ObjectivesReview recruitment progression and statistical analysis plan for Dex-CSDH trial.DesignA UK multi-centre, randomised, double-blind, placebo-controlled trial of dexamethasone versus placebo ...for CSDH.SubjectsSymptomatic, adult CSDH patients admitted to a participating neurosurgical unit.MethodsTrial participants receive a 2 week course of dexamethasone in addition to standard care, including surgery. The primary outcome measure is the modified Rankin Scale (mRS) at 6 months. An mRS of 0–3 requires the patient to be independently mobile and we have considered this a favourable outcome, with scores 4–6 (non-mobile) as unfavourable. The primary analysis will be performed on an intention-to-treat basis, estimating the absolute difference between the two treatment arms in the proportions achieving a favourable outcome. Secondary analysis will be done with an ordinal analysis of mRS scores and proportional odds logistic regression of the original mRS score adjusting for baseline covariates (age, GCS).Results629/750 patients (84%) have been recruited to the Dex-CSDH trial which is on-going as of 20-06-2018. Recruitment progress and follow-up at time of presentation will be reviewed alongside full statistical analysis plan.ConclusionsThe Dex-CSDH trial is drawing close to target following excellent recruitment across 22 UK centres. Transparent communication of the statistical analysis plan is essential prior to unblinding of the data. Up-to-date recruitment and primary endpoint completion rates will also be reviewed.
Objectives: Describe Mexican patients with T1DM and find out if blood glucose (BG) testing frequency impacts glycemic targets (mean BG & estimated HbA1c eHbA1c).
Methods: Included mySugr users with a ...self-reported diagnosis of T1DM and had at least 2 BG logs in at least 14 days (G2D14) in the month prior to their first log entry. G2D14 is the lowest adherence needed to calculate eHbA1c. Users were stratified as low (G2D14 + G3D14) and high testing (G4D14 + G5D14). Subgroup analysis according to baseline eHbA1c was performed. Using a logistic regression model, an exploratory analysis to identify factors associated with BG decrease was also considered.
Results: 118,210 users (13% T1DM) were considered. Users in the highest testing subgroup (G5D14; n=276) in the first month before mySugr usage had a significantly lower baseline eHbA1c (-0.8 %; p < 0.01) compared with users in the lowest category (G2D14; n=254). For all users in the group G2D14 or above, eHbA1c decreased from baseline (1 mo. prior to mySugr usage) and stayed below baseline levels for the entire period of 5 mo. (n=253; mean differences: -0.3% at the first month of mySugr usage, -0.2% at the fourth month of mySugr usage; both changes significantly different from 0 with p < 0.05). No statistically significant difference in eHbA1c between the logging subgroups after 4 months of mySugr use was found. Nevertheless, high logging users with baseline eHbA1c > 8% had a non-significant higher reduction. In the logistic regression model, the factor with the strongest association with BG decrease was the baseline mean BG (log OR: 2.4).
Conclusion: in our RwD setting, the use of mySugr was associated with reduced eHbA1c. Baseline BG was statistically associated with BG reduction intensity. Although no significant difference in eHbA1c improvement between the high and low logging groups was found during mySugr usage, the baseline analysis suggests that users with increased logging had significantly better glycemic control before starting mySugr.
Disclosure
C. Vulcano: Employee; Roche Diabetes Care. H. Mikulski: Employee; Roche Diabetes Care. M. Mitter: Employee; Roche Diabetes Care. B. Ruch: Employee; Roche Diabetes Care.
IntroductionReduction of zygomaticomaxillary (ZMC) fracture is often difficult to evaluate intraoperatively because of it peculiar anatomy and limited accessibility. The purpose of this study is to ...evaluate the efficacy of use of C-arm as a tool for intraoperative monitoring of ZMC fracture reduction.Materials and MethodsGroup I (C-Arm) and Group II (control group) comprised of patients with isolated unilateral displaced Zygomatic complex (ZMC) fractures and having orbital volume change. The efficacy of use of C-arm intra-operatively was evaluated to analyse the reduction of fracture.ResultsIt was observed that mean change in ocular volume was around 1.07cm2 for Group I and 1.51cm2 in Group II. Thus post-operative eye volume was near to normal in Group I than Group II. The change in ocular volume post-operatively was observed to be statistically significant (p-value < 0.05) in both the groups. Post HOC Tukey statistical analysis determined the intergroup relation in change in eye volume between normal, pre- and post-operative and was found to be statistically significant (p-value < 0.05). The intergroup comparison between Group I and Group II was done using ANOVA statistical analysis and was found to be statistically significant (p-value < 0.05).DiscussionOur study revealed that C-arm is definitively an effective tool in the oral and maxillofacial surgery armamentarium, giving better results with minimal surgical exposure and by eliminating operator related error.
Interim analysis of the National Skin Centre Singapore Psoriasis Biologics Registry (SINGPSOR) from August 2017 to May 2021, in which 58 patients were analysed, showing that those receiving biologic ...treatment had significantly more severe psoriasis based on PASI (Psoriasis Area and Severity Index), BSA (body surface area) and PGA (Physician Global Assessment) measures at baseline, demonstrated a statistically non‐significant trend towards greater improvement with treatment, and had a lower percentage of adverse events compared to those receiving conventional systemic therapy. Future analyses of SINGPSOR, with larger sample size and longer follow‐up, will be invaluable to further characterize these patients and their treatment outcomes.
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