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1.  Toward a New Paradigm in Graduate Medical Education in the United States: Elimination of the 24-Hour Call 
Sleep deprivation negatively affects resident performance, education, and safety. Concerns over these effects have prompted efforts to reduce resident hours. This article describes the design and implementation of a scheduling system with no continuous 24-hour calls. Aims included meeting Accreditation Council for Graduate Medical Education work hour requirements without increasing resident complement, maximizing continuity of learning and patient care, maintaining patient care quality, and acceptance by residents, faculty, and administration.
Various coverage options were formulated and discussed. The final schedule was the product of consensus. After re-engineering the master rotation schedule, service-specific conversion of on-call schedules was initiated in July 2003 and completed in July 2004. Annual in-training and certifying examination performance, length of stay, patient mortalities, resident motor vehicle accidents/near misses, and resident satisfaction with the new scheduling system were tracked.
Continuous 24-hour call has been eliminated from the program since July 2004, with the longest assigned shift being 14 hours. Residents have at least 1 free weekend per month, a 10-hour break between consecutive assigned duty hours, and a mandatory 4-hour “nap” break if assigned a night shift immediately following a day shift. Program-wide, duty hours average 66 hours per week for first-year residents, 63 hours per week for second-year residents, and 60 hours per week for third-year residents. Self-reported motor vehicle accidents and/or near misses of accidents significantly decreased (P < .001) and resident satisfaction increased (P  =  .42). The change was accomplished at no additional cost to the institution and with no adverse patient care or educational outcomes.
Pediatric residency training with restriction to 14 consecutive duty hours is effective and well accepted by stakeholders. Five years later, the re-engineered schedule has become the new “normal” for our program.
PMCID: PMC2931239  PMID: 21975977
2.  Worse outcomes for patients undergoing brain tumor and cerebrovascular procedures following the ACGME resident duty-hour restrictions 
Journal of neurosurgery  2014;121(2):262-276.
On July 1, 2003, the Accreditation Council for Graduate Medical Education (ACGME) implemented duty-hour restrictions for resident physicians due to concerns for patient and resident safety. Though duty-hour restrictions have increased resident quality of life, studies have shown mixed results with respect to patient outcomes. In this study, the authors have evaluated the effect of duty-hour restrictions on morbidity, mortality, length of stay, and charges in patients who underwent brain tumor and cerebrovascular procedures.
The Nationwide Inpatient Sample was used to evaluate the effect of duty-hour restrictions on complications, mortality, length of stay, and charges by comparing the pre-reform (2000–2002) and post-reform (2005–2008) periods. Outcomes were compared between nonteaching and teaching hospitals using a difference-in-differences (DID) method.
A total of 90,648 patients were included in the analysis. The overall complication rate was 11.7%, with the rates not significantly differing between the pre –and post–duty hour eras (p = 0.26). Examination of hospital teaching status revealed that complication rates decreased in nonteaching hospitals (12.1% vs 10.4%, p = 0.0004) and remained stable in teaching institutions (11.8% vs 11.9%, p = 0.73) in the post-reform era. Multivariate analysis demonstrated a significantly higher complication risk in teaching institutions (OR 1.33 [95% CI 1.11–1.59], p = 0.0022), with no significant change in nonteaching hospitals (OR 1.11 [95% CI 0.91–1.37], p = 0.31). A DID analysis to compare the magnitude in change between teaching and nonteaching institutions revealed that teaching hospitals had a significantly greater increase in complications during the post-reform era than nonteaching hospitals (p = 0.040). The overall mortality rate was 3.0%, with a significant decrease occurring in the post-reform era in both nonteaching (5.0% vs 3.2%, p < 0.0001) and teaching (3.2% vs 2.3%, p < 0.0001) hospitals. DID analysis to compare the changes in mortality between groups did not reveal a significant difference (p = 0.40). The mean length of stay for all patients was 8.7 days, with hospital stay decreasing from 9.2 days to 8.3 days in the post-reform era (p < 0.0001). The DID analysis revealed a greater length of stay decrease in nonteaching hospitals than teaching institutions, which approached significance (p = 0.055). Patient charges significantly increased in the post-reform era for all patients, increasing from $70,900 to $96,100 (p < 0.0001). The DID analysis did not reveal a significant difference between the changes in charges between teaching and nonteaching hospitals (p = 0.17).
The implementation of duty-hour restrictions correlated with an increased risk of postoperative complications for patients undergoing brain tumor and cerebrovascular neurosurgical procedures. Duty-hour reform may therefore be associated with worse patient outcomes, contrary to its intended purpose. Due to the critical condition of many neurosurgical patients, this patient population is most sensitive and likely to be negatively affected by proposed future increased restrictions.
PMCID: PMC4527330  PMID: 24926647
brain tumor; cerebrovascular; complication; duty-hour restriction; outcome; resident
3.  Numbers of deaths related to intrapartum asphyxia and timing of birth in all Wales perinatal survey, 1993-5 
BMJ : British Medical Journal  1998;316(7132):657-660.
Objectives: To investigate the relation between the timing of birth and the occurrence of death related to an intrapartum event.
Design: Analysis of 107 206 births to Welsh residents in 1993-5, including 608 cases of stillbirth and 407 of neonatal death identified in the all Wales perinatal survey, the cause of death classified with the clinicopathological system.
Subjects: 79 normally formed babies stillborn or who died in the neonatal period, birth weight >1499 g, for whom cause of death was related to an intrapartum event.
Main outcome measures: Relative risk of death due to an intrapartum event according to the hour, day, and month of birth.
Results: Mortality was higher in babies born between 9 00 pm and 8 59 am than in those born between 9 00 am and 8 59 pm; relative risk (95% confidence interval) 2.18 (1.37 to 3.47). July and August births also had a higher death rate than births in other months; relative risk 1.99 (1.23 to 3.23). Weekend births had a higher death rate but it was not significant.
Conclusions: The excess of deaths at night and during months when annual leave is popular may indicate an overreliance on inexperienced staff at these times. Errors of judgment may also be related to physical and mental fatigue, demanding a more disciplined systematic approach at night. Mistakes may be ameliorated by increasing shiftwork, but shifts should be carefully designed to avoid undue disruption of circadian rhythms. In addition, greater supervision by senior staff may be required at night and during summer months.
Key messages In low risk pregnancies the incidence of death due to intrapartum asphyxia is regarded as a sensitive measure of the quality of perinatal care Babies born at night and during summer months are at increased risk of death due to intrapartum asphyxia, raising concerns about variability in care around the time of delivery Errors of judgment may be related to mental fatigue. Staff need to be aware of how their performance may vary, and a more disciplined systematic approach at night may be needed Greater supervision by senior staff may be required at night and during summer months
PMCID: PMC28468  PMID: 9522787
4.  Timing of birth and infant and early neonatal mortality in Sweden 1973-95: longitudinal birth register study 
BMJ : British Medical Journal  2001;323(7325):1327.
To assess the impact of time of birth on infant mortality and early neonatal mortality in full term and preterm births.
Analysis of data from the Swedish birth register, 1973-95.
2 102 324 spontaneous live births of infants without congenital malformation.
Outcome measurements
Absolute and relative risk of infant mortality, early neonatal mortality, and early neonatal mortality related to asphyxia.
Infant mortality, early neonatal mortality, and early neonatal mortality related to asphyxia were higher in infants who were born during the night (9 pm to 9 am) compared with those born during the day for 1973-9, 1980-9, and 1990-5. The difference was more dramatic for preterm infants. The largest difference was observed during 1990-5, when there was a 30% increase in early neonatal mortality (relative risk 1.31, 95% confidence interval 1.10 to 1.57) and a 70% increase in early neonatal mortality related to asphyxia (1.70, 1.22 to 2.38) in preterm infants born during the night compared with rates for preterm infants born during the day. A detailed analysis over 24 hours revealed two “high risk” periods: between 5 pm and 1 am and around 9 am.
Infants born during the night have a greater risk of infant and early neonatal mortality and early neonatal mortality related to asphyxia than those born during the day. There has been no improvement over the past two decades. The problem is more serious for preterm births and was even worse in the 1990s. Shift changes and the hours immediately after such changes are high risk periods for neonatal care.
What is already known on this topicInfants born at night have a greater risk of early neonatal mortality and early neonatal mortality related to asphyxia than those born during the dayThe causes are unclear but may be related to insufficient or less experienced staff or excess workload during the nightWhat this study addsIn Sweden the relative risks of infant and early neonatal mortality and mortality related to asphyxia for infants born during the night compared with during the day did not diminish during 1973-95, are greater for preterm infants, and were greater in the 1990sThere are two “high risk” periods for early neonatal mortality: 5 pm to 1 am and around 9 amThe exact reasons are unclear but better vigilance and an improvement in shift changes may be required to improve neonatal health care further
PMCID: PMC60669  PMID: 11739216
5.  Methicillin-Resistant and Susceptible Staphylococcus aureus Bacteremia and Meningitis in Preterm Infants 
Pediatrics  2012;129(4):e914-e922.
Data are limited on the impact of methicillin-resistant Staphylococcus aureus (MRSA) on morbidity and mortality among very low birth weight (VLBW) infants with S aureus (SA) bacteremia and/or meningitis (B/M).
Neonatal data for VLBW infants (birth weight 401–1500 g) born January 1, 2006, to December 31, 2008, who received care at centers of the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network were collected prospectively. Early-onset (≤72 hours after birth) and late-onset (>72 hours) infections were defined by blood or cerebrospinal fluid cultures and antibiotic treatment of ≥5 days (or death <5 days with intent to treat). Outcomes were compared for infants with MRSA versus methicillin-susceptible S aureus (MSSA) B/M.
Of 8444 infants who survived >3 days, 316 (3.7%) had SA B/M. Eighty-eight had MRSA (1% of all infants, 28% of infants with SA); 228 had MSSA (2.7% of all infants, 72% of infants with SA). No infant had both MRSA and MSSA B/M. Ninety-nine percent of MRSA infections were late-onset. The percent of infants with MRSA varied by center (P < .001) with 9 of 20 centers reporting no cases. Need for mechanical ventilation, diagnosis of respiratory distress syndrome, necrotizing enterocolitis, and other morbidities did not differ between infants with MRSA and MSSA. Mortality was high with both MRSA (23 of 88, 26%) and MSSA (55 of 228, 24%).
Few VLBW infants had SA B/M. The 1% with MRSA had morbidity and mortality rates similar to infants with MSSA. Practices should provide equal focus on prevention and management of both MRSA and MSSA infections among VLBW infants.
PMCID: PMC3313632  PMID: 22412036
Staphylococcus aureus; methicillin resistant; infant; newborn
6.  Post-neonatal Mortality, Morbidity, and Developmental Outcome after Ultrasound-Dated Preterm Birth in Rural Malawi: A Community-Based Cohort Study 
PLoS Medicine  2011;8(11):e1001121.
Using data collected as a follow-up to a randomized trial, Melissa Gladstone and colleagues show that during the first two years of life, infants born preterm in southern Malawi are disadvantaged in terms of mortality, growth, and development.
Preterm birth is considered to be associated with an estimated 27% of neonatal deaths, the majority in resource-poor countries where rates of prematurity are high. There is no information on medium term outcomes after accurately determined preterm birth in such settings.
Methods and Findings
This community-based stratified cohort study conducted between May–December 2006 in Southern Malawi followed up 840 post-neonatal infants born to mothers who had received antenatal antibiotic prophylaxis/placebo in an attempt to reduce rates of preterm birth (APPLe trial ISRCTN84023116). Gestational age at delivery was based on ultrasound measurement of fetal bi-parietal diameter in early-mid pregnancy. 247 infants born before 37 wk gestation and 593 term infants were assessed at 12, 18, or 24 months. We assessed survival (death), morbidity (reported by carer, admissions, out-patient attendance), growth (weight and height), and development (Ten Question Questionnaire [TQQ] and Malawi Developmental Assessment Tool [MDAT]). Preterm infants were at significantly greater risk of death (hazard ratio 1.79, 95% CI 1.09–2.95). Surviving preterm infants were more likely to be underweight (weight-for-age z score; p<0.001) or wasted (weight-for-length z score; p<0.01) with no effect of gestational age at delivery. Preterm infants more often screened positively for disability on the Ten Question Questionnaire (p = 0.002). They also had higher rates of developmental delay on the MDAT at 18 months (p = 0.009), with gestational age at delivery (p = 0.01) increasing this likelihood. Morbidity—visits to a health centre (93%) and admissions to hospital (22%)—was similar for both groups.
During the first 2 years of life, infants who are born preterm in resource poor countries, continue to be at a disadvantage in terms of mortality, growth, and development. In addition to interventions in the immediate neonatal period, a refocus on early childhood is needed to improve outcomes for infants born preterm in low-income settings.
Please see later in the article for the Editors' Summary
Editors' Summary
Being born at term in Africa is not necessarily straightforward. In Malawi, 33 of every 1,000 infants born die in the first 28 days after birth; the lifetime risk for a mother dying during or shortly after pregnancy is one in 36. The comparable figures for the United Kingdom are three infants dying per 1,000 births and a lifetime risk of maternal death of one in 4,700. But for a baby, being born preterm is even more risky and the gap between low- and high-income countries widens still further. According to a World Health Organization report in 2010, a baby born at 32 weeks of gestation (weighing around 2,000 g) in Africa has little chance of survival, while the chances of survival for a baby born at 32 weeks in North America or Europe are similar to one born at term. There are very few data on the longer term outcomes of babies born preterm in Africa and there are multiple challenges involved in gathering such information. As prenatal ultrasound is not routinely available, gestational age is often uncertain. There may be little routine follow-up of preterm babies as is commonplace in high-income countries. Data are needed from recent years that take into account both improvements in perinatal care and adverse factors such as a rising number of infants becoming HIV positive around the time of birth.
Why Was This Study Done?
We could improve outcomes for babies born preterm in sub-Saharan Africa if we understood more about what happens to them after birth. We cannot assume that the progress of these babies will be the same as those born preterm in a high-income country, as the latter group will have received different care, both before and after birth. If we can document the problems that these preterm babies face in a low-income setting, we can consider why they happen and what treatments can be realistically tested in this setting. It is also helpful to establish baseline data so that changes over time can be recorded.
The aim of this study was to document four specific outcomes up to the age of two years, on which there were few data previously from rural sub-Saharan Africa: how many babies survived, visits to a health center and admissions to the hospital, growth, and developmental delay.
What Did the Researchers Do and Find?
The researchers examined a group of babies that had been born to mothers who had taken part in a randomized controlled trial of an antibiotic to prevent preterm birth. The trial had previously shown that the antibiotic (azithromycin) had no effect on how many babies were born preterm or on other measures of the infants' wellbeing, and so the researchers followed up babies from both arms of the trial to look at longer term outcomes. From the original group of 2,297 women who took part in the trial, they compared 247 infants born preterm against 593 term infants randomly chosen as controls, assessed at 12, 18, or 24 months. The majority of the preterm babies who survived past a month of age (all but ten) were born after 32 weeks of gestation. Compared to the babies born at term, the infants born preterm were nearly twice as likely to die subsequently in the next two years, were more likely to be underweight (a third were moderately underweight), and to have higher rates of developmental delay. The commonest causes of death were gastroenteritis, respiratory problems, and malaria. Visits to a health center and admissions to hospital were similar in both groups.
What Do these Findings Mean?
This study documents longer term outcomes of babies born preterm in sub-Saharan Africa in detail for the first time. The strengths of the study include prenatal ultrasound dating and correct adjustment of follow-up age (which takes into account being born before term). Because the researchers defined morbidity using routine health center attendances and self-report of illnesses by parents, this outcome does not seem to have been as useful as the others in differentiating between the preterm and term babies. Better means of measuring morbidity are needed in this setting.
In the developed world, there is considerable investment being made to improve care during pregnancy and in the neonatal period. This investment in care may help by predicting which mothers are more likely to give birth early and preventing preterm birth through drug or other treatments. It is to be hoped that some of the benefit will be transferable to low-income countries. A baby born at 26 weeks' gestation and admitted to a neonatal unit in the United Kingdom has a 67% chance of survival; preterm babies born in sub-Saharan Africa face a starkly contrasting future.
Additional Information
Please access these Web sites via the online version of this summary at
UNICEF presents useful statistics on mother and child outcomes
The World Health Organization has attempted to analyse preterm birth rates worldwide, including mapping the regional distribution and has also produced practical guides on strategies such as Kangaroo Mother Care, which can be used for the care of preterm infants in low resource settings
Healthy Newborn Network has good information on initiatives taking place to improve neonatal outcomes in low income settings
The March of Dimes, a nonprofit organization for pregnancy and baby health, provides information on research being conducted into preterm birth
Tommy's is a nonprofit organization that funds research and provides information on the risks and causes of premature birth
PMCID: PMC3210771  PMID: 22087079
7.  Effects of hospital delivery during off-hours on perinatal outcome in several subgroups: a retrospective cohort study 
Studies have demonstrated a higher risk of adverse outcomes among infants born or admitted during off-hours, as compared to office hours, leading to questions about quality of care provide during off-hours (weekend, evening or night). We aim to determine the relationship between off-hours delivery and adverse perinatal outcomes for subgroups of hospital births.
This retrospective cohort study was based on data from the Netherlands Perinatal Registry, a countrywide registry that covers 99% of all hospital births in the Netherlands. Data of 449,714 infants, born at 28 completed weeks or later, in the period 2003 through 2007 were used. Infants with a high a priori risk of morbidity or mortality were excluded. Outcome measures were intrapartum and early neonatal mortality, a low Apgar score (5 minute score of 0–6), and a composite adverse perinatal outcome measure (mortality, low Apgar score, severe birth trauma, admission to a neonatal intensive care unit).
Evening and night-time deliveries that involved induction or augmentation of labour, or an emergency caesarean section, were associated with an increased risk of an adverse perinatal outcome when compared to similar daytime deliveries. Weekend deliveries were not associated with an increased risk when compared to weekday deliveries. It was estimated that each year, between 126 and 141 cases with an adverse perinatal outcomes could be attributed to this evening and night effect. Of these, 21 (15-16%) are intrapartum or early neonatal death. Among the 3100 infants in the study population who experience an adverse outcome each year, death accounted for only 5% (165) of these outcomes.
This study shows that for infants whose mothers require obstetric interventions during labour and delivery, birth in the evening or at night, are at an increased risk of an adverse perinatal outcomes.
PMCID: PMC3496693  PMID: 22958736
Time of birth; Night; Weekend; Delivery; Perinatal mortality; Perinatal morbidity; Hospital care; Quality of health care
8.  DoMINO: Donor milk for improved neurodevelopmental outcomes 
BMC Pediatrics  2014;14:123.
Provision of mother’s own milk is the optimal way to feed infants, including very low birth weight infants (VLBW, <1500 g). Importantly for VLBW infants, who are at elevated risk of neurologic sequelae, mother’s own milk has been shown to enhance neurocognitive development. Unfortunately, the majority of mothers of VLBW infants are unable to provide an adequate supply of milk and thus supplementation with formula or donor milk is necessary. Given the association between mother’s own milk and neurodevelopment, it is important to ascertain whether provision of human donor milk as a supplement may yield superior neurodevelopmental outcomes compared to formula.
Our primary hypothesis is that VLBW infants fed pasteurized donor milk compared to preterm formula as a supplement to mother’s own milk for 90 days or until hospital discharge, whichever comes first, will have an improved cognitive outcome as measured at 18 months corrected age on the Bayley Scales of Infant Development, 3rd ed. Secondary hypotheses are that the use of pasteurized donor milk will: (1) reduce a composite of death and serious morbidity; (2) support growth; and (3) improve language and motor development. Exploratory research questions include: Will use of pasteurized donor milk: (1) influence feeding tolerance and nutrient intake (2) have an acceptable cost effectiveness from a comprehensive societal perspective?
DoMINO is a multi-centre, intent-to-treat, double blinded, randomized control trial. VLBW infants (n = 363) were randomized within four days of birth to either (1) pasteurized donor milk or (2) preterm formula whenever mother’s own milk was unavailable. Study recruitment began in October 2010 and was completed in December 2012. The 90 day feeding intervention is complete and long-term follow-up is underway.
Preterm birth and its complications are a leading cause long-term morbidity among Canadian children. Strategies to mitigate this risk are urgently required. As mother’s own milk has been shown to improve neurodevelopment, it is essential to ascertain whether pasteurized donor milk will confer the same advantage over formula without undue risks and at acceptable costs. Knowledge translation from this trial will be pivotal in setting donor milk policy in Canada and beyond.
Trial registration
ISRCTN35317141; Registered 10 August 2010.
PMCID: PMC4032387  PMID: 24884424
Human milk; Donor milk; Neurodevelopment; Very low birth weight infants
9.  A Systematic Review of the Effects of Resident Duty Hour Restrictions in Surgery 
Annals of Surgery  2014;259(6):1041-1053.
A systematic review and meta-analysis were performed to evaluate the impact of resident duty hours (RDH) on clinical and educational outcomes in surgery. A total of 135 articles met inclusion criteria. In surgery, recent RDH changes are not consistently associated with improved resident well-being and may have negative impacts on patient outcomes and education.
In 2003, the Accreditation Council for Graduate Medical Education (ACGME) mandated 80-hour resident duty limits. In 2011 the ACGME mandated 16-hour duty maximums for PGY1 (post graduate year) residents. The stated goals were to improve patient safety, resident well-being, and education. A systematic review and meta-analysis were performed to evaluate the impact of resident duty hours (RDH) on clinical and educational outcomes in surgery.
A systematic review (1980–2013) was executed on CINAHL, Cochrane Database, Embase, Medline, and Scopus. Quality of articles was assessed using the GRADE guidelines. Sixteen-hour shifts and night float systems were analyzed separately. Articles that examined mortality data were combined in a random-effects meta-analysis to evaluate the impact of RDH on patient mortality.
A total of 135 articles met the inclusion criteria. Among these, 42% (N = 57) were considered moderate-high quality. There was no overall improvement in patient outcomes as a result of RDH; however, some studies suggest increased complication rates in high-acuity patients. There was no improvement in education related to RDH restrictions, and performance on certification examinations has declined in some specialties. Survey studies revealed a perception of worsened education and patient safety. There were improvements in resident wellness after the 80-hour workweek, but there was little improvement or negative effects on wellness after 16-hour duty maximums were implemented.
Recent RDH changes are not consistently associated with improvements in resident well-being, and have negative impacts on patient outcomes and performance on certification examinations. Greater flexibility to accommodate resident training needs is required. Further erosion of training time should be considered with great caution.
PMCID: PMC4047317  PMID: 24662409
burnout; patient outcomes; patient safety; postgraduate surgical training; residents; resident duty hours; resident wellness; surgical education
10.  Survival and Morbidity Outcomes of Very Low Birth Weight Infants with Down Syndrome 
Pediatrics  2010;126(6):1132-1140.
Individuals with Down syndrome (DS) are at increased risk of several morbidities with lifelong health consequences. Little is known about mortality or morbidity risks in early infancy among very-low-birth-weight (VLBW) infants with DS. Our objective was to compare survival and neonatal morbidities between VLBW infants with DS and VLBW infants with other non-DS chromosomal anomalies, other non-chromosomal birth defects, and VLBW infants without major birth defects.
Data were collected prospectively for infants weighing 401-1500 grams born and/or cared for at one of the study centers participating in the NICHD Neonatal Research Network from 1994 through 2008. Risk of death and morbidities including patent ductus arteriosus (PDA), necrotizing enterocolitis (NEC), late onset sepsis (LOS), retinopathy of prematurity (ROP), and bronchopulmonary dysplasia (BPD), were compared between VLBW infants with DS and infants in the other groups.
Infants with DS were at increased risk of death (adjusted relative risk [RR] 2.47, 95% confidence interval [CI] 2.00-3.07), PDA, NEC, LOS, and BPD relative to infants with no birth defects. Decreased risk of death (RR 0.40, 95% CI 0.31-0.52) and increased risks of NEC and LOS were observed when comparing infants with DS to infants with other non-DS chromosomal anomalies. Relative to infants with non-chromosomal birth defects, infants with DS were at increased risk of PDA and NEC.
The increased risk of morbidities among VLBW infants with DS provides useful information for counseling parents and for caretakers in anticipating the need for enhanced surveillance for prevention of these morbidities.
PMCID: PMC3059605  PMID: 21098157
neonatal mortality; neonatal morbidity; preterm infants; Down syndrome; trisomy 21
11.  Very Low Birth Weight Preterm Infants With Surgical Short Bowel Syndrome: Incidence, Morbidity and Mortality, and Growth Outcomes at 18 to 22 Months 
Pediatrics  2008;122(3):e573-e582.
The objective of this study was to determine the (1) incidence of short bowel syndrome in very low birth weight (<1500 g) infants, (2) associated morbidity and mortality during initial hospitalization, and (3) impact on short-term growth and nutrition in extremely low birth weight (<1000 g) infants.
Infants who were born from January 1, 2002, through June 30, 2005, and enrolled in the National Institute of Child Health and Human Development Neonatal Research Network were studied. Risk factors for developing short bowel syndrome as a result of partial bowel resection (surgical short bowel syndrome) and outcomes were evaluated for all neonates until hospital discharge, death, or 120 days. Extremely low birth weight survivors were further evaluated at 18 to 22 months’ corrected age for feeding methods and growth.
The incidence of surgical short bowel syndrome in this cohort of 12 316 very low birth weight infants was 0.7%. Necrotizing enterocolitis was the most common diagnosis associated with surgical short bowel syndrome. More very low birth weight infants with short bowel syndrome (20%) died during initial hospitalization than those without necrotizing enterocolitis or short bowel syndrome (12%) but fewer than the infants with surgical necrotizing enterocolitis without short bowel syndrome (53%). Among 5657 extremely low birth weight infants, the incidence of surgical short bowel syndrome was 1.1%. At 18 to 22 months, extremely low birth weight infants with short bowel syndrome were more likely to still require tube feeding (33%) and to have been rehospitalized (79%). Moreover, these infants had growth delay with shorter lengths and smaller head circumferences than infants without necrotizing enterocolitis or short bowel syndrome.
Short bowel syndrome is rare in neonates but has a high mortality rate. At 18 to 22 months’ corrected age, extremely low birth weight infants with short bowel syndrome were more likely to have growth failure than infants without short bowel syndrome.
PMCID: PMC2848527  PMID: 18762491
short bowel syndrome; preterm; necrotizing enterocolitis; nutrition
12.  Associations between Stroke Mortality and Weekend Working by Stroke Specialist Physicians and Registered Nurses: Prospective Multicentre Cohort Study 
PLoS Medicine  2014;11(8):e1001705.
In a multicenter observational study, Benjamin Bray and colleagues evaluate whether weekend rounds by stroke specialist physicians, or the ratio of registered nurses to beds on weekends, is associated with patient mortality after stroke.
Please see later in the article for the Editors' Summary
Observational studies have reported higher mortality for patients admitted on weekends. It is not known whether this “weekend effect” is modified by clinical staffing levels on weekends. We aimed to test the hypotheses that rounds by stroke specialist physicians 7 d per week and the ratio of registered nurses to beds on weekends are associated with mortality after stroke.
Methods and Findings
We conducted a prospective cohort study of 103 stroke units (SUs) in England. Data of 56,666 patients with stroke admitted between 1 June 2011 and 1 December 2012 were extracted from a national register of stroke care in England. SU characteristics and staffing levels were derived from cross-sectional survey. Cox proportional hazards models were used to estimate hazard ratios (HRs) of 30-d post-admission mortality, adjusting for case mix, organisational, staffing, and care quality variables. After adjusting for confounders, there was no significant difference in mortality risk for patients admitted to a stroke service with stroke specialist physician rounds fewer than 7 d per week (adjusted HR [aHR] 1.04, 95% CI 0.91–1.18) compared to patients admitted to a service with rounds 7 d per week. There was a dose–response relationship between weekend nurse/bed ratios and mortality risk, with the highest risk of death observed in stroke services with the lowest nurse/bed ratios. In multivariable analysis, patients admitted on a weekend to a SU with 1.5 nurses/ten beds had an estimated adjusted 30-d mortality risk of 15.2% (aHR 1.18, 95% CI 1.07–1.29) compared to 11.2% for patients admitted to a unit with 3.0 nurses/ten beds (aHR 0.85, 95% CI 0.77–0.93), equivalent to one excess death per 25 admissions. The main limitation is the risk of confounding from unmeasured characteristics of stroke services.
Mortality outcomes after stroke are associated with the intensity of weekend staffing by registered nurses but not 7-d/wk ward rounds by stroke specialist physicians. The findings have implications for quality improvement and resource allocation in stroke care.
Please see later in the article for the Editors' Summary
Editors' Summary
In a perfect world, a patient admitted to hospital on a weekend or during the night should have as good an outcome as a patient admitted during regular working hours. But several observational studies (investigations that record patient outcomes without intervening in any way; clinical trials, by contrast, test potential healthcare interventions by comparing the outcomes of patients who are deliberately given different treatments) have reported that admission on weekends is associated with a higher mortality (death) rate than admission on weekdays. This “weekend effect” has led to calls for increased medical and nursing staff to be available in hospitals during the weekend and overnight to ensure that the healthcare provided at these times is of equal quality to that provided during regular working hours. In the UK, for example, “seven-day working” has been identified as a policy and service improvement priority for the National Health Service.
Why Was This Study Done?
Few studies have actually tested the relationship between patient outcomes and weekend physician or nurse staffing levels. It could be that patients who are admitted to hospital on the weekend have poor outcomes because they are generally more ill than those admitted on weekdays. Before any health system introduces potentially expensive increases in weekend staffing levels, better evidence that this intervention will improve patient outcomes is needed. In this prospective cohort study (a study that compares the outcomes of groups of people with different baseline characteristics), the researchers ask whether mortality after stroke is associated with weekend working by stroke specialist physicians and registered nurses. Stroke occurs when the brain's blood supply is interrupted by a blood vessel in the brain bursting (hemorrhagic stroke) or being blocked by a blood clot (ischemic stroke). Swift treatment can limit the damage to the brain caused by stroke, but of the 15 million people who have a stroke every year, about 6 million die within a few hours and another 5 million are left disabled.
What Did the Researchers Do and Find?
The researchers extracted clinical data on 56,666 patients who were admitted to stroke units in England over an 18-month period from a national stroke register. They obtained information on the characteristics and staffing levels of the stroke units from a biennial survey of hospitals admitting patients with stroke, and information on deaths among patients with stroke from the national register of deaths. A quarter of the patients were admitted on a weekend, almost half the stroke units provided stroke specialist physician rounds seven days per week, and the remainder provided rounds five days per week. After adjustment for factors that might have affected outcomes (“confounders”) such as stroke severity and the level of acute stroke care available in each stroke unit, there was no significant difference in mortality risk between patients admitted to a stroke unit with rounds seven days/week and patients admitted to a unit with rounds fewer than seven days/week. However, patients admitted on a weekend to a stroke unit with 1.5 nurses/ten beds had a 30-day mortality risk of 15.2%, whereas patients admitted to a unit with 3.0 nurses/ten beds had a mortality risk of 11.2%, a mortality risk difference equivalent to one excess death per 25 admissions.
What Do These Findings Mean?
These findings show that the provision of stroke specialist physician rounds seven days/week in stroke units in England did not influence the (weak) association between weekend admission for stroke and death recorded in this study, but mortality outcomes after stroke were associated with the intensity of weekend staffing by registered nurses. The accuracy of these findings may be affected by the measure used to judge the level of acute care available in each stroke unit and by residual confounding. For example, patients admitted to units with lower nursing levels may have shared other unknown characteristics that increased their risk of dying after stroke. Moreover, this study considered the impact of staffing levels on mortality only and did not consider other relevant outcomes such as long-term disability. Despite these limitations, these findings support the provision of higher weekend ratios of registered nurses to beds in stroke units, but given the high costs of increasing weekend staffing levels, it is important that controlled trials of different models of physician and nursing staffing are undertaken as soon as possible.
Additional Information
Please access these websites via the online version of this summary at
This study is further discussed in a PLOS Medicine Perspective by Meeta Kerlin
Information about plans to introduce seven-day working into the National Health Service in England is available; the 2013 publication “NHS Services—Open Seven Days a Week: Every Day Counts” provides examples of how hospitals across England are working together to provide routine healthcare services seven days a week; a “Behind the Headlines” article on the UK National Health Service Choices website describes a recent observational study that investigated the association between admission to hospital on the weekend and death, and newspaper coverage of the study's results; the Choices website also provides information about stroke for patients and their families, including personal stories
A US nurses' site includes information on the association of nurse staffing with patient safety
The US National Institute of Neurological Disorders and Stroke provides information about all aspects of stroke (in English and Spanish); its Know Stroke site provides educational materials about stroke prevention, treatment, and rehabilitation, including personal stories (in English and Spanish); the US National Institute of Health SeniorHealth website has additional information about stroke
The Internet Stroke Center provides detailed information about stroke for patients, families, and health professionals (in English and Spanish)
PMCID: PMC4138029  PMID: 25137386
13.  Quantitative and qualitative perceptions of the 2011 residency duty hour restrictions: a multicenter, multispecialty cross-sectional study 
BMC Medical Education  2015;15:57.
July 2011 saw the implementation of the newest duty hour restrictions, further limiting the working hours of first year residents and necessitating a variety of adaptations on the part of residency programs. The present study sought to characterize the perceived impact of these restrictions on residency program personnel using a multi-specialty and multi-site approach.
We developed and administered a survey to internal medicine and general surgery residency programs at three academic medical centers within an urban region. The survey combined quantitative and qualitative components to gain a broader understanding of the impact of the newest regulations. Quantitative responses were compared between Internal Medicine and General Surgery programs with Student t-tests. Other comparisons were performed using ANOVA or Kruskal-Wallis testing as appropriate. For all comparisons, the threshold for significance was set at 0.01. Two independent reviewers coded all qualitative data and assigned one or more themes based on content. Descriptive statistics were calculated and the diversity of themes identified. No between-group comparisons were conducted with the qualitative data.
We found significant differences in the overall perceptions of duty hour restrictions across specialty (internal medicine more positive than general surgery) and across position (first year residents more positive than senior residents and faculty). Notably, individuals who trained at osteopathic medical schools reported significantly more negative views of the duty hour restrictions than those who had trained at allopathic or international medical schools, suggesting an influence of undergraduate medical training. The complementary qualitative data offered insights into the perceived strengths and weaknesses of the duty hour restrictions, as well as actionable suggestions that could help to improve residency program function.
This study characterizes responses to the new duty hour restrictions from a variety of perspectives. Our findings show that individual (type of undergraduate medical education, role in graduate medical education) and program-wide (e.g., specialty) factors contribute to participant satisfaction with DHR. This research highlights the value of a mixed methods approach in the study of duty hour restrictions, with our qualitative arm yielding rich data that complemented and expanded upon the insights derived from the quantitative data.
Electronic supplementary material
The online version of this article (doi:10.1186/s12909-015-0323-4) contains supplementary material, which is available to authorized users.
PMCID: PMC4403846  PMID: 25889722
Residency; Duty hours; Medicine; Surgery; Qualitative; Quantitative; Survey; Intern; Work hours
14.  Teaching Hospital Five-Year Mortality Trends in the Wake of Duty Hour Reforms 
Journal of General Internal Medicine  2013;28(8):1048-1055.
The Accreditation Council for Graduate Medical Education (ACGME) implemented duty hour regulations for residents in 2003 and again in 2011. While previous studies showed no systematic impacts in the first 2 years post-reform, the impact on mortality in subsequent years has not been examined.
To determine whether duty hour regulations were associated with changes in mortality among Medicare patients in hospitals of different teaching intensity after the first 2 years post-reform.
Observational study using interrupted time series analysis with data from July 1, 2000 to June 30, 2008. Logistic regression was used to examine the change in mortality for patients in more versus less teaching-intensive hospitals before (2000–2003) and after (2003–2008) duty hour reform, adjusting for patient comorbidities, time trends, and hospital site.
Medicare patients (n = 13,678,956) admitted to short-term acute care non-federal hospitals with principal diagnoses of acute myocardial infarction (AMI), gastrointestinal bleeding, or congestive heart failure (CHF); or a diagnosis-related group (DRG) classification of general, orthopedic, or vascular surgery.
All-location mortality within 30 days of hospital admission.
In medical and surgical patients, there were no consistent changes in the odds of mortality at more vs. less teaching intensive hospitals in post-reform years 1–3. However, there were significant relative improvements in mortality for medical patients in the fourth and fifth years post-reform: Post4 (OR 0.88, 95 % CI [0.93–0.94]); Post5 (OR 0.87, [0.82–0.92]) and for surgical patients in the fifth year post-reform: Post5 (OR 0.91, [0.85–0.96]).
Duty hour reform was associated with no significant change in mortality in the early years after implementation, and with a trend toward improved mortality among medical patients in the fourth and fifth years. It is unclear whether improvements in outcomes long after implementation can be attributed to the reform, but concerns about worsening outcomes seem unfounded.
PMCID: PMC3710388  PMID: 23592241
patient outcomes; mortality; duty hour reform; ACGME; administrative data
15.  Impact of Resident Duty Hour Limits on Safety in the ICU: A National Survey of Pediatric and Neonatal Intensivists 
Resident duty-hour regulations potentially shift workload from resident to attending physicians. We sought to understand how current or future regulatory changes might impact safety in academic pediatric and neonatal intensive care units (ICUs).
Web-based survey
US academic pediatric and neonatal ICUs
Attending pediatric and neonatal intensivists
We evaluated perceptions on four ICU safety-related risk measures potentially affected by current duty-hour regulations: 1) Attending physician and resident fatigue, 2) Attending physician work-load, 3) Errors (self-reported rates by attending physicians or perceived resident error rates), and 4) Safety culture. We also evaluated perceptions of how these risks would change with further duty hour restrictions.
Measurements and Main Results
We administered our survey between February and April 2010 to 688 eligible physicians, of which 360 (52.3%) responded. Most believed that resident error rates were unchanged or worse (91.9%) and safety culture was unchanged or worse (84.4%) with current duty-hour regulations. Of respondents, 61.9% believed their own work-hours providing direct patient care increased and 55.8% believed they were more fatigued while providing direct patient care. Most (85.3%) perceived no increase in their own error rates currently, but in the scenario of further reduction in resident duty-hours, over half (53.3%) believed that safety culture would worsen and a significant proportion (40.3%) believed that their own error rates would increase.
Pediatric intensivists do not perceive improved patient safety from current resident duty hour restrictions. Policies to further restrict resident duty hours should consider unintended consequences of worsening certain aspects of ICU safety.
PMCID: PMC3427401  PMID: 22614570
Resident duty hours; graduate medical education; Patient Safety; Intensive Care; Pediatrics; Medical Errors
16.  Short- and Long-Term Outcomes in Very Low Birth Weight Infants with Admission Hypothermia 
PLoS ONE  2015;10(7):e0131976.
Neonatal hypothermia remains a common problem and is related to elevated morbidities and mortality. However, the long-term neurodevelopmental effects of admission hypothermia are still unknown. This study attempted to determine the short-term and long-term consequences of admission hypothermia in VLBW preterm infants.
Study Design
This retrospective study measured the incidence and compared the outcomes of admission hypothermia in very low birth weight (VLBW) preterm infants in a tertiary-level neonatal intensive care unit. Infants were divided into the following groups: normothermia (36.5–37.5°C), mild hypothermia (36.0–36.4°C), moderate hypothermia (32.0–35.9°C), and severe hypothermia (< 32°C). We compared the distribution, demographic variables, short-term outcomes, and neurodevelopmental outcomes at 24 months of corrected age among groups.
We studied 341 infants: 79 with normothermia, 100 with mild hypothermia, 162 with moderate hypothermia, and 0 with severe hypothermia. Patients in the moderate hypothermia group had significantly lower gestational ages (28.1 wk vs. 29.7 wk, P < .02) and smaller birth weight (1004 g vs. 1187 g, P < .001) compared to patients in the normothermia group. Compared to normothermic infants, moderately hypothermic infants had significantly higher incidences of 1-min Apgar score < 7 (63.6% vs. 31.6%, P < .001), respiratory distress syndrome (RDS) (58.0% vs. 39.2%, P = .006), and mortality (18.5% vs. 5.1%, P = .005). Moderate hypothermia did not affect neurodevelopmental outcomes at 2 years’ corrected age. Mild hypothermia had no effect on short-term or long-term outcomes.
Admission hypothermia was common in VLBW infants and correlated inversely with birth weight and gestational age. Although moderate hypothermia was associated with higher RDS and mortality rates, it may play a limited role among multifactorial causes of neurodevelopmental impairment.
PMCID: PMC4507863  PMID: 26193370
17.  Developmental outcome of very low birth weight infants in a developing country 
BMC Pediatrics  2012;12:11.
Advances in neonatal care allow survival of extremely premature infants, who are at risk of handicap. Neurodevelopmental follow up of these infants is an essential part of ongoing evaluation of neonatal care. The neonatal care in resource limited developing countries is very different to that in first world settings. Follow up data from developing countries is essential; it is not appropriate to extrapolate data from units in developed countries. This study provides follow up data on a population of very low birth weight (VLBW) infants in Johannesburg, South Africa.
The study sample included all VLBW infants born between 01/06/2006 and 28/02/2007 and discharged from the neonatal unit at Charlotte Maxeke Johannesburg Academic Hospital (CMJAH). Bayley Scales of Infant and Toddler Development Version 111 (BSID) 111 were done to assess development. Regression analysis was done to determine factors associated with poor outcome.
178 infants were discharged, 26 were not available for follow up, 9 of the remaining 152 (5.9%) died before an assessment was done; 106 of the remaining 143 (74.1%) had a BSID 111 assessment. These 106 patients form the study sample; mean birth weight and mean gestational age was 1182 grams (SD: 197.78) and 30.81 weeks (SD: 2.67) respectively. The BSID (111) was done at a median age of 16.48 months. The mean cognitive subscale was 88.6 (95% CI: 85.69 - 91.59), 9 (8.5%) were < 70, mean language subscale was 87.71 (95% CI: 84.85 - 90.56), 10 (9.4%) < 70, and mean motor subscale was 90.05 (95% CI: 87.0 - 93.11), 8 (7.6%) < 70. Approximately one third of infants were identified as being at risk (score between 70 and 85) on each subscale. Cerebral palsy was diagnosed in 4 (3.7%) of babies. Factors associated with poor outcome included cystic periventricular leukomalacia (PVL), resuscitation at birth, maternal parity, prolonged hospitalisation and duration of supplemental oxygen. PVL was associated with poor outcome on all three subscales. Birth weight and gestational age were not predictive of neurodevelopmental outcome.
Although the neurodevelopmental outcome of this group of VLBW infants was within the normal range, with a low incidence of cerebral palsy, these results may reflect the low survival of babies with a birth weight below 900 grams. In addition, mean subscale scores were low and one third of the babies were identified as "at risk", indicating that this group of babies warrants long-term follow up into school going age.
PMCID: PMC3293066  PMID: 22296705
18.  Neonatal Mortality Risk Associated with Preterm Birth in East Africa, Adjusted by Weight for Gestational Age: Individual Participant Level Meta-Analysis 
PLoS Medicine  2012;9(8):e1001292.
In an analysis of four datasets from East Africa, Tanya Marchant and colleagues investigate the neonatal mortality risk associated with preterm birth and how this changes with weight for gestational age.
Low birth weight and prematurity are amongst the strongest predictors of neonatal death. However, the extent to which they act independently is poorly understood. Our objective was to estimate the neonatal mortality risk associated with preterm birth when stratified by weight for gestational age in the high mortality setting of East Africa.
Methods and Findings
Members and collaborators of the Malaria and the MARCH Centers, at the London School of Hygiene & Tropical Medicine, were contacted and protocols reviewed for East African studies that measured (1) birth weight, (2) gestational age at birth using antenatal ultrasound or neonatal assessment, and (3) neonatal mortality. Ten datasets were identified and four met the inclusion criteria. The four datasets (from Uganda, Kenya, and two from Tanzania) contained 5,727 births recorded between 1999–2010. 4,843 births had complete outcome data and were included in an individual participant level meta-analysis. 99% of 445 low birth weight (<2,500 g) babies were either preterm (<37 weeks gestation) or small for gestational age (below tenth percentile of weight for gestational age). 52% of 87 neonatal deaths occurred in preterm or small for gestational age babies. Babies born <34 weeks gestation had the highest odds of death compared to term babies (odds ratio [OR] 58.7 [95% CI 28.4–121.4]), with little difference when stratified by weight for gestational age. Babies born 34–36 weeks gestation with appropriate weight for gestational age had just three times the likelihood of neonatal death compared to babies born term, (OR 3.2 [95% CI 1.0–10.7]), but the likelihood for babies born 34–36 weeks who were also small for gestational age was 20 times higher (OR 19.8 [95% CI 8.3–47.4]). Only 1% of babies were born moderately premature and small for gestational age, but this group suffered 8% of deaths. Individual level data on newborns are scarce in East Africa; potential biases arising due to the non-systematic selection of the individual studies, or due to the methods applied for estimating gestational age, are discussed.
Moderately preterm babies who are also small for gestational age experience a considerably increased likelihood of neonatal death in East Africa.
Please see later in the article for the Editors' Summary.
Editors' Summary
Worldwide, every year around 3.3 million babies die within their first month of life and the proportion of under-five child deaths that are now in the neonatal period (the first 28 days of life) has increased in all regions of the world and is currently estimated at 41%. Of these deaths, over 90% occur in low- and middle-income countries, and a third of all neonatal deaths occur in sub-Saharan Africa. Low birth weight (defined as <2,500 g) is one of the biggest risk factors associated with neonatal deaths but it is the causes of low birth weight, rather than the low weight itself that is thought to lead to neonatal deaths. The two main causes of low birth weight are preterm birth (delivery before 37 weeks gestation) and/or restricted growth in the womb (intra-uterine growth retardation), resulting in babies who are small for their dates (defined as being in the lowest 10% of weight expected for gestational age with reference to a US population).
Why Was This Study Done?
Despite growing international attention focused on neonatal mortality in recent years, the relative importance of low birth weight, small for gestational age, and preterm birth in causing newborn deaths remains unclear. So in this study, the researchers investigated these relationships by calculating the risk of neonatal mortality associated with preterm birth after adjusting for weight for gestational age by conducting a meta-analysis (synthesis of the data) using information from studies reporting neonatal mortality conducted in sub-Saharan Africa.
What Did the Researchers Do and Find?
The researchers identified potential African datasets and selected four out of a possible ten to include in their analysis as these studies included three essential birth outcomes: birth weight; gestational age measured using antenatal ultrasound, or neonatal assessment on the day of birth; and neonatal mortality. These four studies were conducted in Kenya, Tanzania, and Uganda, all in East Africa. The researchers analysed each study separately but also conducted a pooled statistical analysis on all four studies. To give a more detailed analysis, the researchers categorized babies into six groups taking into account whether the babies were moderately preterm (born at 34–36 weeks) or very preterm (born before 34 weeks) and whether their weight was appropriate for their gestational age.
The researchers included a total of 4,843 live births in their analysis and found that overall, 9.2% of babies were low birth weight, 4.0% were preterm, and 20.4% were small for gestational age. Amongst low birth weight babies, 26.1% were preterm, 85.0% were small for gestational age, and 98.8% were either preterm or small for gestational age. In their detailed analysis, the researchers found that the odds (chance) of death in the first 28 days of life were seven times higher for babies born low birth weight compared to those with normal birth weight, with low birth weight infants experiencing a neonatal mortality rate of 80.9/1,000 live births. The odds of death were twice as high for babies born small for gestational age compared to those born appropriate for gestational age, giving a neonatal mortality rate of 29.3/1,000 live births. Furthermore, compared to those born at term, the odds of death were over six times higher for babies born moderately preterm and almost 60 times higher for babies born very preterm with almost half of all very preterm babies dying in the first 28 days of life, giving a neonatal mortality rate 473.6/1,000 live births. However, moderately preterm babies who were small for gestational age had a much greater odds of death than moderately preterm babies who were of the appropriate weight for their gestational age.
What Do These Findings Mean?
These findings from East Africa show that babies born either small for gestational age or preterm contributed 52% of neonatal deaths. The detailed analysis suggests that babies born preterm are at the greatest risk of death, but size for gestational age also plays an important role especially in moderately preterm babies. The results from this study emphasize the pressing need to find ways to prevent preterm delivery and intra-uterine growth retardation and also illustrate the importance of measuring and reporting outcomes of individual babies.
Additional Information
Please access these Web sites via the online version of this summary at
A recent PLOS Medicine study by Oestergaard et al. has the latest global figures on neonatal mortality
UNICEF provides information on neonatal mortality
The World Health Organization (WHO) provides factsheets on the causes of neonatal mortality, including preterm birth
PMCID: PMC3419185  PMID: 22904691
19.  Increased Birth Weight Associated with Regular Pre-Pregnancy Deworming and Weekly Iron-Folic Acid Supplementation for Vietnamese Women 
Hookworm infections are significant public health issues in South-East Asia. In women of reproductive age, chronic hookworm infections cause iron deficiency anaemia, which, upon pregnancy, can lead to intrauterine growth restriction and low birth weight. Low birth weight is an important risk factor for neonatal and infant mortality and morbidity.
We investigated the association between neonatal birth weight and a 4-monthly deworming and weekly iron-folic acid supplementation program given to women of reproductive age in north-west Vietnam. The program was made available to all women of reproductive age (estimated 51,623) in two districts in Yen Bai Province for 20 months prior to commencement of birth weight data collection. Data were obtained for births at the district hospitals of the two intervention districts as well as from two control districts where women did not have access to the intervention, but had similar maternal and child health indicators and socio-economic backgrounds. The primary outcome was low birth weight.
Principal Findings
The birth weights of 463 infants born in district hospitals in the intervention (168) and control districts (295) were recorded. Twenty-six months after the program was started, the prevalence of low birth weight was 3% in intervention districts compared to 7.4% in control districts (adjusted odds ratio 0.29, 95% confidence interval 0.10 to 0.81, p = 0.017). The mean birth weight was 124 g (CI 68 - 255 g, p<0.001) greater in the intervention districts compared to control districts.
The findings of this study suggest that providing women with regular deworming and weekly iron-folic acid supplements before pregnancy is associated with a reduced prevalence of low birth weight in rural Vietnam. The impact of this health system-integrated intervention on birth outcomes should be further evaluated through a more extensive randomised-controlled trial.
Author Summary
Low birth weight is an important risk factor for neonatal and infant morbidity and mortality and may impact on growth and development. Maternal iron deficiency anaemia contributes to intrauterine growth restriction and low birth weight. Hookworm infections and an iron-depleted diet may lead to iron deficiency anaemia, and both are common in many developing countries. A pilot program of deworming and weekly iron-folic acid supplementation for non-pregnant women aiming to prevent iron deficiency was implemented in northern Vietnam. We compared the birth weight of babies born to women who had had access to the intervention to babies born in districts where the intervention had not been implemented. The mean birth weight of the intervention districts' babies was 124 g more than the control districts' babies; the prevalence of low birth weight was also reduced. These results suggest that providing women with deworming and weekly iron-folic acid supplements before pregnancy is associated with increased birth weight in rural Vietnam. This intervention was provided as a health system integrated program which could be replicated in other at-risk rural areas. If so it could increase the impact of prenatal and antenatal programs, improving the health of both women and newborns.
PMCID: PMC3317901  PMID: 22509421
20.  Effects of the 2011 Duty Hour Reforms on Interns and Their Patients: A Prospective Longitudinal Cohort Study 
JAMA internal medicine  2013;173(8):657-663.
In 2003, the first phase of duty hour requirements for U.S. residency programs recommended by the Accreditation Council for Graduate Medical Education (ACGME) was implemented. Evidence suggests that this first phase of duty hour requirements resulted in a modest improvement in resident wellbeing and patient safety. To build on these initial changes, the ACGME recommended a new set of duty hour requirements that took effect in July 2011. We sought to determine the effects of the 2011 duty hour reforms on first year residents (interns) and their patients.
We conducted alongitudinal cohort study of 2323 interns entering one of 51 residency programs at 14 university and community-based GME institutions or graduating from one of four medical schools participating in the study. We compared self-reported duty hours, hours of sleep, depressive symptoms, well-being and medical errors at 3, 6, 9 and 12 months of the internship year between interns serving before (2009 and 2010) and interns serving after (2011) the implementation of the new duty-hour requirements.
58% of invited interns chose to participate in the study. Reported duty hours decreased from an average of 67.0 hours/week before the new rules to 64.3 hours/week after the new rules were instituted (p<0.001). Despite the decrease in duty hours, there were no significant changes in hours slept (7.0→6.8; p=0.17), depressive symptoms (5.8→5.7; p=NS) or well-being (48.5→48.4; p=0.86) reported by interns. With the new duty hour rules, the percentage of interns who reported committing a serious medical error increased from 19.9% to 23.3% (p=0.007).
Although interns report working fewer hours under the new duty hour restrictions, this decrease has not been accompanied by an increase in hours of sleep or an improvement in depressive symptoms or wellbeing but has been accompanied by an unanticipated increase in self-reported medical errors under the new duty hour restrictions.
PMCID: PMC4016974  PMID: 23529201
Graduate; Medical; Education; Residency; Work; Hours; Sleep
21.  Shifting perceptions: a pre-post study to assess the impact of a senior resident rotation bundle 
BMC Medical Education  2013;13:115.
Extended duty hours for residents are associated with negative consequences. Strategies to accommodate duty hour restrictions may also have unintended impacts. To eliminate extended duty hours and potentially lessen these impacts, we developed a senior resident rotation bundle that integrates a night float system, educational sessions on sleep hygiene, an electronic handover tool, and a simulation-based medical education curriculum. The aim of this study was to assess internal medicine residents’ perceptions of the impact of the bundle on three domains: the senior residents’ wellness, ability to deliver quality health care, and medical education experience.
This prospective study compared eligible residents’ experiences (N = 67) before and after a six-month trial of the bundle at a training program in western Canada. Data was collected using an on-line survey. Pre- and post-intervention scores for the final sample (N = 50) were presented as means and compared using the t-test for paired samples.
Participants felt that most aspects of the three domains were unaffected by the introduction of the bundle. Four improved and two worsened perception shifts emerged post-intervention: less exposure to personal harm, reduced potential for medical error, more successful teaching, fewer disruptions to other rotations, increased conflicting role demands and less staff physician supervision.
The rotation bundle integrates components that potentially ease some of the perceived negative consequences of night float rotations and duty hour restrictions. Future areas of study should include objective measures of the three domains to validate our study participants’ perceptions.
PMCID: PMC3766268  PMID: 23987729
22.  The Impact of ACGME Work-Hour Reforms on the Operative Experience of Fellows in Surgical Subspecialty Programs 
In July 2003, the Accreditation Council for Graduate Medical Education (ACGME) introduced a set of regulations that mandated a reduction in the number of hours that medical residents can work. These requirements have generated controversy among medical educators, with some expressing concern that reducing resident hours may limit clinical exposure and competency, particularly in surgical specialties.
This study examines the impact of duty hour restrictions on resident operative experience in residents in 2 surgical subspecialties since the implementation of the ACGME duty hour limits.
We examined operative log data for vascular surgery and pediatric surgery, using the academic year immediately preceding the duty hour restrictions, 2002 to 2003, as a baseline for comparison to subsequent academic years through 2006 to 2007 for vascular surgery and 2007 to 2008 for pediatric surgery.
Graduating fellows in pediatric surgery showed no change in their total operative volume following duty hour restrictions. The pediatric-defined category of neonate procedures showed an increase following duty hour restrictions. Graduating fellows in vascular surgery showed an increase in total major procedures as surgeon. The vascular-defined categories of endovascular-diagnostic, endovascular-therapeutic, and endovascular-graft procedures also increased.
The reduction of duty hours has not resulted in a decrease in operative volume as some have predicted. Operative volume in pediatric surgery remained mainly unchanged, whereas operative volume in vascular surgery increased. We explore possible explanations for the observed findings.
PMCID: PMC3186271  PMID: 22379533
23.  Resident Duty Hours: A Survey of Internal Medicine Program Directors 
Journal of General Internal Medicine  2014;29(10):1349-1354.
In 2011, the Accreditation Council for Graduate Medical Education (ACGME) implemented new Common Program Requirements to regulate duty hours of resident physicians, with three goals: improved patient safety, quality of resident education and quality of life for trainees. We sought to assess Internal Medicine program director (IMPD) perceptions of the 2011 Common Program Requirements in July 2012, one year following implementation of the new standards.
A cross-sectional study of all IMPDs at ACGME-accredited programs in the United States (N = 381) was performed using a 32-question, self-administered survey. Contact information was identified for 323 IMPDs. Three individualized emails were sent to each director over a 6-week period, requesting participation in the survey. Outcomes measured included approval of duty hours regulations, as well as perceptions of changes in graduate medical education and patient care resulting from the revised ACGME standards.
A total of 237 surveys were returned (73 % response rate). More than half of the IMPDs (52 %) reported “overall” approval of the 2011 duty hour regulations, with greater than 70 % approval of all individual regulations except senior resident daily duty periods (49 % approval) and 16-hour intern shifts (17 % approval). Although a majority feel resident quality of life has improved (55 %), most IMPDs believe that resident education (60 %) is worse. A minority report that quality (8 %) or safety (11 %) of patient care has improved.
One year after implementation of new ACGME duty hour requirements, IMPDs report overall approval of the standards, but strong disapproval of 16-hour shift limits for interns. Few program directors perceive that the duty hour restrictions have resulted in better care for patients or education of residents. Although resident quality of life seems improved, most IMPDs report that their own workload has increased. Based on these results, the intended benefits of duty hour regulations may not yet have been realized.
Electronic supplementary material
The online version of this article (doi:10.1007/s11606-014-2912-z) contains supplementary material, which is available to authorized users.
PMCID: PMC4175662  PMID: 24913004
graduate medical education; resident duty hours; compliance; patient safety
24.  Blood Transfusion and Breast Milk Transmission of Cytomegalovirus in Very Low Birth Weight Infants 
JAMA pediatrics  2014;168(11):1054-1062.
Postnatal cytomegalovirus (CMV) infection can cause serious morbidity and mortality in very low birth weight (VLBW) infants. The primary sources of postnatal CMV infection in this population are breast milk and blood transfusion. The current risks attributable to these vectors, and the efficacy of approaches to prevent CMV transmission, are poorly characterized.
To estimate the risk of postnatal CMV transmission from 2 sources: 1) transfusion of CMV-seronegative and leukoreduced blood and 2) maternal breast milk.
Prospective, multicenter birth-cohort study conducted from January 2010 to June 2013. CMV serologic testing of enrolled mothers was performed to determine their status. CMV nucleic acid testing (NAT) of transfused blood components and breast milk was performed to identify sources of CMV transmission. Enrolled VLBW infants underwent serum and urine CMV NAT testing at birth, to evaluate congenital infection, and surveillance CMV NAT testing at 5 additional intervals between birth and 90 days, discharge or death.
Three neonatal intensive care units (2 academically-affiliated and 1 private) in Atlanta, Georgia.
539 VLBW infants (birth weight ≤1500 grams) who had not received a blood transfusion were enrolled, with their mothers, within 5 days of birth.
Blood transfusion and breast milk feeding
Main Outcomes and Measures
Cumulative incidence of postnatal CMV infection, detected by serum or urine NAT.
CMV positive sero-prevalence among enrolled mothers was 76% (352/462). Among 539 enrolled VLBW infants, the cumulative incidence of postnatal CMV infection at 12 weeks was 6.9% (95% CI: 4.2%–9.2%); five infants with postnatal CMV infection developed symptomatic disease or died. Although 58% (310/539) of infants received 2061 transfusions, none of the CMV infections were linked to transfusion, resulting in a CMV infection incidence of 0.0% (95%CI: 0.0%–0.3%) per unit of CMV-seronegative and leukoreduced blood. Twenty-seven of 28 postnatal infections occurred among infants fed CMV-positive breast milk (12-week incidence: 15.3%; 95%CI: 9.3%–20.2%).
Conclusions and Relevance
Transfusion of CMV-seronegative and leukoreduced blood products effectively prevents transmission of CMV to VLBW infants. Among infants managed with this transfusion approach, maternal breast milk is the primary source of postnatal CMV infection.
Trial Registration Identifier: NCT00907686
PMCID: PMC4392178  PMID: 25243446
25.  Increased Duration of Paid Maternity Leave Lowers Infant Mortality in Low- and Middle-Income Countries: A Quasi-Experimental Study 
PLoS Medicine  2016;13(3):e1001985.
Maternity leave reduces neonatal and infant mortality rates in high-income countries. However, the impact of maternity leave on infant health has not been rigorously evaluated in low- and middle-income countries (LMICs). In this study, we utilized a difference-in-differences approach to evaluate whether paid maternity leave policies affect infant mortality in LMICs.
Methods and Findings
We used birth history data collected via the Demographic and Health Surveys to assemble a panel of approximately 300,000 live births in 20 countries from 2000 to 2008; these observational data were merged with longitudinal information on the duration of paid maternity leave provided by each country. We estimated the effect of an increase in maternity leave in the prior year on the probability of infant (<1 y), neonatal (<28 d), and post-neonatal (between 28 d and 1 y after birth) mortality. Fixed effects for country and year were included to control for, respectively, unobserved time-invariant confounders that varied across countries and temporal trends in mortality that were shared across countries. Average rates of infant, neonatal, and post-neonatal mortality over the study period were 55.2, 30.7, and 23.0 per 1,000 live births, respectively. Each additional month of paid maternity was associated with 7.9 fewer infant deaths per 1,000 live births (95% CI 3.7, 12.0), reflecting a 13% relative reduction. Reductions in infant mortality associated with increases in the duration of paid maternity leave were concentrated in the post-neonatal period. Estimates were robust to adjustment for individual, household, and country-level characteristics, although there may be residual confounding by unmeasured time-varying confounders, such as coincident policy changes.
More generous paid maternity leave policies represent a potential instrument for facilitating early-life interventions and reducing infant mortality in LMICs and warrant further discussion in the post-2015 sustainable development agenda. From a policy planning perspective, further work is needed to elucidate the mechanisms that explain the benefits of paid maternity leave for infant mortality.
Nandi and colleagues, in a large study analyzing data from 20 countries, show that extended, paid maternity leave effectively reduces infant mortality in LMICs.
Editors' Summary
In 1990, 12 million children—most of them living in low- and middle-income countries (LMICs)—died before their fifth birthday. Out of every 1,000 children born alive, 90 died before they were five years old. In 2000, world leaders set a target of reducing under-five mortality (deaths) to one-third of its 1990 level by 2015 as Millennium Development Goal 4 (MDG4); this goal, together with seven others, was designed to eradicate extreme poverty globally. Over the years, steady progress was made towards MDG4. Better delivery facilities and programs that encouraged breastfeeding, immunization, and other practices that improved the health of young children reduced the global under-five mortality rate. But, by 2015, the rate had only fallen to 43 deaths per 1,000 live births, and 5.9 million children under five died that year from preventable causes such as preterm birth complications, delivery complications, and infections. Nearly half of these deaths occurred among neonates (babies less than 28 days old); three-quarters of them occurred among infants (children less than 1 year old).
Why Was This Study Done?
In high-income countries, paid leave from employment for mothers is associated with reduced neonatal and infant mortality. Many LMICs now have legislation granting paid maternity leave or gender-neutral parental leave. But does paid maternity leave have the same impact on infant health in LMICs as it does in high-income countries? In this quasi-experimental study, the researchers use the difference-in-differences statistical approach to investigate whether paid maternity leave policies affect infant mortality in LMICs. A quasi-experimental study uses observational data to compare outcomes in a group of people receiving an intervention (the treatment group) with outcomes in a group of people not receiving the intervention (control group); unlike a randomized controlled trial, these groups are not chosen at random. The difference-in-differences approach compares the average change over time in an outcome variable (here, infant mortality) in a treatment group (here, babies born in countries with a change—specifically, an increase—in paid maternity leave duration) with the average change over time in the outcome variable in a control group (here, babies born in countries without a change in paid maternity leave duration).
What Did the Researchers Do and Find?
The researchers assembled a panel of about 300,000 live births in 20 LMICs between 2000 and 2008 using birth history data collected by the Demographic and Health Surveys (which collect information on the demographic, health, and other characteristics of a nationally representative sample of households). The researchers merged these observational data with information on the duration of paid maternity leave provided by each country and used the difference-in-differences approach to estimate the effect of an increase in paid maternity leave duration on the probability of infant (<1 year old), neonatal (<28 days old), and post-neonatal (between 28 days and 1 year old) mortality. Average rates of infant, neonatal, and post-neonatal mortality over the study period were 55.2, 30.7, and 23.0 per 1,000 live births, respectively. Each additional month of paid maternity leave was associated with 7.9 fewer infant deaths per 1,000 live births, a relative reduction in infant mortality of 13%. Notably, the reduction in infant mortality with increased duration of paid maternity leave was concentrated in the post-neonatal period.
What Do These Findings Mean?
These findings suggest that policies that increase the duration of paid maternity leave could help to reduce infant mortality in the 20 LMICs included in this study. These findings may not be generalizable to all LMICs. Moreover, their accuracy may be limited by confounding. That is, unmeasured characteristics—rather than changes in paid maternity leave duration—could be responsible for the observed changes in infant mortality. Although the researchers adjusted for many possible confounders in their analysis, there may be some residual confounding from unmeasured time-varying confounders such as other policy changes made during the study period. Further work is now needed to determine the mechanisms that underlie the observed association between increased duration of paid maternity leave and reduction in infant mortality in LMICs. Paid maternity leave might, for example, improve infant health by giving new mothers time to breastfeed, care for ill babies, or ensure that their babies receive their childhood vaccinations. Finally, before LMICs introduce new policies on paid maternity leave, the optimal balance of paid leave from employment before and after delivery needs to be evaluated.
Additional Information
This list of resources contains links that can be accessed when viewing the PDF on a device or via the online version of the article at
The World Health Organization (WHO) provides information on child health and child mortality, and on global efforts to reduce child mortality (available in several languages); its 2009 publication Home Visits for the Newborn child: A Strategy to Improve Survival is available
The United Nations Children’s Fund (UNICEF) works for children’s rights, survival, development, and protection around the world; it provides information about the failure to meet MDG4 and a link to a 2015 report on global levels and trends in child mortality; its UNICEF data website provides further detailed statistics about child health and mortality
The Millennium Development Goals 2015 Report is available
The Healthy Newborn Network is an online community of more than 80 partner organizations that addresses critical knowledge gaps in newborn health
Wikipedia has pages on paid parental leave around the world, quasi-experiments, and the difference-in-differences analytical approach (note that Wikipedia is a free online encyclopedia that anyone can edit; available in several languages)
PMCID: PMC4811564  PMID: 27022926

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