Patient-reported Outcomes Research Articles

Psychometric properties of the Thai version of the Simple Knee Value in patients with patellofemoral pain

Purpose This study aimed to translate the Simple Knee Value (SKV) into Thai and evaluate its psychometric properties as a single-question assessment tool. Methods The SKV was translated into Thai according to international guidelines. Psychometric properties were assessed in adults aged 18–50 years with patellofemoral pain. Participants completed questionnaires at baseline, 2 weeks, and 2 months. Results Seventy-six patients with patellofemoral pain (mean age 36.8 ± 8.3 years, 56.6% female) participated in this prospective cohort study. SKV scores were moderately correlated with those of the Knee Injury and Osteoarthritis Outcome Score–Patellofemoral Subscale (KOOS-PF) and the Anterior Knee Pain Scale (AKPS). The test-retest reliability was high, with an intraclass correlation coefficient of 0.79 (95% confidence interval: 0.65–0.88). The SKV change scores effectively differentiated between improved and unimproved patients, with a minimal important change of 12.5 points. Conclusions The SKV demonstrated acceptable psychometric properties for assessing patellofemoral pain in young to middle-aged adults. This single-question patient-reported outcome measure is simple and easy to use in daily clinical practice and can serve as an adjunctive assessment tool in patellofemoral pain research.

NCOG-13. ASSESSING CAREGIVER OUTCOMES OF PRIMARY BRAIN TUMOR PATIENTS: A SYSTEMATIC REVIEW OF THE LITERATURE

Abstract BACKGROUND Family caregivers in neuro-oncology are known to have high levels of unmet support needs. Intervention trials and effective support options are scarce. The Response Assessment in Neuro-Oncology (RANO-) Cares working group has been established to determine standards of caregiver outcomes (CO) research reporting in neuro-oncology. We present the current state of methodological quality of reporting on neuro-oncology caregiver outcomes in randomized controlled trials (RCTs). METHODS A systematic literature review (PubMed/Medline, Embase, Web of Science, Emcare, Cochrane Library, PsycINFO; July 2023) was performed to assess to what degree RCTs assessing outcomes of family caregivers of adult primary brain tumor patients adhere to established reporting standards. Using Covidence, screening and data extraction was independently performed by two researchers, with a third guiding consensus. A 33-item checklist (23 applicable to secondary analysis reports) based on the International Society for Quality of Life (ISOQOL) Research criteria for patient-reported outcome reporting was utilized to assess reporting standards. Risk of bias was assessed per RCT. RESULTS Fifteen publications (12 unique RCTs) included 684 neuro-oncology caregivers, with low overall risk of bias. Ten publications (66%) reported on COs as a primary aim and eight (80%) of these satisfied ≥2/3 of the key methodological criteria. Of the five secondary analysis reports (33%) two met ≥2/3 of applicable key criteria. Criteria often missed are related to sample size calculations, details on statistical approaches, discussion of limitations and clinical significance of studies. Only three of the 12 RCTs were definitive trials aimed at improving COs and five should be considered as pilot or feasibility studies. CONCLUSION RCTs investigating neuro-oncology COs have high reporting standards and risk of bias was low. Future studies should focus on specific caregiver interventions to reduce high caregiver burden and with that patients’ quality of life.

INNV-33. ADVANCING PRECISION TREATMENT FOR DIFFUSE MIDLINE GLIOMA: THE DMG LEARNING HUB INITIATIVE

Abstract Diffuse Midline Glioma (DMG) poses a significant challenge in neuro-oncology due to its heterogeneous presentation and limited therapeutic options. Clinical trials often serve as the primary avenue for treatment, yet families encounter numerous barriers in navigating and selecting appropriate trials. Health disparities, including disparities in medical literacy and access to specialized medical centers, further complicate decision-making processes. Existing registries lack comprehensive data integration, focusing on isolated perspectives of either research or clinical data, neglecting the holistic patient profile. Evaluation of treatment endpoints beyond Progression-Free Survival (PFS) and Overall Survival (OS) remain inconsistent, despite being a priority for families. The DMG Learning Hub emerges as a transformative platform designed to empower families by offering informed options and guidance while fostering a collaborative environment where patient families actively contribute to shaping the landscape of clinical trials. Leveraging AI-assisted matching, the platform assists families in navigating the complex decision-making process surrounding clinical trial participation. The inclusion of a patient-reported outcome journal feature enables families to track vital information such as symptom changes and supplement usage, with autonomy over the timing of shared data. Using real-time data sharing facilitates invaluable insights for researchers, bridging gaps that would otherwise be overlooked and enriching the collective understanding of DMG. Harmonizing molecular, imaging, and clinical data within the platform equips care teams with comprehensive, near-real-time information crucial for personalized treatment strategies. This integrated approach not only supports the inclusion of n-of-1 arms in current trials but also extends therapeutic opportunities to patients previously ineligible for studies due to specific disease markers or progression patterns. The DMG Learning Hub represents a significant stride towards precision oncology by synergizing patient-centric priorities with cutting-edge technology, integrating harmonized data, and fostering collaborative efforts, the initiative heralds a promising era of personalized treatment for DMG and beyond the neuro-oncology community.

Association of suture augmentation with graft failure and clinical outcomes following anterior cruciate ligament reconstruction: A systematic review and meta‐analysis of comparative studies with a minimum 2‐year follow‐up

AbstractPurposeTo compare graft failure, nonrevision reoperation, complication, patient‐reported outcome measures (PROMs) and return to sports (RTS) between patients who underwent anterior cruciate ligament reconstruction (ACLR) with and without suture augmentation (SA).MethodsA systematic search was performed on PubMed, Cochrane, Embase and Web of Science databases from the inception of databases to 18 April 2024, according to Preferred Reporting Items for Systematic Reviews and Meta‐Analyses guidelines. Studies comparing clinical outcomes of SA‐ and standard ACLR with a minimum 2‐year follow‐up were included. Data extraction and quality appraisal were performed by two researchers independently.ResultsEight retrospective cohort studies were included, with a total of 408 patients receiving SA‐ACLR and 443 patients receiving standard ACLR. A meta‐analysis of graft failure demonstrated a 62% relative risk reduction (RR [risk ratio], 0.38 [95% confidence interval {CI}, 0.19–0.73]; p = .004) in those receiving SA‐ACLR compared with standard ACLR. An age‐related heterogeneity in graft failure reduction was detected in the subgroup analysis, which was more pronounced in studies with mean ages of <20 years compared with ≥20 years (p = .05; I2 = 73.9%). No significant difference was observed in nonrevision reoperation or complication rates. No clinically relevant difference was observed in PROMs. SA‐ACLR was associated with a significantly higher RTS rate compared with the standard ACLR (RR, 1.12 [95% CI, 1.00–1.24]; p = .04), whereas no significant difference was observed in time to RTS.ConclusionSA‐ACLR is associated with a reduced graft failure rate and increased RTS rate compared with standard ACLR without additional reoperations or complications. However, confidence in the evidence is limited by substantial heterogeneity. Future studies with a higher level of evidence are warranted to validate the benefit of SA and to determine the indication for different risk populations.Level of EvidenceLevel III.

Associations between less knee kinematic variability and worse patient-reported outcomes following anterior cruciate ligament reconstruction

ABSTRACT Individuals with anterior cruciate ligament reconstruction (ACLR) exhibit less knee kinematic variability while walking than uninjured controls, associated with deleterious changes in cartilage composition linked to an increased risk for early knee osteoarthritis (KOA). It is unknown whether less knee kinematic variability is also associated with worse knee-related patient-reported outcomes (PROs) consistent with KOA development. This study examined associations between kinematic variability during gait and PROs in individuals post-ACLR. Gait kinematics and the Knee Injury and Osteoarthritis Outcome Score (KOOS) were collected from 45 participants 6-months post-ACLR (67% Females; 21.45 ± 4.56 years). Overground gait biomechanics using 3D motion capture were collected, and knee kinematics were extracted for post-processing. Sample entropy (SampEn) was used to calculate knee kinematic variability. Pearson’s product-moment correlations were conducted to determine the associations between SampEn and KOOS sub-scores. Additionally, independent samples t-tests were performed to evaluate potential differences in SampEn outcomes between individuals with and without clinically relevant symptoms (defined in the introduction). Less sagittal plane kinematic variability is associated with greater pain (r = 0.37, p = 0.01) and symptoms (r = 0.32, p = 0.03). Symptomatic participants demonstrated less sagittal plane knee kinematic variability compared to asymptomatic participants (p = 0.01). The findings suggest less variable gait patterns 6-months post-ACLR may be linked to KOA-related symptoms.

Plasma Rich in Growth Factors Compared to Xenogenic Bone Graft in Treatment of Periodontal Intra-Osseous Defects—A Prospective, Comparative Clinical Study

Background: Periodontal intra-bony defects are challenging conditions in dental practice, often requiring regenerative approaches for successful treatment. This clinical study aimed to compare the effectiveness of plasma rich in growth factors (PRGF) versus xenogenic bone graft (BXG) in addressing intra-bony defects. Methods: Forty patients aged between 30 and 50 years presenting with generalized periodontitis were included. The study assessed various parameters, including relative attachment level (RAL); probing pocket depth (PPD); gingival marginal level (GML); intra-bony defect depth (IBDD) at baseline, 3, and 6 months; and level of pain, post-operative bleeding, and swelling, as patient-reported outcomes during the first seven days post operation. Results: The results revealed that both PRGF and BXG treatments led to significant reductions in IBDD over the 6-month study period. PRGF demonstrated significant advantages in GML enhancement and post-operative pain management during the initial post-treatment days. However, BXG showed a significantly greater reduction in IBDD compared to PRGF. Post-operative bleeding and swelling levels were comparable between the two treatments. Conclusions: These findings underscore the efficacy of both PRGF and BXG in periodontal regeneration, with treatment decisions guided by patient-specific factors and clinical goals.

Patients with multiple sclerosis have higher rates of worsening following total hip arthroplasty: a propensity-matched analysis.

The progressive nature of multiple sclerosis (MS) may adversely affect outcomes following total hip arthroplasty (THA). As patient-reported outcome measures (PROMs) in this specific group are not well defined, this study aimed to compare the clinical outcomes and the rates of achieving the minimal clinically important difference for improvement (MCID-I) and worsening (MCID-W) between patients with MS and those without MS undergoing THA. We conducted a retrospective analysis of 375 THAs, including 75 MS patients and 300 propensity-matched non-MS patients (4:1), performed between 2016 and 2022. Collected PROMs included Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Mental and Physical, PROMIS Physical Function short form 10-a (PF-10a), and Hip disability and Osteoarthritis Outcome Score-Physical Function Short-form (HOOS-PS). Preoperative and postoperative PROMs and MCID-I/MCID-W rates were compared. A total of 375 THAs, including 75 MS and 300 matched non-MS patients, were analysed. MS patients had higher 90-day postoperative complication rates (9.3% vs. 2.3%, p = 0.012) and infection rates (4.0% vs. 0.3%, p = 0.006). The rates of achieving MCID-I and MCID-W were similar for PROMIS Global Mental, PROMIS Global Physical, and HOOS-PS, but MS patients had a higher rate of experiencing MCID-W for PROMIS PF-10a compared to non-MS patients (16.7% vs. 6.5%, p = 0.022). Additionally, MS patients had a longer mean hospital stay (2.4 vs. 1.9 days, p = 0.005) and lower rates of being discharged home (82.7% vs. 94.3%, p < 0.001). The present study found that MS patients experience similar rates of MCID-I and MCID-W in most PROMs but have a higher rate of MCID-W for PROMIS PF-10a and increased postoperative complications. These findings highlight the need for careful consideration of postoperative risks despite potential improvements. Further research is needed to explore the impact of MS progression on PROMs and perioperative outcomes.

Influence of Preoperative Disability on Outcomes Following Primary Surgical Treatment of Cervical Disc Herniation.

Retrospective review. To evaluate how preoperative disability influences patient-reported outcomes (PROs) following primary surgical intervention for cervical herniated disc. The effect of baseline disability has been evaluated for various spinal surgeries, but not specifically for primary cervical herniated disc. A prospectively maintained single surgeon database was retrospectively reviewed to identify patients who underwent primary cervical spine surgery for herniated nucleus pulposus. Demographics, perioperative data, and baseline/postoperative PROs were collected including Neck Disability Index (NDI), Visual Analog Scale-Arm/Neck (VAS-A/N), 12-Item Short Form Mental/Physical Component Scores (SF-12 MCS/PCS), Patient-Reported Outcome Measure Information System-Physical Function (PROMIS-PF), and 9-Item Patient-Health Questionnaire (PHQ-9). Baseline NDI <50/≥50 defined 2 cohorts. ΔPROs were determined at 6-week postoperatively/final follow-up (average 11.8±7.7 postoperative months). Overall rates of minimal clinically important difference (MCID) achievement were determined for each PRO. Perioperative characteristics/demographics/baseline PROs were compared with χ2 tests (categorical variables)/the Student t test (continuous variables). Intercohort postoperative PROs/ΔPROs/MCID attainment rates were compared with multivariate linear regression (continuous variables)/multivariate logistic regression (categorical variables) accounting for differences in insurance type. Of 190 patients, there were 69 in the NDI ≥50 group. Patients with NDI ≥50 were more likely to have workers' compensation, or Medicare/Medicaid insurance (P<0.001) and report worse baseline PROs (P≤0.001, all). After controlling for insurance type, NDI ≥50 patients continued to report worse PROs at 6 weeks/final follow-up (P≤0.037, all), except PROMIS-PF at 6 weeks postoperatively. NDI ≥50 patients reported greater NDI improvements at 6 weeks (P=0.007) and final follow-up (P<0.001). NDI ≥50 patients experienced higher overall MCID achievement rates for PHQ-9/NDI (P≤0.015, both). NDI ≥50 patients reported worse baseline mental/physical health and neck/arm pain and continued to report inferior postoperative outcomes including disability. Despite inferior absolute outcomes, NDI ≥50 patients reported greater improvements/achievement of clinically significant differences in disability through final follow-up. Further, these patients were more likely to experience clinically significant improvements in depressive burden.

The impact of concomitant meniscal surgery on the clinical outcomes of anterior cruciate ligament reconstruction.

The aim of this study was to compare patient-reported outcomes (PROMs) following isolated anterior cruciate ligament reconstruction (ACLR), with those following ACLR and concomitant meniscal resection or repair. We reviewed prospectively collected data from the UK National Ligament Registry for patients who underwent primary ACLR between January 2013 and December 2022. Patients were categorized into five groups: isolated ACLR, ACLR with medial meniscus (MM) repair, ACLR with MM resection, ACLR with lateral meniscus (LM) repair, and ACLR with LM resection. Linear regression analysis, with isolated ACLR as the reference, was performed after adjusting for confounders. From 14,895 ACLR patients, 4,400 had two- or five-year Knee injury and Osteoarthritis Outcome Scores (KOOS) available. At two years postoperatively, the MM repair group demonstrated inferior scores in KOOS pain (β = -3.63, p < 0.001), symptoms (β = - 4.88, p < 0.001), ADL (β = - 2.43, p = 0.002), sport and recreation (β = - 5.23, p < 0.001), quality of life (QoL) (β = - 5.73, p < 0.001), and International Knee Documentation Committee (β = - 4.1, p < 0.001) compared with the isolated ACLR group. The LM repair group was associated with worse KOOS sports and recreation scores at two years (β = - 4.264, p < 0.001). At five years, PROMs were comparable between the groups. At five years, PROMs were comparable between the groups. Participants undergoing ACLR surgery within 12 weeks from index injury demonstrated superior PROMs at two and five years. Our study showed that MM repair, and to a lesser extent LM repairs in combination with ACLR, were associated with inferior patient-reported outcome measures (PROMs) compared to isolated ACLR at two years postoperatively, while meniscal resection groups exhibited comparable outcomes. However, by five years postoperation, no significant differences in PROMs were evident. Further longer-term, cross-sectional studies are warranted to investigate the outcomes of ACLR and concomitant meniscal surgery.

The Impact of Disc Height on Outcomes Following Cervical Disc Replacement

Study Design. Systematic review Objective. Describe the impact of disc height on outcomes following cervical disc replacement (CDR). Summary of Background Data. Implant sizing and positioning may impact outcomes following CDR. Methods. A systematic review was performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines using the EMBASE and PubMed databases. The goal of this review was to assess the impact of postoperative “disc height” on clinical and radiologic outcomes following CDR. Results. A total of 12 studies were included in the systematic review. In the literature. “disc height” was assessed using multiple different measures: postoperative disc height (DH; n=4), disc height change (DHC; n=4), degree of disc distraction (DDD; n=2), prosthesis height (PH; n=2), functional spinal unit height (FSUH; n=2), and facet distraction (FD; n=1). DH and DHC were the most common measures studied. DHC was associated with statistically and clinically significant differences in several patient-reported outcomes measures (PROMs). However, DH was not associated with any statistically or clinically significant differences in PROMs. With respect to cervical range of motion (ROM), DHC appeared to demonstrate statistically and clinically relevant differences in some of the studies included in this review, while DH was associated with statistically, but not clinically, significant differences. The majority of studies identified DHC &lt;2 mm as an important cutoff to optimize outcomes. Conclusions. “Disc height,” especially as measured by DHC, may be an important intraoperative consideration when selecting implant size during CDR. Maintaining DHC &lt;2 mm may optimize PROMs and ROM. Improving technique and implant sizing may aid in translating ex vivo advantages in implant mobility to in vivo improvements in ROM and PROMs.

Chronic Nasal Disease and Eustachian Tube Function: What Is the Role of Tubomanometry?

Background/objectives: Eustachian tube dysfunction (ETD) presents complex diagnostic challenges in otolaryngology, compounded by concurrent chronic nasal disease. Patient-reported outcome measures (PROMs) often assess ETD severity due to its elusive diagnosis. Tubomanometry (TMM) emerges as a promising diagnostic tool, yet its application alongside chronic nasal disease remains unclear. Our study aims to elucidate TMM’s role in ETD diagnosis within the context of chronic nasal diseases, integrating subjective assessments, clinical examination, and TMM results. Methods: A prospective observational study was conducted with patients suffering from ETD and chronic nasal disease allocated in three different groups according to their nasal pathology. Clinical examination, PROMs in the form of ETDQ-7, and NOSE questionnaires as well as TMM were performed. Results of the above subjective and objective measurements were analysed and correlated statistically to determine the value of TMM in chronic nasal disease patients. Results: All recruited patients suffered from ETD and chronic nasal disease, with similarly affected ETDQ-7 scores across all groups, while NOSE scores differed significantly based on the underground nasal pathology. TMM values confirm the presence of ETD in all three groups, confirming the role of TMM within this cohort. Interestingly, TMM values can still confirm the presence of ETD in patients with chronic nasal disease but cannot discriminate among chronic nasal pathology patients, making TMM a diagnostic tool with uniformity among the chronic nasal pathologies. Conclusions: ETD in individuals with chronic nasal disease presents distinct complexities, requiring a tailored diagnostic approach. In this context, a thorough clinical assessment, integrating ETDQ-7 and NOSE questionnaires, supplemented by TMM where accessible, is crucial to confirm diagnosis. This study confirms that TMM can diagnose ETD in all nasal pathology patients without being influenced by the nature of the disease. This research endeavours to refine diagnostic strategies, enriching clinical decision-making, and enhancing ETD management in patients suffering with chronic nasal diseases.

Comparative study of simultaneous and staged bilateral total knee arthroplasty: is age a key factor in surgical outcomes?

BackgroundThe present study aimed to compare the outcomes of simultaneous bilateral total knee arthroplasty (simBTKA) and staged bilateral total knee arthroplasty (stgBTKA) across different age groups, with a specific focus on patients under and over 65 years old.MethodsA retrospective cohort study design was employed to analyze the medical records of patients who underwent simBTKA or stgBTKA between August 2018 and May 2023. Patients were categorized into 4 groups based on age and surgical approach. Various outcome measures including knee extension strength, patient-reported outcome measures (PROMs), length of stay (LOS), operating room time (ORT), and complication rates were evaluated.ResultsThe study included a total of 162 patients, with 48 patients in the simBTKA group and 114 patients in the stgBTKA group. Across all age groups, simBTKA resulted in a significantly shorter LOS and ORT than stgBTKA (p < 0.05). However, there were no significant differences in PROMs or in knee extension strength between the two surgical approaches. The complication rates were comparable between the groups, with no reported deaths within one year after surgery.ConclusionCompared with stgBTKA, simBTKA demonstrated superior efficacy in terms of reduced hospitalization duration and ORT, irrespective of age. Both surgical approaches yielded comparable clinical outcomes and complication rates across all age groups. Overall, the findings suggest that simBTKA is a viable option for appropriately selected patients, offering outcomes comparable to those of stgBTKA, with the added benefit of reduced hospitalization time and operating room utilization.

Determining doses for backfill cohorts based on patient-reported outcome

BackgroundIncorporating backfill cohorts in phase I oncology trials is a recently developed strategy for dose optimization. However, the efficacy assessment window is long in general, causing a lag in identifying ineffective doses and more patients being backfilled to those doses. There is necessity to investigate how to use patient-reported outcomes (PRO) to determine doses for backfill cohorts.MethodsWe propose a unified Bayesian design framework, called ‘Backfill-QoL’, to utilize patient-reported quality of life (QoL) data into phase I oncology trials with backfill cohorts, including methods for trial monitoring, algorithm for dose-finding, and criteria for dose selection. Simulation studies and sensitivity analyses are conducted to evaluate the proposed Backfill-QoL design.ResultsThe simulation studies demonstrate that the Backfill-QoL design is more efficient than traditional dose-expansion strategy, and fewer patients would be allocated to doses with unacceptable QoL profiles. A user-friendly Windows desktop application is developed and freely available for implementing the proposed design.ConclusionsThe Backfill-QoL design enables continuous monitoring of safety, efficacy and QoL outcomes, and the recommended phase II dose (RP2D) can be identified in a more patient-centered perspective.

Benefits and Harms of Coronary Revascularization in Non-Dialysis-Dependent Chronic Kidney Disease and Ischemic Heart Disease: A Systematic Review and Meta-Analysis.

Key Points In people with non–dialysis-dependent CKD, revascularization may lower all-cause mortality and risk of cardiovascular events.Adverse kidney events, which are often cited as a reason to avoid revascularization, were uncommon.Additional research on the effect of revascularization on patient-reported outcomes in people with non–dialysis-dependent CKD is needed. Background Cardiovascular disease is the leading cause of death in people with CKD. Coronary revascularization can improve cardiac function and prognosis in people with ischemic heart disease; however, in people with CKD, there is concern that potential harms could outweigh benefits of revascularization. Evidence on the balance of these risks and benefits, specifically in people with non–dialysis-dependent CKD, is lacking. Methods We conducted a systematic review of randomized controlled trials to assess the risks and benefits of revascularization, compared with medical management, among adults or children with ischemic heart disease and CKD not requiring KRT (dialysis or transplantation). We searched PubMed, Embase, and the Cochrane Central Register of Controlled Trials through December 12, 2023. Two people independently screened titles and abstracts followed by full-text review, serially extracted data using standardized forms, independently assessed risk of bias, and graded the certainty of evidence (COE). Results Evaluating data from nine randomized controlled trials, we found that people with CKD and ischemic heart disease treated with revascularization may experience lower all-cause mortality compared with people receiving medical management (risk ratio [RR], 0.80; 95% confidence interval [CI], 0.64 to 0.98; COE, low). Revascularization may reduce incidence of myocardial infarction (RR, 0.81; 95% CI, 0.64 to 1.04; COE, low) and heart failure (RR, 0.80; 95% CI, 0.52 to 1.23; COE, low). The effect on cardiovascular mortality is uncertain (hazard ratio, 0.67; 95% CI, 0.37 to 1.20; COE, very low). Evidence was insufficient for patient-reported outcomes and adverse kidney events. Data were limited by heterogeneity of patient populations and the limited number of trials. Conclusions In people with non–dialysis-dependent CKD, revascularization may be associated with lower all-cause mortality compared with medical management and may also lower the risk of cardiovascular events. Additional data surrounding kidney and patient-reported outcomes are needed to comprehensively engage in shared decision making and determine optimal treatment strategies for people with CKD and ischemic heart disease. Clinical Trial registry name and registration number: CRD42022349820 (PROSPERO).

Patient-reported outcomes related to migraine burden among patients treated with standard-of-care preventive medications or calcitonin gene-related monoclonal antibodies: a United States and Europe cross-sectional survey

Objective To evaluate quality of life, migraine disability, and work productivity and activity impairment in patients with migraine who received preventive treatment by comparing standard of care preventive medications and calcitonin gene-related monoclonal antibodies (CGRP mAbs), including galcanezumab alone. Methods This cross-sectional study conducted across the United States (US) and Europe used data from the Adelphi Migraine Disease Specific Programme. Physicians completed record forms for consecutive patients, who then completed self-report forms assessing patient-reported outcomes (PROs) such as quality of life, migraine disability, and work productivity and activity impairment. T-tests, Fisher’s exact test, and Mann-Whitney U test were used for analysis. Results From May 2022 to June 2023, 557 physicians submitted data for 6723 patients. A total of 4036 patients (US 956; Europe 3080) with a history of preventive treatment were included (>60% female, >80% White, mean [standard deviation] age range, 38.7 [12.8] to 46.3 [12.1]). Patients who received 3+ lines of preventive therapy and were receiving CGRP mAbs (including galcanezumab alone) had enhanced health-related quality of life (HRQoL) compared to those who receivedstandard of care. Similar findings were observed across Europe; however, in the US, there was no significant difference in any PROs. Conclusion Patients with migraine in the overall population and Europe who received 3+ lines of preventive migraine therapy and were receiving CGRP mAbs/galcanezumab demonstrated enhanced HRQoL compared to those who received standard of care.

Hindi version of the lower extremity functional scale: a study of translation, validation and cross-cultural adaptation

BACKGROUND: Lower Extremity Function Scale (LEFS) serves as a patient-reported outcome measure, used to evaluate the functional status of lower extremity in different musculoskeletal conditions. It was originally developed in English language (E-LEFS) and numerous translations in different languages are available to measure its usability among different cultures. OBJECTIVES: To translate the English version of the Lower Extremity Function Scale (E-LEFS) into Hindi language and to evaluate its content validity, cross-cultural adaptation along with the concurrent validity and reliability. METHOD: Process of forward and backward translation was carried out by two bilingual translators and a physiotherapist after obtaining developer’s approval, for which the Beaton guidelines were used. For the content validation, Delphi method of was employed in which 12 field experts of more than 5 years of experience participated. Cultural adaptation procedures were then carried out with 12 patients, who reported in out-patient department of the hospital through convenience sampling who were asked about whether the H-LEFS was well understood by the patients. Their responses were recorded as positive and negative responses. This process was followed by concurrent validation which was conducted by comparing the scores with the SF-36 scale, involving 30 patients with activity limitation in their daily life. Lastly, 50 patients were recruited for intra-rater reliability testing. RESULT: The scale was successfully translated and verified by the bi-lingual language experts. Content validity came out to be significant with each item scoring more than 0.92. Nearly all items, excluding item no. 8, 16, 17, 18, and 19 received universal agreement with a content validity ratio of 1. The average scale-level validity stood at 0.98, indicating excellent level of validity and the scale was found to be well adapted by the native people as out of 12 patients, 10 patients provided 100% positive response. Concurrent validation using Pearson’s correlation coefficient came out excellent with the values of 0.993 for E-LEFS and 0.890 for SF-36. Cronbach's alpha and ICC values were calculated as 1.00 for Intra-rater reliability. CONCLUSION: LEFS was well translated into Hindi language with an excellent content and concurrent validity and is found to be highly reliable. Hence, it is recommended for the usage of native Hindi speaking population.

Arts and mental health: assessment of changes in self-reported wellbeing, psychotic-like experiences, mentalisation and self-efficacy for persons with schizophrenia spectrum disorders participating in the creative writing group intervention REWRITALIZE

Purpose Schizophrenia spectrum disorders (SSD) are associated with social difficulties that call for psychosocial interventions as supplement to standard treatment. The aim of the present study was to assess if there were changes in wellbeing, psychotic-like experiences, mentalisation and self-efficacy from pre- to post-intervention, in persons with SSD who took part in a creative writing group intervention in addition to their standard treatment. Materials and methods Participants (n = 73 with SSD) self-reported their level of wellbeing (Patient-reported outcome measures; PROMs), psychotic-like experiences (Inventory of psychotic-like anomalous self-experiences; IPASE), mentalisation (Reflective functioning questionnaire; RFQ and Toronto Alexithymia Scale; TAS), and self-efficacy (General self-efficacy scale; GSE) before and after REWRITALIZE, a creative writing group intervention led by a professional author in which participants were introduced to literary forms, wrote spontaneously on those forms, and engaged in literary conversation about their texts. Results There was a significant difference from pre- to post-intervention in psychotic-like experiences (IPASE), ability to understand one’s own reasons and feelings (TAS), and self-efficacy (GSE). Conclusion Although the study was uncontrolled, these results suggest that REWRITALIZE as supplement to standard treatment may be beneficial to persons with SSD.

Psychometric Evaluation of the Dutch version of the Substance Use Recovery Evaluator (SURE-NL)

Introduction Patient-Reported Outcome Measures (PROMs) are an important source of information that allow for a patient-centered assessment. Outcome measurement of substance use disorder (SUD) treatment traditionally focuses on drug use and deficits in functioning, overlooking other aspects of the personal and dynamic process of recovery. The Substance Use Recovery Evaluator (SURE) is a PROM developed with service user input to monitor the recovery journey and assess treatment outcomes in people with SUD. The objective of this study was to examine the validity and reliability of the Dutch translation of the SURE, the SURE-NL, for measuring indicators of recovery in Dutch-speaking patients with SUD. Methods The original SURE questionnaire was translated from English to Dutch using forward-backward translation. A total of N=171 participants were recruited as part of a naturalistic multicenter study in inpatient (N=149) and outpatient (N=22) SUD treatment centers. We examined the factorial structure, reliability, and concurrent and discriminant validity of the SURE-NL. Results The original 5-factor structure of the SURE showed acceptable fit for the SURE-NL, and internal consistencies of the subscales ranged from .61 to .76 and internal consistency of the total score was .83. Concurrent validity was confirmed through positive correlations of the SURE-NL total and subscale scores with the WHOQoL-BREF subscales, but correlations varied depending on subscale and treatment setting, with higher correlations for the outpatient compared to the inpatient subgroup. Discriminant validity was confirmed through low, mostly non-significant correlations between the SURE-NL and the DASS-21. Conclusions Although the SURE was originally designed for outpatient settings, our findings in a predominantly inpatient sample indicate that the SURE-NL is suitable for assessing personal recovery and recovery capital in Dutch-speaking Belgian patients with SUD. However, subscales should be used and interpreted with caution. Further research is needed with larger Dutch-speaking outpatient samples and the development of a tailored SURE for inpatient settings should be considered.

Alteration of the Gut–Lung Axis After Severe COVID-19 Infection and Modulation Through Probiotics: A Randomized, Controlled Pilot Study

Background: The gut–lung axis could be a potential therapeutic target for improving post-acute COVID-19 symptoms, and probiotics have been proposed as possible modulators. Aim: We conducted a pilot study to understand alterations in the gut–lung axis and to explore the effects of a probiotic in post-acute COVID-19 disease. Methods: We included patients after severe COVID-19 disease (sCOV, n = 21) in a randomized, placebo-controlled trial to test the effect of a probiotic (Pro-Vi 5, Institute Allergosan, Graz, Austria) in a six-month intervention and used patients after mild disease (mCOV, n = 10) as controls, to compare the intestinal microbiome, metabolome, and patient-reported outcomes and biomarkers along the gut–lung axis at baseline and throughout probiotic intervention. Results: Compared to mCOV patients, sCOV patients showed lower microbial richness, which was significantly improved by probiotic intervention. A reorganization of Ruminococcaceae and Lachnospiraceae taxa was observed in sCOV patients but remained unaffected by the intervention. Serum metabolome showed a dysregulation of lipoproteins in accordance with higher BMI and comorbidities in sCOV patients. HDL and LDL fractions/components were temporarily decreased in the probiotic group. Stool metabolome was altered at baseline in sCOV patients and an increase in L-DOPA after 3 months and butyrate after 6 months of intervention could be observed. Probiotics partially improved reduced quality of life and modulated altered immune responses in sCOV patients. Increased intestinal permeability at baseline remained unaffected. Conclusion: The study provides evidence of long-term alterations of the gut–lung axis after severe COVID-19 infection and suggests that probiotics can modulate the biomarkers of the gut–lung axis.

Evaluating the Efficacy and Safety of Botulinum Toxin in Treating Overactive Bladder in the Elderly: A Meta-Analysis with Trial Sequential Analysis of Randomized Controlled Trials

Overactive bladder (OAB) significantly impairs quality of life in the elderly. Although the intradetrusor injection of botulinum toxin type A (BoNT-A) is a treatment option, its effects on older adults remain uncertain. This study aimed to evaluate the efficacy and safety of BoNT-A intradetrusor injections in elderly OAB patients through a systematic review and meta-analysis. A comprehensive literature search was conducted using the PubMed, Embase, Cochrane Library, Scopus, and CINAHL databases from inception to 30 May 2024. The primary outcomes were improvements in daily urinary incontinence (UI) episodes and patient-reported outcomes, while the secondary outcomes focused on potential adverse events. Four randomized controlled trials with 803 participants were included. BoNT-A injections significantly reduced daily UI episodes at 4–6 weeks (mean difference [MD]: −3.82; 95% confidence interval [CI]: −6.29 to −1.35) and at 12 weeks (MD: −2.17; 95% CI: −3.22 to −1.12). However, BoNT-A was associated with an increased risk of elevated post-void residual (Risk Difference [RD]: 0.154; 95% CI: 0.058 to 0.251) and urinary tract infection (RD: 0.111; 95% CI: 0.005 to 0.217), with no significant difference observed in the initiation of catheterization or hematuria. Trial sequential analysis confirmed a sufficient sample size and statistical power. In conclusion, while BoNT-A effectively manages OAB in the elderly, careful post-injection monitoring is warranted due to its potential risks.