Meaningful Clinical Improvement Research Articles

PCN122 Cost-Effectiveness of Brentuximab Vedotin for the Frontline Treatment of Peripheral T-Cell Lymphomas in Canada

Health Canada recently expanded the use of brentuximab vedotin in combination with cyclophosphamide, doxorubicin, prednisone (A+CHP) for the frontline treatment of adult patients with systemic anaplastic large cell lymphoma (sALCL), peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS) or angioimmunoblastic T-cell lymphoma (AITL), whose tumours express CD30. The approval was based on results from the ECHELON-2 trial that compared A+CHP to CHOP (CHP plus vincristine) in CD30+ PTCL. Median progression-free survival (PFS) for A+CHP was 48.2 vs 20.8 months for CHOP, providing a significant improvement in PFS and overall survival. This economic evaluation estimated the cost-effectiveness of A+CHP for its newly-approved indication by Health Canada. A partitioned survival model with a 3-week cycle length and lifetime time horizon was developed to simulate the disease course for the modelled population. The 3 health states modelled were PFS, post-progression survival, and death. Efficacy, safety and quality of life data were obtained from ECHELON-2 for the 3 subgroups combined. Medical resource use and costs were derived from Canadian literature and standard sources. Incremental cost-effectiveness ratios (ICERs) per life years (LYs) gained and per quality-adjusted life-years (QALYs) gained were calculated. Deterministic and probabilistic sensitivity analyses were performed to account for uncertainty in key parameters. A+CHP was associated with an estimated mean gain of 2.90 LYs and 2.38 QALYs and an estimated mean incremental cost of $76,491 vs CHOP; resulting ICERs were $26,340 per LY gained and $32,177 per QALY gained. In sensitivity analyses, time horizon, patient starting age, regimen cost for A+CHP, and discount rate had notable impacts on the results as the ICER was driven by long-term survival gains associated with A+CHP vs CHOP. A+CHP provides a cost-effective and clinically-meaningful improvement in treatment options for adults with previously untreated, CD30-expressing sALCL, PTCL-NOS or AITL in Canada, and is within acceptable ICER ranges for oncology medicines.

Hearing aid use and cognition in older adults: Can we delay decline or even improve cognitive function?

AbstractBackgroundHearing loss is associated with accelerated cognitive decline in older adults, and has been identified as a modifiable risk factor for dementia. Although hearing aids are a successful treatment for hearing loss, it is unknown whether hearing aid use can delay the onset of cognitive decline or improve cognitive function in older adults with hearing loss. This prospective longitudinal study is investigating the effect of hearing aid use on cognitive decline and addresses many of the methodological limitations of previous studies.MethodPatients are recruited from the University of Melbourne Academic Hearing Aids Audiology Clinic and assessed before and every 18 months after hearing aid fitting. When numbers are sufficient, results will be compared with those of a control group of approximately 400 participants of a cohort study of ageing in older adults. Assessments include cognitive function (visually presented computerised assessment battery), hearing, speech perception, quality of life, activity, diet, loneliness and isolation, anxiety, depression, medical health and genetic risk.ResultAt baseline, multiple linear regression for 98 participants (62‐82 years), controlling for age, gender, cardiovascular conditions, education, and working/retired, with mean better ear PTA 31dB showed hearing loss and age predicted significantly poorer executive function, while tertiary education predicted significantly better executive function and visual learning. At 18‐month follow up, results for a subset of participants showed significant improvements in speech perception, listening disability and quality of life. Group mean scores across the cognitive assessment battery showed no significant decline and executive function was significantly improved. There was either clinically significant improvement or stability for executive function for over 97% of the subset, and for females for working memory, visual learning and visual attention, despite significantly greater hearing loss over this period.ConclusionDespite a small initial sample size, hearing loss, age and education significantly predicted baseline cognitive function. At 18‐month follow up, the majority of participants had either remained stable or demonstrated a meaningful clinical improvement in cognitive function, with significant group mean improvements for executive function and working memory. Treatment of hearing loss with hearing aids may delay cognitive decline. These are initial results, and further follow up is required.

Does obesity lead to lower rates of clinically meaningful improvement or satisfaction after total hip arthroplasty? A propensity score-matched study.

Current literature lacks consensus regarding the impact of obesity on clinical outcomes of total hip arthroplasty (THA). The variability of results may reflect the lack of minimal clinically important difference (MCID) analysis, which helps to standardise the interpretation of patient-reported outcome measures (PROMs). We compared the PROMs, patient satisfaction and survivorship between obese and non-obese patients after THA. Prospectively collected registry data of 192 obese patients and 192 propensity score-matched controls who underwent primary THA at a single institution were reviewed. Clinical outcomes and satisfaction rates were assessed at 6 months and 2 years. Reoperations for surgical complications and revision rates were analysed. Obese patients had a significantly poorer Oxford Hip Score (OHS) at 6 months and WOMAC-Function at 2 years. However, there was no difference in overall WOMAC, WOMAC-Pain, WOMAC-stiffness, SF-36 mental and physical component summary (PCS). A similar proportion of patients in each group achieved the MCID for OHS, WOMAC and SF-36 PCS. At 2 years, 90.3% of obese patients and 91.7% of controls were satisfied (p = 0.755). At a mean follow-up of 9 years, there were 5 reoperations (2.6%) for surgical complications in the obese group and 1 (0.5%) in the control group; whereas 12 revisions (6.3%) were recorded in the obese group and 3 (1.6%) in the control group (p = 0.021). Despite a higher revision rate, obese patients undergoing THA may experience a similar level of clinical meaningful improvement and satisfaction as their non-obese counterparts. This study provides valuable prognostic information for obese patients and guides preoperative counselling.

Generation of Neural Progenitor Cells From Canine Induced Pluripotent Stem Cells and Preliminary Safety Test in Dogs With Spontaneous Spinal Cord Injuries.

Advances in stem cell technology, including the use of induced pluripotent stem cells (iPSC) to produce neurons and glial cells, offer new hope for patients with neurological disease and injuries. Pet dogs with spinal cord injuries provide an important spontaneous animal model for evaluating new approaches to stem cell therapy. Therefore, studies were conducted to identify optimal conditions for generating neural progenitor cells (NPC) from canine induced pluripotent stem cells (iPSC) for preliminary evaluation in animals with spinal cord injury. We found that canine NPC could be induced to differentiate into mature neural cells, including glia and neurons. In addition, canine NPC did not form teratomas when injected in NOD/SCID mice. In a pilot study, two dogs with chronic spinal cord injury underwent fluoroscopically guided intrathecal injections of canine NPC. In follow-up MRI evaluations, tumor formation was not observed at the injection sites. However, none of the animals experienced meaningful clinical or electrophysiological improvement following NPC injections. These studies provide evidence that canine iPSC can be used to generate NPC for evaluation in cellular therapy of chronic spinal cord injury in the dog spontaneous injury model. Further refinements in the cell implantation procedure are likely required to enhance stem cell treatment efficacy.

A Randomized Open-Label, Phase 3 Study to Evaluate Imetelstat Versus Best Available Therapy (BAT) in Patients with Intermediate-2 or High-Risk Myelofibrosis (MF) Refractory to Janus Kinase (JAK) Inhibitor

A Randomized Open-Label, Phase 3 Study to Evaluate Imetelstat Versus Best Available Therapy (BAT) in Patients with Intermediate-2 or High-Risk Myelofibrosis (MF) Refractory to Janus Kinase (JAK) Inhibitor

Using the QuickDASH to Model Clinical Recovery Trajectory After Operative Management of Distal Radius Fracture

PurposeThere is a paucity of literature examining the trajectory of meaningful clinical improvement after distal radius fracture (DRF) fixation. We sought to answer the following questions: (1) When do patients meet the minimum clinically important difference (MCID) in the Quick–Disabilities in Arm, Shoulder, and Hand questionnaire (QuickDASH) score change after DRF fixation? (2) What gains in terms of number of MCIDs achieved (as measured by QuickDASH) do patients make as they recover from DRF fixation? (3) What patient and injury factors are characteristic of patients who meet or do not meet the average recovery trajectory?MethodsWe performed a retrospective review of an institutional database of DRF patients treated with operative fixation. The change in QuickDASH scores from before surgery to approximate follow-up intervals of 0 to 2 months, 3 to 6 months, and a minimum of 9 of 12 months was assessed, in which a delta of 14 reflected the MCID. The change in QuickDASH score from before surgery to each follow-up interval was divided by 14 to determine the number of MCIDs, representing appreciable clinical improvement. Patient characteristics were compared between those who did and did not reach average levels of clinical improvement.ResultsThe study included 173 patients. Mean QuickDASH score before surgery was 74 (SD, 19; range, 0–100). After surgery, this improved to 50 (SD, 24; range, 0–100) by 0 to 2 months, 22 (SD, 22; range, 0–98) by 3 to 6 months, and 9.8 (SD, 15; range, 0–75) by a minimum of 9 to 12 months. Overall, 96% of patients reached the MCID by 1 year. Mean cumulative number of MCIDs achieved (ie, number of 14-point decreases in QuickDASH score) at each interval was 1.57, 3.64, and 4.43, respectively. Assuming 4.43 represents maximum average improvement at 1 year, patients achieved 35% (1.57 of 4.43) of recovery from 0 to 2 months after surgery and 82% (3.64 of 4.43) of recovery by 3 to 6 months after surgery. There appeared to be no difference in terms of age, sex, or body mass index with respect to these findings.ConclusionsOverall, 96% of patients undergoing DRF fixation will achieve one QuickDASH MCID by 1 year after surgery. Patients achieved over 80% of total expected functional improvement by 3 to 6 months after surgery, which appeared to be irrespective of age, sex, or body mass index.Type of study/level of evidenceTherapeutic IV.

Clinical Analytics Prediction Engine (CAPE): Development, electronic health record integration and prospective validation of hospital mortality, 180-day mortality and 30-day readmission risk prediction models.

BackgroundNumerous predictive models in the literature stratify patients by risk of mortality and readmission. Few prediction models have been developed to optimize impact while sustaining sufficient performance.ObjectiveWe aimed to derive models for hospital mortality, 180-day mortality and 30-day readmission, implement these models within our electronic health record and prospectively validate these models for use across an entire health system.Materials & methodsWe developed, integrated into our electronic health record and prospectively validated three predictive models using logistic regression from data collected from patients 18 to 99 years old who had an inpatient or observation admission at NorthShore University HealthSystem, a four-hospital integrated system in the United States, from January 2012 to September 2018. We analyzed the area under the receiver operating characteristic curve (AUC) for model performance.ResultsModels were derived and validated at three time points: retrospective, prospective at discharge, and prospective at 4 hours after presentation. AUCs of hospital mortality were 0.91, 0.89 and 0.77, respectively. AUCs for 30-day readmission were 0.71, 0.71 and 0.69, respectively. 180-day mortality models were only retrospectively validated with an AUC of 0.85.DiscussionWe were able to retain good model performance while optimizing potential model impact by also valuing model derivation efficiency, usability, sensitivity, generalizability and ability to prescribe timely interventions to reduce underlying risk. Measuring model impact by tying prediction models to interventions that are then rapidly tested will establish a path for meaningful clinical improvement and implementation.

Inlay hemiarthroplasty of the humeral head for nontraumatic osteonecrosis

BackgroundOsteonecrosis of the humeral head often occurs in younger individuals and presents a difficult clinical situation. The purpose of this study was to evaluate the patient reported outcomes in patients undergoing inlay hemiarthroplasty for nontraumatic osteonecrosis of the humeral head. We hypothesized that patients would achieve a meaningful clinical improvement. MethodsA retrospective review of prospectively collected data on 9 patients undergoing inlay hemiarthroplasty for humeral head osteonecrosis was conducted. The American Shoulder and Elbow Surgeons Shoulder score (ASES), Simple Shoulder Test (SST), visual analog scale for pain (VAS), and range of motion measurements were collected preoperatively and at final follow-up. Radiographs were evaluated for any evidence of component loosening or glenoid wear. The primary outcome was achievement of substantial clinical benefit (SCB) for ASES. ResultsPostoperatively at a mean of 7.2 years the ASES improved from 35 to 73 (p = 0.011), the SST improved from 2 to 6 (p = 0.038), and the VAS for pain decreased from 7 to 3 (p = 0.009). Forward elevation increased from 96° to 138° (p = 0.012) and external rotation increased from 13° to 63° (p = 0.007). SCB for ASES was seen in 7 out of the 9 patients (78%). Asymptomatic mild or moderate glenoid wear was seen in 4/9 (44%) of patients. One patient (11%) developed symptomatic glenoid wear necessitating conversion to total shoulder arthroplasty. ConclusionInlay hemiarthroplasty offers a viable solution to osteonecrosis of the humeral head.Level of Evidence: Level IV; Treatment Study

384 Dupilumab provides early and sustained, clinically-meaningful improvements in both adults and adolescents: A post hoc analysis of patients not achieving Investigator’s Global Assessment of 0/1 in phase 3 trials, LIBERTY AD SOLO 1 and 2, and LIBERTY AD ADOL

This post hoc analysis investigated the proportion of patients with moderate-to-severe atopic dermatitis (AD) who achieved clinically-meaningful responses in ≥1 of the signs, symptoms, or quality of life (QoL) domains of AD, despite not achieving an Investigator’s Global Assessment (IGA) score of 0/1. Data from three phase 3 clinical trials (SOLO 1/2 [adults]: NCT02277743/NCT02277769; ADOL [adolescents]: NCT03054428) were utilized. SOLO patients received 300mg dupilumab weekly (qw)/every 2 weeks (q2w), or placebo.

Cognitive Processing Therapy for Veterans with Posttraumatic Stress Disorder: What is the Median Effective Dose?

ObjectiveCognitive Processing Therapy (CPT) has been disseminated in the Veterans Health Administration (VHA) to treat posttraumatic stress disorder (PTSD). Identifying the median effective dose (MED) of CPT, the number of sessions at which the probability of experiencing clinically meaningful improvement (CMI) is 50%, can assist with treatment. MethodFrom a cohort of Iraq and Afghanistan war veterans who received PTSD psychotherapy in VHA between 2001-2017, veterans who received CPT with available PTSD symptom outcomes (PTSD Checklist; PCL) were identified using natural language processing (n=26,189). Cox proportional hazards regression was used to examine how number of CPT sessions, together with covariates, influenced CMI (10-point PCL reduction). Kaplan-Meier curves were plotted to determine MED. ResultsAt eight sessions, there was a 50% probability of experiencing CMI. The Cox proportional hazard regression indicated a greater likelihood of CMI in fewer sessions for veterans who received individual-only CPT versus any group CPT (HR:1.31, 95%CI:1.23-1.39). Kaplan-Meier curves indicated a 50% probability of experiencing CMI at seven sessions for veterans who received individual-only CPT versus ten sessions for veterans receiving any group CPT. LimitationsPCL data was not available for all veterans who received CPT or at each potential assessment point. Not all veterans continued in CPT until CMI was observed. ConclusionsThe MED of CPT was eight sessions. Fewer sessions were needed to reach MED for veterans who received individual versus group CPT. These results may help those who treat, research, and are recovering from PTSD through accurately anchoring treatment expectations and providing a marker of initial treatment response.

Predictors of rhinorrhea response after posterior nasal nerve cryoablation for chronic rhinitis.

Posterior nasal nerve (PNN) cryoablation has shown promise in improving rhinorrhea due to allergic and nonallergic rhinitis (NAR). Early case series have shown meaningful clinical improvement in 75-80% of patients, but variables predicting PNN cryoablation success have not been studied. The purpose of this study was to evaluate whether disease features and ipratropium nasal spray response predicted rhinorrhea response after PNN cryoablation. A multi-institutional retrospective case-control study of 55 patients who underwent PNN cryoablation for bilateral rhinorrhea due to allergic, nonallergic, or mixed rhinitis was conducted at 3 tertiary medical centers. Patients received a 1-month trial of ipratropium spray. Runny Nose Scores (RNSs) of 0-5 from the 22-item Sino-Nasal Outcome Test were collected prospectively, before and after PNN cryoablation. The mean age of subjects was 55.3 years and 54.6% were women. Mean follow-up was 170 days. NAR comprised 62% of patients. Of the 48 patients who trialed ipratropium spray, 33 (69%) had some response and 15 (31%) had no response. Mean overall preprocedural RNS was 4.2 ± 1.0. After PNN cryoablation, there was a ≥1-point decrease in RNS in 39 patients (71%). Only ipratropium spray (INS) response predicted cryoablation success. For ipratropium spray responders, 28 of 33 (85%) had improved RNS after cryoablation, whereas 5 of 15 (33%) nonresponders improved (p = 0.001). In chronic rhinitis patients, rhinorrhea response to ipratropium was predictive of rhinorrhea improvement after PNN cryoablation. This study has important implications for preoperative counseling and guiding patient expectations when considering PNN cryoablation.

Are Oxford Hip Score and Western Ontario and McMaster Universities Osteoarthritis Index Useful Predictors of Clinical Meaningful Improvement and Satisfaction After Total Hip Arthroplasty?

BackgroundUp to 15% of patients express dissatisfaction after total hip arthroplasty (THA). Preoperative patient-report outcome measures (PROMs) scores can potentially mitigate this by predicting postoperative satisfaction, identifying patients that will benefit most from surgery. The aim of this study was to (1) calculate the minimal clinically important difference (MCID) thresholds for Oxford Hip Score (OHS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and the Short Form-36 (SF-36) mental component summary (MCS) and physical component summary (PCS) scores and (2) identify the threshold values of these PROMs that could be used to predict patient satisfaction and expectation fulfilment. MethodsProspectively collected registry data of 1334 primary THA patients who returned for 2-year follow-up from 1998 to 2016 were reviewed. All patients were assessed preoperatively and postoperatively at 2 years using the OHS, WOMAC, and SF-36 PCS/MCS scores. The MCID for each PROMs was calculated, and the proportion of patients that attained MCID was recorded. The relationship between satisfaction, expectation fulfilment, and MCID attainment was analyzed using Spearman rank correlation. Optimal threshold scores for each PROM that predicted MCID attainment and satisfaction/expectation fulfilment at 2 years were calculated using receiver operating curve analysis. ResultsThe calculated MCID for OHS, WOMAC, SF-36 PCS, and SF-36 MCS were 5.2, 10.8, 6.7, and 6.2, respectively. A threshold value of 24.5 for the preoperative OHS was predictive of achieving WOMAC MCID at 2 years after THA (area under the curve 0.80, P < .001). 93.1% of patients were satisfied, and 95.5% had expectations fulfilled at 2 years. None of the PROMs were able to predict satisfaction. ConclusionOHS and WOMAC scores can be used to determine clinical meaningful improvement but are limited in their ability to predict patient satisfaction after THA.

Jak Inhibition Prevents Bleomycin-Induced Fibrosis in Mice and Is Effective in Patients with Morphea

Jak Inhibition Prevents Bleomycin-Induced Fibrosis in Mice and Is Effective in Patients with Morphea

Updated Analysis of Bellini, a Phase 3 Study of Venetoclax or Placebo in Combination with Bortezomib and Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma

Updated Analysis of Bellini, a Phase 3 Study of Venetoclax or Placebo in Combination with Bortezomib and Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma

222 Biofeedback Therapy for Dyssynergic Defecation Is Effective Among Patients With Opioid Exacerbated Constipation

INTRODUCTION: Up to 90% of patients on opioids complain of constipation (Wurzelmann et al, 2007). Among opioid users, causes of chronic constipation can be multifactorial and related to other contributing factors such as dyssynergic defecation (DD). Biofeedback (BFB) therapy has been shown to be effective in patients with DD, but has not been studied among those who have DD and are on opioids. METHODS: This study was a retrospective analysis of patients enrolled in BFB for DD between 2015 to 2018 at a tertiary referral motility program. For patients that had greater than two sessions, survey and high resolution anorectal manometry (HR-ARM) data were collected at baseline and during each BFB visit. RESULTS: 117 patients met criteria, of these, 20 patients were on active opioid therapy. Compared to those not on narcotic analgesics, opioids users were more likely to have a higher baseline defecation index (DI), intrarectal pressure divided by intra-anal pressure during simulated defecation (0.669 vs. 0.456 P &lt; 0.0007). Decreased rectal sensation at baseline was seen in 20% of opiate patients and 19% of those not on opioids (P = 1.0). Opiate users compared to those not on narcotic analgesics also had a lower baseline health rating on the SF-36 scale (3.9 vs. 3.4 1-5 Likert scale P = 0.05) and were more likely to withdraw before completing a full course of BFB (P &lt; 0.01). On stool diary, opiate users did not report a significant improvement in global bowel satisfaction rating (2.9 to 4.2, 10-point Likert scale P = 0.13), in contrast to non-opiate users who did repot improvement (2.7 to 4.9, P &lt; 0.0001). Opiate users, however, had a significant decrease in number of stooling medications used (1.8 to 1.1 P = 0.04). On HR-ARM, there was a greater change in DI among non-opiate users as compared to opiate users. After BFB, opiate users effectively normalized their dyssynergia (79% improved) (P &lt; 0.0001). Non-opiate users also showed significant improvement in normalizing their dyssynergia (74%) (P &lt; 0.0001). CONCLUSION: Patients with opioid exacerbated constipation and DD showed meaningful clinical improvement in both subjective outcomes as well as manometric parameters. While they had lower baseline health rating at the outset and did not report significant improvement in global bowel satisfaction rating, unlike the non-opioid users, they nevertheless clearly benefited from BFB therapy. Overall, this data suggests that opioid users with DD may benefit from enrollment in BFB therapy.

P1854Clinical implications of physical function and resilience in patients undergoing transcatheter aortic valve implantation

Abstract Background Gait speed, as a measure of physical function and marker of frailty, is now routinely screened when evaluating patients with aortic stenosis (AS) for transcatheter aortic valve implantation (TAVI). Assessment of physical function is important to identify patients for whom TAVI may be futile and to assign patients to a procedural risk category. After TAVI, patients may exhibit physical resilience (improvement in physical function) or vulnerability (worsening). Characterizing the trajectory and clinical consequences of physical function after TAVI represent knowledge gaps in the field. Purpose Evaluate associations between physical resilience (improved gait speed) vs vulnerability (decline) after TAVI and subsequent death/hospitalization. Methods The REPRISE III trial compared a mechanically-expanded vs a self-expanding valve in 912 high/extreme risk patients with symptomatic AS. Patients (n=587) who underwent valve implantation and who had a gait speed recorded both pre- and 1-year post-TAVI were analyzed. Gait speed is based on the 5m walk test (slow: 5m in &gt;6s, &lt;0.83m/s; normal: ≥0.83m/s). Trajectory of physical function after TAVI was characterized in 2 ways. Model 1 examined 4 groups based on slow or normal gait speeds at baseline and 1-year post-TAVI. Model 2 examined gait speed change pre-TAVI to 1 year (adjusted for baseline gait speed). Using a landmark approach, the relationships between baseline and 1-year gait speed were evaluated in multivariable Cox PH models of outcomes between 1 and 2 years post-TAVI. Results A clinically-meaningful improvement (≥0.1m/s), no change (±0.1m/s), or decline (≥0.1/ms) in gait speed 1 year after TAVI was observed in 39%, 36%, and 26% of patients, respectively. Among the 4 groups defined by pre- and 1-year post-TAVI gait speeds, 1 to 2 year mortality or hospitalization rates were: 6.6% (normal/normal), 20.9% (normal/slow), 8.0% (slow/normal), and 21.5% (slow/slow). Adjusted hazard ratios of the 2 models are shown (Table). Table. Outcome by Change in Gait Speed Death/Hospitalization P-value Death P-value Hospitalization P-value Adjusted HR [95% CI] Adjusted HR [95% CI] Adjusted HR [95% CI] Model 1: Baseline/1 year Gait Speed (Normal/Normal (n=150) [referent]) Normal/Slow (n=59) 3.82 [1.61, 9.08] &lt;0.01 2.75 [0.96, 7.86] 0.06 7.31 [1.94, 27.58] &lt;0.01 Slow/Normal (n=114) 1.39 [0.53, 3.59] 0.50 1.44 [0.50, 4.12] 0.50 1.69 [0.38, 7.60] 0.49 Slow/Slow (n=253) 3.88 [1.91, 7.91] &lt;0.01 2.36 [1.02, 5.46] 0.045 3.89 [1.14, 13.27] 0.03 Model 2: Gait speed change Baseline to 1 year per 0.1m/s increase 0.83 [0.74, 0.92] &lt;0.01 0.92 [0.80, 1.04] 0.19 0.75 [0.64, 0.88] &lt;0.01 Conclusion These data reveal there is marked heterogeneity in the trajectory of physical function after TAVI and that this trajectory–more so than baseline physical function–is clinically consequential. Identifying and optimizing factors associated with physical resilience after TAVI may improve outcomes. Acknowledgement/Funding Boston Scientific

Preoperative MRI predictors of health-related quality of life improvement after microscopic lumbar discectomy

BACKGROUNDLumbar herniated nucleus pulposus (HNP) is a common spinal pathology often treated by microscopic lumbar discectomy (MLD), though prior reports have not demonstrated which preoperative MRI factors may contribute to significant clinical improvement after MLD. PURPOSETo analyze the MRI characteristics in patients with HNP that predict meaningful clinical improvement in health-related quality of life scores (HRQoL) after MLD. STUDY DESIGN/SETTINGRetrospective clinical and radiological study of patients undergoing MLD for HNP at a single institution over a 2-year period. PATIENT SAMPLEEighty-eight patients receiving MLD treatment for HNP. OUTCOME MEASURESCephalocaudal Canal Migration; Canal & HNP Anterior-Posterior (AP) Lengths and Ratio; Canal & HNP Axial Areas and Ratio; Hemi-Canal & Hemi-HNP Axial Areas and Ratio; Disc appearance (black, gray, or mixed); Baseline (BL); and 3-month (3M) postoperative HRQoL scores. METHODSPatients >18 years old who received MLD for HNP with BL and 3M HRQoL scores of PROMIS (Physical Function, Pain Interference, and Pain Intensity), ODI, VAS Back, and VAS Leg scores were included. HNP and spinal canal measurements of cephalocaudal migration, AP length, area, hemi-area, and disc appearance were performed using T2 axial and sagittal MRI. HNP measurements were divided by corresponding canal measurements to calculate AP, Area, and Hemi-Area ratios. Using known minimal clinically important differences (MCID) for each ΔHRQoL score, patients were separated into two groups based on whether they reached MCID (MCID+) or did not reach MCID (MCID–). The MCID for PROMIS pain intensity was calculated using a decision tree. A linear regression illustrated correlations between PROMIS vs ODI and VAS Back/Leg scores. Independent t-tests and chi-squared tests were utilized to investigate significant differences in HNP measurements between the MCID+ and MCID– groups. RESULTSThere were 88 MLD patients included in the study (Age=44.6±14.9, 38.6% female). PROMIS pain interference and pain intensity were strongly correlated with ODI and VAS Back/Leg (R≥0.505), and physical function correlated with ODI and VAS Back/Leg (R=−0.349) (all p<.01). The strongest MRI predictors of meeting HRQoL MCID were gray disc appearance, HNP area (>116.6 mm2), and Hemi-Area Ratio (>51.8%). MCID+ patients were 2.7 times more likely to have a gray HNP MRI signal than a mixed or black HNP MRI signal in five out of six HRQoL score comparisons (p<.025). MCID+ patients had larger HNP areas than MCID– patients had in five out of six HRQoL score comparisons (116.6 mm2±46.4 vs 90.0 mm2±43.2, p<.04). MCID+ patients had a greater Hemi-Area Ratio than MCID– patients had in four out of six HRQoL score comparisons (51.8%±14.7 vs 43.9%±14.9, p<.05). CONCLUSIONSPatients who met MCID after MLD had larger HNP areas and larger Hemi-HNP Areas than those who did not meet MCID. These patients were also 2.7× more likely to have a gray MRI signal than a mixed or black MRI signal. When accounting for HNP area relative to canal area, patients who met MCID had greater Hemi-HNP canal occupation than patients who did not meet MCID. The results of this study suggest that preoperative MRI parameters can be useful in predicting patient-reported improvement after MLD.

54. Preoperative MRI predictors of health related quality of life improvement after microscopic lumbar discectomy

54. Preoperative MRI predictors of health related quality of life improvement after microscopic lumbar discectomy

Determinants for Meaningful Clinical Improvement of Pain and Health-Related Quality of Life After Spinal Cord Stimulation for Chronic Intractable Pain

Previous studies demonstrated significant improvement in mean pain scores and quality of life (QOL) scales in patients with chronic pain who underwent spinal cord stimulation (SCS). However, the number of individuals who experience relevant improvements in QOL, termed the meaningful clinical improvement (MCI), is not known. The present study investigated changes in pain measurements based on MCI after SCS. Thirty-four patients with chronic intractable pain completed scales of pain (visual analogue scale [VAS]), QOL (SF-36), and psychological dimensions during a 22-month follow-up period (mean). Patient-centered MCI of the VAS and SF-36 domain scores were determined based on the MacNab criteria of surgical global effectiveness. Independent presurgical predictors for MCI in the VAS and SF-36 domains were analyzed using multiple binary logistic regression. There was significant improvement of pain and QOL after the SCS (p < 0.00001). Twenty-three patients (67.6%) reached an MCI of pain, and 16 (47.7%)-23 (67.7%) reported an MCI of QOL. Predictors of MCI included ≥80% paresthesia coverage of the painful area, lower levels of anxiety and catastrophizing symptoms, shorter pain duration, female gender and no use of opioids before surgery. MCI of pain and QOL was observed in 50%-70% of patients with chronic pain after SCS. The identification of determinants for MCI is a challenge to improve the accuracy of prognostic models in SCS for patients with chronic pain. Our results, if confirmed in other populations with a larger sample size, have implications for patients with chronic pain who are candidates for SCS treatment.

Early intervention service for first episode psychosis in Modena, Northern Italy: The first hundred cases.

To report on the development of an early intervention service in Modena, Italy, with information relevant to the first 4 years of implementation. The 2-year service was offered to people aged 18-35 with psychotic manifestations, within 2 years from psychosis onset/or naïve to antipsychotics, by teams placed within community mental health Centres, according to a "specialist within generalist" model. Treatment included pharmacological consultation, psychoeducation and social inclusion programs. Health of the Nation Outcome Scale was administered at baseline and every 6 months. One hundred cases accepted the treatment from 1 March 2013 to 31 December 2016. Of these, 71% were male with a median age of 23. Ninety percent were diagnosed with non-affective psychosis, yielding an estimated treated incidence of 19.1/105 . General practitioners (GPs)represented the most frequent referrers to the program (38%), followed by referrals from acute general and psychiatric hospital units (22%) and self-referrals (14%). Meaningful clinical improvement was observed, 6 months after enrolment. An early intervention service for psychosis was successfully implemented within existing community outpatient services. GPs represented the main referrals, providing some validation of the "specialist within generalist" model of care. A promising clinical improvement and trend of reduction in duration of untreated psychosis was found, supporting the variety of early detection efforts in the community. The high median age and lack of information about pathways to care underline possible barriers to access for younger patients. These findings will inform refinement of treatments and service models for the Region.