Effectiveness of 'catch-up' human papillomavirus vaccination to prevent cervical neoplasia in immunosuppressed and non-immunosuppressed women.

It is unknown whether the HPV vaccine is effective in immunocompromised women during catch-up ages. We performed a case-control study of 4,357 women with incident CIN2+ (cases) and 5:1 age-matched, incidence-density selected controls (N = 21,773) enrolled in an integrated health care system from 2006 to 2014. Vaccine effectiveness was estimated from multivariable conditional logistic regression models, with results stratified by immunosuppression history, defined as prior HIV infection, solid organ transplant history, or recently prescribed immunosuppressive medications. HPV vaccination resulted in a 19% reduction in CIN2+ rates for women without an immunosuppression history but a nonsignificant 4% reduction for women with an immunosuppression history. Further research is needed to evaluate whether catch-up HPV vaccine effectiveness varies by immunosuppression status, especially given the recent approval of the HPV vaccine for adults up to 45 years of age.

Effectiveness of catch-up human papillomavirus vaccination on incident cervical neoplasia in a US health-care setting: a population-based case-control study.

BACKGROUND: The population effectiveness of human papillomavirus (HPV) catch-up vaccination, defined in the USA as first vaccination at ages 13-26 years, has not been studied extensively. We aimed to assess the risk of cervical intraepithelial neoplasia (CIN) 2, CIN3, adenocarcinoma in situ, or cancer (CIN2+ and CIN3+) by prior HPV vaccination status, age at first dose, and number of doses in women participating in a screening programme within a large integrated health-care system. METHODS: We performed a nested case-control study of women enrolled in Kaiser Permanente Northern California (an integrated health-care delivery system in California, USA). Cases were women with CIN2+ or CIN3+ confirmed by histology between Jan 1, 1995, and June 30, 2014, and incidence density-selected controls were age-matched women without CIN2+ or CIN3+ at the time each case occurred. For each case, we randomly selected five controls. Cases and controls were aged 26 years or younger when the HPV quadrivalent vaccine became available in 2006. Rate ratios (RRs) from conditional logistic regression were estimated by age at time of first HPV quadrivalent vaccine dose (14-17 years, 18-20 years, and ≥21 years), and number of doses (one, two, and three or more doses) compared with no prior vaccination, with adjustment for smoking, hormonal contraceptive prescription, race or ethnicity, sexually transmitted infections, immunosuppression, parity, and number of outpatient visits. FINDINGS: 4357 incident CIN2+ cases and 21 773 matched controls were included in the study. Of these, 1849 were incident CIN3+ cases with 9242 matched controls. The youngest age at time of first vaccination was 14 years. One or more HPV vaccine doses conferred protection against CIN2+ (RR 0·82, 95% CI 0·73-0·93) and CIN3+ (0·77, 0·64-0·94). We found the strongest protection against CIN2+ in women who had received at least three vaccine doses and had received their first dose aged 14-17 years (0·52, 0·36-0·74) or aged 18-20 years (0·65, 0·49-0·88). No significant protection was found in women aged 21 years or older at time of first dose (0·94, 0·81-1·09). Inferences were similar for CIN3+, but with stronger effects for women who received at least three vaccine doses and had received their first dose aged 14-17 years (0·27, 0·13-0·56) or aged 18-20 years (0·59, 0·36-0·97). INTERPRETATION: Catch-up quadrivalent HPV vaccination with three doses was effective against CIN2+ and CIN3+ in girls and women aged 14-20 years at time of first vaccine dose but not for women aged 21 years and older at first dose. FUNDING: US National Cancer Institute.

Human Immunodeficiency Virus (HIV)- and Non-HIV-Associated Immunosuppression and Risk of Cervical Neoplasia.

OBJECTIVE: To estimate the risk of cervical intraepithelial neoplasia grade 2, 2-3, 3, adenocarcinoma in situ, or cancer (CIN 2 or worse) among women with human immunodeficiency virus (HIV)- and non-HIV-associated immunosuppression. METHODS: We performed a case-control study of 20,146 women with incident CIN 2 or worse and 5:1 age-matched, incidence-density selected women in a control group (n=100,144) enrolled in an integrated health care system from 1996 to 2014. Adjusted rate ratios (RRs) from conditional logistic regression were obtained for HIV status (stratified by CD4 T-cells), solid organ transplant history, and immunosuppressive medication use. RESULTS: Risk of CIN 2 or worse was increased among women with HIV (n=36 women in the case group and 79 women in the control group; adjusted RR 2.0, 95% CI 1.3-3.0) compared with those without HIV and in solid organ transplant recipients (n=51 women in the case group and 68 women in the control group; RR 3.3, 95% CI 2.3-4.8) compared with women without a prior transplant. The highest risks were among women with HIV and less than 200 CD4 T-cells/microliter (n=9 women in the case group and eight women in the control group; RR 5.6, 95% CI 2.1-14.7) compared with those without HIV and in solid organ transplant recipients prescribed three or greater immunosuppressive medication classes (n=32 women in the case group and 33 women in the control group; RR 4.1, 95% CI 2.5-6.8) compared with women without a prior transplant and zero medication classes. No increased risks were observed for women with HIV and 500 or greater CD4 T-cells/microliter (n=9 women in the case group and 43 women in the control group; RR 0.8, 95% CI 0.4-1.7) compared with those without HIV or women without prior solid organ transplantation prescribed two or fewer immunosuppressive medication classes (n=1,262 women in the case group and 6,100 women in the control group; RR 0.95, 95% CI 0.89-1.01) compared with women without and a prior transplant and zero medication classes. CONCLUSION: Risk of CIN 2 or worse is increased in women with a prior solid organ transplant or who have HIV and CD4 cells/microliter less than 500 but not in women with HIV and higher CD4 levels or in women without a prior solid organ transplant but who are prescribed only one or two immunosuppressive medication classes.

The Association of Expanded Access to a Collaborative Midwifery and Laborist Model With Cesarean Delivery Rates.

OBJECTIVE: To examine the association between expanded access to collaborative midwifery and laborist services and cesarean delivery rates. METHODS: This was a prospective cohort study at a community hospital between 2005 and 2014. In 2011, privately insured women changed from a private practice model to one that included 24-hour midwifery and laborist coverage. Primary cesarean delivery rates among nulliparous, term, singleton, vertex women and vaginal birth after cesarean delivery (VBAC) rates among women with prior cesarean delivery were compared before and after the change. Multivariable logistic regression models estimated the effects of the change on the odds of primary cesarean delivery and VBAC; an interrupted time-series analysis estimated the annual rates before and after the expansion. RESULTS: There were 3,560 nulliparous term singleton vertex deliveries and 1,324 deliveries with prior cesarean delivery during the study period; 45% were among privately insured women whose care model changed. The primary cesarean delivery rate among these privately insured women decreased after the change, from 31.7% to 25.0% (P=.005, adjusted odds ratio [OR] 0.56, 95% confidence interval [CI] 0.39-0.81). The interrupted time-series analysis estimated a 7% drop in the primary cesarean delivery rate in the year after the expansion and a decrease of 1.7% per year thereafter. The VBAC rate increased from 13.3% before to 22.4% afterward (adjusted OR 2.03, 95% CI 1.08-3.80). CONCLUSION: The change from a private practice to a collaborative midwifery-laborist model was associated with a decrease in primary cesarean rates and an increase in VBAC rates. LEVEL OF EVIDENCE: II.

Prevalence and use of complementary health approaches among women with chronic pelvic pain in a prospective cohort study.

OBJECTIVE: The aim of this study was to examine the prevalence of and factors associated with use of complementary health approaches among women with chronic pelvic pain (CPP). DESIGN: We analyzed data from the Study of Pelvic Problems, Hysterectomy, and Intervention Alternatives, a prospective cohort study of women seeking care for noncancerous pelvic problems with intact uteri at enrollment. Among a subset of 699 participants who reported having CPP, we analyzed the prevalence of complementary health approaches used and associated patient sociodemographic and clinical characteristics, health-related quality of life, attitudes and beliefs, and conventional health care practices. RESULTS: At baseline, slightly over one-half (51%) of women with CPP used at least one complementary health approach in the past year, including acupuncture (8%), special foods or diets (22%), herbs (27%), and vitamins and minerals (29%). During follow-up surveys conducted annually for 4 years, a substantial proportion of women (44.8%) used complementary health approaches at more than half of the assessments. Users of complementary health approaches were more likely to undergo a hysterectomy or oophorectomy or to use gonadotropin-releasing hormone agonists or opioids during the study compared with nonusers. Women with CPP who used complementary health approaches also had more optimal health-related quality of life measured by the Pelvic Problem Impact Questionnaire (31.6 vs 25.6, P < 0.001). CONCLUSION(S): Many women with CPP consistently use complementary health approaches. The substantial interest in and high prevalence of complementary health approaches used alongside conventional medical approaches highlight the need for better understanding of multimodal approaches to address the complex condition of CPP.

Two practice models in one labor and delivery unit: association with cesarean delivery rates.

OBJECTIVE: The objective of the study was to examine the association between labor and delivery practice model and cesarean delivery rates at a community hospital. STUDY DESGIN: This was a retrospective cohort study of 9381 singleton live births at 1 community hospital, at which women were provided labor and delivery care under 1 of 2 distinct practice models: a traditional private practice model and a midwife-physician laborist practice model. Cesarean rates were compared by practice model, adjusting for potential sociodemographic and clinical confounders. Statistical comparisons were performed using the χ(2) test and multivariable logistical regression. RESULTS: Compared with women managed under the midwife/laborist model, women in the private model were significantly more likely to have a cesarean delivery (31.6% vs 17.3%; P < .001; adjusted odds ratio [aOR], 2.11; 95% confidence interval [CI], 1.73-2.58). Women with nulliparous, term, singleton, vertex gestations also were more likely to have a cesarean delivery if they were cared for in the private model (29.8% vs 15.9%; P < .001; aOR, 1.86; 95% CI, 1.33-2.58) as were women who had a prior cesarean delivery (71.3% vs 41.4%; P < .001; aOR, 3.19; 95% CI, 1.74-5.88). CONCLUSION: In this community hospital setting, a midwife-physician laborist practice model was associated with lower cesarean rates than a private practice model.

Use of medical, surgical and complementary treatments among women with fibroids.

OBJECTIVE: To examine the use of medical management, uterus-preserving surgery (UPS), and complementary treatments among women with uterine fibroids. STUDY DESIGN: Prospective cohort study of 933 premenopausal women ages 31-54 years with symptomatic fibroids who participated in the Study of Pelvic Problems, Hysterectomy, and Intervention Alternatives (SOPHIA) for an average of 4.3 years (SD 2.5 years). Incident use of fibroid treatments was determined through annual interviews. Linear regression models were used to compare changes in fibroid-related symptoms among women who underwent UPS versus those who did not undergo surgery. RESULTS: Participants were racially and ethnically diverse, with a mean age of 43 years. During study follow-up, 531 participants (57%) did not undergo UPS or hysterectomy, 250 (27%) had at least one UPS, and 152 (16%) underwent hysterectomy. Complementary and alternative treatments were commonly used, including exercise (45%), diet (34%), herbs (37%), and acupuncture (16%): participants reported significant symptom improvement and few side effects with these interventions. In multivariable linear regression models, women who did not undergo surgery during the study reported improvement in dyspareunia (p<.001), pelvic pain (p<.001), and menstrual cramps (p<.001). However, women who underwent UPS reported greater overall resolution of "pelvic problems" compared with women who did not have surgical treatment (difference in change score 1.18 on a four-point Likert scale, p<.001). CONCLUSION: UPS are effective treatments for women with fibroids, but many women use hormonal or complementary treatments and report significant symptom improvement without surgical intervention.

Effect of enhanced information, values clarification, and removal of financial barriers on use of prenatal genetic testing: a randomized clinical trial.

IMPORTANCE: Prenatal genetic testing guidelines recommend providing patients with detailed information to allow informed, preference-based screening and diagnostic testing decisions. The effect of implementing these guidelines is not well understood. OBJECTIVE: To analyze the effect of a decision-support guide and elimination of financial barriers to testing on use of prenatal genetic testing and decision making among pregnant women of varying literacy and numeracy levels. DESIGN, SETTING, AND PARTICIPANTS: Randomized trial conducted from 2010-2013 at prenatal clinics at 3 county hospitals, 1 community clinic, 1 academic center, and 3 medical centers of an integrated health care delivery system in the San Francisco Bay area. Participants were English- or Spanish-speaking women who had not yet undergone screening or diagnostic testing and remained pregnant at 11 weeks' gestation (n = 710). INTERVENTIONS: A computerized, interactive decision-support guide and access to prenatal testing with no out-of-pocket expense (n = 357) or usual care as per current guidelines (n = 353). MAIN OUTCOMES AND MEASURES: The primary outcome was invasive diagnostic test use, obtained via medical record review. Secondary outcomes included testing strategy undergone, and knowledge about testing, risk comprehension, and decisional conflict and regret at 24 to 36 weeks' gestation. RESULTS: Women randomized to the intervention group, compared with those randomized to the control group, were less likely to have invasive diagnostic testing (5.9% vs 12.3%; odds ratio [OR], 0.45 [95% CI, 0.25-0.80]) and more likely to forgo testing altogether (25.6% vs 20.4%; OR, 3.30 [95% CI, 1.43-7.64], reference group screening followed by invasive testing). Women randomized to the intervention group also had higher knowledge scores (9.4 vs 8.6 on a 15-point scale; mean group difference, 0.82 [95% CI, 0.34-1.31]) and were more likely to correctly estimate the amniocentesis-related miscarriage risk (73.8% vs 59.0%; OR, 1.95 [95% CI, 1.39-2.75]) and their estimated age-adjusted chance of carrying a fetus with trisomy 21 (58.7% vs 46.1%; OR, 1.66 [95% CI, 1.22-2.28]). Significant differences did not emerge in decisional conflict or regret. CONCLUSIONS AND RELEVANCE: Full implementation of prenatal testing guidelines using a computerized, interactive decision-support guide in the absence of financial barriers to testing resulted in less test use and more informed choices. If validated in additional populations, this approach may result in more informed and preference-based prenatal testing decision making and fewer women undergoing testing. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00505596.

Obstetricians' attitudes and beliefs regarding umbilical cord clamping.

OBJECTIVE: Although delayed umbilical cord clamping has been demonstrated to reduce the incidence of intraventricular hemorrhage and neonatal sepsis, and decrease the need for neonatal transfusions (without affecting cord pH, Apgar scores or the need for phototherapy), the extent to which this practice is being employed is unknown. We conducted a survey of US obstetricians to assess their attitudes and beliefs about cord clamping. STUDY DESIGN: Questionnaires were randomly mailed to members of the American College of Obstetricians and Gynecologists (ACOG), and the Collaborative Ambulatory Research Network (CARN). The data were analyzed using Chi-square and Student t tests. RESULTS: The response rates for the CARN and other ACOG members were 47% and 21%, respectively. Most (88%) responders reported their hospital had no umbilical cord clamping policy. The most frequent response for optimal timing of umbilical cord clamping, regardless of gestational age, was "don't know". Potential for neonatal red blood cell transfusion was the only concern cited as a reason for being somewhat or very inclined to delay umbilical cord clamping (51%). Delayed neonatal resuscitation (76%) was listed as a reason to clamp the cord immediately, despite the paucity of literature to support immediate cord clamping in this cohort. CONCLUSION: Despite substantial evidence supporting the practice of delayed cord clamping, few institutions have policies regarding this practice. Moreover, obstetricians' beliefs about the appropriate timing for umbilical cord clamping are not consistent with the evidence that demonstrates its beneficial impact on neonatal outcomes.

Contributions of hysterectomy and uterus-preserving surgery to health-related quality of life.

OBJECTIVE: To document the long-term effect of surgical interventions for noncancerous uterine conditions on health-related quality of life. METHODS: The Study of Pelvic Problems, Hysterectomy and Intervention Alternatives, conducted between 1998 and 2008, was a longitudinal study of 1,503 women with intact uteri experiencing abnormal uterine bleeding with or without leiomyomas, chronic pelvic pain, or pressure resulting from leiomyomas. Baseline and follow-up questionnaires included three condition-specific measures (Pelvic Problem Resolution, Pelvic Problem Impact Overall, and Pelvic Problem Impact on Sex) and five generic measures (Short Form-12 Mental and Physical Component Summaries, Current Health Utility, Feelings about Heath, and Satisfaction with Sex). We modeled changes over time in these patient-reported outcomes stratified by the most invasive treatment undergone (hysterectomy [13.7%], uterus-preserving surgery [9.0%], or nonsurgical therapy [77.3%]). RESULTS: Participants in all three groups reported significant improvement on all condition-specific measures and two of the five generic measures (Current Health Utility and Feelings about Health) from enrollment to final interview (all P values <.01). In general, greater improvements were experienced by women who had surgery. Trajectories modeled around the dates of surgery showed dramatic improvements after hysterectomy and, to a lesser degree, after uterus-preserving surgery. Although women who underwent uterus-preserving surgery tended to show immediate improvement, women who underwent hysterectomy experienced a 6-month delay in improvement in some outcomes with trajectories converging by 4 years postsurgery. CONCLUSION: Women seeking care for noncancerous uterine conditions can expect to experience improvement over time. Those who opt for surgery may experience most improvement. Understanding health-related quality-of-life trajectories may enhance counseling for women deciding between hysterectomy and alternative interventions. LEVEL OF EVIDENCE: II.

Effects of changes in prenatal aneuploidy screening policies in an integrated health care system.

OBJECTIVES: To estimate changes in rates of prenatal testing for aneuploidy over a 5-year period in a large integrated health care system. METHODS: Data from the Kaiser Permanente Northern California cytogenetics laboratory and Regional Prenatal Screening Program were used to estimate rates of prenatal aneuploidy screening and diagnostic testing in females of all ages during 2006-2010. We estimated the number of chromosome abnormalities detected and the proportion of abnormal cytogenetic results. Dichotomous variables were compared using χ tests. Rates of use and aneuploidy detection rates were compared for trend using a linear repeated-measures model. RESULTS: Annual deliveries decreased during this period, from 36,276 to 34,314, whereas births to women aged 35 years or older increased from 21.8% to 22.7% (P=.004). The rate of aneuploidy screening decreased minimally from 76.1% to 75.4% (P=.04). Among women 35 years or older, the rate of screening increased from 53.1% in 2006 to 63.7% in 2010 (P<.001), whereas the percentage having diagnostic testing decreased from 40.9% to 26.8% (P<.001). Among women younger than 35 years old, the rate of screening decreased from 82.5% in 2006 to 78.9% in 2010 and the rate of diagnostic testing decreased from 4.1% to 2.8% (P<.001). Abnormal diagnostic test results increased from 5.9% to 8.2% (P<.001); the number of chromosome abnormalities identified overall was 7.2 per 1,000 births in 2006 and 6.7 per 1,000 births in 2010 (P=.43). CONCLUSIONS: Offering comprehensive aneuploidy testing options to all pregnant women in an integrated health care system resulted in lower use and higher yield of diagnostic testing. LEVEL OF EVIDENCE: II.

Sexual function and aging in racially and ethnically diverse women.

OBJECTIVES: To examine factors influencing sexual activity and functioning in racially and ethnically diverse middle-aged and older women. DESIGN: Cross-sectional cohort study. SETTING: Integrated healthcare delivery system. PARTICIPANTS: One thousand nine hundred seventy-seven women aged 45 to 80. MEASUREMENTS: Self-administered questionnaires assessed sexual desire, activity, satisfaction, and problems. RESULTS: Of the 1,977 participants (876 white, 388 African American, 347 Latina, and 351 Asian women), 43% reported at least moderate sexual desire, and 60% had been sexually active in the previous 3 months. Half of sexually active participants (n=969) described their overall sexual satisfaction as moderate to high. Among sexually inactive women, the most common reason for inactivity was lack of interest in sex (39%), followed by lack of a partner (36%), physical problem of partner (23%), and lack of interest by partner (11%); only 9% were inactive because of personal physical problems. In multivariable analysis, African-American women were more likely than white women to report at least moderate desire (odds ratio (OR)=1.65, 95% confidence interval (CI)=1.25-2.17) but less likely to report weekly sexual activity (OR=0.68, 95% CI=0.48-0.96); sexually active Latina women were more likely than white women to report at least moderate sexual satisfaction (OR=1.75, 95% CI=1.20-2.55). CONCLUSION: A substantial proportion of community-dwelling women remain interested and engaged in sexual activity into older age. Lack of a partner capable of or interested in sex may contribute more to sexual inactivity than personal health problems in this population. Racial and ethnic differences in self-reported sexual desire, activity, and satisfaction may influence discussions about sexual difficulties in middle-aged and older women.

"I'm going to die of something anyway": women's perceptions of tamoxifen for breast cancer risk reduction.

OBJECTIVE: To investigate how ethnically diverse women who are eligible for tamoxifen prophylaxis because of their breast cancer risk decide about tamoxifen use for risk reduction. DESIGN: A qualitative intervention pilot study used focus groups to discuss the use of tamoxifen and to identify the concerns of ethnically diverse women about the preventive use of this drug. Focus group discussion involved exploration of the benefits and risks of tamoxifen prophylaxis, presentation of a standardized educational intervention, and focused discussion on attitudes about tamoxifen for prevention. Prominent themes emerged from iterative review of focus group transcripts. RESULTS: Fear of breast cancer was not prominent, and participants were less inclined to take tamoxifen as preventive therapy after receiving information. Decisions were based on participants' understandings of competing risks and benefits. Specifically, participants expressed limited willingness to take medication with potential serious side effects for risk reduction and were unwilling to discontinue hormone replacement therapy. Uneasiness about the reliability of scientific studies surfaced in the focus groups comprised of White and Latina women. African-American women described faith as important to prevention. CONCLUSIONS: Women were wary of taking a drug for a disease they might not develop. Women felt they had options other than tamoxifen to reduce their risk of breast cancer, including early detection, diet, faith, and complementary and alternative therapies.