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.

Proxy-report in individuals with intellectual disability: A scoping review.

BACKGROUND: Views can be collected from individuals (self-report) or others on their behalf (proxy-report). OBJECTIVE: We aimed to review the literature on methods and statistical approaches used to evaluate observer versus self-report responses from individuals with intellectual disability or Down syndrome. METHODS: A series of key questions related to statistical approaches and data collection methods were formulated a priori to inform the search strategy and review process. These addressed the topics of self-report in individuals with intellectual disability, including Down syndrome. Using the National Library of Medicine database, PubMed, detailed literature searches were performed. The quality of available evidence was then evaluated, the existing literature was summarised, and knowledge gaps and research needs were identified. RESULTS: Fifty relevant original articles were identified which addressed at least one key question. Study details, including: research design, internal validity, external validity, and relevant results are presented. Review of studies of individuals with intellectual disability which used a variety of statistical approaches showed mixed agreement between self-report and proxy-report. CONCLUSION: Few studies identified to-date have used self-report from individuals with Down syndrome, but lessons from the existing intellectual disability literature can guide researchers to incorporate self-report from individuals with Down syndrome in the future.

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.

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 ).

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.

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.

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.

Research on Medical Practices: Why Patients Consider Participating and the Investigational Misconception.

Understanding how patients decide whether to enroll in research can help improve educational materials, protocols, and recruitment rates. However, little is known about patients' willingness to participate in research on medical practices (ROMP), or studies comparing interventions within usual care. We assessed willingness to consider participating in ROMP by surveying 1095 adults in the United States, of whom 834 answered at least one open-ended question about their reasons for being willing or unwilling to consider participating in two scenarios involving ROMP. Most respondents were willing to consider participating in the research scenarios. The most commonly cited reasons for being willing to consider participating included benefit to others and oneself; the top reasons for being unwilling to consider participating included belief that the research was unsafe and an unfavorable view of experimentation. Responses also revealed misconceptions about ROMP among both those who were willing and unwilling to consider participating. Because these misconceptions may present an obstacle to recruiting participants in ROMP, there may be a need for educational initiatives to clarify the nature of these types of studies.

A randomized study of multimedia informational aids for research on medical practices: Implications for informed consent.

BACKGROUND/AIMS: Participant understanding is a key element of informed consent for enrollment in research. However, participants often do not understand the nature, risks, benefits, or design of the studies in which they take part. Research on medical practices, which studies standard interventions rather than new treatments, has the potential to be especially confusing to participants because it is embedded within usual clinical care. Our objective in this randomized study was to compare the ability of a range of multimedia informational aids to improve participant understanding in the context of research on medical practices. METHODS: We administered a web-based survey to members of a proprietary online panel sample selected to match national US demographics. Respondents were randomized to one of five arms: four content-equivalent informational aids (animated videos, slideshows with voice-over, comics, and text) and one no-intervention control. We measured knowledge of research on medical practices using a summary knowledge score from 10 questions based on the content of the informational aids. We used analysis of variance and paired t-tests to compare knowledge scores between arms. RESULTS: There were 1500 completed surveys (300 in each arm). Mean knowledge scores were highest for the slideshows with voice-over (65.7%), followed by the animated videos (62.7%), comics (60.7%), text (57.2%), and control (50.3%). Differences between arms were statistically significant except between the slideshows with voice-over and animated videos and between the animated videos and comics. Informational aids that included an audio component (animated videos and slideshows with voice-over) had higher knowledge scores than those without an audio component (64.2% vs 59.0%, p < .0001). There was no difference between informational aids with a character-driven story component (animated videos and comics) and those without. CONCLUSION: Our results show that simple multimedia aids that use a dual-channel approach, such as voice-over with visual reinforcement, can improve participant knowledge more effectively than text alone. However, the relatively low knowledge scores suggest that targeted informational aids may be needed to teach some particularly challenging concepts. Nonetheless, our results demonstrate the potential to improve informed consent for research on medical practices using multimedia aids that include simplified language and visual metaphors.

Adrift in the Gray Zone: IRB Perspectives on Research in the Learning Health System.

BACKGROUND: Human subjects protection in healthcare contexts rests on the premise that a principled boundary distinguishes clinical research and clinical practice. However, growing use of evidence-based clinical practices by health systems makes it increasingly difficult to disentangle research from a wide range of clinical activities that are sometimes called "research on medical practice" (ROMP), including quality improvement activities and comparative effectiveness research. The recent growth of ROMP activities has created an ethical and regulatory gray zone with significant implications for the oversight of human subjects research. METHODS: We conducted six semi-structured, open-ended focus group discussions with IRB members to understand their experiences and perspectives on ethical oversight of ROMP, including randomization of patients to standard treatments. RESULTS: Our study revealed that IRB members are unclear or divided on the central questions at stake in the current policy debate over ethical oversight of ROMP: IRB members struggle to make a clear distinction between clinical research and medical practice improvement, lack consensus on when ROMP requires IRB review and oversight, and are uncertain about what constitutes incremental risk when patients are randomized to different treatments, any of which may be offered in usual care. They characterized the central challenge as a balancing act, between, on the one hand, making information fully transparent to patients and providing adequate oversight, and on the other hand, avoiding a chilling effect on the research process or harming the physician-patient relationship. CONCLUSIONS: Evidence-based guidance that supports IRB members in providing adequate and effective oversight of ROMP without impeding the research process or harming the physician-patient relationship is necessary to realize the full benefits of the learning health system.

A comparison of institutional review board professionals' and patients' views on consent for research on medical practices.

BACKGROUND/AIMS: In the context of research on medical practices, which includes comparative effectiveness research and pragmatic clinical trials, empirical studies have begun to raise questions about the extent to which institutional review boards' interpretations and applications of research regulations align with patients' values. To better understand the similarities and differences between these stakeholder groups, we compare and contrast two surveys: one of institutional review board professionals and one of patients, which examine views on consent for research on medical practices. METHODS: We conducted online surveys of two target populations between July 2014 and March 2015. We surveyed 601 human subjects research professionals out of 1500 randomly selected from the Public Responsibility in Medicine and Research membership list (40.1% response rate), limiting analysis to 537 respondents who reported having had institutional review board experience. We also surveyed 120 adult patients out of 225 approached at subspecialty clinics in Spokane, Washington (53.3% response rate). Our survey questions probed attitudes about consent in the context of research on medical practices using medical record review and randomization. The patient survey included three embedded animated videos to explain these concepts. RESULTS: A majority of institutional review board professionals distinguished between consent preferences for medical record review and randomization, ranked clinicians as the least preferred person to obtain participant consent (54.6%), and viewed written or verbal permission as the minimum acceptable consent approach for research on medical practices using randomization (87.3%). In contrast, most patients had similar consent preferences for research on medical practices using randomization and medical record review, most preferred to have consent conversations with their doctors rather than with researchers for studies using randomization (72.6%) and medical record review (67.0%), and only a few preferred to see research involving randomization (16.8%) or medical record review (13.8%) not take place if obtaining written or verbal permission would make the research too difficult to conduct. Limitations of our post hoc analysis include differences in framing, structure, and language between the two surveys and possible response bias. CONCLUSION: Our findings highlight a need to identify appropriate ways to integrate patient preferences into prevailing regulatory interpretations as institutional review boards increasingly apply research regulations in the context of research on medical practices. Dialogue between institutional review boards and research participants will be an important part of this process and should inform future regulatory guidance.

Attitudes Toward Risk and Informed Consent for Research on Medical Practices: A Cross-sectional Survey.

BACKGROUND: The U.S. Office for Human Research Protections has proposed that end points of randomized trials comparing the effectiveness of standard medical practices are risks of research that would require disclosure and written informed consent, but data are lacking on the views of potential participants. OBJECTIVE: To assess attitudes of U.S. adults about risks and preferences for notification and consent for research on medical practices. DESIGN: Cross-sectional survey conducted in August 2014. SETTING: Web-based questionnaire. PATIENTS: 1095 U.S. adults sampled from an online panel (n = 805) and an online convenience river sample (n = 290). MEASUREMENTS: Attitudes toward risk, informed consent, and willingness to participate in 3 research scenarios involving medical record review and randomization of usual medical practices. RESULTS: 97% of respondents agreed that health systems should evaluate standard treatments. Most wanted to be asked for permission to participate in each of 3 scenarios (range, 75.2% to 80.4%), even if it involved only medical record review, but most would accept nonwritten (oral) permission or general notification if obtaining written permission would make the research too difficult to conduct (range, 70.2% to 82.7%). Most perceived additional risk from each scenario (range, 64.0% to 81.6%). LIMITATION: Use of hypothetical scenarios and a nonprobability sample that was not fully representative of the U.S. population. CONCLUSION: Most respondents preferred to be asked for permission to participate in observational and randomized research evaluating usual medical practices, but they are willing to accept less elaborate approaches than written consent if research would otherwise be impracticable. These attitudes are not aligned with proposed regulatory guidance. PRIMARY FUNDING SOURCE: National Center for Advancing Translational Sciences at the National Institutes of Health.

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.

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.

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.