Patient perspectives on how to improve education on medication side effects: cross-sectional observational study at a rheumatology clinic in The Netherlands

For the observational phase of the study, the hospital’s digital consultation schedule was prospectively screened for prescheduled visits by patients diagnosed with rheumatoid arthritis (diagnosis treatment code [DBC] 101) and the availability of one of the three rheumatology nurses who acted as independent observers. A total of six consultation hours were selected for observation. All observed HCPs and RA patients were blinded to the aim of the observations. The HCPs were informed that structured observations of consultation hours would be performed to ‘improve overall quality of care’ and gave verbal informed consent. Before the scheduled consultation, verbal informed consent was also obtained from the patients without detailing the exact purpose of the observations, i.e., information about medication side effects. In total, 12 blinded structured observations were performed during the regular consultation visits of patients diagnosed with RA. Six HCPs were observed: 4 rheumatologists, 1 rheumatology fellow and 1 rheumatology nurse. A structured case record form specifically designed for this study was used to measure whether the topics ‘medication’ and ‘medication side effects’ were discussed during each consultation. The case record form further contained the domains ‘method of proving the medication information’,’describing the content of information that was provided in the electronic patient file’ and ‘interaction with other medication’(Supplementary Appendix A).

In January 2019, the hospital’s digital information system was used to make a retrospective selection of patients with a diagnosis treatment code of rheumatoid arthritis (DBC 101) who had visited the rheumatology outpatient department in the previous two months. The electronic patient files of these patients were screened for those patients that had started or changed their medication over the six months prior to the last consultation. A convenience sample of the first 100 patients who met these inclusion criteria were sent a letter asking them to fill out and return an enclosed questionnaire. This questionnaire was an adaptation of the Dutch validated version of the Satisfaction with Information about Medicines Scale (SIMS) [13‐15]. The SIMS questionnaire consists of 17 items, each referring to a particular aspect of information received about medication; for example, information on ‘what your medicine is for’ or ‘whether the medicine has any unwanted effects (side effects)’. For each item, respondents are asked to rate the amount of information they have received as: too much, about right, too little, none received or none needed. The responses can be analyzed at different levels. First, at individual item level, to provide an overview of types of information that an individual patient is lacking. Second, at item sum score level, to provide a total satisfaction rating. Each item is given a score of 1 when rated satisfactory, i.e., ‘about right’ or ‘none needed’ or is given a score of 0 when rated unsatisfactory, i.e., ‘too much’, ‘too little’ or ‘none received’. Sum scores range from 0 to 17 with higher scores indicating a higher degree of overall satisfaction with the amount of medication information received. Third, at two subscale score levels, to identify patients’ satisfaction with information about ‘the action and usage of medication’ (items 1–9) and with information about ‘the potential problems of medication’ (items 10–17) [13‐15]. The Dutch SIMS questionnaire was adapted for the current study by adding several open questions on specific patient characteristics (Supplementary Appendix B). The entire questionnaire consisted of 25 items on two pages. None of the questions were mandatory. No incentives were offered.