NOTABLE ARTICLES OF 2016 - A collection of important studies from the past year as selected by NEJM editors
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NOTABLE ARTICLES OF 2016 A collection of important studies from the past year as selected by NEJM editors
December 2016
Dear Reader,
In 2016, the Journal published trials that sought to answer complicated questions. One such study
looked at whether men with early prostate cancer should undergo prostatectomy, radiation, or
“watchful waiting” to achieve the best outcome at 10 years. This study found that men with low-risk or
intermediate-risk prostate cancer had low prostate-cancer–specific mortality after 10 years, irrespective
of the treatment assigned. Importantly, these data helped with the conundrum of treating prostate cancer.
Since this is a disease of older men, the study balanced the competing issues of aggressive treatment
of a redolent disease with the reality that other factors may claim the life of the patient before he suc-
cumbs to prostate cancer. It provided solid landmarks for men wrestling with what to do when they
were diagnosed with low-intermediate risk prostate cancer.
Another study examined whether inducing labor at 39 weeks in pregnant women 35 years of age or
older, compared to expectant management, reduced stillbirth. While the study was underpowered
to assess differences in perinatal outcomes, it found no effect between the two groups on the rate of
caesarean section. This trial makes an important contribution to our current medical knowledge, and
helps build the foundation for larger, forthcoming studies. And even without larger studies, the data
presented helped pregnant women and their physicians visualize the risks and benefits of inducing
labor.
As the medical information published in NEJM is regularly used in daily practice, we ensure each paper
published meets exacting standards for editorial quality, clinical relevance, and impact on patient out-
comes. Among all papers published in 2016, this “most notable” collection was selected by the editors
as being the most meaningful in improving medical practice and patient care. We hope that you will
take valuable insights from these articles as you continue along your path of lifelong learning.
Jeffrey M. Drazen, M.D.
Editor-In-Chief, The New England Journal of Medicine
Distinguished Parker B. Francis Professor of Medicine
Harvard Medical School
800.843.6356 | f: 781.891.1995 | nejmgroup@mms.org
860 winter street, waltham, ma 02451-1413
nejmgroup.orgcontents
original article
Incidence of Dementia over Three Decades in the Framingham Heart Study............................................. 1
perspective
Is Dementia in Decline? Historical Trends and Future Trajectories........................................ 2
original article
Effects of Testosterone Treatment in Older Men........................................................................................... 5
editorial
Establishing a Framework — Does Testosterone Supplementation Help Older Men? ��������� 6
original article
National Cluster-Randomized Trial of Duty-Hour Flexibility in Surgical Training........................................ 8
editorial
Surgical Resident Duty-Hour Rules — Weighing the New Evidence....................................... 9
perspective
Leaping without Looking — Duty Hours, Autonomy,and the Risks of Research
and Practice.............................................................................................................................. 11
original article
Randomized Trial of Labor Induction in Women 35 Years of Age or Older............................................... 14
editorial
Induction of Labor and Cesarean Delivery.............................................................................. 15
original articles
Randomized Trial of Stent versus Surgery for Asymptomatic Carotid Stenosis......................................... 17
Long-Term Results of Stenting versus Endarterectomy for Carotid-Artery Stenosis.................................. 18
editorial
Endarterectomy, Stenting, or Neither for Asymptomatic Carotid-Artery Stenosis................ 19
original articles
Blood-Pressure Lowering in Intermediate-Risk Persons without Cardiovascular Disease......................... 21
Cholesterol Lowering in Intermediate-Risk Persons without Cardiovascular Disease............................... 22
Blood-Pressure and Cholesterol Lowering in Persons without Cardiovascular Disease............................ 23
editorial
More HOPE for Prevention with Statins.................................................................................. 24
original article
Efficacy of the Herpes Zoster Subunit Vaccine in Adults 70 Years of Age or Older................................... 27
editorial
Preventing Shingles and Its Complications in Older Persons................................................ 28
(continued on next page)
The New England Journal of Medicine is a publication of NEJM Group, a division of the Massachusetts Medical Society.
©2016 Massachusetts Medical Society, All rights reserved.contents (continued from previous page)
original articles
10-Year Outcomes after Monitoring, Surgery, or Radiotherapy for Localized Prostate Cancer................. 30
original article
Patient-Reported Outcomes after Monitoring, Surgery, or Radiotherapy for Prostate Cancer.................. 31
editorial
Treatment or Monitoring for Early Prostate Cancer................................................................ 32
original article
Guillain–Barré Syndrome Associated with Zika Virus Infection in Colombia............................................. 34
editorial
Zika Getting on Your Nerves? The Association with the Guillain–Barré Syndrome.............. 35
original article
A Randomized Trial of Long-term Oxygen for COPD with Moderate Desaturation .................................. 37
editorial
Clinical Usefulness of Long-Term Oxygen Therapy in Adults................................................. 38
perspective
Zika Virus in the Americas — Yet Another Arbovirus Threat ..................................................................... 40
perspective
Reducing the Risks of Relief — The CDC Opioid-Prescribing Guideline ................................................... 44
perspective
Rethinking the Primary Care Workforce — An Expanded Role for Nurses................................................. 481 Notable Articles of 2016 nejm.org
The n e w e ng l a n d j o u r na l of m e dic i n e
Original Article
Incidence of Dementia over Three Decades
in the Framingham Heart Study
Claudia L. Satizabal, Ph.D., Alexa S. Beiser, Ph.D., Vincent Chouraki, M.D., Ph.D.,
Geneviève Chêne, M.D., Ph.D., Carole Dufouil, Ph.D., and Sudha Seshadri, M.D.
A BS T R AC T
BACKGROUND
The prevalence of dementia is expected to soar as the average life expectancy in- From the Boston University Schools of
creases, but recent estimates suggest that the age-specific incidence of dementia Medicine (C.L.S., A.S.B., V.C., S.S.) and
Public Health (A.S.B.), Boston, and the
is declining in high-income countries. Temporal trends are best derived through Framingham Heart Study, Framingham
continuous monitoring of a population over a long period with the use of consis- (C.L.S., A.S.B., V.C., S.S.) — all in Mas-
tent diagnostic criteria. We describe temporal trends in the incidence of dementia sachusetts; and Inserm Unité 1219 and
CIC 1401-EC (Clinical Epidemiology) and
over three decades among participants in the Framingham Heart Study. University of Bordeaux, ISPED (Bordeaux
School of Public Health) — both in Bor-
METHODS deaux, France (G.C., C.D.). Address re-
Participants in the Framingham Heart Study have been under surveillance for in- print requests to Dr. Seshadri at the Bos-
ton University School of Medicine,
cident dementia since 1975. In this analysis, which included 5205 persons 60 years Department of Neurology, 72 E. Concord
of age or older, we used Cox proportional-hazards models adjusted for age and sex St., B602, Boston, MA 02118, or at
to determine the 5-year incidence of dementia during each of four epochs. We also suseshad@bu.edu.
explored the interactions between epoch and age, sex, apolipoprotein E ε4 status, N Engl J Med 2016;374:523-32.
and educational level, and we examined the effects of these interactions, as well DOI: 10.1056/NEJMoa1504327
Copyright © 2016 Massachusetts Medical Society.
as the effects of vascular risk factors and cardiovascular disease, on temporal
trends.
Read Full Article at NEJM.org
RESULTS
The 5-year age- and sex-adjusted cumulative hazard rates for dementia were 3.6 per
100 persons during the first epoch (late 1970s and early 1980s), 2.8 per 100 persons
during the second epoch (late 1980s and early 1990s), 2.2 per 100 persons during
the third epoch (late 1990s and early 2000s), and 2.0 per 100 persons during the
fourth epoch (late 2000s and early 2010s). Relative to the incidence during the first
epoch, the incidence declined by 22%, 38%, and 44% during the second, third,
and fourth epochs, respectively. This risk reduction was observed only among
persons who had at least a high school diploma (hazard ratio, 0.77; 95% confi-
dence interval, 0.67 to 0.88). The prevalence of most vascular risk factors (except
obesity and diabetes) and the risk of dementia associated with stroke, atrial fibril-
lation, or heart failure have decreased over time, but none of these trends com-
pletely explain the decrease in the incidence of dementia.
CONCLUSIONS
Among participants in the Framingham Heart Study, the incidence of dementia
has declined over the course of three decades. The factors contributing to this
decline have not been completely identified. (Funded by the National Institutes of
Health.)
n engl j med 374;6 nejm.org February 11, 2016 523
Back to Table of Contents2 Notable Articles of 2016 nejm.org
PE R S PE C T IV E Is Dementia in Decline?
Is Dementia in Decline?
His tory of Medicine
Is Dementia in Decline? Historical Trends and Future
Trajectories
David S. Jones, M.D., Ph.D., and Jeremy A. Greene, M.D., Ph.D.
Related article, p. 523
I n 2005, researchers from the
Duke Center for Demographic
Studies reported a “surprising
in the dementia epidemic? The
potential decline of dementia,
seen in light of the rise and fall
be extremely difficult to produce
timely and convincing data about
the trajectories of chronic dis-
trend”: data from the National of other major diseases, raises an eases.4 When physicians began to
Long-Term Care Surveys showed even more tantalizing prospect: debate CAD trends in 1974, they
that the prevalence of severe cog- Can we control our burden of had to rely on government data
nitive impairment in the Medi- disease? that were 5 years out of date. It
care population had decreased This is not the first time that took 4 years of concerted effort
significantly between 1982 and the medical profession and the to reach consensus about an in-
1999.1 At a time when baby- public health community have flection that had occurred more
boomer demographics led to pre- struggled to interpret reports of an than a decade earlier. Even though
dictions of a looming dementia unexpected reversal of a chronic- better and timelier data are now
crisis, this finding offered hope. disease epidemic.4 In 1964, Cali- available, dementia researchers
Since that time, other reports fornia health officials reported must still be resourceful in seek-
have similarly shown that the in- that rates of coronary artery dis- ing convincing data. As Satizabal
cidence or prevalence of demen- ease (CAD) had begun to de- et al. indicate, each existing re-
tia is decreasing in various popu- crease. This finding, which defied port has limitations. Their new
lations. Researchers have offered the widespread belief that the data, which overcome many of
many possible explanations, in- CAD epidemic would only worsen these limitations, demonstrate the
cluding increased wealth, better as life expectancy grew, garnered value of investments in long-term,
education, control of vascular risk scant attention. Even a decade longitudinal epidemiologic re-
factors, and use of statins, anti- later, most health officials as- search such as the Framingham
hypertensive agents, and nonste- sumed that CAD was still on the Heart Study. But the data still re-
roidal antiinflammatory drugs.1,2 rise. It was only in 1974 that re- flect only one population sample.
However, even as researchers de- searchers began taking the pros- Whether they are accepted as
scribe their “cautious optimism” pect of decline seriously. By 1978, conclusive evidence of a broad-
about specific populations, they they had accepted that CAD’s na- based reduction in dementia in-
still project a quadrupling of tional decline had begun in the cidence will become clear only
global prevalence over the com- mid-1960s. Similar decreases were over time.
ing decades.3 soon reported in many other high- Second, since trajectories of
In this issue of the Journal, income countries, from Australia chronic-disease incidence reflect
Satizabal and colleagues report to Finland. This recognition trig- complex interactions of many
more “robust evidence” of demen- gered debate over the contribu- causal factors, it will almost al-
tia’s decline (pages 523–32). Using tion of medical and public health ways be uncertain whether de-
surveillance data collected from interventions, in hopes that knowl- creases will continue or reverse.
the Framingham Heart Study edge of the causes of decline Even as consensus about interna-
from 1975 to the present, they would guide policies and resource tional CAD reduction consolidat-
found a 20% decrease in demen- allocation and ensure continua- ed between the 1970s and the
tia incidence each decade, even tion of these health benefits. 1990s, worrisome evidence about
as average body-mass index, dia- The history of the debate on countervailing trends also ap-
betes prevalence, and population CAD decline carries important peared.4 Enthusiasm for anti-CAD
age have increased. Can we now lessons for emerging reports of public health campaigns has been
conclude that the tide has turned dementia’s decline. First, it can fragile, even in countries like
n engl j med 374;6 nejm.org February 11, 2016 507
Back to Table of Contents3 Notable Articles of 2016 nejm.org
PE R S PE C T IV E Is Dementia in Decline?
Finland that demonstrated their 1980s, even after CAD’s decline trol of infectious disease led to
promise so well. The widespread had been accepted and despite dramatic gains in life expectancy,
increases in obesity and diabetes knowledge that dementia shares physicians in the early 20th cen-
could fuel CAD resurgences. many risk factors with CAD, phy- tury came to see CAD and cancer
Many researchers have warned sicians began to warn about an as the inevitable scourges of long
that CAD’s decline could stall or exploding dementia epidemic.5 lives. Over recent decades, that
even reverse — something that The decrease in prevalence that pessimism has largely given way
has happened among young surprised Manton and colleagues as well: CAD and many forms of
adults and other subpopulations in 2005 could have been predict- cancer are increasingly prevent-
in Europe, Australia, and the ed decades earlier. But dementia able and curable. The burden of
United States. Other countries, will remain a problem despite disease of the 20th century, like
such as China, continue to see these decreases. The prevalence that of the 19th, was not an in-
increases in CAD with no evi- of dementia can increase, even if evitable fact of life, but a product
dence of plateau or reversal. the incidence falls, if global pop- of lives lived amid specific —
and malleable — conditions.
What should we expect as can-
History offers reasons for hope. cer and heart disease come under
Evidence of dementia’s decline shows control? Many people think that
we can live even longer lives —
once again that our burden of disease but lives compromised by demen-
tia, vision loss, and hearing loss.
is malleable. Whether that fate is inevitable or
whether these, too, are malleable
All these countervailing trends ulations live longer. The absolute scourges remains to be seen.
could affect dementia as well. number of people with dementia Such questions are better left to
Rocca and colleagues have warned can increase, even if both inci- futurists and geriatricians than
that increases in obesity, diabetes, dence and prevalence fall, if the to historians. Yet Satizabal et al.
and hypertension could under- size of the elderly population believe there’s cause for “cautious
mine the gains achieved through grows. That explains why, 10 years hope.” Primary and secondary pre-
improved education, wealth, and into the era of reports of decreas- vention might diminish the mag-
control of vascular risk factors. ing dementia in selected popula- nitude of the long-feared dementia
Even if a dementia decline has tions, Satizabal and colleagues epidemic. Something else might
begun, it might not last: the out- still write that the “prevalence of save our vision and hearing.
come depends on the balance of dementia is expected to soar as Faced with choices between
diverging trends.2,3 our societies age.” Even research- equally defensible epidemiologic
Third, these ambiguities open ers rigorously examining the evi- projections, physicians and re-
up a battleground for conflicting dence of decreases continue to searchers must think carefully
interpretations by interested par- worry about what the future will about what stories they empha-
ties. Policymakers can use the bring. size to patients and policymak-
same data to tell vastly different History offers reasons for ers. The implications, especially
stories about public health. Fore- hope. Evidence of dementia’s de- for investment in long-term care
casts of CAD’s future continue to cline shows once again that our facilities, are enormous. Our ex-
swing between narratives of tri- burden of disease is malleable. planations of decline are equally
umph and catastrophe.4 The good This lesson has been hard won. important, since they guide in-
news is that more and more Mid-19th-century physicians saw vestments in behavior change,
countries are reporting evidence cholera and tuberculosis as in- medications, and other treat-
of decline. The bad news is the evitable scourges of urban envi- ments.
evidence of the fragility of these ronments. But those epidemics With this latest contribution,
gains. yielded to sanitary reform, im- optimism about dementia is more
Narratives of dementia remain proved standards of living, and justified than ever before. Even if
similarly malleable. In the early eventually medical care. As con- death and taxes remain inevita-
508 n engl j med 374;6 nejm.org February 11, 2016
Back to Table of Contents4 Notable Articles of 2016 nejm.org
PER S PE C T IV E Is Dementia in Decline?
ble, cancer, CAD, and dementia Disclosure forms provided by the authors sights into the dementia epidemic. N Engl J
are available with the full text of this article Med 2013;369:2275-7.
may not. But cautious optimism at NEJM.org. 3. Rocca WA, Petersen RC, Knopman DS,
should not become complacency. et al. Trends in the incidence and prevalence
From the Department of Global Health and
If we can elucidate the changes Social Medicine, Harvard Medical School,
of Alzheimer’s disease, dementia, and cog-
nitive impairment in the United States. Al-
that have contributed to these Boston (D.S.J); the Department of the His- zheimers Dement 2011;7:80-93.
improvements, perhaps we can ex- tory of Science, Harvard University, Cam- 4. Jones DS, Greene JA. The decline and
bridge, MA (D.S.J.); and the Division of
tend them. Today, the dramatic General Internal Medicine and the Depart-
rise of coronary heart disease: understand-
ing public health catastrophism. Am J Pub-
reductions in CAD-related mor- ment of the History of Medicine, Johns lic Health 2013;103:1207-18.
tality are under threat. The incipi- Hopkins University School of Medicine, 5. Beck JC, Benson DF, Scheibel AB, Spar
Baltimore (J.A.G.).
ent improvements in dementia JE, Rubenstein LZ. Dementia in the elderly:
1. Manton KC, Gu XL, Ukraintseva SV. De- the silent epidemic. Ann Intern Med 1982;
are presumably even more fragile. 97:231-41.
clining prevalence of dementia in the U.S. el-
The burden of disease, ever mal- derly population. Adv Gerontol 2005;16:30-7. DOI: 10.1056/NEJMp1514434
leable, can easily relapse. 2. Larson EB, Yaffe K, Langa KM. New in- Copyright © 2016 Massachusetts Medical Society.
Is Dementia in Decline?
n engl j med 374;6 nejm.org February 11, 2016 509
Back to Table of Contents5 Notable Articles of 2016 nejm.org
new england
The
journal of medicine
established in 1812 February 18, 2016 vol. 374 no. 7
Effects of Testosterone Treatment in Older Men
P.J. Snyder, S. Bhasin, G.R. Cunningham, A.M. Matsumoto, A.J. Stephens-Shields, J.A. Cauley, T.M. Gill,
E. Barrett-Connor, R.S. Swerdloff, C. Wang, K.E. Ensrud, C.E. Lewis, J.T. Farrar, D. Cella, R.C. Rosen, M. Pahor,
J.P. Crandall, M.E. Molitch, D. Cifelli, D. Dougar, L. Fluharty, S.M. Resnick, T.W. Storer, S. Anton, S. Basaria,
S.J. Diem, X. Hou, E.R. Mohler III, J.K. Parsons, N.K. Wenger, B. Zeldow, J.R. Landis, and S.S. Ellenberg,
for the Testosterone Trials Investigators*
a bs t r ac t
BACKGROUND
Serum testosterone concentrations decrease as men age, but benefits of raising testos- The authors’ full names, academic de-
terone levels in older men have not been established. grees, and affiliations are listed in the Ap-
pendix. Address reprint requests to Dr.
METHODS Snyder at pjs@mail.med.upenn.edu.
We assigned 790 men 65 years of age or older with a serum testosterone concentration * A complete list of investigators in the
of less than 275 ng per deciliter and symptoms suggesting hypoandrogenism to receive Testosterone Trials is provided in the
either testosterone gel or placebo gel for 1 year. Each man participated in one or more Supplementary Appendix, available at
NEJM.org.
of three trials — the Sexual Function Trial, the Physical Function Trial, and the Vital-
ity Trial. The primary outcome of each of the individual trials was also evaluated in all Drs. Bhasin, Cunningham, Matsumoto,
Stephens-Shields, and Ellenberg contrib-
participants. uted equally to this article.
RESULTS N Engl J Med 2016;374:611-24.
Testosterone treatment increased serum testosterone levels to the mid-normal range for DOI: 10.1056/NEJMoa1506119
men 19 to 40 years of age. The increase in testosterone levels was associated with sig- Copyright © 2016 Massachusetts Medical Society.
nificantly increased sexual activity, as assessed by the Psychosexual Daily Questionnaire
(P6 Notable Articles of 2016 nejm.org
The n e w e ng l a n d j o u r na l of m e dic i n e
Edi t or i a l
Establishing a Framework — Does Testosterone
Supplementation Help Older Men?
Eric S. Orwoll, M.D.
Aging is variably but inevitably accompanied by anemia, bone density, and cardiovascular status).
declines in health; concomitantly, in men, circu- The trials are knitted together by common
lating sex-steroid levels fall with age.1 To what methods and some shared measures, thus maxi-
extent these two processes are causally linked mizing the power of the overall investigation.
and whether testosterone therapy can prevent or This inaugural report describes the findings of
ameliorate important age-related problems have the three main studies (with primary outcomes
been major issues in men’s health. In 2003, a com- related to sexual function, physical function,
mittee assembled by the Institute of Medicine and vitality).
(IOM) found a paucity of randomized, placebo- The results show that testosterone therapy did
controlled clinical trials involving older men and yield certain benefits, but at this point their
noted a lack of definite evidence that testoster- clinical importance is uncertain. Therapy was
one therapy conferred benefits.2 The committee not a panacea, and the findings alone might be
recommended that clinical trials be initiated, insufficient to support a decision to initiate tes-
first to evaluate the efficacy of testosterone tosterone therapy in symptomatic older men. The
supplementation in older men and then to assess study confirmed that testosterone supplementa-
long-term benefits and risks through large-scale tion can yield improvements in sexual function,
trials. but the benefits were modest, tended to wane in
Little has changed to alter the conclusions of the latter months of the treatment period, and,
that report; if anything, the issue of testosterone as the authors note, were not as robust as those
supplementation has become more controversial.3 of phosphodiesterase type 5 inhibitors.6 There
However, in this issue of the Journal, Snyder et al.4 were only small gains in physical performance
describe the long-awaited initial results of the and in indexes of mood and depression; overall
National Institutes of Health–sponsored Testos- vitality was no better with testosterone therapy
terone Trials, which were designed to address than with placebo. For each of the outcomes,
the key issues identified by the IOM. Their re- some older men may have a more vigorous re-
port is important, not only because it deals with sponse to testosterone therapy and thus could be
an essential public health issue but also because more attractive candidates for supplementation;
the investigators have succeeded in conducting however, it was not possible to confidently iden-
the kind of generally well-conceived studies that tify them by the testosterone levels achieved
are sorely needed in the field. The findings be- with therapy. As expected, estradiol levels also
gin to provide a basis for more rational clinical increased; those levels have been linked to key
decisions about testosterone use as well as for health variables in men (e.g., sexual function).7
additional research. It’s not yet clear whether responses (or the lack
The overall design of the Testosterone Trials is thereof) in the Testosterone Trials may be due to
complex.5 It includes seven independent, double- changes in estradiol levels.
blind, placebo-controlled trials intended to ad- There is considerable controversy about pos-
dress specific outcomes that are postulated to be sible adverse effects of testosterone therapy in
related to testosterone deficiency (sexual function, older men, and these studies do not resolve this
vitality, physical function, cognitive function, controversy. Although there were minor effects
682 n engl j med 374;7 nejm.org February 18, 2016
Back to Table of Contents7 Notable Articles of 2016 nejm.org
Editorial
on hemoglobin and prostate-specific antigen late controversy and to engender additional re-
levels, and, reassuringly, no apparent major search questions — as did the Women’s Health
toxic effects, larger and more extended trials Initiative with respect to estrogen-replacement
would be needed to determine whether therapy therapy. Nevertheless, it is a landmark study in
has negative effects on outcomes such as pros- the field of men’s health and no doubt a bell-
tate or cardiovascular health. wether for additional important contributions
Importantly, the study participants were re- from the Testosterone Trials.
cruited on the basis of stringent criteria (age ≥65 Disclosure forms provided by the author are available with the
years, total testosterone levels below the normal full text of this article at NEJM.org.
range in men 19 to 40 years of age [8 Notable Articles of 2016 nejm.org
new england
The
journal of medicine
established in 1812 February 25, 2016 vol. 374 no. 8
National Cluster-Randomized Trial of Duty-Hour Flexibility
in Surgical Training
Karl Y. Bilimoria, M.D., M.S.C.I., Jeanette W. Chung, Ph.D., Larry V. Hedges, Ph.D., Allison R. Dahlke, M.P.H.,
Remi Love, B.S., Mark E. Cohen, Ph.D., David B. Hoyt, M.D., Anthony D. Yang, M.D., John L. Tarpley, M.D.,
John D. Mellinger, M.D., David M. Mahvi, M.D., Rachel R. Kelz, M.D., M.S.C.E., Clifford Y. Ko, M.D., M.S.H.S.,
David D. Odell, M.D., M.M.Sc., Jonah J. Stulberg, M.D., Ph.D., M.P.H., and Frank R. Lewis, M.D.
a bs t r ac t
BACKGROUND
Concerns persist regarding the effect of current surgical resident duty-hour policies on From the Surgical Outcomes and Quality
patient outcomes, resident education, and resident well-being. Improvement Center (SOQIC), Depart-
ment of Surgery and Center for Health-
METHODS care Studies, Feinberg School of Medicine
and Northwestern Medicine, Northwest-
We conducted a national, cluster-randomized, pragmatic, noninferiority trial involving ern University (K.Y.B., J.W.C., A.R.D., R.L.,
117 general surgery residency programs in the United States (2014–2015 academic year). A.D.Y., D.M.M., D.D.O., J.J.S.), and the
Programs were randomly assigned to current Accreditation Council for Graduate Medical American College of Surgeons (K.Y.B.,
M.E.C., D.B.H., C.Y.K.), Chicago, the De-
Education (ACGME) duty-hour policies (standard-policy group) or more flexible policies partment of Statistics, Northwestern Uni-
that waived rules on maximum shift lengths and time off between shifts (flexible-policy versity, Evanston (L.V.H.), and the De-
group). Outcomes included the 30-day rate of postoperative death or serious complica- partment of Surgery, Southern Illinois
University, Springfield (J.D.M.) — all in
tions (primary outcome), other postoperative complications, and resident perceptions Illinois; the Department of Surgery,
and satisfaction regarding their well-being, education, and patient care. Vanderbilt University, Nashville (J.L.T.);
the Department of Surgery and the Cen-
RESULTS ter for Surgery and Health Economics,
In an analysis of data from 138,691 patients, flexible, less-restrictive duty-hour policies Perelman School of Medicine, University
were not associated with an increased rate of death or serious complications (9.1% in the of Pennsylvania (R.R.K.), and the Ameri-
can Board of Surgery (F.R.L.) — both in
flexible-policy group and 9.0% in the standard-policy group, P = 0.92; unadjusted odds Philadelphia; and the Department of Sur-
ratio for the flexible-policy group, 0.96; 92% confidence interval, 0.87 to 1.06; P = 0.44; gery, University of California, Los Ange-
noninferiority criteria satisfied) or of any secondary postoperative outcomes studied. les, School of Medicine, Los Angeles
(C.Y.K.). Address reprint requests to Dr.
Among 4330 residents, those in programs assigned to flexible policies did not report Bilimoria at the Surgical Outcomes and
significantly greater dissatisfaction with overall education quality (11.0% in the flexible- Quality Improvement Center (SOQIC),
policy group and 10.7% in the standard-policy group, P = 0.86) or well-being (14.9% and Department of Surgery, Feinberg School
of Medicine and Northwestern Medicine,
12.0%, respectively; P = 0.10). Residents under flexible policies were less likely than those Northwestern University, 633 N. St. Clair
under standard policies to perceive negative effects of duty-hour policies on multiple St., 20th Fl., Chicago, IL 60611, or at
aspects of patient safety, continuity of care, professionalism, and resident education but k-bilimoria@northwestern.edu.
were more likely to perceive negative effects on personal activities. There were no sig- This article was published on February 2,
nificant differences between study groups in resident-reported perception of the effect of 2016, at NEJM.org.
fatigue on personal or patient safety. Residents in the flexible-policy group were less N Engl J Med 2016;374:713-27.
likely than those in the standard-policy group to report leaving during an operation (7.0% DOI: 10.1056/NEJMoa1515724
Copyright © 2016 Massachusetts Medical Society.
vs. 13.2%, P9 Notable Articles of 2016 nejm.org
The n e w e ng l a n d j o u r na l of m e dic i n e
Edi t or i a l
Surgical Resident Duty-Hour Rules — Weighing the New
Evidence
John D. Birkmeyer, M.D.
Surgical training has always been hard on resi- general-surgery training programs were required
dents. During my own residency more than 20 to adhere to the ACGME rules about maximum
years ago, 100-hour workweeks and in-house call shift length and minimum time off between 24-
every other night were routine. A resident’s life hour shifts. Another 59 programs were granted
outside the hospital was simply not a priority. “flexibility” and did not have to adhere to those
Residency may be even harder on patients. A large rules. Both groups adhered to ACGME require-
body of research has linked sleep deprivation in ments for total workweek hours. Residents who
resident physicians to poor performance in neu- were not required to adhere to the duty-hour rules
robehavioral testing and, more alarmingly, to were less likely to report dissatisfaction with
higher rates of attention failure in patient care.1,2 continuity of care and hand-offs. After 1 year,
Reacting to concerns about both resident well- however, the two groups of teaching hospitals
being and patient safety, the Accreditation Coun- had virtually indistinguishable rates of death,
cil for Graduate Medical Education (ACGME) overall complications, and specific types of com-
implemented duty-hour reforms in 2003 that plications, on the basis of data on risk-adjusted
constrained resident workweeks to 80 hours, clinical outcomes from the American College of
among other changes. A 2011 update added new Surgeons National Surgical Quality Improvement
limits to the length of individual shifts (24 hours Program.
plus 4 hours for transition) and guaranteed a It is not surprising that outcomes did not
minimum amount of time off between 24-hour vary according to whether programs adhered to
shifts (14 hours). Although they are not nearly as ACGME requirements on maximum shift length
stringent as standards set in other occupations and time off between shifts. The patients most
in which performance has implications for pub- likely to be affected by resident handoffs —
lic safety (e.g., airline pilots), the ACGME rules those with acute or deteriorating clinical condi-
were nonetheless criticized by many in the medi- tions — represent only a small percentage of
cal community. Surgeons in particular were surgical patients at teaching hospitals. More
concerned that the new duty-hour rules would important, teaching hospitals have become far
paradoxically increase medical errors as a result less reliant on surgical residents than they used
of increased handoffs — residents signing out to be. In earlier eras, surgical residents had con-
their sickest patients to providers who are not siderable autonomy. During my own residency,
familiar with their cases. In other words, the surgical residents often operated independently,
safety benefits of reducing resident fatigue would particularly at night and on weekends. Today,
be offset by harms associated with disrupting they operate almost exclusively in the presence
continuity of care. of an attending surgeon. Intensive care units,
Extending the results of a previous national which house the sickest surgical patients, are
study based on Medicare claims data,3 a very increasingly “closed” and staffed by board-certi-
ambitious, scientifically robust study by Bilimoria fied intensivists. Postoperative care is delivered
et al. now published in the Journal should help by multidisciplinary teams staffed with associate
allay these concerns.4 By random assignment, 59 providers as well as residents.
n engl j med 374;8 nejm.org February 25, 2016 783
Back to Table of Contents10 Notable Articles of 2016 nejm.org
Editorial
The Flexibility in Duty Hour Requirements for cal leaders should focus on developing safe, re-
Surgical Trainees (FIRST) Trial also assessed the silient health systems that do not depend on
effects of ACGME duty-hour restrictions on resi- overworked resident physicians. They should also
dent perceptions of educational quality and well- recognize the changing expectations of post-
being, with the use of survey data collected millennial learners. To many current residents
annually by the American Board of Surgery. and medical students, 80-hour (or even 72-hour)
Residents in the two groups of teaching hospi- workweeks and 24-hour shifts probably seem
tals had similarly high rates of satisfaction with long enough. Although few surgical residents
the quality of their training. Although residents in would ever acknowledge this publicly, I’m sure
programs not required to adhere to the ACGME that many love to hear, “We can take care of this
duty-hour rules were more likely to be dissatis- case without you. Go home, see your family, and
fied with time for rest, there were no significant come in fresh tomorrow.”
differences in overall resident well-being and Disclosure forms provided by the author are available with the
morale between the two groups. full text of this article at NEJM.org.
What do the results of the FIRST Trial mean
From the Dartmouth–Hitchcock Medical Center and the Dart-
for ACGME policy on resident duty hours? The mouth Institute for Health Policy and Clinical Practice — both
authors conclude, as will many surgeons, that in Lebanon, NH.
surgical training programs should be afforded
more flexibility in applying work-hour rules. This article was published on February 2, 2016, at NEJM.org.
This interpretation implicitly places the burden
1. Veasey S, Rosen R, Barzansky B, Rosen I, Owens J. Sleep loss
of proof on the ACGME. Thus, because the and fatigue in residency training: a reappraisal. JAMA 2002;288:
FIRST Trial found no evidence that removing 1116-24.
restrictions on resident shift length and time 2. Lockley SW, Cronin JW, Evans EE, et al. Effect of reducing
interns’ weekly work hours on sleep and attentional failures.
off between shifts was harmful to patients, N Engl J Med 2004;351:1829-37.
programs should have more autonomy to train 3. Volpp KG, Rosen AK, Rosenbaum PR, et al. Mortality among
residents as they choose. hospitalized Medicare beneficiaries in the first 2 years following
ACGME resident duty hour reform. JAMA 2007;298:975-83.
I reach a different conclusion. The FIRST Trial 4. Bilimoria KY, Chung JW, Hedges LV, et al. National cluster-
effectively debunks concerns that patients will randomized trial of duty-hour flexibility in surgical training.
suffer as a result of increased handoffs and N Engl J Med 2016;374:713-27.
breaks in the continuity of care. Rather than DOI: 10.1056/NEJMe1516572
backtrack on the ACGME duty-hour rules, surgi- Copyright © 2016 Massachusetts Medical Society.
784 n engl j med 374;8 nejm.org February 25, 2016
Back to Table of Contents11 Notable Articles of 2016 nejm.org
The NEW ENGLA ND JOURNAL of MEDICINE
Perspective February 25, 2016
Leaping without Looking — Duty Hours, Autonomy,
and the Risks of Research and Practice
Lisa Rosenbaum, M.D.
Related article, p. 713
I
Leaping without Looking
n 2014, Facebook users were furious to discover randomization at the residency-
that they’d unwittingly been experimented on.1 program level, and neither required
consent of residents or patients.
Researchers had randomly assigned users to news That consent waiver has drawn
feeds with reduced “positive” content or reduced criticism from Public Citizen and
the American Medical Student
“negative” content and found that leveled at investigators who are Association, which in open letters
happy posts beget happy posts comparing the 2011 duty-hour to the Office for Human Research
and that grim ones beget grim restrictions imposed by the Ac- Protections (OHRP) accuse the in-
ones.2 Although that may now creditation Council for Graduate vestigators of “egregious ethical
seem obvious, previous evidence Medical Education (ACGME) with and regulatory violations.”3,4
had suggested that because we more flexible shift lengths for The allegations, focused pri-
tend to compare ourselves to oth- residents. The Flexibility in Duty marily on “serious health risks”
ers, exposure to positive content Hour Requirements for Surgical to residents from long shifts, are
compromises users’ well-being. Trainees (FIRST) trial, whose re- dizzyingly tautological. The critics
There was thus no reason to be- sults are now reported by Bilimo- claim it’s unethical not to obtain
lieve that the status quo — news ria et al. in the Journal, compared residents’ consent; but because
feeds curated by an algorithm 59 surgical training programs pressure on residents to conform
tailored to users’ viewing habits — randomly assigned to an ACGME- makes seeking their consent akin
was any “safer” than the experi- compliant schedule with 58 grant- to coercion, that’s unethical too.
mental interventions. And given ed flexibility in designing shift Thus, there’s no ethical way to
Facebook’s reach, there were com- lengths (still within an 80-hour study the duty-hour rules in a
pelling reasons to find out. Never- workweek). The ongoing Individ- randomized fashion. But that’s
theless, the results triggered out- ualized Comparative Effectiveness fine, because we already know
rage that 700,000 users had been of Models Optimizing Safety and they’re beneficial; we know that
exposed to potential emotional Resident Education (iCOMPARE) because the ACGME made the
damage without their consent. trial involves internal medicine rules in the first place. And if the
Similar accusations have been programs. Both used cluster trials found otherwise, their re-
n engl j med 374;8 nejm.org February 25, 2016 701
Back to Table of Contents12 Notable Articles of 2016 nejm.org
Leaping without Looking
PER S PE C T IV E
sults challenging the status quo tional toll of “work compression” gaged in hand-offs, leave halfway
would be suspect because the in- and the reality that many trainees through an operation because
vestigators, who have publicly ac- don’t actually sleep more, they your shift’s up, or perceive resent-
knowledged the need for data to also speak to a fundamental ment in your supervisors who
inform policy, are consequently challenge in improving care: the think you have it easier than they
too biased to generate those data. factors affecting physicians’ per- did. Given such trade-offs and
To unpack these allegations, formance are so numerous and uncertainties, it’s not just ethical
it’s important to understand that interdependent that no single vari- but laudable to comparatively
even if the trials are considered able, such as sleep, can be under- evaluate duty-hours policies. The
question then becomes: Can the
No drug would be approved solely research be accomplished if con-
sent is required?
on the basis of laboratory evidence. Yet we The Facebook experiment’s re-
sults would have been invalid had
require neither consideration of complexity consent been sought, since we
nor rigorous studies before implementing couldn’t determine how much
users adjusted their emotional
policies with broad implications. Why? content because they knew it was
being monitored. Similarly, requir-
human-subjects research, there stood or targeted in isolation. Be- ing residents’ consent in duty-
are circumstances under which cause of the unknown real-life hour trials would render the re-
federal rules deem it ethical to consequences of such myriad in- sults uninterpretable, given the
waive consent. The key one here teractions, no drug would be ap- selection bias that would be intro-
is that the incremental risk posed proved solely on the basis of lab- duced if those preferring longer
by the research should be, at oratory evidence. Yet we require hours were more likely to par-
most, minimal. For trials like neither consideration of complex- ticipate.
these that evaluate a standard ity nor rigorous studies before The challenges with regard to
practice, the question becomes: implementing policies with simi- patients are more pragmatic. Con-
Is there equipoise between the larly broad implications. Why? sider, for instance, caring for a
status quo and investigational Bioethicist and legal scholar man with a myocardial infarc-
groups in terms of possible risks? Michelle Meyer has described our tion. After obtaining his consent
Though the letters to OHRP “tendency to view a field experi- for percutaneous coronary inter-
claim otherwise, the answer is un- ment designed to study the ef- vention, you’d have to add, “I also
equivocally yes. The complaints fects of an existing or proposed need your consent to be cared for
ignore a considerable body of re- practice as more morally suspi- by residents who are working
search suggesting, as Bilimoria cious than an immediate, univer- longer hours.” If he said no,
et al. point out, that duty-hour re- sal implementation of an untest- would you have to transfer him,
forms have not improved patient ed practice.” She argues that as heart muscle continued to die,
safety; some trials have even people in power often rely on in- to a nonteaching hospital? Surely
raised concerns that they’ve actu- tuition in creating and imple- here the risk posed by seeking
ally worsened quality of care and menting wide-reaching policies. consent is greater than that from
patient outcomes. Indeed, neither residents nor pa- the research itself.
As for risks to residents, the tients consented to the ACGME Moreover, as we examine the
letters cite data suggesting that rules, yet no one finds this omis- implications for efforts to develop
fatigue causes harms such as in- sion ethically suspect. Moreover, “learning health systems,” a corol-
creased motor vehicle accidents, intuition seems particularly sa- lary of this hypothetical situation
needlesticks, and burnout. Yet lient to debates over duty hours, is worth considering. Imagine tell-
there’s little evidence to suggest since everyone knows how it ing a patient, “I need your per-
that shorter hours have reduced feels to be tired. Unfortunately, mission to care for you at a hos-
occupational hazards or burnout few people know how it feels to pital where we’re using a new
rates. Though I suspect that these see a patient through illness, electronic health record, are bas-
findings partly reflect the emo- spend a fifth of your time en- ing your doctor’s reimbursement
702 n engl j med 374;8 nejm.org February 25, 2016
Back to Table of Contents13 Notable Articles of 2016 nejm.org
PER S PE C T IV E Leaping without Looking
on whether you stay healthy, and must understand the values of the slept but should remain foremost
are under pressure to discharge people we’re professing to pro- in our discussions. An essential
you quickly and make sure you tect. In one relevant study, Hal- contribution of the duty-hour
don’t come back. We don’t really pern and colleagues asked patients trials is that, in assessing flexi-
know how all this will affect your undergoing dialysis to imagine bility itself, they remind us that
health, but we believe it’s for the two hypothetical scenarios.5 In autonomy is an ethical concept
better. Can you sign here?” the “research scenario,” patients that matters to both doctors and
The point is that our approach in a trial are randomly assigned patients — in research and in
to human-subjects research per- to a prespecified dialysis dura- practice.
petuates a misleading distinction tion of 4.5 hours or a duration at Disclosure forms provided by the author
between risks posed by research the physician’s discretion (both are available with the full text of this article
at NEJM.org.
and those posed by practice, de- approaches are within the stan-
manding greater scrutiny for in- dard of care). In the “clinical Dr. Rosenbaum is a national correspondent
vestigative efforts while assum- care scenario,” patients receive di- for the Journal.
ing that untested practice is safe. alysis for a duration determined This article was published on February 2,
In describing this phenomenon, by a protocol (also common prac- 2016, and updated on February 4, 2016, at
Meyer cites the moratorium that tice). Participants were more will- NEJM.org.
the OHRP imposed on a study ing in the research than the 1. Meyer MN. Two cheers for corporate ex-
assessing a checklist designed practice setting to give up their perimentation: the A/B illusion and the vir-
to reduce catheter-related blood- own decision-making autonomy, tues of data-driven innovation. Colo Tech L J
2015;13(2):273.
stream infections because re- including written informed con- 2. Kramer ADI, Guillory JE, Hancock JT.
searchers hadn’t obtained physi- sent. They recognized the value Experimental evidence of massive-scale emo-
cians’ or patients’ consent. The of research and didn’t perceive tional contagion through social networks.
Proc Natl Acad Sci U S A 2014;111:8788-90.
OHRP explained that its regula- the hypothetical study as posing 3. Carome MA, Wolfe SM, Almashat S,
tions don’t apply when institu- higher risk than ordinary care. Hall DV. Letter to Jerry Menikoff, director,
tions are merely “implementing” But they expressed deep reserva- and Kristina Borror, director, Division of
Compliance Oversight, Office for Human
practices aiming to improve care, tions about compromising physi- Research Protections, Department of Health
but if they’re “planning research cians’ autonomy to individualize and Human Services, regarding iCOMPARE
activities examining the effective- treatment absent compelling rea- trial. November 19, 2015 (http://www.citizen
.org/documents/2283.pdf).
ness of interventions to improve sons for doing so. 4. Carome MA, Wolfe SM, Almashat S,
the quality of care, then the reg- This last finding highlights Hall DV. Letter to Jerry Menikoff, director,
ulatory protections are important the ultimate irony of both duty- and Kristina Borror, director, Division of
Compliance Oversight, Office for Human
to protect the rights and welfare hour restrictions and objections Research Protections, Department of Health
of human research subjects.” This to studying them: we’ve created and Human Services, regarding FIRST trial.
double standard leaves us, para- an educational system that com- November 19, 2015 (http://www.citizen.org/
documents/2284.pdf).
doxically, with unregulated prac- promises trainees’ freedom to 5. Kraybill A, Dember LM, Joffe S, et al.
tices that may be ineffective and judge for themselves when their Patient and physician views about proto-
unsafe because we can’t surmount patients need them. The value colized dialysis treatment in randomized tri-
als and clinical care. AJOB Empirical Bioeth-
the regulatory hurdles to conduct- that physicians and patients place ics 2015 October 23 (Epub ahead of print).
ing research to improve them. on such autonomy is not measur- DOI: 10.1056/NEJMp1600233
Pharmaceutical Policy Reform
To address this problem, we able in mortality rates or hours Copyright © 2016 Massachusetts Medical Society.
Leaping without Looking
n engl j med 374;8 nejm.org February 25, 2016 703
Back to Table of Contents14 Notable Articles of 2016 nejm.org
new england
The
journal of medicine
established in 1812 March 3, 2016 vol. 374 no. 9
Randomized Trial of Labor Induction in Women
35 Years of Age or Older
Kate F. Walker, M.R.C.O.G., George J. Bugg, M.D., Marion Macpherson, M.D., Carol McCormick, M.Sc.,
Nicky Grace, M.A., Chris Wildsmith, B.A., Lucy Bradshaw, M.Sc., Gordon C.S. Smith, D.Sc.,
and James G. Thornton, M.D., for the 35/39 Trial Group*
a bs t r ac t
BACKGROUND
The risk of antepartum stillbirth at term is higher among women 35 years of age or From the Division of Child Health, Ob-
older than among younger women. Labor induction may reduce the risk of stillbirth, stetrics and Gynaecology, School of Clin-
ical Sciences (K.F.W., M.M., C.M., J.G.T.),
but it also may increase the risk of cesarean delivery, which already is common in and Nottingham Clinical Trials Unit (L.B.),
this older age group. and the University of Nottingham, the
Division of Obstetrics and Gynaecology,
METHODS Nottingham University Hospitals NHS
Trust (G.J.B., N.G.), Nottingham, Still-
We conducted a randomized, controlled trial involving primigravid women who were birth and Neonatal Death Charity, Lon-
35 years of age or older. Women were randomly assigned to labor induction between don (C.W.), and the Department of Ob-
39 weeks 0 days and 39 weeks 6 days of gestation or to expectant management (i.e., stetrics and Gynaecology and National
Institute for Health Research Biomedical
waiting until the spontaneous onset of labor or until the development of a medical Research Centre, Cambridge University,
problem that mandated induction). The primary outcome was cesarean delivery. The Cambridge (G.C.S.S.) — all in the United
trial was not designed or powered to assess the effects of labor induction on stillbirth. Kingdom. Address reprint requests to Dr.
Thornton at the Division of Child Health,
RESULTS Obstetrics and Gynaecology, School of
Medicine, University of Nottingham,
A total of 619 women underwent randomization. In an intention-to-treat analysis, Hucknall Rd., Nottingham NG5 1PB,
there were no significant between-group differences in the percentage of women who United Kingdom, or at jim.thornton@
underwent a cesarean section (98 of 304 women in the induction group [32%] and nottingham.ac.uk.
103 of 314 women in the expectant-management group [33%]; relative risk, 0.99; 95% * A complete list of investigators in the
confidence interval [CI], 0.87 to 1.14) or in the percentage of women who had a 35/39 Trial Group is provided in the
Supplementary Appendix, available with
vaginal delivery with the use of forceps or vacuum (115 of 304 women [38%] and 104 the full text of this article at NEJM.org.
of 314 women [33%], respectively; relative risk, 1.30; 95% CI, 0.96 to 1.77). There were
N Engl J Med 2016;374:813-22.
no maternal or infant deaths and no significant between-group differences in the DOI: 10.1056/NEJMoa1509117
women’s experience of childbirth or in the frequency of adverse maternal or neonatal Copyright © 2016 Massachusetts Medical Society.
outcomes.
CONCLUSIONS Read Full Article at NEJM.org
Among women of advanced maternal age, induction of labor at 39 weeks of gestation,
as compared with expectant management, had no significant effect on the rate of
cesarean section and no adverse short-term effects on maternal or neonatal out-
comes. (Funded by the Research for Patient Benefit Programme of the National Insti-
tute for Health Research; Current Controlled Trials number, ISRCTN11517275.)
n engl j med 374;9 nejm.org March 3, 2016 813
Back to Table of Contents15 Notable Articles of 2016 nejm.org
The n e w e ng l a n d j o u r na l of m e dic i n e
Edi t or i a l
Induction of Labor and Cesarean Delivery
William A. Grobman, M.D.
At the heart of obstetrical care is a seemingly or perinatal outcomes have been too small to
simple calculus: when are the benefits of deliv- guide clinical practice.7
ery greater than the benefits of continued preg- In this issue of the Journal, Walker et al.8 have
nancy? However, making this determination is attempted to rectify this gap in evidence. They
anything but straightforward, given the poten- report the results of a trial in which more than
tially conflicting needs of the mother and the 600 women who were at least 35 years of age
needs of her offspring, which must both be were randomly assigned to labor induction be-
taken into account to maximize maternal and tween 39 weeks 0 days and 39 weeks 6 days of
perinatal health. gestation or to expectant management. This
In the absence of maternal or fetal complica- study was powered to detect at least a 36% rela-
tions, current consensus favors the consideration tive difference between the two groups in the
of delivery between 41 weeks 0 days and 42 weeks frequency of cesarean delivery. A total of 32%
0 days of gestation. In addition, for these women, of the women assigned to the induction group,
delivery is recommended after 42 weeks 0 days as compared with 33% of the women assigned to
and no later than 42 weeks 6 days of gestation, the expectant-management group, underwent a
given the increase in perinatal morbidity and cesarean delivery (relative risk, 0.99; 95% confi-
mortality at these gestational ages.1 Thus, induc- dence interval, 0.87 to 1.14). There were no sig-
tion before 41 weeks 0 days of gestation in the nificant differences between the groups in other
absence of complications is considered not to be adverse maternal or perinatal outcomes, but such
medically indicated. outcomes were uncommon.
One consideration that traditionally has tipped On the basis of the results of this trial, it
the balance toward continuing pregnancy is the would be premature to alter recommendations
concern that labor induction may increase the regarding the timing of delivery in uncomplicated
risk of cesarean delivery, particularly among pregnancies. Although the study did not show
nulliparous women. This belief is based on the evidence of harm from induction at 39 weeks
findings of multiple observational studies in of gestation, it also did not show evidence of
which outcomes in women who underwent in- benefit, and one could argue that medical inter-
duction were compared with those of women ventions in general, and intervention in the
who had spontaneous labor.2 However, sponta- natural progress of gestation specifically, should
neous labor is not a clinical “strategy,” and thus be performed only when benefit has been shown.
it is not the appropriate comparison. Because this trial was not designed or ade-
Observational studies in which outcomes in quately powered to assess differences in perinatal
women who underwent induction were compared outcomes, whether labor induction at 39 weeks of
with those in women who received expectant gestation affects these outcomes remains un-
management generally have not shown an in- known. We do not know whether the findings of
creased risk of cesarean delivery among women this trial are generalizable to women younger
who underwent induction.3-6 However, trials that than 35 years of age or whether the results
have explored whether, in the absence of compli- would differ according to whether or not women
cations, labor induction before 41 weeks 0 days require cervical ripening. Finally, women in this
of gestation is associated with adverse maternal trial received care in the United Kingdom, which
880 n engl j med 374;9 nejm.org March 3, 2016
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