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Maternal Child HealthCCC CornerDec 2008/Jan 2009
OB/GYN CCC Corner - Maternal Child Health for American Indians and Alaska Natives

Volume 6, No. 12, December 2008/January 2009

Abstract of the Month | From Your Colleagues | Hot Topics | Features   

Features

 

American College of Obstetricians and Gynecologists

ACOG Committee Opinion No. 420, Hormone Therapy and Heart Disease

ABSTRACT: The effect of menopausal hormone therapy on coronary heart disease has been the subject of much concern. The Heart and Estrogen/Progestin Replacement Study (HERS) and Women's Health Initiative studies found an increased risk of cardiovascular events with conjugated equine estrogen and medroxyprogesterone acetate use. However, recent evidence suggests that women in early menopause who are in good cardiovascular health are at low risk of adverse cardiovascular outcomes and as such should be considered candidates for the use of conjugated equine estrogen or conjugated equine estrogen and medroxyprogesterone acetate for relief of menopausal vasomotor symptoms. Hormone therapy use should be limited to the treatment of menopausal symptoms at the lowest effective dosage over the shortest duration possible, and continued use should be reevaluated on a periodic basis.

American College of Obstetricians and Gynecologists, ACOG Committee Opinion No. 420, November 2008: hormone therapy and heart disease. Obstet Gynecol. 2008 Nov;112(5):1189-92.
http://www.ncbi.nlm.nih.gov/pubmed/18978127

ACOG Committee Opinion No. 421, Antibiotic Prophylaxis for Infective Endocarditis

ABSTRACT: The recommendations for endocarditis prophylaxis from the American Heart Association have changed for three main reasons: 1) most cases of endocarditis are not attributable to an invasive procedure but rather are the result of randomly occurring bacteremia from routine daily activities; 2) prophylaxis may only prevent a small number of cases of infective endocarditis in women undergoing genitourinary procedures; and 3) the risk of antibiotic associated adverse events exceeds the benefit, if any, from prophylactic antibiotic therapy. The specific changes pertinent to the obstetrician-gynecologist are discussed.

American College of Obstetricians and Gynecologists, ACOG Committee Opinion No. 421, November 2008: antibiotic prophylaxis for infective endocarditis. Obstet Gynecol. 2008 Nov;112(5):1193-4. http://www.ncbi.nlm.nih.gov/pubmed/18978128

ACOG Committee Opinion No. 422: At-risk drinking and illicit drug use: ethical issues in obstetric and gynecologic practice

ABSTRACT: Drug and alcohol abuse is a major health problem for American women regardless of their socioeconomic status, race, ethnicity, and age. It is costly to individuals and to society. Obstetrician-gynecologists have an ethical obligation to learn and use a protocol for universal screening questions, brief intervention, and referral to treatment in order to provide patients and their families with medical care that is state-of-the-art, comprehensive, and effective. In this Committee Opinion, the American College of Obstetricians and Gynecologists' Committee on Ethics proposes an ethical rationale for this protocol in both obstetric and gynecologic practice, offers a practical aid for incorporating such care, and provides guidelines for resolving common ethical dilemmas related to drug and alcohol use that arise in the clinical setting.

American College of Obstetricians and Gynecologists. ACOG Committee Opinion No. 422: at-risk drinking and illicit drug use: ethical issues in obstetric and gynecologic practice. Obstet Gynecol. 2008 Dec;112(6):1449-60. http://www.ncbi.nlm.nih.gov/pubmed/19037056

ACOG Practice Bulletin No. 99, Management of Abnormal Cervical Cytology and Histology

Summary of Recommendations
The following recommendations are based on good and consistent scientific evidence (Level A):

  • Premenopausal women 21 years and older with ASC-US cytology results may undergo immediate colposcopy or may undergo triage testing to determine which of them should be referred to colposcopy. Triage testing may be performed by a single test for high-risk (oncogenic) types of HPV or by repeat cytology screening at 6 months and 12 months. When the index cytology test specimen was obtained by liquid-based cytology or when an HPV specimen was co-collected, "reflex" HPV testing is the preferred approach.
  • Colposcopy is recommended in premenopausal women 21 years and older with ASC-US who are HPV positive, those with two consecutive ASC-US cytology results or with LSIL, or women of any age with ASC-H
  • For premenopausal women 21 years and older with an HPV-positive ASC-US, or ASC-H or LSIL cytology result in whom CIN 2,3 is not identified, follow-up without treatment is recommended using either repeat cervical cytology tests at 6 months and 12 months or an HPV test at 12 month-intervals; a repeat colposcopy is indicated for a cytology result of ASC-US or higher-grade abnormality or a positive high-risk HPV test result. After two consecutive negative cytology results or one negative HPV result women can return to routine screening.
  • In women 21 years and older with HSIL cytology results, immediate loop electrosurgical excision or colposcopy with endocervical assessment are both acceptable management options. In adolescents and pregnant women with HSIL cytology results, colposcopy is recommended. Immediate excision is not acceptable in adolescents and pregnant women. A diagnostic excisional procedure is recommended for all nonpregnant women with HSIL when colposcopy is unsatisfactory or when CIN of any grade is identified on endocervical assessment.
  • Posttreatment management options for women 21 years and older who have CIN 2,3 include a single HPV DNA test at 6–12 months, cytology alone at 6-month intervals or a combination of cytology and colposcopy at 6-month intervals. For adolescents who have undergone treatment, cytology follow-up is preferred. Colposcopy with endocervical sampling is recommended for women who are HPV DNA positive or have a result of ASC-US or greater on repeat cytology. If the HPV DNA test is negative or if two consecutive repeat cytology test results are negative, routine screening commencing at 12 months is recommended for at least 20 years.

The following recommendations are based on limited and inconsistent scientific evidence (Level B):

  • Women 21 years or older with ASC-US who test negative for HPV, or whose HPV status is unknown and who test negative for abnormalities using colposcopy, should have a repeat cytology test in 1 year. Women with ASC-US who have two negative results on repeat cytology at 6-month intervals can return to routine screening.
  • In adolescents (before age 21 years) with ASC-US or LSIL cytology results, or CIN 1 histology results preceded by ASC-US or LSIL or AGC-NOS cytology results, follow-up is recommended at 12-month intervals. At the first follow-up visit (at 12 months), only adolescents with HSIL or greater on the repeat cytology should be referred to colposcopy. At the 24-month follow-up, those with an ASC-US or greater result should be referred to colposcopy. Human papillomavirus DNA testing is unacceptable for adolescents. If HPV testing is inadvertently performed, a positive result should not influence management.
  • In nonpregnant women with ASC and LSIL cytology results who are undergoing colposcopy, endocervical sampling using a brush or curette is preferred for women in whom no lesions are identified and those with an unsatisfactory colposcopy results. Endocervical sampling is acceptable for women with satisfactory colposcopy results and a lesion identified in the transformation zone. Endo-cervical assessment either with colposcopy or by sampling is recommended for all nonpregnant women with HSIL cytology results. Endocervical curettage is unacceptable in pregnant women.
  • The recommended management of pregnant women with a histology diagnosis of CIN 1 is follow-up without treatment. Treatment of pregnant women for CIN 1 is unacceptable.
  • In a woman 21 years and older with CIN 1 that has persisted for at least 2 years, either continued follow-up or treatment is acceptable. If treatment is selected and the colposcopy result is satisfactory, either excision or ablation is acceptable. If treatment is selected and the colposcopy examination is unsatisfactory, the ECC is positive, or the woman has been previously treated, excision is recommended and ablative procedures are unacceptable.
  • Pregnant women with biopsy-proven CIN 2 or CIN 3 in whom there is no suspicion of invasive cancer may postpone re-evaluation with cytology and colposcopy to no sooner than 6 weeks postpartum. Treatment during pregnancy is unacceptable unless invasion is suspected. When invasion is suspected, a diagnostic excisional procedure is recommended.
  • For women 21 years and older, the preferred management of CIN 2,3 identified at the margins of a diagnostic excisional procedure or in an endocervical sample obtained at the end of the procedure is reassessment using cytology with endocervical sampling at 4–6 months following treatment. Performing a repeat diagnostic excisional procedure is acceptable, as is a hysterectomy if a repeat diagnostic procedure is not feasible and for women with a histology diagnosis of recurrent or persistent CIN 2,3
  • In nonpregnant women 21 years and older, both excision and ablation are acceptable treatment modalities in the presence of histology diagnoses of CIN 2,3 and satisfactory colposcopy results. Ablation is unacceptable when colposcopy has not been performed, the endocervical sampling is positive for any grade of CIN, the colposcopy result is unsatisfactory, or a woman has recurrent CIN 2,3.
  • Colposcopy with endocervical sampling is recommended and HPV DNA testing is preferred for women with all subcategories of AGC and AIS. In addition, endometrial sampling is recommended in women 35 years and older and in women younger than 35 years with clinical indications suggesting they may be at risk of neoplastic endometrial lesions (e.g., unexplained vaginal bleeding, chronic anovulation, or atypical endometrial cells). Colposcopy can be performed either at the initial evaluation or after the results are known. If no endometrial pathology is identified, colposcopy is recommended. Endometrial and endocervical sampling are unacceptable in pregnant women.
  • Women 21 years and older with either atypical endocervical, endometrial, or glandular cells NOS who do not have CIN or glandular neoplasia identified histologically should receive repeat cytology testing combined with HPV DNA testing at 6 months if they are HPV DNA positive and at 12 months if they are HPV DNA negative. Referral to colposcopy is recommended for women who subsequently test positive for high-risk HPV DNA or who are found to have ASC-US or greater on their repeat cytology tests. If both tests are negative, women can return to routine cytology testing.
  • Women with AGC, favors neoplasia or AIS cytology results should undergo a diagnostic excisional procedure unless invasive disease is identified during the initial colposcopy workup. The diagnostic excisional procedure used in this setting should provide an intact specimen with interpretable margins. Concomitant endocervical sampling is preferred, except in pregnant women.
  • Hysterectomy is unacceptable as the primary therapy for CIN.
  • Diagnostic ablation or excision is unacceptable as the initial management for ASC or LSIL.

The following recommendations are based primarily on consensus and expert opinion (Level C):

  • Pregnant women with biopsy-proven CIN 2 or CIN 3 in whom there is no suspicion of invasive cancer may postpone re-evaluation with cytology and colposcopy to no sooner than 6 weeks postpartum. Treatment during pregnancy is unacceptable unless invasion is suspected. When invasion is suspected, a diagnostic excisional procedure is recommended.
  • For women 21 years and older, the preferred management of CIN 2,3 identified at the margins of a diagnostic excisional procedure or in an endocervical sample obtained at the end of the procedure is reassessment using cytology with endocervical sampling at 4–6 months following treatment. Performing a repeat diagnostic excisional procedure is acceptable, as is a hysterectomy if a repeat diagnostic procedure is not feasible and for women with a histology diagnosis of recurrent or persistent CIN 2,3.
  • In nonpregnant women 21 years and older, both excision and ablation are acceptable treatment modalities in the presence of histology diagnoses of CIN 2,3 and satisfactory colposcopy results. Ablation is unacceptable when colposcopy has not been performed, the endocervical sampling is positive for any grade of CIN, the colposcopy result is unsatisfactory, or a woman has recurrent CIN 2,3.
  • Colposcopy with endocervical sampling is recommended and HPV DNA testing is preferred for women with all subcategories of AGC and AIS. In addition, endometrial sampling is recommended in women 35 years and older and in women younger than 35 years with clinical indications suggesting they may be at risk of neoplastic endometrial lesions (e.g., unexplained vaginal bleeding, chronic anovulation, or atypical endometrial cells). Colposcopy can be performed either at the initial evaluation or after the results are known. If no endometrial pathology is identified, colposcopy is recommended. Endometrial and endocervical sampling are unacceptable in pregnant women.
  • Women 21 years and older with either atypical endocervical, endometrial, or glandular cells NOS who do not have CIN or glandular neoplasia identified histologically should receive repeat cytology testing combined with HPV DNA testing at 6 months if they are HPV DNA positive and at 12 months if they are HPV DNA negative. Referral to colposcopy is recommended for women who subsequently test positive for high-risk HPV DNA or who are found to have ASC-US or greater on their repeat cytology tests. If both tests are negative, women can return to routine cytology testing.
  • Women with AGC, favors neoplasia or AIS cytology results should undergo a diagnostic excisional procedure unless invasive disease is identified during the initial colposcopy workup. The diagnostic excisional procedure used in this setting should provide an intact specimen with interpretable margins. Concomitant endocervical sampling is preferred, except in pregnant women.
  • Hysterectomy is unacceptable as the primary therapy for CIN.
  • Diagnostic ablation or excision is unacceptable as the initial management for ASC or LSIL.
  • In nonpregnant women 21 years and older with HSIL in whom CIN 2,3 has not been identified, three management options are acceptable: diagnostic excisional procedure; review of the cytology, histology, and colposcopy findings and management of the patient according to the revised interpretation; or if the colposcopy is satisfactory and endocervical sampling is negative, observation with colposcopy and cytology at 6 month-intervals for 1 year. A diagnostic excisional procedure is recommended for women with repeat HSIL cytology results at either the 6-month or 12-month visit. Women with two consecutive negative cytology results can return to routine screening.
  • In adolescents (before age 21 years) with HSIL cytology results, a satisfactory colposcopy result, negative endocervical sampling, and no CIN 2,3 identified on colposcopy biopsy, follow-up is recommended at 6-month intervals with Pap testing and colposcopy for up to 24 months. If during follow-up a high grade colposcopy lesion is identified or HSIL cytology results persist for 1 year, biopsy is recommended. If HSIL persists for 24 months without identification of CIN 2,3, or if the colposcopy result is unsatisfactory, a diagnostic excisional procedure is recommended. After two consecutive negative cytology results, women can return to routine cytology testing.
  • For adolescents and young women with a histology diagnosis of CIN 2,3 NOS and a satisfactory colposcopy result either treatment or observation for up to 24 months using both colposcopy and cytology at 6-month intervals is acceptable. When a histology diagnosis of CIN 2 is specified, observation is preferred. When a histology diagnosis of CIN 3 is specified or when the colposcopy result is unsatisfactory, treatment is recommended. If the colposcopy appearance of the lesion worsens or if an HSIL cytology result or a high-grade colposcopy lesion persists for 1 year, repeat biopsy is recommended. After two consecutive negative cytology results, women with normal colposcopy results can return to routine cytology screening. Treatment is recommended if CIN 3 is subsequently identified or if CIN 2,3 persists for 24 months.
  • In nonpregnant women 21 years and older with HSIL or AGC-NOS cytology results in whom CIN 1 has been identified on colposcopy three management options are acceptable: diagnostic excisional procedure; review of the cytology, histology, and colposcopy findings and management of the patient according to the revised interpretation; or if the colposcopy is satisfactory and endocervical sampling is negative, observation with colposcopy and cytology at 6-month intervals for 1 year. A diagnostic excisional procedure is recommended for women with repeat HSIL cytology results at either the 6-month or 12-month visit. Women with two consecutive negative cytology results can return to routine cytology screening.
  • In women 21 years and older with atypical endocervical, endometrial, or glandular cells NOS, HPV DNA testing is preferred at the time of colposcopy (if not already performed). For women of unknown HPV status who do not have CIN or glandular neoplasia identified histologically, the recommended postcolposcopy management is to repeat cytology testing at 6-month intervals. After four consecutive negative cytology results, women can return to routine cytology testing.
  • Women with a cervical biopsy diagnosis of AIS should undergo excision to exclude invasive cancer. A conization technique that preserves specimen orientation and permits optimal interpretation of histology and margin status is recommended. After conization, hysterectomy is preferred for women who have completed childbearing. Conservative management is acceptable if the margins of the specimen and the postprocedure endocervical curettage results are negative and future fertility is desired. If conservative management is planned and the margins of the specimen are involved or the postprocedure endocervical curettage specimen contains CIN or AIS, re-excision is preferred. Reevaluation at 6 months using a combination of cervical cytology, HPV DNA testing, and colposcopy with endocervical sampling is acceptable in this circumstance. Long-term follow-up after treatment is recommended for all women with AIS.

American College of Obstetricians and Gynecologists. ACOG practice bulletin no. 99: management of abnormal cervical cytology and histology. Obstet Gynecol. 2008  Dec;112(6):1419-44. http://www.ncbi.nlm.nih.gov/pubmed/19037054

ACOG Technology Assessment No. 5, Sonohysterography

ABSTRACT: The goal of sonohysterography is to visualize the endometrial cavity in more detail than is possible with routine transvaginal ultrasound. The procedure consists of the manual injection of sterile fluid under real-time ultrasonographic imaging. The most common indication for sonohysterography is abnormal uterine bleeding. The procedure should not be performed in a woman who is pregnant or who could be pregnant, or who has a pelvic infection or unexplained pelvic tenderness. Physicians who perform or supervise diagnostic sonohysterography should be skilled in vaginal ultrasonography and transcervical placement of catheters; should have training, experience, and demonstrated competence in gynecologic ultrasonography and sonohysterography; and should keep careful records. Portions of this document were developed jointly with the American College of Radiology and the American Institute of Ultrasound in Medicine.

American College of Obstetricians and Gynecologists. ACOG Technology Assessment No. 5. Sonohysterography. Obstet Gynecol 2008;112: 1467–9. http://www.ncbi.nlm.nih.gov/pubmed/19037058

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AHRQ

Depression symptoms are similar in pregnant and nonpregnant women

The symptoms of major depression are essentially the same in women who are pregnant and women who are not, according to a new study by Stanford University researcher Rachel Manber, Ph.D., and her colleagues. The researchers compared three groups of women—pregnant women with major depression, nonpregnant women with major depression, and pregnant women without depressive symptoms. Depressed pregnant women and depressed nonpregnant women had similar severity of depressive symptoms. However, depressed pregnant women had fewer intense feelings of suicide and guilt, and had significantly less difficulty falling asleep, but were more likely to show slowed movement and/or speech.

These findings are consistent with previous findings that childbearing alone has a modest, clinically insignificant effect on psychiatric symptoms. While pregnancy appears to reduce the intensity of some symptoms of depression, standardized measures of depression severity can be used to assess depression during pregnancy.

The researchers recommend that symptoms of psychological distress should not be written off as a normal part of pregnancy and that more attention should be focused on screening and identifying depressed pregnant women. They recruited the two samples of pregnant women (61 depressed and 41 nondepressed) from a larger study conducted at Stanford University through obstetric clinics and ads in local parent and baby magazines. Fifty-three depressed nonpregnant women were recruited from a larger study of acupuncture treatment for depression at the University of Arizona. All of the women were in the same age range, and the two depressed groups had equivalent severity of depressive symptoms.

The researchers administered two standardized measures of depression, the Hamilton Rating Scales for Depression and the Beck Depression Inventory, to all of the women participating in the study.

The study was funded in part by the Agency for Healthcare Research and Quality (HS09988). More details are in "Depression symptoms during pregnancy," by Dr. Manber, Christine Blasey, Ph.D., and John J. B. Allen, Ph.D., in Archives of Women's Mental Health 11, pp. 43–48, 2008. http://www.ahrq.gov/research/dec08/1208RA12.htm

PubMed Abstract: http://www.ncbi.nlm.nih.gov/pubmed/18270654

Correlates of medical and legal help seeking among women reporting intimate partner violence

The duration and severity of domestic abuse that women endure serve as a predictor of whether they will seek medical and legal help, a new study finds. Researchers in Seattle conducted telephone interviews with 1,509 women who participated in a health plan covering Washington and Northern Idaho and said they had experienced physical, sexual, or psychological abuse since reaching the age of 18. Women who were sexually or physically abused were more likely to seek medical care and legal assistance than women who reported only psychological abuse. For example, sexually abused women were 1.3 times as likely to seek medical care as women who were psychologically abused. The longer the abuse continued, the more likely the woman was to obtain legal help. For example, compared with women who were abused for 0 to 2 years, women who were physically abused for 3 to 10 years were 1.4 times more likely to seek legal services. Those who suffered physical abuse for more than 10 years were 1.9 times as likely to get legal help. Women who were psychologically abused were more inclined to obtain legal than medical services.

Duterte, E.E., Bonomi, A.E., Kernic, M.A., and others (2008, January). "Correlates of medical and legal help seeking among women reporting intimate partner violence." (AHRQ grant HS10909). Journal of Women's Health 17(1), pp. 85-95. http://www.ncbi.nlm.nih.gov/pubmed/18240985

Higher education among American Indian elders increases their likelihood of engaging in physical activity

American Indians and Alaska Natives (AI/ANs) report lower levels of leisure-time physical activity than majority populations. This lack of exercise puts them at risk for obesity, hypertension, type 2 diabetes, and cardiovascular disease, which are becoming more prevalent in many AI/AN communities. However, as with many other groups, more educated AI/AN elders have higher levels of physical activity than their less educated counterparts, finds a new study.

University of Washington researchers correlated education with physical activity level among 125 sedentary AI/AN elders (age 50 to 74 years) enrolled in a 6-week trial comparing 2 approaches to physical activity monitoring. They correlated educational level with total caloric expenditure for moderate-intensity physical activities (leisure, work, exercise, and chore-related) and distance traveled during a 6-minute walk test of fitness (6MWT).

Groups at different educational levels (less than high school, completed high school, General Education Degree or some vocational education, and college education) did not differ significantly in adjusted caloric expenditure due to all exercise activity. However, after controlling for relevant demographic and health factors, groups did differ significantly in caloric expenditure due to moderate to vigorous exercise, with the differences increasing significantly with higher levels of educational attainment. A similar significant positive trend was found between higher levels of education and increased distance covered during the 6MWT. The study was supported by the Agency for Healthcare Research and Quality (HS10854).

See "Education is associated with physical activity among American Indian elders," by Craig N. Sawchuk, Ph.D., Andy Bogart, M.S., Stephen Charles, B.A., and others, in the American Indian Alaska Native Mental Health Research 15(1), p. 1-17, 2008.
http://www.ahrq.gov/research/oct08/1008RA7.htm

PubMed Abstract: http://www.ncbi.nlm.nih.gov/pubmed/18493902

Recent U.S. Food and Drug Administration (FDA) Advisory

Oral Sodium Phosphate (OSP) Products for Bowel Cleansing (marketed as Visicol and OsmoPrep, and oral sodium phosphate products available without a prescription)

Audience: All healthcare professionals, consumers
[Posted 12/11/2008] FDA has become aware of reports of acute phosphate nephropathy, a type of acute kidney injury, associated with the use of oral sodium phosphate products (OSP) for bowel cleansing prior to colonoscopy or other procedures. These products include the prescription products, Visicol and OsmoPrep, and OSPs available over-the-counter without a prescription as laxatives (e.g., Fleet Phospho-soda). In some cases when used for bowel cleansing, these serious adverse events have occurred in patients without identifiable factors that would put them at risk for developing acute kidney injury.

FDA is requiring the manufacturer of Visicol and OsmoPrep, the two OSPs available by prescription only, to add a Boxed Warning to the labeling for these products. FDA is also requiring that the manufacturer develop and implement a risk evaluation and mitigation strategy (REMS), which will include a Medication Guide, to ensure that the benefits of these products outweigh the risk of acute phosphate nephropathy, and to conduct a postmarketing clinical trial to further assess the risk of acute kidney injury with use of these products. FDA recommends, in light of the risk of acute phosphate nephropathy, over-the-counter laxative OSP products should not be used for bowel cleansing. Consumers should only use OSPs for bowel cleansing pursuant to a prescription from a healthcare professional. http://www.fda.gov/medwatch/safety/2008/safety08.htm#OSP

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Ask A Librarian - Diane Cooper, M.S.L.S. / NIH

As your partner at the HSRL, I’m here to help you meet your information needs. If you need to find information at either patient point-of-care or as background information for a specific project, I can help. I am here to save you time and ensure you get the information you need. As your information needs evolve, I will expand and enhance my skills and work hard to stay on top of the latest information resources useful to the Indian Health Service. As your direct link to the HSRL and partner in your work, I can support you in the following ways:

  • Help with complex and difficult literature searches to support direct patient care and patient care activities
  • Participate and be a partner in IHS projects and development team activities
  • Assist in manuscript preparation (verify references; editing)
  • Set up current awareness alerts in your field of interest
  • Create customized databases in bibliographic software programs (Endnote; Reference Manager) to organize your information for easy retrieval when you need it
  • Provide instruction on how to search literature databases and other information resources more efficiently

Diane Cooper, MSLS
Biomedical Information Consultant for IHS
Division of Library Services
National Institutes of Health
Bethesda, MD 20892
301.594.2449
cooperd@mail.nih.gov
Diane.Cooper2@ihs.gov

Health Services Research Library (HSRL)
http://hsrl.nihlibrary.nih.gov

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Behavioral Health Insights - Peter Stuart, IHS Psychiatry CCC

Suicide and Antiepileptics – Real Concerns?

FDA ALERT [1/31/2008, Updated 12/16/2008] - The FDA has completed its analysis of reports of suicidality (suicidal behavior or ideation [thoughts]) from placebo-controlled clinical trials of drugs used to treat epilepsy, psychiatric disorders, and other conditions. Based on the outcome of this review, FDA is requiring, under the authorities granted under the Food and Drug Administration Amendments Act (FDAAA) of 2007, that all manufacturers of drugs in this class include a Warning in their labeling and develop a Medication Guide to be provided to patients prescribed these drugs to inform them of the risks of suicidal thoughts or actions.

The drugs affected by these safety labeling changes are commonly referred to as antiepileptic or anticonvulsant drugs (see the list below). FDA’s pooled analyses of 199 clinical trials of eleven antiepileptic drugs used as mono- and adjunctive therapies showed that patients who were randomized to receive one of the antiepileptic drugs had almost twice the risk of suicidal behavior or ideation (0.43%) compared to patients randomized to receive placebo (0.24%). This increase in the risk of suicidal thoughts or behavior represents the occurrence of approximately one additional case of suicidal thinking or behavior for every 530 patients treated with an antiepileptic drug.

The risk of suicidal thoughts or behavior was generally consistent among the eleven drugs analyzed and was observed in patients who were treated for epilepsy, psychiatric disorders, and other conditions. The relative risk for suicidal thoughts or behavior was higher in the clinical trials for epilepsy compared to trials for psychiatric or other conditions. However, the absolute risk differences were similar in the clinical trials for epilepsy and psychiatric indications.
The increased risk was observed as early as one week after starting antiepileptic drug treatment and throughout the observed duration of treatment. The increased risk of suicidal thoughts or behavior was generally consistent among the eleven drugs with varying mechanisms of action and across a range of indications. This observation suggests that the risk applies to all antiepileptic drugs used for any indication.

All patients who are currently taking or starting on any antiepileptic drug for any indication should be monitored for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression.

Psychiatry CCC Editorial Comment:  This advisory is part of a larger concern about adverse consequences of medications used to treat neuropsychiatric conditions. The actual event numbers involved were quite small (4 suicides in a population ~27,000 for a rate of 16/100,000 – lower than the background rate of suicides in our populations) and this was a post-hoc analysis of drug company reporting data thus reducing the power of the analysis to clearly identify causation. The FDA chose to keep the concern at an advisory level and not add a black box warning after extensive hearings.

Unfortunately, similar discussions and reviews related to antidepressants resulted in black box warnings. Recent data suggests that with the black box warnings there has been a reduction in the use of antidepressants particularly in adolescents – now followed by increases in suicide rates that may or may not be linked to the reduction.

The bottom line – treating neuropsychiatric conditions whether they are classically “psychiatric” or not require attention to the mood and emotional status of a person. This includes doing a basic assessment of propensity for self or other injury, mood and substance abuse history, and impulsivity, and incorporating the findings into the treatment plan. If there is a 1) a reasonable indication, 2) appropriate treatment targets and 3) reasonable alignment between the provider and the patient on treatment and treatment risks providers should continue to assertively treat such disorders. They remain some of the biggest contributors to mortality and morbidity in our populations and major sources of distress and suffering.

http://www.fda.gov/cder/drug/InfoSheets/HCP/antiepilepticsHCP.htm

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Breastfeeding - Suzan Murphy

We are very fortunate to have Dr. Frank Nice as a guest writer.  He is highly respected in many arenas including the use of medications during breastfeeding.  He is considered by many lactation professionals to be THE expert on the use of herbs during lactation. He holds numerous degrees in pharmacological sciences and administration and currently serves as a pharmacist at the National Institutes of Health. He retired from USPHS after 30 years of service, has published numerous articles about breastfeeding, medication, and herbs and continues to tirelessly contribute to the betterment of public health. Please welcome Frank J. Nice RPh, DPA, CPHP

Herbal Galactogogues

As with prescription drugs and over the counter (OTC) medications, consumers use herbals to treat a variety of ailments and to maintain health.  In fact, lactation consultants recommend, and breastfeeding mothers take, herbals called galactogogues, to help increase milk supply, usually by initiating the breast milk letdown reflex, but also sometimes by aiding in breast milk ejection.  Commonly used galactogogues include blessed thistle, chaste tree fruit, fennel, fenugreek, garlic, goat’s rue, and milk thistle.  Herbs, among others,  that may also act as galactogogues include alfalfa, anise, borage, caraway, coriander, dandelion, dill, hops, marshmallow root, nettle, oat straw, red clover, red raspberry, and vervain.

Blessed thistle, chaste tree fruit, fennel, fenugreek, garlic, goat’s rue, and milk thistle are considered major galactogogues in that they are the primary herbs used as galactogogues and are commonly used alone.  Alfalfa, anise, borage, caraway, coriander, dandelion, dill, hops, marshmallow, nettle, oat straw, red clover, red raspberry, and vervain are considered minor galactogogues because they are not as commonly used and commonly are used in combination with each other, often in homeopathic preparations.  If one looks at the list of minor galactogogues, along with some of the major galactogogues, it is apparent that many of these herbs find use as food products, especially within particular ethnic groups.

Common daily doses for the major galactogogues are: blessed thistle: 2-6 grams; chaste tree fruit: 30-40 mg; fennel: equivalent to 100-600mg; fenugreek: 6 grams; garlic: 4-9 grams; goat’s rue: 1-2 ml of tincture; milk thistle: 12-15 grams daily.  Dosage forms may include oral capsules, alcoholic extracts, tinctures, oils, seeds, and infusions.

Common daily doses for the minor galactogogues are: alfalfa: up to 60 grams; anise: 10-42 grams; borage: 1-2 grams; caraway: 1.5-6 grams; coriander: 3 grams; dandelion: 15 grams; dill: 3 grams; hops: 500 mg or one bottle of stout beer; marshmallow root: 3 grams; nettle: 1.8 grams; oat straw: 100 grams; red clover: 40-80 mg; red raspberry: 2.7 grams; vervain: 30-50 grams.  Dosage forms are the same as for the major galactogogues and also include teas and beer (hops).

Interesting facts about the major galactogogues include: blessed and milk thistle: these are two distinct herbs, other thistles are also used as galactogogues; chaste tree fruit: also known as chasteberry and vitex, if used in higher doses for breast pain, may negatively affect nursing performance; fennel: may also aid in milk ejection; fenugreek: the most commonly used herbal galactogogue, do not use if allergic to peanuts or legumes; mother and baby may smell like maple syrup; garlic: increases nursing time because baby likes smell of garlic, but if baby does not, opposite may occur; goat’s rue: contains galegin, a precursor of metformin, which also shows galactogogue properties, increases milk production in goats, sheep, and cattle.

Interesting facts about some of the minor galactogogues: alfalfa: do not use if allergic to peanuts or legumes or in mothers with systemic lupus erythematosus; anise: has mild estrogenic properties, which may aid in milk ejection; borage: potential blood thinner in large amounts; caraway: avoid volatile oil form; coriander; also known as cilantro, avoid if allergic to celery; dandelion: contraindicated in bile duct blockage and bowel obstruction;  dill: acts as diuretic to reduce postpartum edema; hops: aids milk letdown; marshmallow root: not the Kraft variety, acts as diuretic; nettle: acts as diuretic; oat straw: yes, regular oat meal; red clover: avoid fermented type, potential blood thinner; red raspberry: may aid in milk ejection, may decrease milk supply after two weeks use; vervain: contraindicated in pregnancy due to oxytocic properties.

For more information, please contact Dr. Nice at Frank.Nice@nih.hhs.gov

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CCC Corner Digest

Nicely laid out hard copy - A compact digest of last month’s CCC Corner

If you want a copy of the CCC Digest mailed to you each month, please contact Jean Howe

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Domestic Violence - Denise Grenier, Tucson / Rachel Locker, Warm Springs

Office of Violence against Women Fact Sheet:

Are Indian and Alaska Native Women at Risk of Experiencing Violence?
According to a December 2004 study by the Bureau of Justice Statistics, American Indians are twice as likely to experience sexual assault crimes compared to all other races. In 2000, the National Institute of Justice published a report on the findings of the National Violence against Women Survey which revealed that one in three Indian women reported having been raped during her lifetime.

What is OVW Doing to Stop Violence against American Indian and Alaska Native Women?
The Office on Violence against Women (OVW) was created by the Violence against Women Act of 1994. Since opening its doors in 1995, OVW has awarded more than $1 billion in grant funding to state, local, and tribal governments to address violence against women. 

Over the past decade, OVW has used more than $100 million in Congressionally-appropriated funding to make grant awards through the STOP Violence Against Indian Women Discretionary Grant Program, and through OVW’s other grant programs, to more than 120 tribal governments.

OVW offers a comprehensive training and technical assistance program designed to provide support and assistance to tribal governments to increase their capacity to develop a coordinated community response to domestic violence, sexual assault, and stalking, and to appropriately administer grant funds.  

What is the “Safety for Indian Women from Sexual Assault Demonstration Initiative”?
OVW has supported demonstration initiatives for Indian country, including its most recent initiative, the Safety for Indian Women from Sexual Assault Offenders Demonstration Initiative. Under this $2 million Initiative, four Federally-recognized Indian tribes received funding to increase their capacity to respond to the needs of Indian women who are victims of sexual assault, and to strengthen the collaboration between the tribal and Federal officials who share responsibility for responding to sexual assault in these communities.

Have OVW Grants Helped Tribal Communities End Violence Against Indian Women?
OVW will make awards totaling just over $30 million to tribal governments under the new Grants to Indian Tribal Governments Program during the summer of 2007. Between January 1, 2004 and June 30, 2005, more than 100 tribal governments used grant funding from OVW to improve their community’s response to violence against American Indian and Alaska Native women. Among the key accomplishments of this group, include:

  • Providing training on how to respond to crimes of domestic violence, sexual assault, and stalking to more than 650 law enforcement officers, nearly 150 prosecutors, and more than 130 judges, and 81 probation and parole officers.
  • Responding to 2,514 incidents of crimes related to violence against women. More than 1,700 of these cases were investigated, and nearly 1,100 offenders were arrested and charged.
  • Providing advocacy and supportive services to approximately 13,000 women and children from tribal communities, and helping more than 15,000 women obtain protective order relief.

http://www.ovw.usdoj.gov/ovw-fs.htm#fs-indian-country

Breaking the barriers: the promise of computer-assisted screening for intimate partner violence
Although intimate partner violence (IPV) affects hundreds of thousands of women, the majority of women seen in health care settings are not screened for IPV. Many women are hesitant to disclose their abusive situations to their health care providers and, sadly, there is evidence that when women do disclose violence, their health care providers do not give them needed support and information. This article discusses the importance of IPV screening and barriers that may contribute to the current lack of screening by providers and the low disclosure rate by IPV survivors, describes how computer-assisted screening for IPV can address those barriers, and reports the findings of an integrative review of studies about computer-assisted self-interview (CASI) IPV screening. Computer screening strategies consistently identified a higher prevalence of IPV and were the approach preferred by the study participants. The findings of these initial studies provide support for the development and testing of computer screening and intervention strategies for IPV.

Renker PR. Breaking the barriers: the promise of computer-assisted screening for intimate partner violence. J Midwifery Womens Health. 2008 Nov-Dec;53(6):496-503.
http://www.ncbi.nlm.nih.gov/pubmed/18984505

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Elder Care News - Bruce Finke, Elder Care Initiative

The Mayo Clinic and the Indian Health Service proudly announce

“An Intensive Case-Based Training in Palliative Care”
May 4-8, 2009; Rochester, Minnesota

This new and innovative intensive program will build on the principles and practice of palliative care previously introduced at the Education in Palliative and End-of-Life Care-Oncology (EPEC-O ™) conferences. It is designed to address some of the suggestions for additional training made by participants. This course will be taught at the Mayo Clinic by its faculty and IHS experts in palliative care. Actual cases will be presented and examined in detail, with an emphasis on an interdisciplinary approach to palliative care. Trainees will gain hands-on experience in dealing with real-life scenarios in the state-of-the-art Simulation Center. Trainees will also round with palliative care and pain management teams and attend weekly interdisciplinary case conferences. 

A portion of the course will be presented by telemedicine as part of the International Telehealth Palliative Care Symposium sponsored by the Alaska Native Tribal Health Consortium. Cultural considerations in providing palliative care for indigenous people will be emphasized.

There is no cost to attend. Funding, provided through the generosity of the Fort Defiance Service Unit, under the direction of Dr. Franklin Freeland CEO, will cover travel and per diem for teams of three or four individuals. Teams should be drawn from individual facilities or Service Units and include a physician, nurse and a social worker. Additionally, a pharmacist or other involved professional will be considered as part of a team.

Approximately 8 teams, 28-32 individuals, will be accepted. Teams with individuals who attended one of the previous EPEC-O™ conferences are strongly encouraged to attend, though this is not a prerequisite.

The deadline for applications is February 28, 2009. Applications will be accepted on a first request, first served basis. Register on line at http://www.csc.ihs.gov.
For questions or more information please contact: Timothy Domer, MD at Timothy.domer@ihs.gov.

The Indian Health Service Clinical Support Center (CSC) is providing meeting support and will act as the accredited sponsor for the 2009 “An Intensive Case-Based Training in Palliative Care” to be held from 1:00 pm Monday, May 4 through 12:00 noon Friday, May 8, 2009, in Rochester, Minnesota.

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Family Planning

Contraceptive nonuse among US women at risk for unplanned pregnancy

BACKGROUND: This study was conducted to assess risk factors for contraceptive nonuse among a nationally representative sample of US women and explored the influence of future pregnancy intentions on contraceptive nonuse.
STUDY DESIGN: Using data from the 2002 National Survey of Family Growth (NSFG), we analyzed 12 months of contraceptive behavior among 3687 women at risk for unplanned pregnancy.
RESULTS: Compared with contraceptive users, contraceptive nonusers were more likely to be older than 40 years (OR 6.3, 95% CI 2.7-14.7), black (OR 1.8, 95% CI 1.2-2.8), less educated (OR 2.4, 95% CI 1.4-4.0), uninsured (OR 1.6, 95% CI 1.1-2.4), Medicaid recipients (OR 1.9, 95% CI 1.2-2.9) or having infrequent intercourse (OR 3.8, 95% CI 2.7-5.3). We found no significant association between future pregnancy intentions and contraceptive behavior.
CONCLUSIONS: While family planning efforts have traditionally focused on disadvantaged women, older women and women who have infrequent sex are also at high risk for nonuse. Future pregnancy intentions, as currently assessed by the NSFG, is not a useful indicator of contraceptive behavior.

Wu J, Meldrum S, Dozier A, Stanwood N, Fiscella K. Contraceptive nonuse among US women at risk for unplanned pregnancy. Contraception. 2008 Oct;78(4):284-9. Epub 2008 Jul 22. http://www.ncbi.nlm.nih.gov/pubmed/18847575

Comparison of metabolic and inflammatory outcomes in women who used oral contraceptives and the levonorgestrel-releasing intrauterine device in a general population

OBJECTIVE: We compared the metabolic and cardiovascular parameters of a reference group of women with those of women who used 2 contraceptive regimes that are used worldwide: the levonorgestrel-releasing intrauterine device and oral contraceptives.
STUDY DESIGN: We investigated a cohort of 2814 women at age 31 years from the general population-based Northern Finland Birth Cohort who were born in 1966. Women were classified as oral contraceptive users (n = 687 women), levonorgestrel-releasing intrauterine device users (n = 168 women), or no use of hormonal contraception (reference group; n = 1959 women). The analyses were adjusted for body mass index, current alcohol use, household income, and area of residence.
RESULTS: Compared with the reference group, oral contraceptive users had higher systolic and diastolic blood pressure, raised levels of inflammatory indices (C-reactive protein), and impaired insulin sensitivity. Levonorgestrel-releasing intrauterine device users displayed a lower high-density lipoprotein and total cholesterol, but a similar cholesterol/ high-density lipoprotein ratio, and higher leukocyte count compared with the reference group. Oral contraception users were insulin-resistant compared with levonorgestrel-releasing intrauterine device users with higher blood pressure, raised lipid levels (such as total cholesterol and triglycerides) and insulin levels, and lower homeostasis model assessment and insulin sensitivity, despite smaller waist and lower waist-hip ratio.
CONCLUSION: Oral contraception usage was associated with adverse findings in several metabolic, cardiovascular, and inflammatory parameters, which is consistent with an increased future risk of cardiovascular and metabolic disease. These findings should invite more criticism of recent trends that encourage the prescription of oral contraceptives for years during reproductive life and especially in premenopausal women. In contrast, levonorgestrel-releasing intrauterine device or progestin-only pills may offer long-term health benefits over oral contraceptives and should be preferred to oral contraceptives for women in their forties and/or with metabolic risk factors for cardiovascular diseases and type 2 diabetes mellitus.

Morin-Papunen L, Martikainen H, McCarthy MI, Franks S, Sovio U, Hartikainen AL, Ruokonen A, Leinonen M, Laitinen J, Järvelin MR, Pouta A. Comparison of metabolic and inflammatory outcomes in women who used oral contraceptives and the levonorgestrel-releasing intrauterine device in a general population. Am J Obstet Gynecol. 2008 Nov;199(5):529.e1-529.e10. Epub 2008 Jun 4. http://www.ncbi.nlm.nih.gov/pubmed/18533124

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Featured Website

Improved healthfinder.gov Makes Health Information Quicker and Easier to Use

An improved and more accessible version of healthfinder.gov, a federal Web site designed to help people stay healthy, was launched today by the U.S. Department of Health and Human Services (HHS).

Its new design and interactive health management tools make information resources more accessible and easier to use for consumers and professionals.

"Many Americans struggle with complex health information Web sites. Healthfinder.gov makes important prevention information more accessible for all Americans, including those with limited time or understanding of medical terms," said HHS Assistant Secretary for Health Joxel Garcia, M.D. "We are proud to present healthfinder.gov as another tool for helping Americans stay healthy."

Healthfinder.gov's features include links to over 6,000 government and nonprofit health information resources on hundreds of health topics. Information is in English and Spanish. The improvements will help users find what they want on those sites.

For instance, Healthfinder.gov's Quick Guide to Healthy Living uses everyday language and examples to:

  • Tell users how taking small steps to improve health can lead to big benefits;
  • Motivate users by showing them the benefits of incorporating healthy behaviors into their lives;
  • Provide tools and encouragement, such as personal health calculators, menu planners and recipes, tips for caregivers, and printable lists of questions to take to the doctor.
  •  

Another new tool offered on the site is myhealthfinder, which provides personalized recommendations for clinical preventive services specific to the user's age, gender, and pregnancy status.

Based on their profiles, users may receive anywhere from five to 15 recommendations. For example, two of the recommendations a 35-year-old man would receive include getting blood pressure and cholesterol checked. Two of the recommendations a 54-year-old woman would receive include getting tested for colorectal cancer and talking with her doctor about taking low-dose aspirin every day to help lower her risk of stroke.

This feature was developed through a joint effort between HHS' Office of Disease Prevention and Health Promotion and the Agency for Healthcare Research and Quality (AHRQ). The feature provides evidence-based recommendations from the AHRQ-sponsored U.S. Preventive Services Task Force, an independent panel of experts in prevention and primary care.

"Health professionals have benefited from online access to task force recommendations for years. Until now, consumers have not had the same advantage," said AHRQ Director Carolyn M. Clancy, M.D. "We are pleased to join with ODPHP to offer myhealthfinder as a personalized, evidence-based prevention decision support tool."

The redesign of healthfinder.gov was based on proven clear communication practices. In addition, several possible versions of the Web site and the new prevention content were consumer tested to ensure that the site is user friendly and that people can find what they are looking for. As a result, healthfinder.gov is easy to understand and navigate, especially for consumers with limited health literacy.

Since 1997, healthfinder.gov has been recognized as a key resource for finding the best government and nonprofit health information on the Internet. It has been certified by HONcode, the oldest and the most used ethical and trustworthy code for medical and health related information available on Internet. It has also been recognized by the Medical Library Association as one of the top 10 most useful Web sites for consumers.

The healthfinder.gov project is coordinated by the Office of Disease Prevention and Health Promotion and its National Health Information Center, with the participation of a steering committee of representatives from federal agencies, including consumer health information specialists, librarians, and others actively engaged in providing online consumer health information.

Improved healthfinder.gov Makes Health Information Quicker and Easier to Use. Press Release, September 22, 2008. Office of Disease Prevention and Health Promotion and the Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/news/press/pr2008/healthfinderpr.htm

http://www.healthfinder.gov/

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Frequently Asked Questions - Neil Murphy, ANMC, Southcentral Foundation

Q. Should I withhold contraception from a woman who is not ‘current’ on her pap?
A. No, there should be no barriers to the use of FDA approved contraception.

With a 48% unintended pregnancy rate nationwide, the Indian Health system adheres to the national benchmarks on this….namely that there should be no obstacles placed in front of FDA approved birth control methods.

Potential barriers could include….

Real barriers: the legal standing of an adolescent in her health care, having a ‘current’ pap smear, first pelvic exams performed for ‘baseline’ data

Perceived barriers: lack of confidentiality, fear of side effects, sexual activity history documented in medical records

This is especially important now that cervical cancer screening has so many permutations that aren’t ‘annual’, but based on age, sexual debut, and prior HPV status, etc….

…so while we encourage ‘bundling’ in some quality assurance issues (induction of labor, etc…) the old bundling of cervical cancer screening and birth control method is not recommended.

In the Indian Health system, the stated policy is that we support the use of all FDA approved birth control methods, (see Chapter 13 below)

All of our recent meetings (the ACOG / IHS Postgraduate Course, our biennial MCH/Women’s Health meetings, etc…) have emphasized the Quick Start system (see Westhoff below).

Questions about adolescent rights in your state?
Alan Guttmacher Institute:
Go to the "State Policies in Brief" links
http://www.guttmacher.org/sections/adolescents.php?scope=U.S.%20specific

See Meeting Lecture Notes - Authors: Ogburn, Espey
http://www.ihs.gov/MedicalPrograms/MCH/F/lecNotes.cfm

Background:
There is a 48% unintended pregnancy rate nationwide.  Cervical cancer rates in reproductive age women pale in comparison.

Let’s look at adolescents as an example…
The pregnancy and abortion rates among adolescents in the United States are higher than in other industrialized nations as a result of intermittent, improper, and lack of use of contraception.

INCREASING ACCESS TO CONTRACEPTION — Barriers that impede the adolescent's access to contraception services should be recognized and removed, when possible.

Access to confidential services — The provider should recognize and respect an adolescent's need for privacy as a basic premise for providing confidential services. This goal can be achieved by facilitating a relationship with an adolescent that is independent from his or her parents. The adolescent should be given an opportunity to provide her medical history and to obtain gynecological and sexual information directly from the clinician. Both the parents and the adolescent may need to be educated regarding the new emphasis on direct interaction with the adolescent, as this approach is different from the approach used when children are younger and communication occurs primarily between the clinician and the parents.

As an example, the following statement may be made to an accompanying parent or guardian, "I would like to make this visit a positive experience for your daughter. It is important to respect an adolescent's privacy as a normal part of her growing up. I would first like to have the opportunity to review health information with you, followed by reviewing health information with your daughter alone. Usually, whatever is discussed between my teenage patients and me is confidential, except in certain situations, such as if she has thoughts of suicide, thoughts of physically harming someone, or reports she has or is being physically or sexually abused. If you feel you need to know more about what she and I have discussed, I strongly encourage you and your daughter to talk to each other directly."

The age of the adolescent is a factor in whether she will choose the option of complete confidentiality. A young teenager may express a preference to have her mother present throughout the office visit, particularly when the mother is aware of the teenager's sexual behavior and is the one who desires the teenager to use a contraceptive method. Despite such a situation, encouraging some independent time with the adolescent is important to obtain a more detailed history about other possible high-risk behaviors.

The provider who is not comfortable providing confidential contraceptive services to a minor should provide names and phone numbers of other clinicians or free clinics skilled in providing this care to adolescents.

Medical record — To keep certain portions of the sexual history in the medical record private, all of this information should be contained in a section identified as confidential. The confidential section may then be released only with the adolescent's permission to a parent, guardian, or other nonmedical party.

Legal issues — A minor's right to access contraceptive services in a health care setting without parental involvement varies from state to state. Many states give adolescents the right to consent to contraceptive services; no specific provisions have been found in consent laws for minors in others. The need for parental consent also may be related to state or federal funding for contraceptive services in local clinics. Thus, a provider should become familiar with the rulings in his or her own state and local clinic protocols.

Deferring the pelvic examination — Many adolescents perceive the pelvic examination to be a barrier to accessing contraceptive services. A pelvic examination is necessary to obtain a Papanicolaou (Pap) smear for cervical dysplasia and neoplasia and to test for sexually transmitted infections (STIs), but is not required by the Food and Drug for the initiation or reinstitution of oral contraceptives.

According to the American Cancer Society and American College of Obstetricians and Gynecologists, cervical cancer screening by a Pap test should begin approximately three years after first penile-vaginal sexual intercourse or age 21 years, whichever comes first. If urine testing for sexually transmitted infection (STI, gonorrhea and Chlamydia) is available and a Pap test is not indicated, the speculum and bimanual components of the pelvic examination may be deferred in an asymptomatic adolescent. In all such cases, external genital inspection must be performed. If urine testing is not available, swabs for gonorrhea and chlamydia testing must be obtained directly from the endocervix via speculum examination. A speculum and bimanual examination and microscopy of vaginal secretions are necessary if the adolescent has gynecologic and genital complaints such as an abnormal-looking discharge or intermenstrual spotting. If urine testing is not available, swabs for gonorrhea and chlamydia testing must be obtained directly from the endocervix via speculum examination.

The first pelvic examination is a milestone for the adolescent and needs to be a private and positive experience to foster communication on sensitive topics between the adolescent and her healthcare providers. Some clinicians offer their adolescent patients the option of having the parent, partner, or a friend present for support during the examination. If this option is offered, it is important to recognize the adolescent may prefer to have the examination alone, but feels obligated to allow her mother or partner to be present for the procedure. In any patient in whom signs of physical trauma are noted, the adolescent should be interviewed alone to elicit a history of possible physical or sexual abuse.

Pelvic examination is not required by the Food and Drug Administration (FDA) for the initiation or reinstitution of oral contraceptives. The OCP package insert states: "Physical examination may be deferred until after initiation of oral contraceptives if requested by the woman and judged appropriate by the clinician". Thus, deferring the pelvic examination may be considered at the first visit if the teenager has no genital complaints (e.g., abnormal vaginal discharge, pruritus, odor, etc) and:

  • She has avoided going to a clinic or physician's office out of fear of a pelvic examination, or
  • She is having her menstrual period during the visit, or
  • Scheduling an appointment for initiating contraception involves a long delay because of the time allocated for complete physical and pelvic examination

Teenagers appreciate that they have a choice in this matter. Subsequent performance of the pelvic examination may be facilitated by making an effort to alleviate fears related to the adolescent's perception of the pain and embarrassment she thinks she will suffer from the procedure. With appropriate education, one program found that among teenagers who deferred the pelvic examination for the situations cited by the FDA, 69 percent returned for the pelvic examination at the three-month visit and 78 percent by the six-month visit.

INCREASING CONTRACEPTIVE USE AND ADHERENCE — Oral contraceptive pills (OCPs) are the most popular prescriptive contraceptive method used by adolescents (44 percent), followed by condoms (37 percent), and depot medroxyprogesterone acetate (DMPA) (10 percent).

Although a variety of hormonal contraceptive methods are available, this discussion will focus on those commonly used by adolescents: OCPs and DMPA. In addition, the transdermal patch will be discussed since it appears to be increasing in popularity among adolescents. Use of the vaginal ring is increasing among older adolescents who are comfortable inserting it. There also is an emerging interest in the intrauterine device. The approved progestin-only subdermal implant (single rod) is effective for three years and is another viable option for adolescents in the future.
Emergency contraception, which is discussed in detail separately, is available by prescription and should be mentioned to all sexually active adolescents.

Motivating factors — The sexually active adolescent is more likely to seek contraception in the following situations:

  • Perceiving pregnancy as a negative outcome
  • Having long-term educational goals
  • Being of older age
  • Experiencing a pregnancy scare or actual pregnancy
  • Having family, friends, and/or a clinician who sanction the use of contraception

Adolescents are more likely to use condoms if they understand condoms can prevent HIV/AIDS, if they carry condoms and are not embarrassed to use them, and if they are worried about getting AIDS.

Initiating contraception — Adolescents vary in their readiness to initiate contraception. From a developmental perspective, sexually active girls in early adolescence have difficulty planning events and activities; they often live for the moment. Therefore, implementing a contraceptive method that requires planning and forethought is difficult at this age without monitoring and adult support. Girls in middle and late adolescence are more capable of higher-level planning, decision making, and problem solving, skills essential to effective contraceptive behavior.

Education — Several points should be discussed at the time of initiating a contraceptive:

  • Selecting the best method based on frequency of use and convenience
  • Risk of side effects
  • Tips on adherence
  • Use of condoms to protect against STIs
  • Practical suggestions to promote use, such as keeping condoms in a purse
  • The availability of and indications for emergency contraception

Sometimes an adolescent is sexually active and does not desire a pregnancy but is undecided about starting a method. In these cases, the discussion should raise her awareness of her risk of pregnancy and STIs. Reviewing stories of her sister(s), friends, or peers at school who are teen mothers may be helpful. Girls who are not engaging in sexual activity also should be educated about the use of condoms and emergency contraception, in case their status changes.
In other cases, a nervous mother or grandmother may desire reliable hormonal contraception for her daughter or granddaughter who is not yet sexually active. The adolescent may have demonstrated an interest in boys and/or may have an older sister who is a teenage mother. In these cases, the clinician should have an open discussion with the adolescent and the parent regarding parental fears, trust, and parent-monitoring skills. Finally, the pros and cons of starting hormonal contraception in an adolescent with growth potential should be considered against the risk of pregnancy. Gaining the adolescent's trust, valuing her opinion, and obtaining her consent for contraception in this case are important.

  • Selecting the best method — A careful history should be obtained prior to beginning the counseling process. This step will help the clinician facilitate counseling regarding any possible absolute or relative contraindications to starting an estrogen-progesterone product.
  • Anticipated adverse effects — The anticipated side effects from hormonal contraception should be reviewed. Breakthrough bleeding or amenorrhea from OCPs, DMPA, and the transdermal patch can be very upsetting. These methods are likely to be discontinued unless the adolescent has been counseled about potential problems and their treatment. As an example, in one study of women treated with DMPA, women who were told about the possibility of amenorrhea were 2.5 times more likely to continue DMPA than those not given this information.

A rash and itching at the application site may be of concern to adolescents using the transdermal patch. Partial or complete detachment of the transdermal patch was reported in 35 percent of adolescents in one study, compared with less than 5 percent in adults. Of note, no detachments were reported when the patch was worn on the arm. The likely explanation may be inadequate care in application and increased activity among teenagers compared with adults.

Noncontraceptive benefits — Reviewing the noncontraceptive benefits of OCPs, DMPA, and the transdermal patch with adolescents also is important. Benefits of OCPs and the transdermal patch include improved bone density and protection against ovarian cancer, endometrial cancer, salpingitis, ectopic pregnancy, benign breast disease, dysmenorrhea, and iron deficiency. The same benefits, with the exception of improved bone density, are provided by DMPA.

Informed consent — Although it is not necessary to obtain written informed consent before the initiation of hormonal contraception in adolescents, the use of a structured informed consent form can ensure that the risks and benefits are adequately discussed. The form used by Texas Children's Hospital for combination hormonal contraceptives is provided as an example.

Barriers to use and adherence — Barriers to the use of hormonal contraception by adolescents include fear of side effects, some of which are not substantiated by evidence.

Fear of side effects — A fear of side effects from OCPs and DMPA injections is a common barrier to the use of hormonal methods. As an example, in one review, adolescents in a private practice setting were overwhelmingly more concerned about weight gain from OCPs and those in an urban hospital-based adolescent clinic were concerned about weight gain, blood clots, birth defects, and infertility.

Weight gain — Many adolescents are concerned that oral contraceptives cause weight gain. However, available data suggest this is not the case. In the review described above. Adolescents who did not adhere to their OCPs were more likely to feel they had gained weight, although actual weight often was unchanged. Most young women did not gain more than 2.3 kg while using OCPs or 3.6 kg while using DMPA during a two-year period.

In another study, the effect of OCP use on body weight and fat distribution was assessed in 49 healthy young women initiating treatment with a low-dose OCPs (30 mcg ethinyl estradiol plus 75 mcg gestodene); anthropometric measurements before and after the initiation of OCP use were compared with those in 31 age-and-weight matched women not using OCPs. Baseline body mass index (BMI), percent fat, percent water, and waist-to-hip ratio (WHR) did not change significantly after six cycles in the OCP users. A similar number of women gained weight in both groups (30.6 percent of users, 35.4 percent of controls); the typical weight gain in the OCP group was only 0.5 kg. The weight gain in these women was caused by accumulation of fat, not body water. Approximately 20 percent of women in both groups lost weight. Thus, adolescents should be reassured that OCP use does not result in an increase in body weight or percent body fat over that seen in nonusers.

Adolescents also are increasingly concerned about weight gain from DMPA. Although weight gain and DMPA use may be concomitant events, a causal relationship has not been established. Factors other than DMPA may be playing a role. As an example, in one study, after six months of DMPA use, weight gain was greater among black than white subjects (4.2 versus 1.2 percent increase or mean weight gain of 2.9 versus 0.9 kg). A higher baseline weight, eating restraint, eating disinhibition, and other medications were predictive for weight gain in the black adolescents. In contrast, the only predictive factor for weight gain in white adolescents was a higher baseline weight. Thus, weight gain while using DMPA appears to occur in adolescents with a propensity for weight gain.

Bone density — DMPA and ultra low-dose estrogen (20 mcg) pills may interfere with achieving optimal peak bone mass in very young women by causing loss in bone density or interference with the increase during a time of expected bone accretion.

Rare cases of osteoporosis, including osteoporotic fractures, have been reported postmarketing in patients taking DMPA. For this reason, the United States Food and Drug Administration has a labeling change to include a warning that DMPA be used as a long-term birth control method (e.g., longer than two years) only if other birth control methods are inadequate.

It is important to review information regarding DMPA and bone density with adolescents. The general opinion is that, if possible, DMPA should be avoided in a girl during early adolescence. However, the data are not sufficient to limit the use of the transdermal patch in adolescents; nor are they sufficient to limit the use of DMPA in older adolescents. In fact, some experts argue that for adolescents in whom DMPA is the only acceptable contraceptive option, the benefit of pregnancy prevention outweighs the potential risk to bone health. This conclusion is based upon the following points:

  • Pregnancy also appears to decrease BMD
  • Most adolescents who use DMPA do so for less than two years
  • There is at least partial recovery of bone density after discontinuation of DMPA 
  • The adolescent can modify other lifestyle factors to maximize bone health (i.e., calcium intake, exercise, avoidance of tobacco use).
  • Estrogen supplementation may provide additional bone protection and may be warranted for girls in whom BMD may already be decreased (e.g., family history of osteoporosis, anorexia nervosa, chronic renal disease). The optimal dose and route for estrogen supplementation is not known; (0.625 mg equine estrogen per day is the only oral dose that has been tested).
  • Spinal bone mineral density can be monitored with dual energy absorptiometry (DXA) and compared with normative data to determine whether DMPA should be continued or discontinued. DXA should be obtained in all young women who use DMPA continuously for two years.

The Society for Adolescent Medicine has published a position paper regarding the black box warning for DMPA. The position paper suggests that:

  • With adequate explanation of benefits and potential risks, DMPA may continue to be prescribed to adolescent girls who need contraception
  • Decisions regarding bone density monitoring of adolescents using DMPA for contraception should be individualized; the decisions should be made by the clinician in concert with the adolescent, and potentially the adolescent's guardian
  • Duration of use of DMPA need not be restricted to two years
  • Adolescents using DMPA should be encouraged to take 1300 mg and 400 IU vitamin D and to exercise each day. Calcium and vitamin D supplements are available separately in tablet form or combined in a single tablet.
  • Estrogen supplementation should be considered for girls who are doing well on DMPA and have osteopenia or are at risk for osteopenia and who have no contraindications to estrogen
  • Pelvic inflammatory disease — The relationship between OCPs pelvic inflammatory disease (PID) is complex. Whereas some studies indicate that the use of OCPs increases the risk of PID, others suggest that OCPs increase the risk for cervicitis and endometritis, but not salpingitis, thereby decreasing the severity of PID.

No association between DMPA and risk of PID has been reported. The intrauterine device (IUD) itself does not increase the risk for PID. However, the presence of the IUD may increase the severity of PID in an adolescent due to their increased risk for STIs.

Venous thromboembolism — The association between OCPs and risk of venous thromboembolism (VTE) appears to be related to estrogen dose and type of progestin. Even low-dose OCPs (30 to 50 mcg estrogen pills) can be associated with a modest increase (three- to sixfold) in the risk of VTE. OCPs containing third-generation progestins also may be associated with a slight increase in risk of VTE.

Many adolescents and their parents also have raised questions about the reports of increased risk of VTE from the transdermal patch. The FDA has required the label for the transdermal patch to contain a warning regarding the possible increased risk of thrombotic events related to a higher-than-average circulating estrogen level. This warning is controversial because it is unclear whether the increased circulating estrogen level will in fact be associated with a higher frequency of adverse events.

The risk of VTE with OCPs or the transdermal patch should be considered in relation to the risk of VTE during pregnancy. The risk of VTE may be 3- to 10-fold higher in pregnant than nonpregnant women.

Nonetheless, it is important to take a careful personal and family history of deep venous thrombosis to identify those adolescent women who might be at high risk before prescribing an OCP or the patch (e.g., those who have antiphospholipid antibodies or nephrotic syndrome).

Other effects — Other side effects from OCPs of concern to adolescents include birth defects (11 percent) and infertility (10 percent).  Many adolescents hear about these effects from an adult who may have used higher-dose OCPs in the 1960s and 1970s or is otherwise misinformed. This situation underscores the importance of dispelling misconceptions about the adverse effects of OCPs, as well as DMPA, especially in adolescent women. There is no evidence to support an association between OCPs and either birth defects or infertility.

Summary — The perceived adverse effects of hormonal contraception is a real barrier to the use of this method among some adolescents.

  • Weight gain is a common concern. However, there is no evidence to suggest OCP use results in an increased body weight or percentage of body fat beyond that seen in nonusers. Among users of DMPA, weight gain appears to occur in those who have an underlying propensity for weight gain.
  • DMPA and low-dose estrogen OCPs may interfere with the achievement of peak bone mass in very young adolescent women. The general opinion is that, if possible, DMPA should be avoided in girls during early adolescence. The data are not sufficient to limit the use of the transdermal patch in adolescents; nor are they sufficient to limit the use of DMPA in older adolescents.
  • Low-dose OCPs are associated with a modest increase in the risk of venous thromboembolism.
  • Inadvertent OCP administration during early pregnancy has not been associated with an increase in risk of congenital anomalies.
  • OCPs do not increase the risk of infertility; in fact, the risk of primary infertility may be reduced in women who have taken an OCP.

Choosing a method and promoting adherence

Here is just one example of a BCM to provoke thought…
OCPs — Common examples of adherence problems with OCPs include not refilling OCP prescriptions, forgetting to take the pill, starting the next pack late, using pills sporadically, and not using a backup method when needed. In one study, 33 percent of adolescents missed a pill in the previous three months. Therefore, the adolescent should be provided clear verbal and written instructions. The clinician should ascertain she has sufficient reading skills to interpret labels and instructions. To optimize compliance with OCPs, an adolescent should be told only three things to remember:

  • When to start the pill
  • Take the pill every day at the same time, especially when doing something else regularly like teeth brushing
  • Call the clinic/office if there are any questions

She should be asked to repeat these three instructions to assess and promote her understanding of them. In addition, she should be given an easy-to-read list stating the clinic's name, a contact person, phone number, and instructions for when she misses pills. She should not rely on her friends or family for information if she has a problem with her medication.

  • When to start the pill — OCPs can be started at any time. In adolescents, they are typically started on the first day of the next menstrual period or the Sunday after the onset of the menstrual period ("Sunday start method"). The rationale for this delayed start date is to make sure that the adolescent is not pregnant. However, as many as 25 percent of adolescents who seek OCPs from family planning clinics never take the first pill. Failure to begin the pill may occur due to ambivalence, confusion about starting instructions, or intervening pregnancy.

To address this issue, a "same day" or "Quick start" method is now the preferred approach. The Quick start method requires increased attention to the adolescent's self report of sexual activity since her last menstrual period, the accuracy of the pregnancy test in the context of her sexual history, and the use of emergency contraception when applicable. (See Westhoff below)

Extended cycle pill or continuous pill use — A schedule that involves continuous pill use for 84 days followed by a week of pill-free days may help to increase OCP adherence in adolescents who wish to avoid a monthly period. The desire to avoid monthly periods may be related to participation in athletic events or summer camps or to the general discomfort and "hassle" of monthly periods.

Continuation rates — Continuation rates for OCPs in adolescents vary based upon the location of services. In free urban community and hospital-based clinics, rates after one year range from 9 to 40 percent. By comparison, a 75 percent continuation rate was noted at one year in a suburban practice. Intermittent use of contraception, method-switching, and periodic abstinence appear to be common in African-American adolescent females; in one series, one-third of such subjects on OCPs reported frequent periodic abstinence in any month.
Intermediate continuation rates have been noted with DMPA. In a retrospective chart review in an urban clinic, the one-year continuation rates were 45 percent with DMPA and 12 percent with OCPs. Lower values (32 percent at one year and 13 percent at two years) with DMPA were noted among inner city, minority adolescents with high pregnancy rates. Among those who discontinued therapy, 40 percent restarted the method at a later time.
Data regarding adherence rates with the transdermal patch in adolescents are limited. In one study of the feasibility and acceptability of the patch in adolescents, 31 of 50 participants (62 percent) completed all three-months of the study, and of these, 87 percent reported perfect compliance and 77 percent planned to continue using the patch.

SPECIAL CIRCUMSTANCES
The mentally handicapped adolescent — The mentally handicapped adolescent has access to contraception under the supervision of a parent or guardian. The availability of DMPA given every three months, the transdermal patch, and continuous OCPs with withdrawal bleeding every three months has significantly increased access to more convenient hormonal contraception, improved adherence, and made menstrual hygiene issues easier.
In most states, following an evaluation by three clinicians and acquisition of parental consent, a mentally handicapped adolescent has access to permanent sterilization after 21 years of age. In some states, under special circumstances such as an ambulating, profoundly mentally handicapped adolescent, sterilization of a mentally handicapped adolescent younger than 21 years of age may be approved after a process involving a review by an ethics committee and/or a court system.

The chronically ill adolescent — Hormonal contraception for the chronically ill adolescent can be a challenge. Estrogen-based hormonal contraceptives, as an example, should not be offered to an adolescent with significant valvular disease who is not being treated with an anticoagulant. Although DMPA is useful in such cases, its effect on fluid retention should be evaluated and monitored.

Similarly, estrogen-based hormonal contraceptives should not be offered to an adolescent with antiphospholipid antibody abnormalities, uncontrollable hypertension, and vascular involvement. DMPA is useful in such cases; there have been no reports of SLE flares with long-term DMPA use.

In addition, multiphasic or ultra-low OCPs are not recommended in adolescents taking many anticonvulsants because anticonvulsants other than valproic acid increase the clearance of sex steroids. DMPA is a good alternative because progesterone levels are high enough to be unaffected by increased P-450 activity.

Medications that alter the effectiveness of estrogen-based hormonal contraceptives by increasing clearance of sex steroids include rifampin, griseofulvin, and anticonvulsants. Herbal medication such as St. John's Wort also can increase clearance of sex steroids. There are inadequate data to support any significant drug interaction between common antibiotics and estrogen-based hormonal contraceptives. Thus it is important the choice of hormonal contraceptives be reviewed in the context of the chronic illness, potential increase in estrogen-related complications, and drug interactions during the counseling process. The risk of pregnancy needs to be weighed against the risk of a medical complication from hormonal contraception. In addition, emergency contraception should be discussed with adolescents whose current treatment may be teratogenic to the fetus or in whom pregnancy would severely compromise health.

Resources:
Westhoff C et al Initiation of Oral Contraceptives Using a Quick Start Compared with a Conventional Start: A Randomized Controlled Trial. Obstet Gynecol. 2007 Jun;109(6):1270-1276.
http://www.ncbi.nlm.nih.gov/pubmed/17540797

Chapter 13 - Maternal and Child Health
F, IHS Manual, Part 3 - Professional Services,

Contraceptive Services - All available Food and Drug Administration (FDA) approved types of contraceptive (mechanical, chemical and natural) methods should be available to those clients requesting such services. The choice of method will be that of the patient based on a careful explanation of each method in accordance with the medical judgment of the provider. Adequate follow-up should be available to respond promptly to complications or side effects of the various methods as well as to assure proper and effective use of the selected method.
http://www.ihs.gov/PublicInfo/Publications/IHSManual/Part3/pt3chapt13/pt3chpt13.htm#12f

Issues concerning the use of hormonal contraception by adolescents
http://www.uptodateonline.com/online/content/topic.do?topicKey=adol_med/2363&selectedTitle=2~150&source=search_result#6

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Indian Child Health Notes - Steve Holve, Pediatrics Chief Clinical Consultant

December 2008

Quote of the month
“The trouble with the world is that the ignorant are cocksure and the intelligent are full of doubt”
Anonymous

Etiquette-Based Medicine
 “Patients ideally deserve to have a compassionate doctor, but might they be satisfied with one who is simply well-behaved? When I hear patients complain about doctors, their criticism often has nothing to do with not feeling understood or empathized with. Instead, they object that "he just stared at his computer screen," "she never smiles," or "I had no idea who I was talking to." During my own recent hospitalization, I found the Old World manners of my European-born surgeon — and my reaction to them — revealing in this regard.”

This is the opening paragraph from a thought provoking essay recently published in the NEJM. The author reviews how much effort has been expended in the past few decades to teach medical students to be more humane and compassionate. He believes there has been no similar effort to teach clinicians “good manners”.

He uses an analogy with the recent decrease in ICU infections with the use of strict checklist protocols.  Rather than a “sophisticated” approach such as developing new antibiotics, success was achieved by strictly following simple hygiene rules. Changing attitudes is hard… changing behavior is much easier. He makes the argument that we might do as well by patients with developing a checklist of better behaviors that we can teach medical students.

Editorial Comment
At first glance it seems wrong to value form over content. Yet, the author makes a compelling case that patient satisfaction might be better served. It is an especially interesting concept since for most of us our work in Indian Health involves a cross cultural component. The author is a psychiatrist and feels that training students to be empathic is laudable but difficult. As he summarizes, “I’m not sure I teach students to see things through the patient’s eye, or to tolerate suffering. I think I can, however, train them to shake a patient’s hand, sit down during a conversation, and pay attention. 

Read the whole post at no charge at the link below:

Kahn, MW. Etiquette-Based Medicine. N Eng J Med. 2008 May 8;358(19):1988-9
http://content.nejm.org/cgi/content/full/358/19/1988

Infectious Disease Updates, Rosalyn Singleton, MD
Changes to the Pneumococcal Polysaccharide Vaccination (PPV23) Recommendation
The Advisory Committee on Immunization Practices (ACIP) met on Oct. 22nd, 2008, and reviewed and expanded the recommendation for the use of the 23-valent pneumococcal polysaccharide vaccine (PPV23). Persons 19 – 64 years of age with asthma as well as persons 19 – 64 years of age who are current smokers were added to the recommendation, and should routinely receive PPV23.

 In addition, the ACIP pneumococcal working group, which included representatives from IHS and tribal health programs, presented information related to the routine use of PPV23 in American Indian/Alaska Native (AI/AN)populations.  Based on this information, the ACIP voted to make the following changes to the recommendation for the use of PPV23 in AI/AN children and adults.

  • Previously, the ACIP recommendation stated that routine use of PPV23 after receipt of pneumococcal conjugate vaccine “could be considered” for AI/AN children.1 In addition to being confusing for providers, the working group found that there are limited data on the effectiveness of this strategy in reducing invasive pneumococcal disease, and noted limited data that suggest that PPV23 vaccination after receipt of pneumococcal conjugate vaccine could cause hyporesponsiveness, although the clinical implications of this finding are not known.  Based on this information the ACIP approved the following change to the recommendation re: the use of PPV23 for AI/AN children. The new recommendation reads:

Routine use of PPV23 after PCV7 is not recommended for Alaska Native or American Indian children aged 24-59 months. However, in special situations, public health authorities may consider recommending the use of PPV23 after PCV7 for Alaska Native or American Indian children aged 24-59 months who are living in areas where the risk of invasive pneumococcal disease is increased.

  • The previous ACIP pneumococcal recommendation stated that “Persons aged 2-64 years who are living in environments or social settings in which the risk for invasive pneumococcal disease or its complications is increased (e.g.., Alaskan Natives and certain American Indian populations) should be vaccinated."2The working group found that there was no data to support such a broad recommendation, and expressed concern that the recommendation was confusing for providers and offensive to some AI/AN people. Based on this information, the ACIP voted to approve the following change to this recommendation:

Routine use of PPV23 is not recommended for Alaska Native or American Indian persons younger than 65 years old unless they have underlying medical conditions that are PPV23 indications.  However, public health authorities may consider recommending PPV23 for Alaska Natives and certain American Indians aged 50-64 years who are living in areas where the risk of invasive pneumococcal disease is increased.

In summary, routine use of PPV23 is still indicated for people, including AI/AN people, who (bold indicates new risk groups):

  • Are 65 years and older
  • Have a chronic health condition (e.g. chronic cardiovascular disease chronic pulmonary disease (including asthma), diabetes mellitus, alcoholism, and chronic liver disease (cirrhosis), or CSF leaks.
  • Are a current smoker
  • Have functional or anatomic asplenia (e.g., sickle cell disease or splenectomy)

1“Preventing Pneumococcal Disease Among Infants and Young Children. Recommendations of the Advisory Committee on Immunization Practices (ACIP). October 06, 2000 / 49(RR09);1-38

2Ibid

Recent literature on American Indian/Alaskan Native Health, Michael L. Bartholomew, MD

Results of a Collaborative School-Based Oral Health Program in a Remote First Nations Community
Dental caries continues to be a significant infectious disease afflicting American Indians and Alaska Native children.  Multiple programs addressing oral health have been implemented with varying success. Dr. Steve Holve presented the current state of oral health in AI/AN communities in the October 2006 edition of the IHS Primary Care Provider.1 Concerns about oral health of native or aboriginal children extend across national boundaries.  Aboriginal children of Canada appear to have an increase prevalence of poor oral health, often 2-3 times poorer than other populations in Canada. Dental decay rates in Canada have been cited to be 3 to 5 times greater in aboriginal children than in non-aboriginal children.  Causes for this increase have been bottle caries, high sugar diets, limited access to dental health care and oral hygiene.

This cross-sectional study reports the results of a collaborative school-based oral health program in a remote First Nations community over the past three years.  The Pediatric Residency Program at the University of British Columbia established a partnership with the people of Hartley Bay.  After meeting with the community and its elders, oral health was identified as a problem.  Four possible interventions addressing oral health were presented.  The community chose a school based intervention consisting of supervised, daily school-based brush-ins after lunch, weekly fluoride rinse, and fluoride varnish applications for those under 9 years of age, dental health anticipatory guidance, and classroom presentations on oral health.  All the children in the community participated. Fifty-eight children were enrolled into the study of which 26 students were given pre-enrollment complete dental examinations.  18 children who were initially enrolled were lost to follow-up.  Therefore only 40 students completed the study.  Thirteen students had both pre and post intervention evaluations.  Each participant was given a Decayed, Missing, and Filled Surfaces (DFMS) score for primary or permanent teeth, cavity free status and an oral health habits questionnaire.  

Over the three-year period, the children evaluated pre and post intervention had significant improvement in DMFS scores.  Improvement in cavity free status and oral health habits were also seen.   The success of this study underscores the importance of collaboration and community input in the design of public health interventions.

Macnab AJ, Rozmus J, Benton D, Gagnon, FA. 3-Year Results of a Collaborative School-Based Oral Health Program in a Remote First Nations Community. Rural and Remote Health 8:882. 2008. http://www.ncbi.nlm.nih.gov/pubmed/18444770

Reference:
1Holve S. Fluoride Varnish Applied at Well Child Care Visits Can Reduce Early Childhood Caries. IHS Primary Care Provider 2006. 31(10):243-245.

January 2009

Editor’s Comment from Steve Holve, CCC Pediatrics

The recent death of Dr. Roger Gollub was an unexpected tragedy. I am using this editorial space to reprint a tribute to Dr. Gollub from Robert McSwain, Director of the Indian Health Service. I would urge you to contribute to the memorial fund listed in the last paragraph.

It is my sad duty to inform you that Dr. Roger Gollub, who recently retired from the U.S. Public Health Service Commissioned Corps, died unexpectedly on November 19, 2008, in Kotzebue, Alaska.  Dr. Gollub had retired in September after serving in the USPHS for over 24 years. During his career, he devoted himself to working with American Indians and Alaska Natives in their communities.

Dr. Gollub was a brilliant and committed scientist and pediatrician. He began his career as a staff pediatrician at the Gallup Indian Medical Center in Gallup, New Mexico.  After two years in the Epidemiology Intelligence Service of the Centers for Disease Control in an assignment with the Colorado Department of Health, he subsequently served for 11 years as the epidemiologist for the IHS Albuquerque Area.  During that time, Dr. Gollub was pediatric advisor to the National IHS Head Start Program and collaborated with other pediatricians on a five-year Healthy Tomorrows grant to serve children with special needs. 

For the past seven years, he served as a full-time pediatrician in the South central Foundation Primary Care Clinic at the Alaska Native Medical Center in Anchorage.  His clinical services included outreach to rural Alaska villages.  Dr. Gollub was in Kotzebue providing a pediatric clinic on the day of his death.

He loved the adventure of living in Alaska, and frequently shared his resulting photographs and stories with friends.  Dr. Gollub chose to retire from the Corps in September so he could also pursue his dream and commitment to research and working with the Alaska Native Head Start program, while continuing his clinical services part-time.

He lived his life serving others. His tragic and untimely death has highlighted some of the public health issues facing the communities he served and his commitment to prevention. Although Dr. Gollub’s co-workers were always amazed at his vast knowledge and teachings, he believed those around him were his greatest teachers, and that he was their student. 

Dr. Gollub was born in University City, Missouri.  Not surprisingly, he was the valedictorian of his high school class.  He attended Yale University, obtained his medical degree from John Hopkins University, and completed his pediatric residency at Case Western Reserve University.

Dr. Gollub is survived by his wife, Diane Abrahams-Gollub; two daughters, Anna and Sarah, his mother, Sheila Gollub; brother, David, and numerous co-workers and friends.  His family has established a memorial fund in Dr. Gollub’s name to benefit the Head Start program for Alaska Native children. Contributions can be sent to the Alaska USA Federal Credit Union, Account # 1429780 and Routing # 325272021.  The address of the bank is P.O. Box 196613 Anchorage, AK 99508-6613.  Further information is available at www.drrogergollubcommunity.org

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International Health Update - Claire Wendland, Madison, WI

Warfare and neglected diseases

Last year The Lancet ran a series of research articles looking at the implications of understanding health as a human right.  In the third article in the series, Chris Beyrer and colleagues explore the intersection of so-called “neglected diseases” and civil conflict.  Using detailed case studies from Burma and Colombia, they make a convincing argument that conflict can drive substantial increases in the rates of these diseases. 

“Neglected diseases” is a blanket term that covers various tropical infections, many resulting from protozoans or helminthes.  They are neglected because they are unprofitable to treat, even though by most estimates they collectively account for about a fourth of the global burden of disease (above better-known infections like malaria or tuberculosis).  These diseases afflict the poorest people in poor countries.  In the wealthy world, then, there is little motivation to research these diseases or provide therapy for them; in the poor countries in which they are found, there is little infrastructure to do either.

Burma is ruled by a military junta with one of the worst human rights records in the world; over forty percent of state expenditure goes to the military, and less than three percent is directed to health.  Neighboring Thailand has nearly eliminated Wuchereria bancrofti, the cause of the disabling chronic disease lymphatic filariasis, by mass chemotherapy in affected zones using diethylcarbamazine.  Burma’s rulers, in contrast, provide neither the drugs nor the community health workers to deliver them.  Filariasis affects roughly 10% of Burma’s population, and some 40% show signs of exposure.  Not only are Burma’s citizens affected, but fleeing refugees are threatening W. bancrofti control in nearby countries.  In Colombia, Beyrer and colleagues document increases in leishmaniasis, yellow fever, and Trypanosoma cruzi (the cause of Chagas’ disease, a progressive cardiomyopathy) in the most violent rural areas.  Neither treatment nor preventive measures can be effectively applied in guerilla-controlled areas; in fact, vaccines and drugs have even been hijacked.

Conflict allows neglected diseases to burgeon in many ways.  It restricts disease surveillance, limits access to diagnostic and curative services, and disables preventive measures like control of disease-bearing insects or distribution of vaccines.  In addition, affected patients may present at very late stages because of difficulty in accessing care, and infections may spread rapidly as displaced people move beyond previous community boundaries.  Donors and researchers may be (understandably) reluctant to investigate or treat outbreaks in unsafe conditions.  The diversion of money from health care to the military clearly also plays a role in many conflicts.

The authors do not offer much in the way of strategies to improve health in conflict settings.  In addition, they do not draw the obvious connections with other kinds of health problems exacerbated by warfare.  We know, for instance, that maternal morbidity and mortality suffer when access to care is lost, and childhood deaths rise as community infrastructure breaks down and safe food and water can no longer be assured.  The focus on neglected infectious diseases seems narrow.  But their conclusion is right: “resolving these health problems cannot be better done than with peace, reconciliation, and the end of chronic conflicts.”

Beyrer C et al.  Neglected diseases, civil conflicts, and the right to health.  The Lancet 370(9587):619-627, 2007 http://www.ncbi.nlm.nih.gov/pubmed/17707757

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MCH Alert

Curriculum Aims to Decrease Incidence and Improve Care of Diabetes among American Indians and Alaska Natives

Diabetes Education in Tribal Schools: Health is Life in Balance is a K-12 curriculum designed to enhance the understanding and appreciation of the problems of diabetes in American Indian and Alaska Native (AI/AN) communities, to empower students to make healthy lifestyle choices, and to stimulate general student interest in diabetes-based science careers. The Diabetes Education in Tribal Schools (DETS) curriculum was developed by the National Institute of Diabetes and Digestive and Kidney Diseases in collaboration with the Indian Health Service Division of Diabetes Treatment and Prevention, the Centers for Disease Control and Prevention Native Diabetes Wellness Program, eight tribal colleges and universities, and the National Institutes of Health Office of Science Education. The curriculum comprises multidisciplinary units with lessons that incorporate National Science Education Standards and AI/AN cultural and community knowledge. The DETS Web site contains information on the curriculum's background, mission, instructional content, federal agencies and contributing partners, tribal colleges and universities, and participating schools. A press release about the DETS national launch, answers to frequently asked questions, and the 2008 DETS implementation test evaluation research summary are also provided.

The curriculum is available at: http://www3.niddk.nih.gov/fund/other/dets/index.htm.

2008 Edition of Women’s Health Data Book Released

Women's Health USA 2008, the seventh edition of the data book, selectively highlights emerging issues and trends in women's health using a variety of data sources. The data book, developed by the Health Resources and Services Administration, includes information and data on population characteristics, health status, and health services utilization. New topics in the 2008 edition include occupational injury, maternal mortality, digestive disorders, oral health, eye health, and urologic disorders. Racial and ethnic, sex and gender, and socioeconomic disparities in women's health are also highlighted. The data book is intended to be a concise reference for policymakers and program managers at the federal, state, and local levels to identify and clarify issues affecting the health of women.

It is available at http://mchb.hrsa.gov/whusa08/.

MCH Library Releases Online Resource Brief on Women’s Health

Women's Health: Resource Brief is an electronic guide to recent resources on Web sites, federal offices of women's health, and other related resources for health professionals and families. The brief, produced by the MCH Library, contains links to related bibliographies, knowledge paths, and organizations developed by the library. Topics include AIDS and HIV in pregnancy, assisted reproductive technologies, breastfeeding and working mothers, depression during pregnancy, domestic violence, maternal morbidity and mortality, nutrition and physical activity for women, nutrition during pregnancy, preconception and pregnancy, and smoking and substance use during pregnancy.

The brief is available at http://www.mchlibrary.info/guides/womenshealth.html.

MCH Library resources on this and other maternal and child health topics are available at http://www.mchlibrary.info/guides.html.

AAP Updates Training on Creating a Safer Sleep Environment to Prevent Sudden Infant Death Syndrome

Reducing the Risk of SIDS in Child Care Speaker's Kit is a tool designed for use by health and education professionals to educate communities about sudden infant death syndrome in child care. The updated kit, produced by the American Academy of Pediatrics' Healthy Child Care America Back to Sleep Campaign, is available in two formats: a PowerPoint version or a downloadable print version, including speaker's notes. Content is available in English and Spanish. Additional supplements available in English only include a sample policy and an alternative sleep position waiver from the North Carolina Healthy Start Foundation.

The kit is available at http://www.healthychildcare.org/section_SIDS.cfm#train.

Readers: An article published in the October 2008 issue of Pediatrics describes a study to evaluate the use of the speaker's kit combined with a training and evaluation effort that incorporated direct observation of child care provider practices. The abstract is available at http://pediatrics.aappublications.org/cgi/content/abstract/122/4/788.

Report Addresses the Scientific Basis for Maternity Practice

Evidence-Based Maternity Care: What It Is and What It Can Achieve presents a discussion of maternity care in the U.S. health care system and identifies key indicators that show the need for improvement. The report, developed by Childbirth Connection in collaboration with the Reforming States Group and the Milbank Memorial Fund, summarizes results of systematic reviews that could be used to improve maternity care quality, identifies barriers to the use of evidence-based maternity care, and offers policy recommendations and other strategies that could lead to wider implementation of evidence-based maternity care in the United States. 
Resources and tools are included.
The report is available at: http://www.childbirthconnection.org/article.asp?ck=10575

Article Explores the Effects of Contact with Stillborn Infants on Maternal Anxiety and Depression

"Seeing and holding a stillborn baby are associated with fewer anxiety and depressive symptoms among mothers of stillborn babies than not doing so," write the authors of an article published in the December 2008 issue of Birth. In the mid-20th century, mothers of stillborn infants rarely had the opportunity to see and hold their newborns. Later in the century, many hospitals began to promote rituals through which mothers could see and hold their stillborn infants, believing that this process would facilitate healthy maternal grief responses. Recently, this practice has been called into question. The goal of the study described in this article was to determine the association between seeing and holding a stillborn infant with maternal anxiety and depression. The authors assessed both the mothers' probability of seeing and holding their infants and the risk for symptoms of anxiety and depression during a subsequent pregnancy and in the long term.

For the study, 2,292 women who reported a singleton stillbirth after 20 weeks' gestation and certainty about whether they were currently pregnant completed interactive questionnaires that explored various topics related to stillbirth. Anxiety and depression rates were measured.

The authors found that

* The great majority of mothers saw (95%) and held (90%) their stillborn infants, and few expressed regret that they did so.

* Almost 80% of mothers who did not see and hold their stillborn infants expressed regret that they did not do so.

* Among participants, 42% and 62% reported symptoms of anxiety and depression, respectively.

* Among mothers who did not see their stillborn infants, those who never were given the opportunity and those who actively resisted tended to have more anxiety symptoms than those who reported that they simply did not wish to see the infant.

* Among mothers who saw their stillborn infants, those who reported that they were given no other options or that the subject was not discussed with them had fewer symptoms of depression than mothers who reported having seen the infant because of their own wish to do so.

* Mothers who perceived that health professionals left the decision to them by offering them the option to see and hold the infant when they had no strong wishes of their own tended to have more symptoms of depression than those who spontaneously wished to see their infant.

* Mothers who were pregnant at the time of the investigation and who had seen and held their stillborn infants had fewer symptom of depression but more symptoms of anxiety than their counterparts who had not seen or held their stillborn infants. However, long-term results suggest that the negative effects are transient.

The authors conclude that "since caregiver interaction may influence a grieving mother's responses during the acute crisis, active management that includes responsiveness, support, and a staff willing to facilitate contact with a stillborn baby is necessary and may provide long-term benefits to the mother."

Cacciatore J, Radestad I, Froen F. 2008. Effects of contact with stillborn babies on maternal anxiety and depression. Birth 35(4):313-320. Abstract available at http://www3.interscience.wiley.com/journal/121523277/abstract.

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MCH Headlines - Judy Thierry HQE

Project Making Medicine; Specialized training in the treatment of child physical and sexual abuse

From Dee Big Foot: "I am pleased to announce that we have received a grant from Indian Health Service and the Children’ Bureau to provide specialized training in the treatment of child physical and sexual abuse.  This funding will allow the Indian Country Child Trauma Center at the University of Oklahoma Health Sciences Center to offer 4 regional trainings with 45 training slots available at each regional location.

If you are interested in attending the training in your region, please check out our website at www.icctc.org for information about the application process.  A limited amount of travel funds are available for applicants who successful apply; I strongly encourage two or more applicants from each site to allow for carpooling or other creative ways to get the most out of the limited funds. 

Please share this information with your colleagues or other mental health or wellness providers in your area.  I do not have current email information for many of our past training participants and I would greatly appreciate if you could help disseminate this announcement as widely as possible. 

Location and Dates:
Phoenix, AZ - February 17-19, 2009
Portland, OR - March 10-12, 2009
Minneapolis, MN - April 13-15, 2009
Anchorage, AK - June 2-5, 2009

 If you have questions, please contact me at dee-bigfoot@ouhsc.edu or Janie Braden at Janie-braden@ouhsc.edu.  You may also call 405-271-8858.

2009 Childhood Obesity Conference: Creating Healthy Places for All Children

The 5th biennial Childhood Obesity Conference is the largest gathering of professionals focused on the prevention of pediatric overweight in the nation with over 1,800 in attendance. The conference is devoted to providing the most pressing and innovative issues related to childhood obesity. Showcased will be presentations focused on issues, strategies and programs as they relate to the environmental, organizational, media advocacy and policy, nutrition and physical activity education, and family and clinical approaches to childhood obesity.

Goals

  • Showcase evidenced-based prevention interventions to reduce overweight and obesity in high risk and low income communities.
  • Feature community efforts to implement environmental and policy strategies that promote and sustain healthy eating and activity behaviors.
  • Accelerate the obesity prevention movement to promote health equities and reduce disparities at the local, state and national levels.
  • Promote collaboration among diverse stakeholders to ensure access to healthy foods and physical activity for all children.

Registration:

To register, sponsor, exhibit, or apply for a poster session, visit www.childhood-obesity.net or call (800) 858-7743.
Early Registration (on or before May 8th) $350
Late Registration (after May 8th) $400
Location:
Westin Bonaventure Hotel | 404 South Figueroa Street | Los Angeles, CA 90071

Breastfeeding Initiation DVD Resource

These DVD’s are a must for all hospitals, nurseries, rooming-in programs and delivery units, even for sites that send their mom’s out for delivery. This is the most explicit documentation and visual/audio education that I have seen on breastfeeding initiation.
 
1. Making Enough Milk, The Key to Successful Breastfeeding…Planning for Day One
2. A Preemie Needs His Mother. First Steps to Breastfeeding Your Premature Baby
3. Breastfeeding, A Guide to Getting Started
4. Breastfeeding Management, Educational Tools for Physicians and Other Professionals

Breastmilk Solutions has 4 DVD’s @ 65$ each or $225 for the set of four – bulk orders may be priced lower.  http://www.breastmilksolutions.com/order.html                                              

FitTV and Discover Communications with DHHS and AHRQ present:

Max’s Magical Delivery Fit for Kids
A ~ 30 minute DVD for Parents and Kids! (5 – 9 year olds)
4 kids enter Max’s world when a giant wooden packing crate arrives at the house on Saturday morning interrupting Super Amazing Asteroid Freaks video game.  A food mobile that runs on bananas (and the peels), vegetables, but not too much – burp! and other technologies are in the box to taking the kids on an inquiry _ “what is too much?”, “how often?” and “how much exercise it takes to burn off food”.  They discover with a special camera that their mom did not eat breakfast and Max ate “way too much” on the way over to deliver the crate.  A “Mission Impossible” sequence with special guest, Surgeon General Richard Carmona issues the challenge of a 5 a day.  The suitcase self destructs of course – into a bunch of grapes. 
Physical activity using clocks to measure # of jumping jacks, balloon bouncing, and jumping rope – beating your own best effort is offered. Seasonal, all weather, indoor activities, varied landscapes, individual and group activities, equipment and no equipment required activities are presented.  Screen time, 5 a day, is reintroduced – the voices trail off as they go outside to leave mom jump roping in the debris.

The parent box
Max instructs Mom in 5 simple steps in nutrition:
≥       “Portions” – meat, rice, veggies, peanut butter, bread, - visuals provided.
≥       “Switch it up” – white for whole wheat, whole wheat pasta, fish and poultry, low fat – skim, steam and bake and grilling,
≥       Healthy Snack options – easy to reach, water, veggies, low fat chips,
≥       Moderation with those sweets –
≥       Involve the whole family, - eat together encourages slower eating and other tips

Fitness Sequence - Mom has to “pedal to ‘power up’ the message” on an exercise bicycle with pictures and vignettes of family walks, bike rides, carwashes, sports with kids, toddlers playing on play sets, and parent/kid play.  “Don’t forget water!” Sweating is a good sign. The arithmetic is 30 minutes of exercise to each 1 hour of TV/ computer time.  Lastly the President’s Challenge is presented - 5 times a week for 6 weeks is for kids and adults with personal activity log. 
http://www.presidentschallenge.org/home_kids.aspx
Lively and attention holding, reinforcing educational tips with visuals and healthy children interacting makes the DVD useable in the classroom or waiting room.
The only thing that would have made it fit my 1950’s - 60’s childhood was for the kids to grab hammers and nails and dismantle the crate and build a fort or tree house.  

Order the video: http://gold.ahrq.gov/eorders/order_page4907.cfm

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Medical Mystery Tour - Neil Murphy, Southcentral Foundation; ANMC

Test your knowledge on Polycystic Ovarian Syndrome (PCOS); The Answers:

1. Menstrual cycles become more irregular in women with polycystic ovarian syndrome (PCOS) as they approach menopause? True/False

Answer
-False

Actually perimenopause may cause women with PCO to have a little more regular menstrual spacing. This change may be related to the elevation, or relative normalization, of the FSH levels as the woman ages. This change in the LH / FSH ratio seems to revert the ovarian function towards normal in this population.

‘Having said that, it does not imply that the basic PCO metabolic abnormalities have dissipated with age. The patient is still at risk for dyslipidemia, etc…. so the patient should still aggressively manage her Metabolic Syndrome with weight loss and optimizing her health status.

Resource:
Polycystic ovary syndrome and the postmenopausal woman. Ireland K, Child T.
J Br Menopause Soc. 2006 Dec;12(4):143-8.
http://www.ncbi.nlm.nih.gov/pubmed/17178014

2. Medical management of adolescents with PCOS is most appropriately directed towards:

a. Maximizing fertility
b. Preventing excessive weight gain
c. Arresting the progression of hirsutism
d. Decreasing insulin levels

Answer
-Preventing excessive weight gain

While PCO is associated with insulin resistance in 75% of cases, and one key to its management is controlling the insulin resistance, it is the control of excess body weight that is the most direct management for the overall syndrome.

As was shown in the Diabetes Prevention Program, intense lifestyle changes and weight loss can decrease the onset of diabetes in 60%, while treatment with metformin can decrease the subsequent onset of diabetes by 30%.

Though it is not easy, exercise and weight loss should predate oral contraceptive use and metformin use. As this is a lifelong syndrome, we also do not know the lifelong effects of agents like metformin on 12 -13 year old girls. In addition, we do not know the lifetime effect of early treatment with oral contraceptive agents which are begun before the maximum skeletal peak bone accrual.

At first it is reasonable to initiate a work up for a proinflammatory milieu and hyperinsulinemia. One could consider a C-reactive protein (CRP) and a provoked insulin challenge (integrated insulin level >150 uIU/mL).

Then one should obtain a detailed nutritional history with the help of a nutritionist. This step can be especially important in adolescents as it can reveal particularly unique dietary indiscretions that are amenable to counseling.

Next, a physical activity regimen should be recommended. As the magnitude of weight loss can be overwhelming, reachable goals should be set and frequent follow-up scheduled to provide positive feedback. Many of the benefits can be seen after they lose only 10% of their body weight. It is much easier to lose 20 lbs. than 75 lbs., hence short term goals should be realistic to be of benefit.

Next, if metformin is used, then a very gradual increase is suggested to allay the anticipated gastrointestinal side effects. Start at 500 mg and increase no quicker than 500 mg per week until the usual maintenance dose of 1500 mg /day is achieved. Remember, there is no hurry, this is a lifelong syndrome and metformin is currently the only agent of its kind in our armamentarium at this juncture.

There is some evidence in patients with a BMI > 30 that 2000 mg / day may be a better option, though again the gastrointestinal side effects are often the rate limiting factor.

Resources:
Guzick DS. Polycystic ovary syndrome. Obstet Gynecol. 2004 Jan;103(1):181-93.
http://www.ncbi.nlm.nih.gov/pubmed/14704263

Ibáñez L, Ferrer A, Ong K, Amin R, Dunger D, de Zegher F. Insulin sensitization early after menarche prevents progression from precocious pubarche to polycystic ovary syndrome. J Pediatr. 2004 Jan;144(1):23-9.
http://www.ncbi.nlm.nih.gov/pubmed/14722514

Knowler WC et al Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403.
http://www.ncbi.nlm.nih.gov/pubmed/11832527

Moran LJ, Noakes M, Clifton PM, Tomlinson L, Galletly C, Norman RJ. Dietary composition in restoring reproductive and metabolic physiology in overweight women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2003 Feb;88(2):812-9.
http://www.ncbi.nlm.nih.gov/pubmed/12574218

3. Intrauterine growth retardation is associated with an increased risk of PCOS in offspring? True/False

Answer
-True

It seems that PCO, like many other disorders in the reproductive lifespan, does have an in utero initiation. Mothers with obesity, GDM, macrosomic infants, IUGR infants, or SGA infants are associated with the stigmata of the PCOS phenotype when the offspring are followed through menarche.

PCOS mothers showed a significantly higher prevalence of SGA newborns which cannot be completely attributed to pregnancy complications, and seems to be more related to the PCOS condition of the mother.

Though genetics are clearly important, there may be epigenentic programming that put the mother herself at risk for insulin resistance.  Evidence in non-human primates reveal that fetal exposure to elevated levels of androgens can result in elevated levels of luteinizing hormone (LH) later in life.

There may be a sequence in the associations between reduced fetal growth and components of the postnatal endocrine system; minor fetal growth reduction appears to be associated with amplified adrenarche, whereas more pronounced prenatal growth restriction seem to precede functional ovarian hyperandrogenism and hyperinsulinemia during adolescence. In conclusion, these findings corroborate the hypothesis that the frequent concurrence of precocious pubarche (with pronounced adrenarche), functional ovarian hyperandrogenism, and hyperinsulinemia in girls may result from a common early origin (low birth weight serving as a marker), rather than from a direct interrelationship later in life.

There is evidence that if children have early adrenarche, an elevated BMI, and/or have acanthosis nigricans, they should be followed closely for PCO, as early as 6 years old.

Resources:
Ibáñez L, Potau N, Francois I, de Zegher F. Precocious pubarche, hyperinsulinism, and ovarian hyperandrogenism in girls: relation to reduced fetal growth. J Clin Endocrinol Metab. 1998 Oct;83(10):3558-62.
http://www.ncbi.nlm.nih.gov/pubmed/9768664

Birth weight in offspring of mothers with polycystic ovarian syndrome. Sir-Petermann T, Hitchsfeld C, Maliqueo M, Codner E, Echiburú B, Gazitúa R, Recabarren S, Cassorla F. Hum Reprod. 2005 Aug;20(8):2122-6.
http://www.ncbi.nlm.nih.gov/pubmed/15802312

4. Brothers of women with PCOS are at greater risk for which of the following conditions?

a. Decrease sperm counts
b. Type 2 diabetes
c. Hirsutism
d. Increased pregnancy wastage

Answer
-Type 2 diabetes

Sons of PCOS women exhibit higher body weight from early infancy. In addition, insulin resistance became evident as the subjects got older, which may place them at risk for the development of type 2 diabetes and cardiovascular disease.

Unfortunately, in the early family history studies, the fathers of PCOS patients could not be found in the kindreds. The males had severe metabolic syndrome and fatal myocardial infarctions and were not available to be studied.

It may be that the female family members may actually be protected by the presence of estrogen earlier in life. Often the family history obtained in the office will identify multiple sisters and multiple cousins with PCOS, rather just sporadically throughout the pedigree. Most likely there is polygenic pattern that we are far from understanding.

Resource:
Recabarren SE, Smith R, Rios R, Maliqueo M, Echiburú B, Codner E, Cassorla F, Rojas P, Sir-Petermann T. Metabolic profile in sons of women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2008 May;93(5):1820-6.
http://www.ncbi.nlm.nih.gov/pubmed/18230657

5. The most appropriate first line modality for ovulation induction in women with PCOS is

a. Ovarian drilling
b. Clomiphene citrate
c. Metformin
d. Exogenous gonadotropins

Answer
-Clomiphene citrate

Clomiphene is superior to metformin in achieving live birth in infertile women with the polycystic ovary syndrome, although multiple birth is a complication.

‘Having said that, it is not unreasonable to treat a PCO patient who is open to pregnancy with metformin. For those couples in whom an immediate pregnancy is not perceived to be absolutely necessary, metformin does increase the rate of live birth and it allows the couple to pursue a more normal lifestyle without the need for precisely timed coitus, etc…

Another related approach is to use metformin to optimize the metabolic milieu so that she is healthier when she does achieve pregnancy. In this longer term scenario, then clomiphene does become a second line agent after the patient has lost some weight and improved her lipid profile. If the patient is young enough, one can use the prospect of a future pregnancy as a motivator over a 3 - 6 month period to encourage weight loss so that perhaps the patient could pursue pregnancy in a non-medicated state.

In fact weight loss should be really considered as a first option for women who are infertile and overweight. It has been demonstrated that weight loss can improve the fertility of obese women through the recovery of spontaneous ovulation, whereas others will have improved response to ovarian stimulation in infertility treatment. Therefore, it is proposed that following the initial assessment of infertility and body mass index or other measurement of obesity, various weight management interventions, including diet, exercise or pharmacotherapeutic approaches, should be considered for overweight and obese infertile women.

Resources:
Clark AM, Thornley B, Tomlinson L, Galletley C, Norman RJ. Weight loss in obese infertile women results in improvement in reproductive outcome for all forms of fertility treatment. Hum Reprod. 1998 Jun;13(6):1502-5.
http://www.ncbi.nlm.nih.gov/pubmed/9688382

Legro RS, Barnhart HX, Schlaff WD, Carr BR, Diamond MP, Carson SA, Steinkampf MP, Coutifaris C, McGovern PG, Cataldo NA, Gosman GG, Nestler JE, Giudice LC, Leppert PC, Myers ER; Cooperative Multicenter Reproductive Medicine Network. Clomiphene, metformin, or both for infertility in the polycystic ovary syndrome. N Engl J Med. 2007 Feb 8;356(6):551-66.
http://www.ncbi.nlm.nih.gov/pubmed/17287476

Legro RS. A 27-year-old woman with a diagnosis of polycystic ovary syndrome. JAMA. 2007 Feb 7;297(5):509-19.
http://www.ncbi.nlm.nih.gov/pubmed/17284701

Norman RJ, Noakes M, Wu R, Davies MJ, Moran L, Wang JX. Improving reproductive performance in overweight/obese women with effective weight management. Hum Reprod Update. 2004 May-Jun;10(3):267-80.
http://www.ncbi.nlm.nih.gov/pubmed/15140873

Pasquali R, Antenucci D, Casimirri F, Venturoli S, Paradisi R, Fabbri R, Balestra V, Melchionda N, Barbara L. Clinical and hormonal characteristics of obese amenorrheic hyperandrogenic women before and after weight loss. J Clin Endocrinol Metab. 1989 Jan;68(1):173-9.
http://www.ncbi.nlm.nih.gov/pubmed/2642485

Correction from last month’s issue:
There was an error in the description of Category III fetal heart rate tracings.
The correct description of Category III is:
• Absent baseline FHR variability and any of the following:
- Recurrent late decelerations
- Recurrent variable decelerations
- Bradycardia
• Sinusoidal pattern

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Medscape*

A Sampling of recent CME offerings from MedScape:

Female Contraception: Reducing the Rate of Unintended Pregnancy
http://www.medscape.com/viewprogram/18691

Multimodal Techniques for Smoking Cessation: A Review of Their Efficacy and Utilisation and Clinical Practice Guidelines
http://www.medscape.com/viewprogram/18741 

NCCN Clinical Practice Guidelines in Oncology Symposium: Breast Cancer
http://www.medscape.com/viewprogram/17588

Healthier Life Steps: A Clinician-Patient Guide from the AMA
http://www.medscape.com/viewprogram/17742

Adherence to Treatment: Improving the Management of Postmenopausal Osteoporosis http://www.medscape.com/viewprogram/17802

Hormone Replacement Therapy Virtual Symposium
http://www.medscape.com/viewprogram/17129

General MedScape access:
Ask the Experts topics in Women's Health and OB/GYN Index, by specialty, Medscape

http://www.medscape.com/pages/editorial/public/ate/index-womenshealth

OB GYN & Women's Health Clinical Discussion Board Index, Medscape
http://boards.medscape.com/forums?14@@.ee6e57b

Clinical Discussion Board Index, Medscape
Hundreds of ongoing clinical discussions available
http://boards.medscape.com/forums?14@@.ee6e57b

Free CME: MedScape CME Index by specialty
http://www.medscape.com/cmecenterdirectory/Default

*NB: Medscape is free to all, but registration is required.  It can be accessed from anywhere with Internet access. You just need to create a personal username and password.

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Menopause Management

Cigarette smoking, androgen levels, and hot flushes in midlife women

OBJECTIVE: To test the hypothesis that cigarette smoking is associated with hot flushes through a mechanism involving androgen levels, progesterone levels, sex hormone-binding globulin levels, or the ratio of androgens to estrogens.
METHODS: Women with and without hot flushes were recruited from Baltimore, Maryland, and the surrounding counties. Women were between 45 and 54 years of age, with at least three menstrual periods in the previous 12 months, and were not postmenopausal. Study participants completed a questionnaire and gave a blood sample for hormone measurements.
RESULTS: Current smokers had significantly higher androstenedione levels and a higher androgen-to-estrogen ratio than never smokers. Current smokers had significantly lower progesterone levels compared with never smokers. Former and current cigarette smokers had increased odds of experiencing hot flushes compared with never smokers (former: odds ratio [OR] 1.41, 95% confidence interval [CI] 0.99-2.01; current: OR 2.43, 95% CI 1.28-4.62). This association, however, was not attenuated by the addition of hormones to the smoking and hot-flush model.
CONCLUSION: Cigarette smoking is associated with hot flushes through a mechanism that may not involve alterations in hormone levels or their ratios.

Cochran CJ, Gallicchio L, Miller SR, Zacur H, Flaws JA. Cigarette smoking, androgen levels, and hot flushes in midlife women. Obstet Gynecol. 2008 Nov;112(5):1037-44.
http://www.ncbi.nlm.nih.gov/pubmed/18978103

Testosterone for low libido in postmenopausal women not taking estrogen

BACKGROUND: The efficacy and safety of testosterone treatment for hypoactive sexual desire disorder in postmenopausal women not receiving estrogen therapy are unknown.
METHODS: We conducted a double-blind, placebo-controlled, 52-week trial in which 814 women with hypoactive sexual desire disorder were randomly assigned to receive a patch delivering 150 or 300 microg of testosterone per day or placebo. Efficacy was measured to week 24; safety was evaluated over a period of 52 weeks, with a subgroup of participants followed for an additional year. The primary end point was the change from baseline to week 24 in the 4-week frequency of satisfying sexual episodes.
RESULTS: At 24 weeks, the increase in the 4-week frequency of satisfying sexual episodes was significantly greater in the group receiving 300 microg of testosterone per day than in the placebo group (an increase of 2.1 episodes vs. 0.7, P<0.001) but not in the group receiving 150 microg per day (1.2 episodes, P=0.11). As compared with placebo, both doses of testosterone were associated with significant increases in desire (300 microg per day, P<0.001; 150 microg per day, P=0.04) and decreases in distress (300 microg per day, P<0.001; 150 microg per day, P=0.04). The rate of androgenic adverse events - primarily unwanted hair growth - was higher in the group receiving 300 microg of testosterone per day than in the placebo group (30.0% vs. 23.1%). Breast cancer was diagnosed in four women who received testosterone (as compared with none who received placebo); one of the four received the diagnosis in the first 4 months of the study period, and one, in retrospect, had symptoms before undergoing randomization.
CONCLUSIONS: In postmenopausal women not receiving estrogen therapy, treatment with a patch delivering 300 microg of testosterone per day resulted in a modest but meaningful improvement in sexual function. The long-term effects of testosterone, including effects on the breast, remain uncertain.

Davis SR, Moreau M, Kroll R, Bouchard C, Panay N, Gass M, Braunstein GD, Hirschberg AL, Rodenberg C, Pack S, Koch H, Moufarege A, Studd J; APHRODITE Study Team. Testosterone for low libido in postmenopausal women not taking estrogen. N Engl J Med. 2008 Nov 6;359(19):2005-17. http://www.ncbi.nlm.nih.gov/pubmed/18987368

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Midwives Corner - Lisa Allee, CNM, Chinle

Midwifery care unequivocally supported and recommended by Cochrane Review

Okay, first the bottom line—Cochrane Review loves midwifery care.  Check out these two direct quotes:Midwife-led care confers benefits for pregnant women and their babies and is recommended.” andAuthors' conclusions: All women should be offered midwife-led models of care and women should be encouraged to ask for this option.” Wow, wow, and wow.  As midwifes we certainly knew this, but this is some awesome confirmation of the value of the midwifery model of care. 

Here are the statistical results: “We included 11trials (12,276 women). Women who had midwife-led models of care were less likely to experience antenatal hospitalisation, risk ratio (RR) 0.90, 95% confidence interval (CI) 0.81 to 0.99), the use of regional analgesia (RR 0.81, 95% CI 0.73 to 0.91), episiotomy (RR 0.82, 95% CI 0.77 to 0.88), and instrumental delivery (RR 0.86, 95% CI 0.78 to 0.96) and were more likely to experience no intrapartum analgesia/anaesthesia (RR 1.16, 95% CI 1.05 to 1.29), spontaneous vaginal birth (RR 1.04, 95% CI 1.02 to 1.06), to feel in control during labour and childbirth (RR 1.74, 95% CI 1.32 to 2.30), attendance at birth by a known midwife (RR 7.84, 95% CI 4.15 to 14.81) and initiate breastfeeding (RR 1.35, 95% CI 1.03 to 1.76). In addition, women who were randomized to receive midwife-led care were less likely to experience fetal loss before 24 weeks’ gestation (RR 0.79, 95% CI 0.65 to 0.97), and their babies were more likely to have a shorter length of hospital stay (mean difference -2.00, 95% CI -2.15 to -1.85). There were no statistically significant differences between groups for overall fetal loss/neonatal death (RR 0.83, 95% CI 0.70 to 1.00), or fetal loss/neonatal death of at least 24 weeks (RR 1.01, 95% CI 0.67 to 1.53).” 

These are some fabulous numbers that all midwives can feel very proud of and can share with whoever needs to be educated on the value of what we do. The authors also do a good job of describing the midwifery model of care.  For example: “The midwife-led model of care is based on the premise that pregnancy and birth are normal life events and is woman-centered. The midwife-led model of care includes: continuity of care; monitoring the physical, psychological, spiritual and social wellbeing of the woman and family throughout the childbearing cycle; providing the woman with individualized education, counseling and antenatal care; continuous attendance during labor, birth and the immediate postpartum period; ongoing support during the postnatal period; minimizing technological interventions; and identifying and referring women who require obstetric or other specialist attention.” 

Overall, this Cochrane review is a document midwives and others in IHS can use if they are needing support to establish, or re-establish, a midwifery service; or to expand the number of midwives so all women in a service unit have the opportunity to be attended by a midwife; or, at some sites, to just remind ourselves, other providers, and the women and families we serve how blessed we are in IHS to have midwifery care as the standard of care. Enjoy.

If you are having trouble getting a copy of this landmark document please contact me at lisa.allee@ihs.gov and I will send you a copy electronically or via snail mail!

Hatem M, Sandall J, Devane D, Soltani H, Gates S. Midwife-led versus other models of care for childbearing women. Cochrane Database of Systematic Reviews 2008, Issue 4. Art. No.: CD004667. DOI: 10.1002/14651858.CD004667.pub2.
http://mrw.interscience.wiley.com/cochrane/clsysrev/articles/CD004667/frame.html

http://www.ncbi.nlm.nih.gov/pubmed/18843666

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Navajo News - John Balintona, Northern Navajo Medical Center, Shiprock, NM

The following is a continuation of the excerpts from the Navajo Area Women’s Health Provider Meeting held in Chinle, Arizona on September 12, 2008.  Navajo Area Chief Clinical Consultant for Women’s Health, Jean Howe, presiding.

WOMEN’S HEALTH CARE ISSUES

  1. GPRA SCREENING RATES
    1. NAIHS met the target goal GPRA rates for the following categories in 2007.
      1. Pap smear screening:  59.8%
      2. Mammogram screening: 43.1%
      3. Colorectal cancer screening:  27.2%
  1. Syphilis Outbreak Update
    1. Rates appear to be trending lower in NAIHS for 2007.
    2. Group continues to advocate for frequent screening, especially during pregnancy when 3 screening tests are recommended (1st prenatal visit, early 3rd trimester, admission to L&D)
  1. Contraceptive Options
    1. Attendees discussed the contraceptive options in each site on the NAIHS.
    2. Reviewed the cost of various contraceptive options.
    3. Implanon training may be available for area providers. A course is planned for the upcoming ACOG meeting in September 2008 in Salt Lake City.  Tentative plan for training at the upcoming Telluride Conference.
  1. Infertility Management
    1. Group reviewed the options for infertility management in the area.
    2. Two sites, Gallup and Shiprock, continue to provide tubal reanastamosis services.  Referring providers are strongly advised to contact either site directly as selection criteria may be strict and is at the discretion of the provider of the service.
  1. Immunization Update
    1. Attendees reviewed the use of the following pertinent immunizations
      1. Influenza vaccine
        -Suggest October 1st for start date of vaccinations
      1. Tdap
        -Advise immunization of postpartum patients
      1. HPV
        -Currently available area-wide
  1. SANE/SART Program
    1. Group reviewed the progress to date in implementing SANE exams in selected facilities on the Navajo Nation and options for forensic examination services in surrounding communities.

Navajo Nation Passes “Healthy Start Act”; Requires Workplaces to Accommodate Breastfeeding
This legislation requires workplaces on the Navajo Nation to submit a written plan on how they will accommodate breastfeeding women in the workplace and allows women unpaid time to breastfeed their infants or to use a breast pump. This news was picked up by wire services across the country. One example of the news coverage can be found at:

http://seattletimes.nwsource.com/html/nationworld/2008301621_webnavajobreastfeed23.html

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Nurses Corner - Sandra Haldane, HQE

Registered nurses are key to detecting, correcting, and preventing medical errors during critical care

Since registered nurses (RNs) play a pivotal role in preventing or reducing the impact of medical errors during critical care, interventions should build on factors that enhance their effectiveness in preventing, intercepting, or correcting these errors, suggests a new study.

Using entries in daily logbooks maintained by a random sample of 502 critical care nurses over a 28-day period, Ann E. Rogers, Ph.D., R.N., of the University of Pennsylvania School of Nursing, and colleagues examined the type and frequency of medical errors detected by critical care nurses. They found 367 errors identified by 184 of the nurse participants during the data-gathering period. Errors in medication administration (most commonly, wrong drug, wrong dosage, or dose not given) were the most frequent problems. They accounted for 163 of the errors—43 percent of which involve giving the wrong dosage of a prescribed medication. Procedural errors were the next most common (115 errors reported), followed by charting errors (55 instances), and transcription errors (55 instances).

The nurses caught only 43 of the 367 errors—mostly medication errors or overlooked allergies—before they reached the patient. Yet, nurses were particularly effective at discovering and correcting errors that had been made by other nurses and other members of the health care team. The incredibly busy pace of critical care units may play a role in errors, with an average of 187 activities performed for each patient each day. Heavy workloads and fatigue are also factors that may affect the ability of RNs to intercept or correct errors, note the researchers. Their results did not show differences in error types or rates based on the size of the critical care unit or of the hospital.

Because procedures for administering medications and other health care procedures are similar across health care institutions despite how they are organized or their size, the researchers suggest that future studies should focus on system- and process-related factors. Their study was funded in part by a grant from the Agency for Healthcare Research and Quality (HS11963).

More details are in "Role of registered nurses in error prevention, discovery and correction," by Dr. Rogers, Grace E. Dean, Ph.D., R.N., Wei-Ting Hwang, Ph.D., and Linda D. Scott, Ph.D., R.N., in the April 2008 Quality and Safety in Health Care 17(2), pp.117-121. http://www.ahrq.gov/research/sep08/0908RA2.htm

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Office of Women's Health, CDC

Condoms and STDs: Updated Fact Sheet for Public Health Personnel

This fact sheet presents evidence concerning the male latex condom and the prevention of STDs, including HIV, based on information about how different STDs are transmitted, the physical properties of condoms, the anatomic coverage or protection that condoms provide, and epidemiologic studies assessing condom use and STD risk. This fact sheet updates previous CDC fact sheets on male condom effectiveness for STD prevention by incorporating additional evidence-based findings from published epidemiologic studies.
Updated fact sheet - http://www.cdc.gov/condomeffectiveness/latex.htm
New fact sheet in brief - http://www.cdc.gov/condomeffectiveness/brief.html

Biomarker Test Not Ready for Routine Clinical Use
Experts respond to new study on diagnostic markers for the early detection of ovarian cancer published in the November 2008 issue of Clinical Cancer Research. CDC states that although this study makes an important contribution, more research is needed before the OvaSure test is accepted into clinical practice for screening women in the general population or for women at ‘‘high risk’’ of ovarian cancer. Read CDC’s letter to the editor and other letters to the editor.
http://www.cdc.gov/genomics/update/current.htm

Assessing the Burden of HPV-Associated Cancers in the United States
CDC’s Division of Cancer Prevention and Control led an effort to produce a journal supplement entitled "Assessing the Burden of HPV-Associated Cancers in the United States (ABHACUS)." This supplement uses cancer registry data to estimate how many HPV-associated cancers occurred in the United States before the release of the HPV vaccine, and to examine current patterns in the distribution of these cancers. Six articles in the supplement focus on cancer sites known to be associated with HPV, including the cervix, vulva, vagina, penis, anus, and some sites in the head and neck (oral cavity and oropharynx). Other articles focus on related topics such as disparities in these types of cancers, how CDC programs address such disparities, behavioral risk factors related to these cancers, and background of the HPV vaccine.
http://www.cdc.gov/cancer/hpv/what_cdc_is_doing/

Human Papillomavirus (HPV) Vaccine Safety
This page provides links to information on HPV vaccine safety, HPV vaccine and disease information.
http://www.cdc.gov/vaccinesafety/concerns/human_papillomavirus_vaccine.htm

Link to CDC Women’s Health Index page:
http://www.cdc.gov/women/index.htm

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Patient Information

Interactive Media Laboratory—Smoking Cessation for Pregnancy and Beyond

Virtual class for health care personnel working with pregnant clients to stop smoking.
Web site with tips, tools, interactive clinical situations with actor patients that make it quite real.
You can order a CDROM to work off line depending on speed of your internet. http://iml.dartmouth.edu/education/cme/Smoking/

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Perinatology Picks

Labor before a primary cesarean delivery: reduced risk of uterine rupture in a subsequent trial of labor for vaginal birth after cesarean

OBJECTIVE: To estimate the effect of the onset of labor before a primary cesarean delivery on the risk of uterine rupture if vaginal birth after cesarean (VBAC) is attempted in the next pregnancy.
METHODS: Longitudinally linked birth records were used to follow women from a primary cesarean delivery to a trial of labor at term for their next birth. The effects of characteristics of both the trial of labor and primary cesarean deliveries on the risk of uterine rupture were examined.
RESULTS: Of 10,160 women who had a trial of labor, 39 (0.38%) had a uterine rupture. Women who were induced or augmented for their trial of labor had a greater relative risk (RR) of uterine rupture (crude RR 4.24, 95% confidence interval [CI] 2.23-8.07). Women whose primary cesarean delivery was planned or followed induction of labor also had an increased risk of uterine rupture (crude RR 2.61, 95% CI 1.24-5.49), and this risk remained after adjustment for other factors. Women with a history of either spontaneous labor or vaginal birth had one uterine rupture for every 460 deliveries; women without this history who required induction or augmentation to proceed with a VBAC attempt had one uterine rupture for every 95 deliveries.
CONCLUSION: Labor before the primary cesarean delivery can decrease the risk of uterine rupture in a subsequent trial of labor. A history of primary cesarean delivery preceded by spontaneous labor is favorable for VBAC.

Algert CS, Morris JM, Simpson JM, Ford JB, Roberts CL. Labor before a primary cesarean delivery: reduced risk of uterine rupture in a subsequent trial of labor for vaginal birth after cesarean. Obstet Gynecol. 2008 Nov;112(5):1061-6. http://www.ncbi.nlm.nih.gov/pubmed/18978106

Methods of Delivering the Placenta at Caesarean Section

Cochrane Abstract:
BACKGROUND: Worldwide, caesarean section is the most common major operation performed on women. Some of the reported short-term morbidities include haemorrhage, postoperative fever and endometritis. The method of delivering the placenta is one procedure that may contribute to an increase or decrease in the morbidity of caesarean section. Two common methods used to deliver the placenta at caesarean section are cord traction and manual removal.
OBJECTIVES: To compare the effects of manual removal of the placenta with cord traction at caesarean section.
SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group’s Trials Register (30 September 2007).
SELECTION CRITERIA: All randomised controlled trials comparing manual removal and cord traction or spontaneous of delivery of the placenta.
DATA COLLECTION AND ANALYSIS: Two authors independently assessed studies and extracted data.
MAIN RESULTS: We included 15 studies (4694 women). There was significant heterogeneity for the duration of surgery, blood loss and haematological outcomes. The only possible contributing factor found was greater protection from blood loss in two trials in which cord traction was combined with uterine massage. A random-effects model meta-analysis was used for these outcomes.  Manual removal of the placenta was associated with more endometritis (relative risk (RR) 1.64, 95% confidence interval (CI) 1.42 to 1.90; 4134 women, 13 trials); more blood loss (ml) (weighted mean difference (WMD) 94.42 ml, 95% CI 17.19 to 171.64; 2001 women, eight trials); more blood loss >1000 ml (RR 1.81, 95% CI 1.44 to 2.28; 872 women, two trials); lower haematocrit after delivery (%) (WMD –1.55, 95% CI –3.09 to –0.01; 384 women, two trials); greater haematocrit fall after delivery (%) (WMD 0.39, 95% CI 0.00 to 0.78; 1777 women, five trials); longer duration of hospital stay (days) (WMD 0.39 days, 95% CI 0.17 to 0.61; 546 women, three trials). The duration of surgery was shorter in one trial but not overall.  There were no significant differences in feto-maternal haemorrhage, blood transfusion, puerperal fever (numbers studied for these outcomes were small).
AUTHORS’ CONCLUSION: Delivery of the placenta with cord traction at caesarean section has more advantages compared to manual removal. These are less endometritis; less blood loss; less decrease in haematocrit levels postoperatively; and shorter duration of hospital stay. Future trials should provide information on interval between the delivery of the infant and of the placenta, change in lochia, blood splashing during placental removal and uterine pain after operation, as well as the effects of delayed cord clamping.

Cochrane Abstract: Methods of delivering the placenta at caesarean section. Obstet Gynecol. 2008 Nov;112(5):1173-4. http://www.ncbi.nlm.nih.gov/pubmed/18978121

External cephalic version-related risks: a meta-analysis

OBJECTIVE: To systematically review the literature on external cephalic version-related complications and to assess if the outcome of a version attempt is related to complications.
DATA SOURCES: In March 2007 we searched MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials.
METHODS OF STUDY SELECTION: Studies reporting on complications from an external cephalic version attempt for singleton breech pregnancies after 36 weeks of pregnancy were selected. We calculated odds ratios (ORs) from studies that reported both on complications as well as on the position of the fetus immediately after the procedure.
TABULATION, INTEGRATION, AND RESULTS: We found 84 studies, reporting on 12,955 version attempts that reported on external cephalic version-related complications. The pooled complication rate was 6.1% (95% CI 4.7-7.8), 0.24% for serious complications (95% confidence interval [CI] 0.17-0.34) and 0.35% for emergency cesarean deliveries (95% CI 0.26-0.47). Complications were not related to external cephalic version outcome (OR 1.2 (95% CI 0.93-1.7). CONCLUSION: External cephalic version is a safe procedure. Complications are not related to the fetal position after external cephalic version.

Grootscholten K, Kok M, Oei SG, Mol BW, van der Post JA. External cephalic version-related risks: a meta-analysis. Obstet Gynecol. 2008 Nov;112(5):1143-51.
http://www.ncbi.nlm.nih.gov/pubmed/18978117

A systematic review of the role of intrapartum hypoxia-ischemia in the causation of neonatal encephalopathy

The object of this review was to determine the incidence, morbidity, and mortality of an umbilical arterial pH < 7.0; the incidence of hypoxic-ischemic encephalopathy; and the proportion of cerebral palsy associated with intrapartum hypoxia-ischemia in nonanomalous term infants. A systematic review of the English language literature on the association between intrapartum hypoxia-ischemia and neonatal encephalopathy was conducted by using PubMed and Embase. For nonanomalous term infants, the incidence of an umbilical arterial pH < 7.0 at birth is 3.7 of 1000, of which 51 of 297 (17.2%) survived with neonatal neurologic morbidity, 45 of 276 (16.3%) had seizures, and 24 of 407 (5.9%) died during the neonatal period. The incidence of neonatal neurologic morbidity and mortality for term infants born with cord pH < 7.0 was 23.1%. The incidence of hypoxic-ischemic encephalopathy is 2.5 of 1000 live births. The proportion of cerebral palsy associated with intrapartum hypoxia-ischemia is 14.5%. The vast majority of cases of cerebral palsy in nonanomalous term infants are not associated with intrapartum hypoxia-ischemia.

Graham EM, Ruis KA, Hartman AL, Northington FJ, Fox HE. A systematic review of the role of intrapartum hypoxia-ischemia in the causation of neonatal encephalopathy. Am J Obstet Gynecol. 2008 Dec;199(6):587-95. http://www.ncbi.nlm.nih.gov/pubmed/19084096

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Primary Care Discussion Forum - Ann Bullock, Cherokee, NC

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A summary of the recent discussion forum on geriatric medication issues from Chris Lamar:
Thank you to everyone who provided feedback and comments on the discussion of geriatric medication issues. To summarize and conclude our case, we started with an elderly woman in her 80s who came in for a routine follow-up. It was quickly noted that she had been taking a number of inappropriate medications:
 
a) Pain management was uncoordinated; rather than treating her pain, each condition was being managed by a different medication and she was receiving overlapping, duplicative, and inappropriate treatments. Ibuprofen was also discontinued due to increased risk of renal problems and interactions with the pharmacodynamics of antihypertensive therapy. She was eventually able to be managed with acetaminophen PRN although other appropriate regimens were suggested.
 
b) Treatment to goal in chronic diseases often is not as aggressively sought in the elderly even though they have the greatest rate of benefit. Treatment to goal (which are often the same as those who are younger), should still be the primary target, tempered by an awareness of the increased risks of adverse events common in the elderly. Our patient received better lipid management and tighter blood pressure control with maximization of ACEI and reduction of risk of bradycardia by removal of the diltiazem (which also interacted with the simvastatin). The A1c was above target somewhat and we'll have to monitor her since her metformin was discontinued due to reduced renal function. Because the risk of hypoglycemia is increased in the elderly (both frequency of and the resulting morbidity), most would aim for an AIC around 8% in someone her age.  Bedtime long or medium-acting insulin may be an option to improve blood sugar control with careful monitoring for hypoglycemia.
 
c) It is not uncommon for patients to be on a medication that was started based on old guidelines or for a condition that is no longer pertinent. Digoxin was discontinued because there wasn’t a clear indication.  There may have been when it was started – but indications change and often medications remain behind. There were also questions about why she was on lansoprazole without complaints or a diagnosis of ulcer or GERD; further, chronic use of proton pump inhibitors may increase the risk of osteoporosis. Glucosamine, an herbal treatment for arthritis, was also discontinued because of new data from recent studies showing no benefit of therapy and no evidence of improvement in our patient.
 
d) Some medications are inappropriate for use in the elderly, period.  Many of these confer great risk (including fall risk).  The Beers list is a good source for identifying these medications (see attached sample). Tylenol PM and alprazolam are both high risk medications appearing on the Beers list and were removed from the patient's treatment.
 
e) Although warfarin is certainly indicated in our patient, the difficulties of frequent monitoring made her unwilling to take the medication, in spite of benefits in the reduction of risk of stroke. Aspirin, while not demonstrably as effective, may provide some benefit. Sometimes we realize that we need to accept the patient's informed decision over our beliefs and treatment guidelines.
 
f) Elderly patients may suffer from some level of cognitive impairment that may necessitate the assistance of a family member or a friend or the simplification of pharmacologic therapy. She eventually showed up with a list of medications that are not consistent with your medication profile and you realize that there are many ways that treatment may fail due to poor communication and lack of understanding or remembering. Our patient increased her ACEI, yet continued to take her old dose in addition. Even with good instructions and education a simplified regimen can consist of multiple medications often taken 2-4 times a day - and we need to consider that some medications are taken on an empty stomach (lansoprazole) and others are taken after eating (aspirin); although these medications are "taken in the morning" we already have two dosing times that the patient must be aware of in order for the medications to work safely and effectively.
 
-----
Below is a summary of the plan developed after your first meeting with the patient.
 
The plan so far:
Need more information:
A better understanding of her cognitive status.  The mini-cog (attached) is a quick screening tool that can be easily used in the primary care setting.
 
A better understanding of her emotional / psychological status.  The PHQ 2 screen for depression, followed by the PHQ 9 is supported by RPMS.  While not specifically validated for the elderly or for the Native population, these tools are in widespread use.  The PHQ 9 follows the DSM diagnostic criteria for depression. (Health Factor and Exam Manual - attached)
 
A better understanding of her home situation and risks (including environmental fall risks – Sue Arnold suggest a PHN referral.
 
Peter Stuart captures the need to understand her preferences for care and her own, personal goals for health and health care.  That will certainly help with the discussions around anticoagulation (risk of stroke vs. risk and burden of warfarin), pain control (risk of adverse events from pain meds vs. benefit in terms of relief of pain and improvement of function), use of bisphosphonates, and other critical discussions.
 
Further testing
Some would like to see an echocardiogram; others don’t feel that they need it.  If the digoxin was started for rate control and she doesn’t have a history of CHF or symptoms suggestive of valvular heart disease, an echo may be optional
 
A DEXA is mentioned but Tim Domer points out that with the history of a fragility fracture, she already “earns” the diagnosis of osteoporosis and should be offered treatment.  Is a DEXA helpful then for follow-up?  Probably not….
 
More optimal management of chronic conditions:
Improved HTN management.  Some readers suggested further tightening up blood pressure control, others warn about the increased risk of aggressive blood pressure control.  A landmark study published earlier this year demonstrated the clear benefit of blood pressure control in reduction of both morbidity and mortality in the very elderly, but used 160/90 as the trigger for treatment and treated to a target of 150 / 80.  So she’s okay. Treatment of Hypertension in Patients 80 Years of Age or Older. Beckett N et al.  N Engl J Med. 2008 Mar 31
 
General consensus to treat lipids to target (LDL less than 100) in this elderly diabetic woman.  This certainly makes sense given multiple studies showing reduction in stroke as well as MI in high risk elderly treated with statins.
 
Discussion about the risk / benefit of warfarin treatment in the setting of paroxysmal a-fib.  This is a major topic for discussion with the patient and her daughter.  As Tobe Probst points out, she is at risk of stroke and that risk can be decreased by anticoagulation.
 
Discussion about whether she needs tighter control of her blood sugars.  The geriatrics literature supports a target AIC in the range of 8% as a comfortable middle ground, limiting the risk of hypoglycemia while avoiding blood sugars over 200.  There are lots of ways to get there…while hewing to the general principle that simpler is better.
 
Given that she does have osteoporosis (defined by her fragility fracture) she is a candidate for bisphosphonates, either IV as suggested by Tim Domer or weekly PO.  She would definitely benefit from vitamin D and calcium.  Tim Domer suggests parenteral vitamin D; a combined Ca/Vit D oral preparation is another option.
 
Agreement that she needs more rational approach to rate control, with a general consensus that the beta blocker may be the best choice, to eliminate the diltiazem and try to wean or eliminate the digoxin.
 
Several different strategies are discussed for pain control, generally trying to avoid ibuprofen because of the risk of GI bleed, use low doses of codeine if at all.  Another strategy not mentioned is to use low doses of a stronger narcotic (e.g. π tab percocet 5/325) rather than higher doses of a week narcotic (codeine), reducing the risk of nausea and constipation.
 
Eliminate meds that put her at increased risk
Alprazolam, Benadryl (Tylenol pm), ibuprofen, codeine.
Folks seem generally comfortable with metformin, although she is at increased risk for acidosis given her age and renal impairment.
 
Interventions to reduce the risk of fall.
Robert McClelland points out the value of an eye exam as part of a fall risk evaluation.  Because she has had a fall in the last year she “screens in” as being at high risk for future falls.  This can be documented using the exam code for fall risk screening (Health Factor and Exam Manual).  Attached are the AGS Evidence-based guidelines for fall risk screening and interventions
 
Tim Domer offers the strategy of a comprehensive geriatric assessment by an interdisciplinary team as an efficient way to manage this older woman’s complicated social and medical condition.

---------
In conclusion, there are many issues associated with the treatment of the elderly including disease states that occur more in the elderly and the difficulties of medication management. We would like to thank you all again for your participation and insights into this patient case and wish you a wonderful Holiday season!
Bruce, Chris, and Ann

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STD Corner - Lori de Ravello, National IHS STD Program

Recommendations for partner services programs for HIV infection, syphilis, gonorrhea, and Chlamydia infection

This report provides updated, integrated recommendations for services provided to partners of persons with human immunodeficiency virus (HIV) infection and three other sexually transmitted diseases (STDs) (i.e., syphilis, gonorrhea, and chlamydial infection) and replaces the CDC 2001 Program Operations Guidelines for STD Prevention---Partner Services and the 1998 HIV Partner Counseling and Referral Services Guidance. These recommendations are intended for health department program managers responsible for overseeing partner services programs for HIV infection and the three other STDs at the state and local levels. The recommendations also might be beneficial for HIV prevention community planning groups, STD program advisory bodies, technical assistance providers, community-based organizations, and clinical care providers. The value of partner services in the control of syphilis and gonorrhea is widely accepted. However, such services are underused among partners of persons with HIV infection. On the basis of evidence of effectiveness and cost-effectiveness of these services, CDC strongly recommends that all persons with newly diagnosed or reported HIV infection or early syphilis receive partner services with active health department involvement. Persons with a diagnosis of, or who are reported with, gonorrhea or chlamydial infection also are suitable candidates for partner services; however, resource limitations and the numerous cases of these infections might preclude direct health department involvement in certain instances. Health departments might need to limit direct involvement in partner services for gonorrhea and chlamydial infection to selected high-priority cases and use other strategies for the remainder (e.g., expedited partner therapy). These recommendations highlight the importance of program collaboration and service integration in the provision of partner services. Because coinfection with HIV and one or more other STDs is common, all persons with a diagnosis of HIV should be tested for other types of STDs, and vice versa; rates of coinfection with HIV and syphilis have been particularly high in recent years. Many persons at risk for these infections also are at risk for other infectious diseases, such as tuberculosis and viral hepatitis, as well as various other health conditions. STD and HIV partner services offer STD, HIV, and other public health programs an opportunity for collaboration to deliver comprehensive services to clients, improve program efficiency, and maximize the positive effects on public health.
  
Centers for Disease Control and Prevention, Recommendations for partner services programs for HIV infection, syphilis, gonorrhea, and chlamydial infection. MMWR Recomm Rep. 2008 Nov 7;57(RR-9):1-83; quiz CE1-4. http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5709a1.htm

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Barbara Stillwater, Alaska State Diabetes Program

QuickStats: Percentage of Large-for-Gestational-Age* Births,† by Race or Hispanic Ethnicity --- United States, 2005

Infants born large for their gestational age (LGA) are at increased risk for birth complications, such as obstructed labor, and for obesity later in life. Information from U.S. birth certificates for 2005 shows that a greater percentage of American Indian/Alaska Native women gave birth to an LGA infant (12%), followed by white (10%) and Hispanic women (9%). Black and Asian/Pacific Islander women were least likely to have given birth to an LGA infant (6%).
* Birthweight at or above the 90th percentile for a given gestational age.
† Includes only singleton live births.
§ Might be of any race.

Infants born large for their gestational age (LGA) are at increased risk for birth complications, such as obstructed labor, and for obesity later in life. Information from U.S. birth certificates for 2005 shows that a greater percentage of American Indian/Alaska Native women gave birth to an LGA infant (12%), followed by white (10%) and Hispanic women (9%). Black and Asian/Pacific Islander women were least likely to have given birth to an LGA infant (6%).

Centers for Disease Control, MMWR Weekly, QuickStats: Percentage of Large-for-Gestational-Age* Births,† by Race or Hispanic Ethnicity --- United States, 2005; November 21, 2008 / 57(46);1258

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5746a4.htm?s_cid=mm5746a4_e

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Women's Health Headlines, Carolyn Aoyama, HQE

Please see the SART training announcement below and the link which takes you to the registration site (http://www.sane-sart.com/).  This training is scheduled for May 28-29, 2009 and is the only national SART training available.  This conference is relevant to any I/T/U facility or Native community interested in building a coordinated community response to sexual assault.

FIFTH NATIONAL SEXUAL ASSAULT RESPONSE TEAM TRAINING CONFERENCE

May 27 - 29, 2009; Seattle, Washington
The Sexual Assault Resource Service (SARS) office in Minneapolis, MN is pleased to announce, in conjunction with the Office for Victims of Crime, Department of Justice, that the Fifth National SART Training Conference will be held in May of 2009 at the Westin Seattle in Seattle Washington. Save the dates of May 27 - 29, 2009 for this exciting training conference.

The focus of the 2009 SART Training Conference will be to continue expanding the capacity of SARTs to promote health and healing of sexual assault victims, hold sex offenders accountable for their crimes, and realize the hope of preventing further sexual violence in their communities.

Team scholarships of $1,000 per team member will again be offered in 2009 to a limited number of SART teams comprised of four team members representing four different SART disciplines; law enforcement scholarships of $1,000 per officer will also be offered. Applications will be available from this website on November 1, 2008. Applications will be accepted from November 1, 2008 to February 2, 2009. The scholarships are designed to assist participants in covering air, hotel, and the Conference Registration Fee.

We will be repeating the interactive scenario which was well received in 2007. Teams representing four disciplines will be required for participation in this interactive learning format. A limited number of SARTs will work as teams, collecting evidence at the scene of the crime through to testifying at the trial, with training by some of our top trainers.

The SART Conference Registration Fee will be $425.00 if registered on or before March 16, 2009. If registering after that date, the conference fee will be $475.00. The Registration Fee includes participation in six Keynote addresses, eight workshops, entrance to the SART Exhibit Hall, three continental breakfasts, three lunches, and printed conference materials. All meetings will be held at the Westin Seattle. We are holding rooms at the prevailing government per diem rate for 2009.

Website: http://www.sane-sart.com/
Questions: Direct to SART Conference Services at: admin@sartconference.com

“What’s new in PubMed on adolescent dating violence”
Measuring sex differences in violence victimization and perpetration within date and same-sex peer relationships

This study examines sex differences in the patterns of repeated perpetration and victimization of physical violence and psychological aggression within dating relationships and same-sex peer relationships. Data were obtained from the Youth Violence Survey: Linkages among Different Forms of Violence, conducted in 2004, and administered to all public school students enrolled in grades 7, 9, 11 and 12 (N = 4,131) in a high-risk school district. Analyses of adolescents who dated in the past year (n = 2,888) show that girls are significantly more likely than boys to report physical violence and psychological aggression perpetration within dating relationships. However, boys are significantly more likely than girls to report physically injuring a date. Boys are also significantly more likely than girls to report physical violence victimization and perpetration within same-sex peer relationships. Implications and directions for future research are discussed.

Swahn MH, Simon TR, Arias I, Bossarte RM. Measuring sex differences in violence victimization and perpetration within date and same-sex peer relationships. J Interpers Violence. 2008 Aug;23(8):1120-38. Epub 2008 Mar 4. http://www.ncbi.nlm.nih.gov/pubmed/18319366

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Save the dates

Telluride Midwinter Conference on Maternal and Child Health

(scroll down to date)

First International Meeting on Indigenous Women’s Health/Third International Meeting on Indigenous Child Health Conference; Many Voices into One Song

IHS Colposcopy Update & Refresher Course

 Advances in Indian Health Conference

  • April 21-24, 2009 in Albuquerque, NM 
  • Indian Health's conference for primary care providers and nurses
  • 28 hours of CME/CE credit
  • Optional Diabetes track
  • Contact the Course Director, Dr. Ann Bullock, at annbull@nc-cherokee.com for more information.

Indian Health Summit

  • July 7-9, 2009, Hyatt Regency Hotel, Denver, Colorado
  • The Health Summit will be a national gathering of Indian Health professionals and administrative leadership, community health advocates and activists, and Tribal leadership. We will join together to build skills and share ideas and innovations
  • http://conferences.thehillgroup.com/healthsummit/index.html

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What's new on the ITU MCH web pages?

There are several upcoming Conferences

and Online CME/CEU resources, etc….

and the latest Perinatology Corners (free online CME from IHS)

…or just take a look at the What’s New page

Did you miss something in the last OB/GYN Chief Clinical Consultant Corner?

The November 2008 OB/GYN CCC Corner is available.

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Abstract of the Month | From Your Colleagues | Hot Topics | Features   

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OB/GYN

Jean Howe, MD, MPH is the Obstetrics and Gynecology Chief Clinical Consultant (OB/GYN C.C.C.). Dr. Howe 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 American Indian and Alaska Native women and also indigenous peoples around the world. Please don't hesitate to contact her by e-mail (jean.howe@ihs.gov) or phone at (928) 674-7422.

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