Correction: A quality improvement initiative for COPD patients: A cost analysis.

[This corrects the article DOI: 10.1371/journal.pone.0235040.].

A quality improvement initiative for COPD patients: A cost analysis.

The objective of this analysis was to evaluate and report on the economic impact of implementing an integrated, quality, and operational improvement program on chronic obstructive pulmonary disease (COPD) care from acute through post-acute care settings. This initiative was established in a cohort of 12 hospitals in Alabama and sought to address COPD readmission through improved workflows pertaining to early diagnosis, efficient care transitions, and patient visibility across the entire care episode. Implementation of the initiative was influenced by lean principles, particularly cross-functional agreement of workflows to improve COPD care delivery and outcomes. A budget impact model was developed to calculate cost savings directly from objective data collected during this initiative. The model estimated payer annual savings over 5 years. Patients were classified for analysis based on whether or not they received noninvasive ventilation. Scenario analyses calculated savings for payers covering different COPD cohort sizes. The base case revealed annual per patient savings of $11,263 for patients treated through the quality improvement program versus traditional care. The model projected cumulative savings of $52 million over a 5-year period. Clinical incorporation of non-invasive ventilation (NIV) resulted in $20,535 annual savings per patient and projected $91 million over 5 years. We conclude that an integrated management program for COPD patients across the care continuum is associated with substantial cost savings and significantly reduced hospital readmissions.

Costos e impacto económico del síndrome de apnea-hipopnea obstructiva del sueño (SAHOS) para la salud pública / Cost and economic impact of obstructive sleep apnea-hypopnea syndrome (OSAHS) on public health

Resumen El síndrome de apnea-hipopnea obstructiva del sueño (SAHOS) no tratado se asocia con costos directos e indirectos significativos. Este trastorno también tiene un impacto negativo sobre el desempeño y la seguridad laboral y está implicado en una proporción considerable de accidentes automovilísticos. El diagnóstico oportuno y la terapia óptima han mostrado disminución en la utilización de los sistemas de salud y en los costos, al tiempo que atenúan los riesgos adversos. Del mismo modo, el SAHOS no tratado se asocia con incremento en las tasas de desempleo. Para los profesionales de la salud, tener un paciente con SAHOS involucrado en una colisión automovilística es de crucial importancia debido al daño personal y público, así como la potencial discapacidad física por el accidente. En Latinoamérica se requiere de la medición de los costos directos e indirectos dado el problema de salud pública que tiene asociado el SAHOS y las implicaciones mencionadas.

Abstract Untreated obstructive sleep apnea-hypopnea syndrome (OSAHS) is associated with significant direct and indirect medical costs. This disorder also has a significant negative impact on work performance and safety, and is implicated in a substantial proportion of motor vehicular crashes. Timely diagnosis and optimal therapy have shown a lower utilization rate related to health care systems and reduced costs, while adverse risks are mitigated at the same time. Prompt diagnosis and optimal therapy have shown to decrease heath care utilizaton and costs, as well as mitigating these adverse risks. Similarly, untreated OSAHS is associated with higher unemployment rates. Forhealthcareprofessionals,having apatientwithOSAHS involved in a MVC is of paramount importance for a several reasons, including personal and public damage, as well as the potential physical disability that may be caused by the accident. In Latin America, measuring direct and indirect costs is necessary considering the public health problem associated with OSAHS and the implications mentioned above.

Cost Savings from Reduced Hospitalizations with Use of Home Noninvasive Ventilation for COPD.

BACKGROUND: Although evidence suggests significant clinical benefits of home noninvasive ventilation (NIV) for management of severe chronic obstructive pulmonary disease (COPD), economic analyses supporting the use of this technology are lacking. OBJECTIVES: To evaluate the economic impact of adopting home NIV, as part of a multifaceted intervention program, for severe COPD. METHODS: An economic model was developed to calculate savings associated with the use of Advanced NIV (averaged volume assured pressure support with autoexpiratory positive airway pressure; Trilogy100, Philips Respironics, Inc., Murrysville, PA) versus either no NIV or a respiratory assist device with bilevel pressure capacity in patients with severe COPD from two distinct perspectives: the hospital and the payer. The model examined hospital savings over 90 days and payer savings over 3 years. The number of patients with severe COPD eligible for home Advanced NIV was user-defined. Clinical and cost data were obtained from a quality improvement program and published reports. Scenario analyses calculated savings for hospitals and payers covering different COPD patient cohort sizes. RESULTS: The hospital base case (250 patients) revealed cumulative savings of $402,981 and $449,101 over 30 and 90 days, respectively, for Advanced NIV versus both comparators. For the payer base case (100,000 patients), 3-year cumulative savings with Advanced NIV were $326 million versus no NIV and $1.04 billion versus respiratory assist device. CONCLUSIONS: This model concluded that adoption of home Advanced NIV with averaged volume assured pressure support with autoexpiratory positive airway pressure, as part of a multifaceted intervention program, presents an opportunity for hospitals to reduce COPD readmission-related costs and for payers to reduce costs associated with managing patients with severe COPD on the basis of reduced admissions.

Sleep and breathing.

The sleep state is associated with significant changes in respiratory physiology, including ventilatory responses to hypoxia and hypercapnia, upper airway and intercostal muscle tone, and tidal volume and minute ventilation. These changes are further magnified in certain disease states, such as chronic obstructive pulmonary disease, restrictive respiratory disorders, neuromuscular conditions, and cardiac diseases. This article discusses the regulation of breathing during sleep in health and associated comorbid conditions.

Medication effects on sleep and breathing.

Sleep respiration is regulated by circadian, endocrine, mechanical and chemical factors, and characterized by diminished ventilatory drive and changes in Pao2 and Paco2 thresholds. Hypoxemia and hypercapnia are more pronounced during rapid eye movement. Breathing is influenced by sleep stage and airway muscle tone. Patient factors include medical comorbidities and body habitus. Medications partially improve obstructive sleep apnea and stabilize periodic breathing at altitude. Potential adverse consequences of medications include precipitation or worsening of disorders. Risk factors for adverse medication effects include aging, medical disorders, and use of multiple medications that affect respiration.

Sleep-disordered breathing and oxidative stress in preclinical chronic mountain sickness (excessive erythrocytosis).

Chronic mountain sickness (CMS) is considered to be a loss of ventilatory acclimatization to high altitude (>2500m) resulting in marked arterial hypoxemia and polycythemia. This case-control study explores the possibility that sleep-disordered breathing (SDB) and associated oxidative stress contribute to the etiology of CMS. Nocturnal respiratory and [Formula: see text] patterns were measured using standard polysomnography techniques and compared between male high-altitude residents (aged 18-25) with preclinical CMS (excessive erythrocytosis (EE), n=20) and controls (n=19). Measures of oxidative stress and antioxidant status included isoprostanes (8-iso-PGF2alpha), superoxide dismutase and ascorbic acid. EE cases had a greater apnea-hypopnea index, a higher frequency of apneas (central and obstructive) and hypopneas during REM sleep, and lower nocturnal [Formula: see text] compared to controls. 8-iso-PGF2alpha was greater in EE than controls, negatively associated with nocturnal [Formula: see text] , and positively associated with hemoglobin concentration. Mild sleep-disordered breathing and oxidative stress are evident in preclinical CMS, suggesting that the resolution of nocturnal hypoxemia or antioxidant treatment may prevent disease progression.

An electrocardiogram-based analysis evaluating sleep quality in patients with obstructive sleep apnea.

OBJECTIVE: The study compares polysomnography (PSG) and cardiopulmonary coupling (CPC) sleep quality variables in patients with (1) obstructive sleep apnea (OSA) and (2) successful and unsuccessful continuous positive airway pressure (CPAP) response. PATIENTS/METHODS: PSGs from 50 subjects (32 F/18 M; mean age 48.4 ± 12.29 years; BMI 34.28 ± 9.33) were evaluated. OSA patients were grouped by no (n = 16), mild (n = 13), and moderate to severe (n = 20) OSA (apnea-hypopnea index (AHI) ≤ 5, >5-15, >15 events/h, respectively). Outcome sleep quality variables were sleep stages in non-rapid eye movement, rapid eye movement sleep, and high (HFC), low (LFC), very low-frequency coupling (VLFC), and elevated LFC broad band (e-LFCBB). An AHI ≤ 5 events/h and HFC ≥ 50 % indicated a successful CPAP response. CPC analysis extracts heart rate variability and QRS amplitude change that corresponds to respiration. CPC-generated spectrograms represent sleep dynamics from calculated coherence product and cross-power of both time series datasets. RESULTS: T tests differentiated no and moderate to severe OSA groups by REM % (p = 0.003), HFC (p = 0.007), VLFC (p = 0.007), and LFC/HFC ratio (p = 0.038) variables. The successful CPAP therapy group (n = 16) had more HFC (p = 0.003), less LFC (p = 0.003), and e-LFCBB (p = 0.029) compared to the unsuccessful CPAP therapy group (n = 8). PSG sleep quality measures, except the higher arousal index (p = 0.038) in the unsuccessful CPAP group, did not differ between the successful and unsuccessful CPAP groups. HFC ≥ 50 % showed high sensitivity (77.8 %) and specificity (88.9 %) in identifying successful CPAP therapy. CONCLUSIONS: PSG and CPC measures differentiated no from moderate to severe OSA groups and HFC ≥ 50 % discriminated successful from unsuccessful CPAP therapy. The HFC ≥ 50 % cutoff showed clinical value in identifying sleep quality disturbance among CPAP users.

Continuous positive airway pressure treatment of sleepy patients with milder obstructive sleep apnea: results of the CPAP Apnea Trial North American Program (CATNAP) randomized clinical trial.

RATIONALE: Twenty-eight percent of people with mild to moderate obstructive sleep apnea experience daytime sleepiness, which interferes with daily functioning. It remains unclear whether treatment with continuous positive airway pressure improves daytime function in these patients. OBJECTIVES: To evaluate the efficacy of continuous positive airway pressure treatment to improve functional status in sleepy patients with mild and moderate obstructive sleep apnea. METHODS: Patients with self-reported daytime sleepiness (Epworth Sleepiness Scale score >10) and an apnea-hypopnea index with 3% desaturation and from 5 to 30 events per hour were randomized to 8 weeks of active or sham continuous positive airway pressure treatment. After the 8-week intervention, participants in the sham arm received 8 weeks of active continuous positive airway pressure treatment. MEASUREMENTS AND MAIN RESULTS: The Total score on the Functional Outcomes of Sleep Questionnaire was the primary outcome measure. The adjusted mean change in the Total score after the first 8-week intervention was 0.89 for the active group (n = 113) and -0.06 for the placebo group (n = 110) (P = 0.006). The group difference in mean change corresponded to an effect size of 0.41 (95% confidence interval, 0.14-0.67). The mean (SD) improvement in Functional Outcomes of Sleep Questionnaire Total score from the beginning to the end of the crossover phase (n = 91) was 1.73 ± 2.50 (t[90] = 6.59; P < 0.00001) with an effect size of 0.69. CONCLUSIONS: Continuous positive airway pressure treatment improves the functional outcome of sleepy patients with mild and moderate obstructive sleep apnea.

Obstructive sleep apnea does not promote esophageal reflux in fibrosing interstitial lung disease.

BACKGROUND: In patients with fibrosing interstitial lung disease (fILD), gastroesophageal reflux (GER) is highly prevalent, perhaps because of the effects of lung fibrosis on altering intrathoracic pressure, diaphragm morphology and lower esophageal sphincter (LES) function. For unclear reasons, obstructive sleep apnea (OSA) is also highly prevalent among patients with fILD. We conducted this study to test our hypothesis that, in patients with fILD, OSA would exacerbate diaphragm/LES dysfunction and increase the propensity for-and severity of - GER. METHODS: We identified patients with fILD who underwent screening polysomnogram and pH or pH/impedence probe at our center during the same week. We examined the association between OSA and GER and used logistic regression to determine independent predictors of OSA or GER. RESULTS: In 54 included subjects, neither OSA (dichotomous) nor apnea hypopnea index (continuous) predicted the presence of GER. Regardless of body position (upright, recumbent), GER was no more frequent or severe among subjects with OSA vs. those without OSA. Subjects with idiopathic pulmonary fibrosis (IPF) had an odds of GER nearly seven-fold greater than subjects with other forms of fILD (odds ratio = 6.84, 95% confidence interval 1.36-34.43, p = 0.02). For the entire cohort and the subgroup with IPF, there was no correlation between pulmonary physiology and GER. CONCLUSIONS: In fILD, OSA does not appear to promote GER. Research is needed to determine if compensatory mechanisms emanating from the crural diaphragm prevent GER in fILD patients with OSA and to sort out whether GER has a role in the pathogenesis of certain forms of fILD.

Basic biology of sleep.

Sleep can be defined as a complex reversible state characterized by behavioral quiescence, diminished responsiveness to external stimuli, and a stereotypical species-specific posture. Both components of sleep, non-rapid eye movement and rapid eye movement, are generated and maintained by central nervous system networks that use specific neurotransmitters located in specific areas of the brain. Widespread changes in physiologic processes occur during sleep, and these changes may influence the presentation and severity of specific medical disorders.

Effect of palatal implants on continuous positive airway pressure and compliance.

OBJECTIVE: Determine if the Pillar palatal implant system reduces continuous positive airway pressure (CPAP) pressure and improves patient compliance with CPAP therapy. STUDY DESIGN: Randomized, double-blind, placebo-controlled study. SETTING: Four geographically dispersed tertiary sleep disorder referral centers. METHODS: Subjects with mild to moderate sleep apnea dissatisfied with CPAP because of pressure-related complaints were randomized to receive Pillar implants or a sham procedure performed in double-blind fashion. Active and sham groups were compared for changes in therapeutic CPAP pressures (primary outcome) with a 90-day follow-up sleep study and CPAP compliance (secondary outcome) with a 90-day smart card report. RESULTS: Twenty-six subjects were randomized to Pillar implants and 25 to a sham implant procedure. There were no differences between groups with regard to demographics and baseline parameters. Both sham and active groups had reduced mean CPAP pressure (-1.1 vs -0.5 cm H(2)O) with no difference between groups (P = .32) at 90-day follow-up. In addition, there was no difference in average daily CPAP use between groups (P = .80). Both groups experienced improvements in Epworth sleepiness scores and Functional Outcome of Sleep Questionnaire scores at 90 days with no differences between groups. The active group reported significantly higher CPAP satisfaction scores than the sham group (P = .04). CONCLUSION: Pillar implants do not significantly reduce CPAP pressure or increase CPAP compliance compared to sham controls but may subjectively improve CPAP satisfaction. These findings do not presently support the use of Pillar implants as an adjunctive treatment to improve CPAP compliance.

An official ATS/AASM/ACCP/ERS workshop report: Research priorities in ambulatory management of adults with obstructive sleep apnea.

An international workshop was held to determine the research priorities for incorporating ambulatory management of adults with obstructive sleep apnea into healthcare systems. The workshop identified the barriers preventing incorporation of portable monitor testing into clinical management pathways and determined the research and development needed to address those barriers. The workshop promoted interaction and collaboration among diverse stakeholders who have interest and expertise in the development and evaluation of portable monitor technology and its clinical application. The consensus of the workshop participants was that outcomes-based research studies are needed to demonstrate the efficacy and cost effectiveness of portable monitor testing. Closely related to this objective is the need to develop clinical sleep research networks capable of performing adequately powered studies. Recommendations were developed regarding research study design and methodology that includes the need to standardize technology, identify the patients most appropriate for ambulatory management of obstructive sleep apnea, ensure patient safety, and identify sources of research funding. The evidence resulting from high-quality comparative effectiveness studies that include cost effectiveness as an outcome will allow decision makers to develop healthcare policies regarding the clinical application of portable monitor testing for the ambulatory management of patients with obstructive sleep apnea.

Pulmonary manifestations of ankylosing spondylitis.

Ankylosing spondylitis, a chronic multisystem inflammatory disorder, can present with articular and extra-articular features. It can affect the tracheobronchial tree and the lung parenchyma, and respiratory complications include chest wall restriction, apical fibrobullous disease with or without secondary pulmonary superinfection, spontaneous pneumothorax, and obstructive sleep apnea. Ankylosing spondylitis is a common cause of pulmonary apical fibrocystic disease; early involvement may be unilateral or asymmetrical, but most cases eventually consist of bilateral apical fibrobullous lesions, many of which are progressive with coalescence of the nodules, formation of cysts and cavities, fibrosis, and bronchiectasis. Mycobacterial or fungal superinfection of the upper lobe cysts and cavities occurs commonly. Aspergillus fumigatus is the most common pathogen isolated, followed by various species of mycobacteria. Prognosis of patients with fibrobullous apical lesions is mainly determined by the presence, extent, and severity of superinfection. Pulmonary function test results are nonspecific and generally parallel the severity of parenchymal involvement. A restrictive ventilatory impairment can develop in patients with ankylosing spondylitis because of either fusion of the costovertebral joints and ankylosis of the thoracic spine or anterior chest wall involvement. Chest radiographic findings may mirror the severity of clinical involvement. Pulmonary parenchymal disease is typically progressive, and cyst formation, cavitation, and fibrosis are seen in advanced cases. No treatment has been shown to alter the clinical course of apical fibrobullous disease. Although several antiinflammatory agents, such as infliximab, etanercept, and adalimumab, are being used to treat ankylosing spondylitis, their effects on pulmonary manifestations are unclear.

Effects of the melatonin MT-1/MT-2 agonist ramelteon on daytime body temperature and sleep.

STUDY OBJECTIVES: A reduction in core temperature and an increase in the distal-proximal skin gradient (DPG) are reported to be associated with shorter sleep onset latencies (SOL) and better sleep quality. Ramelteon is a melatonin MT-1/MT-2 agonist approved for the treatment of insomnia. At night, ramelteon has been reported to shorten SOL. In the present study we tested the hypothesis that ramelteon would reduce core temperature, increase the DPG, as well as shorten SOL, reduce wakefulness after sleep onset (WASO), and increase total sleep time (TST) during a daytime sleep opportunity. DESIGN: Randomized, double-blind, placebo-controlled, cross-over design. Eight mg ramelteon or placebo was administered 2 h prior to a 4-h daytime sleep opportunity. SETTING: Sleep and chronobiology laboratory. PARTICIPANTS: Fourteen healthy adults (5 females), aged (23.2 +/- 4.2 y). MEASUREMENTS AND RESULTS: Primary outcome measures included core body temperature, the DPG and sleep physiology (minutes of total sleep time [TST], wake after sleep onset [WASO], and SOL). We also assessed as secondary outcomes, proximal and distal skin temperatures, sleep staging and subjective TST. Repeated measures ANOVA revealed ramelteon significantly reduced core temperature and increased the DPG (both P < 0.05). Furthermore, ramelteon reduced WASO and increased TST, and stages 1 and 2 sleep (all P < 0.05). The change in the DPG was negatively correlated with SOL in the ramelteon condition. CONCLUSIONS: Ramelteon improved daytime sleep, perhaps mechanistically in part by reducing core temperature and modulating skin temperature. These findings suggest that ramelteon may have promise for the treatment of insomnia associated with circadian misalignment due to circadian sleep disorders.

Circadian rhythm sleep disorders.

Because there is insufficient cellular energy for organisms to perform their functions at the same constant rate and at the same time, all biologic processes show rhythmicity, each with its own unique frequency, amplitude, and phase. Optimal sleep and wakefulness requires proper timing and alignment of desired sleep-wake schedules and circadian rhythm-related periods of alertness. Persistent or recurrent mismatch between endogenous circadian rhythms and the conventional sleep-wake schedules of the environmental day can give rise to several circadian rhythm sleep disorders. Evaluation of suspected circadian rhythm sleep disorders requires proper monitoring of sleep diaries, often over several days to weeks. This article discusses the disorders of the circadian sleep-wake cycle and the therapeutic measures to correct the same.

The new local coverage determination criteria for adherence to positive airway pressure treatment: testing the limits?

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.