TP1-3 Final phase of recruitment and statistics analysis plan for Dex-CSDH trial

2019 ◽  
Vol 90 (3) ◽  
pp. e10.4-e11
Author(s):  
E Edlmann ◽  
A Kolias ◽  
E Thelin ◽  
D Gatt ◽  
Y Al-Tamimi ◽  
...  
Keyword(s):  
Statistical Analysis ◽  
Controlled Trial ◽  
Secondary Analysis ◽  
Statistical Analysis Plan ◽  
Primary Outcome Measure ◽  
Favourable Outcome ◽  
Absolute Difference ◽  
Primary Analysis ◽  
Double Blind ◽  
Intention To Treat

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.

scholarly journals Efficacy of high-volume injections with and without corticosteroid compared with sham for Achilles tendinopathy: a protocol for a randomised controlled trial

2021 ◽  
Vol 7 (4) ◽  
pp. e001136
Author(s):  
Peter Malliaras ◽  
David Connell ◽  
Anders Ploug Boesen ◽  
Rebecca S Kearney ◽  
Hylton B Menz ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Exercise Intervention ◽  
Controlled Trial ◽  
High Volume ◽  
Primary Outcome Measure ◽  
Achilles Tendinopathy ◽  
Double Blind ◽  
Sham Injection ◽  
Intention To Treat ◽  
Randomised Controlled

IntroductionAchilles tendinopathy (AT) is a common and disabling musculoskeletal condition. First-line management involving Achilles tendon loading exercise with, or without, other modalities may not resolve the problem in up to 44% of cases. Many people receive injections. Yet there are no injection treatments with demonstrated long-term efficacy. The aim of the trial is to examine the 12-month efficacy of high-volume injection (HVI) with corticosteroid and HVI without corticosteroid versus sham injection among individuals with AT.Methods and analysisThe trial is a three-arm, parallel group, double-blind, superiority randomised controlled trial that will assess the efficacy of HVI with and without corticosteroid versus sham up to 12 months. We will block-randomise 192 participants to one of the three groups with a 1:1:1 ratio, and both participants and outcome assessors will be blinded to treatment allocation. All participants will receive an identical evidence-based education and exercise intervention. The primary outcome measure will be the Victorian Institute of Sport Assessment – Achilles (VISA-A) at 12 months post-randomisation, a validated, reliable and disease-specific measure of pain and function. Choice of secondary outcomes was informed by core outcome domains for tendinopathy. Data will be analysed using the intention-to-treat principle.Ethics and disseminationEthics approval was obtained via the Monash University Human Ethics Committee (no: 13138). The study is expected to be completed in 2024 and disseminated via peer review publication and conference presentations.Trial registration numberAustralia and New Zealand Clinical trials registry (ACTRN12619001455156)

scholarly journals 117. Adjunctive Daptomycin in the Treatment of staphylococcus Aureus Bacteremia

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S187-S187
Author(s):  
Matthew P Cheng ◽  
Alexander Lawandi ◽  
Guillaume Butler-Laporte ◽  
Samuel De L’Etoile-Morel ◽  
Katryn Paquette ◽  
...  
Keyword(s):  
Staphylococcus Aureus ◽  
Median Duration ◽  
Controlled Trial ◽  
Standard Of Care ◽  
Absolute Difference ◽  
Double Blind ◽  
Intention To Treat ◽  
Care Treatment ◽  
Standard Of Care Treatment ◽  
Treat Analysis

Abstract Background Bloodstream infections (BSI) caused by methicillin-susceptible Staphylococcus aureus (MSSA) are associated with significant morbidity and mortality. The objective of our study was to determine whether daptomycin given in combination with an anti-staphylococcal beta-lactam improved outcomes in MSSA BSI. Methods A randomized, double blind, placebo-controlled trial was performed at two academic hospitals in Montreal, Canada. Patients ≥ 18 years of age with MSSA BSI receiving either cefazolin or cloxacillin monotherapy were considered for inclusion. In addition to the standard of care treatment, participants received a 5-day course of adjunctive daptomycin or placebo. The primary outcome was the duration of MSSA BSI in days. Results Of 318 participants screened, 115 were enrolled and 104 were included in the intention to treat analysis (median age 67 years; 34.5% female). The median duration of bacteremia was 2.04 days among patients who received daptomycin versus 1.65 days in those who received placebo (absolute difference 0.39 days, p=0.40). A modified intention to treat analysis involving participants who remained bacteremic at the time of enrollment found a median duration of bacteremia of 3.06 days among patients who received daptomycin versus 3.0 days in those who received placebo (absolute difference 0.06 days, p=0.77). Ninety-day mortality in the daptomycin arm was 18.9% vs. 17.7% in the placebo arm (p=1.0). There were no significant differences in the proportion of patients who developed renal failure, hepatotoxicity, or rhabdomyolysis between groups. Conclusion Among patients with MSSA BSI, the administration of adjunctive daptomycin therapy to standard of care treatment did not shorten the duration of bacteremia. Disclosures All Authors: No reported disclosures

scholarly journals Statistical analysis plan for the Dex-CSDH trial: a randomised, double-blind, placebo-controlled trial of a 2-week course of dexamethasone for adult patients with a symptomatic chronic subdural haematoma

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Annabel Allison ◽  
Ellie Edlmann ◽  
Angelos G. Kolias ◽  
Carol Davis-Wilkie ◽  
Harry Mee ◽  
...  
Keyword(s):  
Statistical Analysis ◽  
Subdural Haematoma ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Statistical Analysis Plan ◽  
Chronic Subdural Haematoma ◽  
Double Blind ◽  
Additional Material ◽  
Parallel Group ◽  
The Uk

Abstract Background The incidence of chronic subdural haematoma (CSDH) is increasing. Although surgery remains the mainstay of management for symptomatic patients, uncertainty remains regarding the role of steroids. Hence, the Dex-CSDH trial was launched in the UK in 2015 aiming to determine whether, compared to placebo, dexamethasone can improve the 6-month functional outcome of patients with symptomatic CSDH by reducing the rate of surgical intervention and recurrence rate. Methods and design Dex-CSDH is a multi-centre, pragmatic, parallel group, double-blind, randomised trial assessing the clinical utility of a 2-week course of dexamethasone following a CSDH. Seven hundred fifty patients were randomised to either dexamethasone or placebo. The primary outcome is the modified Rankin Scale at 6 months which is dichotomised to favourable (a score of 0–3) versus unfavourable (a score of 4–6). Conclusions This paper and the accompanying additional material describe the statistical analysis plan for the trial. Trial registration ISRCTN, ISRCTN80782810. Registered on 7 November 2014. http://www.isrctn.com/ISRCTN80782810. EudraCT, 2014-004948-35. Registered on 20 March 2015.

scholarly journals A statistical analysis plan for the Adjunctive Corticosteroids for Tuberculous meningitis in HIV-positive adults (ACT HIV) clinical trial

2021 ◽  
Vol 6 ◽  
pp. 280
Author(s):  
Joseph Donovan ◽  
Trinh Dong Huu Khanh ◽  
Guy E. Thwaites ◽  
Ronald B. Geskus ◽  
Keyword(s):  
Clinical Trial ◽  
Statistical Analysis ◽  
Tuberculous Meningitis ◽  
Controlled Trial ◽  
Clinical Trial Data ◽  
Evidence Base ◽  
Statistical Analysis Plan ◽  
Severe Form ◽  
Hiv Positive ◽  
Double Blind

TBM is the most severe form of tuberculosis. Clinical trial data are required to provide an evidence base for adjunctive dexamethasone in HIV-positive individuals with TBM, and to guide clinical practice. This document details the planned analyses at 12 months post randomisation for the ACT HIV clinical trial (NCT03092817); ‘a randomised double-blind placebo-controlled trial of adjunctive dexamethasone for the treatment of HIV co-infected adults with tuberculous meningitis (TBM)’. The primary endpoint of the ACT HIV trial is death (from any cause) over the first 12 months after randomisation. This statistical analysis plan expands upon and updates the analysis plan outlined in the published study protocol.

The effect of a probiotic blend on gastrointestinal symptoms in constipated patients: a double blind, randomised, placebo controlled 2-week trial

2019 ◽  
Vol 10 (6) ◽  
pp. 617-627 ◽  
Author(s):  
K. Airaksinen ◽  
N. Yeung ◽  
A. Lyra ◽  
S.J. Lahtinen ◽  
T. Huttunen ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Gastrointestinal Symptoms ◽  
Area Under The Curve ◽  
Functional Constipation ◽  
Colonic Transit ◽  
Primary Analysis ◽  
Double Blind ◽  
Probiotic Group ◽  
Intention To Treat ◽  
Bowel Movement Frequency

Selected strains of lactobacilli and bifidobacteria are known to ameliorate constipation-related symptoms and have previously shown efficacy on digestive health. In this clinical trial, the safety and effectiveness of a probiotic blend containing lactobacilli and bifidobacteria were evaluated in adults with self-reported bloating and functional constipation. Constipation was diagnosed by the Rome III criteria. A total of 156 adults were randomised into this double-blind and placebo-controlled trial. Participants consumed the combination of Lactobacillus acidophilus NCFM (1010 cfu), Lactobacillus paracasei Lpc-37 (2.5×109 cfu), Bifidobacterium animalis subsp. lactis strains Bl-04 (2.5×109 cfu), Bi-07 (2.5×109 cfu) and HN019 (1010 cfu) (n=78), or placebo (microcrystalline cellulose) (n=78) for two weeks. After treatment the following were measured: primary outcome of bloating and secondary outcomes of colonic transit time, bowel movement frequency, stool consistency, other gastrointestinal symptoms (flatulence, abdominal pain, and burbling), constipation-related questionnaires (PAC-SYM and PAC-QoL) and product satisfaction. Faecal recovery of consumed strains was determined. The enrolled population was defined as constipated, however, the initial bloating severity was lower than in previous similar studies. No clinically significant observations related to the safety of the product were reported. Product efficacy was not shown in the primary analysis for bloating nor for the secondary efficacy analyses. The placebo functioned similarly as the probiotic product. In post-hoc analysis, a statistically significant decrease in flatulence in favour of the probiotic group was observed; day 7 (intention-to-treat (ITT): P=0.0313; per-protocol (PP): 0.0253) and on day 14 (ITT: P=0.0116; PP: P=0.0102) as measured by area under the curve (AUC) analysis. The mean AUC of all symptoms decreased in favour of the probiotic group, indicating less digestive discomfort. The study was registered at the ISRCTN registry (ISRCTN41607808).

scholarly journals The aspirin in reducing events in the elderly trial: Statistical analysis plan

2017 ◽  
Vol 13 (3) ◽  
pp. 335-338 ◽  
Author(s):  
Rory Wolfe ◽  
Anne M Murray ◽  
Robyn L Woods ◽  
Brenda Kirpach ◽  
David Gilbertson ◽  
...  
Keyword(s):  
United States ◽  
Statistical Analysis ◽  
Primary Prevention ◽  
Controlled Trial ◽  
The United States ◽  
Statistical Analysis Plan ◽  
Sensitivity Analyses ◽  
Double Blind ◽  
Age Related

Rationale Aspirin has positive and negative effects on a number of age-related chronic conditions and there is uncertainty regarding its role in primary prevention in people aged 70 years and over. Aims To assess whether daily active treatment of 100 mg enteric-coated aspirin will extend the duration of disability-free life in healthy older participants. Design A double-blind, randomized, placebo-controlled primary prevention trial undertaken in Australia and the United States with careful adjudication of endpoints including stroke. Study outcome In Australia 16,703 individuals were recruited through general practices across five states and territories, and in the United States, 2411 participants were recruited through 34 clinical sites across the country. Follow-up of participants will finish at the end of 2017 with average follow-up exceeding 4.25 years per person. Discussion The statistical analysis plan for ASPREE, finalized after closure of recruitment but before the end of patient follow-up, outlines the primary analyses and a range of subgroup and sensitivity analyses. (International Standard Randomized Controlled Trial Number Register ISRCTN83772183 and clinicaltrials.gov Number NCT01038583)

scholarly journals Treatment of Middle East respiratory syndrome with a combination of lopinavir/ritonavir and interferon-β1b (MIRACLE trial): statistical analysis plan for a recursive two-stage group sequential randomized controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Yaseen M. Arabi ◽  
◽  
Ayed Y. Asiri ◽  
Abdullah M. Assiri ◽  
Hani A. Aziz Jokhdar ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Statistical Analysis ◽  
Supportive Care ◽  
Controlled Trial ◽  
Statistical Analysis Plan ◽  
Two Stage ◽  
Group Sequential ◽  
Double Blind ◽  
Recombinant Interferon ◽  
Randomized Controlled

Abstract The MIRACLE trial (MERS-CoV Infection tReated with A Combination of Lopinavir/ritonavir and intErferon-β1b) investigates the efficacy of a combination therapy of lopinavir/ritonavir and recombinant interferon-β1b provided with standard supportive care, compared to placebo provided with standard supportive care, in hospitalized patients with laboratory-confirmed MERS. The MIRACLE trial is designed as a recursive, two-stage, group sequential, multicenter, placebo-controlled, double-blind randomized controlled trial. The aim of this article is to describe the statistical analysis plan for the MIRACLE trial. The primary outcome is 90-day mortality. The primary analysis will follow the intention-to-treat principle. The MIRACLE trial is the first randomized controlled trial for MERS treatment. Trial registration ClinicalTrials.gov, NCT02845843. Registered on 27 July 2016.

The ‘Act When Mild’ (AwM) Study: A Step Forward in Our Understanding of Early Treatment in Acute Migraine

Cephalalgia ◽  
2008 ◽  
Vol 28 (2_suppl) ◽  
pp. 36-41 ◽  
Author(s):  
PJ Goadsby
Keyword(s):  
Pain Intensity ◽  
Group Treatment ◽  
Controlled Trial ◽  
Evidence Base ◽  
Primary Outcome Measure ◽  
Double Blind ◽  
Intention To Treat ◽  
Severe Stage ◽  
Headache Onset ◽  
Severe Group

An important issue in the management of migraine is the advice given to patients as to when to take their treatment in the course of the attack. While it seems common sense almost to take treatment early in the attack, the evidence base for that advice is not as robust as could be expected. The ‘Act when Mild’ (AwM) Study was a randomized, four-arm, multicentre, multinational, double-blind, placebo-controlled trial of almotriptan (12.5 mg) to compare outcomes after administration of treatment when pain intensity was mild and within 1 h of headache onset (mild/early) with outcomes when pain had become moderate or severe. Of 491 migraineurs enrolled, 403 were evaluable with an intention-to-treat population (ITT) of 404. At the primary end-point, 2 h pain free, on the ITT analysis 49% of patients in the almotriptan 12.5 mg treat early/mild group and 40% in the treat moderate/severe group had responded ( P = 0.21). Of these patients, 43 did not take medication according to their randomly allocated baseline pain intensity (mild or moderate/severe) and were subsequently reassigned, prior to study unblinding, to the appropriate group (AwM population) for re-analysis of the primary outcome measure: 2-h pain-free rates. In the almotriptan arms, 53% of the mild/early group and 37.5% of the moderate/severe group were pain free at 2 h ( P = 0.02; AwM population). The corresponding proportions in the placebo groups were 24.7% and 17.5% (significantly lower than the respective almotriptan arms; P ≤ 0.01). Considering the ITT population, secondary end-points were also significantly in favour of treatment with almotriptan in the mild/early vs. the moderate/severe stage, including: sustained pain-free, 45.6% vs. 30.5% ( P = 0.02); headache recurrence at 24 h, 6% vs. 24% ( P = 0.0124). Adverse events were reported in < 5% of patients, with no significant differences between almotriptan and placebo and no serious events in any group. Treatment with almotriptan while migraine pain is still mild and within 1 h of onset provides statistically significant and clinically relevant enhancements in efficacy compared with waiting until pain has reached higher severity levels.

scholarly journals Efficacy and Safety of CVT-E002, a Proprietary Extract of Panax quinquefolius in the Prevention of Respiratory Infections in Influenza-Vaccinated Community-Dwelling Adults: A Multicenter, Randomized, Double-Blind, and Placebo-Controlled Trial

2011 ◽  
Vol 2011 ◽  
pp. 1-8 ◽  
Author(s):  
Janet E. McElhaney ◽  
Andrew E. Simor ◽  
Shelly McNeil ◽  
Gerald N. Predy
Keyword(s):  
Influenza A ◽  
Respiratory Infections ◽  
Controlled Trial ◽  
Secondary Analysis ◽  
Community Dwelling ◽  
Primary Analysis ◽  
Double Blind ◽  
Upper Respiratory ◽  
To Receive ◽  
Larger Sample

CVT-E002 (a proprietary extract) was found to be effective in the prevention of upper respiratory infections (URIs) in healthy adults, and institutionalized and community-dwelling seniors. A multicenter, randomized, double-blind, placebo-controlled trial was carried out to determine effects of CVT-E002 in the prevention of URIs in influenza-vaccinated community-dwelling adults. 783 community-dwelling adults were randomized to receive placebo, 400 mg or 800 mg treatment/d (1 : 1 : 1) for 6 months. Primary analysis on the incidence of laboratory-confirmed-clinical URIs (LCCUs), including influenza A and B, was performed on those receiving at least one dose. Secondary analysis was performed on study completers and included incidence, severity, and duration of URIs meeting a Jackson-based criteria and safety of CVT-E002. The incidence of LCCUs in the ITT group was 5.5%, 5.2%, and 4.6% in the placebo, 400 mg and 800 mg groups, respectively (P=0.89). Jackson-confirmed URIs were significantly lower in the treated groups (P<0.04). CVT-E002 supplementation reduced the severity and duration of Jackson-confirmed URIs. The results indicate that CVT-E002 can be safely used by similar groups and may prevent symptoms of URIs; larger sample size is warranted.

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