SF-36 Mental Component Summary Scores Research Articles

Minimum 5-Year Clinical and Return-to-Sport Outcomes After Primary Arthroscopic Scapulothoracic Bursectomy and Partial Scapulectomy for Snapping Scapula Syndrome

Background: Snapping scapula syndrome (SSS) is a rare condition that is oftentimes debilitating. For patients whose symptoms are resistant to nonoperative treatment, arthroscopic surgery may offer relief. Because of the rarity of SSS, reports of clinical outcomes after arthroscopic SSS surgery are primarily limited to small case series and short-term follow-up studies. Purpose: To report minimum 5-year clinical and sport-specific outcomes after arthroscopic bursectomy and partial scapulectomy for SSS and to identify demographic and clinical factors at baseline associated with clinical outcomes at minimum 5-year follow-up. Study Design: Case series; Level of evidence, 4. Methods: Patients who underwent arthroscopic bursectomy and partial scapulectomy for SSS between October 2005 and February 2016 with a minimum of 5 years of postoperative follow-up were enrolled in this single-center study. Clinical outcome scores, including the 12-Item Short Form Health Survey (SF-12), American Shoulder and Elbow Surgeons (ASES) Shoulder Score, shortened version of the Disabilities of the Arm, Shoulder and Hand (QuickDASH) score, Single Assessment Numeric Evaluation (SANE), and visual analog scale (VAS) score for pain, were collected at a minimum 5-year follow-up. Additionally, it was determined which patients reached the minimal clinically important difference. Bivariate analysis was used to determine whether baseline demographic and clinical factors had any association with the outcome scores. Results: Of 81 patients eligible for inclusion in the study, follow-up was obtained for 66 patients (age 33.6 ± 13.3 years; 31 female). At a mean follow-up of 8.9 ± 2.5 years (range, 5.0-15.4 years), all of the outcome scores significantly improved compared with baseline. These included the ASES (from 56.7 ± 14.5 at baseline to 87.2 ± 13.9 at follow-up; P < .001), QuickDASH (from 38.7 ± 17.6 to 13.1 ± 14.6; P < .001), SANE (from 52.4 ± 21.2 to 82.7 ± 19.9; P < .001), SF-12 Physical Component Summary (from 39.7 ± 8.3 to 50.3 ± 8.2; P < .001), SF-12 Mental Component Summary (from 48.2 ± 11.7 to 52.0 ± 9.0; P = 0.014) and VAS pain (from 5.2 ± 2.1 to 1.4 ± 2.0; P < .001). The minimal clinically important difference in the ASES score was reached by 77.6% of the patients. Median postoperative satisfaction was 8 out of 10. It was found that 90.5% of the patients returned to sport, with 73.8% of the patients able to return to their preinjury level. At the time of final follow-up, 8 (12.1%) patients had undergone revision surgery for recurrent SSS symptoms. Older age at surgery (P = .044), lower preoperative SF-12 Mental Component Summary score (P = .008), lower preoperative ASES score (P = .019), and increased preoperative VAS pain score (P = .016) were significantly associated with not achieving a Patient Acceptable Symptom State on the ASES score. Conclusion: Patients undergoing arthroscopic bursectomy and partial scapulectomy for SSS experienced clinically significant improvements in functional scores, pain, and quality of life, which were sustained at a minimum of 5 years and a mean follow-up of 8.9 years postoperatively. Higher patient age, inferior mental health status, increased shoulder pain, and lower ASES scores at baseline were significantly associated with worse postoperative outcomes.

370 Is There an Optimal Surgical Approach in Degenerative Cervical Myelopathy?: An Individual Participant Data Meta-Analysis

INTRODUCTION: Contradictions exist about impact of anterior vs. posterior surgical approach on outcomes of degenerative cervical myelopathy (DCM). METHODS: Individual patient data of subjects who underwent surgery for DCM was identified from a pooled dataset of the AO Spine CSM-North America, CSM-International, and CSM-Protect clinical studies. Primary outcomes were changes in short form 36 Physical Component Summary score (SF36-PCS) and mJOA score at 12 months. Secondary outcomes were change in total Neck Disability Index (NDI) score and SF36 Mental Component Summary score (SF36-MCS). Two comparison cohorts were created: i) anterior surgery and ii) posterior surgery. One-stage mixed-effects meta-analysis with study and treatment exposure as random effects was performed and reported with mean differences and 95% confidence intervals. A subgroup analysis planned a priori in mild DCM patients (mJOA 15-17) was performed. RESULTS: A total of 979 patients met eligibility criteria. Patients who had anterior decompressive surgery experienced greater improvements at 1yr of follow-up than those who underwent posterior decompressive surgery in SF36-PCS score (adjusted MD 1.57 [95% CI 0.11 to 3.03], p = 0.0348) and NDI score (adjusted MD 3.32 [95% CI 0.58 to 6.05], p = 0.0172). A greater proportion of patients that underwent anterior surgery achieved clinically important recovery of their NDI (OR 1.49 [95% CI 1.15 to 1.93], p = 0.002; aOR 1.46 [95% CI 1.08 to 1.96], p = 0.013) and SF36-PCS scores at 1yr (OR 1.45 [95% CI 1.12 to 1.88], p = 0.004, aOR 1.34 [95% CI 1.00 to 1.80], p = 0.052). In patients with mild DCM (n = 186), patients who underwent anterior decompressive surgery experienced greater improvements in SF36-PCS score, mJOA score, and Neck Disability Index score than posterior surgical patients. CONCLUSIONS: Anterior surgical decompression for DCM is associated with greater improvements in 1yr patient-reported outcomes than posterior surgical decompression.

Factors associated with increased length of stay in degenerative cervical spine surgery: a cohort analysis from the Canadian Spine Outcomes and Research Network.

Postoperative length of stay (LOS) significantly contributes to healthcare costs and resource utilization. The primary goal of this study was to identify patient, clinical, surgical, and institutional variables that influence LOS after elective surgery for degenerative conditions of the cervical spine. The secondary objectives were to examine the variability in LOS and institutional practices used to decrease LOS. This was a multicenter observational retrospective cohort study of patients enrolled in the Canadian Spine Outcomes and Research Network (CSORN) between January 2015 and October 2020 who underwent elective anterior cervical discectomy and fusion (ACDF) (1-3 levels) or posterior cervical fusion (PCF) (between C2 and T2) with/without decompression for degenerative conditions of the cervical spine. Prolonged LOS was defined as LOS greater than the median for the ACDF and PCF populations. The principal investigators at each participating CSORN healthcare institution completed a survey to capture institutional practices implemented to reduce postoperative LOS. In total, 1228 patients were included (729 ACDF and 499 PCF patients). The median (IQR) LOS for ACDF and PCF were 1.0 (1.0) day and 5.0 (4.0) days, respectively. Predictors of prolonged LOS after ACDF were female sex, myelopathy diagnosis, lower baseline SF-12 mental component summary score, multilevel ACDF, and perioperative adverse events (AEs) (p < 0.05). Predictors of prolonged LOS after PCF were nonsmoking status, education less than high school, lower baseline numeric rating scale score for neck pain and EQ5D score, higher baseline Neck Disability Index score, and perioperative AEs (p < 0.05). Myelopathy did not significantly predict prolonged LOS within the PCF cohort after multivariate analysis. Of the 8 institutions (57.1%) with an enhanced recovery after surgery (ERAS) protocol or standardized protocol, only 3 reported using an ERAS protocol specific to patients undergoing ACDF or PCF. Patient and clinical factors predictive of prolonged LOS after ACDF and PCF are highly variable, warranting individual consideration for possible mitigation. Perioperative AEs remained a consistent independent predictor of prolonged LOS in both cohorts, highlighting the importance of preventing intra- and postoperative complications.

A PROSPECTIVE RANDOMIZED TRIAL OF OPERATIVE VERSUS NONOPERATIVE MANAGEMENT OF FRACTURES OF THE HUMERAL DIAPHYSIS: THE HUMERAL SHAFT FRACTURE FIXATION (HU-FIX) STUDY

This single-centre prospective randomised trial aimed to assess the superiority of operative fixation compared with non-operative management for adults with an isolated, closed humeral shaft fracture.70 patients were randomly allocated to either open reduction and internal fixation (51%, n=36/70) or functional bracing (49%, n=34/70). 7 patients did not receive their assigned treatment (operative n=5/32, non-operative n=2/32); results were analysed based upon intention-to-treat. The primary outcome measure was the DASH score at 3 months. Secondary outcomes included treatment complications, union/nonunion, shoulder/elbow range of motion, pain and health-related quality of life (HRQoL).At 3 months, 66 patients (94%) were available for follow-up; the mean DASH favoured surgery (operative 24.5, non-operative 39.4; p=0.006) and the difference (14.9 points) exceeded the MCID. Surgery was also associated with a superior DASH at 6wks (operative 38.4, non-operative 53.1; p=0.005) but not at 6 months or 1yr. Brace-related dermatitis affected 7 patients (operative 3%, non-operative 18%; OR 7.8, p=0.049) but there were no differences in other complications. 8 patients (11%) developed a nonunion (operative 6%, non-operative 18%; OR 3.8, p=0.140). Surgery was associated with superior early shoulder/elbow range of motion, and pain, EuroQol and SF-12 Mental Component Summary scores. There were no other differences in outcomes between groups.Surgery confers early advantages over bracing, in terms of upper limb function, shoulder/elbow range of motion, pain and HRQoL. However, these benefits should be considered in the context of potential operative risks and the absence of any difference in patient-reported outcomes at 1yr.

Predictive Factors of Pain and Functional Outcome 5 Years Following Total Hip Arthroplasty: A Prospective Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement Cohort Study

BackgroundPrevious reports have identified a number of potential predictors of pain and function after total hip arthroplasty (THA). However, the results of these studies were conflicting, and most had a short follow-up after THA. The purpose of this study was to identify factors predictive of pain and function 5 years after THA. MethodsA multicenter cohort of 7,934 primary unilateral THA patients was prospectively enrolled in the Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement consortium. Demographic data, comorbidities, and patient-reported outcome measures were collected preoperatively and postoperatively at 5 years, including the Hip Disability and OSteoarthritis Outcome Score (HOOS) pain and activities of daily living (ADL) scores. Multivariate logistic regression models with 95% confidence interval were used to identify independent predictors of pain and function at 5 years. ResultsThe patient dissatisfaction percentage was 8.2% at 5 years after THA. The multivariate regression identified the following predictive factors for the HOOS pain score at 5 years: age, educational level, insurance, smoking, race, Charlson Comorbidity Index, back pain severity, number of other lower extremity painful joints, the Knee Injury and Osteoarthritis Outcome Score pain severity of the ipsilateral knee, preoperative Short-Form Health Survey 36-item (SF-36) mental component summary score, and HOOS pain scores. The multivariate regression identified the following predictor factors for HOOS ADL score at 5 years: body mass index, insurance, smoking, race, back pain severity, number of other lower extremity painful joints, Knee Injury and Osteoarthritis Outcome Score pain severity of ipsilateral knee, preop HOOS ADL, and preoperative SF-36 mental component summary score and SF-36 physical component summary score. ConclusionsOverall, 8.2% of patients were dissatisfied 5 years after primary THA. We have identified a number of factors that predict less improvement in pain and function 5 years after THA. These potentially modifiable factors can be targeted with preoperative patient optimization programs to improve patient outcomes and satisfaction after primary THA. Knowledge of these factors that predict less improvement in pain and function can assist the surgeon and patient during shared decision-making, and in setting appropriate patient expectations preoperatively.

Patient-reported outcomes and radiographic progression in patients with rheumatoid arthritis in sustained remission versus low disease activity

ObjectiveTo compare clinical and patient-reported outcomes (PROs) over 5 years between patients with rheumatoid arthritis (RA) in sustained remission (sREM), sustained low disease activity (sLDA) or active disease (AD) in...

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.

Physical activity and health-related quality of life in older adults: depression as a mediator

BackgroundPhysical activity(PA) is associated with health-related quality of life (HRQoL) among older adults, and both are associated with mood, such as depression. However, the indirect effects of PA on HRQoL in older adults have not been clearly established. This study explained how different types and intensities of PA were associated with HRQoL while considering the effects of depression in older adults.MethodsA cross-sectional study was conducted with 7,518 community-dwelling older adults aged 60 years and older. PA (leisure-time, household, and work-related), depression, and HRQoL were measured using the Physical Activity Scale for the Elderly (PASE), the 30-item Geriatric Depression Scale (GDS-30), and the 36-Item Short-Form Health Survey (SF-36), respectively. Information on age, gender, education, monthly income, activities of daily living, smoking, and alcohol drinking was also collected. Regression analysis was used to explore the relationship between PA, depression and HRQoL, and a mediation effect test process was used to verify the mediating mechanism of the depression on this relationship.ResultsThe study showed that after adjusting for a set of covariates, SF-36 Physical Component Summary (PCS) scores were negatively associated with depression (B = -2.046, 95% CI [2.584, -1.509]) and positively with PA (p < 0.001). Similarly, SF-36 Mental Component Summary (MCS) scores were negatively associated with depression (B = -11.657, 95% CI [-12.190, -11.124]). In mediation analyses, we found that depression partially mediated the relationship between different types and intensities PA and PCS (moderate leisure-time PA: B = 0.223, 95%CI [0.153,0.293], P < 0.001; vigorous leisure-time PA: B = 0.323, 95%CI [0.232,0.413], P < 0.001; moderate household PA: B = 0.092, 95%CI [0.045,0.139], P < 0.001; vigorous household PA: B = 0.137, 95%CI [0.085,0.190], P < 0.001; work-related PA: B = 0.193, 95%CI [0.658,0.190], P < 0.001) and MCS (moderate leisure-time PA: B = 1.243, 95%CI [1.008,1.479], P < 0.001; vigorous leisure-time PA: B = 1.800, 95%CI [1.585,2.015], P < 0.001; moderate household PA: B = 0.496, 95%CI [0.274,0.718], P < 0.001; vigorous household PA: B = 0.742, 95%CI [0.521,0.963], P < 0.001; work-related PA: B = 1.026, 95%CI [0.819,1.234], P < 0.001).ConclusionsThis study suggested that leisure-time, household, and work-related PA were negatively associated with depression, while positively affecting HRQoL in Chinese older adults. The relationships between different types and intensities of PA and HRQoL were mediated by depression. Interventions aimed at promoting purposeful exercise and different types of PA may have mental health benefits. It is recommended that geriatric health managers and healthcare planners prioritize interventions to help improve PA intensities, alleviate depressive symptoms to promote beneficial effects on HRQoL in older adults.

Impact of Switching From Immediate- or Prolonged-Release to Once-Daily Extended-Release Tacrolimus (LCPT) on Tremor in Stable Kidney Transplant Recipients: The Observational ELIT Study.

Once-daily extended-release tacrolimus (LCPT) exhibits increased bioavailability versus immediate-release (IR-TAC) and prolonged release (PR-TAC) tacrolimus. Improvements in tremor were previously reported in a limited number of kidney transplant patients who switched to LCPT. We conducted a non-interventional, non-randomized, uncontrolled, longitudinal, prospective, multicenter study to assess the impact of switching to LCPT on tremor and quality of life (QoL) in a larger population of stable kidney transplant patients. The primary endpoint was change in The Essential Tremor Rating Assessment Scale (TETRAS) score; secondary endpoints included 12-item Short Form Survey (SF-12) scores, tacrolimus trough concentrations, neurologic symptoms, and safety assessments. Subgroup analyses were conducted to assess change in TETRAS score and tacrolimus trough concentration/dose (C0/D) ratio by prior tacrolimus formulation and tacrolimus metabolizer status. Among 221 patients, the mean decrease of TETRAS score after switch to LCPT was statistically significant (p < 0.0001 vs. baseline). There was no statistically significant difference in change in TETRAS score after switch to LCPT between patients who had received IR-TAC and those who had received PR-TAC before switch, or between fast and slow metabolizers of tacrolimus. The overall increase of C0/D ratio post-switch to LCPT was statistically significant (p < 0.0001) and from baseline to either M1 or M3 (both p < 0.0001) in the mITT population and in all subgroups. In the fast metabolizers group, the C0/D ratio crossed over the threshold of 1.05ng/mL/mg after the switch to LCPT. Other neurologic symptoms tended to improve, and the SF-12 mental component summary score improved significantly. No new safety concerns were evident. In this observational study, all patients had a significant improvement of tremor, QoL and C0/D ratio post-switch to LCPT irrespective of the previous tacrolimus formulation administered (IR-TAC or PR-TAC) and irrespective from their metabolism status (fast or slow metabolizers).

Association of Bowel Urgency With Quality-of-Life Measures in Patients With Moderately-to-Severely Active Ulcerative Colitis: Results From Phase 3 LUCENT-1 (Induction) and LUCENT-2 (Maintenance) Studies.

Improvement in bowel urgency (BU) was associated with better clinical outcomes in phase 3 LUCENT-1 (induction) and LUCENT-2 (maintenance) studies in moderately-to-severely active ulcerative colitis (UC). We assessed association of BU with quality-of-life (QoL) outcomes. LUCENT-1: 1162 patients randomized 3:1 to intravenous mirikizumab 300mg or placebo every 4 weeks (Q4W) for 12 weeks. LUCENT-2: 544 mirikizumab induction responders re-randomized 2:1 to subcutaneous mirikizumab 200mg or placebo Q4W through Week (W) 40 (W52 of continuous treatment). Patients reported BU severity in the past 24 hours using a validated Urgency Numeric Rating Scale (NRS). In patients with baseline Urgency NRS ≥3, the association between BU Clinically Meaningful Improvement (CMI; ≥3-point decrease) and remission (score 0 or 1) with patient-reported outcomes was assessed at W12 and W52. A significantly greater proportion of patients with versus without BU Remission achieved IBDQ remission (W12: 87.3% vs 42.7%, P < .0001; W52: 91.4% vs 45.5%, p < .0001). Similarly, BU Remission was associated with more patients achieving CMI in SF-36 Physical Component Summary (W12: 69.0% vs 44.4%, P < .0001; W52: 77.5% vs 42.1%, P < .0001) and Mental Component Summary (W12: 53.5% vs 41.0%, P = .0019; W52: 62.0% vs 38.3%, P < .0001) scores. At W12 and W52, patients with BU CMI or Remission showed significant improvements in EQ-5D-5L and Work Productivity and Activity Impairment:UC scores. Significant improvements were also seen in fatigue, abdominal pain, and nocturnal stool. In patients with moderately-to-severely active UC, improvement in BU was associated with improved QoL in phase 3 LUCENT-1 and LUCENT-2 studies. LUCENT-1: NCT03518086; LUCENT-2: NCT03524092.

Relationship between health-related quality of life, depression, and anxiety in older primary care patients and their family members

Objectives Patient-family member dyads experience transitions through illness as an interdependent team. This study measures the association of depression, anxiety, and health-related quality of life (HRQOL) of older adult primary care patient-family member dyads. Methods Baseline data from 1,808 patient-family member dyads enrolled in a trial testing early detection of Alzheimer’s disease and related dementias in primary care. Actor-Partner Independence Model was used to analyze dyadic relationships between patients’ and family members’ depression (PHQ-9), anxiety (GAD-7), and HRQOL (SF-36 Physical Component Summary score and Mental Component Summary score). Results Family member mean (SD) age is 64.2 (13) years; 32.2% male; 84.6% White; and 64.8% being the patient’s spouse/partner. Patient mean (SD) age is 73.7 (5.7) years; 47% male; and 85.1% White. For HRQOL, there were significant actor effects for patient and family member depression alone and depression and anxiety together on their own HRQOL (p < 0.001). There were significant partner effects where family member depression combined with anxiety was associated with the patient’s physical component summary score of the SF-36 (p = 0.010), and where the family member’s anxiety alone was associated with the patient’s mental component summary score of the SF-36 (p = 0.031). Conclusion Results from this study reveal that many dyads experience covarying health status (e.g. depression, anxiety) even prior to entering a caregiving situation.

Tofacitinib Efficacy in Patients with Rheumatoid Arthritis and Probable Depression/Anxiety: Post Hoc Analysis of Phase 3 and 3b/4 Randomized Controlled Trials.

The aim of our work is to assess the prevalence of probable major depressive disorder and/or probable generalized anxiety disorder (pMDD/pGAD) in patients with moderate to severe rheumatoid arthritis (RA), and to evaluate the efficacy of tofacitinib on RA symptoms stratified by baseline pMDD/pGAD status. Data were pooled from five phase 3 randomized controlled trials (RCTs) and one phase 3b/4 RCT, assessing tofacitinib 5 or 10mg twice daily (BID), adalimumab (two RCTs), or placebo. pMDD/pGAD was defined as Short Form-36 Health Survey (SF-36) Mental Component Summary (MCS) score ≤ 38. Efficacy outcomes over 12months included least squares mean change from baseline in SF-36 MCS score and Health Assessment Questionnaire-Disability Index, proportions of patients with pMDD/pGAD in those with baseline pMDD/pGAD, and American College of Rheumatology 20/50/70 response, and Disease Activity Score in 28 joints, erythrocyte sedimentation rate remission (< 2.6) rates. A total of 4404 patients with non-missing baseline values were included. Baseline pMDD/pGAD was reported by 44.5%, 39.8%, 45.4%, and 39.1% of patients receiving tofacitinib 5mg BID, tofacitinib 10mg BID, adalimumab, and placebo, respectively. SF-36 MCS improvements were greater for tofacitinib versus adalimumab/placebo through month 6, with numerical improvements for tofacitinib versus adalimumab sustained through month 12, when the proportions of patients with baseline pMDD/pGAD who continued to have pMDD/pGAD were reduced. RA efficacy outcomes were generally similar in patients with/without baseline pMDD/pGAD. The percentage of patients with pMDD/pGAD reduced from baseline over 1year of treatment with tofacitinib or adalimumab. Effective treatment of underlying RA may lead to improvements in depression and anxiety, based on the SF-36 MCS. Specially designed studies using gold-standard diagnostic tools would be warranted to investigate this further. Video Abstract available for this article. NCT00960440, NCT00847613, NCT00814307, NCT00856544, NCT00853385, NCT02187055. Video Abstract (MP4 204475 KB).

Systematic literature review and network meta-analysis of therapies for psoriatic arthritis on patient-reported outcomes

ObjectivesHead-to-head clinical trials are common in psoriasis, but scarce in psoriatic arthritis (PsA), making treatment comparisons between therapeutic classes difficult. This study describes the relative effectiveness of targeted synthetic (ts)...

Patient-reported outcomes in patients with primary immunodeficiency diseases in Japan: baseline results from a prospective observational study.

Primary immunodeficiency diseases (PIDs) are rare inherited diseases resulting in impaired immunity. People with PID experience lower health-related quality of life (HR-QOL) and disease-related burdens in daily activities. This ongoing, prospective observational study aims to evaluate disease activity, treatment status, treatment-related burden, daily activities, and HR-QOL in patients with PID in Japan over a 1-year period. In this interim report (database lock: July 29, 2022), we present baseline results. Participants were enrolled between November 2021 and May 2022; data were collected four times/year per participant until May 2023 using an online electronic patient-reported outcomes system. Patients with PID and healthy volunteers aged ≥12 years, residing in Japan, and with access to a smartphone were eligible. HR-QOL (primary endpoint) was assessed by the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) and the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36). Work productivity was assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire. Other aspects of PID and burden were assessed with a new questionnaire developed in-house. The study is registered at the University hospital Medical Information Network clinical trials registry (UMIN000045622). The full interim analysis set comprised 71 patients with PID and 47 healthy volunteers. The most common International Union of Immunological Societies PID category was primary antibody deficiency (56.3% of patients). Complications were common, especially recurrent respiratory tract infections (63.4%). Most patients with PID were treated with immunoglobulin replacement therapy (73.2%); 22.4% of these patients had serum immunoglobulin levels <700 mg/dL. Among patients who did not undergo hematopoietic cell transplantation, EQ-5D-5L (n=67) and SF-36 (n=59) Physical and Mental Component Summary scores were significantly lower than in healthy volunteers (p < 0.001). WPAI absenteeism, work productivity loss, and activity impairment scores were significantly lower in 42 working patients with PID than in 37 working healthy volunteers (p < 0.05). Other results indicated that patients with PID experience substantial burdens related to medical visits, expenses, work, and daily activities. This interim analysis confirms that patients with PID in Japan have lower HR-QOL and work productivity compared with healthy individuals and experience substantial limitations and burdens in their daily lives.

Spanish Version of the Anterior Cruciate Ligament-Quality of Life Questionnaire: Translation, Cross-cultural Adaptation, and Validation.

The Anterior Cruciate Ligament-Quality of Life (ACL-QOL) questionnaire is a patient-reported outcome measure used to assess the effect of an anterior cruciate ligament (ACL) injury on the lives of patients. It was originally written in English, which may affect its use when completed by nonnative English speakers. To translate and adapt the ACL-QOL to Spanish and provide evidence of its psychometric properties. Cohort study (diagnosis); Level of evidence, 2. A total of 183 patients with an ACL injury from 4 Catalan hospitals were included: 99 patients who had undergone ACL reconstruction (ACLR) completed the Spanish version of the ACL-QOL (ACL-QOL-Sp) twice (mean interval, 15.2 days) in 2 weeks for test-retest reliability, and 84 patients completed the ACL-QOL-Sp, the Lysholm knee scoring scale, the Knee injury and Osteoarthritis Outcome Score (KOOS), Tegner Activity Scale, and the 12-item Short Form Health Survey (SF-12) before and at 4 and 9 months after ACLR to assess responsiveness. The association between the ACL-QOL-Sp and the other outcome measures was evaluated with the Spearman correlation coefficient. The ACL-QOL-Sp showed good internal consistency (Cronbach alpha = 0.96) and test-retest reliability (intraclass correlation coefficient = 0.97). The standard error of measurement was 3.6, also suggesting the precision of measurements. The smallest detectable change was 9.98 in 94% of patients. No association was found between the ACL-QOL-Sp score and the Tegner score or SF-12 mental component summary score; however, a moderate correlation was found with the overall KOOS score (r = -0.545), Lysholm score (r = 0.509), and SF-12 physical component summary score (r = 0.607). The correlation ranged from weak for the KOOS-Symptoms subscore (r = -0.290) to moderate for the KOOS-Quality of Life subscore (r = -0.698). No ceiling or floor effects were observed. The ACL-QOL-Sp showed a moderate effect size (0.73) at 4 months but a large effect size (1.70) at 9 months. The ACL-QOL-Sp showed adequate internal consistency, test-retest reliability, and responsiveness in evaluating quality of life after ACLR in Spanish-speaking patients.

Validation of the Foot and Ankle Outcome Score (FAOS) for Osteochondral Lesions of the Ankle.

The purpose of this study was to validate the Foot and Ankle Outcome Score (FAOS) for osteochondral lesions of the talus (OLTs). We hypothesize that the FAOS will meet all 4 psychometric criteria for validity in this patient population. From 2008 to 2014, a total of 208 patients with OLTs were included in the construct validity portion of the study. All patients completed FAOS and 12-Item Short-Form Health Survey (SF-12) scores. Twenty additional patients were prospectively recruited and were asked to complete questionnaires to determine the relevance of each of the FAOS questions as it related to their OLT. Forty-four patients completed the FAOS 1 month after the first FAOS to assess reliability via Spearman correlation coefficient. Responsiveness of the FAOS was assessed with 54 patients who had both preoperative and postoperative FAOS scores via Student paired t test with significance determined as P < .05. In total, 229 unique patients were included in this study. Statistically significant associations were found between all FAOS and SF-12 subscales (P < .01). The FAOS symptoms subscale demonstrated the lowest correlation with the SF-12 physical health domains. No floor or ceiling effects were identified. Weak correlations were calculated between the 5 FAOS subscales and the SF-12 mental component summary score. All FAOS domains met the threshold for acceptable content validity (score > 2.0). All FAOS subscales demonstrated acceptable test-retest reliability, with ICC values ranging from 0.81 (ADL) to 0.92 (Pain). This study demonstrates the acceptable yet moderate construct and content validity, reliability, and responsiveness of the FAOS for patients with OLTs of the ankle joint. We endorse the use of the FAOS in evaluating ankle OLTs in both the research and clinical setting and consider it a useful patient-reported, self-administered instrument following surgical intervention. Level IV, retrospective case study.

Do Outcomes Differ After Proximal Hamstring Repair for Patients Receiving Workers' Compensation?

Patients with workers' compensation (WC) insurance claims are often shown to experience inferior patient-reported outcomes (PROs) after an orthopaedic surgical intervention compared with patients without WC claims. To compare the postoperative PROs of patients with WC claims (WC patients) versus those without WC claims (non-WC patients) after proximal hamstring repair (PHR). Cohort study; Level of evidence, 3. WC patients who underwent PHR between November 2011 and to September 2020 were propensity score matched at a 1:2 ratio to non-WC patients according to age, sex, and body mass index. Comorbidity data were collected as well as minimum 1-year postoperative PRO scores for the Lower Extremity Functional Scale (LEFS), the Hip Outcome Score (HOS), and the 12-Item Short From Health Survey (SF-12) Physical Component Summary (PCS) and Mental Component Summary (MCS). The type of work was characterized according to national WC insurance guidelines as light (maximum 20 lbs [9.1 kg]), medium (maximum 50 lbs [22.7 kg]), or heavy (≥50 lbs) [>/=22.7 kg]. A total of 30 patients (10 WC and 20 non-WC) were included. The work type and baseline demographic characteristics of patients did not differ between groups. There were no significant between-group differences in postoperative PRO scores as measured by the LEFS (P = .488), HOS (P = .233), or SF-12 PCS (P = .521). However, the WC cohort showed inferior SF-12 MCS scores compared with the non-WC group (49.28 ± 9.97 vs 54.26 ± 9.69, respectively; P = .032). The WC status was also associated with an increased time needed for patients to return to full-duty work capacity (21 ± 9 vs 9 ± 8 weeks; P = .005). Our findings suggest that WC and non-WC patients who undergo PHR have comparable outcomes. Differences in SF-12 MCS scores and return to work time for full-duty capacity warrant further investigation.

Quality of Life in Teduglutide-Treated Patients with Short Bowel Syndrome Intestinal Failure-A Nested Matched Pair Real-World Study.

Quality of life (QoL) data of chronic intestinal failure (cIF) patients treated with the GLP-2 analogue teduglutide are scarce. This study aims to analyze QoL changes over time in teduglutide-treated patients and compare the results to a matched non-treated cIF control group in a real-world setting. QoL data (SF-36 and SBS-QoLTM) were obtained from adult cIF patients being treated with teduglutide and compared to previously collected QoL data from a PNLiver trial (DRKS00010993), during which patients had been therapy naive. The dataset was then extended by a pairwise matched control group (non-teduglutide-treated PNLiver trial patients) and follow-up data from this group were collected accordingly. Median teduglutide treatment duration and the follow-up period of controls were both 4.3 years. SBS-QoLTM subscales and the SBS-QoLTM sum score showed significant improvements over time in teduglutide-treated patients, as well as for the SF-36 physical and mental component summary scores (all p < 0.02), while non-treated patients showed no significant changes in any of the mentioned scores. Significant differences of QoL changes between treated and non-treated patients were seen for both SF-36 summary scores (p = 0.031 and 0.012). We herein demonstrate for the first time that QoL significantly improved during teduglutide treatment in SBS-cIF patients in a real-world setting compared to individually matched non-treated SBS-cIF patients, indicating relevant clinical benefits.

Construct validity of the PROMIS PF-10 in patients with inflammatory rheumatic diseases and severe limitations in physical functioning

Objective Assessing the construct validity of the Patient-Reported Outcomes Measurement Information System Physical Function 10-Item Short Form (PROMIS PF-10) in a subpopulation of rheumatoid arthritis (RA) or axial spondyloarthritis (axSpA) patients with severe limitations in physical functioning (PF). Method RA/axSpA patients with severe functional limitations completed the PROMIS PF-10, Health Assessment Questionnaire – Disability Index (HAQ-DI for RA) or Bath Ankylosing Spondylitis Functional Index (BASFI for axSpA), 36-item Short Form Health Survey (SF-36), EuroQol 5-dimensions 5-level (index score, EQ-VAS), and performed the Six-Minute Walk Test (6MWT). Construct validity was assessed by computing Spearman rank or Pearson correlation coefficients and testing hypotheses about correlations between the PROMIS PF-10 and measures of PF and quality of life. Results Data from 316 patients (180 RA/136 axSpA, 91.7%/47.8% female, mean ± sd age 58.6 ± 13.2/54.0 ± 11.3 years) were analysed. The median (IQR) PROMIS PF-10 score was 34.5 (31.4–37.6) in RA and 36.0 (32.8–38.3) in axSpA patients. The PROMIS PF-10 correlated strongly with the HAQ-DI, BASFI, and EQ-5D-5L index score (r > 0.6), moderately with the SF-36 Physical Component Summary score, EQ-VAS, and 6MWT (0.30 ≤ r ≤ 0.60), and weakly with the SF-36 Mental Component Summary score (r < 0.30). Five of six hypotheses (83%) were confirmed in both groups. Conclusion The overall strong correlation of the PROMIS PF-10 with measures of PF and moderate to weak correlations with outcomes measuring different constructs were confirmed in subpopulations of RA and axSpA patients with severe functional limitations, supporting its construct validity.

The Impact of Depression and Anxiety on Adult Cancer Patients' Health-Related Quality of Life.

Cancer patients are at high risk for mental illness and, in turn, poorer health-related quality of life. This study used nationally representative United States (US) data to examine nuances of the impact of depression and/or anxiety on HRQoL in different cancer groups (e.g., cancer only, cancer and depression, cancer and anxiety, cancer and both conditions). Adult patients aged 18 years and older with a cancer diagnosis were identified from the Medical Expenditure Panel Survey data for 2012-2016. HRQoL was measured using the SF-12 Physical and Mental Component Summary (PCS & MCS) scores. Multivariate linear regressions were used, controlling for a multitude of factors. Around 12% of the 1712 identified patients with cancer had depression, 13% had anxiety, and 8.4% had both depression and anxiety. Patients with comorbid depression and anxiety had the lowest mean scores of both PCS and MCS compared to patients in other groups. In addition, cancer patients with either depression and/or anxiety were more likely to have lower MCS scores compared to those with cancer only (depression: β = -6.554; anxiety: β = -3.916; both conditions: β = -11.759, p < 0.001). Interestingly, patients with comorbid depression and anxiety were more likely to have higher PCS scores compared to those with cancer only. The psychological burden of cancer is immense, with a substantial impact on patients' HRQoL. Routine screening for depression and anxiety, especially for women and those with low poverty status and comorbidities, should be conducted by healthcare providers to identify those with high odds of having a lower HRQoL. Additionally, early psychiatric interventions, such as psychotherapy and prescription drugs, may positively impact patients' mental well-being and HRQoL.