Good morning. Our first presenter will be Dr. Linda Brubaker. We'll invite her to present on a randomized study of video enhanced versus usual research consent process for the e-optimal study. Thank you, and good morning. On behalf of my colleagues who work in the PFDN, we'd like to present this recruitment and retention study, a randomized control tile of video enhanced versus standard enhanced process in this study. I have relevant disclosures, personal income from editorial stipends from our journal, Female Pelvic Medicine and Reconstructive Surgery, JAMA, and up to date. No other disclosures. We have a rationale for using video in our recruitment process. We know recruitment, and especially retention, can be a big challenge in most clinical studies, especially randomized trials. And we hypothesize that an enhanced informed research consent process might improve the quality and consistency of the information that we share, reduce bias, help potential participants understand the complex processes and concepts that we're talking about, and facilitate recruitment and hopefully retention. There is several Cochrane reviews on this subject. They're listed here. But the quality of prior studies has been relatively limited, and mostly they have included hypothetical studies. So we tucked in a randomized trial as patient participants moved from the optimal study and were being approached for participation into the e-optimal study. We randomized potential participants to the standard informed research consent process with or without a standardized video. And then those participants who enrolled in e-optimal were followed up. Our intervention was a standardized video that include the following key elements, the rationale, broadly, for women's health research, the importance of long-term follow-up, especially in a surgical long-term follow-up, and then we followed up with a detailed invitation to participate in the e-optimal study. Our primary outcome was the proportion of eligible subjects who consented to be enrolled in the extended trial and completed data events at the end of e-optimal. We had two secondary outcomes, the proportion of eligible subjects who enrolled in e-optimal, and then the proportion who completed their data at three, four, and five years. We also had a variety of additional assessments so that we could calculate the total number of in-person clinic visits and quality of life phone calls that were completed, the subjective evaluation of the participant with their information process. And we got some insight into personal level motivation and barriers. And I think you're going to find that data pretty interesting. Their reason for participating and characteristics that were affecting their willingness and ability to participate in research, as we all share a desire to broaden these opportunities for potential participants. Ultimately, 82% of the original optimal subjects were included. The original optimal cohort of 374 included 87% of those, 327 participants, who completed the two-year primary optimal outcome. Of those 305, 82% of the original, but most of those eligible, were enrolled and randomized to either video or no video. And there were no group differences in baseline. Here's our primary outcomes. You can see our primary outcome was achieved similarly in the video and the no video group, with about 79% to 75% of participants achieving the primary outcome. We had very high rates of enrollment, which is, I think, a good thing overall for our work. And you can see the proportions of people who completed the follow-up at each year, with relatively high proportions of follow-up in the upper 90s for the first year, which tailed off to the mid-80s by the final year. So although we saw no difference in the primary composite outcomes, we saw some important differences in the secondary outcomes that favored the video group. The video group had higher rates of feeling that things were very important or strong agreement with factors that affected their decision to participate, including the relationship with the coordinator, our study nurse, a general sense of feeling well-informed about the study, understanding the larger purpose for the study, the nature and the extent of the study, and the broad societal benefits of this type of study. The overall satisfaction with the information provided about the study was higher in the video group than the non-video group. The reasons for research participation remained pretty steady over the five-year process. I'll show you this data graphically on the next slide, and I think this is one of the most important and interesting findings of our study. One of the things that was very important to the participants that they thought was especially important for them was to receive the results from the study. We always talk about this, but when you see this ranked against the common reasons that we incentivize participants, I think you'll be surprised. Only 44% said that money was the most important or very important to them. So here, the results are shown graphically. You can see sharing results and simply verbally expressing our gratitude for participation were highly ranked by our participants. Less wait time and free parking, which are not always available in all studies, were magnets. And all of these were above-money gifts, including the cutest coffee mug that you could design. Our participants mostly drove their own cars. They traveled either between 15 to 60 minutes for their appointment. They preferred to answer their questionnaires in person during a clinical visit. Very few preferred to use the internet to answer it. Now, keep in mind that this is a little bit dated from the time of our study, so this may have changed depending on the demographics of the group in the study. So our conclusions are that a standardized video during the consent process for enrollment in a longitudinal observation extension of a surgical RCT did not affect traditional metrics of recruitment or retention, but it was associated with multiple desirable outcomes, including increased satisfaction with study information, an improved understanding of study purpose, nature, and extent, and a perception of a better relationship with a study coordinator or nurse. I thank you, and I look forward to your questions and discussion. While folks are coming to the microphone, Dr. Brubaker, was consideration given to a ceiling effect, given that this was a prior recruited population that was already enthusiastic about being in research studies? And are there plans to use this intervention in a blank population that has not already participated? I think that's a very insightful comment. We had ceiling effects, I think, in several areas. And of course, since we're hypothesizing a longitudinal extension, we had to use a group of already favorably inclined to research, for sure. So I think your idea of, and you'll probably have it done by the end of the week, Kate, the way you work, but you'll probably have that study done shortly. Let's start over there with another question. Hi, Linda. Excellent work. So let any tools, ideas, shortcuts of how to make these great videos, since we all have great need to consent our patients and help them with, give them feedback, and actually thoughts of why they were so much happier with the videos. I think some of these people learn better with videos. It's probably easier to follow the information. When we speak one-on-one with potential participants, we don't usually go into the big, broad concepts of why research is important, why women's health in research is important, things that have happened to women because of research investigations. We sort of cut to the chase and get down to the specific study. And I think some of those elements help patients. As to how to make it, it probably is a great place to have some lay input on the kind of information individual people might want as you prepare a video for a specific study. And I suspect that there's common elements that we could use across several different videos. That's what I mean. Yeah. Easier. Yeah. Thank you. Sure. Marie-Henri Harvey from Canada. Hi, thank you so much for, again, an excellent study. I was wondering how much, well, two questions, I guess. Was there a standard script for the process, a standard script for the usual consent process? And how much overlap was there between the standard consent and what was in the video in terms of content? Thanks, Marie. That's a great question. So we did not standardize the words or the specific elements of the standard. We assumed that these were accomplished, experienced coordinator efforts. And they did their best effort to recruit as they always do. So we left that alone and then added the standardized video with or without the standardized. So, yeah. Thank you. Dr. Brown. Hi, Heidi Brown, University of Wisconsin. Thank you so much for sharing these results. This type of research is near and dear to my heart. Can you talk a little bit about how results are being communicated to participants for these types of studies? I think the results are being communicated to participants in a suboptimal way overall. I think we think that once we've sent a newsletter or a single letter to say thank you very much, we can check that box and move on. And I think that there's some opportunities to improve that. And I know within PFDN, significant efforts have been made to improve how participants get their information back. But I think it's something, as a research community, we all need to work harder on. Thank you, Heidi. OK, thank you. We're going to move to our next presentation. Thank you all. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. 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Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Looks like we're good. Thank you so much. Thank you. Next we will be welcoming Dr. Andy to the stage to present the impact of treatment for fecal incontinence on defecatory symptoms. All righty. Thank you so much for the opportunity to present our research on behalf of myself and my co-authors from the Pelvic Floor Disorders Network. These are our disclosures. So fecal incontinence and defecatory symptoms commonly coexist. And both of these conditions are associated with high rates of bother. So defecatory symptoms are symptoms like constipation, needing to splint, and difficulty evacuating the bowel. Treatments for fecal incontinence may worsen or improve defecatory symptoms. So we know that although loperamide has been studied for fecal incontinence and, you know, improves fecal incontinence symptoms and quality of life, there are concerns about causing constipation. We also know that interrectal biofeedback is used both as a treatment for fecal incontinence and defecatory symptoms. However, there were no well-designed prospective studies that explored the relationship between defecatory symptoms and response to fecal incontinence treatment. Thus, we decided to, as a planned supplemental study to the CAPABLE trial, to look at the impact of first-line treatments for FI on defecatory symptoms. Our primary aim was to compare the changes in defecatory symptoms in women undergoing treatment for FI with loperamide, sphincter exercises with biofeedback, or both. Our secondary aim was to compare changes in defecatory symptoms between responders and non-responders to FI treatment. So the CAPABLE trial was a randomized controlled factorial trial conducted at the five participating sites of the Pelvic Floor Disorder Network. We included women with fecal incontinence of at least three-month duration, and we excluded women with extremes of stool consistency, so Bristol stool type 1 and 7. These women were randomized to one of four groups, a placebo group, a loperamide-only group, biofeedback-only group, and then a combination group that got both lupiramide and enorectal biofeedback. Response in that study was the St. Mark's. We looked at the St. Mark's VAESY score, and women were considered responders to FI treatment if they had at least a 5-point decrease in the St. Mark's score, which is the clinically important difference of the VAESY score. For this supplemental analysis, our primary outcome was the change in the patient assessment of constipation symptom score, so the PACSIM. The PACSIM is a well-validated tool that measures dexterity symptoms. It has 12 items. My next slide will flash it up so you see what it looks like. There are three subscales looking at stool characteristics and symptoms, rectal symptoms, and abdominal symptoms. The scores range from 0 to 4. There's a subscale and then a global score. And the proposed MID is about 0.5 to 0.6, although this MID has only been looked at in trials evaluating women with chronic constipation. So this is what it looks like. So 12 questions, you go from absent to very severe. For analysis, we looked at change in PACSIM scores from baseline to 24 weeks using a general linear mixed model. We compared women who got loperamide to placebo, those who got biofeedback to placebo, and then those who got a combination treatment to either the loperamide or biofeedback alone. And then we compared the change in responders versus non-responders to FI treatment. So here are results. So baseline, the women who were randomized to placebo and loperamide or biofeedback were not significantly different. Importantly, they had very similar baseline PACSIM scores. Again, combination group, compared to each of the individual arms, there were no significant differences. So when we looked at the change in PACSIM scores, there were small changes from baseline in the placebo and the biofeedback group. Again, this does not meet the defined MID in the literature, although, again, those are for constipation studies. We found, importantly, though, that there were no difference in PACSIM scores between placebo and loperamide or placebo and biofeedback, both for the global score and for the subscale scores. Similarly, when we looked at women who got combination treatment versus either loperamide or biofeedback, we found that there were no differences in the change in PACSIM score up to 24 weeks when you compared combination treatment to single treatment. When we compared responders to FI treatment, again, remember these are women who had improvement in VAESA score of at least 5. We found that responders to FI treatment had greater improvement in their PACSIM scores than non-responders. Our study has strengths. This was a prospective evaluation of common conservative treatments for fecal incontinence. It was a large multi-center trial. We used a valid, reliable, and responsive questionnaire for measuring defecatory symptoms. So the PACSIM has been well studied. Weaknesses are that, again, this is generalizable only to those seeking treatment for fecal incontinence and not those specifically seeking treatment for defecatory symptoms. And we did not collect additional objective measures of defecatory symptoms, so things like transit studies or balloon testing. However, we can conclude that women with defecatory symptoms and women undergoing first-line treatments for fecal incontinence are not significantly different between groups. I think importantly for clinicians treating these women is that loperamide treatment in women with normal bowels who come in with fecal incontinence does not worsen defecatory symptoms, and that women who have clinically important improvement in fecal incontinence symptoms also report greater improvements in defecatory symptoms. Thank you for your attention, and I welcome your questions and discussion. Enough for me. Sure. I know for a fact that fecal incontinence is not a urinary symptom, but I'm not so sure I understand if fecal incontinence is not a defecatory symptom. So I'm kind of wondering the wording when you use defecatory symptoms, try to separate it out from fecal incontinence. If you can help me with some of that wording issue I'm having. Sure, sure. I think that when we talk about defecatory symptoms here, we're talking about things like constipation, difficulty emptying your bowels, splinting to move your bowels. I think that clearly there's overlap between the interrectal symptoms, so fecal incontinence and defecatory dysfunction. Some of my previous work has sort of looked at that overlap. I think that they might have similar causes and underlying mechanisms. But I think, at least when we're presenting here as defecatory symptoms, we're really thinking about difficulty emptying your bowels. Thank you. I have a question, Dr. Indy. As far as you analyzing the responders versus non-responders, did you further break that down by treatment group? Do we know if that difference was driven by one treatment group in particular? We did not do that analysis. We know that there was no difference between the treatment groups and improvement in FI symptoms, and so we did not look at that level of detail. We just looked at people who got better. Interesting. Thank you very much, Dr. Indy. Awesome. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Next, we have Dr. Parker Autry. The title of her presentation is The Impact of Accidental Bowel Leakage on Physical Performance Among Older Adults. Thank you. These are our disclosures. Accidental bowel leakage is a common pelvic floor disorder affecting both women and men with similar prevalence above the age of 70 years. Having bowel leakage symptoms is often multifactorial, with contributing factors being interrelated and interdependent and linked, including bowel dysfunction, anorectal inflammation, anatomic injuries in the pelvic floor with anal sphincter weakness, as well as the less considered central nervous system impairment. As we care for adults with bowel leakage symptoms, it's important to note that it has been associated or has been shown to be a poor marker of overall or the probability for poor survival probability in older adults. Here in bold, we see that institutionalized patients with long-lasting bowel symptoms had a more significant decline in survival probability compared to adults without symptoms. We hypothesize that this association or this observation may be due to a poorly understood association between bowel leakage symptoms and poor physical performance. Keeping this in mind, I would like to introduce you to the concept of whether bowel incontinence is a geriatric syndrome. A geriatric syndrome is a condition that is multifactorial, with shared risk factors to include older age, cognitive impairment, functional impairment, as well as impaired mobility. When considering a conceptual framework to assess this hypothesis, we know that aging increases the incidence of weakness and disability. Both are associated with poor overall survival. As bowel leakage also increases with age, it may be impacted by poor skeletal muscle health, thus making it plausible that living with bowel leakage symptoms may, in turn, impact on disability and skeletal muscle weakness. To explore this hypothesis, we aim to characterize the impact of baseline bowel leakage symptoms on changes in physical performance measures over four years, and to explore the relationship between bowel leakage symptoms and changes in markers of weakness. We performed a secondary analysis of the Health, Aging, and Body Composition Study, which is a longitudinal, multi-centered study of well-functioning community-dwelling older adults ages 70 to 79 years upon enrollment. Accidental bowel leakage was assessed using a single validated question. This secondary analysis included participants who answered this question and completed study participation through year four. Accidental bowel leakage symptoms was our exposure. Our primary outcome used the expanded short physical performance battery that's a reliable and reproducible assessment of physical function specifically designed to assess higher-functioning adults. It entails an assessment of balance with feet together, semitandem, and full tandem positions. It also assesses usual gait velocity, as well as repeat chair rise speed. A small meaningful difference is a change in total score of 0.12 points, with a clinically important difference being a change of 0.22 points. We secondarily observed changes in markers of weakness that are also associated with poor survival in older adults, featuring usual walk speed. A decrease of 0.1 meters per second of gait speed is associated with a 12% median survival difference. Grip strength is a known marker of frailty and predicts functional limitation in mortality. An appendicular skeletal muscle mass, or lean muscle mass, is measured with DEXA scan and is also an objective measure of skeletal muscle mass. 3,075 healthy women and men were enrolled in Health ABC. 161 were excluded due to missing data, leaving 95% of this cohort available for this analysis. Of that 2,914 adults, 8% had bowel leakage symptoms at baseline, leaving 92% of the cohort available for the comparator group. The demographic features of the cohort included a mean age of 73 years, mean BMI, and the overweight range of 27. Bowel leakage symptoms was more common among females than males, and among those classified as white ethnicity compared to black. But considering associated comorbid conditions, bowel leakage symptoms was more common among those with depressive symptoms, as well as those with diabetes, lung disease, and hip and knee arthritis. When we looked at our primary outcome, the expanded physical performance battery, we observed a clinically important decline in scores among both groups. However, we observed that in adults with bowel leakage symptoms, they had a statistically more significant decline in low extremity performance. When we examined each component, we observed a greater decline among them all. Women and men with bowel leakage symptoms had a greater decline in how long they could stand in tandem and semi-tandem and full tandem positions. They also had a slower gait speed. But when we looked at repeated chair rise pace, those with bowel leakage symptoms had a statistically significant slower ability to rise from a seated chair unassisted. When we observed changes in markers of weakness over time, there were no significant differences between groups, but there were some important trends. With fast walking speed, the speed declined over time among those with bowel leakage symptoms. When we looked at grip strength, the baseline difference, the grip strength was lower among those with bowel leakage symptoms and continued to decline over time. And the same phenomenon was observed with lean muscle mass. Based on our data, we should consider aging as well as physical performance impairment as a part of the multifactorial nature of bowel leakage symptoms. To strengthen this study, we have To strengthen this study, we present highly generalizable observations of a diverse group of women and men from different areas of the United States. We analyzed prospectively collected robust measures of physical performance as well as weakness. And we used to compare the group of well-functioning adults without bowel leakage symptoms. In conclusion, accidental bowel leakage may be associated with poor overall health and older adults by contributing to lower overall health and poor overall health. In conclusion, accidental bowel leakage may be associated with poor overall health and older adults by contributing to lower overall physical performance, featuring more significant worsening of low extremity physical performance, as well as significant worsening the ability to rise from a chair unassisted. I acknowledge my funding through the National Institutes on Health GEMSTAR Award. I thank you for your attention and interest and welcome your questions. I'm going to start over here. Hi, Cedric Oliveira, New York. Very nice opinion. What do you think came first, the chicken or the egg? Do you think that the bowel leakage symptoms were worsened by individuals being fearful of standing, rising, walking? Or do you think decrease in muscle function, maybe due to nerve disruption, led to the bowel leakage symptoms? Thank you, that's an excellent question. I believe that in older adults, aging with skeletal muscle weakness and a phenomenon called sarcopenia is what contributes to the onset of symptoms. So I think that the weakness occurs first, leading to the bowel accidents as a marker of poor skeletal muscle health, which in turn, because of what it does to people in terms of how they live with those symptoms, can further weaken that problem, worsen that problem. My question really nicely, I think, follows on that question. Since this is a longitudinal study, and you saw, for example, some decline in some of your markers, did you see new incidents of bowel symptoms in women or men whose strength or speed declined? That begs the question and highlights a weakness of the study, because we did not assess bowel leakage symptoms over time. It was only assessed at baseline. Thank you. Great job. Thank you, Mimi Wieck, of San Diego. Did you control or assess any use of constipating medications, fiber? A lot of, at least my older patients, their diets are just horrible. And just fixing their diet solved the problem. Absolutely. Yes, we weren't able to assess fiber use as much, because this was a longitudinal cohort. We were able to look at use of anti-cholinergic medications that would cause constipation, as well as opium I didn't see a difference. Hi, Lily Ariel. Over here. Hi, Candice. Hi, Dr. Ariel. Great, fabulous study. I'm assuming you collected data on urinary incontinence, as well. And I would imagine that this exact same finding could be applied to urinary incontinence. How do you connect urinary and fecal incontinence in relationship to fecals to physical performance? Thank you for the question. Yes, we did that study last year, actually. We looked at urinary incontinence over time and changes in physical performance measures. And we were actually able to see the exact same phenomenon that's happening, which motivated us to do this study. So it's basically a global pelvic floor issue of the effect of overall skeletal muscle weakness on the pelvic floor that contributes to these symptoms, is my hypothesis. Very good. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Great way to round out a session with a validity paper on fecal incontinence. I know you're all really looking forward to this. I'd like to thank my co-authors in the Pelvic Fluorid Disorders Network for their work on this important topic. Here are our disclosures. So we all know that objective outcomes are not always indicative of patient condition, and this is particularly troublesome for conditions where objective events may be difficult or impossible to observe, or you just don't want to observe them, such as orgasm or fecal incontinence. So we have to rely on patient-reported outcomes, and these outcomes should reflect those things that are important to patients. So we have presented previously the creation of a novel and reliable questionnaire of accidental bowel leakage symptoms. We used a patient-centered approach, and we identified some new domains that were important to patients, including predictability, awareness, control, emptying, and discomfort. This paper focuses on the responsiveness, or the ability to detect change over time, and the minimally important difference of this measure. That is the smallest change that correlates with clinically important symptom improvement. So this is our objective, to determine the responsiveness to change and the minimally important difference for the ABLE scale. This was a mixed method, planned analysis of a randomized controlled trial, the CAPABLE trial, which Dr. Andy previously talked about. Our patient population had greater than or equal to three months of accidental bowel leakage, no watery or hard lumpy stools, no history of malignancy, untreated prolapse, or radiation. Measures were completed at baseline in 24 weeks. Results were reviewed in aggregate, rather than by randomization group, because the parent trial did not demonstrate differences between groups. All participants provided written informed consent. To measure responsiveness, we compared ABLE change scores with change scores of a variety of different measures, some very specific to bowel symptoms and some not. And we also compared it with changes in bowel diaries, including number of accident-free days per week, average numbers of leaks per day, and number of PAD changes per day. We then also looked at our change scores for patients whose accidental bowel leakage did and did not improve based on a number of measures, including the PGII, CRADI, and VASI scores. We divided PGI improvement, we considered PGI improvement if they were very much, much, or a little better, and we considered them improved if the CRADI and VASI scales met their previously published MIDs. We used the area under the receiver-operator curve to determine how well ABLE change scores distinguished whether accidental bowel leakage improved or not, and effect sizes and standardized response means were also calculated. To determine the MID, we used both distribution and anchor-based methodology. And if you take home one thing from this talk, and you want to estimate an MID, half of the standard deviation of the baseline value is usually a very good approximate of an MID for most measures. And we used that here as a way to establish the MID. We also looked at one standard error of measurement. We did use a variety of anchor-based methods. We looked at the difference in mean ABLE change scores in patients who said they were a little bit better on the PGII or met the MID on the CRADI and VASI scales. Here are our results. 296 women gave baseline data in 266 at 24 weeks. Their mean age was 63. Most were Caucasian. And they had an average 1.6 accidental bowel leakage episodes a day. So they were reasonably affected by their fecal incontinence. This table shows the change scores in the variety of measures. In the first row is the new, our new questionnaire, the ABLE questionnaire, and you can see that scores improved with interventions, as did a variety of other measures. All the correlations between our scores change and the other scores on the other questionnaires were in the expected direction and they were all significant. We found similar outcomes with positive, appropriate correlations in the right direction and all significance for our bowel diary outcomes. Here we present the ability to detect patients who improved versus who did not improve using the PGII, the VASI, and the CRADI scales. And as you can see, we were able to distinguish on our scale the improvement in the, distinguish those patients who improved versus those who did not. The effect sizes are there on the right-hand side. The area under the curves were all acceptable with ranges from .72 to .76 and standardized response means for improved patients were large. For the MID, our distribution-based methods estimated the MID as .19 based on the criteria of one standard error measurement and .28 based on the standard deviation criteria. The MIDs for the PGII, CRADI, and VASI ranged from .1 to .45. Using triangulation and discussion, we estimate the MID to be .2. So in conclusion, the ABLE questionnaire is patient-centered. It does present some new domains that are not in many other measures including predictability, awareness, control, emptying and discomfort. We've previously shown that it's reliable with good validity properties. And now we have shown that it is responsive to change in intervention and has an MID of approximately .1. I look forward to your questions as long as they're not too difficult. Thank you.

ABLE questionnaire

patient-centered measure

accidental bowel leakage symptoms

responsiveness to change

minimally important difference

randomized controlled trial

CAPABLE trial

intervention