Clinical- and Cost-Effectiveness of a Mandibular Advancement Device Versus Continuous Positive Airway Pressure in Moderate Obstructive Sleep Apnea.

STUDY OBJECTIVES: Limited evidence exists on the cost-effectiveness of mandibular advancement device (MAD) compared to continuous positive airway pressure (CPAP) therapy in moderate obstructive sleep apnea (OSA). Therefore, this study compares the clinical and cost-effectiveness of MAD therapy with CPAP therapy in moderate OSA. METHODS: In a multicentre randomized controlled trial, patients with an apnea-hypopnea index (AHI) of 15 to 30 events/h were randomized to either MAD or CPAP. Incremental cost-effectiveness and cost-utility ratios (ICER/ICUR, in terms of AHI reduction and quality-adjusted life-years [QALYs, based on the EuroQol Five-Dimension Quality of Life questionnaire]) were calculated after 12 months, all from a societal perspective. RESULTS: In the 85 randomized patients (n = 42 CPAP, n = 43 MAD), AHI reduction was significantly greater with CPAP (median reduction AHI 18.3 [14.8-22.6] events/h) than with MAD therapy (median reduction AHI 13.5 [8.5-18.4] events/h) after 12 months. Societal costs after 12 months were higher for MAD than for CPAP (mean difference €2.156). MAD was less cost-effective than CPAP after 12 months (ICER -€305 [-€3.003 to €1.572] per AHI point improvement). However, in terms of QALY, MAD performed better than CPAP after 12 months (€33.701 [-€191.106 to €562.271] per QALY gained). CONCLUSIONS: CPAP was more clinically effective (in terms of AHI reduction) and cost-effective than MAD. However, costs per QALY was better with MAD as compared to CPAP. Therefore, CPAP is the first-choice treatment option in moderate OSA and MAD may be a good alternative. CLINICAL TRIAL REGISTRATION: Registry: ClinicalTrials.gov; Identifier: NCT01588275.

Cost Effectiveness of Arthrocentesis Compared to Conservative Therapy for Arthralgia of the Temporomandibular Joint: A Randomized Controlled Trial.

AIMS: To determine the cost effectiveness and cost utility of arthrocentesis as an initial treatment for temporomandibular joint (TMJ) arthralgia compared to usual care. METHODS: A two-armed, parallel-design, randomized controlled trial (RCT) was conducted in the Netherlands from January 2009 to June 2012 that included patients with TMJ arthralgia. Patients were randomly allocated to arthrocentesis (n = 40) or usual care (n = 40) for initial treatment. Arthrocentesis consisted of rinsing the intra-articular space with isotonic saline, and usual care included a soft diet, physical therapy, and splint therapy. The duration of the usual care program was 6 weeks, and follow-up was conducted 3, 12, and 26 weeks after its completion. Generalized estimated equation multivariate models were assessed in order to correct for the dependency of repeated measurements in the longitudinal data analysis. An independent samples t test was used to compare the arthrocentesis group with the usual care group for TMJ pain after 26 weeks. Cost effectiveness (total cost from a societal view) was related to TMJ pain (as measured on a visual analog scale [0 to 100 mm]) and to cost utility (quality-adjusted life years). RESULTS: TMJ pain declined more quickly in the arthrocentesis group (n = 36) than in the usual care group (n = 36) (regression coefficient ß = -10.76; 95% confidence interval [CI] = -17.75 to -3.77; P = .003). The estimated mean total (ie, societal) cost over 26 weeks was €589 (US $795) in the arthrocentesis group and €1,680 (US $2,266) in the usual care group. Arthrocentesis was associated with a lower mean cost and better health outcomes than usual care in 98% and 95% of the bootstrap simulations, respectively. CONCLUSION: The results of this study suggest that, from an economical perspective, arthrocentesis may be superior to usual care for the initial treatment of TMJ pain, as it had better health outcomes and lower costs than usual care.

Repeated assessment of temporomandibular joint pain: reasoned decision-making with use of unidimensional and multidimensional pain scales.

BACKGROUND: There are no reports in the literature about patients with painfully restricted temporomandibular joints concerning the reliability of unidimensional and multidimensional pain scales on the basis of a generalizability and decision study. Generalizability and decision studies are designed to aid in reasoned decision-making and therefore are complementary to classic psychometric analyses, in which correlation coefficients express the reliability of a measurement design. The smallest detectable difference as an outcome of the decision study is the smallest statistically significant change that can be detected. PATIENTS: Twenty-five consecutive patients (5 males and 20 females) with painfully restricted mandibular function participated in the current study. DESIGN: Repeated measurements of three levels of unidimensional experienced pain (average, minimal, and maximal pain before the week of assessment; n = 200) and the multidimensional pain rating index of the MPQ (n = 100) were used. The measurement sessions were supervised by two observers on two separate measurement days, 1 week apart, with each measurement repeated twice. RESULTS: Inconsistency in measurement results analyzed in terms of absolute error variance (i.e., the measurement facets plus all the interactions) represented at least 24% of total variance. The smallest detectable difference of visual analog scales varied from 43 to 15 mm, depending on the amount of repetitions, whereas for the pain rating index it varied from 22.7 to 14.4 units. CONCLUSIONS: For statistically and clinically successful treatment of patients with painfully restricted temporomandibular joints, clinicians must overcome at least the smallest detectable difference and 38% of the initial average pain level.