Methods
bleeding, occlusive arteriopathies, lower limb soft-tissue injury, allergy, tibial fractures, traumatic, neurovascular injury, neurological and psychiatric disorders, purulent, fractures, pain, necrosis, photosensitivity, Trauma, injuries, trauma
SYSTEMIC DISEASE, BLEEDING, DEGENERATION, ADVERSE EVENTS, ALLERGY, COMPLICATION, SECONDARY, NECROSIS, PHOTOSENSITIVITY, JENSEN
This economic evaluation was made from the point of view of the Brazilian public health system. All costs are expressed in reais for the financial year 2022. A comprehensive economic perspective would be desirable. However, due to photonic therapies’ emerging and recent characteristics, we have not yet found many controlled clinical studies of applying the technique in tibial fractures. Therefore, it was decided to perform the economic analysis based on a randomized controlled clinical trial in a single centre and simulate the cost-effectiveness and incremental cost model. The clinical results of this study have already been published [The clinical study enrolled 27 adult patients, aged 18 to 72 years, who were admitted to the hospital with tibial fractures and were waiting to resolve soft tissue injuries before undergoing definitive surgery. They received multidisciplinary care following the standard protocol based on Advanced Trauma Life Support criteria [The participants were randomly assigned to either the PBM group (n = 13; using a 144 LED emitting diode device with wavelengths of 420nm, 660nm, and 850nm, 3J per point, for 10 minutes) or the simulated photon therapy (Control) group (n = 14; using a device with identical external features but without light transmission). The research was carried out at the Conjunto Hospitalar do Mandaqui (CHM) in São Paulo, Brazil, following the Declaration of Helsinki and approved by the Research Ethics Committee (3.946.372/CHM).The inclusion criteria for the participant’s selection involved adult individuals (over 18 years), hospitalized due to a traumatic lower limb soft-tissue injury, unfeasible for primary closure or definitive treatment of initial care injuries associated with a tibial and/or ankle fractures. Individuals who presented or reported: chronic systemic diseases, allergy to cefazolin and gentamicin, uncontrollable active bleeding, occlusive arteriopathies, neurovascular injury with a sensory deficit at the injury site, previous surgeries on the affected limb, local or systemic changes that contraindicate surgical intervention, smoking, photosensitivity history, neurological and psychiatric disorders, use of anti-inflammatory drugs in the last 15 days before the trauma, and pregnant women were excluded. In addition, during treatment, individuals who presented any complication (bleeding, operative difficulty, neurovascular injury not diagnosed at admission, among others) at any stage of treatment were not considered or withdrawn from the study. Data from these participants would not be included in the statistical analysis but would be described and discussed as possible adverse events [The assessments of the target outcomes were conducted by the field team in charge of the daily medical check-up (blinded to the group to which the participant was assigned), both before and daily throughout the intervention period until the wounds were determined to be resolved, i.e., with healthy granulation tissue present, free from necrosis or purulent discharge, and therefore suitable for primary closure, closure using a flap or graft, or for choosing secondary intention healing which marked the end of the protocol [The clinical outcomes of this randomized trial have shown the effect and safety of multiwavelength photobiomodulation in patients with soft tissue injuries associated with lower limb fractures, reducing the hospital stay [To simulate the model of cost-effectiveness and incremental cost, the outcome was the evolution of wound resolution by the BATES-JENSEN scale and time of wound resolution in days. The Bates Jensen Wound Assessment Tool (BATES-JENSEN scale) was applied to all participants at the time of enrollment in the study and the days until they were ready for definitive surgery. The scale ranges from 9 to 65 points, with 9 points corresponding to the healed wound, 13 to the regenerating wound and scores above 60 points corresponding to tissue degeneration [This study estimated direct medical costs, non-medical direct costs, and lost productivity.The values were raised from the perspective of the Unified Health System (SUS) as a buyer of the service. For this purpose, the direct costs of the procedures performed during the research period were considered. The values of the materials used, professional fees, hospital costs and costs with the loss of productivity during the absence from work were computed. The reference sources of costs in Brazilian currency (Real) were the databases ComprasNet (Brazil’s government procurement system), SIGTAP (Table of Procedures of the Unified Health System of Brazil), and the Brazilian Ministry of Health Price Database. The estimated value of the photon therapy device was R$800.00.As this is the first clinical trial conducted with photobiomodulation in this clinical condition, we do not have the cost of the procedure in the Brazilian healthcare system’s table. Therefore, to adhere to the methodology of health economic analysis, since the only modification between the PBM group and sham was the application of light, we considered the cost of the intervention as the cost of the equipment. The equipment costs were added to the costs of the experimental group. Since the only modification between the PBM and sham groups was the application of light [The means of the variables of pain evaluation, BATES-JENSEN scale, and wound area were compared between the two groups by analysis of variance (ANOVA), adjusted by the baseline data and possible confounding variables. The cost and effect analysis approach was conducted by examining the ratio of cost differences and differences in intervention effects. Following the formula Cost (treatment 2)—Cost (treatment 1) / Effectiveness (treatment 2)—Effectiveness (treatment 1) [