Short Form-36 Physical Function Research Articles

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.

Patients Consistently Report Worse Outcomes Following Revision Total Knee Arthroplasty Compared to Primary Total Knee Arthroplasty

BackgroundDifferences in patient-reported outcome measures (PROMs) between primary TKA (pTKA) and revision TKA (rTKA) have not been well-studied. Therefore, we compared pTKA and rTKA patients by the rates of achieving the Minimal Clinically Important Difference for Improvement (MCID-I) and Worsening (MCID-W). MethodsA total of 2,448 patients (2,239 pTKAs/209 rTKAs) were retrospectively studied. Patients who completed the Knee Injury and Osteoarthritis Outcome Score-Physical Function Short Form (KOOS-PS), Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 10a (PF10a), PROMIS Global-Mental, or PROMIS Global-Physical questionnaires were identified by Current Procedural Terminology (CPT) codes. Patient-reported outcome measures and MCID-I/MCID-W rates were compared. Multivariate logistic regression models measured relationships between surgery type and postoperative outcomes. ResultsPatients who underwent rTKA (all causes) had lower rates of improvement and higher rates of worsening compared to pTKA patients for KOOS-PS (MCID-I: 54 versus 68%, P < .001; MCID-W: 18 versus 8.6%, P < .001), PF10a (MCID-I: 44 versus 65%, P < .001; MCID-W: 22 versus 11%, P < .001), PROMIS Global-Mental (MCID-I: 34 versus 45%, P = .005), and PROMIS Global-Physical (MCID-I: 51 versus 60%, P = .014; MCID-W: 29 versus 14%, P < .001). Undergoing revision was predictive of worsening postoperatively for KOOS-PS, PF10a, and PROMIS Global-Physical compared to pTKA. Postoperative scores were significantly higher for all 4 PROMs following pTKA. ConclusionPatients reported significantly less improvement and higher rates of worsening following rTKA, particularly for PROMs that assessed physical function. Although pTKA patients did better overall, the improvement rates may be considered relatively low and should prompt discussions on improving outcomes following pTKA and rTKA. Level of EvidenceLevel III, retrospective comparative study.

Investigating the Efficacy and Safety of Diacerein in the Management of Knee Osteoarthritis with reference to its conventional management.

Designated as a "priority disease" by World Health Organization, Osteoarthritis is the most common chronic rheumatic disease. Providing a proper treatment for Osteoarthritis is still a major public health challenge. Diacerein has been proposed as a slow acting, symptom modifying or even disease modifying drug used in Osteoarthritis having a risk-benefit ratio far better than conventionally used drugs. However, the evidence of efficacy and safety of use of Diacerein in Osteoarthritis is yet to be explored. Hence, this study attempted to investigate the efficacy and safety of Diacerein in the management of knee osteoarthritis. This is an analytical cohort study comparing Diacerein with Non-steroidal anti-inflammatory drugs for two months in the management of knee OA. Efficacy was assessed by scores of Lysholm Knee Scoring Scale, Knee injury and Osteoarthritis Outcome Score - Physical Function Short form and Western Ontario and McMaster Universities Osteoarthritis Index. After two months of treatment, the post- treatment scores were significantly superior to the baseline scores in both the treatment groups (p<0.001). There were no significant differences among the post-treatment scores in two different treatment groups (p>0.05). Discoloration of urine and gastritis were the frequently reported adverse effects in Diacerein treatment group and Non-steroidal anti-inflammatory drugs treatment group respectively. Our findings have shown Diacerein is as effective as Non-steroidal anti-inflammatory drugs in treating knee OA patients. Diacerein was generally well tolerated, with a good safety profile. These findings indicate the need for further studies with experimental study design in larger scale.

Do Patients With Hypoallergenic Total Knee Arthroplasty Implants for Metal Allergy Do Worse? An Analysis of Health Care Utilizations and Patient-Reported Outcome Measures

BackgroundMetal allergy is a rare and controversial cause of implant failure and poor outcomes following total knee arthroplasty (TKA). Few studies have investigated clinical and patient-reported outcome measures (PROMs) in patients treated with hypoallergenic implants. This investigation aimed to compare: (1) health care utilizations (eg, hospital length of stay, 90-day readmission rate, and incidence of nonhome discharge) and (2) 1-year PROMs between patients who received hypoallergenic and standard TKA implants. MethodsThis was a retrospective review of prospectively collected data from patients who underwent primary TKA between 2018 and 2019. Propensity score matching (3:1) was used to compare standard TKA patients with those who received hypoallergenic TKA implants, respectively. Knee injury and Osteoarthritis Outcome Score (KOOS) pain, KOOS Physical function Shortform (PS), and Veterans RAND 12-Item Health Survey Mental Component Score were collected preoperatively and at 1-year. After matching, 190 hypoallergenic and 570 standard TKAs were analyzed. ResultsNo differences were observed in length of stay (P = .98), 90-day readmission (P = .89), and nonhome discharge (P = .82). Additionally, there was no significant difference in change from preoperative to 1-year PROMs (KOOS pain, P = .97; KOOS PS, P = .88; Veterans RAND 12-Item Health Survey Mental Component Score, P = .28). Patient-reported satisfaction was similar at 1-year (P = .23). Patients achieved similar rates of Patient Acceptable Symptom State (PASS) and minimal clinically important difference (MCID) for KOOS pain (PASS, P = .77; MCID, P = .33) and KOOS PS (PASS, P = .44; MCID, P = .65). ConclusionPatients treated with hypoallergenic TKA implants for suspected metal allergy had similar outcomes compared to patients who had standard implants and no metal allergy.

Clinical and Radiological Results of Patients Treated with Talon Distalfix Femoral Intramedullary Nail for Femoral Shaft Fractures

Objective: Talon distalfix intramedullary nails have been developed as a solution to the technical difficulties experienced during the placement of locking screws. We aimed to evaluate the radiological and clinical results of retractable talon distal fix for the treatment of femoral shaft fractures.&#x0D; Material and Method: Between January 2017 and January 2022, 28 patients with femoral shaft AO type 32-A and B fractures were treated with Talon distalfix nails. AO Type 32-A and B fractures were included in the study. Demographic characteristics, follow-up times, ASA of Anesthesiologists classification and fracture type were recorded. The duration of the operation, intraoperative blood loss, fluoroscopy time (in min), and time to bone union were recorded. General and technical complications (nonunion, malunion, malrotation, and shortening) were evaluated. Clinical functional outcomes were evaluated using the Knee Injury and the Osteoarthritis Outcome Score Physical Function Shortform (KOOS-PS), Hip Injury and Osteoarthritis Outcome Score Physical Function Shortform (HOOS-PS) and Thoresen criteria.&#x0D; Results: A total of 28 patients (11 female and 17 male) were included in the study. The mean age was 46.8 years and the mean follow-up was 23.7 months. . The mean time to bone union was 22.6 weeks. No nonunion was observed in any of the patients. The mean hospital stay was 3.4 days and the mean Body Mass Index was 24.2. The mean operation time was 40.3±3.4 minutes and the mean scope time was 26.9 seconds. The mean KOOS-PS score and HOOS-PS were 83.4 and 85.6, respectively.&#x0D; Conclusion: Talon distalfix nails can be safely used in AO type A-B fractures of the midshaft femur. Talon distalfix nail application provides advantages including shorter operation times, less radiation exposure, fewer surgical incisions, and less blood loss. In addition, it should be emphasized that the union time is prolonged compared with that of conventional nails.

Intersurgeon Variability of Minimal Clinically Important Difference for Worsening Achievement Rates After Total Joint Arthroplasty

BackgroundUsing the Patient-Reported Outcome Measurement Information System, we sought to evaluate surgeon performance variability via minimal clinically important difference for worsening (MCID-W) achievement rates in primary and revision total knee and hip arthroplasty. MethodsThis retrospective study analyzed 3,496 primary total hip arthroplasty (THA), 4,622 primary total knee arthroplasty (TKA), 592 revision THA, and 569 revision TKA patients. Patient factors collected included demographics, comorbidities, and Patient-Reported Outcome Measurement Information System physical function short form 10a scores. Surgeon factors collected included caseload, years of experience, and fellowship training. The MCID-W rate was calculated as the percent of patients in each surgeon’s cohort who achieved MCID-W. Distribution was presented via a histogram with associated average, standard deviation, range, and interquartile range (IQR). Linear regressions were performed to evaluate the potential correlation between surgeon- and patient-level factors with MCID-W rate. ResultsThe average MCID-W rates of the surgeons represented in the primary THA and TKA cohorts were 12.7 ± 9.2% (range, 0 to 35.3%; IQR, 6.7 to 15.5%) and 18.0 ± 8.2% (range, 0 to 36%; IQR, 14.3 to 22.0%). The average MCID-W rates among the revision THA and TKA surgeons were 36.0 ± 22.2% (range, 9.1 to 90%; IQR, 25.0 to 41.4%) and 21.2 ± 7.7% (range, 8.1 to 37.0%; IQR, 16.6 to 25.4%). Strong correlations were not found between patient- or surgeon-level factors and MCID-W rate of the surgeon. ConclusionWe demonstrated variance in MCID-W achievement rates across surgeons in both primary and revision joint arthroplasty, independent of patient- or surgeon-level factors.

Patient-Reported Outcomes Following Revision Total Hip Arthroplasty Demonstrate Less Improvement and Significantly Higher Rates of Worsening Compared to Primaries

BackgroundPatient-reported outcome measures (PROMs) provide the patient’s perspective following total hip arthroplasty (THA), although differences between primary THA (pTHA) and revision THA (rTHA) remain unclear. Thus, we compared the Minimal Clinically Important Difference for Improvement (MCID-I) and Worsening (MCID-W) in pTHA and rTHA patients. MethodsData from 2,159 patients (1,995 pTHAs/164 rTHAs) who had completed Hip Disability and Osteoarthritis Outcome Score-Physical Function Short Form (HOOS-PS), Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 10a (PF10a), PROMIS Global-Mental, or PROMIS Global-Physical questionnaires were analyzed. The PROMs and MCID-I/MCID-W rates were compared using statistical tests and multivariate logistic regressions. ResultsCompared to the pTHA group, the rTHA group had lower rates of improvement and higher rates of worsening for almost all PROMs, including HOOS-PS (MCID-I: 54 versus 84%, P < .001; MCID-W: 24 versus 4.4%, P < .001), PF10a (MCID-I: 44 versus 73%, P < .001; MCID-W: 22 versus 5.9%, P < .001), PROMIS Global-Mental (MCID-W: 42 versus 28%, P < .001), and PROMIS Global-Physical (MCID-I: 41 versus 68%, P < .001; MCID-W: 26 versus 11%, P < .001). Odds ratios supported rates of worsening following revision for the HOOS-PS (Odds Ratio (OR): 8.25, 95% Confidence Interval (CI): 5.62 to 12.4, P < .001), PF10a (OR: 8.34, 95% CI: 5.63 to 12.6, P < .001), PROMIS Global-Mental (OR: 2.16, 95% CI: 1.41 to 3.34, P < .001), and PROMIS Global-Physical (OR: 3.69, 95% CI: 2.46 to 5.62, P < .001). ConclusionPatients reported higher rates of worsening and lower rates of improvement following rTHA than pTHA, with significantly less score improvement and lower postoperative scores for all PROMs after revision. Most patients reported improvements following pTHA, with few worsening postoperatively. Level of EvidenceLevel III, retrospective comparative study.

Long-term Efficacy of Genicular Nerve Ablation for Chronic Osteoarthritic Knee Pain: A Prospective Observational Longitudinal Study

Objective: When patients with chronic osteoarthritis (OA) knee pain do not respond to conservative treatment and are not suitable for knee arthroplasty, radiofrequency ablation (RFA) of the genicular nerve is probably an alternative treatment. This study aimed to evaluate the efficacy and safety of genicular nerve ablation in severe osteoarthritic knee pain patients. Materials and Methods: Patients with severe chronic OA knee pain were recruited and performed a genicular nerve block (GNB). The patients’ demographic data, numerical rating scale (NRS) at rest and on movement, Thai Oxford knee score (Thai OKS), Thai knee injury and osteoarthritis outcome score physical function short form (Thai KOOS-PS), timed up and go test, brief pain inventory, fall evaluation, and EuroQol 5D-5L were recorded. For the positive block patients (≥50% pain relief for 24 hours), genicular nerve RFA was performed under fluoroscopic or ultrasound guidance. All patients were followed up at the 1st, 3rd, 6th, 9th and 12th months. Results: 21 patients were included in the study, but only 17 were completely followed up for 12 months. At the 12th month, genicular nerve RFA reduced the mean NRS on movement from 7.9±1.6 to 4.0±2.6 (p=0.005), improved knee function (Thai OKS from 18.8±5.3 to 28.5±10.1; p=0.006), but did not significantly improve quality of life (EuroQol-5D-5L from 0.43±0.20 to 0.69±0.33; p=0.130). No adverse events were observed. Conclusion: Genicular nerve radiofrequency ablation in severe chronic OA knee patients demonstrated significant pain relief and functional improvement for up to 12 months without serious adverse events.

Comparison of shock wave therapy and corticosteroid injection in the treatment of greater trochanteric pain syndrome: A single-blind, randomized study.

The aim of this study was to compare the efficacy of the corticosteroid (CS) injection and shock wave therapy (SWT) in the treatment of greater trochanteric pain syndrome (GTPS). Between 2020 September and 2021 October, a total of 60 patients with GTPS (12 males, 48 females; mean age: 50.8±8.5 years; range, 34 to 65 years) were included. The patients were randomly assigned to two groups as the SWT group (n=32) receiving one session of SWT per week for a total of three weeks and CS injection group (n=28) receiving CS and local anesthetic. Both groups were evaluated using the Short Form-36 (SF-36) at baseline and three months and using the Visual Analog Scale (VAS) and Western Ontario and McMaster University Osteoarthritis Index (WOMAC) at baseline, three weeks, and three months. The mean VAS, greater trochanter tenderness, and WOMAC scores of both groups were similar at baseline, while the third-week and three-month scores were significantly lower in both groups compared to baseline (p<0.05). There was no significant difference in the treatment efficacy between the groups (p>0.05). There was a similar improvement in SF-36 physical function, physical role difficulty, and pain subscales in both groups (p<0.05). Our study results show that both CS injection and SWT are effective modalities and none of the treatments is superior to each other.

Custom-made acetabular revision arthroplasty for pelvic discontinuity: Can we handle the challenge? : a prospective cohort study.

The aim of this study was to assess the clinical and radiological results of patients who were revised using a custom-made triflange acetabular component (CTAC) for component loosening and pelvic discontinuity (PD) after previous total hip arthroplasty (THA). Data were extracted from a single centre prospective database of patients with PD who were treated with a CTAC. Patients were included if they had a follow-up of two years. The Hip Disability and Osteoarthritis Outcome Score (HOOS), modified Oxford Hip Score (mOHS), EurQol EuroQoL five-dimension three-level (EQ-5D-3L) utility, and Numeric Rating Scale (NRS), including visual analogue score (VAS) for pain, were gathered at baseline, and at one- and two-year follow-up. Reasons for revision, and radiological and clinical complications were registered. Trends over time are described and tested for significance and clinical relevance. A total of 18 females with 22 CTACs who had a mean age of 73.5 years (SD 7.7) were included. A significant improvement was found in HOOS (p < 0.0001), mOHS (p < 0.0001), EQ-5D-3L utility (p = 0.003), EQ-5D-3L NRS (p = 0.013), VAS pain rest (p = 0.008), and VAS pain activity (p < 0.0001) between baseline and final follow-up. Minimal clinically important improvement in mOHS and the HOOS Physical Function Short Form (HOOS-PS) was observed in 16 patients (73%) and 14 patients (64%), respectively. Definite healing of the PD was observed in 19 hips (86%). Complications included six cases with broken screws (27%), four cases (18%) with bony fractures, and one case (4.5%) with sciatic nerve paresthesia. One patient with concurrent bilateral PD had revision surgery due to recurrent dislocations. No revision surgery was performed for screw failure or implant breakage. CTAC in patients with THA acetabular loosening and PD can result in stable constructs and significant improvement in functioning and health-related quality of life at two years' follow-up. Further follow-up is necessary to determine the mid- to long-term outcome.Cite this article: Bone Jt Open2023;4(2):53-61.

Associations Between Muscle Weakness and Clinical Outcomes in Current and Former Smokers.

Smokers with chronic obstructive pulmonary disease (COPD) are at increased risk of muscle weakness. There are limited data describing weakness in smokers with normal spirometry and preserved ratio-impaired spirometry (PRISm), 2 subgroups at risk of respiratory symptom burden and activity limitations. In this study, we evaluated the associations of 2 weakness measures, sit-to-stand (STS) and handgrip strength (HGS), with clinical outcomes in smokers with COPD, normal spirometry, and PRISm. We evaluated 1972 current and former smokers from the COPD Genetic Epidemiology (COPDGene®) cohort with STS and HGS measurements at their 10-year study visit. Multivariable regression modeling was used to assess associations between weakness measures and the 6-minute walk distance (6MWD) test, the St George's Respiratory Questionnaire (SGRQ), the Short-Form-36 (SF-36), severe exacerbations, and prospective mortality, reported as standardized coefficients (β), odds ratios (ORs), or hazard ratios (HRs). Compared with HGS, STS was more strongly associated with the 6MWD (β=0.45, p<0.001 versus. β=0.25, p<0.001), SGRQ (β=-0.24, p<0.001 versus β=-0.18, p<0.001), SF-36 Physical Functioning (β=0.36, p<0.001 versus β=0.25, p<0.001), severe exacerbations (OR 0.95, p=0.04 versus OR 0.97, p=0.01), and prospective mortality (HR 0.83, p=0.001 versus HR 0.94, p=0.03). Correlations remained after stratification by spirometric subgroups. Compared with males, females had larger magnitude effect sizes between STS and clinical outcomes. STS and HGS are easy to perform weakness measures that provide important information about functional performance, health-related quality of life, severe exacerbations, and survival in smokers, regardless of spirometric subgroup. This iterates the importance of screening current and former smokers for weakness in the outpatient setting.

EFFECT OF THE RESIDENTIAL AREAS OF GERIATRICS LIVING IN TURKEY ON PHYSICAL ACTIVITY, DEPRESSION, AND QUALITY OF LIFE DURING THE COVID-19 PANDEMIC

Objective: The quarantine precautions implemented during the new type of coronavirus epidemic caused some changes in the daily lives of geriatric individuals. This study aimed to examine whether living in rural or urban areas affects physical activity, depression, and quality of life (QoL) in Turkish geriatrics during pandemic.&#x0D; Method: One hundred three geriatrics were assessed with the videoconferencing method, which was performed once. Participants were divided into two groups according to the area where they lived as rural (n:41) or urban (n:62). In addition, physical activity, presence of depression, and QoL of individuals were assessed with the Physical Activity Scale for the Elderly (PASE), Geriatric Depression Scale (GDS), and Short Form-36 (SF-36), respectively.&#x0D; Results: According to the results, PASE (p=0.677), GDS (p=0.742), and all sub-dimensions of SF-36 (p&gt;0.05 for all) except pain (p=0.033) of geriatrics were similar in both groups. Also, while there is a low-level relationship between the GDS scores of those living in rural areas and the sub-dimensions of SF-36 physical function (r=-0.381), mental health (r=-0.381), and social functionality (r=-0.395), there was a moderate correlation between the vitality (r=-0.529) and pain (r=-0.536) sub-dimensions. In addition, a strong correlation was found between GDS and the general health perception sub-dimension of SF-36 (r=-0.611).&#x0D; Conclusion: The pandemic-induced quarantine precautions, which were put into effect throughout Turkey, negatively affected the daily life of all people, especially elderly individuals. Because of these precautions, the similarity of daily living activities of the elderly living in rural and urban areas may have caused similar physical activity, depression, and QoL scores.

Psychiatric symptoms in patients with non-valvular atrial fibrillation

BackgroundAtrial fibrillation (AF) is one of the leading causes of hospitalization and even death worldwide. Complex bidirectional associations have been suggested between psychiatric disorders and AF disease. This study was conducted to investigate the prevalence of psychiatric symptoms in a cohort of Egyptian population presented with symptomatic non-valvular AF (NVAF) and to identify the high-risk subjects in need for professional psychiatric consultation. A total of 100 eligible symptomatic NVAF patients were recruited in this cross-sectional study. Each patient was subjected to: (1) cardiac evaluation included electrocardiogram, trans-esophageal echocardiography, and the European Heart Rhythm Association (EHRA). (2) Psychiatric evaluation consisted of clinical psychiatric interviewing, Hospital Anxiety and Depression Scales (HADS), Mini–Mental State Examination (MMSE), type-D personality screening, and the short form-36 (SF-36) health survey for the assessment of health-related quality of life (HRQoL).ResultsForty-four percent of our enrolled AF patients had anxiety symptoms, 32% had depressive symptoms, 24% had mild cognitive impairment, and 32% had type-D personality. Linear regression analysis demonstrated that the left atrial dimension (LAD) and the age were the main significant predictors of MMSE, while the main predictors of HADS were SF-36 (physical functioning and general health) and the age. Neither psychiatric symptoms, nor type-D personality was a significant predictor for the evaluated cardiac parameters.ConclusionsMild cognitive impairment as well as depressive and anxiety symptoms is not uncommon associates with NVAF patients. Assessment of cognitive function and HRQoL is strongly advised for AF patients presented with enlarged LAD particularly among old adults.

Factors associated with change in health-related quality of life in people with gout: a 3-year prospective cohort study in primary care.

To describe factors associated with change in health-related quality of life (HRQOL) in people living with gout in primary care. In a UK prospective cohort study, adults with a diagnosis of gout registered with 20 general practices completed the Gout Impact Scale (GIS; scale 0-100), 36-item Short Form Physical Function subscale (PF-10; 0-100) and HAQ Disability Index (HAQ-DI; 0-3) via postal questionnaires at baseline and 6, 12, 24 and 36 months. Linear mixed modelling was used to investigate factors associated with changes in HRQOL over 3 years. A total of 1184 participants responded at baseline (adjusted response 65.6%); 990 (83.6%) were male, with a mean age of 65.6 years (s.d. 12.5). A total of 818, 721, 696 and 605 responded at 6, 12, 24 and 36 months, respectively. Factors associated with worse disease-specific and generic HRQOL over 3 years were flare frequency (five or more flares; GIS subscales, PF-10), oligo/polyarticular flares (GIS subscales, PF-10, HAQ-DI), worse pain (GIS subscales, PF-10, HAQ-DI), body pain (GIS subscales, PF-10, HAQ-DI) and more severe depression (GIS subscales, PF-10, HAQ-DI) (P ≤ 0.05). More severe anxiety was associated with worse disease-specific HRQOL only (GIS subscales). Older age (PF-10), being female (PF-10, HAQ-DI) and BMI (HAQ-DI) were associated with worse generic HRQOL (P ≤ 0.05). Gout-specific, comorbid and sociodemographic factors were associated with change in HRQOL over a 3-year period, highlighting people at risk of worse outcomes who could be targeted for interventions.

Influence of Preoperative Disability on Clinical Outcomes in Patients Undergoing Anterior Lumbar Interbody Fusion

Few studies have examined the influence of preoperative disability through the Oswestry Disability Index (ODI) on clinical outcomes in patients undergoing anterior lumbar interbody fusion (ALIF). Patients undergoing ALIF were separated into 2 groups based on ODI<41 (lower disability) versus ODI≥41% (higher disability). Patient-reported outcomes (PROs) were collected at preoperative and postoperative 6-week/12-week/6-month/1-year/2-year time points. Physical function PROs were Patient-Reported Outcomes Measurement Information System Physical Function and 12-item Short Form Physical Component Score. Mental function PROs were 12-item Short Form Mental Component Score and Patient Health Questionnaire-9. Pain PROs were visual analog scale back and visual analog scale leg. ODI was the disability PRO. A total of 148 patients were identified, with 52 patients with lower disability. Higher disability patients demonstrated significant improvement in mental function (P ≤ 0.010, all). Lower disability patients demonstrated superior postoperative PROs in physical function, mental function, back pain, and disability outcomes (P ≤ 0.034, all). Minimum clinically important difference achievement ratesfor lower disability patients were higher for back pain andlower for mental function and disability outcomes (P ≤ 0.041, all). Independent of preoperative disability, patients undergoing ALIF reported significant postoperative improvement in physical function, pain, and disability outcomes. Patients with lower preoperative disability continued to report superior PROs in mental function, back pain, and disability postoperatively. Minimum clinically important difference achievement rates for lower disability patients were higher for back pain and lower in mental function and disability outcomes. Patients undergoing ALIF with higher preoperative disability may experience greater clinically meaningful improvement in mental function and disability.

Is Disease Response a Patient-Centered Clinical Trial Endpoint in Acute Myeloid Leukemia: Differences in Symptom Burden and Physical Function By Response Status in the Beat-AML Master Trial

Objective: To inform regulatory decision making about trial design and drug approval, we examined whether disease response status is a patient-centered endpoint in therapeutic trials for acute myeloid leukemia (AML). Specifically, we estimated the association of response status with patient-reported symptoms and physical function in the Beat-AML Master Trial. Methods: The Beat-AML Master Trial (NCT03013998) is composed of a genomic screening protocol and multiple sub-studies of biomarker-based treatments for sub-types of acute myeloid leukemia. The patient-reported outcome (PRO) assessment occurred at baseline and at specified study visits about once per cycle depending on treatment phase. The PRO assessment included the MD Anderson Symptom Inventory (MDASI) AML/MDS symptom scale (17 items), additional symptom items from the MDASI library relevant to Beat-AML therapies (10 items), and the PROMIS® Physical Function short form (6 items). The two symptom scale scores range from 0-10 where higher scores indicate greater symptom burden; the physical function scale score ranges from 0-100 where higher scores indicate better physical function. Disease response was assessed according to 2017 ELN AML Recommendations, including: complete remission (CR), complete remission without minimal residual disease (CRMRD-), complete remission with hematologic improvement (CRh), complete remission with incomplete blood count recovery (CRi), morphological leukemia free state (MLFS), partial remission (PR), stable disease, progressive disease, recurrence/relapse, and treatment failure. For this analysis, response status was identified for each PRO assessment timepoint. Linear mixed effects models estimated the differences in PRO scores between each response status and CR. The analytic sample was composed of individuals who completed the baseline PRO assessment and at least one PRO assessment post baseline. The minimally important difference (MID) for the PROMIS Physical Function scale is 4 points (Yost, J Clin Epi 2012). The symptom scales do not have established MID, so coefficients were compared to a small effect size (0.20) per Cohen's d. Results: The analytic sample included 240 patients from 11 Beat-AML sub-studies; the median age was 73 years (range: 42-90) and 42.5% were female. Median follow-up time with PRO assessments was 18.4 months. The survey response rate was 80.7%. The mean (standard deviation) PRO scale scores at baseline were: 2.11 (1.67) AML/MDS symptom scale, 1.54(1.54) additional symptoms, and 36.65(9.62) Physical Function. The proportion of patients achieving each response at any point during protocol treatment was 32.1% CR, 7.5% CRMRD-, 6.7% CRh, 23.3% CRi, 19.6% MLFS, 5.8% PR, 73.3% stable disease, 11.7% progressive disease, 20.0% recurrence/relapse, and 7.5% treatment failure, for an average of 2.4 responses per patient. After controlling for age, gender, treatment (sub-study), time since baseline, and adjusting for drop-out missingness, we found that, compared to CR, symptom burden was greater for MLFS and stable disease (coefficient range 0.33 to 0.66) (see Table 1). Symptom burden per the AML/MDS scale only was also greater for recurrence/relapse (coef. 0.49). Physical function was worse (per MID) for MLFS, stable disease, and progressive disease (coefficient range: -4.42 to -4.76). Discussion: PRO data from 11 sub-studies of the Beat AML Master Trial indicate key differences and similarities between disease response statuses in terms of symptom burden and physical function. MLFS was the only type of response that differed from CR with respect to symptom burden and physical function. Stable disease and recurrence/relapse were associated with greater symptom burden than CR, but progressive disease was not, however it was associated with worse physical function. Findings regarding treatment failure may be limited by small sample and wide range of health within that status. Sensitivity analyses will include removing rare symptoms from the symptom scales, which may increase model coefficients. Subsequent analysis will examine the association of the patient's best response status with long term physical function. Conclusion: Further research is warranted to establish the response statuses of CRMRD-, CRh, CRi, and partial remission as clinical trial endpoints that are valuable to patients with respect to health-related quality of life. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

The Impact of Momelotinib on Patient Reported Quality of Life for Symptomatic and Anemic Patients with Myelofibrosis: Results from the Phase 3 Momentum Study

Introduction Disease-related inflammation, anemia and splenomegaly contribute to a host of burdensome symptoms in patients with myelofibrosis (MF), including fatigue, bone pain, night sweats, and others, which can negatively impact health-related quality of life (HRQoL). There are no approved treatments for patients with intermediate- and high-risk MF that specifically target anemia, and approved MF therapies for splenomegaly and symptoms often exacerbate anemia. Momelotinib (MMB) is a Janus kinase (JAK) 1, JAK2, and activin A receptor type 1 (ACVR1) inhibitor with demonstrated symptom, spleen, and anemia benefits in patients with MF. MOMENTUM, a phase 3 study in symptomatic, anemic patients with MF who were previously treated with a JAKi, showed that MMB significantly improved disease-related symptoms compared to danazol (DAN) (24.6% vs 9.2%) as measured by achieving at least a 50% reduction in total symptom score (TSS50) at week 24 compared to baseline. Herein we report the results of patient-reported health status and HRQoL analyses, including impact on fatigue and physical function, for patients treated with MMB compared to DAN in the MOMENTUM study. Methods Patient-reported outcome (PRO) analyses were performed for the following assessments in the intent-to-treat (ITT) population: Myelofibrosis Symptom Assessment Form (MFSAF) v4.0 TSS and individual items, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)-derived scales and items, and Patient-Reported Outcomes Measurement Information System (PROMIS) short form physical function total score 10b and additional PROMIS bank items. Analyses of PRO response were summarized by corresponding meaningful change threshold (MCT) for each PRO. Longitudinal change from baseline scores were analyzed using mixed model for repeated measures (MMRM). Longitudinal responder analyses were performed by generalized estimating equation (GEE) after multiple imputation for missing scores. Odds ratio (OR) for response, 95% confidence interval (CI), and p-value were presented as the treatment effect (MMB vs DAN). Time to first response was analyzed using the Kaplan-Meier method. A stratified log-rank test was performed to compare treatment arms, and hazard ratios (HR) were estimated from a stratified Cox regression model. Results Proportionally greater improvements in MF-related symptoms, physical function, and global quality of life were observed with MMB versus DAN as measured at week 24 by the MFSAF, PROMIS, and EORTC QLQ-C30 questionnaires, respectively. Improvements in all MFSAF individual item scores from baseline at week 24 were greater in the MMB group than in the DAN group based on median scores (Figure 1) and MMRM analysis (Table 1), with the greatest treatment differences noted for night sweats, abdominal discomfort, bone pain, and rib pain, favoring MMB. Longitudinal MFSAF TSS response analysis indicated a higher likelihood of response for patients in the MMB group: an overall OR of 2.50 throughout the 24-week randomized treatment period. HRs for response were greater than 1 (ranging from 1.47 - 3.82) in the time to first response analysis for MFSAF TSS and individual items, excluding itching (0.77), indicating a faster symptom response for more patients in the MMB group for TSS and 6 of 7 individual items. Responder analyses showed that the proportion improved for fatigue was greater in the MMB group based on MFSAF fatigue (18.5% MMB, 9.2% DAN) and EORTC QLQ-C30 fatigue (41.5% MMB, 21.5% DAN), where missing data was considered nonresponse. Consistent with these results, responder analysis using the PROMIS assessments related to physical function also favored MMB (17.7% MMB, 4.6% DAN). This trend was supported by shorter times to first response for physical function in more patients in the MMB group versus the DAN group (HR = 1.93, 95% CI 0.95, 3.91). Improvement in global quality of life as measured by EORTC QLQ-C30 was also greater in the MMB group with a proportion difference of 14.6% between MMB and DAN (95% CI: 1.5-27.7%; p = 0.04). Conclusions Consistent with the positive primary endpoint (TSS50) result of the MOMENTUM study, these responder, longitudinal, and time-to-event analyses demonstrate that MMB provides comprehensive improvements in disease-related symptoms with associated improvement in physical function and overall HRQoL compared with DAN in patients with MF. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Abstract 11123: Effects of Home-Based Ischemic Leg Symptom-Inducing Exercise on Simultaneous Improvement in Treadmill Walking Distance and Patient Reported Outcomes and in Peripheral Artery Disease: The LITE Randomized Clinical Trial

Introduction: An optimal exercise intervention for individuals with peripheral artery disease (PAD) should improve both objective measures of walking and patient reported outcomes (PROs). This study evaluated whether home-based walking exercise conducted at a pace that induced ischemic leg symptoms (high intensity) improved both treadmill walking distance and related PROs more often than walking exercise conducted at a pace that did not induce ischemic leg symptoms (low intensity) and a non-exercise control group (control), respectively. Methods: Post-hoc analysis of PAD patients who participated in the 12-month LITE Trial and were assessed at 12 months follow-up. The LITE Trial randomized people with PAD into home-based high intensity exercise, low intensity exercise, or control. Objective measures of walking were pain-free treadmill walking distance (PFWD) and maximal treadmill walking distance (MWD). PROs related to physical functioning consisted of Walking Impairment Questionnaire (WIQ) and the Short Form-36 (SF-36) physical function score. Participants were categorized into one of four groups at 12-month follow-up: 1) improved both treadmill outcome and PRO, 2) improved treadmill outcome but not PRO, 3) improved PRO but not treadmill outcome; and 4) improved neither treadmill outcome or PRO. Improvement was defined as follow-up score minus baseline &amp;gt0. Results: Of the 305 people with PAD randomized, 186 (61% Black, 46% female) had data for both treadmill testing and at least one PRO available at baseline and 12-month follow-up (age, sex, race). Participants randomized to high intensity exercise were significantly more likely to improve both MWD and WIQ distance and speed (Table), as well as both PFWD and WIQ speed, compared to the other groups. Conclusions: To improve both treadmill outcomes and PROs, patients with PAD should be encouraged to walk for exercise at a pace inducing ischemic leg symptoms, and not at a pace without ischemic leg symptoms.

Higher Dissatisfaction Rate Following Revision Compared With Primary Total Knee Arthroplasty: 1-Year Follow-up of 2151 Primary and 235 Aseptic Revision Surgeries.

Postoperative patient satisfaction is related to preoperative expectations. Information regarding expected results following surgery is therefore important. This study evaluated patient-reported outcome measures (PROMs) and patient satisfaction up to 1 year after primary and aseptic revision total knee arthroplasty (TKA). The study included 2151 primary and 235 aseptic revision TKA surgeries conducted between 2010 and 2018. Pain, Knee Injury and Osteoarthritis Outcome Score-Physical Function-Short Form and European Quality of Life-5 Dimension surveys were recorded preoperatively and at 8 weeks and 1 year. To determine satisfaction, patients were asked to rate their knee function compared with that before surgery and to answer whether they would undergo the surgery again given their current knowledge. Patients who had primary TKA improved in all PROMs in each follow-up up to 1 year, whereas patients who had revision TKA showed improvement at 8 weeks with no further improvement at 1 year. In terms of patient satisfaction, 88% of patients in the primary TKA group reported better knee function, and 87% were willing to have the surgery again at 1 year; the proportions were lower for patients who underwent revision TKA (66% and 68%, respectively). Aseptic revision TKA demonstrates inferior PROMs compared with those of primary TKA 1 year after surgery, and more than 30% of the patients who underwent revision TKA stated that they would not have their TKA revised or were uncertain, given the outcome of the procedure. Thus, patients who are candidates for revision TKA should be informed to expect less of an improvement following revision surgery than with the primary TKA. Our findings can facilitate the shared decision-making process by surgeons and patients based on realistic expectations of surgical outcomes. [Orthopedics. 2023;46(1):e52-e57.].