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Purpose: Type 2 diabetes-related polyneuropathy (DPN) is associated with increased vascular events and mortality, but determinants and outcomes of pain in DPN are poorly understood. We sought to examine the effect of neuropathic pain on vascular events and mortality in patients without DPN, DPN with pain (DPN + P), and DPN without pain (DPN-P).Methods: A retrospective cohort study was conducted within a large health system of adult patients with type 2 diabetes from January 1, 2009 through December 31, 2016. Using an electronic algorithm, patients were classified as no DPN, DPN + P, or DPN-P. Primary outcomes included number of vascular events and time to mortality. Independent associations with DPN + P were evaluated using multivariable negative binomial and Cox proportional hazards regression models, adjusting for demographics, socioeconomic characteristics, and comorbidities.Results: Of 43 945 patients with type 2 diabetes (age 64.6 ± 14.0 years; 52.1% female), 13 910 (31.7%) had DPN: 9104 DPN + P (65.4%) vs 4806 DPN-P (34.6%). Vascular events occurred in 4538 (15.1%) of no DPN patients, 2401 (26.4%) DPN + P, and 1006 (20.9%) DPN-P. After adjustment, DPN + P remained a significant predictor of number of vascular events (incidence rate ratio [IRR] = 1.55, 95% CI, 1.29-1.85), whereas no DPN was protective (IRR = 0.70, 95% CI, 0.60-0.82), as compared to DPN-P. Compared to DPN-P, DPN + P was also a significant predictor of mortality (hazard ratio = 1.42, 95% CI, 1.25-1.61).Conclusions: Our study found a significant association between pain in DPN and an increased risk of vascular events and mortality. This observation warrants longitudinal study of the risk factors and natural history of pain in DPN. [ABSTRACT FROM AUTHOR]

Background: Mapping Patient-Reported Outcomes Measurement Information System-Global Health (PROMIS-GH) to EuroQol 5-dimension, three-level version (EQ-5D-3L) provides a utility score for use in quality-of-life and cost-effectiveness analyses. In 2009, Revicki et al. mapped the PROMIS-GH items to EQ-5D-3L utilities using linear regression (REVReg). More recently, regression was shown to be ill-suited for mapping to preference-based measures due to regression to the mean. Linear and equipercentile equating are alternative mapping methods that avoid the issue of regression to the mean. Another limitation of the prior models is that ordinal predictors were treated as continuous.Methods: Using data collected from the PROMIS Wave 1 sample, we refit REVReg, treating the PROMIS-GH items as categorical variables (CATReg). We applied linear and equipercentile equating to the REVReg model (REVLE, REVequip) and the CATReg model (CATLE, CATequip). We validated and compared the predictive accuracy of these models in a large sample of neurological patients at a single tertiary-care hospital.Results: In the neurological disease patient sample, CATLE produced the strongest correlations between estimated and observed EQ-5D-3L scores and had the lowest mean squared error. The CATequip model had the lowest mean absolute error and had estimated scores that best matched the overall distribution of observed scores.Conclusions: Using linear and equipercentile equating, we created new models mapping PROMIS-GH items to EQ-5D-3L utility scores. EQ-5D-3L utility scores can be more accurately estimated using our models for use in cost-effectiveness studies or studies examining overall health-related quality of life. [ABSTRACT FROM AUTHOR]

Background: When considering an asymptomatic inguinal hernia, surgeons must weigh the risks of watchful waiting against the risk of operative complications. Laparoscopy offers the benefit of reduced postoperative pain, which, for appropriate surgical candidates, may strengthen the case for repair. This study compares general and disease-specific quality of life following totally extraperitoneal (TEP) laparoscopic inguinal hernia repair (LIHR) of asymptomatic and symptomatic hernias.Methods: We summarize prospective data from 387 patients who underwent TEP LIHR between 2009 and 2015 by four surgeons at a single institution. Asymptomatic individuals were identified by pain scores of zero at preoperative clinic visits. Validated quality of life (QOL) measurements were administered preoperatively and at 3 weeks, 6 months, and 1-year postop. Comparisons were made using Chi-square test, t test, or Mann-Whitney U test. Changes over time were assessed using longitudinal mixed effects models.Results: A cohort of 79 asymptomatic cases were compared to 308 symptomatic individuals. The asymptomatic cohort had larger median hernia defects (2.5 vs 2 cm, p < 0.01), was older (mean 63.0 vs 58.9 years, p = 0.03), included fewer indirect hernias (57.7 vs 74.9%, p < 0.01), took pain medication for fewer days (mean 1.2 ± 1.5 vs 2.2 ± 3.0 days, p = 0.02), returned to baseline activities of daily living earlier (median 3 vs 5 days, p < 0.01), and reported decreased postoperative pain (p = 0.02). There was no significant difference in general QOL. There was one recurrence in the asymptomatic group and were two in the symptomatic cohort.Conclusions: Asymptomatic individuals undergoing TEP LIHR reported less postoperative pain, returned to baseline activities, and discontinued pain medication sooner than symptomatic patients. These results are encouraging and may inform patient-centered discussions about asymptomatic hernia repair. [ABSTRACT FROM AUTHOR]

Background: Approximately 20-30 % of morbidly obese patients undergoing Roux-en-Y gastric bypass (RYGB) will experience significant weight regain in the years following surgery. Endoscopic gastrojejunal revision (EGJR) has been shown to be a safe, effective and less invasive alternative to revisional surgery, with promising weight loss outcomes. However, minimal data exist regarding how to perform the procedure most effectively and what factors may predict good outcomes. We compared weight loss outcomes between patients undergoing endoscopic stoma revision by one of two full-thickness suturing techniques.Methods: A retrospective review of patients undergoing EGJR between 06/2012 and 09/2015 was performed. Included patients were adults 18-74 years of age who had experienced weight regain ≥2 years after initial RYGB with stoma dilation ≥15 mm in diameter. Revision was done with either an interrupted (IRT) or purse-string (PST) suture technique. A linear mixed effects model was constructed to predict postoperative weight loss.Results: Fifty revisions (IRT = 36, PST = 14) were performed in 47 patients (92 % female, mean age of 50.9 ± 10.9 years and body mass index of 41.4 ± 7.1 kg/m2). Technical success (stoma diameter ≤10 mm) was achieved in all cases. Final diameter was significantly smaller in the PST group, 6.6 ± 2.2 mm versus 4.8 ± 1.8 mm (p < 0.01), resulting in a significantly greater % stoma reduction (76.8 ± 8.5 % vs. 84.2 ± 5.1 %, p < 0.01) versus the IRT group. PST resulted in greater % excess weight loss over time compared to IRT. Sixteen comorbid conditions resolved among 12 patients. No major complications occurred.Conclusion: Endoscopic revision of the gastric outlet results in meaningful weight loss and comorbidity resolution in select patients experiencing weight regain following RYGB. A PST revision likely results in higher and more sustainable weight loss when compared to IRT. [ABSTRACT FROM AUTHOR]

Background: Mini-laparoscopy, or needlescopy, is an emerging minimally invasive technique that aims to improve on standard laparoscopy in the areas of tissue trauma, pain, and cosmesis. The objective of this study was to determine if there was a difference in functionality between 2 novel mini-laparoscopic instruments when compared to standard laparoscopic tools. Differences were assessed in a simulated surgical environment.Methods: Twenty participants (5 novices, 10 intermediate, 5 expert) were recruited for this institutional review board-approved study in a surgical simulation training center. Group A tools were assembled intracorporeally, and Group B tools were assembled extracorporeally. Using standard laparoscopic graspers, mini-laparoscopic graspers, or a combination of both, each participant performed 3 basic laparoscopic training tasks: a Peg Transfer, Rubber Band Stretch, and Tootsie Roll Unwrapping. Following each round of tasks, participants completed a survey evaluating the mini-laparoscopic graspers with respect to standard laparoscopic graspers. Data were analyzed using Kruskal-Wallis test with Dunn's test for post hoc comparisons.Results: When comparing task times, both mini tools performed at the level of standard laparoscopic graspers in all participant groups. Group A tools were quicker to assemble and disassemble versus Group B tools. According to posttask surveys, all participant groups indicated that both sets of mini-laparoscopic graspers were comparable to the standard graspers.Conclusion: In a nonclinical setting, mini-laparoscopic instruments perform at the level of standard laparoscopic tools. Based on these results, clinical trials would be a reasonable next step in assessing feasibility and safety. [ABSTRACT FROM AUTHOR]

Background. Functional impairment is common in people with chronic liver disease (CLD), and improvement is expected following liver transplantation (LT). The Six-Minute Walk Test (6MWT) is an objective measure of functional performance. Objective. The aims of this study were: (1) to evaluate the feasibility of 6MWT performance after LT, (2) to compare post-LT 6MWT performance over time between patients with and without CLD, (3) to determine when post-LT 6MWT performance approaches expected values, and (4) to investigate predictors of poor 6MWT performance. Methods. The 6MWT was performed by 162 consecutive ambulatory participants (50 healthy controls, 62 with CLD, 50 with LT). Sex, age, and body mass index were used to predict expected 6MWT performance. Chi-square testing, analysis of variance, and Pearson coefficients compared percentage of predicted 6-minute walk distance (%6MWD) across groups. Multivariable mixed models assessed predictors of improvement. Results. The participants' mean age was 53.5 years (SD = 13.0), 39.5% were female, and 39.1% were nonwhite. At 1-month post-LT, only 52% of all LT recipients met the inclusion criteria for 6MWT performance. Mean %6MWD values for female participants improved from 49.8 (SD = 22.2) at 1 month post-LT to 90.6 (SD = 12.8) at 1 year post-LT (P-C0001), which did not differ statistically from the CLD group (X=95.9, SD= 15.6) or the control group (X=95.6, SD=18.0) (P=.58). However, at 1-year post-LT, mean %6MWD values for male participants (X=80.4, SD = 19.5) remained worse than for both the CLD group (X=93.3, SD = 13.7) and the control group (X=91.9, SD = 14.3) (P=.O3). Six-Minute Walk Test performance was directly correlated with the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) physical component score (r=.51, P<.01) and was inversely correlated with nonalcoholic steato-hepatitis(r=-.52, P<.01) and diabetes (r= -.48, P<.05). In multivariate analysis adjusted for age and sex, hepatitis C independently predicted 6MWT improvement (estimated β=698, standard error=27.6, P=.01). Limitations. A significant proportion of patients evaluated for enrollment were excluded due to level of illness early after LT (n=99, 47.4%). Thus, sampling bias occurred in this study toward patients without significant postoperative complications. Conclusions. The 6MWT is a simple test of physical functioning but may be difficult to apply in LT recipients. The 6MWT performance improved following LT but was lower than expected, suggesting a low level of fitness up to 1 year following LT. [ABSTRACT FROM AUTHOR]

Purpose Many unintended pregnancies occur due to to contraceptive misuse and nonuse, which is partly due to to lack of knowledge and low self-efficacy related to contraception. We conducted an exploratory, cross-sectional study among low-income women to examine the relationship between knowledge, skills, and confidence in managing one's health, measured using the Patient Activation Measure (PAM) and factors that influence contraceptive use. Methods A survey and chart review were conducted among 18- to 45-year-old women from a community health center in Chicago, Illinois, to measure the relationship between activation, self-confidence in avoiding pregnancy, contraception use, and contraceptive counseling. Associations between PAM and outcomes were evaluated using the χ 2 test and adjusted logistic regression models. Results Among 112 participants (61% Latina, 15% Black, 14% White), we found no differences in PAM by age, race/ethnicity, or parity. Women with higher PAM were more likely to be confident they could avoid pregnancy compared with women with lower PAM (50% vs. 7%; p = .02). Higher PAM remained a significant predictor for self-confidence after risk adjustment (odds ratio, 3.13; 95% CI, 1.11–8.78; p = .031). Greater confidence in avoiding pregnancy was associated with using a moderately or highly effective contraceptive method (43% vs. 14%; p = .047). Women with lower PAM were less likely to receive contraceptive counseling in the prior month (0% vs. 57%; p < .01). Conclusions Patient activation may be an important construct for understanding factors that influence women's contraceptive use, including self-confidence in avoiding pregnancy until it is desired and receiving contraceptive services in primary care. [ABSTRACT FROM AUTHOR]

Background: Patient-reported outcome measures are increasingly being utilized in clinical care and research to evaluate outcomes following stroke. To optimize the clinical utility of these measures, we aimed to quantify meaningful change by establishing minimal important differences (MIDs), or responder definitions, for 4 domains affected in ischemic and hemorrhagic stroke patients.Methods and Results: We performed a retrospective cohort study of stroke patients seen in the Cleveland Clinic cerebrovascular center between September 2, 2012 and November 7, 2017. Four Patient-Reported Outcome Measurement Information System (PROMIS) scales were completed within 1 month poststroke and again at 6 months. MIDs were estimated using an anchor-based approach based on a global impression of change question and supported using 3 distribution-based methods. Cumulative distribution functions assessed responder thresholds. MIDs were additionally derived across sex, race, and varying levels of severity as defined by the modified Rankin Score and baseline PROMIS score. During the study period, 337 incident stroke patients completed at least 1 PROMIS domain scale at both time points (average age 61±14, 56% female). Estimates from the 4 methods were triangulated to provide a MID range across PROMIS domain: 2.5 to 6.5 T-score points for physical function and fatigue, 2.5 to 7.5 for social role satisfaction, and 3.0 to 8.0 for anxiety. Cumulative distribution functions plots identified between 30% and 40% of patients as having meaningful improvement based on the anchor-based estimates across all 4 domains. Meaningful change thresholds remained consistent across categories of sex and race. Anchor-based MIDs increased with increasing severity, whereas distribution-based MIDs remained consistent across severity levels.Conclusions: Our study is the first to evaluate interpretability of changes in PROMIS scores for stroke survivors. Future studies can utilize these thresholds to identify responders of stroke interventions. Based on our estimated MID ranges, researchers and clinicians can choose a responder threshold for comparing change in domain score at the group level, individual level, or by severity. [ABSTRACT FROM AUTHOR]

Background: The lack of long-term data on quality of life after groin hernia repair presents a challenge in setting patients' postoperative expectations. This study aimed to describe quality of life outcomes after laparoscopic totally extraperitoneal groin hernia repair with a minimum of 2 years follow-up.Study Design: We prospectively evaluated 293 patients who had laparoscopic totally extraperitoneal groin hernia repair in an IRB-approved study. The Short-Form 36-item Health Survey (version 2), Surgical Outcomes Measurement System, and Carolinas Comfort Scale were administered pre- and postoperatively. Pairwise comparisons using nonparametric Wilcoxon signed rank test were made between time points.Results: Mean patient age was 56 ± 15 years and 93% were male; 80% of patients presented with painful hernias and 15% of hernias were recurrent. Mean operative time was 43 ± 16 minutes. No operative complications occurred. Mean duration of narcotic pain medication use was 2.5 ± 3.4 days, and daily activities were resumed and return to work occurred 5.4 ± 4.4 days and 5.4 ± 3.9 days post operation, respectively. Recurrence rate was 2%. The Short-Form 36-item Health Survey outcomes improved from baseline for domains of Physical Functioning, Role Limitations due to Physical Health, and Pain at 2 years post operation; Surgical Outcomes Measurement System outcomes improved for domains of Pain Impact on Quality of Life, Body Image, and Patient Satisfaction (p ≤ 0.05). The percentage of patients reporting no or mild but not bothersome symptoms on the Carolinas Comfort Scale at 2 years post operation for sensation of mesh, pain, and movement limitations were 98%, 95%, and 97%, respectively.Conclusions: Measuring both general and procedure-specific quality of life, patients' perceptions of health status improved significantly 2 years after laparoscopic totally extraperitoneal groin hernia repair. [ABSTRACT FROM AUTHOR]