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Volume 6, No. 7, July 2008
Hot Topics
Obstetrics | Gynecology | Child Health | Chronic Disease and Illness
Obstetrics
Antibiotic Prophylaxis for Prevention of Postpartum Perineal Wound Complications
A Randomized Controlled Trial
OBJECTIVE: To estimate whether prophylactic antibiotics at the time of repair of third- or fourth-degree perineal tears after vaginal delivery prevent wound infection and breakdown.
METHODS: This was a prospective, randomized, placebo-controlled study. Patients who sustained third- or fourth-degree perineal tears after a vaginal delivery were recruited for the study. Each patient was given a single intravenous dose of a second-generation cephalosporin (cefotetan or cefoxitin) or placebo before repair of third- or fourth-degree perineal tears. Obstetricians and patients were blinded to study drug. The perineum was inspected for evidence of infection or breakdown at discharge from the hospital and at 2 weeks postpartum. Primary end points were gross disruption or purulent discharge at site of perineal repair by 2 weeks postpartum.
RESULTS: One hundred forty-seven patients were recruited for the study. Of these, 83 patients received placebo and 64 patients received antibiotics. Forty patients (27.2%) did not return for their 2-week appointment. Of the patients seen at 2 weeks postpartum, 4 of 49 (8.2%) patients who received antibiotics and 14 of 58 (24.1%) patients who received placebo developed a perineal wound complication (P=.037). There were no differences between groups in parity, incidence of diabetes, operative delivery, or third-degree compared with fourth-degree lacerations.
CONCLUSION: By 2 weeks postpartum, patients who received prophylactic antibiotics at the time of third- or fourth-degree laceration repair had a lower rate of perineal wound complications than patients who received placebo.
Duggal N , Mercado C, Daniels K, Bujor A, Caughey AB, El-Sayed YY. Antibiotic Prophylaxis for Prevention of Postpartum Perineal Wound Complications: A Randomized Controlled Trial. Obstet Gynecol. 2008 Jun;111(6):1268-1273. http://www.ncbi.nlm.nih.gov/pubmed/18515507
CCC Editorial Comment:
Avoidance of episiotomy is associated with the lowest rates of 3 rd and 4 th degree lacerations but will not eliminate all such events; when they happen, antibiotic prophylaxis may prevent further complications.
Episiotomy and Increase in the Risk of Obstetric Laceration in a Subsequent Vaginal Delivery
OBJECTIVE: To examine whether episiotomy at first vaginal delivery increases the risk of spontaneous obstetric laceration in the subsequent delivery.
METHODS: A review was conducted of women with consecutive vaginal deliveries at Magee-Womens Hospital between 1995 and 2005, using the Magee Obstetrical Maternal and Infant database. The primary exposure of interest was episiotomy at first vaginal delivery. Multivariable polytomous logistic regression modeling of potential risk factors was used to estimate odds ratios (ORs) for obstetric laceration in the second vaginal delivery.
RESULTS: A total of 6,052 patients were included, of whom 47.8% had episiotomy at first delivery. Spontaneous second-degree lacerations at the time of second delivery occurred in 51.3% of women with history of episiotomy at first delivery compared with 26.7% without history of episiotomy (P<.001). Severe lacerations (third or fourth degree) occurred in 4.8% of women with history of episiotomy at first delivery compared with 1.7% without history of episiotomy (P<.001). Prior episiotomy remained a significant risk factor for second-degree (OR 4.47, 95% confidence interval 3.78–5.30) and severe obstetric lacerations (OR 5.25, 95% confidence interval 2.96–9.32) in the second vaginal delivery after controlling for confounders. Based on these findings, for every four episiotomies not performed one second-degree laceration would be prevented. To prevent one severe laceration, performing 32 fewer episiotomies is required.
CONCLUSION: Episiotomy at first vaginal delivery increases the risk of spontaneous obstetric laceration in the subsequent delivery. This finding should encourage obstetric providers to further restrict the use of episiotomy.
Alperin M , Krohn MA, Parviainen K. Episiotomy and Increase in the Risk of Obstetric Laceration in a Subsequent Vaginal Delivery. Obstet Gynecol. 2008 Jun;111(6):1274-1278. http://www.ncbi.nlm.nih.gov/pubmed/18515508
Maternal Obesity associated with increased risk of neural tube defects
We conducted a metaanalysis of published evidence on the relationship between maternal obesity and the risk of neural tube defects (NTDs). Eligible studies were identified from 3 sources: (1) PubMed search of articles that were published from January 1980 through January 2007, (2) reference lists of publications that were selected from the PubMed search, and (3) reference lists of review articles on obesity and maternal outcomes that were published from January 2000 through January 2007. Twelve studies met inclusion criteria. A Bayesian random effects model was used for the metaanalysis and metaregression. Unadjusted odds ratios for an NTD-affected pregnancy were 1.22 (95% CI, 0.99-1.49), 1.70 (95% CI, 1.34-2.15), and 3.11 (95% CI, 1.75-5.46) among overweight, obese, and severely obese women, respectively, compared with normal-weight women. None of the study characteristics included in the metaregression analysis affected the results significantly. Maternal obesity is associated with an increased risk of an NTD-affected pregnancy.
Rasmussen SA , Chu SY , Kim SY , Schmid CH , Lau J . Maternal obesity and risk of neural tube defects: a metaanalysis. Am J Obstet Gynecol. 2008 Jun;198(6):611-9.
http://www.ncbi.nlm.nih.gov/pubmed/18538144
Diagnostic accuracy of urinary spot protein:creatinine ratio for proteinuria in hypertensive pregnant women: systematic review
OBJECTIVE: To review the spot protein:creatinine ratio and albumin:creatinine ratio as diagnostic tests for significant proteinuria in hypertensive pregnant women.
DESIGN: Systematic review.
DATA SOURCES: Medline and Embase, the Cochrane Library, reference lists, and experts. Review methods Literature search (1980-2007) for articles of the spot protein:creatinine ratio or albumin:creatinine ratio in hypertensive pregnancy, with 24 hour proteinuria as the comparator. RESULTS: 13 studies concerned the spot protein:creatinine ratio (1214 women with primarily gestational hypertension). Nine studies reported sensitivity and specificity for eight cut-off points, median 24 mg/mmol (range 17-57 mg/mmol; 0.15-0.50 mg/mg). Laboratory assays were not well described. Diagnostic test characteristics were recalculated for a cut-off point of 30 mg/mmol. No significant heterogeneity in cut-off points was found between studies over a range of proteinuria. Pooled values gave a sensitivity of 83.6% (95% confidence interval 77.5% to 89.7%), specificity of 76.3% (72.6% to 80.0%), positive likelihood ratio of 3.53 (2.83 to 4.49), and negative likelihood ratio of 0.21 (0.13 to 0.31) (nine studies, 1003 women). Two studies of the spot albumin:creatinine ratio (225 women) found optimal cut-off points of 2 mg/mmol for proteinuria of 0.3 g/day or more and 27 mg/mmol for albuminuria.
CONCLUSION: The spot protein:creatinine ratio is a reasonable "rule-out" test for detecting proteinuria of 0.3 g/day or more in hypertensive pregnancy. Information on use of the albumin:creatinine ratio in these women is insufficient.
Côté AM, Brown MA, Lam E, von Dadelszen P, Firoz T, Liston RM, Magee LA. Diagnostic accuracy of urinary spot protein:creatinine ratio for proteinuria in hypertensive pregnant women: systematic review. BMJ. 2008 May 3;336(7651):1003-6. Epub 2008 Apr 10.
http://www.ncbi.nlm.nih.gov/pubmed/18403498
Cochrane Review: Dietary advice in pregnancy for preventing gestational diabetes mellitus.
BACKGROUND: Gestational diabetes mellitus (GDM) is a form of diabetes that occurs during pregnancy which can result in significant adverse outcomes for mother and child both in the short and long term. The potential for adverse outcomes, in addition to the increasing prevalence of gestational diabetes worldwide, demonstrates the need to assess strategies, such as dietary advice, that might prevent gestational diabetes.
OBJECTIVES: To assess the effects of dietary advice in preventing gestational diabetes mellitus. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (January 2008) and reference lists of retrieved articles.
SELECTION CRITERIA: Quasi-randomised and randomised studies of dietary intervention for preventing glucose intolerance in pregnancy.
DATA COLLECTION AND ANALYSIS: Two review authors independently conducted data extraction and quality assessment. We resolved disagreements through discussion or through a third author.
MAIN RESULTS: Three trials (107 women) were included in the review. One trial (25 pregnant women) analysed high-fibre diets with no included outcomes showing statistically significant differences. Two trials (82 pregnant women) assessed low glycaemic index (LGI) versus high glycaemic index diets for pregnant women. Women on the LGI diet had fewer large for gestational age infants (one trial; relative risk (RR) 0.09, 95% confidence interval (CI) 0.01 to 0.69), infants with lower ponderal indexes (two trials; weighted mean difference (WMD) -0.18, 95% CI -0.32 to -0.04, random-effects analysis) and lower maternal fasting glucose levels (two trials; WMD -0.28 mmol/L 95% CI -0.54 to -0.02, random-effects model). Results for women on the LGI diet on neonatal birth weight were not conclusive under a random-effects model (two trials; WMD -527.64 g, 95% CI -1119.20 to 63.92); however, on a fixed-effect model, women on the LGI diet gave birth to lighter babies (two trials; WMD -445.55 g, 95% CI -634.16 to -256.95). High heterogeneity was observed between the trials in most results and both were relatively small trials. One of these trials also included a standard exercise regimen for all participants. AUTHORS' CONCLUSIONS: While a low glycaemic index diet was seen to be beneficial for some outcomes for both mother and child, results from the review were inconclusive. Further trials with large sample sizes and longer follow up are required to make more definitive conclusions. No conclusions could be drawn from the high-fibre versus control-diet comparison since the trial involved did not report on many of the outcomes we prespecified.
Tieu J , Crowther CA, Middleton P. Dietary advice in pregnancy for preventing gestational diabetes mellitus. Cochrane Database Syst Rev. 2008 Apr 16;(2):CD006674.
http://www.ncbi.nlm.nih.gov/pubmed/18425961
Gynecology
No increased risk with Misoprostol for treatment of early pregnancy failure in women with previous uterine surgery
OBJECTIVE: Misoprostol use in early pregnancy may incur a risk of uterine rupture in women with previous uterine surgery. STUDY DESIGN: We analyzed 488 women who received misoprostol 800 microg vaginally in a study that evaluated medical and surgical management of early pregnancy failure. Subjects received a repeat misoprostol dose if expulsion was not confirmed 2 days after treatment. We compared efficacy, acceptability, and safety in subjects with a history (n = 78 women) or absence (n = 410 women) of uterine surgery, defined as cesarean delivery or myomectomy. RESULTS: Expulsion rates after a single misoprostol dose (69% vs 72%; P = .64) and overall success at 30 days (82% vs 85%; P = .50) were comparable. Pain, bleeding, complications, and acceptability did not differ. No uterine ruptures occurred (95% CI, 0, 3.8%). CONCLUSION: Misoprostol treatment for early pregnancy failure had similar success, acceptability, and complications in women with and without previous uterine surgery.
Chen BA , Reeves MF, Creinin MD, Gilles JM, Barnhart K, Westhoff C, Zhang J; National Institute of Child Health and Human Development Management of Early Pregnancy Failure Trial. Misoprostol for treatment of early pregnancy failure in women with previous uterine surgery. Am J Obstet Gynecol. 2008 Jun;198(6):626.e1-5. Epub 2008 Feb 15.
http://www.ncbi.nlm.nih.gov/pubmed/18279821
Cessation of douching may decrease incidence of bacterial vaginosis
OBJECTIVE: The objective of the study was to evaluate the risk for bacterial vaginosis (BV) in a douching cessation trial.
STUDY DESIGN: Thirty-nine reproductive-age women who reported use of douche products were enrolled into a 20-week study consisting of a 4 week douching observation (phase I) followed by 12-weeks of douching cessation (phase II). In phase III, participants then chose to resume douching or continue cessation for the remaining 4 weeks. Self-collected vaginal samples were obtained twice weekly in the first 16 weeks, and 1 sample was collected during week 20 (1107 samples total). BV was diagnosed by Nugent score of 7 or greater. Conditional logistic regression was used to evaluate douching cessation on the risk of BV.
RESULTS: The adjusted odds ratio (aOR) for BV in the douching cessation phase, as compared with the douching-observation phase was 0.76 (95% confidence interval [CI], 0.33 to 1.76). Among women who reported their primary reason for douching was to cleanse after menstruation, BV was significantly reduced in douching cessation (aOR:0.23; 95% CI, 0.12 to 0.44).
CONCLUSION: Vaginal douching cessation may reduce the risk for BV in a subset of women.
Brotman RM , Ghanem KG, Klebanoff MA, Taha TE, Scharfstein DO, Zenilman JM.
The effect of vaginal douching cessation on bacterial vaginosis: a pilot study. Am J Obstet Gynecol. 2008 Jun;198(6):628.e1-7. Epub 2008 Mar 4. http://www.ncbi.nlm.nih.gov/pubmed/18295180
Green Tea Extract for treatment of external anogenital warts
OBJECTIVE: To estimate the clinical efficacy of topical sinecatechins, a defined green tea extract, in the treatment of external genital and perianal warts.
METHODS: This was a randomized, double-blind, vehicle-controlled trial involving 502 male and female patients aged 18 years and older, with 2-30 anogenital warts ranging from 12 to 600 mm(2) total wart area. Patients applied sinecatechins ointment 15% or 10% or vehicle (placebo) three times daily for a maximum of 16 weeks or until complete clearance of all warts, followed by a 12-week treatment-free follow-up to assess recurrence.
RESULTS: Complete clearance of all baseline and newly occurring warts was obtained in 57.2% and 56.3% of patients treated with sinecatechins ointment 15% and 10%, respectively, compared with 33.7% for vehicle (both P<.001). Significance was observed at weeks 4 and 6 and all subsequent visits. Numbers needed to treat were 4.3 and 4.4. Partial clearance rates of at least 50% were reported for 78.4% and 74.0% of patients in the sinecatechins ointment 15% and 10% groups compared with 51.5% of vehicle patients. During follow-up, recurrence of any wart was observed in 6.5%, 8.3%, and 8.8% in the sinecatechins ointment 15% group, sinecatechins ointment 10% group, and vehicle patients, respectively. A total of 3.7%, 8.3%, and 0.0% developed new warts, respectively. A total of 87.7% and 87.3% of patients in the sinecatechins ointment 15% and 10% groups, and 72.1% of vehicle patients experienced application site reactions; 49.2%, 46.2%, and 65.4% of those, respectively, were mild or moderate. CONCLUSION: Topical sinecatechins ointments 15% and 10% are effective and well-tolerated in the treatment of anogenital warts.
Tatti S , Swinehart JM, Thielert C, Tawfik H, Mescheder A, Beutner KR. Sinecatechins, a Defined Green Tea Extract, in the Treatment of External Anogenital Warts: A Randomized Controlled Trial. Obstet Gynecol. 2008 Jun;111(6):1371-1379. http://www.ncbi.nlm.nih.gov/pubmed/18515521
An Illinois survey demonstrates only 1 in 10 Emergency Departments provides comprehensive medical care for victims of sexual assault
BACKGROUND: Sexual assault is a major public health problem affecting 17 million women in the United States. Hospital emergency departments (EDs) are often the primary point of care for these women. We propose the concept of "comprehensive medical care management" (CMCM) at the primary point of care for victims of sexual assault. The objectives of this study were (a) to describe medical care services provided to sexual assault victims presenting at the EDs in Illinois hospitals, and (b) to identify the percentage of hospitals that always provide all 10 elements of CMCM.
STUDY DESIGN: This is a cross-sectional prevalence study. A 14-item phone survey was administered to 187 eligible EDs in Illinois from July to September 2004. Outcome measures were the percentages of EDs that provide the elements of CMCM: (a) acute medical care; (b) history and physical exam; (c and d) acute and long-term rape crisis counseling; (e and f) prophylactic and therapeutic sexually transmitted infection (STI) management; (g and h) prophylactic and therapeutic HIV management; and (I and j) counseling and provision of emergency contraception.
RESULTS: An 83% response rate of eligible emergency rooms provided the following data: while 100% of emergency rooms provide acute medical care upon presentation, two thirds provide rape crises counseling, two thirds provide STI management, 4 of 10 report counseling and provision of emergency contraceptives, and only 28.2% provide HIV management. About 1 in 10 (9.6%) provides all elements of CMCM.
CONCLUSION: Although there are recommendations from various medical organizations for all 10 elements of CMCM for victims of sexual assault, very few hospitals provide CMCM. Improvements must be made to provide quality comprehensive care for victims of sexual assault.
Patel A , Panchal H , Piotrowski ZH , Patel D . Comprehensive medical care for victims of sexual assault: a survey of Illinois hospital emergency departments. Contraception. 2008 Jun;77(6):426-30. Epub 2008 Apr 10. http://www.ncbi.nlm.nih.gov/pubmed/18477492
Despite increased pregnancy-related risks, women with epilepsy often at risk for unintended pregnancy
BACKGROUND: Women with epilepsy experience more pregnancy-related risks than do their healthy peers. Guidelines recommend highly effective contraception. However, their contraceptive practices remain unknown.
STUDY DESIGN: We conducted a cross-sectional questionnaire study among reproductive-age women (18-44 years) with epilepsy presenting for routine, outpatient visits to an urban, academic medical center. Our questionnaire, in English or Spanish, included demographic characteristics, reproductive history, antiepileptic drug use, sexual behavior and contraception.
RESULTS: Participants had a mean age of 32 years (S.D.=8), 32% spoke Spanish and described themselves as Hispanic. Participants reported a wide range of educational attainment, insurance payor and income.About half of the participants reported at least one pregnancy, and 50% of the 181 pregnancies reported were unplanned. Among the 53% who reported intercourse in the last month, 74% used contraception, 15% were pregnant, 5% did not want to use contraception, 3% sought pregnancy and 3% had hysterectomy. Of those using contraception, 53% used highly effective methods (sterilization, intrauterine device, hormonal pill, patch and injection), and 47% used less effective methods (condom, withdrawal, rhythm and spermicide). Among the 21 participants using hormonal methods, six concomitantly took enzyme-inducing antiepileptic drugs potentially increasing susceptibility to pregnancy.
DISCUSSION: In this sample of women with epilepsy about half reported prior pregnancies; 50% were unplanned. Of those using contraception, only 53% used a highly effective method. Future studies should determine generalizability of these findings and explore reasons for inadequate family planning in women with epilepsy.
Davis AR , Pack AM, Kritzer J, Yoon A, Camus A. Reproductive history, sexual behavior and use of contraception in women with epilepsy. Contraception. 2008 Jun;77(6):405-9. Epub 2008 Apr 18. http://www.ncbi.nlm.nih.gov/pubmed/18477488
Child Health
Hypothermia therapy after traumatic brain injury in children does not improve neurologic outcomes and may increase mortality
BACKGROUND: Hypothermia therapy improves survival and the neurologic outcome in animal models of traumatic brain injury. However, the effect of hypothermia therapy on the neurologic outcome and mortality among children who have severe traumatic brain injury is unknown. METHODS: In a multicenter, international trial, we randomly assigned children with severe traumatic brain injury to either hypothermia therapy (32.5 degrees C for 24 hours) initiated within 8 hours after injury or to normothermia (37.0 degrees C). The primary outcome was the proportion of children who had an unfavorable outcome (i.e., severe disability, persistent vegetative state, or death), as assessed on the basis of the Pediatric Cerebral Performance Category score at 6 months.
RESULTS: A total of 225 children were randomly assigned to the hypothermia group or the normothermia group; the mean temperatures achieved in the two groups were 33.1+/-1.2 degrees C and 36.9+/-0.5 degrees C, respectively. At 6 months, 31% of the patients in the hypothermia group, as compared with 22% of the patients in the normothermia group, had an unfavorable outcome (relative risk, 1.41; 95% confidence interval [CI], 0.89 to 2.22; P=0.14). There were 23 deaths (21%) in the hypothermia group and 14 deaths (12%) in the normothermia group (relative risk, 1.40; 95% CI, 0.90 to 2.27; P=0.06). There was more hypotension (P=0.047) and more vasoactive agents were administered (P<0.001) in the hypothermia group during the rewarming period than in the normothermia group. Lengths of stay in the intensive care unit and in the hospital and other adverse events were similar in the two groups.
CONCLUSIONS: In children with severe traumatic brain injury, hypothermia therapy that is initiated within 8 hours after injury and continued for 24 hours does not improve the neurologic outcome and may increase mortality.
Hutchison JS , et al. Hypothermia therapy after traumatic brain injury in children. N Engl J Med. 2008 Jun 5;358(23):2447-56. http://www.ncbi.nlm.nih.gov/pubmed/18525042
Obesity and type 2 diabetes risk in midadult life: the role of childhood adversity
OBJECTIVE: Child abuse has been associated with poorer physical health in adulthood, but less is known about childhood adversity more broadly, including neglect and family problems, or the pathways from adversity to adult disease. We have examined how different stressful emotional or neglectful childhood adversities are related to adiposity and glucose control in midadulthood, taking into account childhood factors, and whether the relationships are mediated by adult health behaviors and socioeconomic position.
METHODS: This was a prospective longitudinal study of 9310 members of the 1958 British birth cohort who participated in a biomedical interview at 45 years of age. Primary outcomes consisted of continuous measures of BMI, waist circumference, and glycosylated hemoglobin at 45 years and categorical indicators: total obesity (BMI > or = 30), central obesity (waist circumference: > or = 102 cm for men and > or = 88 cm for women), and glycosylated hemoglobin level of > or = 6. RESULTS: The risk of obesity increased by 20% to 50% for several adversities (physical abuse, verbal abuse, witnessed abuse, humiliation, neglect, strict upbringing, physical punishment, conflict or tension, low parental aspirations or interest in education, hardly takes outings with parents, and father hardly reads to child). Adversities with the strongest associations with adiposity (eg, physical abuse) tended to be associated with glycosylated hemoglobin levels of > or = 6, but in most cases associations were explained by adjustment for adulthood mediators such as adiposity. Effects of other adversities reflecting less severe emotional neglect and family environment were largely explained by childhood socioeconomic factors.
CONCLUSIONS: Some childhood adversities increase the risk of obesity in adulthood and thereby increase the risk for type 2 diabetes. Research is needed to understand the interrelatedness of adversities, the social context of their occurrence, and trajectories from adversity to adult disease.
Thomas C , Hyppönen E , Power C . Obesity and type 2 diabetes risk in midadult life: the role of childhood adversity. Pediatrics. 2008 May;121(5):e1240-9.
http://www.ncbi.nlm.nih.gov/pubmed/18450866
Nearly 1 in 10 Girls Engages in Frequent Binge Eating or Purging
OBJECTIVE: To identify predictors of becoming eating disordered among adolescents. DESIGN: Prospective cohort study. SETTING: Self-report questionnaires.
SUBJECTS: Girls (n = 6916) and boys (n = 5618), aged 9 to 15 years at baseline, in the ongoing Growing Up Today Study (GUTS). Main Exposures Parent, peer, and media influences.
MAIN OUTCOME MEASURES: Onset of starting to binge eat or purge (ie, vomiting or using laxatives) at least weekly. RESULTS: During 7 years of follow-up, 4.3% of female subjects and 2.3% of male subjects (hereafter referred to as "females" and "males") started to binge eat and 5.3% of females and 0.8% of males started to purge to control their weight. Few participants started to both binge eat and purge. Rates and risk factors varied by sex and age group (<14 vs > or =14 years). Females younger than 14 years whose mothers had a history of an eating disorder were nearly 3 times more likely than their peers to start purging at least weekly (odds ratio, 2.8; 95% confidence interval, 1.3-5.9); however, maternal history of an eating disorder was unrelated to risk of starting to binge eat or purge in older adolescent females. Frequent dieting and trying to look like persons in the media were independent predictors of binge eating in females of all ages. In males, negative comments about weight by fathers was predictive of starting to binge at least weekly.
CONCLUSIONS: Risk factors for the development of binge eating and purging differ by sex and by age group in females. Maternal history of an eating disorder is a risk factor only in younger adolescent females.
Field AE , Javaras KM, Aneja P, Kitos N, Camargo CA Jr, Taylor CB, Laird NM. Family, peer, and media predictors of becoming eating disordered. Arch Pediatr Adolesc Med. 2008 Jun;162(6):574-9. http://www.ncbi.nlm.nih.gov/pubmed/18524749
Irregular menses linked to vomiting
PURPOSE: Using data from an eating disorders screening initiative conducted in high schools across the United States, we examined the relationship between vomiting frequency and irregular menses in a nonclinical sample of adolescent females.
METHODS: A self-report questionnaire was administered to students from U.S. high schools participating in the National Eating Disorders Screening Program in 2000. The questionnaire included items on frequency of vomiting for weight control in the past 3 months, other eating disorder symptoms, frequency of menses, height, and weight. Multivariable regression analyses were conducted using data from 2791 girls to estimate the risk of irregular menses (defined as menses less often than monthly) associated with vomiting frequency, adjusting for other eating disorder symptoms, weight status, age, race/ethnicity, and school clusters.
RESULTS: Girls who vomited to control their weight one to three times per month were one and a half times more likely (risk ratio [RR] = 1.6; 95% confidence interval [CI] = 1.2-2.2), and girls who vomited once per week or more often were more than three times more likely (RR = 3.2; 95% CI = 2.3-4.4), to experience irregular menses than were girls who did not report vomiting for weight control. Vomiting for weight control remained a strong predictor of irregular menses even when overweight and underweight participants were excluded.
CONCLUSIONS: Our study adds to the evidence that vomiting may have a direct effect on hormonal function in adolescent girls, and that vomiting for weight control may be a particularly deleterious component of eating disorders.
Austin SB , Ziyadeh NJ, Vohra S, Forman S, Gordon CM, Prokop LA, Keliher A, Jacobs D.
Irregular menses linked to vomiting in a nonclinical sample: findings from the National Eating Disorders Screening Program in high schools. J Adolesc Health. 2008 May;42(5):450-7. Epub 2008 Mar 4. http://www.ncbi.nlm.nih.gov/pubmed/18407039
Ocular Trauma Due to a Water-Bottle Cap
A New England Journal of Medicine “Images in Clinical Medicine” presents a case of adolescent eye injury associated with crushing plastic water bottles.
http://content.nejm.org/cgi/content/full/358/21/2265Chronic Disease and Illness
Intensive Glucose Control Does Not Prevent Major Cardiovascular Events in Type 2 Diabetes
Two recent studies published in the NEJM addressing intensive glucose control in adults with type 2 diabetes failed to demonstrate a decrease in major cardiovascular events, although the second study did show a decrease in nephropathy.
ACCORD Study Abstract:
BACKGROUND: Epidemiologic studies have shown a relationship between glycated hemoglobin levels and cardiovascular events in patients with type 2 diabetes. We investigated whether intensive therapy to target normal glycated hemoglobin levels would reduce cardiovascular events in patients with type 2 diabetes who had either established cardiovascular disease or additional cardiovascular risk factors.
METHODS: In this randomized study, 10,251 patients (mean age, 62.2 years) with a median glycated hemoglobin level of 8.1% were assigned to receive intensive therapy (targeting a glycated hemoglobin level below 6.0%) or standard therapy (targeting a level from 7.0 to 7.9%). Of these patients, 38% were women, and 35% had had a previous cardiovascular event. The primary outcome was a composite of nonfatal myocardial infarction, nonfatal stroke, or death from cardiovascular causes. The finding of higher mortality in the intensive-therapy group led to a discontinuation of intensive therapy after a mean of 3.5 years of follow-up.
RESULTS: At 1 year, stable median glycated hemoglobin levels of 6.4% and 7.5% were achieved in the intensive-therapy group and the standard-therapy group, respectively. During follow-up, the primary outcome occurred in 352 patients in the intensive-therapy group, as compared with 371 in the standard-therapy group (hazard ratio, 0.90; 95% confidence interval [CI], 0.78 to 1.04; P=0.16). At the same time, 257 patients in the intensive-therapy group died, as compared with 203 patients in the standard-therapy group (hazard ratio, 1.22; 95% CI, 1.01 to 1.46; P=0.04). Hypoglycemia requiring assistance and weight gain of more than 10 kg were more frequent in the intensive-therapy group (P<0.001).
CONCLUSIONS: As compared with standard therapy, the use of intensive therapy to target normal glycated hemoglobin levels for 3.5 years increased mortality and did not significantly reduce major cardiovascular events. These findings identify a previously unrecognized harm of intensive glucose lowering in high-risk patients with type 2 diabetes.
The Action to Control Cardiovascular Risk in Diabetes Study Group. Effects of Intensive Glucose Lowering in Type 2 Diabetes. N Engl J Med. 2008 Jun 12;358(24):2545-2559. Epub 2008 Jun 6.
PubMed Abstract: http://www.ncbi.nlm.nih.gov/pubmed/18539917
Free Full Text: http://content.nejm.org/cgi/content/full/358/24/2545?query=TOC
ADVANCE Study Abstract:
BACKGROUND: In patients with type 2 diabetes, the effects of intensive glucose control on vascular outcomes remain uncertain. METHODS: We randomly assigned 11,140 patients with type 2 diabetes to undergo either standard glucose control or intensive glucose control, defined as the use of gliclazide (modified release) plus other drugs as required to achieve a glycated hemoglobin value of 6.5% or less. Primary end points were composites of major macrovascular events (death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke) and major microvascular events (new or worsening nephropathy or retinopathy), assessed both jointly and separately.
RESULTS: After a median of 5 years of follow-up, the mean glycated hemoglobin level was lower in the intensive-control group (6.5%) than in the standard-control group (7.3%). Intensive control reduced the incidence of combined major macrovascular and microvascular events (18.1%, vs. 20.0% with standard control; hazard ratio, 0.90; 95% confidence interval [CI], 0.82 to 0.98; P=0.01), as well as that of major microvascular events (9.4% vs. 10.9%; hazard ratio, 0.86; 95% CI, 0.77 to 0.97; P=0.01), primarily because of a reduction in the incidence of nephropathy (4.1% vs. 5.2%; hazard ratio, 0.79; 95% CI, 0.66 to 0.93; P=0.006), with no significant effect on retinopathy (P=0.50). There were no significant effects of the type of glucose control on major macrovascular events (hazard ratio with intensive control, 0.94; 95% CI, 0.84 to 1.06; P=0.32), death from cardiovascular causes (hazard ratio with intensive control, 0.88; 95% CI, 0.74 to 1.04; P=0.12), or death from any cause (hazard ratio with intensive control, 0.93; 95% CI, 0.83 to 1.06; P=0.28). Severe hypoglycemia, although uncommon, was more common in the intensive-control group (2.7%, vs. 1.5% in the standard-control group; hazard ratio, 1.86; 95% CI, 1.42 to 2.40; P<0.001).
CONCLUSIONS: A strategy of intensive glucose control, involving gliclazide (modified release) and other drugs as required, that lowered the glycated hemoglobin value to 6.5% yielded a 10% relative reduction in the combined outcome of major macrovascular and microvascular events, primarily as a consequence of a 21% relative reduction in nephropathy.
The ADVANCE Collaborative Group . Intensive Blood Glucose Control and Vascular Outcomes in Patients with Type 2 Diabetes. N Engl J Med. 2008 Jun 12;358(24):2560-2572. Epub 2008 Jun 6.
PubMed Abstract: http://www.ncbi.nlm.nih.gov/pubmed/18539916
Free Full Text: http://content.nejm.org/cgi/content/full/358/24/2560
Commentary on both articles in the New England Journal of Medicine:
http://content.nejm.org/cgi/content/full/358/24/2630
http://content.nejm.org/cgi/content/full/358/24/2633
http://content.nejm.org/cgi/content/full/358/24/2537
A collaborative approach to diabetes care in community health centers can improve care and be cost-effective
OBJECTIVE: To estimate the incremental cost-effectiveness of improving diabetes care with the Health Disparities Collaborative (HDC), a national collaborative quality improvement (QI) program conducted in community health centers (HCs).
DATA SOURCES/STUDY SETTING: Data regarding the impact of the Diabetes HDC program came from a serial cross-sectional follow-up study (1998, 2000, 2002) of the program in 17 Midwestern HCs. Data inputs for the simulation model of diabetes came from the latest clinical trials and epidemiological studies.
STUDY DESIGN: We conducted a societal cost-effectiveness analysis, incorporating data from QI program evaluation into a Monte Carlo simulation model of diabetes. Data COLLECTION/EXTRACTION METHODS: Data on diabetes care processes and risk factor levels were extracted from medical charts of randomly selected patients.
PRINCIPAL FINDINGS: From 1998 to 2002, multiple processes of care (e.g., glycosylated hemoglobin testing [HbA1C] [71-->92 percent] and ACE inhibitor prescribing [33-->55 percent]) and risk factor levels (e.g., 1998 mean HbA1C 8.53 percent, mean difference 0.45 percent [95 percent confidence intervals -0.72, -0.17]) improved significantly. With these improvements, the HDC was estimated to reduce the lifetime incidence of blindness (17-->15 percent), end-stage renal disease (18-->15 percent), and coronary artery disease (28-->24 percent). The average improvement in quality-adjusted life year (QALY) was 0.35 and the incremental cost-effectiveness ratio was $33,386/QALY.
CONCLUSIONS: During the first 4 years of the HDC, multiple improvements in diabetes care were observed. If these improvements are maintained or enhanced over the lifetime of patients, the HDC program will be cost-effective for society based on traditionally accepted thresholds.
Huang ES , Zhang Q , Brown SE , Drum ML , Meltzer DO , Chin MH . The cost-effectiveness of improving diabetes care in U.S. federally qualified community health centers. Health Serv Res. 2007 Dec;42(6 Pt 1):2174-93; discussion 2294-323. http://www.ncbi.nlm.nih.gov/pubmed/17995559
Patient factors, not physician or clinic factors, account for most of the variance in blood sugar levels among adults with diabetes
From ARHQ: This study supports the hypothesis that medication intensification may be the final common pathway that leads to better glycemic control.
Abstract:
INTRODUCTION: We studied variance in glycated hemoglobin (HbA1c) values among adults with diabetes to identify variation in quality of diabetes care at the levels of patient, physician, and clinic, and to identify which levels contribute the most to variation and which variables at each level are related to quality of diabetes care.
METHODS: Study subjects were 120 primary care physicians and their 2589 eligible adult patients with diabetes seen at 18 clinics. The dependent variable was HbA1c values recorded in clinical databases. Multivariate hierarchical models were used to partition variation in HbA1c values across the levels of patient, physician, or clinic and to identify significant predictors of HbA1c at each level.
RESULTS: More than 95% of variance in HbA1c values was attributable to the patient level. Much less variance was seen at the physician and clinic level. Inclusion of patient and physician covariates did not substantially change this pattern of results. Intensification of pharmacotherapy (t = -7.40, P < .01) and patient age (t = 2.10, P < .05) were related to favorable change in HbA1c. Physician age, physician specialty, number of diabetes patients per physician, patient comorbidity, and clinic assignment did not predict change in HbA1c value. The overall model with covariates explained 11.8% of change in HbA1c value over time.
CONCLUSION: These data suggest that most variance in HbA1c values is attributable to patient factors, although physicians play a major role in some patient factors (e.g., intensification of medication). These findings may lead to more effective care-improvement strategies and accountability measures.
AHRQ commentary at: http://www.ahrq.gov/research/jun08/0608RA12.htm
Abstract and PubMed citation at: O'Connor PJ , Rush WA, Davidson G, Louis TA, Solberg LI, Crain L, Johnson PE, Whitebird RR. Variation in quality of diabetes care at the levels of patient, physician, and clinic. Prev Chronic Dis. 2008 Jan;5(1):A15. Epub 2007 Dec 15. http://www.ncbi.nlm.nih.gov/pubmed/18082004
Antidepressants and therapy may be cost-effective for patients with medically unexplained symptoms
From ARHQ: Individuals complaining of physical problems for which there is little or no disease explanation (somatization) make up 5 to 10 percent of primary care patients. These individuals, many of whom are depressed, often embark on a quest to find a disease that they fear but do not have. This typically results in numerous laboratory tests and consultations, as well as treatments of nonexistent conditions. Not only is this a costly enterprise, but physicians often ignore these patients' emotional distress, note Michigan State University researchers. They hypothesized that use of antidepressants and cognitive-behavioral therapy, combined with a focus on a strong provider-patient relationship, may be of some help to these patients.
Abstract:
OBJECTIVE: This study sought to determine whether an intervention for patients with medically unexplained symptoms in primary care reduced total costs, components of cost, and longer-term costs and whether it led to decreased service use outside the health maintenance organization (HMO).
METHODS: A randomized controlled trial involving 206 patients with medically unexplained symptoms was conducted in a staff-model HMO. The protocol emphasized the provider-patient relationship and included cognitive-behavioral therapy and pharmacological management. Cost data for medical treatments were derived from the HMO's electronic database. Patients were interviewed about work days lost and out-of-pocket expenses for medical care outside the HMO. RESULTS: The difference in total costs ($1,071) for the 12-month intervention was not significant. The treatment group had significantly higher costs for antidepressants than the usual-care group ($192 higher) during the intervention, and a larger proportion received antidepressants. The intervention group used less medical care outside the HMO and missed one less work day per month on average (1.23 days), indicating a slight improvement in productivity, but the difference was not significant. The between-group difference in estimated total cost was smaller in the year after the intervention (difference of $341) but were not significant.
CONCLUSIONS: The total costs for the intervention group were not significantly different, but the group had greater use of antidepressants. Coupled with findings of improved mental health outcomes for this group in a previous study, the results indicate that the intervention may be cost-effective. The longer-term impact needs to be further studied.
AHRQ commentary at: http://www.ahrq.gov/research/jun08/0608RA18.htm
Abstract and PubMed citation at: Luo Z, Goddeeris J, Gardiner JC, Smith RC. Costs of an intervention for primary care patients with medically unexplained symptoms: a randomized controlled trial. Psychiatr Serv. 2007 Aug;58(8):1079-86. http://www.ncbi.nlm.nih.gov/pubmed/17664519
Light and Melatonin May Reduce Dementia Symptoms
Resynchronizing patients' circadian rhythms with light and melatonin may have a "modest benefit" on their dementia symptoms.
CONTEXT: Cognitive decline, mood, behavioral and sleep disturbances, and limitations of activities of daily living commonly burden elderly patients with dementia and their caregivers. Circadian rhythm disturbances have been associated with these symptoms. OBJECTIVE: To determine whether the progression of cognitive and noncognitive symptoms may be ameliorated by individual or combined long-term application of the 2 major synchronizers of the circadian timing system: bright light and melatonin.
DESIGN, SETTING, AND PARTICIPANTS: A long-term, double-blind, placebo-controlled, 2 x 2 factorial randomized trial performed from 1999 to 2004 with 189 residents of 12 group care facilities in the Netherlands; mean (SD) age, 85.8 (5.5) years; 90% were female and 87% had dementia. INTERVENTIONS: Random assignment by facility to long-term daily treatment with whole-day bright (+/- 1000 lux) or dim (+/- 300 lux) light and by participant to evening melatonin (2.5 mg) or placebo for a mean (SD) of 15 (12) months (maximum period of 3.5 years). CONCLUSIONS: Light has a modest benefit in improving some cognitive and noncognitive symptoms of dementia. To counteract the adverse effect of melatonin on mood, it is recommended only in combination with light.
Riemersma-van der Lek RF , Swaab DF, Twisk J, Hol EM, Hoogendijk WJ, Van Someren EJ. Effect of bright light and melatonin on cognitive and noncognitive function in elderly residents of group care facilities: a randomized controlled trial. JAMA. 2008 Jun 11;299(22):2642-55.
http://www.ncbi.nlm.nih.gov/pubmed/18544724
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Dr. Neil Murphy is the Obstetrics and Gynecology Chief Clinical Consultant (OB/GYN C.C.C.). Dr. Murphy is very interested in establishing a dialogue and/or networking with anyone involved in women's health or maternal child health, especially as it applies to Native or indigenous peoples around the world. Please don't hesitate to contact him by e-mail or phone at 907-729-3154.
