CEACs enable a probabilistic visual interpretation of the health economic analysis that can be used by decision-makers to assist in their choice of health service delivery. Implementation To assess feasibility and acceptability we shall look at scores on the http://www.selleckchem.com/products/Tipifarnib(R115777).html QbTest feedback questionnaires. High scores will be taken to indicate high acceptability and feasibility. Mean scores for individual items on each questionnaire will be assessed to determine which aspects of QbTest are perceived negatively or positively by clinicians and service users. Data from clinicians and patients
who participate in interviews will be thematically analysed according to the principles of Braun and Clarke44 to assess themes on the acceptability of QbTest, including patients’ opinion on reduced length or number of clinic visits. Data monitoring No interim analysis or analyses for safety or efficacy are planned. Access to data will be restricted to trial team members and associated regulatory authorities as indicated in the sponsor agreement between sites and individual participant information sheets.
The chief investigator (CH) shall oversee study management, with oversight from the rest of the research team. A sample (10% of the data) will be checked on a regular basis for verification of all entries made. Where corrections are required these will carry a full audit trail and justification, independent from the research team. There are no anticipated adverse
effects of the QbTest, all adverse events will be recorded and monitored and the CH will determine seriousness and causality and report the event to the ethics committee. The trial is overseen by an independent CLAHRC East Midlands Scientific Committee. The members of the committee are drawn externally from outside the institutions of the research team members and the trial sponsor. Study limitations The diagnosis and management of ADHD is inconsistent, as such the ‘assessment as usual’ practice will vary across sites. In order to document this difference each site completed a questionnaire prior to their participation in the trial detailing their ‘assessment as usual’ procedure. Furthermore, basic descriptions of ‘assessment as usual’ will be recorded in the pro-forma (such as number and length of appointments, decision-making and medication). Given this is a pragmatic trial conducted in real-world settings we are interested in the impact of adding QbTest Dacomitinib feedback to ‘assessment as usual’—without changing other aspects of practice. In order to minimise the trial results being influenced by practice in any one site, we are recruiting participants across multiple sites in different regions of the country and include both CAMHS and community paediatrics. In our design, we have attempted to control for variations between sites by stratification of randomisation by site.