SF-36 MCS Research Articles

Quality of Life Improves with Alemtuzumab Over 6Years in Relapsing-Remitting Multiple Sclerosis Patients with or without Autoimmune Thyroid Adverse Events: Post Hoc Analysis of the CARE-MS Studies.

IntroductionIn clinical trials of alemtuzumab, autoimmune thyroid adverse events (AEs) were frequent. Here, we assess the impact of thyroid AEs on health-related quality of life (HRQL) in alemtuzumab-treated patients with relapsing-remitting multiple sclerosis (RRMS).MethodsIn phase 3 CARE-MS I (NCT00530348) and II (NCT00548405) trials, patients with RRMS were administered alemtuzumab 12 mg/day on 5 consecutive days at baseline and on 3 consecutive days 12 months later. Patients could participate in an extension study (NCT00930553) through year 6. HRQL was assessed at baseline and annually using the Functional Assessment of Multiple Sclerosis (FAMS), EuroQoL-5 Dimension Visual Analog Scale (EQ-5D VAS), and 36-Item Short-Form Survey (SF-36) questionnaires. Outcomes were analyzed in patients with or without thyroid AEs (nonserious or serious). A subset of patients with thyroid AEs was analyzed to assess HRQL before and during the onset of thyroid AEs.ResultsA total of 811 CARE-MS patients were treated with alemtuzumab. Of these, 342 (42%) patients experienced thyroid AEs over 6 years; serious thyroid AEs occurred in 44 (5%) patients. At year 6, HRQL outcomes generally remained slightly improved or similar to core study baseline in alemtuzumab-treated patients with or without thyroid AEs: FAMS (least-squares mean change from baseline without thyroid AEs, 0.7; with nonserious thyroid AEs, 5.1; with serious thyroid AEs, − 5.3), EQ-5D VAS (2.0; 3.0; − 6.8), SF-36 mental component summary (MCS [0.6; 1.6; − 2.8]), SF-36 physical component summary (PCS [0.8; 1.0; 1.1]). Over 6 years, 63–82% of patients in each group had improved/stable SF-36 MCS and PCS scores. Among patients with thyroid AE onset in year 3 (peak incidence), there were minimal differences between HRQL outcomes before onset (year 2) and after onset (year 3).ConclusionAutoimmune thyroid AEs (serious and nonserious) had minimal impact on HRQL in alemtuzumab-treated patients. These data may aid therapeutic decisions in patients with relapsing MS.Electronic supplementary materialThe online version of this article (10.1007/s40120-020-00191-7) contains supplementary material, which is available to authorized users.

Ten-Year Results of Unicompartmental Knee Arthroplasty in Patients With Psychological Distress

BackgroundAlthough the influence of psychological distress on the outcomes of total knee arthroplasty has been described extensively, its effect on unicompartmental knee arthroplasty (UKA) is poorly defined. Furthermore, most studies in arthroplasty literature had short follow-ups of ≤1 year. We investigated the influence of psychological distress on long-term patient-reported outcomes and analyzed the change in mental health after UKA in a cohort with minimum 10 years of follow-up. MethodsProspectively collected data of 269 patients undergoing UKA in 2004-2007 were reviewed. Patients were stratified into those with psychological distress (36-item Short-Form health survey [SF-36] Mental Component Summary [MCS] <50, n = 111) and those without (SF-36 MCS ≥50, n = 158). Clinical outcomes were obtained preoperatively, at 2 years, and 10 years. Multiple regression was used to control for age, gender, body mass index, Charlson Comorbidity Index, American Society of Anesthesiologists class, and baseline scores. The rate of expectation fulfillment and satisfaction was compared. ResultsPsychologically distressed patients had poorer Knee Society Knee Score, Function Score, Oxford Knee Score, and SF-36 Physical Component Summary preoperatively, at 2 years, and 10 years. However, an equal proportion in each group attained the minimal clinically important difference for each score. Distressed patients had a comparable rate of satisfaction (91% vs 95%, P = .136) but lower fulfillment of expectations (89% vs 95%, P = .048). The percentage of distressed patients declined from 41% to 35% at follow-up. The mean SF-36 MCS improved by 6.9 points. ConclusionAlthough psychologically distressed patients had relatively greater pain and poorer function preoperatively and up to 10 years after UKA, a similar proportion of them experienced a clinically meaningful improvement in patient-reported outcomes.

Pain catastrophizing is associated with increased physical disability in patients with anterior knee pain

IntroductionThe traditional nociceptive approach to pain identifies the mind and body as functionally separate. However, the biopsychosocial model accounts for the impact of social, psychological and physical factors on the patient experience. The purpose of this study was to determine the relationship between diagnosis, physical disability, and psychological distress among patients with anterior knee pain-one of the most common complaints in an orthopedic clinic. MethodsThis was a single-center, cross-sectional study. Patients presenting for initial evaluation of knee pain completed the Pain Catastrophizing Scale, Kujala Anterior Knee Pain Scale, and SF-12 questionnaires. Statistical analysis was performed using SPSS Version 24. Results207 patients, 108 (52.2%) females and 99 (47.8%) males, with a mean age 44.5 ± 15.4 years were enrolled. The osteoarthritis cohort had the highest pain catastrophizing score (17 ± 14.5), lowest Kujala score (48.3 ± 18.1), lowest SF-12 PCS (37.5 ± 8.3), and lowest SF-12 MCS (50.8 ± 11.0). Across all diagnoses, there was a statistically significant negative correlation between the total Pain Catastrophizing Score (PCS) and the Kujala, SF-12 Physical, and SF-12 Mental Component Scores. Bivariate and multivariate analysis demonstrated a correlation between PCS and duration of symptoms and African-Americans. The Kujala and SF-12 PCS demonstrated a statistically significant correlation with age, smoking, and the Asian Indian ethnicity. The SF-12 MCS showed a significant relationship with the Asian Indian ethnicity. Bivariate analysis also showed a statistically significant relationship between the SF-12 PCS and the SF-12 MCS. ConclusionKnee pain patients presenting to an orthopedic sports medicine clinic demonstrate diminished physical quality of life and psychological reserves. This study determined an association between catastrophizing behavior and other patient reported outcomes measuring pain, physical distress, quality of life and mental/emotional well-being. To optimize patient outcomes, psychological domain should be managed contemporaneously to orthopedic pathology.

Non-treatment of stable ramp lesions does not degrade clinical outcomes in the setting of primary ACL reconstruction.

The purpose of this study was to evaluate the clinical outcomes of various methods of treatment of stable and unstable ramp lesions compared to patients with no meniscal pathology at the time of primary ACL reconstruction. All patients with a preoperative MRI performed at our facility who were enrolled in an institutional ACL registry and 1-year clinical follow-up were identified. A musculoskeletal radiologist reviewed preoperative MRI scans for evidence of a ramp lesion. Ramp lesions were classified as stable if a peripheral tear of the posterior horn of the medial meniscus was identified by MRI, but did not displace into the medial compartment with anteriorly directed probing at the time of surgery. Ramp lesions were classified as unstable if a tear was identified by preoperative MRI at the meniscocapsular junction and the meniscus was displaceable into the medial compartment with probing. Reoperation rates for ACL graft failure or recurrent medial meniscus pathology were collected. Patient-reported outcome scores (IKDC, SF12 PCS, SF12 MCS, and Marx Activity scale) were recorded at baseline and final follow-up. A total of 162 patients were included in the analysis with median 2-year (range 1-5years) clinical follow-up. Patients with a repaired unstable ramp lesion had a significantly higher likelihood of reoperation for recurrent medial meniscus pathology than patients without meniscal pathology at the time of index surgery. Patients with an untreated stable ramp lesion had a similar rate of reoperation when compared to patients without meniscal pathology. At final follow-up, there was no difference between groups in IKDC score, SF12 PCS/MCS, or Marx activity score or change in any score. Patients with untreated stable ramp lesions have similar clinical outcomes at median 2-year (range 1-5years) follow-up when compared to patients without a ramp lesion. Treatment of stable ramp lesions at the time of ACL reconstruction does not have clinical benefit. III.

Predictors of Low-Level Disease-Specific Knowledge in Patients with Chronic Obstructive Pulmonary Disease.

BackgroundDisease-specific knowledge is associated with outcomes of patients, but the knowledge level of chronic obstructive pulmonary disease (COPD) patients is known to be low.ObjectiveWe measured the level of disease-specific knowledge and defined factors associated with poor disease knowledge in COPD patients.Materials and MethodsA cross-sectional survey was performed in five hospitals in South Korea. At enrolment, all patients completed the Bristol COPD Knowledge Questionnaire (BCKQ), Satisfaction with Life Scale (SWLS), Personal Resource Questionnaire (PRQ), St. George’s Respiratory Questionnaire (SGRQ), 36-item Short-Form Health Survey (SF-36), and the Hospital Anxiety and Depression Scale (HADS). The data were analyzed via linear regression to identify factors associated with low-level knowledge of COPD.ResultsA total of 245 COPD patients were enrolled in this study. The mean total BCKQ score was 28.1 (SD, 7.4). The lowest scores were seen for items exploring knowledge of “Oral steroids” and “Inhaled steroids”. In univariate analysis, higher level of education (r = 0.17), low income (r = 0.13), the post-bronchodilator FEV1, % predicted (r = −0.24), the post-bronchodilator FEV1/FVC ratio (r = −0.13), SWLS (r = 0.15), PRQ (r = 0.16), SF-36 MCS (r = 0.13), HADS-A (r = −0.17), and HADS-D (r = −0.28) scores correlated with the BCKQ score (all p < 0.05). FEV1 (r = −0.25, p < 0.001) and HADS-D score (r = −0.29, p < 0.001) were significantly associated with the total BCKQ score in multivariate analysis.ConclusionOur Korean patients with COPD lacked knowledge on oral and inhaled steroid treatments. In particular, patients with higher-level lung function and/or depressive symptoms exhibited poorer disease-specific knowledge; such patients may require additional education.

Mental Health Status Does Not Affect Patient Satisfaction After Knee Replacement

Aim: To determine whether peri-operative mental health scores are associated with patient satisfaction after total knee arthroplasty (TKA). Methods: We conducted a retrospective review of 205 primary TKAs to determine whether the Short Form-12 Mental Component Score (SF-12 MCS) is associated with Press Ganey satisfaction. Univariate logistic regression was used to test for an association between MCS and the likelihood of a 5-star rating for each question. Results: Patients with low preoperative and postoperative MCS were less likely to give a 5-star rating for provider and staff communication, friendliness, and courteousness but had no association with satisfaction with overall care. A change in MCS in patients with a low preoperative MCS was associated with 5-star satisfaction with appointment scheduling. Conclusion: Patient mental health status is minimally associated with patient satisfaction. Thus, poor preoperative mental health status should not be a relative contraindication to TKA.

Personality traits predict residual pain after total hip and knee arthroplasty.

We assessed the role of personality traits, anxiety, and depression in residual pain among patients who underwent total hip (THA) and knee (TKA) arthroplasty. Eighty-three patients (40 THA and 43 TKA) were interviewed pre-operatively (t0); fivedays (t1) after surgery; and one (t2), three (t3), six (t4), and 12months (t5) after surgery. Personality (TCI-R), pain (VAS), anxiety and depression (HADS), quality of life (SF-12), functionality (HHS/KSS), and disability (WOMAC) were evaluated. Pain reduction and functional improvement were reported at t5 (both p < 0.001) in both THA and TKA patients. THA patients showed earlier and greater functional improvement after surgery (both p < 0.001) in comparison with TKA. Residual pain (VAS > 30mm) was noted in 15% of the THA patients and 25% of the TKA patients, and it correlated with the SF-12 PCS (r2 = - 0.412; p < 0.001), SF-12 MCS (r2= - 0.473; p < 0.001), HADS-A (r2 = 0.619; p = <0.001), HADS-D (r2 = 0.559; p < 0.001), functionality (r2 = - 0.482; p < 0.001), and WOMAC (r2 = 0.536; p < 0.001) scores at t5. High pre-operative harm avoidance, persistence, and anxiety scores were predictive of residual pain after both THA and TKA (p < 0.001). The proportion of patients complaining of residual pain in this study was similar to that in previous findings. Multiple predictors of residual pain after THA and TKA have been previously described, and several studies evaluated the influence of psychological factors on the outcome of joint arthroplasty; however, only four studies investigated the role of personality traits in the outcome of THA and TKA patients, and a unique study out of these investigations demonstrated the effect of personality on persisting pain. The current study demonstrated that personality traits and anxiety predict residual pain; thus, pre-operative evaluation of these factors could be helpful in identifying patients at risk for residual pain.

Influence of Depression and Anxiety on Health-Related Quality of Life While Awaiting Lung Transplant

Severe lung disease may have significant effects on mental health, which may be exacerbated by the stress of awaiting lung transplantation (LTx). However, the prevalence of depression and anxiety symptoms in LTx candidates and the effects of these disorders on health-related quality of life (HRQL) has not been well described. We sought to describe the prevalence of depression and anxiety in patients on the LTx waiting list, and associations between depression or anxiety symptoms and HRQL. The Frailty and Sarcopenia in Organ Transplantation study (FROST) is a prospective single-center cohort study of 240 adults listed for solid organ transplantation. Of 70 subjects on the LTx list, we evaluated the 65 with complete data. Prior to transplant, these patients completed the Patient Health Questionnaire (PHQ-9) to screen for depression, the Generalized Anxiety Disorder scale (GAD-7) to screen for anxiety, and the 12-item short form health survey (SF12) to evaluate HRQL using physical and mental component summary scores (PCS & MCS). Using multiple linear regression adjusted for age, gender, and diagnosis, we identified whether depression or anxiety was associated with the SF12 MCS or PCS. 50% of participants were female, with an average age of 59 (SD 13.3). The most common diagnoses were interstitial lung disease (46%), and chronic obstructive pulmonary disease (38%). Average PHQ9 score was 7.2 corresponding to mild depression. 69% of patients had some degree of depression of whom 22% had moderate to severe depression (score ≥ 10). Average GAD7 score was 4.2 corresponding to no anxiety and 6.2% of patients had moderate to severe anxiety. Patients with depression had a lower mean SF12 MCS than those without depression (46 vs. 55, p = 0.001), but there was no significant difference between PCS scores. Patients with anxiety had a lower MCS (43, SD=7 vs. 53, SD=9, p = 0.005), and PCS (30, SD=5 vs. 34, SD=6, p = 0.03) than those without anxiety. A substantial proportion of LTx candidates in this cohort had depression, but the prevalence of anxiety was lower. Both were associated with significant reductions in mental HRQL. Anxiety was also associated with a reduction in physical HRQL. Screening and treatment for depression and anxiety may represent an opportunity to improve HRQL in lung transplant candidates.

Learning curve assessment for total ankle replacement using the transfibular approach

BackgroundTotal ankle arthroplasty is an increasingly effective option for the treatment of end-stage arthritis. One recent innovation utilizes a transfibular, lateral approach. Like any new system, there is likely a learning curve associated with its use. We analyzed a series of patients who received a total ankle arthroplasty via a transfibular approach to state if it is possible to identify and to evaluate effects of a learning curve in the use of this novel total ankle replacement system. Methods76 consecutive patients meeting inclusion and exclusion criteria were retrospectively analyzed. All patients had a minimum of 24 months of follow-up. Intraoperative parameters, preoperative and postoperative subjective outcome scores, radiographic parameters, and complications were recorded and evaluated. ResultsThere were significant learning curve effects on various surgical and postoperative parameters. Surgical time decreased with the curve stabilizing after the 16th patient. With regard to patient outcomes, a learning curve was identified for the VAS, AOFAS, and SF-12 MCS scores. The number of patients required to stabilize these curves were 21, 13, and 16, respectively. Alignment as measured by alpha and gamma angles also improved with experience, with the curves stabilizing at 18 and 15 patients, respectively. There was a larger number cases required for complication rates, with the curve stabilizing after the 39th patient. No significant learning curve was found for ankle ROM, SF-12 PCS, beta angle, tibio-talar ratio (TTR), or tibio-talar surface angle (TTS). ConclusionsThis study demonstrates a significant learning curve with respect to operative time, patient outcomes, and radiographic parameters. Extrapolating this information, we urge surgeons to adequately familiarize themselves with any new implant through a training program in a high-volume center. Level of evidenceIV, case series.

Mental health and prolonged exposure to unaffordable housing: a longitudinal analysis.

When housing is insufficient, or poor quality, or unaffordable there are well established health effects. Despite the pervasiveness of housing affordability problems (widely referred to as Housing Affordability Stress-HAS), little quantitative work has analysed long-term mental health effects. We examine the mental health effects of (prolonged and intermittent) patterns of exposure to housing affordability problems. We analysed a large, nationally representative longitudinal population sample of individuals, following them over five-year periods to assess the relative mental health effects of different patterns of exposure to housing affordability problems. To maximise the number of observations and the robustness of findings, we used 15years (2002-2016) of data, across three pooled exposure windows. Longitudinal regression analysis with Mundlak adjustment was used to estimate the association between prolonged (constant over a 5-year period) and intermittent exposure to HAS, and mental health (as measured using the SF-36 MCS). We found that, on average, both prolonged and intermittent exposure were associated with lower mental health (Beta = -1.338 (95% CI -2.178-0.488) and Beta = -0.516 (95% CI -0.868-0.164), respectively). When we additionally adjusted for baseline mental health, thereby accounting for initial mental health status, coefficients were attenuated but remained significant. Both prolonged and intermittent exposure to HAS negatively impact mental health, irrespective of baseline mental health. Interventions that target affordable housing would benefit population mental health. Mental health interventions should be designed with people's housing context in mind.

The Influence of Preoperative Mental Health on PROMIS Physical Function Outcomes Following Minimally Invasive Transforaminal Lumbar Interbody Fusion.

Retrospective. To demonstrate whether preoperative mental health status can be predictive of postoperative functional outcomes as measured by Patient-Reported Outcome Measurement Information System Physical Function (PROMIS PF) following minimally invasive transforaminal lumbar interbody fusion (MIS TLIF). There is a paucity of scientific investigations into the association between preoperative mental health as evaluated by a validated questionnaire such as the Short Form-12 Mental Health Composite Score (SF-12 MCS) and postoperative outcomes following MIS TLIF. Patients undergoing a primary MIS TLIF were retrospectively reviewed and stratified into cohorts based on preoperative SF-12 MCS scores. The Physical Function scores of PROMIS, of which there are other domains including Pain Interference, Sexual Function, and Cognitive Function, were compared between the cohorts. In addition, the improvement in PROMIS scores based on preoperative SF-12 MCS scores following MIS TLIF was analyzed using multivariate linear regression. One hundred seventy-two patients were included: 85 patients (49.4%) had a preoperative SF-12 MCS score <50 and 87 (50.6%) had a preoperative SF-12 MCS score ≥50. Patients with poorer mental health demonstrated significantly worse PROMIS PF scores preoperatively (33.8 vs. 36.5, P < 0.001), as well as at all postoperative timepoints: 6-weeks (35.1 vs. 38.4, P < 0.001), 3-months (38.9 vs. 42.9, P < 0.001), 6-months (41.4 vs. 45.5, P < 0.001), and 1-year (42.4 vs. 47.6, P < 0.001). However, at the 1-year timepoint, patients with worse mental health reported experiencing significantly less improvement from baseline (postoperative change of 8.6 vs. 11.1, P = 0.002). Patients with worse preoperative mental health not only demonstrated worse preoperative PROMIS PF scores, but also continued to have significantly worse postoperative outcomes. However, the postoperative improvement experienced by patients was similar in the short-term following surgery regardless of preoperative mental health status. Patients with poor mental health experienced significantly less postoperative improvement only at the 1-year timepoint. 3.

Evaluation of Postoperative Mental Health Outcomes in Patients Based on Patient-Reported Outcome Measurement Information System Physical Function Following Anterior Cervical Discectomy and Fusion.

ObjectiveTo assess the relationship of preoperative physical function, as measured by Patient-Reported Outcome Measurement Information System Physical Function (PROMIS PF), to improvement in mental health, as evaluated by Short Form-12 Mental Component Summary (SF-12 MCS) following anterior cervical discectomy and fusion (ACDF). MethodsPatients undergoing primary ACDF were retrospectively reviewed and stratified based on preoperative PROMIS PF scores. PROMIS PF cohorts were tested for an association with demographic characteristics and perioperative variables using chi-square analysis and multivariate linear regression. Multivariate linear regression was utilized to determine the association between PROMIS PF cohorts and improvement in SF-12 MCS. ResultsA total of 129 one- to 3-level ACDF patients were included: 73 had PROMIS PF < 40 (“low PROMIS”) and 56 had PROMIS PF ≥ 40 (“high PROMIS”). The low PROMIS cohort reported worse mental health preoperatively and at all postoperative timepoints except for 1 year. Both cohorts had similar changes in mental health from baseline through the 6-month follow-up. However, at 1 year. postoperatively, the low PROMIS cohort had a statistically greater change in mental health score. ConclusionPatients with worse preoperative physical function reported significantly worse preoperative and postoperative mental health. However, patients with worse preoperative physical function made significantly greater improvements in mental health from baseline. This suggests that patients with worse preoperative physical function can still expect significant improvements in mental health following surgery.

Excellent mid-term osseointegration and implant survival using metaphyseal sleeves in revision total knee arthroplasty

PurposeMetaphyseal fixation in revision total knee arthroplasty (RTKA) is a very promising treatment option for extended bone defects. Currently published mid-term results remain limited. The purpose was to analyse the implant durability, the clinical and the radiological mid-term results in RTKA when using metaphyseal sleeves.MethodsClinical and radiological follow-up examinations were performed in 92 patients (93 knees) with RTKA using hybrid fixation technique (cementless sleeves and stem). Radiographic measurements regarding osseointegration at the bone–sleeve interface were performed and the range of motion (ROM), a subjective satisfaction score (SSS), the American Knee Society Score (KSS), the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) as well as the SF-36 Health survey were examined. Bone defects were analysed using the Anderson Orthopaedic Research Institute (AORI) classification.ResultsNo knee had to be revised due to aseptic loosening at the time of the follow-up (mean 6.3 years ± 2.3, minimum 2 years). Satisfactory radiographic osseointegration at the sleeve/bone interface was detected in 96.1% of cases. 17 knees (18.2%) had to be re-revised, 15 of them due to a recurrent infection and 2 due to aseptic reasons (mediolateral instability and a periprosthetic fracture). The median of the ROM (96°), SSS (8), KSS (87), WOMAC (9), SF-36 MCS (55) and SF-36 PCS (38) showed very satisfying results.ConclusionNo case of aseptic loosening was found in this large series of RTKA with extended bone defects using metaphyseal sleeve fixation. In this large retrospective series, it has been shown that this technique is an excellent treatment option for extended bone defects in RTKA surgery.Level of evidenceRetrospective cohort study, level III.

Social support is a strong determinant of life satisfaction among older adults with chronic obstructive pulmonary disease.

Older adults with chronic obstructive pulmonary disease (COPD) are frequently compromised in terms of social life and functional capacity, triggering reduced in life satisfaction (LS). We investigated the level of LS among elderly patients with COPD and factors associated with LS. This was a prospective cross-sectional survey enroling a sample of 160 COPD subjects aged 65 y or older. At enrolment, all patients completed measures of LS (the Satisfaction with Life Scale; SWLS) and social support (Personal Resource Questionnaire; PRQ). The health-related quality of life (HRQL) was measured using St. George's Respiratory Questionnaire (SGRQ) and 36-item Short-Form Health Survey (SF-36). Anxiety and depression were assessed using the Hospital Anxiety and Depression Scale (HADS). About 30.6% of the patients reported that they were satisfied or highly satisfied with their lives. In univariate analysis, post-bronchodilator FEV1, percentage predicted was significantly associated with SWLS score (r=0.205, P=.009). Age (r=0.207), diabetes (r=0.209), osteoporosis (r=-0.190), PRQ (r=0.388), SGRQ total (r=-0.291), SF-36 PCS (r=0.233), SF-36 MCS (r=0.274), HADS-A (r=-0.291) and HADS-D (r=-0.352) were also associated with SWLS score (all P<.05). Multivariate analysis revealed that FEV1 (r=0.223, P=.04) and PRQ (r=.244, P=.002) were independently associated with SWLS score. Less than one-third of older adults with COPD reported that they were satisfied with their lives. Better lung function and greater social support were independently associated with high LS.

Patient-reported outcome measures in total joint arthroplasty: defining the optimal collection window.

BackgroundThe purpose of this study was to determine the optimal window for collection of patient-reported outcome measures (PROMs) after total joint arthroplasty (TJA).MethodsOur prospectively collected institutional joint registry was queried for patients who underwent primary, unilateral TJAs. The primary outcomes were the net changes in WOMAC, SF-12 MCS, SF-12 PCS, OHS, KSCRS, and UCLA activity rating system at 6, 12, and 24 months postoperatively. Secondary outcomes were data acquisition costs and follow-up attrition rates.ResultsEight hundred sixty-six procedures (450 total hip arthroplasties, 416 TKAs) were analyzed. A consistent plateau in all PROMs was noted by 6 months postoperatively–except for SF-12 MCS which showed no significant changes at any time interval. For TKA, the percentage of overall improvement achieved by 6 months was 88.7%, 84.5%, 100%, and 90.5% for the WOMAC, SF-12 PCS, UCLA, and KSCRS, respectively. For total hip arthroplasty, these values were 92.7%, 83.5%, 88.0%, and 89.8% for WOMAC, SF-12 PCS, UCLA, and OHS, respectively. There were marginal improvements from 6 to 12 months and no improvement from 12 to 24 months. Follow-up rates at 6, 12, and 24 months were 85%, 69%, and 40%, respectively. Our institutional costs for collecting a complete data set per patient were $128, $158, and $272 for 6, 12, and 24 months, respectively.ConclusionsMost of the improvement in PROMs after primary TJA occurs within the first 6 months. In addition, limiting PROMs collection to 6 months appears to be cost-efficient owing to increased attrition rates beyond this time interval.

Early mobilization versus plaster immobilization of simple elbow dislocations: a cost analysis of the FuncSiE multicenter randomized clinical trial

IntroductionThe primary aim was to assess and compare the total costs (direct health care costs and indirect costs due to loss of production) after early mobilization versus plaster immobilization in patients with a simple elbow dislocation. It was hypothesized that early mobilization would not lead to higher direct and indirect costs.Materials and methodsThis study used data of a multicenter randomized clinical trial (FuncSiE trial). From August 25, 2009 until September 18, 2012, 100 adult patients with a simple elbow dislocation were recruited and randomized to early mobilization (immediate motion exercises; n = 48) or 3 weeks plaster immobilization (n = 52). Patients completed questionnaires on health-related quality of life [EuroQoL-5D (EQ-5D) and Short Form-36 (SF-36 PCS and SF-36 MCS)], health care use, and work absence. Follow-up was 1 year. Primary outcome were the total costs at 1 year. Analysis was by intention to treat.ResultsThere were no significant differences in EQ-5D, SF-36 PCS, and SF-36 MCS between the two groups. Mean total costs per patient were €3624 in the early mobilization group versus €7072 in the plaster group (p = 0.094). Shorter work absenteeism in the early mobilization group (10 versus 18 days; p = 0.027) did not lead to significantly lower costs for loss of productivity (€1719 in the early mobilization group versus €4589; p = 0.120).ConclusionFrom a clinical and a socio-economic point of view, early mobilization should be the treatment of choice for a simple elbow dislocation. Plaster immobilization has inferior results at almost double the cost.

Infertility and Health-Related Quality of Life in United States Women Veterans.

Background: To assess associations between infertility and health-related quality of life and medical comorbidities in U.S. women Veterans. Materials and Methods: This cross-sectional observational study involved computer-assisted telephone interviews of Veterans Administration-enrolled women between ages 21 and 52 years. Patients were analyzed in two groups by self-reported history of infertility. Outcomes included health-related quality of life as measured by the short-form 12-item interview (SF-12) physical and mental component summary (PCS and MCS) scores, depression, post-traumatic stress disorder (PTSD), eating disorders, fibromyalgia, other chronic pain, cardiovascular disease risk factors, and cancer. Age-adjusted p-values and adjusted odds ratios (AORs) were calculated using individual multivariate regression models to control for significant confounding covariates. Results: Of the 996 women veterans included, 179 (18.0%) reported a history of infertility. Infertility was associated with worse perceived physical health as determined by the SF-12 PCS [beta coefficient (B) -3.23 (-5.18 to -1.28)] and fibromyalgia [AOR 1.97 (1.22 to 3.19)]. Infertility was also associated with higher rates of depression, other chronic pain, and cancer, which remained significant after adjusting for age (p = 0.021, p = 0.016, and p = 0.045, respectively); however, no association for all was seen after adjustment for other significant covariates. There was no difference in Veterans' mental health using the SF-12 MCS, nor differences seen in PTSD or eating disorder rates, or in cardiovascular risk factors. Conclusions: This novel investigation in U.S. women Veterans found worse physical health-related quality of life and increased rates of fibromyalgia among women reporting a history of infertility, adding to the growing literature on infertility as a marker for overall poorer health.

Clinical Characterization and Cytokine Profile of Fatigue in Patients with Chronic Gvhd

Introduction Chronic graft-versus-host disease (cGVHD) is an autoimmune-like condition caused by allogeneic hematopoietic stem cell transplantation. It is the major cause of non-relapse mortality and morbidity after transplant. The majority of patients with cGVHD experience longstanding fatigue that is associated with decreased quality of life and impaired physical functioning. The pathophysiology and clinical characteristics of fatigue in cGVHD remain poorly understood and no effective treatments exist. Methods This cross-sectional study aimed to describe characteristics of fatigue experienced by patients with cGVHD using SF-36 self-report vitality scale as the primary outcome. 109 patients with fatigue and 72 patients without fatigue were prospectively enrolled and compared using a set of clinical, demographic and behavioral data along with 7 potential cytokine biomarkers of active cGVHD (IFN- γ, IL-6, CXCL-10, MCP-1, CXCL-9, BAFF, ST2). IFN- γ, IL-6, IP-10, and MCP-1 were assayed using V-PLEX by from Meso-ScaleDiscovery (MSD). The BAFF, CXCL9, and ST2 high sensitive assays were developed and customized for clinical testing using MSD electrochemiluminescence immunoassay technology with antibody pairs obtained from R&amp;D Systems. A patient was considered fatigued if SF-36 vitality score was &gt;10 points below the mean of the general population (&lt;40). Results The median Lee cGVHD symptom scale energy score was 6 (1-12) in fatigued individuals as compared to 3 (0-9) in non-fatigued individuals (P=0.0001) suggesting internal validity of the primary endpoint definition. SF-36 MCS and PCS scores were also significantly lower in the fatigued group by 10 points (P=0.0001 for both). Several measures including walk velocity, human activity profile, SF-36 physical and mental health self-report scales were potential predictors of fatigue in univariate analysis (Table 1). Patients with increasing levels of joint involvement were more likely to be fatigued (72% vs 60% with any involvement, p= 0.0067 for increasing involvement score). In addition, fatigued individuals had higher Lee cGVHD symptom burden in skin, breathing, muscles and joints and mental domains. None of the tested cytokines showed significant association with fatigue, even after stratification for time elapsed after cGVHD diagnosis to study enrollment. However, BAFF was shown to decrease in a consistent manner when more time elapsed from cGVHD diagnosis to study enrolment (p=0.015). BAFF levels were significantly associated with NIH joint score, NIH skin score, intensity of immunosuppression and Karnofsky performance status, thus confirming the usefulness of BAFF as a marker of cGVHD activity or severity, but not fatigue. Similarly, none of standard clinical laboratory serum markers of inflammation (e.g. ESR, CRP, C3, C4, albumin) showed significant association with fatigue. Multivariable analysis revealed that NIH joint score (P=0.03), Lee symptom scale sleep (P=0.0004) and depression (P=0.03) questions and PG-SGA nutrition score (P=0.0007) were predictors of fatigue after adjusting for confounders. Antidepressant use or sleep medication use did not differ significantly between the 2 groups (p=0.63 and 0.51, respectively), although patients reporting depression and sleep problems were more likely to be in the fatigued group, thus delineating a potential area for intervention and increasing quality of life. After adjusting for NIH lung score and performance status, known poor predictors of survival in this patient population, fatigue was associated with a slight trend toward lower probability of survival, median 130.6 months vs. median not reached (p=0.074) for fatigued and non-fatigued respectively (HR: 1.45, CI 0.88 to 2.40). Conclusions These results demonstrate that the pathophysiology of fatigue in cGVHD may involve mechanisms other than those reflected by cytokine markers of inflammation known to be associated with disease activity or severity. Musculoskeletal and lung involvement as well as decreased functional performance and capacity are significant features of fatigued patients with cGVHD. Sleep, nutrition and depression may be important therapeutic targets in these patients affected by clinically significant fatigue. Further studies involving longitudinal follow-up and deeper studies of biology are imperative to better understand or treat fatigue in cGVHD patients. Disclosures No relevant conflicts of interest to declare.

TL 18052 - Sagittal tibiotalar alignment in fixed-bearing total ankle replacement

Introduction: Implant positioning is critical in total ankle replacement (TAR). However, the effect of sagittal tibiotalar alignment on functional outcomes in fixed-bearing TAR remains unclear. Furthermore, no studies comparing different fixed-bearing implants with respect to the anteroposterior position of the talar component have been performed to date. Methods: A retrospective analysis of 71 primary TARs in a single center was performed. Prostheses included were the INBONE II® (Wright Medical, Memphis, TN) and the Salto Talaris (Integra LifeSciences, Plainsboro, NJ). Radiographic measurements of the tibial-axis-to-talus ratio (T-T ratio) and the anteroposterior offset ratio (AP offset ratio) were performed preoperatively and postoperatively, respectively. Foot and Ankle Outcome Scores (FAOS) and SF-12 MCS and PCS scales were evaluated preoperatively and 2 years postoperatively. Results: Postoperative sagittal tibiotalar alignment was neutral in 39 ankles and anterior in 32 ankles. No significant differences were observed between groups with respect to clinical outcome scores. Patients with a Salto Talaris prosthesis had a greater AP offset ratio (0.12 ± 0.05) than patients with an INBONE II® implant (0.05 ± 0.04) (P &lt; .01); however, this increased translation did not correlate with the outcome scores. Conclusion: At the 2-year follow-up, the INBONE II® TAA showed a more neutral sagittal alignment compared with the Salto Talaris prosthesis. However, no correlation between the postoperative AP offset ratio and functional outcome scores was observed with the use of the two fixed-bearing TAR. Further studies with longer follow-ups are needed to determine if the difference in sagittal alignment may have an effect on functional outcomes in the long-term.

Predictors of health-related quality of life after non-catastrophic injury sustained in a road traffic crash.

Health-related quality of life (HRQoL) is an important patient-reported outcome that warrants greater attention in individuals who sustained a non-catastrophic injury in a road traffic crash. Additional robust data on HRQoL outcomes after a non-catastrophic injury are needed to effectively identify potential targets for studies of tertiary prevention of poor recovery after a crash. We assessed the association between non-catastrophic road traffic crash injuries and HRQoL and factors that independently affect long-term HRQoL. In this inception cohort study, injured participants (≥17years old) were identified from various sources including hospital emergency departments by a medical examination by a registered healthcare professional in New South Wales (Australia) and followed up after 12months. HRQoL was measured by the European Quality of Life-5 Dimensions (EQ-5D-3L) and Medical Outcomes Survey Short Form 12 items (SF-12). A range of socio-demographic, pre-injury health, psychological, and injury-related factors were considered potential predictors of HRQoL in regression analyses. Among 2019individuals identified, 1201 (59.5%) were followed up after 12months. HRQoL significantly improved between baseline and 12-month follow-up: EQ-5D-3L summary score (0.41-unit difference); SF-12 physical component summary score (PCS; 13.6-unit difference) and mental component summary score (MCS; 3.5-unit difference). Over 12months, HRQoL score was lower for people claiming compensation than others (P<0.0001). Key predictors of better 12-month EQ-5D-3L summary score and visual analogue scale score for pain were age, not claiming compensation, reduced body mass index, less pain severity, less pain-related disability, and less general psychological distress. Significant predictors of SF-12 PCS score were injury to the neck (P=0.02) or head or face (P=0.01), being a driver or passenger at the time of the crash (P<0.0001), hospital admission (P<0.0001) and pain severity (P<0.0001). Baseline variables associated with 12-month SF-12 MCS scores were head or face injury (P=0.02), pre-injury health (P=0.04), pre-injury psychological conditions (P=0.04), trauma-related distress (P=0.0002) and general psychological distress (P<0.0001). A wide spectrum of biopsychosocial factors contribute to HRQoL after a road traffic crash injury. These epidemiological data are potentially important because they could identify potential targets for studies of tertiary prevention of persistently poor HRQoL after such an injury.