Acceptance of and adherence with long-term positive airway pressure treatment in adults with chronic obstructive pulmonary disease: A systematic review protocol.

BACKGROUND: Long-term noninvasive positive airway pressure (PAP) treatment is effective treatment for sleep-related breathing disorders and chronic hypercarbic respiratory failure secondary to chronic obstructive pulmonary disease (COPD). PAP treatment may be delivered as continuous positive airway pressure or noninvasive ventilation. Success in initiating PAP treatment and barriers to its use in adult patients with COPD are largely unknown. This systematic review aims to identify the acceptance of and adherence to PAP treatment prescribed for long-term use in adult patients with COPD and to summarize variables associated with these measures. METHODS: Seven online electronic databases will be searched by an experienced medical librarian to identify records containing the concepts "obstructive airways disease" and "noninvasive positive airway pressure" and "acceptance" or "adherence". Randomized and non-randomized studies of interventions will be included. Citation lists from relevant articles will be reviewed, and experts will be contacted regarding unpublished studies. Abstracts from key conferences between 2018-2023 and Google Scholar search results will be reviewed for inclusion. Titles, abstracts and full texts will be reviewed independently for inclusion by two reviewers. Data extraction will be completed by one author using a pre-established form and primary outcomes confirmed by a second author. Methodological quality will be evaluated. If sufficient data are available for meta-analysis, a pooled summary statistic for the primary outcome will be calculated using a random-effects generic inverse-variance meta-analysis, weighted proportion or weighted medians-based approach. Subgroup analysis will explore clinically meaningful sources of heterogeneity. Variables that are associated with acceptance and adherence will be described. DISCUSSION: Long-term PAP treatment is a complex intervention prescribed to patients with COPD for several indications. Synthesis of the evidence on success with PAP treatment and variables associated with acceptance or adherence will inform program and policy development for supporting patients with COPD who are prescribed this therapy. TRIAL REGISTRATION: Systematic review registration: This protocol was registered with the International Prospective Register of Systematic Reviews (PROSPERO) on July 13, 2021 (registration number CRD42021259262), with revisions submitted on April 17, 2023.

Vaccines for all: A formative evaluation of a multistakeholder community-engaged COVID-19 vaccine outreach clinic for migrant communities.

Background: Racialized, low-income, and migrant populations experience persistent barriers to vaccines against COVID-19. These communities in East and Northeast Calgary were disproportionately impacted by COVID-19, yet faced vaccine access barriers. Diverse multi-stakeholder coalitions and community partnerships can improve vaccine outreach strategies, but how stakeholders perceive these models is unknown. Methods: We conducted a formative evaluation of a low-barrier, community-engaged vaccine outreach clinic in Calgary, Alberta, Canada, on June 5-6, 2021. We delivered an online post-clinic survey to clinic stakeholders, to assess whether the clinic achieved its collectively derived pre-specified goals (effective, efficient, patient-centered, and safe), to asses whether the clinic model was scalable, and to solicit improvement recommendations. Survey responses were analyzed using descriptive statistics and thematic analysis. Results: Overall, 166/195 (85%) stakeholders responded. The majority were from non-healthcare positions (59%), between 30 and 49 years of age (87/136; 64%), and self-identified as racialized individuals (96/136; 71%). Respondents felt the clinic was effective (99.2%), efficient (96.9%), patient-centered (92.3%), and safe (90.8%), and that the outreach model was scalable 94.6% (123/130). There were no differences across stakeholder categories. The open-ended survey responses supported the scale responses. Improvement suggestions describe increased time for clinic planning and promotion, more multilingual staff, and further efforts to reduce accessibility barriers, such as priority check-in for people with disabilities. Conclusion: Diverse stakeholders almost universally felt that this community-engaged COVID-19 vaccine outreach clinic achieved its goals and was scalable. These findings support the value of community-engaged outreach to improve vaccine equity among other marginalized newcomer communities.

Association of clinically significant obstructive sleep apnoea with risks of contracting COVID-19 and serious COVID-19 complications: a retrospective population-based study of health administrative data.

RATIONALE/OBJECTIVES: Despite plausible pathophysiological mechanisms, more research is needed to confirm the relationship between obstructive sleep apnoea (OSA) and the risk of COVID-19 infection or COVID-19-related serious complications. METHODS: We conducted a retrospective population-based cohort study using provincial health administrative data (Ontario, Canada). Adults with physician-diagnosed OSA who received positive airway pressure therapy in the 5 years prepandemic (OSA group) were propensity score matched by baseline characteristics to individuals in the general population at low risk of OSA (non-OSA group) using inverse probability of treatment weighting. Weighted HRs of (1) a positive COVID-19 test and (2) COVID-19-related emergency department (ED) visits, hospitalisations, intensive care unit (ICU) admissions and mortality, within 12 months of pandemic onset, were compared between groups. We also evaluated the impact of comorbid cardiometabolic or chronic airways disease. RESULTS: We identified and matched 324 029 individuals in the OSA group to 4 588 200 individuals in the non-OSA group. Compared with the non-OSA group, those in the OSA group were at a greater hazard of testing positive for COVID-19 (HR=1.17, 95% CI 1.13 to 1.21), having a COVID-19-related ED visit (HR=1.62, 95% CI 1.51 to 1.73), hospitalisation (HR=1.50, 95% CI 1.37 to 1.65) or ICU admission (HR=1.53, 95% CI 1.27 to 1.84). COVID-19-related 30-day mortality was not different (HR=0.98, 95% CI 0.82 to 1.16).We found that for the OSA group, comorbid airways disease but not cardiometabolic conditions increased the hazards of COVID-19-related outcomes, including mortality. CONCLUSION: In this large population-based study, we demonstrated that a recent diagnosis of OSA requiring treatment was associated with an increased hazard of testing positive for COVID-19 and serious COVID-19-related complications, particularly in those with co-existing chronic airways disease.

Temporal and Regional Trends in Obstructive Sleep Apnea Using Administrative Health Data in Alberta, Canada.

Rationale: Obstructive sleep apnea (OSA) is a common treatable condition with important health and societal consequences. Objectives: We aimed to assess the annual incidence and prevalence of clinically recognized and geographic clustering of OSA in Alberta, Canada, using administrative health data case definitions. Methods: We used two administrative health databases in Alberta to identify ICD-9 and ICD-10 (International Classification of Diseases, Ninth and 10th Revisions, respectively) diagnostic codes for adults and children at least 2 years old diagnosed with OSA between 2003 and 2020. We defined OSA using an algorithm developed and validated in Alberta: at least three claims or one hospitalization within 2 years. We mapped residential postal codes to 70 subregional health authorities (SRHAs). Crude, age group- and sex-specific incidence and prevalence, and age group- and sex-standardized rates were calculated for Alberta and SRHAs. Spatial scan statistics identified clusters of SRHAs in which OSA cases were higher (hot spots) or lower (cold spots) than expected. Results: Between 2003 and 2020, OSA prevalence increased from 0.14% to 4.59%. The annual incidence of OSA increased after 2013. Incidence and prevalence were higher in older adults and children aged 2-11 years compared with 12-17 years. Cluster analysis revealed regional variation in OSA incidence and prevalence over time with no consistent pattern except for cold spots in one large metropolitan center (Calgary). Conclusions: From 2003 to 2020, the incidence and prevalence of clinically recognized OSA increased but varied by geography. Administrative health data can be used to guide interventions aimed at improving health service delivery and the quality of OSA care.

Patient-reported Differences in Obstructive Sleep Apnea Care between Jurisdictions with and without Government Funding for Continuous Positive Airway Pressure.

Rationale: Funding for obstructive sleep apnea (OSA) treatment may impact how patients access care, wait times, and costs of care. Objectives: The aim of this study was to compare differences in diagnosis and treatment of OSA between Canadian jurisdictions with and without public funding for continuous positive airway pressure (CPAP). Methods: We administered an anonymous internet survey to Canadian adults reporting a physician diagnosis of OSA. Responses were categorized on the basis of whether the respondent's province provided full or partial funding for CPAP therapy for all patients. We assessed wait times for diagnosis and treatment, patient-borne costs, and model of care delivery compared between jurisdictions with and without universal CPAP funding. Results: We received 600 responses representing all Canadian provinces and territories. The median (interquartile range) age was 59 (49-66) years; 57% were male, and 21% were from rural settings. Patients living in provinces without public CPAP funding (n = 419) were more likely to be diagnosed using home sleep apnea testing (69% vs. 20%; P = 0.00019). Wait times were similar after adjustment for demographics, disease characteristics, and model of care. Although patient-borne costs of care were similar between jurisdictions, patients from regions without CPAP funding reported that cost had a greater influence on the choice of therapy. Sleep specialists were more commonly involved in OSA care in regions with CPAP funding. There was no difference in the current use of therapy between jurisdictions with and without public funding. Conclusions: This survey study demonstrates that public funding for CPAP therapy impacts how Canadians access OSA care but is not associated with differences in wait times or costs. Future research is required to determine the impact of different funding models for OSA care on clinical outcomes.

National strategy on the integration of sleep and circadian rhythms into public health research and policies: Report from the Canadian Sleep and Circadian Network.

Scientists in sleep and circadian rhythms, public health experts, healthcare providers, partners, and stakeholders convened in 2020 for a 2-day meeting organized by the Canadian Sleep and Circadian Network to develop a national strategy for integrating sleep and circadian rhythms into public health and policies in Canada. The objective of this paper is to present the national strategy that emerged from this meeting of 60 participants from across Canada. The meeting focused on 4 key target priorities: (1) atypical working schedules, (2) sleep and circadian rhythms of children and adolescents, (3) insomnia, and (4) impact of sleep apnea on health. Following constructive discussions, it was decided that the following 4 strategic objectives should be prioritized to accelerate the integration of sleep and circadian rhythms into public health policies in Canada: (1) increase public health sleep and circadian rhythm research, (2) increase public health education and knowledge mobilization on sleep, (3) inform and support public health sleep interventions and policies, and (4) promote sleep health training. Participants recommended that research and public health efforts address needs along the continuum of sleep health. The committee noted that strategies and interventions could differ across contexts, settings, sectors, and jurisdictions. The national strategy also identified high-priority research questions in public health and recommended mechanisms to build research capacity, providing a path forward for the integration of sleep and circadian rhythms into public health research and policies.

Impact of wait times for treatment on clinical outcomes in patients with obstructive sleep apnoea: protocol for a randomised controlled trial.

Background: Obstructive sleep apnoea (OSA) is a common chronic condition that is associated with significant morbidity and economic cost. Prolonged wait times are increasingly being recognised as a barrier to diagnosis and treatment of many chronic diseases; however, no study to date has prospectively evaluated the impact of wait times on health outcomes in OSA. Objective: The purpose of this study is to determine whether treatment outcomes for individuals with OSA differ between patients managed using an expedited versus standard pathway. Methods: A pragmatic randomised controlled trial design will be used with a target sample size of 200 adults. Participants with clinically significant uncomplicated OSA will be recruited through referrals to a large tertiary care sleep centre (Calgary, AB, Canada) and randomised to either early management (within 1 month) or usual care (∼6 months) with a 1:1 allocation using a concealed computer-generated randomisation sequence. The primary outcome will be adherence to positive airway pressure (PAP) therapy at 3 months after treatment initiation. Secondary outcomes will include change in sleepiness, quality of life, patient satisfaction, and patient engagement with therapy from baseline to 3 months after PAP initiation, measured using validated questionnaires and qualitative methods. Anticipated results: This study will determine whether expedited care for OSA leads to differences in PAP adherence and/or patient-reported outcomes. More broadly, the findings of this study may improve the understanding of how wait time reductions impact health outcomes for other chronic diseases.

What are the respiratory health research priorities in Alberta, Canada? A stakeholder consultation.

OBJECTIVE: The Respiratory Health Strategic Clinical Network (RHSCN) was launched to facilitate respiratory and sleep health through implementation of innovative, patient-centred, evidence-informed coordinated services in Alberta. In collaboration with project partners, the RHSCN aimed to determine the respiratory research priorities for Alberta. DESIGN: The four phases of this research prioritisation project were (1) identifying research questions from stakeholders, (2) determining which research questions had been answered in existing literature, (3) prioritising unanswered questions and (4) finalising the priorities through an inperson workshop. SETTING: The study occurred in Alberta, Canada over a 2-year period beginning in March 2017. PARTICIPANTS: A total of 448 patients, clinicians and other stakeholders consented to participate in the survey. RESULTS: A total of 595 possible questions were submitted, with 343 unique questions identified. Of the questions, 94 were out of scope, 155 answered by existing literature and 10 were combined with others, while 83 were determined to be unanswered in the literature. Stakeholders were surveyed again to prioritise the remaining 83 questions and they were reviewed by the project's Steering Committee (clinicians and patients). At the inperson workshop, the Steering Committee identified 17 research topics as priority areas for respiratory and sleep research in Alberta. CONCLUSION: A stakeholder-led research prioritisation process identified optimal clinical management/follow-up, equitable access to services, and management of social, psychological and mental health issues related to respiratory/sleep health as priority research areas.

Treatment outcomes among rural and urban patients with obstructive sleep apnea: a prospective cohort study.

STUDY OBJECTIVES: To determine whether adherence to continuous positive airway pressure (CPAP) in adults with uncomplicated obstructive sleep apnea differs by rural vs urban residential address. METHODS: In this prospective cohort study, we recruited adults who initiated CPAP for uncomplicated obstructive sleep apnea that was diagnosed by a physician using sleep specialist-interpreted diagnostic testing. Participants were classified as urban (community size > 100,000) or rural (community size < 100,000) by translating residential postal code into geographic census area. The primary outcome was mean daily hours of CPAP use compared between rural and urban patients. Secondary outcomes included the proportion of patients who were adherent to CPAP, change in Epworth Sleepiness Scale score, change in EuroQOL-5D visual analog score, and Visit-Specific Satisfaction Instrument score. All outcomes were measured 3 months after CPAP initiation. RESULTS: We enrolled 242 patients (100 rural) with a mean (standard deviation) age of 51 (13) years and a respiratory event index of 24 (18) events/h. The mean (95% confidence interval) CPAP use was 3.19 (2.8-3.58) hours/night and 35% were CPAP-adherent, with no difference between urban and rural patients. Among the 65% of patients who were using CPAP at 3 months, the mean CPAP use was 4.89 (4.51-5.28) hours/night and was not different between rural and urban patients. Improvement in the Epworth Sleepiness Scale score and patient satisfaction was similar between groups, but the EuroQOL-5D score improved to a greater extent in rural patients. Urban or rural residence was not associated with CPAP adherence according to multivariable regression analysis. CONCLUSIONS: Rural vs urban residence was not associated with differences in CPAP adherence among patients with uncomplicated OSA diagnosed by a physician using specialist-interpreted sleep diagnostic testing. CITATION: Corrigan J, Tsai WH, Ip-Buting A, et al. Treatment outcomes among rural and urban patients with obstructive sleep apnea: a prospective cohort study. J Clin Sleep Med. 2022;18(4):1013-1020.

Recruitment of patients with chronic kidney disease and obstructive sleep apnoea for a clinical trial.

Obstructive sleep apnoea is common in chronic kidney disease (CKD) and may accelerate the decline in kidney function. Recruitment for a randomised controlled trial to address whether treatment of sleep apnoea with continuous positive airway pressure (CPAP) slows the progression of kidney failure may be challenging because sleep apnoea is often asymptomatic in this patient population. The present report outlines recruitment challenges and how to address them. Adult patients with CKD were recruited for a 12-month randomised, controlled, non-blinded, parallel clinical trial to evaluate the impact of CPAP therapy on kidney function. Patients completed a home sleep apnoea test and those that met pre-specified sleep apnoea and nocturnal hypoxaemia severity criteria were randomised to receive CPAP or no therapy. Although 1,665 patients were eligible to participate in the study over 3 years, only 57 (3.4%) were ultimately randomised. The sequential reasons (and number of patients) for recruitment failure were: no show at clinic appointment (137), insufficient recruiters to approach every eligible patient (461), on therapy for sleep apnoea (122), unable to provide informed consent (67), refused consent (645), home sleep apnoea test not completed (47) or inclusion criteria not met (116), and declined pre-randomisation education session (12). Many challenges limit effective recruitment, which may be addressed by hiring additional recruiters and increasing the awareness of sleep apnoea among patients with CKD. These findings can be used to improve recruitment strategies and the design of future studies.

Description of a Multi-faceted COVID-19 Pandemic Physician Workforce Plan at a Multi-site Academic Health System.

BACKGROUND: The evolving COVID-19 pandemic has and continues to present a threat to health system capacity. Rapidly expanding an existing acute care physician workforce is critical to pandemic response planning in large urban academic health systems. INTERVENTION: The Medical Emergency-Pandemic Operations Command (MEOC)-a multi-specialty team of physicians, operational leaders, and support staff within an academic Department of Medicine in Calgary, Canada-partnered with its provincial health system to rapidly develop a comprehensive, scalable pandemic physician workforce plan for non-ventilated inpatients with COVID-19 across multiple hospitals. The MEOC Pandemic Plan comprised seven components, each with unique structure and processes. METHODS: In this manuscript, we describe MEOC's Pandemic Plan that was designed and implemented from March to May 2020 and re-escalated in October 2020. We report on the plan's structure and process, early implementation outcomes, and unforeseen challenges. Data sources included MEOC documents, health system, public health, and physician engagement implementation data. KEY RESULTS: From March 5 to October 26, 2020, 427 patients were admitted to COVID-19 units in Calgary hospitals. In the initial implementation period (March-May 2020), MEOC communications reached over 2500 physicians, leading to 1446 physicians volunteering to provide care on COVID-19 units. Of these, 234 physicians signed up for hospital shifts, and 227 physicians received in-person personal protective equipment simulation training. Ninety-three physicians were deployed on COVID-19 units at four large acute care hospitals. The resurgence of cases in September 2020 has prompted re-escalation including re-activation of COVID-19 units. CONCLUSIONS: MEOC leveraged an academic health system partnership to rapidly design, implement, and refine a comprehensive, scalable COVID-19 acute care physician workforce plan whose components are readily applicable across jurisdictions or healthcare crises. This description may guide other institutions responding to COVID-19 and future health emergencies.

Alternative Care Pathways for Obstructive Sleep Apnea and the Impact on Positive Airway Pressure Adherence: Unraveling the Puzzle of Adherence.

The high burden of obstructive sleep apnea (OSA), combined with inadequate supply of sleep specialists and constraints on polysomnography resources, has prompted interest in alternative models of care to improve access and treatment effectiveness. In appropriately selected patients, ambulatory clinical pathways and use of nonphysicians or primary care providers to manage OSA can improve timely access and costs without compromising adherence or other clinical outcomes. Although initial studies show promising results, there are several potential barriers that must be considered before broad implementation, and further implementation research and economic evaluation studies are required.

Perspectives on primary care management of obstructive sleep apnea: a qualitative study of patients and health care providers.

STUDY OBJECTIVES: Difficulties in providing timely access to care have prompted interest in primary care delivery models for obstructive sleep apnea (OSA). Sustainable implementation of such models requires codesign with input from key stakeholders. The purpose of this study was to identify patient and provider perspectives on barriers and facilitators to optimal, patient-centered management of OSA in a primary care setting. METHODS: This study was conducted in Alberta, Canada. Data from key stakeholders were collected through an online survey of primary care providers (n = 119), focus groups and interviews with patients living with OSA (n = 28), and workshops with primary care and sleep providers (n = 36). Quantitative survey data were reported using descriptive statistics, and qualitative data were analyzed using an inductive thematic approach. RESULTS: Several barriers were identified, including poor specialist access, variable primary care providers knowledge of OSA, and lack of clarity about provider roles for OSA management. Barriers contributed to patients being poorly informed about OSA, leading them to separate OSA from their overall health and eroding trust in the system. Suggestions for improvement included integration of care providers in a comprehensive model of care, facilitated by improved system navigation and more effective use of technology. Themes were consistent across data collection methods and between stakeholder groups. CONCLUSIONS: Although primary care delivery models may improve access to OSA management, stakeholders identified important challenges in the current system. Innovative models of care, developed with input from patients and providers, may mitigate barriers and support optimal primary care management of OSA.

Effect of CPAP Therapy on Kidney Function in Patients With Chronic Kidney Disease: A Pilot Randomized Controlled Trial.

BACKGROUND: OSA is common in chronic kidney disease (CKD) and may accelerate a decline in kidney function. It is not clear whether treatment of OSA with CPAP improves kidney function. RESEARCH QUESTION: Does treatment with CPAP improve kidney function in patients with CKD and coexisting OSA? STUDY DESIGN AND METHODS: A randomized, controlled, nonblinded, parallel clinical trial was performed of patients with stages 3 and 4 CKD and coexisting OSA comparing the effect of CPAP vs usual care on the estimated glomerular filtration rate (eGFR) and the urine albumin to creatinine ratio (ACR) over 12 months. RESULTS: Fifty-seven patients were enrolled and 30 were randomized to CPAP. They had moderately severe CKD (eGFR, 38.4 ± 1.5 mL/min/1.73 m2) and significant OSA and nocturnal hypoxemia (oxygen desaturation index: 23.9 events/h; interquartile range [IQR], 20.3 events/h; mean peripheral capillary oxygen saturation: 89.5%; IQR, 1.7%); 60% had baseline albuminuria (ACR, > 3 mg/mmol). No significant difference was found between CPAP and usual care in the change in eGFR and ACR over 12 months. Although some improvement in eGFR occurred with CPAP therapy in patients with a lower risk of CKD progression, this did not reach statistical significance. INTERPRETATION: Although CPAP did not provide additional renal benefits over usual care in all CKD patients, some evidence suggested that CPAP slowed the decline in eGFR in CKD patients with a lower risk of CKD progression. These preliminary data support the need for larger clinical trials exploring the effects of CPAP on kidney function. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT02420184; URL: www.clinicaltrials.gov.

An evaluation of rural-urban disparities in treatment outcomes for obstructive sleep apnoea: study protocol for a prospective cohort study.

BACKGROUND: Obstructive sleep apnoea (OSA) is a common and treatable chronic condition that is associated with significant morbidity and economic cost. Geography is increasingly being recognised as a barrier to diagnosis and treatment of many chronic diseases; however, no study to date has investigated the impact of place of residence on health outcomes in OSA. OBJECTIVE: The purpose of this study is to determine whether treatment outcomes for patients initiating continuous positive airway pressure (CPAP) for OSA differ between those who live in urban versus rural settings. METHODS: A prospective cohort design will be used. Participants will be recruited through community-based CPAP providers and assigned to either the rural or urban cohort based on residential postal code. The primary outcome will be the difference in nightly hours of CPAP use between the two groups, measured 3 months after initiation of therapy. Secondary outcomes will include symptoms, quality of life, patient satisfaction and patient-borne costs. ANTICIPATED RESULTS: This study will determine whether there are differences in CPAP adherence or patient-reported outcomes between rural and urban patients with OSA. These results will highlight potential challenges with providing OSA care in rural populations and may inform health interventions to reduce urban-rural inequities.

Predicting CPAP failure in patients with suspected sleep hypoventilation identified on ambulatory testing.

STUDY OBJECTIVES: Home sleep apnea testing (HSAT) is commonly used to diagnose obstructive sleep apnea, but its role in identifying patients with suspected hypoventilation or predicting their response to continuous positive airway pressure (CPAP) therapy has not been assessed. The primary objective was to determine if HSAT, combined with clinical variables, could predict the failure of CPAP to correct nocturnal hypoxemia during polysomnography in a population with suspected hypoventilation. Secondary objectives were to determine if HSAT and clinical parameters could predict awake or sleep hypoventilation. METHODS: A retrospective review was performed of 142 consecutive patients who underwent split-night polysomnography for suspected hypoventilation after clinical assessment by a sleep physician and review of HSAT. We collected quantitative indices of nocturnal hypoxemia, patient demographics, medications, pulmonary function tests, as well as arterial blood gas data from the night of the polysomnography . CPAP failure was defined as persistent obstructive sleep apnea, hypoxemia (oxygen saturation measured by pulse oximetry < 85%), or hypercapnia despite maximal CPAP. RESULTS: Failure of CPAP was predicted by awake oxygen saturation and arterial blood gas results but not by HSAT indices of nocturnal hypoxemia. Awake oxygen saturation ≥ 94% ruled out CPAP failure, and partial pressure of oxygen measured by arterial blood gas ≥ 68 mmHg decreased the likelihood of CPAP failure significantly. CONCLUSIONS: In patients with suspected hypoventilation based on clinical review and HSAT interpretation by a sleep physician, awake oxygen saturation measured by pulse oximetry and partial pressure of oxygen measured by arterial blood gas can reliably identify patients in whom CPAP is likely to fail. Additional research is required to determine the role of HSAT in the identification and treatment of patients with hypoventilation.

Effects of Wait Times on Treatment Adherence and Clinical Outcomes in Patients With Severe Sleep-Disordered Breathing: A Secondary Analysis of a Noninferiority Randomized Clinical Trial.

Importance: Sleep-disordered breathing (SDB) is common and associated with substantial adverse health consequences. Long wait times for SDB care are commonly reported; however, it is unclear whether wait times for care are associated with clinical outcomes. Objective: To evaluate the association of wait times for care with clinical outcomes for patients with severe SDB. Design, Setting, and Participants: This study is a secondary analysis of a randomized clinical noninferiority trial comparing management by alternative care practitioners (ACPs) with traditional sleep physician-led care between October 2014 and May 2017. The study took place at Foothills Medical Centre Sleep Centre, a tertiary care multidisciplinary sleep clinic at the University of Calgary. Patients with severe SDB (defined as a respiratory event index ≥30 events per hour during home sleep apnea testing, mean nocturnal oxygen saturation ≤85%, or suspected sleep hypoventilation syndrome) were recruited for the study. Patients were excluded if they were suspected of having a concomitant sleep disorder other than SDB or had previously been treated with positive airway pressure (PAP) therapy for SDB. Data were analyzed from October 2017 to January 2020. Main Outcomes and Measures: Outcomes were assessed 3 months after treatment initiation with adherence to PAP therapy as the primary outcome. Secondary outcomes included Epworth Sleepiness Scale score, health-related quality of life, and patient satisfaction measured using the Visit-Specific Satisfaction Instrument-9. Multiple regression models were used to assess the associations between wait times and each of the outcomes. t tests were used to compare wait times for patients who were adherent to PAP therapy (≥4 hours per night for 70% of nights) with those for nonadherent patients. Results: One hundred fifty-six patients (112 [71.8%] men; mean [SD] age, 56 [12] years) were included in the analysis. The mean time from referral to initial visit was 88 days (95% CI, 79 to 96 days), and the mean time to treatment was 123 days (95% CI, 112 to 133 days). Shorter wait time to treatment initiation was associated with adherence to PAP therapy (odds ratio, 0.99; 95% CI, 0.98 to 0.99; P = .04), greater improvement in Epworth Sleepiness Scale score (mean coefficient, -9.37; 95% CI, -18.51 to -0.24; P = .04), and higher Visit-Specific Satisfaction Instrument-9 score (mean coefficient, -0.024; 95% CI, -0.047 to -0.0015; P = .04) at 3 months. Compared with nonadherent patients, those who were adherent to treatment waited a mean of 15 fewer days (95% CI, 12 to 19 days) for initial assessment (P = .07) and 30 fewer days (95% CI, 23 to 35 days) for treatment initiation (P = .008). Conclusions and Relevance: Earlier initiation of treatment for severe SDB was associated with better PAP adherence and greater improvements in daytime sleepiness and patient satisfaction. These findings suggest that system interventions to improve timely access may modify patient behavior and improve clinical outcomes. Trial Registration: ClinicalTrials.gov Identifier: NCT02191085.

A Randomized Controlled Trial of an Alternative Care Provider Clinic for Severe Sleep-disordered Breathing.

Rationale: Lack of timely access to diagnosis and treatment of sleep-disordered breathing (SDB) has sparked interest in using nonphysician providers. Previous studies of these alternative care providers (ACPs) excluded patients with more complicated forms of SDB and did not directly explore the impacts of a model incorporating ACPs on healthcare system performance, such as wait times.Objectives: To evaluate the use of ACPs in the management of patients with severe SDB from a clinical and system perspective.Methods: In this noninferiority study, patients with severe SDB (N = 156) were enrolled from October 2014 to July 2016 and randomized to either sleep physician management or management by ACP with same-day sleep physician review. Severe SDB was defined as one of 1) respiratory event index greater than 30/h, 2) mean nocturnal oxygen saturation less than 85%, and 3) arterial carbon dioxide greater than 45 mm Hg with respiratory event index greater than 15/h. The primary outcome was nightly positive airway pressure adherence at 3 months, using a noninferiority margin of 1 hour. Secondary outcomes included sleepiness, quality of life, patient satisfaction, wait times for diagnosis and treatment initiation, and demand for further testing and clinical assessment. Outcomes were evaluated using modified intention-to-treat and per-protocol analyses.Results: Care delivery using ACPs was indeterminate compared with sleep physician care with respect to treatment adherence, because the 95% confidence interval included the noninferiority margin of 1 hour (mean difference, -0.5 [-1.49 to 0.49] h). Patients in the ACP arm reported greater improvements in sleepiness and quality of life; wait times were shorter for initial assessment (28%) and treatment initiation (18%). There was no difference in demand for sleep testing or clinical follow-up. Per-protocol analysis revealed similar results.Conclusions: Management of severe SDB using ACPs was indeterminate compared with sleep physician care. The small decrease in adherence in the ACP arm was balanced by benefits in patient-reported outcomes and reduction in wait times. In systems with unacceptably long wait times for SDB diagnosis and treatment, a small decrease in treatment adherence, as was observed in this study, may be an acceptable trade-off to improve access to care for patients with severe SDB.Clinical trial registered with www.clinicaltrials.gov (NCT02191085).

Effect of CPAP therapy on kidney function in patients with obstructive sleep apnoea and chronic kidney disease: a protocol for a randomised controlled clinical trial.

INTRODUCTION: Obstructive sleep apnoea (OSA) is common in patients with chronic kidney disease (CKD) and may contribute to the progression of kidney disease either through direct effects of hypoxia on the kidney or indirectly through hypoxaemia-induced oxidative stress, endothelial dysfunction, inflammation, activation of the renin-angiotensin and sympathetic nervous systems, and hypertension. Treatment of OSA with continuous positive airway pressure (CPAP) improves many of these physiological abnormalities in patients with normal renal function, though to date there are no trials evaluating the effect of OSA treatment on kidney function in patients with CKD. The purpose of this study is to test the feasibility and efficacy of CPAP therapy in CKD patients with OSA. METHODS AND ANALYSIS: The study is a randomised, controlled, non-blinded, parallel clinical trial in which patients with established CKD are screened for OSA. Patients with OSA are randomised to either conventional medical therapy (control group) or medical therapy and CPAP (CPAP group) and followed for 1 year. The primary outcome is the change in estimated glomerular filtration rate. Secondary outcomes are the change in the urinary albumin/creatinine ratio, the Epworth Sleepiness Scale , Pittsburgh Sleep Quality Index and Kidney Disease Quality of Life questionnaire. ETHICS AND DISSEMINATION: Ethics approval has been obtained from the Conjoint Health Research Ethics Board (ID: REB15-0055). Results from this study will be disseminated through presentations at scientific conferences and publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT02420184; Pre-results.