Increased Frequency of Nontuberculous Mycobacteria Detection at Potable Water Taps within the United States.

Nontuberculous mycobacteria (NTMs) are environmental microorganisms that can cause infections in humans, primarily in the lung and soft tissue. The prevalence of NTM-associated diseases is increasing in the United States. Exposure to NTMs occurs primarily through human interactions with water (especially aerosolized). Potable water from sites across the U.S. was collected to investigate the presence of NTM. Water from 68 taps was sampled 4 times over the course of 2 years. In total, 272 water samples were examined for NTM using a membrane filtration, culture method. Identification of NTM isolates was accomplished by polymerase chain reaction (PCR) amplification of the 16S rRNA and hsp65 genes. NTMs were detected in 78% of the water samples. The NTM species detected most frequently were: Mycobacterium mucogenicum (52%), Mycobacterium avium (30%), and Mycobacterium gordonae (25%). Of the taps that were repeatedly positive for NTMs, the species M. avium, M. mucogenicum, and Mycobacterium abscessus were found to persist most frequently. This study also observed statistically significant higher levels of NTM in chloraminated water than in chlorinated water.

Widespread molecular detection of Legionella pneumophila Serogroup 1 in cold water taps across the United States.

In the United States, 6,868 cases of legionellosis were reported to the Center for Disease Control and Prevention in 2009-2010. Of these reports, it is estimated that 84% are caused by the microorganism Legionella pneumophila Serogroup (Sg) 1. Legionella spp. have been isolated and recovered from a variety of natural freshwater environments. Human exposure to L. pneumophila Sg1 may occur from aerosolization and subsequent inhalation of household and facility water. In this study, two primer/probe sets (one able to detect L. pneumophila and the other L. pneumophila Sg1) were determined to be highly sensitive and selective for their respective targets. Over 272 water samples, collected in 2009 and 2010 from 68 public and private water taps across the United States, were analyzed using the two qPCR assays to evaluate the incidence of L. pneumophila Sg1. Nearly half of the taps showed the presence of L. pneumophila Sg1 in one sampling event, and 16% of taps were positive in more than one sampling event. This study is the first United States survey to document the occurrence and colonization of L. pneumophila Sg1 in cold water delivered from point of use taps.

First-trimester surgical abortion practices: a survey of National Abortion Federation members.

BACKGROUND: Designated providers in specialized clinics perform the majority of approximately 1.1 million first-trimester abortions carried out in the United States each year. Our objective was to assess the first-trimester surgical abortion practices of National Abortion Federation (NAF) members. STUDY DESIGN: We mailed questionnaires to NAF administrators and providers at their 364 active-member facilities in 2002. RESULTS: Two hundred eighty-nine (79%) facilities responded; we received administrative questionnaires from 273 facilities and 293 individual clinicians. NAF facilities provided at least 325,000 first-trimester surgical abortions in the United States in 2001. The majority of providers are obstetrician-gynecologists (63%), male (62%) and at least 50 years old (64%). Half of clinicians (49%) selectively utilize manual vacuum aspiration. Almost half (47%) routinely use a metal curette to verify procedure completion; these providers are more likely to be over 50 years of age or to have 20 years or more of abortion experience. Other practices are more uniform, including routine tissue examination (93%), postoperative antibiotics (88%) and contraceptive provision (oral contraceptives, 99%; depot medroxyprogesterone acetate, 79%). CONCLUSIONS: Most perioperative practices for first-trimester abortions are similar among these respondents, in accord with evidence-based guidelines. The aging of skilled practitioners raises concerns about the future availability of surgical abortion.

Medical abortion practices: a survey of National Abortion Federation members in the United States.

BACKGROUND: Little is known about clinical implementation of medical abortion in the United States following approval of mifepristone as an abortifacient by the Food and Drug Administration (FDA) in 2000. We collected information regarding medical abortion practices of National Abortion Federation (NAF) members for the year 2001. METHODS: Questionnaires were mailed to 337 active US NAF member facilities. RESULTS: A total of 258 facilities responded (77%); 252 nonhospital facilities were included in the analysis. Most of these facilities (87%) offered medical abortion in 2001, providing an estimated 28,400 medical abortions, approximately 52% of medical abortions in the US that year. Over 75% began offering mifepristone/misoprostol abortions within 5 months of the start of mifepristone distribution. Almost all (99%) reported using mifepristone/misoprostol regimens, with most offering one or more evidence-based alternative regimens (83%); a few (4%) used the FDA-approved regimen. CONCLUSION: After FDA approval of mifepristone, NAF member facilities rapidly adopted evidence-based mifepristone/misoprostol regimens.

Second-trimester surgical abortion practices: a survey of National Abortion Federation members.

BACKGROUND: The objective of this analysis was to assess the second-trimester surgical abortion practices of National Abortion Federation (NAF) members in North America and Australia. STUDY DESIGN: In 2002, questionnaires were mailed to 364 active member clinics of NAF for completion by their clinic administrators and individual providers. RESULTS: Two hundred eighty-nine (79%) clinics responded. Most NAF clinics (72%) offer second-trimester abortion services. The majority of second-trimester providers are obstetrician/gynecologists (63%), male (62%) and at least 50 years old (63%). We describe second-trimester surgical abortion practices in terms of patient eligibility, cervical ripening, ultrasound use, anesthesia and postoperative care. CONCLUSIONS: Surgical techniques and postoperative practices for second-trimester abortions are similar among these respondents, suggesting that NAF's efforts to promulgate best practices using evidence-based guidelines are succeeding. The aging of skilled practitioners raises concerns about the future availability of second-trimester abortion.

Improving outcomes through collaboration.

A roundtable was convened to examine the issues surrounding the use of hormonal therapy in the treatment of acne. Obstetrician-gynecologists (OB/ GYNs) and dermatologists often have varying views with regard to the use of oral contraceptives (OCs) and other agents in patients with acne. If polycystic ovary syndrome (PCOS), the most common hormonal cause of acne, has been diagnosed, the use of OCs is not usually disputed. Hormonal evaluation is recommended for certain conditions such as virilization. Although PCOS is often the source of the problem, it is important to rule out a testosterone-producing tumor or an adrenal tumor. It was determined, however, that the perception that OCs cause cervical and breast cancer persists among some dermatologists. Even in women with a family history of breast cancer, OCs do not increase the risk. Nor is cervical cancer related to OC use; rather, it results from human papillomavirus. Thus, patients should be assured that OCs will not increase their risk for either of these cancers. Female patients should be advised to see their gynecologists annually for breast and pelvic examinations and to discuss their concerns surrounding the use of OCs.

Pharmacology of hormonal contraceptives and acne.

Higher free testosterone levels in women are a function of lower levels of sex hormone-binding globulins (SHBG), higher levels of total testosterone, or both. When free testosterone levels are decreased, sebum production, a pathogenic feature of acne vulgaris, is also decreased. Oral contraceptives (OCs) decrease free testosterone levels by reducing testosterone production by the ovaries and adrenal glands, increasing SHBG, and inhibiting conversion of free testosterone to dihydrotestosterone. Studies have shown that the progestin component of OCs lowers androgen levels, which are directly associated with the development of acne lesions. Currently, 3 OCs have received approval for acne from the US Food and Drug Administration. For patients with acne who are already benefiting from OC treatment, there is no need to change the OC; however, when an OC proves insufficient against sebum production, switching to a formulation that is approved for acne is recommended.

The transdermal contraceptive patch: an updated review of the literature.

The transdermal contraceptive patch which contains ethinyl estradiol and norelgestromin has an efficacy similar to current oral contraceptives (OCs). The major advantages include transdermal application and maintenance of adequate hormonal levels for at least 7 days. Side effects are similar to OC except for breast tenderness in the first 2 months of use and skin irritation at the application site. Although concern has been raised about a possible increased risk of venous thromboembolism, current available data comparing the patch to a norgestimate-containing OC ranges from no increase in risk to a 2.4-fold increase.

A phase II trial of Afimoxifene (4-hydroxytamoxifen gel) for cyclical mastalgia in premenopausal women.

BACKGROUND: Many women experience symptoms of cyclical mastalgia, such as breast pain, tenderness, and nodularity. Tamoxifen and other drugs have been used to alleviate cyclical mastalgia symptoms; however, their use is associated with potentially serious side effects. The current study compared the safety and efficacy of two doses of a topical gel containing 4-hydroxytamoxifen (Afimoxifene, formerly known as 4-OHT) with placebo gel for the treatment of moderate to severe cyclical mastalgia. METHODS: Premenopausal women aged at least 18 years experiencing moderate to severe symptoms were randomized to receive placebo, 2 mg, or 4 mg of Afimoxifene daily delivered as a transdermal hydroalcoholic gel for 4 menstrual cycles. The primary efficacy parameter was change in mean pain intensity as measured by the Visual Analog Scale (VAS) for the seven worst pain score days within a cycle from baseline to the fourth cycle. RESULTS: After 4 cycles of treatment, statistically significant improvements relative to placebo were measured in mean VAS score in the 4-mg Afimoxifene group (-12.71 mm [95% confidence interval, -0.96 to -24.47; P = 0.034]). Patient global assessment of pain, physician's assessment of pain, tenderness on palpation, and nodularity following 4 cycles of treatment were significantly more likely to show improvements in the 4-mg group, compared with placebo (P = 0.010 [pain]; P = 0.012 [tenderness]; P = 0.017 [nodularity]). Overall, Afimoxifene was well tolerated with few adverse events and no drug-related SAE occurred in any group. There were no changes in menstrual pattern or plasma hormone levels and no breakthrough vaginal bleeding in patients treated with Afimoxifene. CONCLUSION: After 4 months of treatment, daily topical breast application of Afimoxifene resulted in statistically significant improvements in signs and symptoms of cyclical mastalgia across patient- and physician-rated scales with excellent tolerability and safety.

Oral contraceptives: side effects and depression in adolescent girls.

OBJECTIVE: The study was undertaken to determine the side effects, including depression, of oral contraceptives (OCs) in adolescent girls. METHODS: We conducted a randomized trial of OCs for dysmenorrhea, which assessed side effects and depression. Seventy-six adolescents received an OC (20 microg of ethinyl estradiol/100 mg of levonorgestrel) or a placebo in a double-blind fashion for 3 months. We ascertained OC side effects using open-ended and closed question formats. Participants self-administered the Center for Epidemiologic Studies Depression Scale (CES-D) to assess depressive symptoms. RESULTS: Fifty-seven participants (77%) reported at least one side effect (median=2, range=0-8, interquartile range=1.0-3.25). The number and the type of side effects reported in the OC group and in the placebo group were similar. Mean exit CES-D scores were comparable between groups [OC group, 14.0 (SD=9.2); placebo group, 14.4 (SD=8.1); p=.86]. CONCLUSION: Adolescents treated with an OC or a placebo experienced similar numbers and types of OC side effects, as well as depressive symptoms.

Challenges of conducting a placebo-controlled trial for dysmenorrhea in adolescents.

We recruited adolescents to study oral contraceptives versus placebo for dysmenorrhea. We anticipated high discontinuation and concerns about safety, side effects, and sexual behavior. Treatment discontinuation (11%) and loss to follow-up (1%) were lower than expected. The most common reason for nonenrollment was logistical issues (63%). Most participants remained abstinent.

Self-treatment patterns among adolescent girls with dysmenorrhea.

STUDY OBJECTIVE: To describe both non-pharmacologic and pharmacologic treatments used by adolescents with dysmenorrhea. DESIGN: Cross-sectional study. SETTING: Urban academic medical center. PARTICIPANTS: Healthy adolescents aged 19 years or younger (n = 76) with moderate to severe primary dysmenorrhea were included; those using hormonal contraception were excluded. INTERVENTION: We collected baseline data via interview from adolescent girls at enrollment in a clinical trial of oral contraceptives versus placebo for primary dysmenorrhea. The interview data, collected prior to any intervention, included information on demographics, dysmenorrhea duration and severity, and self-treatment. We used the validated pain subscale of the Moos Menstrual Distress Questionnaire and a 0-10 pain rating scale to estimate pain severity. MAIN OUTCOME MEASURE: Investigator-administered questionnaire. RESULTS: Adolescents' mean age was 16.8 years (SD = 2). Similar proportions described themselves as white (26%), black (30%) or Hispanic (28%). Dysmenorrhea was moderate in 42%, severe in 58%, associated with nausea in 55%, and vomiting in 24%. Of those attending school (n = 66), 46% reported missing one or more days monthly due to dysmenorrhea. Nearly all discussed their pain with someone; however, a minority sought formal medical care. All used nonpharmacological remedies such as sleeping and heat application. Nearly all used at least one medication, 31% reported using two, and 15% used three medications (not concurrently). Many participants reported using medication at sub-therapeutic doses for pain. CONCLUSIONS: Adolescents with moderate and severe dysmenorrhea reported high morbidity. Girls used numerous non-pharmacologic remedies as well as medications for pain but infrequently accessed formal medical care. Medication dosing was often sub-therapeutic.

Measured and reported weight change for women using a vaginal contraceptive ring vs. a low-dose oral contraceptive.

BACKGROUND: Women often stop hormonal contraception because of perceived weight change. We conducted a randomized trial comparing the contraceptive vaginal ring to a low-dose oral contraceptive (OC). We examined the difference between women's reported and measured baseline weights and looked at factors affecting perceived weight change. METHODS: We randomized 201 participants to either the vaginal ring or an OC for three cycles. We weighed participants upon enrollment (n=194) and at exit (n=167), using the same instrument for all measurements. Participants also provided self-reported height and their reactions to perceived weight changes. RESULTS: Baseline weight and body mass index were similar for both groups (mean weight=145.9 lb). Measured weight was, on average, 4.4 lb more than reported weight; this difference was greater in overweight and obese participants. Participants gained an average of 2.8 lb over 3 months; this gain did not differ between groups or by baseline weight. Subjects who reported a "bad change" in weight at exit (n=34) gained an average of 4.4 lb, whereas those who reported "no change" (n=112) gained 2.2 lb and those who reported a "good change" (n=14) gained 3.3 lb. CONCLUSION: Participants underreported their weight, and this difference was greater for heavier women. There was little weight change for the women in our study. Participants' opinions about weight change were not correlated with measured weight changes.

Oral contraceptives for dysmenorrhea in adolescent girls: a randomized trial.

OBJECTIVE: To assess whether a low-dose oral contraceptive (OC) is more effective than placebo treatment for dysmenorrhea pain in adolescents. METHODS: This was a randomized, double-blind, placebo-controlled clinical trial of 76 healthy adolescents aged 19 years or younger reporting moderate or severe dysmenorrhea. Subjects were randomly allocated to receive either an OC (ethinyl estradiol [E2] 20 microg and levonorgestrel 100 microg) or a matching placebo for 3 months. Participants used their usual pain medications as needed during the trial. The main outcome measure was score on the Moos Menstrual Distress Questionnaire (pain subscale) for the third menstrual cycle on treatment. Secondary outcomes included pain intensity (rated 0 to 10), days of any pain, days of severe pain, hours of pain on worst day, and use of pain medications. RESULTS: The mean Moos Menstrual Distress Questionnaire pain score was lower (less pain) in the OC group than the placebo group (3.1, standard deviation 3.2 compared with 5.8, standard deviation 4.5, P = .004, 95% confidence interval for the difference between means 0.88-4.53). By cycle 3, OC users rated their worst pain as less (mean pain rating 3.7 compared with 5.4, P = .02) and used fewer pain medications than placebo users (mean pain pills used 1.3 compared with 3.7, P = .05). By cycle 3, OC users reported fewer days of any pain, fewer days of severe pain, and fewer hours of pain on the worst pain day than placebo users; however, these differences did not reach statistical significance. CONCLUSIONS: Among adolescents, a low-dose oral contraceptive relieved dysmenorrhea-associated pain more effectively than placebo. LEVEL OF EVIDENCE: I.