The third annual Zynx Health Conference will feature case studies from a wide range of Zynx clients including Alegent Health, Ascension Health, Catholic Healthcare West, Memorial Hermann Healthcare, PinnacleHealth, and Vanderbilt University Medical Center. In addition, the keynote speaker will be bestselling author and journalist Malcolm Gladwell (“The Tipping Point,” “Blink”). Space is limited, so please register early. The conference will take place May 9-11 at the Don CeSar Resort in St. Pete Beach, Florida.

Click here for full details on conference logistics, accommodations, and the registration process.

Keep your quality improvement initiatives up-to-date, and enhance your use of Zynx Health evidence-based tools by incorporating new findings from the latest medical literature.

SCREENING MAMMOGRAPHY MAY REDUCE BREAST CANCER MORTALITY IN WOMEN 40 TO 49 YEARS OF AGE BUT DOES NOT BENEFIT THIS PATIENT GROUP AS MUCH AS IT DOES WOMEN 50 YEARS AND OLDER
Qaseem A, Snow V, Sherif K, Aronson M, Weiss KB, Owens DK. Screening mammography for women 40 to 49 years of age: a clinical practice guideline from the American College of Physicians. Ann Intern Med. 2007;146:511-515. PubMed ID: 17404353.

INTRODUCTION: The American Cancer Society and the American College of Obstetricians and Gynecologists recommend that women 40 to 49 years of age have regular screening mammography, but questions have been raised about the reliability of data showing that the procedure is associated with a 15% reduction in breast cancer deaths in this age group. Consequently, Qaseem and colleagues, writing for the Clinical Efficacy Assessment Subcommittee of the American College of Physicians, developed a clinical practice guideline. The guideline was developed for the purpose of enhancing clinicians’ understanding of the risks and benefits of screening mammography for women in this age group, and for the purpose of providing recommendations for clinicians who advise patients on whether or not to undergo this procedure.

SUMMARY: A guideline from the Clinical Efficacy Assessment Subcommittee of the American College of Physicians examines the evidence concerning the risks and benefits of screening mammography and provides recommendations for the procedure’s use in women 40 to 49 years of age. According to the authors, screening mammography in this age group remains a topic of debate—a debate that the authors believe stems from variance in findings of recent meta-analyses. According to the authors, only 3 of the 8 currently published meta-analyses on this subject demonstrate a significant reduction in breast cancer mortality rates from screening mammography in women 40 to 49 years of age. The most recent meta-analysis found that performing screening mammography every 1 to 2 years in this age group leads to a 15% reduction in breast cancer mortality after 14 years of follow-up (relative risk 0.85; 95% confidence interval [CI], 0.73-0.99). The risks of mammography covered by the authors include false-positive results, procedure-related pain, radiation exposure, and diagnosis of cancer that would not have manifested clinically during the patient’s lifetime. The authors point to a wide range of findings with regard to false-positive rates. Outcomes associated with false-positive screenings include perceived increased susceptibility to breast cancer, and small increases in general depression and anxiety, although the authors report that anxiety generally resolves quickly after evaluation. The authors point out that no evidence directly links cancer with mammography-related radiation exposure. The guideline’s recommendations for screening mammography in women 40 to 49 years of age include the following:

(1) Clinicians should perform periodic, individualized assessments of breast cancer risk in order to guide decisions about screening mammography.

(2) Clinicians should inform their patients about screening mammography’s potential benefits and harms.

CONCLUSION: The authors conclude that women 40 to 49 years of age do not benefit from screening mammography as much as women 50 years and older, but the procedure probably reduces breast cancer mortality in the younger age group. The authors note, however, that decisions about performing a screening mammography should be individually tailored to reflect each woman’s risk profile for breast cancer as well as her concerns about the procedure itself.

Class of Evidence: E (ie, a Guideline or Expert Opinion)

ANTICOAGULANT THERAPY RESULTS IN A REDUCTION IN RECURRENT STROKE BUT DOES NOT REDUCE THE RISK OF DEATH OR DISABILITY IN PATIENTS WITH ACUTE CARDIOEMBOLIC STROKE
Paciaroni M, Agnelli G, Micheli S, Caso V. Efficacy and safety of anticoagulant treatment in acute cardioembolic stroke: a meta-analysis of randomized controlled trials. Stroke. 2007;38:423-430. PubMed ID: 17204681.

INTRODUCTION: According to Paciaroni and colleagues, heparinoids have received wide acceptance in clinical practice despite the controversy surrounding the role of immediate anticoagulation in the treatment of acute cardioembolic stroke. The authors note that no definitive data have been obtained regarding the impact of anticoagulants on early stroke recurrence or functional outcome. Therefore, Paciaroni et al conducted a meta-analysis to assess both the safety and efficacy of anticoagulants as initial therapy for acute cardioembolic stroke.

SUMMARY: Researchers conducted a meta-analysis of 7 trials (n=4,624) in order to clarify the role of anticoagulants in the treatment of acute cardioembolic stroke. Data were obtained by searching MEDLINE, EMBASE, and the Cochrane Library. The analysis included only randomized controlled trials that compared anticoagulants with other therapies or placebo as first-line treatment in patients with objectively diagnosed cardioembolic ischemic stroke. Trials in which randomization occurred more than 48 hours after stroke onset were excluded. The anticoagulant regimens investigated were subcutaneous low-molecular-weight heparins (LMWHs), both subcutaneous and IV unfractionated heparin (UFH), and subcutaneous and IV heparinoids. The primary efficacy outcomes were a composite of disability or death at final follow-up, all strokes within 14 days, early recurrent stroke (within 14 days), and pulmonary embolism. Symptomatic intracranial bleeding was the safety outcome. Results showed that, at final follow-up, anticoagulant therapy was associated with a slight reduction in the composite endpoint of death or disability as compared with other treatments (73.5% versus 73.8%; odds ratio [OR] 1.01; 95% confidence interval [CI], 0.82-1.24; P=0.9). Analysis demonstrated that although anticoagulants were not associated with a significant reduction in early stroke (OR 1.18; 95% CI, 0.74-1.88; P=0.49), they led to a nonsignificant reduction in early recurrent stroke (3.0% versus 4.9%; OR 0.68; 95% CI, 0.44-1.06; P=0.09). Symptomatic intracranial bleeding, however, was significantly increased by anticoagulant therapy (2.5% versus 0.7%; OR 2.89; 95% CI, 1.19-7.01; P=0.02; number needed to harm: 55).

CONCLUSION: The authors conclude that although early anticoagulant therapy results in a nonsignificant reduction in ischemic stroke recurrence in patients with acute cardioembolic stroke, it does not reduce the risk of death or disability in these patients, while increasing their risk of intracranial bleeding.

Class of Evidence: M (ie, a Meta-analysis)

IN PATIENTS WITH EXTENSIVE BUT STABLE CORONARY ARTERY DISEASE, ADDING PERCUTANEOUS CORONARY INTERVENTION TO OPTIMAL MEDICAL THERAPY DOES NOT REDUCE THE INCIDENCE OF MAJOR CARDIOVASCULAR EVENTS
Boden WE, O'Rourke RA, Teo KK, Hartigan PM, Maron DJ, Kostuk WJ, et al (for the COURAGE Trial Research Group). Optimal medical therapy with or without PCI for stable coronary disease. N Engl J Med. 2007;356:1503-1516. PubMed ID: 17387127.

INTRODUCTION: Treatment guidelines for initial management of stable coronary artery disease (CAD) recommend a non-invasive approach with optimal medical therapy, which comprises intensive pharmacologic therapy, lifestyle intervention, and risk factor reduction. However, according to Boden and colleagues, approximately 85% of the percutaneous coronary interventions (PCIs) performed in the United States during 2004 were electively added to initial management of patients with stable CAD. The early use of PCI in stable CAD patients has received limited study, according to the authors, with much of the research conducted prior to current standards of medical management. Consequently, Boden et al conducted a randomized controlled trial evaluating initial management with PCI plus optimal medical therapy as compared with optimal therapy alone in patients with stable CAD.

SUMMARY: A randomized controlled trial (n=2,287) compared an initial strategy of percutaneous coronary intervention (PCI) plus optimal medical therapy versus optimal medical therapy alone with respect to efficacy in reducing the risk of major cardiovascular events in patients with stable coronary artery disease (CAD). Patients included in the trial had significant but stable CAD (at least 70% stenosis in at least 1 proximal epicardial coronary artery and evidence of myocardial ischemia, or at least 80% stenosis in at least 1 coronary artery and classic angina). Patients with persistent Canadian Cardiovascular Society class IV angina were excluded. Participants were randomly assigned to undergo PCI plus optimal medical therapy (n=1,149) or optimal medical therapy only (n=1,138). Optimal medical therapy consisted of intensive pharmacologic treatment and lifestyle intervention. The primary outcome was a composite of all-cause death and nonfatal myocardial infarction (MI). Secondary outcomes were a composite of death, stroke, and MI, as well as hospitalization for acute coronary syndrome. The 2 groups were well matched with regard to baseline characteristics. Results showed that over a median follow-up of 4.6 years, the cumulative primary outcome rates for the PCI and medical therapy groups were 19.0% and 18.5%, respectively (for the PCI group, unadjusted hazard ratio [HR] 1.05; 95% confidence interval [CI], 0.87-1.27; P=0.62). With regard to the secondary outcomes during follow-up, the rates for the composite of stroke, death, and nonfatal MI were 20.0% and 19.5%, respectively (HR 1.05; 95% CI, 0.87-1.27; P=0.62), and for hospitalization due to acute coronary syndromes the respective rates were 12.4% and 11.8% (HR 1.07; 95% CI, 0.84-1.37; P=0.56). The adjudicated MI rates were 13.2% and 12.3%, respectively (HR 1.13; 95% CI, 0.89-1.43; P=0.33). All-cause death rates were 7.6% and 8.3%, respectively (HR 0.87; 95% CI, 0.65-1.16; P=0.38). At 5 years, 74% of PCI-group patients and 72% of those in the medical therapy group were found to be free of angina (P=0.35).

CONCLUSION: The authors conclude that adding PCI to optimal medical therapy does not reduce the incidence of major cardiovascular events, including death and nonfatal MI, in patients with extensive but stable coronary artery disease.

Class of Evidence: A (ie, a Randomized Controlled Trial)

TWO HOURS OF IMMEDIATE POSTBIRTH MOTHER-INFANT SKIN-TO-SKIN CONTACT FACILITATES BREAST-FEEDING
Moore ER, Anderson GC. Randomized controlled trial of very early mother-infant skin-to-skin contact and breastfeeding status. J Midwifery Womens Health. 2007;52:116-125. PubMed ID: 17336817.

INTRODUCTION: According to Moore and Anderson, the first 2 hours after delivery is the optimal time for establishing effective breast-feeding. Due to a surge in the infant of levels of circulating catecholamines that occurs immediately after birth, an infant’s olfactory bulbs become extremely sensitive. As a result, infants who experience skin-to-skin contact with the mother immediately after birth are capable of crawling unaided towards the mother’s nipple, and are able to fasten correctly within about an hour. In order to compare the breast-feeding competency of infants who received early infant-mother skin-to-skin contact with those who did not, Moore and Anderson conducted a randomized controlled trial.

SUMMARY: A randomized controlled trial (n=20) compared maternal-infant skin-to-skin contact with standard care (ie, swaddling in a blanket) to assess breast-feeding outcomes during the first month of the infant’s life. Only healthy mothers who were primiparous and who were anticipating a spontaneous vaginal delivery were included. Those who were not planning to breast-feed for a minimum of 1 month were excluded, as were those whose infants weighed less than 5 pounds, had a 5-minute Apgar score less than 7, were not carried for at least 37 weeks, or had medical complications at birth. Mother-infant dyads were randomly assigned to the intervention or control group. In the intervention group, skin-to-skin contact was maintained between mother and naked infant for approximately 2 hours immediately after birth. In the control group, infants were swaddled in prewarmed blankets and returned to the mother after the mother’s episiotomy or perineal laceration repair. The primary outcome was suckling competence, which was evaluated by means of the Infant Breast-Feeding Assessment Tool (IBFAT). The number of breast-feeding problems was tallied using the Breast-feeding Experience Scale (BES). Results showed that initial mean IBFAT scores were higher in the skin-to-skin group as compared with the control group (8.7 [standard deviation {SD} 2.11] versus 6.3 [SD 2.58]; P<0.02). The mean time from birth to the first successful effective breast-feeding was 935 minutes (SD 721) in the intervention group, versus 1,737 minutes (SD 1,001) in the control group (P<0.04). Although no significant between-group differences were detected in BES scores (P=0.25), findings suggested that skin-to-skin mothers had milder and fewer breast-feeding problems. Findings also revealed a relationship between breast-feeding outcomes and maternal nipple protractility. The 6 mothers in each group with erect nipples had significantly higher IBFAT scores for the first breast-feeding (P<0.02), as well as fewer breast-feeding problems 1 month postbirth (P<0.05) as compared with the mothers without erect nipples.

CONCLUSION: The authors conclude that providing healthy infants with continuous mother-infant skin-to-skin contact for a minimum of 2 hours postbirth facilitates breast-feeding.

Class of Evidence: Class of Evidence: A (ie, a Randomized Controlled Trial)

INTRODUCTION: According to Sachs and colleagues, clinicians commonly combine mood stabilizing agents with antidepressants when treating patients with bipolar depression despite a lack of evidence supporting the treatment of this illness with standard antidepressants. Furthermore, the authors note, pivotal studies examining the effectiveness of adjunctive antidepressant therapy were conducted under the aegis of pharmaceutical companies and involved narrow eligibility requirements as well as short-term cross-sectional outcomes. Therefore, Sachs et al undertook a randomized controlled trial in which they not only examined the efficacy of adjunctive antidepressants in patients with bipolar disorder, but also addressed the issue of antidepressant-related affective switch to mania.

SUMMARY: A multicenter, double-blind, randomized controlled trial (n=366) sought to determine the effect of adjunctive treatment with antidepressants on symptoms of bipolar depression and whether such treatment would increase the risk of manic episodes. The trial included patients who were at least 18 years of age with a diagnosis of bipolar I or II disorder in accordance with the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV). Those with an intolerance or nonresponse to paroxetine or bupropion were excluded, as were those receiving treatment for substance abuse or needing additional antipsychotic medication. Participants were randomly assigned to a group receiving treatment with a mood stabilizer plus placebo (n=187) or to a mood stabilizer plus antidepressant group (n=179). Those in the antidepressant group received either paroxetine (maximum of 40 mg/day) or bupropion (maximum of 375 mg/day). Treatment was continued for up to 26 weeks. Conditions of the study were generalizable to routine clinical practice. The primary outcome was a durable recovery, defined as at least 8 consecutive weeks of euthymia, which was assessed at each follow-up visit by means of the Clinical Monitoring Form, a composite assessment tool that includes current mood modules of the Structured Clinical Interview for DSM-IV. Treatment-emergent affective switch was examined as a secondary outcome. Results showed that among patients with bipolar I disorder, rates of durable recovery were similar between groups, but among patients with bipolar II disorder, a nonsignificant trend toward a better response was observed in those who received a mood stabilizer plus placebo. Overall, the rates of durable recovery were 23.5% (42 patients) for the mood stabilizer plus adjunctive antidepressant group versus 27.3% (51 patients) for the mood stabilizer plus placebo group (P=0.40). With regard to treatment-emergent affective switch, the respective rates were 10.1% (18 patients) and 10.7% (20 patients), a nonsignificant difference (P=0.84). Twenty-two patients in the antidepressant group and 17 of those who received placebo discontinued the study medication due to an adverse event (P=0.32). Suicide was attempted by less than 1% of the participants in either group.

CONCLUSION: The authors conclude that the combination of an antidepressant and a mood stabilizer does not lead to a greater reduction in symptoms of bipolar depression as compared with a mood stabilizer alone; they note that adjunctive antidepressant therapy does not appear to increase the risk of treatment-emergent affective switch to mania.

Class of Evidence: A (ie, a Randomized Controlled Trial)

RECENTLY PUBLISHED GUIDELINES

Evidence Alert publishes citations for guidelines released in the previous 2 to 8 weeks from selected organizations. For more information, click on the methodology link located in the upper right panel.

1. Evidence-based guidelines for cardiovascular disease prevention in women: 2007 update. Circulation. 2007;115:1481-501. Epub 2007 Feb 19. PMID: 17309915.

> Click here for a PDF version of the guideline.

2. Adams HP, Jr., Del ZG, Alberts MJ, Bhatt DL, Brass L, Furlan A, et al. Guidelines for the Early Management of Adults With Ischemic Stroke: A Guideline From the American Heart Association/ American Stroke Association Stroke Council, Clinical Cardiology Council, Cardiovascular Radiology and Intervention Council, and the Atherosclerotic Peripheral Vascular Disease and Quality of Care Outcomes in Research Interdisciplinary Working Groups: The American Academy of Neurology affirms the value of this guideline as an educational tool for neurologists. Stroke. 2007;38:1655-1711. PMID: 17431204.

> Click here for a PDF version of the guideline.

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