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.

BACKGROUND: Satisfaction following shoulder arthroplasty (TSA), which is commonly reported using patient-reported outcome measures (PROMs), is partially dependent upon restoring shoulder range of motion (ROM). We hypothesized there exists a minimum amount of ROM necessary to perform functional tasks queried in PROM questionnaires, beyond which further ROM may provide no further improvement in PROMs.
METHODS: A retrospective review of a multicenter international shoulder arthroplasty database was performed between 2004-2020 for patients undergoing anatomic or reverse TSA (aTSA, rTSA) with minimum 2-year follow-up. Our primary outcome was to determine the threshold in postoperative active ROM (abduction, forward elevation [FE], external rotation [ER], and internal rotation [IR] score) whereby additional improvement was not associated with additional improvement in PROMs (Simple Shoulder Test [SST], American Shoulder and Elbow Surgeons [ASES] score, and the Shoulder Pain and Disability Index [SPADI]). For comparison, we also evaluated the Shoulder Arthroplasty Smart (SAS) score, which is not subject to the ceiling effect.
RESULTS: We included 4,459 TSAs (1,802 aTSAs, 2,657 rTSAs) with minimum 2-year follow-up (mean, 56±32 months). The threshold in postoperative ROM that were associated with no further improvement were: active abduction, 107-113° for PROMs versus 163° for the SAS score; active FE, 149-162° for PROMs versus 176° for the SAS score; active ER, 50-52° for PROMs versus 72° for the SAS score; IR score, 4-5 points for all PROMs versus 6 points for the SAS score. Out of 3,508 TSAs with complete postoperative ROM data, 8.5% achieved or exceeded all ROM thresholds (14.5% aTSAs, 4.8% rTSAs).
CONCLUSIONS: Our findings demonstrate that postoperative ROM exceeding 113° of abduction, 162° of FE, 52° of ER, and IR to L1 is associated with minimal additional improvement in PROMs. While individual patient needs vary, the thresholds may provide helpful targets for patients undergoing postoperative rehabilitation.

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.

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.

BACKGROUND: Carpal tunnel syndrome results from chronic compression of the median nerve, causing pain and paresthesia, especially at night. The impact of these symptoms on patients includes disrupted sleep patterns and a desire to alleviate discomfort through hand movements. Our study aims to investigate risk factors, associations, and high-risk patient profiles associated with these nocturnal manifestations in carpal tunnel syndrome.
METHODS: Utilizing a retrospective case-control design, our study comprises 681 patients with carpal tunnel syndrome, including 581 with nocturnal symptoms and 90 without. Data were obtained through personalized phone calls and health records, covering health profiles, medical comorbidities, perioperative variables, and selected outcomes.
RESULTS: Analyzing 591 patients with night symptoms revealed significant differences compared to the non-night symptoms group. The night symptoms group exhibited a lower mean age (51.3 vs. 56.6 years, p = 0.001), higher prevalence of diabetes (30.1% vs. 45.6%, p = 0.003), and paresthesia (98.5% vs. 81.1%, p < 0.001). In addition, the night symptoms group reported a higher incidence of disabling pain (89.2% vs. 70.0%, p < 0.001), weak hand grip (80.5% vs. 62.2%, p < 0.001), and night splints use (37.7% vs. 24.4%, p < 0.001). Preoperatively, the night symptoms group exhibited slightly higher intraoperative anxiety (40.9% vs. 30.0%, p = 0.12) and a slightly longer recovery time (1.7 vs. 1.4 months, p = 0.22), with no significant difference in pain relief scores (8.1 vs. 7.7, p = 0.16).
CONCLUSIONS: Patients with night symptoms show increased likelihood of comorbidities (diabetes, and renal, conditions), along with a propensity for disabling symptoms and paresthesia. Although they experience slightly longer recovery times, they demonstrate improved pain relief scores.
METHODS: Case-Control Study.

UNASSIGNED: Assessing asthma control is an essential part of the outpatient management of children with asthma and can be performed through validated questionnaires such as the Asthma Control Test (ACT). Systematic approaches to incorporating the ACT in outpatient visits are often lacking, contributing to inconsistent completion rates. We conducted a quality improvement initiative to increase the proportion of visits where the ACT is completed for children with asthma in our multi-site pediatric pulmonary clinic network.
UNASSIGNED: We developed an intervention of sending the ACT questionnaire to patients and caregivers through the electronic patient portal to complete prior to their visits. This strategy was first piloted at one clinic beginning in July 2020 and then expanded to 5 other clinics in the network in October 2020. Our outcome measure was average monthly proportion of visits with a completed ACT, tracked using statistical process control charts. The process measure was method of ACT completion tracked using run charts.
UNASSIGNED: At the pilot clinic, average monthly completion rate rose within 3 months of the intervention from 27% to 72% and was sustained more than 22 months. Completion across all clinics increased from 57% pre-intervention to 76% post-intervention. Importantly, the intervention did not rely on clinic staff to administer the questionnaire and did not interfere with existing clinic flow.
UNASSIGNED: An intervention of delivering the ACT electronically to patients and caregivers for completion prior to visits led to a rapid and sustained improvement in ACT completion rates across a large, pediatric pulmonary clinic network.

暂无摘要。

BACKGROUND: 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.
CONCLUSIONS: 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.
BACKGROUND: ClinicalTrials.gov identifier NCT04285229.