BACKGROUND: Atezolizumab is an immune checkpoint inhibitor (ICI) and a frontline treatment of patients with cisplatin-ineligible advanced urothelial carcinoma (UC). There is limited evidence on the prognostic value of patient reported outcomes (PROs) in advanced UC treatment, particularly in the context of ICI therapy.
OBJECTIVE: To investigate the prognostic association of PROs with survival in patients with advanced UC treated with atezolizumab.
METHODS: This study used data from 467 patients with advanced UC initiating atezolizumab in the IMvigor211 trial. Pre-treatment PROs association with overall survival (OS) and progression free survival (PFS) was assessed using Cox proportional hazard analysis. PROs were recorded via the European Organisation for Research and Treatment of Cancer QLQ-C30. Discrimination performance was assessed via the C-statistic (c).
RESULTS: Patient reported physical function, pain, appetite loss, global health, fatigue, role function, constipation, nausea and vomiting, dyspnoea, and insomnia were significantly associated with OS and PFS on univariable and adjusted analysis (P < 0.05). Physical function (c = 0.63), pain (c = 0.63), appetite loss (c = 0.62), global health status (c = 0.62), and fatigue (c = 0.62), were the most prognostic factors of OS. The OS discrimination performance of physical function (c = 0.61) was superior to ECOG PS (c = 0.58). Of patients assessed by investigators as having no performance restrictions (ECOG PS of 0), 38 (18%) and 91 (42%) self-reported low and intermediate physical function scores, respectively.
CONCLUSIONS: Pre-treatment PROs were identified as independent prognostic factors of OS and PFS. Patient-reported physical function was more prognostic of OS than ECOG PS. This highlights a potential for PROs to enable improved patient stratification in ICI trials.

METHODS: This is a prospective cohort study.
OBJECTIVE: The present study aimed to investigate the effects of residual pain after fusion surgery for lumbar degenerative diseases on quality of life (QOL).
BACKGROUND: Residual symptoms after spinal surgery often restrict patients\' activities of daily living and reduce their QOL. However, few studies have comprehensively addressed physical, psychological, and social factors.
METHODS: The study population included a cohort of 208 patients (mean age: 67.9 years) who had undergone posterior interbody fusion for lumbar degenerative disease between 2012 and 2019. We asked the patients to complete the Japanese Orthopaedic Association Back Pain Evaluation Questionnaire (JOABPEQ) and Short Form Health Survey (SF-36) preoperatively, as well as at six, 12, and 24 months postoperatively. The presence of residual postoperative pain (RPP) was determined using the low back pain score of the JOABPEQ at six months postoperatively, and patients with an improvement of < 20 points compared to preoperative assessment were classified as RPP+ based on a previous study.
RESULTS: In all patients, there was a notable postoperative improvement in all JOABPEQ and SF-36 domains compared to preoperative scores. The RPP+ group comprised 60 patients (69.6 years), while the RPP- group comprised 148 patients (67.2 years). In the RPP+ group, the lumbar function in the JOABPEQ and general health in the SF-36 showed limited postoperative enhancement. The pace of improvement in the role-emotional, role-physical, social functioning, vitality, and mental health scores was slower in the RPP+ group compared to the RPP- group.
CONCLUSIONS: In the current study, we found that the presence of residual pain at six months postoperatively affected QOL improvement up to 24 months after surgery. Lingering postoperative pain substantially impacted functional incapacity, social engagement, and psychological well-being. Notably, the lumbar function in the JOABPEQ and general health in the SF-36 showed distinct progression patterns in the RPP+ group.

Introduction Filgotinib is a JAK-1 selective inhibitor approved for ulcerative colitis (UC) treatment in Japan. Its effectiveness has been confirmed but remains unknown in actual clinical practice. Therefore, we aimed to evaluate the effectiveness and safety of filgotinib and identify suitable patients in the Japanese population. Methods We retrospectively reviewed the background, clinical course, and laboratory data of patients treated with filgotinib 200 mg for UC between May 2022 and December 2023. Results The median observation period for the 25 patients was 232 days (interquartile ranges (IQR) 102-405). The median age of the patients was 43 years (IQR 29-55), disease duration was nine years (IQR 2-12), and 36% (9/25) of patients were biologic or small molecule naïve. The median patient-reported outcome (PRO2) and partial Mayo (pMayo) scores at agent initiation were 3 (IQR 1-4) and 4.5 (IQR 3-6), respectively. The PRO2 and pMayo scores improved significantly two weeks after treatment initiation (p < 0.05). Clinical remission rates at 24 weeks after treatment initiation were 60% (15/25) for PRO2 ≤ 1 and 52% (13/25) for pMayo ≤ 1. The Mayo endoscopic subscore significantly improved after filgotinib initiation (p=0.04), and the endoscopic remission rate was 47% (8/17). At 24 weeks, patients in clinical remission, compared to those not in remission, had significantly lower baseline PRO2 and pMayo scores and longer disease duration (p=0.03, p=0.03, and p=0.04, respectively). The filgotinib persistence rate was 68% (17/25), with no discontinuation because of adverse events. Patients who continued treatment had significantly lower PRO2, pMayo scores, and blood neutrophil counts at initiation than those who discontinued (p=0.02, p=0.03, and p=0.02, respectively). Conclusion Filgotinib appears to be effective and safe in Japanese patients with UC. Effectiveness and persistence were high in patients whose PRO2 and pMayo scores were low at the time of treatment initiation.

BACKGROUND: Rheumatoid arthritis (RA) patients often encounter psychological challenges due to chronic pain, fatigue, side effects of medications, and disability. This study examines the relationship between autobiographical narratives and recollection patterns in RA patients. We investigated how different recall strategies for positive life events affect the emotional processing of negative episodes. We hypothesized that vividly recalling positive life events provides psychological resources that support a more intense emotional elaboration of stressful memories, allowing individuals to delve deeper into negative life experiences. Additionally, we explored the impact of these perspectives on self-reported well-being and physical health, proposing that re-living positive events improves overall well-being.
METHODS: We collected and analyzed high-point and low-point life-story episodes from 60 RA patients (85% female; age mean 61 ± 11 years; range 37-79) using episodic narrative interviews and the Narrative Categorical Content Analysis algorithm (NarrCat). Participants were categorized into 2 clusters based on their temporal perspective during high-point episodes: 25 used a Retrospective viewpoint, while 35 employed a Re-experiencing strategy. Depression and anxiety were assessed with the Hospital Anxiety and Depression Scale (HADS), and functioning was measured using the Health Assessment Questionnaire (HAQ).
RESULTS: The Re-experiencing group, which was more likely to articulate their high-point episode in vivid and real-time narrative, used more psychological perspectives (U(58) = 223, p < 0.01) and showed heightened emotional frequency (U(58) = 280, p < 0.05; positive: U(58) = 328, p < 0.05; negative: U(58) = 278, p < 0.05) in low-point episodes. No significant difference emerged between the two groups regarding psychological state (anxiety, depressive symptoms) and physical impairment.
CONCLUSIONS: Vividly recalling positive events may facilitate a deeper exploration of negative memories. The Re-experiencing group showed increased positive emotions during low points, suggesting better emotion regulation. However, no significant association was found between recalling strategies, psychological state, and physical impairment. This indicates that further research is needed to determine whether re-experiencing positive life events is adaptive or maladaptive.

UNASSIGNED: Mental and emotional health can affect outcomes after orthopaedic surgery, and patient resilience has been found to be significantly related to postoperative functional outcomes.
UNASSIGNED: To evaluate the relationship between preoperative patient resilience and 2-year postoperative patient-reported outcomes after rotator cuff repair (RCR). It was hypothesized that patients with low preoperative resilience will have worse patient-reported outcomes at 2 years after RCR versus those with high resilience.
UNASSIGNED: Cohort study; Level of evidence, 3.
UNASSIGNED: Patients who underwent primary arthroscopic RCR in 2020 at a single institution and completed the Brief Resilience Scale (BRS) preoperatively were identified. Other inclusion criteria were American Shoulder and Elbow Surgeons (ASES) and Single Assessment Numeric Evaluation (SANE) scores at the 2-year follow-up. Outcomes were compared in patients as divided into low resilience (BRS score >1 SD below the mean), normal resilience (BRS score ≤1 SD of the mean), and high resilience (BRS score >1 SD above the mean) groups.
UNASSIGNED: Overall, 100 patients (52 male, 48 female; mean age, 60 ± 9 years) were included in this study. Mean BRS scores did not change significantly from preoperative to 2-year follow-up (3.8 ± 0.7 vs 3.9 ± 0.8, P = .404). All patients had preoperative ASES scores. Low-resilience patients (n = 17) had significantly lower preoperative ASES scores compared with normal (n = 64) and high resilience (n = 19) patients (35 vs 42 vs 54, respectively; P = .022). There were no significant group differences in postoperative outcomes (revision rate, ASES score, ASES score improvement from preoperative to 2-year follow-up, or SANE score). Multivariate analysis indicated that preoperative resilience was not significantly associated with ASES score improvement (β estimate = -5.64, P = .150), while resilience at 2-year follow-up was significantly related to ASES score improvement (β estimate = 6.41, P = .031).
UNASSIGNED: Patient-reported outcomes at 2-year follow-up did not differ based on preoperative patient resilience for arthroscopic RCR patients. Multivariate analysis also showed that preoperative resilience was not associated with improvement in ASES scores; however, resilience at 2-year follow-up was associated with ASES score improvement.

BACKGROUND: The prevalence of diabetes and coexisting multimorbidity rises worldwide. Treatment of this patient group can be complex. Providing an evidence-based, coherent, and patient-centred treatment of patients with multimorbidity poses a challenge in healthcare systems, which are typically designed to deliver disease-specific care. We propose an intervention comprising multidisciplinary team conferences (MDTs) to address this issue. The MDT consists of medical specialists in five different specialities meeting to discuss multimorbid diabetes patients. This protocol describes a feasibility test of MDTs designed to coordinate care and improve quality of life for people with diabetes and multimorbidity.
METHODS: A mixed-methods one-arm feasibility test of the MDT. Feasibility will be assessed through prospectively collected data. We will explore patient perspectives through patient-reported outcomes (PROs) and assess the feasibility of electronic questionnaires. Feasibility outcomes are recruitment, PRO completion, technical difficulties, impact of MDT, and doctor preparation time. During 17 months, up to 112 participants will be recruited. We will report results narratively and by the use of descriptive statistics. The collected data will form the basis for a future large-scale randomised trial.
CONCLUSIONS: A multidisciplinary approach focusing on better management of diabetic patients suffering from multimorbidity may improve functional status, quality of life, and health outcomes. Multimorbidity and diabetes are highly prevalent in our healthcare system, but we lack a solid evidence-based approach to patient-centred care for these patients. This study represents the initial steps towards building such evidence. The concept can be efficiency tested in a randomised setting, if found feasible to intervention providers and receivers. If not, we will have gained experience on how to manage diabetes and multimorbidity as well as organisational aspects, which together may generate hypotheses for research on how to handle multimorbidity in the future.
UNASSIGNED: Protocol version: 01 TRIAL REGISTRATION: NCT05913726 - registration date: 21 June 2023.

BACKGROUND: The use of continuous passive motion therapy (CPM) has led to promising results in the early phase of rehabilitation after surgical treatment of rotator cuff tears and arthrolysis of the elbow. However, its use has not been proven in other pathologies of the upper extremity. Therefore, the aim of the underlying study was to evaluate the use of CPM therapy after plate osteosynthesis of proximal humeral fractures.
METHODS: 95 patients with isolated proximal humerus fractures were enrolled in a prospective, randomized study. Patients were assigned to a treatment group with (n = 48, CPM) or without CPM therapy (n = 47, CG). Four patients (2 of each cohort) violated the study protocol and were excluded. CPM therapy was used for 6 weeks after surgery 2-3 times daily. Functional (range of motion) and patient reported outcomes (PROM, Constant Score [CSS], QuickDASH, subjective shoulder value [SSV], pain on visual analogue scale [VAS]) were evaluated at 6 weeks, 3 and 12months. 60 patients completed the 1-year follow-up.
RESULTS: The average patient age was 65.3 years (min: 27, max: 88, SD: ± 14.7). Seventy-two patients were female (79%). There was no difference regarding injury severity (2/3/4 part-fracture: 6/32/7 vs. 9/26/11, p = 0.867) and sex (p = 0.08). However, patients in the CPM group were significantly younger (CPM: 67 [min: 34, max: 82], CG: 74 [min: 27, max: 88], p = 0.032). After 6 weeks we observed a better range of motion for forward flexion (CPM: 90° [min: 50°, max: 180°] vs. CG: 80° [min: 20°, max: 170°] p = 0.035) and abduction (CPM: 80° [min: 40°, max: 180°] vs. CG: 70° [min: 20°, max: 180°], p = 0.048) in the CPM group. There was no difference regarding the further planes of motion or the assessed PROMs at 6 weeks. At 3 and 12 months the results between the treatment groups equalized with no further significant differences.
CONCLUSIONS: The treatment with CPM increases the range of motion after plate osteosynthesis of proximal humerus fractures in the first 6 weeks after surgery. This effect is not sustained after 3 and 12months. The evaluated PROMs are not being influenced by CPM therapy. Hence the results of this prospective randomized study suggest that CPM can be a beneficial asset in the early period of rehabilitation after proximal humerus plate osteosynthesis.
BACKGROUND: The study protocol was registered in the US National Institutes of Health\'s database ( http://www.
RESULTS: gov ) registry under NCT05952622.

Spina bifida includes a spectrum of different neural tube defects. Myelomeningocele is the most serious type and is associated with a risk of paralysis and sensory dysfunction below the affected level, bladder/bowel dysfunction, brain dysmorphology, and impaired health-related quality of life (HRQoL). The aim of this study was to describe the establishment of linguistic, content and face validity of the Swedish version of a Quality-of-Life Assessment for children (QUALAS-C, n = 10 items), teenagers (QUALAS-T, n = 10 items) and adults with spina bifida (QUALAS-A, n = 15 items) based on the original US English versions. The process included close collaboration with the original instrument developer and complied with international standards on patient-reported outcome measurements. The procedure includes forward translation, expert and patient/parent review and reconciliation, back translation, back translation review and cognitive debriefing interviews with 16 people with spina bifida aged 8 to 33, providing them with the possibility of evaluating the clarity, adequacy, and comprehensiveness of QUALAS-C, QUALAS-T and QUALAS-A, respectively. The interviews lasted a median of 15 min (range 8-16) for QUALAS-C, 10 min (range 9-15) for QUALAS-T and 24 min (range 9-38) for QUALAS-A. Four main issues/topics needed attention and discussion after both the forward and back translation. Following the back translation review, all issues were resolved. The patient feedback revealed recognition of the HRQoL issues included in QUALAS, and also difficulties in understanding some questions. After the patients\' evaluation, four items were reworded for clarity. No study participant reported a wish to add to or remove questions from QUALAS. Hence, the Swedish versions of QUALAS became conceptually equivalent to the original US English versions and achieved linguistic, content and face validity. While empowering the voices of people with spina bifida, these results also enable their HRQoL to be properly assessed in research and clinical care in Sweden and in international studies.

The objective of this study was to systematically review the relationship between low health literacy and patient-reported outcomes in patients with benign gynecologic conditions. In this specific population, we also sought to determine the current reported prevalence of low health literacy, examine demographic characteristics that may be related to low health literacy, and collate any health literacy interventions described in the literature. A systematic search of MEDLINE (Medical Literature Analysis and Retrieval System Online), Embase, The Cochrane Library, Web of Science, PubMed, and clinicaltrials.gov was performed on July 12, 2021, and repeated on October 13, 2023, for terms related to health literacy, specific health literacy measures, and benign gynecologic conditions. There were language or publication period restrictions. Inclusion required primary literature to report associations between health literacy and patient-reported outcomes, using validated tools to quantitatively measure each, in adult women with benign gynecologic conditions. Title screening, abstract screening, and full-text review were conducted with Covidence software (Melbourne, Australia) assisting with the review process. Of the 18,701 studies returned using our search strategy, 25 were selected for full-text review. Of these, no studies met inclusion criteria and reported an association between health literacy and patient-reported outcomes. This study identified a large gap in the literature. Future work should be directed at evaluating the association between health literacy and patient-reported outcomes in benign gynecology to inform patient-centered interventions and care provision.

OBJECTIVE: This study aimed to validate the Chemotherapy-Induced Alopecia Distress Scale (CADS) in a diverse English-speaking population and patients with endocrine treatment-induced alopecia (EIA).
OBJECTIVE: Chemotherapy and endocrine therapy commonly cause alopecia in breast cancer patients, leading to significant psychological and social challenges. The CADS was developed to assess the psychosocial impact of alopecia, but its generalizability beyond Korean patients requires further investigation.
METHODS: Data from the CHANCE study (NCT02530177), which focused on non-metastatic breast cancer, was used. The cohort included 256 patients, and CADS data were collected at baseline, 6 months after chemotherapy completion, or 12 months after initiating endocrine therapy. The CADS questionnaire comprised 17 items covering physical and emotional health, daily activities, and relationships. Reliability was assessed using Cronbach\'s alpha, and responsiveness was measured by effect size.
RESULTS: The CADS exhibited good reliability, with Cronbach\'s alpha of 0.91 for the overall score, indicating acceptable internal consistency in both chemotherapy (0.89) and endocrine therapy (0.86) groups. Longitudinal responsiveness was supported by an effect size of 0.49 between decreasing satisfaction with hair growth and increasing emotional distress. Cross-sectional validity was confirmed, with effect sizes of 0.91 and 0.92 for satisfaction with hair growth and emotional and activity domains, respectively.
CONCLUSIONS: The CADS is a valid and responsive tool for assessing the psychosocial impact of chemotherapy-induced alopecia and endocrine treatment-induced alopecia in a diverse Western patient population.