Final Research Plan
Obstructive Sleep Apnea in Adults: Screening
October 30, 2014
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.
The final Research Plan is used to guide a systematic review of the evidence by researchers at an Evidence-based Practice Center. The resulting Evidence Review will form the basis of the USPSTF Recommendation Statement on this topic.
The draft Research Plan was available for comment from August 7 until September 3, 2014 at 5:00 p.m., ET.
Abbreviations: AHI = Apnea-Hypopnea Index; KQ = key question; OSA = obstructive sleep apnea.
This figure is the proposed analytic framework depicting the eight key questions and the research approach that will guide the evidence review outlined in this research plan. In general, the figure illustrates the overarching question (key question 1): whether screening adults for obstructive sleep apnea (OSA) leads to improved health outcomes. The framework starts on the left with the patient population of interest: asymptomatic adults. Moving from left to right, the figure depicts the availability of clinical prediction tools or screening questionnaires that distinguish people who are more or less likely to have OSA (key question 2) and the accuracy and reliability of diagnostic tests for OSA (key question 3). There are the potential harms of screening and diagnostic tools (key question 7). For adults with OSA, treatment may improve intermediate outcomes, such as changes in the apnea-hypopnea index, blood pressure, and daytime somnolence/sleepiness (key question 4), and also health outcomes, such as mortality, quality of life, motor vehicle crashes, cardiovascular events, cerebrovascular events, heart failure, headaches, and cognitive impairment (key question 5). Treatment may also result in harms (key question 8). The framework also includes assessment of the evidence supporting an association between the apnea-hypopnea index and the aforementioned health outcomes (key question 6).
1a. Does screening for obstructive sleep apnea (OSA) in adults improve health outcomes?
1b. Does the evidence on screening for OSA in adults differ for subgroups defined by age, sex, body mass index (BMI), or OSA severity?
2a. What is the accuracy of currently existing clinical prediction tools or screening questionnaires in identifying persons in the general population who are more or less likely to have OSA?
2b. What is the accuracy of multistep screening approaches, such as using a questionnaire or prediction tool followed by overnight home-based oximetry, in identifying persons in the general population who are more or less likely to have OSA?
3a. What is the accuracy and reliability of diagnostic tests for OSA?
3b. Does the accuracy and reliability of diagnostic tests for OSA differ for subgroups defined by age, sex, or BMI?
4a. How much does treatment with continuous positive airway pressure (CPAP), mandibular advancement devices, surgery, or weight loss programs improve intermediate outcomes (i.e., the Apnea-Hypopnea Index [AHI], blood pressure, or sleepiness) in persons with OSA?
4b. Do the benefits of treatment differ for subgroups defined by age, sex, BMI, or OSA severity?
5a. Does treatment with CPAP, mandibular advancement devices, surgery, or weight loss programs improve health outcomes in persons with OSA?
5b. Do the benefits of treatment differ for subgroups defined by age, sex, BMI, or OSA severity?
6. Is there an association between AHI and health outcomes?
7a. Are there harms associated with screening or diagnostic testing for OSA?
7b. Do the harms of screening or diagnostic testing differ for subgroups defined by age, sex, or BMI?
8a. Are there harms associated with treatment of OSA?
8b. Do the harms of treatment differ for subgroups defined by age, sex, BMI, or OSA severity?
Contextual questions are not systematically reviewed and are not shown in the Analytic Framework.
1a. What is the rate of adherence to CPAP, mandibular advancement devices, and weight loss interventions among persons with OSA?
1b. How effective are interventions designed to enhance adherence to CPAP?
2. 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?
3. Is there an association between reduction in sleepiness and quality of life, work productivity, motor vehicle crashes, or other health outcomes?
4. Is there an association between reduction in blood pressure and health outcomes?
5. What are clinically meaningful changes in the AHI, sleepiness (as measured by the Epworth Sleepiness Scale), and blood pressure?
6. Is there an association between OSA and incident diabetes?
The 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 specific to each of the key questions.
| Include | Exclude | |
|---|---|---|
| Populations |
Adults age 18 years or older
KQs 1, 2: Asymptomatic adults and persons with unrecognized symptoms of OSA KQs 3, 7: Asymptomatic adults, persons with unrecognized symptoms of OSA, and referral populations KQs 4–6, 8: Persons with a confirmed diagnosis of OSA; population may include asymptomatic and/or symptomatic adults OSA severity to be defined as mild if the AHI (or RDI) is ≥5 and <15, moderate if the AHI (or RDI) is ≥15 and ≤30, and severe if the AHI (or RDI) is ≥30 |
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 those with a rare condition (e.g., acromegaly) KQs 4–6, 8: 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 4, 5, 8: For nonsurgical interventions, studies must evaluate use at home rather than in a laboratory or facility (although the testing and outcome assessments may occur in sleep laboratories or other settings) |
KQs 4, 5, 8: For nonsurgical treatments, interventions studied only in laboratories (e.g., studies of CPAP conducted in sleep laboratories) |
| Screening |
Screening with the Epworth Sleepiness Scale, STOP Questionnaire, Berlin Questionnaire, Wisconsin Sleep Questionnaire, or STOP-Bang Questionnaire
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) KQ 2b: Combined screening approaches, 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 |
| Diagnostic testing |
Polysomnography conducted in a sleep laboratory, reviewed and interpreted by a qualified physician (the reference standard)
Portable monitors used for home-based testing (including Type II, III, and IV monitors) Home-based testing followed by polysomnography |
|
| Treatment/ management interventions |
CPAP, mandibular advancement devices, surgery, and weight loss programs
Variations of fixed oral CPAP are eligible, including auto-titrating CPAP, nasal CPAP, bilevel CPAP, and humidification with CPAP |
Atrial overdrive pacing, medications, palatal implants, oropharyngeal exercises, tongue-retaining devices, positional alarms, nasal dilator strips, acupuncture, auricular plaster, and other interventions not listed as included Medications to treat sleepiness, sleep quality, or bruxism (rather than used to treat OSA), such as armodafinil, bromocriptine, donepezil, eszopiclone, and modafinil Nasal steroids for treatment of allergic rhinitis or similar treatments that might secondarily improve OSA by treating another condition Studies focusing on potential worsening of OSA that might be caused by treatments for other conditions (e.g., use of testosterone for hypogonadism, use of medications that may cause weight gain) |
| Comparisons |
KQ 1: Screened vs. nonscreened groups
KQ 2: Overnight polysomnography conducted in a sleep laboratory; studies may also determine or compare persons at increased, average, or decreased risk, or persons at higher and lower risk of OSA KQ 3: Studies on accuracy of screening must include a comparison with polysomnography; studies on reliability of screening must include measures of reproducibility (e.g., test-retest, comparison between different laboratories or readers) KQs 4, 5, 8: CPAP vs. control or sham CPAP; mandibular advancement devices vs. no treatment or inactive mandibular advancement devices; surgery vs. sham, conservative treatment, or no treatment; and weight loss interventions vs. control KQ 6: Persons with a higher or lower AHI KQ 7: Screened vs. nonscreened groups or groups undergoing screening and/or diagnostic testing vs. groups not undergoing screening and/or diagnostic testing |
No comparison; nonconcordant historical controls; comparative studies of various interventions (e.g., comparing CPAP with mandibular advancement devices or comparing different types of CPAP)
KQs 2, 3: Studies with verification bias in which only a subgroup had polysomnography as the comparator |
| Outcomes |
KQs 1, 5, 6: 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), motor vehicle crashes, cardiovascular events (including ischemic events and rhythm disturbances, such as atrial fibrillation), cerebrovascular events, incidence of heart failure, headaches, cognitive impairment
KQ 2: Sensitivity, specificity, discrimination, calibration KQ 3: Sensitivity and specificity; measures of reproducibility (e.g., test-retest, comparison between different laboratories or readers) KQ 4: Change in AHI, blood pressure, daytime somnolence or sleepiness (e.g., measured with the Epworth Sleepiness Scale or other validated measures) KQ 7: False-positive results leading to unnecessary treatment, anxiety, condition-specific distress, or stigma KQ 8: Rash, irritation, need for additional sleep medications (e.g., to tolerate CPAP), claustrophobia, oral or nasal dryness, epistaxis, pain, excess salivation, tooth damage or loosening, complications of surgery (e.g., perioperative death, hemorrhage, nerve palsy, additional emergency surgery, cardiovascular events, respiratory failure, rehospitalization, speech or voice changes, difficulty swallowing, airway stenosis) |
|
| Study designs |
KQ 1: RCTs comparing screened vs. nonscreened groups
KQ 2: Prospective cohort studies and cross-sectional studies that developed or evaluated screening questionnaires or clinical prediction tools Previously published systematic reviews (only for the purposes of identifying existing studies) Clinical prediction tools and screening questionnaires must be externally validated KQ 3: Good-quality, recent (within 5 years) systematic reviews comparing diagnostic tests with formal, attended polysomnography conducted in a sleep laboratory Primary studies published after the search cutoff of the most recent systematic review will be included (i.e., bridge searches will be performed to determine whether there is new evidence since the review and whether it is consistent with the review) KQs 4, 5: RCTs; previously published systematic reviews (only for the purposes of identifying existing studies) KQ 6: Good-quality, recent (within 5 years) systematic reviews; bridge searches will be performed to determine what is new since the review and whether it is consistent with the review Prospective cohort studies that follow participants for at least 1 year and are published after the search cutoff of the most recent systematic review will be included Treatment studies included in KQs 4 or 5 reporting both change in AHI and change in a health outcome KQ 7: Studies eligible for KQs 1, 2, or 3 that report harms of screening or diagnostic tests KQ 8: RCTs for all interventions; prospective cohort studies with at least 100 participants that report harms of surgical interventions |
All other designs
KQs 2, 3: 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 |
Abbreviations: KQ = key question; RCT = randomized, controlled trial; RDI = Respiratory Disturbance Index.
The draft Research Plan was posted for public comment on the U.S. Preventive Services Task Force (USPSTF) Web site from August 7 to September 3, 2014. The USPSTF received comments related to the population, screening and diagnostic tests, outcomes, and subpopulations. The USPSTF inserted an additional key question addressing multistep screening approaches and an additional contextual question about interventions to enhance adherence to CPAP. The USPSTF expanded and clarified the descriptions of the eligible population, screening tests, and outcomes. The evidence review will be limited to adults, since OSA in children and adolescents presents and is managed differently from OSA in adults.