Ecological momentary assessment of pelvic pain and urinary urgency variability in urologic chronic pelvic pain syndrome and their association with illness impact and quality of life: Findings from the multidisciplinary approach to the study of chronic pelvic pain symptom patterns study.

PURPOSE: This study tested the hypothesis that ecological momentary assessment (EMA) of pelvic pain (PP) and urinary urgency (UU) would reveal unique Urologic Chronic Pelvic Pain Syndrome (UCPPS) phenotypes that would be associated with disease specific quality of life (QOL) and illness impact metrics (IIM). MATERIALS AND METHODS: A previously validated smart phone app (M-app) was provided to willing Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) participants. M-app notifications were sent 4-times daily for 14 days inquiring about PP and UU severity. A clustering algorithm that accounted for variance placed participants into PP and UU variability? clusters. Associations between clusters and QOL and IIM were then determined. RESULTS: A total of 204 participants enrolled in the M-app study (64% female). M-app compliance was high (median 63% of surveys). Cluster analysis revealed k = 3 (high, low, none) PP clusters and k = 2 (high, low) UU clusters. When adjusting for baseline pain severity, high PP variability, but not UU variability, was strongly associated with QOL and IIM; specifically worse mood, worse sleep and higher anxiety. UU and PP clusters were associated with each other (p < 0.0001), but a large percentage (33%) of patients with high PP variability had low UU variability. CONCLUSIONS: PP variability is an independent predictor of worse QOL and more severe IIM in UCPPS participants after controlling for baseline pain severity and UU. These findings suggest alternative pain indices, such as pain variability and unpredictability, may be useful adjuncts to traditional measures of worst and average pain when assessing UCPPS treatment responses.

Validation of a simple body map to measure widespread pain in urologic chronic pelvic pain syndrome: A MAPP Research Network study.

PURPOSE: In patients with urologic chronic pelvic pain syndrome (UCPPS), the presence of widespread pain appears to identify a distinct phenotype, with a different symptom trajectory and potentially different response to treatment than patients with pelvic pain only. MATERIALS AND METHODS: A 76-site body map was administered four times, at weekly intervals, to 568 male and female UCPPS participants in the MAPP Network protocol. The 76 sites were classified into 13 regions (1 pelvic region and 12 nonpelvic regions). The degree of widespread pain was scored from 0 to 12 based on the number of reported nonpelvic pain regions. This continuous body map score was regressed over other measures of widespread pain, with UCPPS symptom severity, and with psychosocial variables to measure level of association. These models were repeated using an updated body map score (0-12) that incorporated a threshold of pain ≥ 4 at each site. RESULTS: Body map scores showed limited variability over the 4 weekly assessments, indicating that a single baseline assessment was sufficient. The widespread pain score correlated highly with other measures of widespread pain and correlated with worsened UCPPS symptom severity and psychosocial functioning. Incorporating a pain severity threshold ≥4 resulted in only marginal increases in these correlations. CONCLUSIONS: These results support the use of this 13-region body map in the baseline clinical assessment of UCPPS patients. It provides reliable data about the presence of widespread pain and does not require measurement of pain severity, making it relatively simple to use for clinical purposes.

Early and recent exposure to adversity, TLR-4 stimulated inflammation, and diurnal cortisol in women with interstitial cystitis/bladder pain syndrome: A MAPP research network study.

Both early (ELA) and recent life adversity (RLA) have been linked with chronic pain conditions and persistent alterations of neuroendocrine and inflammatory responses. Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) is a chronic urologic disorder characterized by bladder and/or pelvic pain, and excessive urinary frequency and/or urgency. IC/BPS has been associated with high levels of ELA as well as a distinct inflammatory signature. However, associations between ELA and RLA with inflammatory mechanisms in IC/BPS that might underlie the link between adversity and symptoms have not been examined. Here we investigated ELA and RLA in women with IC/BPS as potential risk factors for inflammatory processes and hypothalamic-pituitaryadrenal (HPA) abnormalities using data from the Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network. Women with IC/BPS and healthy controls (n = 154 and 32, respectively) completed surveys, collected salivary cortisol at awakening and bedtime for 3 days, and gave a blood sample which was analyzed for 7 LPS-stimulated cytokines and chemokines (IL-6, TNFα, IL-1ß, MIP1α, MCP1, IL-8, and IL-10). Two cytokine/chemokine composites were identified using principal components analysis. Patients with greater exposure to RLA or cumulative ELA and RLA of at least moderate severity showed elevated levels of a composite of all cytokines, adjusting for age, body mass index, and study site. Furthermore, there was a trending relationship between ELA and the pro-inflammatory composite score. Nocturnal cortisol and cortisol slope were not associated with ELA, RLA, or inflammation. The present findings support the importance of adverse events in IC/BPS via a biological mechanism and suggest that ELA and RLA should be assessed as risk factors for inflammation as part of a clinical workup for IC/BPS.

Reliability and Validity of Pain and Urinary Symptom Severity Assessment in Urological Chronic Pelvic Pain: A MAPP Network Analysis.

PURPOSE: We assessed the reliability and validity of an efficient severity assessment for pelvic pain and urinary symptoms in urological chronic pelvic pain syndrome, which consists of interstitial cystitis/bladder pain syndrome and chronic prostatitis/chronic pelvic pain syndrome. MATERIALS AND METHODS: A total of 578 patients were assessed using brief, empirically derived self-report scales for pelvic pain severity (PPS) and urinary symptom severity (USS) 4 times during a 1-month period and baseline clinic visit that included urological, pain and illness-impact measures. Mild, moderate and severe categories on each dimension were examined for measurement stability and construct validity. RESULTS: PPS and USS severity categories had adequate reliability and both discriminant validity (differential relationships with specific clinical and self-report measures) and convergent validity (common association with nonurological somatic symptoms). For example, increasing PPS was associated with pelvic tenderness and widespread pelvic pain, whereas USS was associated with urgency during a bladder filling test and increased sensory sensitivity. PPS and USS categories were independently associated with nonurological pain and emotional distress. A descriptive analysis identified higher likelihood characteristics associated with having moderate to severe PPS or USS or both. Lack of sex interactions indicated that the measures are comparable in interstitial cystitis/bladder pain syndrome and chronic prostatitis/chronic pelvic pain syndrome. CONCLUSIONS: Women and men with urological chronic pelvic pain syndrome can be reliably subgrouped using brief self-report measures of mild, moderate or severe pelvic pain and urinary symptoms. Comparisons with a broad range of clinical variables demonstrate the validity and potential clinical utility of these classifications, including use in clinical trials, health services and biological research.

Temporal Relationships between Pain, Mood and Urinary Symptoms in Urological Chronic Pelvic Pain Syndrome: A MAPP Network Study.

PURPOSE: We sought to determine the time-lagged, bidirectional relationships among clinical variables of pelvic pain, urinary symptoms, negative mood, nonpelvic pain and quality of life in men and women with urological chronic pelvic pain syndrome, incorporating interstitial cystitis/bladder pain syndrome and chronic prostatitis/chronic pelvic pain syndrome. MATERIALS AND METHODS: A total of 204 female and 166 male patients were assessed up to 24 times over a 48-week period on the 5 primary outcomes. A lagged autoregressive analysis was applied to determine the directional relationship of one variable to another 2 weeks later, beyond that of the concurrent relationships at each time point and autocorrelations and trends over time. RESULTS: The results show clear evidence for a bidirectional positive relationship between changes in pelvic pain severity and urinary symptom severity. Increases in either variable predicted significant increases in the other 2 weeks later, beyond that explained by their concurrent relationship at each time point. Pelvic pain and to a lesser degree urinary frequency also showed similar bidirectional relationships with negative mood and decreased quality of life. Interestingly, neither pelvic pain or urinary symptom severity showed lagged relationships with nonpelvic pain severity. CONCLUSIONS: Results document for the first time specific short-term positive feedback between pelvic pain and urinary symptoms, and between symptoms of urological chronic pelvic pain syndrome, mood and quality of life. The feedforward aspects of these relationships can facilitate a downward spiral of increased symptoms and worsening psychosocial function, and suggest the need for multifaceted treatments and assessment to address this possibility in individual patients.

A longitudinal analysis of urological chronic pelvic pain syndrome flares in the Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network.

OBJECTIVE: To describe the frequency, intensity and duration of urological chronic pelvic pain syndrome symptom exacerbations ('flares'), as well as risk factors for these features, in the Multidisciplinary Approach to the Study of Chronic Pelvic Pain Epidemiology and Phenotyping longitudinal study. PARTICIPANTS AND METHODS: Current flare status ('urological or pelvic pain symptoms that are much worse than usual') was ascertained at each bi-weekly assessment. Flare characteristics, including start date, and current intensity of pelvic pain, urgency and frequency (scales of 0-10), were assessed for participants' first three flares and at three randomly selected times when they did not report a flare. Generalized linear and mixed effects models were used to investigate flare risk factors. RESULTS: Of the 385 eligible participants, 24.2% reported no flares, 22.9% reported one flare, 28.3% reported 2-3 flares, and 24.6% reported ≥4 flares, up to a maximum of 18 during the 11-month follow-up (median incidence rate = 0.13/bi-weekly assessment, range = 0.00-1.00). Pelvic pain (mean = 2.63-point increase) and urological symptoms (mean = 1.72) were both significantly worse during most flares (60.6%), with considerable within-participant variability (26.2-37.8%). Flare duration varied from 1 to 150 days (94.3% within-participant variability). In adjusted analyses, flares were more common, symptomatic, and/or longer-lasting in women and in those with worse non-flare symptoms, bladder hypersensitivity, and chronic overlapping pain conditions. CONCLUSION: In this foundational flare study, we found that pelvic pain and urological symptom flares were common, but variable in frequency and manifestation. We also identified subgroups of participants with more frequent, symptomatic, and/or longer-lasting flares for targeted flare management/prevention and further study.

Examining self-defining memories and aggression in a sample of criminal offenders.

Self-defining memories (SDMs) are a type of autobiographical memory that people use as a narrative way to explain their self-identity. We sought to examine the relationships between SDMs, aggression, and criminality in a sample of men, 18-64 years of age, recruited in Spain. The sample included three groups: incarcerated criminal offenders with mental illness, incarcerated criminal offenders without mental illness, and healthy community controls. Analyses of the relationship between SDMs and criminal status demonstrated that incarcerated offenders, regardless of mental health status, endorsed phenomenological characteristics of SDMs of their transgressive self at a higher level than community controls. Aggression differed across all three groups, such that inmates demonstrated higher levels of trait aggression than community controls. The associations between aggression and age at event of SDMs did not differ between groups. Further investigation of the relationship between SDMs, aggression, and criminal status may augment understanding of factors of criminality.

Virtual reality-based Mindfulness-Oriented Recovery Enhancement (MORE-VR) as an adjunct to medications for opioid use disorder: a Phase 1 trial.

INTRODUCTION: Medications for opioid use disorder (MOUD) are the most effective interventions for this condition, yet many patients discontinue treatment. Though adjunct psychosocial treatments are recommended to increase retention and reduce relapse, the scarcity of trained providers hinders access to and utilization of evidence-based interventions. We conducted a Phase 1 study to assess the feasibility of a virtual reality-delivered Mindfulness-Oriented Recovery Enhancement (MORE-VR) intervention for patients receiving MOUD. PATIENTS AND METHODS: Patients receiving buprenorphine or methadone for OUD (N = 34) were scheduled for 8 weekly sessions of MORE-VR. Enrollment and retention rates were analyzed. Participants reported on the usability and acceptability of MORE-VR, opioid use, and craving and affect before and after each VR session. Heart rate was monitored during one session of MORE-VR. RESULTS: Twenty-three participants completed four or more MORE-VR sessions (minimum recommended intervention dose). Participants reported high usability and acceptability of MORE-VR, which had an excellent safety profile. Illicit opioid use decreased significantly from pre- to post-treatment (F = 4.44, p=.04). We observed a significant within-session decrease in opioid craving (F = 39.3, p<.001) and negative affect (F = 36.3, p<.001), and a significant within-session increase in positive affect (F = 23.6, p<.001). Heart rate shifted during cue-exposure and mindfulness practices (F = 6.79, p<.001). CONCLUSIONS: High retention, usability and acceptability rates and low adverse events demonstrated that MORE-VR is a feasible, engaging, and safe intervention. Our findings show that MORE-VR can be delivered as an adjunctive intervention to MOUD and suggest that MORE-VR may improve OUD treatment outcomes and modulate autonomic responses. MORE-VR's efficacy will be tested in a subsequent Phase 2 trial. TRIAL REGISTRATION: ClinicalTrials.gov NCT05034276; https://classic.clinicaltrials.gov/ct2/show/NCT05034276.

MORE-VR is a digital therapeutic that uses Virtual Reality to deliver an 8-week mindfulness-based intervention for opioid use disorder treatment.Patients with OUD reported high completion rates, usability and acceptability.In participants receiving MORE-VR as an adjunct to MOUD, reduced craving and opioid use was reported over time.

Widespread pain phenotypes impact treatment efficacy results in randomized clinical trials for interstitial cystitis/bladder pain syndrome: a Multidisciplinary Approach to the Study of Chronic Pelvic Pain network study.

ABSTRACT: Pain clinical trials are notoriously complex and often inefficient in demonstrating efficacy, even for known efficacious treatments. A major issue is the difficulty in the a priori identification of specific phenotypes to include in the study population. Recent work has identified the extent of widespread pain as an important determinant of the likelihood of response to therapy, but it has not been tested in clinical trials for the treatment of interstitial cystitis/bladder pain syndrome (IC/BPS). We explored this hypothesis using data from 3 previously published trials testing treatments for IC/BPS, which suggested modest benefits but did not meet a priori primary outcome statistical significance criteria. Importantly, these studies also collected symptom questionnaire data that allowed us to retrospectively identify participants with and without widespread pain. Analyzing the treatment by the degree of widespread pain revealed a difference in outcome and statistical significance level for each trial. Participants with predominately local pain (ie, limited widespread pain symptoms) responded to therapy targeting local symptoms, whereas those with widespread pain did not. Alternatively, participants with widespread pain beyond their local pelvic pain responded to more centrally acting treatments. Our results suggest that differentiating patients based on widespread vs more localized pain is a key consideration for designing future clinical trials for conditions with variable pain profiles, such as IC/BPS and potentially other pain-based syndromic disorders.

The association between adverse childhood experiences and perinatal depression symptom trajectories.

BACKGROUND: Having a history of adverse childhood experiences is associated with an increased risk for treatment-resistant depression in the general population. Whether this relationship is true in the perinatal context is unknown. OBJECTIVE: This study aimed to examine the association between adverse childhood experiences and the trajectories of antenatal and postpartum depression among people enrolled in a perinatal collaborative care program for mental healthcare. STUDY DESIGN: This retrospective cohort study included all pregnant and postpartum people who were referred to and enrolled in a perinatal collaborative care program for mental healthcare and who delivered at a single, quaternary care institution between March 2016 and March 2021. Individuals referred to the collaborative care program were linked with a care manager and had access to evidence-based mental health treatment such as a psychiatric consult, pharmacotherapy, and psychotherapy. All individuals enrolled in the collaborative care program underwent adverse childhood experience screens at intake. A score of >3 on the validated Adverse Childhood Experiences Questionnaire was defined as a high adverse childhood experience score. Depression symptom monitoring occurred via electronic Patient Health Questionaire-9 screening every 2 to 4 weeks, and escalation of care was recommended for those without evidence of improvement. Antenatal depression trajectories were determined by comparing the earliest available prenatal Patient Health Questionaire-9 score closest to the time of referral to collaborative care with the latest Patient Health Questionaire-9 score before delivery. Postpartum trajectories were determined by comparing the earliest postpartum Patient Health Questionaire-9 score after delivery with the latest score before 12 weeks' postpartum. Depression trajectories were categorized as improved, stable, or worsened based on whether the Patient Health Questionaire-9 scores changed by at least 2 standard deviations (ie, 5 points on the Patient Health Questionaire-9 scale). Bivariable and multivariable analyses were performed. RESULTS: Of the 1270 people who met the inclusion criteria, 294 (23.1%) reported a high adverse childhood experience score. Those with a high adverse childhood experience score were more likely to experience a worsened antenatal depression trajectory than those with a low adverse childhood experience score (10.3% vs 4.3%; P=.008). This association persisted after adjusting for potential confounders (adjusted odds ratio, 2.39; 95% confidence interval, 1.05-5.46). There was no significant difference in the postpartum depression trajectories between those with a high and those with a low adverse childhood experience score. CONCLUSION: Having a high adverse childhood experience score is associated with a worsened antenatal depression trajectory for those enrolled in a collaborative care program. Given its high prevalence, future research should evaluate effective modalities of perinatal depression prevention and treatment specific for pregnant people with a history of adverse childhood experiences.

From formative design to service-ready therapeutic: A pragmatic approach to designing digital mental health interventions across domains.

As digital mental health interventions (DMHIs) proliferate, there is a growing need to understand the complexities of moving these tools from concept and design to service-ready products. We highlight five case studies from a center that specializes in the design and evaluation of digital mental health interventions to illustrate pragmatic approaches to the development of digital mental health interventions, and to make transparent some of the key decision points researchers encounter along the design-to-product pipeline. Case studies cover different key points in the design process and focus on partnership building, understanding the problem or opportunity, prototyping the product or service, and testing the product or service. We illustrate lessons learned and offer a series of questions researchers can use to navigate key decision points in the digital mental health intervention (DMHI) development process.

Mediators of the association between childhood trauma and pain sensitivity in adulthood: a Multidisciplinary Approach to the Study of Chronic Pelvic Pain Research Network analysis.

ABSTRACT: Urologic chronic pelvic pain syndrome (UCPPS) is a complex, debilitating condition in which patients often report nonpelvic pain in addition to localized pelvic pain. Understanding differential predictors of pelvic pain only vs widespread pain may provide novel pathways for intervention. This study leveraged baseline data from the Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network's Symptom Pattern Study to investigate the impact of childhood sexual and nonsexual violent trauma on pelvic and nonpelvic pain sensitivity among adult patients with UCPPS, as well as potential mediators of this association. Study participants who met inclusion criteria for UCPPS completed questionnaires assessing childhood and recent trauma, affective distress, cognitive dysfunction, and generalized sensory sensitivity. Experimental pain sensitivity was also evaluated using standardized pressure pain applied to the pubic region and the arm. Bivariate analyses showed that childhood violent trauma was associated with more nonviolent childhood trauma, more recent trauma, poorer adult functioning, and greater pain sensitivity at the pubic region, but not pain sensitivity at the arm. Path analysis suggested that childhood violent trauma was indirectly associated with pain sensitivity at both sites and that this indirect association was primarily mediated by generalized sensory sensitivity. More experiences of recent trauma also contributed to these indirect effects. The findings suggest that, among participants with UCPPS, childhood violent trauma may be associated with heightened pain sensitivity to the extent that trauma history is associated with a subsequent increase in generalized sensory sensitivity.

A qualitative examination of the implementation of a perinatal collaborative care program.

AIM: To identify implementation strategies for collaborative care (CC) that are successful in the context of perinatal care. BACKGROUND: Perinatal depression is one of the most common complications of pregnancy and is associated with adverse maternal, obstetric, and neonatal outcomes. Although treating depressive symptoms reduces risks to mom and baby, barriers to accessing psychiatric treatment remain. CC has demonstrated benefit in primary care, expanding access, yet few studies have examined the implementation of CC in perinatal care which presents unique characteristics and challenges. METHODS: We conducted qualitative interviews with 20 patients and 10 stakeholders from Collaborative Care Model for Perinatal Depression Support Services (COMPASS), a perinatal collaborative care (pCC) program implemented since 2017. We analyzed interview data by employing the Exploration, Preparation, Implementation, Sustainment (EPIS) framework to organize empirically selected implementation strategies from Expert Recommendations for Implementing Change (ERIC) to create a guide for the development of pCC programs. FINDINGS: We identified 14 implementation strategies used in the implementation of COMPASS. Strategies were varied, cutting across ERIC domains (eg, plan, educate, finance) and across EPIS contexts (eg, inner context - characteristics of the pCC program). The majority of strategies were identified by patients and staff as facilitators of pCC implementation. In addition, findings show opportunities for improving the implementation strategies used, such as optimal dissemination of educational materials for obstetric clinicians. The implementation of COMPASS can serve as a model for the process of building a pCC program. The identified strategies can support the implementation of this evidence-based practice for addressing postpartum depression.

The Impact of Education on Depression Assessment: Differential Item Functioning Analysis.

A person's level of education can affect their access to health care, and their health outcomes. Increasing rates of depression are another looming public health concern. Therefore, vulnerability is compounded for individuals who have a lower level of education and depression. Assessment of depressive symptoms is integral to many domains of health care including primary care and mental health specialty care. This investigation examined the degree to which education influences the psychometric properties of self-report items that measure depressive symptoms. This study was a secondary data analysis derived from three large internet panel studies. Together, the studies included the Beck Depression Inventory-II, the Center for Epidemiologic Studies Depression Scale, the Patient Health Questionnaire, and the Patient Reported Outcomes Measurement Information System measures of depression. Using a differential item functioning (DIF) approach, we found evidence of DIF such that some items on each of the questionnaires were flagged for DIF with effect sizes ranging from McFadden's Pseudo R2 = .005 to .022. For example, results included several double-barreled questions flagged for DIF. Overall, questionnaires assessing depression vary in level of complexity, which interacts with the respondent's level of education. Measurement of depression should include consideration of possible educational disparities, to identify people who may struggle with a written questionnaire, or may be subject to subtle psychometric biases associated with education.

Longitudinal Changes in the Pelvic Pain Only and Widespread Pain Phenotypes Over One Year in the MAPP-I Urologic Chronic Pelvic Pain Syndrome (UCPPS) Cohort.

OBJECTIVE: To examine how often urologic chronic pelvic pain syndrome (UCPPS) patients progressed from Pelvic Pain Only at baseline to Widespread Pain, or vice versa, during 1-year longitudinal follow-up. METHODS: Men and women with UCPPS enrolled in the MAPP-I Epidemiology and Phenotyping Study completed a self-report body map to indicate their locations of pain every 2 months over 12 months. Patients were categorized at each assessment into one of three pain phenotypes: (1) Pelvic Pain Only, (2) an Intermediate group, (3) Widespread Pain. Only patients who completed 3 or more follow-ups were included in this longitudinal analysis. The primary outcome measure was pain classification at the majority (≥60%) of follow-up assessments. Longitudinal trends of somatic symptom burden were also assessed. RESULTS: Among the 93 UCPPS participants with Pelvic Pain Only at baseline, only 2% (n = 2) showed a Widespread Pain phenotype for the majority of assessments over 12 months. Among the 121 participants who had Widespread Pain at baseline, 6% (n = 7) demonstrated Pelvic Pain Only for the majority of assessments over 12 months. Over half of participants (≥53%) stayed in their baseline phenotypic group. Somatic symptom burden remained stable over 12 months for each of the groups with high intra-class correlation coefficient (0.67 to 0.82). CONCLUSION: It was uncommon for UCPPS patients to progress from Pelvic Pain Only to Widespread Pain, or vice versa, over 12 months. These data suggest that Pelvic Pain Only and Widespread Pain are distinct UCPPS phenotypes that are relatively stable over 12 months of follow up.

A Mobile Phone Application for Assessing Daily Variation in Pain Location and Pain Intensity in Patients with Urologic Chronic Pelvic Pain Syndrome: A MAPP Network Study.

Introduction: We created and tested a mobile app that facilitates the ecological momentary assessment of pain intensity and pain location and identifies heterogeneous patient pain phenotypes. Methods: A mobile app was created with patient, clinician and researcher input. A sample of 20 participants with urologic chronic pelvic pain syndrome were then asked to complete a 14-day pain assessment using the app. Data were analyzed to assess compliance, usability and the ability for the app to capture variation in pain intensity and pain location. Ecological momentary assessment pain data were then compared to end-of-week pain summary questions to determine construct validity. Results: Mean compliance was 70±8%, higher earlier in the study period (p <0.0005) and better in older individuals (p <0.0001). During the 14-day assessment, 90% of participants reported daily variation in pelvic pain intensity (SD 0.64-3.02; out of 10), 95% reported variation in their nonpelvic pain (SD 0.17-3.63; out of 10) and 100% reported variations in number of sites with pain (SD 0.22-1.44; out of 7). Pelvic pain and nonpelvic pain intensity, as determined by cumulative app scores, were associated with patient reported end-of-week scores; worst pain (r pelvic =0.67; r nonpelvic =0.53) and average pain (r pelvic =0.78; r nonpelvic =0.73). Conclusions: The easy-to-use app captured unique patterns of pain not fully captured by traditional end-of-day/week summary questions or by traditional in-office assessments. Mobile apps for assessing chronic conditions will become increasingly important as telehealth becomes more commonplace.

Enhancing behavioral treatment for women with pelvic floor disorders: Study protocol for a pilot randomized controlled trial.

Approximately one in four American women report bothersome urinary symptoms (e.g., urgency, frequency), which greatly impact quality of life, including mental health. Bidirectional relationships have been found between urinary symptoms and anxiety, such that urinary symptoms worsen emotional distress (i.e., anxiety and depression), and in turn anxiety can exacerbate these symptoms. Current methods to treat urinary symptoms, such as physical therapy and medications, do not address their emotional impact. As such, our multidisciplinary team is conducting a randomized control trial (RCT) of cognitive-behavior therapy (CBT) using the Unified Protocol (UP) versus supportive therapy in the context of integrated behavioral treatment in the urogynecology context. Women with bothersome urinary symptoms and anxiety are recruited from the Northwestern Medicine Integrated Pelvic Health Program (IPHP) -a transdisciplinary clinic including urogynecologists, urologists, colorectal surgeons, nurses, and physical therapists- and Northwestern Medicine Urology. Participants are randomized to one of two interventions: UP or supportive therapy. All participants attend therapy once per week for 12 weeks. Assessments of urinary symptoms, anxiety, and other indicators of psychological and physical functioning are completed at baseline, mid-treatment, post-treatment, and at 3- and 6-month follow-ups using patient-reported outcomes. The study has been preregistered on clinicaltrails.gov (ID: NCT03623880) and is currently ongoing.

Interview Administration of PROMIS Depression and Anxiety Short Forms.

BACKGROUND: Health literacy reflects a person's reading and numeracy abilities applied to understanding health-related information. These skills may influence how patients report symptoms, leading to underestimates or overestimates of symptom severity. No prior studies have examined health literacy measurement bias. OBJECTIVE: The purpose of the current study was to determine whether PROMIS (Patient-Reported Outcomes Measurement Information System) anxiety and depression short forms, administered by interview, capture symptoms equally across health literacy groups. We examined the psychometric properties of PROMIS anxiety and depression short forms using differential item functioning (DIF) analysis by level of health literacy. METHODS: The sample analyzed included 888 adults, age 55 to 74 years, in Chicago, IL. Health literacy was measured using the Test of Functional Health Literacy in Adults. PROMIS short forms assessed anxiety and depression. KEY RESULTS: DIF was present in 3 of 8 depression items, and 3 of 7 anxiety items. All items flagged for DIF had lower item-slopes for people with limited health literacy. CONCLUSIONS: Items with DIF were less strongly related to anxiety and depression, and thus less precise. Overall, impact of DIF on PROMIS scores was negligible, likely mitigated by interview administration. Although overall test impact of health literacy was minimal, DIF analyses flagged items that were potentially too complex for people with limited health literacy. Design and validation of patient-reported surveys should incorporate respondents with a range of health literacy and methods to identify and reduce measurement bias. [HLRP: Health Literacy Research and Practice. 2019;3(3):e196-e204.]. PLAIN LANGUAGE SUMMARY: This study suggests that people with limited health literacy may respond differently to questions about depression and anxiety than people with adequate health literacy. Therefore, it is important to be aware of differences in literacy ability when creating and using questionnaires.