Patient-reported Outcomes Research Articles

Clinical relevance of current patient-reported outcome measures for ankle fracture: surgeons' perspective.

Determine the relevance of the most frequently used patient-reported outcome measures (PROMs) for monitoring patient recovery after ankle fracture, from the clinical perspective of orthopaedic trauma surgeons, given lack of validated PROMs. Prospective cohort. Orthopaedic Trauma Association committee meetings, electronic correspondence. Orthopaedic trauma surgeons. Delphi method for consensus activities. IV. Most clinically relevant PROMs for ankle fracture recovery. Several English-language PROMs were identified based on use in literature and relevance to ankle fractures. 7 were selected by expert consensus. These are the Ankle Fracture Outcome of Rehabilitation Measure (A-FORM), Foot and Ankle Ability Measure (FAAM), American Academy of Orthopaedic Surgeons (AAOS), Foot and Ankle Disability Index (FADI) Score, Lower Extremity Functional Scale (LEFS), Olerud-Molander Ankle Score (OMAS), and Patient-Reported Outcome Measurement Information System Physical Function (PROMIS PF). The most clinically relevant PROM is the A-FORM, followed by the AAOS, LEFS, PROMIS PF, FADI, and OMAS, and the least clinically relevant overall, the FAAM. Understanding which PROM best matches physician expectations for tracking recovery is an important step toward a robust, evidence-based approach to patient care. The A-FORM was identified as the most clinically relevant among the most used PROMs. These results will aid surgeons, clinicians, and scientists to identify a uniformly, clinically relevant PROM for the treatment and study of outcomes and recovery after isolated ankle fracture.

Handy Insights: Could Online Patient-Reported Outcome Measures be used to Assess Hand Injury Rehabilitation?

This protocol explores the use of online patient-reported outcome measures (PROMs) to assess recovery following hand trauma surgery. Hand injuries significantly impact patients’ functional abilities and quality of life, making PROMs crucial for tracking recovery and guiding rehabilitation. This study leverages online versions of the Michigan Hand Outcomes Questionnaire (MHQ) and Hand Injury Severity Score (HISS) to assess patient perceptions of their recovery over time.Our prospective cohort study involves 250 participants who will complete these PROMs at four intervals post-surgery. We aim to understand how demographic factors such as age, gender, and injury severity influence recovery perceptions and outcomes. This research seeks to enhance patient care by identifying factors that influence postoperative outcomes and by tailoring rehabilitation strategies accordingly.•Prospective cohort study following hand trauma surgery.•Online PROMs using the MHQ and HISS.•Data collection at four time points: baseline, 2-4 weeks, 6-8 weeks, and 10-14 weeks post-surgery.By making these tools accessible online, this protocol aims to improve patient engagement, increase response rates, and provide valuable insights to guide personalized rehabilitation strategies.

Prospective Outcomes After Serial Platelet-Rich Plasma (PRP) Injection in Vocal Fold Scar and Sulcus.

Vocal fold scar and sulcus pose significant treatment challenges with no current optimal treatment. Platelet-rich plasma (PRP), an autologous concentration of growth factors, holds promise for regenerating the superficial lamina propria. This study aims to evaluate the potential benefits of serial PRP injections on mucosal wave restoration and vocal function. In a prospective clinical trial across two institutions, patients with vocal fold scar underwent four serial PRP injections, one month apart. Blinded independent laryngologists and expert listeners used pretreatment and one-month post-fourth injection videostroboscopy and CAPE-V assessments to evaluate mucosal wave and voice quality changes, respectively. Additionally, patient reported outcome measures (PROMs) were evaluated. In the study, 15 patients received 55 PRP injections without adverse effects. Eight patients (53.3%) had mild, three patients (20%) had moderate, and four patients (26.7%) had severe scar. There was an average reduction of 8.7 points in post-treatment VHI-10 scores (p = 0.007). The raters observed an improvement in post-treatment voice in 73.4% of cases, and CAPE-V scores showed a reduction of 18.8 points on average (p = 0.036). The videostroboscopic VALI ratings showed an improvement in mucosal wave rating from 2.0 to 4.0. On average, the raters perceived the post-PRP exams to be better in 56.7% of cases. PRP has been validated as a safe autologous option for treatment of vocal fold scar. While results for mucosal wave and voice quality varied, there was a consistent improvement in PROMs. 3: Prospective cohort study, with blinded analysis Laryngoscope, 134:5021-5027, 2024.

Hybrid Cochlear Implant Outcomes and Improving Outcomes With Electric-Acoustic Stimulation.

Electric-acoustic stimulation (EAS) provides cochlear implant (CI) recipients with preserved low-frequency acoustic hearing in the implanted ear affording auditory cues not reliably transmitted by the CI including fundamental frequency, temporal fine structure, and interaural time differences (ITDs). A prospective US multicenter clinical trial was conducted examining the safety and effectiveness of a hybrid CI for delivering EAS. Fifty-two adults (mean age 59.9 yr) were enrolled in the study and followed up to 5 years postactivation. Testing included unaided and aided audiometric thresholds, speech perception (Consonant-Nucleus-Consonant [CNC] words in quiet and AzBio sentences +5 dB SNR), and patient-reported outcomes (Speech, Spatial, and Qualities of Hearing Scale). Functionally aidable hearing, defined as low-frequency pure-tone average (125-500 Hz) <80 dB HL, was maintained for 77% of patients through 1 year, with 66.7% maintaining through 5 years. Speech perception was significantly improved at all postoperative timepoints compared with preoperative performance with hearing aid(s), and patient-reported outcomes indicated significantly improved subjective speech understanding, spatial hearing, and sound quality. Participants with preserved acoustic hearing using EAS reported significantly higher subjective spatial hearing and sound quality than participants with electric-only hearing in the implanted ear. Patients with high-frequency hearing loss demonstrate significant long-term benefit with a hybrid CI including high rates of functional hearing preservation, significantly improved speech perception, and subjective patient-reported outcomes. EAS with binaural acoustic hearing affords benefit for subjective spatial hearing and sound quality beyond CI listening configurations using monaural acoustic hearing.

Veterans' Experiences of and Preferences for Patient-Centered, Measurement-Based PTSD Care.

Up to 50% of veterans drop out of trauma-focused evidence-based psychotherapies (TF-EBP) without completing treatment or recovering; evidence suggests this is in part because their posttraumatic stress disorder (PTSD) care is insufficiently patient-centered. There is also evidence that measurement-based care (MBC) for mental health should be personalized to the patient, yet this is not common practice in VA PTSD care. To explore veterans' experiences and preferences for aligning measurement-based PTSD care with their own treatment goals. Qualitative interviews were conducted with veterans (n=15) with PTSD who had received at least 2 sessions of a TF-EBP. Survey on the administration of outcomes questionnaires and demographics and an interview about their most recent TF-EBP episode. Half of veterans had symptom-focused goals and half did not; all had at least one treatment goal that was not symptom-focused. They typically met their goals about functioning and coping skills but not their symptom reduction goals. We found veterans overall were receptive to MBC but preferred patient-reported outcomes measures about functioning, wellbeing, coping skills, and understanding their trauma more than the commonly used PTSD symptom scale (the PCL-5). Many veterans in this sample disliked the PCL-5 because it reinforced their maladaptive cognitions. Such veterans might be more receptive to MBC if offered patient-report outcomes measures that better align with their functional and wellbeing goals. For many goal/outcome areas, psychometrically sound measures exist and require better implementation in PTSD care. For some areas, scale development is needed.

Development of the First Patient-Reported Experience Measure (PREM) for Hearing Loss in Audiology Care-My Hearing PREM.

Patient-reported experience measures (PREMs) provide important insights into the challenges experienced when living with a chronic condition. Although patient-reported outcome measures (PROMs) exist in audiology, there are no validated PREMs to help clinicians understand patient perspectives and identify areas where patients may need additional support or interventions. The aim of this study was to develop and evaluate content for the new 'My Hearing PREM', which captures lived experiences of hearing loss from patients' perspectives. My Hearing PREM was developed and tested in two key phases. Phase 1 involved generating the PREM prototype in accordance with our conceptual model of the lived experience of hearing loss. In Phase 2, cognitive interviews were conducted with adults with hearing loss to appraise the content of the PREM (relevance, clarity, acceptability and comprehensiveness) and assess its respondent burden. Key stakeholders (e.g., adults with hearing loss, patient and public representatives, clinicians and researchers) were consulted throughout Phases 1 and 2 to review and refine the PREM. Interview data were analysed using thematic analysis. Sixteen participants (aged 16 years and over) with hearing loss took part in cognitive interviews, recruited from UK audiology departments and non-clinical settings (e.g., lip-reading classes, national charity links and social media). Most PREM items were found to be relevant, clear, acceptable and comprehensive. Several problems were identified, including items not working well with the response scale options, irrelevant questions and a lack of clarity about terms (e.g., healthcare professionals) and whether questions should be answered based on the use of hearing aids (or not). The PREM was amended accordingly. Currently, no hearing loss-specific PREMs exist in audiology. Involving multiple stakeholders in the development of the PREM helped to ensure that the items were relevant, clear, acceptable and comprehensive. The PREM is undergoing further evaluation and refinement in preparation for investigating the feasibility of implementing it into clinical practice. Ongoing Patient and Public Involvement and Engagement (PPIE) with key groups (South Asian Women's groups, young people's groups, learning disability networks and student populations) was integral to the study. PPIE members reviewed patient information sheets and consent forms, advised on recruitment, reviewed the interview schedule and checked coding and analysis procedures. PPIE members provided feedback on the PREM's comprehensibility. Members of the public, including adults attending lip-reading classes and hearing aid users from the South Asian community, provided feedback on iterative PREM drafts.

A qualitative study on the experiences of autologous haematopoietic stem cell transplant for Multiple Sclerosis

AimAutologous haematopoietic stem cell transplant (HSCT) is an effective treatment for people with highly-active relapsing multiple sclerosis (MS), who are not adequately responding to disease-modifying therapies. To date, research has predominantly focused on disease-specific outcome measures. There is a lack of research exploring patient experiences of this complex treatment. The study aims to explore the experience of considering and receiving HSCT treatment for MS. MethodsSemi-structured interviews were conducted online with 12 adults with MS who had undergone HSCT treatment. Interview topics covered the experience of deciding on the treatment, the HSCT process itself, and the patient-reported outcomes following HSCT. Interviews were audio-recorded and transcribed verbatim. A thematic analysis approach was employed. ResultsThree main themes were identified: (1) Balancing hope and fear explores the decision-making experience when considering HSCT as a treatment; (2) Distinct emotional experience, highlights the unique challenges faced on all stages of the treatment journey; and (3) Adjusting to outcomes, explores how participants make sense of the aftermath of the treatment, including managing the ongoing uncertainty of MS and complications arising from HSCT. DiscussionHSCT is a complex treatment, both physically and psychologically for pwMS. A comprehensive and holistic care pathway is required to support people with MS at all stages of the treatment process, to ensure patient-centred planning and care.

Patient-Reported Outcomes Following Thoracic Aortic Surgery – Does Sex Matter?

Patient-Reported Outcomes Following Thoracic Aortic Surgery – Does Sex Matter?

A contemporary analysis of the Australian clinical and genetic landscape of spinal muscular atrophy: a registry based study

New paradigms of diagnosis and treatment have changed the neurodegenerative trajectory for individuals with spinal muscular atrophy (SMA). Registries are a critical tool to provide real-world data on treatment patterns, their effects and health care provision within this evolving paradigm of care. This study aimed to evaluate the phenotypic and genotypic landscape, treatment patterns and health impact of SMA in Australia through the national registry. This cross-sectional study investigated demographic, clinical and genetic information, sequelae of weakness, treatment patterns and patient-reported outcomes amongst individuals with SMA enrolled in the Australian Neuromuscular Disease Registry (ANMDR) from 1st January 2020 to 30th April 2023. Descriptive statistics were used for analysis and Chi-Squared or Fisher's exact tests for associations. 195 individuals with SMA enrolled into the ANMDR. 5/195 (2.6%) were deceased by censor date. Of (n=190) individuals living with SMA, 104/190 (54.7%) were children. Minimum Australian prevalence was 0.73/100,000. SMN2 copies were inversely associated with phenotype in those with homozygous SMN1 deletions (p<0.0001)). Treatment was utilised in 154/190 (81%) of the population, with 65/137 (47.6%) of individuals perceiving improvements with therapeutic intervention on Patient/Parent Global Impression of Improvement scale (p<0.0001). Engagement with multidisciplinary care practitioners was significantly higher among children with SMA than adults (93% versus 12%, p<0.0001). Despite diagnostic and therapeutic advances, mortality and the multi-systemic health impact of SMA continue to be experienced within the Australian population. Healthcare provision must align with patient-centred outcomes, adapting to meeting their changing but ongoing care requirements. The study identified the considerable unmet need for multidisciplinary care, not only for adults with SMA but also for the emerging cohort of treated children, emphasising the imperative for comprehensive healthcare provision to address their evolving needs. No funding was received for this study.

Telehealth visit type and patient-reported outcomes among patients with cancer

BackgroundRelaxed licensing restrictions on telehealth use during the COVID-19 pandemic allowed broad use irrespective of visit type. As these telehealth waivers expire, optimal uses of telehealth must be assessed to inform policy and clinical care. We evaluated patient experience associated with telehealth and in-person new or established visits. MethodsPatients seen in-person and via telehealth for urologic cancer care from August 2019 to June 2022 received a survey on satisfaction with care, perceptions of communication during their visit, travel time, travel costs, and days of work missed. We assessed survey responses with descriptive statistics. ResultsSurveys were completed for 1,031 patient visits (N = 494 new visits, N = 537 established visits). Satisfaction rates were high for all visit modalities among new and established patients (mean score range 59.9–60.7 [maximum 63], P > 0.05). Patient-rated quality of the encounter did not differ by visit type and modality (P > 0.05, for nearly all comparisons). New in-person patient visits were associated with significantly higher travel costs (mean $496.10, SD $1021) compared with new telehealth visits (mean $26.60, SD $141; P < 0.001); 27% of new in-person patients required plane travel and 41% required a hotel stay (P < 0.001 vs. 0.8% and 3.2% of new telehealth patients, respectively). ConclusionsSatisfaction outcomes among patients with urologic cancer receiving new patient telehealth care equaled those of new patients cared for in-person while costs were significantly lower. Offering telehealth exemption beyond COVID-19 licensing waivers to include new patient visits would allow for ongoing delivery of high-quality urologic cancer care irrespective of geographic location.

Development, Validation, and Clinical Utility of Electronic Patient-Reported Outcome Measure-Enhanced Prediction Models for Overall Survival in Patients With Advanced Non-Small Cell Lung Cancer Receiving Immunotherapy.

Electronic patient-reported outcome measures (ePROMs) are increasingly collected routinely in clinical practice and may be prognostic for survival in adults with advanced non-small cell lung cancer (NSCLC) in addition to clinical data. This study developed ePROM-enhanced models for predicting 1-year overall survival in patients with advanced NSCLC at the start of immunotherapy. This is a single-center study using consecutive patients from a tertiary cancer hospital in England. Using Cox proportional hazards models, we developed one clinical factor-only model and three ePROM-enhanced models, each including one of the following factors: quality of life (as measured by EuroQoL five-dimension five-level utility score) and overall symptom burden and number of moderate-to-severe symptoms (as measured by patient-reported version of Common Terminology Criteria for Adverse Events). Predictive performance was evaluated and compared through bootstrapping internal validation, and clinical utility was determined via decision curve analysis. The clinical factor-only model contained age, histology, performance status, and neutrophile-to-lymphocyte ratio. While calibration was similar between the clinical factor-only and ePROM-enhanced models, the latter showed improved discrimination by 0.020 (95% CI, 0.011 to 0.024), 0.024 (95% CI, 0.016 to 0.031), and 0.024 (95% CI, 0.014 to 0.029) when enhanced with ePROMs on quality of life, overall symptom burden, and number of moderate-to-severe symptoms, respectively. If care decisions are to be made at risk thresholds between 25% and 75%, the ePROM-enhanced models led to higher net benefit than the clinical factor-only model and the default strategies of intervention for all and intervention for none. The ePROM-enhanced models outperformed the clinical factor-only model in predicting 1-year overall survival for patients with advanced NSCLC receiving immunotherapy and showed potential clinical utility for informing decisions in this population. Future studies should focus on validating the models in external data sets.

085 Abrocitinib improves patient-reported outcomes in patients with moderate to severe atopic dermatitis. Data from RE-DERMA registry

085 Abrocitinib improves patient-reported outcomes in patients with moderate to severe atopic dermatitis. Data from RE-DERMA registry

Developing STEP-SE: A Qualitative Usability Study of a Novel Patient-Reported Outcomes Tool for Managing Side Effects in Shared Decision-Making for Schizophrenia Spectrum Disorder Care.

Schizophrenia treatment with antipsychotics often results in side effects that impact adherence and quality of life. Managing these effects remains challenging, as it requires balancing efficacy and tolerability. The Schizophrenia Technological Evaluation of Patient Side Effects (STEP-SE) app aims to aid side effects monitoring and management through shared decision-making (SDM). This study aimed to evaluate the usability of the STEP-SE app for patients and clinicians in managing antipsychotic side effects. Sixteen stable outpatients and 14 psychiatrists participated in semi-structured interviews after using the STEP-SE app. Questions explored ease of use, information clarity, user needs fulfilment, patient-clinician collaboration, treatment adherence improvement, patient empowerment and clinical utility. Data were analysed thematically. Overall satisfaction with STEP-SE was high. Both groups found that the tool improved patient involvement, provided reliable information to enhance therapeutic alliance, posed low risks of misunderstanding and had an intuitive interface. Patients felt more motivated and empowered. Clinicians appreciated guideline consistency. Preferences differed regarding data visualization formats. STEP-SE shows potential for aiding SDM on antipsychotic side effects. Patients gained motivation, and clinicians felt reassured. Refinements around mobile access, graphics and features could augment utility. Generalizability is limited given the stable patient sample. Preliminary findings suggest that STEP-SE effectively engages patients, empowers them and supports clinicians in collaborative side effect management. Further testing with diverse user groups is warranted. The current study was designed to gather patient and public feedback for the development of our decision aid tool, STEP-SE. Participants interacted with the tool's prototype in interactive sessions, providing insights and identifying technical issues. Their feedback was crucial for enhancing the tool, with each suggestion and bug report carefully considered for future iterations. The participants' contributions were key in optimizing STEP-SE's features and ensuring its relevance and reliability. We thank all who shared their time and perspectives, significantly shaping the tool's user-centred design.

Joint Models Inform the Longitudinal Assessment of Patient-Reported Outcomes in Clinical Trials: A Simulation Study and Secondary Analysis of the Restrictive versus Liberal Fluid Therapy for Major Abdominal Surgery (RELIEF) Randomized Controlled Trial

Evaluate the utility of a joint model when analysing a patient-reported endpoint as part of a randomized controlled trial in which censoring occurs when patients die during follow-up. The present study comprises two parts: first we re-analyzed data from a previously published randomized controlled trial comparing two fluid regimens in the first 24 hours of major abdomino-pelvic surgery ('RELIEF' trial). In this trial, patient-reported disability was measured at multiple timepoints before and after surgery. Next, we conducted a simulation study to jointly emulate patient-reported disability and survival, similar to the RELIEF trial, under nine treatment-outcome scenarios. In both parts, we compared a joint model analysis to a linear mixed effect model combined with one of several traditional methods of handling longitudinal missingness: available data analysis, complete case analysis, last observation carried forward, and worst-case assumption. In part one, the joint model revealed no between-group differences in patient-reported disability at one, three, six, and 12 months after surgery. The worst-case approach consistently resulted in the largest deviation from the joint model estimates, although in this particular setting none of the approaches materially changed the study's conclusions. In part two, the simulations revealed that across all treatment-outcome scenarios, the joint model expectedly produced unbiased estimates of patient-reported disability. Similarly, employing an approach based on all available data (i.e., relying on the maximum likelihood estimator for handling missingness) yielded disability estimates close to the simulated values, albeit with slight bias across some scenarios. The last observation carried forward approach mirrored the joint model's estimates except when the treatment had a non-null effect on patient-reported disability. The worst case analysis resulted in high bias, which was particularly evident when the treatment had a large effect on survival. The complete case analysis resulted in high bias across all scenarios. In randomized trials that employ a patient-reported outcome as one of their endpoints, a joint model can address bias arising from informative missingness related to death. Methods for handling missingness based on all available data appear to be a reasonable alternative to joint models, with only slight bias across some simulated scenarios.

Association Between Serum Vitamin D Level and Uncontrolled Chronic Rhinosinusitis With Nasal Polyposis.

Objective: Chronic rhinosinusitis with nasal polyposis (CRSwNP) is characterized by type 2 inflammation, and studies have shown that conventional therapy usually yields unsatisfactory results. While recent studies have indicated the potential effect of vitamin D on allergic and inflammatory diseases, including CRSwNP. Therefore, this study aimed to investigate the relationship between serum vitamin D levels and the severity of CRSwNP using endoscopic evaluations, imaging, patient-reported outcome measures, absolute eosinophilic count, and serum vitamin D levels and determine the prevalence of vitamin D deficiency in patients with CRSwNP. Methods: Serum vitamin D levels were measured in 104 patients with uncontrolled CRSwNP, who failed maximum medical management and were scheduled for functional endoscopic sinus surgery. Vitamin D levels were compared between patients using the Lund- Mackay (LM) score, Sinonasal Outcome Test-22 (SNOT-22), total nasal polyp scores, and absolute eosinophil counts. Results: The 104 included patients had an average age of 42.09 ± 13.3 years, and 63.5% of them were male. Mean value of vitamin D was 57.9 ± 31.2 nmol/L. The average SNOT-22 score was 65.49 ± 21.3. The mean LM score was 14.48 ± 6.64. The total nasal polyp score was 4.3 ± 2.08. Vitamin D levels were negatively correlated with LM score (r = -.210, P = .032) and polyp grade (r = -.264, P = .007), but did not correlate with other variables. Conclusions: Our study indicates that vitamin D deficiency or insufficiency is common in patients with CRSwNP. We found that low serum vitamin D levels were negatively correlated with the Lund-Mackay score and the total nasal polyp score, providing additional support for an association between low vitamin D levels and a greater severity of CRSwNP.

Clinical comparison of laparoscopic and open surgical approaches for uterus-preserving myomectomy: a retrospective analysis on patient-reported outcome, postoperative morbidity and pregnancy outcomes.

Uterine fibroids pose clinical challenges due to varied symptoms and impact on fertility. Aim of this research is to compare open and laparoscopic myomectomy, with focus on evaluating their effects on patients' quality of life and analyzing their implications for pregnancy outcomes. This retrospective study compares open and laparoscopic myomectomy outcomes in 168 patients treated October 2017 and July 2023. Preoperative characteristics and postoperative outcomes in terms of symptoms and pregnancy outcomes were examined. The patient cohort comprised patients with a high symptom burden. Only 51.2% expressing a desire for future pregnancies, highlighting diverse motivations for uterus-preservation. No significant differences were observed in preoperative symptoms. Larger and multiple myomas were associated with a higher likelihood of laparotomy. Recurrence rates were lower after laparoscopy (10.2% vs. 23.8%, p = 0.02). Cesarean section recommendations were more frequent post-laparotomy group (36.6% vs. 86.6%, p = 0.000). Morbidities and satisfaction showed no significant differences between approaches, with slightly better bleeding improvement after laparotomy. Despite similar pregnancy outcomes, a high proportion of patients did not conceive postoperatively (75.4%). Among patients who became pregnant postoperatively (n = 31), most patients conceived after one year or more, with no dependence on the surgical approach (p = 0.227). Both open and laparoscopic myomectomy surgeries showed high patient satisfaction, symptom alleviation, and comparable pregnancy results. A preference emerged for laparoscopy in terms of cesarean section recommendations and recurrence risk. Laparoscopic procedures tended to offer higher operative satisfaction and fewer complications. The study emphasized the complexity of therapeutic decision-making.

Ivarmacitinib, a selective Janus kinase 1 inhibitor, in patients with moderate-to-severe active rheumatoid arthritis and inadequate response to conventional synthetic DMARDs: results from a phase III randomised clinical trial

ObjectiveTo assess the efficacy/safety of ivarmacitinib, a selective Janus kinase (JAK) 1 inhibitor, in patients with moderate-to-severe active rheumatoid arthritis (RA) who had an inadequate response to conventional synthetic disease-modifying...

Sex differences in patient-reported outcomes and perception of ascites burden amongst outpatients with decompensated cirrhosis and ascites.: Sex Differences in Ascites Burden Perception.

Perception of the ascites burden and its effects on quality of life may be different between sexes. This study assessed sex differences in perception of ascites burden and its impact on health related QoL (HRQoL) in patients with recurrent or refractory ascites. The North American Consortium for the Study of End-stage Liver Disease prospectively enrolled outpatients with cirrhosis and large ascites requiring repeat large volume paracenteses. Demographics, laboratory results, co-morbidities, medications, frailty measurements, self-reported questionnaires related to functional status, physical activities, and HRQoL (generic = SF36 & ascites specific = ascites Q) were compared between sexes. 392 men (59.6±10.7yrs) and 184 women (59.5±11.1yrs) with predominantly alcohol related liver disease 51% and 43% respectively), median MELD-Na: 13, were enrolled. Both groups had similar co-morbidities and cirrhosis complications, ascites duration and severity, and frailty scores (p=0.94). Women had more symptoms related to their ascites (Ascites Q score =66±21 vs. 60±21 in men, p=0.001) (higher value = feeling worse). 35% of women felt depressed versus 22% of men (p=0.0009), with lower mental but not physical functioning components of SF36 (p=0.019). Women continued to conduct their daily activities as adequately as men as indicated by Duke Status Activity index (p=0.27) and Godin Leisure Activity Index (p=0.47). Women with cirrhosis and ascites experienced worse emotional HRQoL than men without difference in daily function. Our analyses underscore the differences in the lived experience of women versus men with cirrhosis and highlight the need for patient-reported metrics to provide patient-centered care.

A Prospective Study on Gait Impairment in Patients With Symptomatic Lumbar Canal Stenosis and Impact of Surgical Intervention on Gait Function.

Prospective observational cohort study. To analyze the effect of decompression surgery on gait characteristics in patients with stenosis. Also, to test the hypothesis that patient-reported functional outcomes and gait parameters (spatiotemporal, kinetic, and kinematic measures) will improve postoperatively and achieve normal values when compared with matched healthy controls. Lumbar spinal stenosis is one of the leading causes of disability among elderly population. Gait impairment is one of the primary symptoms of degenerative conditions involving lumbar spine. Research suggests that decompressive surgery can positively influence gait parameters in patients with spinal stenosis. Studies have shown improvements in walking speed, stride length, and balance post-surgery. Thirty-two patients with single-level lumbar stenosis and 32 healthy volunteers were prospectively recruited. All patients underwent gait analysis preoperatively and 6 months postoperatively as per standard protocol. Spatiotemporal, kinematic, and kinetic parameters were analyzed. Stepwise linear regression models were used to detect significant relationships between changes in functional score (Visual Analogue Scale/Oswestry Disability Index) and gait parameters. Significant improvement was noted in functional scores(P<0.05) 6 months post-surgery. Spatiotemporal (swing phase, mean velocity, cadence, stride length, step length, and step width) and kinetic parameters (hip, knee, and ankle power) were significantly better after surgery, reaching normal levels. Kinematic parameters significantly improved after surgery but did not reach normal levels when compared with controls. A significant correlation was found between changes in functional scores with changes in certain kinematic parameters (knee-power, ankle plantarflexion, swing time, peak ankle dorsiflexion in swing, peak-hip, and knee flexor moment). Decompression surgery in lumbar stenosis produces improvement in gait parameters, pain scores, and functional outcomes that significantly improve gait posture and speed.

Development of a minimum data set for long COVID: a Delphi study protocol

IntroductionPrevious consensus-based long COVID research has focused on establishing research priorities, developing clinical definitions, core outcomes and a list of recommendations of patient-reported outcome measures that can be used to...