The Design of a Prospective Trial to Evaluate the Role of Preoperative Frailty Assessment in Older Women Undergoing Surgery for the Treatment of Pelvic Organ Prolapse: The FASt Supplemental Trial.

OBJECTIVE: We present the rationale for and the design of a prospective trial to evaluate the role of preoperative frailty and mobility assessments in older women undergoing surgery for the treatment of pelvic organ prolapse (POP) as a planned prospective supplemental trial to the ASPIRe (Apical Suspension Repair for Vault Prolapse In a Three-Arm Randomized Trial Design) trial. The Frailty ASPIRe Study (FASt) examines the impact of preoperative frailty and mobility on surgical outcomes in older women (≥65 years) participating in the ASPIRe trial. The primary objective of FASt is to determine the impact of preoperative age, multimorbidity, frailty, and decreased mobility on postoperative outcomes in older women (≥65 years old) undergoing surgery for POP. METHODS: The selection of the preoperative assessments, primary outcome measures, and participant inclusion is described. Frailty and mobility measurements will be collected at the preoperative visit and include the 6 Robinson frailty measurements and the Timed Up and Go mobility test. The main outcome measure in the FASt supplemental study will be moderate to severe postoperative adverse events according to the Clavien-Dindo Severity Classification. CONCLUSIONS: This trial will assess impact of preoperative age, multimorbidity, frailty, and decreased mobility on postoperative outcomes in older women (≥65 years old) undergoing surgical procedures for the correction of apical POP. Information from this trial may help both primary care providers and surgeons better advise/inform women on their individual risks of surgical complications and provide more comprehensive postoperative care to women at highest risk of complications.

Outcomes of native tissue transvaginal apical approaches in women with advanced pelvic organ prolapse and stress urinary incontinence.

INTRODUCTION AND HYPOTHESIS: Limited data exist comparing different surgical approaches in women with advanced vaginal prolapse. This study compared 2-year surgical outcomes of uterosacral ligament suspension (ULS) and sacrospinous ligament fixation (SSLF) in women with advanced prolapse (stage III-IV) and stress urinary incontinence. METHODS: This was a secondary analysis of a multicenter 2 × 2 factorial randomized trial comparing (1) ULS versus SSLF and (2) behavioral therapy with pelvic floor muscle training versus usual care. Of 374 subjects, 117/188 (62.7%) in the ULS and 113/186 (60.7%) in the SSLF group had advanced prolapse. Two-year surgical success was defined by the absence of (1) apical descent > 1/3 into the vaginal canal, (2) anterior/posterior wall descent beyond the hymen, (3) bothersome bulge symptoms, and (4) retreatment for prolapse. Secondary outcomes included individual success outcome components, symptom severity measured by the Pelvic Organ Prolapse Distress Inventory, and adverse events. Outcomes were also compared in women with advanced prolapse versus stage II prolapse. RESULTS: Success did not differ between groups (ULS: 58.2% [57/117] versus SSLF: 58.5% [55/113], aOR 1.0 [0.5-1.8]). No differences were detected in individual success components (p > 0.05 for all components). Prolapse symptom severity scores improved in both interventions with no intergroup differences (p = 0.82). Serious adverse events did not differ (ULS: 19.7% versus SSLF: 16.8%, aOR 1.2 [0.6-2.4]). Success was lower in women with advanced prolapse compared with stage II (58.3% versus 73.2%, aOR 0.5 [0.3-0.9]), with no retreatment in stage II. CONCLUSIONS: Surgical success, symptom severity, and overall serious adverse events did not differ between ULS and SSLF in women with advanced prolapse. ClinicalTrials.gov Identifier: NCT01166373.

A deleterious gene-by-environment interaction imposed by calcium channel blockers in Marfan syndrome.

Calcium channel blockers (CCBs) are prescribed to patients with Marfan syndrome for prophylaxis against aortic aneurysm progression, despite limited evidence for their efficacy and safety in the disorder. Unexpectedly, Marfan mice treated with CCBs show accelerated aneurysm expansion, rupture, and premature lethality. This effect is both extracellular signal-regulated kinase (ERK1/2) dependent and angiotensin-II type 1 receptor (AT1R) dependent. We have identified protein kinase C beta (PKCß) as a critical mediator of this pathway and demonstrate that the PKCß inhibitor enzastaurin, and the clinically available anti-hypertensive agent hydralazine, both normalize aortic growth in Marfan mice, in association with reduced PKCß and ERK1/2 activation. Furthermore, patients with Marfan syndrome and other forms of inherited thoracic aortic aneurysm taking CCBs display increased risk of aortic dissection and need for aortic surgery, compared to patients on other antihypertensive agents.

Acute occupational injury among adolescent farmworkers from South Texas.

PURPOSE: This combined cross-sectional/cohort study addressed research gaps by estimating the rate of non-fatal occupational injury and identifying potential determinants among a population of adolescent farmworkers who are largely Hispanic and migrant. METHODS: The cohort included 410 farmworkers (aged 13-19 years) attending high school in South Texas along the border with Mexico. Data collection involved a self-administered, Web-based survey that solicited information on demographics, farm work variables including person-time at risk, occupational injury, health status and health risk behaviours. Cox regression was used to identify potential risk factors for non-fatal injury events experienced during a 9-month recall period. RESULTS: Depending on the definition of injury, the rate of non-fatal injury ranged from 27.0-73.6/100 full time equivalents. Variables with an increased and statistically significant HR in an adjusted Cox model included: age groups <15 years-old (5.82) and 16 years-old (4.47), usually sleeping <8 h during the week (2.10), feeling tense, stressed or anxious sometimes/often (2.25), not watching TV (2.65), working around ditches (2.01) and detasseling (2.70). CONCLUSIONS: The high observed rates of non-fatal injury combined with the potential negative consequences and cost of these injuries signifies a compelling need for injury prevention efforts targeting adolescent, Hispanic, farmworkers.

Chronic back pain and associated work and non-work variables among farmworkers from Starr County, Texas.

OBJECTIVES: This study estimated the prevalence of chronic back pain among migrant farmworker family members and identified associated work and non-work variables. METHODS: Migrant farmworkers (n = 390 from 267 families) from Starr County, Texas were interviewed in their home once a year for 2 years. The original survey included items measuring demographics, smoking, sleep, farm work, and chronic back pain. For this cross-sectional analysis, multi-level logistic regression was used to identify associated work and other variables associated with chronic back pain while accounting for intraclass correlations due to repeated measures and multiple family members. RESULTS: The prevalence of chronic back pain during the last migration season ranged from 9.5% among the youngest children to 33.3% among mothers. Variables significantly associated with chronic back pain were age (odds ratio [OR], 1.03, per year increase), depressive symptoms while migrating (OR, 8.72), fewer than 8 hours of sleep at home in Starr County (OR, 2.26), fairly bad/very bad quality of sleep while migrating (OR, 3.25), sorting crops at work (OR, 0.18), and working tree crops (OR, 11.72). CONCLUSION: The role of work exposures, depressive symptoms, and sleep in chronic back pain among farmworkers warrants further examination. Refinements in outcome and exposure assessments are also needed given the lack of a standardized case definition and the variety of tasks and crops involved in farm work in the United States.

A cohort study of injuries in migrant farm worker families in South Texas.

PURPOSE: This cohort study estimated the frequency of and risk factors for work injuries among migrant farmworker families over a two-year period. METHODS: The cohort consisted of 267 families. Bilingual interviewers asked mothers to respond for their family soliciting demographic, psychosocial, employment, and work-related injury information. Cox regression was used to examine risk factors for first injury events. RESULTS: Of the 267 families, nearly 60% migrated and 96% of these completed the follow-up interviews. These families represented about 310 individuals each year who had participated in farmwork on average 6 days a week, 10 hours a day, for 2.7 months in the past year. Twenty-five work-related injuries were reported with an overall rate of 12.5/100 FTE (95% C.I., 8.6-19.0). Working for a contractor increased the hazard ratio, and use of car seat belts and working for more than one employer during the season decreased it. CONCLUSIONS: If person-time at risk for injuries is taken into account the reported injuries are substantial. Because the injuries were quite diverse, specific interventions may have to focus on improved working conditions (physical and economic), ergonomic modifications, and enhanced enforcement of existing regulations.