Important Differences In Patient-reported Outcomes Research Articles

Minimal clinically important differences in patient-reported outcomes after coronary artery bypass surgery in the arterial revascularization trial.

This article identifies minimal clinically important differences (MCIDs) in quality of life (QoL) measures among patients who had coronary artery bypass grafting (CABG) and were enrolled in the arterial revascularization trial (ART). The European Quality of Life-5 Dimensions (EQ-5D) and the Short Form Health Survey 36-Item (SF-36) physical component (PC) and mental component (MC) scores were recorded at baseline, 5 years and 10 years in ART. The MCIDs were calculated as changes in QoL scores anchored to 1-class improvement in the New York Heart Association functional class and Canadian Cardiovascular Society scale at 5 years. Cox proportional hazard models were used to evaluate associations between MCIDs and mortality. Patient cohorts were examined for the SF-36 PC (N = 2671), SF-36 MC (N = 2815) and EQ-5D (N = 2943) measures, respectively. All QoL scores significantly improved after CABG compared to baseline. When anchored to the New York Heart Association, the MCID at 5 years was 17 (95% confidence interval: 17-20) for SF-36 PC, 14 (14-17) for the SF-36 MC and 0.12 (0.12-0.15) for EQ-5D. Using the Canadian Cardiovascular Society scale as an anchor, the MCID at 5 years was 15 (15-17) for the SF-36 PC, 12 (13-15) for the SF-36 MC and 0.12 (0.11-0.14) for the EQ-5D. The MCIDs for SF-36 PC and EQ-5D at 5 years were associated with a lower risk of mortality at the 10-year follow-up point after surgery. MCIDs for CABG patients have been identified. These thresholds may have direct clinical applications in monitoring patients during follow-up and in designing new trials that include QoL as a primary study outcome. ISRCTN46552265.

Shoulder & Elbow

The December 2023 Shoulder & Elbow Roundup360 looks at: Clavicle fractures: is the evidence changing practice?; Humeral shaft fractures, and another meta-analysis…let’s wait for the trials now!; Hemiarthroplasty or total elbow arthroplasty for distal humeral fractures…what does the registry say?; What to do with a first-time shoulder dislocation?; Deprivation indices and minimal clinically important difference for patient-reported outcomes after arthroscopic rotator cuff repair; Prospective randomized clinical trial of arthroscopic repair versus debridement for partial subscapularis tears; Long-term follow-up following closed reduction and early movement for simple dislocation of the elbow; Sternoclavicular joint reconstruction for traumatic acute and chronic anterior and posterior instability.

The effect of risankizumab on achieving minimal clinically important differences in patient-reported outcomes in patients with psoriatic arthritis: results from KEEPsAKE 1 and 2.

Psoriatic arthritis (PsA) is a chronic inflammatory disease that reduces the quality of life. This study assessed the effects of risankizumab (RZB) on the achievement of minimal clinically important differences (MCID) in patient-reported outcomes (PROs). KEEPsAKE-1 and -2 are randomized, placebo-controlled Phase 3 clinical studies assessing RZB (150 mg) vs. placebo (PBO) in adult patients with PsA with inadequate response or intolerance to disease-modifying antirheumatic drugs and/or biologics. Patients were randomized 1:1 to receive RZB or PBO for 24 weeks; starting at Week 24, all patients received RZB 150 mg through Week 52. PROs assessed were Patient's Global Assessment of Disease Activity (PtGA), Patient's Assessment of Pain, Health Assessment Questionnaire-Disability Index (HAQ-DI), Short-Form 36 Physical and Mental Component Summary scores (PCS and MCS, respectively), 5-Level EQ-5D (EQ-5D-5L), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue), and Work Productivity and Activity Impairment (WPAI). The proportion of patients achieving MCID at Weeks 24 and 52 are reported. Odds ratios of achieving MCID with RZB treatment at Week 24, relative to PBO, were estimated by logistic regression controlling for baseline and stratification factors. In KEEPsAKE-1, RZB- vs. PBO-treated patients were more likely to report MCID in all PROs at Week 24; similar results were obtained in KEEPsAKE-2, except for SF-36 MCS and WPAI presenteeism domain. In KEEPsAKE-1 and KEEPsAKE-2, 65% and 62% of RZB-treated patients, respectively, reported MCID in PtGA at Week 24, which increased to 74% and 68%, respectively, at Week 52. Approximately 48% of all PBO-treated patients reported MCID in PtGA at Week 24 and, after initiating RZB, >65% reported MCID at Week 52. Results were similar in the remaining PROs. These data demonstrate that patients with PsA receiving RZB treatment are more likely to report clinically important improvements in PROs compared with patients receiving PBO.

Effects of local intraoperative epidural use of triamcinolone acetonide-soaked Gelfoam on postoperative outcomes in patients undergoing posterolateral lumbar spinal fusion surgery: a randomized, placebo-controlled, double-blind trial.

Prior evidence has supported the use of local intraoperative epidural steroids in lumbar discectomy for improvements in postoperative pain and outcomes. However, currently there is a paucity of data regarding the efficacy of local epidural steroids in spinal fusion procedures. The present investigation aimed to evaluate the impact of local epidural administration of triamcinolone acetonide-soaked Gelfoam on postoperative pain and patient-reported outcomes in patients undergoing instrumented posterolateral lumbar spinal fusion. In this randomized, double-blind, placebo-controlled trial, patients were randomly divided into two groups (treatment and control). Patients in the treatment group received a Gelfoam carrier soaked in 1 ml of triamcinolone acetonide (40 mg), which was placed over the nerve roots in the epidural space before the closure. Patients in the control group received a Gelfoam carrier soaked in normal saline in a similar fashion to the treatment group. Patients were followed up during their hospital stay and at 4 and 12 weeks postoperatively. The primary outcome measure was early postoperative visual analog scale (VAS) scores for pain both at rest and with movement. A total of 100 patients were recruited in this study and were randomly allocated to the treatment or control group. No significant difference was found in baseline demographic, clinical, and surgical characteristics between the two groups. Postoperative VAS scores for pain both at rest and with movement were comparable between the treatment and control groups. Cumulative morphine consumption, length of hospital stay, and incidence of postoperative complications such as surgical site infection were also similar between the two groups. There was no significant difference in patient-reported outcomes including VAS scores for back and leg pain as well as the Oswestry Disability Index at 4 and 12 weeks postoperatively. The proportion of patients who achieved a minimum clinically important difference for patient-reported outcomes were also similar between the two groups. In contrast to the existing literature on the beneficial use of local intraoperative epidural steroids in conventional lumbar discectomy, the present study did not demonstrate such significant efficacy for the use of local epidural steroids in instrumented posterolateral lumbar spinal fusion. However, there is still a lack of evidence in this regard and further high-quality clinical trials are required to evaluate the efficacy of local epidural steroids in this group of patients.

Titanium-coated PEEK Versus Uncoated PEEK Cages in Lumbar Interbody Fusion: A Systematic Review and Meta-analysis of Randomized Controlled Trial.

Systematic review and meta-analysis. This study was performed to compare the fusion and subsidence rate of titanium-coated polyetheretherketone (Ti-PEEK) versus polyetheretherketone (PEEK) cages after lumbar fusion and to investigate the clinical effect on patient-reported outcomes (PROMs). Ti-PEEK cages have been developed to combine the advantages of both titanium alloy and PEEK, but whether they are superior to uncoated PEEK cages in bone fusion is still inconclusive. PubMed, EMBASE, ISI Web of Science, CENTRAL, and CNKI were searched to identify randomized controlled trials that compared the efficacy of Ti-PEEK and PEEK cages in lumbar fusion. Difference in fusion rate and subsidence rate was indicated by risk ratio and its associated 95% confidence interval (95% confidence interval). Mean difference was calculated for Oswestry Disability Index and visual analogue scale for low back pain. Subgroup analysis was performed by time course after the surgery. The Grading of Recommendations, Assessment, Development and Evaluation approach was used to evaluate the certainty of evidence. Four randomized controlled trials involving 325 patients (160 patients in Ti-PEEK group and 165 patients in PEEK group) that underwent lumbar fusion were included by our current study. Low to moderate evidence suggested that Ti-PEEK and PEEK cages exhibited equivalent fusion rate and subsidence rate at any follow-up time. Low to moderate evidence suggested that there was no difference in PROMs except for visual analogue scale measured at 6 months (mean difference: -0.57, 95% confidence interval -0.94, -0.21; P =0.002) but the difference was not clinically relevant according to the minimal clinically important difference. Low to moderate evidence showed that Ti-PEEK and PEEK had equivalent effect in bone fusion and cages subsidence at any follow-up time after lumbar fusion surgeries. Low to moderate evidence showed no clinically important difference in PROMs.

PD08-07 ASSOCIATION BETWEEN PELVIC NODAL RADIOTHERAPY AND PATIENT-REPORTED OUTCOMES AMONG MEN UNDERGOING EXTERNAL-BEAM RADIOTHERAPY FOR PROSTATE CANCER

You have accessJournal of UrologyProstate Cancer: Localized: Radiation Therapy (PD08)1 Sep 2021PD08-07 ASSOCIATION BETWEEN PELVIC NODAL RADIOTHERAPY AND PATIENT-REPORTED OUTCOMES AMONG MEN UNDERGOING EXTERNAL-BEAM RADIOTHERAPY FOR PROSTATE CANCER Christopher Wallis, Jacob Tallman, Li-Ching Huang, Zhiguo Zhao, David Penson, Tatsuki Koyama, Ralph Conwill, Michael Goodman, Ann Hamilton, Xiao-Cheng Wu, Lisa Paddock, Antoinette Stroup, Matthew Cooperberg, Mia Hashibe, Brock O'Neil, Sherrie Kaplan, Sheldon Greenfield, Daniel Barocas, and Karen Hoffman Christopher WallisChristopher Wallis More articles by this author , Jacob TallmanJacob Tallman More articles by this author , Li-Ching HuangLi-Ching Huang More articles by this author , Zhiguo ZhaoZhiguo Zhao More articles by this author , David PensonDavid Penson More articles by this author , Tatsuki KoyamaTatsuki Koyama More articles by this author , Ralph ConwillRalph Conwill More articles by this author , Michael GoodmanMichael Goodman More articles by this author , Ann HamiltonAnn Hamilton More articles by this author , Xiao-Cheng WuXiao-Cheng Wu More articles by this author , Lisa PaddockLisa Paddock More articles by this author , Antoinette StroupAntoinette Stroup More articles by this author , Matthew CooperbergMatthew Cooperberg More articles by this author , Mia HashibeMia Hashibe More articles by this author , Brock O'NeilBrock O'Neil More articles by this author , Sherrie KaplanSherrie Kaplan More articles by this author , Sheldon GreenfieldSheldon Greenfield More articles by this author , Daniel BarocasDaniel Barocas More articles by this author , and Karen HoffmanKaren Hoffman More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000001976.07AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The role of pelvic radiotherapy in men undergoing external-beam radiotherapy (EBRT) for prostate cancer remains controversial. We sought to compare patient-reported outcomes (PROs) for men receiving whole pelvis radiotherapy (WPRT) versus prostate-only radiotherapy (PORT), longitudinally over 5 years. METHODS: CEASAR is a multi-institution prospective population-based cohort study of men with clinically localized prostate cancer from 2011-2012. We compared PROs between men receiving WPRT vs. PORT using the validated 26-item Expanded Prostate Index Composite and Short Form Health Survey. We fit multivariable longitudinal linear regression models adjusting for demographics, clinical data, baseline PROs, and propensity scores to mitigate confounding by indication. RESULTS: Among 587 men treated with EBRT, 102 (17%) received WPRT while 485 (83%) received PORT. Men who received WPRT were more likely to have high-risk disease (58% vs. 18%) and to receive androgen deprivation therapy. In unadjusted analysis, disease-specific functional outcomes were similar between WPRT and PORT groups from baseline through 5 years, with the exception of worse sexual (from 6 months to 5 years) and hormonal function (at 6 months) with WPRT. In adjusted analyses, no significant differences were found in most PROs through 5-years except marginally clinically significant differences in hormonal function at 3-years (adjusted mean difference 4.7, 95% CI [1.2-8.3]; minimum clinically important difference 4-6) and 5-years (4.2, [0.4-8.0]) following treatment.Crude estimates of general health-related function identified baseline differences between treatment groups in physical functioning which persisted over time, but not in other domains. In adjusted analyses, we found a transient statistically, but not clinically, significant difference in emotional well-being at 6 months that resolved by 1 year and no differences in physical functioning or energy and fatigue. CONCLUSIONS: In this large, prospective cohort of men with localized prostate cancer, the use of pelvic, in addition to prostate, radiation therapy was not associated with clinically important differences in patient-reported outcomes through five years. Source of Funding: This study was supported by the Agency for Healthcare Research and Quality (1R01HS019356, 1R01HS022640), the Patient-Centered Outcomes Research Institute (CE-12-11-4667), and the National Cancer Institute (NIH/NCI grant 5T32CA106183). Data management was facilitated by Vanderbilt University’s Research Electronic Data Capture (REDCap) system, which is supported by the Vanderbilt Institute for Clinical and Translational Research grant (UL1TR000011 from NCATS/NIH) © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e116-e116 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Christopher Wallis More articles by this author Jacob Tallman More articles by this author Li-Ching Huang More articles by this author Zhiguo Zhao More articles by this author David Penson More articles by this author Tatsuki Koyama More articles by this author Ralph Conwill More articles by this author Michael Goodman More articles by this author Ann Hamilton More articles by this author Xiao-Cheng Wu More articles by this author Lisa Paddock More articles by this author Antoinette Stroup More articles by this author Matthew Cooperberg More articles by this author Mia Hashibe More articles by this author Brock O'Neil More articles by this author Sherrie Kaplan More articles by this author Sheldon Greenfield More articles by this author Daniel Barocas More articles by this author Karen Hoffman More articles by this author Expand All Advertisement Loading ...

Mirabegron Add-On Therapy to Tamsulosin in Men with Overactive Bladder: Post Hoc Analyses of Efficacy from the MATCH Study.

IntroductionMATCH was a randomized, double-blind, placebo-controlled study enrolling Japanese and Korean men aged ≥ 40 years who still had overactive bladder (OAB) symptoms while receiving tamsulosin. After a 4-week single-blind screening period in which patients received placebo and tamsulosin, patients were randomized to mirabegron 50 mg + tamsulosin or placebo + tamsulosin for 12 weeks (n = 568). This post hoc analysis investigated the proportion of treatment responders for each treatment group and for subgroups stratified by age based on voiding diaries and patient-reported outcomes (PROs).MethodsResponders were defined as those achieving normalization or clinically meaningful improvements in efficacy, or clinically important differences in PROs [≥ 10-point improvement in OAB questionnaire (OAB-q) symptom bother or total health-related quality of life (HRQoL) subscales at end of treatment (EoT; minimally important difference [MID]) or OAB symptom score (OABSS) total score decreased by ≥ 3 points at EoT [minimally clinically important change (MCIC)]].ResultsAt EoT, micturition frequency normalization was achieved by 30.7% of tamsulosin + mirabegron patients and 18.6% of tamsulosin + placebo patients. Normalization of urgency and incontinence was 19.1% and 60.7% for tamsulosin + mirabegron and 18.2% and 60.0% for tamsulosin + placebo. Normalization of OAB symptoms based on OABSS was 17.1% for tamsulosin + mirabegron and 14.5% for tamsulosin + placebo. Higher proportions of patients in the mirabegron add-on group versus the placebo group reported clinically meaningful improvements in micturitions, urgency, and incontinence and in MCIC for OABSS and MID for the OAB-q subscales. Double- and triple-responder findings were as predicted by the results of single-responder analyses. These results were mirrored in the age groups using cut-offs of 65 and 75 years.ConclusionMirabegron therapy added on to tamsulosin resulted in a higher frequency of responders in terms of normalization (e.g., micturition frequency normalization), clinically meaningful improvements in efficacy (e.g., ≥ 50% decrease in urgency), and minimally important changes in PROs (e.g., MCIC in OABSS).Trial RegistrationClinicalTrials.gov identifier, NCT02656173.

Patient-reported health and 1-year mortality in patients with ischemic heart disease – findings from the Denheart study

Abstract Background Though survival has improved markedly in ischemic heart disease (IHD), it remains a leading cause of death worldwide. Screening tools to identify patients at risk are ever in demand. Large-scale studies exploring the association between patients' self-reported mental and physical health and mortality are lacking. Purpose (i) to describe patient-reported outcomes (PROs) at discharge in IHD patients deceased and alive at one year, (ii) to investigate the discriminant predictive performance of PRO instruments on mortality, (iii) to investigate differences in time to death among survey responders/non-responders and among three diagnostic sub-groups (chronic ischemic heart disease/stable angina, non-STEMI/unstable angina and STEMI), and (iv) to investigate predictors of one-year mortality among sociodemographic, clinical and self-reported factors. Methods Data from the national DenHeart survey with register-data linkage was used. A total of 14,115 adults with IHD were discharged during one year. Eligible (n=13,476) were invited to complete a questionnaire and 7,167 (53%) responded. Questionnaires included the Health survey short form 12-items (SF-12), Hospital Anxiety and Depression Scale (HADS), EuroQoL-5-dimensions (EQ-5D), HeartQoL, Edmonton Symptom Assessment Scale (ESAS) and ancillary questions. Clinical and demographic characteristics were obtained from registries as were data on one-year mortality. Comparative analyses investigated differences in PROs, and discriminant PRO-performance was explored by Receiver Operating Characteristics (ROC) curves. Kaplan-Meier survival analysis explored differences in time to death across sub-groups. Predictors of mortality were explored using multifactorially adjusted cox regression analyses with time to death as underlying timescale. Results Highly significant and clinically important differences in PROs were found between those alive and those deceased at one year. The best discriminant performance was observed for the physical component scale of the SF-12 (Area Under the Curve (AUC) 0.706) (Figure 1). One-year mortality among responders and non-responders was 2% and 7%, respectively. Significant differences in time to death was observed between responders and non-responders (p<0.001) and among diagnostic subgroups (p<0.001). Strongest predictors of one-year mortality included STEMI (hazard ratio (HR) 2.9 95% confidence interval (CI) 2.3–3.7), Tu comorbidity index score 3+ (HR 3.6, 95% CI 2.7–4.8) and patient-reported feeling unsafe about returning home from hospital (HR 2.07, 95% CI 1.2–3.61). Conclusions One-year post-discharge mortality was expectedly low, however notably higher in certain subgroups. Though clinical predictors may be difficult to modify, factors such as feeling unsafe about returning home should be addressed at discharge. PRO-performance estimates may guide clinicians and researchers in choosing appropriate predictive patient-reported outcome tools. Figure 1. PRO instruments ROC curves Funding Acknowledgement Type of funding source: None

Practical issues encountered while determining Minimal Clinically Important Difference in Patient-Reported Outcomes

BackgroundUsing a real dataset, we highlighted several major methodological issues raised by the estimation of the Minimal Clinically Important Difference (MCID) of a Patient-Reported Outcomes instrument. We especially considered the management of missing data and the use of more than two times of measurement. While inappropriate missing data management and inappropriate use of multiple time points can lead to loss of precision and/or bias in MCID estimation, these issues are almost never dealt with and require cautious considerations in the context of MCID estimation.MethodsWe used the LIGALONGO study (French Randomized Controlled Trial). We estimated MCID on the SF-36 General Health score by comparing many methods (distribution or anchor-based). Different techniques for imputation of missing data were performed (simple and multiple imputations). We also consider all measurement occasions by longitudinal modeling, and the dependence of the score difference on baseline.ResultsThree hundred ninety-three patients were studied. With distribution-based methods, a great variability in MCID was observed (from 3 to 26 points for improvement). Only 0.2 SD and 1/3 SD distribution methods gave MCID values consistent with anchor-based methods (from 4 to 7 points for improvement). The choice of missing data imputation technique clearly had an impact on MCID estimates. Simple imputation by mean score seemed to lead to out-of-range estimate, but as missing not at random mechanism can be hypothesized, even multiple imputations techniques can have led to an slight underestimation of MCID. Using 3 measurement occasions for improvement led to an increase in precision but lowered estimates.ConclusionThis practical example illustrates the substantial impact of some methodological issues that are usually never dealt with for MCID estimation. Simulation studies are needed to investigate those issues.Trial registrationNCT01240772 (ClinicalTrials.gov) registered on November 15, 2010.

Preoperative Mental Health May Not Be Predictive of Improvements in Patient-Reported Outcomes Following a Minimally Invasive Transforaminal Lumbar Interbody Fusion.

Prior literature has associated poor preoperative mental health with inferior patient-reported outcomes (PROs) after spinal procedures. Therefore, the objective of this study was to test for association of preoperative Short Form 12 (SF-12) mental health composite score (MCS) with improvements in Oswestry Disability Index (ODI) and back and leg visual analogue scale (VAS) pain scores after a minimally invasive transforaminal lumbar interbody fusion (MIS TLIF). A surgical database of patients who underwent a primary, 1 level MIS TLIF was reviewed. Preoperative SF-12 MCS was tested for association with preoperative ODI, back VAS, and leg VAS. Preoperative MCS was then tested for association with changes in ODI, back VAS, and leg VAS from preoperative to postoperative visits. These tests were conducted using multivariate regression controlling for baseline characteristics and the preoperative score of the PRO being assessed. A total of 113 patients were included in the analysis. At baseline, higher preoperative MCS was associated with lower preoperative ODI (coefficient: -0.58, P < .001), lower preoperative back VAS (-0.05, P = .003), and lower preoperative leg VAS (-0.06, P = .003). However, there was no association between preoperative MCS and improvement in PROs at any postoperative timepoint (P > .05). The percent of patients achieving a minimum clinically important difference in PROs at 6 months did not differ between the bottom and top MCS halves (P > .05). The results of this study suggest that better preoperative mental health is associated with lower perceived preoperative disability and decreased severity of back and leg pain. In contrast to other studies, the present study was unable to demonstrate that preoperative mental health is predictive of improvement in PROs at any postoperative timepoint after MIS TLIF. 3. These results suggest that surgeons should exercise care in assuming that patients with poorer preoperative mental health are inferior surgical candidates.

Development of Deployable Predictive Models for Minimal Clinically Important Difference Achievement Across the Commonly Used Health-related Quality of Life Instruments in Adult Spinal Deformity Surgery.

Retrospective analysis of prospectively-collected, multicenter adult spinal deformity (ASD) databases. To predict the likelihood of reaching minimum clinically important differences in patient-reported outcomes after ASD surgery. ASD surgeries are costly procedures that do not always provide the desired benefit. In some series only 50% of patients achieve minimum clinically important differences in patient-reported outcomes (PROs). Predictive modeling may be useful in shared-decision making and surgical planning processes. The goal of this study was to model the probability of achieving minimum clinically important differences change in PROs at 1 and 2 years after surgery. Two prospective observational ASD cohorts were queried. Patients with Scoliosis Research Society-22, Oswestry Disability Index , and Short Form-36 data at preoperative baseline and at 1 and 2 years after surgery were included. Seventy-five variables were used in the training of the models including demographics, baseline PROs, and modifiable surgical parameters. Eight predictive algorithms were trained at four-time horizons: preoperative or postoperative baseline to 1 year and preoperative or postoperative baseline to 2 years. External validation was accomplished via an 80%/20% random split. Five-fold cross validation within the training sample was performed. Precision was measured as the mean average error (MAE) and R values. Five hundred seventy patients were included in the analysis. Models with the lowest MAE were selected; R values ranged from 20% to 45% and MAE ranged from 8% to 15% depending upon the predicted outcome. Patients with worse preoperative baseline PROs achieved the greatest mean improvements. Surgeon and site were not important components of the models, explaining little variance in the predicted 1- and 2-year PROs. We present an accurate and consistent way of predicting the probability for achieving clinically relevant improvement after ASD surgery in the largest-to-date prospective operative multicenter cohort with 2-year follow-up. This study has significant clinical implications for shared decision making, surgical planning, and postoperative counseling. 4.

Risk Factors Associated With Failure to Reach Minimal Clinically Important Difference in Patient-Reported Outcomes Following Anterior Cervical Discectomy and Fusion

The minimum clinically importance difference (MCID) represents a threshold for improvements in patient-reported outcomes (PROs) that patients deem important. No previous study has comprehensively examined risk factors for failure to achieve MCID after anterior cervical discectomy and fusion (ACDF) procedures for radiculopathic symptomatology. The purpose of this study is to determine risk factors for failure to reach MCID for Neck Disability Index (NDI), Visual Analog Scale (VAS) neck pain, and VAS arm pain in patients undergoing 1- or 2-level ACDF procedures. A surgical registry of patients who underwent primary, 1- or 2-level ACDF from 2014 to 2016 was reviewed. Rates of MCID achievement for NDI, VAS neck pain, and VAS arm pain at final follow-up were calculated based on published MCID values. Patients were then categorized into demographic and procedural categories. Bivariate regression was used to test for association of demographic and procedural characteristics with failure to reach MCID for each PRO. The final multivariate model including all demographic and procedural categories as controls was created using backward stepwise regression. Eighty-three, 84, and 77 patients were included in the analysis for VAS neck, VAS arm, and NDI, respectively. Rates of MCID achievement for VAS neck, VAS arm, and NDI were 55.4%, 36.9%, and 76.6%, respectively. On bivariate analysis, patients with Charlson Comorbidity Index (CCI) ≥ 2 were less likely to achieve MCID for NDI than patients with CCI < 2 (P = .025). On multivariate analysis, CCI ≥ 2 (P = .025) was further associated with failure to reach MCID for NDI. The results of this study suggest that the majority of patients do not reach MCID for arm pain. Additionally, higher comorbidity burden as evidenced by higher CCI scores is a negative predictive factor for the achievement of MCID in neck disability following ACDF. 3.

Friday, September 28, 2018 10:30 AM–12:00 PM abstracts: complications of cervical spine surgery: 157. Risk factors associated with failure to reach minimum clinically important difference in patient-reported outcomes after anterior cervical discectomy and fusion

BACKGROUND CONTEXT The minimum clinically importance difference (MCID) represents a threshold for improvements in patient-reported outcomes (PROs) that patients deem important following spine surgery. However, no study has comprehensively examined potential risk factors for failure to achieve MCID after anterior cervical discectomy and fusion procedures. PURPOSE To determine risk factors for failure to reach MCID for Neck Disability Index (NDI), Visual Analogue Scale (VAS) neck pain, and VAS arm pain in patients undergoing one- or two-level ACDF procedures. STUDY DESIGN/SETTING Retrospective analysis of a prospectively maintained surgical database. PATIENT SAMPLE A total of 229 patients who underwent primary, one- or two-level ACDF from 2005 to 2016. OUTCOME MEASURES NDI, CCI, ASA, VAS neck and VAS arm pain. METHODS Rates of overall MCID achievement for NDI, VAS neck pain, and VAS arm pain at final clinical follow up were calculated based on published MCID values. Bivariate testing via Poisson regression with robust error variance was used to test for association of demographic and procedural characteristics with failure to reach MCID for each PRO. The final multivariate model including all demographic and procedural categories as controls was created using backward, stepwise regression until only those variables with p RESULTS After exclusion of patients with incomplete PRO survey data, 78, 78, and 73 patients were included in the analysis for VAS neck, VAS arm, and NDI, respectively. Rates of MCID achievement for VAS neck, VAS arm, and NDI were 52.56%, 35.90%, and 73.97%, respectively. Upon bivariate analysis, patients with Charlson Comorbidity Index (CCI)≥2 were less likely to achieve MCID for NDI than patients with CCI 2 (RR 0.69, p=.017) were associated with failure to reach MCID for NDI. CONCLUSIONS The results of this study suggest that the majority of patients do not reach MCID for arm pain. Additionally, higher comorbidity burden as evidenced by higher CCI and ASA scores may be negative predictive factors for the achievement of MCID in neck disability following ACDF.

Patient acceptable symptom state and minimally clinically important difference for patient-reported outcomes in systemic sclerosis: A secondary analysis of the sclereduc trial

We aimed to determine patient acceptable symptom state (PASS) and minimally clinically important improvement (MCII) estimates for patient-reported outcomes (PROs) in systemic sclerosis (SSc). Two hundred and twenty patients participated in the SCLEREDUC trial, a 12-month, randomised controlled study comparing the efficacy on disability assessed by the HAQ-DI at 12-months of physical therapy compared to usual care in patients with SSc. Self-rated state and change in patient health at 12 months post-randomization were assessed by using 2 external anchoring questions from the Medical Outcomes Study 36-Item Short Form. Patients who self-rated their health as “excellent”, “very good” or “good” were considered as having an acceptable symptom state and those who self-rated their health change at 12 months as “somewhat better” were considered as minimally improved. PASS estimates were obtained using the 75th percentile method and the MCII estimates by using the mean change in scores method. Answers to both anchoring questions at 12 months were available for 151/220 (68.6%) participants. PASS (95% CI) and mean (SD) MCII estimates at 12 months were respectively: 53.75 (34.00 to 68.00) and −6.74 (32.02) for the joint-pain visual analog scale (range 0–100), 1.41 (1.13 to 1.63) and −0.21 (0.48) for the Health Assessment Questionnaire Disability Index (HAQ-DI, range 0–3), 1.27 (1.07 to 1.62) and −0.13 (0.45) for the scleroderma HAQ (sHAQ, range 0–3), 26.00 (17.00 to 37.00) and −3.38 (9.87) for the Cochin Hand Function Scale (range 0–90), and 19.40 (17.20 to 21.90) and −5.69 (6.79) for the McMaster-Toronto Arthritis Patient Preference Disability Questionnaire (range 0–30). For all PROs, higher scores indicate higher symptoms levels. The present study provides PASS and MCII estimates for commonly used PROs in SSc. These estimates are useful in interpreting the clinical relevance of outcomes used in patients’ care and in clinical trials. ClinicalTrials.gov identifier: NCT00318188 .

Patient acceptable symptom state and minimal clinically important difference for patient-reported outcomes in systemic sclerosis: A secondary analysis of a randomized controlled trial comparing personalized physical therapy to usual care

BackgroundTo estimate patient acceptable symptom state (PASS) and minimal clinically important difference (MCID) for patient-reported outcomes in systemic sclerosis (SSc). MethodsWe conducted a secondary analysis of the SCLEREDUC trial, a 12-month randomized controlled trial comparing the efficacy of physical therapy to usual care in 220 SSc patients followed-up from September 2005 to October 2010. Self-rated state and change in patient health at 12 months were assessed by using 2 external anchors extracted from the Medical Outcomes Study 36-Item Short-Form. Patients who self-rated their health as “excellent”, “very good” or “good” were the PASS group and those who self-rated their health change as “somewhat better” were the MCID group. Main outcomes were the estimates of PASS by using the 75th percentile method and of MCID by using the mean change in scores method for pain and activity limitation. ResultsPASS (95% confidence interval) and mean (SD) MCID estimates at 12 months were 53.75 (34.00 to 68.00) and −6.74 (32.02) for the joint-pain visual analog scale (range 0–100), 1.41 (1.13 to 1.63) and −0.21 (0.48) for the Health Assessment Questionnaire (HAQ, range 0–3), 1.27 (1.07 to 1.62) and −0.13 (0.45) for the scleroderma HAQ (range 0–3), 26.00 (17.00 to 37.00) and -3.38 (9.87) for the Cochin Hand Function Scale (range 0–90), and 19.40 (17.20 to 21.90) and −5.69 (6.79) for the McMaster-Toronto Arthritis Patient Preference Disability Questionnaire (range 0–30), respectively. ConclusionsWe provide, for the first time, the PASS and MCID estimates for pain and activity limitation in SSc. Trial registrationClinicalTrials.gov Identifier: NCT00318188. First Posted: April 26, 2006.

Risk Factors Associated With Failure to Reach Minimal Clinically Important Difference in Patient-reported Outcomes Following Minimally Invasive Transforaminal Lumbar Interbody Fusion for Spondylolisthesis.

Retrospective cohort. To determine risk factors associated with failure to reach the minimal clinically important difference (MCID) in patient-reported outcomes (PROs) for patients undergoing minimally invasive transforaminal lumbar interbody fusion (MIS TLIF) for spondylolisthesis. The MCID of PROs are often utilized to determine the benefit of spinal procedures. However, negative predictive factors for reaching MCID in patients surgically treated for lumbar spondylolisthesis have been difficult to elucidate. A prospectively maintained surgical database of patients who were diagnosed with lumbar spondylolisthesis and surgically treated with a single level MIS TLIF from 2010 to 2016 was reviewed. Patients with incomplete PRO survey data or <6-month follow-up were excluded from the analysis. MCID for visual analogue scale (VAS) back, VAS leg, and Oswestry Disability Index (ODI) was obtained from established values in the literature. All risk factors were then assessed for association with failure to reach MCID using bivariate and multivariate regression adjusting for preoperative characteristics. A total of 165, 76, and 73 patients treated with MIS TLIF for spondylolisthesis had complete PRO data for VAS back, VAS leg, and ODI, respectively, and were thus included in the analysis for the respective PRO. Overall, 75.76%, 71.05%, and 61.64% of patients treated with a single level MIS TLIF for spondylolisthesis reached MCID for VAS back, VAS leg, and ODI, respectively. On multivariate analysis, patients were less likely to achieve MCID for VAS back following surgical treatment if they received workers' compensation (P<0.001). No other measured factors were noted to independently correlate with MCID achievement. The results of this study suggest that a majority of patients with spondylolisthesis achieve MCID for commonly measured PROs following MIS TLIF for spondylolisthesis. However, worker's compensation insurance status may serve as a negative predictive factor for reaching MCID.

ACL Reconstruction: Do Outcomes Differ by Sex?

Anterior cruciate ligament (ACL) reconstruction is frequently performed to restore knee stability and function following ACL injury. Female sex is known to predispose to ACL injury; however, it remains unclear whether female sex predisposes to poor outcomes following ACL reconstruction. We hypothesized that male and female patients exhibit no differences in (1) graft failure risk, (2) contralateral ACL injury risk, (3) knee laxity, and (4) patient-reported outcome scores following ACL reconstruction. A systematic review of the literature was performed to identify studies in which results of ACL reconstruction were reported by sex at a minimum of two years. Study findings were reviewed, and meta-analysis was performed when data were sufficiently homogenous. Thirteen studies were identified from the literature review. Meta-analysis revealed no difference in graft failure risk (eight studies), contralateral ACL rupture risk (three studies), or postoperative knee laxity on physical examination (six studies). There was no evidence of a clinically important difference in patient-reported outcomes according to sex. Results of ACL reconstruction were similar in male and female patients. More high-quality studies are needed to further evaluate these findings.

SAT0291 Evaluation of Sleep Quality in Psoriatic Arthritis Patients

BackgroundPsoriatic arthritis (PsA) is an inflammatory arthritis associated with psoriasis (1). PsA and its associated psoriatic skin lesions have been found to lower the health-related quality of life, effecting physical...

Analysis of Gastrointestinal and Hepatic Chronic Grant-versus-Host Disease Manifestations on Major Outcomes: A Chronic Grant-versus-Host Disease Consortium Study

Although data support adverse prognosis of overlap subtype of chronic grant-versus-host disease (GVHD), the importance of site of gastrointestinal (GI) and type of hepatic involvement is not known. Using data from the Chronic GVHD Consortium observational cohort study (N = 567, total of 2115 visits), we examined whether the site of GI (esophageal, upper GI, or lower GI) and type of hepatic (bilirubin, alkaline phosphatase, alanine aminotransferase) involvement are associated with overall survival (OS) and nonrelapse mortality (NRM), symptoms, quality of life (QOL) and functional status measures. In multivariate analysis utilizing data from enrollment visits only, lower GI involvement (HR, 1.67; P = .05) and elevated bilirubin (HR, 2.46; P = .001) were associated with OS; both were also associated with NRM. In multivariable analysis using all visits (time-dependent covariates), GI score greater than zero (HR, 1.69; P = .02) and elevated bilirubin (HR, 3.73; P < .001) were associated with OS; results were similar for NRM. Any esophageal involvement and GI score greater than zero were associated with both symptoms and QOL, whereas elevated bilirubin was associated with QOL. We found no consistent evidence that upper GI involvement, alkaline phosphatase, alanine aminotransferase, or NIH liver score add prognostic value for survival, overall symptom burden, or QOL. These data support important differences in patient-reported outcomes according to GI and hepatic involvement among chronic GVHD-affected patients and identify those with elevated bilirubin or higher GI score at any time, or lower GI involvement at cohort enrollment, as patients at greater risk for mortality under current treatment approaches.

Gastrointestinal and Hepatic Involvement in Chronic Gvhd: An Analysis From the Chronic Gvhd Consortium

AbstractAbstract 1940 Background:Chronic graft-versus-host disease (GVHD) is a significant source of morbidity, mortality, impaired patient-reported quality of life (QOL), greater symptom burden, and prolonged duration of immune suppressive therapy following allogeneic hematopoietic cell transplantation (HCT). While available data support the adverse prognosis of overlap subtype of chronic GVHD, the relative importance of site of gastrointestinal (GI) and type of hepatic involvement is not known. Methods:We analyzed prospectively acquired observational cohort data to examine whether the site of GI involvement (esophageal, upper GI, lower GI) and type of hepatic laboratory test abnormality (bilirubin, alkaline phosphatase (AP), alanine aminotransferase (ALT) elevation over the upper limit of normal based on study site-specific laboratory reference ranges) among chronic GVHD-affected patients are associated with overall survival (OS) and non-relapse mortality (NRM), symptoms (Lee Symptom Scale), and quality of life (QOL) per SF-36 and FACT-BMT instruments. Results:This analysis included 567 individual subjects with baseline and 1548 follow up visits. The majority were incident cases (59%), adults (98%), and predominantly White/Non-Hispanic. Median time from HCT to cohort enrollment was 11.9 months (range 3–294 months). Overall NIH chronic GVHD severity was mild in 10%, moderate in 52%, and severe in 38% at enrollment. Prior acute GVHD was noted in 66%, KPS < 80% in 17%, and platelet count at chronic GVHD onset of < 100 K/uL in 23%. At enrollment, GI involvement was seen in 40% (upper GI 20%, esophagus 16%, lower GI 13%), and liver involvement was seen in 52% (AP 38%, ALT 38%, bilirubin 10%). Time from transplant to cGVHD onset was not different for patients with or without GI involvement or hepatic involvement. In multivariate analysis utilizing data from enrollment visits only and adjusting for patient and transplant variables, lower GI involvement (HR 1.7, p=0.03) and elevated bilirubin (HR 2.36, p=0.001) were associated with OS; both were also associated with NRM. In multivariable analysis using all visits (time-dependent covariates), GI score greater than zero (HR 1.7, p=0.01) and elevated bilirubin (HR 3.7, p<0.001) were associated with OS; results were similar for NRM. Separate models were constructed to examine the relationship of severity of GI and hepatic involvement (0–3 severity score per NIH consensus) and mortality: Increasing lower GI severity at enrollment was significantly associated with non-relapse mortality, with progressively increasing HR for greater severity levels (lower GI score 2/3 vs. 0: HR 5.5, 95% CI 2.3–13.1, p = 0.0001). Increasing bilirubin was also associated with NRM (bilirubin score 2/3 vs. 0: HR 3.3, 95% CI 1.3–8.4, p=0.01). A similar association was observed for bilirubin elevation and NRM in the time-dependent model (bilirubin 2/3 vs. 0: HR 8.9, 95% CI 3.3–24, p < 0.0001). When analyzing all visits, any esophageal involvement and GI score greater than zero were associated with both symptoms and QOL while elevated bilirubin was associated with QOL. We found no consistent evidence that upper GI involvement, AP, ALT, or NIH liver score add prognostic value for survival, overall symptom burden, or quality of life. Conclusion:These data support important differences in patient-reported outcomes according to GI and hepatic involvement among chronic GVHD affected patients, and identify those with elevated bilirubin or higher GI score at any time, or lower GI involvement at cohort enrollment, as patients at greater risk for mortality under current treatment approaches. Disclosures:No relevant conflicts of interest to declare.