Jeroen van de Pol

90 Chapter 4 Methods Desing and setting This study was a trial-based cost-effectiveness and cost-utility analysis of the DREAMeR study (Netherlands Trial Register; NTR5713). The design, conduct and reporting of this analysis adheres to the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) and International Society for Pharmacoeconomics and Outcomes Research (ISPOR) guidelines [20-22]. The DREAMeR study was a pragmatic randomized controlled trial (RCT) performed in 35 community pharmacies of the franchise formula Service Apotheek and collaborating general practices in the Netherlands [23]. The target population comprised patients aged 70 years and over using seven or more chronic drugs. The selected pharmacists were accredited and experienced with CMRs. Pharmacists received a day of training before the start of the study, where they were instructed on all aspects of the study. The general practitioners (GPs) were informed by the pharmacists about the study. Participants were recruited by their community pharmacists. First, the pharmacists screened all their patients by the inclusion criteria. Then the pharmacists sent the lists with the selected patients to patients' GPs. The GPs judged the patients on the exclusion criteria. An anonymized list was then sent to the researcher to randomly assign 50 patients per pharmacy who would be invited first. These patients were subsequently invited by letter and/ or telephone consultation by their pharmacist. Randomization of participants to the intervention or control group was carried out at patient level and performed after recruitment of the participants. Block randomization per pharmacy using a computer-generated list of random numbers was applied by the researcher to obtain equal numbers of persons per pharmacy per group. A block consisted of the number of patients who agreed to participate in a pharmacy. The study design, study protocol, procedure and informed consent were approved by the Medical Ethics Committee of the University Medical Centre of Utrecht (protocol number 15/737). Participation was voluntary and all participants have signed informed consent. The full study protocol of this RCT has been published elsewhere [23]. Intervention and comparator The intervention was a CMR with a patient centered approach, focused on patient's preferences, personal goals andhealth-related complaints. TheCMRswereperformed according to a structured method described in the Dutch multidisciplinary guideline ‘Polypharmacy in the elderly’ [9]. Before the start of the CMR, questionnaires were completed about health-related complaints which could be used as input for the pharmacist. In addition, proposing personal goals together with patients was new in this study. The pharmacist discussed all aspects (e.g. effectiveness, safety and practical