Reported Outcomes Measurement Information System Research Articles

Global health measures from a National Down Syndrome Registry.

People with Down syndrome (DS) have a unique medical profile which may impact views of health. We aimed to study the use of global health measures for DS in a national cohort. We prospectively surveyed parents of individuals with DS from the DS-Connect® registry with validated Patient Reported Outcomes Measurement Information System (PROMIS)® instruments of global health. Analyses included use of scoring manuals and the PROMIS® scoring service, descriptive statistics, and t-tests. We received completed surveys from 223 parents of individuals with DS; previously published limitations of the instrument in this population were shown again. T-scores differed from the available comparative standardized scores to these measures from PROMIS® reference population on Fatigue (p < 0.001) and Global Health (p < 0.001), but not on Pain Interference (p = 0.41).

Unmet Needs and Burden of Caregivers of Patients Being Evaluated for a Liver Transplant Are Similar to Those of Cancer Caregivers.

The caregivers (CG) of patients with serious illnesses often experience stress and psycho-social issues. High burden is expected for CG of patients for whom liver transplant (LT) is the only curative option. This study aims to measure the burden, unmet needs, and quality of life (QoL) of CG of patients being evaluated for LT. This cross-sectional study enrolled CG of patients being evaluated for LT. CaTCoN (Caregiving Tasks, Consequences and Needs Questionnaire) was used to assess caregiving consequences and needs related to interactions with healthcare professionals (HCPs). ZBI-12 (Zarit Burden Interview) was used to assess CG burden, and PROMIS-29 (Patient Reported Outcomes Measurement Information System) to assess QoL. Caregivers completed the study instruments in person, while they were in the clinic. CaTCoN scores from our study were compared with cancer caregivers' historical data. 18 CG were enrolled, mean age 54 [14] years; 72% were white and 77% were women. 61% worked full time; 45% provided >20hours of care per week. Two-thirds cared for patients with alcoholic liver disease. All CaTCoN scores were no different from CGs of cancer patients (all P > .05). The total ZBI score (mean SD 12.4 [8.3]) did not differ from published scores for CG of cancer patients (12.0 [8.5]). 44% had high (≥12) ZBI scores reflecting "high burden." Their PROMIS-29 T scores, compared to those with low burden, showed more anxiety (P = .01), depression (P = .04), fatigue (P = .02) and deteriorated social function (P = .009). Physical function and social function were diminished among these CGs compared to the general population (P < .0001). CGs of patients being evaluated for LT suffer from high burden similar to cancer CGs and have reduced physical and social function. Despite the small sample size, the data completion rate was almost 100%.

Feasibility of PROMIS using computerized adaptive testing during inpatient rehabilitation

BackgroundThere has been an increased significance on patient-reported outcomes in clinical settings. We aimed to evaluate the feasibility of administering patient-reported outcome measures by computerized adaptive testing (CAT) using a tablet computer with rehabilitation inpatients, assess workload demands on staff, and estimate the extent to which rehabilitation inpatients have elevated T-scores on six Patient Reported Outcomes Measurement Information System® (PROMIS®) measures.MethodsPatients (N = 108) with stroke, spinal cord injury, traumatic brain injury, and other neurological disorders participated in this study. PROMIS computerized adaptive tests (CAT) were administered via a web-based platform. Summary scores were calculated for six measures: Pain Interference, Sleep Disruption, Anxiety, Depression, Illness Impact Positive, and Illness Impact Negative. We calculated the percent of patients with T-scores equivalent to 2 standard deviations or greater above the mean.ResultsDuring the first phase, we collected data from 19 of 49 patients; of the remainder, 61% were not available or had cognitive or expressive language impairments. In the second phase of the study, 40 of 59 patients participated to complete the assessment. The mean PROMIS T-scores were in the low 50 s, indicating an average symptom level, but 19–31% of patients had elevated T-scores where the patients needed clinical action.ConclusionsThe study demonstrated that PROMIS assessment using a CAT administration during an inpatient rehabilitation setting is feasible with the presence of a research staff member to complete PROMIS assessment.

Defining the minimal clinically important difference in smartphone-based mobility after spine surgery: correlation of survey questionnaire to mobility data.

Patient-reported outcome measures (PROMs) are the gold standard for assessing postoperative outcomes in spine surgery. However, PROMs are also limited by the inherent subjectivity of self-reported qualitative data. Recent literature has highlighted the utility of patient mobility data streamed from smartphone accelerometers as an objective measure of functional outcomes and complement to traditional PROMs. Still, for activity-based data to supplement existing PROMs, they must be validated against current metrics. In this study, the authors assessed the relationships and concordance between longitudinal smartphone-based mobility data and PROMs. Patients receiving laminectomy (n = 21) or fusion (n = 10) between 2017 and 2022 were retrospectively included. Activity data (steps-per-day count) recorded in the Apple Health mobile application over a 2-year perioperative window were extracted and subsequently normalized to allow for intersubject comparison. PROMS, including the visual analog scale (VAS), Patient Reported Outcome Measurement Information System Pain Interference (PROMIS-PI), Oswestry Disability Index (ODI), and EQ-5D, collected at the preoperative and 6-week postoperative visits were retrospectively extracted from the electronic medical record. Correlations between PROMs and patient mobility were assessed and compared between patients who did and those who did not achieve the established minimal clinically important difference (MCID) for each measure. A total of 31 patients receiving laminectomy (n = 21) or fusion (n = 10) were included. Change between preoperative and 6-week postoperative VAS and PROMIS-PI scores demonstrated moderate (r = -0.46) and strong (r = -0.74) inverse correlations, respectively, with changes in normalized steps-per-day count. In cohorts of patients who achieved PROMIS-PI MCID postoperatively, indicating subjective improvement in pain, there was a 0.784 standard deviation increase in normalized steps per day, representing a 56.5% improvement (p = 0.027). Patients who did achieve the MCID of improvement in either PROMIS-PI or VAS after surgery were more likely to experience an earlier sustained improvement in physical activity commensurate to or greater than their preoperative baseline (p = 2.98 × 10-18) than non-MCID patients. This study demonstrates a strong correlation between changes in mobility data extracted from patient smartphones and changes in PROMs following spine surgery. Further elucidating this relationship will allow for more robust supplementation of existing spine outcome measure tools with analyzed objective activity data.

Integrating PROMIS Measures in a Treat-to-Target Approach to Standardize Patient-Centered Treatment of Rheumatoid Arthritis.

To evaluate the effect of a patient-centered rheumatoid arthritis (RA) treat-to-target (T2T) disease management approach on patient outcomes and patient satisfaction with care. In this longitudinal, observational pilot study, rheumatologists implemented a modified T2T approach that integrated Patient Reported Outcomes Measurement Information System (PROMIS) measures for depression, fatigue, pain interference, physical function, and social function into RA care. Study participants selected 1 PROMIS domain to target treatment and completed quarterly follow-up assessments. Participants were classified as improved if their Clinical Disease Activity Index (CDAI) changed by > 5 points. Change in PROMIS t scores was examined for the group with improved CDAI, and then compared to those with unchanged or worsened CDAI. Satisfaction with care was assessed using multiple measures, including the Functional Assessment of Chronic Illness Therapy-Treatment Satisfaction-Patient Satisfaction Scale. The analytical sample (n = 119, median age 57 years, 90.8% female) was split between those with CDAI > 10 (n = 63) and CDAI ≤ 10 (n = 53). At 1 year, there was improvement in CDAI by > 5 points in 66% and 13% of individuals with baseline CDAI > 10 and baseline CDAI ≤ 10, respectively. Across all participants, improvement in CDAI by > 5 points correlated with improvements in the 5 PROMIS domains. Satisfaction with RA treatment also increased. The integration of PROMIS measures into the T2T approach for RA care was associated with improvements in disease activity, and improvement in disease activity was associated with improvements in PROMIS measures.

Impact of the COVID-19 Pandemic on Personal Networks and Neurological Outcomes of People with Multiple Sclerosis (P12-3.001)

Impact of the COVID-19 Pandemic on Personal Networks and Neurological Outcomes of People with Multiple Sclerosis (P12-3.001)

5606726 IMPACT OF ALLOGENEIC STEM CELL TRANSPLANTATION ON PHYSICAL, MENTAL, AND SOCIAL HEALTH OF ADULT SICKLE CELL DISEASE PATIENTS: A MIXED-METHODS STUDY

Background: Sickle cell disease (SCD) is characterized by chronic hemolytic anemia and recurrent painful vaso-occlusive crises, resulting in considerable physical and psychosocial disease burden and early mortality. In recent years, the application of allogeneic hematopoietic stem cell transplantation (HSCT) as a curative treatment for adult SCD patients has increased. As a result, a deeper understanding of the complex relationship between physical, mental, and social health before and after curation is needed. Aim: To explore the experiences and perspectives of adult SCD patients on the impact of HSCT on their physical, mental, and social health. Methods: A mixed methods study design, consisting of a semi-structured interview and completion of 9 Patient Reported Outcomes Measurement Information System (PROMIS®) item banks per participant was used. Adult SCD patients who underwent HSCT ≥ 1 year ago at the Amsterdam University Medical Center were eligible to take part in this study. Interviews were recorded, transcribed verbatim, and thematically analyzed using MAXQDA® software. Standardized T-scores of PROMIS® measures were evaluated and compared to reference scores of the Dutch general population. Results: Ten SCD patients with a median age of 29,5 years (range 19-49) were included in the study and interviewed between October 2021 and May 2022. Median time since HSCT was 2.7 years (range 1 - 3.5). All patients had successful engraftment. Relevant themes were (1) pain/living pain free, (2) physical wellbeing, (3) mental wellbeing, (4) perspective/outlook, (5) education and work, (6) family and friends and (7) activities and participation. Living pain free and the emergence of a future perspective were major improvements for most participants which resonated strongly in their daily lives. Nevertheless, emotional struggles with processing the impact of having had SCD on the one hand, while adjusting to the novel circumstances on the other hand, were common among participants. Before and after HSCT, participants experienced a lack of psychological help. Two patients with ongoing pain from avascular bone necrosis had mixed feelings about the success of the transplant. These two patients scored within the mild, moderate, or severe symptom category on ≥ 7 of 9 PROMIS® item banks. While mean PROMIS® T-scores of all participants fell within the reference values of the general population (Figure 1), a large variation between patients was observed which matched with our findings from the qualitative data. Conclusions: Adult SCD patients experience significant improvements in many aspects of their physical, mental, and social health after cure by HSCT. Yet, they are confronted with a new and often unfamiliar reality, which carries different challenges. Pain as a result of irreversible complications of SCD continues to have a negative impact on quality of life after HSCT. Clinicians should acknowledge these challenges and aim at creating realistic expectations in future transplant candidates. Moreover, patients expressed a need for tailored psychological care, which should be offered before and after HSCT.

Targeted Muscle Reinnervation for Limb Amputation to Avoid Neuroma and Phantom Limb Pain in Patients Treated at a Pediatric Hospital.

Patients undergoing major limb amputation with TMR were included with minimum one year follow-up and completed questionnaires. Primary clinical outcomes included incidence of symptomatic neuromas, PLP, residual limb pain, narcotic use, and neuromodulator use. A follow-up phone survey was conducted assessing five pediatric Patient Reported Outcomes Measurement Information System (PROMIS) metrics adapted to assess residual limb and PLP. Nine patients (seven male and two female patients, avg. age = 16.83 ± 7.16 years) were eligible. Average time between surgery and phone follow-up was 21.3 ± 9.8 months. Average PROMIS Pediatric t-scores for measures of pain behavior, interference, quality-affective, and quality-sensory for both PLP and residual limb pain were nearly 1 standard deviation lower than the United States general pediatric population. One patient developed a symptomatic neuroma 1 year after surgery. Compared with an adult patient sample reported by Valerio et al, our TMR patients at Nationwide Children's Hospital (NCH) showed similar PLP PROMIS t-scores in pain behavior (50.1 versus 43.9) and pain interference (40.7 versus 45.6). Both pediatric and adult populations had similar residual limb pain including PROMIS pain behavior (36.7 adult versus 38.6 pediatric) and pain interference (40.7 adult versus 42.7 pediatric). TMR at the time of amputation is feasible, safe, and should be considered in the pediatric population.

Development of an item bank for measuring prosthetic mobility in people with lower limb amputation: The Prosthetic Limb Users Survey of Mobility (PLUS-M).

Achieving mobility with a prosthesis is a common post-amputation rehabilitation goal and primary outcome in prosthetic research studies. Patient-reported outcome measures (PROMs) available to measure prosthetic mobility have practical and psychometric limitations that inhibit their use in clinical care and research. To develop a brief, clinically meaningful, and psychometrically robust PROM to measure prosthetic mobility. A cross-sectional study was conducted to administer previously developed candidate items to a national sample of lower limb prosthesis users. Items were calibrated to an item response theory model and two fixed-length short forms were created. Instruments were assessed for readability, effective range of measurement, agreement with the full item bank, ceiling and floor effects, convergent validity, and known groups validity. Participants were recruited using flyers posted in hospitals and prosthetics clinics across the United States, magazine advertisements, notices posted to consumer websites, and direct mailings. Adult prosthesis users (N=1091) with unilateral lower limb amputation due to traumatic or dysvascular causes. Not applicable. Candidate items (N=105) were administered along with the Patient Reported Outcome Measurement Information System Brief Profile, Prosthesis Evaluation Questionnaire - Mobility Subscale, and Activities-Specific Balance Confidence Scale, and questions created to characterize respondents. A bank of 44 calibrated self-report items, termed the Prosthetic Limb Users Survey of Mobility (PLUS-M), was produced. Clinical and statistical criteria were used to select items for 7- and 12-item short forms. PLUS-M instruments had an 8th grade reading level, measured with precision across a wide range of respondents, exhibited little-to-no ceiling or floor effects, correlated expectedly with scores from existing PROMs, and differentiated between groups of respondents expected to have different levels of mobility. ThePLUS-M appearstobe well suited to measuring prosthetic mobility in people with lower limb amputation. PLUS-M instruments are recommended for use in clinical and research settings.

The health impact of long COVID: a cross-sectional examination of health-related quality of life, disability, and health status among individuals with self-reported post-acute sequelae of SARS CoV-2 infection at various points of recovery

ObjectiveThe novel Coronavirus (COVID-19) has continued to present a significant burden to global public health efforts. The purpose of this study was to estimate the health-related quality of life, disability, and health status of individuals with self-reported long COVID at various lengths of recovery.MethodsWe conducted a cross-sectional online survey of individuals with self-reported long COVID. Participants were asked to complete the five-item EuroQOL EQ-5D-5L and EQ visual analog scale, the 12-item World Health Organization Disability Assessment Schedule (WHODAS) 2.0 and the 10-item Patient Reported Outcome Measurement Information System (PROMIS) Global Health v1.2 short form. Descriptive and inferential statistics were used to characterize the responses and differences across groups.ResultsEighty-two participants from 13 countries completed the EQ-5D-5L, 73 completed the WHODAS 2.0 and 80 participants completed the PROMIS. The mean EQ-5D-5L utility score was 0.51. The mean WHODAS score was 49.0. In the previous 30 days, participants reported their symptoms affected them for a mean of 24 days, they were totally unable to carry out usual activities for 15 days, and they cut back or reduced activities for 26 days. The mean PROMIS physical health and mental health scores were 10.7 and 8.6, respectively, corresponding to below-average health. No significant differences were detected across time or according to severity of acute infection.ConclusionsLong COVID presents a significant chronic health burden to adults in the US and abroad. This health burden may persist for many months post-acute infection.

Posterior Approach Total Hip Arthroplasty Utilizing a Monoblock Dual-Mobility Construct Without Posterior Hip Precautions: A Series of 580 Hips With One Dislocation

BackgroundInstability remains a devastating complication following total hip arthroplasty. Here we describe a mini-posterior approach with a monoblock dual-mobility implant without “traditional posterior hip precautions” yielding excellent results. MethodsThere were 580 consecutive hips in 575 patients who underwent total hip arthroplasty utilizing a monoblock dual-mobility implant and a mini-posterior approach. With this technique, the acetabular component positioning does not rely on tradition intra-operative radiographic abduction and anteversion goals but rather uses patient-specific anatomic landmarks (anterior acetabular rim and, when visible, the transverse acetabular ligament) to set cup position; stability is assessed with a significant, dynamic intra-operative test of range of motion. Patients’ mean age was 64 years (range, 21 to 94), and 53.7% were women. ResultsMean abduction was 48.4° (range, 29° to 68°) and mean anteversion was 24.7° (range, −1° to 51°). Patient Reported Outcomes Measurement Information System scores improved in every measured domain from preoperative to final postoperative visit. There were seven (1.2%) patients who required reoperation, with mean time to reoperation of 1.3 months (range, one to 176 days). Only one patient (0.2%) who had a preoperative history of spinal cord injury and Charcot arthropathy dislocated. ConclusionA posterior approach hip surgeon may want to consider using a monoblock dual-mobility construct and avoidance of traditional posterior hip precautions to achieve early hip stability with an extremely low dislocation rate and high patient satisfaction scores.

A Matched Comparison of the Rates of Achieving the Minimal Clinically Important Difference Following Conversion and Primary Total Hip Arthroplasty

BackgroundPatient-reported outcome measures (PROMs) are often lower following conversion total hip arthroplasty (cTHA) compared to matched primary total hip arthroplasty (THA) controls. However, the minimal clinically important differences (MCIDs) for any PROMs are yet to be analyzed for cTHA. This study aimed to (1) determine if patients undergoing cTHA achieve primary THA-specific 1-year PROM MCIDs at comparable rates to matched controls undergoing primary THA and (2) establish 1-year MCID values for specific PROMs following cTHA. MethodsA retrospective case-control study was conducted using 148 cases of cTHA which were matched 1:2 to 296 primary THA patients. Previously defined anchor values for 2 PROM measures in primary THA were used to compare cTHA to primary THA, while novel cTHA-specific MCID values for 2 PROMs were calculated through a distribution method. Predictors of achieving the MCID of PROMs were analyzed through multivariate logistic regressions. ResultsConversion THA was associated with decreased odds of achieving the primary THA-specific 1-year Hip dysfunction and Osteoarthritis Outcome Score for Joint Replacement PROM (Odds Ratio: 0.319, 95% Confidence Interval: 0.182-0.560, P < .001) and Patient Reported Outcomes Measurement Information System Physical Function Short-Form-10a PROM (Odds Ratio: 0.531, 95% Confidence Interval: 0.313-0.900, P = .019) MCIDs in reference to matched primary THA patients. Less than 60% of cTHA patients achieved an MCID. The 1-year MCID of the Hip dysfunction and Osteoarthritis Outcome Score for Joint Replacement and Patient Reported Outcomes Measurement Information System Physical Function Short-Form-10a specific to cTHA were +10.71 and +4.68, respectively. ConclusionWhile cTHA is within the same diagnosis-related group as primary THA, patients undergoing cTHA have decreased odds of achieving 1-year MCIDs of primary THA-specific PROMs. Level of EvidenceLevel III, retrospective comparative study.

Activity and Participation, Bimanual Function, and Prosthesis Satisfaction are Strong Predictors of General Well-Being Among Upper Limb Prosthesis Users

ObjectiveTo determine the role of multiple factors on general well-being for upper limb prosthesis users. DesignRetrospective cross-sectional observational design. SettingProsthetic clinics across the United States. ParticipantsAt the time of analysis, the database consisted of 250 patients with unilateral upper limb amputation seen between July 2016 and July 2021. InterventionNot applicable. Main Outcomes MeasuresDependent variable: well-being (Prosthesis Evaluation Questionnaire- Well-Being). Independent variables included in analysis: activity and participation (Patient Reported Outcomes Measurement Information System [PROMIS] Ability to Participate in Social Roles and Activities), bimanual function (PROMIS-9 UE), prosthesis satisfaction (Trinity Amputation and Prosthesis Experience Scales-Revised; TAPES-R), PROMIS pain interference, age, gender, average daily hours worn, time since amputation, and amputation level. ResultsA multivariate linear regression model using a forward enter method was applied. The model included 1 dependent variable (well-being) and 9 independent variables. Within the multiple linear regression model, the strongest predictors of well-being were activity and participation (β=0.303, P<.0001), followed by prosthesis satisfaction (β=0.257, P<.0001), pain interference (β=-0.187, P=.001), and bimanual function (β=0.182, P=.004). Age (β=-0.036, P=.458), gender (β=-0.051, P=.295), time since amputation (β=0.031, P=.530), amputation level (β=0.042, P=.385), and hours worn (β=-0.025, P=.632) were not significant predictors of well-being. ConclusionReducing pain interference and improving clinical factors such as prosthesis satisfaction and bimanual function with their associated effects on activity and participation will positively affect the well-being of individuals living with upper limb amputation/congenital deficiency.

Assessing Fatigue in Patients Receiving Kidney Replacement Therapy Using PROMIS Computer Adaptive Testing

Fatigue is a debilitating symptom for many patients receiving kidney replacement therapy (KRT). Patient-reported outcome measures can help clinicians identify and manage fatigue efficiently. We assessed the measurement characteristics of the Patient Reported Outcome Measurement Information System (PROMIS)-Fatigue Computer Adaptive Test (PROMIS-F CAT) in patients receiving KRT using the previously validated Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaire. Cross-sectional study. 198 adults treated with dialysis or recipients of a kidney transplant in Toronto, Canada. Demographic data, FACIT-F scores, KRT type. Measurement properties of PROMIS-F CAT T scores. Reliability and test-retest reliability were assessed using standard errors ofmeasurement and intraclass correlation coefficient (ICC), respectively. Construct validity was assessed using correlation and comparisons across predefined groups expected to have different levels of fatigue. Receiver operating characteristic (ROC) curves were used to assess the discrimination of PROMIS-F CAT, with clinically relevant fatigue defined by a FACIT-F score of≤30. Of the 198 participants, 57% were male, the mean±SD age was 57±14 years; 65% had received a kidney transplant. Based onthe FACIT-F score, 47 patients (24%) hadclinically relevant fatigue. PROMIS-F CATandFACIT-F were strongly correlated (ρ=-0.80, P<0.001). PROMIS-F CAT had excellent reliability (>0.90 for 98% of sample), and goodtest-retest reliability (ICC=0.85). TheROC analysis demonstrated outstanding discrimination (area under ROC=0.93 [95%, CI 0.89-0.97]). APROMIS-F CAT cutoff score of≥59 accurately identified most patients with clinically relevant fatigue (sensitivity=0.83; specificity=0.91). A convenience sample of clinically stable patients. FACIT-F items are a part of the PROMIS-F item bank, although there was minimal overlap with only 4 FACIT-F items completed in PROMIS-F CAT. PROMIS-F CAT has robust measurement properties with low question burden to assess fatigue among patients with KRT.

The Impact of Surgical Timing After Ankle Fracture on Clinical and Long-Term Patient Reported Outcomes

The goal of this study is to evaluate the effect of time-to-surgery following closed ankle fractures on long-term patient reported outcomes, fracture healing, and wound complications. To date, little research has been done focusing on the impact "time to definitive fixation" has on patient reported outcomes. We performed a retrospective analysis of 215 patient records who underwent open reduction and internal fixation (ORIF) for an ankle fracture from July 2011 to July 2018. A total of 86 patients completed the patient reported outcome measurement information systems (PROMIS) survey at long-term follow-up. Primary outcomes were the rate of delayed union, postoperative wound complications, patient reported outcome measurement information system (PROMIS) pain interference (PI), and physical function (PF) scores. No differences were found when comparing time to surgery on a continuous scale with rates of delayed union, nonunion, or wound complications (p=.84, .47, and .63, respectively). PROMIS scores were collected at a median of 4.5 years (2.0 interquartile range (IQR), range 2.5-12.3) postoperatively. The time from ankle fracture to surgery was independently associated with worse PROMIS PI scores (unstandardized β 0.38, 95% CI 0.07-0.68) but not PROMIS PF scores. Severe Lauge-Hansen injuries were independently associated with decreased PROMIS PF scores (unstandardized β -7.02, 95% CI -12.0 to -2.04). Increased time to surgical intervention and severe Lauge-Hansen injuries were independently associated with worse long-term patient reported outcomes. Surgical timing did not impact union rates or wound complications. Surgeons should be aware that delaying ankle fracture repair beyond 12 days after injury may negatively affect long-term patient reported pain scores.

Outcomes are Compromised When Revising Patellofemoral Arthroplasties for Patellar Component Failures

BackgroundOutcomes of patellofemoral arthroplasty (PFA) to total knee arthroplasty (TKA) conversion are reported to be similar to primary cases. The purpose of this study was to determine whether the cause for conversion from PFA to TKA correlated to outcomes when compared to a matched cohort. MethodsA retrospective chart review was performed to identify aseptic PFA to TKA conversions between 2000 and 2021. A cohort of primary TKAs was matched by patient sex, body mass index, and American Society of Anesthesiology score. Clinical outcomes, including range of motion, complication rates, and patient reported outcomes measurement information systems scores, were compared. Chi-squared, Fisher’s Exact, and t-tests were performed. There were 20 PFA to TKA conversions that met inclusion criteria and were matched to 60 primary cases. ResultsThere were 7 cases revised for arthritis progression, 5 for femoral component failure, 5 for patellar component failure, and 3 for patellar maltracking. PFA to TKA conversions for patellar failure (fracture, component loosening) had worse postoperative flexion (115 versus 127°, P = .023) and more complications of stiffness (40 versus 0%, P = .046) than primary TKAs. Conversions for failed patellar components had worse patient reported outcomes measurement information systems physical function (32 versus 45, P = .0046), physical health (42 versus 49, P = .0258), and pain scores (45 versus 24, P = .0465). No differences were found in rates of infection, manipulations under anesthesia, or reoperations. ConclusionPFA to TKA conversion outcomes were similar to primary TKA, except in patients who had failed patellar components and demonstrated worse postoperative range of motion and patient-reported outcomes. Surgeons should avoid thin patellar resections and extensive lateral releases to minimize patellar failures.

Abstract P239: Impact of American Heart Association/American Stroke Association Online Support Network on Quality of Life

Introduction: Support of patients with cardiovascular (CV) disease and stroke is often associated with improved health-related quality of life (HRQOL). Hypothesis: We assessed the hypothesis that change in patient HRQOL, perception of emotional and informational support, and satisfaction with the American Heart Association/American Stroke Association’s (AHA/ASA) online Support Network (SN) would be observed from before joining the SN to two months after joining the SN. Methods: Using a pre/post-test design, between April 2018 and March 2020, 2,542 adult patients completed a baseline online survey, of whom 412 completed a survey two months later (response rate=16%). Self-report instruments included: Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Questionnaire, Emotional Support (ES), Informational Support (IS), and an AHA/ASA-developed measure of satisfaction with the SN. After converting raw scores into T-scores, linear mixed effects models were used to compare pre and post T-scores. Results: Patients were on average 56± 12.8 years of age, female (63.3%), non-Hispanic White (76.5%), married (58.3%), employed (49.8%), and &gt;high school education (85.0%). 83.5% reported having a CV condition, most commonly hypertension (38.8%), myocardial infarction (31.3%), high cholesterol (31.1%), atrial fibrillation (25.2%); 58.0% reported ≤ 4 co-morbidities. T-scores (mean±SD) did not differ significantly from before to two months after joining the SN: physical health domain (pre=39.2±3.6, post=39.3±3.4) and mental health domain (pre=43.3±9.6, post=44.5±9.7); ES (pre=49.5±9.8, post=49.3±9.8), and IS (pre=49.8±10.3, post=50.5±10.5). At two months, satisfied, neutral, and dissatisfied with SN were 46.3%,44.2%, and 5.1% respectively. 61.5% were likely to recommend the SN to others. Conclusions: In conclusion, HRQOL measures remained stable. Before and after SN participation, physical and mental domain global health scores were lower than the U.S. general population mean of 50, while ES and IS scores approximated the U.S. general population mean. Satisfaction with the SN was moderate with the majority of respondents likely to recommend to others. Future research might explore extending the timeframe to observe change in global health scores.

One-food versus six-food elimination diet therapy for the treatment of eosinophilic oesophagitis: a multicentre, randomised, open-label trial

Empirical elimination diets are effective for achieving histological remission in eosinophilic oesophagitis, but randomised trials comparing diet therapies are lacking. We aimed to compare a six-food elimination diet (6FED) with a one-food elimination diet (1FED) for the treatment of adults with eosinophilic oesophagitis. We conducted a multicentre, randomised, open-label trial across ten sites of the Consortium of Eosinophilic Gastrointestinal Disease Researchers in the USA. Adults aged 18-60 years with active, symptomatic eosinophilic oesophagitis were centrally randomly allocated (1:1; block size of four) to 1FED (animal milk) or 6FED (animal milk, wheat, egg, soy, fish and shellfish, and peanut and tree nuts) for 6 weeks. Randomisation was stratified by age, enrolling site, and gender. The primary endpoint was the proportion of patients with histological remission (peak oesophageal count <15 eosinophils per high-power field [eos/hpf]). Key secondary endpoints were the proportions with complete histological remission (peak count ≤1 eos/hpf) and partial remission (peak counts ≤10 and ≤6 eos/hpf) and changes from baseline in peak eosinophil count and scores on the Eosinophilic Esophagitis Histology Scoring System (EoEHSS), Eosinophilic Esophagitis Endoscopic Reference Score (EREFS), Eosinophilic Esophagitis Activity Index (EEsAI), and quality of life (Adult Eosinophilic Esophagitis Quality-of-Life and Patient Reported Outcome Measurement Information System Global Health questionnaires). Individuals without histological response to 1FED could proceed to 6FED, and those without histological response to 6FED could proceed to swallowed topical fluticasone propionate 880 μg twice per day (with unrestricted diet), for 6 weeks. Histological remission after switching therapy was assessed as a secondary endpoint. Efficacy and safety analyses were done in the intention-to-treat (ITT) population. This trial is registered on ClinicalTrials.gov, NCT02778867, and is completed. Between May 23, 2016, and March 6, 2019, 129 patients (70 [54%] men and 59 [46%] women; mean age 37·0 years [SD 10·3]) were enrolled, randomly assigned to 1FED (n=67) or 6FED (n=62), and included in the ITT population. At 6 weeks, 25 (40%) of 62 patients in the 6FED group had histological remission compared with 23 (34%) of 67 in the 1FED group (difference 6% [95% CI -11 to 23]; p=0·58). We found no significant difference between the groups at stricter thresholds for partial remission (≤10 eos/hpf, difference 7% [-9 to 24], p=0·46; ≤6 eos/hpf, 14% [-0 to 29], p=0·069); the proportion with complete remission was significantly higher in the 6FED group than in the 1FED group (difference 13% [2 to 25]; p=0·031). Peak eosinophil counts decreased in both groups (geometric mean ratio 0·72 [0·43 to 1·20]; p=0·21). For 6FED versus 1FED, mean changes from baseline in EoEHSS (-0·23 vs -0·15; difference -0·08 [-0·21 to 0·05]; p=0·23), EREFS (-1·0 vs -0·6; difference -0·4 [-1·1 to 0·3]; p=0·28), and EEsAI (-8·2 vs -3·0; difference -5·2 [-11·2 to 0·8]; p=0·091) were not significantly different. Changes in quality-of-life scores were small and similar between the groups. No adverse event was observed in more than 5% of patients in either diet group. For patients without histological response to 1FED who proceeded to 6FED, nine (43%) of 21 reached histological remission; for patients without histological response to 6FED who proceeded to fluticasone propionate, nine (82%) of 11 reached histological remission. Histological remission rates and improvements in histological and endoscopic features were similar after 1FED and 6FED in adults with eosinophilic oesophagitis. 6FED had efficacy in just less than half of 1FED non-responders and steroids had efficacy in most 6FED non-responders. Our findings indicate that eliminating animal milk alone is an acceptable initial dietary therapy for eosinophilic oesophagitis. US National Institutes of Health.

A Reduction in Opioid Prescription Size After Total Joint Arthroplasty Can be Safely Performed Without an Increase in Complications

BackgroundExcessive opioid prescriptions after total joint arthroplasty (TJA) increase risks for adverse opioid-related events, chronic opioid use, and unlawful opioid diversion. Decreasing postoperative prescriptions may improve quality after TJA. Concerns exist that a decrease in opioids prescribed may increase complications, such as readmissions, emergency department (ED) visits, or worsened patient-reported outcomes (PROs). The purpose of this study was to explore whether a reduction in opioids prescribed after TJA resulted in increased complications. MethodsData originated from a statewide database prospectively abstracted, including oral morphine equivalents prescribed at discharge, readmissions, ED visits, and PROs. Data were collected from 84,998 TJA occurring 1 year before and after the creation of an opioid-prescribing protocol that had decreased prescriptions by approximately 50%. Trends were monitored using Shewhart control charts. Regression models were used to determine statistically significant changes over time. ResultsAll groups showed a reduction in opioids prescribed by almost 50% without an increase in emergency room visits or readmissions and without a detrimental effect on PROs. Compared to baseline data before opioid reduction, opioid-naive total knee arthroplasty had significant improvements in all outcomes (P = .03, P = .02, P < .001, P < .001). Opioid-tolerant total knee arthroplasty and total hip arthroplasty had no worsened outcomes and significant improvement in (Knee Injury and Osteoarthritis Outcome score for Joint Replacement P = .03) and (Hip Disability and Osteoarthritis Outcome Score for Joint Replacement P = .03). Opioid-naive total hip arthroplasty had significant improvements in Hip Disability and Osteoarthritis Outcome Score Joint Replacement (P = .003) and Patient Reported Outcomes Measurement Information System (P = .001). ConclusionsPostoperative opioid prescription recommendations from a statewide registry decreased prescribing by approximately 50% without decreasing PROs or increasing ED visits or readmissions. A reduction in opioids prescribed after TJA can be accomplished safely and without increased complications.

Impact of Preoperative 12-item Short Form Mental Composite Scores on Clinical Outcomes in Cervical Disc Replacement.

Retrospective cohort study. We aim to examine the effects of preoperative mental health status on demographic, perioperative characteristics, and postoperative outcomes in patients undergoing cervical disc replacement (CDR). The effect of preoperative mental health status has not been widely studied in CDR. Patients undergoing primary CDR were retrospectively collected and stratified into 2 cohorts by 12-item Short Form Survey Mental Composite Score (SF-12 MCS) ≥48.9. Patients without preoperative SF-12 MCS scores or diagnosis of infection, malignancy, or trauma were excluded. Demographic information, perioperative characteristic, and patient reported outcome measures (PROMs) were collected. Patient reported outcome measurement information system physical function (PROMIS-PF)/SF-12 Physical Component Score (PCS)/SF-12 MCS/visual analog scale (VAS) neck/VAS leg/neck disability index (NDI) were collected preoperatively and 6 weeks/12 weeks/6 months/1 year postoperatively. Eighty-seven patients were included, (47 having SF-12 MCS≥48.9). For PROMs, both cohorts had significant improvement from preoperative baseline, besides SF-12 PCS/MCS at 1 year for the depressed cohort and SF-12 MCS at all time points. The non-depressed cohort demonstrated significantly higher PROMIS-PF preoperatively and at 12 weeks, SF-12 PCS at 12 weeks, SF-12 MCS at all time points, decreased VAS neck at 12 weeks and NDI preoperatively and at 12 weeks, overall minimal clinically important difference (MCID) in most patients in all PROMs besides SF-12 MCS, and higher MCID for PROMIS-PF at 12 weeks. The depressed cohort demonstrated overall MCID in most patients with PROMIS-PF/SF-12 MCS/VAS neck/NDI, and a higher MCID for 6 weeks/12 weeks/6 months postoperatively and overall SF-12 PCS. Whereas both cohorts demonstrated significantly improved PROMs from baseline, the non-depressed cohort demonstrated better physical function, mental health, decreased pain, and disability at various time points, whereas the depressed cohort demonstrated higher mental health MCID achievement at every time point except 1 year. These findings may be useful in managing expectations for patients undergoing cervical surgery.