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Draft Research Plan

Screening for Obstructive Sleep Apnea


Note: This is a draft Research Plan. This draft is distributed solely for the purpose of receiving public input. It has not been disseminated otherwise by the USPSTF.

The final Research Plan will be 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.

This draft Research Plan is available for comment from August 7 to September 3, 2014, at 5:00 p.m., ET. You may wish to read the entire Research Plan before you comment.


I. Proposed Analytic Framework

Select Text Description below for details.

 Abbreviations: AHI = apnea-hypopnea index; KQ = key question; OSA = obstructive sleep apnea.

[D] Select for Text Description.

II. Proposed Key Questions to Be Systematically Reviewed

1a. What is the direct evidence that screening for obstructive sleep apnea (OSA) in adults improves health outcomes?
1b. How does the evidence differ for subgroups defined by age, sex, body mass index (BMI), or severity of OSA?
2. How accurately do currently existing clinical prediction tools or screening questionnaires distinguish 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. How 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 (apnea-hypopnea index [AHI], blood pressure, or sleepiness) in persons diagnosed with OSA?
4b. How do the benefits of treatment differ for subgroups defined by age, sex, BMI, or severity of OSA?
5a. How does intervention with CPAP, mandibular advancement devices, surgery, or weight loss programs improve health outcomes in persons diagnosed with OSA?
5b. How do the benefits of intervention differ for subgroups defined by age, sex, BMI, or severity of OSA?
6. What is the evidence supporting an association between AHI and health outcomes?
7a. What are the harms associated with screening or diagnostic testing for OSA?
7b. Do the harms differ for subgroups defined by age, sex, or BMI?
8a. What are the harms associated with treatment of OSA?
8b. How do the harms of treatment differ for subgroups defined by age, sex, BMI, or severity of OSA?

III. Proposed Contextual Questions

Contextual questions will not be systematically reviewed and are not shown in the Analytic Framework.

  1. What is the rate of adherence to CPAP, mandibular advancement devices, and weight loss interventions in persons with OSA?
  2. What are the barriers to undergoing diagnostic testing for OSA (e.g., availability of polysomnography, ability to tolerate testing) and how often do those barriers prevent completion of testing?
  3. What is the evidence supporting an association between a reduction in sleepiness and quality of life, work productivity, motor vehicle crashes, or other health outcomes?
  4. What is the evidence supporting an association between a reduction in blood pressure and health outcomes?
  5. What are clinically meaningful changes in AHI, sleepiness (as measured by the Epworth Sleepiness Scale), and blood pressure?
  6. What is the evidence supporting an association between OSA and incident diabetes?

IV. Proposed Research Approach

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 (KQs).

  Include Exclude
Populations 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; the population may include asymptomatic and/or symptomatic adults

OSA severity to be defined as mild for AHI (or RDI) ≥5 and <15; moderate for AHI (or RDI) ≥15 and ≤30; and severe for AHI (or RDI) ≥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 Program

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, the STOP Questionnaire, the Berlin questionnaire, the Wisconsin Sleep Questionnaire, or the STOP-Bang Questionnaire

Risk stratification tools or clinical prediction rules that include multiple factors (e.g., the Multivariate Apnea Prediction Index)

Studies assessing single patient characteristics or risk factors
Diagnostic testing PSG conducted in a sleep laboratory, reviewed and interpreted by a qualified physician is the reference standard

Portable monitors used for home-based testing (including Type II, Type III, and Type IV monitors)

Home-based testing followed by PSG

 
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 in the included column

Medications to treat sleepiness, sleep quality, or bruxism (rather than used to treat OSA), such as armodafinil, bromocriptine, donepezil, eszopiclone, and modafininl

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 versus nonscreened groups

KQ 2: Overnight PSG 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 PSG; 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 versus control or sham CPAP; mandibular advancement devices versus no treatment or inactive mandibular advancement devices; surgery versus sham, conservative treatment, or no treatment; and weight loss interventions versus control

KQ 6: Persons with higher and lower AHIs

KQ 7: Screened versus nonscreened groups or groups undergoing screening and/or diagnostic testing versus 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 PSG 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 SF-36), motor vehicle crashes, cardiovascular 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, needing 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 palsies, additional emergency surgery, cardiovascular events, respiratory failure, rehospitalization, speech or voice changes, difficulty swallowing, airway stenosis)

 
Study designs KQ 1: RCTs comparing screened versus 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 to help identify 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 PSG 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 what is new since the review and whether it is consistent with the review)

KQs 4, 5: RCTs; previously published systematic reviews will be used only to help identify 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, following participants for at least 1 year, 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 reporting harms of screening or diagnostic tests

KQ 8: RCTs for all interventions; prospective cohort studies with at least 100 participants reporting 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 Non-English

Abbreviations: AHI = apnea-hypopnea index; CPAP = continuous positive airway pressure; KQ = key question; OSA = obstructive sleep apnea; PSG = polysomnography; RCT = randomized, controlled trial; RDI = respiratory disturbance index.

AHRQ Publication No. 14-05216-EF-5
Current as of August 2014


Internet Citation:

U.S. Preventive Services Task Force. Screening for Obstructive Sleep Apnea: Draft Research Plan. AHRQ Publication No. 14-05216-EF-5. http://www.uspreventiveservicestaskforce.org/draftresplan.htm



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