Sleep and Alertness in a Duty-Hour Flexibility Trial in Internal Medicine.


Journal

The New England journal of medicine
ISSN: 1533-4406
Titre abrégé: N Engl J Med
Pays: United States
ID NLM: 0255562

Informations de publication

Date de publication:
07 03 2019
Historique:
entrez: 12 3 2019
pubmed: 12 3 2019
medline: 2 4 2019
Statut: ppublish

Résumé

A purpose of duty-hour regulations is to reduce sleep deprivation in medical trainees, but their effects on sleep, sleepiness, and alertness are largely unknown. We randomly assigned 63 internal-medicine residency programs in the United States to follow either standard 2011 duty-hour policies or flexible policies that maintained an 80-hour workweek without limits on shift length or mandatory time off between shifts. Sleep duration and morning sleepiness and alertness were compared between the two groups by means of a noninferiority design, with outcome measures including sleep duration measured with actigraphy, the Karolinska Sleepiness Scale (with scores ranging from 1 [extremely alert] to 9 [extremely sleepy, fighting sleep]), and a brief computerized Psychomotor Vigilance Test (PVT-B), with long response times (lapses) indicating reduced alertness. Data were obtained over a period of 14 days for 205 interns at six flexible programs and 193 interns at six standard programs. The average sleep time per 24 hours was 6.85 hours (95% confidence interval [CI], 6.61 to 7.10) among those in flexible programs and 7.03 hours (95% CI, 6.78 to 7.27) among those in standard programs. Sleep duration in flexible programs was noninferior to that in standard programs (between-group difference, -0.17 hours per 24 hours; one-sided lower limit of the 95% confidence interval, -0.45 hours; noninferiority margin, -0.5 hours; P = 0.02 for noninferiority), as was the score on the Karolinska Sleepiness Scale (between-group difference, 0.12 points; one-sided upper limit of the 95% confidence interval, 0.31 points; noninferiority margin, 1 point; P<0.001). Noninferiority was not established for alertness according to the PVT-B (between-group difference, -0.3 lapses; one-sided upper limit of the 95% confidence interval, 1.6 lapses; noninferiority margin, 1 lapse; P = 0.10). This noninferiority trial showed no more chronic sleep loss or sleepiness across trial days among interns in flexible programs than among those in standard programs. Noninferiority of the flexible group for alertness was not established. (Funded by the National Heart, Lung, and Blood Institute and American Council for Graduate Medical Education; ClinicalTrials.gov number, NCT02274818.).

Sections du résumé

BACKGROUND
A purpose of duty-hour regulations is to reduce sleep deprivation in medical trainees, but their effects on sleep, sleepiness, and alertness are largely unknown.
METHODS
We randomly assigned 63 internal-medicine residency programs in the United States to follow either standard 2011 duty-hour policies or flexible policies that maintained an 80-hour workweek without limits on shift length or mandatory time off between shifts. Sleep duration and morning sleepiness and alertness were compared between the two groups by means of a noninferiority design, with outcome measures including sleep duration measured with actigraphy, the Karolinska Sleepiness Scale (with scores ranging from 1 [extremely alert] to 9 [extremely sleepy, fighting sleep]), and a brief computerized Psychomotor Vigilance Test (PVT-B), with long response times (lapses) indicating reduced alertness.
RESULTS
Data were obtained over a period of 14 days for 205 interns at six flexible programs and 193 interns at six standard programs. The average sleep time per 24 hours was 6.85 hours (95% confidence interval [CI], 6.61 to 7.10) among those in flexible programs and 7.03 hours (95% CI, 6.78 to 7.27) among those in standard programs. Sleep duration in flexible programs was noninferior to that in standard programs (between-group difference, -0.17 hours per 24 hours; one-sided lower limit of the 95% confidence interval, -0.45 hours; noninferiority margin, -0.5 hours; P = 0.02 for noninferiority), as was the score on the Karolinska Sleepiness Scale (between-group difference, 0.12 points; one-sided upper limit of the 95% confidence interval, 0.31 points; noninferiority margin, 1 point; P<0.001). Noninferiority was not established for alertness according to the PVT-B (between-group difference, -0.3 lapses; one-sided upper limit of the 95% confidence interval, 1.6 lapses; noninferiority margin, 1 lapse; P = 0.10).
CONCLUSIONS
This noninferiority trial showed no more chronic sleep loss or sleepiness across trial days among interns in flexible programs than among those in standard programs. Noninferiority of the flexible group for alertness was not established. (Funded by the National Heart, Lung, and Blood Institute and American Council for Graduate Medical Education; ClinicalTrials.gov number, NCT02274818.).

Identifiants

pubmed: 30855741
doi: 10.1056/NEJMoa1810641
pmc: PMC6457111
mid: NIHMS1523726
doi:

Banques de données

ClinicalTrials.gov
['NCT02274818']

Types de publication

Comparative Study Equivalence Trial Journal Article Multicenter Study Randomized Controlled Trial Research Support, N.I.H., Extramural

Langues

eng

Sous-ensembles de citation

IM

Pagination

915-923

Subventions

Organisme : NINR NIH HHS
ID : K99 NR017416
Pays : United States
Organisme : NHLBI NIH HHS
ID : U01HL125388
Pays : United States
Organisme : NINR NIH HHS
ID : P20 NR018075
Pays : United States
Organisme : NHLBI NIH HHS
ID : U01 HL125388
Pays : United States
Organisme : NHLBI NIH HHS
ID : U01 HL126088
Pays : United States
Organisme : NHLBI NIH HHS
ID : U01HL126088
Pays : United States
Organisme : NINR NIH HHS
ID : F31 NR014603
Pays : United States

Investigateurs

Margot Boigon (M)
Jill Patton (J)
Donna Astiz (D)
Cheryl O'Malley (C)
Richard J Hamill (RJ)
Michael Rosenblum (M)
Charles Smith (C)
Joel Katz (J)
Maria Yialamas (M)
Dominick Tammaro (D)
Jennifer Bolyard (J)
Claudia A Kroker-Bode (CA)
Michael J McFarlane (MJ)
Keith Armitage (K)
Amanda Ewing (A)
Abby L Spencer (AL)
Tammy Wichman (T)
Richard Paluzzi (R)
Aimee Zaas (A)
Suzanne Kraemer (S)
Benjamin Goodman (B)
Lorenzo Di Francesco (L)
Mary Harris (M)
Jillian Catalanotti (J)
Sal Pindiprolu (S)
Paul Foster (P)
Sean M Drake (SM)
Sanjay Desai (S)
Erica N Johnson (EN)
Elizabeth Nilson (E)
William D Surkis (WD)
Jonathon Doroshow (J)
Jatin M Vyas (JM)
Michael Frank (M)
Eric H Green (EH)
Cinnamon Bradley (C)
Soma Wali (S)
Sapna Kuehl (S)
Harvey Friedman (H)
Ronald Witteles (R)
Marissa A Blum (MA)
Curtis Mirkes (C)
Michael Phy (M)
Emily Stewart (E)
Richard Kopelman (R)
Kari Roberts (K)
Jodi Friedman (J)
Brian Gable (B)
Eric Warm (E)
Suzanne Brandenburg (S)
Steven V Angus (SV)
Leigh M Eck (LM)
Susan D Wolfsthal (SD)
Richard M Forster (RM)
James O'Dell (J)
Debra L Bynum (DL)
Lisa Bellini (L)
Mark Pasanen (M)
Kenneth P Steinberg (KP)
Stephanie Ann Call (SA)
Hal H Atkinson (HH)
Melvin Blanchard (M)
Thomas Ciesielski (T)
Nathan Lerfald (N)
Mark D Siegel (MD)

Informations de copyright

Copyright © 2019 Massachusetts Medical Society.

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Auteurs

Mathias Basner (M)

From the University of Pennsylvania (M.B., D.A.A., J.A.S., L.M.B., M.C., A.J.E., S.K.M., D.S.S., K.G.V., D.F.D.), Corporal Michael J. Crescenz Veterans Affairs Medical Center (D.A.A., K.G.V.), Children's Hospital of Philadelphia (O.E.-S., J.H.S.), and Pulsar Informatics (C.G.M., S.C., D.J.M.) - all in Philadelphia; Johns Hopkins University, Baltimore (S.V.D., A.L.S., J.T., D.M.S.); and Brigham and Women's Hospital, Boston (J.T.K., D.W.B.).

David A Asch (DA)

From the University of Pennsylvania (M.B., D.A.A., J.A.S., L.M.B., M.C., A.J.E., S.K.M., D.S.S., K.G.V., D.F.D.), Corporal Michael J. Crescenz Veterans Affairs Medical Center (D.A.A., K.G.V.), Children's Hospital of Philadelphia (O.E.-S., J.H.S.), and Pulsar Informatics (C.G.M., S.C., D.J.M.) - all in Philadelphia; Johns Hopkins University, Baltimore (S.V.D., A.L.S., J.T., D.M.S.); and Brigham and Women's Hospital, Boston (J.T.K., D.W.B.).

Judy A Shea (JA)

From the University of Pennsylvania (M.B., D.A.A., J.A.S., L.M.B., M.C., A.J.E., S.K.M., D.S.S., K.G.V., D.F.D.), Corporal Michael J. Crescenz Veterans Affairs Medical Center (D.A.A., K.G.V.), Children's Hospital of Philadelphia (O.E.-S., J.H.S.), and Pulsar Informatics (C.G.M., S.C., D.J.M.) - all in Philadelphia; Johns Hopkins University, Baltimore (S.V.D., A.L.S., J.T., D.M.S.); and Brigham and Women's Hospital, Boston (J.T.K., D.W.B.).

Lisa M Bellini (LM)

From the University of Pennsylvania (M.B., D.A.A., J.A.S., L.M.B., M.C., A.J.E., S.K.M., D.S.S., K.G.V., D.F.D.), Corporal Michael J. Crescenz Veterans Affairs Medical Center (D.A.A., K.G.V.), Children's Hospital of Philadelphia (O.E.-S., J.H.S.), and Pulsar Informatics (C.G.M., S.C., D.J.M.) - all in Philadelphia; Johns Hopkins University, Baltimore (S.V.D., A.L.S., J.T., D.M.S.); and Brigham and Women's Hospital, Boston (J.T.K., D.W.B.).

Michele Carlin (M)

From the University of Pennsylvania (M.B., D.A.A., J.A.S., L.M.B., M.C., A.J.E., S.K.M., D.S.S., K.G.V., D.F.D.), Corporal Michael J. Crescenz Veterans Affairs Medical Center (D.A.A., K.G.V.), Children's Hospital of Philadelphia (O.E.-S., J.H.S.), and Pulsar Informatics (C.G.M., S.C., D.J.M.) - all in Philadelphia; Johns Hopkins University, Baltimore (S.V.D., A.L.S., J.T., D.M.S.); and Brigham and Women's Hospital, Boston (J.T.K., D.W.B.).

Adrian J Ecker (AJ)

From the University of Pennsylvania (M.B., D.A.A., J.A.S., L.M.B., M.C., A.J.E., S.K.M., D.S.S., K.G.V., D.F.D.), Corporal Michael J. Crescenz Veterans Affairs Medical Center (D.A.A., K.G.V.), Children's Hospital of Philadelphia (O.E.-S., J.H.S.), and Pulsar Informatics (C.G.M., S.C., D.J.M.) - all in Philadelphia; Johns Hopkins University, Baltimore (S.V.D., A.L.S., J.T., D.M.S.); and Brigham and Women's Hospital, Boston (J.T.K., D.W.B.).

Susan K Malone (SK)

From the University of Pennsylvania (M.B., D.A.A., J.A.S., L.M.B., M.C., A.J.E., S.K.M., D.S.S., K.G.V., D.F.D.), Corporal Michael J. Crescenz Veterans Affairs Medical Center (D.A.A., K.G.V.), Children's Hospital of Philadelphia (O.E.-S., J.H.S.), and Pulsar Informatics (C.G.M., S.C., D.J.M.) - all in Philadelphia; Johns Hopkins University, Baltimore (S.V.D., A.L.S., J.T., D.M.S.); and Brigham and Women's Hospital, Boston (J.T.K., D.W.B.).

Sanjay V Desai (SV)

From the University of Pennsylvania (M.B., D.A.A., J.A.S., L.M.B., M.C., A.J.E., S.K.M., D.S.S., K.G.V., D.F.D.), Corporal Michael J. Crescenz Veterans Affairs Medical Center (D.A.A., K.G.V.), Children's Hospital of Philadelphia (O.E.-S., J.H.S.), and Pulsar Informatics (C.G.M., S.C., D.J.M.) - all in Philadelphia; Johns Hopkins University, Baltimore (S.V.D., A.L.S., J.T., D.M.S.); and Brigham and Women's Hospital, Boston (J.T.K., D.W.B.).

Alice L Sternberg (AL)

From the University of Pennsylvania (M.B., D.A.A., J.A.S., L.M.B., M.C., A.J.E., S.K.M., D.S.S., K.G.V., D.F.D.), Corporal Michael J. Crescenz Veterans Affairs Medical Center (D.A.A., K.G.V.), Children's Hospital of Philadelphia (O.E.-S., J.H.S.), and Pulsar Informatics (C.G.M., S.C., D.J.M.) - all in Philadelphia; Johns Hopkins University, Baltimore (S.V.D., A.L.S., J.T., D.M.S.); and Brigham and Women's Hospital, Boston (J.T.K., D.W.B.).

James Tonascia (J)

From the University of Pennsylvania (M.B., D.A.A., J.A.S., L.M.B., M.C., A.J.E., S.K.M., D.S.S., K.G.V., D.F.D.), Corporal Michael J. Crescenz Veterans Affairs Medical Center (D.A.A., K.G.V.), Children's Hospital of Philadelphia (O.E.-S., J.H.S.), and Pulsar Informatics (C.G.M., S.C., D.J.M.) - all in Philadelphia; Johns Hopkins University, Baltimore (S.V.D., A.L.S., J.T., D.M.S.); and Brigham and Women's Hospital, Boston (J.T.K., D.W.B.).

David M Shade (DM)

From the University of Pennsylvania (M.B., D.A.A., J.A.S., L.M.B., M.C., A.J.E., S.K.M., D.S.S., K.G.V., D.F.D.), Corporal Michael J. Crescenz Veterans Affairs Medical Center (D.A.A., K.G.V.), Children's Hospital of Philadelphia (O.E.-S., J.H.S.), and Pulsar Informatics (C.G.M., S.C., D.J.M.) - all in Philadelphia; Johns Hopkins University, Baltimore (S.V.D., A.L.S., J.T., D.M.S.); and Brigham and Women's Hospital, Boston (J.T.K., D.W.B.).

Joel T Katz (JT)

From the University of Pennsylvania (M.B., D.A.A., J.A.S., L.M.B., M.C., A.J.E., S.K.M., D.S.S., K.G.V., D.F.D.), Corporal Michael J. Crescenz Veterans Affairs Medical Center (D.A.A., K.G.V.), Children's Hospital of Philadelphia (O.E.-S., J.H.S.), and Pulsar Informatics (C.G.M., S.C., D.J.M.) - all in Philadelphia; Johns Hopkins University, Baltimore (S.V.D., A.L.S., J.T., D.M.S.); and Brigham and Women's Hospital, Boston (J.T.K., D.W.B.).

David W Bates (DW)

From the University of Pennsylvania (M.B., D.A.A., J.A.S., L.M.B., M.C., A.J.E., S.K.M., D.S.S., K.G.V., D.F.D.), Corporal Michael J. Crescenz Veterans Affairs Medical Center (D.A.A., K.G.V.), Children's Hospital of Philadelphia (O.E.-S., J.H.S.), and Pulsar Informatics (C.G.M., S.C., D.J.M.) - all in Philadelphia; Johns Hopkins University, Baltimore (S.V.D., A.L.S., J.T., D.M.S.); and Brigham and Women's Hospital, Boston (J.T.K., D.W.B.).

Orit Even-Shoshan (O)

From the University of Pennsylvania (M.B., D.A.A., J.A.S., L.M.B., M.C., A.J.E., S.K.M., D.S.S., K.G.V., D.F.D.), Corporal Michael J. Crescenz Veterans Affairs Medical Center (D.A.A., K.G.V.), Children's Hospital of Philadelphia (O.E.-S., J.H.S.), and Pulsar Informatics (C.G.M., S.C., D.J.M.) - all in Philadelphia; Johns Hopkins University, Baltimore (S.V.D., A.L.S., J.T., D.M.S.); and Brigham and Women's Hospital, Boston (J.T.K., D.W.B.).

Jeffrey H Silber (JH)

From the University of Pennsylvania (M.B., D.A.A., J.A.S., L.M.B., M.C., A.J.E., S.K.M., D.S.S., K.G.V., D.F.D.), Corporal Michael J. Crescenz Veterans Affairs Medical Center (D.A.A., K.G.V.), Children's Hospital of Philadelphia (O.E.-S., J.H.S.), and Pulsar Informatics (C.G.M., S.C., D.J.M.) - all in Philadelphia; Johns Hopkins University, Baltimore (S.V.D., A.L.S., J.T., D.M.S.); and Brigham and Women's Hospital, Boston (J.T.K., D.W.B.).

Dylan S Small (DS)

From the University of Pennsylvania (M.B., D.A.A., J.A.S., L.M.B., M.C., A.J.E., S.K.M., D.S.S., K.G.V., D.F.D.), Corporal Michael J. Crescenz Veterans Affairs Medical Center (D.A.A., K.G.V.), Children's Hospital of Philadelphia (O.E.-S., J.H.S.), and Pulsar Informatics (C.G.M., S.C., D.J.M.) - all in Philadelphia; Johns Hopkins University, Baltimore (S.V.D., A.L.S., J.T., D.M.S.); and Brigham and Women's Hospital, Boston (J.T.K., D.W.B.).

Kevin G Volpp (KG)

From the University of Pennsylvania (M.B., D.A.A., J.A.S., L.M.B., M.C., A.J.E., S.K.M., D.S.S., K.G.V., D.F.D.), Corporal Michael J. Crescenz Veterans Affairs Medical Center (D.A.A., K.G.V.), Children's Hospital of Philadelphia (O.E.-S., J.H.S.), and Pulsar Informatics (C.G.M., S.C., D.J.M.) - all in Philadelphia; Johns Hopkins University, Baltimore (S.V.D., A.L.S., J.T., D.M.S.); and Brigham and Women's Hospital, Boston (J.T.K., D.W.B.).

Christopher G Mott (CG)

From the University of Pennsylvania (M.B., D.A.A., J.A.S., L.M.B., M.C., A.J.E., S.K.M., D.S.S., K.G.V., D.F.D.), Corporal Michael J. Crescenz Veterans Affairs Medical Center (D.A.A., K.G.V.), Children's Hospital of Philadelphia (O.E.-S., J.H.S.), and Pulsar Informatics (C.G.M., S.C., D.J.M.) - all in Philadelphia; Johns Hopkins University, Baltimore (S.V.D., A.L.S., J.T., D.M.S.); and Brigham and Women's Hospital, Boston (J.T.K., D.W.B.).

Sara Coats (S)

From the University of Pennsylvania (M.B., D.A.A., J.A.S., L.M.B., M.C., A.J.E., S.K.M., D.S.S., K.G.V., D.F.D.), Corporal Michael J. Crescenz Veterans Affairs Medical Center (D.A.A., K.G.V.), Children's Hospital of Philadelphia (O.E.-S., J.H.S.), and Pulsar Informatics (C.G.M., S.C., D.J.M.) - all in Philadelphia; Johns Hopkins University, Baltimore (S.V.D., A.L.S., J.T., D.M.S.); and Brigham and Women's Hospital, Boston (J.T.K., D.W.B.).

Daniel J Mollicone (DJ)

From the University of Pennsylvania (M.B., D.A.A., J.A.S., L.M.B., M.C., A.J.E., S.K.M., D.S.S., K.G.V., D.F.D.), Corporal Michael J. Crescenz Veterans Affairs Medical Center (D.A.A., K.G.V.), Children's Hospital of Philadelphia (O.E.-S., J.H.S.), and Pulsar Informatics (C.G.M., S.C., D.J.M.) - all in Philadelphia; Johns Hopkins University, Baltimore (S.V.D., A.L.S., J.T., D.M.S.); and Brigham and Women's Hospital, Boston (J.T.K., D.W.B.).

David F Dinges (DF)

From the University of Pennsylvania (M.B., D.A.A., J.A.S., L.M.B., M.C., A.J.E., S.K.M., D.S.S., K.G.V., D.F.D.), Corporal Michael J. Crescenz Veterans Affairs Medical Center (D.A.A., K.G.V.), Children's Hospital of Philadelphia (O.E.-S., J.H.S.), and Pulsar Informatics (C.G.M., S.C., D.J.M.) - all in Philadelphia; Johns Hopkins University, Baltimore (S.V.D., A.L.S., J.T., D.M.S.); and Brigham and Women's Hospital, Boston (J.T.K., D.W.B.).

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