82 CHAPTER 4 study was prematurely stopped due to recruitment difficulties, with a total of 62 patients out of 220 originally planned. 36% of patients in the placebo arm and 19% of patients in the atorvastatin arm dropped out of the study, mainly due to (perceived) side effects. The most common side effect in both groups was muscle pains or cramps (37%). The median duration of treatment was 8 months (5-26 months in the atorvastatin group, 3-17 months in the placebo group) and median follow-up time was also similar between the two groups (17 (IQR 6-28) months for atorvastatin, 14 (IQR 5-36) months for placebo). No significant difference was found in the percentage of patients who developed arthritis (29% in the atorvastatin group vs. 19% in the placebo group) or fulfilled the 2010 ACR/EULAR classification criteria for RA (26% in the atorvastatin vs. 19% in the placebo group). With the limited number of participants, the study was underpowered and formally inconclusive, but the fact that more patients developed RA in the intervention group makes it very unlikely that a true preventive effect exists [68]. Individual perspectives of at-risk individuals on early and preventive treatment Studies on patient preferences with respect to clinical trials have also investigated the likelihood of patients to participate in preventive studies, as well as what requirements are necessary for participation. Patients with a lower risk of developing RA were less inclined to partake in preventive trials than patients with CSA [70]. Moreover, a ≥ 20% decrease of RA risk was associated with increased willingness to undergo treatment when the probability of serious adverse events was ≤ 10% [71]. Similarly, van Boheemen et al. showed that the willingness to use preventive medications increased from 53% to 69% in at-risk individuals when the disease risk increased from 30% to 70% risk [72]. This clearly indicates that patients require a better understanding of their own risk in order to make decisions regarding preventive treatment. Importantly, this requires personalized risk communication that needs to be understandable for the patient, tailored to their social status and education [70,73]. While effectiveness of treatment has a positive impact on patients’ willingness to take medication, perceived risk of side-effects has a negative impact: patients are less likely to participate if the achieved benefit is lower than the perceived expected benefit. Moreover, patients prefer and are more likely to adhere to lifestyle modifications than pharmacological therapies, and have a positive perception of interventions that might lead to substantial decrease or even complete elimination of disease risk. Additionally, treatment needs to be safe and a non-invasive route of administration (i.e. oral tablet taken at home) was usually preferred,
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