Melissa L. Constantine

A new measure of sexual function in women with pelvic floor disorders (PFD): the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR)

Introduction and hypothesisThe objective of this study was to create a valid, reliable, and responsive sexual function measure in women with pelvic floor disorders (PFDs) for both sexually active (SA) and inactive (NSA) women.MethodsExpert review identified concept gaps and generated items evaluated with cognitive interviews. Women underwent Pelvic Organ Prolapse Quantification (POPQ) exams and completed the Incontinence Severity Index (ISI), a prolapse question from the Epidemiology of Prolapse and Incontinence Questionnaire (ISI scores), the Pelvic Floor Distress Inventory-20 (PFDI-20), and the Female Sexual Function Index (FSFI). Principle components and orthogonal varimax rotation and principle factor analysis with oblique rotation identified item grouping. Cronbach’s alpha measured internal consistency. Factor correlations evaluated criterion validation. Change scores compared to change scores in other measures evaluated responsiveness among women who underwent surgery.ResultsA total of 589 women gave baseline data, 200 returned surveys after treatment, and 147 provided test-retest data. For SA women, 3 subscales each in 2 domains (21 items) and for NSA women 2 subscales in each of 2 domains (12 items) emerged with robust psychometric properties. Cronbach’s alpha ranged from .63 to .91. For SA women, correlations were in the anticipated direction with PFDI-20, ISI, and FSFI scores, POPQ, and EPIQ question #35 (all p < .05). PFDI-20, ISI, and FSFI subscale change scores correlated with Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire International Urogynecological Association-revised (PISQ-IR) factor change scores and with mean change scores in women who underwent surgery (all p < .05). For NSA women, PISQ-IR scores correlated with PFDI-20, ISI scores, and with EPIQ question #35 (all p < .05). No items demonstrated differences between test and retest (all p ≥ .05), indicating stability over time.ConclusionsThe PISQ-IR is a valid, reliable, and responsive measure of sexual function.

The PISQ-IR: considerations in scale scoring and development

IntroductionThis 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).MethodsStandard 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.ResultsItem 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.ConclusionThe 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.

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.

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.

Adrift in the gray zone: IRB perspectives on research in the learning health system

ABSTRACT Background: Human subjects protection in health care 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 semistructured, open-ended focus-group discussions with institutional review board (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.

Imperfect informed consent for prenatal screening: Lessons from the Quad screen

Objective The study evaluated patient informed consent (IC) for the Quad screen and examined differences in IC between test acceptors and test refusers. A multidimensional model of IC was used. Methods Women seeking prenatal care at nine obstetrics clinics in a large Midwestern city completed surveys between February and December 2006. Surveys contained measures for three dimensions of IC: intention, understanding and controlling influence. Results 56.2% of women did not meet criteria for all three of our dimensions of IC and therefore failed to give it. The failure rate was higher among women who choose to screen (72.6%) than women who choose not screen (50%) (p < 0.001). Women who met all criteria for IC were over three times less likley to choose to screen (or = 0.32, CI 0.17–0.62 (p < 0.01)) than women who did not meet criteria for IC. Conclusion The decision to screen for fetal anomalies is less of a deliberated action than the decision not to screen. Women who lack a fundamental understanding of the purpose and nature of the screen may be operating on the belief that the screen is part of standard care and presents no need to deliberate.

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.

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.

Item and instrument development to assess sexual function and satisfaction in outcomes research

This article looks at two of the major issues associated with the development of condition-specific quality of life measures. The first issue is the process of conceptualization. The importance of conceptualization to developing sound questions and instruments is evaluated, and the need to utilize multiple perspectives in the conceptualization process is discussed. The second issue addressed is fundamentals of writing survey questions. Questions from a range of sexual function questionnaires are presented and discussed relative to seven basic guidelines associated with question and response category development.

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.