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 Quarterly versus annual ECG screening for atrial fibrillation in older Chinese (AF-CATCH): a prospective, randomised, controlled trial

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
W Zhang ◽  
Y Chen ◽  
J.G Wang ◽  
Keyword(s):  
Atrial Fibrillation ◽  
Randomised Controlled Trial ◽  
Detection Rate ◽  
Controlled Trial ◽  
Hazard Ratio ◽  
Private Company ◽  
Significant Difference ◽  
Randomised Controlled ◽  
Incident Cases

Abstract Background Screening for atrial fibrillation before symptoms manifested and subsequent initiation of oral anticoagulants (OACs), could prevent stroke and death. The most cost-effective strategy to screen atrial fibrillation in high-risk population aged 65 and over remains unknown. Methods We performed a randomised controlled trial that compares different screening frequencies of 30-second single-lead electrocardiography (ECG) in the detection of atrial fibrillation in Chinese residents (≥65 years old) in 5 community health centres in Shanghai. Participants without atrial fibrillation were randomised in a 1:1 ratio into annual (G1) and quarterly screening (G2) groups: the quarterly screening group was further randomised in a 3:1 ratio into subgroups of quarterly screening (G2–1) and quarterly screening PLUS (G2–2, ECG weekly for 1-month then quarterly). The primary outcome was the detection rate of atrial fibrillation. The intention-to-treat analysis was performed for all randomised patients who had at least one ECG recording during follow-up. Results Between April 17, 2017, and June 26, 2018, a total of 8240 participants were randomised into G1 (n=4120), G2–1 (n=3090) and G2–2 (n=1030), with a mean of 1.6, 3.5 and 5.2 ECG records respectively during a median of 2.1 years follow-up (13,284 person-years). 73 incident cases of atrial fibrillation occurred: 26 in G1 (4.1/1000 person-years) and 47 in G2 (6.7/1000 person-years; hazard ratio with G1, 1.71; 95% confidence interval [CI] 1.06–2.76; P=0.03). 40 incident cases were detected in G2–1 (7.2/1000 person-years; hazard ratio with G1, 1.83; 95% CI 1.12–3.00; P=0.02) and 7 in G2–2 (4.8/1000 person-years; hazard ratio with G1, 1.24; 95% CI 0.54–2.86; P=0.61). No significant difference was noted between G2–1 and G2–2 (hazard ratio with G2–1, 0.68; 95% CI 0.30–1.52; P=0.35). Conclusion Quarterly 30-second single-lead ECG screening significantly increased the detection rate of incident atrial fibrillation. FUNDunding Acknowledgement Type of funding sources: Private company. Main funding source(s): Bayer Healthcare Company

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

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.

scholarly journals The Effects of Time-Restricted Eating versus Standard Dietary Advice on Weight, Metabolic Health and the Consumption of Processed Food: A Pragmatic Randomised Controlled Trial in Community-Based Adults

Nutrients ◽  
2021 ◽  
Vol 13 (3) ◽  
pp. 1042
Author(s):  
Nicholas Phillips ◽  
Julie Mareschal ◽  
Nathalie Schwab ◽  
Emily Manoogian ◽  
Sylvie Borloz ◽  
...  
Keyword(s):  
Weight Loss ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Smartphone Application ◽  
Metabolic Health ◽  
Dietary Advice ◽  
Processed Food ◽  
Significant Difference ◽  
Randomised Controlled ◽  
Pragmatic Randomised Controlled Trial

Weight loss is key to controlling the increasing prevalence of metabolic syndrome (MS) and its components, i.e., central obesity, hypertension, prediabetes and dyslipidaemia. The goals of our study were two-fold. First, we characterised the relationships between eating duration, unprocessed and processed food consumption and metabolic health. During 4 weeks of observation, 213 adults used a smartphone application to record food and drink consumption, which was annotated for food processing levels following the NOVA classification. Low consumption of unprocessed food and low physical activity showed significant associations with multiple MS components. Second, in a pragmatic randomised controlled trial, we compared the metabolic benefits of 12 h time-restricted eating (TRE) to standard dietary advice (SDA) in 54 adults with an eating duration > 14 h and at least one MS component. After 6 months, those randomised to TRE lost 1.6% of initial body weight (SD 2.9, p = 0.01), compared to the absence of weight loss with SDA (−1.1%, SD 3.5, p = 0.19). There was no significant difference in weight loss between TRE and SDA (between-group difference −0.88%, 95% confidence interval −3.1 to 1.3, p = 0.43). Our results show the potential of smartphone records to predict metabolic health and highlight that further research is needed to improve individual responses to TRE such as a shorter eating window or its actual clock time.

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