Efetividade e implementação de um programa de autogestão personalizado para prevenir recorrências e incapacidade e promover a saúde músculo-esquelética em utentes com lombalgia

MyBack" project aims to compare the effectiveness of a personalized self-management programme for low back pain recurrences and usual care compared to usual care alone, in patients seeking primary health care, while also seeking to pilot test the acceptability, feasibility and results of an implementation strategy designed to facilitate its adoption across patients and health professionals, through a hybrid type I, randomized, controlled and multicentre study of effectiveness and implementation. Low back pain (LBP) is a long-term health condition with a variable clinical course and multiple interrelated episodes. Most LBP episodes have a favourable prognosis, but recurrence is common with about 33-70% of people experiencing a recurrence within a year, 40% of whom seek health care. The recurrence of an LBP episode is the main occurrence responsible for the demand for health care services, prescription of sickness certificates and limitations in carrying out day-to-day activities, with great impact on the consumption of healthcare resources. Moreover, episodes of recurrence improve the probability of developing persistent and disabling LBP, further contributing to the individual, social and economic impact of this condition. Results of recent systematic reviews show that treatment for an LBP episode is not effective in preventing future recurrences, even when this treatment is planned with the purpose of avoiding new episodes, and therefore specific post-discharge programs need to be designed. The few existing studies on specific programs to prevent recurrence indicate that the combination of education and exercise reduces the risk of a new episode of back pain in the medium (RR= 0.55, 95% CI: 0.41-0.74) and long term (RR= 0.73, 95% CI 0.55-0.96). However, these studies are of poor to moderate methodological quality and their results are imprecise, which generates considerable uncertainty regarding the effect of the interventions and their generalisation. In addition, these studies have not been complemented with comprehensive, prospective assessments of their impact in real practice settings (for example, on primary health care), including their cost-effectiveness, neither have they considered if their implementation is feasible with enough fidelity to preserve their effectiveness. The programme to be tested is a personalized program, adjusted to the biopsychosocial characteristics and physical capacities of the patient, and aims to promote the use of selfmanagement strategies in patients at risk of recurrence of LBP episodes, in order to enable them to manage their symptoms in the long term, prevent functional and occupational disability and reduce the need to seek healthcare due to recurrence of this condition. Hybrid design studies simultaneously evaluate the impact of interventions in real contexts (effectiveness) and the implementation strategy. They enhance the ability to identify important intervention-implementation interactions that inform decisions about optimal implementation and widespread impact and can accelerate the introduction of high-value health innovations, informed by the current scientific evidence, in real practice contexts. In the spectrum of hybrid studies of effectiveness and implementation, designs differ according to the emphasis placed on intervention (effectiveness) or implementation evaluation. This project uses a hybrid type I study, which favours the study of the effectiveness of "MyBack" programme, in the context of primary health care. Through the effectiveness component, this project intend to determine whether or not MyBack programme reduces the frequency and severity of recurrence, the impact on functionality, musculoskeletal health and quality of life, and to investigate its cost-effectiveness from the perspective of the healthcare services, when compared to usual practice. The acceptability, feasibility and results of the implementation strategy designed to facilitate the adoption, implementation and future sustainability of the programme will be assessed through mixed methods. The project is designed for a 3-year time period and is aligned with the sustainable development goals, in particular with the objective of strengthening the capacity of all countries for early warning, risk reduction and management national and global health risk. The design of this study was informed by the recent studies developed by the research team, namely, the study regarding the implementation of a stratified model of treatment for patients with low back pain who seek primary health care (SPLIT Project) and a large observational population-based cohort study (EpiReuma.pt). These studies demonstrate that the planned and implemented methods of identification, evaluation and recruitment of participants have been successful and that the implementation of high-value innovative practices is possible and sustainable in the context of primary health care.