Evidence map›Paper›PMID 34170235›Full record

Trial reportJournal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine2022

Diagnosis and management of sleep apnea by a clinical nurse: a noninferiority randomized clinical trial.

Annie C Lajoie, Alexis Privé, Annie Roy-Hallé, Diane Pagé, Serge Simard, Frédéric Séries

Registry-linked trialAbstract readRandomized Controlled TrialEquivalence Trial
In one paragraph

Trial report in Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03455920 (Management of Sleep Apnea Patients by a Clinical Nurse), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03455920 nacompletednot on this map

Management of Sleep Apnea Patients by a Clinical Nurse (Supernurse)

TypeinterventionalSponsorAnnie C LajoieRan2017 to 2020Enrolled200ConditionsSleep Apnea Syndromes, Sleep Apnea, Multidisciplinary Communication, Sleep Apnea, ObstructiveArmsClinical nurse (supernurse) evaluation, Pulmonologist evaluation
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Annie C LajoieCentre de Recherche de l'Institut de Cardiologie et de Pneumologie de Québec-Université Laval (CRIUCPQ-UL), Quebec City, Canada.
Alexis PrivéCentre de Recherche de l'Institut de Cardiologie et de Pneumologie de Québec-Université Laval (CRIUCPQ-UL), Quebec City, Canada.
Annie Roy-HalléCentre de Recherche de l'Institut de Cardiologie et de Pneumologie de Québec-Université Laval (CRIUCPQ-UL), Quebec City, Canada.
Diane PagéCentre de Recherche de l'Institut de Cardiologie et de Pneumologie de Québec-Université Laval (CRIUCPQ-UL), Quebec City, Canada.
Serge SimardCentre de Recherche de l'Institut de Cardiologie et de Pneumologie de Québec-Université Laval (CRIUCPQ-UL), Quebec City, Canada.
Frédéric SériesCentre de Recherche de l'Institut de Cardiologie et de Pneumologie de Québec-Université Laval (CRIUCPQ-UL), Quebec City, Canada.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

STUDY

objectivesReferences for the evaluation of obstructive sleep apnea often exceed the sleep clinic's capacity. We aimed to assess the noninferiority of a nurse-communicated model compared with a traditional physician-led model for the initial management of uncomplicated obstructive sleep apnea in the sleep clinic.

methodsIn this noninferiority, open-label randomized controlled trial, patients referred for the evaluation of uncomplicated obstructive sleep apnea (home sleep apnea test with respiratory event index ≥ 20 events/h) were randomized to a nurse-communicated or a physician-led management. The primary endpoint was noninferiority in the mean change from baseline of the Epworth Sleepiness Scale score at 3 and 6 months, assuming a noninferiority margin of -2.0 points. Secondary outcomes included quality of life (Quebec Sleep Questionnaire) and positive airway pressure adherence.

resultsTwo hundred participants were randomized to a nurse-communicated (n = 101) or physician-led management (n = 99). Overall, 48 participants were lost at follow-up (27.7% and 20.4% in the nurse-communicated and physician-led groups, respectively). Most participants were treated with positive airway pressure (78.2% and 80.6% in the nurse-communicated and physician-led management groups, respectively). There was substantial missing data for the Epworth Sleepiness Scale (33% and 58% at 3 and 6 months in the nurse-communicated group and 29% and 55% in the physician-led group) and Quebec Sleep Questionnaire (86% and 91% at 3 and 6 months and 79.6% and 85.7% in the physician-led group). The difference in mean change between groups for the Epworth Sleepiness Scale was -0.71 (95% confidence interval -2.25 to 0.83) at 3 months and -0.21 (95% confidence interval -1.85 to 1.45) at 6 months. For each domain of the Quebec Sleep Questionnaire at 3 and 6 months, the lower bound of the 95% confidence interval was greater than the prespecified noninferiority margin. Positive airway pressure adherence was similar between groups.

conclusionsAmong patients with uncomplicated obstructive sleep apnea, nurse-communicated management was noninferior to physician-led management in terms of sleepiness, quality of life, and positive airway pressure adherence at 6 months. CLINICAL

trial registrationRegistry: ClinicalTrials.gov; Name: Management of Sleep Apnea Patients by a Clinical Nurse (Supernurse), URL: https://clinicaltrials.gov/ct2/show/NCT03455920; Identifier: NCT03455920. CITATION: Lajoie AC, Privé A, Roy-Hallé A, Pagé D, Simard S, Séries F. Diagnosis and management of sleep apnea by a clinical nurse: a noninferiority randomized clinical trial.

Indexed as

Sleep Apnea, ObstructiveSleep Apnea SyndromesContinuous Positive Airway PressureHumansPolysomnographyQuality of LifeTreatment Outcomenurse-communicated managementobstructive sleep apneapositive airway pressuresleep-disordered breathing

Identifiers

PMID34170235
PMCPMC8807928

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.