Real-World Evidence From a Digital Health Treatment Program for Female Urinary Incontinence: Observational Study of Outcomes Following User-Centered Product Design.

BACKGROUND: Urinary incontinence (UI) affects millions of women with substantial health and quality-of-life impacts. Supervised pelvic floor muscle training (PFMT) is the recommended first-line treatment. However, multiple individual and institutional barriers impede women's access to skilled care. Evidence suggests that digital health solutions are acceptable and may be effective in delivering first-line incontinence treatment, although these technologies have not yet been leveraged at scale. OBJECTIVE: The primary objective is to describe the effectiveness and safety of a prescribed digital health treatment program to guide PFMT for UI treatment among real-world users. The secondary objectives are to evaluate patient engagement following an updated user platform and identify the factors predictive of success. METHODS: This retrospective cohort study of women who initiated device use between January 1, 2022, and June 30, 2023, included users aged ≥18 years old with a diagnosis of stress, urgency, or mixed incontinence or a score of >33.3 points on the Urogenital Distress Inventory Short Form (UDI-6). Users are prescribed a 2.5-minute, twice-daily, training program guided by an intravaginal, motion-based device that pairs with a smartphone app. Data collected by the device or app include patient-reported demographics and outcomes, adherence to the twice-daily regimen, and pelvic floor muscle performance parameters, including angle change and hold time. Symptom improvement was assessed by the UDI-6 score change from baseline to the most recent score using paired 2-tailed t tests. Factors associated with meeting the UDI-6 minimum clinically important difference were evaluated by regression analysis. RESULTS: Of 1419 users, 947 met inclusion criteria and provided data for analysis. The mean baseline UDI-6 score was 46.8 (SD 19.3), and the mean UDI-6 score change was 11.3 (SD 19.9; P<.001). Improvement was reported by 74% (697/947) and was similar across age, BMI, and incontinence subtype. Mean adherence was 89% (mean 12.5, SD 2.1 of 14 possible weekly uses) over 12 weeks. Those who used the device ≥10 times per week were more likely to achieve symptom improvement. In multivariate logistic regression analysis, baseline incontinence symptom severity and maximum angle change during pelvic floor muscle contraction were significantly associated with meeting the UDI-6 minimum clinically important difference. Age, BMI, and UI subtype were not associated. CONCLUSIONS: This study provides real-world evidence to support the effectiveness and safety of a prescribed digital health treatment program for female UI. A digital PFMT program completed with visual guidance from a motion-based device yields significant results when executed ≥10 times per week over a period of 12 weeks. The program demonstrates high user engagement, with 92.9% (880/947) of users adhering to the prescribed training regimen. First-line incontinence treatment, when implemented using this digital program, leads to statistically and clinically substantial symptom improvements across age and BMI categories and incontinence subtypes.

Development and Pilot Test of a Multi-Component Intervention to Support Women's Recovery from Female Genital Fistula.

INTRODUCTION AND HYPOTHESIS: We evaluated a pilot multi-component reintegration intervention to improve women's physical and psychosocial quality of life after genital fistula surgery. METHODS: Twelve women undergoing fistula repair at Mulago Specialized Women and Neonatal Hospital (Kampala, Uganda) anticipated in a 2-week multi-component intervention including health education, psychosocial therapy, physiotherapy, and economic investment. We assessed feasibility through recruitment, retention, and adherence, acceptability through intervention satisfaction, and preliminary effectiveness through reintegration, mental health, physical health, and economic status. We collected quantitative data at enrollment, 6 weeks, 3 months, and 6 months. We conducted in-depth interviews with six participants. Quantitative data are presented descriptively, and qualitative data analyzed thematically. RESULTS: Participants had a median age of 34.5 years (25.5-38.0), 50% were married/partnered, 42% were separated, 50$ had completed less than primary education, and 67% were unemployed. Mean number of sessions received was 12 for health education (range 5-15), 8 for counseling (range 8-9), and 6 for physiotherapy (range 4-8). Feasibility was demonstrated by study acceptance among all those eligible (100%); comfort with study measures, data collection frequency and approach; and procedural fidelity. Acceptability was high; all participants reported being very satisfied with the intervention and each of the components. Participant narratives echoed quantitative findings and contributed nuanced perspectives to understanding approach and content. CONCLUSIONS: Our results suggest that the intervention and associated research were both feasible and acceptable, and suggested certain modifications to the intervention protocol to reduce participant burden. Further research to determine the effectiveness of the intervention above and beyond surgery alone with regard to the health and well-being of women with fistulas is warranted.

Our business, not the robot's: family conversations about privacy with social robots in the home.

The targeted use of social robots for the family demands a better understanding of multiple stakeholders' privacy concerns, including those of parents and children. Through a co-learning workshop which introduced families to the functions and hypothetical use of social robots in the home, we present preliminary evidence from 6 families that exhibits how parents and children have different comfort levels with robots collecting and sharing information across different use contexts. Conversations and booklet answers reveal that parents adopted their child's decision in scenarios where they expect children to have more agency, such as in cases of homework completion or cleaning up toys, and when children proposed what their parents found to be acceptable reasoning for their decisions. Families expressed relief when they shared the same reasoning when coming to conclusive decisions, signifying an agreement of boundary management between the robot and the family. In cases where parents and children did not agree, they rejected a binary, either-or decision and opted for a third type of response, reflecting skepticism, uncertainty and/or compromise. Our work highlights the benefits of involving parents and children in child- and family-centered research, including parental abilities to provide cognitive scaffolding and personalize hypothetical scenarios for their children.

A digital health program for treatment of urinary incontinence: retrospective review of real-world user data.

INTRODUCTION AND HYPOTHESIS: To determine the effectiveness of a prescription digital therapeutic (pDTx) in reducing urinary incontinence (UI) symptoms in real-world users. METHODS: This is a retrospective cohort study of real-world data from users of a pDTx designed to guide pelvic floor muscle training(PFMT) between July 1, 2020-December 31, 2021. The primary outcome was UI symptom change as reported via in-app Urogenital Distress Inventory (UDI-6). Included subjects were female, ≥ 18 years with a diagnosis of stress, urgency, or mixed UI who completed the UDI-6 at baseline and 8 weeks. Demographic, symptom, and adherence data were summarized. Paired t-test and Wilcoxon signed rank test were used to analyze change in outcomes from baseline to 8 weeks across adherence and UI diagnosis groups. RESULTS: Of 532 women with UI, 265 (50%) met criteria and were included in the analysis. Mean age was 51.2 ± 11.5 years (range 22-84, N = 265). Mean body mass index (BMI) was 27.3 ± 6.2 kg/m2 (range 15.2-46.9, N = 147). Most participants had stress UI (59%) followed by mixed UI (22%), urgency UI/OAB (11%), and unspecified UI (8%). UDI-6 scores improved by 13.90 ± 15.53 (p ≤ 0.001); 62% met or exceeded MCID. Device-reported PFMT adherence was 72% at 4 weeks and 66% at 8 weeks (100% = 14 uses/week). Participants in each diagnosis category reported significant improvement on UDI-6 score from baseline to 8 weeks. No association between UDI-6 score improvement and adherence category, age, BMI, or UI subtype was identified. CONCLUSIONS: This study demonstrates effectiveness of a pDTx in reducing UI symptoms in a real-world setting. Users achieved statistically and clinically significant symptom improvement over an 8-week period.

Healthcare resource use and cost burden of urinary incontinence to United States payers.

OBJECTIVE: To assess healthcare resource utilization and costs for female patients diagnosed with stress or mixed urinary incontinence (SUI/MUI) compared to a matched cohort of patients without SUI/MUI. METHODS: We conducted a retrospective matched cohort study of women using the IBM MarketScan research database. Women diagnosed with SUI/MUI between July 1, 2014 and June 30, 2016 were identified using International Classification of Diseases 9 and 10 codes for SUI or MUI with the date of first diagnosis as the index date from which 2-year postindex healthcare resource use and direct cost data were derived from claims, examined, and compared 1:1 with patients without a SUI/MUI diagnosis, matched by age and Charlson's Comorbidity Index. RESULTS: A total of 68 636 women with SUI/MUI were matched 1:1 with controls. In the 2-year postindex date, a significantly higher proportion of SUI/MUI patients had ≥1 inpatient visit and ≥1 outpatient visit compared to the control group (inpatient: 18.89% vs. 12.10%, p < 0.0001; outpatient: 88.44% vs. 73.23%, p < 0.0001). Mean primary care visits were significantly higher in SUI/MUI patients compared to controls (7.33 vs. 5.53; p < 0.0001) as were specialist visits (1.2 vs. 0.08; p < 0.0001). Mean all-cause outpatient costs were higher in SUI/MUI patients compared to controls ($7032.10 vs. $3348.50; p < 0.0001), as were inpatient costs ($3990.70 vs. $2313.70; p < 0.0001). CONCLUSION: Women with SUI/MUI consume significantly higher medical resources and incur higher costs to payers, compared to women without SUI/MUI. While reasons for this are not fully understood, improved and standardized treatment for women with SUI/MUI may positively affect cost and outcomes.

Adherence to professional society guidelines among women with stress or mixed urinary incontinence.

AIMS: The objective of this analysis was to describe longitudinal adherence with recommended urinary incontinence (UI) evaluation and treatment guidelines over a 2-year period in patients newly diagnosed with stress (SUI) or mixed UI (MUI), and average 2-year cost associated with initial treatment. METHODS: A retrospective claims analysis using the IBM MarketScan database was conducted. Women diagnosed with SUI/MUI between July 1, 2014 and June 30, 2016 were identified using the International Classification of Diseases (ICD) 9 and 10 codes for SUI or MUI. Newly diagnosed SUI/MUI patients who did not have a UI-related diagnosis for at least 1 year before their index date were assessed. RESULTS: 103 813 patients with newly diagnosed SUI or MUI were identified. Of those, 96.15% (99 821/103 813) received an initial evaluation in accordance with professional guidelines (e.g., patient history, physical examination, urinalysis). Only 6.8% (5086/74 925) and 7.7% (2229/28 888) of patients with SUI and MUI, respectively, received a first-line behavioral treatment (e.g., pelvic floor muscle exercises, bladder training), according to guidelines. The 2-year average UI-related medical costs associated with guideline adherence for SUI were $5770.93 ± $9454.81 and for MUI, $4416.16 ± $7401.53. Nonadherence was observed in 59.2% (44 382/74 925) of SUI and 64.1% (18 530/28 888) of MUI patients. Two-year average UI-related medical costs for the nonadherent group were $8568.00 ± $11 275.52 for SUI and $6986.66 ± $10 765.55 for MUI, significantly more than the adherent group (p < 0.0001). CONCLUSION: The majority of SUI or MUI patients do not receive a documented behavioral intervention as their first-line treatment, which is a recommendation by professional society guidelines. This was found to affect the cost burden for payers; those that were nonadherent had significantly higher costs 2-year postindex.

Retrospective claims analysis of physical therapy utilization among women with stress or mixed urinary incontinence.

OBJECTIVE: To describe the characteristics of women with stress or mixed urinary incontinence (SUI/MUI) receiving physical therapy (PT) services, including referral patterns and PT utilization. METHODS: Female patients with claims associated with an SUI or MUI diagnosis (International Classification of Disease-Clinical Modification [ICD-9-CM]: 625.6, 788.33, or ICD-10-CM: N39.3, N39.46) between July 01, 2014 and June 30, 2016 were identified in International business machines (IBM)'s MarketScan Research Database. Inclusion criteria included the absence of pregnancy claims and ≥80% medical and pharmacy enrollment pre- and postindex. First SUI/MUI diagnosis claim determined index. Patients were followed for 2 years, and associated UI-associated PT encounters were identified. Descriptive statistics were calculated for patients with at least one PT visit during the postindex period. RESULTS: In a cohort of 103,813 women with incident SUI or MUI diagnosis, 2.6% (2792/103,813) had at least one PT visit in the 2 years following their diagnosis. Mean age at index PT encounter was 50.55 years. A total of 52.36% (1462/2792) women had one to four PT visits; 21.2% (592/2792) had >8 PT visits. In subanalysis of the PT cohort (1345/2792), women who received PT only had the lowest average 2-year postindex total medical cost (mean: $12,671; SD: $16,346), compared with PT plus medications (mean: $27,394; SD: $64,481), and PT plus surgery (mean: $33,656; SD: $26,245), respectively. Over 40% had their first PT visit ≥3 months after their index date. CONCLUSIONS: The percentage of women with a PT visit associated with an incident SUI or MUI diagnosis was low (2.6%), and 30% of this group completed three or more PT visits. This suggests poor adherence to clinical guidelines regarding supervised treatment of UI in women. IMPACT STATEMENT: Our study suggests underutilization of PT among insured women with SUI and MUI in the 2 years following diagnosis. Interventions to improve this gap in first-line care may represent an opportunity for an increased role for PTs in the care of women with UI.

Function and disability status among women with fistula using WHODAS2.0: A descriptive study from Rwanda and Democratic Republic of Congo.

OBJECTIVE: To assess function and disability among women in Rwanda and Democratic Republic of Congo living with fistula and identify characteristics associated with higher disability scores. METHODS: Women presenting for fistula care were recruited. Eligible participants underwent a physical examination to classify fistula type and completed the WHO Disability Assessment Schedule 2.0 questionnaire to ascertain the impact of fistula on function across six domains: cognition, mobility, self-care, getting along, life activities, and participation. Disability scores were calculated (where 0 = no disability and 100 = complete disability). Participants were grouped according to no, low, or high disability status; results were examined to determine the domains most affected. RESULTS: Among 69 participants, fistula type included: vesicovaginal (59.4%), ureterovaginal (14.5%), total absence of proximal urethra (11.6%), and rectovaginal (14.5%). Median disability score was 43.0/100 (interquartile range 26.0-67.0); 83% exhibited high disability status. Life activities and participation in society domains were most affected. Women with rectovaginal fistula reported the lowest scores, and those with total absence of proximal urethra reported the highest scores. CONCLUSION: WHO Disability Assessment Schedule 2.0 represents a simple, robust measure of global disability status, aligns with research efforts to estimate maternal disability, and may inform health needs and resource allocation for this population. In this study, disability was common, varied by fistula type, and affected physical, mental, and social domains.

Female Urinary Incontinence Evidence-Based Treatment Pathway: An Infographic for Shared Decision-Making.

Objectives: Urinary incontinence (UI) is a highly prevalent burdensome condition among adult females in the United States, yet rates of care-seeking, evaluation, and treatment are nonoptimal. Components of evaluation and treatment are informed by research and professional society guidelines; however, a visual representation of this guidance does not exist. The objectives of this study are to review the literature regarding female UI care and to synthesize this information into a graphical format to facilitate health education, health care delivery, and shared decision-making. Methods: We reviewed published society guidelines, position statements, and associated references from the American College of Obstetrics and Gynecology, the Women's Preventive Services Initiative, American Academy of Family Physicians, American College of Physicians, the Society of Urodynamics and Female Urology, the American Urological Association, and the American Urogynecologic Society, and searched PubMed for related literature. We synthesized these findings into an evidence-based infographic depicting female UI risk factors, influences on care-seeking and provision, screening, evaluation, and a stepwise treatment approach. Results: This study summarizes current evidence and professional guidelines related to female UI into a compelling visual format and accompanying narrative. The infographic is intended as a tool for patient education, clinical practice, and research to facilitate shared decision-making and health care delivery. Conclusions: Female UI is highly prevalent, yet diagnosis and treatment are suboptimal. Use of an evidence-based infographic may positively impact patient knowledge and certainty about UI treatment and support health care provider counseling and decision-making.

Prevalence of urinary incontinence in pregnant and postpartum women in the Democratic Republic of Congo.

INTRODUCTION AND HYPOTHESIS: The objective was to describe the prevalence of urinary incontinence in pregnant and postpartum women in the Democratic Republic of Congo and to identify factors associated with urinary incontinence (UI) in these populations. METHODS: We interviewed eligible women who sought prenatal or postnatal reproductive health clinic consultations over a 2-year period. Interviews collected information about demographics, obstetric history, and urinary incontinence symptoms, as well as the impact on the quality of life, via a validated questionnaire. Descriptive analyses compared women with and without urinary incontinence and compared characteristics of UI, stratified by pregnancy status. Logistic regression identified factors associated with UI among the entire sample, pregnant women, and postpartum women. RESULTS: Overall, 268 out of 880 women had UI (30.5%); the prevalence was 33.4% (168 out of 503) among pregnant women and 26.5% (100 out of 377) among postpartum women, p = 0.03. Women who were pregnant were significantly more likely to experience stress incontinence (p = 0.01) and less likely to report moderate or large amounts of leakage (p = 0.002). A history of macrosomia and being currently pregnant were associated with UI in the entire sample (p < 0.05). Among pregnant women, the risk of UI decreased with increasing gestational age and increased with a history of macrosomia (p ≤ 0.01). Among postpartum women, a history of macrosomia and prior episiotomy were associated with UI (p < 0.05). CONCLUSIONS: Urinary incontinence is prevalent in pregnant and postpartum women in the Democratic Republic of Congo and is associated with a history of macrosomia. Efforts should focus on screening, evaluation, and treatment.

Rehabilitative care practices in the management of childbirth-related pelvic fistula: A systematic review.

INTRODUCTION AND HYPOTHESIS: Childbirth-related pelvic fistula (CRF) often requires surgery, yet even with successful repair, mental health conditions, musculoskeletal impairments, urinary and fecal incontinence and sexual dysfunction persist for many women. Postoperative rehabilitation, (i.e., physiotherapy, mental health counseling) may address these concerns and has been reported for this population. This review aims to summarize the literature and level of evidence of rehabilitative care practices in fistula care to inform clinical practice, research and policy recommendations. METHODS: A systematic literature review was conducted using Africa-Wide Information, CINAHL, Cochrane, Embase, Global Health, PAIS Index, PubMed and SCOPUS searching keywords and MeSH terms to identify women with CRF admitted for surgery. Two researchers progressively screened titles, abstracts and full-text articles. Eligible articles were classified primary if intervention details and outcomes were reported or secondary if rehabilitation was described, but no specific outcomes reported. Relevant study details, strengths and limitations, and key findings were extracted. RESULTS: Eighteen articles were included: eight primary, ten secondary. Primary articles reported on urethral plugs for postoperative urinary incontinence (UI) (2/8), menstrual cup to manage UI (1/8), physiotherapy and health education (3/8) and mental health counseling (2/8). Secondary articles describe rehabilitation components in the context of program descriptions, qualitative analyses or reviews. All evidence was low or very low quality. CONCLUSIONS: Research on rehabilitative care is very limited and highlights inconsistencies in practice. This review provides support for the feasibility of rehabilitation and establishes the need for future interventional studies that involve a comparator and reliable outcome measures.

Evaluation of Postpartum Pelvic Floor Physical Therapy on Obstetrical Anal Sphincter Injury: A Randomized Controlled Trial.

OBJECTIVE: The aim of the study was to evaluate a short course of postpartum pelvic floor physical therapy (PFPT) on symptoms and quality of life after obstetrical anal sphincter injuries (OASIS). METHODS: This was a multicenter, randomized controlled trial. Adult women were eligible if they had a vaginal delivery complicated by OASIS and did not have a prior vaginal delivery after 24 weeks' gestation. Participants were randomized to standard care plus PFPT or standard care alone. The primary outcome was change in the Pelvic Floor Distress Inventory (PFDI-20) at 12 weeks postpartum. Secondary outcomes included other validated questionnaires assessing pelvic floor symptoms and bother. RESULTS: We approached 89 eligible women; 50 were enrolled and randomized. We excluded 6 participants in the PFPT group and 1 in the standard care group who withdrew before study initiation or did not provide baseline data at 2 weeks postpartum. Thus, we analyzed 19 in the PFPT group and 24 in the standard care group. The groups were similar with regard to most baseline characteristics.The PFPT group reported significant improvement in pelvic floor symptoms and bother compared with the standard care group, reflected by a decrease of 29.2 (interquartile range = -58.3 to -4.2) compared with 0.0 (interquartile range = -14.6 to 20.8) on the PFDI-20 from 2 to 12 weeks postpartum (P = 0.002). Significant differences also were observed for all PFDI-20 subscales (all P ≤ 0.02). CONCLUSIONS: At 12 weeks postpartum, the PFPT group reported a significant improvement in pelvic floor symptoms and bother compared with the standard care group.

Development of a wireless accelerometer-based Intravaginal device to detect pelvic floor motion for evaluation of pelvic floor dysfunction.

Urinary incontinence (UI) is experienced by an estimated 51% of women in the U.S. and often results from impaired function or weakening of the pelvic floor muscles. Pelvic floor muscle training (PFMT) is a frontline nonsurgical treatment, yet a number of symptomatic individuals cannot accurately perform a pelvic floor muscle contraction with simple verbal or written instruction. Long-term adherence to PFMT regimens is often a barrier to resolution of symptoms. Various biofeedback tools have been utilized to aid correct pelvic floor muscle performance and adherence. One novel device, the leva® Pelvic Digital Health System, utilizes an intravaginal probe embedded with MEMS accelerometer sensors that allow real-time visualization of the shape and motion of the vagina during PFMT. Early positive results with this device prompted design of a wearable version. The purpose of this study was to design a wearable, wireless clinical research device to optimize MEMS accelerometer sensor placement to detect maximal movement during a pelvic floor muscle exercise (PFME) and to test the form factor for retention and user acceptability. The device comprised a ring designed to sit at the fornix with an extension following the length of the vagina. This paper presents design components and results from clinical testing of 10 subjects. It was determined that a ring form factor alone, similar to other vaginal rings (pessaries, estrogen rings) provided less accurate visual information about PFME performance. By contrast, we determined that a ring with an extension allowed for device retention and improved real-time detection of vaginal shape and motion during PFMT.

Evaluation of an accelerometer-based digital health system for the treatment of female urinary incontinence: A pilot study.

AIMS: To assess the effectiveness and patient satisfaction of pelvic floor muscle training (PFMT) guided by an intravaginal accelerometer-based system for the treatment of female urinary incontinence (UI). METHODS: Premenopausal women with mild-to-moderate stress or mixed UI were recruited to participate in PFMT with an accelerometer-based system for 6 weeks with supervision. Objective outcomes included pelvic floor muscle (PFM) contraction duration, number of contractions in 15 seconds, and angular displacement of the accelerometer relative to earth during PFM contraction. Subjective outcomes and quality-of-life were assessed with validated, condition-specific questionnaires. Results are presented as means, standard error of the mean, and 95% confidence intervals unless otherwise indicated. RESULTS: Twenty-three women (age 42.0 ± 10.7 years, mean ± standard deviation) completed the study. Scores on the Urogenital Distress Inventory (UDI) decreased from 36.7 ± 4.7 at baseline to 1.45 ± 0.8 at 6 weeks (P < .0001). The Patient's Global Impression of Severity score decreased from 1.5 ± 0.1 to 0.2 ± 0.1 (P < .0001) at study endpoint. At 6 weeks, the PFM contraction duration increased from 13 ± 2.6 at baseline to 187 ± 9.6 seconds (P < .0001). Repeated contractions in 15 seconds increased from 5.9 ± 0.4 at enrollment to 9.6 ± 0.5 at 6 weeks (P < .0001). Maximum pelvic floor angle (a measure of lift) increased from 65.1 ± 2.0° to 81.1 ± 1.8° (P < .0001). Increasing PFM contraction duration and maximum pelvic floor angle correlated with decreasing UDI-6 scores, r = -0.87, P = .01; r = -0.97, P = .0003, respectively. No device-related adverse events occurred. CONCLUSIONS: Pilot testing of this accelerometer-based system demonstrates improvements in objective PFM measures, patient-reported UI severity and condition-specific quality of life, with results evident after 1 week of use.

Insomnia and risk for suicidal behavior: A test of a mechanistic transdiagnostic model in veterans.

BACKGROUND: Insomnia has been shown to have direct and indirect associations with suicidal ideation, attempts, and death in U.S. military and veteran populations. However, transdiagnostic models of insomnia and psychopathology have not been used to examine the contribution of psychopathology. METHOD: The present study is a secondary analysis examining the associations among insomnia symptoms, posttraumatic stress disorder (PTSD) and depressive symptoms, interpersonal theory of suicide variables, and risk for suicidal behavior in community veterans (n = 392). Serial mediation was used to test sequential associations, allowing for examination of direct and indirect associations. RESULTS: The model with insomnia, PTSD, and depressive symptoms, and thwarted belongingness, accounted for 29% of the variance in risk. Insomnia symptoms had an indirect association through PTSD and depressive symptoms, and thwarted belongingness. The model with insomnia, PTSD, and depressive symptoms, and perceived burdensomeness accounted for 35% of the variance in risk. Insomnia symptoms had an indirect association through PTSD and depressive symptoms, and perceived burdensomeness. LIMITATIONS: Data are cross-sectional, precluding the testing of causal associations. CONCLUSIONS: In veterans, insomnia symptoms may be associated with increased PTSD and depressive symptoms, which may be associated with increased risk for suicidal behavior directly and indirectly through relationship disruptions.

Development of a core set of outcome measures for OAB treatment.

INTRODUCTION AND HYPOTHESIS: Standardized measures enable the comparison of outcomes across providers and treatments giving valuable information for improving care quality and efficacy. The aim of this project was to define a minimum standard set of outcome measures and case-mix factors for evaluating the care of patients with overactive bladder (OAB). METHODS: The International Consortium for Health Outcomes Measurement (ICHOM) convened an international working group (WG) of leading clinicians and patients to engage in a structured method for developing a core outcome set. Consensus was determined by a modified Delphi process, and discussions were supported by both literature review and patient input. RESULTS: The standard set measures outcomes of care for adults seeking treatment for OAB, excluding residents of long-term care facilities. The WG focused on treatment outcomes identified as most important key outcome domains to patients: symptom burden and bother, physical functioning, emotional health, impact of symptoms and treatment on quality of life, and success of treatment. Demographic information and case-mix factors that may affect these outcomes were also included. CONCLUSIONS: The standardized outcome set for evaluating clinical care is appropriate for use by all health providers caring for patients with OAB, regardless of specialty or geographic location, and provides key data for quality improvement activities and research.

PTSD symptoms and suicide risk in veterans: Serial indirect effects via depression and anger.

BACKGROUND: Suicide rates are higher in veterans compared to the general population, perhaps due to trauma exposure. Previous literature highlights depressive symptoms and anger as contributors to suicide risk. PTSD symptoms may indirectly affect suicide risk by increasing the severity of such cognitive-emotional factors. METHOD: A sample of community dwelling veterans (N=545) completed online surveys, including the PTSD Checklist-Military Version, Suicidal Behaviors Questionnaire-Revised, Multidimensional Health Profile-Psychosocial Functioning, and Differential Emotions Scale -IV. Bivariate and serial mediation analyses were conducted to test for direct and indirect effects of PTSD symptoms on suicide risk. RESULTS: In bivariate analyses, PTSD symptoms, depression, anger, and internal hostility were positively related to suicide risk. In serial mediation analyses, there was a significant total effect of PTSD symptoms on suicide risk in both models. PTSD symptoms were also indirectly related to suicidal behavior via depression and internal hostility, and via internal hostility alone. Anger was not a significant mediator. LIMITATION: Our cross-sectional sample was predominantly White and male; prospective studies with diverse veterans are needed. DISCUSSION: Our findings may have implications for veteran suicide prevention. The effects of PTSD and depression on anger, particularly internal hostility, are related to suicide risk, suggesting a potential mechanism of action for the PTSD-suicide linkage. A multi-faceted therapeutic approach, targeting depression and internal hostility, via cognitive-behavioral techniques such as behavioral activation and cognitive restructuring, may reduce suicide risk in veterans who have experienced trauma.