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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 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]

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]

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]

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: 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]

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]

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]

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.

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 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]

Abstract Aims Heart failure with reduced ejection fraction (HFrEF) significantly impacts health‐related quality of life (HR‐QoL). Existing HR‐QoL questionnaires can show inconsistencies, potentially misrepresenting patient self‐reports. This study examines the variation in HR‐QoL measurement tools for HFrEF patients, identifying related determinants. Methods and results We retrospectively analysed 134 hospitalized patients with acute decompensated HFrEF at a Taiwanese tertiary centre's Heart Failure Post‐Acute‐Care (HF‐PAC) programme. Participants completed the EuroQol‐5 dimension (EQ‐5D) questionnaire, the EQ‐5D visual analogue scale (VAS), and the Minnesota Living with Heart Failure Questionnaire (MLHFQ). Utility values were obtained from the EQ‐5D questionnaire. Demographic features were depicted using descriptive statistics, while multivariate regression was used to ascertain relationships between HR‐QoL measurements and determinants. Average scores for EQ‐5D, MLHFQ, EQ‐5D utility, and VAS were 6.1 ± 1.6, 21.8 ± 21.3, 81.7 ± 27.0, and 59.5 ± 14.6, respectively. Significant correlations were observed among the three tools. The New York Heart Association functional class showed a notable association with all tool scores. Other associations encompassed EQ‐5D with coronary artery disease, mineralocorticoid receptor antagonists, and the 6 min walk test; EQ‐5D VAS with chronic kidney disease; and MLHFQ with age. Conclusions This study illuminates the variance in HR‐QoL measurement tools for Taiwanese HFrEF patients. Using a range of these tools is beneficial in unveiling diverse determinants and approaching comprehensive patient‐centred care. However, for a more precise HR‐QoL assessment in Taiwanese HFrEF patients, recalibrating the EQ‐5D‐derived utility scores might be necessary, emphasizing the importance of patient‐specific considerations within the HF‐PAC programme.

Abstract Background Sleep loss is a key factor contributing to disease burden in people with atopic dermatitis (AD). Mitigating itch to improve sleep is an important outcome of AD treatment. This study explored the content validity and measurement properties of the Sleep-Loss Scale, a single-item rating scale for assessing itch interference with sleep in clinical trials of AD treatments. Methods Concept elicitation and cognitive debriefing interviews were conducted with 21 adults and adolescents (12–17 years of age) with moderate-to-severe AD to develop a conceptual model of patient experience in AD and explore the content validity of the scale. Data collected from adults with moderate-to-severe AD enrolled in a phase 2b study (NCT03443024) were used to assess Sleep-Loss Scale’s psychometric performance, including reliability, construct validity, and ability to detect change. Meaningful within-patient change (MWPC) thresholds were also determined using anchor-based methods. Results Qualitative findings from concept elicitation highlighted the importance of sleep-loss related to itch in AD. Debriefing analysis of the Sleep-Loss Scale indicated that the scale was relevant, appropriate, and interpreted as intended. Trial data supported good reliability, construct validity and ability to detect improvement. MWPC was defined as a 1-point improvement using trial data, a finding supported by qualitative data. Conclusions The Sleep-Loss Scale provides a valid and reliable patient-reported measure of the impact of itch on sleep in patients with AD, and can detect change, indicating it is fit-for-purpose to evaluate the efficacy of AD treatments in moderate-to-severe patients.

Abstract Background Symptom assessment is the key factor in determining disease status and optimal management of exocrine pancreatic insufficiency (EPI). There is a need for a standardized patient-reported outcome (PRO) questionnaire to assess symptoms in patients diagnosed with EPI. The purpose of this qualitative study was to increase understanding of the EPI symptom experience from the patients’ perspective, and to develop and evaluate the content validity of the EPI Symptom Questionnaire (EPI-SQ) in US patients with EPI. Methods Concept elicitation interviews (Phase I) were conducted to understand the symptom experience in patients with a clinical diagnosis of EPI (i.e., fecal pancreatic elastase value of ≤ 200 mcg/g based on most recent value) due to chronic pancreatitis or pancreatectomy. The EPI-SQ was developed based on the data extracted from Phase I interviews and feedback from clinical experts. Next, separate cognitive interviews (Phase II) were conducted to evaluate participants’ understanding of the instructions, items, response scales, and recall periods of the instrument. Results During Phase I interviews (n = 21), 19 participants (90%) reported abdominal pain as the most frequent EPI symptom and lifestyle changes were the most frequently endorsed impacts (n = 18; 86%). Phase II results indicated that all participants (n = 7) felt the 12-item EPI-SQ was relevant to their symptom experience and that they understood the items, instructions, and response options as intended. Conclusion The qualitative data from this study support the content validity of the EPI-SQ in measuring EPI symptom severity in US patient populations diagnosed with EPI.

Abstract Introduction Ixekizumab, an interleukin 17A (IL-17A) inhibitor, has demonstrated rapid and sustained improvement in the signs and symptoms in patients with active radiographic axial spondyloarthritis (r-axSpA) in global and Chinese populations. We studied the effect of ixekizumab on patient-reported outcomes (PROs) (including patient global, spinal pain, stiffness, and fatigue) and overall health-related quality of life (HRQoL) of ixekizumab in the phase 3 study in China. Methods In this Chinese phase 3, randomized, double-blind, placebo-controlled study, patients with r-axSpA were randomized (1:1) to receive ixekizumab 80 mg every 4 weeks (IXEQ4W; starting dose 160 mg) or placebo for 16 weeks. At week 16, patients receiving placebo were switched to IXEQ4W, and those receiving IXEQ4W continued, until week 52. Data for patient global, spinal pain, spinal pain at night, stiffness, and fatigue were collected through week 52. Minimally clinical important differences (MCIDs) were determined for spinal pain and spinal pain at night. The subgroup analyses by baseline disease duration since diagnosis and baseline C-reactive protein (CRP) level were conducted post hoc. Results Compared with placebo, patients treated with IXEQ4W reported significantly greater improvement with a rapid onset in changes from baseline of PROs (patient global, spinal pain, spinal pain at night, stiffness, and fatigue) through week 16. Improvements were maintained through week 52. A similar trend of improvement was also observed in MCID response in spinal pain and spinal pain at night. The improvement in overall HRQoL was supported by EQ-5D-5L assessment. Subgroup analyses demonstrated that IXEQ4W provided significantly greater efficacy at week 16 compared with placebo, irrespective of baseline disease duration or baseline CRP level. Conclusion IXEQ4W provided rapid and sustained improvement in clinically relevant PROs and overall HRQoL through 1-year treatment in Chinese patients with r-axSpA. Regardless of the baseline disease duration or baseline CRP level, consistent efficacy was observed. Trial Registration ClinicalTrials.gov identifier NCT04285229.

Background: Implant-based breast reconstruction (IBR), following mastectomy, significantly impacts patients' quality of life (QoL), necessitating accurate measurement through psychometrically robust patient-reported outcome measure (PROM) tools. This bibliometric analysis aims to discern trends, identify gaps, and evaluate the use of such tools in the IBR literature. Methods: The 100 most cited publications regarding QoL in implant-based reconstruction were identified on Web of Science, across all available journal years (from 1977 to 2024) on 10 March 2024. Study details, including the citation count, main content focus, outcome measures, and usage of psychological questionnaires, were extracted and tabulated from each publication. The Oxford Centre for Evidence-Based Medicine (OCEBM) levels of evidence (LOE) of each study were assessed. Results: The 100 most cited publications on QoL in implant-based reconstruction were identified, encompassing 64,192 patients and 28,114 reconstructed breasts. Citations per publication ranged from 62 to 457 (mean, 124.95 ± 73.05), with the highest-cited study being authored by Al-Ghazal (n = 457). The vast majority of publications were LOE II (n = 52), representative of prospective cohort studies, systematic reviews of non-randomised studies, and systematic review and meta-analysis. The number of publications for LOE V, IV, III, and I was 0, 7, 41, and 0, respectively. The main content focus was "quality of life" in 83 publications, with significant utilisation of the BREAST-Q questionnaire. A total of 80 publications used validated questionnaires with psychometric development. Conclusions: This analysis demonstrates that the research methodologies within IBRmostly consist of moderate-quality publications; however, notably, there was a lack of LOE I studies, underscoring a gap in high-quality research within the field. Moreover, only 62/100 used validated PROM tools. Future IBR research studies should be focussed on most robust methodologies, incorporating validated PROM tools, to optimise shared-decision making and informed consent. [ABSTRACT FROM AUTHOR]

Objective: It has long been documented that cognitive behavioral therapy (CBT) has positive impacts on improving mental health (MH) and quality of life (QoL) in the general population, but investigations on its effect on cancer survivors remain limited, especially for QoL outcomes. The purpose of this meta‐analysis is to investigate the effects of CBT as compared to control on cancer patients' MH and QoL outcomes. Control is defined in this study as standard therapy, waitlist control, and active/alternative therapy. Methods: In total, 154 clinical trials creating a sample size of 1627 individuals were collected. Analysis focusing on MH and QoL excluded 29 clinical trials resulting in a final analysis of 132 clinical trials (and 1030 effect sizes). R Statistical Software (version 4.2.2) and the robumeta package were utilized to complete analysis, which entailed robust variance estimation (RVE) in intercept‐only meta‐regression, and univariate meta‐regression (for moderator analysis). Results: Across 132 clinical trials and 1030 effect size estimates, we identified that CBT moderately improves MH and QoL in cancer patients d = 0.388, 95% CI 0.294–0.483, p < 0.001. Additionally, age and delivery format can influence the efficacy of CBT in this patient population. Conclusions: CBT statistically improves the MH and QoL psychosocial parameters in cancer patients with greater efficacy in younger patients. Important clinical and intervention‐related factors, that is, age and delivery, should be considered when oncologists consider CBT as a psychotherapeutic intervention for individuals with cancer. [ABSTRACT FROM AUTHOR]

Purpose: The functional interaction between the hip and spine in patients undergoing total hip arthroplasty (THA) is clinically significant, as it impacts post-operative outcomes. Therefore, this study aimed to identify factors associated with the progression of sagittal spinal deformity and assess the association with patient-reported outcomes. Methods: This retrospective case–control study included 200 patients who underwent primary THA and completed a mean follow-up duration of 42.2 months (range, 24.0–78.0). We employed a multivariate logistic regression to identify variables predictive of a post-THA sagittal vertical axis (SVA) ≥ 50 mm, which was indicative of a spinal sagittal imbalance. Propensity score-matched cohorts for age, sex, body mass index, follow-up duration, hip flexion contracture, developmental dysplasia, pelvic incidence (PI), and SVA were created, and the outcomes were compared between the two groups. Results: PI (odds ratio 1.39; 95% confidence interval 1.04–1.86, p = 0.033) was associated with an SVA ≥ 50 mm. After successfully matching patients with (n = 50) and without (n = 50) an SVA ≥ 50 mm, the minimum clinically important difference showed significant differences between the 50 matched pairs (p = 0.016 for EuroQol-5D, p = 0.003 for Hip Disability and Osteoarthritis Outcome Score Joint Replacement, and p < 0.001 for low back pain). Conclusion: PI is associated with the development of a positive sagittal spinal malalignment post-THA. This finding can assist surgeons in managing patient expectations and in optimising outcomes. Feasible strategies are warranted to minimise the risk of spinal deformity progression post-THA. [ABSTRACT FROM AUTHOR]

Introduction: Ixekizumab, an interleukin 17A (IL-17A) inhibitor, has demonstrated rapid and sustained improvement in the signs and symptoms in patients with active radiographic axial spondyloarthritis (r-axSpA) in global and Chinese populations. We studied the effect of ixekizumab on patient-reported outcomes (PROs) (including patient global, spinal pain, stiffness, and fatigue) and overall health-related quality of life (HRQoL) of ixekizumab in the phase 3 study in China. Methods: In this Chinese phase 3, randomized, double-blind, placebo-controlled study, patients with r-axSpA were randomized (1:1) to receive ixekizumab 80 mg every 4 weeks (IXEQ4W; starting dose 160 mg) or placebo for 16 weeks. At week 16, patients receiving placebo were switched to IXEQ4W, and those receiving IXEQ4W continued, until week 52. Data for patient global, spinal pain, spinal pain at night, stiffness, and fatigue were collected through week 52. Minimally clinical important differences (MCIDs) were determined for spinal pain and spinal pain at night. The subgroup analyses by baseline disease duration since diagnosis and baseline C-reactive protein (CRP) level were conducted post hoc. Results: Compared with placebo, patients treated with IXEQ4W reported significantly greater improvement with a rapid onset in changes from baseline of PROs (patient global, spinal pain, spinal pain at night, stiffness, and fatigue) through week 16. Improvements were maintained through week 52. A similar trend of improvement was also observed in MCID response in spinal pain and spinal pain at night. The improvement in overall HRQoL was supported by EQ-5D-5L assessment. Subgroup analyses demonstrated that IXEQ4W provided significantly greater efficacy at week 16 compared with placebo, irrespective of baseline disease duration or baseline CRP level. Conclusion: IXEQ4W provided rapid and sustained improvement in clinically relevant PROs and overall HRQoL through 1-year treatment in Chinese patients with r-axSpA. Regardless of the baseline disease duration or baseline CRP level, consistent efficacy was observed. Trial Registration: ClinicalTrials.gov identifier NCT04285229. [ABSTRACT FROM AUTHOR]

• Patients with HypoPP can have impaired quality of life. • Patients with HypoPP can suffer from fatigue and pain. • Attention should be given to muscle weakness and fatigue in patients with HypoPP. Primary hypokalemic periodic paralysis (HypoPP) is a skeletal muscle channelopathy most commonly caused by pathogenic variants in the calcium channel gene, CACNA1S. HypoPP can present with attacks of paralysis and/or permanent muscle weakness. Previous studies have shown that patients with HypoPP can have impaired quality of life (QoL). In this cross-sectional study, we aimed to describe the QoL in patients with HypoPP caused by pathogenic variants in CACNA1S using The Individualized Neuromuscular Quality of Life (INQoL) questionnaire, a validated tool to measure the QoL of patients with neuromuscular diseases (higher score, worse QoL). We showed that muscle weakness and fatigue were the symptoms with the greatest impact on participants' lives and that "activities", in the life domain of the INQoL, was most affected by HypoPP. Furthermore, we showed that the total INQoL score increased with age. Low QoL was primarily driven by progressive permanent muscle weakness and not attacks of paralysis, although half of the participants reported that attacks of paralysis challenged their daily life. The results suggest that special attention should be given to muscle weakness and fatigue in patients with HypoPP. [ABSTRACT FROM AUTHOR]

Objectives: Evaluate patterns of stringent disease control with 2 years of guselkumab across key disease-identified domains and patient-reported outcomes (PROs) in subgroups of patients with psoriatic arthritis (PsA) defined by baseline characteristics. Method: This post hoc analysis of DISCOVER-2 (Clinicaltrials.gov NCT03158285) evaluated biologic-naïve PsA patients (≥ 5 swollen/ ≥ 5 tender joints, C-reactive protein [CRP] ≥ 0.6 mg/dL) randomized to guselkumab every 4 weeks (Q4W); guselkumab at Weeks 0 and 4, then Q8W; or placebo with crossover to guselkumab Q4W at Week 24. Achievement of American College of Rheumatology 50/70% improvement (ACR50/70), Investigator's Global Assessment (IGA) 0, dactylitis/enthesitis resolution, Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue response (≥ 4-point improvement), HAQ-Disability Index (HAQ-DI) response (≥ 0.35-point improvement), PsA Disease Activity Score (PASDAS) low disease activity (LDA), and minimal disease activity (MDA) was assessed at Weeks 24, 52, and 100 in subgroups defined by sex and baseline medication use, body mass index, PsA duration, swollen/tender joints, CRP, and psoriasis severity/extent. Patients with missing categorical response data were considered nonresponders. Results: 442/493 (90%) guselkumab-randomized patients completed treatment through Week 100. Significant multi-domain efficacy of guselkumab versus placebo was shown across adequately sized patient subgroups. A pattern of continuous improvement was observed across key PsA domains and PROs within patient subgroups: 65%–85% of guselkumab-randomized patients had enthesitis/dactylitis resolution, 50%–70% achieved complete skin clearance, 60%–80% reported meaningful improvements in function/fatigue, 40%–65% achieved PASDAS LDA, and 35%–50% achieved MDA at Week 100. Conclusion: Patients with active PsA receiving guselkumab demonstrated durable achievement of stringent endpoints associated with disease control across key PsA domains and PROs, regardless of baseline characteristics. Key Points • Among biologic-naïve patients with highly active psoriatic arthritis (PsA), efficacy of guselkumab across stringent disease endpoints and patient-reported outcomes (PROs) at Week 24 was consistent regardless of baseline demographics and disease characteristics. • Within guselkumab-randomized PsA patient subgroups, major improvements in joint disease activity, complete skin clearance, dactylitis/enthesitis resolution, clinically meaningful improvements in PROs, and achievement of low overall disease activity were maintained through Week 100. • Durable stringent endpoint achievement indicating disease control was observed with guselkumab, regardless of baseline patient or disease characteristics. [ABSTRACT FROM AUTHOR]

The primary focus of this research is the proposition of a methodological framework for the clinical application of the long COVID symptoms and severity score (LC-SSS). This tool is not just a self-reported assessment instrument developed and validated but serves as a standardized, quantifiable means to monitor the diverse and persistent symptoms frequently observed in individuals with long COVID. A 3-stage process was used to develop, validate, and establish scoring standards for the LC-SSS. Validation measures included correlations with other patient-reported measures, confirmatory factor analysis, Cronbach's α for internal consistency, and test-retest reliability. Scoring standards were determined using K-means clustering, with comparative assessments made against hierarchical clustering and the Gaussian Mixture Model. The LC-SSS showed correlations with EuroQol 5-Dimension 5-Level (r s = −0.55), EuroQol visual analog scale (r s = −0.368), Patient Health Questionnaire-9 (r s = 0.538), Beck Anxiety Inventory (r s = 0.689), and Insomnia Severity Index (r s = 0.516), confirming its construct validity. Structural validity was good with a comparative fit index of 0.969, with Cronbach's α of 0.93 indicating excellent internal consistency. Test-retest reliability was also satisfactory (intraclass correlation coefficient 0.732). K-means clustering identified 3 distinct severity categories in individuals living with long COVID, providing a basis for personalized treatment strategies. The LC-SSS provides a robust and valid tool for assessing long COVID. The severity categories established via K-means clustering demonstrate significant variation in symptom severity, informing personalized treatment and improving care quality for patients with long COVID. • This study introduces the long COVID symptoms and severity score (LC-SSS), a novel, validated tool incorporating unsupervised machine learning to categorize symptom severity. This addresses a critical gap in standardized and quantifiable monitoring of long COVID, going beyond the limitations of traditional patient-reported outcome measures and offering a refined, personalized assessment framework. • The research demonstrates that the LC-SSS is strongly correlated with existing health quality measures, showing high construct and structural validity, excellent internal consistency, and satisfactory test-retest reliability. K-means clustering further identified 3 distinct severity categories among patients with long COVID, which can guide personalized treatment strategies, highlighting the tool's efficacy in capturing the complexity of long COVID symptoms. • By enabling precise classification of symptom severity, the LC-SSS facilitates tailored treatment plans and informs healthcare resource allocation and policy formulation for long COVID management. Its integration into clinical practice promises to improve diagnostic accuracy, enhance care quality, and potentially uplift patient outcomes in the context of health economics and outcomes research, making a significant contribution to the field. [ABSTRACT FROM AUTHOR]

Chemotherapy (CT) remains a backbone treatment of epithelial ovarian cancer (EOC) inducing persistent peripheral neuropathy (CIPN). Using a dedicated patient-reported outcome tool, this study investigated persistent CIPN and its pharmacogenetic predictors in a cohort of long-term EOC survivors. Vivrovaire was a French multicenter cohort of patients with EOC free of disease 3 years after CT completion. Persistent CIPN was assessed using the FACT/GOG-Ntx4 self-questionnaire. The association of homozygous (hom) or heterozygous (het) single nucleotide polymorphisms (SNPs) in selected genes was evaluated. 130 patients were included with a median time from CT completion of 63 [35–180] months. The median CIPN score was 37 [18–44], with 35 (26.9%) patients reporting severe CIPN (<33). SNPs were identified as follows: CYP2C8 [hom, n = 32 (24.6%)/het, n = 99, (76.2%)]; CYP3A4 [hom, n = 0 (0%)/het, n = 8 (6.2%)], ERCC1 [hom, n = 21 (16.2%)/het, n = 57 (43.8%)], and XPC [hom, n = 45 (34.6%)/het, n = 66 (50.8%)]. In univariate analysis, the identification of ≥1 hom SNP was associated with a lower CIPN score (continuous variable; p = 0.045). Patients harboring hom or het CYP2C8_rs1934951 SNP reported more likely severe CIPN (threshold <33) score (OR 2.482; 95% CI [1.126–5.47], p = 0.024). In the multivariate analyses, age, interval from CT completion, type and number of CT courses were not significantly associated with CIPN score (OR 5.165, 95% CI [0.478–55.83], p = 0.176). Persistent CIPN is common among ovarian cancer long-term survivors. CYP2C8 _rs1934951 SNP may be associated with severe residual CIPN in EOC survivors. More studies are warranted to identify predictive factors of CIPN. • CIPN is a common concern in ovarian cancer survivors. • Using a PRO tool, about 25% of patients report persistent severe CIPN. • CYP2C8_rs1934951 SNP may be associated with a severe long-term CIPN. [ABSTRACT FROM AUTHOR]

Objective: This study aimed to examine physicians' and patients' perceptions regarding symptom burden and impact in women experiencing natural vasomotor symptoms (nVMS) or vasomotor symptoms induced by endocrine therapy for breast cancer (iVMS). Methods: The cross-sectional survey based on real-world clinical consultations was conducted in the USA and five European countries. Obstetrician–gynecologists, primary-care physicians and oncologists provided demographic and symptom data for patients experiencing VMS; patients optionally self-reported their experiences via questionnaires, including their symptom profile and work/activity burden through the Menopause Quality of Life (MENQOL) and Work Productivity and Activity Impairment (WPAI) tools. Results: Physicians completed survey forms on 2451 consulting patients; patients completed 1029 questionnaires. nVMS and iVMS severity was significantly associated with the severity of mood symptoms and sleep disturbances (p < 0.0001). However, around half of the patients with mild nVMS/iVMS also experienced moderate–severe mood changes (55.4%/43.7%) or sleep disturbances (42.4%/40.4%). Presence of mood/sleep disturbances alongside nVMS increased MENQOL vasomotor scores (p = 0.004/p < 0.001). Presence of sleep disturbances increased WPAI activity impairment (p < 0.001) but mood changes did not. Similar findings were reported for iVMS patients. Conclusion: Significant burden from the triad of natural or induced menopausal symptoms, sleep disturbances and mood changes affected women's daily activities, work and quality of life more than vasomotor symptoms alone. [ABSTRACT FROM AUTHOR]

Objective: Although breast magnetic resonance imaging (MRI) is a valuable screening tool, breast MRI testing burden was associated with cancer worry and quality of life. We aimed to develop and validate the MRI‐related distress scale (MRI‐DS) to assess comprehensive distress specifically related to breast MRI. Methods: We enrolled women aged above 18 years, diagnosed breast cancer, had MRI examination at least one time, and who could speak and read Korean in phase I and enrolled women aged above 18 years, visited outpatient clinic of breast general surgery, had undergone MRI examination at least once, and could speak and read Korean in phase II. We excluded patients who had any physical or psychiatric conditions in both phases. We recruited from a tertiary university‐based hospital in South Korea between April and August 2023. Results: All 18 items had acceptable levels of item correlation (≥0.30) in the explanatory factor analysis with a four‐factor solution. The fit indices for the four‐factor solution model were good. The discriminant validity of the MRI‐DS had a moderate correlation with general anxiety or quality of life. In the known‐group analysis, those who reported MRI as the most burden breast examination had higher total scores. Conclusion: The validity of the MRI‐DS has been confirmed as a scale for measuring the specific distress caused by breast MRI. The MRI‐DS is recommended to health professional to communicate with patients with MRI. Clinical Implications: It can be used to assess the distress associated with MRI screening in breast cancer patients. Physician could use MRI‐DS to discuss the reasons for distress caused by breast MRI screening and to address specific sources of discomfort associated with it. [ABSTRACT FROM AUTHOR]

A heart-healthy diet is an important component of secondary prevention in ischemic heart disease. The Danish Health Authority recommends using the validated 19-item food frequency questionnaire HeartDiet in cardiac rehabilitation practice to assess patients' need for dietary interventions, and HeartDiet has been included in national electronic patient-reported outcome instruments for cardiac rehabilitation. This study aims to evaluate challenges and benefits of its use. The objectives are to: 1) describe HeartDiet responses of patients with ischemic heart disease and discuss HeartDiet's suitability as a screening tool, 2) discuss whether an abridged version should replace HeartDiet. A cross-sectional study using data from a national feasibility test. HeartDiet was sent electronically to 223 patients with ischemic heart disease prior to cardiac rehabilitation. Data were summarised with descriptive statistics, and Spearman's rank correlations, explorative factor analysis, and Cohen's kappa coefficient were used to derive and evaluate abridged versions. The response rate was 68 % (n = 151). Evaluated with HeartDiet, no respondents had a heart-healthy diet. There was substantial agreement between HeartDiet and an abridged 9-item version (kappa = 0.6926 for Fat Score, 0.6625 for FishFruitVegetable Score), but the abridged version omits information on milk products, wholegrain, nuts, and sugary snacks. With the predefined cut-offs, HeartDiet's suitability as a screening tool to assess needs for dietary interventions was limited, since no respondents were categorised as having a heart-healthy diet. An abridged version can replace HeartDiet, but the tool's educational potential will be compromised, since important items will be omitted. • A heart-healthy diet is important in secondary prevention in ischemic heart disease. • Patients should receive adequate support to obtain heart-healthy dietary habits. • HeartDiet food frequency questionnaire may aid referral for dietary interventions. [ABSTRACT FROM AUTHOR]

Introduction: There is a lack of information on return to sport and patient-reported outcome measures (PROMs) in amateur athletes after isolated spine injuries. Methods: A single-center cohort study in amateur athletes aged 18 to 60 with isolated spine injuries; clinical data collection and follow-up via telephone interview and standardized PROMs (Short-Form 36, Oswestry and Neck Disability Index, Tampa Scale of Kinesiophobia, Hospital Anxiety and Depression Scale, Pain Visual Analog Scale). Bivariate analyses of potential influencing factors on PROMs were conducted using the Wilcoxon Signed-Rank Test. p-values < 0.05 were considered statistically significant. Results: Out of the 80 included participants, 78% (n = 62) were active in sport at follow-up. PROMs were slightly worse than those described for the age-adjusted general population. There were consistent associations of better PROMs with having reached the subjective preinjury level of performance in sport, while injury severity and surgical or conservative therapy did not show consistent associations with PROMs. Conclusion: Most amateur athletes resume their sports activity after a spine injury. Better outcomes are associated with individuals' resumption of sport and subjective level of performance, while injury severity and surgical or conservative therapy do not show consistent associations with PROMs, highlighting the importance of patient education, rehabilitation, and encouragement. [ABSTRACT FROM AUTHOR]