Download Regular Moderate Exercise Throughout Pregnancy Not Associated

OUTCOMES RESEARCH IN REVIEW
Regular Moderate Exercise Throughout Pregnancy Not
Associated with Increased Risk of Preterm Delivery
Di Mascio D, Magro-Malosso ER, Saccone G, et al. Exercise during pregnancy in normal-weight women and
risk of preterm birth: a systematic review and meta-analysis of randomized controlled trials. Am J Obstet Gynecol
2016 Jun 16.
Study Overview
Objective. To evaluate if exercise during pregnancy has
an effect on the risk of preterm birth.
Design. Systematic review and meta-analysis of randomized controlled trials.
Study selection. The authors followed the protocol
for conducting meta-analyses recommended by the
Cochrane Collaboration. MEDLINE, EMBASE, Web
of Science, Scopus, ClinicalTrials.gov, OVID, and the
Cochrane Library were searched from the inception of
each database to April 2016. Selection criteria included
randomized clinical trials that examined the effect of
aerobic exercise on preterm birth. Keywords included
exercise or physical activity and pregnancy and preterm
birth or preterm delivery. Studies were included only if
women were randomized to an aerobic exercise program
prior to 23 weeks, participants had uncomplicated singleton pregnancies and no contraindication to exercise, and
preterm birth was an outcome.
Nine studies met the inclusion criteria and were included in the meta-analysis. The quality of included studies was
good overall, with most studies having low risk of selection
or attrition bias and low or unclear risk of reporting bias.
Most of the studies did not include blinding of participants
and research personnel or of the outcome assessment.
Sample sizes ranged from 14 to 697, with 2 studies with
< 100 participants, 3 with 100 to 200 participants, and 3
with 290 to 687 participants. All of the women randomized to the experimental group began an exercise program
by 22 weeks’ gestation. The types of physical activity used
in the experimental group included strength and flexibility
training, cycling, stretching, resistance, dance, joint mobilization, walking, and toning. Participants engaged in the
activity for 35 to 90 minutes (mean, 57 minutes) 3 times
a week in 8 studies and 4 times a week in 1 study. The
intensity of the aerobic activities ranged from less than
60% to less than 80% of age-predicted maximum heart
rate. Participants in 3 control groups were explicitly told
not to engage in exercise while those in the others were
neither encouraged or discouraged from doing so.
Main outcome measure. Incidence of preterm birth (birth
prior to 37 weeks’ gestation).
Main results. A total of 2059 women were included in the
meta-analysis, with 1022 in the exercise group and 1037 in
Outcomes Research in Review Section Editors
Kristina Lewis, MD, MPH
Wake Forest School of Medicine
Winston-Salem, NC
William Hung, MD, MPH
Mount Sinai School of Medicine
New York, NY
Katrina F. Mateo, MPH
NYU School of Medicine
New York, NY
346 JCOM August 2016 Vol. 23, No. 8
Gordon Ngai, MD, MPH
Mount Sinai School of Medicine
New York, NY
Karen Roush, PhD, RN
Lehman College
Bronx, NY
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the control group. The incidence of preterm birth was similar in the experimental and the control groups (4.5% vs 4.4%
respectively, 95% confidence interval [CI], –0.07 to 0.17).
The mean gestational age at delivery was also similar, with a
mean difference of 0.05 (95% CI, –0.07 to 0.17). Women in
the exercise group had a decreased risk of cesarean delivery
(0.82%), with 17.9% having a cesarean delivery compared
to 22% in the control group ( 95% CI, 0.69 to 0.97).
Conclusion. Exercise during pregnancy in women with
singleton, uncomplicated pregnancy is not associated
with increased risk of preterm delivery. Additionally, it is
associated with a decreased risk of cesarean delivery.
Commentary
Preterm birth accounts for most perinatal deaths in the
United States and places surviving infants at risk for serious short- and long-term health problems [1]. Though
the rate of preterm births in the United States has been
slowly declining in recent years, at 9.57% it continues
to be one of the highest among high-income countries
[2]. Determining factors that contribute to incidence
of preterm birth is critical to reducing this unacceptably
high rate. According to the authors of this meta-analysis,
the role of exercise related to preterm birth remains controversial due to past beliefs that the increased release of
catecholamines during exercise would stimulate myometrial activity and ongoing concerns about possible adverse
effects. The health benefits of regular exercise are wellknown, including in pregnancy where it has been shown
to lower the risk of gestational diabetes and preeclampsia.
Researchers have investigated exercise during pregnancy in earlier reviews; however, this appears to be the
first with both preterm birth as the primary outcome and
an adequate number of clinical trials in the sample. Prior
reviews that examined the effects of exercise on preterm
birth, either specifically or as one of a number of pregnancy outcomes, included only 3 to 5 studies pertaining
to preterm birth [3–5].
The strengths of this review were the low statistical
heterogeneity and high quality of the included studies,
lack of publication bias, and the large sample of 2059
participants. As noted by the authors, however, lack of
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stratification by body mass (underweight, overweight,
obese), differences in the types and intensity of exercise
among interventions, as well as possible differences in
adherence may have affected outcomes. In addition, in 6
studies women in the control group were not specifically
instructed to refrain from exercise and there is no information about their exercise habits. The risk of contamination bias exists because some of these women may have
engaged in a regular program of exercise. However, considering that levels of regular exercise in pregnant women
are low, it is unlikely that this would occur at a rate that
would have a significant effect on the outcomes [6].
Applications for Clinical Practice
The results of this meta-analysis provide strong support
for the American College of Obstetrics and Gynecology
recommendation that women with uncomplicated pregnancies be encouraged to engage in moderate-intensity
exercise 20 to 30 minutes per day during pregnancy [7].
Clinicians should advise all women with uncomplicated
singleton pregnancies and no medical contraindications
to engage in regular aerobic and strength-conditioning
exercise throughout their pregnancy.
—Karen Roush, PhD, RN
References
1. March of Dimes. 2015 Premature birth report cards. Accessed at
www.marchofdimes.org/mission/prematurity-reportcard.aspx.
2. CDC. FastStats: Birthweight and gestation. Accessed at www.
cdc.gov/nchs/fastats/birthweight.htm.
3. Kramer MS, McDonald SW. Aerobic exercise for women during
pregnancy. Cochrane Database Syst Rev 2006;(3):CD000180.
4. Muktabhant B, Lawrie TA, Lumbiganon P, Laopaiboon
M. Diet or exercise, or both, for preventing excessive
weight gain in pregnancy. Cochrane Database Syst Rev
2015;(6):CD007145.
5. Thangaratinam S, Rogozinska E, Jolly K, et al. Effects of
interventions in pregnancy on maternal weight and obstetric
outcomes: Meta-analysis of randomized evidence. BMJ 2012
May 16;344:e2088.
6. Nascimento SL, Surita FG, Cecatti JG. Physical exercise during pregnancy: a systematic review. Curr Opin Obstet Gynecol
2012 Dec;24:387–94.
7. ACOG Committee Opinion No. 650: Physical activity and
exercise during pregnancy and the postpartum period. Obstet
Gynecol 2015;126:e135–42.
Vol. 23, No. 8 August 2016 JCOM 347
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Can Patient Navigators Increase Cancer Screening Rates in
Primary Care Practice?
Percac-Lima S, Ashburner JM, Zai AH, et al. Patient navigation for comprehensive cancer screening in highrisk patients using a population-based health information technology system: a randomized clinical trial. JAMA
Intern Med 2016;176:930–7.
Study Overview
Objective. To evaluate patient navigation (PN) for breast,
cervical, and colorectal cancer (CRC) screening using a
population-based information technology (IT) system
within a primary care network.
Design. Randomized clinical trial.
Setting and participants. Patients were from 18 primary
care practices in the Massachusetts General Primary Care
Practice-Based Research Network, which included 4
community health centers. The study used a population
health IT application (TopCare [SRG Technology]) to
identify patients overdue for breast, cervical and/or CRC
screening. Women were deemed eligible and overdue
for breast cancer [1] and cervical cancer [2] screening
based on United States Preventive Services Task Force
(USPSTF) recommendation statements. Patients aged 50
to 75 years without prior total colectomy were considered
eligible for CRC screening and overdue if they did not
have a colonoscopy in the past 10 years or sigmoidoscopy/barium enema/colonography in the past 5 years.
The study identified patients at high risk for nonadherence via a point system based on history of nonadherence to cancer screening tests, missed appointments, and primary language spoken (non-English speaking). A total of 1956 patients were identified, and after
excluding those who were participating in an existing PN
program, left the primary care network, died, or were
lost to follow-up, the final study population consisted of
1612 patients overdue for at least 1 screening at the start
of the study period.
Intervention: The intervention was a PN program comprising 4 part-time patient navigators with at least 2
years’ experience with cancer navigation and who worked
50% of their time in other PN programs. The navigators
tracked intervention patients using the IT system, con348 JCOM August 2016 Vol. 23, No. 8
tacted them in their own language, and used extensive
outreach efforts to assist them in completing their cancer screening. Most contact with patients took place via
phone calls.
Main outcome measures. The primary outcome was
the mean cancer screening test completion rate over
the follow-up period for each eligible patient, with all
eligible cancers combined in intention-to-treat analyses.
Secondary outcomes included assessing the proportion of
patients completing any and each cancer screening during
follow-up among those who were eligible and overdue
for at least 1 cancer screening at baseline in intentionto-treat analyses. Additionally, as-treated analyses were
conducted, in which patients who left the network or
died during follow-up were removed from the intervention and control groups and patients who could not be
reached were removed from the intervention group.
Results. A total of 792 patients were randomized to the
intervention group (PN) and 820 patients were randomized to usual care. The mean age in the intervention
and control groups was 56.9 and 57.1 years, respectively.
The intervention and control groups were well-matched
in terms of sex, primary language, insurance, proportion of patients connected to a specific physician or
seen in a community health center, number of clinic
visits over the past 3 years, and risk for nonadherence.
Among patients eligible and overdue for cancer screening, mean cancer screening completion rates were
higher in the intervention group compared with the
control group for all cancers combined (10.2% vs 6.8%;
95% CI [for the difference] 1.5% to 5.2%; P < 0.001)
and for breast (14.7% vs 11.0%; 95% CI 0.2% to 7.3%;
P = 0.04), cervical (11.1% vs 5.7%; 95% CI 0.8% to 5.2%;
P = 0.002), and colon (7.6% vs 4.6%;95% CI 0.8% to
5.2%; P = 0.01) cancer. The secondary outcome, the
proportion of overdue patients who completed any cancer
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OUTCOMES RESEARCH IN REVIEW
screening during follow-up, was higher in the intervention group (25.5% vs 17.0%; 95% CI 4.7% to 12.7%;
P < 0.001). More patients in the intervention group completed screening for breast (23.4% vs 16.6%; 95% CI 1.8%
to 12.0%; P = 0.009), cervical (14.4% vs 8.6%; 95% CI
1.6% to 10.5%; P = 0.007), and colorectal (13.7% vs 7.0%;
95% CI 3.2% to 10.4%; P < 0.001) cancer. The effect size
increased in the as-treated analyses.
Conclusion. PN, using a health IT application, improved
cancer screening completion rates among patients at high
risk for nonadherence over an 8-month period in an
academic primary care network.
Commentary
The potential of PN to help individuals traverse the
complexity of the current health care system continues
to attract great interest as value-based care becomes a
reality for physicians and health systems. Several studies
have demonstrated PN to be an effective modality to
improve adherence to recommended screenings [3–5];
however, issues surrounding cost, patient perception, and
the “outsourcing” of care from the primary care physician to navigators require attention. At this time, the
most robust aggregation of data demonstrating benefit
outweighing harm for cancer screening is published by
the USPSTF [6]. Breast cancer [7], cervical cancer [8],
and CRC [9] have the greatest weight of evidence to support screening.
The study was conducted at a single academic medical
center with established IT infrastructure and an established PN program, which limits application of the results
to large networked organizations and/or private practice
settings. One important limitation in the CRC screening
component was the lack of alternatives to colonoscopy.
Studies have demonstrated greater adherence to CRC
screening with methods other than colonoscopy [10],
especially among racial/ethnic minorities. Although the
authors estimate the intervention cost approximately
$100,000, the study does not include the cost of the
population health IT solution. The costs associated with
both the IT solution in addition to PN may ultimately
outweigh the benefits. The short time frame of the
study may also limit effect size and add to long-term
cost considerations. Lastly, a high percentage of patients
randomized to the intervention group were unable to
be contacted, declined PN services, had competing
comorbidities, or were screened elsewhere. On the other
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hand, the study has several strengths. Statistically, the
study utilized intention-to-treat analyses, where estimate
of treatment effect is generally conservative. As compared
to the current literature, the authors evaluate 3 different
types of cancer—a pragmatic approach from a clinician’s
perspective. Additionally, the authors focused efforts
on individuals at high risk for nonadherence, a strategy
also practicable by clinicians. Another realistic element
of the study is that patient navigators had other responsibilities, which implies applicability to resource-limited
settings.
Applications for Clinical Practice
PN has been shown to be an effective means of improving population-based health outcomes, and this study
demonstrates it improves cancer screening rates, assuming the appropriate IT infrastructure is in place. The costs
and benefits of PN should be assessed when considering
use of PN in nonadherent populations, and PN interventions should be tailored to available resources and the
unique practice environment.
—Ajay Dharod, MD
References
1. Calonge N, Petitti DB, DeWitt TG, et al. Screening for breast
cancer: US Preventive Services Task Force recommendation
statement. Ann Intern Med 2009;151:716–26.
2. Moyer VA; US Preventive Services Task Force. Screening for
cervical cancer: US Preventive Services Task Force recommendation statement. Ann Intern Med 2012;156:880–91.
3. Phillips CE, Rothstein JD, Beaver K, et al. Patient navigation to increase mammography screening among inner city
women. J Gen Intern Med 2011;26:123–9.
4. Jandorf L, Braschi C, Ernstoff E, et al. Culturally targeted
patient navigation for increasing African Americans’ adherence
to screening colonoscopy: a randomized clinical trial. Cancer
Epidemiol Biomarkers Prev 2013;22:1577–87.
5. Braschi CD, Sly JR, Singh S, et al. Increasing colonoscopy
screening for Latino Americans through a patient navigation
model: a randomized clinical trial. J Immigr Minor Health
2014;16:934–40.
6. US Preventive Services Task Force. Published recommendations. 2016. Accessed 12 July 2016 at www.uspreventiveservicestaskforce.org/BrowseRec/Index/browse-recommendations.
7. US Preventive Services Task Force. Final recommendation statement: Breast cancer: Screening. 2016. Accessed 12 July 2016
at www.uspreventiveservicestaskforce.org/Page/Document/
RecommendationStatementFinal/breast-cancer-screening1.
8. US Preventive Services Task Force. Final Recommendation
Statement: Cervical cancer: Screening. 2016. Accessed 12 July
2016 at www.uspreventiveservicestaskforce.org/Page/Document/
RecommendationStatementFinal/cervical-cancer-screening.
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9. US Preventive Services Task Force. Final Recommendation
Statement: Colorectal cancer: Screening. 2016. Accessed 12
July 2016 at www.uspreventiveservicestaskforce.org/Page/
Document/RecommendationStatementFinal/colorectal-
cancer-screening2.
10. Inadomi JM, Vijan S, Janz NK, et al. Adherence to colorectal
cancer screening: a randomized clinical trial of competing
strategies. Arch Intern Med 2012;172:575–82.
Copyright 2016 by Turner White Communications Inc., Wayne, PA. All rights reserved.
350 JCOM August 2016 Vol. 23, No. 8
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