scholarly journals A double-blind randomised controlled trial on the effect of Tocovid, a tocotrienol-rich capsule on postoperative atrial fibrillation at the National Heart Institute, Kuala Lumpur: an interim blinded analysis

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Ahmad Farouk Musa ◽  
Jeswant Dillon ◽  
Mohamed Ezani Md Taib ◽  
Alwi Mohamed Yunus ◽  
Abdul Rais Sanusi ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Randomised Controlled Trial ◽  
Hospital Stay ◽  
Controlled Trial ◽  
Control Group ◽  
Inflammatory Agent ◽  
Significant Difference ◽  
The Mean ◽  
Anti Inflammatory ◽  
Randomised Controlled

Abstract Introduction Post-operative atrial fibrillation (POAF) is associated with poorer outcomes, increased resource utilisation, morbidity and mortality. Its pathogenesis is initiated by systemic inflammation and oxidative stress. It is hypothesised that a potent antioxidant and anti-inflammatory agent such as tocotrienol, an isomer of Vitamin E, could reduce or prevent POAF. 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

Tocovid, a tocotrienol-rich vitamin E in preventing atrial fibrillation in post-coronary artery bypass grafting (CABG) surgery: A preliminary result

2021 ◽  
Author(s):  
Ahmad Farouk Musa ◽  
Jeswant Dillon ◽  
Mohamed Ezani Md T ◽  
Alwi Mohamed Yunus ◽  
Abdul Rais Sanusi ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Vitamin E ◽  
Hospital Stay ◽  
Incidence Rate ◽  
Statistical Difference ◽  
Control Group ◽  
Inflammatory Agent ◽  
Significant Difference ◽  
The Mean ◽  
Anti Inflammatory

Abstract Introduction: Post-operative atrial fibrillation (POAF) is associated with poor outcome, increased resource utilisation, morbidity and mortality. Its pathogenesis is initiated by systemic inflammation and oxidative stress. It is hypothesised that a potent antioxidant and anti-inflammatory agent such as tocotrienol, an isomer of Vitamin E, could prevent POAF.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 (LoHS) after surgery and the health-related quality of life (HRQoL). Results: The recruitment started in January 2019 but the preliminary results are unblinded since the study is still ongoing. 202 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 withdrawn; 4% of them died. The mean age group was 61.44 ± 7.30 with no statistical difference between them, with males having a preponderance for AF. The incidence rate of POAF was 24.36% and the mean time for developing POAF was 55.38 ± 29.9 hours post-CABG. Obesity is not a predictive factor. No statistically significant difference was observed when comparing left atrial size, NYHA group, ejection fraction and the premorbid history. The mean cross-clamp time was 71 ± 34 minutes and the mean bypass time was 95 ± 46 minutes, with no statistical difference. There was a three-fold 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 lower incidence rate of POAF was noted though the study is still ongoing. It remains to be seen if our prophylactic intervention using Tocovid would reduce the incidence of AF.

Capsular closure versus unrepaired interportal capsulotomy after hip arthroscopy in patients with femoroacetabular impingement, results of a patient-blinded randomised controlled trial

2021 ◽  
pp. 112070002110057
Author(s):  
Niels H Bech ◽  
Inger N Sierevelt ◽  
Sheryl de Waard ◽  
Boudijn S H Joling ◽  
Gino M M J Kerkhoffs ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Femoroacetabular Impingement ◽  
Hip Arthroscopy ◽  
Controlled Trial ◽  
Poor Quality ◽  
Control Group ◽  
Treatment Groups ◽  
Significant Difference ◽  
Randomised Controlled

Background: Hip capsular management after hip arthroscopy remains a topic of debate. Most available current literature is of poor quality and are retrospective or cohort studies. As of today, no clear consensus exists on capsular management after hip arthroscopy. Purpose: To evaluate the effect of routine capsular closure versus unrepaired capsulotomy after interportal capsulotomy measured with NRS pain and the Copenhagen Hip and Groin Outcome Score (HAGOS). Materials and methods: All eligible patients with femoroacetabular impingement who opt for hip arthroscopy ( n = 116) were randomly assigned to one of both treatment groups and were operated by a single surgeon. Postoperative pain was measured with the NRS score weekly the first 12 weeks after surgery. The HAGOS questionnaire was measured at 12 and 52 weeks postoperatively. Results: Baseline characteristics and operation details were comparable between treatment groups. Regarding the NRS pain no significant difference was found between groups at any point the first 12 weeks after surgery ( p = 0.67). Both groups significantly improved after surgery ( p < 0.001). After 3 months follow-up there were no differences between groups for the HAGOS questionnaire except for the domain sport ( p = 0.02) in favour of the control group. After 12 months follow-up there were no differences between both treatment groups on all HAGOS domains ( p  > 0.05). Conclusions: The results of this randomised controlled trial show highest possible evidence that there is no reason for routinely capsular closure after interportal capsulotomy at the end of hip arthroscopy. Trial Registration: This trial was registered at the CCMO Dutch Trial Register: NL55669.048.15.

Abstract TP233: Are Baseline Characteristics of Stroke Patients Included Into an Observational Study Similar to Patients Included Into a Randomised Controlled Trial?

Stroke ◽  
2016 ◽  
Vol 47 (suppl_1) ◽  
Author(s):  
Anna Schulte ◽  
Falko Jürries ◽  
Anna Messerschmid ◽  
Nico Behnke ◽  
Jan Liman ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Stroke Severity ◽  
Stroke Patients ◽  
Exclusion Criteria ◽  
Observational Trial ◽  
Significant Difference ◽  
Baseline Characteristics ◽  
Randomised Controlled

Introduction: Undiagnosed atrial fibrillation (UAF) is a major burden in ischemic stroke. However, randomised trials have partly shown astonishingly low AF detection rates (e. g. in the CRYSTAL-AF study). This may be due to differences in baseline and stroke characteristics between studies. Hypothesis: We hypothesized that stroke patients in a randomised controlled trial have less severe strokes than patients in an observational trial with similar inclusion and exclusion criteria. Methods: We used data from the Find-AF observational (NCT 01855035) and the Find-AF randomised controlled trial (ISRCTN 46104198). We included only patients at study site Goettingen of the Find-AF randomised controlled trial (n=153) and only included patients from the Find-AF observational trial that fulfilled the inclusion/exclusion criteria of Find-AF randomised (n=90). We compared baseline characteristics of screened versus included patients in Find-AF randomised and baseline characteristics and stroke severity parameters between both studies. Data are shown as mean (Standard Deviation) or Median (25%; 75% percentile) and were compared by chi-square, t-test or Mann-Whitney U test. Results: Table 1 shows as comparison between baseline characteristics of both studies Comparing patients fulfilling the inclusion/exclusion criteria of Find-AF randomised, but unwilling to give informed consent to randomised patients showed a significant difference in age (77 ± 11 vs. 74 ± 8; p< 0.001), but no difference in gender (p=0.581). Conclusions: Both studies included patients similar in age, gender and many comorbidities. Major differences occurred in NIHSS and MRS. As NIHSS is a predictor of atrial fibrillation, randomized controlled trials investigating AF detection should include a minimum NIHSS to avoid a selection bias towards less severe strokes.

scholarly journals Effect of a financial incentive (shopping point) on increasing the number of daily walking steps among community-dwelling adults in Japan: a randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e037303
Author(s):  
Fumiya Tanji ◽  
Yasutake Tomata ◽  
Saho Abe ◽  
Sanae Matsuyama ◽  
Yumika Kotaki ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Financial Incentive ◽  
Controlled Trial ◽  
Intervention Group ◽  
Community Dwelling ◽  
Control Group ◽  
Intervention Period ◽  
The Mean ◽  
Randomised Controlled

ObjectiveThe aim of this study was to investigate the effect of a financial incentive on the number of daily walking steps among community-dwelling adults in Japan.Study designTwo-arm, parallel-group randomised controlled trial.Setting/participantsWe recruited physically inactive community-dwelling adults from Sendai city, Japan. Eligible participants were randomly allocated to an intervention or a wait list control group. Pedometers were used to assess the mean number of daily steps in three periods: baseline (weeks 1–3), intervention (weeks 4–6) and follow-up (weeks 7–9).InterventionThe intervention group was offered a financial incentive (shopping points) to meet the target number of increased daily steps in the intervention period.Main outcome measuresThe primary outcome was an increase in the mean number of daily steps in the intervention and follow-up periods compared with baseline.ResultsSeventy-two participants (69.4% women; mean age, 61.2±16.2 years; mean number of daily steps at baseline, 6364±2804) were randomised to the intervention (n=36) and control groups (n=36). During the intervention period, the increase in mean daily steps was significantly higher in the intervention group (1650, 95% CI=1182 to 2119) than in the control group (514, 95% CI=136 to 891; p<0.001). However, the difference between groups was not significant at follow-up after the incentives were removed (p=0.311). In addition, compared with controls, a significantly higher proportion of participants in the intervention group showed an increase in mean daily steps of ≥1000 (69.4% vs 30.6%, respectively; OR=5.17, 95% CI=1.89 to 14.08). There were no adverse effects from the intervention.ConclusionsThe present results suggest that financial incentives are effective in promoting short-term increases in physical activity.Trial registration numberUMIN000033276.

scholarly journals Prophylactic Administration of Per Rectal Misoprostol vs Intramuscular Injection of Oxytocin in Third-stage of Labour for Prevention of Postpartum Haemorrhage: A Randomised Controlled Trial

2021 ◽  
Author(s):  
Sougata Kumar Burman ◽  
Ritwik Samanta ◽  
Kumari Kanak Lata ◽  
Jayeeta Mukherjee ◽  
Tapan Kumar Dey
Keyword(s):  
Randomised Controlled Trial ◽  
Adverse Effects ◽  
Blood Loss ◽  
Postpartum Haemorrhage ◽  
Controlled Trial ◽  
Effective Control ◽  
Control Group ◽  
Third Stage ◽  
The Mean ◽  
Randomised Controlled

Introduction: In India, the routine Active Management of Third- Stage of Labour (AMTSL) with conventional intramuscular oxytocin, at the rural, resource-constrained areas, is often compromised due to lack of trained healthcare personnel and proper maintenance of cold chain system, causing maternal mortality and morbidity from Postpartum Haemorrhage (PPH). In these scenarios, tablet misoprostol, can be efficacious and convenient alternative. Aim: To evaluate efficacy and safety of misoprostol administered per rectum with respect to intramuscular oxytocin for effective control of PPH in a Randomised Controlled Trial (RCT). Materials and Methods: In this RCT, conducted in Sambhunath Pandit Hospital, kolkata, West Bengal, India from September 2015 to August 2016, total 80 eligible pregnant mothers in normal labour with prior consent and fulfilled criteria, were allocated to two separated groups (n=40) by computer generated randomisation table. Control group received 10 IU injection oxytocin and case group received 600 μg misoprostol tablet per rectally within one minute of cord clamping and cutting. The primary outcome measures were mean third- stage and mean postpartum blood loss up to eight hours after delivery. Secondary outcome variables were Mean Arterial Pressure (MAP) after eight hours postdelivery, haemoglobin and haematocrit after 24 hours of delivery and reported side effects. Data was entered into a Microsoft excel spreadsheet and statistical analysis was done by Statistical Package for the Social Sciences (SPSS) version 20.0.1 and Graph Pad Prism version 5.0. Results: Total sample size was 80 equally divided into two groups, with a mean age of 23.20±3.1558 years and 23.7750±3.8927 years in case and control group respectively. The mean third-stage blood loss (332.4105±72.6632 mL versus {vs} 329.0088±59.4503 mL, p=0.8193) and mean total blood loss (426.5575±80.0215 mL vs 424.8783±61.5808 mL, p=0.9165) were statistically indifferent between misoprostol and oxytocin groups by two-sample t-tests. The mean for eight hours postpartum MAP (p=0.0894), 24 hours postpartum haemoglobin (p=0.4534) and haematocrit (p=0.1325) were statistically insignificant between the two groups by two- sample t-tests. Incidence of adverse effects like shivering, diarrhoea, compared by Pearson’s Chi-square test, were found to be more but non significant in misoprostol group. Conclusion: This study concludes that per-rectal misoprostol is equally effective as intramuscular oxytocin to control PPH without significant adverse effects.

scholarly journals The Effectiveness of Online Course Intervention to Improve Knowledge of Antimicrobial Resistance among Dental Students, in Comparison to Reference Group Using a Randomized Controlled Trial

2019 ◽  
Vol 7 (17) ◽  
pp. 2917-2923
Author(s):  
Khalid T. Aboalshamat ◽  
Assim M. Banjar ◽  
Mahmoud I. Al-Jaber ◽  
Noor M. Turkistani ◽  
Mohammed T. Al-Amoudi
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Dental Students ◽  
Online Course ◽  
Control Group ◽  
Study Group ◽  
Control Groups ◽  
Significant Difference ◽  
Randomised Controlled ◽  
And Control

AIM: This study aimed to assess the effectiveness of a recognised antimicrobial resistance (AMR) online module on knowledge and perception among dental students, using a randomised controlled trial study design. METHODS: Dental students (n = 64, aged 21-25 years) in clinical years agreed to participate in this triple-blinded, parallel, randomised controlled trial. There were 34 students in the study group and 30 students in the control group. The study group participated in an online course covering information about AMR, while students in the control group received another online course about microorganisms in dentistry. Both groups were assessed three times using online questionnaires: before the intervention (T1), after the intervention (T2), and two months later (T3). Each one of T1, T2 and T3 had 22 questions. The questions were repeated each time in T1, T2, and T3 asking about AMR but with different question format, to avoid the possibility of students to memorise the answers. RESULTS: The mean (m) of correct answers for all students on T1 was 12.56, with standard deviation (SD) of 3.2. On T2, m = 14.03 and SD = 3.85, and on T3, m = 14.36 and SD = 3.71. Scores ranged from 0 to 22. The participants in the study and control groups showed significant score improvements from T1 to T2, immediately after the intervention, but there was no significant difference between T2 and T3. The study group students’ scores did not improve significantly from T1 to T3, in contrast to the control group students’ scores. More importantly, there was no significant difference in improvement from T1 to T2 when comparing the study and control groups. CONCLUSION: Online courses might not be reliable learning methods for ensuring the optimal levels of AMR knowledge that are needed by dental practitioners.

A randomised controlled trial comparing compression therapy after stripping for primary great saphenous vein incompetence

2019 ◽  
Vol 34 (10) ◽  
pp. 669-674 ◽  
Author(s):  
Attila G Krasznai ◽  
Tim A Sigterman ◽  
Janine P Houtermans-Auckel ◽  
Ed Eussen ◽  
Maarten Snoeijs ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Saphenous Vein ◽  
Great Saphenous Vein ◽  
Controlled Trial ◽  
Compression Therapy ◽  
Full Recovery ◽  
Control Group ◽  
Post Operative Pain ◽  
Significant Difference ◽  
Randomised Controlled

Background Venous insufficiency of the lower extremity affects up to 40–60% of general adult population in the Western population, of which around 25% has varicose veins mostly treated by ablation of the incompetent great saphenous vein. Although endovenous options are available, the majority is still treated with stripping of the great saphenous vein for which there is no consensus regarding postoperative compressive therapy. The objective of this prospective randomised controlled trial was to evaluate 4 h compared to 72 h of leg compression after great saphenous vein stripping. Method Patients in the Zuyderland Medical Centre with an indication for stripping of the great saphenous vein were eligible for inclusion in this study. Patients were randomised to 4 or 72 h of leg compression (standard elastic bandaging) after stripping of the great saphenous vein. Primary outcome was change in leg volume after 14 days. Secondary outcomes were post-operative pain scores, complications and time to full recovery. Results A total of 78 patients were randomised, 36 patients enrolled the intervention (4 h) group and 42 patients the control group (72 h). The intervention group (4 h) showed a 57 mL reduction in leg volume after 14 days, compared to 6 mL of the control group (72 h) ( p = 0.11). Post-operative pain, complications and time to full recovery did not statistically differ. Conclusion Wearing leg compression four hours after stripping is non-inferior in preventing leg oedema compared with 72 h compression therapy. No statistically significant difference in pain and time to full recovery was shown.

scholarly journals Use of a Human Patient Simulator to Improve Physiotherapy Cardiorespiratory Clinical Skills in Undergraduate Physiotherapy Students: A Randomised Controlled Trial

2011 ◽  
Author(s):  
Anne Jones ◽  
Lorraine Sheppard
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Simulator Training ◽  
Control Group ◽  
Human Patient ◽  
Patient Simulator ◽  
Significant Difference ◽  
Human Patient Simulator ◽  
Randomised Controlled ◽  
Physiotherapy Students

To investigate whether additional training with a human patient simulator improves cardiorespiratory physiotherapy practice in undergraduate physiotherapy students. Method: A randomised controlled trial was undertaken with 50 third year physiotherapy students from James Cook University, Queensland Australia. Participants in the intervention group underwent two four hour sessions of patient simulator training in addition to their normal cardiorespiratory physiotherapy training prior to attending clinical placements. Participants in both the intervention and control groups were assessed weekly for six weeks on their clinical ability whilst on clinical placement. Results: Mann-Whitney was used to compare the training group with the control group. No significant difference was found between groups.Conclusion: This study indicates that simulation, as undertaken in this manner, does not improve clinical ability in cardiorespiratory physiotherapy. Further studies are needed to determine if more training time is required, or whether simulation must be fully integrated into the curriculum.

scholarly journals Effect of a structured educational intervention on explanatory models of relatives of patients with schizophrenia

2006 ◽  
Vol 188 (3) ◽  
pp. 286-287 ◽  
Author(s):  
S. Das ◽  
B. Saravanan ◽  
K. P. Karunakaran ◽  
S. Manoranjitham ◽  
P. Ezhilarasu ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Educational Programme ◽  
Explanatory Models ◽  
Control Group ◽  
Significant Difference ◽  
Randomised Controlled ◽  
Biomedical Treatment ◽  
Trial Participants

SummaryWe examined the effect of a structured educational programme on explanatory models of illness among the relatives of people with schizophrenia, in a randomised controlled trial. Participants were assessed at baseline (n=100) and after 2 weeks (n=75) using a vignette from the Short Explanatory Model Interview. There was a reduction in non-biomedical causal explanatory models at follow-up among those who had completed the structured educational programme compared with the control group. There was no significant difference in non-biomedical treatment explanatory models between the two groups.

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