Implementation of an evidence-based tobacco control intervention for school teachers in India: Evaluating the effects of a capacity-building strategy.

Background: Tobacco-Free Teachers, Tobacco-Free Society (TFT-TFS) is an evidence-based intervention that promotes tobacco use cessation among teachers and tobacco control policies among schools in India. This study tested an implementation model to build Bihar Department of Education (DOE) capacity to support and deliver TFT-TFS within schools, leveraging DOE training infrastructure. Method: We used a training-of-trainers (TOT) "cascade" implementation strategy to embed the TFT-TFS program into the Bihar DOE infrastructure. We trained 46 Cluster Coordinators to train and support Headmasters to implement TFT-TFS in their schools over one academic year. We selected three school districts, representing approximately 46 clusters and 219 schools. We used the RE-AIM framework to assess program adoption (Headmaster participation in at least one of six TFT-TFS trainings), implementation (of four core program components), and reach (teachers' participation in three or more group discussions). Using a non-inferiority design, we hypothesized that program adoption, implementation, and reach would not be inferior to the high standards demonstrated when TFT-TFS was originally tested in the Bihar School Teachers Study. We used self-reported checklists to measure outcomes and SPSS Version 25 to analyze data. Results: For adoption, 94% of Headmasters attended the first training, although participation declined by the sixth training. Among the 112 schools out of 219 with complete Headmaster checklist data, all met our minimum criteria for implementing TFT-TFS. Over 99% of schools posted a school tobacco control policy and distributed quit booklets. However, only 69% of schools met our criteria for program reach. Conclusions: This study outlines the processes for taking a tobacco control intervention to scale and implementing it through the Bihar DOE infrastructure. These findings provide a foundation for other Indian states and low- and middle-income countries to implement tobacco control and other health programs for schoolteachers. Trial registration: NCT05346991. Plain Language Summary: Each year in India, more than 1.2 million people die from tobacco-related causes, and India has the world's highest oral cancer burden. The world needs more evidence on how to bring cost-effective tobacco control interventions to scale, especially in low- and middle-income countries (LMICs). To address this gap, from 2017 to 2021, we examined the process of scaling up Tobacco-Free Teachers, Tobacco-Free Society (TFT-TFS), an evidence-based intervention promoting tobacco use cessation among teachers and tobacco control policies in schools. Our study tested an implementation model aimed at building the Bihar State Department of Education (DOE) capacity to support and deliver TFT-TFS. We used a training-of-trainers model to embed TFT-TFS into Bihar DOE infrastructure, training 46 Cluster Coordinators to in turn train and support Headmasters to implement TFT-TFS over one academic year. We hypothesized that program adoption, implementation, and reach would not be inferior to the high standards demonstrated when we originally tested TFT-TFS through the Bihar School Teachers Study (2013-2017). For adoption, 94% of Headmasters attended the first training, although participation declined by the sixth training. Of 112 schools (out of 219 with complete Headmaster checklist data), all met our minimum criteria for implementing TFT-TFS. Over 99% of schools posted a school tobacco control policy and distributed quit booklets. However, only 69% of schools met our criteria for program reach. Study findings offer other Indian states and LMICs lessons to implement tobacco control and other health programs for schoolteachers within educational systems.

The relationship between organizational policies and practices and work limitations among hospital patient care workers.

OBJECTIVE: We examined relationships between organizational policies and practices (OPPs) (safety practices, ergonomic practices, and people-oriented culture) and work limitations in a sample of hospital workers. METHODS: We used the 6-item Work Limitations Questionnaire (WLQ) to assess workers' perceptions of health-related work limitations. Self-reported OPPs and the WLQ were collected from workers in Boston, Massachusetts (n = 1277). We conducted random-intercept multi-level logistic regression models for each OPP using stepwise selection of covariates. RESULTS: As the unit-average ergonomic practice score increased by one, the odds of a worker reporting work limitations decreased by approximately 39% (P-value = 0.018), adjusted for job title, age, and body mass index. A similar relationship existed for people-oriented culture (P-value = 0.038). The association between safety practices and work limitations was similar, but not statistically significant. CONCLUSIONS: This study demonstrated the importance of workplace OPPs. OPPs that promote positive and supportive environments and that foster improvements in ergonomics may help reduce work limitations.

Food Hardship and Obesity in a Sample of Low-Income Immigrants.

Very little work has examined the relationship between food hardship (having inconsistent financial resources to buy food) and obesity among immigrant groups. A cross-sectional study was conducted in a low-income, multi-racial/ethnic adult sample in greater Boston, MA (n = 828). Modified Poisson regression models estimated the association between food hardship obesity (BMI ≥ 30) among adults reporting food hardship; interactions were tested by place of birth. Body mass index (BMI) was based on anthropometric height and weight. In adjusted models, those experiencing food hardship were more likely to be obese (RR 1.17, CI 1.07, 1.29) than those not experiencing food hardship. Participants from Haiti reporting food hardship were more likely to be obese than those not reporting hardship (RR 1.58, CI 1.23, 2.04); this was not the case among other groups (US born, Puerto Rican, Latin American, Other). The relationship between food hardship and weight may vary among immigrant subgroups.

Effects of a worksite tobacco control intervention in India: the Mumbai worksite tobacco control study, a cluster-randomised trial.

OBJECTIVES: We assessed a worksite intervention designed to promote tobacco control among workers in the manufacturing sector in Greater Mumbai, India. METHODS: We used a cluster-randomised design to test an integrated health promotion/health protection intervention, the Healthy, Safe, and Tobacco-free Worksites programme. Between July 2012 and July 2013, we recruited 20 worksites on a rolling basis and randomly assigned them to intervention or delayed-intervention control conditions. The follow-up survey was conducted between December 2013 and November 2014. RESULTS: The difference in 30-day quit rates between intervention and control conditions was statistically significant for production workers (OR=2.25, p=0.03), although not for the overall sample (OR=1.70; p=0.12). The intervention resulted in a doubling of the 6-month cessation rates among workers in the intervention worksites compared to those in the control, for production workers (OR=2.29; p=0.07) and for the overall sample (OR=1.81; p=0.13), but the difference did not reach statistical significance. CONCLUSIONS: These findings demonstrate the potential impact of a tobacco control intervention that combined tobacco control and health protection programming within Indian manufacturing worksites. TRIAL REGISTRATION NUMBER: NCT01841879.

Lifting and exertion injuries decrease after implementation of an integrated hospital-wide safe patient handling and mobilisation programme.

OBJECTIVE: With increasing emphasis on early and frequent mobilisation of patients in acute care, safe patient handling and mobilisation practices need to be integrated into these quality initiatives. We completed a programme evaluation of a safe patient handling and mobilisation programme within the context of a hospital-wide patient care improvement initiative that utilised a systems approach and integrated safe patient equipment and practices into patient care plans. METHODS: Baseline and 12-month follow-up surveys of 1832 direct patient care workers assessed work practices and self-reported pain while an integrated employee payroll and injury database provided recordable injury rates collected concurrently at 2 hospitals: the study hospital with the programme and a comparison hospital. RESULTS: Safe and unsafe patient handling practice scales at the study hospital improved significantly (p<0.0001 and p=0.0031, respectively), with no differences observed at the comparison hospital. We observed significant decreases in recordable neck and shoulder (Relative Risk (RR)=0.68, 95% CI 0.46 to 1.00), lifting and exertion (RR=0.73, 95% CI 0.60 to 0.89) and pain and inflammation (RR=0.78, 95% CI 0.62 to 1.00) injury rates at the study hospital. Changes in rates at the comparison hospital were not statistically significant. CONCLUSIONS: Within the context of a patient mobilisation initiative, a safe patient handling and mobilisation programme was associated with improved work practices and a reduction in recordable worker injuries. This study demonstrates the potential impact of utilising a systems approach based on recommended best practices, including integration of these practices into the patient's plan for care.

Implementing an Integrated Health Protection/Health Promotion Intervention in the Hospital Setting: Lessons Learned From the Be Well, Work Well Study.

OBJECTIVE: This study reports findings from a proof-of-concept trial designed to examine the feasibility and estimates the efficacy of the "Be Well, Work Well" workplace intervention. METHODS: The intervention included consultation for nurse managers to implement changes on patient-care units and educational programming for patient-care staff to facilitate improvements in safety and health behaviors. We used a mixed-methods approach to evaluate feasibility and efficacy. RESULTS: Using findings from process tracking and qualitative research, we observed challenges to implementing the intervention due to the physical demands, time constraints, and psychological strains of patient care. Using survey data, we found no significant intervention effects. CONCLUSIONS: Beyond educating individual workers, systemwide initiatives that respond to conditions of work might be needed to transform the workplace culture and broader milieu in support of worker health and safety.

Management of recurrent stress urinary incontinence after burch and sling procedures.

AIMS: To examine treatment options selected for recurrent stress urinary incontinence (rSUI) in follow-up after Burch, autologous fascial and synthetic midurethral sling (MUS) procedures. METHODS: We performed a secondary analysis of the SISTER and ToMUS trials of participants who underwent primary stress urinary incontinence (SUI) treatment (without prior SUI surgery or concomitant procedures). Using Kaplan-Meier analysis, retreatment-free survival rates by initial surgical procedure were compared. Mean MESA (Medical Epidemiologic and Social Aspects of Aging) stress index was also compared between those retreated for rSUI compared to those not retreated. RESULTS: Half of the women in the SISTEr trial met inclusion criteria for this analysis (329/655, 174 Burch and 155 fascial sling), as did 444/597 (74%) of subjects in ToMUS (221 transobturator midurethral sling (TMUS), and 223 retropubic midurethral sling (RMUS). Types of surgical retreatment included autologous fascial sling (19), synthetic sling (1), and bulking agent (18). Five-year retreatment free survival rates (and standard errors) were 87% (3%), 96% (2%), 97% (1%), and 99% (0.7%) for Burch, autologous fascial sling, TMUS, and RMUS groups respectively (P < 0.0001). For all index surgery groups, the mean MESA stress index at last visit prior to retreatment for those retreated (n = 23) was significantly higher than mean MESA stress index at last visit for those not retreated (n = 645) (P < 0.0001). CONCLUSION: In these cohorts, 6% of women after standard anti-incontinence procedures were retreated within 5 years, mostly with injection therapy or autologous fascial sling. Not all women with rSUI chose surgical retreatment.

The cost of preoperative urodynamics: A secondary analysis of the ValUE trial.

AIMS: Urodynamic studies (UDS) are generally recommended prior to surgical treatment for stress urinary incontinence (SUI), despite insufficient evidence that it impacts treatment plans or outcomes in patients with uncomplicated SUI. This analysis aimed to calculate the cost incurred when UDS was performed as a supplement to a basic office evaluation and to extrapolate the potential savings of not doing UDS in this patient population on a national basis. METHODS: This is a secondary analysis from the Value of Urodynamic Evaluation (ValUE) trial, a multicenter non-inferiority randomized trial to determine whether a basic office evaluation (OE) is non-inferior in terms of SUI surgery outcomes to office evaluation with addition of urodynamic studies (UDS). All participants underwent an OE; those patients who randomized to supplementary UDS underwent non-instrumented uroflowmetry, filling cystometry, and a pressure flow study. Costs associated with UDS were calculated using 2014 U.S. Medicare allowable fees. Models using various patient populations and payor mixes were created to obtain a range of potential costs of performing UDS in patients undergoing SUI surgery annually in the United States. RESULTS: Six hundred thirty women were randomized to OE or OE plus UDS. There was no difference in surgical outcomes between the two groups. The per patient cost of UDS varied from site to site, and included complex cystometrogram $314-$343 (CPT codes 51728-51729) plus complex uroflowmetry $16 (CPT code 51741). Extrapolating these costs for US women similar to our study population, 13-33 million US dollars could be saved annually by not performing preoperative urodynamics. CONCLUSION: For women with uncomplicated SUI and a confirmatory preoperative basic office evaluation, tens of millions of dollars US could be saved annually by not performing urodynamic testing. In the management of such women, eliminating this preoperative test has a major economic benefit.

Missing data frequency and correlates in two randomized surgical trials for urinary incontinence in women.

INTRODUCTION AND HYPOTHESIS: Missing data is frequently observed in clinical trials; high rates of missing data may jeopardize trial outcome validity. PURPOSE: We determined the rates of missing data over time, by type of data collected and compared demographic and clinical factors associated with missing data among women who participated in two large randomized clinical trials of surgery for stress urinary incontinence, the Stress Incontinence Surgical Treatment Efficacy Trial (SISTEr) and the Trial of Midurethral Sling (TOMUS). METHODS: The proportions of subjects who attended and missed each follow-up visit were calculated. The chi-squared test, Fisher's exact test and t test were used to compare women with and without missing data, as well as the completeness of the data for each component of the composite primary outcome. RESULTS: Data completeness for the primary outcome computation in the TOMUS trial (62.3%) was nearly double that in the SISTEr trial (35.7%). The follow-up visit attendance rate decreased over time. A higher proportion of subjects attended all follow-up visits in the TOMUS trial and overall there were fewer missing data for the period that included the primary outcome assessment at 12 months. The highest levels of complete data for the composite outcome variables were for the symptoms questionnaire (SISTEr 100 %, TOMUS 99.8%) and the urinary stress test (SISTEr 96.1%, TOMUS 96.7%). In both studies, the pad test was associated with the lowest levels of complete data (SISTEr 85.1%, TOMUS 88.3%) and approximately one in ten subjects had incomplete voiding diaries at the time of primary outcome assessment. Generally, in both studies, a higher proportion of younger subjects had missing data. This analysis lacked a patient perspective as to the reasons for missing data that could have provided additional information on subject burden, motivations for adherence and study design. In addition, we were unable to compare the effects of the different primary outcome assessment time-points in an identically designed trial. CONCLUSIONS: Missing visits and data increased with time. Questionnaire data and physical outcome data (urinary stress test) that could be assessed during a visit were least prone to missing data, whereas data for variables that required subject effort while away from the research team (pad test, voiding diary) were more likely to be missing. Older subjects were more likely to provide complete data.

Social contextual factors and tobacco use among Indian teachers: insights from the Bihar School Teachers' Study.

OBJECTIVE: Tobacco use within India has significant effects on the global burden of tobacco-related disease. As role models and opinion leaders, teachers are at the forefront of tobacco control efforts, yet little is known about their own tobacco use. This study examines the association between factors in the social environment and tobacco use among teachers in Bihar, India. METHODS: The study was based on the Bihar School Teachers' Study baseline survey. Seventy-two Bihar government schools (grades 8-10) were randomly selected for the study and all school personnel were invited to complete the survey in June/July in 2009 and 2010. We assessed the relation between social contextual factors and current smoking/smokeless tobacco use by fitting a series of logistic regression models. RESULTS: After controlling for clustering of teachers in schools and other covariates, our results showed teachers with one or more coworkers who used tobacco were twice as likely to be smokeless tobacco users as teachers with no co-workers who used tobacco. Teachers who reported rules prohibiting smoking at home were significantly less likely to smoke than teachers without such rules. Older male teachers also had significantly greater odds of smoking/using smokeless tobacco. CONCLUSION: These findings provide direction for future interventions targeting the social context.

5-year longitudinal followup after retropubic and transobturator mid urethral slings.

PURPOSE: Few studies have characterized longer-term outcomes after retropubic and transobturator mid urethral slings. MATERIALS AND METHODS: Women completing 2-year participation in a randomized equivalence trial who had not undergone surgical re-treatment for stress urinary incontinence were invited to participate in a 5-year observational cohort. The primary outcome, treatment success, was defined as no re-treatment or self-reported stress incontinence symptoms. Secondary outcomes included urinary symptoms and quality of life, satisfaction, sexual function and adverse events. RESULTS: Of 597 women 404 (68%) from the original trial enrolled in the study. Five years after surgical treatment success was 7.9% greater in women assigned to the retropubic sling compared to the transobturator sling (51.3% vs 43.4%, 95% CI -1.4, 17.2), not meeting prespecified criteria for equivalence. Satisfaction decreased during 5 years but remained high and similar between arms (retropubic sling 79% vs transobturator sling 85%, p=0.15). Urinary symptoms and quality of life worsened with time (p <0.001), and women with a retropubic sling reported greater urinary urgency (p=0.001), more negative impact on quality of life (p=0.02) and worse sexual function (p=0.001). There was no difference in the proportion of women experiencing at least 1 adverse event (p=0.17). Seven new mesh erosions were noted (retropubic sling 3, transobturator sling 4). CONCLUSIONS: Treatment success decreased during 5 years for retropubic and transobturator slings, and did not meet the prespecified criteria for equivalence with retropubic demonstrating a slight benefit. However, satisfaction remained high in both arms. Women undergoing a transobturator sling procedure reported more sustained improvement in urinary symptoms and sexual function. New mesh erosions occurred in both arms over time, although at a similarly low rate.

Online self-administered training of PTSD treatment providers in cognitive-behavioral intervention skills: results of a randomized controlled trial.

Despite potential advantages in scalability and efficiency of web-based training for trauma providers, few controlled trials of feasibility and effectiveness of web-based mental health training have been performed. Our study compared web-based training in 3 intervention skills (motivation enhancement [ME], goal setting [GS], behavioral task assignment [BTA]) with web-based training plus telephone consultation, and a no-training control. The primary outcome measures included objective measures of skills acquisition (standardized patient assessments). Results showed significant differences among the training conditions. The overall tests of differences among the groups were statistically significant for ME and BTA skills (p < .001 and p = .005, respectively), but not for GS (p = .245). The web training plus consultation group improved in ME skills by 0.35 units compared to 0.12 units in the web only group (p < .001) and no change in the control group (p = .001). For BTA skills, the web training plus consultation improved by 0.27 units compared to 0.17 units in the web only group (p = .175) and no change in the control group (p = .004). Overall, these findings support the use of web-based dissemination for large-scale training programs for trauma providers in health care delivery systems. Further studies are needed to clarify the specific role of consultation as an adjunct to web-based training.

Pathways between acculturation and health behaviors among residents of low-income housing: the mediating role of social and contextual factors.

Acculturation may influence health behaviors, yet mechanisms underlying its effect are not well understood. In this study, we describe relationships between acculturation and health behaviors among low-income housing residents, and examine whether these relationships are mediated by social and contextual factors. Residents of 20 low-income housing sites in the Boston metropolitan area completed surveys that assessed acculturative characteristics, social/contextual factors, and health behaviors. A composite acculturation scale was developed using latent class analysis, resulting in four distinct acculturative groups. Path analysis was used to examine interrelationships between acculturation, health behaviors, and social/contextual factors, specifically self-reported social ties, social support, stress, material hardship, and discrimination. Of the 828 respondents, 69% were born outside of the U.S. Less acculturated groups exhibited healthier dietary practices and were less likely to smoke than more acculturated groups. Acculturation had a direct effect on diet and smoking, but not physical activity. Acculturation also showed an indirect effect on diet through its relationship with material hardship. Our finding that material hardship mediated the relationship between acculturation and diet suggests the need to explicate the significant role of financial resources in interventions seeking to promote healthy diets among low-income immigrant groups. Future research should examine these social and contextual mediators using larger, population-based samples, preferably with longitudinal data.

Pelvic organ prolapse in a cohort of women treated for stress urinary incontinence.

OBJECTIVE: The aim of our study was to observe pelvic organ prolapse (POP) over time, treated and untreated, in a group of highly characterized women being followed up subjectively and objectively over 5-7 years following continence surgery. STUDY DESIGN: We measured baseline prolapse symptoms and anatomic prolapse in subjects enrolled in the trial of midurethral sling (TOMUS) and E-TOMUS, and measured these same parameters annually for 5-7 years after the index surgery. Additional information about subsequent treatment for POP was also recorded. RESULTS: In all, 597 women were randomized to 1 of 2 midurethral sling procedures in the TOMUS; concomitant vaginal procedures for POP were allowed at the surgeon's discretion. Stage 2 POP was present at baseline in 291 subjects (49%). Symptoms of POP were reported in 67 (25%). Of the asymptomatic women, 34 of 223 (15%) underwent a concomitant POP repair at the time of index sling surgery. Anatomic progression of prolapse in women with asymptomatic, unoperated stage 2 POP over the next 72 months was infrequent and occurred in only 3 of 189 subjects (2%); none underwent surgery for POP. Most symptomatic women (47/67 [70%]) underwent a concomitant repair for POP at the index sling surgery. Three of the 47 women who had undergone concomitant repair for symptomatic stage 2 POP underwent repeat POP surgery (2 at 36 months and 1 at 48 months.) CONCLUSION: For patient populations similar to the TOMUS and E-TOMUS populations, surgeons may counsel women with asymptomatic stage 2 POP that their prolapse is unlikely to require surgery in the next 5-7 years.

Work-family conflict, psychological distress, and sleep deficiency among patient care workers.

This study examined whether work-family conflict was associated with sleep deficiencies, both cross-sectionally and longitudinally. In this two-phase study, a workplace health survey was completed by a cohort of patient care workers (n = 1,572). Additional data were collected 2 years later from a subsample of the original respondents (n = 102). Self-reported measures included work-family conflict, workplace factors, and sleep outcomes. The participants were 90% women, with a mean age of 41 ± 11.7 years. At baseline, after adjusting for covariates, higher levels of work-family conflict were significantly associated with sleep deficiency. Higher levels of work-family conflict also predicted sleep insufficiency nearly 2 years later. The first study to determine the predictive association between work-family conflict and sleep deficiency suggests that future sleep interventions should include a specific focus on work-family conflict.

Processes to manage analyses and publications in a phase III multicenter randomized clinical trial.

BACKGROUND: The timely publication of findings in peer-reviewed journals is a primary goal of clinical research. In clinical trials, the processes leading to publication can be complex from choice and prioritization of analytic topics through to journal submission and revisions. As little literature exists on the publication process for multicenter trials, we describe the development, implementation, and effectiveness of such a process in a multicenter trial. METHODS: The Hepatitis C Antiviral Long-Term Treatment against Cirrhosis (HALT-C) trial included a data coordinating center (DCC) and clinical centers that recruited and followed more than 1,000 patients. Publication guidelines were approved by the steering committee, and the publications committee monitored the publication process from selection of topics to publication. RESULTS: A total of 73 manuscripts were published in 23 peer-reviewed journals. When manuscripts were closely tracked, the median time for analyses and drafting of manuscripts was 8 months. The median time for data analyses was 5 months and the median time for manuscript drafting was 3 months. The median time for publications committee review, submission, and journal acceptance was 7 months, and the median time from analytic start to journal acceptance was 18 months. CONCLUSIONS: Effective publication guidelines must be comprehensive, implemented early in a trial, and require active management by study investigators. Successful collaboration, such as in the HALT-C trial, can serve as a model for others involved in multidisciplinary and multicenter research programs. TRIAL REGISTRATION: The HALT-C Trial was registered with clinicaltrials.gov (NCT00006164).

Analysis of Ordinal Outcomes with Longitudinal Covariates Subject to Missingness.

We propose a mixture model for data with an ordinal outcome and a longitudinal covariate that is subject to missingness. Data from a tailored telephone delivered, smoking cessation intervention for construction laborers are used to illustrate the method, which considers as an outcome a categorical measure of smoking cessation, and evaluates the effectiveness of the motivational telephone interviews on this outcome. We propose two model structures for the longitudinal covariate, for the case when the missing data are missing at random, and when the missing data mechanism is non-ignorable. A generalized EM algorithm is used to obtain maximum likelihood estimates.

Does concern motivate behavior change? Exploring the relationship between physical activity and body mass index among low-income housing residents.

OBJECTIVE: To explore relationships between concerns and physical activity and body mass index (BMI) among a racially/ethnically diverse low-income population. METHOD: A cross-sectional survey documented behavioral risks among racially/ethnically diverse low-income residents in the Boston area (2005-2009). Multivariable logistic regressions were conducted in 2012 for each concern, using SAS version 9.2. RESULTS: Those very/moderately concerned about weight were more likely to have higher BMIs, be in the preparation/action stage, received behavioral counseling, participated in a weight management program, and be interested in participating in one in the future. Those very/moderately concerned about physical activity were more likely to have higher BMIs, received behavioral counseling, and participated in a physical activity program. CONCLUSION: Individuals with elevated BMIs or low levels of physical activity are concerned. While level of concern is important, these findings suggest that it is not likely to be a sufficient catalyst to behavior change.

Inflammatory and tissue remodeling urinary biomarkers before and after mid urethral sling surgery for stress urinary incontinence.

PURPOSE: Urinary biomarkers were measured in women at baseline and 1 year after surgery for stress urinary incontinence, and associations with clinicodemographic covariates and outcomes were analyzed. MATERIALS AND METHODS: Preoperative and postoperative urine specimens from 150 women were assayed for inflammatory biomarkers (tumor necrosis factor-α, interferon-γ, interleukin-1ß, interleukin-6, interleukin-10, interleukin-12p70, interleukin-17 and nerve growth factor) and tissue remodeling biomarkers (collagenase activity, matrix metalloproteinases-1, 2, 9 and 13, and NTx [N-telopeptide cross-linked collagen], epidermal growth factor and heparin-binding epidermal growth factor-like growth factor). Paired t-tests were used to compare changes in biomarkers during 1 year (significance p <0.05). Linear regression models correlated baseline and changes in biomarker levels with covariates (significance p ≤ 0.001). Logistic regression models, controlling for age, were used to analyze associations of baseline and changes in biomarker levels with surgical failure (significance p <0.05). RESULTS: During 1 year interleukin-12p70 decreased (mean ± SD 0.53 ± 1.4 to 0.28 ± 0.62 pg/mg creatinine, p = 0.04) and nerve growth factor increased (0.034 ± 0.046 to 0.044 ± 0.060 pg/ml/mOsm, p = 0.03). Baseline NTx level per mg creatinine was positively associated with age and postmenopausal status (p = 0.001), and negatively associated with current estrogen use (p = 0.0001). Baseline collagenase activity per mg creatinine was positively associated with age (p = 0.001). Epidermal growth factor per mOsm, NTx per mOsm and interferon-γ per mOsm were negatively correlated with age, current estrogen use and UDI (Urogenital Distress Inventory)-irritative subscale score, respectively (p ≤ 0.001). Subjects with lower baseline NTx per mg creatinine were less likely to experience surgical failure (OR 0.49, 95% CI 0.26-0.93, p = 0.03). Changes in biomarker levels were not associated with any covariates or surgical failure. CONCLUSIONS: Stress urinary incontinence surgery was significantly less likely to fail in women with lower baseline NTx levels. Studies are needed to validate NTx as a possible independent biomarker for stress urinary incontinence surgery outcomes.