Short Form-36 Physical Function Research Articles

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

Revision total knee arthroplasty (rTKA) remains underexplored regarding patient-reported outcome measures (PROMs), particularly in terms of time to reach Minimal Clinically Important Difference (MCID). This study addresses this gap by comparing the time to achieve MCID between primary TKA (pTKA) and rTKA patients, providing valuable insights into their recovery trajectories. A total of 8,266 TKAs (7,618 pTKA and 648 rTKA) were retrospectively studied in a multi-institutional arthroplasty registry. Patients who completed the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Physical, PROMIS Physical Function Short Form 10a (PF-10a), and Knee Injury and Osteoarthritis Outcome Score-Physical Function Short Form (KOOS-PS) questionnaires were identified by Current Procedural Terminology (CPT) codes. Survival curves with and without interval-censoring were utilized to evaluate the time to achieve MCID. Comparing the time to achieve MCID, rTKAs were significantly faster than pTKA for PROMIS Global Physical (3.5 versus 3.7 months, P = 0.004) and KOOS-PS (3.3 versus 4.2 months, P < 0.001), but similar for PROMIS PF-10a (4.4 versus 4.8 months, P = 0.057). Interval-censoring also showed similar trends with earlier times to achieve MCID for rTKAs for PROMIS Global Physical (0.6 to 0.61 versus 0.97 to 0.97 months, P = 0.009) and KOOS-PS (0.97 to 0.97 versus 1.47 to 1.47 months, P < 0.001), but not for PROMIS PF-10a (2.43 to 2.54 versus 1.90 to 1.91 months, P = 0.92). The present study revealed that the time to achieve MCID was faster in patients undergoing rTKA compared to those undergoing pTKA. These findings allow surgeons to reassure preoperative revision TKA patients that their recovery to a minimal clinically important difference postoperatively may be quicker than expected, especially when compared to their initial recovery after primary TKA.

Comparing Rates of Minimal Clinically Important Difference Between Manual and Robotic-Assisted Total Knee Arthroplasty.

Differences in patient-reported outcome measures (PROMs) between manual total knee arthroplasty (mTKA) and robotic-assisted TKA (rTKA) have not been adequately assessed. We compared the minimal clinically important difference for improvement (MCID-I) and Worsening (MCID-W) between mTKA and rTKA patients. Patients who underwent primary TKA (874 mTKA, 439 rTKA) with complete pre-operative and one-year post-operative PROMs were retrospectively identified using a multi-hospital joint arthroplasty registry. Patient-Reported Outcomes Measurement Information System Physical Function Short Form 10a (PROMIS PF-10a), PROMIS Global - Physical, or Knee Injury and Osteoarthritis Outcome Score-Physical Function Short Form (KOOS-PS) were collected. The MCID-I, MCID-W, and "no significant change" rates were calculated using distribution-based methods. Propensity-score matching was performed to control for confounding. Similar 90-day pulmonary embolism (P = 0.26), deep venous thrombosis (P = 0.67), and emergency department visit (P = 0.35) rates were found. The 90-day readmission rate for mTKA was 1.7 and 3.4% for rTKA (P = 0.08), and overall revision rates were 2.2% for mTKA and 0.7% for rTKA (P = 0.07). Revision-free survival was 99% at one and two years for both groups (P = 0.65 and P = 0.43, respectively). There were no differences in the proportion of patients achieving MCID-I or MCID-W for PROMIS PF-10a, PROMIS Global - Physical, or KOOS-PS. The MCID-I for PROMIS PF-10a was achieved in 65.5 and 62.2% of patients who had mTKA and rTKA, respectively (P = 0.32). Our study demonstrated similar complication rates, and MCID-I and MCID-W attainment rates between mTKA and rTKA patients. Future studies should assess MCID attainment rates in the long term and in larger cohorts, comparing mTKA and rTKA.

Cultural adaptation and validation of the knee injury and osteoarthritis outcome score into Sinhala language in patients with primary knee osteoarthritis: a cross-sectional study

BackgroundKnee Injury and Osteoarthritis Outcome Score (KOOS) scale is a patient-reported outcome measurement tool. It evaluates both short- and long-term consequences of knee injury and primary osteoarthritis. This study aims to translate and validate the KOOS scale for a Sinhala-speaking Sri Lankan population.MethodsA cross sectional study was conducted in three hospitals. Four hundred and fifteen patients comprising 185 males and 227 females (3 subjects did not reveal their gender) with knee osteoarthritis (KOA) participated in the study. Seventy nine participants without KOA were recruited as controls. The functionality and quality of life level in patients and healthy participants were assessed using translated versions of the KOOS and Short Form-36 (SF-36) scales. Internal consistency of the instrument was assessed by Cronbach alpha. Construct validity and test-retest reliability were examined using the Intraclass Correlation Coefficient (ICC). Confirmatory Factor Analysis (CFA) was used to assess factorial validity.ResultsThe mean age (± sd) of the KOA subjects was 54.9 (± 9.2) years and for the control group was 49.2 (± 8.0) years. Majority of the respondents were female and Sinhalese in both groups. Internal consistency reliability was high (Cronbach’s alpha values ≥ 0.70). The test–retest reliability was excellent with the intraclass correlation coefficient for all subscales being above 0.90. Construct validity was assessed by the magnitude of the correlation coefficient between KOOS and SF-36 subscale scores. KOOS Pain scale moderately correlated with SF-36 bodily pain (Pearson’s r = 0.41). SF-36 physical function scores had a weak positive correlation with all KOOS subscales and SF-36 emotional wellbeing was not significantly correlated with KOOS Quality of Life (QoL) subscale. A five-factor Confirmatory Factor Analysis (CFA) model yielded a Comparative Fit Index (CFI) = 0.950, Tucker Lewis Index (TLI) = 0.946, Root Mean Square Error of Approximation (RMSEA) = 0.082 and Standardised Root Mean squared Residual (SRMR) = 0.072.ConclusionThe Sinhala translation of the KOOS scale is a reliable and valid instrument to assess KOA in a Sinhala-speaking Sri Lankan population. Studies to assess its use as a scale to evaluate responsiveness are recommended.

Six-year follow-up of participants in two clinical trials of rituximab or cyclophosphamide in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome.

In this six-year follow-up study, we used patient-reported outcome measures (PROMs) to compare values at baseline, at 18 months, and at six-year follow up from the CycloME and the RituxME trials. Based on the hypothesis that ME/CFS in a subgroup of patients is a variant of an autoimmune disease, we performed two clinical trials between 2014 and 2017. The RituxME trial was a randomized, double-blind and placebo-controlled phase III trial of 151 patients, assessing the B-cell depleting antibody rituximab. The CycloME trial was an open-label phase II trial of 40 patients using intravenous cyclophosphamide. Here we report six-year follow-up from both trials, using the Short Form 36 Physical Function (SF-36 PF) and DePaul short form (DSQ-SF) questionnaires. Of the patients available after six years, 75.7% of RituxME and 94.4% of CycloME patients participated. In the RituxME rituximab group, the mean SF-36 PF scores were 32.9 at baseline, 42.4 at 18 months and 45.5 at six years. In the placebo group, the mean SF-36 PF scores were 32.3 at baseline, 45.5 at 18 months and 43.1 at six years. In the CycloME trial, mean SF-36 PF increased from 35.4 at baseline to 54.4 at 18 months, and 56.7 at six years. At six-year follow-up, 44.1% of cyclophosphamide-, 27.6% of rituximab- and 20.4% of placebo-treated patients had an SF-36 PF ≥ 70, and further, 17.6%, 8.6% and 7.4% of the corresponding patient groups had an SF-36 PF ≥ 90, which is within normal range. In terms of worsening at six years, 5.9% of cyclophosphamide-treated, 10.3% of rituximab-, and 14.8% of placebo-treated patients had a drop in SF-36 PF of 20 points or more from baseline. There were no serious unexpected adverse reactions. After six years, 44.1% of the cyclophosphamide group scored an SF-36 PF of at least 70, and 17.6% of at least 90, suggesting that cyclophosphamide in a subgroup may modulate the disease course in a beneficial way. However, cyclophosphamide carries toxicity concerns and should not be used for ME/CFS patients outside clinical trials. Rather, these data should encourage efforts to better understand the disease mechanisms and to search for targeted and less toxic immune modulatory treatment for this patient group.

Same-day discharge after laparoscopic hysterectomy for benign/premalignant disease: A multicentre randomised controlled trial.

To evaluate whether physical function and quality of life was influenced by discharge on the same-day after a total laparoscopic hysterectomy. Multicentre non-inferiority randomised controlled trial. Five teaching hospitals and two university hospitals in the Netherlands. Patients undergoing laparoscopic hysterectomy for benign or premalignant disease. Following informed consent, participants were allocated 1:1 either to same-day discharge (SDD) or next-day discharge (NDD). The primary outcome was physical function at 7 days after surgery measured by the Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function short Form 10A. Secondary outcomes were physical function and quality of life at 1 and 3 days and 6 weeks after surgery measured with PROMIS short Form 10A and the EuroQol questionnaire (EQ-5D-5L). Two hundred and five patients were included of whom 105 were allocated to SDD and 100 to NDD. Physical function 7 days after surgery was 35.95 in the SDD group and 35.63 in the control group (mean difference 0.32; 95% CI [0.07-0.57]). As the upper limit of the 95% CI does not exceed the non-inferiority margin of 4 points, non-inferiority of SDD could be demonstrated. No difference in physical function nor quality of life on Days 1 and 3 and 6 weeks could be found. This research demonstrates same-day discharge after laparoscopic hysterectomy is non-inferior to next day discharge in physical function 7 days after surgery.

Establishing minimal clinically important differences and patient acceptable symptom state thresholds following birmingham hip resurfacing.

Birmingham Hip Resurfacing (BHR) has emerged as a compelling and innovative alternative to total hip arthroplasty (THA), especially among young, active patients. However, the Minimal Clinically Important Difference (MCID) and the Patient Acceptable Symptom State (PASS) thresholds have not yet been determined for patients undergoing BHR. Therefore, the current study aimed to (1) determine the MCID and PASS thresholds for both the Hip disability and Osteoarthritis Outcome Score (HOOS)-Pain and HOOS physical function shortform (PS), for patients who underwent BHR; and (2) identify factors influencing the achievement of MCID and PASS for HOOS-Pain and HOOS-PS. Prospectively collected data from patients undergoing BHR was analyzed. Patients with osteoarthritis and completed preoperative and 1-year postoperative PROMs were included. Distribution-based and anchored-based approaches were used to estimate MCID and PASS, respectively. The optimal cut-off point for PASS thresholds was calculated using the Youden index. MCID for HOOS-Pain and PS were calculated to be 9.2 and 9.3, respectively. The PASS threshold for HOOS-Pain and PS were ≥ 77.7 and ≥ 87.3, respectively. The current study identified several factors affecting postoperative achievement of thresholds. Baseline Mental Component Summary (MCS) scores were a predictor for achieving MCID for postoperative HOOS-Pain, achieving MCID for postoperative HOOS-PS, achieving PASS for postoperative HOOS-Pain, and achieving PASS for postoperative HOOS-PS. Furthermore, baseline HOOS-Pain was a significant predictor for achieving MCID for postoperative HOOS-PS, achieving PASS for postoperative HOOS-Pain, and achieving PASS for postoperative HOOS-PS. MCID and PASS thresholds were established for HOOS-Pain and PS domains following BHR with most patients achieving these clinically meaningful benchmarks. Additionally, several factors affecting achievement of MCID and PASS were identified, including modifiable risk factors that may allow clinicians to implement optimization strategies and further improve outcomes.

Isolated Medial Patellofemoral Ligament Reconstruction for Recurrent Patellar Instability Regardless of Tibial Tubercle–Trochlear Groove Distance and Patellar Height: Minimum 5-Year Outcomes

Background: It remains unclear which subset of patients with recurrent patellofemoral instability would benefit from a concomitant bony realignment procedure in addition to a medial patellofemoral ligament (MPFL) reconstruction. Purpose: To provide midterm results for patients who underwent an isolated MPFL reconstruction as part of an ongoing prospective trial. Study Design: Case series; Level of evidence, 4. Methods: Patients with recurrent patellar instability were prospectively enrolled in an institutional registry beginning in March 2014. Exclusion criteria included history of a previous surgery for patellar instability, an off-loadable (inferior/lateral) chondral defect, anterior knee pain ≥50% of their chief complaint, and a “jumping J” sign. All patients underwent primary, unilateral, isolated MPFL reconstruction regardless of their bony anatomic characteristics. Patient-reported outcome measures (PROMs), episodes of recurrent instability, and ability to return to sport were obtained annually. Radiographic measurements of baseline radiographs and MRI were obtained at baseline. Results: A total of 138 patients underwent isolated MPFL reconstruction between March 2014 and December 2019. The mean radiographic measurements were tibial tubercle–trochlear groove, 15.1 ± 4.9 mm; Caton-Deschamps index, 1.14 ± 0.16; patellar trochlear index, 46.9% ± 15.1%; trochlear depth index, 2.5 ± 1.2 mm; tibial tubercle to lateral trochlear ridge, −8.4 ± 5.7 mm; and patellar tendon to lateral trochlear ridge, 5.7 ± 6.2 mm. Trochlear dysplasia, defined as a trochlear depth index <3 mm, was present in 79/125 (63%) patients. A total of 50 patients reached ≥5 years, of whom 40 (80%) completed follow-up PROMs. A total of 119 patients reached ≥2 years, of whom 89 (75%) completed follow-up PROMs. Six patients (5%) reported recurrent instability with a mean time of 2.97 years after surgery. All PROMs improved over time except for the Pediatric Functional Activity Brief Scale (Pedi-FABS), which had no change. At 2 years, the mean changes from baseline for Knee injury and Osteoarthritis Outcome Score (KOOS) Quality of Life subscale (QOL), Pedi-FABS, International Knee Documentation Committee (IKDC) score, KOOS Physical Function Short Form (PS), and Kujala score were 42.1, 0.6, 35.1, –23.5, and 32.3, respectively. All changes had P values <.001 except for Pedi-FABS, which showed no change and had P > .999. At 5 years, the mean changes from baseline for KOOS-QOL, Pedi-FABS, IKDC, KOOS-PS, and Kujala score were 42.6, –2.8, 32.6, –21.5, and 31.6, respectively. All changes had P values <.001 except for Pedi-FABS, which showed no change and had P > .453. In total, 89% of patients returned to sport with a mean of 9.1 months. Conclusion: Midterm outcomes for patients who underwent isolated MPFL reconstruction were favorable and were maintained at 5 years. Outcomes for the expanded cohort of patients with a minimum 2-year follow-up support previously published results.

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 &gt;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&amp;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.

Use of 1.5-Stage Functional Articulating Hip Spacers for Two-Stage Treatment of Hip Infection

BackgroundA two-stage treatment is commonly used for chronic hip infections. This study compared the clinical efficacy and complications associated with 1.5-stage functional articulating hip spacers (FAHS) and handmade spacers utilized during two-stage treatment. MethodsThis retrospective study included 50 patients who had hip infections, of which 41 were periprosthetic joint infections, 3 were internal fixation infections, and 6 had septic arthritis. They were divided into two groups according to the spacer type: 23 patients treated with handmade spacers comprising 1 to 2 Kirschner wires as an endoskeleton (group A) and 27 patients treated with 1.5-stage FAHS comprising a cemented femoral stem, metal femoral head, and polyethylene acetabular liner or cemented acetabular cup (group B). Clinical characteristics, surgical data, infection control rate, spacer complications, modified Harris hip, visual analog scale, and 36-item short-form physical functioning scale scores were compared between the groups. All patients were followed up for at least 24 months after the last surgical procedure. ResultsNo significant differences were noted in the infection eradication rate between the two groups (100 versus 96.30%, P = 1.0). The incidence of mechanical complications, especially spacer fracture, was significantly lower in group B than in group A (P = .044). Hip function and quality of life were significantly better in group B during the interim period. Group B patients had a longer interval time (median 7.40 versus 4.30 months, P = .004) and a lower reimplantation rate than group A patients (42.31 versus 82.61%, P = .004). ConclusionsThe 1.5-stage FAHS surgical technique is feasible for the treatment of hip infection, with a lower mechanical complication rate, better hip function, and better quality of life during the interim period compared to that of handmade spacers. The 1.5-stage FAHS with maintained function could delay or negate the need for second-stage revision.

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&amp;lt;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&amp;lt;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&lt;0.01). They also gave higher importance ratings for fixed activities that they performed than fixed activities that they did not perform (P&lt;0.01). The importance of the generated activities correlated with the Brief Pain Inventory (P&lt;0.05) and Western Ontario and McMaster Universities Osteoarthritis Index (P&lt;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&lt; 0.001), foot/ankle osteoarthritis (β=-4.8, 95%CI [-5.5, -4.1], p&lt; 0.001), and hallux valgus (β=-4.6, 95%CI [-5.3, -3.9], p&lt; 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 &lt; 0.01) and pain intensity (OR = 1.03; 95% CI 1.02 to 1.04; p &lt; 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 &gt; 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>.