Scoring (manual, automated, automated with manual review)

Transcription

1 A. Source and Extractor Author, Year Reference test PMID RefID Index test 1 Key Question(s) Index test 2 Extractor B. Study description Sampling population A Recruitment Multicenter? Enrollment method B Years Country Funding source Index Test Readers BLIND to Reference Test Results? A Patients representative of the general population? Patients referred to a specialized center? [However defined] high-risk patients? B Consecutive patients, random sampling, case series/convenience sample C. Participant characteristics and baseline severity/risk Study design* Prospective vs retrospective (exclude case control studies) Cross-sectional * Change from Cross-sectional if other design used. Inclusion criteria Exclusion criteria D. Description of facility-based polysomnography and portable device monitoring (whatever is applicable) D1. PSG Equipment Manufacturer (Location) Setting (eg, Sleep lab) Scoring (manual, automated, automated with manual review) Standard scoring system used? If not, describe criteria used Denominator* Definition of Apnea: Definition of Hypopnea: Thresholds used: Definitions: : * Total sleep time (AHI) versus Total recording time (RDI)

2 D2. Other Devices Type Name (equipment) Manufacturer (Location) Channels A Actigraphy (Y/N) Setting B Timing C Scoring (manual, automated, automated with manual review) Scoring system, if not identical that for PSG Denominator D RDI or AHI (only with Type II devices) Definition of Apnea: Definition of Hypopnea: Thresholds used: Definitions: : A Describe Flow and Effort channels / indicate nd if not described in the study B Setting: sleep lab/ hospital/community center, etc, C Timing: Simultaneous with PSG/ Different day; If different, how many days between PSG and device measurement D Total sleep time (AHI) versus Total recording time (RDI) D2.1 (Type definitions) Type Portability Indicative Indicative signals 2 airflow/ Identifies AHI Nchannels effort channels sleep / wake I Facility-based ~14-16 EEG, EOG, EMG, ECG/HR, airflow, effort, SaO2 Yes Yes Yes II Portable 7 (may have EEG), HR*, EOG, chin EMG, ECG/HR, airflow, Yes Yes Yes effort, SaO2 III Portable 4 Airflow and/or effort, ECG/HR, SaO2 Yes No No IV Portable ~1-3** [All monitors not qualifying for type III] No No*** No AHI: Apnea-Hypopnea index; ECG: electrocardiogram; EEG: Electroencephalogram; EMG: electromyography; EOG: Electro-oculogram; HR: heart rate; SaO2: arterial O2 saturation; *Heart rate is allowed instead of EEG in type II monitors. Essentially, many type II monitors gather the same signals as type I monitors. **May have more than three channels, provided that criteria for type III are not met; ***May include monitors that measure signals that are in principle able to identify arousals from sleep.

3 D3. Questionnaire Description of Test Used Name * Description of Test (only if not on our list) Thresholds Used (Cut-Offs included) ** : * Epworth / STOP-BANG/ Stanford / Berlin/ Pittsburgh Scale/ Friedman surgical or staging ** Use Enter (return carriage) at the end of each threshold definition E.1 Baseline Characteristics. If total not presented, add rows for subgroups evaluated and note significant differences N enrolled (analyzed) Male, Age, y Race BMI* HTN, (how defined?) or BP AFib/AFlutter, CVD, NIDDM, Smokers, (define) GERD, MVA etc, Cognitive Function ** Depression, Other Comorbidities, Is this a Special Population? (which?) * Mean±SD. If median, SE, range, IQR, or other, specify these. Motor vehicle accident. Including CVD, CAD, IHD, previous MI, previous stroke, etc. ** Either score on a test (which test?) or with cognitive dysfunction E.2 Baseline Characteristics. Habitual Snoring * Bed partner, Craniofacial abnormalities/ congenital abnormalities * Mean±SD. If median, SE, range, IQR, or other, specify these. Epworth MSLT Other Clinical symptoms, Other characteristics F. PSG: Polysomnography (facility-based) Results. Mean AHI AHI 5 (Range) AHI 10 AHI 15 AHI 20 AHI 30 AHI?* AHI: Apnea-hypopnea index; RDI: respiratory distress index * Fill in this column only if any cut-offs other than 5 & 15 are used. Replace? with number. G1. Results: Concordance [agreement between measurements assume no gold standard] Comparison N Enrolled N Analyzed Concordance Metric* Value (95 CI or LOA)** Other Text Description (eg, of bias) Index Ref * Bland Altman plot; LOA, Limits of Agreement (±2SD); NOT correlation coefficients and OLS regression ** Delete or correct the incorrect value/item. If change, highlight yellow.

4 G2. Results: Diagnostic performances (Extract all reported data) [assumes gold standard] Comparison (Index v Index Reference standard Sn data Sp data Sens (95 CI) Spec (95 CI) Ref) cutoff cutoff TP FN TN FP ROC AUC (Q*) Other TP, Index + / Ref + FP, Index + / Ref FN, Index / Ref + TN, Index / Ref on Results: H. Subgroup Analysis (If present) If sub-group analysis is presented, copy the relevant tables (6 or 7) for presenting each sub-group separately. Record only those studies that have assessed an interaction test for the groups I. REASONS FOR TREATMENT DISCONTINUATION or DROPOUT or LACK OF COMPLIANCE or LACK OF ANALYSIS n/n Dropout or analysis failure Reasons J. Methodological Quality Prospective or Retrospective? Verification bias? (Yes/No; if yes describe) Blinding? (Yes/No) Analytic problem? (Yes/No, if yes describe) * Adequate description of tests (Yes/No, if no describe) Clear description of population studied (Yes/No, if no describe) Data loss / not analyzed () Overall Quality (A/B/C) * e.g., improper accounting for multiple measurements in same patient (should do clustered analysis). Quality: Grade A (good) studies fulfill most commonly held concepts of high quality, including the following: blinding of assessors to results of the other test, blinding to clinical information, enrollment of consecutive patients, random order of measurements or simultaneous measurements with the compared methods, clear description of the evaluated population, setting, and measurement methods; appropriate measurement of outcomes; appropriate statistical and analytic methods and reporting; no reporting errors; not excessive data loss (<20); and no obvious bias. Grade B (moderate) studies may be susceptible to some bias, but not sufficient to invalidate the results. Such studies do not meet the criteria described in category A. They have some deficiencies but none likely to cause major bias. Study may be missing information making assessment of the limitations and potential problems difficult. Grade C (poor) studies are subject to significant bias that may invalidate the results. Such studies may have serious errors in design, analysis or reporting. These studies may have large amounts of missing information or discrepancies in reporting.

5 K. OTHER COMMENTS CONCERNING THE STUDY