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Background: Following COVID-19 infection, as many as a third of patients have long-term symptoms, known as post-acute sequelae (PASC). The mechanisms contributing to PASC remain largely unknown and, due to the heterogeneity of symptoms, treating PASC provides unique challenges. Objective: Our study sought to (1) identify clinical symptom profiles based on PROMIS Global Health (GH) items, (2) evaluate demographic and clinical differences across profiles, and (3) identify predictors of change in health-related quality of life (HRQL) over time. Design: This was an observational cohort study of patients with PASC who completed PROMIS-GH between 2/11/21 and 12/3/21 as part of routine care, with data extracted from the electronic health record. Participants: There were 1407 adult patients (mean age 49.6 ± 13.7, 73% female, 81% White race) with PASC seen in the recovery clinic between 2/11/21 and 12/3/21, with 1129 (80.2%) completing PROMIS-GH as routine care. Main Measures: HRQL was measured with PROMIS-GH at initial visit and after 12 months. Key Results: Latent profile analysis identified symptom classes based on five PROMIS-GH items (mental health, ability to carry out physical activities, pain, fatigue, and emotional problems). Four latent profiles were identified: (1) "Poor HRQL" (n = 346), (2) "Mixed HRQL: good mental/poor physical" (n = 232), (3) "Mixed HRQL: poor mental/good physical" (n = 324), and (4) "Good HRQL" (n = 227). Demographics and comorbidities varied significantly across profile with patients with more severe COVID-19 infection more likely to be in profiles 1 and 2. Overall, patients improved 2 T-score points on PROMIS-GH after 12 months, with differences by profile. Predictors of improved HRQL included profile, lower body mass index, and fewer COVID symptoms. Conclusions: Patients with PASC have distinct HRQL symptom profiles which were able to differentiate across COVID-19 severity and symptoms. Improvement over 12 months differed by profile. These profiles may be used to better understand the mechanisms behind PASC. Future research should evaluate their ability to guide treatment decisions to improve HRQL. [ABSTRACT FROM AUTHOR]

Background Debilitating symptoms of recurrent Clostridioides difficile infection (rCDI) often lead to long-term effects on health-related quality-of-life (HRQOL). In ECOSPOR III, SER-109, an investigational oral microbiome therapeutic, was superior to placebo in reducing rCDI. We investigated the validity, reliability, and responsiveness of a 32-item, CDI-specific questionnaire—the Clostridium difficile Quality of Life Survey (Cdiff32)—across mental, physical, and social domains in patients with rCDI. Methods In this post hoc analysis of a phase 3 clinical trial, 182 outpatients with rCDI completed Cdiff32 and EQ-5D at baseline and at 1 and 8 weeks. Cdiff32 was evaluated for item performance, internal reliability, and convergent validity. To assess known-groups validity, Cdiff32 scores were compared by disease recurrence status at week 1; internal responsiveness was evaluated in the nonrecurrent disease group by 8 weeks by means of paired t test. Results All 182 patients (mean age [standard deviation], 65.5 [16.5] years; 59.9% female) completed baseline Cdiff32. Confirmatory factor analysis identified 3 domains (physical, mental, and social relationships) with good item fit. High internal reliability was demonstrated (Cronbach α = 0.94 with all subscales >0.80). Convergent validity was evidenced by significant correlations between Cdiff32 subscales and EQ-5D (r = 0.29–0.37; P <.001). Cdiff32 differentiated patients by disease recurrence status at week 1 (effect sizes, 0.38–0.42; P <.05 overall), with significant improvement from baseline through week 8 in patients with nonrecurrent disease at week 1 (effect sizes, 0.75–1.02; P <.001 overall). Conclusions Cdiff32 is a valid, reliable, and responsive disease-specific HRQOL questionnaire that is fit for purpose for interventional treatment trials. The significant improvement in patients with nonrecurrent disease by 8 weeks demonstrates the negative impact of rCDI on HRQOL. [ABSTRACT FROM AUTHOR]

Purpose: The Modified Low Back Pain Disability Questionnaire (MDQ) is a commonly used tool to assess functioning of patients with low back pain (LBP). Recently, the Patient-Reported Outcomes Measurement Information System (PROMIS) was suggested as an alternative platform to assess LBP patient-reported health. We sought to map between the MDQ and PROMIS Physical Function (PROMIS-PF) and Pain Interference (PROMIS-PI) scales using multiple methods.Methods: In a retrospective analysis of LBP patients seen at Cleveland Clinic 11/14/18-12/11/19, T-scores from each PROMIS scale were mapped to MDQ total score individually and together. MDQ item and total scores were mapped to each PROMIS scale. Linear regression as well as linear and equipercentile equating were used. Split sample internal validation using root mean squared error (RMSE), mean absolute error (MAE), and correlations were used to assess accuracy of mapping equations.Results: 13585 patients completed the three scales. In the derivation cohort, average age was 59.0 (SD = 15.8); 53.3% female and 82.9% white. Average MDQ total, PROMIS-PF, and PROMIS-PI T-scores were 40.3 (SD = 19.0), 37.2 (SD = 7.6), and 62.9 (SD = 7.2), respectively. For estimating MDQ total scores, methods that used both PROMIS-PF and PROMIS-PI had closest estimated means, lowest RMSE and MAE, and highest correlations. For estimating each of PROMIS-PF and PROMIS-PI T-scores, the best performing method was equipercentile equating using the MDQ items.Conclusions: We created and internally validated maps between MDQ and PROMIS-PF and PROMIS-PI using linear regression, linear and equipercentile equating. Our equations can be used by researchers wishing to translate scores between these scales. [ABSTRACT FROM AUTHOR]

Importance: Long-term health effects have been indicated following COVID-19; however, the impact of COVID-19 on health-related quality of life (HRQOL), including who may experience ongoing symptoms, is unknown. Objective: To identify change in HRQOL following COVID-19 compared to pre-infection HRQOL and a matched control group, and identify predictors of patients who worsen. Design: Retrospective pre-post cohort study with a matched control group. Setting: Large healthcare system in northeast Ohio. Participants: A total of 3,690 adult patients diagnosed with COVID-19 who completed HRQOL surveys during routine care for ambulatory visits before and after infection. Propensity-score 1:1 match was utilized to identify controls without COVID who completed HRQOL at two time points. Main Outcomes: HRQOL was assessed with PROMIS Global Health: global mental and physical health summary scores. Pre- and post-COVID PROMIS Global Health was completed as part of routine care from 1/1/2019 to 2/29/2020 and 4/4/2020 to 11/1/2021, respectively, and extracted from the electronic health record. Results: COVID-19 patients (mean age 53±15; 66% female) completed PROMIS Global Health in the year prior (median 11.1 months) and after diagnosis (median 7.8 months). Compared to before infection, COVID-19 patients had a significant reduction in global mental health and stable global physical health (−0.85 and 0.05 T-score points, respectively) with clinically meaningful reduction (≥5 T-score points) experienced by 27% and 23% of patients, respectively. Predictors of worsening global health included being female, having depression, being hospitalized for COVID-19, and better pre-COVID global health. Compared to the control group, there was significantly worse global mental and physical health decline following COVID-19 (−0.53 and −0.37 T-score points, respectively). Conclusions and Relevance: A quarter of patients with COVID-19 experienced meaningful reductions in HRQOL. Reductions in global mental and physical health were modest, although significantly worse than a control group. Additionally, identified predictors of patients who worsen may assist clinicians when counseling patients of their risk of worse HRQOL following COVID-19. [ABSTRACT FROM AUTHOR]

Objectives: Measures of health-related quality of life (HRQOL) are collected throughout healthcare systems and used in clinical, economic, and outcomes studies to direct patient-centered care and inform health policy. Studies have demonstrated increases in stressors unique to the COVID-19 pandemic, however, their effect on HRQOL is unknown. Our study aimed to assess the change in self-reported global health during the pandemic for patients receiving care in a large healthcare system compared with 1 year earlier.Methods: An observational cross-sectional study of 2 periods was conducted including adult patients who had a healthcare appointment and completed the Patient-Reported Outcomes Measurement Information System Global Health (PROMIS GH) as standard care during the COVID-19 pandemic and a year earlier. The effect of time on PROMIS global mental health (GMH) and global physical health (GPH) was evaluated through multiple statistical methods.Results: There were 38 037 patients (mean age 56.1 ± 16.6 years; 61% female; 87% white) who completed the PROMIS GH during the pandemic (August 2020) and 33 080 (age 56.7 ± 16.5 years; 61% female; 86% white) who had completed it 1 year earlier (August 2019). GMH was significantly worse, whereas GPH was similar during the pandemic compared with a year earlier (adjusted estimate [standard error]: -1.21 (0.08) and 0.11 (0.08) T-score points, respectively).Conclusions: Our study found modest, nonclinically meaningful decreases in GMH and similar GPH during the COVID-19 pandemic compared with a year earlier in patients cared for in a large healthcare system. Nevertheless, healthcare systems are likely seeing a biased sample of patients during these times. Findings from our study have implications for the interpretation of HRQOL during this pandemic. [ABSTRACT FROM AUTHOR]

Objectives: Patient-reported outcome measures (PROMs) are increasingly utilized in the evaluation of patients with rheumatic diseases. The aim of our study was to assess the patient experience with completing PROMs within rheumatology clinics, and identify patient characteristics associated with a more positive experience. Methods: We conducted a retrospective cross-sectional study of adult patients seen in rheumatology clinics between 1/1/2017 and 6/30/2017. Patients were included in the study if they completed at least one patient-reported experience question following completion of PROMs. Patient characteristics associated with more positive experiences were identified through multivariable proportional odds models. Results: 12,597 adult patients (mean age 59 ± 15; 76% female; 84% white) completed PROMs, as well as questions on their experience completing PROMs. Patients agreed/strongly agreed that PROM questions were easy to understand (97%), useful (84%), helped their physician understand their health (78%), improved communication with their provider (78%) and improved control over their own care (70%). Predictors of better experience with PROMs included being younger, non-white, having lower income, and being a new patient. Worse self-reported health also predicted better experience with PROMs. Conclusion: Our study found a positive patient experience with PROMs, which is a crucial component of their successful implementation and utilization. Findings from this study suggest PROMs may be particularly beneficial in new patients, minorities, those with lower income, and worse self-reported quality of life. Collecting PROMs could provide opportunities to improve patient–provider communication and enhance control over care for rheumatology patients who could most benefit. [ABSTRACT FROM AUTHOR]

Self-reported measures of health-related quality of life (HRQOL) are increasingly used in clinical management and evaluation of patient outcomes. HRQOL measures are used to monitor patient progress and treatment response, investigate effects of medical interventions, and provide patient-based data for quality improvement initiatives and policy decisions. Given the importance of HRQOL, it is imperative that the instruments used to assess HRQOL are precise, valid, reliable, and responsive, and that the HRQOL data are appropriately collected, analyzed, and presented. This article reviews the key attributes of studies involving HRQOL data, discusses best practices for selecting appropriate instruments, and provides guidelines for the assessment, analysis, and presentation of these data. A checklist and a reviewer guide are included to serve as templates for authors and reviewers when submitting and reviewing studies involving HRQOL. [ABSTRACT FROM AUTHOR]

Self-reported measures of health-related quality of life (HRQOL) are increasingly used in clinical management and evaluation of patient outcomes. HRQOL measures are used to monitor patient progress and treatment response, investigate effects of medical interventions, and provide patient-based data for quality improvement initiatives and policy decisions. Given the importance of HRQOL, it is imperative that the instruments used to assess HRQOL are precise, valid, reliable, and responsive, and that the HRQOL data are appropriately collected, analyzed, and presented. This article reviews the key attributes of studies involving HRQOL data, discusses best practices for selecting appropriate instruments, and provides guidelines for the assessment, analysis, and presentation of these data. A checklist and a reviewer guide are included to serve as templates for authors and reviewers when submitting and reviewing studies involving HRQOL. [ABSTRACT FROM AUTHOR]

Study Design: Retrospective cohort study.Objective: To (1) confirm validity of Patient-Reported Outcomes Measurement Information System (PROMIS) physical function and pain interference computer-adaptive tests (CATs) and (2) assess the validity of PROMIS Global Health (GH) and five additional PROMIS CATs: social role satisfaction, fatigue, anxiety, depression, and sleep disturbance in a population of patients with chronic low back pain (cLBP) who completed a 3-month Interdisciplinary Pain Program (IPP).Summary Of Background Data: Recent recommendations for assessing outcomes in patients with cLBP have included PROMIS scales; however, there is a need for further evaluation, and PROMIS GH has not been studied in this population.Methods: The study cohort included patients with cLBP who completed the entirety of a 3-month IPP between August 2016 and December 2018. Patient-reported outcome measures (PROMs) were analyzed before the start of the IPP and at graduation. Convergent and discriminant validity were evaluated using Pearson correlation coefficients. Known groups' validity assessed the change in PROMIS scores stratified by improvement on the Modified LBP Disability Questionnaire. Responsiveness was evaluated with standardized response means based on global impression of change.Results: IPP was completed by 217 patients (67.7% women, age 53.8 ± 12.8). Convergent validity was supported (P < 0.01 for all pairwise PROMs comparisons). All PROMs improved significantly by graduation, with the largest improvement for PROMIS pain interference, physical function, social role satisfaction, and Modified LBP Disability Questionnaire. Known groups' validity demonstrated the greatest change on PROMIS physical function, social role satisfaction, pain interference, and depression. Responsiveness was supported for all PROMs in 170 (78.3%) patients who indicated at least minimal improvement (standardized response means 0.43-1.06).Conclusion: Our study provides support of PROMIS CATs, highlights the importance of including other meaningful outcome measures, such as social role satisfaction, and provides the first validation of PROMIS GH, in patients with cLBP. PROMs collection can be streamlined through the use of PROMIS CATs which offer advantages over legacy measures.Level Of Evidence: 3. [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: Laparoscopic inguinal hernia repair has been shown to offer patients the benefit of less postoperative pain as compared to traditional open techniques. However, the risk of experiencing significant postoperative pain may affect patient's decision making. We aimed to elucidate potential patterns of pain and the predictors of such, up to 2 years postoperatively, using both generic and specific quality of life tools.Methods: Patients undergoing laparoscopic totally extra-peritoneal inguinal hernia repair were identified from a prospectively maintained database. Short form-36, Surgical Outcomes Measurement System (SOMS) and Carolinas Comfort Scale (CCS) surveys were administered pre- and postoperatively at 3 weeks, 6 months, 1 and 2 years. Patients with concomitant procedures were excluded. Significant pain was considered mild but bothersome or worse on either specific tool (SOMS scores ≥3/4, CCS scores ≥2). Predictors of significant pain were determined by logistic regression.Results: From 2009 to 2015, 482 patients enrolled in our database underwent elective TEP repair of 626 hernias and completed an assessment tool. Mean age was 57 (±15) years, with 93 % male. Reported pain on all three tools improved significantly from baseline over time (p < 0.01). Significant pain on either specific tool, related or unrelated to surgery, was reported by 52 % of respondents (158/301) preoperatively, and postoperatively by 50 % at 3 weeks (111/220), 21 % at 6 months (15/70), 13 % at 1 year (14/108), and 25 % at 2 years (30/121). Significant pain at 6 months-2 years correlated more significantly with general health status than surgical factors.Conclusions: Significant pain can be as high as 50 % at 3 weeks on surgery-specific quality of life measures, but with significant improvement by 6 months which is maintained through 2 years. Poor quality of life and general health were the main predictors of pain after 6 months. [ABSTRACT FROM AUTHOR]

Objective: To determine the extent to which low testosterone levels impact health-related quality of life in patients undergoing active surveillance (AS) for prostate cancer.Materials and Methods: Eligible AS patients were grouped as having low, low-normal, or normal testosterone levels (<300 vs 300-400 vs ≥400 ng/dL). Patients were surveyed with the Expanded Prostate Cancer Index Composite-26 (EPIC-26), Patient Reported Outcomes Measurement Information System (PROMIS), Memorial Anxiety Scale for Prostate Cancer, and treatment outlook satisfaction questions at enrollment and successively during follow-up.Results: The cohort consisted of 223 patients, 74 (33%) of which had low testosterone levels. The mean age was 66.8 ± 7.2 years, with 85% being Caucasian. Mean prostate-specific antigen did not differ between groups. Obesity was significantly higher for men with low testosterone levels (P < .01). All PROMIS-Global items were comparatively lower in men with lower testosterone. EPIC-26 scores for the sexual domain were worse in men with lower testosterone. After age and obesity adjustment, men with normal testosterone levels had significantly better PROMIS Physical, Overall, and Mental Health, EPIC-26 Hormonal, and treatment satisfaction responses when compared to those patients with low testosterone levels. Those with normal testosterone levels reported hormonal EPIC-26 domain responses 65% higher than for those with low testosterone, and 12% higher treatment satisfaction during 2-year follow-up when corrected for age and obesity (P < .05).Conclusion: Men with testosterone levels ≥400 ng/dL reported some improved measures of health-related quality of life including greater satisfaction with treatment outcome. These findings are hypothesis generating in the controversial area of exogenous testosterone administration in men on AS. [ABSTRACT FROM AUTHOR]

Despite declining physical function, individuals with ALS report relative preservation of overall health perception, or health-related quality of life (HRQoL). This paradoxical finding is attributed to psychological adaptation to deficits. The aim of this cross-sectional study was to examine reprioritization of factors that determine HRQoL with disease progression. As standard care, patients with ALS self-reported ALSFRS-R (measure of bulbar, motor, and respiratory function), PHQ-9 (measure of depression), and EQ-5D-3L (utility index that includes a visual analog scale asking about health perception [EQ-VAS]). ALS was staged by the FT9 method and classified into early (stages 0–2) and late (stages 3–4) disease. Multigroup structural equation modeling was used to evaluate weights of physical (PHY) and psychological well-being (PSY) for early and late disease, on EQ-VAS (as a measure of overall HRQoL). There were 578 patients (mean age 61.5 ± 11.9, 59% male) with ALS: 423 (73%) early and 155 (27%) late disease. A measurement model was established with good model fit (RMSEA = 0.076, CFI = 0.943, SRMR = 0.045). In adjusted models, standardized weights of PHY and PSY on HRQoL in early disease were 0.34 (standard error = 0.06) and 0.24 (0.06) respectively, whereas for late disease they were 0.39 (0.07) and 0.42 (0.07). Importantly, PHY and PSY were significantly correlated in early but not in late disease. Our study found health perception is more representative of psychological well-being and less representative of physical function across the disease progression. Greater allocation for psychological health would be the most effective strategy to maximize subjective health status as ALS advances. [ABSTRACT FROM AUTHOR]

Objective: To describe differences in clinical and demographic characteristics between patients with episodic migraine (EM) or chronic migraine (CM) and determine the effect of migraine subtype on patient‐reported outcome measures (PROM). Background: Prior studies have characterized migraine in the general population. While this provides a basis for our understanding of migraine, we have less insight into the characteristics, comorbidities, and outcomes of migraine patients who present to subspecialty headache clinics. These patients represent a subset of the population that bears the greatest burden of migraine disability and are more representative of migraine patients who seek medical care. Valuable insights can be gained from a better understanding of CM and EM in this population. Methods: We conducted a retrospective observational cohort study of patients with CM or EM seen in the Cleveland Clinic Headache Center between January 2012 and June 2017. Demographics, clinical characteristics, and patient‐reported outcome measures (3‐Level European Quality of Life 5‐Dimension [EQ‐5D‐3L], Headache Impact Test‐6 [HIT‐6], Patient Health Questionnaire‐9 [PHQ‐9]) were compared between groups. Results: Eleven thousand thirty‐seven patients who had 29,032 visits were included. More CM patients reported being on disability 517/3652 (14.2%) than EM patients 249/4881 (5.1%) and had significantly worse mean HIT‐6 (67.3 ± 7.4 vs. 63.1 ± 7.4, p < 0.001) and median [interquartile range] EQ‐5D‐3L (0.77 [0.44–0.82] vs. 0.83 [0.77–1.00], p < 0.001), and PHQ‐9 (10 [6–16] vs. 5 [2–10], p < 0.001). Conclusions: There are multiple differences in demographic characteristics and comorbid conditions between patients with CM and EM. After adjustment for these factors, CM patients had higher PHQ‐9 scores, lower quality of life scores, greater disability, and greater work restrictions/unemployment. [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]

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: 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]

Background: Inguinal hernia repair is the most common surgery in the world. Health-related quality of life (HRQOL) outcomes are arguably the most important elements of successful repair. This study is aimed to describe short- and long-term quality of life outcomes in patients undergoing laparoscopic inguinal hernia repair. Methods: We prospectively followed patients who underwent totally extraperitoneal laparoscopic inguinal hernia repair (TEP) as part of an Institutional Review Board-approved study. HRQOL was measured preoperatively, or 3 weeks, 6 months, and 1 year postoperatively using Short Form 36 Health Survey Version 2 (SF-36v2) and Carolinas Comfort Scale. Postoperative HRQOL scores were compared to baseline using paired t tests. Results: Between June 2009 and February 2014, 1,175 patients underwent TEP by four surgeons. Of those, 301 patients with 388 hernias were registered in the database and followed by a research coordinator. Mean age was 56.4 ± 15.2 years and 93 % were male. Mean body mass index was 26.1 ± 3.7 kg/m. Seventy-eight percent presented with pain, the majority of which were described as mild. Hernias were unilateral right-sided in 43 %, left-sided in 28 %, and bilateral in 29 %. Eighty-five percent were primary hernias. Average operative time was 43.5 ± 17.9 min and there were no intraoperative complications. Urinary retention occurred in 6 %. Visual analog scale at discharge was 1.9 ± 1.7. Analgesics were used an average of 2.5 ± 3.4 days and return to activities of daily living and work occurred on postoperative 5.5 ± 4.4 and 5.6 ± 3.9 days. Recurrence occurred in 2.1 %. Significant improvements between baseline and 1 year were found in role limitations due to physical health (81.5 ± 25.6 vs. 91.8 ± 19.4, p = 0.02), social functioning (87.4 ± 21.3 vs. 92.9 ± 15.3, p = 0.02), and pain (78.2 ± 19.7 vs. 86.6 ± 15.9, p = 0.007). Conclusions: TEP results in significant improvement in HRQOL including physical health, social functioning, and pain at 1 year. On average, patients are able to return to activities of daily living and work within a week. [ABSTRACT FROM AUTHOR]