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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]

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: Home‐based primary care promotes aging in place but is not immediately responsive to urgent needs. Community paramedicine leverages emergency medical services clinicians to expedite in‐home care, though limited evidence supports this model. We evaluated the primary care and acute care use of older adults evaluated urgently by a community paramedic with telemedicine physician compared to a physician home visit model. Methods: This prospective cohort study enrolled older adults in home‐based primary care who requested an urgent evaluation. We allocated participants to the physician home visit model or physician home visit plus community paramedic model by ZIP code. We observed primary care and acute care use for 6 months following enrollment. The primary outcome was the median number of primary care and acute care visits per participant. Secondary outcomes included 30‐day readmission rates, median wait times, and physician productivity. Data analysis included descriptive statistics, comparison of means and proportions, and negative binomial regression modeling reported as incidence rate ratios (IRR). Results: We screened 255 participants, determined 203 eligible, allocated 199, and completed observation for 167 (84 community paramedicine, 83 physician home visit). Participants were mostly female, age 76–86 years, with 3–5 comorbidities, living in a home/apartment. Community paramedic participants had 29% more primary care visits (IRR 1.29, 95% confidence interval [CI] 1.06–1.57) and shorter wait times for urgent evaluations (1 vs. 5 days, p < 0.001) without increasing acute care use (IRR 0.75, 95% CI 0.48–1.18) or 30‐day readmissions (IRR 1.32, 95% CI 0.49–3.55). Physician productivity increased 81% (40 vs. 22 visits/week, p < 0.001). Conclusion: Older adults evaluated by a community paramedic for urgent needs were seen sooner, used acute care similarly to patients evaluated by a physician home visit, and nearly doubled physician efficiency. This suggests that older adults may benefit from combining emergency medical services and primary care resources for urgent evaluations. [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]

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]

Objective To assess whether men with a family history of prostate cancer are more likely to fail active surveillance because of recategorization of their tumors on subsequent surveillance biopsies. Methods Men enrolled in an institutional review board–approved active surveillance program were studied, and data on first- and/or second-degree family history of prostate cancer was collected. Analyses were performed to compare the frequency of family history with recategorization (higher grade or volume disease) on surveillance biopsies. Results Men with and without family history were recategorized with higher grade disease at a similar frequency (30.9% vs 32.8%). There was no evidence that men with a family history with higher grade disease had more aggressive pathology at the time of radical prostatectomy than men without a family history. Although those with a family history tended to have a shorter time period to recategorization with more positive cores, the difference was not significant. Conclusion Our results suggest that men with a family history of prostate cancer are not at an increased risk for recategorization on active surveillance. Men with a family history of prostate cancer should not be deterred from considering active surveillance as a treatment option. [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]