Daniel J. Bratton
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View article: Realizing the benefits of the estimand framework when reporting and communicating clinical trial results—some recommendations
Realizing the benefits of the estimand framework when reporting and communicating clinical trial results—some recommendations Open
Reports of the results of clinical studies are integral to regulatory decision making. They are used to support marketing authorization, to substantiate labeling information, and to inform academic publications, trial postings, and promoti…
View article: Clinical characterisation of exacerbations of severe eosinophilic asthma occurring on mepolizumab and placebo
Clinical characterisation of exacerbations of severe eosinophilic asthma occurring on mepolizumab and placebo Open
Asthma exacerbations in people treated with mepolizumab result in less peak expiratory flow reduction than placebo but similar symptom scores. Symptoms recover slower, indicating these exacerbations may be less prednisolone responsive. htt…
View article: Patient‐Reported Outcome Measures for Severe Recurrent Bilateral Nasal Polyps: Psychometric Evaluation and Content Validity
Patient‐Reported Outcome Measures for Severe Recurrent Bilateral Nasal Polyps: Psychometric Evaluation and Content Validity Open
Objective To date, no patient‐reported outcome measures have been specifically developed to assess pharmacological treatment effect in participants with severe chronic rhinosinusitis (CRS) with recurrent bilateral nasal polyps (NP). These …
View article: Facilities for optimizing and designing multiarm multistage (MAMS) randomized controlled trials with binary outcomes
Facilities for optimizing and designing multiarm multistage (MAMS) randomized controlled trials with binary outcomes Open
We introduce two commands, nstagebin and nstagebinopt, that can be used to facilitate the design of multiarm multistage (MAMS) trials with binary outcomes. MAMS designs are a class of efficient and adaptive randomized clinical trials that …
View article: Mepolizumab improves work productivity, activity limitation, symptoms, and rescue medication use in severe eosinophilic asthma
Mepolizumab improves work productivity, activity limitation, symptoms, and rescue medication use in severe eosinophilic asthma Open
Patients with severe eosinophilic asthma experience daily activity limitations and reduced productivity at work. Using anonymized individual patient‐level data from two previously conducted randomized, double‐blind, placebo‐controlled stud…
View article: Response to mepolizumab treatment is sustained across 4-weekly dosing periods
Response to mepolizumab treatment is sustained across 4-weekly dosing periods Open
Background Mepolizumab (100 mg delivered s.c. every 4 weeks) is indicated for add-on maintenance treatment for patients with severe eosinophilic asthma. Mepolizumab has been shown to reduce exacerbations and the requirement for daily oral …
View article: Adding new experimental arms to randomised clinical trials: Impact on error rates
Adding new experimental arms to randomised clinical trials: Impact on error rates Open
Background: Experimental treatments pass through various stages of development. If a treatment passes through early-phase experiments, the investigators may want to assess it in a late-phase randomised controlled trial. An efficient way to…
View article: Update: Mepolizumab treatment in patients with severe eosinophilic asthma and prior omalizumab use
Update: Mepolizumab treatment in patients with severe eosinophilic asthma and prior omalizumab use Open
Over the last two decades, several biologic therapies have emerged for the targeted treatment of severe asthma, defined as asthma inadequately controlled by guideline-recommended treatment with high-dose inhaled corticosteroids (ICS) and b…
View article: Effect of continuous positive airway pressure therapy on circadian patterns of cardiac repolarization in patients with obstructive sleep apnoea: data from a randomized trial
Effect of continuous positive airway pressure therapy on circadian patterns of cardiac repolarization in patients with obstructive sleep apnoea: data from a randomized trial Open
In this exploratory study, CPAP treatment led to an overall reduction in the QTc-interval compared with subtherapeutic CPAP. This reduction seems more pronounced during evening hours and in patients with a QTc above 430 ms.
View article: Help for Future Research: Lessons Learned in Trial Design, Recruitment, and Delivery From the “hELP” Study
Help for Future Research: Lessons Learned in Trial Design, Recruitment, and Delivery From the “hELP” Study Open
The aim of this commentary is to document our experience and lessons learned of running a randomized controlled trial (RCT) in vulvar erosive lichen planus (ELPV), an uncommon and underresearched condition. Vulvar erosive lichen planus cau…
View article: Risk of Sleepiness-Related Accidents in Switzerland: Results of an Online Sleep Apnea Risk Questionnaire and Awareness Campaigns
Risk of Sleepiness-Related Accidents in Switzerland: Results of an Online Sleep Apnea Risk Questionnaire and Awareness Campaigns Open
The OSAS awareness campaign of the Swiss Lung League reached a large number of people of both genders and of a wide age range. Many participants suffered from excessive sleepiness and symptoms of sleep apnea were highly prevalent. The camp…
View article: Obstructive sleep apnoea and quality of life in Ehlers-Danlos syndrome: a parallel cohort study
Obstructive sleep apnoea and quality of life in Ehlers-Danlos syndrome: a parallel cohort study Open
NCT02435745.
View article: Type I error rates of multi-arm multi-stage clinical trials: strong control and impact of intermediate outcomes
Type I error rates of multi-arm multi-stage clinical trials: strong control and impact of intermediate outcomes Open
The proposed methods allow the PWER and FWER to be controlled in various MAMS designs, potentially increasing the uptake of the MAMS design in practice. The methods are also applicable in cases where the I and D outcomes are identical.
View article: Simulated Obstructive Sleep Apnea Increases P-Wave Duration and P-Wave Dispersion
Simulated Obstructive Sleep Apnea Increases P-Wave Duration and P-Wave Dispersion Open
Intrathoracic pressure swings through simulated obstructive sleep apnea increase P-wave duration and Pd in healthy subjects and in patients with PAF. Our findings imply that intrathoracic pressure swings prolong the intra-atrial and inter-…
View article: ECG risk markers for atrial fibrillation and sudden cardiac death in minimally symptomatic obstructive sleep apnoea: the MOSAIC randomised trial
ECG risk markers for atrial fibrillation and sudden cardiac death in minimally symptomatic obstructive sleep apnoea: the MOSAIC randomised trial Open
Objective Obstructive sleep apnoea (OSA), atrial fibrillation (AF) and sudden cardiac death (SCD) may occur concomitantly, and are of considerable epidemiological interest, potentially leading to morbidity and mortality. Effective treatmen…
View article: In patients with minimally symptomatic OSA can baseline characteristics and early patterns of CPAP usage predict those who are likely to be longer-term users of CPAP.
In patients with minimally symptomatic OSA can baseline characteristics and early patterns of CPAP usage predict those who are likely to be longer-term users of CPAP. Open
In patients with minimally symptomatic OSA, our study has shown that male gender (and not OSA severity or symptom burden) is associated with increased long-term use of CPAP at 6 months. Although, in general, early patterns of CPAP usage pr…
View article: Systemic therapy for vulval Erosive Lichen Planus (the ‘hELP’ trial): study protocol for a randomised controlled trial
Systemic therapy for vulval Erosive Lichen Planus (the ‘hELP’ trial): study protocol for a randomised controlled trial Open
ISRCTN 81883379 . Date of registration 12 June 2014.
View article: Prevalence and Risk Factors of Sleep Disordered Breathing in Fabry disease
Prevalence and Risk Factors of Sleep Disordered Breathing in Fabry disease Open
Excessive daytime sleepiness (EDS) is a frequently reported and not well-understood symptom in patients with Fabry disease (FD). Sleep-disordered breathing (SDB) is a possible factor. As deposition of glycosphingolipids in the upper airway…