Health Survey Physical Component Score Research Articles

Stiffness-related disability following long segmental posterior instrumentation and fusion: is it influenced by postoperative spinopelvic alignment?

PurposeThe aims of this study were to investigate the correlations between Chinese version of Lumbar Stiffness Disability Index (C-LSDI) and other clinical outcomes, and to identify the factors independently affecting stiffness-related disability after long-segment fusion in patients with degenerative lumbar scoliosis (DLS).MethodsWe performed a retrospective study of 118 consecutive surgically treated DLS cases at a single institute. Pre- and post-operative radiological parameters and postoperative health related quality of life (HRQOL) were examined to determine their correlation coefficients with postoperative C-LSDI. Patients were divided into two groups by the medium number of postoperative C-LSDI: low-stiffness group (C-LSDI < 48 points) and high-stiffness group (C-LSDI ≥ 48 points). Subsequently, differences between the two groups were assessed, and the presumed factors affecting C-LSDI evaluation were further analyzed.ResultsCoronal parameters and global sagittal parameters showed significant correlations with postoperative C-LSDI. The correlation coefficients between C-LSDI and Oswestry Disability Index (ODI), Japanese Orthopedic Association-29 (JOA-29), the Scoliosis Research Society-22 questionnaire (SRS-22) Function, and the Short Form-36 Health Survey (SF-36) Physical Component Scores were over 0.5. In multiple linear regression, postoperative sagittal vertical axis (β = 0.084, p = 0.025), fusion levels (β = 2.13, p = 0.012), and body mass index (β = 0.867, p = 0.022) were independent related factors for C-LSDI.ConclusionThis study showed that all HRQOLs demonstrated the varying degree of correlations with C-LSDI, of which the ODI, JOA-29, SRS-22 Function, and SF-36 PCS were most relevant, with moderate strength of associations.Moreover, longer fusion levels, higher BMI, and greater postoperative SVA independently affect C-LSDI after long segmental posterior instrumentation and fusion for DLS.

Sustained improvements in patient-reported outcomes after long-term sutimlimab in patients with cold agglutinin disease: results from the CADENZA study open-label extension

Cold agglutinin disease (CAD) is a rare subtype of autoimmune haemolytic anaemia characterised by classical complement pathway-mediated haemolysis, fatigue, and poor quality of life (QoL). Sutimlimab, a C1s inhibitor, rapidly halted haemolysis, and improved patient-reported outcomes (PROs) in patients with CAD in two phase 3 trials (CARDINAL and CADENZA). Here we report PROs from the CADENZA open-label extension (Part B). The first patient was enrolled in CADENZA (NCT03347422) in March 2018 (Part A) and the last patient completed the study in December 2021 (Part B). All patients who completed the 26-week Part A were eligible to receive biweekly doses of sutimlimab in Part B for up to 1 year after the last patient completed Part A. PROs were assessed throughout Part B, until the last on-treatment visit with available assessment (LV), and after a 9-week washout. In total, 32/39 patients completed Part B; median Part B treatment duration: 99 weeks. Patients switching from placebo to sutimlimab in Part B experienced rapid improvement in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score and other PROs. Sustained, clinically important improvements in FACIT-Fatigue were observed throughout Part B in patients who switched to sutimlimab and those continuing sutimlimab treatment (combined-group mean [SE] change from baseline at LV: 8.8 [2.1]). Similarly, the combined-group mean [SE] change for 12-Item Short Form Health Survey physical (4.9 [1.7]) and mental (4.0 [1.8]) component scores exceeded clinically important changes from baseline at LV. EuroQol visual analogue scale showed consistent and sustained increases from baseline with sutimlimab treatment. Following a 9-week washout, all PROs approached baseline values. Continued inhibition of the classical complement pathway with sutimlimab results in meaningful long-term improvements in PROs (fatigue and QoL) in patients with CAD. Sanofi.

Riluzole for Degenerative Cervical Myelopathy

The modified Japanese Orthopaedic Association (mJOA) scale is the most common scale used to represent outcomes of degenerative cervical myelopathy (DCM); however, it lacks consideration for neck pain scores and neglects the multidimensional aspect of recovery after surgery. To use a global statistical approach that incorporates assessments of multiple outcomes to reassess the efficacy of riluzole in patients undergoing spinal surgery for DCM. This was a secondary analysis of prespecified secondary end points within the Efficacy of Riluzole in Surgical Treatment for Cervical Spondylotic Myelopathy (CSM-PROTECT) trial, a multicenter, double-blind, phase 3 randomized clinical trial conducted from January 2012 to May 2017. Adult surgical patients with DCM with moderate to severe myelopathy (mJOA scale score of 8-14) were randomized to receive either riluzole or placebo. The present study was conducted from July to December 2023. Riluzole (50 mg twice daily) or placebo for a total of 6 weeks, including 2 weeks prior to surgery and 4 weeks following surgery. The primary outcome measure was a difference in clinical improvement from baseline to 1-year follow-up, assessed using a global statistical test (GST). The 36-Item Short Form Health Survey Physical Component Score (SF-36 PCS), arm and neck pain numeric rating scale (NRS) scores, American Spinal Injury Association (ASIA) motor score, and Nurick grade were combined into a single summary statistic known as the global treatment effect (GTE). Overall, 290 patients (riluzole group, 141; placebo group, 149; mean [SD] age, 59 [10.1] years; 161 [56%] male) were included. Riluzole showed a significantly higher probability of global improvement compared with placebo at 1-year follow-up (GTE, 0.08; 95% CI, 0.00-0.16; P = .02). A similar favorable global response was seen at 35 days and 6 months (GTE for both, 0.07; 95% CI, -0.01 to 0.15; P = .04), although the results were not statistically significant. Riluzole-treated patients had at least a 54% likelihood of achieving better outcomes at 1 year compared with the placebo group. The ASIA motor score and neck and arm pain NRS combination at 1 year provided the best-fit parsimonious model for detecting a benefit of riluzole (GTE, 0.11; 95% CI, 0.02-0.16; P = .007). In this secondary analysis of the CSM-PROTECT trial using a global outcome technique, riluzole was associated with improved clinical outcomes in patients with DCM. The GST offered probability-based results capable of representing diverse outcome scales and should be considered in future studies assessing spine surgery outcomes.

Gender Differences in Pain, Function, and Quality of Life Five Years Following Primary Total Knee Arthroplasty

BackgroundMultiple authors have sought to determine what patient characteristics influence outcomes after total knee arthroplasty (TKA). The impact of gender on outcomes after TKA remains controversial. Previous studies had less than 5 years of follow-up after TKA. The aim of this evaluation was to determine what differences in pain, function, and quality of life (QoL) exist between female and male patients 5 years after primary TKA. MethodsA prospective, multicenter cohort of 11,602 unilateral primary TKA patients (7,284 females and 4,318 males) was prospectively evaluated. All patients were enrolled in the Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement. Demographic data, musculoskeletal and medical comorbid conditions, and patient-reported outcome measures, including the Knee Injury and Osteoarthritis Outcome (KOOS) and Short-Form (36-item) Health Survey mental component score (MCS) and physical component score (PCS) were collected preoperatively and at 5 years after TKA. Descriptive statistics were generated, and stratified by gender, and differences in pain, function, and QoL between female and male patients were evaluated. Multivariate regression models with a 95% confidence interval (CI) were used to assess the role of patient gender as a predictive factor for KOOS pain and function in daily living (ADL) scores reported 5 years after primary TKA, while adjusting for other variables. ResultsPrior to surgery, female patients reported worse pain (KOOS pain 46 versus 52), function (KOOS ADL 53 versus 59), and QoL (KOOS QoL 26 versus 29) than male patients. The differences in preoperative scores ranged from 2.70 (KOOS QoL) to 6.12 (KOOS ADL). At 5 years after TKA, female patients reported slightly worse pain (87 versus 89), function (85 versus 87), and QoL (74 versus 75) when compared to male patients. The differences in the mean 5-year postoperative KOOS scores (range, 0.99 to 2.73), although statistically significant (P < .001), were clinically negligible. Female patients achieved greater improvement in pain (41 versus 37), function (32 versus 29), and QoL (48 versus 46) scores in comparison to male patients. Female patients also reported lower preoperative PCS global function (33 versus 35) scores, 5-year postoperative PCS scores (45 versus 46), and MCS global mental function scores (52 versus 54). Similarly, the differences in the 5-year postoperative Short-Form (36-item) Health Survey MCS and PCS scores were clinically negligible. Multivariate regression analysis showed that female gender was not independently predictive for either pain (β = −1.08; 95% CI [−1.25 to 1.03] [P = .85]) or function (β = 0.64; 95% CI [−0.51 to 1.79] [P = .28]) 5 years after surgery. ConclusionsThere are no clinically significant gender differences in pain, function, or QoL 5 years after TKA. Female patients typically have worse symptoms prior to surgery, improve more than male patients, and end up with pain, function, and QoL scores clinically equal to male patients. These data can enhance the shared decision-making process between female patients and surgeons and assist in setting appropriate patient expectations prior to TKA.

The Mediating Role of Pain Cognitions and Pain Sensitivity in the Treatment Effect of Perioperative Pain Neuroscience Education in People Undergoing Surgery for Lumbar Radiculopathy

Though perioperative pain neuroscience education (PPNE) positively influences patients’ surgical outcomes, little is known about the mechanisms behind this treatment’s success. Therefore, this study aims to evaluate the potential mediating role of pain cognitions and pain sensitivity in the treatment effect of PPNE on postoperative quality of life in people undergoing surgery for lumbar radiculopathy. This secondary analysis uses data from 120 participants of a randomized controlled trial who were randomized to receive either PPNE or perioperative biomedical education before undergoing surgery for lumbar radiculopathy. Quality of life was assessed 1-year postsurgery using the short form 36-item health survey (SF36) physical and mental component scores. Potential mediators included pain cognitions (ie, kinesiophobia, pain catastrophizing, and hypervigilance) and pain sensitivity (ie, endogenous nociceptive modulation), assessed 6 weeks postsurgery. Mediation models were constructed using structural equation modeling, and 95% confidence intervals (CIs) were calculated using 10,000 bootstrap samples. Analyses show a significant total effect for PPNE (estimate = .464, 95% CI [.105, .825]) and a significant indirect effect via pain catastrophizing on the SF36 physical component (estimate = .124, 95% CI [.001, .293]). No mediating effect was found through the remaining pain cognitions or pain sensitivity measures. Also, no potential mediators were identified for the treatment effect of PPNE on the SF36 mental component. Our findings suggest that pain catastrophizing mediates the treatment effect of PPNE on physical health-related quality of life in people undergoing surgery for lumbar radiculopathy. PerspectiveThis secondary analysis identified pain catastrophizing as a mediator for PPNE in people undergoing surgery for lumbar radiculopathy. More so, its findings indicate that this educational intervention can enhance the postoperative physical health-related quality of life of these patients by addressing their catastrophizing thoughts. Trial registrationClinicaltrials.gov (NCT02630732).

Decreased Effective Patellar Tendon Length following Distalization Tibial Tubercle Osteotomy without Patellar Tendon Tenodesis.

Distalization tibial tubercle osteotomy (TTO) is an effective treatment for improving patellar height in patients with patella alta associated with patellofemoral instability and cartilage lesions. The addition of a patellar tendon tenodesis has been suggested; nonetheless, concerns exist regarding possible increased patellofemoral cartilage stresses. To evaluate pre- and postoperative patellar tendon length and alignment parameters on magnetic resonance imaging (MRI), as well as patient-reported outcome measures (PROMs) after distalization TTO without patellar tendon tenodesis. Case series; Level of evidence, 4. Twenty skeletally mature patients who underwent distalization TTO with or without anteromedialization at our institution between December 2014 and August 2021 were included. All patients underwent pre- and postoperative MRIs of the affected knee. The Caton-Deschamps index (CDI), the axial and sagittal tibial tubercle-trochlear groove (TT-TG) distances, the distances from the tibial plateau to the patellar tendon insertion and the tibial tubercle, and the patellar tendon length were assessed. PROMs included the International Knee Documentation Committee Subjective Knee Evaluation Form, the Knee injury and Osteoarthritis Outcome Score-Quality of Life subscale, the Kujala Anterior Knee Pain Scale, and the Veterans RAND 12-Item Health Survey mental and physical component scores. The mean patient age at surgery was 27.4 years (range, 14-42 years). Radiographic parameters demonstrated improved patellar height (CDI decreased from 1.36 to 1.11; P < .001) after distalization TTO. The distance from the tibial plateau to the patellar tendon insertion significantly decreased from 20.1 mm preoperatively to 17.9 mm postoperatively (P < .020), and the patellar tendon length decreased from 53.4 mm preoperatively to 46.0 mm postoperatively (P < .001). The patellar tendon insertion was not distalized after distalization TTO, likely because of scarring of the patellar tendon proximal to the osteotomy site. Patients demonstrated significant pre- to postoperative improvements on all PROMs (P≤ .024 for all ). There were 4 (20%) complications-2 cases of arthrofibrosis, 1 postoperative infection, and 1 osteotomy delayed union. Distalization TTO without patellar tendon tenodesis was associated with improved radiographic outcomes and PROMs. It provides an additional tool for surgical management of patellofemoral pathology with associated patella alta.

Minimally invasive sacroiliac joint fusion using triangular titanium implants versus nonsurgical management for sacroiliac joint dysfunction: a systematic review and meta-analysis.

Minimally invasive sacroiliac joint (MISIJ) fusion is a surgical option to relieve SIJ pain. The aim of this systematic review and meta-analysis was to compare MISIJ fusion with triangular titanium implants (TTI) to nonoperative management of SIJ dysfunction. We searched MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials. We included prospective clinical trials that compared MISIJ fusion to nonoperative management in individuals with chronic low back pain attributed to SIJ dysfunction. We evaluated pain on visual analogue scale, Oswestry Disability Index (ODI) score, health-related quality of life (HRQoL) using the 36-Item Short Form Health Survey (SF-36) physical component (PCS) and mental component summary (MCS) scores, patient satisfaction, and adverse events. A total of 8 articles representing 3 trials that enrolled 423 participants were deemed eligible. There was a significant reduction in pain score with MISIJ fusion compared with nonoperative management (standardized mean difference [SMD] -1.71, 95% confidence interval [CI] -2.03 to -1.39). Similarly, ODI scores (SMD -1.03, 95% CI -1.24 to -0.81), SF-36 PCS scores (SMD 1.01, 95% CI 0.83 to 1.19), SF-36 MCS scores (SMD 0.72, 95% CI 0.54 to 0.9), and patient satisfaction (odds ratio 6.87, 95% CI 3.73 to 12.64) were significantly improved with MISIJ fusion. No significant difference was found between the 2 groups with respect to adverse events (SMD -0.03, 95% CI -0.28 to 0.23). Our analysis showed that MISIJ fusion with TTI shows a clinically important and statistically significant improvement in pain, disability score, HRQoL, and patient satisfaction with a similar adverse event profile to nonoperative management in patients with chronic low back pain attributed to SIJ dysfunction.

To Stage or Not to Stage? Comparison of Patient-Reported Outcomes, Complications, and Discharge Disposition After Staged and Simultaneous Bilateral Posterior Total Hip Arthroplasty

BackgroundPatients who have bilateral hip arthritis can be treated with bilateral total hip arthroplasty (bTHA) in either a staged or simultaneous fashion. The goal of this study was to determine whether staged and simultaneous posterior bTHA patients differ in regard to (1) patient-reported outcome measures, (2) 90-day complication rates, and (3) discharge dispositions and cumulative lengths of stay. MethodsPatients who (1) underwent simultaneous bTHA or staged bTHA (within 12 months) using the posterior approach, and (2) completed preoperative and 1-year postoperative Hip dysfunction and Osteoarthritis Outcome Score for Joint Replacement surveys were included in the study. A total of 266 patients (87 simultaneous bTHA and 179 staged bTHA) were included. Chart review was performed to collect patient-level variables, postoperative complications, discharge dispositions, and lengths of stay. ResultsStaged bTHA patients had higher Hip dysfunction and Osteoarthritis Outcome Score for Joint Replacement, Lower Extremity Activity Scale, and Veterans RAND 12-Item Health Survey physical component scores compared to simultaneous bTHA patients at 6 weeks after surgery (P = .019, .006, and .008, respectively), but these differences did not meet the minimal clinically important difference threshold for any questionnaire. Simultaneous bTHA was associated with higher rate of periprosthetic fractures (P = .034) and discharge to a location other than home (P < .001). ConclusionsThere were statistically significant, but likely not clinically meaningful differences in patient-reported outcomes for staged and simultaneous bTHA patients at 6 weeks after surgery. Surgeons should be aware of the higher periprosthetic fracture risk and greater likelihood of discharge to a rehabilitation facility associated with simultaneous bTHA. Further research should aim to understand which patients may benefit most from simultaneous bTHA.

Association of radiological severity of hip involvement with clinical characteristics and sagittal spinopelvic balance in patients with ankylosing spondylitis.

This is the first study to analyze the associations between the radiological severity of hip involvement with clinical characteristics and sagittal spinopelvic balance in patients with ankylosing spondylitis (AS). We evaluated 182 patients with AS who were referred to outpatient clinics. Patient demographic data and clinical and radiographic parameters were collected. Patients were divided into three groups based on the Bath Ankylosing Spondylitis Radiology Hip Index. Clinical characteristics and spinopelvic parameters acquired by a low-dose biplanar imaging system were evaluated among these groups. Patients with more severe hip involvement were older and had longer disease duration and diagnostic delay, with lower Harris Hip Score (p < 0.001) and 12-item Short Form Health Survey Physical Component Score (p < 0.001) and higher Bath Ankylosing Spondylitis Disease Activity Index (p = 0.030) and Functional Index (p < 0.001). Patients with more severe hip involvement had significantly higher sacroiliac grade (p < 0.001) and higher modified Stoke Ankylosing Spondylitis Spinal Score (p < 0.001). Patients with moderate and severe hip involvement had similar lumbar lordosis and spino-sacral angle, whereas patients with severe hip involvement had lower pelvic tilt, pelvic femoral angle, higher sacral slope, and sagittal vertical axis. The severity of hip involvement is associated with physical function and is not consistent with the severity of spinal involvement. Severe hip involvement impairs the ability to retrovert the pelvis to accommodate the sagittal deformity, and spinopelvic parameters should be concretely evaluated in preoperative counseling of patients with AS waiting for total hip arthroplasty. Key Points • The severity of hip involvement in patients with AS is associated with physical function. • Severe hip involvement impairs the ability to retrovert the pelvis to accommodate the sagittal deformity.

Efficacy and safety of givosiran for acute hepatic porphyria: Final results of the randomized phase III ENVISION trial

Acute hepatic porphyria (AHP) is caused by defects in hepatic heme biosynthesis, leading to disabling acute neurovisceral attacks and chronic symptoms. In ENVISION (NCT03338816), givosiran treatment for 6 months reduced attacks and other disease manifestations, compared with placebo. Here we report data from the 36-month final analysis of ENVISION. Ninety-four patients with AHP (age ≥12 years) and recurrent attacks were randomized 1:1 to monthly double-blind subcutaneous givosiran 2.5mg/kg (N=48) or placebo (N=46) for 6 months. In the open-label extension (OLE) period, 93 patients received givosiran 2.5 or 1.25mg/kg for 6 months or more before transitioning to 2.5mg/kg. Endpoints were exploratory unless otherwise noted. During givosiran treatment, median annualized attack rate (AAR) was 0.4. Through Month 36, annualized days of hemin use remained low in the continuous givosiran group (median, 0.0 to 0.4) and decreased in the placebo crossover group (16.2 to 0.4). At end of OLE, in the continuous givosiran and placebo crossover groups, 86% and 92%, respectively, had 0 attacks. AAR was lower than historical AAR in 98% and 100%, respectively (post hoc analysis), and there were 0 days of hemin use in 88% and 90%, respectively. The 12-item Short Form Health Survey physical and mental component scores increased by 8.6 and 8.1, respectively (continuous givosiran) and 9.4 and 3.2, respectively (placebo crossover). EQ-5D health-related questionnaire scores increased by 18.9 (continuous givosiran) and 9.9 (placebo crossover). Lowering of urinary delta-aminolevulinic acid and porphobilinogen levels was sustained. Safety findings demonstrated a continued positive risk/benefit profile for givosiran. Long-term monthly givosiran treatment provides sustained and continued improvement in clinical manifestations of AHP. Acute hepatic porphyria (AHP) is a group of rare, chronic, multisystem disorders associated with overproduction and accumulation of neurotoxic heme intermediates (delta-aminolevulinic acid [ALA] and porphobilinogen [PBG]), sometimes resulting in recurrent acute attacks and long-term complications. Givosiran, a small interfering RNA that prevents accumulation of ALA and PBG, is approved for the treatment of AHP. These final 36-month results of ENVISION, a phase 3 study of givosiran in patients with AHP and recurrent attacks, show that long-term monthly treatment with givosiran leads to continuous and sustained reductions in annualized attack rate and use of hemin over time, as well as improved quality of life, with an acceptable safety profile. These results are important to physicians, patients, families, and caregivers who are grappling with this debilitating and potentially life-threatening disease with few effective and tolerable treatment options. NCT03338816.

Long-term sutimlimab improves quality of life for patients with cold agglutinin disease: CARDINAL 2-year follow-up

AbstractCold agglutinin disease (CAD) is a rare form of autoimmune hemolytic anemia with a substantial burden on patient’s quality of life. CARDINAL was a 2-part, open-label, single-arm, multicenter phase 3 study evaluating the C1s inhibitor, sutimlimab, for treatment of CAD. Part A consisted of the pivotal study phase, with the part B extension phase assessing long-term safety and durability of response including patient-reported outcomes, which is the focus of this report. Altogether, 22 patients continued from part A to part B, majority female (68.2%) with a median age of 71.5 years (range, 55-85). Throughout treatment, score improvement on the Functional Assessment of Chronic Illness Therapy (FACIT)–Fatigue scale exceeded a predefined, group-level clinically important change of ≥5 points vs baseline, with a mean (standard error [SE]) change of 11.7 (3.7) points at week 135. The 12-Item Short Form Health Survey physical and mental component scores remained above baseline, with week 123 mean change (SE) exceeding clinically important changes of 3.9 for physical and 2.8 for mental component scores at 4.7 (2.8) and 3.8 (5.7) points, respectively. EuroQol Visual Analogue Scale, scoring patients’ self-rated health, also remained above baseline with a change of 17.1 (5.6) points at week 135. Patient Global Impression of (fatigue) Severity improved vs baseline, corroborating FACIT-Fatigue scores. Patient Global Impression of Change indicated a reduction in perceived disease burden. Data from CARDINAL part B support sustained alleviation of CAD disease burden after long-term treatment with sutimlimab over 2 years, returning toward baseline upon treatment cessation. This trial was registered at www.clinicaltrials.gov as #NCT03347396.

Non-esterified erythrocyte linoleic acid, arachidonic acid, and subjective sleep outcomes

ObjectiveThis study investigated whether non-esterified erythrocyte omega-6 PUFAs were associated with subjective assessment of sleep quality and duration, and risk for obstructive sleep apnea. MethodsIn this secondary analysis of the cross-sectional OPPERA-II study, 538 adults completed the Pittsburgh Sleep Quality Index (PSQI), reported their usual hours of sleep, and answered STOP screening questions for obstructive sleep apnea. Circulating non-esterified erythrocyte concentrations of omega-6 PUFA linoleic acid and arachidonic acid were quantified by liquid chromatography tandem mass spectroscopy. Sleep outcomes were dichotomized as poor (PSQI ≤5) vs good (PSQI ≥6) sleep quality, insufficient or excessive (≤6 or >9 h) vs good (7-9 h) sleep duration, and high (≥2 affirmative responses) vs low (<2 affirmative responses) risk for obstructive sleep apnea. Non-esterified omega-6 PUFAs and the continuous covariates of body mass index, Short Form (SF) 12 Health Survey Physical and Mental Component scores and resting measures of systolic and diastolic blood pressure were standardized for multivariable analysis. Categorical covariates were study site, age, sex, and race/ethnicity. Multivariable-adjusted logistic regression first estimated odds ratios (OR) and 95% confidence limits (CL) for sleep outcomes using linoleic acid as the main exposure. Analysis was then repeated using arachidonic acid as the main exposure. ResultsIn the multivariable-adjusted model, each standard deviation increase in non-esterified erythrocyte linoleic acid was associated with higher odds of poor sleep quality (OR=1.2, 95% CL: 1.1, 1.5), insufficient or excessive sleep (OR= 1.3, 95% CL: 1.1, 1.6) and high-risk for obstructive sleep apnea (OR=1.3, 95% CL: 1.1, 1.6). Likewise, for each standard deviation increase in non-esterified erythrocyte arachidonic acid, odds increased of poor sleep quality (OR=1.2, 95% CL: 1.1, 1.5), and insufficient or excessive sleep (OR=1.2, 95% CL: 1.1, 1.5). Odds of being high risk for obstructive sleep apnea increased with greater circulating arachidonic acid, but the association did not reach statistical significance (OR=1.1, 95% CL: 0.9, 1.4). ConclusionNon-esterified erythrocyte linoleic acid and arachidonic acid were associated with poor sleep quality and insufficient or excessive sleep duration. Linoleic acid, but not arachidonic acid, was also associated with high risk for obstructive sleep apnea.

Improvement in predominant back pain following minimally invasive decompression for spinal stenosis.

The objective of this study was to assess the outcomes of patients with predominant back pain (pBP) undergoing minimally invasive decompression surgery compared with patients with nonpredominant back pain (npBP). This was a retrospective cohort study. Patients were divided into two groups based on the presenting complaint: 1) pBP, defined as visual analog scale (VAS) back pain score > VAS leg pain score; and 2) npBP. Changes in patient-reported outcome measures (PROMs) were compared at the early (< 6 months) and late (≥ 6 months) postoperative time points. Outcomes measures were: 1) PROMs (Oswestry Disability Index [ODI], VAS back and leg pain scores, 12-Item Short-Form Health Survey Physical Component Score [SF-12 PCS], and Patient-Reported Outcomes Measurement Information System Physical Function [PROMIS PF]), and 2) minimal clinically important difference (MCID) achievement rate and time. For the late MCID achievement point, a second analysis was conducted restricting VAS back and leg pain scores only to patients with preoperative scores ≥ 5. Three hundred ninety patients were included (126 with pBP and 264 with npBP). There were no differences in patient demographics and operated levels. There were no differences in preoperative ODI, SF-12 PCS, and PROMIS PF scores. The pBP cohort had a significantly greater preoperative VAS back pain score than the npBP cohort, whereas the npBP cohort had a significantly greater preoperative VAS leg pain score than the pBP cohort. There were no differences in the absolute values or changes in ODI, VAS back pain, SF-12 PCS, and PROMIS PF scores at any time point. There was a significant difference in the early VAS leg pain scores (greater in npBP) that disappeared by the late postoperative time point. There was no difference in the MCID achievement rate in the ODI, SF-12 PCS, or PROMIS PF scores. By the late postoperative time point, 51.2% and 55.3% achieved an MCID on the ODI, 58.1% and 62.7% on the SF-12 PCS, 60% and 67.6% on the PROMIS PF, 81.1% and 73.2% on VAS back pain scores for those with preoperative scores ≥ 5, and 72% and 83.6% on VAS leg pain scores for those with preoperative scores ≥ 5 for the pBP and npBP cohorts, respectively. Additionally, there were no differences in time to MCID achievement for any PROMs. The pBP and npBP cohorts showed similar improvement in PROMs and MCID achievement rates. This result shows that minimally invasive laminectomy is equally effective for patients presenting with pBP or npBP.

Demographic, Clinical, and Psychosocial Predictors of Exercise Adherence: The STRRIDE Trials.

To identify baseline demographic, clinical, and psychosocial predictors of exercise intervention adherence in the Studies of a Targeted Risk Reduction Intervention through Defined Exercise (STRRIDE) trials. A total of 947 adults with dyslipidemia or prediabetes were enrolled into an inactive control group or one of ten exercise interventions with doses of 10-23 kcal/kg/week, intensities of 40-80% of peak oxygen consumption, and training for 6-8-months. Two groups included resistance training. Mean percent aerobic and resistance adherence were calculated as the amount completed divided by the prescribed weekly minutes or total sets of exercise times 100, respectively. Thirty-eight clinical, demographic, and psychosocial measures were considered for three separate models: 1) clinical + demographic factors, 2) psychosocial factors, and 3) all measures. A backward bootstrapped variable selection algorithm and multiple regressions were performed for each model. In the clinical and demographic measures model (n=947), variables explained 16.7% of the variance in adherence (p<0.001); lesser fasting glucose explained the greatest amount of variance (partial R2 = 3.2%). In the psychosocial factors model (n=561), variables explained 19.3% of the variance in adherence (p<0.001); greater 36-Item Short Form Health Survey (SF-36) physical component score explained the greatest amount of variance (partial R2 = 8.7%). In the model with all clinical, demographic, and psychosocial measures (n=561), variables explained 22.1% of the variance (p<0.001); greater SF-36 physical component score explained the greatest amount of variance (partial R2 = 8.9%). SF-36 physical component score was the only variable to account for >5% of the variance in adherence in any of the models. Baseline demographic, clinical, and psychosocial variables explain approximately 22% of the variance in exercise adherence. The limited variance explained suggests future research should investigate additional measures to better identify participants who are at risk for poor exercise intervention adherence.

The Role of Severe Lateral Facet Patellar Osteoarthritis in Patient Selection for Success of a Medial Unicompartmental Knee Arthroplasty: Mean Follow-Up of 10 Years

BackgroundLateral facet patellar osteoarthritis (LFPOA) has been reported as a contraindication for medial unicompartmental (UKA). The purpose of this paper was to determine if severe LFPOA was related to lower survivorship and patient-reported outcomes following medial UKA. MethodsA total of 170 medial UKAs were performed. Severe LFPOA was defined as Outerbridge grade 3 to 4 damage on the lateral facet cartilage surfaces of the patella as noted intraoperatively. There were 122 of 170 patients (72%) who had noLFPOA and 48 of 170 patients (28%) who had had severe LFPOA. A routine patelloplasty was performed in all patients. Patients completed the Veterans RAND 12-Item Health Survey (VR-12) Mental Component Score (MCS) and Physical Component Score (PCS), Knee Injury and Osteoarthritis Outcome Score (KOOS), and Knee Society Score. ResultsThere were 4 patients in the noLFPOA group who required total knee arthroplasty and 2 in the LFPOA group. There was no significant difference in mean survival time: noLFPOA = 17.2 years [95% confidence interval (CI): 17 to 18] and LFPOA = 18.0 years [95% CI: 17 to 19] (P = .94). At mean follow-up of 10 years, there were no significant differences in knee flexion or extension. Patello-femoral crepitus without pain was noted in 7 patients who had LFPOA and 21 patients who had noLFPOA. There were no significant differences in VR-12 MCS, PCS, KOOS subscales, or Knee Society Score between groups. Patient acceptable symptom state (PASS) was achieved in 80% (90 of 112) for KOOS ADL in the noLFPOA group and 82% (36 of 44) in the LFPOA group (P = .68). PASS was achieved in 82% (92 of 112) for KOOS Sport in the noLFPOA group and 82% (36/44) in the LFPOA group (P = .87). ConclusionAt a mean of 10 years, patients who had LFPOA had equivalent survivorship and functional outcomes to patients who did not have LFPOA. These long-term results suggest that asymptomatic grade 3 or 4 LFPOA is not a contraindication to medial UKA.

Correlation Between Periprocedural Myocardial Infarction, Mortality, and Quality of Life in Coronary Revascularization Trials: A Meta-analysis.

The prognostic importance of periprocedural myocardial infarction (pMI) and its inclusion in the composite outcomes of coronary revascularization trials are controversial. We assessed whether pMI is a surrogate for all-cause or cardiac mortality and quality of life (QoL) outcomes in coronary revascularization trials. All randomized trials comparing percutaneous coronary intervention vs coronary artery bypass grafting (MEDLINE, EMBASE, Cochrane Library) were identified. Trials were included if they reported data for pMI and mortality. Trial-level associations between pMI and all-cause or cardiac mortality and QoL were assessed using the coefficient of determination (R 2 ). The criterion for surrogacy was set at 0.7. Subgroup analyses based on pMI definition and on key clinical/procedural variables were performed. Twelve trials were included (11,549 patients; weighted mean follow-up: 5.6 years). There was a positive correlation between pMI and all-cause mortality (slope, 1.81; 95% CI, 1.00-2.63; R 2 = 0.72). In the trials that defined pMI as a rise in cardiac biomarkers >5 times the upper reference limit, pMI positively correlated with both all-cause (slope, 2.07; 95% CI, 1.00-3.14; R 2 = 0.93) and cardiac mortality (slope, 0.70; 95% CI, 0.20-1.19; R 2 = 0.87); no such relationships were present in trials that used a lower biomarker threshold. An inverse correlation was found between pMI and long-term changes in the Short Form Health Survey Physical Component score (slope, -4.66; 95% CI, -5.75 to -3.57; R 2 =0.99). In the published coronary revascularization trials, pMI defined by larger biomarker elevations was associated with subsequent mortality and reduced QoL. These findings suggest that large pMI should be included as an outcome measure in coronary revascularization trials.

Changes in health-related quality of life and associations with improvements in clinical efficacy: a Phase 2 study of mirikizumab in patients with ulcerative colitis

ObjectiveMirikizumab, a monoclonal antibody targeting the interleukin-23 p19 subunit, was effective in a Phase 2 study (NCT02589665) of moderately-to-severely active ulcerative colitis (UC). We studied mirikizumab’s impact on health-related quality...

Effect of a Remotely Delivered Self-directed Behavioral Intervention on Body Weight and Physical Health Status Among Adults With Obesity

The effectiveness of remotely delivered, self-directed, weight loss programs in routine clinical practice is largely unknown. To test whether a self-directed, remotely administered behavioral lifestyle intervention improves weight and self-reported general health status compared with usual care. In this randomized clinical trial, 511 adults with a body mass index (BMI) of 30 or more and less than 45 (based on electronic health record [EHR] weight and height), were enrolled from 30 Veterans Health Administration (VHA) sites between February 15, 2018, and December 18, 2018 (final follow-up February 18, 2021). Participants were randomly assigned to the intervention group (n = 254) or the control group (n = 257). Both received usual care. Participants randomized to the intervention received Diabetes Prevention Program-based self-directed videos, handouts, and coaching messages via an online platform or US mail for 12 months. Coprimary outcomes were weight measured in primary care and recorded in the EHR and self-reported general health status using the Medical Outcomes Study 12-Item Short Form Health Survey (SF-12) physical component score (PCS; higher scores are better [range, 0-100]) at the 12-month follow-up. The between-group minimal clinically important differences are 3 kg for weight and 5 points for the SF-12 PCS. Linear mixed models used weights and SF-12 PCS measured at either time point, with participants analyzed according to randomization assignment. Statistical significance for each coprimary outcome was based on a 2-sided α level of .025. Among 511 participants randomized (mean age, 57.4 [SD, 13.9] years; 231 female [45%]), 429 (84.0%) had EHR-based weights and 410 (80.2%) had SF-12 PCS data at 12 months. The unadjusted mean weight at 12 months declined from 102.7 kg to 99.8 kg in the intervention group compared with 101.9 kg to 101.0 kg in the control group (adjusted between-group mean difference, -1.93 [97.5% CI, -3.24 to -0.61]; P = .001). At 12 months, the unadjusted mean SF-12 PCS scores declined from 44.8 to 44.3 among intervention participants compared with 44.5 to 43.2 among control participants (adjusted between-group mean difference, intervention minus control, 0.69 [97.5% CI, -1.11 to 2.49]; P = .39). Cardiovascular events represented the highest percentage of serious adverse events, accounting for 25% of events in the intervention group and 35% in the control group. Among adults with obesity, a remotely delivered self-directed, behavioral lifestyle intervention, compared with usual care, resulted in statistically significantly greater weight loss at 12 months, although the difference was not clinically important. There was no significant difference in self-reported general physical health status at 12 months. ClinicalTrials.gov Identifier: NCT03260140.

Examining the Delivery of a Tailored Chinese Mind-Body Exercise to Low-Income Community-Dwelling Older Latino Individuals for Healthy Aging: Feasibility and Acceptability Study.

BackgroundOlder Latino individuals are disproportionally affected by various chronic conditions including impairments in physical and cognitive functions, which are essential for healthy aging and independent living.ObjectiveThis study aimed to evaluate the feasibility and acceptability of FITxOlder, a 12-week mind-body exercise program, in community-dwelling low-income, predominantly older Latino individuals, and assess its preliminary effects on health parameters relevant to healthy aging and independent living.MethodsThis 12-week, single-arm, stage 1B feasibility study had a pre- and poststudy design. A total of 13 older adults (mean age 76.4, SD 7.9 years; 11/13, 85% Latino) of a congregate meal program in a senior center were enrolled. FITxOlder was a tailored Chinese mind-body exercise program using Five Animal Frolics led by a bilingual community health worker (CHW) participating twice a week at the senior center and facilitated by mobile health technology for practice at home, with incrementally increasing goals moving from once a week to at least 3 times a week. The feasibility and acceptability of the study were examined using both quantitative and qualitative data. Healthy aging–related outcomes (eg, physical and cognitive function) were assessed using paired 2-tailed t tests. Qualitative interview data were analyzed using thematic analysis.ResultsThe attendance rate for the 24 exercise sessions was high (22.7/24, 95%), ranging from 93% (1.8/2) to 97% (1.9/2) over the 12 weeks. Participants were compliant with the incremental weekly exercise goals, with 69.2% (9/13) and 75.0% (9/12) meeting the home and program goals in the last 4 weeks, respectively. Approximately 83% (10/12) to 92% (11/12) of the participants provided favorable feedback on survey questions regarding the study and program implementation, such as program content and support, delivery by the CHW, enjoyment and appeal of the Five Animal Frolics, study burden and incentives, and safety concerns. The qualitative interview data revealed that FITxOlder was well accepted; participants reported enjoyment and health benefits and the desire to continue to practice and share it with others. The 5-time sit-to-stand test (mean change at posttest assessment=−1.62; P<.001; Cohen d=0.97) and 12-Item Short Form Health Survey physical component scores (mean change at post intervention=5.71; P=.01; Cohen d=0.88) exhibited changes with large effect sizes from baseline to 12 weeks; the other parameters showed small or medium effect sizes.ConclusionsThe research findings indicated that the CHW-led and mobile health–facilitated Chinese qigong exercise program is feasible and acceptable among low-income Latino older adults. The trending health benefits of the 12-week FITxOlder program suggest it is promising to promote physical activity engagement in underserved older populations to improve health outcomes for healthy aging and independent living. Future research with larger samples and longer interventions is warranted to assess the health benefits and suitability of FITxOlder.

Majority of patients find sleep patterns return to normal 6 months following rotator cuff repair.

Rotator cuff tears have a wide variability in presentation, with some causing pain and reduced function but others remaining completely asymptomatic. Sleep disturbances are a primary driver for patients with rotator cuff tears to see a physician, and one of the main goals of rotator cuff repair (RCR) surgery is to restore normal sleep patterns in these patients. The primary purpose of this study aimed to determine the percentage of patients undergoing RCR who report preoperative sleep disturbances. Second, this study sought to identify at what postoperative follow-up intervals patients stopped reporting sleep disturbances and how the percentages change over time. It was hypothesized that the majority of patients undergoing arthroscopic RCR would report preoperative and initial postoperative sleep disturbances and that 75% of patients would report resolution of sleep disturbances by 1 year postoperatively. A total of 326 patients undergoing primary arthroscopic RCR were prospectively enrolled in this study. Validated patient-reported outcome measures were obtained preoperatively and postoperatively, including the visual analog pain scale score, American Shoulder and Elbow Surgeons score, Single Assessment Numeric Evaluation score, Simple Shoulder Test (SST) score, and Veterans RAND 12-Item Health Survey physical and mental component scores. According to question 2 of the SST, 291 patients (89%) reported preoperative sleep disturbances. Within the cohort of patients who reported resolution of sleep disturbances, 46% reported resolution by 3 months postoperatively; an additional 31%, by 6 months; a further 14%, by 12 months; and the final 8%, by 24 months. Age ≥ 65 years was significantly associated with increased reporting of resolution compared with age < 65 years. All patient-reported outcome measures, including the visual analog pain scale score, American Shoulder and Elbow Surgeons score, Single Assessment Numeric Evaluation score, SST score, and Veterans RAND 12-Item Health Survey (physical component) score, showed statistically significant improvements after surgery. Eighty-nine percent of patients reported preoperative sleep disturbances. Seventy-seven percent of patients reported resolution of sleep disturbances by 6 months postoperatively, and 81% of patients reported resolution of sleep disturbances by 2 years postoperatively.