Characterizing Decisional Conflict in Patients Presenting to Sleep Surgery Clinic and an Exploration of Resource Limitations.

OBJECTIVES: Numerous therapies exist for adult obstructive sleep apnea (OSA), creating potential for patient decisional conflict (DC) that impacts treatment adherence and post-treatment regret. We evaluated the prevalence of elevated DC in OSA patients presenting for positive airway pressure (PAP) alternative therapies and identified gaps in available resources about OSA therapies. STUDY DESIGN: Cross-sectional study. METHODS: A cross-sectional study was performed based on questionnaires completed by adult OSA patients presenting to an academic sleep surgery clinic from March to October 2020. Surveys examined sleep symptoms, sleep apnea treatment history, goals of therapy, and the SURE checklist, a validated 4-item DC screening scale. Additional qualitative data about OSA decision tool needs were queried with structured interviews in a smaller subset of patients. RESULTS: Among 100 respondents, 60 were open to multiple treatment options, whereas 22 were not interested in surgical treatment. Eighty-one respondents (81%) had elevated DC (SURE score < 4). High DC was not associated with CPAP history, OSA severity, or daytime sleepiness (Epworth Sleepiness Scale score ≥ 10). Elevated DC was related to uncertainty regarding optimal treatment choice in 54% of respondents (n = 54), and lack of knowledge regarding risks and benefits of each treatment option in 71% (n = 71). Common themes identified in 9 interviewed patients suggested helpful resources should ideally compare treatment modalities and educate on surgery details, efficacy, and recovery. CONCLUSIONS: The majority of OSA patients presenting to sleep surgery clinics have elevated decisional conflict influenced by limited knowledge about options and the risks and benefits of each therapy. There is a need for decision tools that can reduce decisional conflict and promote equitable knowledge about PAP alternative OSA treatments. LEVEL OF EVIDENCE: 4 Laryngoscope, 131:2384-2390, 2021.

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.

Exploring policy driven systemic inequities leading to differential access to care among Indigenous populations with obstructive sleep apnea in Canada.

BACKGROUND: In settler societies such as Australia, Canada, New Zealand and the United States, health inequities drive lower health status and poorer health outcomes in Indigenous populations. This research unravels the dense complexity of how historical policy decisions in Canada can influence inequities in health care access in the 21(st) century through a case study on the diagnosis and treatment of obstructive sleep apnea (OSA). In Canada, historically rooted policy regimes determine current discrepancies in health care policy, and in turn, shape current health insurance coverage and physician decisions in terms of diagnosis and treatment of OSA, a clinical condition that is associated with considerable morbidity in Canada. METHODS: This qualitative study was based in Saskatchewan, a Western Canadian province which has proportionately one of the largest provincial populations of an Indigenous subpopulation (status Indians) which is the focus of this study. The study began with determining approaches to OSA care provision based on Canadian Thoracic Society guidelines for referral, diagnosis and treatment of sleep disordered breathing. Thereafter, health policy determining health benefits coverage and program differences between status Indians and other Canadians were ascertained. Finally, respirologists who specialized in sleep medicine were interviewed. All interviews were audio-recorded and the transcripts were thematically analyzed using NVIVO. RESULTS: In terms of access and provision of OSA care, different patient pathways emerged for status Indians in comparison with other Canadians. Using Saskatchewan as a case study, the preliminary evidence suggests that status Indians face significant barriers in accessing diagnostic and treatment services for OSA in a timely manner. CONCLUSIONS: In order to confirm initial findings, further investigations are required in other Canadian jurisdictions. Moreover, as other clinical conditions could share similar features of health care access and provision of health benefits coverage, this policy analysis could be replicated in other provincial and territorial health care systems across Canada, and other settler nations where there are differential health coverage arrangements for Indigenous peoples.

Management of obstructive sleep apnea in the indigent population: a deviation of standard of care?

Comprehensive management of patients with obstructive sleep apnea (OSA) typically is managed best via a multidisciplinary approach, involving otolaryngologists, sleep psychologists/psychiatrists, pulmonologists, neurologists, oral surgeons, and sleep trained dentists. By utilizing these resources, one could fashion a treatment individualized to the patient, giving rise to the holistic phrase of "personalized medicine." Unfortunately, in situations and environments with limited resources, the treatment options in an otolaryngologist's armamentarium are restricted--typically to continuous positive airway pressure (CPAP) versus sleep surgery. However, a recent patient encounter highlighted here shows how a hospital's reimbursement policy effectively dictated a patient's medical management to sleep surgery. This occurred although the current gold standard for the initial treatment of OSA is CPAP. Changing the course of medical/surgical management by selectively restricting funding is a cause of concern, especially when it promotes patients to choose a treatment option that is not considered the current standard of care.

Medicare long-term CPAP coverage policy: a cost-utility analysis.

STUDY OBJECTIVES: CPAP is an effective treatment for OSA that may reduce health care utilization and costs. Medicare currently reimburses the costs of long-term CPAP therapy only if the patient is adherent during a 90-day trial. If not, Medicare requires a repeat polysomnogram (PSG) and another trial which seems empirically not cost-effective. We modeled the cost-effectiveness of current Medicare policy compared to an alternative policy (clinic-only) without the adherence criterion and repeat PSG. DESIGN: Cost-utility and cost-effectiveness analysis. SETTING: U.S. Medicare Population. PATIENTS OR PARTICIPANTS: N/A. INTERVENTIONS: N/A. MEASUREMENTS AND RESULTS: We created a decision tree modeling (1) clinic only follow-up vs. (2) current Medicare policy. Costs were assigned based on Medicare reimbursement rates in 2012. Sensitivity analyses were conducted to test our assumptions. We estimated cumulative costs, overall adherence, and QALY gained for a 5-year time horizon from the perspective of Medicare as the payer. Current Medicare policy is more costly than the clinic-only policy but has higher net adherence and improved utility. Current Medicare policy compared to clinic-only policy costs $30,544 more per QALY. CONCLUSIONS: Current CMS policy promotes early identification of those more likely to adhere to CPAP therapy by requiring strict adherence standards. The policy effect is to deny coverage to those unlikely to use CPAP long-term and prevent wasted resources. Future studies are needed to measure long-term adherence in an elderly population with and without current adherence requirements to verify the cost-effectiveness of a policy change.

An integrated health-economic analysis of diagnostic and therapeutic strategies in the treatment of moderate-to-severe obstructive sleep apnea.

STUDY OBJECTIVES: Obstructive sleep apnea (OSA) is a common disorder associated with substantially increased cardiovascular risks, reduced quality of life, and increased risk of motor vehicle collisions due to daytime sleepiness. This study evaluates the cost-effectiveness of three commonly used diagnostic strategies (full-night polysomnography, split-night polysomnography, unattended portable home-monitoring) in conjunction with continuous positive airway pressure (CPAP) therapy in patients with moderate-to-severe OSA. DESIGN: A Markov model was created to compare costs and effectiveness of different diagnostic and therapeutic strategies over a 10-year interval and the expected lifetime of the patient. The primary measure of cost-effectiveness was incremental cost per quality-adjusted life year (QALY) gained. PATIENTS OR PARTICIPANTS: Baseline computations were performed for a hypothetical average cohort of 50-year-old males with a 50% pretest probability of having moderate-to-severe OSA (apnea-hypopnea index [AHI] ≥ 15 events per hour). MEASUREMENTS AND RESULTS: For a patient with moderate-to-severe OSA, CPAP therapy has an incremental cost-effectiveness ratio (ICER) of $15,915 per QALY gained for the lifetime horizon. Over the lifetime horizon in a population with 50% prevalence of OSA, full-night polysomnography in conjunction with CPAP therapy is the most economically efficient strategy at any willingness-to-pay greater than $17,131 per-QALY gained because it dominates all other strategies in comparative analysis. CONCLUSIONS: Full-night polysomnography (PSG) is cost-effective and is the preferred diagnostic strategy for adults suspected to have moderate-to-severe OSA when all diagnostic options are available. Split-night PSG and unattended home monitoring can be considered cost-effective alternatives when full-night PSG is not available.

Low socioeconomic status is a risk factor for CPAP acceptance among adult OSAS patients requiring treatment.

STUDY OBJECTIVE: To evaluate whether socioeconomic status (SES) has a role in obstructive sleep apnea syndrome (OSAS) patients' decision to accept continuous positive airway pressure (CPAP) treatment. DESIGN: Cross-sectional study; patients were recruited between March 2007 and December 2007. SETTING: University-affiliated sleep laboratory. PATIENTS: 162 consecutive newly diagnosed (polysomnographically) adult OSAS patients who required CPAP underwent attendant titration and a 2-week adaptation period. RESULTS: 40% (n = 65) of patients who required CPAP therapy accepted this treatment. Patients accepting CPAP were older, had higher apnea-hypopnea index (AHI) and higher income level, and were more likely to sleep in a separate room than patients declining CPAP treatment. More patients who accepted treatment also reported receiving positive information about CPAP treatment from family or friends. Multiple logistic regression (after adjusting for age, body mass index, Epworth Sleepiness Scale, and AHI) revealed that CPAP purchase is determined by: each increased income level category (OR, 95% CI) (2.4; 1.2-4.6), age + 1 year (1.07; 1.01-1.1), AHI ( > or = 35 vs. < 35 events/hr) (4.2, 1.4-12.0), family and/or friends with positive experience of CPAP (2.9, 1.1-7.5), and partner sleeps separately (4.3, 1.4-13.3). CONCLUSIONS: In addition to the already known determinants of CPAP acceptance, patients with low SES are less receptive to CPAP treatment than groups with higher SES. CPAP support and patient education programs should be better tailored for low SES people in order to increase patient treatment initiation and adherence.

Continuous positive airway pressure devices for the treatment of obstructive sleep apnoea-hypopnoea syndrome: a systematic review and economic analysis.

OBJECTIVES: To determine the clinical effectiveness, safety and cost-effectiveness of continuous positive airway pressure (CPAP) devices for the treatment of obstructive apnoea-hypopnoea syndrome (OSAHS), compared with the best supportive care, placebo and dental devices. DATA SOURCES: The main search was of fifteen electronic databases, including MEDLINE, EMBASE and the Cochrane Library, up to November 2006. REVIEW METHODS: Randomised controlled trials (RCTs) comparing CPAP with best supportive/usual care, placebo, and dental devices in adults with a diagnosis of OSAHS were included. The primary outcomes of interest were subjective daytime sleepiness assessed by the Epworth Sleepiness Scale (ESS) and objective sleepiness assessed by the Maintenance of Wakefulness Test (MWT) and the Multiple Sleep Latency Test (MSLT). A new economic model was developed to assess incremental cost per quality-adjusted life-year (QALY). The cost-effectiveness of CPAP was compared with that of the use of dental devices and conservative management. The costs and QALYs were compared over a lifetime time horizon. Effectiveness was based on the RCT evidence on sleepiness symptoms (ESS), which was 'mapped' to utilities using individual patient data from a subset of studies. Utilities were expressed on the basis of generic HRQoL instruments [the EQ-5D (EuroQoL-5 Dimensions) in the base-case analysis]. The base-case analysis focused on a male aged 50. A series of subgroup and scenario analyses were also undertaken. RESULTS: The searches yielded 6325 citations, from which 48 relevant clinical effectiveness studies were identified, 29 of these providing data on daytime sleepiness. The majority of the included RCTs did not report using an adequate method of allocation concealment or use an intention-to-treat analysis. Only the studies using a sham CPAP comparator were double blinded. There was a statistically significant benefit with CPAP compared with control (placebo and conservative treatment/usual care) on the ESS [mean difference (MD) -2.7 points, 95% CI -3.45 to -1.96]. However, there was statistical heterogeneity, which was reduced when trials were subgrouped by severity of disease. There was also a significant benefit with CPAP compared with usual care on the MWT. There was a non-statistically significant difference between CPAP and dental devices (six trials) in the impact on daytime sleepiness (ESS) among a population with moderate symptom severity at baseline (MD -0.9, 95% CI -2.1 to 0.4). A review of five studies evaluating the cost-effectiveness of CPAP was undertaken. All existing cost-effectiveness studies had limitations; therefore a new economic model was developed, based on which it was found that, on average, CPAP was associated with higher costs and benefits than dental devices or conservative management. The incremental cost per QALY gained of CPAP was below 20,000 pounds in the base-case analysis and most alternative scenarios. There was a high probability of CPAP being more cost-effective than dental devices and conservative management for a cost-effectiveness threshold of 20,000 pounds per QALY gained. CONCLUSIONS: CPAP is an effective and cost-effective treatment for OSAHS compared with conservative/usual care and placebo in populations with moderate to severe daytime sleepiness, and there may be benefits when the disease is mild. Dental devices may be a treatment option in moderate disease but some uncertainty remains. Further research would be potentially valuable, particularly investigation of the effectiveness of CPAP for populations with mild sleepiness and further trials comparing CPAP with dental devices.

Estimating the marginal value of 'better' research output: 'designed' versus 'routine' data in randomised controlled trials.

We recently completed a study which demonstrated that the costs of health technology assessment (HTA) by randomised controlled trial (RCT) can be reduced by substituting routine datasets for data designed and collected specifically for a trial. This cost reduction, however, had the effect of reducing the quality of the research output. In the present study we attempted to tease out the values attached to the 'better' information provided by designed data RCTs using a mock grants committee. Two valuation techniques, implied values and willingness to pay, were used. Ex ante valuations were determined by comparing alternative research proposals - a more costly version using designed data and a cheaper version using routine data. Ex post valuations were determined by comparing results of both versions. The exercise was performed on four exemplar studies. Overall, the committee expressed a general lack of trust towards routine data both ex ante and ex post and placed high values on the better information from the designed data studies - particularly information on preferences. This suggests that currently available routine datasets are not perceived to be able to provide efficient alternatives to designed data for RCTs.