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Purpose: Financial toxicity (FT) has been linked to higher symptom burden and poorer clinical outcomes for patients with cancer. Despite the availability of validated tools to measure FT, a simple screen remains an unmet need. We evaluated item 12 ("My illness has been a financial hardship to my family and me") of the COmprehensive Score for Financial Toxicity (COST) measure as a single-item FT screening measure., Methods: In this secondary analysis, 711 patients with cancer (690 with breast cancer) were recruited via a web-based survey from a philanthropic organization. COST items 1-11 were scored according to Functional Assessment of Chronic Illness Therapy scoring guidelines, with lower scores indicating worse FT. Analyses focused on establishing a correlation, examining item properties, and sensitivity/specificity of item 12 relative to the total COST score., Results: Item 12 had a correlation of r = 0.53 with the COST-11 score, and an increase of one point on item 12 is associated with a decrease of approximately three total points on the full scale ( b , 3.35; P < .001; adjusted R 2 , 0.28). Item analysis with the graded-response item in response theory modeling showed very good discrimination ( a , 2.096) for item 12, indicating that it can reliably distinguish between low and high FT in patients. Sensitivity ranged between 75.6% and 95.7% on all item 12 thresholds to screen positive for FT using two COST cutoffs as criteria. Maximizing both sensitivity and specificity was to be found for higher item 12 scores., Conclusion: To our knowledge, this is the first validation of a single-item screening measure for FT. Overall, these results illustrate that item 12 from the COST measure is a good candidate for a single-item screener. Clinicians can choose among item 12 screening thresholds depending on their tolerance for low specificity.

Introduction: Hepatic encephalopathy (HE) is a frequent complication of cirrhosis, leading to preventable hospitalizations and increased mortality. Despite the availability of validated neuro-psychometric tests to diagnose HE, only 10% of clinicians regularly screen for HE due to lack of time, equipment, and trained personnel., Materials and Methods: We studied the association between patient-reported cognitive function and the National Institutes of Health Toolbox Cognition Battery (a validated measure of HE) in patients with cirrhosis. A single-center prospective study of adult patients undergoing liver transplantation evaluation was performed from 10/2020 to 12/2021. Cognition was assessed using the National Institutes of Health Toolbox Cognition Battery and a brief Patient-Reported Outcomes Measurement Information System (PROMIS) survey., Results: Twenty-three liver transplantation candidates were enrolled; the mean age was 56.4 (±9.7) years, 39% were female and the most common etiologies of cirrhosis were primary biliary cirrhosis/primary sclerosing cholangitis/overlap syndrome (30%), hepatitis C (22%) and alcohol-associated liver disease (22%). The mean MELD-Na was 14.9 (±6.4). The mean PROMIS Cognitive Function T-score (PROMIS CF ) was 49.2 (±9.6). The mean T-scores for the List Sort Working Memory test, Flanker Inhibitory Control and Attention test, and Pattern Comparison Processing Speed test were 46.4 (±9.9), 37.8 (±6.2), and 50.22 (±16.4), respectively. PROMIS CF correlated with the List Sort Working Memory test (r = 0.45, P = .03). The mean hospitalization rate was 1.6 days admitted per month. On adjusted multivariate analysis, PROMIS CF predicted total hospitalization days (P < .001), hospital admissions (P = .01), and hospitalization rate (P < .001)., Conclusions: A brief survey can screen for HE and predict hospitalizations in patients with cirrhosis., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this article., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: Post-transplant health-related quality of life (HRQOL) is associated with health outcomes for kidney transplant (KT) recipients. However, pretransplant predictors of improvements in post-transplant HRQOL remain incompletely understood. Namely, important pretransplant cultural factors, such as experience of discrimination, perceived racism in healthcare, or mistrust of the healthcare system, have not been examined as potential HRQOL predictors. Also, few have examined predictors of decline in HRQOL post-transplant., Methods: Using data from a prospective cohort study, we examined HRQOL change pre- to post-transplant, and novel cultural predictors of the change. We measured physical, mental, and kidney-specific HRQOL as outcomes, and used cultural factors as predictors, controlling for demographic, clinical, psychosocial, and transplant knowledge covariates., Results: Among 166 KT recipients (57% male; mean age 50.6 years; 61.4% > high school graduates; 80% non-Hispanic White), we found mental and physical, but not kidney-specific, HRQOL significantly improved post-transplant. No culturally related factors outside of medical mistrust significantly predicted change in any HRQOL outcome. Instead, demographic, knowledge, and clinical factors significantly predicted decline in each HRQOL domain: physical HRQOL-older age, more post-KT complications, higher pre-KT physical HRQOL; mental HRQOL-having less information pre-KT, greater pre-KT mental HRQOL; and, kidney-specific HRQOL-poorer kidney functioning post-KT, lower expectations for physical condition to improve, and higher pre-KT kidney-specific HRQOL., Conclusions: Instead of cultural factors, predictors of HRQOL decline included demographic, knowledge, and clinical factors. These findings are useful for identifying patient groups that may be at greater risk of poorer post-transplant outcomes, in order to target individualized support to patients., (© 2024 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

Background: Frailty is prevalent in patients with end-stage liver disease and predicts waitlist mortality, posttransplant mortality, and frequency of hospitalizations. The Liver Frailty Index (LFI) is a validated measure of frailty in liver transplant (LT) candidates but requires an in-person assessment., Methods: We studied the association between patient-reported physical function and LFI in a single-center prospective study of adult patients with cirrhosis undergoing LT evaluation from October 2020 to December 2021. Frailty was assessed with the LFI and 4-m gait speed. Patient-reported physical function was evaluated using a brief Patient-Reported Outcomes Measurement Information System (PROMIS) survey., Results: Eighty-one LT candidates were enrolled, with a mean model of end-stage liver disease-sodium of 17.6 (±6.3). The mean LFI was 3.7 (±0.77; 15% frail and 59% prefrail) and the mean PROMIS Physical Function score was 45 (±8.6). PROMIS Physical Function correlated with LFI ( r  = -0.54, P  < 0.001) and 4-m gait speed ( r  = 0.48, P  < 0.001). The mean hospitalization rate was 1.1 d admitted per month. After adjusting for age, sex, and model of end-stage liver disease-sodium, patient-reported physical function-predicted hospitalization rate ( P  = 0.001)., Conclusions: This study suggests that a brief patient-reported outcome measure can be used to screen for frailty and predict hospitalizations in patients with cirrhosis., Competing Interests: The authors declare no conflicts of interest., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Purpose: Patient-reported outcome (PRO) analyses often involve calculating raw change scores, but limitations of this approach are well documented. Regression estimators can incorporate information about measurement error and potential covariates, potentially improving change estimates. Yet, adoption of these regression-based change estimators is rare in clinical PRO research., Methods: Both simulated and PROMIS® pain interference items were used to calculate change employing three methods: raw change scores and regression estimators proposed by Lord and Novick (LN) and Cronbach and Furby (CF). In the simulated data, estimators' ability to recover true change was compared. Standard errors of measurement (SEM) and estimation (SEE) with associated 95% confidence limits were also used to identify criteria for significant improvement. These methods were then applied to real-world data from the PROMIS® study., Results: In the simulation, both regression estimators reduced variability compared to raw change scores by almost half. Compared to CF, the LN regression better recovered true simulated differences. Analysis of the PROMIS® data showed similar themes, and change score distributions from the regression estimators showed less dispersion. Using distribution-based approaches to calculate thresholds for significant within-patient change, smaller changes could be detected using both regression estimators., Conclusions: These results suggest that calculating change using regression estimates may result in more increased measurement sensitivity. Using these scores in lieu of raw differences can help better identify individuals who experience real underlying change in PROs in the course of a trial, and enhance the established methods for identifying thresholds for meaningful within-patient change in PROs., (© 2022. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

Background: Personality traits influence clinical outcomes in chronic diseases, but their impact in cirrhosis is unknown. We studied the personality of patients with cirrhosis undergoing liver transplant (LT) evaluation and determined their correlation to clinical outcomes., Methods: A multicenter' prospective study of adult patients undergoing LT evaluation was performed from January 2018 to October 2019. The "Big Five" personality traits of conscientiousness, extraversion, openness, neuroticism, and agreeableness plus agency were assessed with the Midlife Development Inventory Personality Scale and compared with the general population. Frailty was assessed with the Liver Frailty Index., Results: Two hundred sixty-three LT candidates were enrolled. Twenty-four percent had hepatitis C virus, 25% nonalcoholic steatohepatitis, and 25% ethyl alcohol (mean model for end-stage liver disease = 15.7). Compared with the general population, LT candidates had higher openness (3.1 versus 2.9; P < 0.001), extraversion (3.2 versus 3.1; P < 0.001), agreeableness (3.5 versus 3.4; P = 0.04), agency (2.9 versus 2.6; P < 0.001), neuroticism (2.2 versus 2.1; P = 0.001), and lower conscientiousness (3.3 versus 3.4; P = 0.007). Patients with higher conscientiousness were more likely to receive an LT (HR = 2.76; P = 0.003)., Conclusions: Personality traits in LT candidates differ significantly from the general population, with higher conscientiousness associated with a higher likelihood of receiving a transplant., Competing Interests: The authors declare no conflicts of interest., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Living donor liver transplantation (LDLT) provides a source for transplant in the setting of the deceased donor organ shortage. Seeing as living donors do not derive any medical benefit from the procedure, fully understanding the impact of donation on donor health-related quality of life (HRQOL) is essential. A systematic search of the MEDLINE database was performed from 2008-2020, using relevant Medical Subject Headings. Articles were evaluated for study design, cohort size and follow-up time and excluded if they contained significant methodological flaws. A total of 43 articles were included: 20 (47%) were cross-sectional and 23 (53%) were longitudinal. The mean number of donors per study was 142 (range:8-578) with follow-up ranging from 12-132 months. Forty-two unique HRQOL metrics were implemented across the 43 studies, the majority of which were questionnaires. Of the 31 studies that used the Medical Outcomes Study Short Form 36 questionnaire, 9.1% of donors reported physical QOL did not return to pre-LDLT levels for at least 2 years after donation. Mental QOL remained stable or improved after LDLT, with mean mental composite scores increasing from 50 to 52 at 3 months post-LDLT in one study. The predicted probability of poor sexual desire decreased at 1-year post-LDLT (male: 0.08, female: 0.26) relative to pre-LDLT (male: 0.44, female: 0.76; P<0.001) and three months post-LDLT (male: 0.35, female 0.69; P=0.001). Forty percent of donors found LDLT to be financially burdensome at 3 months and 19% at 2 years post-LDLT. Female gender and obesity were consistent predictors of worse HRQOL. Laparoscopy-assisted donor hepatectomy was associated with shorter hospitalizations than open donor hepatectomy (10.3 vs. 18.3 days, P=0.02). No studies used the National Institutes of Health Patient Reported Outcomes Measurement Information System (PROMIS) measures of HRQOL. Our review demonstrates that LDLT can have a long-lasting negative impact on physical QOL in 9.1% of donors and can cause both sexual dysfunction and significant financial strain. Future studies should consider using standardized and extensively validated patient reported outcomes measures, such as PROMIS, in order to directly compare outcomes across studies and gain further insight into the impact of LDLT on D-HRQOL., Competing Interests: Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://dx.doi.org/10.21037/dmr-20–151).The series “Living Donor Liver Transplantation” was commissioned by the editorial office without any funding or sponsorship.AJT and DPR reports T32 NIH Grant from Transplant Surgery Scientist Program, Northwestern University. The authors have no other conflicts of interest to declare.

Background and Objectives: Clinical guidelines advocate using long-acting reversible contraceptives (LARC) to reduce unintended pregnancy, but LARC use in Australia is poor. Additionally, little is known about contraceptive practices of women with a history of unintended pregnancy. The aim of this study was to describe current contraception use according to a history of unintended pregnancy., Method: Data were analysed from women recruited into The Australian Contraceptive ChOice pRoject (ACCORd) trial., Results: Approximately 47% (128/275) of women aged 16-45 years reported unintended pregnancies, and 30% had an abortion (83/275). Contraceptive data available from 117 women showed that condoms (24%, n = 28/117) and the oral contraceptive pill (22%, n = 26/117) were most commonly used among women reporting one unintended pregnancy or more., Discussion: These findings support implementing interventions to increase the uptake of effective contraception, as successfully demonstrated in the ACCORd trial, in general practice.

The psychometric properties of the English-language NIH Toolbox for Assessment of Neurological and Behavioral Function (NIH Toolbox) have been examined in numerous populations. This study evaluated the reliability and validity of the Spanish-language NIH Toolbox. Participants were children aged 3 to 7 years and adults aged 18 to 85 years who took part in the NIH Toolbox norming study in Spanish. Results supported the internal consistency reliability of included measures. Test-retest reliability was strong for most tests, though it was weaker for the test of olfaction among children and the test of locomotion among adults. Spearman's correlations and general linear models showed Spanish tests were often associated with age, sex, and education. Convergent validity for the two language measures that underwent more intensive development, evaluated via Spearman's correlations with legacy measures, was strong. Results support using the Spanish-language NIH Toolbox to measure neurological and behavioral functioning among Spanish-speaking individuals in the United States.

Background: Health-related quality of life (HRQOL) measures are commonly used in oncology research. Interest in their use for monitoring or screening is increasing. The Functional Assessment of Cancer Therapy (FACT) is one of the most widely used HRQOL instruments. Consequently, oncology researchers and practitioners have an increasing need for reference values for the Functional Assessment of Cancer Therapy-General (FACT-G) and its 7-item rapid version, the Functional Assessment of Cancer Therapy-General 7 (FACT-G7), to compare FACT scores across specific subgroups of patients in research trials and practice. The objectives of this study are to provide 1) reference values from a sample of the general US adult population and a sample of adults diagnosed with cancer and 2) cutoff scores for quality of life., Methods: A sample of the general US population (N = 1075) and a sample of patients with cancer from 12 studies (N = 5065) were analyzed. Cutoff scores were established using distribution- and anchor-based methods. Mean values for the cancer sample were analyzed by performance status, cancer type, and disease status. Also, t tests and established criteria for meaningful differences were used to compare values., Results: FACT-G and FACT-G7 scores in the general US population sample and cancer sample were generally comparable. Among the sample of patients with cancer, FACT-G and FACT-G7 scores worsened with declining performance status and increasing disease status., Conclusions: These data will aid interpretation of the magnitude and meaning of FACT scores, and allow for comparisons of scores across studies., (© 2014 American Cancer Society.)

Context: Effective lung transplant education helps ensure informed decision making by patients and better transplant outcomes., Objective: To understand the educational needs and experiences of lung transplant patients., Design: Mixed-method study employing focus groups and patient surveys., Setting: Barnes-Jewish Hospital in St Louis, Missouri., Patients: 50 adult lung transplant patients: 23 pretransplant and 27 posttransplant., Main Outcome Measures: Patients' interest in receiving specific transplant information, the stage in the transplant process during which they wanted to receive the education, and the preferred format for presenting the information., Results: Patients most wanted information about how to sustain their transplant (72%), when to contact their coordinator immediately (56%), transplant benefits (56%), immunosuppressants (54%), and possible out-of-pocket expenses (52%). Patients also wanted comprehensive information early in the transplant process and a review of a subset of topics immediately before transplant (time between getting the call that a potential donor has been found and getting the transplant). Patients reported that they would use Internet resources (74%) and converse with transplant professionals (68%) and recipients (62%) most often., Discussion: Lung transplant patients are focused on learning how to get a transplant and ensuring its success afterwards. A comprehensive overview of the evaluation, surgery, and recovery process at evaluation onset with a review of content about medications, pain management, and transplant recovery repeated immediately before surgery is ideal.

Background: In India, female motorized two-wheeler users involved in road traffic accidents account for 70,000 injuries and fatalities annually. Despite federal helmet laws, New Delhi exempted female pillion riders (backseat passengers) from mandatory helmet usage in response to religious and cultural opposition. This study attempts to elucidate factors influencing female pillion riders' helmet usage, hypothesizing religious-based opposition and poor understanding of helmet efficacy., Materials and Methods: A cross-section of female pillion riders in five areas of New Delhi were approached by trained surveyors. Surveys were self-completed (n = 52) or completed with assistance (n = 243). Demographics, helmet use habits, opinions, and media influence data were collected. Data were analyzed using χ(2), Fisher exact test, and multivariable logistic regression., Results: Of 305 women surveyed, 69.8% were Hindus (n = 213), 10.8% Muslims (n = 33), and 10.4% Sikhs (n = 32). More Muslim (33.3%, P = 0.001) and Sikh (25%, P = 0.04) women opposed mandatory helmet use compared with Hindu women (10.6%). There were 66 women who self-reported helmet use, with one woman (Sikh) who abstained from helmets for religious practices (0.9%). The most common reason for helmet disuse was discomfort (n = 40, 36.7%). Most respondents reported media positively influenced helmet use (57.7%)., Conclusions: Despite arguments of infringement on religious rights, women pillions ride without helmets for comfort and appearance purposes primarily. Furthermore, though significantly fewer Sikh and Muslim women support mandatory helmet laws, supporters remain a clear majority in both groups. Most women report media outlets as influential on helmet use, principally television, suggesting that mass media campaigns may improve helmet compliance., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Background: Metastatic renal cell cancer is associated with poor long-term survival and has no cure. Traditional clinical endpoints are best supplemented by patient-reported outcomes designed to assess symptoms and function. Normative data was obtained on the National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy-Kidney Symptom Index (NFKSI) to aid in score interpretation and planning of future trials., Methods: General population data were obtained from 2000 respondents, who completed the 19-item NFKSI-19, as well the SF-36 (Short Form 36-item instrument) and the PROMIS-29 (29-item Patient Reported Outcomes Measurement Information System), both general health status measures. Basic demographic and self-reported comorbidity data were also collected., Results: The sample was 50% female, 85.7% caucasian, with an equal distribution across age bands from 18 years to 75 years and older. Most respondents (62.8%) had more than a high school education and reported an Eastern Cooperative Oncology Group performance status of normal activity without symptoms (63.4%). Score distributions on the NFKSI-19, its subscales, and individual items are summarized., Conclusions: The NFKSI-19 and its subscales now have scores for the general US population, allowing comparability to generic questionnaires such as the SF-36 and PROMIS-29. These data can be used to guide treatment expectations and plan future comparative effectiveness research using the scales., (Copyright © 2012 American Cancer Society.)

We examine if social and economic factors, fuelwood availability, market and media access are associated with owning a modified stove and variation in household emissions from biomass combustion, a significant environmental and health concern in rural India. We analyze cross-sectional household socio-economic data, and PM(2.5) and particulate surface area concentration in household emissions from cookstoves (n=100). This data set combines household social and economic variables with particle emissions indexes associated with the household stove. The data are from the Foundation for Ecological Society, India, from a field study of household emissions. In our analysis, we find that less access to ready and free fuelwood and higher wealth are associated with owning a replacement/modified stove. We also find that additional kitchen ventilation is associated with a 12% reduction in particulate emissions concentration (p<0.05), after we account for the type of stove used. We did not find a significant association between replacement/modified stove on household emissions when controlling for additional ventilation. Higher wealth and education are associated with having additional ventilation. Social caste, market and media access did not have any effect on the presence of replacement or modified stoves or additional ventilation. While the data available to us does not allow an examination of direct health outcomes from emissions variations, adverse environmental and health impacts of toxic household emissions are well established elsewhere in the literature. The value of this study is in its further examination of the role of social and economic factors and available fuelwood from commons in type of stove use, and additional ventilation, and their effect on household emissions. These associations are important since the two direct routes to improving household air quality among the poor are stove type and better ventilation.

Mass-based dose parameters (for example, PM(2.5)) are most often used to characterize cookstove particulate matter emissions. Particle surface area deposition in the tracheobronchial (TB) and alveolar (A) regions of the human lung is also an important metric with respect to health effects, though very little research has investigated this dose parameter for cookstove emissions. Field sampling of cookstove emissions was performed in two regions of rural India, wherein PM(2.5), particulate surface area concentration in both TB and A regions, and carbon monoxide (CO) were measured in 120 households and two roadside restaurants. Novel indices were developed and used to compare the emissions and efficiency of several types of household and commercial cookstoves, as well as to compare mass-based (PM(2.5)) and surface area-based measurements of particle concentration. The correlation between PM(2.5) and surface area concentration was low to moderate: Pearson's correlation coefficient (R) for PM(2.5) vs surface area concentration in TB region is 0.38 and for PM(2.5) vs surface area concentration in A region is 0.47, indicating that PM(2.5) is not a sufficient proxy for particle surface area concentration. The indices will also help communicate results of cookstove studies to decision makers more easily.

This manuscript describes the randomized clinical trial titled Stage-Matched Intervention to Increase Dual Method Use or Project PROTECT. Project PROTECT compared two approaches to promote the use of dual methods of contraception among high-risk women. The intervention arm received tailored individualized feedback based on the Transtheoretical Model of Behavior Change using a computer-based multimedia program. The control arm received general information on contraception. The primary outcomes of this trial were 1) self-reported use of dual methods of contraception and 2) the biological outcomes of an unintended pregnancy or an incident or recurrent sexually transmitted disease. In this report, we describe the significance and background of the problem, the specific aims of the study, study organization, patient selection, randomization, outcome variables, data collection, procedures used for follow-up and testing, primary and secondary outcomes, and statistical analyses. We also describe participant characteristics and procedures used to assure patient safety and trial monitoring.

Objective: This study was undertaken to use multivariable methods to develop clinical predictive models for the occurrence of uterine rupture by using both antepartum and early intrapartum factors., Study Design: This was a planned secondary analysis from a multicenter case-control study of uterine rupture among women attempting vaginal birth after cesarean (VBAC) delivery. Multivariable methods were used to develop 2 separate clinical predictive indices--one that used only prelabor factors and the other that used both prelabor and early labor factors. These indices were also assessed with the use of Receiver operating characteristic curves., Results: We identified 134 cases of uterine rupture and 665 noncases. No single individual factor is sufficiently sensitive or specific for clinical prediction of uterine rupture. Likewise, the 2 clinical predictive indices were neither sufficiently sensitive nor specific for clinical use (receiver operating characteristic curve [area under the curve] 0.67 and 0.70, respectively)., Conclusion: Uterine rupture cannot be predicted with either individual or combinations of clinical factors. This has important clinical and medical-legal implications.

Objectives: We examined whether incarcerated women would substantially increase birth control initiation if contraceptive services were available within the prison compared with after their release back into the community., Methods: During phase 1 of the study, a nurse educator met with women at the Rhode Island Adult Correctional Institute and offered them referrals for contraceptive services at a community health clinic after their release. During phase 2, contraceptive services were offered to women during their incarceration., Results: The majority of the participants (77.5%) reported a desire to initiate use of birth control methods. Within 4 weeks of their release, 4.4% of phase 1 participants initiated use of a contraceptive method, compared with 39.1% of phase 2 participants (odds ratio [OR]=14.6; 95% confidence interval [CI]=5.5, 38.8)., Conclusions: Provision of contraceptive services to women during their incarceration is feasible and greatly increases birth control initiation compared to providing services only in the community.

Objective: Efficacy study of suppressive vaginal metronidazole in reducing recurrent symptomatic episodes of bacterial vaginosis., Study Design: Multicenter prospective study with initial 10-day open-label metronidazole gel in which asymptomatic responders randomly assigned to receive twice weekly metronidazole vaginal gel or placebo for 16 weeks and off therapy for 12 weeks., Results: Of 157 eligible women with recurrent bacterial vaginosis, 112 of 127 returning evaluable women (88.2%) responded clinically and were randomly assigned. During suppressive therapy, recurrent bacterial vaginosis occurred in 13 women (25.5%) receiving metronidazole and 26 (59.1%) receiving placebo (MITT analysis, relative risk [RR] 0.43, CI = 0.25-0.73, P = .001). During the entire 28-week follow-up, recurrence occurred in 26 (51.0%) on treatment compared with 33 (75%) on placebo (RR 0.68, CI = 0.49-0.93, P = .02). Probability for remaining cured was 70% for metronidazole compared with 39% on placebo, which declined to 34% and 18%, respectively, by 28 weeks follow-up. Adverse effects were uncommon; however, secondary vaginal candidiasis occurred significantly more often in metronidazole-treated women (P = .02)., Conclusion: Suppressive therapy with twice-weekly metronidazole gel achieves a significant reduction in the recurrence rate of bacterial vaginosis; however, secondary vaginal candidiasis is common.

Objective: This study was undertaken to determine incidence and risk factors for uterine rupture in women attempting vaginal birth after cesarean delivery (VBAC) in a wide range of hospital settings., Study Design: We performed a case-control study nested within a cohort of women who have had a prior cesarean to determine the incidence and risk factors for uterine rupture in women attempting VBAC., Results: The incidence rate of uterine rupture in those who attempt VBAC was 9.8 per 1000. A prior vaginal delivery was associated with a lower risk of uterine rupture (adjusted odds ratio [OR] = 0.40, 95% CI 0.20-0.81). Although prostaglandins alone were not associated with uterine rupture, sequential use of prostaglandin and pitocin was associated with uterine rupture (adjusted OR = 3.07, 95% CI 0.98-9.88)., Conclusion: Women with a prior cesarean should be offered VBAC, and women with a prior cesarean and prior vaginal delivery should be encouraged to VBAC. Although other studies have suggested that prostaglandins should be avoided, we suggest that inductions requiring sequential agents be avoided.

Objective: This study was undertaken to compare clinical outcomes in women with 1 versus 2 prior cesarean deliveries who attempt vaginal birth after cesarean delivery (VBAC) and also to compare clinical outcomes of women with 2 prior cesarean deliveries who attempt VBAC or opt for a repeat cesarean delivery., Study Design: We performed a secondary analysis of a retrospective cohort study, in which the medical records of more than 25,000 women with a prior cesarean delivery from 16 community and tertiary care hospitals were reviewed by trained nurse abstractors. Information on demographics, obstetric history, medical and social history, and the outcomes of the index pregnancy was obtained. Comparisons of obstetric outcomes were made between women with 1 versus 2 prior cesarean deliveries, and also between women with 2 prior cesarean deliveries who opt for VBAC attempt versus elective repeat cesarean delivery. Both bivariate and multivariate techniques were used for these comparisons., Results: The records of 20,175 women with one previous cesarean section and 3,970 with 2 prior cesarean sections were reviewed. The rate of VBAC success was similar in women with a single prior cesarean delivery (75.5%) compared with those with 2 prior cesarean deliveries (74.6%), though the odds of major morbidity were higher in those with 2 prior cesarean deliveries (adjusted odd ratio[OR] = 1.61 95% CI 1.11-2.33). Among women with 2 prior cesarean deliveries, those who opt for a VBAC attempt had higher odds of major complications compared with those who opt for elective repeat cesarean delivery (adjusted OR = 2.26, 95% CI 1.17-4.37)., Conclusion: The likelihood of major complications is higher with a VBAC attempt in women with 2 prior cesarean deliveries compared with those with a single prior cesarean delivery. In women with 2 prior cesarean deliveries, while major complications are increased in those who attempt VBAC relative to elective repeat cesarean delivery, the absolute risk of major complications remains low.

Objective: We sought to determine whether women with diet-controlled gestational diabetes mellitus who attempt vaginal birth after cesarean delivery are at increased risk of failure, when compared with their non-diabetic counterparts., Study Design: We identified 13,396 women who attempted vaginal birth after cesarean delivery among 25,079 pregnant women with a previous cesarean delivery who were delivered between 1995 and 1999 at 16 community and university hospitals. Analysis was limited to 9437 women without diabetes mellitus and 423 women with diet-controlled diabetes mellitus who attempted vaginal birth after cesarean delivery with a singleton gestation and 1 previous low-flap cesarean delivery. Data that were collected by trained abstractors, included demographics, medical history, and both pregnancy and neonatal outcomes. Multivariable logistic regression analysis was performed to determine an adjusted odds ratio for vaginal birth after cesarean delivery success among women with diet-controlled gestational diabetes compared with women with no diabetes mellitus. We controlled for birth weight, maternal age, race, tobacco, chronic hypertension, hospital settings, labor management, and obstetric history., Results: Forty-nine percent of the women with gestational diabetes mellitus and 67% of the women with no diabetes mellitus attempted vaginal birth after cesarean delivery. The success rate for attempted vaginal birth after cesarean delivery among gestational diabetic women was 70%, compared with 74% for non-diabetic women. We found that gestational diabetes mellitus is not an independent risk factor for vaginal birth after cesarean delivery failure. The relative risk for vaginal birth after cesarean delivery success in women with gestational diabetes mellitus compared with women without gestational diabetes mellitus was 0.94 (95% CI, 0.87-1.00). After an adjustment was made for confounding, the odds ratio for success with gestational diabetes mellitus was 0.87 (95% CI, 0.68-1.10)., Conclusion: Women with diet-controlled gestational diabetes mellitus who were carrying singleton fetuses who had no more than 1 previous low flap cesarean delivery should be counseled that their disease does not decrease their chances for a successful vaginal birth after cesarean delivery. Among diet-controlled diabetic women, the overall success rate for vaginal birth after cesarean delivery remains acceptable, and attempted vaginal birth after cesarean delivery should not be discouraged solely on the basis of gestational diabetes mellitus.

Objective: To evaluate whether cesarean delivery is a risk factor for emergent postpartum hysterectomy., Methods: We performed a case-control study of patients who delivered at Women & Infants Hospital between January 1989 and February 2000. Fifty cases of emergent postpartum hysterectomy performed within 14 days of delivery met our inclusion criteria. Using a computer-generated list, two patients admitted to the labor department at a time point similar to that of each case patient were selected as controls (n = 100). We reviewed medical records for demographic data, route of delivery, labor characteristics, surgical history, and indication for hysterectomy. Cases and controls were compared, and logistic regression was used to calculate the odds ratio (OR) and the 95% confidence interval (CI) for the association of delivery route and emergent hysterectomy., Results: Cesarean delivery was associated with a 13-fold increased risk of emergent hysterectomy when we controlled for previous cesarean delivery, dilation and curettage or abortion before the index pregnancy, use of prostaglandin, and use of pitocin (OR 12.9; 95% CI 5.2, 32.3)., Conclusion: Cesarean delivery is a significant risk factor for postpartum hysterectomy.

Objective: We investigated the association between endometritis and reproductive morbidity., Study Design: Participants were 614 women in the PID Evaluation and Clinical Health (PEACH) Study with pelvic pain, pelvic organ tenderness, and leukorrhea, mucopurulent cervicitis, or untreated cervicitis. We compared women with endometritis (>or=5 neutrophils or >or=2 plasma cells), Neisseria gonorrhoeae or Chlamydia trachomatis upper genital tract infection (UGTI) or both to women without endometritis/UGTI for outcomes of pregnancy, infertility, recurrent pelvic inflammatory disease (PID), and chronic pelvic pain (CPP), adjusting for age, race, education, PID history, and baseline infertility., Results: Endometritis/UGTI was not associated with reduced pregnancy (odds ratio [OR] 0.8, 95% CI 0.6-1.2) or elevated infertility (OR 1.0, 95% CI 0.6-1.6), recurrent PID (OR 0.6, 95% CI 0.4-0.9), or CPP (OR 0.6, 95% CI 0.4-0.9). PEACH participants with and without endometritis/UGTI had higher age- and race-specific pregnancy rates than 1997 national rates., Conclusion: Among women with clinically suspected mild-to-moderate PID treated with standard antibiotics, endometritis/UGTI was not associated with reproductive morbidity.

Objective: Pelvic inflammatory disease (PID) is a common and morbid intraperitoneal infection. Although most women with pelvic inflammatory disease are treated as outpatients, the effectiveness of this strategy remains unproven., Study Design: We enrolled 831 women with clinical signs and symptoms of mild-to-moderate pelvic inflammatory disease into a multicenter randomized clinical trial of inpatient treatment initiated by intravenous cefoxitin and doxycycline versus outpatient treatment that consisted of a single intramuscular injection of cefoxitin and oral doxycycline. Long-term outcomes were pregnancy rate, time to pregnancy, recurrence of pelvic inflammatory disease, chronic pelvic pain, and ectopic pregnancy., Results: Short-term clinical and microbiologic improvement were similar between women randomized to the inpatient and outpatient groups. After a mean follow-up period of 35 months, pregnancy rates were nearly equal (42.0% for outpatients and 41.7% for inpatients). There were also no statistically significant differences between outpatient and inpatient groups in the outcome of time to pregnancy or in the proportion of women with pelvic inflammatory disease recurrence, chronic pelvic pain, or ectopic pregnancy., Conclusion: Among women with mild-to-moderate pelvic inflammatory disease, there was no difference in reproductive outcomes between women randomized to inpatient treatment and those randomized to outpatient treatment.

Objective: Among women diagnosed with pelvic inflammatory disease, we examined the associations between hormonal or barrier methods of contraception and upper genital tract infection or inflammation., Methods: Participants were 563 patients from a treatment trial for pelvic inflammatory disease. All had pelvic pain; pelvic organ tenderness; and leukorrhea, mucopurulent cervicitis, or untreated cervicitis. Contraceptive use within the prior 4 weeks was compared among women with baseline upper genital tract gonorrhea or chlamydia, women with endometritis without upper genital tract gonorrhea or chlamydia, and women with neither upper genital tract gonorrhea or chlamydia nor endometritis., Results: Inconsistent condom use was significantly and independently associated with a 2 to 3 times elevated risk for upper genital tract infection. Upper genital tract gonorrhea or chlamydia was not significantly associated with use of oral contraceptives, use of medroxyprogesterone, condoms used consistently, nor other barrier methods., Conclusion: No hormonal or barrier contraceptive method was related to a reduction in upper genital tract disease among women with clinical pelvic inflammatory diseases.

Objective: Careful detection and treatment of pelvic inflammatory disease are essential for the prevention of adverse sequelae. The purpose of this study was to evaluate the diagnostic test characteristics of clinical criteria for the diagnosis of pelvic inflammatory disease., Study Design: We performed a cross-sectional analysis of the baseline characteristics of 651 patients enrolled in a multicenter randomized treatment trial for pelvic inflammatory disease. Clinical and laboratory findings were recorded for all patients, and endometrial sampling was performed. We calculated sensitivity and specificity and performed receiver operating characteristic curve analysis and multivariate logistic regression, using histologic endometritis as the criterion standard., Results: The minimal criteria for pelvic inflammatory disease, as recommended by the Centers for Disease Control and Prevention, had a sensitivity of 83%, in comparison with a 95% sensitivity for adnexal tenderness (P =.001). Of the supportive clinical criteria, the finding most highly associated with endometritis was a positive test result for Chlamydia trachomatis or Neisseria gonorrhoeae (adjusted odds ratio, 4.3; 95% confidence interval, 2.89--6.63). A multivariate logistic regression model indicated that combinations of criteria significantly improve the prediction of endometritis., Conclusion: Sensitivity can be maximized by using the presence of adnexal tenderness as a minimal criterion for the diagnosis of pelvic inflammatory disease, and supportive criteria are helpful in estimating the probability of endometritis.

Context: Bacterial vaginosis (BV) is a strong independent risk factor for adverse pregnancy outcomes. BV is found in 9% to 23% of pregnant women. Symptoms include vaginal discharge, pruritus, or malodor, but often women with BV are asymptomatic., Objectives: To determine whether screening and treating pregnant women for BV reduces adverse pregnancy outcomes, as part of an assessment for the U.S. Preventive Services Task Force., Data Sources: Randomized clinical trials of BV treatment in pregnancy that measured pregnancy outcomes were identified from multiple searches in MEDLINE from 1966 to 1999, the Cochrane Controlled Trials Register and Library, and national experts., Study Selection: All randomized controlled trials of BV treatment in pregnancy that specifically measured pregnancy outcomes., Data Extraction: The following information was abstracted: study design and blinding, diagnostic methods, antibiotic interventions, timing of antibiotic treatment in pregnancy, criteria for treatment, comorbidities, demographic details, risk factors for preterm delivery such as previous preterm delivery, compliance, rates of spontaneous and total preterm delivery less than 37 weeks and less than 34 weeks, preterm premature rupture of membranes, low birth weight less than 2500 grams, spontaneous abortion, postpartum endometritis, and neonatal sepsis. For each study, we measured the effect of treatment by calculating the difference in the rate of a given pregnancy outcome in the control group minus the treatment group (the absolute risk reduction [ARR]). A stepwise procedure based on the profile likelihood was applied to assess heterogeneity, to pool studies when appropriate, and to calculate the mean and 90% confidence intervals (CIs) for the effect of treatment., Data Synthesis: Seven randomized controlled trials met inclusion criteria for the meta-analysis. We found no benefit to BV treatment in average-risk women for any pregnancy outcome. Results of studies of high-risk populations, women with previous preterm delivery, were statistically heterogeneous. They clustered into two groups; one showed no benefit (ARR=-0.08, 90% CI=-0.19 to 0.04), whereas the three homogeneous studies showed potential benefit of BV treatment (pooled ARR=0.22; 90% CI=0.13 to 0.31) for preterm delivery before 37 weeks. Four high-risk studies reported results for preterm delivery less than 34 weeks. The pooled estimate showed no benefit (ARR=0.04; 90% CI=-0.02 to 0.09), but variation was noted among individual studies. Two trials of high-risk women found an increase in preterm delivery less than 34 weeks in women who did not have BV but received BV treatment. Comparisons of patient populations, treatment regimens, and study designs did not explain the heterogeneity among studies., Conclusions: We found no benefit to routine BV screening and treatment. A subgroup of high-risk women may benefit from BV screening and treatment; however, there may be a subgroup for whom BV treatment could increase the occurrence of preterm delivery.

Objective: Correlates of abnormal human immunodeficiency virus cervical cytologic findings were examined among women infected with human immunodeficiency virus and uninfected women., Study Design: We performed a cross-sectional analysis of baseline data on demographically similar women with infection or risk factors for it., Results: Among 1050 women without hysterectomy, squamous intraepithelial lesions were more common among women infected with human immunodeficiency virus than among uninfected women (18.8% vs 5.3%; P <.001). In multivariate analysis the association of squamous intraepithelial lesions with human papillomavirus infection was strong; adjusted prevalence ratios were 27 for high-risk, 25 for intermediate-risk, and 10 for low-risk types (95% confidence intervals, 12-58, 12-54, and 4-25, respectively). Much lower adjusted prevalence ratios were seen for the only other factor significantly associated with squamous intraepithelial lesions, namely, infection with human immunodeficiency virus in conjunction with a reduced CD4(+) cell count. Adjusted prevalence ratios were 1.9 for CD4(+) cell counts <200 and 1.6 for CD4(+) cell counts between 200 and 500 (95% confidence intervals, 1.2-3.0 and 1.0-2.5, respectively). Adjusted attributable fractions calculated for this study population indicated that if both human immunodeficiency virus and human papillomavirus were removed, 47.6% of the observed lesions with atypical squamous cells of uncertain significance and 93.4% of the observed squamous intraepithelial lesions would be prevented., Conclusion: Squamous intraepithelial lesions are more common among human immunodeficiency virus-infected women and are associated most commonly with high- and intermediate-risk human papillomavirus types and secondarily with human immunodeficiency virus-associated immune compromise.

Objective: To determine women's awareness and level of understanding of the risks and sequelae of sexually transmitted diseases (STDs)., Study Design: The study was a cross-sectional survey of 103 women seen at an urban center. We recruited women from several clinical sites: (1) patients with signs or symptoms of an STD seen in a busy women's urgent care unit, (2) women enrolled in clinical studies for STDs or bacterial vaginosis, (3) patients admitted to the hospital and found to have an STD, and (4) women at high risk based on age and sexual activity. A trained female interviewer administered the survey to women agreeing to participate. The questionnaire assessed the patient's awareness of various STDs and their association with adverse outcomes. The survey also evaluated women's knowledge regarding STD prevention. Descriptive analyses were performed using SAS (Cary, North Carolina) on the 103 patients surveyed., Results: The median age of our survey population was 23, 66% were nonwhite, and 37% were on public assistance or uninsured. The population was at high risk for STDs based on the reported history of infection with Neisseria gonorrhoeae and Chlamydia trachomatis (6% and 38%, respectively). Of the 103 women surveyed, 33% had never heard of pelvic inflammatory disease (PID), and 79.6% could not identify any adverse sequelae of PID. Sixty-five percent were unaware that PID increases the risk of ectopic pregnancy, and 56.3% were unaware that it could result in chronic pelvic pain. When asked if they knew of any methods to prevent or reduce their risk of STDs, only 18% mentioned barrier contraception (condoms). Over 57% of respondents could not name a way to prevent STDs., Conclusion: Increased educational efforts targeted at high-risk individuals are necessary to improve knowledge of STDs and their adverse sequelae. With greater knowledge and awareness, individuals and couples may be more likely to practice protective behaviors, such as reducing high-risk exposure, and to increase preventive measures, such as barrier contraception use.

Objective: To compare the efficacy and safety of a 3-day regimen of clindamycin vaginal ovules with a 7-day regimen of clindamycin vaginal cream for the treatment of bacterial vaginosis (BV)., Methods: Women with a clinical diagnosis of BV were treated with a 3-day course of clindamycin ovules or a 7-day course of clindamycin cream administered intravaginally. Three hundred and eighty-four patients received study drug and were included in the evaluable patient population (ovule group, n = 204; cream group, n = 180). Assessments included pelvic examination and diagnostic testing. Primary efficacy endpoints were a resolution of two of three diagnostic criteria at the first follow-up visit and three of three diagnostic criteria at the second., Results: Cure rates in the evaluable patient population were similar between treatment groups: 53.7% (109/204) for the ovule group and 47.8% (85/180) for the cream group (p = 0.2471, 95% CI -4.1-16.0%). The most commonly reported medical event, vulvovaginal pruritus, had similar incidence in both treatment groups., Conclusions: A 3-day course of clindamycin vaginal ovules is as effective and well-tolerated as a 7-day course of clindamycin vaginal cream in the treatment of BV.

Objective: To compare the compliance, side effects and efficacy of amoxicillin and azithromycin for the treatment of Chlamydia trachomatis infection in pregnancy., Methods: This is a randomized single-blind trial of women diagnosed with C. trachomatis before 33 weeks gestation. Women were randomlyassigned either 500 mg amoxicillin orally three times per dayfor 7 days or a single dose of 1 g azithromycin orally. Patients were interviewed by telephone approximately 3-7 days following therapy to assess compliance and side effects. Test of cure was performed at a follow-up visit 4-6 weeks following completion of therapy., Results: Thirty-nine patients were randomized with 19 receiving amoxicillin and 20 receiving azithromycin. There were no differences in baseline data between the two groups, and there were no statistically significant differences in side effects, compliance or efficacy. In the amoxicillin group 84% of women took all pills, while 100% completed the single 1 g dose of azithromycin. Side effects were common in both groups (38% overall), with 40% of the azithromycin group reporting moderate to severe gastrointestinal side effects compared to 17% in the amoxicillin group (p = 0.11). Of patients who returned for follow-up test of cure, 3 of 15 (20%) in the amoxicillin group were positive compared with 1 of 19 (5%) in the azithromycin group (p = 0.3)., Conclusions: Side effects of therapy for C. trachomatis in pregnancy are common. Amoxicillin was slightly better tolerated than azithromycin. Compliance and cure rates with both regimens was high.

Objective: To assess six-month and three- to four-year patient-oriented outcomes after laparoscopic Burch retropubic urethropexy., Study Design: Twenty-two women with urodynamically proven genuine stress incontinence with urethral hypermobility underwent laparoscopic Burch retropubic urethropexy. Preoperatively, all 22 women completed a questionnaire concerning their incontinence. Postoperative measures of symptoms of incontinence, impact of incontinence on daily activities and patient satisfaction were assessed at six months and three to four years postoperatively. In those women who were followed, the questionnaire data at the three-time points (preoperative, six months and three to four years) were compared., Results: Thirteen women (59%) completed postoperative questionnaires at six months and three to four years. When compared to preoperative data, there was a significant improvement in symptoms of stress incontinence at six months (P = .0005) and at three to four years (P = .002). There was also a significant reduction in limitations on daily activities at six months (P = .0005) and at three to four years (P = .0005) as compared to preoperative data. Twelve of the 13 women considered their surgery successful at six months and at three to four years., Conclusion: After laparoscopic Burch retropubic urethropexy, there was a significant improvement in patient-oriented outcomes, including complaints of incontinence and functional status.