Objective adherence to dental device versus positive airway pressure treatment in adults with obstructive sleep apnea.

Although mandibular advancement device (MAD) treatment of adults with obstructive sleep apnea (OSA) is generally less efficacious than positive airway pressure (PAP), the two treatments are associated, with similar clinical outcomes. As a sub-analysis of a randomized trial comparing the effect of MAD versus PAP on blood pressure, this study compared objectively measured adherence to MAD versus PAP treatment in adults with OSA. Adults with OSA (age 54.1 ± 11.2 [standard deviation] years, 71.1% male, apnea-hypopnea index 31.6 ± 22.7 events/h) were randomized to MAD (n = 89) or PAP (n = 91) treatment for 3-6 months. Objective adherence was assessed with a thermal sensor embedded in the MAD and a pressure sensor in the PAP unit. In a per protocol analysis, no difference was observed in average daily hours of use over all days in participants on MAD (n = 35, 4.4 ± 2.9 h) versus PAP (n = 51, 4.7 ± 1.6 h, p = .597) treatment when days with missing adherence data were included as no use. MAD was used on a lower percentage of days (62.5 ± 36.4% versus 79.9 ± 19.8%, p = .047), but with greater average daily hours of use on days used (6.4 ± 1.9 h versus 5.7 ± 1.2 h, p = .013). Average daily hours of use in the first week were associated with long-term adherence to MAD (p < .0001) and PAP (p = .0009) treatment. Similar results were obtained when excluding days with missing adherence data. In conclusion, no significant difference was observed in objectively measured average daily hours of MAD and PAP adherence in adults with OSA, despite differences in the patterns of use. MAD adherence in the first week predicted long-term use.

Comparing two measures of sleep depth/intensity.

STUDY OBJECTIVES: To compare delta spectral power (delta) and odds ratio product (ORP) as measures of sleep depth during sleep restriction with placebo or a drug that increases delta. METHODS: This is a secondary analysis of data from a study of 41 healthy participants randomized to receive placebo or gaboxadol 15 mg during sleep restriction. Participants underwent in-laboratory sleep studies on two baseline, four sleep restriction (5-h), and two recovery nights. Relation between delta or ORP and sleep depth was operationally defined as the degree of association of each metric to the probability of arousal or awakening occurring during the next 30 s (arousability). RESULTS: ORP values in wake, N1, N2, N3, and REM were significantly different. Delta differed between both N2 and N3 and other sleep stages but not between wake and N1 or N1 and REM. Epoch-by-epoch and individual correlations between ORP and delta power were modest or insignificant. The relation between ORP and arousability was linear across the entire ORP range. Delta also changed with arousability but only when delta values were less than 300 µV2. Receiver-operating-characteristic analysis found the ability to predict imminent arousal to be significantly greater with ORP than with log delta power for all experimental conditions. Changes in ORP, but not log delta, across the night correlated with next-day physiologic sleep tendency. CONCLUSIONS: Compared to delta power, ORP is more discriminating among sleep stages, more sensitive to sleep restriction, and more closely associated with arousability. This evidence supports ORP as a measure of sleep depth/intensity.

A potential new form of jail diversion and reconnection to mental health services: I. Stakeholders' views on acceptability.

The most effective point of intervention to prevent unnecessary arrest/incarceration of persons with serious mental illnesses is the initial encounter with police. We piloted a new police-mental health linkage system. When officers run an enrolled participant's name/identifiers, they receive an electronic message that the person has mental health considerations and that they should call for information. The linkage specialist receives the call and assists telephonically. In this qualitative study to examine acceptability of the linkage system, we conducted nine focus groups with diverse stakeholders (e.g., enrolled patients, officers). Focus groups revealed that patients enrolled with the hope that the linkage system would prevent negative interactions with police and minimize risk of arrest. Officers reported preferring not to arrest mental health patients and were genuinely invested in helping them, and felt that the linkage system might be an additional tool during encounters. Findings revealed acceptability of the intervention, and further research is warranted.

SMART DOCS: a new patient-centered outcomes and coordinated-care management approach for the future practice of sleep medicine.

ABSTRACT: The practice of medicine is currently undergoing a transformation to become more efficient, cost-effective, and patient centered in its delivery of care. The aim of this article is to stimulate discussion within the sleep medicine community in addressing these needs by our approach as well as other approaches to sleep medicine care. The primary goals of the Sustainable Methods, Algorithms, and Research Tools for Delivering Optimal Care Study (SMART DOCS) are: (1) to introduce a new Patient-Centered Outcomes and Coordinated-Care Management (PCCM) approach for the future practice of sleep medicine, and (2) to test the PCCM approach against a Conventional Diagnostic and Treatment Outpatient Medical Care (CONV) approach in a randomized, two-arm, single-center, long-term, comparative effectiveness trial. The PCCM approach is integrated into a novel outpatient care delivery model for patients with sleep disorders that includes the latest technology, allowing providers to obtain more accurate and rapid diagnoses and to make evidence-based treatment recommendations, while simultaneously enabling patients to have access to personalized medical information and reports regarding their diagnosis and treatment so that they can make more informed health care decisions. Additionally, the PCCM approach facilitates better communication between patients, referring primary care physicians, sleep specialists, and allied health professionals so that providers can better assist patients in achieving their preferred outcomes. A total of 1,506 patients 18 y or older will be randomized to either the PCCM or CONV approach and will be followed for at least 1 y with endpoints of improved health care performance, better health, and cost control. CLINICAL TRIALS NUMBER: http://www.clinicaltrials.gov, NCT02037438.

The COMET Sleep Research Platform.

INTRODUCTION: The Comparative Outcomes Management with Electronic Data Technology (COMET) platform is extensible and designed for facilitating multicenter electronic clinical research. BACKGROUND: Our research goals were the following: (1) to conduct a comparative effectiveness trial (CET) for two obstructive sleep apnea treatments-positive airway pressure versus oral appliance therapy; and (2) to establish a new electronic network infrastructure that would support this study and other clinical research studies. DISCUSSION: The COMET platform was created to satisfy the needs of CET with a focus on creating a platform that provides comprehensive toolsets, multisite collaboration, and end-to-end data management. The platform also provides medical researchers the ability to visualize and interpret data using business intelligence (BI) tools. CONCLUSION: COMET is a research platform that is scalable and extensible, and which, in a future version, can accommodate big data sets and enable efficient and effective research across multiple studies and medical specialties. The COMET platform components were designed for an eventual move to a cloud computing infrastructure that enhances sustainability, overall cost effectiveness, and return on investment.

Strategies for de-identification and anonymization of electronic health record data for use in multicenter research studies.

BACKGROUND: De-identification and anonymization are strategies that are used to remove patient identifiers in electronic health record data. The use of these strategies in multicenter research studies is paramount in importance, given the need to share electronic health record data across multiple environments and institutions while safeguarding patient privacy. METHODS: Systematic literature search using keywords of de-identify, deidentify, de-identification, deidentification, anonymize, anonymization, data scrubbing, and text scrubbing. Search was conducted up to June 30, 2011 and involved 6 different common literature databases. A total of 1798 prospective citations were identified, and 94 full-text articles met the criteria for review and the corresponding articles were obtained. Search results were supplemented by review of 26 additional full-text articles; a total of 120 full-text articles were reviewed. RESULTS: A final sample of 45 articles met inclusion criteria for review and discussion. Articles were grouped into text, images, and biological sample categories. For text-based strategies, the approaches were segregated into heuristic, lexical, and pattern-based systems versus statistical learning-based systems. For images, approaches that de-identified photographic facial images and magnetic resonance image data were described. For biological samples, approaches that managed the identifiers linked with these samples were discussed, particularly with respect to meeting the anonymization requirements needed for Institutional Review Board exemption under the Common Rule. CONCLUSIONS: Current de-identification strategies have their limitations, and statistical learning-based systems have distinct advantages over other approaches for the de-identification of free text. True anonymization is challenging, and further work is needed in the areas of de-identification of datasets and protection of genetic information.

A convenient expiratory positive airway pressure nasal device for the treatment of sleep apnea in patients non-adherent with continuous positive airway pressure.

BACKGROUND: While continuous positive airway pressure (CPAP) effectively treats obstructive sleep apnea (OSA), adherence to CPAP is suboptimal. The short-term efficacy of and adherence with a convenient expiratory positive airway pressure (EPAP) nasal device was evaluated in OSA patients non-adherent with CPAP. METHODS: Participants were OSA patients who refused CPAP or used CPAP less than 3 h per night. After demonstrating tolerability to the EPAP device during approximately 1 week of home use, patients underwent a screening/baseline polysomnogram (PSG1) and a treatment PSG (PSG2). Patients meeting prespecified efficacy criteria underwent PSG3 after about 5 weeks of EPAP treatment. RESULTS: Forty-seven of 59 eligible patients (80%) tolerated the device and underwent PSG1. Forty-three patients (27 m, 16f; 53.7±10.9 years) met AHI entry criteria and underwent PSG2. Mean AHI decreased from 43.3±29.0 at baseline to 27.0±26.7 (p<0.001) at PSG2. Twenty-four patients (56%) met efficacy criteria; their mean AHI was 31.9±19.8, 11.0±7.9, 16.4±12.2 at PSG1, PSG2, and PSG3, respectively (p<0.001, PSG1 vs. both PSG2 and PSG3). Mean Epworth Sleepiness Scale (ESS) scores were 12.3±4.8 at baseline, 11.1±5.1 at PSG1, and 8.7±4.4 at PSG3 (p=0.001 compared to baseline). Device use was reported an average of 92% of all sleep hours. CONCLUSIONS: The improvements in AHI and ESS, combined with the high degree of treatment adherence observed, suggest that the convenient EPAP device tested may become a useful therapeutic option for OSA.

Enhancing slow wave sleep with sodium oxybate reduces the behavioral and physiological impact of sleep loss.

STUDY OBJECTIVES: To investigate whether enhancement of slow wave sleep (SWS) with sodium oxybate reduces the impact of sleep deprivation. DESIGN: Double-blind, parallel group, placebo-controlled design SETTING: Sleep research laboratory PARTICIPANTS: Fifty-eight healthy adults (28 placebo, 30 sodium oxybate), ages 18-50 years. INTERVENTIONS: A 5-day protocol included 2 screening/baseline nights and days, 2 sleep deprivation nights, each followed by a 3-h daytime (08:00-11:00) sleep opportunity and a recovery night. Sodium oxybate or placebo was administered prior to each daytime sleep period. Multiple sleep latency test (MSLT), psychomotor vigilance test (PVT), Karolinska Sleepiness Scale (KSS), and Profile of Mood States were administered during waking hours. MEASUREMENTS AND RESULTS: During daytime sleep, the sodium oxybate group had more SWS, more EEG spectral power in the 1-9 Hz range, and less REM. Mean MSLT latency was longer for the sodium oxybate group on the night following the first daytime sleep period and on the day following the second day sleep period. Median PVT reaction time was faster in the sodium oxybate group following the second day sleep period. The change from baseline in SWS was positively correlated with the change in MSLT and KSS. During recovery sleep the sodium oxybate group had less TST, SWS, REM, and slow wave activity (SWA) than the placebo group. CONCLUSIONS: Pharmacological enhancement of SWS with sodium oxybate resulted in a reduced response to sleep loss on measures of alertness and attention. In addition, SWS enhancement during sleep restriction appears to result in a reduced homeostatic response to sleep loss.

Smoking in urban outdoor public places: Behaviour, experiences, and implications for public health.

This paper identifies factors that influence where people smoke outdoors and examines the impact of smoking on people who use outdoor public places. Direct observations of smoking at 12 outdoor public places and semi-structured interviews with 35 non-smoking and smoking adults were used to gather information in Toronto, Canada, about where people smoke, and smoking related behaviours, perspectives, and experiences. Observation and interview data show that smoking at building entrances was problematic. In total, approximately 37% of smoking observed across the sites was within 9m of building entrances. Shelter, convenience, the social culture of smoking, visibility, and the presence of non-smokers were key factors that influenced where people smoked. Clearly defined rules for smoking at building entrances may allow users of public spaces to avoid tobacco smoke when entering and exiting. However, further research is needed regarding the effectiveness of outdoor restrictions and potential unintended consequences.

Tobacco promotions at point-of-sale: the last hurrah.

OBJECTIVES: The retail environment provides important opportunities for tobacco industry communication with current, former, and potential smokers. This study documented the extent of tobacco promotions at the retail point-of-sale and examined associations between the extent of tobacco promotions and relevant city and store characteristics. METHODS: In each of 20 Ontario cities, 24 establishments were randomly selected from lists of convenience stores, gas stations, and grocery stores. Trained observers captured the range, type and intensity of tobacco promotions from April to July 2005. The extent of tobacco promotions was described using weighted descriptive statistics. Weighted t-tests and ANOVAs, and hierarchical linear modeling, were used to examine the relationships between tobacco promotions and city and store characteristics. RESULTS: Extensive tobacco promotions were found in Ontario stores one year prior to the implementation of a partial ban on retail displays, particularly in chain convenience stores, gas station convenience stores and independent convenience stores. The multivariate hierarchical linear model confirmed differences in the extent of tobacco promotions by store type (p < 0.01); in addition, tobacco promotions were found to be higher among stores close to a school (p = 0.01) and in neighbourhoods with lower median household incomes (p < 0.01). Independent convenience stores with a greater number of employees had more tobacco promotions; however, the relationship was reversed for grocery stores. DISCUSSION: Tobacco promotions were extensive at the point-of-sale. Public health messages about the harms of tobacco use may be compromised by the pervasiveness of these promotions.

Slow wave sleep enhancement with gaboxadol reduces daytime sleepiness during sleep restriction.

STUDY OBJECTIVES: To evaluate the impact of enhanced slow wave sleep (SWS) on behavioral, psychological, and physiological changes resulting from sleep restriction. DESIGN: A double-blind, parallel group, placebo-controlled design was used to compare gaboxadol (GBX) 15 mg, a SWS-enhancing drug, to placebo during 4 nights of sleep restriction (5 h/night). Behavioral, psychological, and physiological measures of the impact of sleep restriction were assessed in both groups at baseline, during sleep restriction and following recovery sleep. SETTING: Sleep research laboratory. PARTICIPANTS: Forty-one healthy adults; 9 males and 12 females (mean age: 32.0 +/- 9.9 y) in the placebo group and 10 males and 10 females (mean age: 31.9 +/- 10.2 y) in the GBX group. INTERVENTIONS: Both experimental groups underwent 4 nights of sleep restriction. Each group received either GBX 15 mg or placebo on all sleep restriction nights, and both groups received placebo on baseline and recovery nights. MEASUREMENTS AND RESULTS: Polysomnography documented a SWS-enhancing effect of GBX with no group difference in total sleep time during sleep restriction. The placebo group displayed the predicted deficits due to sleep restriction on the multiple sleep latency test (MSLT) and on introspective measures of sleepiness and fatigue. Compared to placebo, the GBX group showed significantly less physiological sleepiness on the MSLT and lower levels of introspective sleepiness and fatigue during sleep restriction. There were no differences between groups on the psychomotor vigilance task (PVT) and a cognitive test battery, but these measures were minimally affected by sleep restriction in this study. The correlation between change from baseline in MSLT on Day 6 and change from baseline in SWS on Night 6 was significant in the GBX group and in both group combined. CONCLUSIONS: The results of this study are consistent with the hypothesis that enhanced SWS, in this study produced by GBX, reduces physiological sleep tendency and introspective sleepiness and fatigue which typically result from sleep restriction.

Survivor dragon boating: a vehicle to reclaim and enhance life after treatment for breast cancer.

The authors investigated the psychosocial impact of dragon boat participation on women who have been treated for breast cancer. Open-ended qualitative interviews were completed by 10 new members recruited from two breast cancer survivor dragon boat teams. Our findings indicate that the women's experience of survivor dragon boating surpassed their expectations and offered them hope and increased strength and the ability to regain control of their lives. Key themes emerging from the in-depth interviews that encapsulate the experiences of women in their first season of dragon boating follow: awakening of the self, common bond, regaining control, being uplifted, and transcending the fear of death. The interview data support the emerging hypothesis that dragon boating is a vehicle for improving women's wellness and post-treatment quality of life.

'We Will Never Ever Forget.': the Swissair flight 111 disaster and its impact on volunteers and communities.

In collaboration with a Community Advisory Group we examined the impact of the 1998 Swissair Flight 111 disaster on volunteer responders and surrounding communities. We conducted qualitative interviews and administered a set of structured questionnaires to 13 volunteer disaster workers and conducted a focus group with community leaders. Community silence and limited help-seeking behaviour were typical reactions to the SA 111 disaster. The nature and duration of the disaster response efforts contributed to a probable 46 per cent PTSD rate in the community volunteers. Community-based, culturally appropriate followup, as well as the development of volunteer protocols for future disaster response efforts, are necessary to minimize long-term health impacts and to promote resilience among community residents and volunteers exposed to a major disaster.