Predicting Outcome of Total Knee Arthroplasty by Cluster Analysis of Patient-Reported Outcome Measures.

BACKGROUND: Total knee arthroplasties (TKAs) exhibit an 8 to 30% risk of suboptimal outcomes, resulting in persistent symptoms, individual morbidity, and revision surgery, prompting a contemporary focus on risk reduction and outcome improvement. This study introduces hierarchical cluster analysis as a way of preoperatively assessing the likelihood of success/failure of TKA based on several patient-reported outcome measures, which have been analyzed both intact and with component questions as individual variables. METHODS: The study utilized data on 1,433 TKAs from The Miriam Hospital's Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement (FORCE-TJR) registry. Outcomes are expressed as Knee Injury and Osteoarthritis Outcome Score (KOOS) pain and function scores. Criteria for success/failure were developed with an integrative, anchor-based, minimum clinically important difference. Preoperative and postoperative patient-reported outcome measures (PROMs) were studied by cluster analysis. RESULTS: There were three sequential cluster analyses that revealed clusters of patients, based upon preoperative patient responses, that were predictive of surgical outcomes. Clusters varied most significantly in their responses to individual component questions of preoperative PROMs. Extracting and combining the clinically meaningful patient-reported component questions yielded a new, and clinically relevant, outcome measure that has the potential to preoperatively predict postoperative outcomes of total knee arthroplasty. CONCLUSION: In contrast to a single medical, psychological, or social variable, cluster analysis offers the opportunity to develop a whole-patient profile that reflects the contextual interactions of sociodemographic and clinical variables in predicting outcomes. In the context of determining clinical meaningfulness, cluster analysis has one of its major strengths.

Psychometric characteristics of the Spanish version of the HIV Symptom Index.

BACKGROUND: The aim of this study was to determine the psychometric properties of the Spanish-language version of the HIV-Symptom Index (HIV-SI) questionnaire in Spanish patients undergoing antiretroviral therapy. METHODS: Between 2014 and 2016, an observational, multicenter, prospective cohort study was conducted in seventeen Spanish hospitals to validate HIV-SI questionnaire in terms of: construct validity (confirmatory factor analysis), internal consistency (Cronbach's alpha), convergent validity (Pearson's correlation coefficient) and Known-group validity. In addition, a sensitivity to change analysis was also performed. RESULTS: A total of 232 patients were included in the study. They had a mean age of 46.17 (SD9.82) and were 75% male. The median overall score for the HIV-SI was 10 (IQR 4- 19.5) and the most common symptoms reported were feelings of nervousness or anxiety, fatigue or energy loss, feeling sad or depressed, stomach pain or bloating, and difficulty sleeping. In the current study, the Spanish HIV-SI questionnaire showed a high internal consistency (α = 0.89) and adequate construct validity (CFI and TLI > 0.90). When contrasted with the MOS-HIV questionnaire, an inverse correlation was found. It showed a good association with the mental (r=-0.61; P < 0.0001) and physical score (r=-0.60; P < 0.0001). In a multivariate analysis, the age of the patient, female condition, hepatitis C coinfection, concomitant treatment and non-adherence resulted in a higher HIV-SI score. CONCLUSIONS: Our study has shown that the Spanish HIV-SI is a valid and reliable self-administered PROM for routine measurement of patient- reported symptoms among Spanish patients on antiretroviral treatment.

Long-Term Association Between Patient-Reported Outcomes and Psychological Factors in Patients With a Distal Radius Fracture.

Purpose: The outcome after a distal radius fracture (DRF) is often evaluated with radiography, clinical examination, and patient-reported outcome measures. However, research has identified associations between psychological factors and outcomes after a DRF. A knowledge gap exists about psychological factors and their potential implications for long-term outcomes after a DRF. The aim of this study was to examine the long-term association between psychological factors and patient-reported outcomes. Methods: This multicenter investigation included patients aged 15-75 years with closed physes presenting with an acute DRF. Patients who completed a long-term follow-up (after 11-13 years) with patient-reported outcome measures were invited to participate in the study, and surveys measuring psychological factors were sent to the patients. Results: Two hundred and four patients (70%) completed the follow-up (mean [range] age at injury, 56 [18-75] years; 154 were females [75%]). Multivariable analysis showed that higher age, injury to the dominant hand, and greater pain catastrophizing were associated with an increase in scores on the Disabilities of the Arm, Shoulder, and Hand questionnaire. Conclusions: A decade after sustaining a DRF, patients with higher scores on the Pain Catastrophizing Scale reported inferior outcomes as measured by the Disabilities of the Arm, Shoulder, and Hand. The Pain Catastrophizing Scale accounts for 13% of the observed variance in Disabilities of the Arm, Shoulder, and Hand. Type of study/level of evidence: Therapeutic level IIb.

Inhibition of HOXC11 by artesunate induces ferroptosis and suppresses ovarian cancer progression through transcriptional regulation of the PROM2/PI3K/AKT pathway.

BACKGROUND: Ferroptosis, a non-apoptotic form of regulated cell death, plays a critical role in the suppression of various tumor types, including ovarian cancer. Artesunate (ART), a derivative of artemisinin, exhibits extensive antitumor effects and is associated with ferroptosis. This study aimed to investigate the mechanisms through which ART induces ferroptosis to inhibit ovarian cancer. METHODS: RNA sequencing was conducted to identify differentially expressed genes associated with ART-induced ferroptosis. Dual-luciferase reporter assays and electrophoretic mobility shift assays were performed to confirm the interaction between Homeobox C11 (HOXC11) and the Prominin 2 (PROM2) promoter. Cell Counting Kit-8 (CCK-8) assays, flow cytometry, and wound healing assays were used to analyze the antitumor effects of ART. Western blot, biochemical assays and transmission electron microscope were utilized to further characterize ART-induced ferroptosis. In vivo, the effects of ART on ferroptosis were examined using a xenograft mouse model. RESULTS: RNA sequencing analysis revealed that the HOXC11, PROM2 and Phosphatidylinositol 3-Kinase/ Protein Kinase B (PI3K/AKT) pathways were downregulated by ART. HOXC11 was found to regulate PROM2 expression by binding to its promoter directly. HOXC11 overexpression reversed ART-induced effects on ovarian cancer cell proliferation, migration, apoptosis and ferroptosis by activating the PROM2/PI3K/AKT signaling axis. Conversely, silencing PROM2 in HOXC11-overexpressing cells restored ART-induced ferroptosis and its associated antitumor effects by inhibiting the PI3K/AKT pathway. Consistently, in vivo studies using a xenograft mouse model confirmed that ART-induced tumor inhibition was mediated by ferroptosis through the suppression of the HOXC11/PROM2/PI3K/AKT pathway. CONCLUSION: This study identifies the HOXC11/PROM2/PI3K/AKT axis as a novel regulatory mechanism underlying ART-induced ferroptosis in ovarian cancer. Targeting the HOXC11/PROM2 axis may represent a promising therapeutic strategy for enhancing ferroptosis, offering new insights for the treatment of ovarian cancer.

National audit of patient reported experience of radical cystectomy for bladder cancer pathways.

Objective: The objective of this study was to measure and describe the national patient experience of radical cystectomy (RC) pathways in the UK using the validated Cystectomy-Pathway Assessment Tool (C-PAT). Patients and Methods: A cohort of 1081 patients who underwent RC for bladder cancer, between 1 January 2021 and 31 July 2022 at 33 UK cystectomy centres, returned completed C-PAT responses. SPSS was employed for data summary statistics, including median, interquartile range, Mann Whitney U test or Chi-square test with a 95% confidence interval to assess statistical significance between potentially associated variables. Open-text responses in the C-PAT tool were analysed and coded using NVivo software. Results: In this cohort, the greatest perceived delay in the RC pathway, reported by 19% of patients (n = 208), was at the GP consultation to first hospital referral stage with suspected bladder cancer. Around 10% of patients perceived delays at each of the other stages in their pathway. Cancer nurse specialist (CNS) contact was strongly associated with an improved patient experience (p < 0.001); however, 9.5% of patients reported that they were not assigned a cancer nurse specialist in their pathway. Overall, 96% (n = 1028) reported their experience of RC pathway care to be good or excellent. There were no significant differences in reported patient experience found between cystectomy centres. Conclusion: This audit demonstrates the feasibility of measuring patient experience of RC pathways at scale. The C-PAT tool demonstrated utility in identifying specific pathway areas for quality improvement. Overall UK patients report a high quality pathway experience. A focus on improving the referral pathway between primary and secondary care is necessary.

Feasibility of the Challenge Assessment, the Gait Outcomes Assessment List and 'Moving Together' ('Sammen I Bevægelse'), a Group-Based Motor Skills Intervention for Independent School-Aged Children with Cerebral Palsy.

This single group pre and posttest study evaluated the feasibility of a new 10-week group-based motor skills enhancement intervention: "Moving Together," and associated use of the Challenge assessment and Gait Outcomes Assessment List (GOAL). Participant attendance/completion and satisfaction with the assessments and intervention were evaluated, and a first estimate of associated motor skill-related changes obtained. Ten ambulatory children with cerebral palsy (7-14 years) and their parents participated. Ninety percent of Challenge sessions were attended and 82.5% of GOAL questionnaires completed. Program attendance was 83% overall. Satisfaction with assessments was high for the Challenge and moderate for the GOAL, and intervention satisfaction was high. Mean change scores (95% CI) post-intervention for the Challenge and GOAL were 4.2 (-11.4 to 3.1) and 3.6 (-14.4 to 4.0) points (/100) respectively. Challenge and GOAL use was feasible and appropriate for "MovingTogether" and associated with gains in motor skill performance and functional abilities.

Impact of rehabilitation with dental implants on the quality of life of patients undergoing maxillofacial reconstruction: a systematic review.

PURPOSE: Maxillofacial reconstruction with dental implants in microvascular tissue flaps aims to improve mastication. However, the quality of life (QoL) impact of this intervention is yet to be determined. This systematic review assessed the QoL impact of maxillofacial reconstruction with implant-supported teeth compared to no dental rehabilitation, removable dentures, and obturator (modified denture). Additionally, we examined instruments applied to measure QoL in maxillofacial reconstruction. METHODS: Databases Ovid Medline and Embase, Scopus, Web of Science and Handle on QoL were searched. Cohort, case-control and randomized controlled trials (RCT) were narratively synthesized for QoL captured through validated instruments. Study methodological quality was assessed using Cochrane Risk of Bias 2 and Risk of Bias in Non-randomized studies of Exposure. Instruments underwent COSMIN content validity analysis. RESULTS: Of a total of 2735 studies screened, the three included studies (two cohort and one RCT) showed improved QoL with maxillofacial reconstruction compared to obturator and no dental rehabilitation. However, these studies have high risk of bias due to confounding. None of the instruments achieved a sufficient relevance rating for maxillofacial reconstruction, having been designed for other target populations and there is no evidence on their content validity for this population, but the EORTC QLQ30 H&N35 satisfied more COSMIN criteria than the UW-QOL and OHIP-14. CONCLUSION: Although studies showed favourable QoL with maxillofacial reconstruction involving dental implants, these have high risk of bias and further studies are needed to establish the impact. Existing QoL instruments lack content validity and tailored instruments are needed for QoL evaluation in maxillofacial reconstruction.

A phase II trial examining the safety and preliminary efficacy of repetitive transcranial magnetic stimulation (rTMS) for people living with multiple sclerosis.

BACKGROUND: Multiple sclerosis (MS) is a chronic neurological condition and the leading cause of non-traumatic disability in young adults. MS pathogenesis leads to the death of oligodendrocytes, demyelination, and progressive central nervous system neurodegeneration. Endogenous remyelination occurs in people with MS (PwMS) but is insufficient to repair the damage. Our preclinical studies in mice indicate that endogenous remyelination can be supported by the delivery of repetitive transcranial magnetic stimulation (rTMS). Our phase I trial concluded that 20 sessions of rTMS, delivered over 5 weeks, are safe and feasible for PwMS. This phase II trial aims to investigate the safety and preliminary efficacy of rTMS for PwMS. METHODS: Participants must be aged 18-65 years, diagnosed with MS by a neurologist, stable and relapse free for 6 months, have an Extended Disability Status Scale (EDSS) between 1.5 and 6 (inclusive), willing to travel to a study site every weekday for 4 consecutive weeks, and able to provide informed consent and access the internet. Participants from multiple centres will be randomised 2:1 (rTMS to sham) stratified by sex. The intervention will be delivered with a Magstim Rapid2 stimulator device and circular 90-mm coil or MagVenture MagPro stimulator device with C100 circular coil, positioned to stimulate a broad area including frontal and parietal cortices. For the rTMS group, pulse intensity will be set at 18% (MagVenture) or 25% (Magstim) of maximum stimulator output (MSO), and rTMS applied as intermittent theta burst stimulation (iTBS) (~ 3 min per side; 600 pulses). For the sham group, the procedure will be the same, but the intensity is set at 0%. Each participant will attend 20 intervention sessions over a maximum of 5 weeks. Outcome measures include MS Functional Composite Score (primary), Fatigue Severity Scale, Hospital Anxiety and Depression Scale, Quality of Life, and Pittsburgh Sleep Quality Index/Numeric Rating Scale and adverse events (secondary) and advanced MRI metrics (tertiary). Outcomes will be measured at baseline and after completing the intervention. DISCUSSION: This study will determine if rTMS can improve functional outcomes or other MS symptoms and determine whether rTMS has the potential to promote remyelination in PwMS. TRIAL REGISTRATION: Registered with Australian New Zealand Clinical Trials Registry, 20 January 2022; ACTRN12622000064707.

Measurement properties of the Mental Health Literacy Scale (MHLS): A systematic review.

BACKGROUND: Since its creation, the Mental Health Literacy Scale (MHLS) has been used worldwide in mental health literacy studies. OBJECTIVE: This study aimed to systematically evaluate, summarize, and compare the measurement properties of MHLS validation studies. METHODS: PsycINFO, CINAHL, ERIC, Scopus, Embase, MEDLINE, and PubMed databases were searched from May 30, 2015, to December 31, 2023. Peer-reviewed studies validating the MHLS and its measurement properties were included, irrespective of language, study population, and setting. Studies using the MHLS as an outcome measure, as a comparative instrument to validate another instrument, or using other MHL measures and grey literature was excluded. RESULTS: Of the 685 search results, 16 studies were deemed eligible. The COnsensus-based Standards for the selection of health status Measurement INstruments (COSMIN) RoB criteria showed 15/15 studies exhibited 'Very Good' or 'Adequate' internal consistency, 3/6 reliability, 1/8 content validity, 14/14 structural validity, 6/7 hypothesis testing for convergent validity, 2/7 hypothesis testing for known-group validity, and 0/1 error measurement. The Cronbach's alpha ranged from 0.720 to 0.890, and the Intra-class Correlation Coefficient ranged from 0.741 to 0.99, while content validity was limited regarding the quality of evidence rating. The four-factor and unidimensional structures were 35.7 % and 28.6 %, respectively, the most common models. CONCLUSION: The MHLS exhibited strong evidence of construct validity and reliability, ensuring consistent and accurate evaluation of MHL and improving research credibility and generalizability. However, the low number of identical language versions of MHLS studies prohibited statistical pooling and quantitative summaries.

Several factors predict the achievement of the patient acceptable symptom state and minimal clinically important difference for patient-reported outcome measures following anterior cruciate ligament reconstruction: A systematic review.

PURPOSE: To summarize the predictors of the patient acceptable symptom state (PASS), minimal clinically important difference (MCID) and minimal important change (MIC) for patient-reported outcome measures (PROMs) following anterior cruciate ligament reconstruction (ACLR). METHODS: MEDLINE, PubMed and Embase were searched from inception to 5 January 2024. The authors adhered to PRISMA/R-AMSTAR guidelines, and the Cochrane Handbook for Systematic Reviews of Interventions. Data on statistical associations between predictive factors and PROMs were extracted. Inverse odds ratios (ORs) and confidence intervals (reverse group comparison) were calculated when appropriate to ensure comparative consistency. RESULTS: Thirteen studies comprising 21,235 patients (48.1% female) were included (mean age 29.3 years). Eight studies comprising 3857 patients identified predictors of PASS, including lateral extra-articular tenodesis (LET) (OR = 11.08, p = 0.01), hamstring tendon (HT) autografts (OR range: 2.02-2.63, p ≤ 0.011), age over 30 (OR range: 1.37-2.28, p ≤ 0.02), male sex (OR range: 1.03-1.32, p ≤ 0.01) and higher pre-operative PROMs (OR range: 1.04-1.21). Eight studies comprising 18,069 patients identified negative predictors of MCID or MIC, including female sex (OR = 0.93, p = 0.034), absence of HT autografts (OR = 0.70, p < 0.0001), higher pre-operative PROMs (OR = 0.76-0.84, p ≤ 0.01), meniscectomy (OR = 0.67, p = 0.014) and collision sports (OR = 0.02-0.60, p ≤ 0.05). CONCLUSION: Higher pre-operative PROMs, age over 30, male sex, LETs and HT autografts predicted PASS achievement. Lower pre-operative PROMs, male sex, non-collision sports, and lack of meniscectomies predicted MCID/MIC achievement. This review provides a comprehensive understanding of the predictors of clinically significant post-ACLR outcomes, thus improving clinical decision-making and the management of patient expectations. LEVEL OF EVIDENCE: Level IV.

Role of the GalNAc-galectin pathway in the healing of premature rupture of membranes.

BACKGROUND: Premature rupture of the membranes (PROM) is a key cause of preterm birth and represents a major cause of neonatal mortality and morbidity. Natural products N-acetyl-d-galactosamine (GalNAc), which are basic building blocks of important polysaccharides in biological cells or tissues, such as chitin, glycoproteins, and glycolipids, may improve possible effects of wound healing. METHODS: An in vitro inflammation and oxidative stress model was constructed using tumor necrosis-α (TNF-α) and lipopolysaccharide (LPS) action on WISH cells. Human amniotic epithelial cells (hAECs) were primarily cultured by digestion to construct a wound model. The effects of GalNAc on anti-inflammatory and anti-oxidative stress, migration and proliferation, epithelial-mesenchymal transition (EMT), glycosaminoglycan (GAG)/hyaluronic acid (HA) production, and protein kinase B (Akt) pathway in hAECs and WISH cells were analyzed using the DCFH-DA fluorescent probe, ELISA, CCK-8, scratch, transwell migration, and western blot to determine the mechanism by which GalNAc promotes amniotic wound healing. RESULTS: GalNAc decreased IL-6 expression in TNF-α-stimulated WISH cells and ROS expression in LPS-stimulated WISH cells (P < 0.05). GalNAc promoted the expression of Gal-1 and Gal-3 with anti-inflammatory and anti-oxidative stress effects. GalNAc promoted the migration of hAECs (50% vs. 80%) and WISH cells through the Akt signaling pathway, EMT reached the point of promoting fetal membrane healing, and GalNAc did not affect the activity of hAECs and WISH cells (P > 0.05). GalNAc upregulated the expression of sGAG in WISH cells (P < 0.05) but did not affect HA levels (P > 0.05). CONCLUSIONS: GalNAc might be a potential target for the prevention and treatment of PROM through the galectin pathway, including (i) inflammation; (ii) epithelial-mesenchymal transition; (iii) proliferation and migration; and (iv) regression, remodeling, and healing.

[Translated article] Patient-reported outcome measures for assessing atopic dermatitis in clinical practice.

Atopic dermatitis is a chronic skin condition that affects up to 20% of children and 10% of adults worldwide. Due to the high burden of dermatological signs and symptoms, atopic dermatitis has a significant impact on the quality of life of patients and their families. In the absence of objective measures to accurately assess severity and symptom burden, patient-reported outcome measures are essential to monitor the impact and progression of the disease, as well as the efficacy of treatments. Although there are currently no standardised guidelines for their use in clinical practice, there are some initiatives, such as the Harmonise Outcome Measures for Eczema and Vivir con Dermatitis Atópica, that can provide guidance. As healthcare systems move toward value-based healthcare models, patient-reported measures are becoming increasingly important for incorporating the patient perspective and improving the quality of healthcare services. The use of these measures can help monitor disease activity and guide treatment decisions. This article discusses the impact of atopic dermatitis and describes the patient-reported outcome measures commonly used in atopic dermatitis and the recommendations of the initiatives that have selected a core set of measures to best assess atopic dermatitis in clinical practice. Considering the recommendations of these initiatives and based on our experience in clinical practice, we propose the use of the Dermatology Life Quality Index to assess the impact of the disease on quality of life, the Patient-Oriented Eczema Measure to assess symptom severity, and the Numerical Rating Scale or the Visual Analogue Scale to measure itch intensity. To systematise the administration of these measures and to integrate them into hospital information systems and medical records, we emphasise the importance of telemedicine platforms that allow the electronic administration of these instruments.

Establishing the Patient-Acceptable Symptom State for the Numeric Rating Scale-Pain Score in a Postoperative Non-Shoulder Hand and Upper-Extremity Population.

PURPOSE: The patient-acceptable symptom state (PASS) is a threshold score on a patient-reported outcome measurement beyond which patients consider themselves "well." Our purpose was to establish the PASS for the numeric rating scale (NRS) for pain in a 1-year postoperative hand surgery population. METHODS: This retrospective study included adult patients undergoing non-shoulder upper-extremity surgery at a single, tertiary medical center identified over a 9-month period. At 1 year after surgery, NRS pain and responses to a pain-specific anchor question were collected. Patients were dichotomized based on achieving "PASS(+)" or failing to achieve "PASS(-)" an acceptable symptom state based upon their response to a pain-specific anchor question. Threshold values of a PASS(+) state were calculated for the NRS pain score using the following three methods: (1) mean score of PASS(+) patients, (2) Tubach method (75th percentile threshold for PASS(+) patients), and (3) the Youden index (receiver operating curve analysis to maximize sensitivity and specificity). RESULTS: Of 233 included patients, mean age was 54 years (±17), and 58% (n = 136) were women. Mean NRS pain scores differed between PASS(+) and PASS(-) patients (0.7 ± 1.2 vs 3.8 ± 2.7, respectively). PASS(-) patients were more likely to be non-White and have a diagnosed psychiatric comorbidity. Patient-acceptable symptom state estimates ranged from 0.73 to 2.1 for NRS pain, depending on the calculation method (0.73 for the mean score method, 1.0 for the Tubach method, and 2.1 for the Youden index). The area under the curve for the Youden index method was 0.86 consistent with excellent discrimination. CONCLUSIONS: We propose the value of 2.1 to represent the PASS threshold for the NRS pain score in this population. CLINICAL RELEVANCE: This PASS value should be used when interpreting NRS pain score outcomes at a population level. This threshold is expected to yield excellent discrimination for patient satisfaction when applied to a postoperative hand surgery population.

Perceptions, Attitudes and Needs of Periodontitis Patients: A Qualitative Systematic Review.

AIM: Patient-reported outcomes (PROs) hold significant potential in guiding clinical decision making, yet their utilization in periodontal trials has been limited. This systematic review aimed to critically synthesize and analyse qualitative studies that evaluated the knowledge and impact of periodontitis and its treatment on patients' lives, as well as their motivations, expectations and experiences in seeking treatment. MATERIALS AND METHODS: Six databases were searched up to March 2024 for qualitative studies on periodontitis patients. Studies were quality-assessed using the JBI Critical Appraisal and ConQual tools. Two authors independently extracted the findings, with discrepancies resolved by a third reviewer. RESULTS: Thirteen studies from 2006 to 2023 across four continents, involving 215 participants, identified five themes related to periodontitis: (i) knowledge about periodontitis and its treatment; (ii) impact of periodontitis on patients' lives; (iii) motivation and treatment expectations; (iv) obstacles to treatment; and (v) treatment impact on patients' lives. CONCLUSION: Significant physical and psychosocial impacts of periodontitis on patients' lives were identified, along with critical gaps in knowledge and awareness, emphasizing the important role of dentists in patient education. Specific PROs for use in validated instruments tailored to periodontitis were identified. These results can enhance patient-centred care by guiding future studies in accurately assessing patient perspectives on their condition and treatment.

Development and preliminary validation of a diagnostic prediction model to optimise outpatient management of patients with urolithiasis using urinary stones and intervention quality of life (USIQoL) measure.

PURPOSE: Patients with urinary calculi undergo resource-intensive follow-up. Application of a PROM, Urinary Stones and Intervention Quality of Life (USIQoL), can potentially optimise current practices if it matches the outcomes of traditional follow-up. Our objective was to develop, and conduct, a preliminary validation of the USIQoL based prediction model to aid triage. METHODS: We performed a two phase prospective cohort study. The 1st phase included development of the USIQoL-based decision model using multicentre data. The 2nd phase involved prospective single-blind external validation for the outpatient application. The aim was to evaluate correlations between the USIQoL scores and key predictors; clinical outcomes and global health ratings (EuroQoL EQ-5D). We used statistical analysis to validate USIQoL cut-off scores to aid triage and the decision to intervene. RESULTS: Of 503 patients invited, 91% (n = 455, Development [305] and Validation [150]; M = 308, F = 147) participated. The relationship between USIQoL domain scores and clinical outcomes was consistently significant (estimated odds: PPH 1.24, p < 0.001, 95% CI 1.13-1.36; PSH 1.22, p < 0.001, 95% CI 1.12-1.33). The ROC values for the model were ≥ 0.75. The optimum domain cut-off scores were derived with rising scores implying increased need to intervene. The model demonstrated satisfactory sensitivity (0.81-0.89) and specificity (0.36-0.47). CONCLUSIONS: The study demonstrates satisfactory correlation between the USIQoL and clinical outcomes making this model a valid aid for triage and optimising outpatient management with the cut-off scores able to identify high risk patients who need active treatment.

Comparison of the European Foot and Ankle Score (EFAS) and the Self-Reported Foot and Ankle Score (SEFAS) in patients with foot and ankle surgery.

BACKGROUND: The European Foot and Ankle Score EFAS and the Self-reported Foot and Ankle Score SEFAS are two Patient Reported Outcome Measures (PROMs) used in foot and ankle surgery. The EFAS has been published in recent years, while the SEFAS is a validated questionnaire based on the New Zealand total ankle questionnaire. METHODS: We compared the EFAS to the SEFAS, Short Form 36 (SF-36) and Numeric Rating Scale (NRS) regarding reliability and validity based on the results of 126 patients undergoing foot and ankle surgery in a single center. RESULTS: Both the EFAS and SEFAS demonstrate good psychometric properties with comparable reliability and validity. The EFAS questionnaire portrays pain and physical function as well as those well-established tools of SEFAS, NRS and SF-36. CONCLUSIONS: In conclusion both the EFAS and SEFAS show good psychometric properties with comparable results for internal consistency, test-retest reliability, sensitivity to change and strong correlation for the corresponding domains describing pain and physical function. LEVELS OF EVIDENCE: III.

Revision Total Knee Arthroplasty Achieves Minimal Clinically Important Difference Faster Than Primary Total Knee Arthroplasty.

BACKGROUND: Revision total knee arthroplasty (rTKA) remains underexplored regarding patient-reported outcome measures (PROMs), particularly in terms of time to reach minimal clinically important difference (MCID). This study addresses this gap by comparing the time to achieve MCID between primary TKA (pTKA) and rTKA patients, providing valuable insights into their recovery trajectories. METHODS: A total of 8,266 TKAs (7,618 pTKA and 648 rTKA) were retrospectively studied in a multi-institutional arthroplasty registry. Patients who completed the patient-reported outcomes measurement information system (PROMIS) global physical, PROMIS physical function short form 10a (PF-10a), and knee injury and osteoarthritis outcome score physical function short form (KOOS-PS) questionnaires were identified by Current Procedural Terminology codes. Survival curves with and without interval censoring were utilized to evaluate the time to achieve MCID. RESULTS: Comparing the time to achieve MCID, rTKAs were significantly faster than pTKA for PROMIS global physical (3.5 versus 3.7 months, P = 0.004) and KOOS-PS (3.3 versus 4.2 months, P < 0.001), but similar for PROMIS PF-10a (4.4 versus 4.8 months, P = 0.057). Interval censoring also showed similar trends with earlier times to achieve MCID for rTKAs for PROMIS global physical (0.6 to 0.61 versus 0.97 to 0.97 months, P = 0.009) and KOOS-PS (0.97 to 0.97 versus 1.47 to 1.47 months, P < 0.001), but not for PROMIS PF-10a (2.43 to 2.54 versus 1.90 to 1.91 months, P = 0.92). CONCLUSIONS: The present study revealed that the time to achieve MCID was faster in patients undergoing rTKA compared to those undergoing pTKA. These findings allow surgeons to reassure preoperative rTKA patients that their recovery to a MCID postoperatively may be quicker than expected, especially when compared to their initial recovery after primary TKA. LEVEL OF EVIDENCE: Level III.

Unveiling the burden of COPD: perspectives on a patient-reported outcome measure to support communication in outpatient consultations-an interview study among patients.

Introduction: Chronic Obstructive Pulmonary Disease (COPD) profoundly affects physical, psychological, and social aspects of life, yet these issues often remain unaddressed. Patient-Reported Outcomes Measures (PROM) have the potential to address these issues by promoting person-centered communication. However, their impact in COPD practice remains uncertain. This study aimed to investigate how patients with COPD perceive the usefulness of a new holistic PROM for general palliative care (PRO-Pall) before and during outpatient consultations. Methods: Semi-structured telephone interviews were conducted with patients diagnosed with moderate to very severe COPD, 2-5 days after consultation at a respiratory outpatient clinic in Denmark. Interviews were transcribed verbatim and analyzed inductively using qualitative content analysis. Results: Nine patients (five males; mean age: 66 years) participated in the study with four themes emerging: (1) Unlocking thoughts: Completing PRO-Pall stimulated patients' self-reflection, which revealed previously overlooked COPD-related issues, particularly psychosocial challenges. (2) Unmasking concerns: Patients felt encouraged to be honest, rather than concealing their concerns. (3) Breaking the ice: PRO-Pall responses enabled direct questioning by healthcare professionals during consultations, initiating discussions on patients' sensitive yet vital COPD-related matters. (4) Deepening the dialogue: Healthcare professionals' targeted and attentive approach fostered more holistic and meaningful discussions, providing most patients with a deeper understanding of psychosocial issues affecting their well-being. Conclusion: Completing PRO-Pall prior to outpatient consultations prompted most patients with COPD to unveil previously unacknowledged psychosocial challenges. During consultations, addressing these challenges initiated open discussions on individual concerns, enhancing most patients' understanding of the multifaceted burden of COPD.

MORe PREcISE: Longitudinal patient reported outcome measures in stroke at 3 and 6 months.

BACKGROUND AND PURPOSE: Post-stroke morbidity is common, but little is known about the burden on patients' lives from their own perspective. Understanding morbidity from the point of view of the patient may support targeted intervention in post-stroke recovery. This study used a stroke specific Patient Reported Outcome Measure (PROM) containing Mental health (MH) and Physical Health (PH) domains and 5 stroke specific questions. We aimed to consider trends over a 6-month period and further assess the association between the MH and PH measures and common clinical measures. METHODS: A multicenter prospective cohort study was conducted at 19 hospital sites across England and Wales. Patients were enrolled from August 2018 to September 2019. Clinical measures and PROMs were assessed at three timepoints: acutely following the index stroke, at 3 and 6-months post-stroke. Clinical measures and PROMs were assessed in each of these points. RESULTS: Physical health PROM domains show significant gradual improvement across the study period (χ2 42.6312, p<0.0001), whereas cognitive function domains (χ2 3.7849, p<0.875) did not echo this trend. All clinical measures (GAD-7, PHQ9, MoCA, MRS) were associated with poorer PROM MH outcomes, (aMD -4.4, CI -0.59, -0.29, p≤0.001, aMD -0.45, CI -0.59, -0.32, p=<0.001, aMD 0.75, CI 0.56, 0.95, aMD -1.91, CI -2.41, -1.47, p≤0.001). Clinical measures of disability, as per the MRS, are associated with poor PROM PH scores (aMD -0.57, 95% CI -0.94, -0.20, p=0.003). CONCLUSIONS: This research indicates there is unmet cognitive burden in stroke survivors. PROMs may be able to measure unmet more discretely than common clinical tools that are used post-stroke. Further research and guidance on how to integrate PROMs into current clinical frameworks is essential.

Development of a novel patient reported outcome measure for health-related quality of life in amyotrophic lateral sclerosis (PROQuALS): study protocol.

BACKGROUND: Patient reported outcome measures (PROMs) can be used to assess the impact of health conditions upon an individual's health-related quality of life (HRQoL). Whilst PROMs have been used to quantify the HRQoL impact of amyotrophic lateral sclerosis (ALS), existing instruments may not fully capture what matters to people living with ALS (plwALS) or be appropriate to be used directly to inform the cost-effectiveness of new treatments. This highlights a need for a new condition-specific PROM that can both capture what's important to plwALS and be used in economic evaluation. This study has two key aims: 1) to produce a novel PROM for measuring HRQoL in plwALS (PROQuALS). 2) to value a set of items from the novel PROM to generate an associated preference-weighted measure (PWM) that will enable utility values to be generated. METHODS: A mixed-methods study design will be conducted across three stages. Stage 1 involves concept elicitation and the generation of draft PROM content from a robust and comprehensive systematic review of HRQoL in ALS, with input from plwALS. Stage 2 consists of cognitive debriefing of the draft PROM content to ascertain its content validity (Stage 2a), followed by a psychometric survey (Stage 2b) to assess statistical performance. Evidence from Stage 2 will be used to make decisions on the final content and format of the novel PROM. Stage 3 will involve valuation and econometric modeling using health economics methods to generate preference weights, so a PWM derived from the novel PROM can be used in the cost-effectiveness analyses of treatments. Patient and clinical advisory groups will have critical, collaborative input throughout the project. DISCUSSION: The novel PROM will be designed to comprehensively assess important aspects of HRQoL to plwALS and to quantify HRQoL in terms of subjective impact. The PROQuALS measure will be available for use in research and healthcare settings. The associated PWM component will extend and enable the use of PROQuALS in cost-effective analyses of new treatments for ALS. TRIAL REGISTRATION: Not applicable.