide scanning system.
RESULTS: Open CO2 ESVH group showed the highest number of endothelial detachments. Mean scoring of the immunohistochemistry method using the CD31 antibody was much lower in the open CO2 ESVH group (33.25% ± 28.71, P
METHODS: We conducted a prospective, randomised, controlled trial. We supplied the treatment group with Tocovid capsules and the control group with placebo containing palm superolein.
RESULTS: Since January 2019, we have recruited the target population of 250 patients. However, the result is still blinded as we are still analysing blood samples for tocotrienol levels. 89.2% of patients completed the study with a 3.6% mortality and a 7.6% attrition rate. 35.2% of the patients developed POAF, the mean time being 46.06 ± 26.96 hours post-CABG. We did not observe any statistically significant difference when we compared left atrial size, New York Heart Association (NYHA) functional class, ejection fraction and premorbid history, besides EuroSCORE II (The European System for Cardiac Operative Risk Evaluation II) status except for older age group, right atrial size, and pleural effusion. There was also no difference in bypass time, cross clamp time or number of anastomoses. However, we noted a significant difference in death (p = 0.01) and renal failure requiring dialysis (p = 0.007) among patients with POAF; those patients also had a longer CICU stay (p = 0.005), HDU stay (p = 0.02), and total hospital stay (p = 0.001).
CONCLUSIONS: POAF is associated with a higher incidence of renal failure and death while it increases CICU, HDU, and total hospital stay. It remains to be seen whether Tocovid reduces POAF and its associated sequelae.
CLINICAL TRIAL REGISTRATION: NCT03807037 (Registered on 16 January 2019).