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Context: The Upper Limb Functional Index (ULFI) is a popular tool with valid psychometric properties to assess upper limb function in patients with musculoskeletal conditions. The aim of the study was to cross-culturally adapt and validate the German version of the ULFI. Design: Cross-cultural validation. Methods: A 2-stage cross-cultural adaptation of the ULFI was performed according to international guidelines through consecutive forward and backward translations. Psychometric properties of internal consistency, test–retest reliability, criterion, face and content validity, and factor structure were determined from the included German participants suffering from upper limb conditions (n = 100), who fulfilled the following inclusion criteria: (1) older than 18 years old, (2) German as native language, and (3) medical diagnosis of musculoskeletal upper limb condition. Participants completed the ULFI; Disabilities of the Arm, Shoulder, and Hand; EuroQol Health Questionnaire 5 Dimensions; and Short Form-12 questionnaires. Results: The ULFI-G showed good internal consistency (α =.88); excellent test–retest reliability (intraclass correlation coefficient2:1 =.98); directly strong correlation with Disabilities of the Arm, Shoulder, and Hand (r =.84); fair correlation with Disabilities of the Arm, Shoulder, and Hand-sport (r =.54); inversely fair correlation with EuroQol Health Questionnaire 5 Dimensions (r = −.62); and Short Form 12's physical health domain (r = −.7). A single-factor structure was revealed. Conclusions: The ULFI-G showed adequate psychometric properties and proved to be a valid tool for upper limb functional assessment in German population. [ABSTRACT FROM AUTHOR]

Background: Bowel urgency, the sudden and immediate need to have a bowel movement, is common in patients with ulcerative colitis (UC) and Crohn's disease (CD). While its impact in UC is well established, less is known about its importance in CD. Further, what level of bowel urgency control patients with UC or CD would consider to be acceptable or in remission has not been established. This qualitative study aimed to understand perceptions of bowel urgency and remission in these patients. Methods: Semi-structured combined concept elicitation and cognitive interviews were conducted to explore how adults with moderate-to-severe UC or CD and current or recent bowel urgency think about the concept of bowel urgency and its remission. The Urgency Numeric Rating Scale (UNRS) was used to examine different levels of bowel urgency severity and to investigate what level of bowel urgency patients would consider as representing remission. Results: Forty adults (n = 19 UC, n = 21 CD) recruited from six US sites completed the study. Sociodemographic and clinical characteristics were similar in both groups. Both groups reported impacts of bowel urgency on physical, social, professional, and emotional aspects of their lives. Most participants (n = 15 UC, n = 18 CD) reported having experienced one or more incidents of urgency-related fecal incontinence. Most participants considered remission to be a state with a normal or reduced number of bowel movements and no or less frequent bowel urgency, and they noted that remission would increase their ability to engage in daily activities without fear of fecal incontinence. Participants were able to map different levels of severity of bowel urgency to UNRS score ranges (scale: 0–10), and they indicated that a mean UNRS score of 5 (UC) or 4 (CD) would be the highest point on the NRS at which they would still consider their bowel urgency to be in remission. Conclusions: Bowel urgency is an important issue for patients with either moderate-to-severe UC or CD, and its remission would improve their lives. Further, these patients may still consider bowel urgency to be in remission even at UNRS scores as high as 4 or 5. Plain English summary: Bowel urgency is the sudden need to rush to the bathroom to have a bowel movement, which is common in people with ulcerative colitis and Crohn's disease. We interviewed adults with moderate or severe ulcerative colitis or Crohn's disease to better understand their experiences. They said that bowel urgency often made them feel anxious, depressed, or embarrassed and interfered with their social lives, work, and chores. Most felt that they would be in "remission" if the bowel urgency stopped or happened less often. They added that this would help them feel more relaxed and be more active. Interestingly, they would consider even a moderate amount of bowel urgency as being in "remission." This information can help healthcare providers better understand the toll that bowel urgency takes on patients with ulcerative colitis or Crohn's disease and better manage their treatment. [ABSTRACT FROM AUTHOR]

Background Direct-to-implant breast reconstruction (DIR) is becoming more and more accepted. There is a lack of high-quality studies assessing differences in patient-reported quality of life (QoL) between different implant placement methods. The aim of this randomized controlled (clinical) trial was to compare QoL between women reconstructed by sub- or prepectoral implant placement. Methods We included women over 18 years eligible for DIR. Patients were randomly assigned to reconstruction by subpectoral or prepectoral implant placement. Assessment of QoL and patient satisfaction was made using the BREAST-Q questionnaire for postmastectomy breast reconstruction and compared between the sub- and prepectoral reconstructed groups preoperatively and after 3 and 12 months of follow-up. Results A total of 42 women were allocated to sub- or prepectoral reconstruction with 21 patients in each group. There were no differences in patient characteristics between groups. Regarding all the selected BREAST-Q scales: (1) satisfaction with the reconstructed breast, (2) satisfaction with the breast implant, (3) satisfaction with the overall outcome, (4) psychosocial well-being, (5) sexual well-being, and (6) physical well-being—we found no significant differences between the two groups. Assessing each group independently we found, that in both groups sexual well-being improved after surgery postoperatively compared to the preoperative scores. Conclusion We found high satisfaction and QoL following both sub- and prepectoral breast reconstruction. We found no significant differences between groups suggesting both methods for DIR can be used. Despite our high-quality data, a larger sample size and longer postoperative follow-up are needed to further investigate the differences in QoL between sub- and prepectoral breast reconstruction. [ABSTRACT FROM AUTHOR]

Background: Low back pain (LBP) is a highly prevalent condition that comprise a large portion of outpatient practice, challenging the diagnosis and treatment. However, the diagnostic tools are limited to clinical history, physical examination and imaging. Degenerative disc disease (DDD) is a significant cause of LBP, and emerging literature confirms the elevated levels of biomarkers in the discs. These biomarkers may serve as a tool for diagnosis, but may also be useful in predicting the treatment outcome. Here, we examine the expression of various cytokines on 1‐year recovery from patients with LBP. Methods: Patient‐reported outcome (PRO) in terms of pain intensity (VAS), disability (ODI), and quality of life (Eq‐5D) is collected from 44 patients at baseline and 12 months after surgery to study the influence of baseline TNF‐α, IL‐1β, and IL‐6 mRNA expression in both annulus fibrosus (AF) and nucleus pulposus (NP). Results: Between baseline and follow‐up, our cohort showed improvement in VAS back pain (p < 0.001), VAS leg pain (p < 0.001), ODI (p = 0.02), and Eq‐5D (p = 0.01). Baseline levels of IL‐1 β was positively correlated with VAS back pain scores in AF (p = 0.05) and NP (p = 0.01) at 1‐year follow‐up. TNF‐α expression at baseline was also positively correlated to ODI scores (p = 0.01) at follow‐up and inversely correlated to improvements in ODI score between baseline and follow‐up, suggesting that high TNF‐α expression at baseline is associated with poor outcomes from surgery. Conclusion: The results from our study support that TNF‐α expression at baseline can serve as a very important predictor of treatment response from lumbar fusion surgery. [ABSTRACT FROM AUTHOR]

Purpose: Mapping or matching the items in a clinical outcome assessment (COA) to concepts that define a condition is a common method for evaluating a COA's concept coverage. The purpose of this research was to address the lack of formal guidance for conducting this task by developing a framework for best practices in COA concept mapping and applying it to a case study. Methods: To develop the framework, we examined the literature and created a draft set of best practices which was then reviewed by experienced researchers through focus groups before being finalized. To conduct the case study, we extracted data from a systematic review of knee osteoarthritis (KO) symptoms and impacts and used the framework to map relevant concepts to items in the SF-36v2® Health Survey (SF-36v2). Results: The framework guides researchers in defining the purpose of and data sources for the mapping, establishing guiding principles and decision-making thresholds, and conducting the mapping exercise. The results of the case study demonstrate the usefulness of the framework in identifying 27/36 items (75%) in the SF-36v2 that addressed concepts that define KO. Conclusion: This case study illustrates how the framework for best practices in COA concept mapping may be used, highlighting how establishing clear concept definitions and guiding principles and following a structured process throughout can help produce consistent, reliable, and reproducible results. The results from this rigorous approach can provide valuable evidence to support decisions about the appropriateness of a COA for the intended patient population. Plain English Summary: In health-related quality of life research, mapping items in a clinical outcome assessment (COA) to concepts that define a health condition is one way to evaluate an instrument's content validity (or, how well the instrument addresses the concepts it intends to measure). Without formal guidance on how to do this mapping, researchers can be inconsistent. This article describes the development of a framework for best practices in COA concept mapping. Informed by the literature and input from researchers with expertise in COA development and evaluation, the final framework guides researchers through the mapping process from start to finish, from helping to define the purpose of the task and identify the data sources, to establishing guiding principles and decision-making thresholds, conducting the mapping, and displaying the results. A case study—in which items from the SF-36v2® Health Survey were mapped to concepts from a systematic review of knee osteoarthritis symptoms and impacts—shows the framework in action, demonstrating how following the best practices can lead to consistent results that can support the evaluation of an instrument's content validity. [ABSTRACT FROM AUTHOR]

Background and purpose: The study evaluated the concordance between patient-reported outcomes (PRO) and clinician-reported outcomes (CRO) of acute radiation dermatitis (RD) symptoms following adjuvant radiotherapy for early-stage and locally advanced breast cancer. Material and methods: This is a secondary analysis of a multi-center randomized phase 3 trial (376 patients). Ordinal logistic regression analysis was used to compare the Skin Symptom Assessment (SSA) independently reported by both patients and clinicians. Concordance between patient- and clinician-reported SSAs for RD symptoms was measured by percent concordance, concordance index (C-statistic), and Cohen’s Kappa. Analyses were performed across all patients in the original modified intention-to-treat analysis and those with only grade 2–3 (CTCAE) RD. Results: PROs were significantly more severe than CROs across all RD symptoms (Odds Ratio [OR] > 1; p < 0.0001). Pigmentation (OR 5.4), blistering/peeling (OR 4.0), and pain/soreness (OR 3.9) were the most differentially reported symptoms. Poor-to-low concordance was noted between patient- and clinician-reported SSAs for all RD symptoms for the entire cohort (percent concordance < 50%, C-statistic 0.52–0.63, Cohen’s Kappa 13.9–23.4%) and those with grade 2–3 RD (percent concordance < 50%, C-statistic 0.56–0.66, Cohen’s Kappa 2.0–24.5%). Similarly, poor-to-low concordance was noted in both Mepitel film and standard-of-care arms. Conclusion: PROs and CROs have poor concordance in breast RD, and patients report worse outcomes than clinicians, regardless of RD severity or prophylaxis. PROs must be further integrated into routine clinical practice and clinical trial design to reduce the risk of underreporting symptoms. [ABSTRACT FROM AUTHOR]

This study evaluated patient‐reported outcomes (PROs) of Medicine Access Programmes (MAPs) for Australian metastatic breast cancer patients on ribociclib. Limited patient awareness of MAP enrolment was identified, emphasising the need for improved education and consent processes. Most patients expressed gratitude for accessing non‐funded medications and perceived enhanced medication adherence as a key benefit. Integrating PRO data with real‐world registry data provides comprehensive insight for future MAP development. [ABSTRACT FROM AUTHOR]

Acute respiratory tract infections (ARTIs) are a heterogenous group of diseases. Often, it is difficult to obtain a precise diagnosis in general practice but also difficult to determine when the patient is recovered. The lack of a precise definition of recovery after ARTI complicates scientific research aiming to optimize diagnostics and compare treatments. The study aimed to define cutoff points to determine the end of an ARTI as a proxy for recovery in patients diagnosed with ARTI in general practice using a validated patient-reported outcome instrument; The ARTI Questionnaire (ARTIQ). A total of 259 participants was divided in 2 groups—1 with ARTI and 1 without. Histograms and area under the curve were calculated for each of the 5 dimensions within the ARTIQ to evaluate the discriminative effect. For the most discriminative dimensions receiver operating comparison curves were performed to determine relevant cutoff points for having or not having ARTI symptoms and serve as a proxy for recovery in clinical research. The highest discriminative effect was found in 2 dimensions: "physical—upper airways" and "physical—lower airways." When combining these dimensions, the area under the curve was 0.97. Sensitivity, specificity, and predictive values were calculated for selected cutoff points. Cutoff points serving as proxy for recovery from ARTI using a patient-reported outcome were identified. The specific cutoff point for a certain research project must be selected considering the specific clinical situation of interest. • It is difficult to define when a patient has recovered after acute respiratory tract infection (ARTI) complicating clinical research trying to optimize diagnostics or compare treatments. • The study presents an approach to measure recovery after ARTI diagnosed in general practice—using a patient-reported outcome instrument to determine end of ARTI as a proxy for recovery. • A more precise definition of recovery after ARTI will enhance the quality of clinical research on diagnostics and new treatment modalities on ARTI in general practice. [ABSTRACT FROM AUTHOR]

Background: Patient‐reported outcome measures (PROMs) for hair loss focus mainly on Alopecia Areata. We created a PROM (i.e., HAIR‐Q) that is applicable to any hair loss condition. The HAIR‐Q measures satisfaction with hair. Patients/Methods: Concept elicitation interviews were conducted and analyzed to develop a draft scale. Content validity was established through multiple rounds of patient and expert input. Psychometric properties of the scale were examined in an online sample (i.e., Prolific) using Rasch measurement theory (RMT) analysis. Test–retest reliability and tests of construct validation were examined. Results: Content validity of a 22‐item draft scale was established with input from 11 patients, 12 experts and an online Prolific sample of 59 people who had a variety of hair loss treatments. In the RMT analysis (n = 390), 8 items were dropped. Data for the 14‐item scale fit the Rasch model (χ2 = 89.85, df = 70, p = 0.06). All 14 items had ordered thresholds and good item fit. Reliability was high with person separation index and Cronbach alpha values ≥0.91, and intraclass correlation coefficient of 0.94 based on a sample of 97 participants. Higher (better) scores on the scale were associated with having more hair, looking younger than ones' age, satisfaction with hair overall, being less bothered by hair loss, and for those who had a hair loss treatment in the past year, being more satisfied with their hair now than before treatment (p < 0.001). Conclusion: The HAIR‐Q evidenced reliability and validity and can be used in research and to inform clinical care to measure satisfaction with hair from the patient perspective. [ABSTRACT FROM AUTHOR]

Introduction: The evidence on complication rates after gynecological surgery is based on multiple types of studies, and the level of evidence is generally low. We aimed to validate the registration of complications in the Swedish National Quality Register of Gynecological Surgery (GynOp), by cross‐linkage to multiple national registers. Material and Methods: A national register‐based study using prospectively collected data was conducted, including women who had surgery on the uterus or adnexa for benign indications from January 1, 2017, to December 31, 2020. In Sweden, complications after gynecological surgery are registered in GynOp, and if the complication has rendered any interaction with healthcare, it is also in national health registers. The GynOp register, the National Patient Register, the Prescribed Drugs Register, and the Cause of Death Register were cross‐linked. Complications in GynOp and complications according to ICD10 were analyzed, as well as the cause of death if occurring within 3 months of surgery and prescription of antibiotics ≤30 days. Comparisons between the registries were descriptive. Results: During the study period 32 537 surgeries were performed, of which 26 214 (80.6%) were minimally invasive. Complications were reported in GynOp for 569 women (1.7%) at surgery, 1045 (3.2%) while admitted, and 3868 (13.7%) from discharge to 3 months after surgery. In comparison, according to the Patient Register, 2254 women (6.9%) had postoperative complications within 3 months of discharge (difference of 6.8 percentage points [95% confidence interval 6.2–7.2]). Furthermore, 4117 individuals (12.7%) had a prescription of antibiotics ≤30 days which could indicate a postoperative infection. The rates of hemorrhage, wound dehiscence, and thrombosis were comparable between GynOp and the Patient Register while diagnoses not leading to contact with specialized care had higher rates in the quality register. The coverage of complications was 79.1% in GynOp and 46.1% in the Patient Register, using the total number of complications from both registers as the denominator. Conclusions: A higher frequency of complications is captured in GynOp than in the National Patient Register. Patient‐reported outcomes assessed by a physician are beneficial in identifying complications indicating the importance of structured pre‐defined follow‐up over a set period. [ABSTRACT FROM AUTHOR]

Objectives: This randomized controlled trial compared the outcomes of recombinant human fibroblast growth factor (rhFGF)-2 plus carbonate apatite (CO3Ap) granules with rhFGF-2 alone in the treatment of intrabony periodontal defects. Materials and methods: Patients with Stage III Grade B/C periodontitis who had completed initial periodontal therapy and had intrabony defects with a depth of ≥ 3 mm were included. Defects were treated solely with rhFGF-2 (control) or rhFGF-2 plus CO3Ap (test). Periodontal parameters and a patient-reported outcome measure (PROM) were assessed at baseline, at 6, 9 and 12 months postoperatively. The primary outcome was the change in clinical attachment level (CAL) from baseline to 12 months postoperatively. Using the Friedman test with Dunn's post-test, intragroup data were compared over time, and Mann-Whitney U test was used to assess intergroup data at each time point. Results: Forty-eight sites in 38 patients were subjected to analysis. At 12 months postoperatively, CAL in both groups showed a significant improvement from baseline (p < 0.001). CAL gain was 3.4 ± 1.3 mm in the test group and 3.2 ± 1.2 mm in the control group, with no significant intergroup difference (p = 0.567). Radiographic bone fill in the test group (67.2%) was significantly greater than in the control group (32.4%) (p < 0.001). PROM scores showed no difference between groups. Conclusions: At 12 months, the outcomes including CAL gain and PROM showed no significant differences between groups, although the combination treatment enhanced radiographic bone fill. Clinical relevance: The use of rhFGF-2 (with/without CO3Ap) could lead to significant improvement in clinical parameters in the treatment of intrabony periodontal defects. The benefit of adding CO3Ap to rhFGF-2 therapy needs further evaluation. Clinical Trial Registration Number: The University Hospital Medical Information Network-Clinical Trials Registry (UMIN-CTR) : UMIN000040783. [ABSTRACT FROM AUTHOR]

Objective: To investigate whether the combination of chemotherapy with staged Chinese herbal medicine (CHM) therapy could enhance health-related quality of life (QoL) in non-small-cell lung cancer (NSCLC) patients and prolong the time before deterioration of lung cancer symptoms, in comparison to chemotherapy alone. Methods: A prospective, double-blind, randomized, controlled trial was conducted from December 14, 2017 to August 28, 2020. A total of 180 patients with stage I B–IIIA NSCLC from 5 hospitals in Shanghai were randomly divided into chemotherapy combined with CHM (chemo+CHM) group (120 cases) or chemotherapy combined with placebo (chemo+placebo) group (60 cases) using stratified blocking randomization. The European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life-Core 30 Scale (QLQ-C30) was used to evaluate the patient-reported outcomes (PROs) during postoperative adjuvant chemotherapy in patients with early-stage NSCLC. Adverse events (AEs) were assessed in the safety analysis. Results: Out of the total 180 patients, 173 patients (116 in the chemo+CHM group and 57 in the chemo+placebo group) were included in the PRO analyses. The initial mean QLQ-C30 Global Health Status (GHS)/QoL scores at baseline were 57.16 ± 1.64 and 57.67 ± 2.25 for the two respective groups (P>0.05). Compared with baseline, the chemo+CHM group had an improvement in EORTC QLQ-C30 GHS/QoL score at week 18 [least squares mean (LSM) change 17.83, 95% confidence interval (CI) 14.29 to 21.38]. Conversely, the chemo+placebo group had a decrease in the score (LSM change −13.67, 95% CI −22.70 to −4.63). A significant between-group difference in the LSM GHS/QoL score was observed, amounting to 31.63 points (95% CI 25.61 to 37.64, P<0.001). The similar trends were observed in physical functioning, fatigue and appetite loss. At week 18, patients in the chemo+CHM group had a higher proportion of improvement or stabilization in GHS/QoL functional and symptom scores compared to chemo+placebo group (P<0.001). The median time to deterioration was longer in the chemo+CHM group for GHS/QoL score [hazard ratio (HR)=0.33, 95% CI 0.23 to 0.48, P<0.0010], physical functioning (HR=0.43, 95% CI 0.25 to 0.75, P=0.0005), fatigue (HR=0.47, 95% CI 0.30 to 0.72, P<0.0001) and appetite loss (HR=0.65, 95% CI 0.42 to 1.00, P=0.0215). The incidence of AEs was lower in the chemo+CHM group than in the chemo+placebo group (9.83% vs. 15.79%, P=0.52). Conclusion: The staged CHM therapy could help improve the PROs of postoperative patients with early-stage NSCLC during adjuvant chemotherapy, which is worthy of further clinical research. (Registry No. NCT03372694) [ABSTRACT FROM AUTHOR]

Objective: To evaluate the feasibility of the Sleep Health through University Student Habits (SHUSH) program, a brief sleep improvement intervention based upon principles of cognitive-behavioral therapy for insomnia (CBT-I) developed for Japanese university students. Methods: Pretest-posttest, single-arm pilot study design with 3-month follow up was used to evaluate the feasibility of SHUSH. We developed then offered a 90-min sleep education class based upon the two-process model of sleep regulation, sleep restriction, stimulus control, and sleep hygiene. We recommended individualized sleep prescriptions (e.g., prescribed time to bed and prescribed time out of bed) from 11 days of daily sleep diary data. We then offered 15min of individualized follow-up meetings each week for three consecutive weeks in person or online in which we supported adherence to sleep prescriptions. Fifteen university students with self-reported sleep disturbance (Insomnia Severity Index; ISI score ≥ 9) completed the SHUSH program. Participants were on average age 19.7 years old; nine were women, and they were students in occupational therapy and physical therapy. We assessed validated Japanese versions of sleep-related (e.g., ISI, Sleep hygiene practice scale; SHPS), mental health-related (e.g., Generalized Anxiety Disorder Screener) patient-reported outcomes (PROs) and daily sleep diary variables (e.g., sleep onset latency and sleep efficiency). Results: Comparing baseline and posttest data, a statistically significant difference was observed in insomnia symptom severity, daytime sleepiness, sleep hygiene practices, eveningness to morningness, anxiety, depression, sleep diary improvements (e.g., sleep onset latency, total time in bed, and sleep efficiency). Comparing posttest and 3-mo follow up data (n = 10), a statistically significant difference wasn't observed for most PRO effects. However, there was a statistically significant difference in ineffective sleep behaviors (i.e., SHPS-J). We did observe a rebound effect for some SHPS-J items. Conclusion: SHUSH was developed as a brief cognitive-behavioral intervention for insomnia. SHUSH participants showed improvements on sleep-related and mental health-related PROs after 4 weeks of intervention. At 3 months follow-up sleep quality and mental health gains were maintained. SHUSH was a feasible program. Randomized controlled trials are needed to test treatment efficacy on sleep related and mental health related PROs in the future. [ABSTRACT FROM AUTHOR]

Introduction: Treatment resistant depression (TRD) affects approximately 10-- 30% of patients with major depressive disorder, and most patients with TRD do not respond to real-world treatments (RWT). Treatment with esketamine nasal spray (NS) plus a selective serotonin or serotonin norepinephrine reuptake inhibitor (SSRI/SNRI) has significant long-term clinical benefit over RWT in patients with TRD. However, the impact on patient-reported function remains to be determined. Methods: The ICEBERG analysis was an indirect treatment comparison performed using data from two studies of patients with TRD: SUSTAIN-2 (esketamine NS; NCT02497287) and the European Observational TRD Cohort (EOTC; RWT; NCT03373253; clinicaltrials.gov). Here, patient--reported functional remission, assessed using the Sheehan Disability Scale (SDS), was defined as SDS ≤6 at Month 6. Analyses were conducted using propensity score re--weighting and multivariable models based on 18 covariates. Results: At Month 6, the probability of functional remission in esketamine NS --treated patients from SUSTAIN-2 (n=512) was 25.6% (95% confidence interval [CI] 21.8-29.4), while the adjusted probability for RWT patients from the EOTC (n=184) was 11.5% (95% CI 6.9-16.1; relative risk: 2.226 [95% CI 1.451-3.416]; p=0.0003). In the total combined population (N=696), patients who did not achieve clinical response or remission had a low probability of achieving functional remission (5.84% and 8.76%, respectively). However, for patients who did achieve clinical response or remission, the probability of achieving functional remission was greater (43.38% and 54.15%, respectively), although many still did not achieve this status. Conclusions: For patients with TRD, esketamine NS had a significant functional benefit versus RWT after 6 months of treatment. Irrespective of treatment, achievement of clinical response or remission was insufficient to attain functional remission. Nevertheless, clinical remission increased the likelihood of achieving functional remission, further supporting an important role for clinical remission in for the path towards functional recovery. [ABSTRACT FROM AUTHOR]

Background: Rotator cuff tears (RCT) are a common musculoskeletal condition, especially in the aging population. The prevalence of rotator cuff tears varies based on factors like age, occupation, and activity level. In the general population, the prevalence of rotator cuff tears is estimated to be around 20 to 25%. Rotator cuff tears (RCT) have an impact in patients' pain level, shoulder function, sleep disturbance, and quality of life. Primary tendon surgery is in mostly cases necessary. This study aimed to examine if treatment of rotator cuff lesions with implantation of micro-fragmented adipose tissue can improve patients' reported pain and function compared to conventional surgery. Methods: The study is a prospective superiority parallel-group single-center randomized controlled trial including 30 patients between 40 and 69 years of age in Denmark. Patients will be allocated 1:1 ratio to reconstruction of the supraspinatus tendon with an injection of micro-fragmented adipose tissue into the related muscle (stem cell treatment) or the standard of care (SOC), which is conventional surgery. Patients, project assistants, physicians, and outcome adjudicators are not blinded to randomization due to practical constraints. The radiologist and the statistician performing the analysis will be blinded. The primary outcome will be the Oxford shoulder score at 12 months post-surgery. Discussion: This study will assess whether adding micro-fragmented adipose tissue therapy to conventional rotator cuff tear treatment can enhance recovery, accelerate return to daily activities, and improve functional outcomes. The research will also determine if this minimally invasive procedure could be standardized for routine patient care. Trial registration: ClinicalTrials.gov NCT06505135. Registered on July 10, 2024. [ABSTRACT FROM AUTHOR]

Summary The lack of standardization in patient‐reported outcome measures (PROMs) has made measurement and comparison of quality of life (QoL) outcomes in research focused on obesity treatment challenging. This study reports on the results of the second and third global multidisciplinary Standardizing Quality of life measures in Obesity Treatment (S.Q.O.T.) consensus meetings, where a core set of PROMs to measure nine previously selected patient‐reported outcomes (PROs) in obesity treatment research was established.The S.Q.O.T. II online and S.Q.O.T. III face‐to‐face hybrid consensus meetings were held in October 2021 and May 2022. The meetings were led by an independent moderator specializing in PRO measurement. Nominal group techniques, Delphi exercises, and anonymous voting were used to select the most suitable PROMs by consensus. The meetings were attended by 28 and 27 participants, respectively, including a geographically diverse selection of people living with obesity (PLWO) and experts from various disciplines.Out of 24 PROs and 16 PROMs identified in the first S.Q.O.T. consensus meeting, the following nine PROs and three PROMs were selected via consensus: BODY‐Q (physical function, physical symptoms, psychological function, social function, eating behavior, and body image), IWQOL‐Lite (self‐esteem), and QOLOS (excess skin). No PROM was selected to measure stigma as existing PROMs deemed to be inadequate.A core set of PROMs to measure QoL in research focused on obesity treatment has been selected incorporating patients' and experts' opinions. This core set should serve as a minimum to use in obesity research studies and can be combined with clinical parameters. [ABSTRACT FROM AUTHOR]

Objectives: There are often discrepancies in the evaluation of disease activity between patients and physicians in systemic lupus erythematosus (SLE). In this study, we examined the factors that affect those evaluations. Methods: Physician visual analogue scale (Ph-VAS), patient VAS (Pt-VAS), Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2k), glucocorticoid (GC) usage and dose, age, Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index, and three patient-reported outcomes (SLE symptom checklist [SSC], short-form 36 questionnaire [SF-36], and LupusPRO) were obtained from a study performed in 2019 using 225 SLE outpatients of the Kyoto Lupus Cohort at Kyoto University Hospital. Correlations among Ph-VAS, Pt-VAS, or dif (Pt-VAS-Ph-VAS) (Pt-VAS minus Ph-VAS) and other factors were examined. Results: We found a significant discrepancy between Pt-VAS (median 38.0 mm) and Ph-VAS (median 18.7 mm) scores (p < 0.001). SSC score showed a significant correlation with Pt-VAS and dif (Pt-VAS-Ph-VAS) (p < 0.001). Among SSC items, fatigue showed the most significant correlation with dif (Pt-VAS-Ph-VAS). We also showed that higher dif (Pt-VAS-Ph-VAS) was associated with lower quality of life (QOL) evaluated by SF-36 and LupusPRO. Conclusions: Pt-VAS scores tended to be higher than Ph-VAS scores, and the discrepancy was influenced mainly by fatigue. Higher dif (Pt-VAS-Ph-VAS) was associated with lower patient QOL. [ABSTRACT FROM AUTHOR]

Adult Acquired Buried Penis (AABP) is a morbid condition that often requires surgical intervention. This retrospective study of 46 patients who underwent AABP surgery from November 2017 to July 2023 evaluates surgical outcomes, functional outcomes, and patient-reported outcomes. The median follow-up (FU) was 46 months. Patients were categorized by surgical complexity using the Pariser classification, with 76.1% undergoing high-complexity procedures (Pariser ≥ III). Common comorbidities included obesity (58.7%), prior circumcision (52.2%), and hypertension (52.2%). The low-complexity group had a shorter hospital stay (p = 0.02). No other significant differences were noted between groups in terms of Body Mass Index, operative time, or FU. Sexual dysfunction (45.7%) and urinary issues (38.1%) were the main reasons for surgical consultation. Skin grafting was required in 63.0% of patients; partial graft loss was more common in full thicknes skin graft group (p = 0.04). Postoperative complications occurred in 32.6% of patients, 13.3% of which were classified severe (Clavien ≥ III). The median increase in stretched penile length was 2 cm. The recurrence rate was 21.7%. The 12-month recurrence-free survival rate was 89.1%. All groups saw significant improvements in urinary and sexual function post-surgery (p < 0.05), and high patient satisfaction was reported (90.3%). Despite the complication rate, AABP surgery significantly improves quality of life, with ongoing advancements in technique anticipated to enhance outcomes further. [ABSTRACT FROM AUTHOR]

Objective: The FACE‐Q Skin Cancer Module is a Patient‐Reported Outcome Measure (PROM) utilized to assess outcomes following facial skin cancer resection. However, the lack of Minimal Important Difference (MID) estimates hinders the interpretability of the PROM scores. This study established MID estimates for the four outcome scales from the FACE‐Q Skin Cancer Module using distribution‐based methods. Methods: A prospective cohort study at four hospitals in the United States, enrolled participants who underwent Mohs Micrographic Surgery (MMS) for facial skin cancer between April 2020 and April 2022. Participants completed the Satisfaction with Facial Appearance, Appearance‐related Psychosocial Distress, Cancer Worry, and Appraisal of Scars scales at four time points: pre‐operatively, 2‐week, 6‐month, and 1‐year post‐surgery. Results: A total of 990 patients participated in the study, with completion rates of 98.4% for the pre‐operative assessment, 70.8% at 2 weeks, 59.3% at 6 months, and 60.4% at 1 year. MID estimates, calculated using 0.2 standard deviation and 0.2 standardized response mean, were determined for the four scales. The mean MID estimates, based on a Rasch transformed score ranging from 0 to 100, were 5 for the Appraisal of Scars scale and 4 for the remaining three scales. Conclusion: This multicenter study provides valuable MID estimates for the FACE‐Q Skin Cancer Module, specifically for the MMS patient population, enabling clinicians and researchers to better interpret scores, determine appropriate sample sizes, and apply the findings in clinical care. [ABSTRACT FROM AUTHOR]

Background: Loss of mobility is common in persons with multiple sclerosis (PwMS), but little is known about this impairment from the patient's perspective. Objective: The aim is to model longitudinal variation in a mobility patient-reported outcome (PRO) and compare trajectories to those observed for Timed 25-Foot Walk (T25FW) in a retrospective cohort. Methods: Latent-class growth analysis was applied to 47,508 measures of Performance Scales© Mobility PRO (PS-Mobility) over ~4 years for 8524 PwMS. For 7347 PwMS, there were 41,988 T25FW measures during this period. Repeated measures correlation and concordance of trajectory assignment were evaluated. Results: At the group level, PS-Mobility and T25FW linearly worsened and repeated-measures correlation was moderate. Eight latent classes with varying shapes that worsened described PS-Mobility variation, compared to six latent classes for T25FW that differed by intercept. The agreement between PS-Mobility and T25FW cluster assignment was modest. A higher proportion of individuals who were Black/African American, older, Medicaid beneficiaries, living in deprived neighborhoods, had longer disease duration, had progressive disease, and ever smokers were assigned to more impaired clusters. Discussion: Cross-sectionally, PS-Mobility and T25FW were highly correlated, but longitudinally correlation was modest to moderate, underscoring the importance of considering both objective and subjective perspectives in evaluating mobility changes in PwMS. [ABSTRACT FROM AUTHOR]

Purpose: Ductal carcinoma in situ (DCIS) of the breast is one of the most common pre-invasive cancers diagnosed in women. Quality of life (QoL) is extremely important to assess in studies including these patients due to the favorable prognosis of the disease. The primary objective of this systematic review was to compile a comprehensive list of QoL issues, all existing QoL assessment tools, and patient-reported outcome measures used to assess DCIS. Methods: A search was conducted on Ovid MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials databases from inception to August 2023, using keywords such as “ductal carcinoma in-situ”, “quality of life”, and “patient-reported outcomes.” QoL issues and QoL tools in primary research studies were extracted. Results: A total of 67 articles identified issues pertaining to patients with DCIS spanning physical, functional, and psychosocial QoL domains. Physical and functional issues observed in patients included pain, fatigue, and impaired sexual functioning. Psychosocial issues such as anxiety, depression, and confusion about one’s disease were also common. QoL tools included those that assessed general QoL, breast cancer-specific tools, and issue-specific questionnaires. Conclusion: The current instruments available to assess QoL in patients with DCIS do not comprehensively capture the issues that are pertinent to patients. Thus, the modification of existing tools or the creation of a DCIS-specific QoL tool is recommended to ensure that future research will be sensitive towards challenges faced by patients with DCIS. [ABSTRACT FROM AUTHOR]

Purpose: Radiation dermatitis (RD) is a painful side effect of radiation therapy (RT). The objective of this analysis was to investigate the validity and reliability of the Skin Symptom Assessment (SSA) questionnaire in evaluating the severity of patient- and clinician-reported outcomes for RD in breast cancer patients by comparing it to a validated assessment tool, the Radiation-Induced Skin Reaction Assessment Scale (RISRAS) questionnaire. Methods: This study compared patient and clinician-reported outcomes for RD from previous clinical trials conducted in a Canadian cancer centre. The analysis included 376 and 38 patients in the two trials using Mepitel Film (doi.org/10.1200) and StrataXRT (clinicaltrials.gov identifier: NCT05594498), respectively. Patients in both studies completed the SSA and RISRAS questionnaires at baseline, 2-weeks post-RT, and 3 months after completion of RT. Clinician SSA and RISRAS assessments were collected at baseline and 2-weeks post-RT. These time points were analyzed longitudinally to investigate the SSA’s validity in RD symptom assessment. Results: The majority of patient-reported items on the SSA and RISRAS assessments demonstrated positive significant associations between symptoms of itchiness, between pain/soreness and pain/discomfort, and between blistering or erythema with burning sensation items. All items in the clinician-reported SSA and clinician component of RISRAS showed positive statistical significance between items measuring erythema, pigmentation or edema with dry desquamation, and blistering/peeling with moist desquamation. Conclusions: The SSA has been validated for assessing patient- and clinician-reported symptoms of RD accurately as outcomes correlate well with the previously validated RISRAS assessment. [ABSTRACT FROM AUTHOR]

Purpose: Previous literature has produced heterogeneous results on StrataXRT for prevention of acute radiation dermatitis (RD) in breast cancer. This pilot study aimed to assess the feasibility and efficacy of StrataXRT in a cancer center. Methods: The study consisted of five cohorts: (1) patients with large breasts treated with local radiation therapy (RT) either in the supine position or (2) the prone position, (3) patients receiving locoregional breast RT with any breast size, and (4) patients receiving chest wall RT, either locally or (5) locoregionally. The primary endpoint of the study was RD grade as assessed using the Common Terminology Criteria for Adverse Events. Secondary endpoints included incidence of moist desquamation (MD), patient- and clinician-reported skin assessments, patient quality of life as assessed by the Skindex-16, and patient satisfaction. These outcomes were compared with those from a published trial from the same institution assessing standard of care and Mepitel Film (MF) as prevention of breast RD. Results: Forty-five patients receiving RT to the breast or chest wall were enrolled. Two withdrew, leaving 43 evaluable patients. Overall, two (4.7%) patients had grade 3 RD, 14 (32.6%) had grade 2 RD, and 27 (62.8%) had grade 1 RD. Ten patients (23.3%) developed MD during/after RT. Conclusion: StrataXRT is effective in preventing grade 3 RD in patients, and the most promising results were observed within the prone cohort. Further research includes evaluating the efficacy of StrataXRT against the standard of care for the prophylaxis of RD. Trial registration: The study protocol was registered at ClinicalTrials.gov (identifier: NCT05594498) on October 13, 2022. [ABSTRACT FROM AUTHOR]

The epidemiology data and global burden of diabetic foot disease underscores the need for effective prevention strategies, which requires an early diagnosis. Patient-reported outcome measures are instruments based on a simple format, which favours their application. Currently, there is an absence of instruments with a broad enough scope to capture the diverse aspects involved in diabetic foot disease. To develop a questionnaire for the assessment of patients with diabetic foot disease and carry out an analysis of its validity and reliability. The study was developed in two stages. Stage 1: the Delphi Panel was composed of 22 experts. The questionnaire is made up of 25 questions selected, after three rounds, from an initial sample of 68 questions. Stage 2: A validation study was performed. With a sample of 273 subjects, an exploratory factor analysis and an analysis of internal consistency, items response, and validity were carried out using the Diabetes Quality of Life, SF-12v2, Foot Function Index and EuroQol EQ5D questionnaires. Measurements of error and sensitivity to change were also analyzed. A 25-item questionnaire (DiaFootQ) was developed. It comprised two dimensions: 1) lifestyle and function; and 2) footwear and foot self-care. Sample (n=273) mean age was 69.77 years (±11.08). The internal consistency of DiafootQ was α=0.916, and item response values were ICC=0.862–0.998. External validity correlation levels ranged from r=0.386 to r=0.888. DiaFootQ was developed. Integrating the main aspects involved in diabetic foot disease could help to detect more accurately the risk or severity of these patients. DiaFootQ is a well-structured, valid, and reliable tool whose use should be promoted in clinical and research settings. • The DiaFootQ is a new instrument for the assessment and monitoring of patients with diabetic foot disease. • A thorough Delphi method was used for the DiaFootQ development. • DiaFootQ is highly innovative since it provides reports from the multiple aspects of diabetic foot disease. • The DiaFootQ proved to have adequate face, content, internal and external validity. [ABSTRACT FROM AUTHOR]

Background: Radio-Taiso, a long-standing exercise program in Japan, could be a sustainable public health strategy for maintaining quality of life (QoL) in older adults with frailty. This study aimed to investigate whether Radio-Taiso provided greater benefits for health-related quality of life (HRQoL) and to identify the mechanisms underlying the effectiveness in this population. Methods: A 12-week randomized controlled trial enrolled 226 older Japanese adults with pre-frailty or frailty, assessed using the modified frailty phenotype. Participants were randomly allocated to the intervention (Radio-Taiso + nutrition program) or control (nutrition program) groups. The Radio-Taiso program comprised five 60-min group sessions and daily practice at the participants' homes. The primary outcome was the change in the mental domain of HRQoL, assessed using the SF-36®. The secondary outcomes included six physical fitness items and exercise self-efficacy. Results: Overall, 104 and 105 participants in the intervention and control groups, respectively, were analyzed based on the intention-to-treat principle. The median daily practice rate of Radio-Taiso was 94.1% (interquartile range, 73.2-98.8%). Although general linear models adjusted for baseline values and allocation stratification factors showed that the intervention group obtained greater benefits (adjusted mean differences) in the up-and-go (0.3; 95% confidence interval [CI], 0.1 to 0.6 s), 2-min step-in-place (-3.2; 95% CI, -6.2 to -0.2 steps) tests, and exercise self-efficacy scale (-1.4; 95% CI, -2.6 to -0.1 points) than the control group, there were no group differences in changes in the mental domain score of HRQoL. Conclusion: Radio-Taiso provided greater benefits for agility/dynamic balance, aerobic endurance, and exercise self-efficacy in older adults with frailty; however, these changes do not improve HRQoL. [ABSTRACT FROM AUTHOR]

Toremifene, a selective estrogen receptor modulator, is commonly used in China for premenopausal breast cancer patients. This real‐world study aimed to compare patient‐reported outcome (PRO) and survival between toremifene and aromatase inhibitor (AI) plus ovarian function suppression (OFS) in patients with moderate‐/high‐risk premenopausal hormone receptor (HR)‐positive breast cancer. The primary endpoint was PROs, assessed using SF‐36 and EQ‐5D‐5L questionnaires between January and March 2023. A total of 392 patients were included, with 171 receiving toremifene and 221 receiving AI. The toremifene group showed significantly higher scores in the role physical (p = 0.034) and mental health (p = 0.009) dimensions of SF‐36 and lower anxiety/depression (AD) scores (p = 0.038) in EQ‐5D‐5L compared to AI group. The estimated 5‐ and 8‐year disease‐free survival (DFS) rates were similar in toremifene and AI groups: 96.5% versus 91.9%, and 87.4% versus 87.8% (p = 0.39), respectively. Adverse event rates were similar in two groups, except for a greater risk of endometrial thickening (p < 0.001) and a lower occurrence of morning stiffness (p < 0.001) in the toremifene compared to the AI group. Premenopausal HR‐positive breast cancer patients receiving toremifene plus OFS had better role physical and mental health outcomes and lower AD dimensions than those receiving AI plus OFS. Both treatments had comparable DFS and favorable tolerability profiles. [ABSTRACT FROM AUTHOR]

Background: The role that preoperative Satisfaction with Breast plays in a patient's postoperative course after postmastectomy breast reconstruction (PMBR) is not understood. The aim of this study is to understand the impact of the preoperative score on postoperative outcome as an independent variable. Methods: We examined patients who underwent PMBR between 2017 and 2021 and who completed the BREAST-Q Satisfaction with Breasts at 1 year postoperatively. Two multiple linear regression models (Model 1 with the preoperative Satisfaction with Breasts score and Model 2 without the preoperative score), likelihood ratio tests, simple t-statistics, and sample patient dataset to predict the 1 year score were performed. Multiple imputation was used to account for missing preoperative scores. Results: Overall, 2324 patients were included. Model 1 showed that the preoperative score is significantly associated with the postoperative score (β = 0.09, 95% confidence interval 0.04–0.14; p < 0.001). Comparing Model 1 and Model 2 demonstrated that including preoperative Satisfaction with Breasts in a regression significantly improves model fit (test statistic = 10.04; p = 0.0021). Using the absolute value of the t-statistics as a measure of variable importance in linear regression, the importance of the preoperative score was quantified as 3.39—more important than neoadjuvant radiation, mastectomy weight, body mass index, bilateral prophylactic mastectomy, and race, but less than adjuvant radiation, reconstruction type, and psychiatric diagnoses. Conclusion: Preoperative Satisfaction with Breasts scores are an important independent predictor of postoperative satisfaction after PMBR. Just as vital sign and work-up are carefully documented before surgery, preoperative scores should be collected to pre-emptively gauge patients' satisfaction and optimize postoperative outcomes. [ABSTRACT FROM AUTHOR]

Objective: The objective of this study was to assess satisfaction and psychosocial status before and after facial bone contouring surgery using the Face-Q. Methods: The Face-Q, a multimodular patient-reported outcome (PRO) instrument, comprises independently functioning scales and checklists designed to assess outcomes in facial aesthetic patients. A prospective cohort study was conducted from November 2020 to May 2022. Participants undergoing facial bone contouring surgery (reduction mandibuloplasty and/or malarplasty) were asked to complete the Face-Q preoperatively and 12 months postoperatively. Comparative analyses were conducted using normative Face-Q data from 534 matched normal individuals. Face-Q scores were evaluated for each domain on a scale of 0 to 100, with higher scores indicating greater satisfaction with appearance or a superior quality of life. Results: A total of 284 patients (274 female and 10 male) completed the Face-Q preoperatively and 12 months postoperatively. Of these, 146 underwent reduction mandibuloplasty, 18 underwent malarplasty, and 120 underwent both procedures. Post-surgery, patients experienced significant improvements in overall appearance, features altered by surgery, and quality of life, excluding the patient-perceived age. Preoperatively, patients demonstrated significantly lower scores compared to normative data, with scores significantly increasing postoperatively to levels representative of the general population. Satisfaction with outcome was significantly correlated with postoperative Face-Q measurements but not preoperatively. Conclusion: Facial bone contouring surgery significantly improves the satisfaction and quality of life in patients with square faces, reaching a level at least equivalent to the normative population. The use of Face-Q should be highlighted in the clinic practice. Level of Evidence IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 [ABSTRACT FROM AUTHOR]

Background Methods Results Conclusions Overall symptom severity (OSS) and patient‐reported chronic rhinosinusitis (CRS) control are global measures of CRS identified as consensus, essential criteria for CRS disease control assessment. We sought to determine the functional relationship between these two metrics.Using an international multicenter mixed‐methods design, 260 CRS patients were recruited. OSS score was measured using a visual analog scale. Patient‐reported CRS control was measured as “controlled,” “partly controlled,” and “uncontrolled.” Twelve participants underwent semi‐structured interviews to discuss OSS and patient‐reported CRS control.The majority of interviewed participants felt OSS and patient‐reported CRS control measured different constructs—while OSS only measured symptoms, patient‐reported CRS control was more global, including not only symptom severity but also concepts such as medication usage, activity impairment, and exacerbations. Nevertheless, OSS score was strongly correlated with (ρ = 0.67, p < 0.001) and highly predictive of patient‐reported CRS control. OSS score of >4 (95% confidence interval [CI]: 1.8–4.2) had 74.7% sensitivity and 93.2% specificity in identifying patients reporting their CRS as not controlled. OSS score of >6.6 (95% CI: 4.1–7.1) had 77.0% sensitivity and 75.9% specificity in identifying patients reporting their CRS as uncontrolled. The 22‐item Sinonasal Outcome Test score was also predictive of patient‐reported CRS disease control but OSS was significantly more predictive.Patients conceptually view patient‐reported CRS control as a more global measure that subsumes OSS. Quantitatively, however, OSS is highly correlated with patient‐reported CRS control, possibly reflecting their redundancy. For ease of use, we recommend patient‐reported CRS control be reflected by OSS <4 for controlled, 4 ≤ OSS < 7 for partly controlled, and OSS ≥7 for uncontrolled CRS. [ABSTRACT FROM AUTHOR]

Background: Chronic cough, a cough lasting >8 weeks, includes refractory chronic cough (RCC) and unexplained chronic cough (UCC). Patient-reported outcome (PRO) measures are needed to better understand chronic cough impacts that matter most to patients. The 19-item Leicester Cough Questionnaire (LCQ), an existing PRO measure of chronic cough, assesses impacts of cough across physical, psychological, and social domains. However, the content validity of the LCQ evaluating these concepts in patients with RCC/UCC had not been established. Objectives: To evaluate the content validity of the LCQ in patients with RCC/UCC. Design: A cross-sectional, qualitative interview study. Methods: First, previously completed qualitative interview results in adults with RCC/UCC (N = 30) were evaluated and mapped to LCQ concepts. Next, a clinical cough expert reviewed each LCQ item and assessed the salience of its concepts for patients with RCC/UCC. Finally, semistructured interviews—including both concept elicitation and cognitive debriefing—were conducted in adults with RCC/UCC (N = 20) to elicit a comprehensive set of participant experiences and to assess the appropriateness of using the LCQ in this population. Results: Concepts reported in the past and present qualitative interviews were included across all LCQ items, and most impacts reported to be the "most bothersome" were assessed in the LCQ. In the current study, all participants indicated that reduced cough frequency would be an important treatment target. During cognitive debriefing, each LCQ item was endorsed by ⩾70% of participants. Additionally, participants were generally able to understand, recall, and select a response for each LCQ item. All participants and the clinical expert indicated that the LCQ was appropriate and assessed the impacts most relevant to patients with RCC/UCC. Conclusion: Our findings support the content validity of the LCQ and demonstrate that this measure is fit-for-purpose and includes important cough impacts in adults with RCC/UCC. [ABSTRACT FROM AUTHOR]

Background: Computerized adaptive testing (CAT) is an effective way to reduce time, repetitious redundancy, and respond burden, and has been used to measure outcomes in many diseases. This study aimed to develop and validate a comprehensive disease-specific CAT for chronic obstructive pulmonary disease (COPD) patient-reported outcome measurement. Methods: The discrimination and difficulty of the items from the modified patient-reported outcome scale for COPD (mCOPD-PRO) were analyzed using item response theory. Then the initial item, item selection method, ability estimation method, and stopping criteria were further set based on Concerto platform to form the CAT. Finally, the reliability and validity were validated. Results: The item discrimination ranged from 1.05 to 2.71, and the item difficulty ranged from − 3.08 to 3.65. The measurement reliability of the CAT ranged from 0.910 to 0.922 using random method, while that ranged from 0.910 to 0.924 using maximum Fisher information (MFI) method. The content validity was good. The correlation coefficient between theta of the CAT and COPD assessment test and modified Medical Research Council dyspnea scale scores using random method was 0.628 and 0.540 (P < 0.001; P < 0.001) respectively, while that using MFI method was 0.347 and 0.328 (P = 0.007; P = 0.010) respectively. About 11 items (reducing by 59.3%) on average were tested using random method, while about seven items (reducing by 74.1%) on average using MFI method. The correlation coefficient between theta of the CAT and mCOPD-PRO total scores using random method was 0.919 (P < 0.001), while that using MFI method was 0.760 (P < 0.001). Conclusions: The comprehensive disease-specific CAT for COPD patient-reported outcome measurement is well developed with good psychometric properties, which can provide an efficient, accurate, and user-friendly measurement for patient-reported outcome of COPD. [ABSTRACT FROM AUTHOR]

Background: Incisional hernia (IH) is common and recurrence rates remain high. Although the goal of treatment should be to improve quality of life, studies addressing this aspect are notably absent. We aimed to evaluate the long‐term recurrence rate of open mesh repair of IH, investigate the burden of persisting discomfort, explore patient satisfaction, and identify risk factors for negative outcomes. Methods: A single‐center, retrospective study was conducted on all open mesh repairs of IH performed between January 2002 and October 2013. Clinical data were gathered from medical records and operative reports, while patient‐reported outcome measures (PROMs) were obtained through telephone interviews. Risk factors for recurrence were assessed by survival analysis. PROMs were analyzed across patient subgroups by clinical and demographic variables. Results: This study included 271 patients undergoing medical record review, with 136 patients completing the telephone interview. Recurrence rates at 2, 5, 10, and 15 years were 6%, 8%, 11%, and 12%, respectively. Risk factors for recurrence were obesity and an estimated mesh‐defect overlap <7 cm. Bridged repair posed no increased risk. For PROMs, the median follow‐up time was 13.6 years after which 78.7% of the patients reported no discomfort, and 89.0% were satisfied with their surgery. Patients <65 years and females experienced more long‐term discomfort. Conclusions: Recurrence rates were higher in obese patients and when the estimated mesh‐defect overlap was <7 cm, but not in bridged repairs. Young patients and females are at increased risk for long‐term discomfort. High satisfaction levels were reported. [ABSTRACT FROM AUTHOR]

Introduction: This study evaluated the psychometric properties of the newly developed chronic constipation-therapeutic efficacy and satisfaction test (CC-TEST) among patients with chronic constipation. Methods: Japanese patients with moderate or severe chronic constipation underwent a 4-week remedy. The baseline, 2-week, and 4-week assessments included the CC-TEST, Constipation Scoring System (CSS), Medical Outcome Study Short Form-8 Health Survey (SF-8), and Hospital Anxiety and Depression Scale (HADS). The CC-TEST comprises three domains: (1) symptoms; chronic constipation symptom severity (seven items), defecation status (five items), (2) impact for daily life; dissatisfaction with daily life level (DS; four items), and (3) therapeutic response; therapeutic efficacy measured by patients and medication compliance (four items). Results: Of 201 eligible patients at baseline, 110 completed the 4-week treatment and the survey responses. Cronbach's α values for the stool, defecation, and abdominal symptom subscales, as well as the total symptom score and DS subscale, showed good internal consistency reliability (0.72–0.80). Pearson's r for comparisons between corresponding items (CC-TEST symptoms with CSS, and CC-TEST DS with SF-8 physical and mental component summary scores) was significant. After 4 weeks, scores for symptoms, defecation status, and DS items/subscales notably decreased, with a significant effect size (p < 0.005, Cohen's d; 0.30–1.16). Statistically significant differences emerged between treatment responders and nonresponders using the three responder definitions, in changes in scores for most CC-TEST symptoms, defecation status, and DS items/subscales (p < 0.05). Conclusion: CC-TEST demonstrates commendable reliability, convergent and known-group validity, and responsiveness to treatment effects. As a simple, comprehensive, and versatile patient-reported outcome measure, CC-TEST may be well suited for clinical trials and primary care of Japanese patients with chronic constipation. [ABSTRACT FROM AUTHOR]

Background: Clinical prediction models (CPM), such as the SCOAP-CERTAIN tool, can be utilized to enhance decision-making for lumbar spinal fusion surgery by providing quantitative estimates of outcomes, aiding surgeons in assessing potential benefits and risks for each individual patient. External validation is crucial in CPM to assess generalizability beyond the initial dataset. This ensures performance in diverse populations, reliability and real-world applicability of the results. Therefore, we externally validated the tool for predictability of improvement in oswestry disability index (ODI), back and leg pain (BP, LP). Methods: Prospective and retrospective data from multicenter registry was obtained. As outcome measure minimum clinically important change was chosen for ODI with ≥ 15-point and ≥ 2-point reduction for numeric rating scales (NRS) for BP and LP 12 months after lumbar fusion for degenerative disease. We externally validate this tool by calculating discrimination and calibration metrics such as intercept, slope, Brier Score, expected/observed ratio, Hosmer–Lemeshow (HL), AUC, sensitivity and specificity. Results: We included 1115 patients, average age 60.8 ± 12.5 years. For 12-month ODI, area-under-the-curve (AUC) was 0.70, the calibration intercept and slope were 1.01 and 0.84, respectively. For NRS BP, AUC was 0.72, with calibration intercept of 0.97 and slope of 0.87. For NRS LP, AUC was 0.70, with calibration intercept of 0.04 and slope of 0.72. Sensitivity ranged from 0.63 to 0.96, while specificity ranged from 0.15 to 0.68. Lack of fit was found for all three models based on HL testing. Conclusions: Utilizing data from a multinational registry, we externally validate the SCOAP-CERTAIN prediction tool. The model demonstrated fair discrimination and calibration of predicted probabilities, necessitating caution in applying it in clinical practice. We suggest that future CPMs focus on predicting longer-term prognosis for this patient population, emphasizing the significance of robust calibration and thorough reporting. [ABSTRACT FROM AUTHOR]

INTRODUCTION: Screening for early esophageal adenocarcinoma (EAC) may potentially reduce EAC-related mortality and morbidity. This study aimed to examine the Dutch population's intended uptake of 3 hypothetical EAC screening test scenarios and preferences for potential future organization. METHODS: A total of 8,350 Dutch individuals aged 45-75 years were invited, of whom 2,258 completed a web-based survey. Participants were randomly assigned to 1 of 3 hypothetical screening test scenarios (i.e., transnasal endoscopy, ingestible cell collection device, or breath analysis). The primary outcome was intended uptake. Secondary outcomes included acceptance of screening eligibility criteria and preferences regarding invitation, counseling, and diagnostic follow-up. We performed exploratory univariable and multivariable regression analyses to assess which determinants were associated with EAC screening intent. RESULTS: Intended uptake of screening was highest in the breath analysis scenario (95%), followed by conventional upper endoscopy (78%), an ingestible cell collection device (75%), and transnasal endoscopy (68%) (P < 0.001). Anticipating discomfort was most strongly associated with decreased intention to undergo transnasal endoscopy (odds ratio 0.18, 95% confidence interval 0.11-0.29) or swallow a cell collection device (odds ratio 0.20, 95% confidence interval 0.13-0.32). Cancer worry and high acceptance of test sensitivity/specificity were consistently associated with a positive intention to participate in screening. Inviting persons for screening based on gastroesophageal reflux disease symptoms, age, or the output of a risk prediction model was acceptable to 74%, 69%, and 66%, respectively. Inviting only men was acceptable for only 41% of women. The majority (58%) preferred to be invited by a public health organization, and 32% of the participants preferred to discuss their decision to participate with a healthcare professional. DISCUSSION: Participants in this study self-selected through a web-based survey, potentially introducing selection bias. Participants generally intended to participate in EAC screening, although the level of intent depended on the discomfort and performance associated with the offered screening test. Determining eligibility based on gastroesophageal reflux disease symptoms, age, or a risk calculator, but not sex, would be acceptable to most individuals. [ABSTRACT FROM AUTHOR]

Patients with class III malocclusion often exhibit mandibular prognathism and complain of "prognathic appearance". The overall positive effects of orthognathic surgery on facial appearance have been demonstrated using patient-reported outcome measures (PROMs), but studies investigating the correlation between subjective PROMs results and objective measurements of imaging studies are sparse in the literature. This study recruited consecutive patients with skeletal class III malocclusion who underwent two-jaw orthognathic surgery between January 2016 and January 2021. The PROMs survey was conducted focusing on subjective perception of mandibular appearance. Lateral cephalometric images were measured to examine the correlation with the PROMs results. A total of 96 patients were eligible for this study. Of these, 74 patients (77.1%) reported complete correction of prognathic appearance postoperatively, whereas 22 patients (22.9%) perceived residual prognathic appearance. In a comparison of postoperative measurements between completely and incompletely satisfied patients, there were significant differences in SNB, ANB, convexity, facial angle, Nv-B, Nv-Pog, SN'B', soft tissue facial angle, lip–chin–throat angle, N'v-B′, and N'v-Pog'. The PROM results were significantly associated with the objective measurements of imaging studies. Investigating the correlation between PROMs and objective measurements enables integration of patients' perception of the outcomes into future therapeutic strategy and surgical planning, contributing to the enhancement of patient satisfaction. [ABSTRACT FROM AUTHOR]

Glenoid component loosening remains the most common reason for revision of anatomic total shoulder arthroplasty (aTSA). We assessed early clinical and radiographic outcomes following aTSA using a press-fit short stem and a peripherally enhanced fixation glenoid. 275 consecutive patients with end-stage glenohumeral arthritis and Walch A- or B-type glenoid morphology who underwent primary aTSA in 2017-2018 at two high-volume shoulder arthroplasty institutions were evaluated, and patient-reported outcomes (PROMs) and radiographic findings were studied in those with completed baseline and minimum 2-year follow-up, respectively. Patient demographics, glenoid morphology, body mass index (BMI), Charlson Comorbidity Index (CCI), range of motion, American Shoulder and Elbow Surgeons (ASES) score, and Simple Assessment Numeric Evaluation score were collected. Radiographic analysis of glenoid and humeral components was performed. Multivariable logistic, equal adjacent odds ordinal, and beta regression were respectively used to identify predictors of glenoid radiolucent lines, humeral calcar resorption, and total ASES score. Patients were 43% female, with a mean age of 66, a median BMI of 30, and median follow-up of 28.4 months. ASES and Simple Assessment Numeric Evaluation scores improved by respective medians of 54.4 and 55.0 points, forward elevation by median 35°, and external rotation by median 30° (all P <.001 for preoperative to postoperative change). Postoperative radiographs of 177 cases showed 10 (5.7%) glenoid osteolysis, 51 (28.8%) glenoid radiolucent lines, and 81 (45.8%) calcar resorptions. The follow-up duration (median 40.1 vs. 27.2 months; P <.001), BMI (median 27.5 vs. 30.7; P <.001), and Charlson Comorbidity Index (Q3 0 vs. 1; P =.02) were associated with glenoid osteolysis in bivariate analyses. In multiple logistic regression, surgeon (C vs. A/B) was the only statistically significant predictor of glenoid radiolucent lines [OR 0.27, 95% CI (0.1, 0.8)]. By descending importance, Surgeon C [OR 6.5 (2.0, 20.5)], humeral canal filling ratio [upper vs. lower quartile OR 2.3 (1.3, 4.0)], mediolateral humeral head deviation [upper vs. lower quartile OR 1.9 (1.0, 3.5)], and glenoid osteolysis [OR 13.5 (2.6, 71.6)] significantly predicted greater calcar resorption. Longer follow-up duration marginally statistically significantly predicted lower ASES score [upper vs. lower quartile OR 0.8 (0.6, 1.0)]. Following aTSA with a peripherally enhanced fixation glenoid, pain, range of motion, and patient-reported outcomes significantly improved at a minimum of 2 years with only 5.7% glenoid osteolysis despite heterogeneous preoperative glenoid pathologies. [ABSTRACT FROM AUTHOR]

Background Abemaciclib-induced diarrhea is a relevant concern in clinical practice. Postbiotics have emerged as a promising option for managing it. Materials and Methods We conducted a retrospective-prospective, 2-group, observational study to assess the impact of the postbiotic PostbiotiX-Restore, derived by Lactobacillus paracasei CNCM I-5220, on abemaciclib-induced diarrhea in patients with hormone receptor-positive HER2-negative breast cancer. The prospective population (Postbio group) received postbiotic during the first cycle of abemaciclib, while the retrospective one received standard care (Standard group). Diarrhea grading was defined according to the National Cancer Institute's Common Terminology Criteria for Adverse Events. Results During the first cycle, diarrhea occurred in 78.9% of patients in the Standard cohort and 97.1% in the Postbio one, with most cases being G1-G2. Severe (G3) diarrhea was significantly less frequent in the Postbio group (0%) compared to the Standard one (7.9%; P  = .029). Over the entire study period, while the grading difference was not statistically significant, G3 events were less frequent in the Postbio population (5.9%) than the Standard one (15.4%). Moreover, Postbio patients required fewer dose reductions due to diarrhea compared to the Standard group (P  = .002). Notably, in the Postbio population, G1 and G2 events had short median durations (3 and 1 days, respectively) and, for the 2 patients experiencing G3 events during the second abemaciclib cycle (off postbiotic), diarrhea lasted only 1 day. Conclusions Our study demonstrates the effect of PostbiotiX-Restore in mitigating abemaciclib-induced diarrhea, resulting in reduced severity, fewer dose reductions, and shorter duration. Further exploration and validation in larger cohorts are needed. [ABSTRACT FROM AUTHOR]

Study Design: Retrospective cohort study. Objectives: In patients undergoing adult spinal deformity (ASD) surgery we sought to: 1) report preoperative and postoperative lumbosacral fractional (LSF) curve and maximum coronal Cobb angles and 2) determine their impact on radiographic, clinical, and patient-reported outcomes (PROs). Methods: A single-institution cohort study was undertaken. The LSF curve was the cobb angle between the sacrum and most tilted lower lumbar vertebra. Coronal/sagittal vertical axis (CVA/SVA) were collected. Patients were compared between 4 groups: 1) Neutral Alignment (NA); 2) coronal malalignment only (CM); 3) Sagittal malalignment only (SM); and 4) Combined-Coronal-Sagittal-Malalignment (CCSM). Outcomes including postoperative CM, postoperative coronal vertical axis, complications, readmissions, reoperation, and PROs. Results: A total of 243 patients underwent ASD surgery with mean total instrumented levels of 13.5. Mean LSF curve was 12.1±9.9°(0.2-62.3) and mean max Cobb angle was 43.0±26.5° (0.0-134.3). The largest mean LSF curves were seen in patients with CM (14.6°) and CCSM (13.1°) compared to NA (12.1°) and SM (9.5°) (p=0.100). A higher LSF curve was seen in patients with fusion to the sacrum and instrumentation to the pelvis (p=0.009), and a higher LSF curve was associated with more TLIFs (p=0.031). Postoperatively, more TLIFs were associated with greater amount of LSF curve correction (p<0.001). Comparing the LSF and the max Cob angle among Qiu types, the highest mean max Cobb angle was in Qiu Type B patients (p=0.025), whereas the highest mean LSF curve was in Qiu Type C patients (p=0.037). Moreover, 82.7% of patients had a LSF curve opposite the max Cobb angle. The LSF curve was larger than the max Cobb angle in 22/243 (9.1%) patients, and most of these 22 patients were Qiu Type A (59.1%). Regarding correction, the max Cobb angle achieved more correction than the LSF curve, judged by the percent improved from preop (54.5% Cobb vs. 46.5% LSF, p=0.025) in patients with max cobb>20° and LSF curve >5°. The LSF curve underwent greater correction in Qiu Type C patients (9.2°) compared to Type A (5.7°) and Type B (5.1°) (p=0.023); however, the max Cobb angle was similarly corrected among Qiu Types: Type A 21.8°, Type B 24.6°, and Type C 25.4° (p=0.602). Minimal differences were seen comparing the preop/postop/change in LSF curve and max Cobb angle regarding postop CM, postop CVA, complications, readmissions, reoperation, and PROs. Conclusions: The LSF curve was highest in patients with CM, CCSM, and Qiu Type C curves. Most patients had a LSF curve opposite the max Cobb angle. The max Cobb angle was more often corrected than the LSF curve. The LSF curve underwent greater correction among Qiu Type C patients, whereas the max Cobb angle was similarly corrected among all Qiu Types. No clear trend was seen regarding postoperative complications and PROs between the LSF curve and max Cobb angle. [ABSTRACT FROM AUTHOR]

Introduction: Symptom status and treatment changes among patients with chronic obstructive pulmonary disease (COPD) using inhaler treatment in real-world clinical settings are not well understood, particularly according to class of treatment. We investigated the proportion of symptomatic patients among those with COPD using inhaler treatment, based on COPD Assessment Test (CAT) scores in clinical practice, and changes in inhaler treatments and symptoms at 1-year follow-up. Methods: This was a retrospective analysis of data from a multicenter, prospective cohort study conducted at medical institutions with respiratory specialists in Japan. The primary endpoint was the proportion of patients with CAT scores ≥ 10 or < 10 in each inhaler treatment group at registration. Results: Of 414 patients in the full analysis set, 76 (18.4%), 261 (63.0%), and 77 (18.6%) were using long-acting muscarinic antagonist (LAMA), LAMA + long-acting β2-agonist (LABA), and inhaled corticosteroids (ICS) + LABA, respectively, at registration. The proportions of patients with CAT scores ≥ 10 or < 10 per inhaler treatment group at registration, respectively, were 32.9% and 67.1% in the LAMA group, 55.0% and 45.0% in the LAMA + LABA group, and 50.0% and 50.0% in the ICS + LABA group. Most patients (> 75%) in each inhaler treatment group showed no change in inhaler treatment at 1 year, regardless of their CAT score at registration. Approximately 70–80% of patients with CAT scores ≥ 10 at registration still had CAT scores ≥ 10 at 1 year; 10–30% of patients with CAT scores < 10 at registration had CAT scores ≥ 10 at 1 year. Conclusion: In real-world Japanese clinical practice, a considerable proportion of patients have persistent symptoms (CAT score ≥ 10) despite using mono or dual inhaler treatment; > 75% of symptomatic patients with COPD using inhaler treatment did not undergo treatment escalation at 1-year follow-up and remained symptomatic. Trial Registration: ClinicalTrials.gov identifier, NCT05903989. [ABSTRACT FROM AUTHOR]

Abstract Background Bowel urgency, the sudden and immediate need to have a bowel movement, is common in patients with ulcerative colitis (UC) and Crohn’s disease (CD). While its impact in UC is well established, less is known about its importance in CD. Further, what level of bowel urgency control patients with UC or CD would consider to be acceptable or in remission has not been established. This qualitative study aimed to understand perceptions of bowel urgency and remission in these patients. Methods Semi-structured combined concept elicitation and cognitive interviews were conducted to explore how adults with moderate-to-severe UC or CD and current or recent bowel urgency think about the concept of bowel urgency and its remission. The Urgency Numeric Rating Scale (UNRS) was used to examine different levels of bowel urgency severity and to investigate what level of bowel urgency patients would consider as representing remission. Results Forty adults (n = 19 UC, n = 21 CD) recruited from six US sites completed the study. Sociodemographic and clinical characteristics were similar in both groups. Both groups reported impacts of bowel urgency on physical, social, professional, and emotional aspects of their lives. Most participants (n = 15 UC, n = 18 CD) reported having experienced one or more incidents of urgency-related fecal incontinence. Most participants considered remission to be a state with a normal or reduced number of bowel movements and no or less frequent bowel urgency, and they noted that remission would increase their ability to engage in daily activities without fear of fecal incontinence. Participants were able to map different levels of severity of bowel urgency to UNRS score ranges (scale: 0–10), and they indicated that a mean UNRS score of 5 (UC) or 4 (CD) would be the highest point on the NRS at which they would still consider their bowel urgency to be in remission. Conclusions Bowel urgency is an important issue for patients with either moderate-to-severe UC or CD, and its remission would improve their lives. Further, these patients may still consider bowel urgency to be in remission even at UNRS scores as high as 4 or 5.

Background Direct-to-implant breast reconstruction (DIR) is becoming more and more accepted. There is a lack of high-quality studies assessing differences in patient-reported quality of life (QoL) between different implant placement methods. The aim of this randomized controlled (clinical) trial was to compare QoL between women reconstructed by sub- or prepectoral implant placement.

Chronic obstructive pulmonary disease (COPD) is one of the common respiratory diseases, and the acute exacerbation of COPD is an acute event that severely reduces the quality of life in patients with COPD. We searched PubMed, CNKI, Wanfang Data Knowledge Service Platform, Vip.com and Chinese Biomedical Literature, sifted out 69 representative literatures according to the inclusion and exclusion criteria, and found that there were 23 patient-reported outcome (PRO) assessment tools used in patients with acute exacerbation of COPD. Except for the EXACT-PRO, all of them directly use PRO assessment tools of stable patients. These assessment tools are divided into general, disease-specific and symptom-specific assessment tools, mainly involving symptoms, physiological field, social field, psychological emotion, daily activities and other fields. The number of items is from one to 100, and the response scale is mostly in the form of Likert, and its development and assessment are based on classical test theory. It is suggested that future studies on quality of life of patients with acute exacerbation of COPD should focus on the following points: strengthening the research on specific assessment tools; attaching importance to the combined application of classical test theory, item response theory and generalizability theory; paying attention to the study of the minimal clinically important difference of assessment tools; selecting assessment tools appropriately.

Paolo Iovino,1 Paola Obbia,2 Vincenzo De Luca,3 Clara Donnoli,4 Lola Patumi,5 Lisa Leonardini,5 Ernesto Palummeri,6 Manuela Ruatta,2 Anna Maddalena Basso,2 Yari Longobucco,1 Laura Rasero,1 Giuseppe Liotta,4 Maddalena Illario3 1Department of Health Sciences, University of Florence, Florence, Italy; 2Directorate of Health Professions, Local Health Agency Cuneo 1, Cuneo, Italy; 3Department of Public Health, Federico II University of Naples, Naples, Italy; 4Department of Biomedicine and Prevention, Tor Vergata University of Rome, Rome, Italy; 5Programma Mattone Internazionale Salute, ULSS 4 Veneto Orientale Local Health Agency, San Donà di Piave (VE), Italy; 6Ligurian Health Agency, Genoa, Liguria Region, ItalyCorrespondence: Maddalena Illario, Università degli Studi di Napoli Federico II, Via Sergio Pansini n.5, Napoli, 80131, Italy, Tel +39 081 7464211, Email illario@unina.itPurpose: Chronic diseases in older age are major sources of burden for healthcare systems. Compliance with medications is the key to treatment success for these patients, especially for frail individuals living in community settings. However, adherence to long-term medications in this population is not optimal, which leads to the need for frequent screening of compliance within large-scale public health surveys. In this context, a brief, simple and valid measure capturing medication adherence is not yet available. This study aims to develop and psychometrically test the Therapeutic Adherence Scale, a brief four-item tool that measures medication adherence in community-dwelling older adults affected by chronic diseases.Methods: We conducted a three-phase process of instrument development, content validity assessment and psychometric testing.Results: Of the candidate nine items derived from a review of the literature, only four were deemed essential to capture intentional and nonintentional nonadherence. These items underwent structural validity, convergent and known-groups validity, and internal consistency on a sample of 269 participants (mean age = 7.91 years, SD = 7.26). Confirmatory factor analysis confirmed satisfactory fit indices (RMSEA = 0.000, CFI = 1.00, TLI = 1.00). Scores of the TAS were higher for those perceiving loneliness (ρ = 0.33, p < 0.001), those declaring memory loss in the last year (ρ = 0.29, p < 0.001), and those exhibiting worse mental quality of life (ρ = − 0.15, p = 0.03) compared with the other groups. Cronbach’s alpha and split-half reliability coefficients were acceptable, with values of 0.68 and 0.77, respectively.Conclusion: The Therapeutic Adherence Scale is a brief, valid and reliable self-report measure of medication adherence that can be used in practice and research to screen patients living in community settings. This tool is also free to use, which contributes to advancing knowledge on the field of medication adherence of older adults affected by chronic diseases.Keywords: aged, factor analysis, medication adherence, patient-reported outcome, psychometrics, self-report, statistical, questionnaire

Abstract Background Rotator cuff tears (RCT) are a common musculoskeletal condition, especially in the aging population. The prevalence of rotator cuff tears varies based on factors like age, occupation, and activity level. In the general population, the prevalence of rotator cuff tears is estimated to be around 20 to 25%. Rotator cuff tears (RCT) have an impact in patients’ pain level, shoulder function, sleep disturbance, and quality of life. Primary tendon surgery is in mostly cases necessary. This study aimed to examine if treatment of rotator cuff lesions with implantation of micro-fragmented adipose tissue can improve patients’ reported pain and function compared to conventional surgery. Methods The study is a prospective superiority parallel-group single-center randomized controlled trial including 30 patients between 40 and 69 years of age in Denmark. Patients will be allocated 1:1 ratio to reconstruction of the supraspinatus tendon with an injection of micro-fragmented adipose tissue into the related muscle (stem cell treatment) or the standard of care (SOC), which is conventional surgery. Patients, project assistants, physicians, and outcome adjudicators are not blinded to randomization due to practical constraints. The radiologist and the statistician performing the analysis will be blinded. The primary outcome will be the Oxford shoulder score at 12 months post-surgery. Discussion This study will assess whether adding micro-fragmented adipose tissue therapy to conventional rotator cuff tear treatment can enhance recovery, accelerate return to daily activities, and improve functional outcomes. The research will also determine if this minimally invasive procedure could be standardized for routine patient care. Trial registration ClinicalTrials.gov NCT06505135. Registered on July 10, 2024.

Abstract Background Computerized adaptive testing (CAT) is an effective way to reduce time, repetitious redundancy, and respond burden, and has been used to measure outcomes in many diseases. This study aimed to develop and validate a comprehensive disease-specific CAT for chronic obstructive pulmonary disease (COPD) patient-reported outcome measurement. Methods The discrimination and difficulty of the items from the modified patient-reported outcome scale for COPD (mCOPD-PRO) were analyzed using item response theory. Then the initial item, item selection method, ability estimation method, and stopping criteria were further set based on Concerto platform to form the CAT. Finally, the reliability and validity were validated. Results The item discrimination ranged from 1.05 to 2.71, and the item difficulty ranged from − 3.08 to 3.65. The measurement reliability of the CAT ranged from 0.910 to 0.922 using random method, while that ranged from 0.910 to 0.924 using maximum Fisher information (MFI) method. The content validity was good. The correlation coefficient between theta of the CAT and COPD assessment test and modified Medical Research Council dyspnea scale scores using random method was 0.628 and 0.540 (P

Context: The University of Wisconsin Running Injury and Recovery Index (UWRI) was developed to evaluate the key elements that runners use to self-assess their own running ability following common running-related injuries. The aim of this study was to translate and culturally adapt the UWRI and to evaluate the psychometric properties of its Turkish version (UWRI-Tr) in runners. Design: Prospective cohort study. Methods: The study included 129 runners. The UWRI-Tr, the Lower Extremity Functional Scale, the Oswestry Disability Index, the Hip Outcome Score, the International Knee Documentation Committee Subjective Knee Evaluation Form, and the Foot and Ankle Ability Measure were applied for the validation purposes. Internal consistency, reliability, construct validity, and discriminant validity of the UWRI-Tr were tested. Results: The test–retest reliability of the UWRI-Tr was excellent with an intraclass correlation coefficient of.85 and a Cronbach α value of.84. There was a small to strong correlation among the UWRI-Tr and Lower Extremity Functional Scale (r =.278), Oswestry Disability Index (r = −.744), Hip Outcome Score (r =.684), The International Knee Documentation Committee Subjective Knee Evaluation Form (r =.758), and Foot and Ankle Ability Measure (r =.498 and.767), indicating that its construct validity was appropriate for use with Turkish runners. Conclusions: The UWRI-Tr was shown to be a valid and reliable tool to use in clinical and research settings as a sport-specific measurement tool. [ABSTRACT FROM AUTHOR]

Introduction: Patterns of treatment response can inform clinical decision-making. This study assessed the course and impact of achieving minimal clinically important improvement (MCII) in clinical measures and patient-reported outcomes (PROs) with guselkumab in patients with active psoriatic arthritis (PsA). Methods: Post hoc analyses evaluated 1120 patients with PsA receiving guselkumab every 4 or 8 weeks (Q4W/Q8W) or placebo from DISCOVER-1 (31% tumor necrosis factor inhibitor-experienced) and DISCOVER-2 (biologic-naïve). Achievement of MCII in clinical Disease Activity Index for PsA (cDAPSA), patient global assessment (PtGA) of arthritis, PtGA of psoriasis, patient-reported pain, Functional Assessment of Chronic Illness Therapy-Fatigue, Health Assessment Questionnaire-Disability Index, 36-item Short-Form Health Survey Physical Component Summary score, PtGA Arthritis + Psoriasis, and PsA Disease Activity Score (PASDAS) was compared between the guselkumab and placebo groups using Cox regression. Logistic regression adjusting for baseline factors evaluated associations between early (W4/W8) MCII achievement and stringent response (≥%50/%70 improvement in American College of Rheumatology response criteria, cDAPSA low disease activity [LDA], PASDAS LDA, and minimal disease activity) at W24/W52 among guselkumab-randomized patients. Results: Among patients with highly active PsA (baseline cDAPSA = 44.1–45.0, PASDAS = 6.4–6.5), times to MCII were significantly faster for guselkumab vs. placebo (hazard ratios 1.3–2.5; P < 0.05). Across measures, at first timepoint assessed, MCII rates were significantly higher with guselkumab (Q4W/Q8W 28–68%/29–65%) vs. placebo (19–47%; both P < 0.05). Early (W4/W8) MCII with guselkumab associated with higher odds of achieving stringent responses at W24/W52 (odds ratios 1.4–17.2/1.4–5.4). Conclusions: In a mixed PsA population, significant proportions of patients treated with guselkumab achieved early (W4/W8) MCII across clinical and PRO measures, which associated with a higher likelihood of attaining clinically relevant improvements and low levels of disease activity at W24/W52. Trial registration: DISCOVER-1 (NCT03162796). DISCOVER-2 (NCT03158285). [ABSTRACT FROM AUTHOR]

Background: The commonly used international patient‐reported outcome scales for breast cancer were developed before the advent of multiple targeted therapies and immunotherapies, rendering them potentially insufficient for current clinical practices. Therefore, it is necessary to develop a specific patient‐reported outcome scale tailored for breast cancer patients in China to optimize the management model for these patients. Methods: A comprehensive literature search was performed in the PubMed, Embase, Wanfang, and CNKI databases to extract dimensions and items for a potential patient‐reported outcome scale. The Delphi method was used to modify, add, subtract, and adjust the language of items until the experts reached a consensus on the first draft. This draft was further refined using a cognitive test and a presurvey. The optimized scale was used for a formal survey, and the items were further analyzed and screened using metrics such as the coefficient of variation, correlation coefficient, internal item consistency, factor analysis, reliability, and validity. Results: A total of 10,954 articles were analyzed, and 237 were used to create a pool of 277 patient‐reported outcome items. Through two rounds of Delphi expert consultation, the experts' authority coefficients were 0.739 and 0.826. After a cognitive test, several items were adjusted to enhance understanding. Further adjustments were made following a presurvey of 200 advanced breast cancer patients, resulting in a 38‐item patient‐reported outcomes scale, termed NCC‐BC‐A. In the national formal survey, 588 advanced breast cancer patients participated. Principal component analysis showed good consistency among the items and sufficient difference between the dimensions. The results were normally distributed with good variation. The Cronbach's α coefficient of the scale was 0.925 and the test–retest reliability was 0.9041. Conclusion: The NCC‐BC‐A scale has high validity and reliability. It comprehensively considered the characteristics of systemic treatment for breast cancer, and the specific context within China. Its implementation may help clinicians to pay more attention to quality of life of breast cancer patients and to optimize the system for managing this condition. [ABSTRACT FROM AUTHOR]

Total Knee Arthroplasty (TKA) is frequently performed for advanced osteoarthritis, with patient-reported outcome measures (PROMs) traditionally reporting on efficacy. These subjective evaluations, although useful, may inaccurately reflect post-TKA activity levels. With technological advancements, smart implantable devices (SIDs) offer objective, real-time gait metrics, potentially providing a more accurate postoperative recovery assessment. This study compares these objective metrics with PROMs to evaluate TKA success more effectively. We conducted a retrospective cohort study with 88 participants undergoing TKA using a SID. Eligible patients were aged 18 years or older and had advanced osteoarthritis. We excluded those who had bilateral TKAs, joint infections, or neuromuscular disease. The SID system collected daily gait metrics, including step count, distance traveled, walking speed, stride length, cadence, and functional knee range of motion. The PROMs, including Knee Injury and Osteoarthritis Outcome Score–Joint Replacement, Veterans Rand 12 Physical Component Summary, and Veterans Rand 12 Mental Component Summary, were analyzed against SID gait metrics. Among the 88 patients, 80 provided continuous data over 12 weeks. All gait metrics, except stride length, significantly increased at the 12-week point (P <.05). The PROMs also significantly improved postoperatively (P <.05). Initial low positive correlations between 12-week PROMs and SID metrics decreased after adjusting for demographic variables, leaving only weak correlations between the Veterans Rand 12 Physical Component Summary and Knee Injury and Osteoarthritis Outcome Score–Joint Replacement with functional knee range of motion (r = 0.389, P =.002; r = 0.311, P =.014, respectively), and Veterans Rand 12 Mental Component Summary with step count (r = 0.406, P =.001) and distance traveled (r = 0.376, P =.003). This study indicates that both PROMs and SID gait metrics show significant improvements post-TKA, though they correlate weakly with each other, suggesting a possible discrepancy between perceived recovery and actual functional improvement. The SID gait metrics might provide a valuable addition to traditional PROMs by offering an objective representation of physical capabilities unaffected by patient compliance or subjective perceptions of recovery. Further research is needed to validate these findings in larger populations and to explore whether integrating SID metrics can enhance long-term functional outcomes. [ABSTRACT FROM AUTHOR]