Short Form-36 Physical Function Research Articles

Single-Center Pilot Study of Remote Therapeutic Monitoring in Patients with Operative Spinal Pathologies

ObjectivesSpine pathology affects a significant portion of the population, leading to neck and back pain, impacting quality of life, and potentially requiring surgical intervention. Current pre- and postoperative monitoring methods rely on patient reported outcome (PRO) measures and lack continuous objective data on patients' recoveries. Remote therapeutic monitoring (RTM) using wearable devices offers a promising solution to bridge this gap, providing real-time physical function data. This study aims to assess the feasibility and correlation between changes in physical function and daily activity levels using RTM for individuals with operative spinal pathologies. MethodsA single-center pilot study involving 21 participants with operative spinal pathologies was conducted at an academic hospital. Participants were provided Bluetooth-enabled Fitbit Inspire 2 activity trackers and asked to wear them daily for 100 days. The Healthcare Recovery Solutions (HRS) mobile application facilitated remote administration of the PROMIS - Physical Function Short Form 6b PROs questionnaire at days 1, 30, and 90. Linear regression, Students' paired T tests, and one-way ANOVA were used to analyze collected data. ResultsAverage compliance with RTM was found to be 82.4% compared to only 48% for PROMs. Changes in daily steps were moderately positively correlated with changes in PROs at both 30 and 90 days. Participant satisfaction with RTM was high, and responses indicated greater satisfaction with RTM compared to PROMs. ConclusionsRTM offers continuous and objective data collection, presenting a potential solution to the limitations of intermittent clinical assessments and self-reported outcomes. The study demonstrated a moderate correlation between changes in activity levels and changes in PROs, suggesting that RTM data could serve as a surrogate for PROs. Participants' high compliance and satisfaction with RTM underscore its feasibility and potential clinical utility. This study lays the groundwork for larger future investigations into the clinical benefits and broader application of RTM in spine care.

Mental Health Scores but not Sleep Quality are Lower in Veterans with Gulf War Illness that have Low Physical Function

PURPOSE: Gulf War Illness (GWI) is a poorly understood illness that impacts about a third of Veterans who were deployed to the Gulf Region during the 1990-1991 Gulf War (GW). GW Veterans have twice the odds of having depression compared to non-deployed Veterans. Depression and sleep quality are associated with impaired physical function, which is notable since physical activity is a modifiable health behavior that can be an effective method to reduce mild to moderate depressive symptoms and improve sleep. We hypothesize that Veterans categorized with GWI and with high physical function scores will have fewer depressive symptoms and better sleep quality compared to those with low physical function. Evaluating the connection between physical and mental health in Veterans with GWI could support behavioral health interventions intended to improve symptom management. Methods: GW Veterans were enrolled in an ongoing VA multi-site remote clinical research study and completed web-based questionnaires: the Modified Kansas questionnaire, short-form 36 (SF-36), Patient Reported Outcomes Measurement Information System (PROMIS)-Emotional Distress Anxiety and Depression, and the Pittsburgh Sleep Quality Index (PSQI). The modified Kansas was used to designate GWI based on 6 self-reported symptom domains. Symptom onset was also required within 5 years of deployment. The SF-36 assessed eight functional domains, including physical functioning measuring mobility disability. GW Ill Veterans were grouped based on the SF-36 physical function score such that those with ≤70 were considered in the poor physical function group (low) and >70 were in the high physical function group (high). The PROMIS Anxiety assessed anxiety and PROMIS Depression assessed negative mood and decreased positive affect. The PSQI global score assessed sleep quality over a one-month period and ranges from 0-21 where a greater score reflects poorer sleep quality. Data were analyzed using student t-tests and linear regressions using Graphpad Prism 9. RESULTS: 63 Veterans (low group: 12 females/35 males, 60±4 years old; high group: 3 females/13 males, 59±5 years old) completed the web-based questionnaires. Anxiety and depression scores were greater in the low vs high group (Anxiety= low: 70.0±29; high: 45.4±14.0, P=0.001; Depression= low: 64.2.0±34.5; high: 41.3±14.7, P=0.01). Sleep quality (low: 12.8±4.0; high: 11.9±4.7, P=0.44) was not different between the groups. Anxiety scores (R2=0.19, P=0.0004) and depression scores (R2=0.11, P=0.007) were related to physical function, thus greater physical function was associated with lower (better) mental health scores. Sleep quality (R2=0.07, P=0.03) was related to physical function, so greater physical function was associated with better sleep quality. CONCLUSIONS: Gulf War Illness is a chronic multi-symptom condition that can be debilitating. Insight about physical function, depression and sleep symptoms could guide therapeutic approaches. The SF-36 is recommended as a core data element in GWI research and as such can provide information on the physical aspects of health. These findings suggest that depression and anxiety differ in those with low versus high physical function and that physical function is related to mental health and sleep quality. Future research should examine how GW Veterans are able to maintain their physical function to improve overall health. VA CSR&D. This is the full abstract presented at the American Physiology Summit 2024 meeting and is only available in HTML format. There are no additional versions or additional content available for this abstract. Physiology was not involved in the peer review process.

Comparison of Allergic Diseases in terms of Anxiety, Depression and Quality of Life

Studies have shown the frequency of anxiety and depression and decreased quality of life (QoL) in patients with allergic diseases. The aim of this study was to evaluate anxiety and depression symptoms and QoL in patients with asthma, allergic rhinitis (AR), urticaria/angioedema (U/A) and drug allergy without any psychiatric diagnosis and to compare these four diseases in these respects. In this cross-sectional study demographic and clinical characteristics were collected from patients’records. Hospital Anxiety and Depression Scale (HADS) and Short Form 36 (SF-36) were used to assess anxiety and depression symptoms and QoL. A total of 159 patients were included in the study and grouped as asthma (n=43, 27.1%), AR (n=45, 28.3%), U/A (n=44, 27.7%) and drug allergy (n=27, 17%). There was a significant difference in HADS anxiety score and SF-36 physical functioning subscore (p<0.001 and p=0.001, respectively). HADS anxiety score was higher in the U/A group and SF-36 physical functioning was lower in asthma group. Among asthmatics, SF-36 subscores of physical role functioning, emotional role functioning, social role functioning were lower in the patients at step 4 and 5 (n=22, 51.2%) than in those at step 2 and 3 (n=21, 48.8%) (p=0.001, p=0.031 and p=0.005, recpectively). In the U/A group, there was a positive moderate correlation between the urticaria activity score 7 and the HADS anxiety score (r:0.579, p<0.001). Our study showed that U/A patients had more anxiety symptoms comparing to other allergic diseases. Disease activity and severity had a significant relationship with anxiety level in U/A patients and with QoL in asthmatics.

Sijunzi decoction, a classical Chinese herbal formula, improves fatigue symptoms with changes in gut microbiota in chronic fatigue syndrome: A randomized, double-blind, placebo-controlled, multi-center clinical trial

BackgroudChronic fatigue syndrome (CFS) severely impact patients’ quality of life and lacks well-acknowledged drug therapy. Sijunzi decoction (SJZD), a classical Chinese herbal formula, has been widely used for spleen deficiency syndrome like fatigue in China. However, there is a lack of evidence on the efficacy of SJZD in treating CFS. PurposeTo evaluate the efficacy and safety of SJZD for CFS. Study designA multi-center, double-blinded, randomized controlled trial. MethodsParticipants with definite diagnoses of CFS and spleen deficiency syndrome were randomly assigned in 1:1 ratio to receive SJZD or placebo granules for 2 months. The primary outcome was the change of Chalder fatigue questionnaire (CFQ) scoring after treatment. Other outcomes included changes in short form-36 physical function (SF36-PF) score, spleen deficiency scale score, Euroqol Questionnaire-Visual Analogue Scale (ED-VAS) score, and clinical global impression (CGI) evaluating by corresponding questionnaires. Fecal metagenome sequencing was conducted to explore the potential mechanism of SJZD effect. ResultsFrom June 2020 to July 2021, 105 of 127 participants completed the study at four hospitals in China. After a 2-month treatment, intention-to-treat (ITT) analysis found participants who received SJZD had larger reduction than placebo control (mean change 6.65 [standard deviation (SD) 6.11] points vs. 5.31 [SD 5.19] points; difference 1.34, 95 % confidence interval [CI] -0.65 to 3.33). Per-protocol (PP) analysis reported confirmative results with a significant difference between SJZD and placebo groups (2.24, 95 % CI 0.10 to 4.39). SJZD also significantly improved overall health status compared with placebo in per-protocol population (p = 0.009). No significant difference was found between groups in changes of SF36-PF, spleen deficiency scale scoring, and CGI. Fecal metagenome sequencing and correlation analyses indicated that the beneficial effect of SJZD may be related to the abundance change of Pediococcus acidilactici. No serious adverse event or abnormal laboratory test was found during the whole study. ConclusionOur results indicated that SJZD can improve fatigue symptom and overall health status in patients with CFS under good medication adherence. Potential therapeutic effects may be related to the regulation of gut microbiota. Large-scale trials with longer intervention period are encouraged to further support SJZD's application. Clinical trial registration(ID, ISRCTN23930966, URL = https://www.isrctn.com/ISRCTN23930966).

Measuring important activities for patients with knee osteoarthritis: a cross-sectional study

Background/Aims Some patient-reported outcome measures ask questions about fixed (ie standardised) activities. Other patient-reported outcome measures ask questions about activities that patients choose or generate. However, patients' appraisals of the importance of fixed and generated activities have not been directly compared and little is known about the construct of activity importance. The aim of this study was to compare patients' importance ratings for fixed and generated activities. It also examined relationships among patients' ratings of activity importance, pain and physical function. Methods Within a prospective cross-sectional design, 60 participants with knee osteoarthritis completed the Brief Pain Inventory, Western Ontario and McMaster Universities Osteoarthritis Index, as well as the McMaster Toronto Arthritis Patient Preference Questionnaire and a Patient-Reported Outcomes Measurement Information System physical function short form, which were modified to measure the importance of generated or fixed activities respectively. Results Participants rated generated activities as more important than fixed activities (P<0.01). They also gave higher importance ratings for fixed activities that they performed than fixed activities that they did not perform (P<0.01). The importance of the generated activities correlated with the Brief Pain Inventory (P<0.05) and Western Ontario and McMaster Universities Osteoarthritis Index (P<0.01), but the fixed activities' importance did not. Participants preferred to rate generated activities more than fixed activities (63.8%) and believed that their ratings of generated activities would better inform physicians than fixed activities (55.0%). Conclusions The results from this study identified benefits of including generated activities within patient-reported outcome measures and clarified the construct of activity importance for patients with musculoskeletal pain. Implications for practice Allied health professionals may maximise activity importance for their patients by focusing on patient-generated activities. However, the best instructions for collecting patient-generated activities are unknown.

Differences in Baseline Physical Function and Mental Health PROM Scores in Patients with Foot and Ankle Conditions

Introduction/Purpose: This study sought to establish normative values for baseline physical and mental health by foot and ankle diagnosis using validated Patient-Reported Outcomes Measurement Information System (PROMIS) scores and to compare the correlation between these two outcomes across common foot and ankle diagnoses. Additionally, it investigated the effect of specific foot and ankle diagnoses on self-reported mental health at first presentation. Methods: We retrospectively reviewed baseline PROMIS Physical Function Short Form 10a (PF10a) and PROMIS Global-Mental (PGM) scores of 14,374 patients who had one of the 10 most common foot and ankle diagnoses seen at our institution between 2016 and 2021. Pearson correlation coefficients were calculated to assess the relationship between PF10a and PGM by diagnosis. A multivariable regression model was also used to determine the effect of each diagnosis on PGM score. Results: On unadjusted analysis, patients diagnosed with an ankle fracture had the lowest mean physical function, while patients with hallux valgus had the highest (PF10a=33.9 vs 46.7). Patients with foot/ankle osteoarthritis had the worst mean self-reported mental health, while patients with hallux rigidus had the best (PGM=49.9 vs 53.4). PF10a and PGM scores were significantly positively correlated for all diagnoses; the correlation was strongest in patients diagnosed with foot/ankle osteoarthritis or hammertoes (r=0.511) and weakest in patients with ankle fractures (r=0.239) or ankle sprains (r=0.287). Chronic conditions, including hammertoes (β=-4.9, 95%CI [-5.6, -4.2], p< 0.001), foot/ankle osteoarthritis (β=-4.8, 95%CI [-5.5, -4.1], p< 0.001), and hallux valgus (β=-4.6, 95%CI [-5.3, -3.9], p< 0.001) were associated with the largest negative effects on patients’ self-reported mental health. Conclusion: Self-reported physical function and mental health varied across common foot and ankle diagnoses and were more tightly correlated in chronic than acute conditions. The effect of diagnosis on mental health scores appears to be worse for more chronic diagnoses, including those that are generally associated with relatively unimpaired physical function. Comparison of mean unadjusted PROMIS Physical Function 10a and PROMIS Global-Mental scores by diagnosis.

492 Pain and falls among persons with multiple sclerosis.

OBJECTIVES/GOALS: Falls are very common among persons with multiple sclerosis (PwMS) due to the disabling symptoms associated with the disease. The relationship between pain and falls is underexplored. This study investigated the relationship between the facets of pain (intensity and interference) and falls in the context of co-occurring symptoms of MS. METHODS/STUDY POPULATION: This is a survey-based study that included 915 adults with MS. Participants provided data on demographics, clinical data, concerns about falling, symptom severity, and occurrence of falls in the past 6 months. Participants also completed the Patient Reported Outcome Measurement Information System (PROMIS) pain interference and pain intensity short forms. Pain interference and pain intensity were separately entered into univariate and multivariable logistic regression models developed to examine the associations between falls incidence and pain. Multivariable models were adjusted for age, sex, years since diagnosis, MS type, Patient Determined Disease Steps, MS status, concerns about falling, fatigue severity, PROMIS depression short form, and PROMIS physical function short form. RESULTS/ANTICIPATED RESULTS: Univariate regression analyses indicated that pain interference (OR = 1.05; 95% CI 1.03 to 1.06; p < 0.01) and pain intensity (OR = 1.03; 95% CI 1.02 to 1.04; p < 0.01) were both associated with falls. Only pain interference remained significantly associated with falls in multivariable regression analysis (OR = 1.02; 95% CI 1.00 to 1.05; p = 0.03). The model explained 25% of the variance in falls. Pain intensity was not associated with falls (OR = 0.98; 95% CI 0.95 to 1.01; p > 0.05) in multivariable regression analysis. DISCUSSION/SIGNIFICANCE: The findings suggest that pain is associated with falls among PwMS. Interventions designed to reduce falls incidence among PwMS may consider the inclusion of pain management as an integral component of those programs.

Diagnosis-Specific Thresholds of the Minimal Clinically Important Difference and Patient Acceptable Symptom State for KOOS After Total Knee Arthroplasty.

This article was updated on May 1, 2024 because of a previous error, which was discovered after the preliminary version of the article was posted online. The byline that had read "Ahmed K. Emara, MD 1 *, Ignacio Pasqualini, MD 1 *, Alison K. Klika, MS 1 , Melissa N. Orr, BS 1 , Pedro J. Rullán, MD 1 , Nicolas S. Piuzzi, MD 1 , and the Cleveland Clinic Arthroplasty Group†" now reads "Ahmed K. Emara, MD 1 *, Ignacio Pasqualini, MD 1 *, Yuxuan Jin, MS 1 , Alison K. Klika, MS 1 , Melissa N. Orr, BS 1 , Pedro J. Rullán, MD 1 , Nicolas S. Piuzzi, MD 1 , and the Cleveland Clinic Arthroplasty Group†". Literature-reported minimal clinically important difference (MCID) and patient acceptable symptom state (PASS) thresholds for patient-reported outcome measures demonstrate marked variability. The purpose of this study was to determine the minimal detectable change (MDC), MCID, and PASS thresholds for the Knee injury and Osteoarthritis Outcome Score (KOOS) Pain subdomain, Physical Function Short Form (PS), and Joint Replacement (JR) among patients with osteoarthritis (OA) who underwent primary total knee arthroplasty (TKA). A prospective cohort of 6,778 patients who underwent primary TKA was analyzed. Overall, 1-year follow-up was completed by 5,316 patients for the KOOS Pain, 5,018 patients for the KOOS PS, and 4,033 patients for the KOOS JR. A total of 5,186 patients had an OA diagnosis; this group had an average age of 67.0 years and was 59.9% female and 80.4% White. Diagnosis-specific MDCs and MCIDs were estimated with use of a distribution-based approach. PASS values were estimated with use of an anchor-based approach, which corresponded to a response to a satisfaction question at 1 year postoperatively. The MCID thresholds for the OA group were 7.9 for the KOOS Pain, 8.0 for the KOOS PS, and 6.7 for the KOOS JR. A high percentage of patients achieved the MCID threshold for each outcome measure (KOOS Pain, 95%; KOOS PS, 88%; and KOOS JR, 94%). The MDC 80% to 95% confidence intervals ranged from 9.1 to 14.0 for the KOOS Pain, 9.2 to 14.1 for the KOOS PS, and 7.7 to 11.8 for the KOOS JR. The PASS thresholds for the OA group were 77.7 for the KOOS Pain (achieved by 73% of patients), 70.3 for the KOOS PS (achieved by 68% of patients), and 70.7 for the KOOS JR (achieved by 70% of patients). The present study provided useful MCID, MDC, and PASS thresholds for the KOOS Pain, PS, and JR for patients with OA. The diagnosis-specific metrics established herein can serve as benchmarks for clinically meaningful postoperative improvement. Future research and quality assessments should utilize these OA-specific thresholds when evaluating outcomes following TKA. Doing so will enable more accurate determinations of operative success and improvements in patient-centered care. Prognostic Level II . See Instructions for Authors for a complete description of levels of evidence.

Effects of 16-week circuit training on physical fitness parameters, pulmonary function, and quality of life in healthy women.

Circuit training (CT) is an important type of training that can combine different types of exercises in a single form of training. This study aimed to investigate the effects of 16-week CT on physical fitness parameters, pulmonary function, and quality of life in healthy women. Twenty-nine healthy women (median age: 37.00 [31.50/39.50] years) were included in the study. CT was applied to the participants for a total of 16 weeks. Participants' body composition with the Bioelectrical Impedance Analysis System, knee flexor and extensor muscle strength with the Biodex System-4 Pro, flexibility with the sit-and-reach test, pulmonary function with a spirometer device, and quality of life with Short Form-36 were assessed. A significant difference was found between the participants' pretest and posttest median and interquartile range values of waist-hip ratio, body mass index, right/left knee flexor/extensor mean peak torque (60°/s,180°/s), right hamstring/quadriceps (H/Q) ratio (60°/s), flexibility, and SF-36 Mental Health Score (P˂0.050). There was no significant difference between the participants' pretest and posttest median and interquartile range values of total body fat, fat percentage, right H/Q ratio (180°/s), left H/Q ratio (60°/s,180°/s), pulmonary function, and Short Form-36 Physical Function Score (P˃0.050). CT decreased waist-hip ratio and body mass index, increased knee flexor/extensor strength and flexibility, and improved mental health. The 16-week CT may be an alternative approach to improve physical fitness parameters and mental health without any positive effects on body fat and pulmonary functions in healthy women.

Validation of the Patient-Reported Outcomes Measurement Information System (PROMIS®) physical function questionnaire in late-onset Pompe disease using PROPEL phase 3 data

BackgroundThe construct validity and interpretation of the Patient-Reported Outcome Measurement Information System (PROMIS®) Physical Function short form 20a (PF20a) questionnaire were evaluated for patients with late-onset Pompe disease (LOPD), a rare, autosomal recessive, progressive neuromuscular disorder treatable by enzyme replacement therapy (ERT).MethodsIn the phase 3 PROPEL study, adults with LOPD underwent testing of physical functioning and had PRO measurements at baseline and at weeks 12, 26, 38, and 52 while receiving experimental or standard-of-care ERT. All patients were pooled for analyses, without comparisons between treatment groups. Associations and correlations between PROMIS PF20a scores and the 6-minute walk distance (6MWD), % predicted forced vital capacity (FVC), manual muscle test (MMT) of the lower extremities, Gait, Stairs, Gowers’ maneuver, Chair (GSGC) score, and Rasch-built Pompe-specific Activity (R-PAct) scale were evaluated by calculating regression coefficients in linear regression models and Pearson correlation coefficients (R); patients’ age, sex, race, ERT prior to study, body mass index, and study treatment were included as covariables. The minimal clinically important difference (MCID) of PROMIS PF20a was determined using distribution- and anchor-based methods.Results123 patients received at least 1 dose of ERT. In multivariable analyses, PROMIS PF20a scores had strong correlations with R-PAct scores (R = 0.83 at baseline and R = 0.67 when evaluating changes between baseline and 52 weeks) and moderate correlations with the 6MWD (R = 0.57 at baseline and R = 0.48 when evaluating changes between baseline and 52 weeks). Moderate correlations were also observed between PROMIS PF20a and MMT (R = 0.54), GSGC (R=-0.51), and FVC (R = 0.48) at baseline. In multivariable linear regression models, associations were significant between PROMIS PF20a and 6MWD (P = 0.0006), MMT (P = 0.0034), GSGC (P = 0.0278), and R-PAct (P < 0.0001) at baseline, between PROMIS PF20a and 6MWD (P < 0.0001), FVC (P = 0.0490), and R-PAct (P < 0.0001) when combining all measurements, and between PF20a and 6MWD (P = 0.0016) and R-PAct (P = 0.0001) when evaluating changes in scores between baseline and 52 weeks. The anchor-based and distribution-based MCID for a clinically important improvement for PROMIS PF20a were 2.4 and 4.2, respectively.ConclusionsPROMIS PF20a has validity as an instrument both to measure and to longitudinally follow physical function in patients with LOPD.Trial registrationClinicalTrials.gov, NCT03729362. Registered 2 November 2018, https://www.clinicaltrials.gov/search?term=NCT03729362.

Mental Health Effects on the Minimal Clinically Important Difference in Total Joint Arthroplasty.

The effect of mental health on patient-reported outcome measures is not fully understood in total joint arthroplasty (TJA). Thus, we investigated the relationship between mental health diagnoses (MHDs) and the Minimal Clinically Important Difference for Improvement (MCID-I) and Worsening (MCID-W) in primary TJA and revision TJA (rTJA). Retrospective data were collected using relevant Current Procedural Terminology and MHDs International Classification of Diseases, 10th Revision, codes with completed Hip Disability and Osteoarthritis Outcome Score-Physical Function Short Form, Knee Injury and Osteoarthritis Outcome Score-Physical Function Short Form, Patient-reported Outcomes Measurement Information System (PROMIS)-Physical Function Short Form 10a, PROMIS Global-Mental, or PROMIS Global-Physical questionnaires. Logistic regressions and statistical analyses were used to determine the effect of a MHD on MCID-I/MCID-W rates. Data included 4,562 patients (4,190 primary TJAs/372 rTJAs). In primary total hip arthroplasty (pTHA), MHD-affected outcomes for Hip Disability and Osteoarthritis Outcome Score-Physical Function Short Form (MCID-I: 81% versus 86%, P = 0.007; MCID-W: 6.0% versus 3.2%, P = 0.008), Physical Function Short Form 10a (MCID-I: 68% versus 77%, P < 0.001), PROMIS Global-Mental (MCID-I: 38% versus 44%, P = 0.009), and PROMIS Global-Physical (MCID-I: 61% versus 73%, P < 0.001; MCID-W: 14% versus 7.9%, P < 0.001) versus pTHA patients without MHD. A MHD led to lower rates of MCID-I for PROMIS Global-Physical (MCID-I: 56% versus 63%, P = 0.003) in primary total knee arthroplasty patients. No effects from a MHD were observed in rTJA patients. The presence of a MHD had a prominent negative influence on pTHA patients. Patients who underwent rTJA had lower MCID-I rates, higher MCID-W rates, and lower patient-reported outcome measure scores despite less influence from a MHD. Level III, retrospective comparative study.

Comparison of pain intensity measurements among patients with low-back pain

<p>Pain intensity is the most frequently assessed health domain in clinical studies among patients with low-back pain. Visual analogue scale (VAS) and Numeric rating scale (NRS) have been the mostly used measurement tools for pain intensity. We proposed to correlate these instruments to a generic health-related quality of life measurement tool in order to show the scale with superior clinical relevance.</p>. <p>We used cross-sectional, convenience sampling. 120 patients with chronic low-back pain administered the 29-item Patient Reported Outcomes Measurement Information System Profile with NRS included, and the VAS scale in the National Institute of Mental Health, Neurology and Neurosurgery. We determined the correlation between PROMIS domain T-scores and VAS and NRS scores.</p>. <p>We performed Spearman rank correlation test to calculate the correlation coefficient. We found VAS scales measuring pain had weak to moderate correlations with all PROMIS health domains (r = 0.24&ndash;0.55). Therefore, we compared correlation of PROMIS domain scores with PROMIS pain intensity numeric rating scale and VAS scales. PROMIS domains had moderate to strong correlations with pain intensity scale (r = 0.45&ndash;0.71). PROMIS physical function short form [r = &ndash;0.65, 95% CI (&ndash;0.75) &ndash; (&ndash;0.55)] and PROMIS pain interference short form (r = 0.71, 95% CI 0.63 &ndash; 0.79) had the strongest correlation with pain intensity item.</p>. <p>NRS has showed greater correlation with PROMIS domain T-scores than VAS scale. This may prove that NRS has greater connection to another health domains, thus it correlated more to health-related quality of life than visual scale. We recommend NRS to use in further clinical studies conducted among patients with low-back pain.</p>.

Patient-Reported Outcomes Measurement Information System Physical Function and Global Physical Health Subscale Strongly Correlate and Perform Similarly to the Knee Injury and Osteoarthritis Outcome Score-Physical Function Short Form

BackgroundArthroplasty surgeons use a variety of patient-reported outcome measures (PROMs) to assess functional well-being, including the Knee Injury and Osteoarthritis Outcome Score (KOOS) Physical Function short form (KOOS-PS), Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 10a (PROMIS PF SF 10a), and PROMIS Global-10 Physical Health subscale. However, there is a paucity of literature assessing their concurrent validity and performance. MethodsBetween June 2016 and December 2020, patient visits at an arthroplasty clinic for knee concerns were identified. Patients who completed KOOS-PS, PROMIS PF SF 10a, and PROMIS Global-10, including its physical and mental health subscales, at the same visit were identified. Spearman rho (ρ) correlations were calculated and ceiling and floor effects identified. Overall, 5,303 patient encounters were included. ResultsAmong physical function domains, strong correlation existed between the KOOS-PS and PROMIS PF SF 10a (ρ = 0.76, P < .001), KOOS-PS and PROMIS Global Physical Health (ρ = 0.71, P < .001), and PROMIS PF SF 10a and PROMIS Global Physical Health (ρ = 0.78, P < .001). No physical function–focused PROM had an appreciable floor effect (ie, at or more than 1%). The KOOS-PS had a small but measurable ceiling effect (n = 105 [2.0%]). ConclusionsAll of the examined PROMs are acceptable to measure the functional status of patients with knee pathology, with the PROMIS Global-10 also being able to capture elements of mental health too. The PROMIS Global-10 may be of most value of the PROMs assessed, as the United States Centers for Medicare and Medicaid Services already incorporate the mental health component into new alternative payment models.

Minimal important difference of the 12-item World Health Organization Disability Assessment Schedule (WHODAS) 2.0 in persons with chronic low back pain

BackgroundThe World Health Organization Disability Assessment Schedule 2.0 12-item survey (WHODAS-12) is a questionnaire developed by the WHO to measure functioning across health conditions, cultures, and settings. WHODAS-12 consists of a subset of the 36 items of WHODAS-2.0 36-item questionnaire. Little is known about the minimal important difference (MID) of WHODAS-12 in persons with chronic low back pain (LBP), which would be useful to determine whether rehabilitation improves functioning to an extent that is meaningful for people experiencing the condition. Our objective was to estimate an anchor-based MID for WHODAS-12 questionnaire in persons with chronic LBP.MethodsWe analyzed data from two cohort studies (identified in our previous systematic review) conducted in Europe that measured functioning using the WHODAS-36 in adults with chronic LBP. Eligible participants were adults with chronic LBP with scores on another measure as an anchor to indicate participants with small but important changes in functioning over time [Short-form-36 Physical Functioning (SF36-PF) or Oswestry Disability Index (ODI)] at baseline and follow-up (study 1: 3-months post-treatment; study 2: 1-month post-discharge from hospital). WHODAS-12 scores were constructed as sums of the 12 items (scored 0–4), with possible scores ranging from 0 to 48. We calculated the mean WHODAS-12 score in participants who achieved a small but meaningful improvement on SF36-PF or ODI at follow-up. A meaningful improvement was an MID of 4–16 on ODI or 5–16 on SF36-PF.ResultsOf 70 eligible participants in study 1 (mean age = 54.1 years, SD = 14.7; 69% female), 18 achieved a small meaningful improvement based on SF-36 PF. Corresponding mean WHODAS-12 change score was − 3.22/48 (95% CI -4.79 to -1.64). Of 89 eligible participants in study 2 (mean age = 65.5 years, SD = 11.5; 61% female), 50 achieved a small meaningful improvement based on ODI. Corresponding mean WHODAS-12 change score was − 5.99/48 (95% CI − 7.20 to -4.79).ConclusionsUsing an anchor-based approach, the MID of WHODAS-12 is estimated at -3.22 (95% CI -4.79 to -1.64) or -5.99 (95% CI − 7.20 to -4.79) in adults with chronic LBP. These MID values inform the utility of WHODAS-12 in measuring functioning to determine whether rehabilitation or other health services achieve a minimal difference that is meaningful to patients with chronic LBP.

Steady-State Hemoglobin Is Associated with Self-Reported Ability to Perform Challenging Physical Function Activities, but Not Global Physical Function in Individuals with Sickle Cell Anemia

Introduction People living with sickle cell disease (SCD) need high levels of physical function to support independent living. Researchers should prioritize identifying modifiable targets that improve physical function. People with SCD who have physical limitations and low muscular capacity are at risk of poor function and lower quality of life. This abstract describes domain-specific and global self-reported physical function among adults living with SCD and identifies cross-sectional associations between hemoglobin and physical function. Methods Respondents consented to chart abstraction and completed the PROMIS Physical Function Short Form 8b survey. We operationalized domain-specific function as binary variables indicating no impairment versus any impairment in 8 activities. We calculated participants' global physical function using PROMIS' HealthMeasures web tool calibrated to the US population and converted to t-scores (range: 20.3 [worst] to 60.1 [best]). Eligible participants met the following criteria: age 18+ when surveyed,labs drawn during a non-acute encounter within +/- 30 days of the survey, no pregnancy-related outcome the year before survey, no history of bone marrow transplant, and available covariate data. We estimated cross-sectional associations between hemoglobin and 8 physical function sub-domains using multivariable logistic regression. We fit heteroscedastic tobit regressions to estimate the association between hemoglobin and global physical function. We adjusted the models for age, sex, recruitment site, history of renal damage, disease-modifying therapy (DMT) use, body mass index, and lactate dehydrogenase (LDH). We used STATA/SE 18.0 to perform the analyses separately by SCD subtype: sickle cell anemia (SCA) - HbSS/HbSβ 0, versus other subtypes (variant SCD). Results Between 2016 and 2023, 331 people with SCD at 7 GRNDaD sites completed the survey; 119 adults met eligibility criteria (52% female). The median age was 31 years (IQR: 24 , 39 years); 95% identified as Black, and 65% had SCA [Table 1]. Seventeen percent reported no limitation in any domain. Those with While For those with SCA, the hardest activity was heavy housework (74% reported limitation), while the easiest was running errands (39% reported limitation). For those with variant SCD, the hardest activity was heavy housework (88% reported limitation), while the easiest was climbing stairs (64% reported limitation). In adjusted logistic regression models among those with SCA, higher steady state hemoglobin was associated with higher odds of full function when carrying groceries (OR = 1.59, 95% CI = 1.05 , 2.41), performing 2 hours of labor (OR = 2.17, 95% CI = 1.29 , 3.65), and heavy housework (OR = 1.78, 95% CI = 1.04 , 3.06) [Figure 1]. Hemoglobin was not associated with any function sub-domains for individuals with variant SCD. In adjusted tobit regression models, hemoglobin was not associated with global physical function for those with SCA (β= 0.23 95% CI = -0.99 , 1.45) nor with variant SCD (β= -0.10, 95% CI= -0.77 , 0.58). Conclusions People with SCA reported better age-adjusted subjective function than those with variant disease, perhaps reflecting availability of treatments for SCA. In SCA, hemoglobin was positively associated with higher function in the 3 PROMIS sub-domains that respondents ranked as most challenging. Hemoglobin was not associated with global physical function for either SCD subtype. research in larger longitudinal samples is needed to explicate potential mechanisms linking hemoglobin to self-reported function sub-domains, corroborate the observed patterns of self-reported function by subtype, investigate associations between hemoglobin and objectively measured physical function, and identify how within-person changes in hemoglobin may contribute to changes in performing challenging everyday physical function activities.

Hyponatremia, hypernatremia and impairment of functional, psychological and sexual domains

ObjectiveTo determine the influence of serum sodium on physical, psychologic and sexual function.MethodsThis is a cross-sectional survey on 3340 community-dwelling men aged 40–79 years from a prospective cohort study in eight European countries, the European Male Ageing Study (EMAS). Participants filled-out the Short Form-36 (SF-36), the Physical Activity Scale for the Elderly (PASE), and the EMAS sexual function questionnaire. For all the analyses, serum sodium corrected for glycaemia ([Na+]G) was used.ResultsThe relationship between [Na+]G and SF-36 physical function score (F = 3.99; p = 0.01), SF-36 mental health score (F = 7.69; p < 0.001), and PASE score (F = 14.95; p < 0.001) were best described by a quadratic equation, with worse scores for [Na+]G in either the lowest or the highest ends of the range. After dividing the sample into [Na+]G < 136 mmol/L (n = 81), 136–147 mmol/L (n = 3223) and > 147 mmol/L (n = 36), linear regression analyses with linear spline functions adjusted for confounders did not confirm these relationships. Similarly, erectile dysfunction and [Na+]G, were in a quadratic relationship (F = 9.00; p < 0.001). After adjusting for confounders, the linear regression with spline functions denoted a significantly worsened erectile function for increases in serum [Na+]G > 147 mmol/L (B = 0.15 [0.04;0.26], p < 0.01) but no relationship with [Na+]G < 136 mmol/L. Likewise, the relationship of [Na+]G with concerns about sexual dysfunction was confirmed only for men with serum [Na+]G > 147 mmol/L.ConclusionsThis is the first study supporting an association between [Na+]G and sexual function. A worsening of erection and concerns about sexual function were observed for the highest values of [Na+]G, independently of other relevant factors.

Observational Study of Repeat Immunoadsorption (RIA) in Post-COVID ME/CFS Patients with Elevated ß2-Adrenergic Receptor Autoantibodies-An Interim Report.

There is increasing evidence for an autoimmune aetiology in post-infectious Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). SARS-CoV-2 has now become the main trigger for ME/CFS. We have already conducted two small proof-of-concept studies on IgG depletion by immunoadsorption (IA) in post-infectious ME/CFS, which showed efficacy in most patients. This observational study aims to evaluate the efficacy of IA in patients with post-COVID-19 ME/CFS. The primary objective was to assess the improvement in functional ability. Due to the urgency of finding therapies for post-COVID-Syndrome (PCS), we report here the interim results of the first ten patients, with seven responders defined by an increase of between 10 and 35 points in the Short-Form 36 Physical Function (SF36-PF) at week four after IA. The results of this observational study will provide the basis for patient selection for a randomised controlled trial (RCT), including sham apheresis, and for an RCT combining IA with B-cell depletion therapy. Trial registration number: NCT05629988.

Establishing a common metric for physical function: Linking SARC-F and PROMIS® physical function

IntroductionAligned with the increasing need for standardized assessment of physical function in older individuals with cancer and other conditions, several patient-reported outcome measures (PROMs) have been developed and published. The aim of this study is to link the Strength, Assistance with walking, Rising from a chair, Climbing stairs, and Falls questionnaire (SARC-F), and the Patient-Reported Outcomes Measurement Information System® (PROMIS®) Physical Function Short Form 8c (PROMIS PF 8c), and make their scores convertible, in order to expand the use of both instruments in research and inform clinicians and researchers about the interchangeability of critical cut-off scores. Materials and MethodsThe sample included 300 participants recruited from an online panel. Participants were included if they had received a cancer diagnosis from a clinician and reported receiving anti-cancer treatment. We conducted five linking procedures and selected an optimal one to generate the crosswalk table between the two measures. ResultsThe linked T scores of all five methods showed acceptably small mean differences from the observed T scores, and the standard deviation (SD), and root-mean-squared deviation (RMSD) of the differences were generally similar across all methods. After comparing across all statistics, the Stocking-Lord approach was considered as the optimal approach to compute the crosswalk table for converting SARC-F raw scores to PROMIS PF 8c scores. The crosswalk table shows that the SARC-F cut-off value of 4 between healthy versus symptomatic with a corresponding score of 37 fell in the range of moderate physical function limitation from 30 to 39 on the PROMI PF 8c T score metric. DiscussionThe linkage in this study has potential for improving clinical and research activities for people with cancer and perhaps others with a similar range of physical function. It facilitates the interpretability in scores of both measures on a common metric anchored on general population for further group-level analysis. Researchers can use this crosswalk to harmonize data collected from either instrument without requiring all cohorts to administer the same instrument for a prospective data collection or retrospective data analysis purpose or for a cross-study effectiveness study.

Musculoskeletal system symptoms in patients with COVID-19 and the impact of these symptoms on quality of life.

Coronavirus disease 2019 (COVID-19) is a respiratory disease caused by the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) and also affects the musculoskeletal system. This study was conducted to investigate the musculoskeletal symptoms, type of pain and effect on quality of life in patients presenting with pain after COVID-19. This prospective, descriptive study included 97 patients aged 18 years or older who were diagnosed with COVID-19 based on a positive polymerase chain reaction test result, with or without musculoskeletal pain prior to COVID-19 infection. Patients who applied to the post-COVID-19 outpatient clinic with the complaint of pain at least 1 month and maximum 1 year after the diagnosis of COVID-19 were included. Patients' demographic characteristics and musculoskeletal examination findings were evaluated. The patients were examined, and the questionnaire forms were completed. The pain was assessed using the visual analog scale (VAS), the Douleur-Neuropathique-4 (DN-4) questionnaire, while the quality of life was assessed using the Short Form-36 (SF-36) survey. Patients were divided into groups in terms of gender, age, body mass index. Shapiro-Wilk's test, the independent samples t-test and the Mann-Whitney U test were used for statistical analyses. The mean age of the patients was 46.5 ± 13.5 years, 30 of them were male. Pain increased in patients with pre-COVID-19 arthralgia and myalgia (p< 0.001). Post-COVID-19 VAS was significantly higher than pre-COVID-19 VAS (7 ± 1.2 vs. 3.2 ± 1.9, p< 0.05). Pre-COVID-19 patients with myalgia had significantly worse SF-36 physical function, social function, pain, general health perception (p< 0.05). The mean scores of females in the SF-36 physical function, pain were significantly worse than males (p< 0.05). According to DN-4, 41 (42.3%) patients had neuropathic pain. There was moderate negative correlation between VAS, DN-4 and SF-36 (p< 0.05). Arthralgia, myalgia, and neuropathic pain, all of which negatively affect the quality of life, are often observed in the patients infected with COVID-19.

Evaluating and Comparing the Correlation and Performance of PROMIS and FAAM ADL in a Foot and Ankle Patient Population.

There is a paucity of literature assessing 2 of the commonly used static Patient-Reported Outcomes Measurement Information System (PROMIS) forms (PROMIS Global-10 and PROMIS Physical Function Short Form 10a [PF SF 10a]) and the Foot and Ankle Ability Measure Activities of Daily Living (FAAM ADL). The PROMIS Global-10, PROMIS PF SF 10a, and FAAM ADL were compared among new foot and ankle patients. Spearman rho (ρ) correlations were calculated, and ceiling and floor effects were determined. The FAAM ADL demonstrated strong correlations with PROMIS PF SF 10a, P = .88, 95% confidence interval (CI): 0.86-0.90, P < .001, and PROMIS Global-10 Physical Health (P = .75, 95% CI: 0.71-0.78, p < .001). The FAAM ADL and PROMIS Global-10 Mental Health demonstrated a moderate correlation (P = .41, 95% CI: 0.34-0.47, P < .001). No PROM demonstrated an appreciable floor effect. The PROMIS Global-10 Physical Health demonstrated the lowest ceiling effect (n=11 [1.6%]). Because the PROMIS Global-10 captures physical health adequately, provides mental health insight, and performs as well (if not better), we recommend the PROMIS Global-10 among the PROMs studied.Level of Evidence: Level III.