Improvement In PCS Research Articles

Vancomycin-soaked femoral head allograft in opening wedge high tibia osteotomy enables earlier postoperative recovery and reduces infection rates compared to allogenic bone chips.

To investigate the benefits of vancomycin-soaked femoral head allograft versus allogenic bone chips as an osteotomy gap filler in reducing infection rates and perioperative pain control after medial opening wedge high tibial osteotomy (MOW-HTO). Retrospective analysis of 114 knees that underwent MOW-HTO between 2013 and 2020. Osteotomy gaps were filled with vancomycin-soaked femoral head allograft (Study Group) or allogenic bone chips (Control Group). Both groups received systemic antibiotics. Perioperative parameters studied included pain, blood loss, length of stay, postoperative day (POD1) pain scores at rest, with activity as well as ambulatory distance. Patients in the Study Group were also followed up prospectively and clinical outcome scores, namely Knee Society Score, Oxford knee score (OKS) and Physical and Mental Component of the Short-Form 36 Questionnaire (PCS and MCS, respectively). Statistical analyses using Student's T-test were performed between the groups. Patients of the study group had significantly better POD1 visual analogue scale (VAS) at rest (0.9 ± 1.6 vs 2.9 ± 1.2, p < 0.001) as well as when active (3.0 ± 1.9 vs 5.8 ± 1.5, p < 0.001). A greater proportion of patients in the study group ambulated on POD 1, (90.6% vs 26.0%, p < 0.001). Of those who ambulated on POD1, study group patients managed to cover a greater ambulatory distance (13.9 ± 7.4m vs 8.4 ± 9.3m, p < 0.05). The proportion of study group patients requiring patient-controlled analgesia (PCA) was also significantly less compared to the control group (32.8% vs 58.0%, p < 0.05). Of those requiring PCA, the amount of morphine requirement was also significantly reduced in the group with vancomycin-soaked allograft (8.7 ± 8.1mg vs 23.9 ± 33.0mg, p < 0.05). The study group also had a reduced length of stay (3.5 ± 2.0days vs 5.5 ± 2.6days, p < 0.001). Patients in the study group demonstrated significant improvement in Knee Society Knee Score (KSKS), OKS, PCS and MCS at 12months postoperatively. The study group had a significantly reduced incidence of superficial wound infections compared to the control group (3.1% vs 18.0%, p < 0.05). Vancomycin-soaked femoral head allograft reduced superficial and deep wound infections in MOW-HTO. It was also effective in reducing postoperative pain, thereby enabling early ambulation and shorter hospital stays. Retrospective comparative study, III.

P521 Correlation of histological assessment of mucosal healing with long-term clinical and patient-reported outcomes in patients with moderately to severely active ulcerative colitis treated with upadacitinib: results from the Phase 3 U-ACHIEVE maintenance trial

Abstract Background Establishing mucosal healing (MH) as a treatment goal for ulcerative colitis (UC) requires evidence of improvement in both endoscopic and histologic assessments of the intestinal mucosa and long-term sequalae. Currently, guidelines on how to interpret the histological index, Geboes Score (GS), with respect to clinically meaningful outcomes, are lacking. We examined the relationship between GS and long-term clinical and patient-reported outcomes in patients with active UC treated with upadacitinib. Methods GS and long-term clinical and patient-reported outcomes from the U-ACHIEVE maintenance trial (NCT02819635) were analysed. Patients were assigned to the following GS intervals [0, 2.0), [2.0, 3.1], and (3.1, 5.4]. The intervals were selected to assess patients who achieved the histology threshold for MH (&amp;lt;2.0) and those who achieved the histologic and endoscopic mucosal improvement threshold without MH [2.0, 3.1]. A predictive analysis (n=497) assessed the relationship between outcomes at Week 52 and GS intervals at end of induction (Week 8/16), and a cross-sectional analysis (n=211) examined outcomes at Week 52 and GS intervals at end of maintenance (Week 52). Odds ratios (ORs) with 95% confidence intervals (CIs) were derived from logistic regression adjusting for baseline characteristics. Results Adjusted ORs for long-term outcomes and GS intervals at Week 8/16 are provided in the Table 1. Patients with GS &amp;lt;2.0 at end of induction had a significantly higher likelihood of achieving clinical remission per adapted Mayo score (OR=1.8, p&amp;lt;0.030) and endoscopic improvement (OR=1.8, p&amp;lt;0.015) at Week 52 than patients with GS &amp;gt;3.1. Results were directionally similar, but not statistically significant, for all other outcomes. No significant differences were seen in the likelihood of achieving any outcome at Week 52 among patients with GS between 2.0 and 3.1 vs those with GS &amp;gt;3.1. Patients with GS &amp;lt;2.0 at Week 52 had a significantly greater likelihood of achieving all clinical endpoints and clinically meaningful improvements in UC-SQ, IBDQ, SF-36 PCS, and EQ-5D index scores at Week 52 compared to patients with GS &amp;gt;3.1 (Table 2). In patients with GS between 2.0 and 3.1 vs GS &amp;gt;3.1, results were numerically smaller than for patients with GS &amp;lt;2.0, and not significant for absence of rectal bleeding, low faecal calprotectin levels, and all patient-reported outcomes. Conclusion Evidence from the U-ACHIEVE maintenance trial of upadacitinib demonstrates that histological assessment of MH by GS at end of induction or maintenance is associated with long-term benefits, with GS &amp;lt;2.0 representing a relevant threshold for desirable clinical and patient-reported outcomes after one year of maintenance therapy.

The oxford knee score minimal clinically important difference for revision total knee arthroplasty

BackgroundMinimal clinically important difference (MCID) is crucial for interpreting meaningful improvements in patient-reported outcome measures (PROMs). No previous study has evaluated the MCID for the Oxford Knee Score (OKS) in revision total knee arthroplasty (TKA). This study aimed to propose the OKS MCID for revision TKA. MethodsProspectively collected data from 191 patients who underwent revision TKA at a single institution was analysed. Clinical assessment was performed preoperatively and at 2 years using OKS and Short-Form 36 Physical Component Score (SF-36 PCS). MCID was evaluated with a three-pronged methodology, using (1) anchor-based method with linear regression, (2) anchor-based method with receiver operating characteristic (ROC) and area under curve (AUC), (3) distribution-based method with standard deviation (SD). The anchors used were improvement in SF-36 PCS ≥ 12, patient satisfaction, and implant survivorship following revision TKA. ResultsThe MCID determined by anchor-based linear regression method using improvements in SF-36 PCS was 4.9 points. The MCID determined by anchor-based ROC was 10.5 points for satisfaction (AUC = 74.8%) and 13.5 points for implant survivorship (AUC = 73.7%). The MCID determined by distribution-based method of 0.5 SD was 4.7. ConclusionThe proposed MCID for OKS following revision TKA is 4.9 points. Patients who achieve an improvement in OKS of at least 10.5–13.5 points by 2 years are likely to be satisfied with their surgery and not require a subsequent re-revision TKA. Patients undergoing revision TKA should aim for an improvement in OKS of at least 10.5–13.5 points as a target score.

Hepatic Fat Reduction Due to Resmetirom in Patients With Nonalcoholic Steatohepatitis Is Associated With Improvement of Quality of Life

Nonalcoholic steatohepatitis (NASH) is a chronic liver disease associated with adverse clinical outcomes and impaired health-related quality of life (HRQL). Patients with biopsy-proven non-cirrhotic NASH with hepatic fat fraction of ≥10% by magnetic resonance imaging-proton density fat fraction were enrolled in a phase 2, multicenter, double-blind, randomized, placebo-controlled study of resmetirom. HRQL was assessed using Short Form-36 throughout 36 weeks of treatment. One hundred twenty-five NASH patients were enrolled (50 ± 11 years old, 50% male, 94% white, body mass index 35 ± 6 kg/m2, 39% with diabetes mellitus). Of these, 84 patients received 80 mg of resmetirom daily, and 41 received placebo. At baseline, HRQL scores were not different from general population norms (Physical Component Summary [PCS] 47.9 ± 9.3 vs 50, Mental Component Summary 50.4 ± 10.0 vs 50; all P > .05). By treatment week 12, patients who received resmetirom experienced improvement of Bodily Pain and Short Form-6D utility scores (P < .05); no HRQL improvement was noted in placebo (all P > .05). Improvement in PCS continued up to week 36 of treatment with resmetirom, again with no improvement in placebo group (all P > .05). Adjusted for the baseline score and clinicodemographic confounders, meeting the endpoint of a decrease in proton density fat fraction of ≥30% by week 12 (met by 54 of 116 treatment completers; 47 of 54 on resmetirom) was independently associated with greater improvements in Physical Functioning and PCS scores at week 36 (P < .05). Patients with improvement in NASH and fibrosis on liver biopsy also showed improvement in components of HRQL. Patients with NASH treated who improved their hepatic fat fraction and/or Nonalcoholic Fatty Liver Disease Activity Score on serial liver biopsy experienced improvement of HRQL. Further studies are needed to confirm long-term sustainability of that improvement. gov #NCT02912260.

Selective Retention of Bone Marrow Stromal Cells with Gelatin Sponge for Repair of Intervertebral Disc Defects after Microendoscopic Discectomy: A Prospective Controlled Study and 2-Year Follow-Up.

Objective Discectomy remains the classic procedure for treating lumbar intervertebral disc (IVD) herniation, but the occurrence of defects after discectomy is thought to be an important cause generating recurrent and accelerated IVD degeneration. Previous studies attempted suture of the annulus fissure, but the validity of this technique on restraining the degenerative process is controversial. On the other hand, cell therapies have been shown in multiple clinical and basic studies. Our purpose was to investigate the effectiveness of selective retention of autologous Bone Marrow Stromal Cells (BMSCs) with gelatin sponge in combination with annulus fibrosus suture (AFS) for the repair of IVD defects following mobile microendoscopic discectomy (MMED). Methods This prospective, two-armed, and controlled clinical study was conducted from December 2016 to December 2018. Written informed consent was obtained from each patient. Forty-five patients with typical symptoms, positive signs of radiculopathy, and obvious lumbar disc herniation observed by MRI were enrolled. Patients were divided into 3 groups with different treating methods: MMED (n = 15), MMED+AFS (n = 15), and MMED+AFS+BMSCs (n = 15). A postoperative 2-year follow-up was performed to evaluate the patient-reported outcomes of VAS, ODI, and SF-36. The improvement rate of VAS and ODI was calculated as [(latest‐preoperative)/preoperative] to evaluate the therapeutic effect of the three groups. Assessment parameters included Pfirrmann grade, intervertebral disc height (IDH), and disc protrusion size (DPS), as measured by MRI to evaluate the morphological changes. Results All patients enrolled had a postoperative follow-up at 3, 6, 12, and 24 months. VAS and ODI scores were significantly improved compared to the preoperative status in all three groups with a mean DPS reduction rate over 50%. At the final follow-up, the improvement rate of the VAS score in the MMED+AFS+BMSCs group was significantly higher than the MMED+AFS and MMED groups (80.1% ± 7.6% vs. 71.3% ± 7.0% vs. 70.1% ± 7.8%), while ODI improvement showed a significant change (65.6% ± 8.8% vs. 59.9% ± 5.5% vs. 57.8% ± 8.1%). All participants showed significant improvement in SF-36 PCS and MCS; the differences between each group were not significant. The mean IDH loss rate of the MMED+AFS+BMSCs group was also significantly lower than other groups (−17.2% ± 1.3% vs. −27.6% ± 0.7% vs. −29.3% ± 2.2%). The Pfirrmann grade was aggravated in the MMED and MMED+AFS groups while maintained at the preoperative grade in the MMED+AFS+BMSCs group. No adverse events of cell transplantation or recurrence were found in all patients during the postoperative follow-up period. Conclusions It is feasible and effective to repair lumbar IVD defects using SCR-enriched BMSCs with gelatin sponges, which warrants further study and development as a cell-based therapy for IVD repair.

Only partial improvement in health-related quality of life after treatment of chronic hepatitis C virus infection with direct acting antivirals in a real-world setting-results from the German Hepatitis C-Registry (DHC-R).

Improvement of health-related quality of life (HRQoL) is frequently reported as a benefit when treating hepatitis C virus infection (HCV) with direct acting antivirals (DAA). As most of the available data were obtained from clinical trials, limited generalizability to the real-world population might exist. This study aimed to investigate the impact of DAA therapy on changes in HRQoL in a real-world setting. HRQoL of 1180 participants of the German Hepatitis C-Registry was assessed by Short-Form 36 (SF-36) questionnaires. Scores at post-treatment weeks 12-24 (FU12/24) were compared to baseline (BL). Changes of ≥2.5 in mental and physical component summary scores (MCS and PCS) were defined as a minimal clinical important difference (MCID). Potential predictors of HRQoL changes were analysed. Overall, a statistically significant increase in HRQoL after DAA therapy was observed, that was robust among various subgroups. However, roughly half of all patients failed to achieve a clinically important improvement in MCS and PCS. Low MCS (p<.001, OR=0.925) and PCS (p<.001, OR=0.899) BL levels were identified as predictors for achieving a clinically important improvement. In contrast, presence of fatigue (p=.023, OR=1.518), increased GPT levels (p=.005, OR=0.626) and RBV containing therapy regimens (p=.001, OR=1.692) were associated with a clinically important decline in HRQoL after DAA therapy. In conclusion, DAA treatment is associated with an overall increase of HRQoL in HCV-infected patients. Nevertheless, roughly half of the patients fail to achieve a clinically important improvement. Especially patients with a low HRQoL seem to benefit most from the modern therapeutic options.

Effect of Marital Status on Outcomes Following Total Joint Arthroplasty.

The purpose of this study is to investigate whether the specific socioeconomic factor such as marital status has any effect on clinical outcomes and patient-reported outcome measures (PROMs) after primary total hip (THA) and knee (TKA) arthroplasty. We retrospectively reviewed patients who underwent primary THA or TKA from January 2019 to August 2019 who answered all PROM questionnaires. Both THA and TKA patients were separated into two groups based on their marital status at the time of surgery (married vs. non-married). Demographics, clinical data, and PROMs (FJS-12, HOOS, JR, KOOS, JR, and VR-12 PCS&MCS) were collected at various time-periods. Demographic differences were assessed using chi-square and independent sample t tests. Clinical data and mean PROMs were compared using multilinear regressions while accounting for demographic differences. This study included 389 patients who underwent primary THA and 193 that underwent primary TKA. In the THA cohort, 256 (66%) patients were married and 133 (34%) were non-married. In the TKA cohort, there were 117 (61%) married patients and 76 (39%) non-married patients. Length of stay was significantly shorter for married patients in both the THA (1.30 vs. 1.64; p = 0.002) and TKA (1.89 vs. 2.36; p = 0.024) cohorts. Surgical-time, all-cause emergency department visits, discharge disposition, and 90-day all-cause adverse events (readmissions/revisions) did not statistically differ between both cohorts. Both HOOS, JR and KOOS, JR score improvements from baseline to 1-year did not statistically differ for the THA and TKA cohorts, respectively. Although VR-12 PCS (p = 0.012) and MCS (p = 0.004) score improvement from baseline to 1-year statistically differed for the THA cohort, they did not for the TKA cohort. Total joint arthroplasty may yield similar clinical benefits in all patients irrespective of their marital status. Although some PROMs statistically differed among married and non-married patients, the differences are likely not clinically significant. Surgeons should continue to assess levels of psychosocial support in their patients prior to undergoing TJA to optimize outcomes. III, Retrospective Cohort Study.

P172 Quality of life improvements in patients with PsA who achieve remission or low disease activity targets: results from two clinical trials of ixekizumab at three years of treatment

P172 Quality of life improvements in patients with PsA who achieve remission or low disease activity targets: results from two clinical trials of ixekizumab at three years of treatment

Health- and Vision-Related Quality of Life in a Randomized Controlled Trial Comparing Methotrexate and Mycophenolate Mofetil for Uveitis

To evaluate changes in health-related and vision-related quality of life (VRQoL) among patients with noninfectious uveitis who were treated with antimetabolites. Secondary analysis of a randomized controlled trial. Patients with noninfectious uveitis from India, the United States, Australia, Saudi Arabia, and Mexico. From 2013 through 2017, 216 participants were randomized to receive 25 mg weekly oral methotrexate or 1.5 g twice daily oral mycophenolate mofetil. Median changes in quality of life (QoL) were measured using Wilcoxon signed-rank tests, and differences between treatment groups were measured using linear mixed models, adjusting for baseline QoL score, age, gender, and site. Among Indian patients, VRQoL scores from a general scale (the National Eye Institute Visual Function Questionnaire [NEI-VFQ]) and a culturally specific scale (the Indian Visual Function Questionnaire [IND-VFQ]) were compared using Pearson correlation tests. Vision-related QoL (NEI-VFQ and IND-VFQ) and health-related QoL (HRQoL; physical component score [PCS] and mental component score [MCS] of the Medical Outcomes Study 36-Item Short Form Survey [SF-36v2]) were measured at baseline, the primary end point (6 months or treatment failure before 6 months), and the secondary end point (12 months or treatment failure between 6 and 12 months). Among 193 participants who reached the primary end point, VRQoL increased from baseline by a median of 12.0 points (interquartile range [IQR], 1.0-26.1, NEI-VFQ scale), physical HRQoL increased by a median of 3.6 points (IQR, -1.4 to 14.9, PCS SF-36v2), and mental HRQoL increased by a median of 3.0 points (IQR, -3.7 to 11.9, MCS SF-36v2). These improvements in NEI-VFQ, SF-36v2 PCS, and SF-36v2 MCS scores all were significant (P < 0.01). The linear mixed models showed that QoL did not differ between treatment groups for each QoL assessment (NEI-VFQ, IND-VFQ, PCS SF-36v2, and MCS SF-36v2; P > 0.05 for all). The NEI-VFQ and IND-VFQ scores for Indian participants were correlated highly at baseline and the primary and secondary end points (correlation coefficients, 0.87, 0.80, and 0.90, respectively). Among patients treated with methotrexate or mycophenolate mofetil for uveitis, VRQoL and HRQoL improved significantly over the course of 1 year and did not differ by treatment allocation. These findings suggest that antimetabolites could improve overall patient well-being and daily functioning.

Trends in healthy life expectancy between 2002 and 2018 in Germany - Compression or expansion of health-related quality of life (HRQOL)?

The question of whether rising life expectancy has led to additional life years spent in good health or poor health is of major public health relevance. We tested the theories of compression or expansion of morbidity for Germany with respect to the mental and physical component summary scales (MCS/PCS) of the health-related quality of life (HRQOL) questionnaire (SF-12). Data of 90,758 women and 81,400 men were obtained from the German Socio-Economic Panel between 2002 and 2018. Linear and logistic regression analyses were applied to estimate temporal changes in MCS and PCS in different life stages. The development of healthy life expectancy (H-LE) expressed by life years without severe functional limitations was calculated by applying the Sullivan method.Overall, a significant increase of MCS and PCS was found in both genders. The rise was mainly due to declining proportions of severe limitations (norm values < 40 points) while the proportions of norm values > 60 points did not change substantially. Improvements were most apparent for the ‘young seniors’ (65–79 years) and at ‘old age’ (80 years +). In contrast, no improvements in PCS were found for ‘later working life’ (50–64 years) and decreasing levels were observed for persons of ‘middle working age’ (30–49 years). During the study period, H-LE at age 50 increased in women/men by 2.93/2.90 years (MCS) and 1.92/2.53 years (PCS), respectively. Our results support the hypothesis of absolute compression of morbidity. However, since consistent improvements were not found for ages below 65 years, it remains open to debate whether the positive health trend will also persist in the future. Our findings suggest that health promotion efforts should be strengthened for people of middle and later working age to support healthy aging.

High levels of interleukin-6 in patients with rheumatoid arthritis are associated with greater improvements in health-related quality of life for sarilumab compared with adalimumab

BackgroundIncreased levels of cytokines, including interleukin-6 (IL-6), reflect inflammation and have been shown to be predictive of therapeutic responses, fatigue, pain, and depression in patients with rheumatoid arthritis (RA), but limited data exist on associations between IL-6 levels and health-related quality of life (HRQoL). This post hoc analysis of MONARCH phase III randomized controlled trial data evaluated the potential of baseline IL-6 levels to differentially predict HRQoL improvements with sarilumab, a fully human monoclonal antibody directed against both soluble and membrane-bound IL-6 receptor α (anti-IL-6Rα) versus adalimumab, a tumor necrosis factor α inhibitor, both approved for treatment of active RA.MethodsBaseline serum IL-6 levels in 300/369 randomized patients were categorized into low (1.6–7.1 pg/mL), medium (7.2–39.5 pg/mL), and high (39.6–692.3 pg/mL) tertiles. HRQoL was measured at baseline and week (W)24 and W52 by Short Form 36 (SF-36) physical/mental component summary (PCS/MCS) and domain scores, Functional Assessment of Chronic Illness Therapy -fatigue, and duration of morning stiffness visual analog scale (AM-stiffness VAS). Linear regression of changes from baseline in HRQoL (IL-6 tertile, treatment, region as a stratification factor, and IL-6 tertile-by-treatment interaction as fixed effects) assessed predictivity of baseline IL-6 levels, with low tertile as reference. Pairwise comparisons of improvements between treatment groups were performed by tertile; least squares mean differences and 95% CIs were calculated. Similar analyses evaluated W24 patient-level response on minimum clinically important differences (MCID).ResultsAt baseline, patients with high versus medium or low IL-6 levels (n = 100, respectively) reported worse (nominal p < 0.05) SF-36 MCS and role-physical, bodily pain, social functioning, role-emotional domain, and AM-stiffness VAS scores. There was a greater treatment effect with sarilumab versus adalimumab in high tertile versus low tertile groups in SF-36 PCS, physical functioning domain, and AM-stiffness VAS (nominal interaction p < 0.05). PCS improvements ≥MCID were higher in high (odds ratio [OR] 6.31 [2.37, 16.81]) versus low (OR 0.97 [0.43, 2.16]) tertiles with sarilumab versus adalimumab (nominal interaction p < 0.05). Adverse events between IL-6 tertiles were similar.ConclusionsPatients with high baseline IL-6 levels reported better improvements in PCS, physical functioning domain, and AM-stiffness scores with sarilumab versus adalimumab and safety consistent with IL-6R blockade.Trial registrationNCT02332590. Registered on 5 January 2015

Surgical Management of Insertional Achilles Tendinopathy in the Young and Elderly Result in Similar Clinical Outcomes

Category:Other; AnkleIntroduction/Purpose:Insertional Achilles tendinitis (IAT) is a common cause of chronic posterior heel pain. Non-operative treatment has demonstrated evidence of success, with similar failure rates in both the young and the elderly. Surgical management can reproducibly improve patients’ pain and functional status. Older patients are considered to be at a higher risk for surgical complications due to associated comorbidities when compared to patients under the age of 60. The aim of this study is to investigate the impact of comorbidities and peri-operative variables on functional patient reported outcomes following surgical treatment of IAT in those over and under the age of 60.Methods:Retrospective review of prospectively collected data pertaining to a consecutive series of adult patients who underwent surgical management of IAT by a single surgeon (J.B.). Patients were separated into those 60 years of age and younger, and those above 60. Patients undergoing concomitant surgical procedures or revisions were excluded. Patient demographics, co- morbidities, perioperative variables, and post-operative complications were collected. Visual Analogue Scale (VAS), Short Form Health Survey Physical Component Score (SF-36 PCS), wound infection, and recurrence were assessed with a minimum follow-up of 12 months. Statistics were obtained using linear regression mixed models, and chi-squared analysis.Results:38 operative cases were identified including 17 patients over and 21 patients under 60 years of age (mean 66.8 +/- 5.1yrs, 49.1 +/- 8.4yrs, respectively). There were no significant differences in demographics, rates of co-morbidities, or post-operative infection between the two groups. Both young and elderly groups experienced improvements in mean VAS pain scores at 6 months (3.3 and 2.7, respectively, P = 0.416) and 12 months (5.0 and 4.1, respectively, P = 0.322) post-operatively. SF-36 PCS improvements were also observed in both young and elderly cohorts at 6 (mean 22.1 and 9.3, respectively, P = 0.122) and 12 months (mean 30.4 and 20.4, respectively, P = 0.158). Linear regression analysis showed no statistical difference between the presence of co-morbidities, or age, on clinical outcomes.Conclusion:None of the co-morbidities nor peri-operative variables assessed were linked to increased risk of failed surgical correction of IAT in elderly patients, suggesting surgical correction of IAT in geriatric populations is an appropriate and reproducible treatment option. Further higher-powered studies, with longer follow-up times would be of use to better elucidate the influence of co-morbidities on recurrence.

225. Severity of cervical disc degeneration and health-related quality of life outcomes following anterior cervical discectomy and fusion

BACKGROUND CONTEXT Cervical disc degeneration is a common radiographic finding among patients with cervical spine pathology. While not all patients with radiographic evidence of disc degeneration are symptomatic, there has been little literature exploring the relationship between severity of cervical disc degeneration and postoperative health-related quality of life (HRQOL) outcomes in patients following anterior cervical discectomy and fusion (ACDF). PURPOSE The purpose of this study was to explore the relationship between the severity of cervical disc degeneration and postoperative HRQOL outcomes in patients’ status post one- to three-level ACDFs. STUDY DESIGN/SETTING Retrospective cohort study. PATIENT SAMPLE A cohort of patients status post ACDF with available preoperative/postoperative cervical radiographic imaging was obtained using Standardized Query Language (SQL) of a hospital database from a single-center, high-volume academic hospital from January 2013 to December 2018. OUTCOME MEASURES The primary outcomes of interest were HRQOL outcomes: Short Form-12 Physical/Mental Component Scores (SF-12 PCS/MCS), neck disability index (NDI), and visual analog scale arm/neck scores (VAS Arm/Neck). METHODS Patient demographics and case characteristics were obtained via SQL query and electronic medical record (EMR) chart reviews. HRQOL outcomes were obtained via SQL query with at least 1-year follow-up. Cervical disc degeneration was graded using a previously established scoring system incorporating: middle intervertebral disc height loss, anterior osteophyte length, and endplate sclerosis. Patients were then categorized into mild, moderate, or severe degeneration groups. Statistical analysis was performed with regression to examine the relationship between severity of disc degeneration and patient/clinical outcomes. RESULTS Of the 211 patients in the final cohort, 27 had mild degeneration, 100 moderate degeneration and 84 severe degeneration. Univariate analysis showed a significantly higher age in patients with severe disc degeneration compared to mild and moderate (58.4 vs 55.5 vs 52.5; p: 0.034). among HRQOL outcomes, patients with severe disc degeneration reported significant improvement in SF-12 PCS (9.4 vs 3.6 vs 4.9; p: 0.024) and VAS neck scores (-4.6 vs -2.6 vs -3.8; p: 0.036). This was further supported with multiple linear regression analysis, showing significant improvement in SF-12 PCS (β: 3.59; p: 0.005) and VAS neck (β: -1.13; p: 0.005) scores in the severe degeneration group when compared with the mild and moderate disc degeneration groups. Patients among all three groups showed significant improvement in SF-12 PCS, NDI, VAS neck, and VAS arm scores after surgical intervention. CONCLUSIONS Overall, our data validates that patients suffering from preoperative severe disc degeneration report the greatest improvement in symptoms and functional status when compared to patients with mild and moderate disease. Cervical disc degeneration has been meticulously studied at a basic science level, however clinical data regarding its effect on patient clinical outcomes has been lacking. Our study provides evidence that the preoperative degree of cervical disc degeneration has a significant effect on postoperative patient-reported outcomes, and discussion of these findings can help physicians and patients make informed decisions during the preoperative period. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.

P106. Impact of predominant preoperative symptoms on outcomes of CDR

BACKGROUND CONTEXT Cervical pathologies can commonly present with both neck and radicular symptoms. Cervical disc replacement (CDR) is typically indicated in the treatment of radicular symptoms, though it has also been shown to improve neck pain. Its efficacy has yet to be studied between patients presenting with primarily neck, arm, or equivalent neck and arm pain. PURPOSE To assess whether predominant preoperative symptom has an impact on outcomes of CDR. STUDY DESIGN/SETTING Retrospective review of prospectively collected data. PATIENT SAMPLE A total of 107 patients who had undergone CDR by three surgeons at a single academic institution. OUTCOME MEASURES PROMs (NDI, neck/arm VAS, SF-12 PCS/MCS) were collected prospectively as standard of care preoperatively and at each follow-up (2wk, 6wk, 12wk, and 6mo). METHODS Based on predominant symptom, patients were divided into three groups: NECK (VAS Neck>VAS Arm,n=41), ARM (VAS Arm>VAS Neck,n=28), and NA (VAS Neck=VAS Arm,n=38). Differences in postoperative PROMs and change in PROMs from the preoperative time-point were compared using t-tests. RESULTS Compared to the ARM cohort (4.61±2.82), NECK (6.73±2.48; p=0.005) and NA (6.69±2.85;p=0.007) patients had significantly worse preoperative neck VAS scores, which is not unexpected as groups were created based on preoperative VAS. Although all three groups demonstrated significant improvement in neck VAS by 2wks, which was maintained until 6mo, NECK patients had significantly worse neck VAS than ARM patients at 2 weeks (p=0.020), 12 weeks (p=0.002), and 6 months (p=0.003), with no differences in the amount of improvement among the three groups at any time point. Compared to the NECK cohort (3.28±2.85), ARM (7.45±2.02; p CONCLUSIONS All three cohorts demonstrated significant improvement in NDI and neck VAS with no differences in the degree of improvement. All groups demonstrated improvement in arm VAS, with greater and earlier improvement seen in ARM and NA compared to NECK. All groups demonstrated improvements in PCS and MCS scores, with greater and earlier PCS improvement seen in ARM and earlier MCS improvement seen in NA. Overall, all groups showed improvement following CDR; however, the improvement in ARM and NA is greater and seen earlier compared to NECK. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.

Preoperative patient activation is predictive of improvements in patient-reported outcomes following minimally invasive lumbar decompression.

To determine whether there is an association between preoperative 10-Item Patient Activation Measure (PAM-10) scores and clinical outcomes following MIS LD. Patients undergoing a primary MIS LD were retrospectively reviewed and stratified according to their preoperative PAM-10 scores: "low PAM," "moderate PAM," and "high PAM." Preoperative PAM score cohorts were tested for improvements in Oswestry Disability Index (ODI), 12-Item Short-Form Physical Component Score (SF-12 PCS), and Visual Analog Scale (VAS) back and leg pain using multivariate linear regression. Eighty-nine patients were included: 29 had a low PAM score, 32 had a moderate PAM score, and 28 had a high PAM score. Cohorts experienced similar preoperative VAS back pain, VAS leg pain, ODI, and SF-12 PCS. Patients with low PAM scores experienced a trend of higher pain scores throughout 6 months with VAS back pain being significant at 3 months and VAS leg pain being significant at 6-week and 3-month follow-up. Patients with lower PAM scores experienced a worse improvement in ODI at 6-week, 3-month, and 6-month timepoints. Lastly, patients with lower PAM scores demonstrated less improvement in SF-12 PCS at 3-month and 6-month follow-up. Lower preoperative PAM scores were associated with worse improvement in clinical outcomes following MIS LD. Patients with lower PAM scores had diminished improvement in long-term patient-reported outcomes including ODI, SF-12, and VAS back and leg pain. Our investigation suggests that preoperative PAM assessments may be an effective tool to predict postoperative outcomes following MIS LD.

Improvement in Health-Related Quality of Life After Total Ankle Arthroplasty Compares Well With Other Successful Orthopaedic and Nonorthopaedic Procedures.

Background. Ankle arthritis is a major cause of disability. Orthopaedic literature suggests improvement in health-related quality of life (HRQOL) after total ankle arthroplasty (TAA). This has not been compared with improvements observed in successful orthopaedic and nonorthopaedic procedures, including anterior cervical discectomy/fusion (ACDF), total knee arthroplasty (TKA), coronary artery bypass grafting (CABG), and orthotopic liver transplant (OLT). We hypothesize that the effects after TAA are comparable to several successful surgical procedures. Methods. 500 consecutive TAA patients were included and grouped with 2 other large series. Short Form-36 (SF36) were collected at standardized intervals. A systematic literature review identified studies comparing preoperative and postoperative SF36 physical (PCS) and mental component summary (MCS) scores. Using meta-analyses, we pooled the data for each procedure to compare with the TAA group. Results. Patients in all cohorts had preoperative SF36 MCS and PCS scores that were significantly lower than that in the general population. Improvements in HRQOL after TAA were not statistically different from improvements reported in PCS and MCS after ACDF, TKA, and OLT. However, improvement in PCS after TAA was better than that observed after CABG. Conclusions. Disability with ankle arthritis is severe. Disability associated with cervical disc disease, knee arthrosis, coronary artery disease, and liver failure is also severe, with surgical intervention providing major improvements in HRQOL postoperatively. The improvement in HRQOL after TAA did not differ statistically from ACDF, TKA, CABG, and OLT. Our investigation suggests that the HRQOL benefits of TAA meet benchmarks set by some of modern medicine's best.Levels of Evidence: Level III: Systematic review.

P217 Efficacy and safety of filgotinib for patients with RA naïve to MTX therapy: FINCH3 primary outcome results

Abstract Background Filgotinib (FIL), an orally administered, potent, selective inhibitor of janus kinase 1 (JAK1), has shown good efficacy and was well tolerated for treatment of rheumatoid arthritis (RA). The objectives of this study were to compare efficacy and safety of FIL with and without methotrexate (MTX) in patients with RA who were naïve to MTX therapy. Methods This Phase 3, double-blind, active-controlled study randomised patients with moderately to severely active RA (2:1:1:2) to FIL 200mg daily+MTX, FIL 100mg+MTX, FIL 200mg (+placebo [PBO]), or MTX (+PBO) up to 52 weeks; results are through week 24. Primary endpoint was proportion achieving ACR20 response at week 24. Safety endpoints included adverse events types and rates. Results Of 1,252 randomised patients, 1,249 received study drug (416 FIL 200mg+MTX; 207 FIL 100mg+MTX; 210 FIL 200mg monotherapy; 416 MTX monotherapy) and were analysed; 1,130 completed week 24. Most (76.9%) were female; mean time since RA diagnosis was 2.2 years (median 0.4 years); mean (standard deviation [SD]) DAS28-CRP was 5.7 (1.0); and 35.9% were using oral steroids at baseline. At week 24, significantly more patients in the FIL 200mg+MTX (81.0%; P&amp;lt;0.001) and FIL 100mg+MTX (80.2%; P&amp;lt;0.05) arms achieved an ACR20 response compared to MTX monotherapy (71.4%)(Table 1). Compared to MTX monotherapy, more patients receiving FIL with or without MTX achieved ACR50 and ACR70 responses, DAS28-CRP &amp;lt;2.6 and ≤3.2, and reported improvements in SF-36 PCS (Table 1). The onset of activity was rapid, with significantly more patients achieving ACR50 and DAS28-CRP &amp;lt;2.6 with FIL than MTX at week 2. The FIL safety profile was consistent with prior studies through week 24. Serious AEs were observed in 4.1%, 2.4%, 4.8%, and 2.9% of patients in the FIL 200mg+MTX, FIL 100mg+MTX, FIL 200mg monotherapy, and MTX monotherapy groups, respectively. There was 1 death from lupus cardiomyopathy. Conclusion The JAK1 inhibitor FIL in combination with MTX led to significant improvements in RA signs and symptoms, physical function, and patient-reported outcomes compared to MTX alone and was well tolerated in patients with early active RA naïve to MTX. Clinically meaningful response to FIL occurred as early as 2 weeks after treatment initiation. Disclosures N. McKay: None. D. van der Heijde: Corporate appointments; Director of Imaging Rheumatology bv. Consultancies; Consultant for AbbVie, Amgen, Astellas, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Daiichi, Eli Lilly, Galapagos, Gilead, Glaxo-Smith-Kline, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda Pharmaceutical Company Ltd., UCB. R. Westhovens: Corporate appointments; Advisor for Celltrion and Galapagos/Gilead. Other; Advisor for Celltrion and Galapagos/Gilead. W.F.C. Rigby: Consultancies; Consultant for Gilead. D.W.T. Ching: Corporate appointments; Speaker for AbbVie. Member of speakers’ bureau; Speaker for AbbVie. B. Bartok: Corporate appointments; Employee of Gilead Sciences, Inc. Shareholder/stock ownership; Shareholder of Gilead Sciences, Inc. F. Matzkies: Corporate appointments; Employee of Gilead Sciences, Inc. Shareholder/stock ownership; Shareholder of Gilead Sciences, Inc. Z. Yin: Corporate appointments; Employee of Gilead Sciences, Inc. Shareholder/stock ownership; Shareholder of Gilead Sciences, Inc. Y. Guo: Corporate appointments; Employee of Gilead Sciences, Inc. Shareholder/stock ownership; Shareholder of Gilead Sciences, Inc. C. Tasset: Corporate appointments; Employee of Galapagos NV. J.S. Sundy: Corporate appointments; Employee of Gilead Sciences, Inc. Shareholder/stock ownership; Shareholder of Gilead Sciences, Inc. N. Mozaffarian: Corporate appointments; Employee of Gilead Sciences, Inc. Shareholder/stock ownership; Shareholder of Gilead Sciences, Inc. O.D. Messina: Honoraria; Received Honoraria from Pfizer, Amgen, and Americas Health Foundation (AHF). R.B.M. Landewé: Consultancies; Consultant for AbbVie, AstraZeneca, BMS, Galapagos, Pfizer, Eli Lilly, Novartis, and UCB. T. Atsumi: None. G.R. Burmester: Honoraria; Received Honoraria from AbbVie, Gilead, Eli Lilly, and Pfizer.

PROMIS Physical Function Predicts Postoperative Pain and Disability Following Anterior Cervical Discectomy and Fusion.

This was a retrospective study. The objective of this study was to determine if preoperative Patient-Reported Outcomes Measurement Information System Physical Function (PROMIS PF) score is predictive of improvement in pain and physical function following anterior cervical discectomy and fusion (ACDF). Few studies have investigated the predictive nature of PROMIS PF of patients undergoing spine surgery, such as ACDF. Patients undergoing a primary, 1-3-level ACDF were retrospectively reviewed and were stratified into 3 cohorts according to preoperative PROMIS PF scores: minimal disability (score 50-60), mild disability (score 40-50), moderate disability (score 30-40), and severe disability (score 20-30). Preoperative PROMIS PF cohorts were tested for an association with demographics, perioperative characteristics, and improvement in Neck Disability Index (NDI), 12-Item Short-Form Physical Component Score (SF-12 PCS), and Visual Analog Scale (VAS) neck and arm pain using χ analysis and multivariate linear regression. A total of 126 patients were included: 11 had a minimal disability, 44 had mild disability, 54 had moderate disability, and 17 had severe disability. Patients with a severe disability experienced no statistically significant increase in their length of stay. Greater preoperative disability demonstrated lower NDI and SF-12 PCS scores preoperatively and at each postoperative timepoint. Greater preoperative disability had worse VAS neck and arm pain preoperatively and 6-week and 3-month postoperatively. Although patients with severe disability trended worse VAS neck and arm pain at the 6-month follow-up, this did not reach statistical significance. In this investigation, patients with worse PROMIS PF scores reported greater pain and disability in the preoperative period and experienced less improvement in NDI, SF-12 PCS, and VAS back and leg following ACDF. PROMIS PF is an efficient and accurate instrument that can effectively evaluate strength, mobility, and coordination in the preoperative period and may be used to predict clinical outcomes following ACDF.

Patient\u2019s early satisfaction with care: a predictor of health-related quality of life change among outpatients with substance dependence

BackgroundAlthough research on health-related quality of life (HRQoL) has increased in the addiction field, few studies have focused on the determinants of HRQoL changes. This study aimed to describe dependent patients’ HRQoL changes at a 3-month follow-up and to assess whether satisfaction with care can predict those changes among outpatients starting care for alcohol or opioid dependence.MethodsHRQoL was measured with the SF-12 at baseline and 3 months later in a prospective cohort of dependent outpatients. Satisfaction was assessed with the EQS-C early after inclusion. Data on sociodemographics, clinical characteristics and patients’ levels of anxiety and depression were also collected. A multivariable analysis was performed to identify factors associated with HRQoL changes in both the physical and mental component summary scores (PCS and MCS, respectively).ResultsOf the 172 patients included at baseline, a total of 136 patients assessed their satisfaction with care. The mean PCS and MCS scores were initially low, and HRQoL improvement was significant after 3 months for both the PCS and MCS. Never having been married (β = 5.5; p = 0.001) and a lower baseline PCS score (β = − 0.6; p < 0.0001) were associated with significant PCS improvement, whereas being legally compelled to undergo drug treatment (β = − 5.9; p = 0.02) was associated with less PCS change. Higher early satisfaction with care (β = 0.1; p = 0.02) and a lower baseline MCS score (β = − 0.7; p < 0.0001) were associated with significant MCS improvement.ConclusionThe study supported the hypothesis that greater satisfaction with care may predict HRQoL improvement among dependent outpatients. Further studies are needed to understand the factors that affect patients’ early satisfaction to identify areas of improvement and thus improve HRQoL.

Improved health-related quality of life in the first year after laparoscopic niche resection: a prospective cohort study

ObjectiveTo evaluate changes in health-related quality of life (HRQOL) the first year after laparoscopic niche resection. Study designProspective cohort study in women with a large niche (residual myometrium thickness <3.0 mm) after caesarean section who underwent laparoscopic niche resection between May 2010 and January 2018. Women were included consecutively. 36-Item Short Form Survey (SF-36) was sent at baseline, three and twelve months postoperatively. All participants that filled out the questionnaire at baseline were included. Physical (PCS) and mental component summary scores (MCS) and scores for subdomains were calculated. Scores were analysed over time using Wilcoxon signed rank test. Results146 participants responded to the SF-36 at baseline, of which 129 (88.4 %) responded at three or twelve months follow-up. After three months, median PCS and MCS improved, compared to baseline (p = 0.014 and p = 0.008, respectively). Subdomains physical functioning, bodily pain, general health, vitality, mental health and social functioning improved significantly. At twelve months follow-up, improvement in PCS and MCS did not reach statistical significance (p = 0.053 and p = 0.063, respectively). Subdomains bodily pain (77.6–89.8, p < 0.001), mental health (76–80, p = 0.004) and social functioning (75–87.5, p = 0.016) improved significantly. Women with symptom relief as main goal of the intervention showed larger improvement in PCS than women with distorted anatomy and to restore anatomy as main goal for the intervention (p = 0.001). ConclusionLaparoscopic niche resection improves HRQOL in women with a large niche in physical and mental domains three and twelve months postoperatively.