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BACKGROUND: There has been a significant increase in methamphetamine use and methamphetamine use disorder (Meth UD) in the United States, with evolving racial and ethnic differences. OBJECTIVES: This secondary analysis explored racial and ethnic differences in baseline sociodemographic and clinical characteristics as well as treatment effects on a measure of substance use recovery, depression symptoms, and methamphetamine craving among participants in a pharmacotherapy trial for Meth UD. METHODS: The ADAPT-2 trial (ClinicalTrials.gov number, NCT03078075; N=403; 69% male) was a multisite, 12-week randomized, double-blind, trial that employed a two-stage sequential parallel design to evaluate the efficacy of combination naltrexone (NTX) and oral bupropion (BUP) vs. placebo for Meth UD. Treatment effect was calculated as the weighted mean change in outcomes in the NTX-BUP minus placebo group across the two stages of treatment. RESULTS: Of the 403 participants in the ADAPT-2 trial, the majority (65%) reported non-Hispanic White, while 14%, 11% and 10% reported Hispanic, non-Hispanic Black, and non-Hispanic other racial and ethnic categories respectively. At baseline non-Hispanic Black participants reported less severe indicators of methamphetamine use than non-Hispanic White. Treatment effects for recovery, depression symptoms and methamphetamine cravings did not significantly differ by race and ethnicity. CONCLUSIONS: Although we found racial and ethnic differences at baseline, our findings did not show racial and ethnic differences in treatment effects of NTX-BUP on recovery, depression symptoms and methamphetamine cravings. However, our findings also highlight the need to expand representation of racial and ethnic minority groups in future trials.

BACKGROUND: Improving shared decision-making using a treat-to-target approach, including the use of clinical outcome measures, is important to providing high quality care for rheumatoid arthritis (RA). We developed an Electronic Health Record (EHR) integrated, patient-facing sidecar dashboard application that displays RA outcomes, medications, and lab results for use during clinical visits (RA PRO dashboard). The purpose of this study was to assess clinician perceptions and experiences using the dashboard in a university rheumatology clinic. METHODS: We conducted focus group (FG) discussions with clinicians who had access to the dashboard as part of a randomized, stepped-wedge pragmatic trial. FGs explored clinician perceptions towards the usability, acceptability, and usefulness of the dashboard. FG data were analyzed thematically using deductive and inductive techniques; generated themes were categorized into the domains of the Technology Acceptance Model (TAM). RESULTS: 3 FG discussions were conducted with a total of 13 clinicians. Overall, clinicians were enthusiastic about the dashboard and expressed the usefulness of visualizing RA outcome trajectories in a graphical format for motivating patients, enhancing patient understanding of their RA outcomes, and improving communication about medications. Major themes that emerged from the FG analysis as barriers to using the dashboard included inconsistent collection of RA outcomes leading to sparse data in the dashboard and concerns about explaining RA outcomes, especially to patients with fibromyalgia. Other challenges included time constraints and technical difficulties refreshing the dashboard to display real-time data. Methods for integrating the dashboard into the visit varied: some clinicians used the dashboard at the beginning of the visit as they documented RA outcomes; others used it at the end to justify changes to therapy; and a few shared it only with stable patients. CONCLUSIONS: The study provides valuable insights into clinicians perceptions and experiences with the RA PRO dashboard. The dashboard showed promise in enhancing patient-clinician communication, shared decision-making, and overall acceptance among clinicians. Addressing challenges related to data collection, education, and tailoring dashboard use to specific patient populations will be crucial for maximizing its potential impact on RA care. Further research and ongoing improvements in dashboard design and implementation are warranted to ensure its successful integration into routine clinical practice.

BACKGROUND: By 2035, the number of newly diagnosed cancer cases will double and over 50% will be in older adults. Given this rapidly growing demographic, a need exists to understand how age influences oncology patients symptom burden. The study purposes were to evaluate for differences in the occurrence, severity, and distress of 38 symptoms in younger (

Purpose: Physical activity research among patients with metastatic breast cancer (MBC) is limited. This study examined the feasibility and potential benefits of Fit2ThriveMB, a tailored mHealth intervention. Methods: Insufficiently active individuals with MBC (n = 49) were randomized 1:1 to Fit2ThriveMB (Fit2ThriveMB app, Fitbit, and weekly coaching calls) or Healthy Lifestyle attention control (Cancer.Net app and weekly calls) for 12 weeks. Fit2ThriveMB aimed to increase daily steps via an algorithm tailored to daily symptom rating and step goal attainment. The primary outcome was feasibility defined as ≥ 80% completion rate. Secondary feasibility metrics included meeting daily step goal and wearing the Fitbit ≥ 70% of study days, fidelity, adherence to intervention features and safety. Secondary outcomes included physical activity, sedentary time, patient reported outcomes (PROs), health-related quality of life (QOL) and social cognitive theory constructs. A subsample (n = 25) completed functional performance tests via video conferencing. Results: The completion rate was 98% (n = 1 died). No related adverse events were reported. Fit2ThriveMB participants (n = 24) wore the Fitbit 92.7%, met their step goal 53.1%, set a step goal 84.6% and used the app 94.1% of 84 study days. Intent-to-treat analyses indicated trends toward improvements in activity, QOL, and some PROs, social cognitive theory constructs, and functional performance tests favoring the Fit2ThriveMB group. Significant effects favoring Fit2ThriveMB were observed for self-efficacy and goal-setting. However, some PROs and functional performance improvements favored the control group (p-values > 0.05). Conclusions: Fit2ThriveMB is feasible and safe for patients with MBC and warrants further evaluation in randomized controlled trials with larger sample sizes. Registration Clinicaltrials.gov NCT04129346, https://clinicaltrials.gov/ct2/show/NCT04129346 [ABSTRACT FROM AUTHOR]

Purpose: To create a preference-based value set scoring system for the MobQoL-7D outcome measure, and to examine differences in the health state preferences of the general population and individuals with impaired mobility. Methods and materials: A preference elicitation study was undertaken to ascribe utility weights to all health states (i.e., all unique combination of answers) described by the MobQoL-7D. The elicitation exercise was developed using the Online Elicitation of Personal Utility Functions (OPUF) tool. Two UK sample groups were recruited; firstly a representative general population sample (N = 504), secondly a balanced sample of individuals with impaired mobility (N = 368). Distinct preference-based value sets were developed for each sample. Differences in dimension ranking, weighting, and overall utility values were assessed. Results: The general population sample considered most health states, especially the more severe states, to be worse than the mobility impaired sample comparatively. Statistically significant differences between the samples were observed in four of the seven MobQoL-7D dimensions. Conclusions: This study is the first to provide preference-based value sets for the MobQoL-7D, ready for use in economic evaluations, QALY calculation, and other clinical or research applications. The study demonstrates how the general public and individuals with impaired mobility value health states differently. IMPLICATIONS FOR REHABILITATION: The MobQoL-7D offers a concise and valid tool for rehabilitation professionals to measure and monitor quality of life and quality-adjusted life years (QALYs) in the context of mobility impairment. The MobQoL-7D value set calculator allows summary utility scores and QALYs to be calculated using MobQoL-7D outcome data; the first of its kind. The general public and individuals with impaired mobility value health states differently, which could impact cost-per QALY calculations and subsequent service commissioning and funding decisions. [ABSTRACT FROM AUTHOR]

Background: The CRC-PIPAC-II study prospectively assessed bidirectional therapy (BT) consisting of first-line palliative systemic therapy and electrostatic precipitation oxaliplatin-based pressurized intraperitoneal aerosol chemotherapy (ePIPAC-OX) in patients with unresectable colorectal peritoneal metastases (CPM). This study describes the exploration of patient-reported outcomes (PROs). Methods: In this phase II trial, 20 patients with isolated CPM were treated with up to three cycles of BT, each cycle consisting of two to three courses of systemic therapy, followed by ePIPAC-OX (92 mg/m2). Patients were asked to complete the EuroQoL EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-CR29 questionnaires at baseline, during the first cycle of BT, and one and four weeks after each consecutive BT cycle. PRO scores were calculated and compared between baseline and each subsequent time point using linear-mixed modeling (LMM). PROs were categorized into symptom scales and function scales. Symptom scales ranged from 0 to 100, with 100 representing the maximum symptom load. Function scales ranged from 0 to 100, with 100 representing optimal functioning. Results: Twenty patients underwent a total of 52 cycles of bidirectional therapy. Most PROs (29 of 37, 78%) were not significantly affected during trial treatment. In total, only eight PROs (22%) were significantly affected during trial treatment: Six PROs (index value, global health status, emotional functioning, C30, appetite, and insomnia) showed transient improvement at different time points. Two PROs transiently deteriorated: pain initially improved during the first BT cycle [− 16, p < 0.001] yet worsened temporarily one week after the first two BT cycles (+ 20, p < 0.001; + 17, p = 0.004; respectively). Abdominal pain worsened temporarily one week after the first BT cycle (+ 16, p = 0.004), before improving again four weeks after treatment ended (− 10, p = 0.004). All significant effects on Pros were clinically significant and all deteriorations in PROs were of temporary nature. Discussion: Patients undergoing BT for unresectable CPM had significant, but reversible alterations in several PROs. Most affected PROs concerned improvements and only two PROs showed deteriorations. Both deteriorated PROs returned to baseline after trial treatment and were of a temporary nature. These outcomes help to design future studies on the role of ePIPAC in the palliative setting. [ABSTRACT FROM AUTHOR]

Purpose: Aphasia, which is one of the most common consequences of stroke, has severe impact on everyday life. Quality of life in persons with aphasia changes dramatically. In the recent years, there has been a lot of interest in assessing health-related quality of life, but few questionnaires are adapted to people with aphasia (PwA). The Stroke Aphasia Quality of Life-39 scale (SAQOL-39) Generic Version is suitable for people with and without aphasia. Our study examined the reliability and validity of a translation of the SAQOL-39 g into Slovenian in Slovenian-speaking PwA. Methods: Translation, back-translation from English into Slovenian language was performed. Seventy-three PwA with broad range of severity and times post-onset of stroke were included in the study of psychometric properties of the Slovenian translation. Results: The psychometric properties in Slovenian version were quite similar to other languages, with high internal consistency and test-retest reliability (Cronbach alpha > 0.94; ICC ≥0.99). Conclusion: The Slovenian translation of the SAQOL-39 g is a valid and reliable measure of quality of life in PwA. It can be clinically used as an additional tool for goal setting in Slovenian PwA. [ABSTRACT FROM AUTHOR]

Purpose: Systemic Lupus Erythematosus (SLE) significantly affects both the quality of life related to health and non-health aspects. This study aims to evaluate the psychometric properties of the Persian version of the Lupus_PRO questionnaire, version 1.7. The questionnaire serves as a specific self-report outcome scale for assessing the treatment outcomes of Lupus disease. Methods: The Lupus_PRO questionnaire, version 1.7, was translated into Persian using the standard forward-backward method. After being completed by 218 patients with Lupus, the psychometric properties of the instrument were examined. The Convergent and Discriminant Validity of the scale were assessed using Average Variance Extracted and Cross Loadings, respectively. The construct validity of the questionnaire was also evaluated through Confirmatory Factor Analysis (CFA). Cronbach's alpha was calculated to assess the reliability of the questionnaire dimensions. Findings: Out of the 218 patients with lupus who participated in the current study, 13 (6%) were male, and 205 (94%) were female. The mean (SD) age of participants was 40.29 (10.94) years. The Average Variance Extracted (AVE) for HRQOL and Non-HRQOL constructs, except for the Coping and Cognition dimension, was greater than 0.50, indicating satisfactory convergent validity. The interdimensional correlation coefficient (Discriminant Validity) for each dimension with other questionnaire dimensions was less than 0.10, indicating that the questionnaire has good convergent and discriminant validity. Additionally, the results of the Confirmatory Factor Analysis (CFA) indicated that the questionnaire was a suitable fit. In terms of reliability, Cronbach's alpha for the various questionnaire dimensions ranged from 0.51 to 0.91, indicating good internal consistency. Conclusion: The Persian version of the Lupus_PRO questionnaire, version 1.7, demonstrates acceptable validity and reliability in the Iranian population. This instrument can effectively measure various aspects of the quality of life in patients with lupus. [ABSTRACT FROM AUTHOR]

Aim: To characterize and stratify health‐related quality of life in individuals with type 1 diabetes (T1D) using body mass index (BMI) and clustering analysis. Material and Methods: Baseline data on individuals with T1D were pooled from two studies. A post hoc analysis of health‐related quality of life, measured using the 36‐item Short‐Form questionnaire, was performed, referenced to the 2010 US general population. Descriptive statistics were presented for the pooled cohort and per BMI category. K‐means clustering was performed. One‐way analysis of variance was conducted to examine differences in clinical characteristics between clusters. Results: The pooled cohort consisted of 2256 individuals with T1D (age: 45.4 ± 15.0 years, BMI: 26.2 ± 4.6 kg/m2, diabetes duration: 22.7 ± 13.5 years). All quality‐of‐life domains were slightly lower than 50(the general population's mean), except for vitality. Individuals with a BMI ≥30 kg/m2 reported lower scores for bodily pain, physical functioning, general health, and vitality. A first cluster with a high and a second cluster with a low quality of life were identified, with significant differences in the mental (Cluster 1: 53.8 ± 6.8 vs. Cluster 2: 39.5 ± 10.7; p < 0.001) and physical component summary scores (Cluster 1: 49.6 ± 6.3 vs. Cluster 2: 35.2 ± 12.0; p < 0.001), which exceeded differences found between BMI categories. Conclusions: In our population of people living with T1D, higher BMI may have adversely impacted physical domains of quality of life, but larger differences between the high‐ and low‐quality‐of‐life cluster indicate that more factors play a role. [ABSTRACT FROM AUTHOR]

The use of conforming and congruent bearings in total knee arthroplasty (TKA) have rapidly increased due to the benefits of increased stability and the potential for replicating normal knee kinematics. However, limited data exist for these newly available bearings. This study evaluated revision-free survivorship and patient-reported outcome measures (PROMs) of a large granular database of primary TKAs using a single conforming bearing design. A total of 1,306 consecutive primary TKAs performed using a single conforming bearing design (85% cemented and 15% cementless) were retrospectively reviewed. Kaplan-Meier survivorship estimates were calculated based on the latest clinical follow-up. The PROMs and minimal clinically important differences were evaluated. A total of 93% of cases achieved minimum 1-year clinical follow-up (mean 3.5 years; range, 1 to 7), with a subset of 261 cases that achieved minimum 5-year follow-up (mean 5.8 years; range, 5 to 7). All-cause and aseptic Kaplan-Meier survivorship estimates were 97.6 (95% CI [confidence interval], 97 to 99) and 98.1% (95% CI, 97 to 99) at 7.0 years. Revision-free survivorship did not differ by cemented or cementless fixation (98 versus 97%, P =.163). All PROM scores significantly improved from preoperative baseline (P <.001), and ≥ 86% of patients achieved minimal clinically important differences for Knee Society pain and Knee Injury and Osteoarthritis Outcome Score for Joint Replacement total scores. A total of 89% of cases reported their knees to 'sometimes or always' feel normal. For cases with minimum 5-year PROMs, 93% were 'very satisfied' or 'satisfied.' Conforming-bearing TKA demonstrated excellent survivorship up to 7.0 years. In addition, PROMs were comparable to other designs reported in the literature. While mid-term (mean 3.5-year) results are promising, long-term data are warranted on survivorship due to potential polyethylene wear in conforming bearings with more surface area in contact with articulating surfaces. IV. [ABSTRACT FROM AUTHOR]

Importance: Many women report inadequate symptom control after sacral neuromodulation (SNM), despite 50% reduction in urgency incontinence episodes (UUIE) after test stimulation. Objective: To determine the ideal percent UUIE reduction after test stimulation that predicts 24‐month success. Study Design: Using data from a multicenter SNM trial, we constructed receiver operating characteristic curves to identify an ideal threshold of percent UUIE reduction after test stimulation. We defined 24‐month success as Patient Global Impression of Improvement of "very much better" to "better." We compared predictive accuracy of two models predicting success: (1) percent UUIE reduction alone and (2) with baseline characteristics. Results: Of 149 women (median [IQR] baseline daily UUIE 4.7 [3.7, 6.0]), the ideal threshold for 24‐month success was 72% (95% confidence interval 64,76%) UUIE reduction with accuracy 0.54 (0.42, 0.66), sensitivity 0.71 (0.56, 0.86) and specificity 0.27 (0.05, 0.55). The accuracy of the 50% reduction threshold was 0.60 (0.49, 0.71), sensitivity 0.95 (0.88, 1.0) and specificity 0.04 (0.0, 0.12). Percent reduction in UUIE was not better than chance in predicting 24‐month success (concordance index [c‐index] 0.47 [0.46, 0.62]); adding age, body mass index, diabetes mellitus and visual or hearing impairment the c‐index was 0.68 (0.61, 0.78). Conclusions: Among women who received an internal pulse generator (IPG) due to ≥50% UUIE reduction after test stimulation, we found no ideal threshold that better predicted 24‐month success. Percent reduction in UUIE after test stimulation poorly predicts 24‐month success with or without clinical factors. Given this, re‐evaluating how we determine who should receive an IPG is needed. [ABSTRACT FROM AUTHOR]

Aim: To determine outcome measurement when odontogenic sinusitis (ODS) is treated by Endoscopic Sinus Surgery (ESS). Materials and Methods: A PRISMA compliant systematic review using MeSH headings on Pubmed, Ovid and Embase. Inclusion criteria: Adults with odontogenic maxillary sinus disease undergoing ESS. Exclusion criteria: Adolescents, odontogenic disease related to; trauma, neoplasia, tumour resection, palatal cleft or fungal infection, previous sinus surgery, endoscopic surgery not involving the middle meatus. Results: A total of 1462 papers were identified, 68 eligible for review. No randomised controlled trials were identified. Twenty‐three papers (34%) reported a successful outcome as no disease at endoscopy and reduced sinonasal symptoms; 14 papers (21%) based outcomes on endoscopy, reduced symptoms and resolution of sinus opacification or reduced mucosal thickness; 1 paper established success on reduced symptoms only and 7 papers (10%) based outcomes on radiographic findings only. Other primary measures of success were excision and closure of oro‐antral fistula, 6 (9%), removal of odontogenic cysts, 5 (7%), removal of displaced dental implants, 4 (6%), removal of displaced root of tooth, 3 (4%). Five papers (7%) reported no outcome measure. Additional measures of outcome were; retention of dental implants perforating the sinus floor, survival of sinus floor grafting with subsequent implant placement and retention of teeth with persistent apical periodontitis. Conclusion: Reported outcome measures were very heterogeneous. In consideration of the weak evidence base for the role of ESS in ODS management, more consistent measurement and reporting of patient symptoms, clinical and radiological signs with endoscopic findings is recommended to enable meta‐analysis. [ABSTRACT FROM AUTHOR]

AbstractPurposeMaterials and methodsResultsConclusionsInterdisciplinary multimodal pain treatment (IMPT) offers long-term benefits for patients with chronic musculoskeletal pain (CMP). Many patients, despite reporting a clinically relevant decrease of the self-reported Pain Disability Index (PDI), do not achieve such change for the 6-minutes walking test (6MWT). The objective is to identify factors that are associated with no clinically meaningful improvement on the 6MWT in patients with CMP who reported a clinically important improvement on disability (PDI) after 10-weeks of IMPT.Nine hundred and eighty-three patients reporting a clinically important change on the PDI (primary outcome) after IMPT were included. Logistic regression analysis was used to identify baseline and change scores of physiological and psychologic factors independently associated with a clinically important improvement on the 6MWT.Three hundred (32%) patients achieved a clinically important change on the 6MWT. A higher increase of the heart rate (HR) during the 6MWT at post-treatment compared to the HR increase at pre-treatment increases the probability of achieving a clinically relevant change on the 6MWT. Higher self-reported working capacity and anxiety at baseline resulted in a lower probability of achieving a clinically relevant increase of the metres walked.None of the other factors targeted by IMPT contributed significantly to the final model. These results question the feasibility of the 6MWT as a secondary outcome measure as it merely seems to measure patient’s behaviour (performance) and not capacity. [ABSTRACT FROM AUTHOR]

Background: Outcome measures are crucial to support a treat-to-target approach to rheumatoid arthritis (RA) care, yet their integration into clinical practice remains inconsistent. We developed an Electronic Heath Record-integrated, patient-facing side-car application to display RA outcomes (disease activity, functional status, pain scores), medications, and lab results during clinical visits ("RA PRO Dashboard"). The study aimed to evaluate patient perceptions and attitudes towards the implementation of a novel patient-facing dashboard during clinical visits using a mixed-methods approach. Methods: RA patients whose clinicians used the dashboard at least once during their clinical visit were invited to complete a survey regarding its usefulness in care. We also conducted semi-structured interviews with a subset of patients to assess their perceptions of the dashboard. The interviews were transcribed verbatim and analyzed thematically using deductive and inductive techniques. Emerging themes and subthemes were organized into four domains of the Ecological Model of Health. Results: Out of 173 survey respondents, 79% were interested in seeing the dashboard again at a future visit, 71% felt it improved their understanding of their disease, and 65% believed it helped with decision-making about their RA care. Many patients reported that the dashboard helped them discuss their RA symptoms (76%) and medications (72%) with their clinician. Interviews with 29 RA patients revealed 10 key themes: the dashboard was perceived as a valuable visual tool that improved patients' understanding of RA outcome measures, enhanced their involvement in care, and increased their trust in clinicians and the clinic. Common reported limitations included concerns about reliability of RA outcome questionnaires for some RA patients and inconsistent collection and explanation of these measures by clinicians. Conclusions: In both the quantitative and qualitative components of the study, patients reported that the dashboard improved their understanding of their RA, enhanced patient-clinician communication, supported shared decision-making, and increased patient engagement in care. These findings support the use of dashboards or similar data visualization tools in RA care and can be used in future interventions to address challenges in data collection and patient education. [ABSTRACT FROM AUTHOR]

Background: Clinically-oriented outcome measures are increasingly being recognized as lacking in consideration of factors important to patients. There is an emerging move of guideline bodies advocating a more patient-centred approach. Aneurysms in autogenous arteriovenous fistula (AVF) can be considered unsightly and a constant reminder for patients of their dependence on dialysis. However, their impact on patient's perception has not previously been reported. Methods: Between April 2017–18, the Vascular Access Questionnaire (VAQ) was administered to prevalent haemodialysis patients across ten dialysis units via structured interviews, as part of a quality improvement project. Data for the subgroup of patients with aneurysmal AVF (categorised as per classification by Valenti et al.), were retrospectively evaluated and compared to the wider cohort. Results: Data were collected for 539 patients (median age: 66 years; 59% male), of whom 195 (36%) had aneurysmal AVF, with Type 2 morphology (cannulation site) being the most common (75%). Duration of AVF was found to be significantly associated with aneurysmal development, with estimated likelihoods of 11%, 43% and 61% after one, five and ten years, respectively. Interestingly, patients with diabetes had a significantly lower prevalence of aneurysmal development than those that were non-diabetic (25% vs. 43%, p < 0.001). Overall VAQ scores were not found to differ significantly by aneurysm status (p = 0.816) or across morphology types (p = 0.277). However, patients with aneurysmal AVF were significantly more concerned with the appearance of their AVF (p < 0.001) than the wider cohort. Despite this, patients with aneurysmal AVF gave significantly higher scores for satisfaction and ease of use and lower scores for bruising and clotting (p < 0.05). Conclusions: Aneurysmal AVF are often cited as an important factor by patients for not proceeding with fistula formation. In this evaluation of patient reported experiences, those with aneurysmal AVF reported high satisfaction levels. This may help clinicians highlight positive patient reported outcomes of aneurysmal AVF during preprocedural consent processes. [ABSTRACT FROM AUTHOR]

Patient-reported outcomes (PROs) are often used as primary outcomes in clinical research studies. PROs are usually measured in ordinal scales and they tend to have excess variability beyond the binomial distribution, a property called overdispersion. Beta-binomial distribution has been previously proposed in this context in order to fit PROs, and beta-binomial regression (BBR) as a good alternative for modelling purposes, including the extension to mixed-effects models in a longitudinal framework. Many PROs have various health dimensions, which are commonly correlated within subjects. However, in clinical analysis, dimensions are separately analysed. In this work, we propose a multidimensional BBR model that incorporates a multidimensional outcome including several PROs in a joint analysis. The proposal has been evaluated and compared to the independent analysis through a simulation study and a real data application with patients with respiratory disease. Results show the advantages that a multidimensional approach offers in terms of parameter significance and interpretation. Additionally, the methods proposed in this work are implemented in the PROreg R-package developed by the authors. [ABSTRACT FROM AUTHOR]

Patient-reported outcomes (PROs), such as health-related quality of life (HRQL), are important outcome measures for patients with chronic liver diseases (CLDs). Presence of cirrhosis and advanced liver disease have been associated with worsened HRQL and fatigue. On the other hand, some patients with earlier stages of CLD also experience fatigue, causing PRO impairment. Treatment for some CLDs may improve HRQL and, sometimes, levels of fatigue. We aimed to provide an in-depth expert review of concepts related to fatigue and HRQL in patients with primary biliary cholangitis, hepatitis C virus and MASLD (metabolic dysfunction-associated steatotic liver disease). A panel of experts in fatigue and CLD reviewed and discussed the literature and collaborated to provide this expert review of fatigue in CLD. Herein, we review and report on the complexity of fatigue, highlighting that it is comprised of peripheral (neuromuscular failure, often in conjunction with submaximal cardiorespiratory function) and central (central nervous system dysfunction) causes. Fatigue and HRQL are measured using validated self-report instruments. Additionally, fatigue can be measured through objective tests (e.g. grip strength). Fatigue has deleterious effects on HRQL and one's ability to be physically active and socially engaged but does not always correlate with CLD severity. Treatments for hepatitis C virus and MASLD can improve levels of fatigue and HRQL, but current treatments for primary biliary cholangitis do not seem to affect levels of fatigue. We conclude that obtaining PRO data, including on HRQL and fatigue, is essential for determining the comprehensive burden of CLD and its potential treatments. [ABSTRACT FROM AUTHOR]

The decision to treat shoulder osteoarthritis (OA) definitively with shoulder arthroplasty (SA) is multifactorial, considering objective findings, subjective information, and patient goals. The first goal of this study was to determine if Patient Reported Outcome Measurement Information System (PROMIS) measures correlated with patients with shoulder OA who underwent SA within 1 year. The second goal of this study was to determine if score cut-offs in PROMIS domains could further discriminate which shoulder OA patients underwent SA within 1 year. This retrospective case-control study examined patients with a diagnosis of shoulder OA who consulted an orthopedic provider from November 1, 2020 to May 23, 2022, and recorded PROMIS measures in the domains of Physical Function, Depression, and/or Pain Interference. A surgical group was defined as patients who underwent SA within 1 year of the most recent PROMIS measures and the nonsurgical patients were defined as the control group. Mean PROMIS scores were compared between the surgical and control groups. Separate logistic regression models controlling for age, race, ethnicity, and comorbidity count were performed for each PROMIS domain as a 1) continuous variable, and then as 2) binary variable defined by PROMIS score cut-off points to determine which scores correlated with undergoing SA to further characterize the potential clinical utility of PROMIS score cut-offs in relating to undergoing SA. The surgical group of 478 patients was older (68.2 vs. 63.8 years), more often of White race (82.6% vs. 70.9%), and less often of Hispanic Ethnicity (1.5% vs. 2.9%) than the control group of 3343 patients. Using optimal cut-offs in PROMIS scores, Pain Interference ≥63 (odds ratio [OR] = 2.97 (2.41-3.64), P <.001), Physical Function ≤39 (OR = 1.81 (95% confidence interval, 1.48-2.22), P <.001), and depression ≥49 (OR = 1.82 (95% confidence interval, 1.50-2.22), P <.001) were all found to correlate with undergoing SA within 1 year in multivariable logistic regressions. The results of this study demonstrate that cut-off scores for PROMIS measures differentiated patients undergoing SA within 1 year. These cut-off scores may have clinical utility in aiding in decision-making regarding surgical candidates for SA. Further research is needed to validate these cut-off scores and determine how they relate to patient outcomes after SA. [ABSTRACT FROM AUTHOR]

Purpose: Facial feminization surgery (FFS) is associated with improved psychological outcomes in transgender patients. We aimed to evaluate the impact of FFS on patient satisfaction with facial appearance using validated, patient-reported outcome tools. Methods: Patients were recruited to complete a FACE-Q survey at least 6 months after their FFS. FACE-Q modules used included "Satisfaction with Facial Appearance Overall," "Facial Attributes" (forehead/eyebrows, nose, cheeks, cheekbone, chin, jawline, and neck), "Decision," "Outcomes," "Psychological Function," and "Social Function." "Satisfaction with Facial Appearance Overall" was compared to FACE-Q outcomes in transgender patients on hormone replacement therapy (HRT), alone. Results: Twenty-three patients completed the survey. Rhinoplasty was the most common procedure (82.6%). Insurance was rated as a major barrier in 50% of patients. "Satisfaction with Facial Appearance Overall" using the FACE-Q was 69.3, with "Psychological Function" rated at 73.7 and "Social Function" rated at 76.1. FFS was associated with a higher overall satisfaction in facial appearance compared to patients on HRT for 3 months (69.3 vs. 48.5, p<0.01) and 12 months, alone (69.3 vs. 54.4, p<0.001). Wait time for FFS of less than a year (β=−20.4, p=0.04) and undergoing FFS at a younger age (β=−1.4, p<0.001) were independently associated with higher satisfaction scores in overall facial appearance. Conclusions: FFS is associated with greater satisfaction with overall facial appearance, especially compared to transgender patients only on HRT. Insurance was the greatest barrier to receiving FFS. Improved access to surgery is needed to yield higher overall satisfaction with facial appearance. [ABSTRACT FROM AUTHOR]

Introduction Early discontinuation of endocrine therapy (ET) is higher among patients with early breast cancer (EBC) compared to patients with metastatic hormone receptor-positive (HR+) breast cancer (MBC). In our clinical experience the reasons for this may include a significant burden of ET side effects impacting quality of life (QOL) in patients with EBC. We hypothesized that QOL is lower in patients with HR + EBC compared to patients with HR + MBC on ET. Methods We conducted a cross-sectional observational study to assess QOL utilizing FACT-ES & EORTC QLQ C30 tools among patients with EBC and MBC receiving ET across 5 Irish hospitals. Results A total of 417 patients were enrolled—EBC (79% n  = 331) and MBC 21% (n  = 86). Using the FACT-ES, we found no difference in overall QOL by stage (139.2 vs 141, P  = .33). Patients with HR + MBC had a lower symptom burden from ET compared to HR + EBC (61.4 vs 54, P  < .01). In adjusted multivariate linear regression models, there was no difference in QOL for patients with EBC and MBC receiving ET. Conclusions There was no significant difference in overall QOL for patients with EBC and MBC. However, patients with EBC experienced more endocrine symptoms. In adjusted multivariate linear regression models, the stage did not predict QOL. Our results suggest that endocrine symptoms are significant contributors to impaired QOL for patients with EBC but the role of other determinants of QOL (eg, stage) is less clear. Future work could include the development of stage-specific QOL tools and utilization of electronic patient-reported outcomes (ePROs) to identify and manage emergent toxicities. [ABSTRACT FROM AUTHOR]

Actigraphy is a quantitative means of measuring activity data that has proven viable in post-surgery recovery analysis for arthroplasties in lower extremities, but scant literature has been published on the utilization actigraphy to evaluate shoulder motion and function before and after shoulder arthroplasty. The purpose of this prospective cohort study is to identify if actigraphy can serve as a valid means for objective evaluation of shoulder function and motion before and after shoulder arthroplasty. Secondarily, the data collected by the actigraphy can be analyzed with standard patient-reported outcomes to report correlations between the subjective and objective methods used in this study. Sixty-four subjects wore an actigraphy device for one day at pre-op, six, twelve and twenty-four weeks. In addition, subjects completed three patient-reported outcome surveys at each time-point. Student t-tests were used to compare percent activity preoperatively with 24-weeks and to compare PROs preoperatively with 24-week results; categorical variables were compared with one-way ANOVAs. All Patient reported outcome scores significantly improved following arthroplasty (p-value<0.001). The percent of physical activity was highly correlated with vector magnitude (p-value<0.001), but neither percent activity or the vector magnitude were correlated with any of the PROs: UCLA Pain p-value = 0.656, SANE p-value = 0.328, UCLA Function p-value = 0.532. Actigraphy results from this study mirror findings in previous literature utilizing the technology in similar manners and demonstrate its potential for motion and function analysis before and after total shoulder arthroplasties. Despite both being suitable methods independently for the evaluation of shoulder function, there was no significant correlation between standard actigraphy measurements and PROs at 24-weeks. Future research to determine clinical utility and an overall broader scope for actigraphy monitoring could benefit from improved technology, such as increased battery life for prolonged durations of data collection during observation periods. [ABSTRACT FROM AUTHOR]

Objective Background Methods Results Conclusion To assess patient reported outcomes of patients with migraine receiving preventative medications, and to compare patient reported outcomes and unplanned care of patients on calcitonin gene–related peptide inhibitors (CGRPi) with those on other preventative medications.Patient reported outcome measures can be useful in conditions such as migraine with frequent disability. CGRPi are newer migraine preventative medications that can improve patients’ quality of life.This was a retrospective cohort analysis of Patient Reported Outcomes Measurement Information System (PROMIS) data combined with administrative claims data from a large regional health plan for adult patients (≥18 years) with migraine who were on preventative medications from January 2019 to March 2022. PROMIS scores of patients on CGRPi were compared to scores of patients who switched from other preventative medications to CGRPi (pre vs. post), between patients adherent to CGRPi versus non‐adherent, and changes in all‐cause/migraine‐related unplanned care (emergency department) use by the CGRPi cohort.There were 1245 patients on other preventative medications (antiseizure [532/1245 (43%)], antidepressants [316/1245 (25%)], and beta‐blockers [397/1245 (32%)]), 148 who were on CGRPi, and 112 who had switched from other preventative medications to CGRPi. The mean age was 44 years old, 88% were females, 50% were married, and 75% were on commercial insurance. Patients with migraine had higher T‐scores in pain, fatigue, anxiety, and sleep disturbance than the general population. Patients on CGRPi had a statistically significant reduction in pain T‐scores (60.4 [standard deviation (SD) 7.4] to 58.4 [SD 8.2], p = 0.003) post initiation of medications, especially those who switched from other preventative medications to CGRPi (61.4 [SD 6.9] to 58.7 [SD 8.3], p < 0.001). The pain T‐score reduction occurred only among the adherent group. There was a lower proportion of patients with all‐cause unplanned care among patients on CGRPi (43% [64/148] to 32% [47/148], p < 0.001), but the reduction in migraine‐related unplanned care was not statistically significant (9% [14/148] to 6% [9/148], p = 0.197).Our findings suggest that patients had an improvement in pain reduction scores after initiating CGRPi. PROMIS scores could provide important information about quality‐of‐life improvement for prescribers. [ABSTRACT FROM AUTHOR]

Introduction: Rare genetic neurodevelopmental disorders and intellectual disability (ID), collectively called genetic ID (GID), can profoundly impact daily functioning and overall well-being of affected individuals. To improve our understanding of the impact of GID and advancing both care and research, measuring relevant patient reported outcomes (PROs) is crucial. Currently, various PROs are measured for GID. Given the shared comorbidities across disorders, we aim to develop a generic core PRO set for children and adults with GID. Methods and results: Developing the generic core PRO set entails the following steps: 1) providing an overview of potentially relevant PROs by scoping reviews and qualitative research; 2) integrating and conceptualizing these PROs (i.e., describing the content of the PROs in detail) into a pilot generic core PRO set; and 3) prioritizing relevant PROs by a European Delphi survey and consensus meetings. Conclusions: This protocol presents the steps for developing a generic core PRO set for children and adults with GID. The next step involves selecting suitable patient reported outcome measures (PROMs) to adequately measure these PROs: the generic core PROM set. This generic core PROM set needs validation in the GID population, and eventually implementation in care and research, facilitating the aggregation and analysis of PRO data and guaranteeing continuous integration of the patient perspective in both care and research. [ABSTRACT FROM AUTHOR]

Background: Previous research has suggested that alternative (respiratory) care providers (ACP) may provide affordable, accessible care for sleep-disordered breathing (SDB) that decreases wait-times and improves clinical outcomes. The objective of this study was to compare ACP-led and sleep physician-led care for SDB on patient reported outcome and experiences, with a focus on general and health-related quality of life, sleepiness, and patient satisfaction. Methods: We conducted a secondary analysis of a randomized trial in which participants with severe SDB were assigned to either ACP-led or physician-led management. We created longitudinal linear mixed models to assess the impacts of treatment arm and timepoint on total and domain-level scores of multiple patient-reported outcome measures and patient-reported experience measures. Results: Patients in both treatment arms (ACP-led n = 81; sleep-physician = 75) reported improved outcomes on the Sleep Apnea Quality of Life Index, Health Utilities Index, and Epworth Sleepiness Scale. Patients in each group had similar and clinically meaningful improvements on domains assessing cognition, emotion, and social functioning. The linear mixed models suggested no significant difference between treatment arms on the patient-reported outcomes. However, scores significantly improved over time. Conclusions: Management of SDB using ACPs was comparable to physician-led care, as measured bypatient-reported outcome and experience measures. While loss to follow-up limits our findings, these results provide some support for the use of this novel health service delivery model to improve access to high quality SDB care. Clinical trial registration: This is analysis of data from the study registered Clinicaltrials.gov (NCT02191085). [ABSTRACT FROM AUTHOR]

Background: The use of electronic intake forms within the electronic health record (EHR) is an emerging method for routinely collecting patient-reported outcomes (PRO). However, few studies have evaluated experiences/perspectives toward electronic forms among outpatients receiving care within Integrative Health and Medicine (IHM) clinics. The study purpose was to understand patients' perspectives of electronic intake and PRO forms in the outpatient IHM setting. Methods: Electronic intake (e.g., treatment expectations, medical history, chief complaints, prior experience with integrative modalities) and PRO forms (i.e., Patient Reported Outcome Measurement Information System [PROMIS]-29, Perceived Stress Scale 4, Oswestry Disability Index) were designed in collaboration with clinic leadership and the Information Technology team. Semi-structured interviews were used to gather perspectives of the functionality and acceptability of the forms among outpatients receiving care at the IHM center. Interviews were coded to describe themes regarding perceptions and suggestions for improvement. Results: Qualitative interviews were completed with 10 participants (median age 51 years, 70% female, 30% Black/African American). Participants considered electronic intake and PRO forms as relevant to their health concerns, valuable for conveying important health information to providers, and easy to navigate. Suggested changes to the intake form included adding relevant open-ended questions, save and print functions, and examples and definitions to prompt responses. Conclusion: Participants felt the electronic format was a feasible and acceptable method of collecting patient information and PROs. Future goals are to implement the revised forms in a common EHR to patients receiving care at multiple IHM clinics across the United States. [ABSTRACT FROM AUTHOR]

AbstractPurposeMethodResultsConclusions\nIMPLICATIONS FOR REHABILITATIONPatient reported outcomes (PROs) in the context of Gamma Knife Stereotactic Radiosurgery (GKSRS) for benign brain tumor have been under-researched. This study examined changes in PROs and adjustment trajectories post-GKSRS.50 adults (54% female) aged on average 53.18 (SD = 14.76) years with benign brain tumor were assessed 1 week before GKSRS, 1–2 weeks post-GKSRS, and at 3-month follow-up. Telephone-based questionnaires of anxiety and depressive symptoms, cognitive function, symptom burden, and health-related quality of life (HRQoL) were completed.Significant improvements in HRQoL, perceived cognitive ability, anxiety, and total brain tumor symptoms were evident between pre-GKSRS and 3-month follow-up. Conversely, there was a significant short-term increase in depressive symptoms at post-GKSRS; however, levels did not differ from pre-GKSRS at follow-up. No significant changes were evident on PROs of headaches or fatigue. About half of the participants (46–51%) experienced reliable improvement in global HRQoL, and one-third (31–34%) reported improved anxiety symptoms. Increased depressive symptoms was seen in 34% of participants post-GKSRS and 18% at follow-up.At 3 months post-GKSRS, improvements in HRQoL, anxiety, perceived cognitive ability, and total brain tumor symptoms were evident. Routine monitoring and support for pre-GKSRS anxiety and depressive symptoms post-GKSRS is recommended.Individuals receiving Gamma Knife radiosurgery for benign brain tumor experience positive impacts on global, emotional, and physical HRQoL, perceived cognitive ability, anxiety, and overall brain tumor symptoms following treatment.Due to heightened levels of anxiety observed prior to treatment, routine screening and support for anxiety are recommended before individuals receive Gamma Knife radiosurgery.Symptoms of depression may increase following Gamma Knife radiosurgery, therefore routine monitoring and management of mood symptoms is recommended after treatment.Evidence-based psychological interventions are needed for healthcare professionals to support individuals undergoing Gamma Knife radiosurgery.Individuals receiving Gamma Knife radiosurgery for benign brain tumor experience positive impacts on global, emotional, and physical HRQoL, perceived cognitive ability, anxiety, and overall brain tumor symptoms following treatment.Due to heightened levels of anxiety observed prior to treatment, routine screening and support for anxiety are recommended before individuals receive Gamma Knife radiosurgery.Symptoms of depression may increase following Gamma Knife radiosurgery, therefore routine monitoring and management of mood symptoms is recommended after treatment.Evidence-based psychological interventions are needed for healthcare professionals to support individuals undergoing Gamma Knife radiosurgery. [ABSTRACT FROM AUTHOR]

Achieving a minimal clinically important difference (MCID) in patient-reported outcomes following total knee arthroplasty (TKA) is common, yet up to 20% patient dissatisfaction persists. Unmet expectations may explain post-TKA dissatisfaction. No prior studies have quantified patient expectations using the same patient-reported outcome metric as used for MCID to allow direct comparison. This was a prospective study of patients undergoing TKA with 5 fellowship-trained arthroplasty surgeons at one academic center. Baseline Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) and Pain Interference (PI) domains were assessed. Expected PROMIS scores were determined by asking patients to indicate the outcomes they were expecting at 12 months postoperatively. Predicted scores were generated from a predictive model validated in the Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement (FORCE-TJR) dataset. T -tests were used to compare baseline, expected, and predicted PROMIS scores. Expected scores were compared to PROMIS MCID values obtained from the literature. Regression models were used to identify patient characteristics associated with high expectations. There were 93 patients included. Mean age was 67 years (range, 30 to 85) and 55% were women. Mean baseline PROMIS PF and PI was 34.4 ± 6.7 and 62.2 ± 6.4, respectively. Patients expected significant improvement for PF of 1.9 times the MCID (MCID = 11.3; mean expected improvement = 21.6, 95% confidence interval [CI] 19.6 to 23.5, P <.001) and for PI of 2.3 times the MCID (MCID = 8.9; mean expected improvement = 20.6, 95% CI 19.1-22.2, P <.001). Predicted scores were significantly lower than expected scores (mean difference = 9.5, 95% CI 7.7 to 11.3, P <.001). No unique patient characteristics were associated with high expectations (P >.05). To our knowledge, this study is the first to quantify preoperative patient expectations using the same metric as MCID to allow for direct comparison. Patient expectations for improvement following TKA are ∼2× greater than MCID and are significantly greater than predicted outcome scores. This discrepancy challenges currently accepted standards of success after TKA and indicates a need for improved expectation setting prior to surgery. [ABSTRACT FROM AUTHOR]

Background: The aim of this study was to evaluate the impact of mental health attributes, such as the presence of psychiatric comorbidities or psychological comorbidities (low resilience), on outcomes after rotator cuff repair (RCR) and total shoulder arthroplasty (TSA). Methods: PubMed, Cochrane, and Google Scholar (results pages 1–20) were searched up to November 2023. Mental health problems of interest included the presence of psychiatric comorbidities (depression, anxiety) or indicators of poor psychological functioning, such as low resilience or the presence of distress. Patients were assigned to poor or good mental health groups in this study based on their grouping in the original study. Results: Fourteen studies were included in the meta-analysis. Patients with good mental health had greater improvements in postoperative American Shoulder and Elbow Surgeons and Simple Shoulder Test scores in the TSA cohort (P=0.003 and P=0.01), RCR cohort (P<0.001), and the combined TSA and RCR cohort (P<0.001). No difference was found in visual analog scale score, satisfaction, external rotation, or flexion between the two mental health groups. Patients with poor mental health undergoing RCR experienced higher rates of adverse events and transfusions (P<0.001). Patients with poor mental health also had greater rates of revision and emergency department visits in the TSA cohort (P<0.001), RCR cohort (P=0.05 and P=0.03), and combined cohort (P<0.001). Patients with poor mental health undergoing TSA had a higher rate of re-admission (P<0.001). Conclusions: Patients with poor preoperative mental health showed inferior patient-reported outcome scores and increased rates of adverse events, revisions, and re-admissions. Level of evidence: III. [ABSTRACT FROM AUTHOR]

Severe sagittal plane deformity with loss of L4-S1 lordosis is disabling and can be improved through various surgical techniques. However, data are limited on the differing ability of anterior lumbar interbody fusion (ALIF), pedicle subtraction osteotomy (PSO), and transforaminal lumbar interbody fusion (TLIF) to achieve alignment goals in severely malaligned patients. Severe adult spinal deformity patients with preoperative PI-LL >20°, L4-S1 lordosis <30°, and full body radiographs and PROMs at baseline and 6-week postoperative visit were included. Patients were grouped into ALIF (1–2 level ALIF at L4-S1), PSO (L4/L5 PSO), and TLIF (1–2 level TLIF at L4-S1). Comparative analyses were performed on demographics, radiographic spinopelvic parameters, complications, and PROMs. Among the 96 included patients, 40 underwent ALIF, 27 underwent PSO, and 29 underwent TLIF. At baseline, cohorts had comparable age, sex, race, Edmonton frailty scores, and radiographic spinopelvic parameters (P > 0.05). However, PSO was performed more often in revision cases (P < 0.001). Following surgery, L4-S1 lordosis correction (P = 0.001) was comparable among ALIF and PSO patients and caudal lordotic apex migration (P = 0.044) was highest among ALIF patients. PSO patients had higher intraoperative estimated blood loss (P < 0.001) and motor deficits (P = 0.049), and in-hospital ICU admission (P = 0.022) and blood products given (P = 0.004), but were otherwise comparable in terms of length of stay, blood transfusion given, and postoperative admission to rehab. Likewise, 90-day postoperative complication profiles and 6-week PROMs were comparable as well. ALIF can restore L4-S1 sagittal alignment as powerfully as PSO, with fewer intraoperative and in-hospital complications. When feasible, ALIF is a suitable alternative to PSO and likely superior to TLIF for correcting L4-S1 lordosis among patients with severe sagittal malalignment. [ABSTRACT FROM AUTHOR]

Ecological momentary assessment (EMA) allows for the collection of participant-reported outcomes (PROs), including pain, in the normal environment at high resolution and with reduced recall bias. Ecological momentary assessment is an important component in studies of pain, providing detailed information about the frequency, intensity, and degree of interference of individuals' pain. However, there is no universally agreed on standard for summarizing pain measures from repeated PRO assessment using EMA into a single, clinically meaningful measure of pain. Here, we quantify the accuracy of summaries (eg, mean and median) of pain outcomes obtained from EMA and the effect of thresholding these summaries to obtain binary clinical end points of chronic pain status (yes/no). Data applications and simulations indicate that binarizing empirical estimators (eg, sample mean, random intercept linear mixed model) can perform well. However, linear mixed-effect modeling estimators that account for the nonlinear relationship between average and variability of pain scores perform better for quantifying the true average pain and reduce estimation error by up to 50%, with larger improvements for individuals with more variable pain scores. We also show that binarizing pain scores (eg, <3 and ≥3) can lead to a substantial loss of statistical power (40%-50%). Thus, when examining pain outcomes using EMA, the use of linear mixed models using the entire scale (0-10) is superior to splitting the outcomes into 2 groups (<3 and ≥3) providing greater statistical power and sensitivity. [ABSTRACT FROM AUTHOR]

Purpose: Since the COVID-19 pandemic, psycho-oncological care has increasingly been provided virtually and/or telephonically. We examined whether patients' therapeutic alliance (TA) – an essential processual outcome – differs due to altered modes of care delivery (MOCD) and assessed, if MOCD impacts patients' care satisfaction and patient reported outcomes. Methods: Survey and documentation data from newly diagnosed cancer patients that were cared for in the new form of care 'isPO' in Germany, were analyzed. Patients were surveyed after completing the one-year psycho-oncological care program. MOCD was operationalized by the ratio of patients' face-to-face, telephonic or video-based consultations to all their consultations. Regression analyzes were conducted to determine a possible relationship between MOCD and TA, between MOCD and patients' care satisfaction ('subjective effectiveness' and 'satisfaction and needs-orientation') and patient reported outcomes (anxiety and depression, sense of coherence, global health status). Findings: MOCD does not significantly influence TA. Regression models on the possible effect on subjective effectiveness and satisfaction and needs-orientation do not show statistical significance with only MOCD as the predictor. MOCD does not predict any of the patient reported outcomes. Conclusions: During the pandemic, neither TA, care satisfaction nor patient reported outcomes were affected by the MOCD in the new form of care 'isPO'. Therefore, the MOCD didn't negatively affect quality of care, which indicates that telephone or video consultations seem to be useful alternatives for psycho-oncological care in Germany. [ABSTRACT FROM AUTHOR]

Study Design: Retrospective cohort study. Objective: The primary objective was to evaluate the impact of the upper instrumented level (UIV) being at C2 vs C3 in posterior cervical construct on patient reported outcomes (PROs) up to 24 months after surgery for cervical degenerative myelopathy (DCM). Secondary objectives were to compare operative time, intra-operative blood loss (IOBL), length of stay (LOS), adverse events (AEs) and re-operation. Methods: Patients who underwent a posterior cervical instrumented fusion (3 and + levels) with a C2 or C3 UIV, with 24 months follow-up were analyzed. PROs (NDI, EQ5D, SF-12 PCS/MCS, NRS arm/neck pain) were compared using ANCOVA. Operative duration, IOBL, AEs, and re-operation were compared. Subgroup analysis was performed on patient presenting with pre-operative malalignment (cervical sagittal vertical axis ≥40 mm and/or T1slope- cervical lordosis >15°). Results: 173 patients were included, of which 41 (24%) had a C2 UIV and 132 (76%) a C3 UIV. There was no statistically significant difference between the groups for the changes in PROs up to 24 months. Subgroup analysis of patients with pre-operative malalignment showed a trend towards greater improvement in the NDI at 12 months with a C2 UIV (P =.054). Operative time, IOBL and peri-operative AEs were more in C2 group (P <.05). There was no significant difference in LOS and re-operation (P >.05). Conclusion: In this observational study, up to 24 months after surgery for posterior cervical fusion in DCM greater than 3 levels, PROs appear to evolve similarly. [ABSTRACT FROM AUTHOR]

Shared decision-making (SDM) is an essential component of patient-centered healthcare and disease management. However, the association of SDM with healthcare resource utilization and patient-reported outcomes among multimorbid individuals is not well understood. This study sought to evaluate the association of SDM with healthcare resource utilization and patient-reported outcomes among United States (US) adults with multimorbidity. Data were collected from the 2020 Medical Expenditure Panel Survey (MEPS) for this cross-sectional study. Eligible participants were US adults with two or more comorbidities. The predictor variable was SDM (optimal versus not optimal). The outcome variables were healthcare resource utilization and patient-reported outcomes. Logistic regression models, adjusted for demographic characteristics, assessed associations with SDM for each healthcare resource utilization and patient-reported outcome variable. The analysis maintained the complex survey data and was weighted to produce nationally representative estimates. Individuals who reported optimal SDM in adjusted analyses utilized more healthcare resources compared to those who reported not optimal SDM. Individuals with optimal SDM had more than one outpatient visit (odds ratio OR = 1.23, 95% CI = 1.03–1.47), emergency room visit (OR = 1.55, 95% CI = 1.17–2.06), and inpatient discharge (OR = 1.44, 95% CI = 1.05–1.96). Additionally, these individuals had higher odds of reporting limitations in their ability to work or engage in other activities due to their physical health in the past four weeks (OR = 1.27, 95% CI = 1.01–1.60). This study indicated evidence of increased healthcare resource utilization among patients who participate in SDM with their providers, which should be explored in future studies. [ABSTRACT FROM AUTHOR]

Abstract Background Outcome measures are crucial to support a treat-to-target approach to rheumatoid arthritis (RA) care, yet their integration into clinical practice remains inconsistent. We developed an Electronic Heath Record-integrated, patient-facing side-car application to display RA outcomes (disease activity, functional status, pain scores), medications, and lab results during clinical visits (“RA PRO Dashboard”). The study aimed to evaluate patient perceptions and attitudes towards the implementation of a novel patient-facing dashboard during clinical visits using a mixed-methods approach. Methods RA patients whose clinicians used the dashboard at least once during their clinical visit were invited to complete a survey regarding its usefulness in care. We also conducted semi-structured interviews with a subset of patients to assess their perceptions of the dashboard. The interviews were transcribed verbatim and analyzed thematically using deductive and inductive techniques. Emerging themes and subthemes were organized into four domains of the Ecological Model of Health. Results Out of 173 survey respondents, 79% were interested in seeing the dashboard again at a future visit, 71% felt it improved their understanding of their disease, and 65% believed it helped with decision-making about their RA care. Many patients reported that the dashboard helped them discuss their RA symptoms (76%) and medications (72%) with their clinician. Interviews with 29 RA patients revealed 10 key themes: the dashboard was perceived as a valuable visual tool that improved patients’ understanding of RA outcome measures, enhanced their involvement in care, and increased their trust in clinicians and the clinic. Common reported limitations included concerns about reliability of RA outcome questionnaires for some RA patients and inconsistent collection and explanation of these measures by clinicians. Conclusions In both the quantitative and qualitative components of the study, patients reported that the dashboard improved their understanding of their RA, enhanced patient-clinician communication, supported shared decision-making, and increased patient engagement in care. These findings support the use of dashboards or similar data visualization tools in RA care and can be used in future interventions to address challenges in data collection and patient education.

Abstract Background Previous research has suggested that alternative (respiratory) care providers (ACP) may provide affordable, accessible care for sleep-disordered breathing (SDB) that decreases wait-times and improves clinical outcomes. The objective of this study was to compare ACP-led and sleep physician-led care for SDB on patient reported outcome and experiences, with a focus on general and health-related quality of life, sleepiness, and patient satisfaction. Methods We conducted a secondary analysis of a randomized trial in which participants with severe SDB were assigned to either ACP-led or physician-led management. We created longitudinal linear mixed models to assess the impacts of treatment arm and timepoint on total and domain-level scores of multiple patient-reported outcome measures and patient-reported experience measures. Results Patients in both treatment arms (ACP-led n = 81; sleep-physician = 75) reported improved outcomes on the Sleep Apnea Quality of Life Index, Health Utilities Index, and Epworth Sleepiness Scale. Patients in each group had similar and clinically meaningful improvements on domains assessing cognition, emotion, and social functioning. The linear mixed models suggested no significant difference between treatment arms on the patient-reported outcomes. However, scores significantly improved over time. Conclusions Management of SDB using ACPs was comparable to physician-led care, as measured bypatient-reported outcome and experience measures. While loss to follow-up limits our findings, these results provide some support for the use of this novel health service delivery model to improve access to high quality SDB care. Clinical trial registration This is analysis of data from the study registered Clinicaltrials.gov (NCT02191085).

Abstract Introduction Rare genetic neurodevelopmental disorders and intellectual disability (ID), collectively called genetic ID (GID), can profoundly impact daily functioning and overall well-being of affected individuals. To improve our understanding of the impact of GID and advancing both care and research, measuring relevant patient reported outcomes (PROs) is crucial. Currently, various PROs are measured for GID. Given the shared comorbidities across disorders, we aim to develop a generic core PRO set for children and adults with GID. Methods and results Developing the generic core PRO set entails the following steps: 1) providing an overview of potentially relevant PROs by scoping reviews and qualitative research; 2) integrating and conceptualizing these PROs (i.e., describing the content of the PROs in detail) into a pilot generic core PRO set; and 3) prioritizing relevant PROs by a European Delphi survey and consensus meetings. Conclusions This protocol presents the steps for developing a generic core PRO set for children and adults with GID. The next step involves selecting suitable patient reported outcome measures (PROMs) to adequately measure these PROs: the generic core PROM set. This generic core PROM set needs validation in the GID population, and eventually implementation in care and research, facilitating the aggregation and analysis of PRO data and guaranteeing continuous integration of the patient perspective in both care and research.

Abstract Background Clinically-oriented outcome measures are increasingly being recognized as lacking in consideration of factors important to patients. There is an emerging move of guideline bodies advocating a more patient-centred approach. Aneurysms in autogenous arteriovenous fistula (AVF) can be considered unsightly and a constant reminder for patients of their dependence on dialysis. However, their impact on patient’s perception has not previously been reported. Methods Between April 2017–18, the Vascular Access Questionnaire (VAQ) was administered to prevalent haemodialysis patients across ten dialysis units via structured interviews, as part of a quality improvement project. Data for the subgroup of patients with aneurysmal AVF (categorised as per classification by Valenti et al.), were retrospectively evaluated and compared to the wider cohort. Results Data were collected for 539 patients (median age: 66 years; 59% male), of whom 195 (36%) had aneurysmal AVF, with Type 2 morphology (cannulation site) being the most common (75%). Duration of AVF was found to be significantly associated with aneurysmal development, with estimated likelihoods of 11%, 43% and 61% after one, five and ten years, respectively. Interestingly, patients with diabetes had a significantly lower prevalence of aneurysmal development than those that were non-diabetic (25% vs. 43%, p

Abstract Global outcomes have been reported to be associated with cerebrovascular reactivity (CVR) in the acute phase following moderate and severe traumatic brain injury (TBI). The association of CVR in the acute and chronic phase of injury with patient-reported health-related quality of life metrics (HRQOL) metrics has never been explored. The aim of this study is to examine the association of CVR, as measured by the cerebral oxygen indices (COx and COx_a), in the acute and chronic phase following moderate and severe TBI, with patient reported HRQOL. In this prospective cohort study, performed in a Canadian quaternary care center, the association between continuous acute and chronic phase CVR with patient reported HRQOL outcomes following moderate and severe TBI was examined. The main outcomes of interest of this study were validated measures of patient-reported HRQOL over various domains as measured by both the 12-Item Short-Form Health Survey (SF-12) and a Quality of Life after Brain Injury (QOLIBRI) questionnaire. In the 29 subjects of this cohort, acute phase CVR was found to be significantly more active in those with a favorable Mental Component Summary (MCS) scores of the SF-12 at early follow-up when measured by COx (-0.015 [IQR: -0.067 to 0.032] vs 0.040 [IQR: 0.019 to 0.137] for Favorable first MCS vs Unfavorable respectively; Mann–Whitney U test p-value = 0.046) and COx_a (0.038 [IQR: 0.009 to 0.062] vs 0.112 [IQR: 0.065 to 0.167] for Favorable first MCS vs Unfavorable respectively; Mann–Whitney U test p-value = 0.014). Further, multivariable logistic regression analysis found acute phase COx and COx_a to improve model performance when predicting favorable versus unfavorable early MCS scores over established parameters such as age and measures of injury severity. Associations between outcomes and chronic phase CVR were limited, potentially due to short recording periods. This is the first ever pilot study to identify a relationship between acute phase CVR following moderate-to-severe TBI with mental and cognitive outcomes as experienced by patients. Given the small cohort, these findings will need to be confirmed in a larger multicenter study. This highlights the need for additional examination of the role dysfunctional CVR may play in mental and cognitive outcomes, as well as patient-reported outcomes more generally following TBI.

Background: Determine the effect of a novel acellular cannulated dermal allograft on tendon-to-bone healing, retear rates, and clinical outcomes over a 12-month period. Methods: This was a single surgeon prospective nonrandomized case series. Patients with medium sized full-thickness superior and posterosuperior rotator cuff tears, as confirmed by magnetic resonance imaging, were consented. Patients were excluded if they had fatty atrophy indicative of Goutallier grade III or IV. The allograft is a cannulated rectangular prism that has a 5-year shelf life, does not require prehydration, and does not need to be trimmed to size. Outcome metrics included ultrasound assessment at 1-year as well as 6-month patient-reported outcomes (PROs) scores. Results: 31 patients consented and enrolled in this consecutive cohort series. 9 patients were excluded, and statistical analysis was performed on the remaining 22 patients. There were 9 females and 13 males. The average age was 59.27 ± 7.48 year old. The average supraspinatus short axis measurement in males was 0.56 ± 0.12 cm and 0.52 ± 0.09 cm in females (P = .44). The average supraspinatus long axis measurement in males was 0.61 ± 0.18 cm and 0.55 ± 0.14 cm in females (P = .46). The average infraspinatus short axis measurement in males was 0.48 ± 0.10 cm and 0.50 ± 0.13 in females (P = .74). The average infraspinatus long axis measurement in males was 0.44 ± 0.12 cm and 0.43 ± 0.08 cm in females (P = .84). Of the 19 patients who completed baseline and 6-month PRO’s, 17 achieved the minimal clinical important difference for American Shoulder and Elbow Surgeons and Patient-Reported Outcomes Measurement Information SystemUE 7a. Retear occurred in 2 cases. The remaining 20 cases have all demonstrated healing or fully healed repairs at their most recent clinical visits with no additional cases of retears. Conclusion: This study is the first to report the results of a novel acellular dermal allograft for rotator cuff repair augmentation. Satisfactory PRO measures and robust tendon healing at 1 year, as measured by ultrasound, demonstrate the utility of a cannulated human acellular dermal allograft as a viable biologic augmentation device for rotator cuff repair.

Abstract Background SMA is a hereditary neuromuscular disease that causes progressive muscle weakness and atrophy. Several studies have shown that the burden of SMA is very high at many levels. Functional assessment tools currently used do not completely address the impact of the disease in patients’ life. The objective of this qualitative study was to identify aspects of SMA that are relevant to patients and to design items useful for assessment purposes. Results Five focus group sessions were run during an annual SMA families meeting in Madrid, Spain. Focus groups were composed by parents of SMA type I children, sitter children type II-III, parents of sitter children type II-III, adult patients, and parents of walker children. Two trained facilitators conducted the focus groups using a semi-structured guideline to cover previously agreed topics based on the input of a Scientific and Patient Advisory Committee. The guideline was adapted for the different groups. According to what was communicated by participants, SMA entails a high burden of disease for both patients and their parents. Burden was perceived in physical, psychological, and social areas. Patient’s physical domain was the most relevant for participants, especially for parents of non-ambulant children, followed by limitations of motor scales to capture all changes, parents psychological burden, treatment expectations and patient’s psychological burden. Ten domains were the main areas identified as impacted by the disease: mobility and independence, fatigue and fatigability, infections and hospital consultations, scoliosis and contractures, vulnerability, pain, feeding, time spent in care, breathing, and sleep and rest. Conclusions This study confirms the necessity of evaluating other aspects of the disease that are not assessed in the functional motor scale. Measures of other aspects of the disease, such as pain, fatigue, feeding, should be also considered. A patient-reported outcomes instrument measuring such aspects in a valid and reliable way would be very useful. This study generated a list of new items relevant to be systematically measured in the assessment of the impact of SMA on the patients’ everyday life.

Abstract Background Cancer stage at diagnosis is an important prognostic indicator for patient outcomes, with detection at later stages associated with increased mortality and morbidity. The impact of cancer stage on patient-reported outcomes is poorly understood. This research aimed to understand symptom burden and health related quality of life (HRQoL) impact by cancer stage for ten cancer types: 1) ovarian, 2) lung, 3) pancreatic, 4) esophageal, 5) stomach, 6) head and neck, 7) colorectal, 8) anal, 9) cervical, and 10) liver and bile duct. Methods Ten narrative literature reviews were performed to identify and collate published literature on patient burden at different stages of disease progression. Literature searches were conducted using an AI-assisted platform to identify relevant articles published in the last five (2017–2022) or ten years (2012–2022) where articles were limited. Conference abstracts were searched for the last two years (2020–2022). The geographic scope was limited to the United States, Canada, Europe, and global studies, and only journal articles written in English were included. Results A total of 26 studies with results stratified by cancer stage at diagnosis (and before treatment) were selected for the cancer types of lung, pancreatic, esophageal, stomach, head and neck, colorectal, anal, and cervical cancers. Two cancer types, ovarian cancer, and liver and bile duct cancer did not return any search results with outcomes stratified by disease stage. A general trend was observed for worse patient-reported outcomes in patients with cancer diagnosed at an advanced stage of disease compared with diagnosis at an earlier stage. Advanced disease stage was associated with greater symptom impact including general physical impairments such as pain, fatigue, and interference with functioning, as well as disease/region-specific symptom burden. Poorer HRQoL was also associated with advanced disease with commonly reported symptoms including anxiety and depression. Conclusions Overall, the general trend for greater symptom burden and poorer HRQoL seen in late stage versus early-stage disease across the included cancer types supports the importance for early diagnosis and treatment to improve patient survival and decrease negative impacts on disease burden and HRQoL.

Abstract Purpose Clinical and patient reported outcomes are often collected before and after the procedure to benchmark and study outcomes for patients. These outcomes and scores are useful for tracking patient outcomes after surgery, however, the fact that these commonly used measures typically provide information about a patient’s level of pain and function at a single point in time is a limitation. Methods We present early functional recovery and return to work outcomes after primary THA from a novel questionnaire administered in a global, multi-center, prospective clinical study. Results By 6 and 12 weeks post-op, a large proportion of study subjects were able to perform functional recovery outcomes after their THA: walk without an aid (74%; 94%); drive (76%; 97%); basic activities of daily living (94%; 99%); perform light household duties (91%; 96%); perform moderate-to-heavy household duties (54%; 86%); go up and down a flight of stairs (92%; 99%); put on socks/stockings (77%; 93%); bend down to pick up an object from the floor (87%; 97%); stand up from a chair (96%; 99%); perform leisure recreational activities (54%; 84%); perform primary goal identified pre-THA (69%; 86%). 60% were able to return to work by 12 weeks post-op. These questions showed strong association with the Forgotten Joint Score. Conclusion Excellent patient reported early functional recovery outcomes and satisfaction were observed at 6- and 12-weeks post-op in this cohort and is the first reported data using a novel PRO. Clinical trial registration NCT03189303, registered June 14, 2017.

Abstract Background Patient reported outcomes (PROs) are being used frequently in clinical practice. PROs often serve several purposes, such as increasing patient involvement, assessing health status, and monitoring and improving the quality-of-care at an aggregated level. However, the lack of representative PRO-data may have implications for all these purposes. This study aims to assess the association of non-administration of (not sending an electronic invite to PRO) and non-response to (not responding to PRO) electronically administered PROs with social inequality in a primary healthcare cancer rehabilitation setting. Furthermore, it examines whether the workflows surrounding PRO have an impact on non-administration and non-response. Methods This is a cross sectional study using routinely collected data from electronic health records and registers including cancer survivors (CSs) over 18 years booked for an initial consultation in a primary healthcare cancer rehabilitation setting using PROs for systematic health status assessment. During the study period two different PRO platforms were used, each associated with different workflows. Non-administration and non-response rates were calculated for sociodemographic characteristics for each PRO platform. Crude and adjusted odds ratios were calculated using univariate and multivariate logistic regression. Results In total, 1868 (platform 1) and 1446 (platform 2) CSCSs were booked for an initial consultation. Of these, 233 (12.5%) (platform 1) and 283 (19.6%) (platform 2) were not sent a PRO (non-administration). Among those who received a PRO, 157 (9.6%) on platform 1 and 140 (12.0%) on platform 2 did not respond (non-response). Non-administration of and non-response to PROs were significantly associated with lower socioeconomic status. Moreover, the workflows surrounding PROs seem to have an impact on non-inclusion in and non-response to PROs. Conclusions Non-administration of and non-response to PROs in clinical practice is associated with determinants of social inequality. Clinical workflows and the PRO platforms used may potentially worsen this inequality. It is important to consider these implications when using PROs at both the individual and aggregated levels. A key aspect of implementing PROs in clinical practice is the ongoing focus on representativeness, including a focus on monitoring PRO administration and response.

Abstract Multiple sclerosis (MS) is a chronic neurological disease frequently associated with significant fatigue, anxiety, depression, and stress. These symptoms are difficult to treat, and prominently contribute to the decreases in quality of life observed with MS. The underlying mechanisms of these “silent” symptoms are not well understood and include not just the psychological responses to a chronic disease, but also biological contributions from bidirectional psycho-neuro-immune (dys)regulation of systemic inflammatory biology. To address these issues, we conducted a prospective, observational pilot study to investigate the psychological, biological, and neuroarchitecture changes associated with a mindfulness-based stress reduction (MBSR) program in MS. The overarching hypothesis was that MBSR modulates systemic and central nervous system inflammation via top-down neurocognitive control over forebrain limbic areas responsible for the neurobiological stress response. 23 patients were enrolled in MBSR and assessed pre/post-program with structural 3 T MRI, behavioral measures, hair cortisol, and blood measures of peripheral inflammation, as indexed by the Conserved Transcriptional Response to Adversity (CTRA) profile. MBSR was associated with improvements across a variety of behavioral outcomes, as well as on-study enlargement of the head of the right hippocampus. The CTRA analyses revealed that greater inflammatory gene expression was related to worse patient-reported anxiety, depression, stress, and loneliness, in addition to lower eudaimonic well-being. Hair cortisol did not significantly change from pre- to post-MBSR. These results support the use of MBSR in MS and elucidate inflammatory mechanisms related to key patient-reported outcomes in this population.

Efrat Neter,1 Efrat Esterkin-Hubner,2 Lea Glass-Marmor,2 Anat Wolkowitz,2 Idit Lavi3 ,† Ariel Miller2,4 1Ruppin Academic Center, Emeq Hefer, Israel; 2Multiple Sclerosis Center & Department of Neurology,Carmel Medical Center, Haifa, Israel; 3Department of Community Medicine & Epidemiology, Carmel Medical Center, Haifa, Israel; 4Rappaport Faculty of Medicine, Technion Institute of Technology, Haifa, Israel†Idit Lavi passed away on 31.7.2022Correspondence: Efrat Neter, Ruppin Academic Center, 3 Bait, Emeq Hefer, 4025000, Israel, Tel +972-54-6462677, Fax +972-9-8983043, Email neter@ruppin.ac.il; neter@ruppin.ac.ilPurpose: To evaluate the acceptability, retention, and efficacy of face-to-face intervention, incorporating education and Motivational Interviewing (MI) to support persons with relapsing-remitting multiple sclerosis (PwRRMS) and increase self-reported medication adherence.Patients and Methods: PwRRMS (N = 60) prescribed Disease Modifying Treatment (DMT), who were identified as non-adherent and consented to participate in an intervention, received verbal education and counseling from their treating physician, a tailored MI counseling and a booster session via telephone with a health psychologist, and a concluding MI counseling six months later. Each PwRRMS filled a battery of patient-reported outcomes (PROs) at baseline, six and 12 months later. The design was a quasi-experimental pre-test post-test across a year.Results: Of the sixty identified persons who consented to enroll, 52 completed the intervention and 46 completed the follow-up. At six months following the baseline, adherence scores increased (median = 12.0) and were significantly different than at baseline (median=10.0, p = 0.030). Still, at 12 months follow-up there was no significant difference from baseline in reported adherence (median = 11.0, p = 0.106).Conclusion: This study demonstrated reasonable retention and initial efficacy of a combined psycho-education and MI protocol for PwRRMS to enhance medication adherence to DMT. To maintain the change, a more sustained intervention is required.Plain Language Summary: The study focused on persons with relapsing-remitting multiple sclerosis (PwRRMS) who do not adhere to their prescribed medication.Following the identification of non-adherent persons, PwRRMS were offered an intervention to increase their adherence. The study examined how many of those identified consented to enroll in the intervention, how many remained in the intervention, and whether the intervention was efficacious in terms of self-reported adherence.The intervention included verbal education and counseling from the treating physician, immediately followed by tailored counseling by a psychologist. There was a booster session via telephone with the psychologist, and a concluding counseling meeting six months later. Participants were followed for a year after the initial counseling.Two-thirds of PWMS identified as non-adherent consented to enroll (n = 60), 52 completed the intervention and 46 completed the follow-up. At six months following counseling, self-reported adherence scores significantly increased, but at 12 months follow-up there was no significant difference from baseline in reported adherence. To maintain the change, a more sustained intervention is required.Keywords: disease modifying therapy, medication adherence, medication beliefs, motivational interviewing, multiple sclerosis, participatory medicine, patient reported outcomes

Ganesan Baranidharan,1,2 Beatrice Bretherton,1,3 Richard G Feltbower,4 Jake Timothy,5 Almas Latif Khan,6,7 Ashok Subramanian,8 Mushtaq Ahmed,9 Tracey A Crowther,1,10 Helen Radford,10,11 Harun Gupta,12 Muthusamy Chandramohan,13 Douglas P Beall,14 Timothy R Deer,15 Thomas Hedman16 1Pain Management Department, Leeds Teaching Hospitals NHS Trust, Leeds, UK; 2School of Medicine, University of Leeds, Leeds, UK; 3School of Biomedical Sciences, Faculty of Biological Sciences, University of Leeds, Leeds, UK; 4Leeds Institute for Data Analytics, School of Medicine, University of Leeds, Leeds, UK; 5Department of Neuroscience, Leeds Teaching Hospitals NHS Trust, Leeds, UK; 6Department of Spine Surgery, Leeds Teaching Hospitals NHS Trust, Leeds, UK; 7Institute of Medical and Biological Engineering, University of Leeds, Leeds, UK; 8Somerset Spinal Surgery Service, Musgrove Park Hospital, Taunton, UK; 9Department of Trauma and Orthopaedic Surgery, Dudley Group NHS Foundation Trust, Dudley, UK; 10Research & Innovation, Leeds Teaching Hospitals NHS Trust, Leeds, UK; 11Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK; 12Department of Radiology, Leeds Teaching Hospitals NHS Trust, Leeds, UK; 13Radiology Department, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK; 14Comprehensive Specialty Care, Edmond, OK, USA; 15The Spine and Nerve Center of the Virginias, Charleston, WV, USA; 16Department of Biomedical Engineering, University of Kentucky, Lexington, KY, USACorrespondence: Ganesan Baranidharan, Pain Management Department, Leeds Teaching Hospitals NHS Trust, Leeds, UK, Email g.baranidharan@nhs.netPurpose: An early-stage, multi-centre, prospective, randomised control trial with five-year follow-up was approved by Health Research Authority to compare the efficacy of a minimally invasive, laterally implanted interspinous fixation device (IFD) to open direct surgical decompression in treating lumbar spinal stenosis (LSS). Two-year results are presented.Patients and Methods: Forty-eight participants were randomly assigned to IFD or decompression. Primary study endpoints included changes from baseline at 8-weeks, 6, 12 and 24-months follow-ups for leg pain (visual analogue scale, VAS), back pain (VAS), disability (Oswestry Disability Index, ODI), LSS physical function (Zurich Claudication Questionnaire), distance walked in five minutes and number of repetitions of sitting-to-standing in one minute. Secondary study endpoints included patient and clinician global impression of change, adverse events, reoperations, operating parameters, and fusion rate.Results: Both treatment groups demonstrated statistically significant improvements in mean leg pain, back pain, ODI disability, LSS physical function, walking distance and sitting-to-standing repetitions compared to baseline over 24 months. Mean reduction of ODI from baseline levels was between 35% and 56% for IFD (p< 0.002), and 49% to 55% for decompression (p< 0.001) for all follow-up time points. Mean reduction of IFD group leg pain was between 57% and 78% for all time points (p< 0.001), with 72% to 94% of participants having at least 30% reduction of leg pain from 8-weeks through 24-months. Walking distance for the IFD group increased from 66% to 94% and sitting-to-standing repetitions increased from 44% to 64% for all follow-up time points. Blood loss was 88% less in the IFD group (p=0.024) and operating time parameters strongly favoured IFD compared to decompression (p< 0.001). An 89% fusion rate was assessed in a subset of IFD participants. There were no intraoperative device issues or re-operations in the IFD group, and only one healed and non-symptomatic spinous process fracture observed within 24 months.Conclusion: Despite a low number of participants in the IFD group, the study demonstrated successful two-year safety and clinical outcomes for the IFD with significant operation-related advantages compared to surgical decompression.Keywords: lumbar spinal stenosis, surgical decompression, posterior lateral arthrodesis, patient reported outcomes, minimally invasive spine, interspinous fixation device

Abstract Background The IMPACT survey aimed to elucidate the humanistic, clinical and economic burden of osteogenesis imperfecta (OI) on individuals with OI, their families, caregivers and wider society. Research methodology, demographics and initial insights from the survey have been previously reported. The cost of illness (healthcare resource use, productivity loss, out-of-pocket spending) and drivers of the economic impact of OI are reported here. Methods IMPACT was an international mixed-methods online survey in eight languages (fielded July–September 2021) targeting adults (aged ≥ 18 years) or adolescents (aged ≥ 12–17 years) with OI, caregivers with or without OI and other close relatives. Survey domains included demographics, socioeconomic factors, clinical characteristics, treatment patterns, quality of life and health economics. The health economic domain for adults, which included questions on healthcare resource use, productivity loss and out-of-pocket spending, was summarised. Regression and pairwise analyses were conducted to identify independent drivers and associations with respondent characteristics. Results Overall, 1,440 adults with OI responded to the survey. Respondents were mostly female (70%) and from Europe (63%) with a median age of 43 years. Within a 12-month period, adults with OI reported visiting a wide range of healthcare professionals. Two-thirds (66%) of adults visited a hospital, and one-third (33%) visited the emergency department. The mean total number of diagnostic tests undergone by adults within these 12 months was 8.0. Adults had undergone a mean total of 11.8 surgeries up to the time point of the survey. The proportions of adults using queried consumables or services over 12 months ranged from 18–82%, depending on the type of consumable or service. Most adults (58%) were in paid employment, of which nearly one-third (29%) reported missing a workday. Of the queried expenses, the mean total out-of-pocket spending in 4 weeks was €191. Respondent characteristics such as female sex, more severe self-reported OI and the experience of fractures were often associated with increased economic burden. Conclusion IMPACT provides novel insights into the substantial cost of illness associated with OI on individuals, healthcare systems and society at large. Future analyses will provide insights into country-specific economic impact, humanistic impact and the healthcare journey of individuals with OI.

In recent years, diabetes technologies have revolutionized the care of people with type 1 diabetes (T1D). Emerging evidence suggests that people with type 2 diabetes (T2D) can experience similar benefits from these advances in technology. While glycaemic outcomes are often a primary focus, the lived experience of the person with diabetes is equally important. In this review, we describe the impact of diabetes technologies on patient‐reported outcome measures (PROMs). We highlight that most of the published studies investigated PROMs as secondary outcomes. Continuous glucose monitoring systems may have an important role in improving PROMs in individuals with T1D, which may be driven by the prevention or proactive management of hypoglycaemia. In people with T2D, continuous glucose monitoring may also have an important role in improving PROMs, particularly in those treated with insulin therapy. The impact of insulin pumps on PROMs seems positive in T1D, while there is limited evidence in T2D. Studies of hybrid closed‐loop therapies suggest increased treatment satisfaction, improved quality of life and decreased diabetes‐related distress in T1D, but it is unclear whether these benefits are because of a ‘class‐effect’ or individual systems. We conclude that PROMs deserve a more central role in trials and clinical practice, and we discuss directions for future research. [ABSTRACT FROM AUTHOR]

Background: ASTHMAXcel PRO, an enhanced version of the ASTHMAXcel mobile application, has been developed to deliver comprehensive, guideline-based asthma education while also facilitating the collection of patient-reported outcomes (PROs) and enhancing user experience. Objective: To perform field testing and conduct formative and summative evaluation of the ASTHMAXcel PRO application to assess its impact on patient satisfaction, usability, and usage. Methods: Twenty-eight adult patients completed a baseline visit during which ASTHMAXcel PRO was introduced, health literacy was assessed, and demographic data were collected. They were instructed to use the app for 4 weeks. The Questionnaire for User Interface Satisfaction (QUIS) and the Unified Theory of Acceptance and Use of Technology (UTAUT) questionnaire were administered at baseline and 4 weeks to assess user satisfaction and technology acceptance, respectively. Semi-structured interviews were conducted to gather feedback regarding the application from patients. Results: The baseline total scores were high for both UTAUT and QUIS (mean (SD): 64.2 (10.1), 6.8 (2.2) respectively) indicating that user satisfaction and acceptance began at high levels. UTAUT total score, as well as all domain scores, improved significantly from baseline to 4 weeks (p < 0.02). QUIS total score along with several domain scores (screen, system capabilities, usability) also increased from baseline to 4-weeks (p = 0.03, 0.01, 0.03, 0.01, respectively). These improvements remained significant when adjusting for age, gender, education, and health literacy. Patients reported that the application was helpful, informative, and easy to understand and use. Conclusion: The significant increases in satisfaction and technology adoption observed among ASTHMAXcel PRO users demonstrate that the application is viable and has the potential to improve upon usability challenges faced by existing mobile health applications. [ABSTRACT FROM AUTHOR]

Background: Same day discharge (SDD) following atrial fibrillation (AF) ablation procedure has emerged as routine practice, and primarily driven by operator discretion. However, the impacts of SDD on clinical outcomes, healthcare system costs, and patient reported outcomes (PROs) have not been systematically studied. Methods: We retrospectively analyzed patients undergoing routine AF ablation procedures with SDD versus overnight observation (NSDD). After propensity adjustment we compared postprocedure adverse events (AEs), healthcare system costs, and changes in PROs. Results: We identified 310 cases, with 159 undergoing SDD and 151 staying at least one midnight in the hospital (NSDD). Compared with NSDD, SDD patients were similar age (mean 64 vs. 66, p = 0.3), sex (26% female vs. 27%, p = 0.8), and with lower mean CHADS2‐VA2Sc scores (2.0 vs. 2.7; p < 0.011). The primary outcome of AEs was noninferior in SDD versus NSDD patients (odds ratio 0.45, 95% confidence interval 0.21−0.99; noninferiority margin of 10%). There were also no differences in overall cost to the healthcare system between SDD and NSDD (p = 0.11). PROs numerically favored SDD (p = NS for all scores). Conclusions: Physician selection for SDD appears at least as safe as NSDD with respect to clinical outcomes and SDD is not significantly less costly to the health system. There is a trend towards more favorable, general PROs among SDD patients. Routine SDD should be strongly considered for patients undergoing routine AF ablation procedures. [ABSTRACT FROM AUTHOR]