135 ACCEPTANCE protocol 5 Ethics approval This study involves human participants and was approved by the medical research ethics committee of the Foundation ‘Evaluation of Ethics in Biomedical Research’ (BEBO, Assen, the Netherlands (reference NL69909.056.19). Results will be submitted for publication in peer-reviewed journals. Participants gave informed consent to participate in the study before taking part. The study was registered in the Netherlands Trial Register (NL7854) on 3 July 2019. In case of protocol modifications, the medical research ethics committee (and the study participants if necessary) will be notified. Since the smart inhaler programme is additional to usual care and patients will use their inhalation medication as prescribed, we do not expect any risk of participation for patients. Also, no risks on the use of the electronic monitoring devices have been reported previously nor are expected. Adverse events are recorded in the study database. Serious adverse events are reported to the sponsor and the medical research ethics committee without undue delay. Participants are informed that they can withdraw from the study at any time without giving a reason. Due to the pragmatic set-up of the study, participants may continue study participation when they switch from Symbicort to other inhaler medications during the study. Switching of inhalers will be documented and data collection will be continued, with the exception of medication adherence data. To promote participation and retention, patients will be financially compensated for their participation with a gift voucher. The compensation will be proportional to the number of visits completed (€20 per visit, maximum of €80). Participating general practices will be reimbursed with €200 for study participation and an additional €100 per patient (intervention group) or €34 (control group). Pharmacies will be reimbursed with €400 for study participation when the invitation letters to potential eligible patients are sent, and an additional €25 for each patient that is eligible. This compensates for the anticipated time a general practice and pharmacy will spend performing study-related activities and answering questions from patients regarding the study. Provenance and peer review Not commissioned; externally peer reviewed. Data availability statement No data are available. Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.
RkJQdWJsaXNoZXIy MTk4NDMw