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.

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.

Summative Assessment of Interprofessional "Collaborative Practice" Skills in Graduating Medical Students: A Validity Argument.

PURPOSE: To describe how the authors developed an objective structured clinical examination (OSCE) station to assess aspects of collaborative practice competency and how they then assessed validity using Kane's framework. METHOD: After piloting the collaborative practice OSCE station in 2015 and 2016, this was introduced at the Cumming School of Medicine in 2017. One hundred fifty-five students from the class of 2017 and 22 students from the class of 2018 participated. To create a validity argument, the authors used Kane's framework that views the argument for validity as 4 sequential inferences on the validity of scoring, generalization, extrapolation, and implications, RESULTS: Scoring validity is supported by psychometric analysis of checklist items and the fact that the contribution of rater specificity to students' ratings was similar to OSCE stations assessing clinical skills alone. The claim of validity of generalization is backed by structural equation modeling and confirmatory factor analysis that identified 5 latent variables, including 3 related to collaborative practice ("provides an effective handover," "provides mutual support," and "shares their mental model"). Validity of extrapolation is argued based upon the correlation between the rating for "shares their mental model" and the rating on in-training evaluations for "relationship with other members of the health care team," in addition to the association between performance on the collaborative practice OSCE station and the subsequent rating of performance during residency. Finally, validity of implications is supported by the fact that pass/fail decisions on the collaborative practice station were similar to other stations and by the observation that ratings on different aspects of collaborative practice associate with pass/fail decisions. CONCLUSIONS: Based upon the validity argument presented, the authors posit that this tool can be used to assess the collaborative practice competence of graduating medical students and the adequacy of training in collaborative practice.

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).

Cognitive Load Theory for debriefing simulations: implications for faculty development.

The debriefing is an essential component of simulation-based training for healthcare professionals, but learning this complex skill can be challenging for simulation faculty. There are multiple competing priorities for a debriefer's attention that can contribute to a high mental workload, which may adversely affect debriefer performance and consequently learner outcomes. In this paper, we conceptualize the debriefer as a learner of debriefing skills and we discuss Cognitive Load Theory to categorize the many potential mental loads that can affect the faculty debriefer as learner. We then discuss mitigation strategies that can be considered by faculty development programmes to enhance professional development of debriefing staff.

Pneumothoraces in collagen VI-related dystrophy: a case series and recommendations for management.

Collagen VI-related dystrophy (collagen VI-RD) is a rare neuromuscular condition caused by mutations in the COL6A1, COL6A2 or COL6A3 genes. The phenotypic spectrum includes early-onset Ullrich congenital muscular dystrophy, adult-onset Bethlem myopathy and an intermediate phenotype. The disorder is characterised by distal hyperlaxity and progressive muscle weakness, joint contractures and respiratory insufficiency. Respiratory insufficiency is attributed to chest wall contractures, scoliosis, impaired diaphragmatic function and intercostal muscle weakness. To date, intrinsic parenchymal lung disease has not been implicated in the inevitable respiratory decline of these patients. This series focuses on pneumothorax, an important but previously under-recognised disease manifestation of collagen VI-RD. We describe two distinct clinical presentations within collagen VI-RD patients with pneumothorax. The first cohort consists of neonates and children with a single pneumothorax in the setting of large intrathoracic pressure changes. The second group is made up of adult patients with recurrent pneumothoraces, associated with chest computed tomography scan evidence of parenchymal lung disease. We describe treatment challenges in this unique population with respect to expectant observation, tube thoracostomy and open pleurodesis. Based on this experience, we offer recommendations for early identification of lung disease in collagen VI-RD and definitive intervention.

Evaluation of an alternative care provider clinic for severe sleep-disordered breathing: a study protocol for a randomised controlled trial.

INTRODUCTION: Despite the high prevalence of sleep-disordered breathing (SDB) and the significant health consequences associated with untreated disease, access to diagnosis and treatment remains a challenge. Even patients with severe SDB (severe obstructive sleep apnoea or hypoventilation), who are at particularly high risk of adverse health effects, are subject to long delays. Previous research has demonstrated that, within a sleep clinic, management by alternative care providers (ACPs) is effective for patients with milder forms of SDB. The purpose of this study is to compare an ACP-led clinic (ACP Clinic) for patients with severe SDB to physician-led care, from the perspective of clinical outcomes, health system efficiency and cost. METHODS AND ANALYSIS: The study is a randomised, controlled, non-inferiority study in which patients who are referred with severe SDB are randomised to management by a sleep physician or by an ACP. ACPs will be supervised by sleep physicians for safety. The primary outcome is positive airway pressure (PAP) adherence after 3 months of therapy. Secondary outcomes include: long-term PAP adherence; clinical response to therapy; health-related quality of life; patient satisfaction; healthcare usage; wait times from referral to treatment initiation and cost-effectiveness. The economic analysis will be performed using the perspective of a publicly funded healthcare system. ETHICS AND DISSEMINATION: Ethics approval was obtained from the Conjoint Health Research Ethics Board (ID: REB13-1280) at the University of Calgary. Results from this study will be disseminated through presentations at scientific conferences and publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT02191085; Pre-results.

Cognitive Load Theory for the Design of Medical Simulations.

STATEMENT: Simulation-based education (SBE) has emerged as an effective and important tool for medical educators, but research about how to optimize training with simulators is in its infancy. It is often difficult to generalize results from experiments on instructional design issues in simulation because of the heterogeneity of learner groups, teaching methods, and rapidly changing technologies. We have found that cognitive load theory is highly relevant to teaching in the simulation laboratory and a useful conceptual framework to reference when designing or researching simulation-based education. Herein, we briefly describe cognitive load theory, its grounding in our current understanding of cognitive architecture, and the evidence supporting it. We focus our discussion on a few well-established cognitive load effects with examples from simulation training and recommend some instructional applications with theoretical potential to improve learning outcomes.