ObjectiveTo compare cost effectiveness of endovascular revascularisation (ER) and supervised exercise therapy (SET) as primary treatment for patients with intermittent claudication (IC) due to iliac artery obstruction.MethodsCost utility analysis from a restricted societal perspective and time horizon of 12 months. Patients were included in a multicentre randomised controlled trial (SUPER study, NCT01385774, NTR2648) which compared effectiveness of ER and SET. Health status and health related quality of life (HRQOL) were measured using the Euroqol 5 dimensions 3 levels (EQ5D-3L) and VascuQol-25-NL. Incremental costs were determined per allocated treatment and use of healthcare during follow up. Effectiveness of treatment was determined in quality adjusted life years (QALYs). The difference between treatment groups was calculated by an incremental cost utility ratio (ICER).ResultsSome 240 patients were included, and complete follow up was available for 206 patients (ER 111 , SET 95). The mean costs for patients allocated to ER were €4 031 and €2 179 for SET, a mean difference of €1 852 (95% bias corrected and accelerated [bca] bootstrap confidence interval 1 185 – 2 646). The difference in QALYs during follow up was 0.09 (95% bcaCI 0.04 – 0.13) in favour of ER. The ICER per QALY was €20 805 (95% bcaCI 11 053 – 45 561). The difference in VascuQol sumscore was 0.64 (95% bcaCI 0.39 – 0.91), again in favour of ER.ConclusionER as a primary treatment, results in slightly better health outcome and higher QALYs and HRQOL during 12 months of follow up. Although these differences are statistically significant, clinical relevance must be discussed due to the small differences and relatively high cost of ER as primary treatment.
MULTIFILE
BackgroundSubstance use disorders (SUDs) are prevalent in the general population, tend to follow a chronic course, are associated with many individual and social problems, and often have their onset in adolescence. However, the knowledge base from prospective population surveys and treatment-outcome studies on the course of SUD in adolescents is limited at best. The present study aims to fill this gap and focuses on a subgroup that is particularly at risk for chronicity: adolescents in addiction treatment. We will investigate the rate of persistent SUD and its predictors longitudinally from adolescence to young adulthood among youth with DSM-5 SUD from the start of their addiction treatment to 2 and 4 years following treatment-entry. In addition to SUD, we will investigate the course of comorbid mental disorders, social functioning, and quality of life and their association with SUD over time.Methods/designIn a naturalistic, multi-center prospective cohort design, we will include youths (n = 420), who consecutively enter addiction treatment at ten participating organizations in the Netherlands. Inclusion is prestratified by treatment organization, to ensure a nationally representative sample. Eligible youths are 16 to 22 years old and seek help for a primary DSM-5 cannabis, alcohol, cocaine or amphetamine use disorder. Assessments focus on lifetime and current substance use and SUD, non-SUD mental disorders, family history, life events, social functioning, treatment history, quality of life, chronic stress indicators (hair cortisol) and neuropsychological tests (computerized executive function tasks) and are conducted at baseline, end of treatment, and 2 and 4 years post-baseline. Baseline data and treatment data (type, intensity, duration) will be used to predict outcome – persistence of or desistance from SUD.DiscussionThere are remarkably few prospective studies worldwide that investigated the course of SUD in adolescents in addiction treatment for longer than 1 year. We are confident that the Youth in Transition study will further our understanding of determinants and consequences of persistent SUD among high-risk adolescents during the critical transition from adolescence to young adulthood.Trial registrationThe Netherlands National Trial Register Trial NL7928. Date of registration January 17, 2019.
Migraine, tension-type headache (TTH) and headaches attributed to temporomandibular disorders (TMD) are prevalent in patients with TMD-pain. The objective was to describe the course of headache complaints as compared to the course of TMD complaints in TMD-pain patients with headache during usual care multidisciplinary treatment for TMD. This was a 12-week longitudinal observational study following adults with TMD-pain and headache during a usual-care multidisciplinary TMD-treatment. The Graded Chronic Pain Scale was used for both TMD and headache to measure pain-related disability (primary outcome measure), pain intensity, days with pain and days experiencing disability (secondary outcome measures). Stratified for the headache type, general linear modelling for repeated measures was used to analyze changes over time in the TMD complaints and the headache complaints. TMD-pain patients with migraine (n = 22) showed significant decrease of pain-related disability for both TMD and headache complaints over time. No difference in the effect over time was found between the two complaints. Patients with TMD-pain and TTH (n = 21) or headache attributed to TMD (n = 17) did not improve in disability over time. For the secondary outcome measures, the results were equivocal. In conclusion, TMD-pain patients with migraine, improvement in TMD-related disability was comparable to headache-related disability for TMD-pain patients with TTH or with headache attributed to TMD, no improvements in disability were found.
