Statistical analysis plan for the Maximizing the Efficacy of Sedation and Reducing Neurological Dysfunction and Mortality in Septic Patients with Acute Respiratory Failure trial

2020 ◽  
Vol 22 (1) ◽  
pp. 63-71
Author(s):  
Rameela Chandrasekhar ◽  
◽  
Christopher G Hughes ◽  
Brenda T Pun ◽  
Onur M Orun ◽  
...  
Keyword(s):  
Statistical Analysis ◽  
Randomised Trial ◽  
Randomised Clinical Trial ◽  
Statistical Analysis Plan ◽  
Brain Dysfunction ◽  
Neurological Dysfunction ◽  
Long Term Effects ◽  
Double Blind ◽  
Mechanically Ventilated

BACKGROUND: The best sedative medication to reduce delirium, mortality and long term brain dysfunction in mechanically ventilated septic patients is unclear. This multicentre, double-blind, randomised trial investigates the short term and long term effects of dexmedetomidine versus propofol for sedation in mechanically ventilated severely septic patients. OBJECTIVES: To describe the statistical analysis plan for this randomised clinical trial comprehensively and place it in the public domain before unblinding. METHODS: To ensure that analyses are not selectively reported, we developed a comprehensive statistical analysis plan before unblinding. This trial has an enrolment target of 420 severely septic and mechanically ventilated adult patients, randomly assigned to dexmedetomidine or propofol in a 1:1 ratio. Enrolment was completed in January 2019, and the study was estimated to be completed in September 2019. The primary endpoint is days alive without delirium or coma during first 14 study days. Secondary outcomes include 28-day ventilator-free days, 90-day all-cause mortality and cognitive function at 180 days. Time frames all begin on the day of randomisation. All analyses will be conducted on an intention-to-treat basis. CONCLUSION: This study will compare the effects of two sedatives in mechanically ventilated severely septic patients. In keeping with the guidance on statistical principles for clinical trials, we have developed a comprehensive statistical analysis plan by which we will adhere, as this will avoid bias and support transparency and reproducibility. TRIAL REGISTRATION: ClinicalTrials.gov (NCT01739933).

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 HOspitalised Pneumonia Extended (HOPE) Study to reduce the long-term effects of childhood pneumonia: protocol for a multicentre, double-blind, parallel, superiority randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (4) ◽  
pp. e026411
Author(s):  
Anne B Chang ◽  
Siew Moy Fong ◽  
Tsin Wen Yeo ◽  
Robert S Ware ◽  
Gabrielle B McCallum ◽  
...  
Keyword(s):  
Research Ethics ◽  
Randomised Trial ◽  
Long Term Effects ◽  
Double Blind ◽  
Childhood Pneumonia ◽  
Department Of Health ◽  
Increased Risk ◽  
Amoxicillin Clavulanate ◽  
Randomised Controlled

IntroductionEarly childhood pneumonia is a common problem globally with long-term complications that include bronchiectasis and chronic obstructive pulmonary disease. It is biologically plausible that these long-term effects may be minimised in young children at increased risk of such sequelae if any residual lower airway infection and inflammation in their developing lungs can be treated successfully by longer antibiotic courses. In contrast, shortened antibiotic treatments are being promoted because of concerns over inducing antimicrobial resistance. Nevertheless, the optimal treatment duration remains unknown. Outcomes from randomised controlled trials (RCTs) on paediatric pneumonia have focused on short-term (usually <2 weeks) results. Indeed, no long-term RCT-generated outcome data are available currently. We hypothesise that a longer antibiotic course, compared with the standard treatment course, reduces the risk of chronic respiratory symptoms/signs or bronchiectasis 24 months after the original pneumonia episode.Methods and analysisThis multicentre, parallel, double-blind, placebo-controlled randomised trial involving seven hospitals in six cities from three different countries commenced in May 2016. Three-hundred-and-fourteen eligible Australian Indigenous, New Zealand Māori/Pacific and Malaysian children (aged 0.25 to 5 years) hospitalised for community-acquired, chest X-ray (CXR)-proven pneumonia are being recruited. Following intravenous antibiotics and 3 days of amoxicillin-clavulanate, they are randomised (stratified by site and age group, allocation-concealed) to receive either: (i) amoxicillin-clavulanate (80 mg/kg/day (maximum 980 mg of amoxicillin) in two-divided doses or (ii) placebo (equal volume and dosing frequency) for 8 days. Clinical data, nasopharyngeal swab, bloods and CXR are collected. The primary outcome is the proportion of children without chronic respiratory symptom/signs of bronchiectasis at 24 months. The main secondary outcomes are ‘clinical cure’ at 4 weeks, time-to-next respiratory-related hospitalisation and antibiotic resistance of nasopharyngeal respiratory bacteria.Ethics and disseminationThe Human Research Ethics Committees of all the recruiting institutions (Darwin: Northern Territory Department of Health and Menzies School of Health Research; Auckland: Starship Children’s and KidsFirst Hospitals; East Malaysia: Likas Hospital and Sarawak General Hospital; Kuala Lumpur: University of Malaya Research Ethics Committee; and Klang: Malaysian Department of Health) have approved the research protocol version 7 (13 August 2018). The RCT and other results will be submitted for publication.Trial registrationACTRN12616000046404.

scholarly journals Long-term effects of a modified, low-protein infant formula on growth and body composition: Follow-up of a randomized, double-blind, equivalence trial

2021 ◽  
Author(s):  
Stefanie M.P. Kouwenhoven ◽  
Nadja Antl ◽  
Martijn J.J. Finken ◽  
Jos W.R. Twisk ◽  
Eline M. van der Beek ◽  
...  
Keyword(s):  
Body Composition ◽  
Infant Formula ◽  
Long Term Effects ◽  
Double Blind ◽  
Equivalence Trial ◽  
Low Protein

scholarly journals Impacts of treatments on recurrence and 28-year survival of ischemic stroke patients

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Ting-Ann Wang ◽  
Tzy-Haw Wu ◽  
Shin-Liang Pan ◽  
Hsiu-Hsi Chen ◽  
Sherry Yueh-Hsia Chiu
Keyword(s):  
Ischemic Stroke ◽  
Cerebrovascular Disease ◽  
Cox Regression ◽  
Controlled Trial ◽  
Stroke Recurrence ◽  
Long Term Effects ◽  
Stroke Patients ◽  
Double Blind ◽  
Term Survival

AbstractAspirin and nicametate are well-established therapies for preventing recurrence and mortality from stroke in patients diagnosed as ischemic stroke. However, their respective effects on the recurrence, making allowance for the duration of recurrence and death without the occurrence of recurrence, and long-term survival have not been well elucidated. We aimed to evaluate long-term effect of two kinds of treatment on cerebrovascular death among ischemic stroke patients with or without the recurrence of stroke. Data used in this study were derived from the cohort based on a multicenter randomized double-blind controlled trial during 1992 to 1995 with the enrollment of a total of 466 patients with first-time non-cardioembolic ischemic stroke who were randomly allocated to receive aspirin (n = 222) or nicametate (n = 244). The trial cohort was followed up over time to ascertain the date of recurrence within trial period and death until Sep of 2019. The time-dependent Cox regression model was used to estimate the long-term effects of two treatments on death from cerebrovascular disease with and without recurrence. A total of 49 patients experienced stroke recurrence and 89 cerebrovascular deaths was confirmed. Patients treated with nicametate were more likely, but non statistically significantly, to have recurrence (aHR: 1.73, 95% CI 0.96–3.13) as compared with those treated by aspirin. Nicametate reduced the risk of cerebrovascular death about 37% (aHR: 0.63, 95% CI 0.41–0.97) compared with aspirin. The aspirin group had a lower recurrence rate than the nicametate group even with recurrence after 1–2 years of follow-up of first stroke but the latter had significantly reduced death from cerebrovascular disease for nicametate group, which requires more research to verify.

116 A double-blind study of three sodium intakes, and the long- term effects of sodium restriction in essential hypertension

1988 ◽  
Vol 6 (4) ◽  
pp. S742 ◽  
Author(s):  
Nirmala D. Markandu ◽  
Donald R.J. Singer ◽  
Giuseppe A. Sagnella ◽  
Francesco P. Cappuccio ◽  
A. L. Sugden ◽  
...  
Keyword(s):  
Essential Hypertension ◽  
Blind Study ◽  
Double Blind Study ◽  
Sodium Restriction ◽  
Long Term Effects ◽  
Double Blind

The long-term effects of homeopathic treatment of chronic headaches: one year follow-up and single case time series analysis

2001 ◽  
Vol 90 (02) ◽  
pp. 63-72 ◽  
Author(s):  
H Walach ◽  
T Lowes ◽  
D Mussbach ◽  
U Schamell ◽  
W Springer ◽  
...  
Keyword(s):  
Time Series ◽  
Single Case ◽  
Double Blind Study ◽  
Long Term Effects ◽  
Double Blind ◽  
Homeopathic Treatment ◽  
Chronic Headaches ◽  
One Year

AbstractLittle is known about long-term effects of homeopathic treatment. Following a double-blind, placebo controlled trial of classical homeopathy in chronic headaches, we conducted a 1-year observational study of 18 patients following the double-blind phase, and a complete follow-up study of all trial participants. Eighteen patients received free treatment for daily diary data (frequency, intensity, duration of headaches) over the course of 1 y. All patients enrolled in the double-blind study were sent a 6-week headache diary, a follow-up questionnaire, a personality inventory and a complaint list. Eighty-seven, of the original 98 patients enrolled returned questionnaires, 81 returned diaries. There was no additional change from the end of the trial to the one-year follow-up. The improvement seen at the end of the 12-week trial was stable after 1 y. No differential effects according to treatment after the trial could be seen. Patients with no treatment following the trial had the most improvement after 1 y. Five of 18 patients can be counted responders according to ARIMA analysis of single-case time-series. Patients with double diagnoses and longer treatment duration tended to have clearer improvements than the rest of the patients. Approximately 30% of patients in homeopathic treatment will benefit after 1 y of treatment. There is no indication of a specific, or of a delayed effect of homeopathy.

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