Effect of Group-Administered Behavioral Treatment on Urinary Incontinence in Older Women: A Randomized Clinical Trial.

Importance: Urinary incontinence (UI) guidelines recommend behavioral interventions as first-line treatment using individualized approaches. A one-time, group-administered behavioral treatment (GBT) could enhance access to behavioral treatment. Objective: To compare the effectiveness, cost, and cost-effectiveness of GBT with no treatment for UI in older women. Design, Setting, and Participants: Multisite randomized clinical trial (the Group Learning Achieves Decreased Incidents of Lower Urinary Symptoms [GLADIOLUS] study), conducted from July 7, 2014, to December 31, 2016. The setting was outpatient practices at 3 academic medical centers. Community-dwelling women 55 years or older with UI were recruited by mail and screened for eligibility, including a score of 3 or higher on the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), symptoms of at least 3 months' duration, and absence of medical conditions or treatments that could affect continence status. Of 2171 mail respondents, 1125 were invited for clinical screening; 463 were eligible and randomized; 398 completed the 12-month study. Interventions: The GBT group received a one-time 2-hour bladder health class, supported by written materials and an audio CD. Main Outcomes and Measures: Outcomes were measured at in-person visits (at 3 and 12 months) and by mail or telephone (at 6 and 9 months). The primary outcome was the change in the ICIQ-SF score. Secondary outcome measures assessed UI severity, quality of life, perceptions of improvement, pelvic floor muscle strength, and costs. Evaluators were masked to group assignment. Results: Participants (232 in the GBT group and 231 in the control group) were aged 55 to 91 years (mean [SD] age, 64 [7] years), and 46.2% (214 of 463) were African American. In intent-to-treat analyses, the ICIQ-SF scores for GBT were consistently lower than control across all time points but did not achieve the projected 3-point difference. At 3 months, the difference in differences was 0.96 points (95% CI, -1.51 to -0.41 points), which was statistically significant but clinically modest. The mean (SE) treatment effects at 6, 9, and 12 months were 1.36 (0.32), 2.13 (0.33), and 1.77 (0.31), respectively. Significant group differences were found at all time points in favor of GBT on all secondary outcomes except pelvic floor muscle strength. The incremental cost to achieve a treatment success was $723 at 3 months; GBT dominated at 12 months. Conclusions and Relevance: The GLADIOLUS study shows that a novel one-time GBT program is modestly effective and cost-effective for reducing UI frequency, severity, and bother and improving quality of life. Group-administered behavioral treatment is a promising first-line approach to enhancing access to noninvasive behavioral treatment for older women with UI. Trial Registration: ClinicalTrials.gov identifier: NCT02001714.

Costs and Sustainability of a Behavioral Intervention for Urinary Incontinence Prevention.

INTRODUCTION: Many women choose behavioral interventions as first line treatment for urinary incontinence. We developed a 20-minute abbreviated video, which proved to be similar to a 2-hour in-person class in a randomized trial. This study examines economic end points for the 20-minute video relative to the 2-hour class. METHODS: We randomized 332 participants to the 2-hour class and 315 to the 20-minute video. We estimated the cost for the 2-hour class, the 20-minute video and followup health care utilization. Participants were followed for 3, 12 and 24 months, and asked about health care utilization, quality of life and lost productivity. To measure perceived value, we queried each participant regarding willingness to pay. Regression analysis was used for statistical comparisons. RESULTS: The estimated per participant cost for a 2-hour class was $38, which was more than the marginal cost of the video ($0). We found no significant differences between the treatment groups at each followup for quality of life, lost productivity or health care utilization. Women were willing to pay $26, $21 and $30 for a copy of the DVD, video on the Web and in-person class, respectively, all of which were less than the average cost of the in-person class ($38). CONCLUSIONS: Poor adherence remains a challenge for many behavioral interventions designed to prevent urinary incontinence. The 20-minute video is less expensive than the 2-hour class and is equally effective. Distributing the video on the Internet will improve access and will be easier to sustain than in-person classes.

A Randomized Controlled Trial to Compare 2 Scalable Interventions for Lower Urinary Tract Symptom Prevention: Main Outcomes of the TULIP Study.

PURPOSE: We compared 2-year urinary incontinence and urgency scores of older women who attended a 2-hour bladder health class vs those who viewed a 20-minute abbreviated class video for the purpose of urinary incontinence prevention. MATERIALS AND METHODS: A randomized, 2-arm, parallel design study was done to test the superiority of the 20-minute video over the 2-hour class. Outcomes at baseline, and 3, 12 and 24 months were the scores on questions 1 to 3 of ICIQ-SF (International Consultation on Incontinence Short Form) as the primary outcome and on IUSS (Indevus Urgency Severity Scale). Intent to treat analysis was done to compare the change from baseline in each intervention group across time and also with each other. Multiple imputation was used for missing data. RESULTS: A total of 647 women participated in the study. Mean age was 63 years and approximately 28% of the participants were African American, primarily from an urban setting. The 2 arms were balanced on body mass index at baseline, age, race/ethnicity, education, employment status, income and marital status. No differences in primary or secondary outcomes were demonstrated between the 2 groups from baseline to the 3, 12 or 24-month visits. CONCLUSIONS: The absence of significant differences in the outcome measures of ICIQ-SF and IUSS between the 2-hour class and the 20-minute video groups demonstrates that the 2 interventions were comparable. As urinary incontinence and urgency tend to rise annually in older women, instruction in bladder health self-care provided through either the 2-hour class or the 20-minute video format is a useful intervention to prevent urinary incontinence in older women.

Gardening/Yard Work and Depressive Symptoms in African Americans.

BACKGROUND: The purpose of this study was to examine the frequency of gardening/yard work in relation to depressive symptoms in African-Americans while controlling for biological and social factors. METHODS: A secondary analysis was performed on the National Survey of American Life (n=2,903) using logistic regression for complex samples. Gardening/Yard work was measured by self-reported frequency. Depressive symptoms were measured with the Center for Epidemiologic Studies Depression scale. RESULTS: Biological and social factors, not gardening/yard work, were associated with depressive symptoms. CONCLUSIONS: Biological and social factors may need to be addressed before the association between gardening/yard work and depressive symptoms can be determined.

Transforming Patient-Centered Care: Development of the Evidence Informed Decision Making through Engagement Model.

BACKGROUND: In response to the passage of the Affordable Care Act in the United States, clinicians and researchers are critically evaluating methods to engage patients in implementing evidence-based care to improve health outcomes. However, most models on implementation only target clinicians or health systems as the adopters of evidence. Patients are largely ignored in these models. A new implementation model that captures the complex but important role of patients in the uptake of evidence may be a critical missing link. DISCUSSION: Through a process of theory evaluation and development, we explore patient-centered concepts (patient activation and shared decision making) within an implementation model by mapping qualitative data from an elective induction of labor study to assess the model's ability to capture these key concepts. The process demonstrated that a new, patient-centered model for implementation is needed. In response, the Evidence Informed Decision Making through Engagement Model is presented. We conclude that, by fully integrating women into an implementation model, outcomes that are important to both the clinician and patient will improve. CONCLUSIONS: In the interest of providing evidence-based care to women during pregnancy and childbirth, it is essential that care is patient centered. The inclusion of concepts discussed in this article has the potential to extend beyond maternity care and influence other clinical areas. Utilizing the newly developed Evidence Informed Decision Making through Engagement Model provides a framework for utilizing evidence and translating it into practice while acknowledging the important role that women have in the process.

Knowledge, practice, and barriers toward cervical cancer screening in Elmina, Southern Ghana.

AIMS: The aims of this study were: 1) to assess the level of knowledge of women about Pap smear tests, 2) to determine the practices of women regarding Pap smear tests, and 3) to determine the barriers to Pap smear tests in Elmina, Ghana. METHODS: A cross-sectional study was conducted with 392 randomly selected sexually active females aged 10-74 years using structured interview questions. The Institutional Review Board of the University of Cape Coast gave ethical approval for the study and informed consent was obtained from participants. Data were analyzed with SPSS software (v19.0) using frequencies, chi-square test, and exploratory factor analysis. RESULTS: The results revealed that 68.4% had never heard about cervical cancer, 93.6% had no knowledge on the risk factors, nine (2.3%) reported multiple sexual partners and being sexually active as risk factors, and 92% did not know about the prevention and treatment of cervical cancer. The majority (97.7%) had never heard of the Pap smear test. Only three (0.8%) women out of 392 had had a Pap smear test. Reasons for seeking a Pap smear test included referral, fear of cervical cancer, and radio campaigns. A significant association was found between institutional and personal barriers and having a Pap smear test. CONCLUSION: Comprehensive education on cervical cancer screening and removal of access barriers are critical in reducing risk associated with the disease and promoting women's health.

Depressive Symptoms and Walking in African-Americans.

OBJECTIVE: Although increased frequency of physical activity is associated with fewer depressive symptoms in African-Americans, most studies do not focus on a specific type of activity. Identifying the activity can provide helpful information for designing interventions that focus on depressive symptoms. The objective of this study was to examine the odds of depressive symptoms in relation to walking in African-Americans. DESIGN AND SAMPLE: A secondary analysis was performed on the National Survey of American Life. The sample was made up of community-dwelling African-American women (n = 1,903) and men (n = 1,075) who did not meet the DSM-IV-TR criteria for depression. MEASURES: Walking was measured by self-reported frequency (i.e., never, rarely, sometimes, often). Depressive symptoms were measured with the Center for Epidemiologic Studies Depression scale. Logistic regression for complex samples was used to examine the odds of depressive symptoms in relation to walking. RESULTS: Women who reported often walking had lower odds for depressive symptoms than women who reported never walking (OR = 0.56, 95% CI = 0.38-0.82). Walking frequency was not related to depressive symptoms in men. CONCLUSIONS: Walking frequency is a modifiable risk factor for elevated depressive symptoms in African-American women.

Moving toward patient-centered care: Women's decisions, perceptions, and experiences of the induction of labor process.

BACKGROUND: Patient preferences and clinician practices are possible causative factors to explain the increase in induction of labor, but scientific studies that demonstrate this link are limited. The purpose of this study is to identify factors that influence inductions from the perspective of women. METHODS: A qualitative investigation using grounded theory methodology was conducted. Women were interviewed preinduction and postinduction. Analysis of the interviews was conducted using constant comparison to identify codes, categories, and themes. Through this process the complex intersection between women, their clinician, and the application of evidence-based care in clinical practice was explored. RESULTS: Five major themes from the preinduction interview were identified; safety of baby, women's trust in their clinician, relief of discomfort and/or anxiety, diminish potential or actual risk, and lack of informed decision making. Five major themes were identified from the postinduction interview; lack of informed decision making, induction as part of a checklist, women's trust in their clinician, happy with induction, and opportunities to improve the experience. CONCLUSIONS: Lack of informed decision making was cited as a barrier to optimal care. This study has important implications for patient-centered research and clinical care, requiring the inclusion of women and the salient concepts of care that they identify.

Modifiable influences on female HPV vaccine uptake at the clinic encounter level: a literature review.

PURPOSE: A review of the literature to identify modifiable influences on female human papillomavirus (HPV) vaccine uptake relevant to clinical practice in order to support nurse practitioners (NPs) in the prevention of cervical cancer. DATA SOURCES: PubMed, CINAHL, reference lists of publications that surfaced in the electronic search. CONCLUSIONS: Six influences are modifiable and potentially amenable to being addressed at the clinic encounter level: (a) cost and insurance coverage, (b) provider recommendation, (c) vaccination opportunity, (d) HPV and HPV vaccine knowledge, (e) vaccine safety concerns, and (f) HPV risk. IMPLICATIONS FOR PRACTICE: NPs have an important role in improving HPV vaccine uptake and research suggests several areas they can address to increase vaccination during clinic visits.

Nurse engagement and contributions to the clinical and translational science awards initiative.

CTSAs are mandated to follow a multidisciplinary model. Requests for applications direct responsive applications to "integrate clinical and translational science across multiple departments, schools," listing disciplines in addition to medicine such as engineering, nursing, and public health. This inventory of nurse engagement in CTSAs describes the extent of nursing's CTSA engagement from the perspective of participating nurse scientists within individual CTSAs, including institutional/national contributions and best practices that foster a multidisciplinary model. Of the 50 CTSAs affiliated with a nursing school, 44 responded (88% response rate). Of the ten CTSAs not affiliated with a nursing school, four responded (40% response rate). Overall funding success rates of nurse applicants are: TL1 fellowships 81%, KL2 fellowships 54%, and nurse-led pilots 58%. At most CTSAs nursing is contributing to the accomplishment of the CTSA mandate. The strongest categories of contribution are community engagement, implementation science, and training. Best practices to enhance multidisciplinary collaboration are: (1) inclusion of multiple disciplines on key committees who meet regularly to guide individual core and overall CTSA strategic planning and implementation; (2) required multidisciplinary co-mentors (ideally from different schools within the CTSA) on training grants and as co-investigators on pilot projects; and (3) documentation of multidisciplinary activity in annual reports.

Leisure-time physical activity in relation to depressive symptoms in African-Americans: results from the National Survey of American Life.

OBJECTIVE: To examine the frequency of leisure-time physical activity (LTPA) in relation to depressive symptoms in a nationally representative sample of African American (AA) women and AA men with guidance by Stokols' Social Ecological Framework. METHOD: A secondary analysis of AA women (n=1811) and AA men (n=1038) was performed on the National Survey of American Life, where a four stage national area probability sampling was conducted. Interviews were conducted 2001-2003. Clinically depressed AA were excluded from the current study. LTPA was measured by self-report frequency (never, rarely, sometimes, often) of participation in sports/exercise. Depressive symptoms were measured with the Center for Epidemiologic Studies Depression scale. Logistic regression for complex samples was used to examine the relationship between LTPA and depressive symptoms, adjusting for biopsychobehavioral and sociophysical environmental factors. RESULTS: Compared with AA women and AA men who reported never participating in LTPA, the multivariate OR for depressive symptoms in AA women and AA men who reported participating in LTPA often was 0.42 (95% CI=0.24-0.72) and 0.41 (95% CI=0.25-0.69) respectively. CONCLUSION: Increased frequency of LTPA was associated with fewer depressive symptoms in a nationally representative sample of non-clinically depressed AAs.

Using risk to target HPV vaccines in high-risk, low-resource organizations.

Organizations in developed countries with limited financial resources may find it difficult to determine whether it is preferable to use these resources for HPV vaccination, management of HPV-related diseases, or a "hybrid" strategy, such as vaccinating only the highest risk individuals. We determined the organizational costs and clinical impacts of three different organizational approaches to female HPV vaccination in a low-resource setting, including vaccinating everyone, vaccinating no one, or vaccinating only those considered high-risk. To determine patients at highest risk, HPV risk factors were identified using information routinely gathered at the annual preventive maintenance visit. The three vaccination strategies were then compared using a decision tree analysis. The three strategies demonstrated very little difference in cost. However, the least expensive strategy was to vaccinate no one. In contrast, the strategy with the best clinical outcomes was for the organization to vaccinate everyone. Organizations with limited resources must decide how to best allocate these funds to provide the greatest clinical benefits. This study showed little difference in costs but improved clinical outcomes when using the universal HPV vaccination strategy. Thus, the improvement in clinical outcomes when vaccinating everyone may be worth the relatively small increase in cost of vaccinating everyone.

Spontaneous pushing to prevent postpartum urinary incontinence: a randomized, controlled trial.

INTRODUCTION AND HYPOTHESIS: The risk for urinary incontinence can be 2.6-fold greater in women after pregnancy and childbirth compared with their never-pregnant counterparts, with the incidence increasing with parity. We tested the hypothesis that the incidence of de novo postpartum urinary incontinence in primiparous women is reduced with the use of spontaneous pushing alone or in combination with perineal massage compared with women who experienced traditional directed pushing for second-stage management. METHODS: This was a prospective clinical trial enrolling and randomizing 249 women into a four-group design: (1) routine care with coached or directed pushing, (2) spontaneous self-directed pushing, (3) prenatal perineal massage initiated in the third trimester, and (4) the combination of spontaneous pushing plus perineal massage. Self-report of incontinence was assessed using analysis of variance (ANOVA) and covariance (ANCOVA) models in 145 remaining women at 12 months postpartum using the Leakage Index, which is sensitive to minor leakage. RESULTS: No statistical difference in the incidence of de novo postpartum incontinence was found based on method of pushing (spontaneous/directed) (P value = 0.57) or in combination with prenatal perineal massage (P value = 0.57). Fidelity to pushing treatment of type was assessed and between-groups crossover detected. CONCLUSIONS: Spontaneous pushing did not reduce the incidence of postpartum incontinence experienced by women 1 year after their first birth due to high cross-over between randomization groups.

Measuring urinary incontinence in a population of women in northern Mexico: prevalence and severity.

INTRODUCTION AND HYPOTHESIS: This study was designed to estimate the prevalence of urinary incontinence and its associated risk factors among women in northern Mexico. The type and severity of incontinence were also assessed. METHODS: This cross-sectional population-based study assessed self-reported urinary incontinence in a random sample of 1,307 women aged 25-54 years. Logistic regression was used to estimate the association of urinary incontinence with sociodemographic and reproductive characteristics and other medical conditions. RESULTS: Overall, 18.4% of participants reported having involuntary loss of urine at some time within the last 12 months (95% CI, 16.4-20.7%). Among women reporting urinary incontinence, stress incontinence was the most common form (56.8%), followed by mixed (31.1%) and urge incontinence (10.0%). Approximately half of the women with urinary incontinence symptoms reported a severity index of moderate (25.8%) to severe (26.2%), with 30% stating that their leakage was extremely bothersome. Forty percent of incontinent women reported use of some sort of protection, although only 28% had ever talked to a physician about their symptoms. In adjusted analyses, high body mass index (BMI) ≥ 25 kg/m(2), chronic urinary tract infections, and a history of a hysterectomy or uterine leiomyomata were associated with increased odds of reporting incontinence symptoms. Increased odds of reporting severe urinary incontinence was associated with chronic urinary tract infections, current smoking and high BMI. CONCLUSION: Our results suggest that there might be a need to develop a culturally sensitive screening questionnaire in order to identify and counsel women with mild incontinence symptoms in the primary care setting.

Knowledge, attitudes, and demographic factors influencing cervical cancer screening behavior of Zimbabwean women.

AIMS: The aims of this study were (1) to estimate what proportion of rural females had received cervical screening, (2) to assess knowledge, beliefs, attitudes, and demographics that influence cervical screening, and (3) to predict cervical screening accessibility based on demographic factors, knowledge, beliefs, and attitudes that influence cervical screening. METHODS: The study sample consisted of randomly selected, sexually active, rural females between 12 and 84 years of age. Five hundred fourteen females responded to an individually administered questionnaire. RESULTS: Of the 514 participants, 91% had never had cervical screening and 81% had no previous knowledge of cervical screening tests; 80% of the group expressed positive beliefs about cervical screening tests after an educational intervention. Females who were financially independent were 6.61% more likely to access cervical screening compared with those who were dependent on their husbands. Females in mining villages were 4.47% more likely to access cervical screening than those in traditional rural reserve villages. Females in resettlement villages were 20% less likely to access cervical screening than those in traditional rural reserve villages. CONCLUSIONS: Accessibility of screening services could be improved through planning and implementation of screening programs involving community leaders and culturally appropriate messages. The government should incorporate the human papillomavirus (HPV) vaccine in its immunization program for adolescents, and health education should be intensified to encourage women and their partners to comply with diagnostic and treatment regimens.

The CTSA mandate: are we there yet?

The ultimate aim of the National Institutes of Health Clinical and Translational Science Award (CTSA) initiative is to accelerate the movement of discoveries that can benefit human health into widespread public use. To accomplish this translational mandate, the contributions of multiple disciplines, such as dentistry, nursing, pharmacy, public health, biostatistics, epidemiology, and bioengineering, are required in addition to medicine. The research community is also mandated to establish new partnerships with organized patient communities and front line health care providers to assure the bidirectional flow of information in order that health priorities experienced by the community inform the research agenda. This article summarizes current clinical research directives, the experience of the University of Michigan faculty during the first 2 years of CTSA support, and recommendations to enhance the effectiveness of future CTSA as well as other interdisciplinary initiatives. While the manuscript focuses most closely on the CTSA Community Engagement mission, the challenges to interdisciplinarity and bidirectionality extend beyond the focus of community engagement.

Physical Activity Effects on Depressive Symptoms in Black Adults.

OBJECTIVES: Randomized trials found physical activity (PA) effective in decreasing depressive symptoms. Few studies included Black participants. The purpose of this systematic literature review was to determine the effects of PA on depressive symptoms in Black adults. METHODS: Articles were abstracted by conducting a computer and hand search of eligible studies. RESULTS: Eight of 13 studies found a significant inverse relationship between PA and depressive symptoms in Black adults. Sources for the heterogeneity were explored. CONCLUSION: Future studies should include representative samples of Black adults, incorporate a theory which considers multiple levels of influence, account for genetic factors in the etiology of depressive symptoms, include individuals diagnosed with depression and with health conditions which may increase the risk of depressive symptoms, account for intra-group ethnic heterogeneity, measure and differentiate between social support and social network, consider aspects of the physical environment and use standardized measurements of PA.