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INTRODUCTION: Atopic dermatitis is a complex, chronic, inflammatory skin disease that requires long-term control of symptoms like itch and sleep loss and improvement in quality of life, in addition to reduction of clinical signs. Lebrikizumab is a selective interleukin-13 inhibitor approved in the European Union, United Kingdom, United Arab Emirates, Canada, and Japan for treatment of moderate-to-severe atopic dermatitis in adults and adolescents. Here, we assess the magnitude of changes across signs and symptoms of atopic dermatitis with lebrikizumab monotherapy over the 16-week induction period in two phase 3 studies, ADvocate1 and ADvocate2. METHODS: Eligible adults (aged ≥ 18 years) and adolescents (aged 12 to < 18 years and weighing ≥ 40 kg) with moderate-to-severe atopic dermatitis were randomized to receive either 250 mg of lebrikizumab or placebo subcutaneously every two weeks. Least squares mean percentage change from baseline through week 16 was compared between lebrikizumab and placebo using mixed model repeated measure analysis for the following endpoints: Eczema Area and Severity Index (EASI), Pruritus Numeric Rating Scale (NRS), Sleep-Loss Scale, Patient-Oriented Eczema Measure (POEM), and Dermatology Life Quality Index (DLQI). RESULTS: In both trials, significant (P < 0.05) improvements were observed for lebrikizumab treatment compared with placebo at each 2-week timepoint for EASI, Pruritus NRS, Sleep-Loss Scale, and POEM, and at each 4-week timepoint for DLQI, through week 16. Statistically significant (P < 0.001) improvements were observed at 16 weeks for lebrikizumab treatment versus placebo in ADvocate1/ADvocate2 for EASI (71.9%/75.0% vs. 35.6%/43.3%), Pruritus NRS (53.3%/46.3% vs. 21.4%/18.0%), Sleep-Loss Scale (57.7%/55.6% vs. 23.9%/25.5%), POEM (54.4%/45.8% vs. 18.8%/16.9%), and DLQI (64.2%/60.5% vs. 28.5%/32.2%). Patient photos show improvements in skin appearance when disease measures improve. CONCLUSIONS: Lebrikizumab monotherapy resulted in significant and fast improvements in multiple dimensions of disease (clinical signs, symptoms, and quality of life) over 16 weeks in patients with moderate-to-severe atopic dermatitis. TRIAL REGISTRATION: ClinicalTrials.gov identifiers, NCT04146363; NCT04178967.

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AIM: To investigate associations between Body Image concerns (BICs) measured by the ICD Body Image Concerns Questionnaire (ICD-BICQ) and other Patient-Reported-Outcomes (PROs), in a cohort of patients with an Implantable Cardioverter Defibrillator (ICD). METHODS AND RESULTS: In a cross-sectional survey, we included patients >18 years implanted with a first-time ICD (VVI, DDD and CRT-D) who had lived with their ICD from 3-24 months. They completed the 39-item ICD-BICQ together with the Generalized Anxiety Disorder-scale, Patient Health-Questionnaire, Type D-Scale, Health Status-Questionnaire and the Florida Patient Acceptance-Survey. Data were analyzed using linear regression to compare personality constructs between patients with and without BICs. Logistic repression and receiver operating characteristic curves were used to predict patients with BICs based on other PROs.A total of 330 patients completed the survey. Five patients were excluded due to re-operations leaving 325 patients in the analyses. A total of 20% reported BICs at the recommended cut-off at 36-points. Patients with BICs reported higher anxiety and depression levels, lower device acceptance and health status, had a Type D personality as compared to patients without BICs. FPAS was moderately able to predict BICs, while other PROs only had limited ability to predict BICs. CONCLUSION: Patients with BICs reported poorer PROs. The PRO instruments were not able to predict patients with BICs, indicating that the ICD-BICQ provides independent relevant clinical information. In clinical practice, healthcare professionals can use the ICD-BICQ to identify and obtain information on possible BICs. The ICD-BICQ can also be used to evaluate new operation techniques.

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Objectives: To report lessons from integrating the methods and perspectives of clinical informatics (CI) and implementation science (IS) in the context of Improving the Management of symPtoms during and following Cancer Treatment (IMPACT) Consortium pragmatic trials. Materials and Methods: IMPACT informaticists, trialists, and implementation scientists met to identify challenges and solutions by examining robust case examples from 3 Research Centers that are deploying systematic symptom assessment and management interventions via electronic health records (EHRs). Investigators discussed data collection and CI challenges, implementation strategies, and lessons learned. Results: CI implementation strategies and EHRs systems were utilized to collect and act upon symptoms and impairments in functioning via electronic patient-reported outcomes (ePRO) captured in ambulatory oncology settings. Limited EHR functionality and data collection capabilities constrained the ability to address IS questions. Collecting ePRO data required significant planning and organizational champions adept at navigating ambiguity. Discussion: Bringing together CI and IS perspectives offers critical opportunities for monitoring and managing cancer symptoms via ePROs. Discussions between CI and IS researchers identified and addressed gaps between applied informatics implementation and theory-based IS trial and evaluation methods. The use of common terminology may foster shared mental models between CI and IS communities to enhance EHR design to more effectively facilitate ePRO implementation and clinical responses. Conclusion: Implementation of ePROs in ambulatory oncology clinics benefits from common understanding of the concepts, lexicon, and incentives between CI implementers and IS researchers to facilitate and measure the results of implementation efforts.

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BACKGROUND: Fewer than 20% of adults with chronic gastrointestinal (GI) symptoms have accessed care to evaluate or manage their symptoms. We sought to characterize whether adults with chronic GI symptoms would use an app for symptom monitoring and the effects of participation in a digitally delivered GI chronic care program. METHODS: We provided a digital digestive care management app to adults via their employer-sponsored benefits. We evaluated participants' self-reported GI symptoms at baseline and between 30 and 90 days post-registration. GI symptoms (e.g., abdominal pain and constipation) were rated on a scale of 0 (no symptoms) to 4 (very severe symptoms). RESULTS: A total of 1936 participants were enrolled (75% female; 67% White, 11% Asian/Pacific Islander, 6% Hispanic, 7% Black; mean age: 43 years). Their most common GI conditions were irritable bowel syndrome (IBS), gastroesophageal reflux disease (GERD), and acid reflux. Participants of all genders and races reported statistically significant improvements in all symptoms between baseline and the end of the intervention (P < 0.05). At baseline, 79.5% of participants reported at least moderate GI symptom severity for at least one symptom. In contrast, at the end of the intervention, only 47.8% of participants reported moderate or severe symptoms, and 310 (16.0%) participants reported no symptoms. Participants who were scheduled with their care team reported greater symptom improvement than those who were not scheduled (P = 0.004). Participants reported feeling greater control of their health (83%), better management of their digestive symptoms (83%), increased happiness (76%), and greater productivity at work (54%). CONCLUSION: Demographically diverse participants engaged with a digital digestive chronic care program and reported significant improvements in digestive symptom severity.

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Cleft palate presents multifaceted challenges impacting speech, hearing, appearance, and cognition, significantly affecting patients' quality of life (QoL). While surgical advancements aim to restore function and improve appearance, traditional clinical measures often fail to comprehensively capture patients' experiences. Patient-reported outcomes measure (PROMs) have emerged as crucial tools in evaluating QoL, offering insights into various aspects such as esthetic results, speech function, and social integration. This review explores PROMs relevant to cleft palate complications, including velopharyngeal insufficiency, oronasal fistulas, maxillary hypoplasia, sleep-disordered breathing, and caregiver QoL. Additionally, the review highlights the need for cleft palate-specific scales to better address the unique challenges faced by patients. By incorporating PROMs, healthcare providers can achieve more personalized, patient-centered care, improve communication, and enhance treatment outcomes. Future research should focus on developing and validating specialized PROMs to further refine patient assessments and care strategies.

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Background: Little is known about patients' postoperative week-by-week progress after undergoing posterior approach total hip arthroplasty (THA) with regard to pain, function, return to work, and driving. Purpose: We sought to evaluate a large cohort of patients undergoing posterior approach THA with modified posterior hip precautions to better understand the trajectory of recovery. Methods: Patients at a single institution undergoing primary posterior approach THA by fellowship-trained arthroplasty surgeons were prospectively enrolled. Patient functional status and early rehabilitation recovery milestones were evaluated preoperatively and each week postoperatively for 6 weeks. Results: Of 312 patients who responded to weekly questionnaires, there were varying response rates per question. At 1 week after surgery, 15% (39/256) of respondents had returned to work, increasing to 57% (129/225) at week 6. At 6 weeks, 77% of patients (174/225) had returned to driving; 25% (56/225) were taking pain medication (including prescription opioids or nonsteroidal anti-inflammatory drugs); and 15% (34/225) were using assistive devices (down from 91%, 78%, 56%, 35%, and 27% at weeks 1, 2, 3, 4, and 5, respectively). Average postoperative Hip dysfunction and Osteoarthritis Outcome Score for Joint Replacement and Lower Extremity Functional Scale scores were significantly higher than preoperative scores. Respondents reported significantly less pain at each week postoperatively than the previous week. Conclusion: These findings suggest that there may be an expected pathway for recovery after posterior THA using perioperative pain protocols, modified postoperative precautions, and physical therapy protocols to improve patient outcomes after THA, with most patients returning to normal at 4 weeks. Defining the expected recovery timeline may help surgeons in counseling patients preoperatively and guiding their recovery.

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Objectives: To assess tolerability of COVID-19 vaccination in patients with RA and controls based on patient-reported outcomes (PROs). Methods: In total, 266 study participants were included at 6 ± 1 weeks after their second vaccination (BioNTech/Pfizer (72.2%), AstraZeneca (18.8%) and Moderna (9.0%)). In a cross-sectional, observational study design, PRO data were recorded regarding both total and symptom-level tolerability. Results: Overall tolerability was very high according to the patients' self-assessment scores (1.71 for the first and 1.72 for the second vaccination, 6-point Likert scale [1 (very good) to 6 (very poor)]) and did not differ significantly between patients with RA (n = 204) and controls (n = 62). Self-rated overall tolerability regarding first vaccination was significantly better (P = 0.002) in patients receiving mRNA vaccines (n = 193, mean tolerability 1.59) as compared with vector-vaccinated patients (n = 73, mean tolerability 2.04). Homologous or heterologous vaccination regimens had no statistically significant effect on vaccine tolerability (P = 0.131). Reservations about the vaccination were rare (6.4% for the first and 6.0% for the second vaccination) but significantly associated with poorer overall tolerability (P < 0.001) and significantly reduced willingness to recommend vaccination to others (P < 0.001 for the first and P = 0.004 for the second vaccination). Conclusion: Based on these real-world data, tolerability of COVID-19 vaccination was very good in both RA patients and controls. Reservations against COVID-19 vaccination were rare overall, but if present, associated with a significantly worse tolerability and a significantly lower degree of recommendation.

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Background: Despite widespread usage of the SRS-22r questionnaire (Scoliosis Research Society Questionnaire-22r), the English version has only sparingly been subjected to analysis using modern psychometric techniques for patients with adolescent idiopathic scoliosis (AIS). The study purpose was to improve interpretation and clinical utility of the SRS-22r for adolescents with AIS by generating additional robust evidence, using modern statistical techniques. Questions about (1) Structure and (2) Item and Scale Functioning are addressed and interpreted for clinicians and researchers. Methods: This retrospective case review analyzed SRS-22r data collected from 1823 patients (mean age 14.9±2.2years) with a primary diagnosis of AIS who clinically completed an SRS-22r questionnaire.Individual SRS-22r questions and domain scores were retrieved through data queries. Patient information collected through chart review included diagnosis, age at assessment, sex, race and radiographic parameters. From 6044 SRS-22r assessments, 1 assessment per patient was randomly selected. Exploratory structural equation modeling (ESEM) and item response theory (IRT) techniques were used for data modeling, item calibration, and reliability assessment. Results: ESEM demonstrated acceptable fit to the data: χ2 (130)=343.73, p<.001; RMSEA=0.035; CFI=0.98; TLI=0.96; SRMR=0.02. Several items failed to adequately load onto their assigned factor. Item fit was adequate for all items except SRSq10 (Self-Image), SRSq16 (Mental Health), and SRSq20 (Mental Health). IRT models found item discriminations are within normal levels for items in psychological measures, except items SRSq1 (pain), SRSq2 (pain), and SRSq16 (mental health). Estimated reliability of the Function domain (ρ=0.69) was low, however, Pain, Self-Image and Mental Health domains exhibited high (ρ>0.80) reliability. Conclusions: Modern psychometric assessment of the SRS-22r, in adolescent patients with AIS, are presented and interpreted to assist clinicians and researchers in understanding its strengths and limitations. Overall, the SRS-22r demonstrated good psychometric properties in all domains except function. Cautious interpretation of the total score is suggested, as it does not reflect a single HRQoL construct.

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BACKGROUND: The merits of technology have been adopted in capturing patient-reported outcomes (PROs) by incorporating PROs into electronic systems. Following the development of an electronic system, evaluation of system performance is crucial to ensuring the collection of meaningful data. In contemporary PRO literature, electronic system validation is overlooked, and evidence on validation methods is lacking. OBJECTIVE: This study aims to introduce a generalized concept to guide electronic patient-reported outcome (ePRO) providers in planning for system-specific validation methods. METHODS: Since electronic systems are essentially products of software engineering endeavors, electronic systems used to collect PRO should be viewed from a computer science perspective with consideration to the health care environment. On this basis, a testing model was blueprinted and applied to a newly developed ePRO system designed for clinical use in pediatric dentistry (electronic Personal Assessment Questionnaire-Paediatric Dentistry) to investigate its thoroughness. RESULTS: A behavior-based model of ePRO system validation was developed based on the principles of user acceptance testing and patient-centered care. The model allows systematic inspection of system specifications and identification of technical errors through simulated positive and negative usage pathways in open and closed environments. The model was able to detect 15 positive errors with 1 unfavorable response when applied to electronic Personal Assessment Questionnaire-Paediatric Dentistry system testing. CONCLUSIONS: The application of the behavior-based model to a newly developed ePRO system showed a high ability for technical error detection in a systematic fashion. The proposed model will increase confidence in the validity of ePRO systems as data collection tools in future research and clinical practice.

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The outcomes reported in trials across all stages of chronic kidney disease (CKD) are highly variable and often do not include outcomes that are directly relevant to patients and caregivers. Frequently, the outcomes reported in trials are often unvalidated surrogate biochemical end points. The omission of outcomes that are meaningful and important to patients can diminish the value of trials in supporting treatment decisions. In response, there have been increasing efforts across many health and medical disciplines to develop core outcome sets, defined as the minimum set of outcomes to be reported in all trials in a specific health area to improve the relevance and consistency of reporting trial outcomes. The international Standardized Outcomes in Nephrology (SONG) initiative was established in 2014 and has since developed seven core outcome sets for different diagnosis and treatment stages of CKD. The core outcomes were based on consensus among patients, caregivers, and health professionals. Each core outcome set includes at least one patient-reported outcome, including fatigue (hemodialysis), life participation (kidney transplantation, peritoneal dialysis, early CKD not yet requiring kidney replacement therapy, children and adolescents, and glomerular disease), and pain (polycystic kidney disease). This article outlines how patient-reported outcomes are currently reported in trials, discusses core patient-reported outcomes that have been established for trials in kidney disease, and outlines strategies for implementing core patient-reported outcomes in trials.

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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.

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Background/Objectives: Psoriasis (PsO) is a chronic inflammatory skin disease that severely impacts patients' quality of life (QoL). Its global prevalence is about 2%, with significant regional variations. PsO manifests in the form of erythematous and scaly plaques, causing intense pruritus and discomfort and limiting daily activities. The condition often includes comorbidities such as psoriatic arthritis, cardiovascular diseases, and metabolic syndrome, further deteriorating QoL. Psychological well-being is notably affected, with high levels of depression and anxiety due to the visible lesions, leading to social stigma and isolation. QoL indexes like WHO-QoL and SF-36 assess various well-being aspects, while patient-reported outcomes (PROs) provide a comprehensive understanding of PsO's impact. However, there are no universally shared PROs in outpatient practice to fully understand the impact of the disease and associated therapies. This study aims to evaluate differences between DLQI and WHO-5 in adult patients with moderate-to-severe PsO treated with tildrakizumab 100 mg or 200 mg. Methods: The study was conducted at the University Hospital of Siena, Italy, from May 2023 to April 2024. Data from 15 patients treated with tildrakizumab 200 mg and 15 patients treated with tildrakizumab 100 mg, observed for at least 28 weeks, were recorded. Demographic data, PASI, DLQI, and WHO-5 scores were analyzed. Patients in the 100 mg group (G100) were selected to match the demographic characteristics of the 200 mg group (G200). Reduction rates of DLQI and WHO-5 were assessed at baseline values and after 4, 16, and 28 weeks. Results: Both groups experienced improvements in QoL. The group treated with 200 mg showed more pronounced and rapid reductions in DLQI and WHO-5 scores compared to the 100 mg group. WHO-5 demonstrated faster improvements in overall well-being than DLQI, indicating its greater sensitivity to changes in mental well-being and overall QoL. No differences in adverse events were observed between the two groups, with no major adverse events reported. Conclusions: In our study, WHO-5 proved more sensitive than DLQI in capturing well-being changes in PsO patients treated with tildrakizumab. However, a combined use of both WHO-5 and DLQI questionnaires should be encouraged in clinical practice. Furthermore, this study confirmed the superior QoL improvement associated with tildrakizumab 200 mg compared to 100 mg. Future research should explore the long-term impact on QoL and comparative effectiveness among other biologic therapies in diverse patient populations.

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BACKGROUND: Healthcare professionals are faced with the new challenges of preventing and managing drug-related problems (DRPs) with oral anticancer therapy (OAT): side-effects, drug-drug interactions (DDIs), non-adherence, or medication errors. This study aims to assess the impact of ONCORAL, a real-life multidisciplinary care plan for cancer patients based on community and hospital follow-up, for the first OAT cycle. METHODS: A prospective cohort study was conducted between October 1, 2021 and October 1, 2022 including all outpatients starting OAT treatment. During the first OAT cycle, the program consists of 6 weekly scheduled face-to-face or phone consultations to prevent and manage DRPs. Nurse and pharmacist interventions (NPIs) are realized to optimize treatments (primary outcomes). Secondary outcomes included the relative dose intensity (RDI) of the first cycle. RESULTS: A total of 562 NPIs were performed by the ONCORAL team: that is, 87.1% of the 209 patients included, for a mean of 3.1 ±â€…2.2 NPIs/patient. NPIs-concerned DRPs detected by the nurse and pharmacist (346, 61.6%), symptoms and/or adverse effects reported as PROs by the patient or family (138, 24.6%), or pathway issues (78, 13.9%). Seventy-three DDIs were detected and managed during medication review, in a quarter of patients (n = 54/209), leading to the discontinuation of a daily concomitant medication in 30 cases. The mean RDI at the end of the first cycle, calculated for 209 patients, was 83.1 ±â€…23.9% (17.56-144.23). CONCLUSION: In these ambulatory cancer patients, the interest in tailored monitoring of DRPs as a whole, including the prevention and management of drug interactions in addition to symptoms and adverse effects, is highlighted.

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STUDY OBJECTIVES: To use a nationally representative sample to (1) evaluate the factor structure of the PROMIS parent proxy pediatric sleep scales (Spanish translation), (2) examine the invariance of these scales across sex and across different developmental periods of childhood and adolescence, (3) confirm the information and precision of the scales using item response theory (IRT), and (4) provide age-based normative information. METHODS: Parents of a nationally representative sample of 5,525 Spanish children and adolescents ages 5-16 years (56.1% boys) completed the Spanish translation parent proxy short versions of the Sleep Disturbance and Sleep-Related Impairment scales. We conducted confirmatory factor analyses (CFA), invariance analyses, and graded response IRT analyses. RESULTS: CFAs conducted separately on males and females within three age groups (early childhood: ages 5-8 years; middle childhood: ages 9-12 years; adolescence: ages 13-16 years) indicated all items had a substantial loading with one exception (the sleep continuity item ["my child slept through the night"] had a substantially lower loading and was removed for subsequent analyses). The scores on the two scales demonstrated invariance across sex within each age group. Using IRT analyses, both scales showed a high degree of information and precision from slightly below the trait means to slightly above two standard deviations above the trait means. CONCLUSIONS: The strong psychometric properties of the short versions of the parent proxy PROMIS pediatric sleep disturbance and sleep-related impairment scales, coupled with age-based norms, suggests these scales are likely to be useful for research and clinical applications.

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BACKGROUND CONTEXT: Lumbar spinal fusion is an increasingly common operation to treat symptoms related to degenerative disorders of the spine including radiculopathy and pain. As the volume of spine surgeries grows, it is becoming increasingly common for procedures to take place in non-tertiary care centers, including orthopaedic specialty hospitals (OSH). While previous research demonstrates that surgical outcomes at an OSH are non-inferior to those at a tertiary referral center (TRC), the implications of this difference on patient-reported outcome measures (PROMs) have not been sufficiently assessed. PURPOSE: The objectives of this study were (1) to determine if changes in patient reported outcome measures (PROMs) after elective lumbar spinal fusion surgery differ between patients who undergo surgery at an orthopedic specialty hospital (OSH) and those who undergo surgery at a tertiary referral center (TRC) and (2) to characterize differences in short-term outcomes between hospitals. STUDY DESIGN: Retrospective cohort study. PATIENT SAMPLE: Adult patients (≥ 18 years old) who underwent primary, elective single-level posterior lumbar decompression and fusion between January 2014 and December 2021 at a tertiary referral center or an orthopaedic specialty hospital. OUTCOME MEASURES: PROMs: Oswestry Disability Index (ODI), Short-form 12 (SF12) Mental Component Summary (MCS); SF12 Physical Component Summary (PCS); Visual Analogue Back and Leg (VAS Back/Leg) METHODS: PROMs were collected preoperatively, 6 months after surgery, and 1 year after surgery. Six-month and 1-year delta PROM values were calculated by subtracting the preoperative PROM score from the 6-month or 1-year score, respectively. Multivariable linear regression analyses were conducted to assess the independent effect of hospital location on postoperative PROM scores. RESULTS: A total of 288 patients were identified as part of the study cohort including 205 patients who underwent surgery at the tertiary hospital and 83 patients who underwent surgery at the OSH. OSH patients had shorter length of stay (1.57 ± 0.72 vs. 3.28 ± 1.32, p<0.001), however there was no difference in discharge disposition or 90-day readmission rates between hospitals (p>0.05). At 6 months, having surgery at the specialty hospital was associated with higher PCS (estimate = 2.96, confidence interval: 0.21 - 5.71, p=0.035). At 1-year postoperatively, the location of surgery no longer demonstrated significant associations with PROM scores. Preoperative PROM scores demonstrated significant associations with 6-month and 1-year scores for each PROM (p<0.05) except VAS leg at 6 months postoperatively. CONCLUSION: To our knowledge, this is one of the largest studies investigating PROMs at OSH versus TRCs for single-level lumbar fusions. We demonstrated that at one-year follow-up, there is not a significant difference in PROM improvement between patients who undergo surgery at a TRC and patients who do so at an OSH.

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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.

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Background: The Optimal Screening for Prediction of Referral and Outcome Yellow Flag (OSPRO-YF) Tool is a 10-item multidimensional screening tool utilized to evaluate pain-related psychological traits in individuals with musculoskeletal pain conditions. The validity of postoperatively collected OSPRO-YF is unclear. This study sought to assess validity of the OSPRO-YF by comparing it to patient-reported outcome scores in both preoperative and postoperative settings. Hypothesis: The authors hypothesized that OSPRO-YF overall score would correlate with shoulder and global function PROs at preoperative and postoperative timepoints. Methods: A review of 101 patients undergoing shoulder surgery by one sports medicine orthopedic surgeon at a large academic institution was conducted. 90 and 54 patients had complete preoperative and postoperative patient-reported outcome responses. OSPRO-YF, American Shoulder and Elbow Surgeons (ASES) Evaluation Form, and Patient-Reported Outcomes Measurement Information System Computer Adaptive Test (PROMIS-CAT) were routinely administered before and after surgery at the senior author's clinic visits. Concurrent validity of OSPRO-YF at either timepoint was assessed by comparing scores with PROs cross-sectionally using Pearson correlations and multiple comparison corrections. Results: Preoperatively, higher OSPRO-YF total score was associated with greater concurrent PROMIS-CAT Pain Interference (r = 0.43; P < .01) and Depression (r = 0.36; P = .05) and lower ASES (r = -0.34; P < .01). Higher postoperative OSPRO-YF was also associated with greater concurrent PROMIS-CAT Pain Interference (r = 0.43; P < .01) and Depression (r = 0.36; P < .01) and lower ASES (r = -0.34; P = .01). ASES had strong correlation with Single Assessment Numeric Evaluation and Pain scores at both preoperative and postoperative timepoints. Single Assessment Numeric Evaluation was not significantly associated with OSPRO-YF total score or number of yellow flags at either timepoints. Conclusion: The study findings support the clinical validity of the 10-item OSPRO-YF tool when administered before or after shoulder surgery. For patients exhibiting suboptimal recovery or those identified as high risk at initial screening, assessment of pain-related psychological distress postoperatively may be particularly beneficial in guiding rehabilitation.

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Background: Rotator cuff calcific tendinitis is a common cause of shoulder discomfort. Ultrasound-guided barbotage consists of needle aspiration and a subsequent lavage of calcium deposits in the shoulder. While barbotage has proven benefit, other options have also shown similar symptom improvement. This study aims to examine pain outcomes of patients following barbotage of calcific tendinitis. We hypothesize that barbotage will improve shoulder pain scores compared to preprocedure scores. Methods: This is a retrospective chart review of 179 ultrasound-guided barbotage interventions for calcific tendinitis of the rotator at a New England urban medical center. Patient pain scores were analyzed using a Friedman's analysis of variance at a significance level of α = 0.05, and statistical significance between groups was elucidated using nonparametric post-hoc tests of significance between groups. Results: Pain scores at preprocedure, 2-month, 6-month, and 12-month follow-ups yielded significant differences. Post-hoc nonparametric analysis revealed pain scores at 2 months were significantly lower than preprocedure and at 6 months. Additionally, 47.5% of cases in this study went on to require a secondary procedure of the respective shoulder after their barbotage treatment. Conclusion: Upon analysis, utilization of barbotage as a treatment for calcific tendonitis of the shoulder appears to produce notable pain reduction in the short term (specifically at the 2-month follow-up), but begins to lose some efficacy over long-term evaluation. Additionally, a large portion of patients required further interventions of their shoulder, including corticosteroid injections, more barbotage, or surgery, raising further concerns over its long-term benefit.

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BACKGROUND: Acute ankle sprains represent one of the most common traumatic injuries to the musculoskeletal system. Many individuals with these injuries experience unresolved symptoms such as instability and recurrent sprains, leading to chronic ankle instability (CAI), which affects their ability to maintain an active lifestyle. While rehabilitation programs focusing on sensorimotor, neuromuscular, strength and balance training are primary treatments, some patients require surgery when rehabilitation fails. A critical analysis of the patient-reported outcome tools (PROs) used to assess CAI surgical outcomes raises some concerns about their measurement properties in CAI patients, which may ultimately affect the quality of evidence supporting current surgical practice. The aim of this research is to develop and validate a new PRO for the assessment of ankle instability and CAI treatment outcomes, following recent methodological guidelines, with the implicit aim of contributing to the generation of scientifically meaningful evidence for clinical practice in patients with ankle instability. METHODS: Following the COnsensus-based Standards for the selection of Health Measurement Instruments (COSMIN), an Ankle Instability Treatment Index (AITI) will be developed and validated. The process begins with qualitative research based on face‒to‒face interviews with CAI individuals to explore the subjective experience of living with ankle instability. The data from the interviews will be coded following an inductive approach and used to develop the AITI content. The preliminary version of the scale will be refined through an additional round of face‒to‒face interviews with a new set of CAI subjects to define the AITI content coverage, relevance and clarity. Once content validity has been examined, the AITI will be subjected to quantitative analysis of different measurement properties: construct validity, reliability and responsiveness. DISCUSSION: The development of AITI aims to address the limitations of existing instruments for evaluating surgical outcomes in patients with CAI. By incorporating patient input and adhering to contemporary standards for validity and reliability, this tool seeks to provide a reliable and meaningful assessment of treatment effects. TRIAL REGISTRATION: Not applicable.

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Background: The utilization rate of antipsychotics to treat different mental disorders is rising. However, little is known about their side effects' impact on depression levels. Therefore, the objective of this study was to examine the association between antipsychotic side effects and depression among psychiatric patients treated with antipsychotics. Methods: This is a prospective, single-center, interview-based, cross-sectional study that examined the association between antipsychotic side effects and depression among adult patients (e.g., ≥18 yrs.) with psychiatric illnesses (e.g., depression, schizophrenia, bipolar disorder) visiting outpatient clinics in a university-affiliated tertiary care center. Antipsychotic side effects were assessed using the Arabic version of the Glasgow Antipsychotic Side-effect Scale (GASS), while depression was assessed using the Arabic version of the 9-item Patient Health Questionnaire (PHQ-9). Univariate and multiple linear regressions were conducted to examine the association between the PHQ-9 and GASS scores. Results: One hundred patients met the inclusion criteria and consented to participate. Most of the patients were females (72 %) with a mean age of 38 years. Schizophrenia (37 %) and bipolar disorder (54 %) were the most common mental disorders among the recruited patients. The majority of patients were treated with atypical (e.g., second-generation) antipsychotics (88 %) for at least six months (74 %). Controlling for age, gender, annual family income, education, employment status, marital status, number of comorbidities, duration of treatment with antipsychotics, the type of antipsychotic, and psychiatric illness, higher GASS scores, which indicate more severe antipsychotic side effects, predicted higher PHQ-9 score (e.g., higher levels of depression) (ß = 0.419, 95 % CI=[0.307-0.532], p-value < 0.0001). Conclusion: Early identification and management of antipsychotic side effects among psychiatric patients should enhance patient adherence and improve treatment outcomes. Future studies should verify the findings of this study using more robust study designs.