Search

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]

Objective The purpose of this study was to test the reliability of the Activity Measure for Post-Acute Care (AM-PAC) "6-Clicks" mobility and activity short forms between patients and therapist proxies. As a secondary aim, reliability was examined when patients completed their self-report before versus after the therapist evaluation. Methods Patients being seen for an initial physical therapist (N = 70) or occupational therapist (N = 71) evaluation in the acute care hospital completed the "6-Clicks" mobility short form (if a physical therapist evaluation) or activity short form (if an occupational therapist evaluation). Whether patients completed their self-assessment before or after the evaluation was randomized. Patient- and therapist-rated "6-Clicks" raw scores were converted to AM-PAC T-scores for comparison. Reliability was assessed with intraclass correlation coefficients (ICCs) and Bland–Altman plots, and agreement was assessed with weighted kappa values. Results The ICCs for the "6-Clicks" mobility and daily activity short forms were 0.57 (95% CI = 0.42–0.69) and 0.45 (95% CI = 0.28–0.59), respectively. For both short forms, reliability was higher when the patient completed the self-assessment after versus before the therapist evaluation (ICC = 0.67, 95% CI = 0.47–0.80 vs ICC = 0.50, 95% CI = 0.26–0.67 for the mobility short form; and ICC = 0.52, 95% CI = 0.29–0.70 vs ICC = 0.34, 95% CI = 0.06–0.56 for the activity short form). Conclusion Reliability of the "6-Clicks" total scores was moderate for both the mobility and activity short forms, though higher for the mobility short form and when patients' self-report occurred after the therapist evaluation. Impact Reliability of the AM-PAC "6-Clicks" short forms is moderate when comparing scores from patients with those of therapists responding as proxies. The short forms are useful for measuring participants' function in the acute care hospital; however, it is critical to recognize limitations in reliability between clinician- and patient-reported AM-PAC scores when evaluating longitudinal change and recovery. [ABSTRACT FROM AUTHOR]

Objective For patients diagnosed with the novel coronavirus, COVID-19, evidence is needed to understand the effect of treatment by physical therapists in the acute hospital on patient outcomes. The primary aims of this study were to examine the relationship of physical therapy visit frequency and duration in the hospital with patients' mobility status at discharge and probability of discharging home. Methods This retrospective study included patients with COVID-19 admitted to any of 11 hospitals in 1 health system. The primary outcome was mobility status at discharge, measured using the Activity Measure for Post-Acute Care 6-Clicks basic mobility (6-Clicks mobility) and the Johns Hopkins Highest Level of Mobility scales. Discharge to home versus to a facility was a secondary outcome. Associations between these outcomes and physical therapy visit frequency or mean duration were tested using multiple linear or modified Poisson regression. Potential moderation of these relationships by particular patient characteristics was examined using interaction terms in subsequent regression models. Results For the 312 patients included, increased physical therapy visit frequency was associated with higher 6-Clicks mobility (b = 3.63; 95% CI, 1.54–5.71) and Johns Hopkins Highest Level of Mobility scores (b = 1.15; 95% CI, 0.37–1.93) at hospital discharge and with increased probability of discharging home (adjusted relative risk = 1.82; 95% CI, 1.25–2.63). Longer mean visit duration was also associated with improved mobility at discharge and the probability of discharging home, though the effects were less pronounced. Few moderation effects were observed. Conclusion Patients with COVID-19 demonstrated improved mobility at hospital discharge and higher probability of discharging home with increased frequency and longer mean duration of physical therapy visits. These associations were not generally moderated by patient characteristics. Impact Physical therapy should be an integral component of care for patients hospitalized due to COVID-19. Providing sufficient physical therapist interventions to improve outcomes must be balanced against protection from viral spread. Lay Summary Patients with COVID-19 can benefit from more frequent and longer physical therapy visits in the hospital. [ABSTRACT FROM AUTHOR]

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]

Objectives Patient-reported outcome measures (PROMs) can direct patient-centred care and increase patient satisfaction with the visit. The objective of this study was to assess the relationship between the collection of PROMs and visit satisfaction, as measured by the Clinician and Group Practice Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) survey. Methods An electronic platform for collection of patient-reported information was implemented in rheumatology clinics between August and September 2016. Adult patients were included in the study if they completed CG-CAHPS after an ambulatory visit. The pre-implementation cohort consisted of patients seen between January and June 2016; the post-implementation cohort consisted of patients seen between January and June 2017. The CG-CAHPS scores were compared between cohorts. Mixed effect models were constructed to identify predictors of visit satisfaction. Results Characteristics were similar between the 2117 pre- and 2380 post-implementation patients. Visit satisfaction was high in both cohorts but did not differ [odds ratio = 0.97 (95% CI: 0.79, 1.19)]. Predictors of improved satisfaction included being an established patient, being male, older age and reporting higher quality of life. However, sensitivity analyses in the post-implementation cohort suggested that implementing PROMs might convey benefits for new patients, in particular. Conclusion Collection of PROMs had no effect on visit satisfaction in rheumatology clinics, although there might be benefits for new patients. These largely null findings might be attributable to high satisfaction levels in our cohorts or to lack of provider review of PROM data with patients. Further research is indicated to determine the impact of provider communication of PROM results to patients on different domains of visit satisfaction. [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]

Introduction Direct-to-consumer ads for testosterone replacement therapies have significantly increased over the past several years. Subsequently, testing for low serum testosterone has correspondingly increased. Aims We sought to determine the testing behaviors of practitioners as well as the characteristics of men who are undergoing testing for low testosterone. Methods Men aged 18-85 years were queried from the institutional electronic data warehouse from 2009 to 2012. Men were considered 'tested' if their serum total testosterone level had been measured for any purpose. Tested men ( TM) were compared with those not tested ( NT). Main Outcome Measures The frequency and timing of testing for low testosterone as well as patient demographics and clinical characteristics were compared between TM and NT using multivariable logistic regression models. Results Of the 321,674 total men, 10,133 (3.2%) underwent testing with a serum total testosterone (mean age of 55.2 ± 14.1 years). The frequency of testing increased from 2.5% to 3.6% during the study period ( P < 0.001). Multivariable analysis demonstrated that TM were significantly ( P < 0.001) more likely to be Caucasian and have increased body mass index. In addition, TM were significantly more likely to have comorbid conditions including decreased libido (adjusted odds ratio [ aOR] 10.0, 95% confidence interval [ CI] 8.5, 11.7), infertility ( aOR 4.8, 95% CI 3.6, 6.6), erectile dysfunction (a OR 3.6, 95% CI 3.4, 3.8), osteoporosis ( aOR 3.3, 95% CI 2.8, 3.8), depression ( aOR 1.7, 95% CI 1.6, 1.8), prostate cancer ( aOR 1.7, 95% CI 1.5, 1.8), hypertension ( aOR 1.3. 95% CI 1.2, 1.4), chronic obstructive pulmonary disease ( aOR 1.2, 95% CI 1.0, 1.4), and benign prostatic hyperplasia ( aOR 1.2, 95% CI 1.1, 1.2). Among TM, only 889 (9%) men underwent testing between 7 am and 12 pm. Conclusions The rate of testosterone testing is increasing with most testing practices directed toward a subset of men with comorbidities that are associated with hypogonadism. Compliance of physicians obtaining early morning serum testosterone levels is low. Further education of practitioners is required to appropriately test patients for hypogonadism. Malik RD, Lapin B, Wang CE, Lakeman JC, and Helfand BT. Are we testing appropriately for low testosterone?: Characterization of tested men and compliance with current guidelines. J Sex Med 2015;12:66-75. [ABSTRACT FROM AUTHOR]

Abstract: Objective: Aortic valve replacement (AVR) is the standard treatment for severe, symptomatic aortic stenosis (AS). However, many patients are not referred for surgery and fewer undergo AVR. Transcatheter aortic valve implantation (TAVI) has emerged as a solution for high-risk AS patients. We sought to measure the impact of TAVI on the undertreatment of AS. Methods: Patients with AS were identified by retrospective medical record review and evaluation of echocardiograms were performed in a single-center tertiary-care institution. A total of 179, 183, 214, and 265 patients had AS in 2006, 2007, 2008, and 2009, respectively, with the introduction of TAVI occurring in 2008 and continuing through 2009. The primary endpoints were the rates of unoperated AS and surgical referral. Results: The rates of unoperated AS were 50.6% before TAVI and 40.7% after TAVI (p =0.002). Referral rates to surgery were 63.6% before TAVI and 74.1% after TAVI (p =0.003). Reasons for nonreferral were patient–family decision, perceived high operative risk, and the presence of comorbidities. Operative mortality was 3.7% and not statistically significant different between years. Three-year patient survival was 82.5% in the AVS group and 43.9% in the UNOP group (p <0.001). Conclusions: The introduction of TAVI was associated with an increase in surgical referrals and a decrease in the rate of unoperated AS. This positive impact was due to increases in both TAVI and AVR volume. Increased volume was not associated with worse patient survival. A significant population of patients with AS are still treated medically. [Copyright &y& Elsevier]