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  1. Article ; Online: Cost-Utility Analysis of Continuous Positive Airway Pressure Therapy Compared With Usual Care for Obstructive Sleep Apnea in the Public Health System in Brazil.

    Pachito, Daniela V / Eckeli, Alan L / Drager, Luciano F

    Value in health regional issues

    2023  Volume 40, Page(s) 81–88

    Abstract: Objectives: This study aimed to conduct a cost-utility analysis of continuous positive airway pressure (CPAP) therapy compared with usual care as treatment of moderate to severe cases of obstructive sleep apnea (OSA) in Brazil, where decentralized ... ...

    Abstract Objectives: This study aimed to conduct a cost-utility analysis of continuous positive airway pressure (CPAP) therapy compared with usual care as treatment of moderate to severe cases of obstructive sleep apnea (OSA) in Brazil, where decentralized policies of CPAP provision are in place.
    Methods: Markov cohort model comparing CPAP therapy with usual care, that is, no specific treatment for OSA, for moderate to severe cases was used. The payer perspective from the Unified Health System, Brazil, was adopted. Effectiveness parameters and costs related to health states were informed by literature review. Resource use related to CPAP therapy was defined by specialists and costs informed by recent purchase and leasing contracts. Incremental cost-effectiveness ratios were generated for purchase and leasing contracts to reflect current practices. A conservative willingness-to-pay threshold was set at 1 gross domestic product per capita per quality-adjusted life-year (QALY) (Brazilian reais [BRL] 40 712/QALY). Uncertainties were explored in deterministic and probabilistic sensitivity analyses.
    Results: Incremental cost-effectiveness ratio for the purchase modality was 8303 BRL/QALY and for leasing 45 192 BRL/QALY. Considering the adopted willingness-to-pay threshold, provision of CPAP by the purchase modality was considered cost-effective but not the leasing modality. The parameter related to the greatest uncertainty was the reduction in the risk of having a stroke attributable to CPAP. Probabilistic analysis confirmed the robustness of results.
    Conclusions: CPAP therapy is a cost-effective alternative compared with usual care for moderate to severe OSA for the purchase modality. These results should help underpinning the decision making related to a uniform policy of CPAP provision across the country.
    MeSH term(s) Humans ; Continuous Positive Airway Pressure/methods ; Cost-Benefit Analysis ; Brazil ; Public Health ; Sleep Apnea, Obstructive/therapy
    Language English
    Publishing date 2023-12-05
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2679127-4
    ISSN 2212-1102 ; 2212-1099
    ISSN (online) 2212-1102
    ISSN 2212-1099
    DOI 10.1016/j.vhri.2023.10.006
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Non-invasive positive pressure ventilation for central sleep apnoea in adults.

    Pinto, Ana Carolina Pereira Nunes / Rocha, Aline / Pachito, Daniela V / Drager, Luciano F / Lorenzi-Filho, Geraldo

    The Cochrane database of systematic reviews

    2022  Volume 10, Page(s) CD012889

    Abstract: Background: Central sleep apnoea (CSA) is characterised by abnormal patterns of ventilation during sleep due to a dysfunctional drive to breathe. Consequently, people with CSA may present poor sleep quality, sleep fragmentation, inattention, fatigue, ... ...

    Abstract Background: Central sleep apnoea (CSA) is characterised by abnormal patterns of ventilation during sleep due to a dysfunctional drive to breathe. Consequently, people with CSA may present poor sleep quality, sleep fragmentation, inattention, fatigue, daytime sleepiness, and reduced quality of life.
    Objectives: To assess the effectiveness and safety of non-invasive positive pressure ventilation (NIPV) for the treatment of adults with CSA.
    Search methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and Scopus on 6 September 2021. We applied no restrictions on language of publication. We also searched clinical trials registries for ongoing and unpublished studies, and scanned the reference lists of included studies to identify additional studies.
    Selection criteria: We included randomised controlled trials (RCTs) reported in full text, those published as abstract only, and unpublished data.
    Data collection and analysis: Two review authors independently selected studies for inclusion, extracted data, and assessed risk of bias of the included studies using the Cochrane risk of bias tool version 1.0, and the certainty of the evidence using the GRADE approach. In the case of disagreement, a third review author was consulted.
    Main results: We included 15 RCTs with a total of 1936 participants, ranging from 10 to 1325 participants. All studies had important methodological limitations. We assessed most studies (11 studies) as at high risk of bias for at least one domain, and all studies as at unclear risk of bias for at least two domains. The trials included participants aged > 18 years old, of which 70% to 100% were men, who were followed from one week to 60 months. The included studies assessed the effects of different modes of NIPV and CSA. Most participants had CSA associated with chronic heart failure. Because CSA encompasses a variety of causes and underlying clinical conditions, data were carefully analysed, and different conditions and populations were not pooled. The findings for the primary outcomes for the seven evaluated comparisons are presented below.  Continuous positive airway pressure (CPAP) plus best supportive care versus best supportive care in CSA associated with chronic heart failure In the short term, CPAP plus best supportive care may reduce central apnoea hypopnoea index (AHI) (mean difference (MD) -14.60, 95% confidence interval (CI) -20.11 to -9.09; 1 study; 205 participants). However, CPAP plus best supportive care may result in little to no difference in cardiovascular mortality compared to best supportive care alone. The evidence for the effect of CPAP plus best supportive care on all-cause mortality is very uncertain. No adverse effects were observed with CPAP, and the results for adverse events in the best supportive care group were not reported. Adaptive servo ventilation (ASV) versus CPAP in CSA associated with chronic heart failure The evidence is very uncertain about the effect of ASV versus CPAP on quality of life evaluated in both the short and medium term. Data on adverse events were not reported, and it is not clear whether data were sought but not found. ASV versus bilevel ventilation in CSA associated with chronic heart failure In the short term, ASV may result in little to no difference in central AHI. No adverse events were detected with ASV, and the results for adverse events in the bilevel ventilation group were not reported. ASV plus best supportive care versus best supportive care in CSA associated with chronic heart failure In the medium term, ASV plus best supportive care may reduce AHI compared to best supportive care alone (MD -20.30, 95% CI -28.75 to -11.85; 1 study; 30 participants). In the long term, ASV plus best supportive care likely increases cardiovascular mortality compared to best supportive care (risk ratio (RR) 1.25, 95% CI 1.04, 1.49; 1 study; 1325 participants). The evidence suggests that ASV plus best supportive care may result in little to no difference in quality of life in the short, medium, and long term, and in all-cause mortality in the medium and long term. Data on adverse events were evaluated but not reported. ASV plus best supportive care versus best supportive care in CSA with acute heart failure with preserved ejection fraction Only adverse events were reported for this comparison, and no adverse events were recorded in either group. ASV versus CPAP maintenance in CPAP-induced CSA In the short term, ASV may slightly reduce central AHI (MD -4.10, 95% CI -6.67 to -1.53; 1 study; 60 participants), but may result in little to no difference in quality of life. Data on adverse events were not reported, and it is not clear whether data were sought but not found. ASV versus bilevel ventilation in CPAP-induced CSA In the short term, ASV may slightly reduce central AHI (MD -8.70, 95% CI -11.42 to -5.98; 1 study; 30 participants) compared to bilevel ventilation. Data on adverse events were not reported, and it is not clear whether data were sought but not found.
    Authors' conclusions: CPAP plus best supportive care may reduce central AHI in people with CSA associated with chronic heart failure compared to best supportive care alone. Although ASV plus best supportive care may reduce AHI in people with CSA associated with chronic heart failure, it likely increases cardiovascular mortality in these individuals. In people with CPAP-induced CSA, ASV may slightly reduce central AHI compared to bilevel ventilation and to CPAP. In the absence of data showing a favourable impact on meaningful patient-centred outcomes and defining clinically important differences in outcomes in CSA patients, these findings need to be interpreted with caution. Considering the level of certainty of the available evidence and the heterogeneity of participants with CSA, we could draw no definitive conclusions, and further high-quality trials focusing on patient-centred outcomes, such as quality of life, quality of sleep, and longer-term survival, are needed to determine whether one mode of NIPV is better than another or than best supportive care for any particular CSA patient group.
    MeSH term(s) Adult ; Male ; Humans ; Adolescent ; Female ; Sleep Apnea, Central/therapy ; Sleep Apnea, Obstructive/therapy ; Continuous Positive Airway Pressure ; Disorders of Excessive Somnolence ; Heart Failure
    Language English
    Publishing date 2022-10-24
    Publishing country England
    Document type Journal Article ; Review ; Research Support, Non-U.S. Gov't ; Systematic Review
    ISSN 1469-493X
    ISSN (online) 1469-493X
    DOI 10.1002/14651858.CD012889.pub2
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Legal action for access to resources inefficiently made available in health care systems in Brazil: a case study on obstructive sleep apnea.

    Pachito, Daniela V / Finkelstein, Beny / Albertini, Claudia / Gaspar, Antonio / Pereira, Carolina / Vaz, Paulo / Eckeli, Alan Luiz / Drager, Luciano F

    Jornal brasileiro de pneumologia : publicacao oficial da Sociedade Brasileira de Pneumologia e Tisilogia

    2023  Volume 49, Issue 2, Page(s) e20220092

    Abstract: Objective: Obstructive sleep apnea (OSA) is a highly prevalent chronic disease, associated with morbidity and mortality. Although effective treatment for OSA is commercially available, their provision is not guaranteed by lines of care throughout Brazil, ...

    Abstract Objective: Obstructive sleep apnea (OSA) is a highly prevalent chronic disease, associated with morbidity and mortality. Although effective treatment for OSA is commercially available, their provision is not guaranteed by lines of care throughout Brazil, making legal action necessary. This study aimed at presenting data related to the volume of legal proceedings regarding the access to diagnosis and treatment of OSA in Brazil.
    Methods: This was a descriptive study of national scope, evaluating the period between January of 2016 and December of 2020. The number of lawsuits was analyzed according to the object of the demand (diagnosis or treatment). Projections of total expenses were carried out according to the number of lawsuits.
    Results: We identified 1,462 legal proceedings (17.6% and 82.4% related to diagnosis and treatment, respectively). The projection of expenditure for OSA diagnosis in the public and private spheres were R$575,227 and R$188,002, respectively. The projection of expenditure for OSA treatment in the public and private spheres were R$2,656,696 and R$253,050, respectively. There was a reduction in the number of lawsuits between 2017 and 2019.
    Conclusions: Legal action as a strategy for accessing diagnostic and therapeutic resources related to OSA is a recurrent practice, resulting in inefficiency and inequity. The reduction in the number of lawsuits between 2017 and 2019 might be explained by the expansion of local health care policies or by barriers in the journey of patients with OSA, such as difficulties in being referred to specialized health care and low availability of diagnostic resources.
    MeSH term(s) Humans ; Brazil ; Sleep Apnea, Obstructive/diagnosis ; Delivery of Health Care
    Language Portuguese
    Publishing date 2023-02-20
    Publishing country Brazil
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2223157-2
    ISSN 1806-3756 ; 1806-3713
    ISSN (online) 1806-3756
    ISSN 1806-3713
    DOI 10.36416/1806-3756/e20220092
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Pharmacological treatment for central sleep apnoea in adults.

    Rocha, Aline / Pinto, Ana Carolina Pereira Nunes / Pachito, Daniela V / Drager, Luciano F / Lorenzi-Filho, Geraldo / Atallah, Álvaro N

    The Cochrane database of systematic reviews

    2023  Volume 2, Page(s) CD012922

    Abstract: Background: The term central sleep apnoea (CSA) encompasses diverse clinical situations where a dysfunctional drive to breathe leads to recurrent respiratory events, namely apnoea (complete absence of ventilation) and hypopnoea sleep (insufficient ... ...

    Abstract Background: The term central sleep apnoea (CSA) encompasses diverse clinical situations where a dysfunctional drive to breathe leads to recurrent respiratory events, namely apnoea (complete absence of ventilation) and hypopnoea sleep (insufficient ventilation) during sleep. Studies have demonstrated that CSA responds to some extent to pharmacological agents with distinct mechanisms, such as sleep stabilisation and respiratory stimulation. Some therapies for CSA are associated with improved quality of life, although the evidence on this association is uncertain. Moreover, treatment of CSA with non-invasive positive pressure ventilation is not always effective or safe and may result in a residual apnoea-hypopnoea index.
    Objectives: To evaluate the benefits and harms of pharmacological treatment compared with active or inactive controls for central sleep apnoea in adults.
    Search methods: We used standard, extensive Cochrane search methods. The latest search date was 30 August 2022.
    Selection criteria: We included parallel and cross-over randomised controlled trials (RCTs) that evaluated any type of pharmacological agent compared with active controls (e.g. other medications) or passive controls (e.g. placebo, no treatment or usual care) in adults with CSA as defined by the International Classification of Sleep Disorders 3rd Edition. We did not exclude studies based on the duration of intervention or follow-up. We excluded studies focusing on CSA due to periodic breathing at high altitudes.
    Data collection and analysis: We used standard Cochrane methods. Our primary outcomes were central apnoea-hypopnoea index (cAHI), cardiovascular mortality and serious adverse events. Our secondary outcomes were quality of sleep, quality of life, daytime sleepiness, AHI, all-cause mortality, time to life-saving cardiovascular intervention, and non-serious adverse events. We used GRADE to assess certainty of evidence for each outcome.
    Main results: We included four cross-over RCTs and one parallel RCT, involving a total of 68 participants. Mean age ranged from 66 to 71.3 years and most participants were men. Four trials recruited people with CSA associated with heart failure, and one study included people with primary CSA. Types of pharmacological agents were acetazolamide (carbonic anhydrase inhibitor), buspirone (anxiolytic), theophylline (methylxanthine derivative) and triazolam (hypnotic), which were given for between three days and one week. Only the study on buspirone reported a formal evaluation of adverse events. These events were rare and mild. No studies reported serious adverse events, quality of sleep, quality of life, all-cause mortality, or time to life-saving cardiovascular intervention. Carbonic anhydrase inhibitors versus inactive control Results were from two studies of acetazolamide versus placebo (n = 12) and acetazolamide versus no acetazolamide (n = 18) for CSA associated with heart failure. One study reported short-term outcomes and the other reported intermediate-term outcomes. We are uncertain whether carbonic anhydrase inhibitors compared to inactive control reduce cAHI in the short term (mean difference (MD) -26.00 events per hour, 95% CI -43.84 to -8.16; 1 study, 12 participants; very low certainty). Similarly, we are uncertain whether carbonic anhydrase inhibitors compared to inactive control reduce AHI in the short term (MD -23.00 events per hour, 95% CI -37.70 to 8.30; 1 study, 12 participants; very low certainty) or in the intermediate term (MD -6.98 events per hour, 95% CI -10.66 to -3.30; 1 study, 18 participants; very low certainty). The effect of carbonic anhydrase inhibitors on cardiovascular mortality in the intermediate term was also uncertain (odds ratio (OR) 0.21, 95% CI 0.02 to 2.48; 1 study, 18 participants; very low certainty). Anxiolytics versus inactive control Results were based on one study of buspirone versus placebo for CSA associated with heart failure (n = 16). The median difference between groups for cAHI was -5.00 events per hour (IQR -8.00 to -0.50), the median difference for AHI was -6.00 events per hour (IQR -8.80 to -1.80), and the median difference on the Epworth Sleepiness Scale for daytime sleepiness was 0 points (IQR -1.0 to 0.00). Methylxanthine derivatives versus inactive control Results were based on one study of theophylline versus placebo for CSA associated with heart failure (n = 15). We are uncertain whether methylxanthine derivatives compared to inactive control reduce cAHI (MD -20.00 events per hour, 95% CI -32.15 to -7.85; 15 participants; very low certainty) or AHI (MD -19.00 events per hour, 95% CI -30.27 to -7.73; 15 participants; very low certainty). Hypnotics versus inactive control Results were based on one trial of triazolam versus placebo for primary CSA (n = 5). Due to very serious methodological limitations and insufficient reporting of outcome measures, we were unable to draw any conclusions regarding the effects of this intervention.
    Authors' conclusions: There is insufficient evidence to support the use of pharmacological therapy in the treatment of CSA. Although small studies have reported positive effects of certain agents for CSA associated with heart failure in reducing the number of respiratory events during sleep, we were unable to assess whether this reduction may impact the quality of life of people with CSA, owing to scarce reporting of important clinical outcomes such as sleep quality or subjective impression of daytime sleepiness. Furthermore, the trials mostly had short-term follow-up. There is a need for high-quality trials that evaluate longer-term effects of pharmacological interventions.
    MeSH term(s) Male ; Adult ; Humans ; Aged ; Female ; Sleep Apnea, Central/drug therapy ; Carbonic Anhydrase Inhibitors ; Buspirone ; Apnea ; Triazolam ; Theophylline ; Acetazolamide ; Heart Failure ; Hypnotics and Sedatives ; Disorders of Excessive Somnolence
    Chemical Substances Carbonic Anhydrase Inhibitors ; Buspirone (TK65WKS8HL) ; Triazolam (1HM943223R) ; Theophylline (C137DTR5RG) ; Acetazolamide (O3FX965V0I) ; Hypnotics and Sedatives
    Language English
    Publishing date 2023-02-27
    Publishing country England
    Document type Systematic Review ; Journal Article ; Review
    ISSN 1469-493X
    ISSN (online) 1469-493X
    DOI 10.1002/14651858.CD012922.pub2
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: Economic evaluation of CPAP therapy for obstructive sleep apnea: a scoping review and evidence map.

    Pachito, Daniela V / Bagattini, Ângela M / Drager, Luciano F / Eckeli, Alan L / Rocha, Aline

    Sleep & breathing = Schlaf & Atmung

    2021  Volume 26, Issue 1, Page(s) 17–30

    Abstract: Purpose: To synthesize findings of economic evaluations investigating cost-effectiveness of continuous positive airway pressure (CPAP) for obstructive sleep apnea (OSA) and of strategies of organization of care related to CPAP therapy.: Methods: ... ...

    Abstract Purpose: To synthesize findings of economic evaluations investigating cost-effectiveness of continuous positive airway pressure (CPAP) for obstructive sleep apnea (OSA) and of strategies of organization of care related to CPAP therapy.
    Methods: Scoping review with searches conducted in MEDLINE, CRD, LILACS, and Embase in August 2020. Eligible studies were economic evaluations comparing CPAP to other alternative or assessing strategies of care for CPAP therapy. Results were presented narratively, and incremental cost-effectiveness ratios (ICER) were presented in evidence maps.
    Results: Of 34 studies, 3 concluded that CPAP is less costly and more effective when compared to usual care. Most studies indicated that CPAP is associated with better health outcomes, but at higher prices. ICER ranged from USD 316 to 98,793 per quality-adjusted life years (QALY) gained (median 16,499; IQR 8267 to 33,119). One study concluded that CPAP is more costly and less effective, when treatment is applied to all patients, regardless of disease severity. Variability of ICER was mainly due to definition of population and applied time horizons. When CPAP was compared to mandibular advancement device, ICER ranged from USD 21,153 to 361,028 (median 89,671; IQR 26,829 to 295,983), which represents the investment in CPAP therapy required to obtain one extra QALY. Three studies assessed the effects of organizing CPAP therapy in primary care, which was cost-effective or cost-saving.
    Conclusions: Compared to usual care, CPAP is cost-effective after the second year of treatment, when indicated for moderate-to-severe OSA. CPAP therapy may be even more cost-effective by using different strategies of organization of care. These findings may inform decision making related to CPAP reimbursement in health systems.
    Clinical trial registration number: Not applicable.
    MeSH term(s) Humans ; Continuous Positive Airway Pressure/economics ; Cost of Illness ; Cost-Benefit Analysis ; Sleep Apnea, Obstructive/economics ; Sleep Apnea, Obstructive/therapy
    Language English
    Publishing date 2021-03-31
    Publishing country Germany
    Document type Journal Article ; Review
    ZDB-ID 1500381-4
    ISSN 1522-1709 ; 1520-9512
    ISSN (online) 1522-1709
    ISSN 1520-9512
    DOI 10.1007/s11325-021-02362-8
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article ; Online: Adapting shift work schedules for sleep quality, sleep duration, and sleepiness in shift workers.

    Hulsegge, Gerben / Coenen, Pieter / Gascon, Gregg M / Pahwa, Manisha / Greiner, Birgit / Bohane, Ciarán / Wong, Imelda S / Liira, Juha / Riera, Rachel / Pachito, Daniela V

    The Cochrane database of systematic reviews

    2023  Volume 9, Page(s) CD010639

    Abstract: Background: Shift work is associated with insufficient sleep, which can compromise worker alertness with ultimate effects on occupational health and safety. Adapting shift work schedules may reduce adverse occupational outcomes.: Objectives: To ... ...

    Abstract Background: Shift work is associated with insufficient sleep, which can compromise worker alertness with ultimate effects on occupational health and safety. Adapting shift work schedules may reduce adverse occupational outcomes.
    Objectives: To assess the effects of shift schedule adaptation on sleep quality, sleep duration, and sleepiness among shift workers.
    Search methods: We searched CENTRAL, PubMed, Embase, and eight other databases on 13 December 2020, and again on 20 April 2022, applying no language restrictions.
    Selection criteria: We included randomised controlled trials (RCTs) and non-RCTs, including controlled before-after (CBA) trials, interrupted time series, and cross-over trials. Eligible trials evaluated any of the following shift schedule components. • Permanency of shifts • Regularity of shift changes • Direction of shift rotation • Speed of rotation • Shift duration • Timing of start of shifts • Distribution of shift schedule • Time off between shifts • Split shifts • Protected sleep • Worker participation We included studies that assessed sleep quality off-shift, sleep duration off-shift, or sleepiness during shifts.
    Data collection and analysis: Two review authors independently screened the titles and abstracts of the records recovered by the search, read through the full-text articles of potentially eligible studies, and extracted data. We assessed the risk of bias of included studies using the Cochrane risk of bias tool, with specific additional domains for non-randomised and cluster-randomised studies. For all stages, we resolved any disagreements by consulting a third review author. We presented the results by study design and combined clinically homogeneous studies in meta-analyses using random-effects models. We assessed the certainty of the evidence with GRADE.
    Main results: We included 11 studies with a total of 2125 participants. One study was conducted in a laboratory setting and was not considered for drawing conclusions on intervention effects. The included studies investigated different and often multiple changes to shift schedule, and were heterogeneous with respect to outcome measurement. Forward versus backward rotation Three CBA trials (561 participants) investigated the effects of forward rotation versus backward rotation. Only one CBA trial provided sufficient data for the quantitative analysis; it provided very low-certainty evidence that forward rotation compared with backward rotation did not affect sleep quality measured with the Basic Nordic Sleep Questionnaire (BNSQ; mean difference (MD) -0.20 points, 95% confidence interval (CI) -2.28 to 1.89; 62 participants) or sleep duration off-shift (MD -0.21 hours, 95% CI -3.29 to 2.88; 62 participants). However, there was also very low-certainty evidence that forward rotation reduced sleepiness during shifts measured with the BNSQ (MD -1.24 points, 95% CI -2.24 to -0.24; 62 participants). Faster versus slower rotation Two CBA trials and one non-randomised cross-over trial (341 participants) evaluated faster versus slower shift rotation. We were able to meta-analyse data from two studies. There was low-certainty evidence of no difference in sleep quality off-shift (standardised mean difference (SMD) -0.01, 95% CI -0.26 to 0.23) and very low-certainty evidence that faster shift rotation reduced sleep duration off-shift (SMD -0.26, 95% CI -0.51 to -0.01; 2 studies, 282 participants). The SMD for sleep duration translated to an MD of 0.38 hours' less sleep per day (95% CI -0.74 to -0.01). One study provided very low-certainty evidence that faster rotations decreased sleepiness during shifts measured with the BNSQ (MD -1.24 points, 95% CI -2.24 to -0.24; 62 participants). Limited shift duration (16 hours) versus unlimited shift duration Two RCTs (760 participants) evaluated 80-hour workweeks with maximum daily shift duration of 16 hours versus workweeks without any daily shift duration limits. There was low-certainty evidence that the 16-hour limit increased sleep duration off-shift (SMD 0.50, 95% CI 0.21 to 0.78; which translated to an MD of 0.73 hours' more sleep per day, 95% CI 0.30 to 1.13; 2 RCTs, 760 participants) and moderate-certainty evidence that the 16-hour limit reduced sleepiness during shifts, measured with the Karolinska Sleepiness Scale (SMD -0.29, 95% CI -0.44 to -0.14; which translated to an MD of 0.37 fewer points, 95% CI -0.55 to -0.17; 2 RCTs, 716 participants). Shorter versus longer shifts One RCT, one CBA trial, and one non-randomised cross-over trial (692 participants) evaluated shorter shift duration (eight to 10 hours) versus longer shift duration (two to three hours longer). There was very low-certainty evidence of no difference in sleep quality (SMD -0.23, 95% CI -0.61 to 0.15; which translated to an MD of 0.13 points lower on a scale of 1 to 5; 2 studies, 111 participants) or sleep duration off-shift (SMD 0.18, 95% CI -0.17 to 0.54; which translated to an MD of 0.26 hours' less sleep per day; 2 studies, 121 participants). The RCT and the non-randomised cross-over study found that shorter shifts reduced sleepiness during shifts, while the CBA study found no effect on sleepiness. More compressed versus more spread out shift schedules One RCT and one CBA trial (346 participants) evaluated more compressed versus more spread out shift schedules. The CBA trial provided very low-certainty evidence of no difference between the groups in sleep quality off-shift (MD 0.31 points, 95% CI -0.53 to 1.15) and sleep duration off-shift (MD 0.52 hours, 95% CI -0.52 to 1.56).
    Authors' conclusions: Forward and faster rotation may reduce sleepiness during shifts, and may make no difference to sleep quality, but the evidence is very uncertain. Very low-certainty evidence indicated that sleep duration off-shift decreases with faster rotation. Low-certainty evidence indicated that on-duty workweeks with shift duration limited to 16 hours increases sleep duration, with moderate-certainty evidence for minimal reductions in sleepiness. Changes in shift duration and compression of workweeks had no effect on sleep or sleepiness, but the evidence was of very low-certainty. No evidence is available for other shift schedule changes. There is a need for more high-quality studies (preferably RCTs) for all shift schedule interventions to draw conclusions on the effects of shift schedule adaptations on sleep and sleepiness in shift workers.
    MeSH term(s) Humans ; Sleep Quality ; Sleep Duration ; Shift Work Schedule ; Sleepiness ; Sleep
    Language English
    Publishing date 2023-09-11
    Publishing country England
    Document type Systematic Review ; Journal Article ; Review ; Research Support, Non-U.S. Gov't
    ISSN 1469-493X
    ISSN (online) 1469-493X
    DOI 10.1002/14651858.CD010639.pub2
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  7. Article ; Online: Non-invasive positive airway pressure therapy for improving erectile dysfunction in men with obstructive sleep apnoea.

    Barbosa, Frederico T / Silva, Michele P / Fontes, Luís Eduardo S / Pachito, Daniela V / Melnik, Tamara / Riera, Rachel

    The Cochrane database of systematic reviews

    2021  Volume 9, Page(s) CD013169

    Abstract: Background: Obstructive sleep apnoea syndrome (OSAS) is associated with several chronic diseases, including erectile dysfunction (ED). The association of OSAS and ED is far more common than might be found by chance; the treatment of OSAS with non- ... ...

    Abstract Background: Obstructive sleep apnoea syndrome (OSAS) is associated with several chronic diseases, including erectile dysfunction (ED). The association of OSAS and ED is far more common than might be found by chance; the treatment of OSAS with non-invasive positive airway pressure therapy is associated with improvement of respiratory symptoms, and may contribute to the improvement of associated conditions, such as ED.
    Objectives: To assess the effectiveness and acceptability of non-invasive positive airway pressure therapy for improving erectile dysfunction in OSAS.
    Search methods: We identified studies from the Cochrane Airways Trials Register, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, AMED EBSCO, and LILACS, the US National Institutes of Health ongoing trials register ClinicalTrials.gov, and the World Health Organisation international clinical trials registry platform to 14 June 2021, with no restriction on date, language, or status of publication. We checked the reference lists of all primary studies, and review articles for additional references, and relevant manufacturers' websites for study information. We also searched specific conference proceedings for the British Association of Urological Surgeons; the European Association of Urology; and the American Urological Association to 14 June 2021.
    Selection criteria: We considered randomised controlled trials (RCTs) with a parallel or cross-over design, or cluster-RCTs, which included men aged 18 years or older, with OSAS and ED. We considered RCTs comparing any non-invasive positive airway pressure therapy (such as continuous positive airways pressure (CPAP), bilevel positive airway pressure (BiPAP), variable positive airway pressure (VPAP), or similar devices) versus sham, no treatment, waiting list, or pharmacological treatment for ED. The primary outcomes were remission of ED and serious adverse events; secondary outcome were sex-related quality of life, health-related quality of life, and minor adverse events.
    Data collection and analysis: Two review authors independently conducted study selection, data extraction, and risk of bias assessment. A third review author solved any disagreement. We used the Cochrane RoB 1 tool to assess the risk of bias of the included RCTs. We used the GRADE approach to assess the certainty of the body of evidence. To measure the treatment effect on dichotomous outcomes, we used the risk ratio (RR); for continuous outcomes, we used the mean difference (MD). We calculated 95% confidence intervals (CI) for these measures. When possible (data availability and homogeneous studies), we used a random-effect model to pool data with a meta-analysis.
    Main results: We included six RCTs (all assessing CPAP as the non-invasive positive airway pressure therapy device), with a total of 315 men with OSAS and ED. All RCTs presented some important risk of bias related to selection, performance, assessment, or reporting bias. None of included RCTs assessed the ED remission rate, and we used the provided ED mean scores as a proxy. CPAP versus no CPAP There is uncertainty about the effect of CPAP on mean ED scores after 4 weeks, using the International index of erectile function (IIEF-5, higher = better; MD 7.50, 95% CI 4.05 to 10.95; 1 RCT; 27 participants; very low-certainty evidence), and after 12 weeks (IIEF-ED, ED domain; MD 2.50, 95% CI -1.10 to 6.10; 1 RCT; 57 participants; very low-certainty evidence, downgraded due to methodological limitations and imprecision). There is uncertainty about the effect of CPAP on sex-related quality of life after 12 weeks, using the Self-esteem and relationship test (SEAR, higher = better; MD 1.00, 95% CI -8.09 to 10.09; 1 RCT; 57 participants; very low-certainty evidence, downgraded due to methodological limitations and imprecision); no serious adverse events were reported after 4 weeks (1 RCT; 27 participants; very low-certainty evidence, downgraded due to methodological limitations and imprecision). CPAP versus sham CPAP One RCT assessed this comparison (61 participants), but we were unable to extract outcomes for this comparison due to the factorial design and reporting of this trial. CPAP versus sildenafil (phosphodiesterase type 5 inhibitors) Sildenafil may slightly improve erectile function at 12 weeks when compared to CPAP, measured with the IIEF-ED (MD -4.78, 95% CI -6.98 to -2.58; 3 RCTs; 152 participants; I² = 59%; low-certainty evidence, downgraded due to methodological limitations). There is uncertainty about the effect of CPAP on sex-related quality of life after 12 weeks, measured with the Erectile Dysfunction Inventory of Treatment Satisfaction questionnaire (EDITS, higher = better; MD -1.24, 95% CI -1.80 to -0.67; 2 RCTs; 122 participants; I² = 0%; very low-certainty evidence, downgraded due to methodological limitations). No serious adverse events were reported for either group (2 RCTs; 70 participants; very low-certainty evidence, downgraded due to methodological limitations and imprecision). There is uncertainty about the effects of CPAP when compared to sildenafil for the incidence of minor adverse events (RR 1.33, 95% CI 0.34 to 5.21; 1 RCT; 40 participants; very low-certainty evidence, downgraded due to methodological limitations and imprecision). The confidence interval was wide and neither a significant increase nor reduction in the risk of minor adverse events can be ruled out with the use of CPAP (4/20 men complained of nasal dryness in the CPAP group, and 3/20 men complained of transient flushing and mild headache in the sildenafil group).
    Authors' conclusions: When compared with no CPAP, we are uncertain about the effectiveness and acceptability of CPAP for improving erectile dysfunction in men with obstructive sleep apnoea. When compared with sildenafil, there is some evidence that sildenafil may slightly improve erectile function at 12 weeks.
    MeSH term(s) Continuous Positive Airway Pressure ; Erectile Dysfunction/therapy ; Humans ; Incidence ; Intubation ; Male ; Randomized Controlled Trials as Topic ; Sleep Apnea, Obstructive/complications ; Sleep Apnea, Obstructive/therapy
    Language English
    Publishing date 2021-09-23
    Publishing country England
    Document type Journal Article ; Review ; Systematic Review
    ISSN 1469-493X
    ISSN (online) 1469-493X
    DOI 10.1002/14651858.CD013169.pub2
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  8. Article: COVID-19 pandemic is associated with increased sleep disturbances and mental health symptoms but not help-seeking: a cross-sectional nation-wide study.

    Moreno, Claudia Roberta de Castro / Conway, Silvia G / Assis, Márcia / Genta, Pedro Rodrigues / Pachito, Daniela V / Tavares, Almir / Sguillar, Danilo A / Moreira, Gustavo / Drager, Luciano F / Bacelar, Andrea

    Sleep science (Sao Paulo, Brazil)

    2022  Volume 15, Issue 1, Page(s) 1–7

    Abstract: Objective: This study aimed firstly to describe sleep-related and mental health symptoms before and during the COVID-19 pandemic in a national-wide sample and, secondly, to verify attitudes towards help-seeking to treat these symptoms.: Material and ... ...

    Abstract Objective: This study aimed firstly to describe sleep-related and mental health symptoms before and during the COVID-19 pandemic in a national-wide sample and, secondly, to verify attitudes towards help-seeking to treat these symptoms.
    Material and methods: Data were collected through an online questionnaire sent through the Brazilian Sleep Association's social media. The questionnaire included sociodemographic and sleep aspects questions currently and before the pandemic period. In addition, the survey addressed current and previous anxiety, depression, and burnout symptoms. The outcome help-seeking was addressed in the questionnaire as well by a single question asked when the participant reported mental or sleep problems.
    Results: The study covered 6,360 participants, mean age 43.5 years (SD=14.3), 76.7% female and 63.7% with undergraduate or higher degree filled out the survey. Seventy percent of participants reported sleep disturbances and 80% reported symptoms of anxiety during the pandemic. Help-seeking behavior was found only in one third of them. Hours of sleep reduced from 7.12 to 6.2h, which can be related with the increase in 28.2% of dissatisfaction with sleep duration during the pandemic. The highest frequency of complaints related to sleep was difficulty to fall asleep three or more times a week (going from 27.6% before the pandemic to 58.9% during the pandemic; p<0.001). Moreover, it was observed that help-seeking was more prevalent in men than women, and more in younger participants than in older ones.
    Conclusion: There was an increase of sleep and mental self-reported problems during the pandemic, which was not followed by help-seeking.
    Language English
    Publishing date 2022-05-31
    Publishing country Brazil
    Document type Journal Article
    ZDB-ID 2697016-8
    ISSN 1984-0063 ; 1984-0659
    ISSN (online) 1984-0063
    ISSN 1984-0659
    DOI 10.5935/1984-0063.20220027
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  9. Article ; Online: Insomnia episodes, new-onset pharmacological treatments, and other sleep disturbances during the COVID-19 pandemic: a nationwide cross-sectional study in Brazilian health care professionals.

    Drager, Luciano F / Pachito, Daniela V / Moreno, Claudia R C / Tavares, Almir R / Conway, Silvia G / Assis, Márcia / Sguillar, Danilo A / Moreira, Gustavo A / Bacelar, Andrea / Genta, Pedro R

    Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine

    2022  Volume 18, Issue 2, Page(s) 373–382

    Abstract: Study objectives: To evaluate the impact of the coronavirus disease 2019 (COVID-19) pandemic on insomnia and other sleep disturbances in health care professionals.: Methods: A survey was distributed using social media and organizational emails to ... ...

    Abstract Study objectives: To evaluate the impact of the coronavirus disease 2019 (COVID-19) pandemic on insomnia and other sleep disturbances in health care professionals.
    Methods: A survey was distributed using social media and organizational emails to Brazilian active health care professionals during the COVID-19 outbreak. We explored potential associated factors including age, sex, occupation, workplace, work hours, income, previous infection with COVID-19, recent/current contact with COVID-19 patients, regional number of incident deaths, anxiety, and burnout. We evaluated new-onset/previous insomnia worsening episodes (primary outcome), new pharmacological treatments, sleep quality, duration, nightmares, and snoring (secondary outcomes).
    Results: A total of 4,384 health professionals from all regions of the country were included in the analysis (44 ± 12 years, 76% females, 53.8% physicians). Overall, 55.7% were assisting patients with COVID-19, and 9.2% had a previous COVID-19 infection. The primary outcome occurred in 32.9% of respondents in parallel to 13% new pharmacological treatments for insomnia. The sleep quality worsened for 61.4%, while 43.5% and 22.8% reported ≥ 1-hour sleep duration reduction and worsening or new-onset nightmares, respectively. Multivariate analyses showed that age (odds ratio [OR]: 1.008; 95% confidence interval [CI] 1.001-1.015), females (OR: 1.590; 95% CI 1.335-1.900), weight change (decrease: OR: 1.772; 95% CI 1.453-2.161; increase: OR: 1.468; 95% CI 1.249-1.728), prevalent anxiety (OR: 3.414; 95% CI 2.954-3.948), new-onset burnout (OR: 1.761; 95% CI 1.489-2.083), family income reduction > 30% (OR: 1.288; 95% CI 1.069-1.553), and assisting patients with COVID-19 (OR: 1.275; 95% CI 1.081-1.506) were independently associated with new-onset or worsening of previous insomnia episodes.
    Conclusions: We observed a huge burden of insomnia episodes and other sleep disturbances in health care professionals during the COVID-19 pandemic.
    Citation: Drager LF, Pachito DV, Moreno CRC, et al. Insomnia episodes, new-onset pharmacological treatments, and other sleep disturbances during the COVID-19 pandemic: a nationwide cross-sectional study in Brazilian health care professionals.
    MeSH term(s) Anxiety ; COVID-19 ; Cross-Sectional Studies ; Depression ; Female ; Health Personnel ; Humans ; Male ; Pandemics ; SARS-CoV-2 ; Sleep ; Sleep Initiation and Maintenance Disorders/drug therapy ; Sleep Initiation and Maintenance Disorders/epidemiology
    Language English
    Publishing date 2022-01-11
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2397213-0
    ISSN 1550-9397 ; 1550-9389
    ISSN (online) 1550-9397
    ISSN 1550-9389
    DOI 10.5664/jcsm.9570
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  10. Article ; Online: Telehealth Strategies to Support Referral Management to Secondary Care in Brazil: A Cost-Effectiveness Analysis.

    Pachito, Daniela V / de Azeredo-da-Silva, André Luis F / de Oliveira, Patrícia Roberta B P / Bagattini, Ângela Maria / Basso, Josué / Gehres, Luana G / Mallmann, Érica de B / Rodrigues, Átila S / Riera, Rachel / Gadenz, Sabrina D

    Value in health regional issues

    2022  Volume 31, Page(s) 74–80

    Abstract: Objectives: This study aimed to assess the cost-effectiveness of a remotely operated referral management system (RORMS) compared with a conventional referral management system (CRMS) in Brazil.: Methods: This is a model-based cost-effectiveness ... ...

    Abstract Objectives: This study aimed to assess the cost-effectiveness of a remotely operated referral management system (RORMS) compared with a conventional referral management system (CRMS) in Brazil.
    Methods: This is a model-based cost-effectiveness analysis under the perspective of the Unified Healthcare System (Sistema Único de Saúde [SUS]) in Brazil. A Markov microsimulation model was developed to compare costs and referral outcomes of the RORMS and the CRMS. Model consisted of 4 states representative of sequential stepwise assessments of referral suitability, 3 states representative of referral outcomes, and 1 exit model state. Target population represented cases being referred from primary healthcare units to specialized care in SUS. Model inputs related to costs and effectiveness in the RORMS arm were obtained from the data set of a RORMS between July and December 2019. Model inputs for the CRMS model arm were obtained from administrative data sets of 2 Brazilian localities for the year 2019. Relative effect size of RORMS in comparison with CRMS in SUS was obtained from published studies. Effectiveness outcome was unnecessary referrals averted. The incremental cost-effectiveness ratio was calculated for the base case. Probabilistic sensitivity analysis was conducted.
    Results: In the base-case analyses, RORMS dominated CRMS, with expected cost-savings from $50.42 to $80.62 per unnecessary referral averted. RORMS was the dominant strategy in 83.7% of 100 000 simulations in the probabilistic sensitivity analysis. In 16.2% of simulations, incremental cost-effectiveness ratio was between $0 and $222 per unnecessary referral averted.
    Conclusions: Model-based simulations indicate that the RORMS is likely to be cost saving in comparison with the CRMS.
    MeSH term(s) Brazil ; Cost-Benefit Analysis ; Humans ; Referral and Consultation ; Secondary Care ; Telemedicine
    Language English
    Publishing date 2022-05-11
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2679127-4
    ISSN 2212-1102 ; 2212-1099
    ISSN (online) 2212-1102
    ISSN 2212-1099
    DOI 10.1016/j.vhri.2022.03.003
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