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1.
Occup Environ Med ; 74(5): 336-343, 2017 05.
Article in English | MEDLINE | ID: mdl-27919058

ABSTRACT

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.


Subject(s)
Moving and Lifting Patients/methods , Musculoskeletal Pain/prevention & control , Occupational Diseases/prevention & control , Occupational Injuries/prevention & control , Safety Management/methods , Adult , Analysis of Variance , Boston/epidemiology , Databases, Factual , Female , Health Personnel , Health Promotion/methods , Hospitals , Humans , Male , Middle Aged , Musculoskeletal Pain/epidemiology , Musculoskeletal System/injuries , Occupational Diseases/epidemiology , Occupational Injuries/epidemiology , Physical Exertion , Program Evaluation , Quality Improvement
2.
Tob Control ; 26(2): 210-216, 2017 03.
Article in English | MEDLINE | ID: mdl-26883793

ABSTRACT

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.


Subject(s)
Health Promotion/methods , Smoking Cessation/statistics & numerical data , Smoking Prevention/methods , Smoking/epidemiology , Adult , Cluster Analysis , Female , Follow-Up Studies , Humans , India , Male , Middle Aged , Smoke-Free Policy , Surveys and Questionnaires , Workplace
3.
Neurourol Urodyn ; 35(3): 344-8, 2016 Mar.
Article in English | MEDLINE | ID: mdl-25598512

ABSTRACT

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.


Subject(s)
Fascia/transplantation , Suburethral Slings , Urinary Incontinence, Stress/surgery , Urologic Surgical Procedures/instrumentation , Adult , Autografts , Disease-Free Survival , Female , Humans , Kaplan-Meier Estimate , Middle Aged , Prosthesis Design , Randomized Controlled Trials as Topic , Recurrence , Reoperation , Risk Factors , Time Factors , Treatment Outcome , Urinary Incontinence, Stress/diagnosis , Urinary Incontinence, Stress/physiopathology , Urologic Surgical Procedures/adverse effects , Urologic Surgical Procedures/methods
4.
J Urol ; 193(1): 203-10, 2015 Jan.
Article in English | MEDLINE | ID: mdl-25158274

ABSTRACT

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.


Subject(s)
Suburethral Slings , Urinary Incontinence, Stress/surgery , Female , Follow-Up Studies , Humans , Longitudinal Studies , Middle Aged , Suburethral Slings/adverse effects , Time Factors
5.
Prev Med ; 74: 24-30, 2015 May.
Article in English | MEDLINE | ID: mdl-25657167

ABSTRACT

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.


Subject(s)
Faculty/statistics & numerical data , Family Relations , Smoking/epidemiology , Sociological Factors , Tobacco, Smokeless/statistics & numerical data , Adult , Female , Humans , India/epidemiology , Logistic Models , Male , Middle Aged , Social Environment , Social Norms , Surveys and Questionnaires
6.
J Urol ; 191(3): 703-9, 2014 Mar.
Article in English | MEDLINE | ID: mdl-24140551

ABSTRACT

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.


Subject(s)
Biomarkers/urine , Suburethral Slings , Urinary Incontinence, Stress/surgery , Urinary Incontinence, Stress/urine , Age Factors , Female , Humans , Middle Aged , Risk Factors , Treatment Failure
7.
J Trauma Stress ; 27(6): 703-11, 2014 Dec.
Article in English | MEDLINE | ID: mdl-25522731

ABSTRACT

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.


Subject(s)
Cognitive Behavioral Therapy/education , Evidence-Based Practice/education , Stress Disorders, Post-Traumatic/therapy , Veterans Health/education , Cognitive Behavioral Therapy/methods , Computer-Assisted Instruction/methods , Education, Distance/methods , Education, Distance/organization & administration , Female , Humans , Male , Patient Simulation , Program Evaluation , United States , Workforce
8.
N Engl J Med ; 362(22): 2066-76, 2010 Jun 03.
Article in English | MEDLINE | ID: mdl-20479459

ABSTRACT

BACKGROUND: Midurethral slings are increasingly used for the treatment of stress incontinence, but there are limited data comparing types of slings and associated complications. METHODS: We performed a multicenter, randomized equivalence trial comparing outcomes with retropubic and transobturator midurethral slings in women with stress incontinence. The primary outcome was treatment success at 12 months according to both objective criteria (a negative stress test, a negative pad test, and no retreatment) and subjective criteria (self-reported absence of symptoms, no leakage episodes recorded, and no retreatment). The predetermined equivalence margin was +/-12 percentage points. RESULTS: A total of 597 women were randomly assigned to a study group; 565 (94.6%) completed the 12-month assessment. The rates of objectively assessed treatment success were 80.8% in the retropubic-sling group and 77.7% in the transobturator-sling group (3.0 percentage-point difference; 95% confidence interval [CI], -3.6 to 9.6). The rates of subjectively assessed success were 62.2% and 55.8%, respectively (6.4 percentage-point difference; 95% CI, -1.6 to 14.3). The rates of voiding dysfunction requiring surgery were 2.7% in those who received retropubic slings and 0% in those who received transobturator slings (P=0.004), and the respective rates of neurologic symptoms were 4.0% and 9.4% (P=0.01). There were no significant differences between groups in postoperative urge incontinence, satisfaction with the results of the procedure, or quality of life. CONCLUSIONS: The 12-month rates of objectively assessed success of treatment for stress incontinence with the retropubic and transobturator approaches met the prespecified criteria for equivalence; the rates of subjectively assessed success were similar between groups but did not meet the criteria for equivalence. Differences in the complications associated with the two procedures should be discussed with patients who are considering surgical treatment for incontinence. (ClinicalTrials.gov number, NCT00325039.)


Subject(s)
Suburethral Slings , Urinary Incontinence, Stress/surgery , Urologic Surgical Procedures/methods , Comparative Effectiveness Research , Female , Follow-Up Studies , Humans , Intention to Treat Analysis , Intraoperative Complications/epidemiology , Middle Aged , Patient Satisfaction , Postoperative Complications/epidemiology , Treatment Outcome , Urination Disorders/etiology , Urodynamics , Urologic Surgical Procedures/instrumentation
9.
Cancer Causes Control ; 24(4): 637-47, 2013 Apr.
Article in English | MEDLINE | ID: mdl-22729935

ABSTRACT

PURPOSE: The aim of this study was to compare and contrast correlates of fruit and vegetable consumption in two blue-collar populations: construction laborers and motor freight workers. METHODS: Cross-sectional data were collected from two groups of male workers: (1) construction laborers (n = 1,013; response rate = 44 %) randomly selected from a national sample, as part of a diet and smoking cessation study; and (2) motor freight workers (n = 542; response rate = 78 %) employed in eight trucking terminals, as part of a tobacco cessation and weight management study. Data were analyzed using linear regression modeling methods. RESULTS: For both groups, higher income and believing it was important to eat right because of work were positively associated with fruit and vegetable consumption; conversely, being white was associated with lower intake. Construction laborers who reported eating junk food due to workplace stress and fatigue had lower fruit and vegetable intake. For motor freight workers, perceiving fast food to be the only choice at work and lack of time to eat right were associated with lower consumption. CONCLUSION: Comparing occupational groups illustrates how work experiences may be related to fruit and vegetable consumption in different ways as well as facilitates the development of interventions that can be used across groups.


Subject(s)
Facility Design and Construction , Fruit , Health Behavior , Motor Vehicles , Occupational Health , Transportation , Vegetables , Adult , Cross-Sectional Studies , Diet , Feeding Behavior , Female , Humans , Male , Middle Aged , Prognosis , Smoking Cessation
10.
Cancer Causes Control ; 24(4): 805-11, 2013 Apr.
Article in English | MEDLINE | ID: mdl-23334887

ABSTRACT

PURPOSE: To assess the association between intention to quit smoking and perceptions of household environmental risks among racially/ethnically diverse residents of low-income housing. METHODS: Baseline data were collected from 2007 to 2009 for the Health in Common Study, which assessed social and physical determinants of cancer risk-related behaviors among residents of 20 low-income housing developments in the Greater Boston metropolitan area. Participants were surveyed about their tobacco use and concerns about household exposures. Household environmental inspections were also conducted to identify conditions associated with increased risk of exposure to indoor environmental agents, including pesticides, mold, and cleaning products. RESULTS: Intention to quit smoking was associated with a greater degree of concern about exposures in the home, yet not with the actual presence of household hazards, as identified by home inspections and survey findings. CONCLUSIONS: An ecological approach targeting multiple levels of influence may help to highlight the importance of both quitting tobacco and reducing potential household environmental exposures as part of comprehensive efforts to promote individual and household health.


Subject(s)
Air Pollution, Indoor/statistics & numerical data , Attitude to Health , Environmental Exposure/adverse effects , Poverty/psychology , Smoking Cessation/psychology , Smoking/psychology , Adolescent , Adult , Aged , Family Characteristics , Female , Follow-Up Studies , Health Surveys , Humans , Intention , Male , Middle Aged , North Carolina , Prognosis , Risk Factors , Smoking/epidemiology , Young Adult
11.
Am J Public Health ; 103(11): 2035-40, 2013 Nov.
Article in English | MEDLINE | ID: mdl-24028234

ABSTRACT

OBJECTIVES: We assessed a school-based intervention designed to promote tobacco control among teachers in the Indian state of Bihar. METHODS: We used a cluster-randomized design to test the intervention, which comprised educational efforts, tobacco control policies, and cessation support and was tailored to the local social context. In 2009 to 2011, we randomly selected 72 schools from participating school districts and randomly assigned them in blocks (rural or urban) to intervention or delayed-intervention control conditions. RESULTS: Immediately after the intervention, the 30-day quit rate was 50% in the intervention and 15% in the control group (P = .001). At the 9-month postintervention survey, the adjusted 6-month quit rate was 19% in the intervention and 7% in the control group (P = .06). Among teachers employed for the entire academic year of the intervention, the adjusted 6-month abstinence rates were 20% and 5%, respectively, for the intervention and control groups (P = .04). CONCLUSIONS: These findings demonstrate the potent impact of an intervention that took advantage of social resources among teachers, who can serve as role models for tobacco control in their communities.


Subject(s)
Faculty , Health Promotion/methods , Smoking Cessation/statistics & numerical data , Smoking Prevention , Adult , Feasibility Studies , Female , Health Surveys , Humans , India/epidemiology , Male , Middle Aged , Prevalence , Program Evaluation , Rural Population , Smoking/epidemiology , Urban Population
12.
Implement Res Pract ; 4: 26334895231159428, 2023.
Article in English | MEDLINE | ID: mdl-37091538

ABSTRACT

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.

13.
Gastroenterology ; 140(5): 1490-500.e3, 2011 May.
Article in English | MEDLINE | ID: mdl-21335007

ABSTRACT

BACKGROUND & AIMS: Iron may influence severity and progression of non-hemochromatotic liver diseases. Our aim was to assess the relationship of iron and HFE genetic variations to progression and outcomes in the HALT-C Trial and whether PegIFN therapy influenced iron variables. METHODS: Participants were randomized to receive long-term PegIFN [n = 400] or no therapy [n = 413] for 3.5 y, with follow-up for up to 8.7 y [median 6.0 y]. Associations of patient characteristics with iron variables at baseline and over time were carried out using Kaplan-Meier analyses, Cox regression models, and repeated measures analysis of covariance. RESULTS: Participants who developed clinical outcomes [CTP > 7, ascites, encephalopathy, variceal bleeding, SBP, HCC, death] had significantly higher baseline scores for stainable iron in hepatocytes and in portal tract cells than those without. There were significant direct correlations between stainable iron in portal triads and lobular and total Ishak inflammatory and fibrosis scores [P < 0.0001]. Iron in triads at baseline increased risk of outcomes (HR = 1.35, P = 0.02). Stainable iron in hepatocytes decreased, whereas that in portal stromal cells increased significantly [P < 0.0001] over time. Serum iron and TIBC fell significantly over time [P < 0.0001], as did serum ferritin [P = 0.0003]. Chronic PegIFN treatment did not affect stainable iron. HFE genetic variations did not correlate with outcomes, including development of hepatocellular carcinoma. CONCLUSIONS: Stainable iron in hepatocytes and portal tract cells is a predictor of progression and clinical and histological outcomes in advanced chronic hepatitis C. Chronic low-dose PegIFN therapy did not improve outcomes, nor iron variables.


Subject(s)
Hepatitis C, Chronic/metabolism , Hepatocytes/metabolism , Iron/metabolism , Portal System/metabolism , Antiviral Agents/administration & dosage , Disease Progression , Female , Follow-Up Studies , Hepatitis C, Chronic/drug therapy , Hepatitis C, Chronic/pathology , Hepatocytes/pathology , Humans , Injections, Subcutaneous , Interferon alpha-2 , Interferon-alpha/administration & dosage , Male , Middle Aged , Polyethylene Glycols/administration & dosage , Portal System/pathology , Prognosis , Prospective Studies , Recombinant Proteins
14.
Gastroenterology ; 141(3): 900-908.e1-2, 2011 Sep.
Article in English | MEDLINE | ID: mdl-21699796

ABSTRACT

BACKGROUND & AIMS: The gradual accumulation of hepatic fibrosis in chronic liver disease results in clinical complications. The rate of hepatic fibrosis score progression (RFSP) in predicting clinical outcomes was assessed by extending the 4-year Hepatitis C Antiviral Long-term Treatment Against Cirrhosis (HALT-C) Trial to include preenrollment liver biopsies. METHODS: The RFSP was calculated from the linear regression slope of Ishak fibrosis score vs time in 457 patients with liver biopsies (≥10-mm length) prior to the HALT-C Trial (575 biopsies) plus 1101 on-study biopsies (total 1676 biopsies). Individual slopes were calculated if duration from first to last biopsy was > 4 years. RESULTS: The RFSP as average fibrosis score vs average time in intervals (0-3 and >3 years prestudy, screening, month 24 and 48 on-study) in 455 patients in cohorts of baseline Ishak score ranged from 0.005 with Ishak score 2 to 0.124 with Ishak 6. The RFSP in individual patients (-0.35 to +0.97 Ishak units/year) had a mean of 0.12 ± 0.23 in 344 patients with prestudy and on-study biopsies (group A) and only 0.17 ± 0.22 in 169 with prestudy and screening biopsies (group B). Group A patients with RFSP slope ≥ 0.2 (95 patients, 27.6%) had higher 7-year cumulative rates of non-hepatocellular carcinoma outcomes (46% vs 8%, respectively) and with a hepatocellular carcinoma (10% vs 3%, respectively) than RFSP slope < 02 (249 patients, 72.4%) (P < .0001). RFSP and screening Ishak score correlated independently (P <.0001) with clinical outcomes in multivariate analysis. CONCLUSIONS: Rapid RFSP (>0.2), which occurred in 26.7% of HALT-C Trial patients, correlated strongly with clinical outcomes.


Subject(s)
Antiviral Agents/therapeutic use , Disease Progression , Hepatitis C, Chronic/drug therapy , Hepatitis C, Chronic/pathology , Liver Cirrhosis/prevention & control , Liver/pathology , Adult , Biopsy , Carcinoma, Hepatocellular/epidemiology , Carcinoma, Hepatocellular/pathology , Drug Therapy, Combination , Female , Fibrosis , Hepatitis C, Chronic/diagnosis , Humans , Interferon-alpha/therapeutic use , Liver Cirrhosis/pathology , Liver Neoplasms/epidemiology , Liver Neoplasms/pathology , Male , Middle Aged , Polyethylene Glycols/therapeutic use , Prevalence , Prognosis , Recombinant Proteins/therapeutic use , Ribavirin/therapeutic use , Time Factors , Treatment Outcome
15.
J Urol ; 188(2): 485-9, 2012 Aug.
Article in English | MEDLINE | ID: mdl-22704099

ABSTRACT

PURPOSE: We examined preoperative and postoperative patient related factors associated with continence status up to 7 years after surgery for stress urinary incontinence. MATERIALS AND METHODS: Women randomized to Burch colposuspension or fascial sling surgery and assessed for the primary outcome of urinary continence 2 years after surgery were eligible to enroll in a prospective observational study. Survival analysis was used to investigate baseline and postoperative factors in the subsequent risk of stress urinary incontinence, defined as self-report of stress urinary incontinence symptoms, incontinence episodes on a 3-day diary or surgical re-treatment. RESULTS: Of the women who participated in the randomized trial 74% (482 of 655) were enrolled in the followup study. Urinary continence rates decreased during a period of 2 to 7 years postoperatively from 42% to 13% in the Burch group and from 52% to 27% in the sling group, respectively. Among the baseline factors included in the first multivariable model age (p = 0.03), prior stress urinary incontinence surgery (p = 0.02), menopausal status (0.005), urge index (0.006), assigned surgery (p = 0.01) and recruiting site (p = 0.02) were independently associated with increased risk of incontinence. In the final multivariable model including baseline and postoperative factors, Burch surgery (p = 0.01), baseline variables of prior urinary incontinence surgery (p = 0.04), menopausal status (p = 0.03) and postoperative urge index (p <0.001) were each significantly associated with a greater risk of recurrent urinary incontinence. CONCLUSIONS: Preoperative and postoperative urgency incontinence symptoms, Burch urethropexy, prior stress urinary incontinence surgery and menopausal status were negatively associated with long-term continence rates. More effective treatment of urgency urinary incontinence in patients who undergo stress urinary incontinence surgery may improve long-term overall continence status.


Subject(s)
Postoperative Complications/physiopathology , Suburethral Slings , Urethra/surgery , Urinary Incontinence, Stress/surgery , Urodynamics/physiology , Female , Follow-Up Studies , Humans , Menopause , Middle Aged , Proportional Hazards Models , Recurrence , Reoperation , Risk Factors , Survival Analysis , Urinary Incontinence, Urge/physiopathology
16.
Hepatology ; 53(4): 1100-8, 2011 Apr.
Article in English | MEDLINE | ID: mdl-21480316

ABSTRACT

UNLABELLED: Chronic hepatitis C virus infection can cause chronic liver disease, cirrhosis and liver cancer. The Hepatitis C Antiviral Long-term Treatment against Cirrhosis (HALT-C) Trial was a prospective, randomized controlled study of long-term, low-dose peginterferon therapy in patients with advanced chronic hepatitis C who failed to respond to a previous course of optimal antiviral therapy. The aim of this follow-up analysis is to describe the frequency and causes of death among this cohort of patients. Deaths occurring during and after the HALT-C Trial were reviewed by a committee of investigators to determine the cause of death and to categorize each death as liver- or nonliver-related and as related or not to complications of peginterferon. Rates of liver transplantation were also assessed. Over a median of 5.7 years, 122 deaths occurred among 1,050 randomized patients (12%), of which 76 were considered liver-related (62%) and 46 nonliver-related (38%); 74 patients (7%) underwent liver transplantation. At 7 years the cumulative mortality rate was higher in the treatment compared to the control group (20% versus 15%, P = 0.049); the primary difference in mortality was in patients in the fibrosis compared to the cirrhosis stratum (14% versus 7%, P = 0.01); comparable differences were observed when liver transplantation was included. Excess mortality, emerging after 3 years of treatment, was related largely to nonliver-related death; liver-related mortality was similar in the treatment and control groups. No specific cause of death accounted for the excess mortality and only one death was suspected to be a direct complication of peginterferon. CONCLUSION: Long-term maintenance peginterferon in patients with advanced chronic hepatitis C is associated with an excess overall mortality, which was primarily due to nonliver-related causes among patients with bridging fibrosis.


Subject(s)
Antiviral Agents/adverse effects , Hepatitis C, Chronic/mortality , Interferon-alpha/adverse effects , Liver Cirrhosis/mortality , Polyethylene Glycols/adverse effects , Adult , Aged , Aged, 80 and over , Cause of Death , Disease Progression , Female , Hepatitis C, Chronic/drug therapy , Humans , Interferon alpha-2 , Liver Cirrhosis/drug therapy , Liver Transplantation , Male , Middle Aged , Recombinant Proteins , Ribavirin/therapeutic use
17.
Hepatology ; 54(2): 396-405, 2011 Aug.
Article in English | MEDLINE | ID: mdl-21520194

ABSTRACT

UNLABELLED: The incidence of liver disease progression among subjects with histologically advanced but compensated chronic hepatitis C is incomplete. The Hepatitis C Antiviral Long-term Treatment against Cirrhosis Trial was a randomized study of 3.5 years of maintenance peginterferon treatment on liver disease progression among patients who had not cleared virus on peginterferon and ribavirin therapy. Patients were followed subsequently off therapy. Because maintenance peginterferon treatment did not alter liver disease progression, we analyzed treated and control patients together. Among 1,050 subjects (60% advanced fibrosis, 40% cirrhosis), we determined the rate of progression to cirrhosis over 4 years and of clinical outcomes over 8 years. Among patients with fibrosis, the incidence of cirrhosis was 9.9% per year. Six hundred seventy-nine clinical outcomes occurred among 329 subjects. Initial clinical outcomes occurred more frequently among subjects with cirrhosis (7.5% per year) than subjects with fibrosis (3.3% per year) (P<0.0001). Child-Turcotte-Pugh (CTP) score≥7 was the most common first outcome, followed by hepatocellular carcinoma. Following occurrence of a CTP score≥7, the rate of subsequent events increased to 12.9% per year, including a death rate of 10% per year. Age and sex did not influence outcome rates. Baseline platelet count was a strong predictor of all clinical outcomes. During the 8 years of follow-up, death or liver transplantation occurred among 12.2% of patients with advanced fibrosis and 31.5% of those with cirrhosis. CONCLUSION: Among patients with advanced hepatitis C who failed peginterferon and ribavirin therapy, the rate of liver-related outcomes, including death and liver transplantation, is high, especially once the CTP score reaches at least 7.


Subject(s)
Antiviral Agents/therapeutic use , Hepatitis C, Chronic/complications , Hepatitis C, Chronic/drug therapy , Interferon-alpha/therapeutic use , Polyethylene Glycols/therapeutic use , Disease Progression , Female , Hepatitis C, Chronic/pathology , Humans , Interferon alpha-2 , Male , Middle Aged , Prospective Studies , Recombinant Proteins , Treatment Outcome
18.
Am J Obstet Gynecol ; 207(5): 421.e1-6, 2012 Nov.
Article in English | MEDLINE | ID: mdl-22840975

ABSTRACT

OBJECTIVE: The purpose of this study was to assess prospectively the effects of midurethral sling surgery on sexual function and activity. STUDY DESIGN: Sexual activity and function was assessed in 597 women with stress urinary incontinence who were enrolled in a randomized equivalence trial of retropubic compared with transobturator midurethral slings. Repeated measures analysis of variance was used to assess changes in Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire scores over a 2-year period. RESULTS: Significant, similar improvements in sexual function were seen in both midurethral sling groups. Mean Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire scores increased from 32.8 at baseline to 37.6 at 6 months and 37.3 at 24 months (P < .0001). Dyspareunia, incontinence during sex, and fear of incontinence during sex each significantly improved after surgery. Preoperative urge incontinence was associated with abstinence after surgery (P = .02); postoperative urge incontinence negatively impacted sexual function (P = .047). CONCLUSION: Midurethral sling surgery for stress urinary incontinence significantly improves sexual function, although coexistent urge incontinence has a negative impact.


Subject(s)
Pelvic Organ Prolapse/surgery , Sexual Behavior/physiology , Suburethral Slings , Urinary Incontinence/surgery , Adult , Aged , Female , Gynecologic Surgical Procedures/instrumentation , Gynecologic Surgical Procedures/methods , Humans , Middle Aged , Pelvic Organ Prolapse/physiopathology , Surveys and Questionnaires , Treatment Outcome , Urinary Incontinence/physiopathology
19.
Am J Ind Med ; 55(2): 107-16, 2012 Feb.
Article in English | MEDLINE | ID: mdl-22113975

ABSTRACT

BACKGROUND: With the high prevalence of musculoskeletal disorders (MSDs) for patient care unit workers, prevention efforts through ergonomic practices within units may be related to symptoms associated with typical work-related MSDs. METHODS: We completed a cross-sectional survey of patient care workers (n = 1,572) in two large academic hospitals in order to evaluate relationships between self-reported musculoskeletal pain, work interference due to this pain, and limitations during activities of daily living (functional limitations) and with ergonomic practices and other organizational policy and practices metrics within the unit. Bivariate and multiple logistic regression analyses tested the significance of these associations. RESULTS: Prevalence of self-reported musculoskeletal symptoms in the past 3 months was 74% with 53% reporting pain in the low back. 32.8% reported that this pain interfered with their work duties and 17.7% reported functional limitations in the prior week. Decreased ergonomic practices were significantly associated with reporting pain in four body areas (low back, neck/shoulder, arms, and lower extremity) in the previous 3 months, interference with work caused by this pain, symptom severity, and limitations in completing activities of daily living in the past week. Except for low back pain and work interference, these associations remained significant when psychosocial covariates such as psychological demands were included in multiple logistic regressions. CONCLUSIONS: Ergonomic practices appear to be associated with many of the musculoskeletal symptoms denoting their importance for prevention efforts in acute health care settings.


Subject(s)
Ergonomics , Musculoskeletal Diseases/etiology , Occupational Diseases/etiology , Occupational Exposure/adverse effects , Pain/etiology , Patient Care/methods , Adult , Cross-Sectional Studies , Female , Health Status Indicators , Health Surveys , Humans , Low Back Pain/epidemiology , Low Back Pain/etiology , Low Back Pain/prevention & control , Male , Multivariate Analysis , Musculoskeletal Diseases/epidemiology , Musculoskeletal Diseases/prevention & control , Occupational Diseases/epidemiology , Occupational Diseases/prevention & control , Occupational Health , Organizational Policy , Pain/epidemiology , Pain/prevention & control , Prevalence , Self Report , United States/epidemiology
20.
Am J Ind Med ; 55(2): 117-26, 2012 Feb.
Article in English | MEDLINE | ID: mdl-22025077

ABSTRACT

BACKGROUND: Patient care workers in acute care hospitals are at high risk of injury. Recent studies have quantified risks and demonstrated a higher risk for aides than for nurses. However, no detailed studies to date have used OSHA injury definitions to allow for better comparability across studies. METHODS: We linked records from human resources and occupational health services databases at two large academic hospitals for nurses (n = 5,991) and aides (n = 1,543) in patient care units. Crude rates, rate ratios, and confidence intervals were calculated for injuries involving no days away and those involving at least 1 day away from work. RESULTS: Aides have substantially higher injury rates per 100 full-time equivalent workers (FTEs) than nurses for both injuries involving days away from work (11.3 vs. 7.2) and those involving no days away (9.9 vs. 5.7). Back injuries were the most common days away (DA) injuries, while sharps injuries were the most common no days away (NDA) injuries. Pediatric/neonatal units and non-inpatient units had the lowest injury rates. Operating rooms and the float pool had high DA injury rates for both occupations, and stepdown units had high rates for nurses. NDA injuries were highest in the operating room for both nurses and aides. CONCLUSIONS: This study supports the importance of a continuing emphasis on preventing back and sharps injuries and reducing risks faced by aides in the hospital setting. Uniform injury definitions and work time measures can help benchmark safety performance and focus prevention efforts.


Subject(s)
Nurses , Nursing Assistants , Nursing Staff, Hospital , Occupational Diseases/epidemiology , Occupational Exposure/adverse effects , Adult , Confidence Intervals , Databases, Factual , Ergonomics , Female , Humans , Male , Massachusetts , Middle Aged , Occupational Diseases/etiology , Occupational Diseases/prevention & control , Occupational Exposure/statistics & numerical data , Occupational Health , Regression Analysis , Risk , Risk Assessment , United States , United States Occupational Safety and Health Administration
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