Validation of bladder health scales and function indices for women's research.

BACKGROUND: Existing bladder-specific measures lack the ability to assess the full range of bladder health, from poor to optimal health. OBJECTIVE: This study aimed to report evidence of validity of the self-administered, multidimensional bladder health scales and function indices for research in adult women. STUDY DESIGN: A cross-sectional population-based validation study with random assignment to paper or electronic administration was conducted using national address-based probability sampling supplemented by purposive sampling of women with lower urinary tract symptoms in 7 clinical research centers. Construct validity of the bladder health scales and function indices was guided by a multitrait-multimethod approach using health and condition-specific questionnaires, bladder diaries, expert ratings of bladder health, and noninvasive bladder function testing. Internal dimensional validity was evaluated using factor analysis; internal reliability was assessed using paired t-tests and 2-way mixed-effects intraclass correlation coefficient models. Chi-square, Fisher exact, or t-tests were used for mode comparisons. Convergent validity was evaluated using Pearson correlations with the external construct measures, and known-group validity was established with comparison of women known and unknown to be symptomatic of urinary conditions. RESULTS: The sample included 1072 participants. Factor analysis identified 10 scales, with Cronbach's alpha ranging from 0.74 to 0.94. Intraclass correlation coefficients of scales ranged from 0.55 to 0.94. Convergent validity of the 10 scales and 6 indices ranged from 0.52 to 0.83. Known-group validity was confirmed for all scales and indices. Item distribution was similar by mode of administration. CONCLUSION: The paper and electronic forms of the bladder health scales and function indices are reliable and valid measures of bladder health for use in women's health research.

Validation of the Surgical Preparedness Assessment in women with pelvic floor disorders.

INTRODUCTION AND HYPOTHESIS: We sought to further develop and validate the Surgical Preparedness Assessment (SPA) scale to evaluate patient preparedness for urogynecological surgery. METHODS: This was a planned ancillary analysis of a randomized controlled trial (RCT) evaluating the impact of a preoperative telehealth call on patient preparedness for urogynecological surgery. Patients completed the Preoperative Preparedness Questionnaire (PPQ), the modified Preparedness for Colorectal Cancer Surgery Questionnaire (PCSQ), the Pelvic Floor Distress Inventory (PFDI-20), the Satisfaction Decision Scale (SDS), and the Decision Regret Scale (DRS). Content validity was established through expert opinion and patient cognitive interviews. Factor analysis identified item grouping into domains. Cronbach's alpha reported internal consistency. Known group validity was assessed by comparing intervention arms. External validity was evaluated by comparing intervention arms and correlations with SDS and DRS. RESULTS: Eleven items and 3 domains met the criteria (information needs, satisfaction and pain, and catheterization). Cronbach's alpha values were acceptable for domains and ranged from 0.74 to 0.93. SPA scores did not correlate with other patient-reported outcomes. Mean SPA scores were lower among women who received a telehealth call vs those who did not (1.30 ± 0.31 vs 1.51 ± 0.44; p = 0.002). CONCLUSIONS: The content-valid SPA demonstrates high internal consistency and known group validity.

Measuring Bladder Health: Development and Cognitive Evaluation of Items for a Novel Bladder Health Instrument.

PURPOSE: We describe the item development and cognitive evaluation process used in creating the Prevention of Lower Urinary Tract Symptoms Bladder Health Instrument (PLUS-BHI). MATERIALS AND METHODS: Questions assessing bladder health were developed using reviews of published items, expert opinion, and focus groups' transcript review. Candidate items were tested through cognitive interviews with community-dwelling women and an online panel survey. Items were assessed for comprehension, language, and response categories and modified iteratively to create the PLUS-BHI. RESULTS: Existing measures of bladder function (storage, emptying, sensation components) and bladder health impact required modification of time frame and response categories to capture a full range of bladder health. Of the women 167 (18-80 years old) completed individual interviews and 791 women (18-88 years) completed the online panel survey. The term "bladder health" was unfamiliar for most and was conceptualized primarily as absence of severe urinary symptoms, infection, or cancer. Coping mechanisms and self-management strategies were central to bladder health perceptions. The inclusion of prompts and response categories that captured infrequent symptoms increased endorsement of symptoms across bladder function components. CONCLUSIONS: Bladder health measurement is challenged by a lack of awareness of normal function, use of self-management strategies to mitigate impact on activities, and a common tendency to overlook infrequent lower urinary tract symptoms. The PLUS-BHI is designed to characterize the full spectrum of bladder health in women and will be validated for research use.

Rationale and design of the validation of bladder health instrument for evaluation in women (VIEW) protocol.

BACKGROUND: Bladder health is an understudied state and difficult to measure due to lack of valid and reliable instruments. While condition specific questionnaires assess presence, severity and degree of bother from lower urinary tract symptoms, the absence of symptoms is insufficient to assume bladder health. This study describes the methodology used to validate a novel bladder health instrument to measure the spectrum of bladder health from very healthy to very unhealthy in population based and clinical research. METHODS: Three samples of women are being recruited: a sample from a nationally representative general population and two locally recruited clinical center samples-women with a targeted range of symptom severity and type, and a postpartum group. The general population sample includes 694 women, 18 years or older, randomly selected from a US Postal delivery sequence file. Participants are randomly assigned to electronic or paper versions of the bladder health instrument along with a battery of criterion questionnaires and a demographic survey; followed by a retest or a two-day voiding symptom diary. A total of 354 women around 7 clinical centers are being recruited across a spectrum of self-reported symptoms and randomized to mode of completion. They complete the two-day voiding symptom diary as well as a one-day frequency volume diary prior to an in-person evaluation with a standardized cough stress test, non-invasive urine flowmetry, chemical urine analysis and post void residual measurement. Independent judge ratings of bladder health are obtained by interview with a qualified health care provider. A total of 154 postpartum women recruited around 6 of the centers are completing similar assessments within 6-12 weeks postpartum. Dimensional validity will be evaluated using factor analysis and principal components analysis with varimax rotation, and internal consistency with Cronbach's alpha. Criterion validity will be assessed using multitrait-multimethod matrix including correlations across multiple data sources and multiple types of measures. DISCUSSION: We aim to validate a bladder health instrument to measure the degree of bladder health within the general population and among women (including postpartum) recruited from local clinical centers. Trial registration NCT04016298 Posted July 11, 2019 ( https://www.clinicaltrials.gov/ct2/show/NCT04016298?cond=bladder+health&draw=2&rank=1 ).

Validation of a single summary score for the Prolapse/Incontinence Sexual Questionnaire-IUGA revised (PISQ-IR).

INTRODUCTION AND HYPOTHESIS: The Prolapse/Incontinence Sexual Questionnaire-International Urogynecology Association (IUGA) Revised (PISQ-IR) measures sexual function in women with pelvic floor disorders (PFDs) yet is unwieldy, with six individual subscale scores for sexually active women and four for women who are not. We hypothesized that a valid and responsive summary score could be created for the PISQ-IR. METHODS: Item response data from participating women who completed a revised version of the PISQ-IR at three clinical sites were used to generate item weights using a magnitude estimation (ME) and Q-sort (Q) approaches. Item weights were applied to data from the original PISQ-IR validation to generate summary scores. Correlation and factor analysis methods were used to evaluate validity and responsiveness of summary scores. RESULTS: Weighted and nonweighted summary scores for the sexually active PISQ-IR demonstrated good criterion validity with condition-specific measures: Incontinence Severity Index = 0.12, 0.11, 0.11; Pelvic Floor Distress Inventory-20 = 0.39, 0.39, 0.12; Epidemiology of Prolapse and Incontinence Questionnaire-Q35 = 0.26 0,.25, 0.40); Female Sexual Functioning Index subscale total score = 0.72, 0.75, 0.72 for nonweighted, ME, and Q summary scores, respectively. Responsiveness evaluation showed weighted and nonweighted summary scores detected moderate effect sizes (Cohen's d > 0.5). Weighted items for those NSA demonstrated significant floor effects and did not meet criterion validity. CONCLUSIONS: A PISQ-IR summary score for use with sexually active women, nonweighted or calculated with ME or Q item weights, is a valid and reliable measure for clinical use. The summary scores provide value for assesing clinical treatment of pelvic floor disorders.

Validation of an instrument to assess barriers to care-seeking for accidental bowel leakage in women: the BCABL questionnaire.

INTRODUCTION AND HYPOTHESIS: Fewer than 30% of women with accidental bowel leakage (ABL) seek care, despite the existence of effective, minimally invasive therapies. We developed and validated a condition-specific instrument to assess barriers to care-seeking for ABL in women. METHODS: Adult women with ABL completed an electronic survey about condition severity, patient activation, previous care-seeking, and demographics. The Barriers to Care-seeking for Accidental Bowel Leakage (BCABL) instrument contained 42 potential items completed at baseline and again 2 weeks later. Paired t tests evaluated test-retest reliability. Factor analysis evaluated factor structure and guided item retention. Cronbach's alpha evaluated internal consistency. Within and across factor item means generated a summary BCABL score used to evaluate scale validity with six external criterion measures. RESULTS: Among 1,677 click-throughs, 736 (44%) entered the survey; 95% of eligible female respondents (427 out of 458) provided complete data. Fifty-three percent of respondents had previously sought care for their ABL; median age was 62 years (range 27-89); mean Vaizey score was 12.8 (SD = 5.0), indicating moderate to severe ABL. Test-retest reliability was excellent for all items. Factor extraction via oblique rotation resulted in the final structure of 16 items in six domains, within which internal consistency was high. All six external criterion measures correlated significantly with BCABL score. CONCLUSIONS: The BCABL questionnaire, with 16 items mapping to six domains, has excellent criterion validity and test-retest reliability when administered electronically in women with ABL. The BCABL can be used to identify care-seeking barriers for ABL in different populations, inform targeted interventions, and measure their effectiveness.

Evaluation of use of stage of tobacco epidemic to predict post-immigration smoking behaviors.

INTRODUCTION: This research uses the Lopez stage of tobacco epidemic model to evaluate post-immigration smoking behavior. Stage is a composite measure of tobacco norms of a country: smoking prevalence, cigarette consumption, and tobacco-related morbidity. The Lopez model characterizes the changing relationship between smoking prevalence and tobacco-related mortality and morbidity as a country progresses through the 4 successive stages of the tobacco epidemic. METHODS: Survey data from Southeast Asian and Latino immigrants (from stage 1 and stage 2 countries) (n = 2,076) were used to evaluate stage of tobacco epidemic of country of emigration. Stage was compared with standard acculturation measures and community identification measures to understand post-immigration smoking behavior in the United States. Comparative analysis by stage and gender includes bivariate associations and logistic regression models to predict post-immigration smoking behavior. RESULTS: Males:Pre-immigration prevalence and consumption rates of our study sample conform to prevalence and consumption of stage 1 and stage 2 countries predicted by the Lopez model. Post-immigration smoking uptake is equivalent to pre-immigration uptake for stage 1 males. The uptake rate for stage 2 males post-immigration is significantly lower (22.1%) than pre-immigration uptake (41.4%). Stage is a statistically significant predictor of post-immigration smoking uptake (OR = 3.08, CI = 1.82-5.22, p < .01). Females:Stage of country of birth is not significantly predictive of post-migration smoking uptake. CONCLUSIONS: The finding of stage to be a strong predictor of post-immigration smoking behavior among males provides a promising measurement tool. Prevalence and consumption of females in our study sample support the need for revisions to the stage model.

Patient recall 6 weeks after surgical consent for midurethral sling using mesh.

INTRODUCTION AND HYPOTHESIS: We aimed to determine patient recall of specific surgical risks and benefits discussed during consent for midurethral sling (MUS) surgery immediately after consent and at 6 weeks follow-up. Specifically we sought to determine whether or not women recalled specific risks related to the placement of mesh. METHODS: Surgeons consented patients for MUS in their usual fashion during audio recorded consent sessions. After consent and again at 6 weeks postoperatively, women completed a checklist of risks, benefits, alternatives, and general procedural items covered during consent. In addition, women completed the Decision Regret Scale for Pelvic Floor Disorders (DRS-PFD). Audio files were used to verify specific risks, benefits, alternatives, and procedural items discussed at consent. Recall of specific risks, benefits, and alternatives were correlated with DRS-PFD scores. RESULTS: Sixty-three women completed checklists immediately post consent and at 6 weeks postoperatively. Six-week recall of benefits, alternatives, and description of the operation did not change. Surgical risk recall as measured by the patient checklist deteriorated from 92 % immediately post consent to 72 % at 6 weeks postoperatively (p < .001). Recall of the risk for mesh erosion declined from 91 to 64 % (p < .001). Recall that mesh was placed during the MUS procedure declined from 98 to 84 % (p = .01). DRS-PFD scores were correlated with poorer surgical risk recall and surgical complications (r = .31, p = .02). CONCLUSIONS: Recall of MUS surgery risks deteriorated over time. Specifically, women forgot that mesh was placed or might erode. Further investigations into methods and measures of adequate consent that promote recall of long-term surgical risks are needed.

The PISQ-IR: considerations in scale scoring and development.

INTRODUCTION: This paper provides a detailed discussion of the psychometric analysis and scoring of a revised measure of sexual function in women with pelvic floor disorders (PFD): the Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR). METHODS: Standard tools for evaluating item distributions, relationships, and psychometric properties were used to identify sub-scales and determine how the sub-scales should be scored. The evaluation of items included a nonresponse analysis, the nature of missingness, and imputation methods. The minimum number of items required to be answered and three different scoring methods were evaluated: simple summation, mean calculation, and transformed summation. RESULTS: Item nonresponse levels are low in women who are sexually active and the psychometric properties of the scales are robust. Moderate levels of item nonresponse are present for women who are not sexually active, which presents some concerns relative to the robustness of the scales. Single imputation for missing items is not advisable and multiple imputation methods, while plausible, are not recommended owing to the complexity of their application in clinical research. The sub-scales can be scored using either mean calculation or transformed summation. Calculation of a summary score is not recommended. CONCLUSION: The PISQ-IR demonstrates strong psychometric properties in women who are sexually active and acceptable properties in those who are not sexually active. To score the PISQ-IR sub-scales, half of the items must be answered, imputation is not recommended, and either mean calculation or transformed sum methods are recommended. A summary score should not be calculated.

The Inflection Point Model: A Model to Explore the Hidden Burdens of Non-Cancerous Genitourinary Conditions.

OBJECTIVE: To propose a conceptual model to identify points along the condition course where actions or inaction affect downstream burdens of non-cancerous genitourinary conditions (NCGUC). MATERIALS AND METHODS: The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) convened an interdisciplinary meeting to comprehensively consider the burdens of NCGUCs. Subsequently, the authors met monthly to conceptualize the model. RESULTS: Inflection points (IP) describe time points during a condition course that are sensitive to change. Our proposed Inflection Point Model (IPM) helps conceptualize burden/benefit trade-offs in any related decision and provides a platform to identify the downstream aggregate burden of a NCGUC across multiple socio-ecological levels at a single time point, which may be summed across the condition course to measure cumulative burden. Two personae demonstrate the utility of this model to better understand impacts of 2 common NCGUCs. CONCLUSION: The IPM may be applied in multiple contexts: narrowly to explore burden of a single NCGUC at a single IP; or more broadly, to address multiple conditions, multiple IPs, or multiple domains/levels of social ecology. Applying the IPM may entail combining population data describing prevalence of NCGUCs, associated behaviors, and resulting outcome patterns that can be combined with suitable mathematical models to quantify aggregate and cumulative burden. The IPM challenges stakeholders to expand from the individual to include broader levels of social ecology. Application of the IPM will undoubtedly identify data gaps and research needs that must be fulfilled to delineate and address the burden of NCGUCs.

Exploring the relationship between acculturation and smoking behavior within four Southeast Asian communities of Minnesota.

OBJECTIVES: This study sought to measure the prevalence of smoking among the Hmong, Vietnamese, Lao, and Cambodian communities of Minnesota and explore the relationship between smoking and acculturation within these communities. METHODS: A community-based participatory research framework was used through all phases of this study. Standard as well as community-developed measures of acculturation were used. Data were obtained by face-to-face and telephone interviews with 1,628 respondents from July 2006 to March 2007. RESULTS: Vietnamese and Cambodian men smoke at higher rates than men in the U.S. general population (35% and 58% compared with 20%, respectively). Most men across the Vietnamese, Cambodian, and Lao populations started smoking prior to immigration to the United States, although most former smokers quit smoking after immigration to the United States. Most male Hmong respondents started smoking after immigration. Education was predictive of smoking status across genders, with less education associated with greater odds of being a smoker. Logistic regression found some acculturation measures to be predictive of smoking status across both genders: Less acculturated male respondents and more acculturated female respondents are more likely to be smokers. DISCUSSION: Results of this study suggest that the role of acculturation in tobacco use may not be straightforward as has been presented previously. Other factors, such as social norms and cultural or linguistic isolation, may also be playing a role in tobacco use patterns and may play different roles for different subgroups. Further research is needed within each population and subgroups within those populations to understand these relationships and how they affect smoking behavior.

Challenges to code status discussions for pediatric patients.

OBJECTIVES: In the context of serious or life-limiting illness, pediatric patients and their families are faced with difficult decisions surrounding appropriate resuscitation efforts in the event of a cardiopulmonary arrest. Code status orders are one way to inform end-of-life medical decision making. The objectives of this study are to evaluate the extent to which pediatric providers have knowledge of code status options and explore the association of provider role with (1) knowledge of code status options, (2) perception of timing of code status discussions, (3) perception of family receptivity to code status discussions, and (4) comfort carrying out code status discussions. DESIGN: Nurses, trainees (residents and fellows), and attending physicians from pediatric units where code status discussions typically occur completed a short survey questionnaire regarding their knowledge of code status options and perceptions surrounding code status discussions. SETTING: Single center, quaternary care children's hospital. MEASUREMENTS AND MAIN RESULTS: 203 nurses, 31 trainees, and 29 attending physicians in 4 high-acuity pediatric units responded to the survey (N = 263, 90% response rate). Based on an objective knowledge measure, providers demonstrate poor understanding of available code status options, with only 22% of providers able to enumerate more than two of four available code status options. In contrast, provider groups self-report high levels of familiarity with available code status options, with attending physicians reporting significantly higher levels than nurses and trainees (p = 0.0125). Nurses and attending physicians show significantly different perception of code status discussion timing, with majority of nurses (63.4%) perceiving discussions as occurring "too late" or "much too late" and majority of attending physicians (55.6%) perceiving the timing as "about right" (p<0.0001). Attending physicians report significantly higher comfort having code status discussions with families than do nurses or trainees (p≤0.0001). Attending physicians and trainees perceive families as more receptive to code status discussions than nurses (p<0.0001 and p = 0.0018, respectively). CONCLUSIONS: Providers have poor understanding of code status options and differ significantly in their comfort having code status discussions and their perceptions of these discussions. These findings may reflect inherent differences among providers, but may also reflect discordant visions of appropriate care and function as a potential source of moral distress. Lack of knowledge of code status options and differences in provider perceptions are likely barriers to quality communication surrounding end-of-life options.

The relationship between acculturation and knowledge of health harms and benefits associated with smoking in the Latino population of Minnesota.

OBJECTIVES: This study sought to examine the relationship between acculturation and the knowledge of smoking and health and perception of benefits associated with smoking within the Latino population of Minnesota. In addition to standard acculturation measures, this study employed a multidimensional model and measures of acculturation. METHODS: A telephone and in-person administered survey was conducted across the state of Minnesota with Latino men and women. RESULTS: A total of 804 participants completed the survey, 54% were men. The average age of respondents was 37 years; 81% were foreign born and 68% completed the interview in Spanish. Knowledge of the relationship between smoking and lung cancer (99%) and heart disease (93%) was high. Acculturated respondents indicate a more refined knowledge of the relationship between smoking and health conditions not related to smoking (poor vision and arthritis). Smokers identify more benefits associated with smoking than do non-smokers, with gender (male), education (less than high school) and greater acculturation being significant predictors of perceiving benefits.