Draft Research Plan
Obstructive Sleep Apnea in Adults: Screening
December 17, 2020
Recommendations made by the USPSTF are independent of the U.S. government. They should not be construed as an official position of the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services.
Abbreviations: AHI=apnea-hypopnea index; OSA=obstructive sleep apnea.
- Does screening for obstructive sleep apnea (OSA) in adults improve health outcomes, including for specific subgroups of interest?
- What is the accuracy of screening questionnaires, clinical prediction tools, and multistep screening approaches (e.g., using a questionnaire followed by home-based oximetry/testing) in identifying persons in the general population who are more or less likely to have OSA, including for specific subgroups of interest?
- What are the harms associated with screening or subsequent diagnostic testing for OSA, including for specific subgroups of interest?
- How effective is treatment with positive airway pressure or mandibular advancement devices for improving intermediate outcomes (i.e., the apnea-hypopnea index or blood pressure) in persons with OSA, including for specific subgroups of interest?
- How effective is treatment with positive airway pressure or mandibular advancement devices for improving health outcomes in persons with OSA, including for specific subgroups of interest?
- What are the harms associated with treatment of OSA with positive airway pressure or mandibular advancement devices, including for specific subgroups of interest?
Contextual Questions will not be systematically reviewed and are not shown in the Analytic Framework.
- What are the barriers to undergoing diagnostic testing for OSA (e.g., availability of polysomnography, ability to tolerate testing)? How often do those barriers prevent completion of testing?
- Is there an association between the apnea-hypopnea index and health outcomes?
The proposed Research Approach identifies the study characteristics and criteria that the Evidence-based Practice Center will use to search for publications and to determine whether identified studies should be included or excluded from the Evidence Review. Criteria are overarching as well as specific to each of the Key Questions.
| Include | Exclude | |
|---|---|---|
| Populations | KQs 1–3: Adults age 18 years or older who are asymptomatic or have unrecognized symptoms of OSA
KQ 2: Adults referred for sleep testing who have not been diagnosed with OSA are also eligible KQs 4–6: Persons with a confirmed diagnosis of OSA; population may include asymptomatic or symptomatic adults All KQs: A priori subgroups of interest include those defined by age, sex, BMI category, and OSA severity* |
All KQs: Children and adolescents; pregnant women; studies of adults with acute stroke or other acute conditions that can trigger onset of OSA; studies focused on screening, diagnosis, or treatment of OSA among persons with a rare condition (e.g., acromegaly)
KQs 4–6: Studies of persons with suspected but unconfirmed OSA |
| Setting | Studies conducted in countries categorized as “Very High” on the Human Development Index, as defined by the United Nations Development Programme | KQs 1-3: Populations screened for OSA in perioperative settings
KQs 4–6: Interventions studied only in laboratories (e.g., studies of CPAP conducted in sleep laboratories) |
| Screening | Externally validated questionnaires, including the ESS, STOP Questionnaire, Berlin Questionnaire, Wisconsin Sleep Questionnaire, and STOP-BANG Questionnaire; externally validated risk stratification or clinical prediction tools that include multiple factors (e.g., the multivariable apnea prediction index); may include findings from physical examination (e.g., neck circumference, Mallampati classification); combined screening approaches are also eligible, which may use a questionnaire or clinical prediction tool followed by home-based oximetry testing for persons who score above a defined threshold on the questionnaire or clinical prediction tool | Studies assessing single patient characteristics or risk factors |
| Treatment | Interventions appropriate for screen-detected or newly detected OSA, including PAP and MADs; variations of fixed oral PAP are eligible, including auto-titrating CPAP, nasal CPAP, bilevel CPAP, and humidification with CPAP | All other interventions for OSA, including surgery, atrial overdrive pacing, medications, palatal implants, oropharyngeal exercises, tongue-retaining devices, positional alarms, nasal dilator strips, acupuncture, and auricular plaster; medications to treat sleepiness, sleep quality, or bruxism (rather than used to treat OSA), such as eszopiclone and modafinil; nasal steroids for treatment of allergic rhinitis or similar treatments that might secondarily improve OSA by treating another condition |
| Comparisons | KQs 1, 3: Screened versus nonscreened groups or groups undergoing screening and/or diagnostic testing vs. groups not undergoing screening and/or diagnostic testing
KQ 2: Studies on accuracy of screening must include a comparison with PSG KQs 4–6: CPAP versus control or sham PAP; MADs vs. no treatment or inactive MADs |
All KQs: No comparison; nonconcordant historical controls; comparative studies of various interventions (e.g., comparing CPAP with MADs or comparing different types of CPAP)
KQ 2: Studies with verification bias in which only a subgroup had PSG as the comparator |
| Outcomes | KQs 1, 5: Mortality, quality of life (both disease-specific measures, such as the Functional Outcomes of Sleep Questionnaire, and general measures, such as the 36-Item Short-Form Health Survey); measures of sleepiness; motor vehicle crashes; cardiovascular events (including ischemic events and rhythm disturbances, such as incident atrial fibrillation); cerebrovascular events; incidence of heart failure, headaches, and cognitive impairment
KQ 2: Sensitivity, specificity, discrimination, and calibration KQ 3: False-positive results leading to unnecessary treatment, anxiety, condition-specific distress, or stigma KQ 4: Change in AHI, blood pressure KQ 6: Rash, irritation, need for additional sleep medications (e.g., to tolerate CPAP), claustrophobia, oral or nasal dryness, epistaxis, pain, excess salivation, and tooth damage or loosening |
All other outcomes
KQ 2: Acceptability of screening |
| Study designs | KQs 1, 5, 6: RCTs
KQ 2: Prospective cohort studies and cross-sectional studies that developed or evaluated screening questionnaires, clinical prediction tools, or combined screening approaches KQ 3: Studies eligible for KQ 1 or 2 that report harms of screening or diagnostic test KQ 4: Good-quality, recent (within 5 years) systematic reviews reporting on change in AHI or blood pressure in studies comparing CPAP or MAD with an eligible control |
All other designs
KQ 2: Questionnaires, tools, and tests not validated in a group of participants separate from the sample used to develop the test |
| Language | English | Languages other than English |
| Study quality | Good or fair | Poor (according to design-specific USPSTF criteria) |
* OSA severity will be defined as mild if the AHI (or RDI) is ≥5 to <15, moderate if the AHI (or RDI) is ≥15 to ≤30, and severe if the AHI (or RDI) is ≥30.
Abbreviations: AHI=apnea-hypopnea index; BMI=body mass index; CPAP=continuous positive airway pressure; ESS=Epworth Sleepiness Scale; KQ=key question; MAD=mandibular advancement device; OSA=obstructive sleep apnea; PAP=positive airway pressure; PSG=polysomnography; RCT=randomized, controlled trial; RDI=respiratory disturbance index; STOP-BANG=snoring, tiredness, observed apnea, high blood pressure, BMI, age, neck circumference, and male gender; USPSTF=U.S. Preventive Services Task Force.