The new local coverage determination criteria for adherence to positive airway pressure treatment: testing the limits?
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ABSTRACT: Background
To our knowledge, the new local coverage determination (LCD) adherence criteria for continued reimbursement of continuous positive airway pressure after 90 days has heretofore not been validated, including the effects of the policy on care for patients with obstructive sleep apnea.Methods
We examined a retrospective database of 150 patients who received neuropsychologic testing prior to treatment and 3 and 6 months post treatment. We categorized participants using the new LCD criteria. Comparisons of neuropsychologic variables were made between adherent and nonadherent groups.Results
Fifty-five participants (37%) failed to meet the new criteria, although this number may not reflect the actual rates of adherence in clinical settings because some efforts beyond standard care were made to ensure adherence to treatment among many of the participants. Of the 50 patients who did not receive any special adherence intervention, only 28 (56%) met the criteria. On most measures, patients with poor adherence demonstrated neuropsychologic improvements similar to their adherent counterparts. Nonadherent patients realized additional improvements in working memory between 3 and 6 months post treatment.Conclusions
This study highlights the potential effects of the new criteria for adherence on patients with obstructive sleep apnea and their clinical care. These data were taken from a study that was not designed to examine these criteria, so controlled trials are needed to better understand the effect of the guidelines on adherence and treatment outcomes.Trial registration
clinicaltrials.gov; Identifier: NCT00939601.
SUBMITTER: Aloia MS
PROVIDER: S-EPMC2951756 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Study objectivesAdherence to positive airway pressure (PAP) therapy for obstructive sleep apnea (OSA) remains a challenge in children. We hypothesized that the presence of another family member on PAP therapy (parent, sibling, other family member) would be associated with better adherence in the child.MethodsWe conducted a retrospective chart review to identify children < 18 years of age who had a new diagnosis of OSA between Jan 2011 and May 2013. Outcomes were objective PAP adherence at 1 week, 1 month, and 3 months. Potential predictors included family member on PAP therapy, patient demographics, and clinical characteristics. Group differences between children with and without a family member on PAP therapy were determined using χ(2) test and Wilcoxon two-sample test. PAP adherence measures at each time point and patterns of change across time between the two groups were examined using mixed-effects models.ResultsThe final analytic sample included 56 children: age 13.2 ± 3.7 years, 60% male, 67% African American, 65% obese, and 32% with developmental disabilities. The mean obstructive apnea-hypopnea index was 25.2 ± 28.7, and 19 (33%) had a family member on PAP therapy. Overall PAP adherence was 2.8 ± 2.4 h/night at 3 months. At month 3, the group with a family member on PAP therapy had significantly greater average nightly PAP use on all nights (3.6 ± 0.6 vs. 2.3 ± 0.39) and on nights used (4.8 ± 0.6 vs. 3.8 ± 0.40); (p value = 0.04).ConclusionsOverall PAP adherence was low, but having a family member on PAP therapy as a "role model" was associated with better adherence.CommentaryA commentary on this article appears in this issue on page 941.
| S-EPMC4918996 | biostudies-literature
Project description:STUDY OBJECTIVES:Centers for Medicare and Medicaid Services (CMS) reimbursement for positive airway pressure (PAP) devices for obstructive sleep apnea treatment is dependent on patients meeting adherence expectations within the first 3 months on therapy. Adherence is defined as usage of the device for at least 4 hours per night on 70% of nights during a consecutive 30-day period. We hypothesize that the adherence pattern may be established beyond this initial period, which may limit the opportunity to treat many patients. METHODS:Treatment and adherence data from PAP devices were monitored via wireless modems for 42 consecutive PAP-naïve military veterans who completed 1 year of nightly monitoring. Their baseline characteristics were as follows: age (mean ± standard deviation) 58.5 ± 12.5 years; body mass index 33.7 ± 5.7 kg/m2; diagnostic apnea-hypopnea index (pretreatment) 28.1 ± 18.5 events/h; apnea-hypopnea index on PAP: 4.3 ± 3.3 events/h. We examined daily, monthly, quarterly, semiannual, and annual reports, and the best 30-day adherence report for each quarter. RESULTS:In the first 3 months, 19 of 42 participants were adherent by CMS criteria, and 23 of 42 participants were not. Of the 19 adherent participants, 13 remained adherent and 6 became nonadherent or stopped PAP treatment for the remainder of the year. In the 23 initially nonadherent participants, 16 stopped PAP treatment, and 7 participants (30.4%) became adherent (using CMS criteria) during the rest of the year. Thus, PAP adherence during the first 3 months was predictive for the rest of the year in only 68.4%. PAP nonadherence during the first 3 months was predictive for further nonadherence in only 69.6% of the cases. Overall, this led to a 65% sensitivity and 72% specificity of using adherence at 3 months in predicting adherence at 1 year. CONCLUSIONS:CMS adherence criteria affecting PAP coverage are restrictive and can result in the withholding of therapy in many patients who otherwise might become adherent. CLINICAL TRIAL REGISTRATION:Registry: ClinicalTrials.gov, Title: Remote Monitoring in Obstructive Sleep Apnea, Identifier: NCT01678560, URL: https:// clinicaltrials.gov/ct2/show/NCT01678560.
| S-EPMC6374085 | biostudies-literature
Project description:Background and Purpose- Continuous positive airway pressure (CPAP) for the treatment of obstructive sleep apnea may improve stroke recovery, but adherence is poor. We assessed the effectiveness of an intensive CPAP adherence program during and after inpatient stroke rehabilitation on 3-month adherence and stroke recovery. Methods- In a single-arm study, 90 stroke rehabilitation patients were enrolled into an intensive CPAP adherence program. CPAP was continued after a run-in among qualifying patients with evidence of obstructive sleep apnea. The primary outcome was CPAP adherence, defined as ≥4 hours of use on ≥70% of days, over 3 months. Results- A total of 62 patients qualified for continued CPAP and 52 of these were willing to continue CPAP after discharge from rehabilitation. At 3 months, the average daily CPAP use was 4.7 hours (SD 2.6), and 32/52 (62%) patients were adherent. Factors significantly associated with adherence included more severe stroke, aphasia, and white race. Compared with nonadherent patients, adherent patients experienced greater improvements in the cognitive component of the Functional Independence Measure ( P=0.02) and in the National Institutes of Health Stroke Scale ( P=0.03). Conclusions- This intensive CPAP adherence program initiated during stroke rehabilitation can lead to CPAP adherence in the majority of patients with evidence of obstructive sleep apnea, including those with more severe stroke and aphasia, and may promote recovery. Clinical Trial Registration- URL: https://www.clinicaltrials.gov . Unique identifier: NCT02809430.
| S-EPMC9367631 | biostudies-literature
Project description: Not available
| S-EPMC5822419 | biostudies-literature
Project description:Study objectivesDecreased early positive airway pressure (PAP) adherence is predictive of poor long-term adherence. We hypothesized that cloud-based sleep coaches (CBSC) providing protocol-driven live telephone contact with patients starting treatment would improve early adherence.MethodsAt PAP set-up patients were randomized to: (1) standard care (SC) including respiratory therapist PAP setup, wireless adherence monitoring, and elective use of a mobile adherence feedback application (PAPapp); or (2) SC+CBSC. Primary 3-month endpoints were adherence (all nights, nights used, % of nights ≥ 4 hours use, and % participants with ≥ 4 hours use on ≥ 70% of nights [% ≥ 4 ≥ 70%]) and secondary endpoints were change in Epworth sleepiness scale (ESS) and satisfaction with treatment and PAPapp use.ResultsTwo hundred fifty participants were randomized (SC 126, SC+CBSC 124). Characteristics SC versus SC+CBSC (mean ± SD) for age (55.2 ± 13.4 versus 54.9 ± 11.5 years), diagnostic apnea-hypopnea index (36.7 ± 21.1 versus 36.6 ± 20.6 events/h), and ESS (10.8 ± 6.1 versus 11.2 ± 6.0) did not differ. At 3 months, the % of days with ≥ 4 hours of PAP use (SC: 48.1 ± 36.8% versus SC+CBSC: 57.9 ± 35.4%, P = 0.032), use all nights (SC:3.7 ± 2.7 hours versus SC + CBSC: 4.4 ± 2.6 hours, P=0.027), and PAPapp use satisfaction were greater with SC+CBSC (intention to treat analysis). The [% ≥ 4 ≥ 70%] did not differ between groups in the intention to treat analysis but was higher in those completing CBSC interventions. The ESS improvement and patient satisfaction did not differ between groups.ConclusionsThe CBSC system improved PAP adherence at 3 months.Clinical trial registrationRegistry: ClinicalTrials.gov; Title: ThErapy Adherence Management in Veterans; Identifier: NCT03243487; URL: https://clinicaltrials.gov/ct2/show/NCT03243487.
| S-EPMC7161456 | biostudies-literature
Project description:Study objectivesChildren with obstructive sleep apnea are increasingly being treated with positive airway pressure (PAP), particularly if they have underlying medical conditions. Although PAP is an effective treatment, its use is challenging due to poor adherence. We hypothesized that demographic, psychosocial, and polysomnographic parameters would be related to PAP adherence. We therefore prospectively collected data potentially pertaining to PAP adherence, and correlated it with PAP use.MethodsFifty-six patients and their parents completed a series of psychosocial questionnaires prior to PAP initiation. Objective adherence data were obtained after 1 and 3 months of PAP use.ResultsThe population was primarily obese; 23% had neurodevelopmental disabilities. PAP adherence varied widely, with PAP being worn 22 ± 8 nights in month-1, but mean use was only 3 ± 3 h/night. The greatest predictor of use was maternal education (p = 0.002 for nights used; p = 0.033 for mean h used/night). Adherence was lower in African American children vs other races (p = 0.021). In the typically developing subgroup, adherence correlated inversely with age. Adherence did not correlate with severity of apnea, pressure levels, or psychosocial parameters other than a correlation between family social support and nights of PAP use in month-3.ConclusionsPAP adherence in children and adolescents is related primarily to family and demographic factors rather than severity of apnea or measures of psychosocial functioning. Further research is needed to determine the relative contributions of maternal education, socioeconomic status and cultural beliefs to PAP adherence in children, in order to develop better adherence programs.
| S-EPMC3365086 | biostudies-literature
Project description:BackgroundPositive airway pressure (PAP) has become a prominent treatment for children with sleep-disordered breathing. However, there are no large-scale studies to clarify whether PAP is well tolerated in children, and which factors are associated with better adherence to PAP therapy. In this study, we aimed to clarify adherence patterns of PAP therapy in a large paediatric population.MethodsWe did a cross-sectional big-data analysis in children from Oct 1, 2014, to Aug 1, 2018, using existing data derived from PAP devices uploaded nightly in the AirView cloud database. The AirView database is a usage tracking system available to all patients who are assigned PAP therapy, which requires consent from the patient or parent or guardian. All patients older than 4 years and younger than 18 years who used continuous or automated PAP devices were evaluated. Only patients living in the USA and enrolled with a single insurance company were included. If patients were participating in an engagement programme, programme onset must have been within 7 days of therapy onset. Our primary outcome was the proportion of patients who used PAP continuously over 90 days. The primary outcome was assessed in all patients who met the age inclusion criterion and had reliable age data available. Data on missing PAP use were imputed as zero, but data on other metrics were not imputed and excluded from analysis.FindingsWe used data recorded from Oct 1, 2014, to Aug 1, 2018. Of 40 140 children screened, 36 058 (89·8%) were US residents and 20 553 (90·1%) of them met the eligibility criteria and had accessible data (mean age 13·0 years [SD 3·7]). On the basis of 90 days of monitoring data, 12 699 (61·8%) patients continuously used PAP. Factors significantly associated with adherence included age group, residual apnoea-hypopnoea index, use and onset of patient engagement programmes, PAP pressure, and nightly median PAP mask leak, all over the 90-day study period.InterpretationTo our knowledge, our study represents the largest analysis of children using PAP therapy to date. The findings suggest that adherence to PAP therapy is lower than in previous reports from adults. However, numerous actionable factors were associated with improvements in adherence and should be used strategically in clinical decision making to improve PAP adherence in children.FundingResMed.
| S-EPMC7847310 | biostudies-literature
Project description:Study objectivesContinuous positive airway pressure (CPAP) therapy is considered the front-line treatment for moderate-severe obstructive sleep apnea (OSA). However, nonuse rates are very high, such that adherence to CPAP has become a major concern. Although the literature on CPAP use is vast, further research is required to understand patients' experiences of CPAP use and nonuse. This is the goal of this study.MethodsThis study draws on in-depth interviews with 61 Jewish-Israeli patients with OSA who received a recommendation to use a CPAP device. The sample includes both patients who started using CPAP devices as well as patients who rejected this course of treatment. It follows principles of constructivist-grounded theory in both sampling and analysis.ResultsThe study shows that regardless of patients' status of adherence, their attitudes toward CPAP devices are characterized by ambivalence. Users of CPAP expressed ambivalent adherence, pondering whether they should stop using the device; and patients who rejected the CPAP expressed ambivalent nonadherence, wondering whether they should give the CPAP another chance. This study identifies the experiences involved in using, as well as not using, CPAP devices that produce patients' ambivalence.ConclusionsBoth adherence and nonadherence to CPAP are dynamic processes that are characterized by patients' ambivalence and contingent upon diverse factors. These findings have practical implications as they suggest that all patients, regardless of their initial adherence status, would benefit from a close follow-up.
| S-EPMC5695983 | biostudies-literature
Project description:Background Studies have shown that a significant percentage of patients with obstructive sleep apnea (OSA) do not tolerate continuous positive airway pressure (CPAP) therapy and long-term use may be as low as 30%. Given the lower levels of symptoms and health-related risks, patients with mild sleep apnea may be at even higher risk for non-adherence to long term CPAP. The purpose of our study was to investigate the prevalence and associations of long-term CPAP adherence in first time users with mild sleep apnea diagnosed by home sleep apnea testing (HSAT). Methods We identified all the patients who were diagnosed with mild sleep apnea (5 = < AHI < 15) by home sleep apnea testing from 01/2013 to 06/2019 at a large, combined community and hospital-based sleep practice. Only first time CPAP users were included. Compliance was defined as CPAP usage ≥ 4 h per night on ≥ 70% of nights over 30 consecutive days. We defined long term adherence as compliance on the 12th month following CPAP set up. Patient demographics, comorbidities, and CPAP compliance at 1st, 3rd, 6th, 9th and 12th month after therapy initiation were collected. We compared and identified the factors that had significant difference (P < 0.1) between compliant and non-compliant groups at the 12th month. Results 222 patients were included in the analysis. 57 (25.7%) patients were adherent with long term CPAP treatment. The following factors were associated with a greater likelihood for long-term CPAP adherence: older age, lower body mass index (BMI), presence of a bed partner, non-smoker, presence of Diabetes Mellitus (DM), presence of Heart Failure (CHF), lack of depression, and compliance at 1st, 3rd, 6th and 9th month. Conclusions Long term CPAP compliance in mild sleep apnea patients is low. Long term adherence to CPAP can be predicted based on CPAP adherence during the first three months. Supplementary Information The online version contains supplementary material available at 10.1186/s12890-023-02612-3.
| S-EPMC10472589 | biostudies-literature
Project description:STUDY OBJECTIVES:Poor adherence undermines the effectiveness of positive airway pressure (PAP) therapy for sleep apnea. Disparities exist in PAP adherence by race/ethnicity and neighborhood socioeconomic status (SES), but the etiology of these differences is poorly understood. We investigated whether home environmental factors contribute to PAP adherence and whether identified factors explain disparities in adherence by SES. METHODS:Adult patients with sleep apnea were surveyed at clinic visits about their sleep environment. Medical records were abstracted for demographic data, sleep apnea severity, comorbidities, and objective PAP adherence. We evaluated the association between aspects of home sleep environment with PAP adherence using multivariate linear and logistic regression, and assessed effect modification by SES factors. RESULTS:Participants (n = 119) were diverse, with 44% nonwhite and 35% uninsured/Medicaid. After adjusting for age, sex, race/ethnicity, insurance, neighborhood SES, education, and marital status, participants who endorsed changing sleeping location once per month or more (18%, n = 21) had 77% lower odds of meeting PAP adherence criteria (> 4 h/night for 70% of nights) and less PAP use (median -11 d/mo, 95% confidence intervals -15.3, -6.5). Frequency of sleeping location change was the only environmental factor surveyed associated with PAP adherence. CONCLUSIONS:Frequent change in sleeping location is associated with reduced PAP adherence, independent of sociodemographic factors. This novel finding has implications for physician-patient dialogue. PAP portability considerations in device selection and design may modify adherence and potentially improve treatment outcomes. Prospective investigation is needed to confirm this finding and inform design of possible interventions.
| S-EPMC6175782 | biostudies-literature