Strengths and limitations
FMS, MCI, disability
DISABLING DISEASE, FMS
This study is novel in conducting a pragmatic trial-based CUA in the Spanish public healthcare sector on a MCI programme for patients with FMS and achieving the described sample size. Multiple challenges were overcome during this process, including the multicentre strategy throughout the healthcare region, personnel training, patient follow-up monitoring, and the outbreak of COVID-19.Regarding the study design, economic evaluations conducted alongside RCTs are described in the literature as piggyback evaluations (Concerning the cost outcomes used for this study, none of the direct medical cost components could be specifically identified for the diagnosis and attention of FMS, which could have led to an overestimation of the real costs. Nevertheless, given the societal perspective of the study, this obstacle may have been offset by the lack of data about over-the-counter drugs and out-of-pocket health services consumption, especially for rehabilitation and psychological help. Given the non-inclusion of information on non-health costs (such as administrative costs, training, waiting time, and travelling, among others) or care-given costs, the study findings should not be over-interpreted in terms of societal benefits. However, the primary care cost variations included in the SA were weighted according to the regional health expenditure from 2021, including additional operating expenses. Future research must address these estimates in more detail.Performing a SA by excluding individuals with < 66% session attendance pursued implementation assessment purposes. Given the limited resources of the public health system, health programmes may tend to be reduced and simplified to meet other priorities. Even though not all patients would reach this level of participation in the MCI in practice, this methodological decision on the SA only excluded a small portion of the sample (12.4%) and entailed a standard therapeutic adherence expectation.Likewise, the human capital approach may tend to overestimate productivity losses since work replacement is not considered as in another method, such as the friction cost approach. However, this methodological limitation could have been outweighed by the 47% of the sample who were no in employment (pensioners and homemakers) whose loss of contribution to society could not be captured. In addition, productivity losses were only accountable for the registered sick-leave days in the eCAP system, and, unfortunately, no data were available regarding publicly funded disability pension (DP). However, patients with FMS are rarely granted DP in Spain unless diagnosed with another more severe disabling disease.Finally, the study findings are not generalizable beyond the assessed regional population, even though the proposed MCI may serve as an example to adapt the programme to other national or international contexts.