BACKGROUND: Since 2011, a tailored, interdisciplinary head and neck rehabilitation (IHNR) program, covered by the basic healthcare insurance, is offered to advanced head and neck cancer (HNC) patients in the Netherlands Cancer Institute (NKI). This program is developed to preserve or restore patients' functioning, and to optimize health-related quality of life (HRQoL). It applies an integrated approach to define patients' individual goals and provide rehabilitation care throughout the cancer care continuum. The aim of the current study is to assess the (cost-) effectiveness of the IHNR approach compared to usual supportive care (USC) consisting of monodisciplinary and multidisciplinary care in advanced HNC patients.METHODS: This multicenter prospective observational study is designed to compare (cost-)effectiveness of the IHNR to USC for advanced HNC patients treated with chemoradiotherapy (CRT) or bioradiotherapy (BRT). The primary outcome is HRQoL represented in the EORTC QLQ-C30 summary score. Functional HRQoL, societal participation, utility values, return to work (RTW), unmet needs (UN), patient satisfaction and clinical outcomes are secondary outcomes, assessed using the EORTC QLQ-H&N35, USER-P, EQ-5D-5 L, and study-specific questionnaires, respectively. Both patient groups (required sample size: 64 per arm) are requested to complete the questionnaires at: diagnosis (baseline; T0), 3 months (T1), 6 months (T2), 9 months (T3) and 12 months (T4) after start of medical treatment. Differences in outcomes between the intervention and control group will be analyzed using mixed effects models, Chi-square test and descriptive statistics. In addition, a cost-effectiveness analysis (CEA) will be performed by means of a Markov decision model. The CEA will be performed using a societal perspective of the Netherlands.DISCUSSION: This prospective multicenter study will provide evidence on the effectiveness and cost-effectiveness of IHNR compared to USC. RTW and societal participation, included as secondary outcomes, have not been studied sufficiently yet in cancer rehabilitation. Interdisciplinary rehabilitation has not yet been implemented as usual care in all centers, which offers the opportunity to perform a controlled clinical study. If demonstrated to be (cost-)effective, national provision of the program can probably be advised.TRIAL REGISTRATION: The study has been retrospectively registered in the Netherlands Trial Registry on April 24th 2018 ( NTR7140 ).
Background: In patients with burns, an early accurate diagnosis of burn depth facilitates optimal treatment. Laser Doppler imaging combined with clinical assessment leads to an accurate estimate of burn depth. However, the actual effects of the introduction of laser Doppler imaging on therapeutic decisions, clinical outcomes, and costs are unknown. Methods: A randomized controlled trial was conducted in the Dutch burn centers, including 202 patients with burns of indeterminate depth. In the standard care group, estimation of burn depth was based on clinical assessment only; in the laser Doppler imaging group, clinical assessment and laser Doppler imaging were combined. Primary outcome was time to wound healing. Furthermore, therapeutic decisions and cost-effectiveness were analyzed. Results: Mean time to wound healing was 14.3 days (95 percent CI, 12.8 to 15.9 days) in the laser Doppler imaging group and 15.5 days (95 percent CI, 13.9 to 17.2 days) in the standard care group (p = 0.258). On the day of randomization, clinicians decided significantly more often on operative or nonoperative treatment in the laser Doppler imaging group (p < 0.001), instead of postponing their treatment choice. Analyses in a subgroup of admitted patients requiring surgery showed a significant earlier decision for surgery and a shorter wound healing time in the laser Doppler imaging group. Mean total costs per patient were comparable in both groups. Conclusions: Laser Doppler imaging improved therapeutic decisions. It resulted in a shorter wound healing time in the subgroup of admitted patients requiring surgery and has the potential for cost savings of €875 per scanned patient.
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.
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