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Identifying optimal stratification techniques for subgrouping patients with low back pain (LBP) into treatment groups for the purpose of identifying optimal management and improving clinical outcomes is an important area for further research. Our study aimed to compare performance of the STarT Back Tool (SBT) and 3 stratification techniques involving PROMIS domain scores for use in patients presenting to a spine clinic for chronic LBP. Retrospective cohort study. Adult patients with chronic LBP seen in a spine center between November 14, 2018 and May 14, 2019 who completed patient-reported outcomes (PROs) as part of routine care, and were followed up with completed PROs 1 year later. Four stratification techniques, including SBT, and 3 PROMIS-based techniques: the NIH Task Force recommended Impact Stratification Score (ISS), symptom clusters based on latent class analysis (LCA), and SPADE symptom clusters. The 4 stratification techniques were compared according to criterion validity, construct validity, and prognostic utility. For criterion validity, overlap in characterization of mild, moderate, and severe subgroups were compared to SBT, which was considered the gold standard, using quadratic weighted kappa statistic. Construct validity compared techniques' ability to differentiate across disability groups defined by modified Oswestry LBP Disability Questionnaire (MDQ), median days in the past month unable to complete activities of daily living (ADLs), and worker's compensation using standardized mean differences (SMD). Prognostic utility was compared based on the techniques' ability to predict long-term improvement in outcomes, defined as improvement in global health and MDQ at 1-year. There were 2,246 adult patients with chronic LBP included in our study (mean age 61.0 [SD 14.0], 55.0% female, 83.4% white). All stratification techniques resulted in roughly a third of patients grouped into mild, moderate, and severe categories, with ISS and LCA demonstrating substantial agreement with SBT, while SPADE had moderate agreement. Construct validity was met for all techniques, with large effects demonstrated between mild and severe categories for differentiating MDQ, ADLs, and worker's compensation disability groups (SMD range 0.57–2.48). All stratification techniques demonstrated ability to detect improvement by 1-year, with severe groups experiencing the greatest improvement in multivariable logistic regression models. All 4 stratification techniques demonstrated validity and prognostic utility for subgrouping patients with chronic LBP based on risk of long-term disability. ISS and LCA symptom clusters may be the optimal methods given the improved feasibility of including only a few relevant PROMIS domains. Future research should investigate multidisciplinary treatment approaches to target mild, moderate, and severe patients based on these techniques. [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]

Background Context: Improving prognostic stratification for patients with low back pain (LBP) outside of a primary care setting has been identified as an important area for further research.Purpose: Our study aimed to identify clinical symptom classes of patients presenting to a spine clinic based on 4 Patient Reported Outcome Measurement Information System (PROMIS) domains and evaluate demographic and clinical differences across classes.Study Design: An observational cross-sectional study of patients seen in spine centers at a large health system.Patient Sample: Adult patients with LBP seen in a spine center between November 14, 2018 and May 14, 2019 who completed patient-reported outcomes as part of routine care.Outcome Measures: PROMIS physical function, pain interference, satisfaction with social roles and activities, and fatigue.Methods: Latent class analysis identified symptom classes based on PROMIS domain scores ≥1 standard deviation worse (meaningfully worse) than the general population. A multivariable multinomial logistic regression model was constructed to evaluate differences in symptom classes based on demographics and socioeconomic characteristics. Lastly, the ability of the profiles to discriminate across levels of disability, based on the modified Oswestry Disability Questionnaire (ODI), was evaluated.Results: There were 7,144 adult patients included in the study who visited spine clinics for a primary complaint of LBP and completed all 4 PROMIS domains (age 58.7±15.9, 54% female). Three distinct classes were identified. Class 1 ("Significant Symptoms," n=3238) had PROMIS scores that were meaningfully worse than the population average for all domains. Class 2 ("Mixed Symptoms," n=1366) had meaningfully worse scores on physical function and pain interference but average scores on other domains. Class 3 ("Mild Symptoms," n=2540) had average scores across all domains. Compared to patients in Class 3, those in Class 2 were more likely older, and those in Classes 1 and 2 were more likely to be divorced, have lower household income, and no employment. Level of disability was significantly different across each class (average (SD) ODI for Classes 1-3: 53.4 (14.3), 39.9 (12.5), 22.9 (12.1), p<.01).Conclusions: Patients presenting to specialty clinics for LBP demonstrate distinct clinical symptom classes which could be utilized to inform specific symptom-based treatment. Future research should evaluate the ability of these classes to predict long-term disability. [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]

• Patient-reported outcome measures (PROMs) of >500 stroke survivors with suspected acute symptomatic seizure (ASyS) evaluated. • One in 5 patients had convulsive or electrographic ASyS; 37.4% were discharged on antiseizure medications (ASMs). • Physical Function and Satisfaction with Social Roles and Activities were the most affected health domains. • PROMs comparable between groups: ASyS (electrographic and/or convulsive), ASM use (hospital discharge/day of PROM). • Lack of impact of ASyS and associated ASM use on PROMs suggests need to create ASyS-specific PROMs. Acute symptomatic seizures (ASyS) after stroke are not uncommon. However, the impact of ASyS and its management with anti-seizure medications (ASMs) on patient-reported outcome measures (PROMs) remains poorly investigated. The objective of our study is to evaluate the association between PROMs and ASyS and ASMs following stroke. We performed a retrospective cohort study of all stroke patients who underwent inpatient continuous EEG (cEEG) monitoring performed due to suspected ASyS, including the ones with observed convulsive ASyS, from 04/01/2012 to 03/31/2018, who completed PROMs within 6 months of hospital discharge. Patient-reported outcome measures, including one Neuro-QoL and six PROMIS v1.0 domain scales, were completed by patients as the standard of care in ambulatory stroke clinics. Since ASMs are sometimes used without clearly diagnosed ASyS, we performed group comparisons based on ASM status at discharge, irrespective of their ASyS status. T-tests or Wilcoxon rank sum tests compared continuous variables across groups and chi-square tests or Fisher's exact tests were used for categorical variables. A total of 508 patients were included in the study [mean age 62.0 ± 14.1 years, 51.6% female; 244 (48.0%) ischemic stroke, 165 (32.5%) intracerebral hemorrhage, and 99 (19.5%) subarachnoid hemorrhage]. A total of 190 (37.4%) patients were discharged on ASMs. At the time of the first PROM, conducted a median of 47 (IQR = 33–78) days after the suspected ASyS, and 162 (31.9%) were on ASMs. ASM use was significantly higher in patients diagnosed with ASyS. Physical Function and Satisfaction with Social Roles and Activities were the most affected health domains. Patient-reported outcome measures were not significantly different between groups based on ASyS (electrographic and/or convulsive), ASM use at hospital discharge, or ASM status on the day of PROM completion. There were no differences in multiple domain-specific PROMs in patients with recent stroke according to ASyS status or ASM use suggesting the possible lack of the former's sensitivity to detect their impact. Additional research is necessary to determine if there is a need for developing ASyS-specific PROMs. [ABSTRACT FROM AUTHOR]