Current Resources for Evidence‐Based Practice January/February 2013

Abstract

Published simultaneously in the Journal of Midwifery & Women's Health, 58(1). The randomized clinical trial is considered the gold standard research methodology for answering questions about the effectiveness of specific health care interventions because that design reduces the likelihood of bias. Randomization decreases bias by assigning study participants to intervention or control groups by chance rather than choice and creating study groups that are comparable at baseline. However, some questions cannot be answered by randomized trials. Therefore, the Cochrane Collaboration includes the Non‐Randomised Studies Methods Group (NRSMG) to provide guidance about the use of non‐randomized studies for inclusion in reviews of effectiveness of health care interventions. Because the potential for bias is greater for non‐randomized studies, review authors must pay more attention to study designs, assessment of bias, and how confounders and heterogeneity (differences in study methodology) are examined across studies evaluated for inclusion (Reeves et al., 2008Reeves B.C. Deeks J.J. Higgins J.P.T. Wells G.A. Including non‐randomized studies.in: Higgins J.P.T. Green S. Cochrane handbook for systematic reviews of interventions. John Wiley & Sons, Ltd, Chichester, UK2008: 13.1-13.34Crossref Scopus (540) Google Scholar). The following review of exclusive breastfeeding included randomized and non‐randomized studies. Health benefits of breastfeeding are well known, and breastfeeding can be lifesaving in developing countries. However, the ideal duration of exclusive breastfeeding remains controversial. Previous recommendations have been to begin to introduce solid food between four and six months of age; these recommendations have been applied universally with less focus on carefully observing each infant's growth and intervening as needed. In a recent Cochrane review Kramer and Kakuma, 2012Kramer M.S. Kakuma R. Optimal duration of exclusive breastfeeding.Cochrane Database of Systematic Reviews. 2012; 8: CD003517https://doi.org/10.1002/14651858.CD003517.pub2Crossref PubMed Scopus (692) Google Scholar examined the effect of six months of exclusive breastfeeding compared to three to four months of exclusive breastfeeding followed by ongoing breastfeeding and solid food (mixed breastfeeding) on child health, growth, development, and maternal health. A secondary purpose of the review was to assess the effects of exclusive breastfeeding for more than six months compared with exclusive breastfeeding for six months on maternal and infant health. This review included controlled clinical trials and observational studies reported in all languages that examined the impact of exclusive breastfeeding to six months on growth, development, morbidity, and mortality of healthy term infants and their mothers. Studies included were required to have an internal control group to compare three to four months exclusive breastfeeding followed by liquid or solid food introduction and mixed breastfeeding to at least six months. Studies that compared infants exclusively breastfed for more than six months with those exclusively breastfed for six months were included. Cochrane criteria were applied to assess the quality of studies. Twenty‐three studies, 11 conducted in developing countries and 12 from developed countries, were included. Comparisons included the following: controlled trials of exclusive breastfeeding for 4–6 months compared to mixed breastfeeding in developing countries; observational studies of exclusive vs. mixed breastfeeding for 3–7 months in developing countries; observational studies of exclusive breastfeeding for more than 6 months vs. mixed breastfeeding in developing countries; observational studies of exclusive vs. mixed breastfeeding for 3–7 months in developed countries; and observational studies of exclusive breastfeeding for more than 6 months vs. mixed breastfeeding in developed countries. None of the studies, controlled trials or observational, showed that infants exclusively breastfed for six months had deficits in weight or length between 4–7 months or after 7 months. However, because of the large sample size required to demonstrate an effect, it was not possible to rule out a modestly increased risk of under‐nutrition with exclusive breastfeeding for 6 months. The data were inadequate to draw any conclusions about exclusive breastfeeding longer than six months. Infants exclusively breastfed for at least 6 months had lower risk for gastrointestinal and respiratory illnesses. Although data were conflicting, exclusive breastfeeding for six months without infant iron supplementation in countries where mothers may have lower iron stores may lead to poorer newborn hematologic status in infants by 6 months. Significant reductions in eczema, asthma, and other atopic conditions were observed. Mothers who breastfed exclusively for six months had delayed menses, and the contraceptive effect of exclusive breastfeeding was an additional benefit, particularly in developing countries. In addition, mothers who breastfed exclusively experienced more rapid weight loss, a potential advantage in developed countries but not as much of an advantage for lower weight women in developing countries. Practical implications of this review include encouraging exclusive breastfeeding to six months in both developing and developed countries with the possible exception of situations where mothers are at risk for low iron status. The authors reminded clinicians to manage infants on an individual basis so that any potential adverse effects or reductions in growth are not missed. In the future, larger studies, particularly randomized controlled trials, will assist in assessing the risk of malnutrition in developing countries. Based on the broad evidence base supporting breastfeeding, Healthy People 2020 (U.S. Department of Health and Human Services, 2011aU.S. Department of Health and Human Services Healthy people 2020. Maternal, infant and child health. Author, Washington, DC2011http://www.healthypeople.gov/2020/topicsobjectives2020/objectiveslist.aspx?topicId=26Google Scholar) includes the goals of increasing breastfeeding initiation in the United States and increasing the proportion of infants breastfed exclusively for 3 and 6 months. This review adds to the evidence encouraging exclusive breastfeeding for 6 months. In January 2011, the U.S. Surgeon General released The Surgeon General's Call to Action to Support Breastfeeding (U.S. Department of Health and Human Services, 2011bU.S. Department of Health and Human Services The surgeon general's call to action to support breastfeeding. Author, Washington, DC2011http://www.surgeongeneral.gov/library/calls/breastfeeding/index.htmlGoogle Scholar) calling for increased support and removal of barriers for breastfeeding women. Specific actions are suggested for mothers and their families, communities, employers and the health care system. Clinicians can find the report and related helpful breastfeeding resources at http://www.hhs.gov/news/press/2011pres/01/20110120a.html •Azithromycin versus penicillin G benzathine for early syphilis•Genital ulcer disease treatment for reducing sexual acquisition of HIV•Topical microbicides for prevention of sexually transmitted infections•Toremifene versus tamoxifen for advanced breast cancer •Antispasmodics for labor•Effect of partogram use on outcomes for women in spontaneous labor at term•Exercise for pregnant women for preventing gestational diabetes mellitus•Hypnosis during pregnancy, childbirth, and the postnatal period for preventing postnatal depression•Immediate versus deferred delivery of the preterm baby with suspected fetal compromise for improving outcomes•Intermittent oral iron supplementation during pregnancy•Pulmonary artery flow catheters for directing management in pre‐eclampsia•Relaxation therapy for preventing and treating preterm laborSpecialized antenatal clinics for women with a multiple pregnancy for improving maternal and infant outcomes•Symphysial fundal height (SFH) measurement in pregnancy for detecting abnormal fetal growth •Antibiotic regimens for the empirical treatment of newborn infants with necrotizing enterocolitis•Body positioning for spontaneously breathing preterm infants with apnea•Telemedicine for the support of parents of high‐risk newborn infants •Adjuvant platinum‐based chemotherapy for early stage cervical cancer•Antiretroviral pre‐exposure prophylaxis (PrEP) for preventing HIV in high‐risk individuals•Chemotherapy versus surgery for initial treatment in advanced ovarian epithelial cancer•Education for contraceptive use by women after childbirth•Hormone therapy in postmenopausal women and risk of endometrial hyperplasia•Interventions for emergency contraception•Open retropubic colposuspension for urinary incontinence in women •Abdominal decompression for suspected fetal compromise/pre‐eclampsia•Abdominal decompression in normal pregnancy•Alternative versus conventional institutional settings for birth•Biochemical tests of placental function for assessment in pregnancy•Caesarean section versus vaginal delivery for preterm birth in singletons•Different intensities of glycaemic control for pregnant women with pre‐existing diabetes•Expedited versus conservative approaches for vaginal delivery in breech presentation•Induction of labor for improving birth outcomes for women at or beyond term•Operative versus conservative management for ‘fetal distress’ in labor•Piracetam for fetal distress in labor•Pneumococcal vaccination during pregnancy for preventing infant infection•Prostaglandins for preventing postpartum hemorrhage•Regimens of fetal surveillance for impaired fetal growth•Traditional birth attendant training for improving health behaviors and pregnancy outcomes•Zinc supplementation for improving pregnancy and infant outcome •Allopurinol for preventing mortality and morbidity in newborn infants with hypoxic‐ischemic encephalopathy•Antifungal therapy for newborn infants with invasive fungal infection•Bronchodilators for the prevention and treatment of chronic lung disease in preterm infants•Cromolyn sodium for the prevention of chronic lung disease in preterm infants•Optimal duration of exclusive breastfeeding•Effect of restricted pacifier use in breastfeeding term infants for increasing duration of breastfeeding•Effect of timing of umbilical cord clamping and other strategies to influence placental transfusion at preterm birth on maternal and infant outcomes•First‐line chemotherapy in low‐risk gestational trophoblastic neoplasia•Intravenous midazolam infusion for sedation of infants in the neonatal intensive care unit•Intraventricular antibiotics for bacterial meningitis in neonates•Surfactant for pulmonary hemorrhage in neonates •Assessing the risk of venous thromboembolic events in women taking progestin‐only contraception: a meta‐analysis•Cranberry‐containing products for prevention of urinary tract infections in susceptible populations•Treatment of hyperprolactinemia: a systematic review and meta‐analysis •Accuracy of single progesterone test to predict early pregnancy outcome in women with pain or bleeding: meta‐analysis of cohort studies•Diagnostic accuracy of spot urinary protein and albumin to creatinine ratios for detection of significant proteinuria or adverse pregnancy outcome in patients with suspected pre‐eclampsia: systematic review and meta‐analysis•Elective single embryo transfer and perinatal outcomes: a systematic review and meta‐analysis•The effectiveness of antenatal interventions to prevent postnatal depression in high‐risk women•Treatment with magnesium sulfate in pre‐term birth: a systematic review and meta‐analysis of observational studies•Universal voluntary HIV testing in antenatal care settings: a review of the contribution of provider‐initiated testing and counseling •Can home monitoring reduce mortality in infants at increased risk of sudden infant death syndrome? A systematic review•Probiotic supplement reduces risk of necrotizing enterocolitis and mortality in preterm very low‐birth‐weight infants: an updated meta‐analysis of 20 randomized, controlled trials•Pulse oximetry screening for critical congenital heart defects in asymptomatic newborn babies: a systematic review and meta‐analysis Featured Review: Nelson, H. D., M, Zakher, B, & Mitchell, J. (2012) Menopausal hormone therapy for the primary prevention of chronic conditions: A systematic review to update the U.S. preventive services task force recommendations. Annals of Internal Medicine, 157, 104–113. This systematic review was completed to update previous recommendations by the U.S. Preventive Services Task Force (USPSTF) related to the use of menopausal hormonal therapy, including estrogen or estrogen combined with progestin to prevent chronic conditions. In previous USPSTF reviews, recommendations were made against the use of estrogen combined with progestin (2002) or estrogen alone (2005) for the prevention of chronic conditions because initial results of the Women's Health Initiative (WHI) trials demonstrated adverse effects on women's health. The authors examined benefits and harms of menopausal hormone therapy for postmenopausal women eligible for hormone therapy. Fifty‐one articles from nine randomized controlled trials involving more than 31,000 women were included in this review. Benefits included less invasive breast cancer and breast cancer mortality among women who received estrogen only. Women who received estrogen and progestin had less colorectal cancer in one trial although not in another. The incidence of diabetes was lower for women receiving estrogen plus progestin in two trials but not for those receiving estrogen only. In two trials, hip, vertebral, and total fractures were reduced for estrogen only and estrogen plus progestin; these results were not observed in another trial. Lung, endometrial, ovarian and cervical cancers were not increased for women receiving estrogen and progestin; lung cancer was not increased in the estrogen only trial. All‐cause mortality was not increased for estrogen only or estrogen plus progestin trials. Harms of hormonal therapy were also observed. Invasive breast cancer was increased in the estrogen plus progestin trial. Women who received estrogen plus progestin had more abnormal mammography results such as larger tumors and more advanced stages of cancer. Women receiving estrogen and progestin (but not estrogen only) had an increase in coronary heart disease (CHD) such as non‐fatal myocardial infarction and CHD death. Stroke and thromboembolic events (pulmonary embolus and deep vein thrombosis) were increased for estrogen only and estrogen plus progestin groups. Deaths from breast cancer among women receiving estrogen plus progestin were increased and were increased for lung cancer. Gallbladder disease was increased for women receiving estrogen and progestin and estrogen only. Dementia measures were increased for women receiving estrogen and progestin and urinary incontinence was increased for women in both hormonal treatment groups. Comment: The review was limited by the small number of trials, although the total number of women participating in the trials was large. Trials were rated of fair quality primarily because of high attrition or low adherence to medications. Applicability of the review is limited as most participating women were 60 to 69 years of age. Reviewers concluded that estrogen and estrogen plus progestin decreased fracture risk and increased risk for stroke, gallbladder disease, urinary incontinence, and thromboembolic events. Breast cancer risk and probable dementia risk are increased with estrogen plus progestin, and estrogen alone decreased breast cancer risk. Future research should include women during or immediately after the menopause transition. Research is also needed on long‐term outcomes, including cancer and mortality, to better understand the effects of menopausal hormone therapy. The USPSTF updated its 2002 and 2005 recommendations October 23, 2012 and continues to recommend against estrogen plus progestin and estrogen alone for the prevention of chronic conditions in postmenopausal women. These recommendations are for average risk postmenopausal women and do not apply to the use of hormone therapy for menopausal symptoms (U.S. Preventative Services Task Force, 2012U.S. Preventative Services Task Force Menopausal hormone therapy for the primary prevention of chronic conditions. Author, Rockville, MD2012http://www.uspreventiveservicestaskforce.org/uspstf12/menohrt/menohrtfinalrstab1-2.htmGoogle Scholar). Featured review: Tuuli, M. G., Frey, H. A., Odibo, A. O., Macones, G. A., & Cahill, A. G. (2012). Immediate compared with delayed pushing in the second stage of labor: A systematic review and meta‐analysis. Obstetrics & Gynecology, 120(3), 660–668. In previous studies researchers have examined the effects of delayed pushing in the second stage of labor, often referred to as laboring down, compared with immediate pushing once complete cervical dilatation is determined. The optimal time to encourage women to begin pushing has not been firmly established, particularly when epidural anesthesia is used. The authors of this updated systematic review and meta‐analysis synthesized data from existing trials that compared immediate with delayed pushing in second stage labor. The primary outcome they examined was spontaneous vaginal birth. Only randomized controlled trials (RCTs) were included, and the quality of studies was determined based on three criteria: a valid method of randomization, complete follow‐up with loss of less than 10% of participants, and the use of intention‐to‐treat analysis. Twelve RCTs, which included 1531 women who began pushing immediately and 1584 who delayed pushing upon complete dilatation, were selected for this review. One study included both multiparas and primigravid women; the remaining studies included only primigravid women. Regional anesthesia was used in all studies. Of the studies, nine were assessed as high quality and three as lower quality for not meeting one or more of the criteria. The authors also assessed studies for applicability to modern obstetrics using the rate of operative vaginal birth and determined that the rates were very high (>30% in 7 of 12 studies) compared to national data. Delayed pushing was associated with a higher rate of spontaneous vaginal birth; however, when only the nine high‐quality studies were examined, the difference was smaller and not statistically significant. When parity was accounted for, spontaneous vaginal birth was higher among primigravidas who delayed pushing as well as multiparas (only one study). There was no difference in cesarean birth between immediate and delayed pushing groups; three studies did not include any cesarean births. No significant difference in instrumental births was observed between immediate and delayed pushing groups; however, a decrease in instrumental births for primigravidas but not multiparas was observed when data were stratified on parity. Total length of second stage was increased by 57 minutes for women who delayed pushing, and active pushing was reduced by 20 minutes in all 12 studies included. Fever occurred nearly twice as often among women who delayed pushing in the largest study, and the increase was observed in a dose response manner. Apgar scores were not different between the two groups. Comment: The authors discussed their results in relationship to a prior meta‐analysis that showed increased spontaneous vaginal birth with delayed pushing. In their current review, spontaneous vaginal birth was not different between women with regional anesthesia randomized to immediate vs delayed pushing groups when only studies evaluated as high‐quality were included. However, spontaneous vaginal birth was higher among primigravid women when stratified by parity. Effects of delayed pushing on other maternal and neonatal outcomes could not be determined because of heterogeneity among studies. Increased total duration of second stage labor and shorter active pushing in the delayed pushing groups were new findings in this review and meta‐analysis. 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Simulation based learning in midwifery education: A systematic review. Women & Birth: Journal of the Australian College of Midwives, 25(2), 64–78. Melissa D. Avery, PhD, CNM, FACNM, FAAN is professor and chair, Child and Family Health Co‐operative Unit, University of Minnesota, School of Nursing, Minneapolis, MN.