Recently Published Projects

Objectives: Background: The first entry complications at laparoscopy in obese individuals is unclear. The role of the entry device rather than technique in the course of complications is a necessary evaluation to further understand first access injuries. Purpose: To summarise findings from both randomised and observational studies assessing first access injuries in obese patients according to the characteristics of the entry device utilised. Data Sources: Embase, Cochrane Library, Scopus, PubMed including MEDLINE, Web of Science and Clinicaltrials.gov were searched for eligible articles published in English with no date limits. Study Selection: 2 authors screened article abstracts to retrieve trials investigating laparoscopic first access injuries with eligibility resting on studies that recruited obese individuals and providing device type with outcomes detailing all injuries sustained. Data Extraction: The screening authors extracted data documenting the obese class of patients enrolled in the trials, alongside the type of entry device employed and the resultant complications incurred in establishing abdominal entry.

Objectives: Purpose: To systematically review the evidence on screening and treating asymptomatic adults with obstructive sleep apnea (OSA) or those with unrecognized symptoms for OSA. Data Sources: PubMed/MEDLINE, the Cochrane Library, Embase, and trial registries through August 23, 2021; reference lists of retrieved articles; outside experts; and reviewers, with surveillance of the literature through September 23, 2022. Study Selection: Two investigators independently selected English-language studies using a priori criteria. Eligible studies included randomized, controlled trials (RCTs) of screening for or treatment of OSA reporting on health outcomes, studies evaluating accuracy of screening questionnaires or clinical prediction tools in asymptomatic adults with OSA or persons with unrecognized symptoms of OSA, and systematic reviews of treatment reporting on changes in blood pressure (BP) and apnea-hypopnea index (AHI) scores. Data Extraction: One investigator extracted data and a second checked accuracy. Two reviewers independently rated data quality for all included studies using predefined criteria. Data Synthesis: No reviewed RCT directly compared screening with no screening. In two studies (702 total participants), the screening accuracy measured as AUC of the Multivariable Apnea Prediction (MVAP) score followed by unattended home sleep testing for detecting severe OSA syndrome (AHI ≥30 and Epworth Sleepiness Scale [ESS] score >10) was 0.80 (95% confidence interval [CI], 0.78 to 0.82) and 0.83 (95% CI, 0.77 to 0.90), respectively. Studies evaluating the Snoring, Tiredness, Observed apnea, blood Pressure, Body mass index, Age, Neck circumference, Gender (STOP-BANG) Questionnaire (k=4) and the Berlin Questionnaire (BQ) (k=2) enrolled different populations and used different criteria for a positive screening test. Recent systematic reviews of positive airway pressure (PAP) and mandibular advancement devices (MADs) show an association between PAP and MAD and reduction in BP and AHI, however reduction in BP outcomes versus inactive control is relatively small (2 to 3 mm Hg). Meta-analysis found that PAP compared with any control was associated with a significantly larger reduction in ESS score change (pooled mean difference, -2.33 [95% CI, -2.75 to -1.90]; 47 trials, 7,024 participants), modest improvement in sleep-related quality of life (QOL) (standardized mean difference, 0.30 [95% CI, 0.19 to 0.42]; 18 trials, 3,083 participants), and improved general health-related QOL measured by the SF-36 mental health component summary score change (2.20 [95% CI, 0.95 to 3.44]; 15 trials, 2,345 participants) and SF-36 physical health component summary score change (pooled mean difference, 1.53 [95% CI, 0.29 to 2.77]; 13 trials, 2,031 participants). Meta-analysis also found that use of MADs was associated with a significantly larger ESS score change than controls (pooled mean difference, -1.67 [95% CI, -2.09 to -1.25]; 10 trials, 1,540 participants). Reporting of other health outcomes was sparse; no included trial found significant benefit associated with PAP or MAD on mortality, cardiovascular outcomes, stroke, or motor vehicle accidents. Common adverse effects of PAP and MADs included oral or nasal dryness, irritation, and pain, among others. Limitations: Two studies assessing the accuracy of the MVAP score oversampled participants at high risk of OSA and those with OSA syndrome. No study prospectively evaluated screening Screening for Obstructive Sleep Apnea in Adults v RTI–UNC EPC tools to report calibration or clinical utility for improving health outcomes. Three studies assessing the accuracy of the STOP-BANG and two assessing the BQ enrolled different populations and used different criteria for positive screening tests. Most included trials assessing the benefit of PAP and MADs reported outcomes over a relatively short duration (12 weeks or less), and most pooled estimates showing improvement in excessive sleepiness or QOL (except benefit of PAP for improving ESS scores) fell short of the range considered to be a minimal clinically important difference. Populations enrolled in trials of treatment were referred for treatment; no trial enrolled populations who were identified by screening in primary care. Conclusions: The accuracy and clinical utility of potential screening tools for OSA that could be used in primary care settings are uncertain. PAP and MADs reduce AHI, BP and ESS score. Trials of PAP have not established whether treatment reduces mortality or improves most other health outcomes, except for its modest improvement in sleep-related QOL and general health–related QOL.

Objectives: Purpose: To systematically review the evidence on screening and treating asymptomatic adults with obstructive sleep apnea (OSA) or those with unrecognized symptoms for OSA. Data Sources: PubMed/MEDLINE, the Cochrane Library, Embase, and trial registries through August 23, 2021; reference lists of retrieved articles; outside experts; and reviewers, with surveillance of the literature through September 23, 2022. Study Selection: Two investigators independently selected English-language studies using a priori criteria. Eligible studies included randomized, controlled trials (RCTs) of screening for or treatment of OSA reporting on health outcomes, studies evaluating accuracy of screening questionnaires or clinical prediction tools in asymptomatic adults with OSA or persons with unrecognized symptoms of OSA, and systematic reviews of treatment reporting on changes in blood pressure (BP) and apnea-hypopnea index (AHI) scores. Data Extraction: One investigator extracted data and a second checked accuracy. Two reviewers independently rated data quality for all included studies using predefined criteria. Data Synthesis: No reviewed RCT directly compared screening with no screening. In two studies (702 total participants), the screening accuracy measured as AUC of the Multivariable Apnea Prediction (MVAP) score followed by unattended home sleep testing for detecting severe OSA syndrome (AHI ≥30 and Epworth Sleepiness Scale [ESS] score >10) was 0.80 (95% confidence interval [CI], 0.78 to 0.82) and 0.83 (95% CI, 0.77 to 0.90), respectively. Studies evaluating the Snoring, Tiredness, Observed apnea, blood Pressure, Body mass index, Age, Neck circumference, Gender (STOP-BANG) Questionnaire (k=4) and the Berlin Questionnaire (BQ) (k=2) enrolled different populations and used different criteria for a positive screening test. Recent systematic reviews of positive airway pressure (PAP) and mandibular advancement devices (MADs) show an association between PAP and MAD and reduction in BP and AHI, however reduction in BP outcomes versus inactive control is relatively small (2 to 3 mm Hg). Meta-analysis found that PAP compared with any control was associated with a significantly larger reduction in ESS score change (pooled mean difference, -2.33 [95% CI, -2.75 to -1.90]; 47 trials, 7,024 participants), modest improvement in sleep-related quality of life (QOL) (standardized mean difference, 0.30 [95% CI, 0.19 to 0.42]; 18 trials, 3,083 participants), and improved general health-related QOL measured by the SF-36 mental health component summary score change (2.20 [95% CI, 0.95 to 3.44]; 15 trials, 2,345 participants) and SF-36 physical health component summary score change (pooled mean difference, 1.53 [95% CI, 0.29 to 2.77]; 13 trials, 2,031 participants). Meta-analysis also found that use of MADs was associated with a significantly larger ESS score change than controls (pooled mean difference, -1.67 [95% CI, -2.09 to -1.25]; 10 trials, 1,540 participants). Reporting of other health outcomes was sparse; no included trial found significant benefit associated with PAP or MAD on mortality, cardiovascular outcomes, stroke, or motor vehicle accidents. Common adverse effects of PAP and MADs included oral or nasal dryness, irritation, and pain, among others. Limitations: Two studies assessing the accuracy of the MVAP score oversampled participants at high risk of OSA and those with OSA syndrome. No study prospectively evaluated screening Screening for Obstructive Sleep Apnea in Adults v RTI–UNC EPC tools to report calibration or clinical utility for improving health outcomes. Three studies assessing the accuracy of the STOP-BANG and two assessing the BQ enrolled different populations and used different criteria for positive screening tests. Most included trials assessing the benefit of PAP and MADs reported outcomes over a relatively short duration (12 weeks or less), and most pooled estimates showing improvement in excessive sleepiness or QOL (except benefit of PAP for improving ESS scores) fell short of the range considered to be a minimal clinically important difference. Populations enrolled in trials of treatment were referred for treatment; no trial enrolled populations who were identified by screening in primary care. Conclusions: The accuracy and clinical utility of potential screening tools for OSA that could be used in primary care settings are uncertain. PAP and MADs reduce AHI, BP and ESS score. Trials of PAP have not established whether treatment reduces mortality or improves most other health outcomes, except for its modest improvement in sleep-related QOL and general health–related QOL.

Objectives: Purpose: To systematically review the evidence on screening and treating asymptomatic adults with obstructive sleep apnea (OSA) or those with unrecognized symptoms for OSA. Data Sources: PubMed/MEDLINE, the Cochrane Library, Embase, and trial registries through August 23, 2021; reference lists of retrieved articles; outside experts; and reviewers, with surveillance of the literature through September 23, 2022. Study Selection: Two investigators independently selected English-language studies using a priori criteria. Eligible studies included randomized, controlled trials (RCTs) of screening for or treatment of OSA reporting on health outcomes, studies evaluating accuracy of screening questionnaires or clinical prediction tools in asymptomatic adults with OSA or persons with unrecognized symptoms of OSA, and systematic reviews of treatment reporting on changes in blood pressure (BP) and apnea-hypopnea index (AHI) scores. Data Extraction: One investigator extracted data and a second checked accuracy. Two reviewers independently rated data quality for all included studies using predefined criteria. Data Synthesis: No reviewed RCT directly compared screening with no screening. In two studies (702 total participants), the screening accuracy measured as AUC of the Multivariable Apnea Prediction (MVAP) score followed by unattended home sleep testing for detecting severe OSA syndrome (AHI ≥30 and Epworth Sleepiness Scale [ESS] score >10) was 0.80 (95% confidence interval [CI], 0.78 to 0.82) and 0.83 (95% CI, 0.77 to 0.90), respectively. Studies evaluating the Snoring, Tiredness, Observed apnea, blood Pressure, Body mass index, Age, Neck circumference, Gender (STOP-BANG) Questionnaire (k=4) and the Berlin Questionnaire (BQ) (k=2) enrolled different populations and used different criteria for a positive screening test. Recent systematic reviews of positive airway pressure (PAP) and mandibular advancement devices (MADs) show an association between PAP and MAD and reduction in BP and AHI, however reduction in BP outcomes versus inactive control is relatively small (2 to 3 mm Hg). Meta-analysis found that PAP compared with any control was associated with a significantly larger reduction in ESS score change (pooled mean difference, -2.33 [95% CI, -2.75 to -1.90]; 47 trials, 7,024 participants), modest improvement in sleep-related quality of life (QOL) (standardized mean difference, 0.30 [95% CI, 0.19 to 0.42]; 18 trials, 3,083 participants), and improved general health-related QOL measured by the SF-36 mental health component summary score change (2.20 [95% CI, 0.95 to 3.44]; 15 trials, 2,345 participants) and SF-36 physical health component summary score change (pooled mean difference, 1.53 [95% CI, 0.29 to 2.77]; 13 trials, 2,031 participants). Meta-analysis also found that use of MADs was associated with a significantly larger ESS score change than controls (pooled mean difference, -1.67 [95% CI, -2.09 to -1.25]; 10 trials, 1,540 participants). Reporting of other health outcomes was sparse; no included trial found significant benefit associated with PAP or MAD on mortality, cardiovascular outcomes, stroke, or motor vehicle accidents. Common adverse effects of PAP and MADs included oral or nasal dryness, irritation, and pain, among others. Limitations: Two studies assessing the accuracy of the MVAP score oversampled participants at high risk of OSA and those with OSA syndrome. No study prospectively evaluated screening Screening for Obstructive Sleep Apnea in Adults v RTI–UNC EPC tools to report calibration or clinical utility for improving health outcomes. Three studies assessing the accuracy of the STOP-BANG and two assessing the BQ enrolled different populations and used different criteria for positive screening tests. Most included trials assessing the benefit of PAP and MADs reported outcomes over a relatively short duration (12 weeks or less), and most pooled estimates showing improvement in excessive sleepiness or QOL (except benefit of PAP for improving ESS scores) fell short of the range considered to be a minimal clinically important difference. Populations enrolled in trials of treatment were referred for treatment; no trial enrolled populations who were identified by screening in primary care. Conclusions: The accuracy and clinical utility of potential screening tools for OSA that could be used in primary care settings are uncertain. PAP and MADs reduce AHI, BP and ESS score. Trials of PAP have not established whether treatment reduces mortality or improves most other health outcomes, except for its modest improvement in sleep-related QOL and general health–related QOL.

Objectives: Purpose of the Review: The Centers for Medicare and Medicaid Services (CMS) nominated the topic to the Agency for Healthcare Research and Quality for a Technology Assessment. The scope of the report’s protocol was developed to inform CMS’s coverage decisions. The report will address contextual questions (CQs) and conduct a systematic review (SR). The CQs cover background material to help to understand the findings of the SR, including information on currently-used treatment modalities for OSA, the postulated rationales for use of CPAP, currently-used measures of AHI and related measures in contemporary research and clinical settings, validated sleep questionnaires. The CQs also cover discussion of the ideal study designs for establishing validity of surrogate or intermediate measures. The CQs will be addressed using a, best-evidence, but nonsystematic approach. The SR will (1) summarize evidence on the validity of measures of sleep and breathing as surrogates (or intermediate outcomes) for clinically significant outcomes in patients with OSA, effectively assessing the linkage between the former and the latter, and (2) synthesize evidence on the (comparative) efficacy, effectiveness and safety of CPAP to prevent clinically important outcomes. The SR will attempt to describe heterogeneity of treatment effects in terms of diversity of patient populations, devices and treatment protocols, outcome definitions and study design characteristics. For included randomized controlled trials (RCT), we will examine the concordance among AHI (and similar measures), validated sleep questionnaires, and clinical outcomes. The intended audience includes CMS and non-CMS stakeholders including guideline developers, clinicians and other providers of care for patients with OSA, healthcare policy makers, and patients.