PROMIS Global Health Research Articles

Paper 52: Pre- and Post-operative Patient Management by an Integrated Care Team Reduces Postoperative Failure Rates Following Osteochondral Allograft Transplantation in the Knee

Objectives: To assess the effects of an integrated care team including a health behavior psychologist on postoperative adherence and associated outcomes for patients undergoing osteochondral and/or meniscus allograft transplantation in the knee. Methods: With IRB approval and documented informed consent, patients were prospectively enrolled into a registry dedicated to following outcomes after OCA and meniscus allograft transplantation surgery between January of 2016 and April of 2021. Patients undergoing primary osteochondral and/or meniscus allograft transplantation to address symptomatic full-thickness cartilage loss and/or meniscus deficiency were included. Patient adherence rates and outcomes were compared based on two cohorts: patients that did not see a behavioral health psychologist preoperatively, and patients that met preoperatively identify potential barriers to adherence, set expectations for postoperative protocols, and identify a plan to moderate risk factors to non-adherence. Patients in both cohorts met preoperatively with the rest of the integrated care team specializing in joint preservation. Data were collected preoperatively, and at all follow-up visits at 3 months, 6 months, and yearly post-operatively. Visual analog scale (VAS) pain scores, International Knee Documentation Committee scores, PROMIS Global Health, and PROMIS Pain interference scores were collected. Treatment failure was defined as any reoperation to revise any of the osteochondral and/or meniscus allografts (revision) or for conversion to arthroplasty in the affected knee. Functional survival (success) was defined as patient- reported pain and function scores improved from pre-operative levels without need for revision or arthroplasty. Patients were categorized as nonadherent when documented evidence of a break from the physical therapy protocol was recounted to a member of the healthcare team by the patient or their physical therapy provider. Data were included for analyses when applicable registry data were available for at least one year following surgery. Chi-square or Fisher’s exact tests were used to analyze differences in proportions, while unpaired t-Tests, one-way analysis of variance tests, or rank sum tests were used to assess significant differences in variables with continuous data. Significance was set a priori at p < 0.05. Results: For patients in the study (n=213), 23.4% were documented to be nonadherent. Of those who were nonadherent, 4 (8.0%) were in the Health Psych cohort versus 46 (92.0%) who were not. Patients in the No Health Psych cohort were significantly more likely to be nonadherent to postoperative rehabilitation protocols (p = .023, OR = 3.4). Tobacco use (p<.001, OR = 7.9), higher preoperative PROMIS Pain Interference score (p<.001), lower preoperative PROMIS Mental Health score (p<.001), older age (p<.001) and higher BMI (p<.001) were also significantly associated with nonadherence. 81.6% of adherent patients had successful outcomes (mean final follow-up 46.7 months, range 12-75), while 40% of nonadherent patients required revision or total knee arthroplasty during the study period, such that nonadherent patients were 3x more likely (p = .004) to experience treatment failure. In this cohort of patients, male sex (p<.001, OR = 3.4) and bipolar OCA transplantation surgeries (p<.001, OR = 5.0) were also significantly associated with increased risk for treatment failure. Conclusions: Preoperative education and postoperative support for patients provided by an integrated care team including a health psychologist can significantly improve adherence and outcomes following osteochondral and meniscal allograft transplantation in the knee.

Poster 364: Prospective Assessment of Outcomes after Femoral Condyle Osteochondral Allograft with Concurrent Meniscus Allograft Transplantation

Objectives: To report outcomes and associated risk factors for treatment failure (revision surgery or conversion to arthroplasty) in a consecutive series of patients undergoing concurrent femoral condyle osteochondral allograft (OCA) and meniscus allograft (MAT) transplantation using advances in tissue preservation and surgical techniques. Methods: Patients who underwent primary femoral condyle OCA transplantation and concomitant MAT (OCAT+MAT) between 2016-2020 with minimum 2-year follow up data regarding complications, failures, adherence, and patient reported outcome measures (PROMs) were analyzed. Patients who required OCA and/or MAT revision or conversion to artificial arthroplasty were defined as treatment failures. Patient reported outcome measures (PROMs) including VAS pain, IKDC, SANE, PROMIS Global Health and Physical Function, were collected at 3 and 6 months and then yearly after transplantation. Fisher’s exact tests were used to compare proportions and repeated measures ANOVA tests were used to compare longitudinal PROMs data for statistically significant (p<0.05) differences. Results: A total of 21 consecutively enrolled patients met inclusion criteria with mean age of 35 (15-54) years and mean BMI of 27 (19-36) kg/m2. OCAT+MAT was performed in the medial compartment in 14 cases and lateral compartment in 7 cases. Realignment osteotomies were performed in 4 cases. Initial success rate (mean follow-up of 44 mos) was 76% based on 1 revision and 4 arthroplasties performed. Overall success rate was 81% based on successful revision. Statistically significant (p<0.002) and clinically meaningful improvements were noted for all measured PROMs (VAS pain, IKDC, SANE, PROMIS) at 2-year follow up. Patients requiring conversion to arthroplasty were significantly older (mean age, 48.3 v 32.2 years, p=0.0076) than patients with successful outcomes. Nonadherence with postoperative restrictions and rehabilitation protocol was an independent risk factor for conversion to arthroplasty (p=0.022, OR=42). Conclusions: Combined femoral condyle OCA and meniscus allograft transplantation was associated with successful short- to mid-term outcomes in 81% of cases. Older age and nonadherenceto postoperative protocols are risk factors for decreased outcomes.

Nurse Resiliency and Health in Practicing Nurses Before and During COVID-19.

The aim of this study was to compare the degree of resilience and self-perceived physical and mental health in nurses before and during the COVID-19 pandemic. Work-related stress among nurses is recognized as an antecedent of burnout, which in turn impacts resiliency and well-being. The work of nursing has long been noted as stressful. Although nurse resilience and perceived well-being have been shown to decrease during a period of usual stress (constant and chronic), the impact and significance of prolonged stress on nurse resilience and well-being illuminates throughout the literature. Replicating a cross-sectional prepandemic study, nurses were resurveyed in 2020 during the COVID-19 pandemic. In both studies, the Connor-Davidson Resilience Scale and PROMIS Global Health was used to measure respondent's: 1) resilience level; 2) physical health status; and 3) mental health status, respectively. Independent 2-sample t tests were performed to compare the pre-and-post score differences in the 3 outcomes. To identify characteristics that were associated with the pre-and-post differences, comparison analyses were also performed within each level of the respondents' characteristic variables. A higher proportion of postsurvey respondents reported working more than 8 hours of overtime per week, had thoughts of quitting their current job, and thought their workload was too much compared with the presurvey respondents. Generally, the postgroup resilience scores and self-perceived physical and mental scores were statistically significantly lower compared with the pregroup scores, but those differences were only observed in certain subgroups defined by respondents' characteristics. Self-perceived physical and mental health are significantly associated with the degree of resilience and worsened during the COVID-19 pandemic, especially in younger and older nurse cohorts. Engaged nurse leaders are key to implement interventions that build resilience and perceived well-being during periods of usual and prolonged stress.

Psychometric properties and general population reference values for PROMIS Global Health in Hungary

ObjectivesPatient-Reported Outcomes Measurement Information System–Global Health (PROMIS-GH) is a widely used generic measure of health status. This study aimed to (1) assess the psychometric properties of the Hungarian PROMIS-GH and to (2) develop general population reference values in Hungary.MethodsAn online cross-sectional survey was conducted among the Hungarian adult general population (n = 1700). Respondents completed the PROMIS-GH v1.2. Unidimensionality (confirmatory factor analysis and bifactor model), local independence, monotonicity (Mokken scaling), graded response model fit, item characteristic curves and measurement invariance were examined. Spearman’s correlations were used to analyse convergent validity of PROMIS-GH subscales with SF-36v1 composites and subscales. Age- and gender-weighted T-scores were computed for the Global Physical Health (GPH) and Global Mental Health (GMH) subscales using the US item calibrations.ResultsThe item response theory assumptions of unidimensionality, local independence and monotonicity were met for both subscales. The graded response model showed acceptable fit indices for both subscales. No differential item functioning was detected for any sociodemographic characteristics. GMH T-scores showed a strong correlation with SF-36 mental health composite score (rs = 0.71) and GPH T-scores with SF-36 physical health composite score (rs = 0.83). Mean GPH and GMH T-scores of females were lower (47.8 and 46.4) compared to males (50.5 and 49.3) (p < 0.001), and both mean GPH and GMH T-scores decreased with age, suggesting worse health status (p < 0.05).ConclusionThis study established the validity and developed general population reference values for the PROMIS-GH in Hungary. Population reference values facilitate the interpretation of patients’ scores and allow inter-country comparisons.

1114-P: Patient-Reported Outcomes (PROs) during a Study of Feasibility of Continuous Glucose Monitor (CGM) Use in Publicly Insured Youth with Type 2 Diabetes (T2D)

Publicly insured youth of minority and lower SES backgrounds are disproportionately impacted by the burden of T2D. The role of CGM use in this population is understudied, and patient-reported outcomes are important to assess while examining feasibility and acceptability of CGM adoption. This study assessed PROs during a feasibility study of CGM use. Youth were provided or prescribed flash CGM using established clinic workflows; PROs were collected from youth and parents at baseline, 3 and 12-month visits using age-appropriate measures (PAID-diabetes distress; PedsQL-health-related quality of life; PROMIS Global Health; DTA-diabetes technology attitudes). Baseline and 3-month data are presented. Participants at baseline included 30 youth with T2D (M age 15.1 years; 53% female; 90% Hispanic; 60% Spanish-speaking; 87% using insulin; M HbA1C 10.2%); 19 parents completed PROs at baseline. Parents and youth had moderate-to-positive attitudes about diabetes technology. Youth endorsed fair levels of global health; and youth and parents endorsed fair general and diabetes-related health-related quality of life. These PROs point to potential areas for future study to understand sources of lower self-reported health and quality of life, and to develop tailored interventions to address PROs while supporting CGM use in publicly-insured youth with T2D. Disclosure M.L.Tanenbaum: None. S.Hanes: None. K.K.Hood: Consultant; Cecelia Health. D.M.Maahs: Advisory Panel; Medtronic, LifeScan Diabetes Institute, MannKind Corporation, Consultant; Abbott, Research Support; Dexcom, Inc. S.Shah: Research Support; Boehringer-Ingelheim, Takeda Pharmaceutical Co., Ltd.

French Version of the Musculoskeletal Pain Intensity and Interference Questionnaire for Professional Orchestra Musicians (MPIIQM-F): Cross-Cultural Adaptation and Preliminary Validation.

The Musculoskeletal Pain Intensity and Interference Questionnaire for Professional Orchestra Musicians (MPIIQM) is a prominent patient-reported outcome measure (PROM) in the musicians' health literature. It has been published in at least four languages, but not in French. To cross-culturally adapt the MPIIQM into French and establish the preliminary psychometric properties (validity, reliability, and responsiveness) of the MPIIQM-F. Standardized cross-cultural adaptation methods included forward translations, an expert committee, and verbal field tests in the target population. Psychometric properties were assessed in a population of French-speaking professional orchestra musicians who participated in three evaluation sessions. Evaluated properties include content, face, structural and construct validity, reliability (internal consistency, test-retest reliability, minimal detectable change [MDC], measurement error), and responsiveness (effect size and standardized response means [SRM]). Sixty-one French-speaking orchestra musicians participated in the psychometric validation. Exploratory factor analysis revealed a two-factor solution equivalent to previous versions, confirming the Pain Intensity and Interference subscales. Spearman correlations for construct validity were as hypothesized for four of six hypotheses (minor deviances for the other two hypotheses) using the Brief Pain Inventory, Disability of the Arm, Shoulder and Hand Performing Arts Module, and PROMIS Global Health Scale as comparators. Reliability results demonstrated high internal consistency (Cronbach's a=0.84-0.89), excellent test-retest reliability (intraclass correlation coefficient = 0.91-0.97), and small measurement error with MDC for the overall scale <10%. Responsiveness resulted in moderate to large effect sizes and SRM (0.54-0.87). Preliminary validation of the MPIIQM-F suggests good validity, reliability, and responsiveness, indicating its suitability for use in French-speaking orchestra musicians.

A randomized phase III clinical trial of acupuncture for chemotherapy-induced peripheral neuropathy in survivors of cancer.

TPS12144 Background: Chemotherapy-induced peripheral neuropathy (CIPN) is a common and debilitating side effect in cancer survivors that can last long after completion of neurotoxic chemotherapy. Patients with CIPN often experience neuropathy symptoms such as pain, tingling, numbness, paresthesia, and dysesthesia, which can lead to significant functional decline and diminished quality of life. This outcome highlights the importance of developing effective CIPN treatments to improve quality of life for this population. Identifying nonpharmacological approaches to reduce CIPN symptoms and improve cancer survivors’ outcomes is urgently needed. Acupuncture is a widely used, minimally invasive Traditional Chinese Medicine technique that has shown promising evidence as an effective and safe treatment for CIPN. We hypothesize that acupuncture may reduce CIPN pain and improve overall CIPN symptoms in cancer survivors. Methods: We are conducting a two-arm, parallel randomized clinical trial comparing electroacupuncture (EA) versus sham acupuncture (SA) in cancer survivors. The EA arm includes ten sessions of EA over eight weeks using a standardized, semi-fixed protocol developed by our group. The SA arm includes a sham technique that uses a combination of non-acupuncture points and a non-insertion procedure in ten sessions over eight weeks. The primary outcome of this study is the Brief Pain Inventory-Short Form average pain item. The secondary outcomes are quantitative sensory testing measures and patient-reported outcomes that include the Neuropathic Pain Scale, Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity, CIPN-20, PROMIS Global Health Scale, and Patients' Global Impression of Change. The primary end point is week 12 and the secondary end point is week 24; treatment effects are assessed at baseline and at weeks 4, 8, 12, 18, and 24. The eligibility criteria includes: 1) Patients must be have no evidence of disease or have stable disease; 2) CIPN diagnosis with moderate-to-severe CIPN pain, defined by a score of 4 or greater on a scale 0-10 numerical scale rating; 3) completed neurotoxic chemotherapy at least three months prior; and 4) no changes in anti-neuropathy medications within three months of enrollment. As of February 2023, we have accrued 89 participants, with a total accrual target of 250 participants. Accrual completion is anticipated by December 2024. The demographic breakdown of our participants is as following: 71% white, 15% black or African American, 10% Asian, 3% more than one race, and 1% Native Hawaiian or Pacific Islander. 89% of the participants are non-Hispanic or Latino, 10% are Hispanic or Latino, and 1% are unknown. 71% of the participants are female and 29% are male. Clinical trial information: NCT04917796 .

Expanding the use of patient-reported outcomes (PROs): Screening youth with type 1 diabetes from underrepresented populations

AimYouth from lower socioeconomic status (SES) have suboptimal type 1 diabetes (T1D) outcomes. Patient reported outcomes (PROs) measure psychosocial states and are associated with T1D outcomes, however are understudied in low SES youth. We aimed to evaluate associations between PROs and public insurance status, a proxy for low SES. MethodsWe analyzed survey data from 129 youth with T1D (age 15.7 ± 2.3 years, 33 % publicly insured) screened with PROMIS Global Health (PGH, measuring global health) and Patient Health Questionnaire (PHQ-9, measuring depressive symptoms) during diabetes appointments. Correlation and regression analyses evaluated differences in PGH and PHQ-9 by insurance status. ResultsFor youth with public insurance, lower global health correlated with lower self-monitoring blood glucose (SMBG; r = 0.38,p = 0.033) and older age (r = −0.45,p = 0.005). In youth with private insurance, lower global health correlated with lower SMBG (r = 0.27,p = 0.018) and female sex (rho = 0.26,p = 0.015). For youth with private insurance, higher depressive symptoms correlated with higher body mass index (r = 0.22,p = 0.03) and fewer SMBG (r = −0.35,p = 0.04). In multivariate regression analyses, public insurance was inversely associated with global health (p = 0.027). ConclusionPGH is a particularly salient PRO in youth with public insurance. Global health may be an important psychosocial factor to assess in youth with T1D from low SES backgrounds.

Quality of life and perception after pulmonary vein isolation and app-based mental training - Results from the randomized controlled MENTAL AF Trial

Abstract Funding Acknowledgements Type of funding sources: Foundation. Main funding source(s): German Heart Foundation Introduction It was recently shown that app-based mental training (MT) reduces atrial fibrillation (AF) related symptoms as compared to usual care in patients undergoing catheter ablation for AF. We now report the effect of MT on quality of life (QoL) and AF burden. Methods MENTAL AF was a RCT with two parallel treatment groups enrolling patients undergoing catheter ablation for symptomatic AF during August 2019 and July 2021. Patients were randomized in a 1:1-ratio to app-based MT or usual care. The MT group gained access to a daily 10-minute app-based breathing, relaxation and meditation training, with a minimum requirement of 2 sessions/week. A total of 183 patients were randomized of which 151 could be included in the final analysis (76 in the MT and 75 in the usual care group). The primary outcome was the intergroup difference of the mean AF6 sum scores during the 3 months study period. Secondary outcomes included web-based QoL measures as assessed by the AF Effect on Quality of Life (AFEQT) and PROMIS Global Health as well as time in AF/atrial tachycardia documented on 7-day Holter. Results Baseline characteristics were well balanced between the MT vs control group, respectively: mean (SD) age 60.6 (8.7) vs 61.5 (8.7) years, female patients 42 vs 40%, paroxysmal AF 55 vs 55%, and left ventricular ejection fraction 58.0 (7.3) vs 57.5 (7.8) %. The primary outcome of AF6 sum score was 8.9 (6.9) points in the MT and 12.5 (10.1) in the usual care group (P = .011). The median difference of the AFEQT Global Score from baseline to 3 month was 18.3 (IQR 11.7 to 35) in the MT and 10.8 (IQR 1.7 to 31.7) in the usual care group (P = .026). The PROMIS Physical Health domain improved by 4.6 (IQR 0; 7.5) in the MT as compared to 0 (-2.6; 4.7) in the usual care group; P = .000. As for the Mental Health domain there was a trend towards a more pronounced improvement [2.9 (IQR 0 to 5.2) vs 0.8 (IQR -2.6 to 4.7); P = .061]. On 3-month follow-up 7-day-Holter 10 patients (16.9 %) in the MT vs 11 patients (14.3 %) in the usual care group exhibited AF/ atrial tachycardia (P = .67). During the registration period 35 patients (53.8 %) in usual care and 25 patients (35.7 %) in MT reported heart rhythm-related symptoms (P = .034). Conclusion MENTAL AF shows that an app-based mind &amp; body intervention as an adjunctive treatment tool improves QoL despite an equal actual arrhythmia burden on 7-day Holter. These results suggest that mental training unfolds its effect by a modification of disease perception and coping.

The impact of stigma on perceived quality of life and experience of anxiety and depression in individuals diagnosed with MS

Stigma experienced by persons living with multiple sclerosis (PwMS) is underrepresented in the literature. Discovering how the experience of stigma impacts quality of life and mood symptoms in PwMS may guide future care considerations with the goal of improving overall quality of life. A retrospective review of data from the Quality of Life in Neurological Disorders (Neuro-QoL) set of measures and PROMIS Global Health (PROMIS-GH) scale was conducted. Multivariable linear regression was used to assess relationships between baseline (first visit) Neuro-QoL Stigma, Anxiety, Depression, and PROMIS-GH. Mediation analyses examined whether mood symptoms mediated the relationship between stigma and quality of life (PROMIS-GH). 6,760 patients (mean age 60.2±8.9 years, 27.7% male, 74.2% white) were included. Neuro-QoL Stigma was significantly related to PROMIS-GH Physical Health (beta=-0.390, 95% CI [-0.411, -0.368]; p<0.001) and PROMIS-GH Mental Health (beta=-0.595, 95% CI [-0.624, -0.566]; p<0.001). Neuro-QoL Stigma was also significantly related to Neuro-QoL Anxiety (beta=0.721, 95% CI [0.696, 0.746]; p<0.001) and Neuro-QoL Depression (beta=0.673, 95% CI [0.654, 0.693]; p<0.001). Mediation analyses revealed that both Neuro-QoL Anxiety and Depression partially mediated the relationship between Neuro-QoL Stigma and PROMIS-GH Physical and Mental Health. Results demonstrate stigma is associated with decreased quality of life in both physical and mental health domains in PwMS. Stigma was also associated with more significant symptoms of anxiety and depression. Finally, anxiety and depression play a mediating role in the relationship between stigma and both physical and mental health in PwMS. Therefore, tailoring interventions to effectively reduce symptoms of anxiety and depression in PwMS may be warranted, as it will likely improve overall quality of life and reduce negative impacts of stigma.

P347 Practical recommendations for the collection of the patient-reported outcomes included in the Health Outcomes Observatory (H2O) core data set for patients with inflammatory bowel disease

Abstract Background Large scale data integration and comparison require standardised data collection. As part of the Health Outcomes Observatory (H2O) project, a core data set for IBD (including case-mix variables, biomarkers, clinical and patient-reported outcomes) that can uniformly be implemented across IBD centres was defined through an international, multi-stakeholder Delphi process. The next step was to identify the most appropriate instruments and minimum frequency to measure the patient-reported outcomes included in this core data set. Fierens L et al, UEG Week 2022. Methods A group of key stakeholders assessed potential instruments that were identified through a literature review. The literature review report included details on the development process, validation studies, extensiveness, required licenses and available translations of the identified instruments. The stakeholders were then asked to indicate in a survey which instrument(s) they considered most important to include in the core data set and at what minimum frequency they would collect these data. The collected insights were discussed at an online consensus meeting in Sept 2022 where a final selection of instruments and minimum frequency was agreed on. Results In total, 18 stakeholders from 10 different countries completed the survey (7 IBD specialists, 4 patient advocates, 3 pharma experts, 2 IBD nurses, 1 expert in patient-reported outcome measurements and 1 regulator). Also 18 stakeholders attended the consensus meeting (6 IBD specialists, 5 patient advocates, 3 academic researchers, 3 pharma experts and 1 IBD nurse from 11 different countries). The PRO-2 (both for UC and CD) and the IBD-Control were indicated as the most appropriate instruments to collect the IBD-specific outcomes, and the PROMIS Global Health and PROMIS Self-Efficacy short form to collect the generic patient-reported outcomes. At the consensus meeting it was additionally agreed to use the generic Health Monitor (disease acceptance and control) and to supplement the set with additional single items to measure bowel incontinence, bowel urgency, IBD medication adherence and the extent to which patients feel informed (Figure). It was agreed that the IBD-specific outcomes would be collected at every consultation with an IBD practitioner, and generic outcomes every 12 months. Conclusion This study recommends an instrument set and minimum frequency to measure the patient-reported outcomes included H2O core data set for IBD, agreed on by a group of key stakeholders. This set will initially be implemented in five European university clinics and subsequently in additional IBD clinics, enabling data integration and comparisons on a larger scale.

Lessening the Impact of Financial Toxicity (LIFT): a protocol for a multi-site, single-arm trial examining the effect of financial navigation on financial toxicity in adult patients with cancer in rural and non-rural settings

BackgroundAlmost half of the patients with cancer report cancer-related financial hardship, termed “financial toxicity” (FT), which affects health-related quality of life, care retention, and, in extreme cases, mortality. This increasingly prevalent hardship warrants urgent intervention. Financial navigation (FN) targets FT by systematically identifying patients at high risk, assessing eligibility for existing resources, clarifying treatment cost expectations, and working with patients and caregivers to develop a plan to cope with cancer costs. This trial seeks to (1) identify FN implementation determinants and implementation outcomes, and (2) evaluate the effectiveness of FN in improving patient outcomes.MethodsThe Lessening the Impact of Financial Toxicity (LIFT) study is a multi-site Phase 2 clinical trial. We use a pre-/post- single-arm intervention to examine the effect of FN on FT in adults with cancer. The LIFT trial is being conducted at nine oncology care settings across North Carolina in the United States. Sites vary in geography (five rural, four non-rural), size (21–974 inpatient beds), and ownership structure (governmental, non-profit). The study will enroll 780 patients total over approximately 2 years. Eligible patients must be 18 years or older, have a confirmed cancer diagnosis (any type) within the past 5 years or be living with advanced disease, and screen positive for cancer-related financial distress. LIFT will be delivered by full- or part-time financial navigators and consists of 3 components: (1) systematic FT screening identification and comprehensive intake assessment; (2) connecting patients experiencing FT to financial support resources via trained oncology financial navigators; and (3) ongoing check-ins and electronic tracking of patients’ progress and outcomes by financial navigators. We will measure intervention effectiveness by evaluating change in FT (via the validated Comprehensive Score of Financial Toxicity, or COST instrument) (primary outcome), as well as health-related quality of life (PROMIS Global Health Questionnaire), and patient-reported delayed or forgone care due to cost. We also assess patient- and stakeholder-reported implementation and service outcomes post-intervention, including uptake, fidelity, acceptability, cost, patient-centeredness, and timeliness.DiscussionThis study adds to the growing evidence on FN by evaluating its implementation and effectiveness across diverse oncology care settings.Trial registrationClinicalTrials.gov NCT04931251. Registered on June 18, 2021.

Association of Chronic Pancreatitis Pain Features With Physical, Mental, and Social Health

Pain is a cardinal symptom of chronic pancreatitis (CP). Using Patient-Reported Outcomes Measurement Information System (PROMIS) measures, we characterized physical and mental health and symptom profiles of a well-defined cohort of individuals with CP and compared them with control subjects. Among patients with CP, we also examined associations between pain (intensity, temporal nature) and PROMIS symptom profiles and the prevalence of clinically significant psychological comorbidities. We analyzed baseline data in 488 CP patients and 254 control subjects enrolled in PROCEED (Prospective Evaluation of Chronic Pancreatitis for Epidemiologic and Translational Studies), an ongoing longitudinal cohort study. Participants completed the PROMIS-Global Health, which captures global physical and mental health, and the PROMIS-29 profile, which captures 7 symptom domains. Self-reported pain was categorized by severity (none, mild-moderate, severe) and temporal nature (none, intermittent, constant). Demographic and clinical data were obtained from the PROCEED database. Pain was significantly associated with impairments in physical and mental health. Compared with participants with no pain, CP participants with severe pain (but not mild-moderate pain) had more decrements in each PROMIS domain in multivariable models (effect sizes, 2.54-7.03) and had a higher prevalence of clinically significant depression, anxiety, sleep disturbance, and physical disability (odds ratios, 2.11-4.74). Similar results were noted for constant pain (but not intermittent pain) for PROMIS domains (effect sizes, 4.08-10.37) and clinically significant depression, anxiety, sleep disturbance and physical disability (odds ratios, 2.80-5.38). Severe and constant pain are major drivers for poor psychological and physical health in CP. Systematic evaluation and management of psychiatric comorbidities and sleep disturbance should be incorporated into routine management of patients with CP. (ClinicalTrials.gov, Number: NCT03099850).

Poster 177: The Impact of Pre-Referral Diagnostic Tests on Care of Atraumatic Shoulder Pain

Objectives:There is a paucity of evidence quantifying the utility and value of pre-referral imaging tests among patients with atraumatic shoulder pain. The primary aim of this study was to assess the prevalence and relative influence of radiographs and MRIs obtained prior to referral to an orthopedic specialist among patients with atraumatic shoulder pain. We hypothesized that there are no patient factors independently associated with undergoing a pre-referral MRI or radiograph. Similarly, there are no factors associated with change of care based on imaging findings, nor do patient factors influence post-referral imaging.Methods:A total of 665 consecutive new adult patients age 35 and older presenting to a single specialty care clinic were included in the study cohort. PROMIS Global Health, PROMIS Mental Health, Patient Health Questionnaire (symptoms of depression), and Generalized Anxiety Disorder questionnaire were completed at the first specialty care visit. Pre-referral shoulder imaging studies were obtained in 462 of 665 (69%) patients; 49% (n = 324) had radiographs and 21% (n = 138) had MRI. We used logistic regression to identify factors independently associated with prereferral imaging and post-referral imaging. We also recorded whether or not pre-referral imaging changed treatment.Results:Pre-referral MRI was associated with worse overall health (P=0.012), greater symptoms of depression (P=0.049), and longer duration of symptoms (P=0.0072). Pre-referral radiographs were associated with worse PROMIS Global Physical Health (P<0.001), worse PROMIS Global Mental Health (p=0.012), greater symptoms of anxiety (p=0.055), greater symptoms of depression (p=0.026), and longer duration of symptoms (p<0.005). There was no relationship between diagnosis and pre-referral MRI or radiographs (p=0.34, p= 0.17). There were no factors associated with post-referral MRI. Post-referral radiograph was associated with worse PROMIS Global Mental Health (p=0.013) and duration of symptoms (p=0.014). Eight of the pre-referral radiographs (2.5%) helped distinguish arthritis from adhesive capsulitis, and six (4%) of the pre-referral MRIs were useful for planning surgery. Ultimately, no images were necessary prior to referral, all could have waited for an order from the specialist.Conclusions:The finding that patient factors, including symptoms of depression or anxiety and poorer overall health correlated with pre-referral imaging suggests that non-specialists may feel pressed to order imaging when patients are more incapable, worried and despairing, perhaps to demonstrate compassion, and possibly in an attempt to prioritize specialty care. Specialists were less influenced by patient factors in ordering imaging tests, perhaps due to a more selective and discerning use of tests largely for planning surgery on discrete pathology. Given that pre-referral imaging does little to influence specialist management, a preferred approach may be immediate specialist referral or electronic consultation without imaging when typical supportive treatments such as a simple set of rotator cuff strengthening exercises are unsatisfying to the patient.

A randomized phase III clinical trial of acupuncture for chemotherapy-induced peripheral neuropathy (CIPN) in cancer survivors.

TPS12145 Background: Chemotherapy-induced peripheral neuropathy (CIPN) is a common and debilitating side effect in cancer survivors that can last long after completion of neurotoxic chemotherapy. Patients with CIPN often experience neuropathy symptoms such as pain, tingling, numbness, paresthesia, and dysesthesia, which can lead to significant functional decline and diminished quality of life (QoL). Our prior study showed that more than half of breast cancer survivors who received taxane-based chemotherapy experienced persistent peripheral neuropathy symptoms for a mean duration of 5.6 years after completing chemotherapy. This outcome highlights the importance of developing effective CIPN treatments to improve cancer survivors’ QoL. Identifying nonpharmacological approaches to reduce CIPN symptoms and improve cancer survivors’ outcomes is urgently needed. Acupuncture is a widely used, minimally invasive Traditional Chinese Medicine technique that has shown promising evidence as an effective and safe treatment for CIPN. We hypothesize that acupuncture may reduce CIPN pain and improve overall CIPN symptoms in cancer survivors. Methods: We are conducting a two-arm, parallel randomized clinical trial comparing electroacupunture (EA) versus sham acupuncture (SA) in cancer survivors at Memorial Sloan Kettering Cancer Center, New York, NY. The EA arm includes a total of ten sessions of EA over eight weeks using a standardized, semi-fixed protocol developed by our group based on the previously published pilot study (NCT03183037). The SA arm includes a sham technique that uses a combination of non-acupuncture points and a non-insertion procedure in ten sessions over eight weeks. The primary outcome of this study is the Brief Pain Inventory-Short Form (BPI-SF) average pain item. The secondary outcomes are quantitative sensory testing measures and additional patient-reported outcomes that include the BPI-SF pain interference subscale, Neuropathic Pain Scale (NPS), Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx), CIPN-20, PROMIS Global Health Scale, and Patients’ Global Impression of Change (PGIC). The primary end point is week 12 and the secondary end point is week 24; treatment effects are assessed at baseline and at weeks 4, 8, 12, 18, and 24. Eligibility criteria includes: 1) Moderate-to-severe CIPN pain, defined by a score of 4 or greater on a 0–10 numeric rating scale; 2) completion of neurotoxic chemotherapy at least three months prior to enrollment; and 3) no changes in anti-neuropathy medications within three months of enrollment. We have accrued 30 participants as of February 2022, with a total accrual target of 250 participants. Accrual completion is anticipated by December 2024. Funding resource: NIH R37 CA248563. Clinical trial information: NCT04917796.

Measurement properties and interpretability of the PROMIS item banks in stroke patients: a systematic review.

Both the International Consortium for Health Outcomes Measurement and the National Institutes of Health recommend the use of Patient-Reported Outcomes Measurement Information System (PROMIS®) measures in clinical care and research for stroke patients. This study aimed to systematically review the literature on the measurement properties and interpretability of PROMIS measures in stroke patients. Nine databases were searched from January 1st, 2007 till April 12th, 2021 for studies concerning the measurement properties and interpretability of PROMIS measures in stroke patients. The findings of these studies were analyzed according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guideline for systematic reviews of Patient-Reported Outcome Measures (PROMs). Ten studies were included. The PROMIS Global Health was studied the most: its two subscales had sufficient structural validity in one study of very good quality, sufficient construct validity with > 75% of hypotheses tested confirmed (high GRADE rating), sufficient internal consistency, i.e. α ≥ 0.70 in two studies (high GRADE rating), sufficient reliability, i.e. ICC ≥ 0.70 in one study of doubtful quality, and indeterminate responsiveness in one study of inadequate quality. For other PROMIS measures, the measurement properties and interpretability were limitedly studied. The PROMIS Global Health showed sufficient structural and construct validity and internal consistency in stroke patients. There is a need for further research on content validity, structural validity, and measurement invariance of PROMIS measures in stroke patients. Trial Registration Information: CRD42020203044 (PROSPERO).

Race, ethnicity and patient-reported outcomes in childhood-onset systemic lupus erythematosus.

This study assesses the association of race/ethnicity with the Patient-Reported Outcomes Measurement Information System (PROMIS®) in childhood-onset systemic lupus erythematosus (cSLE) patients from the Childhood Arthritis and Rheumatology Research Alliance (CARRA) Registry. cSLE patients enrolled in the CARRA Registry within two years of cSLE diagnosis who met ACR and/or SLICC classification criteria for lupus were included. Baseline demographics, laboratory, and disease features as well as patient-reported outcomes were obtained. Multivariable linear regression analysis was used to examine the association of race and ethnicity with PROMIS scores at registry enrolment. 425 cSLE patients met inclusion criteria: 83.8% were female, 30.6% non-Hispanic White, 29.7% Black, 22.1% Hispanic. The mean age at diagnosis was 13.9 years (SD 2.5). Household income and highest parental education varied by race/ethnic group, as did frequency of rash, leukopenia, and anti-Smith antibodies. The cohort had low-moderate baseline disease activity (SLEDAI mean: 6.0 [SD 6.7]). The overall PROMIS Global Health mean T-score was 38.6 (SD 6.5), more than one standard deviation below the general population mean of 50. There was no association between race/ethnicity and PROMIS scores in multivariable linear regression analysis. In this multiethnic paediatric lupus cohort, PROMIS global health was lower when compared with the general paediatric US population. Moreover, PROMIS global health, pain interference, and physical function mobility did not vary across races/ethnicities.

Differential item functioning to validate setting of delivery compatibility in PROMIS-global health.

Patient-reported outcomes measures (PROMs) such as PROMIS are increasingly utilized in healthcare to assess patient perception and functional status, but the effect of delivery setting remains to be fully investigated. To our knowledge, no current study establishes the absence of differential item functioning (DIF) across delivery setting for these PROMIS- Global Health (PROMIS-GH) measures among orthopedic patients. We sought to investigate the correlation of PROMIS-GH scores across in-clinic versus remote delivery by evaluating DIF within the Global Physical Health (GPH) and Global Mental Health (GMH) items. We hypothesize that the setting of delivery of the GPH and GMH domains of PROMIS-GH will not impact the results of the measure, allowing direct comparison between the two delivery settings. Five thousand and seven hundred and eighty-five complete PROMIS-Global Health measures were analyzed retrospectively using the 'Lordif' package on the R platform. DIF was measured for GPH and GMH domains across setting of response (in-clinic vs remote) during the pre-operative period, immediate post-operative period, and 1-year post-operative period using Monte Carlo estimation. McFadden pseudo-R2 thresholds (> 0.02) were used to assess the magnitude of DIF for individual PROMIS items. No GPH or GMH items contained in the PROMIS-GH instrument yielded DIF across in-clinic vs remote delivery setting during the pre-operative, immediate post-operative, or 1-year post-operative window. The GPH and GMH domains within the PROMIS-GH instrument may be delivered in the clinic or remotely with comparable accuracy. This cross-delivery setting validation analysis may aid to improve the quality of patient care by allowing mixed platform PROMIS-GH data tailored to individual patient circumstance.

Health-Related Quality of Life Mildly Affected Following COVID-19: a Retrospective Pre-post Cohort Study with a Propensity Score-Matched Control Group.

ImportanceLong-term health effects have been indicated following COVID-19; however, the impact of COVID-19 on health-related quality of life (HRQOL), including who may experience ongoing symptoms, is unknown.ObjectiveTo identify change in HRQOL following COVID-19 compared to pre-infection HRQOL and a matched control group, and identify predictors of patients who worsen.DesignRetrospective pre-post cohort study with a matched control group.SettingLarge healthcare system in northeast Ohio.ParticipantsA total of 3,690 adult patients diagnosed with COVID-19 who completed HRQOL surveys during routine care for ambulatory visits before and after infection. Propensity-score 1:1 match was utilized to identify controls without COVID who completed HRQOL at two time points.Main OutcomesHRQOL was assessed with PROMIS Global Health: global mental and physical health summary scores. Pre- and post-COVID PROMIS Global Health was completed as part of routine care from 1/1/2019 to 2/29/2020 and 4/4/2020 to 11/1/2021, respectively, and extracted from the electronic health record.ResultsCOVID-19 patients (mean age 53±15; 66% female) completed PROMIS Global Health in the year prior (median 11.1 months) and after diagnosis (median 7.8 months). Compared to before infection, COVID-19 patients had a significant reduction in global mental health and stable global physical health (−0.85 and 0.05 T-score points, respectively) with clinically meaningful reduction (≥5 T-score points) experienced by 27% and 23% of patients, respectively. Predictors of worsening global health included being female, having depression, being hospitalized for COVID-19, and better pre-COVID global health. Compared to the control group, there was significantly worse global mental and physical health decline following COVID-19 (−0.53 and −0.37 T-score points, respectively).Conclusions and RelevanceA quarter of patients with COVID-19 experienced meaningful reductions in HRQOL. Reductions in global mental and physical health were modest, although significantly worse than a control group. Additionally, identified predictors of patients who worsen may assist clinicians when counseling patients of their risk of worse HRQOL following COVID-19.

Patient Reported Outcome Measures (PROMIS) of Primary Total Ankle Arthroplasty in Patients Under 50 Years of Age

Category:Ankle; Ankle ArthritisIntroduction/Purpose:Compared to more prevalent arthritic conditions, ankle arthritis is complicated by an earlier age of onset. With advancements in 4th generation primary and revision componentry, total ankle arthroplasty (TAA) is considered an option for end-stage ankle arthritis in younger patients aligning with paradigm shifts in knee arthroplasty. Recently published data demonstrates excellent survivorship and complication rates in short/mid-term follow-up of younger patients who received a primary TAA. Additionally, older TAA patients display comparable PROMIS relative to hip/knee arthroplasty. However, there remains a paucity of literature surrounding the PROMIS of younger patients undergoing TAA. Thus, our aim was to assess PROMIS of individuals less than 50 years of age receiving a primary total ankle arthroplastyMethods:A retrospective cohort analysis of adult patients < 50 years who received a primary total ankle replacement at a single academic institution between 2003 and 2019 was conducted. Patient demographics, diagnosis, treatment, and outcome characteristics were recorded from a chart review of 41 patients with at least one year of post-surgical follow-up (Table 1). Post- operative PROMIS scores were obtained via telephone interviews. Primary outcomes that were measured included emotional and physical health, activity limitation, ambulation, and global health. SF-36, PROMIS Global Health, and Sickness Impact Profile Ambulation were used. Functional outcomes in our study sample were compared with age and gender-matched norms from a general US population, and 95% confidence intervals were calculated for each functional outcome mean. Student t-test was used for continuous variables, and chi-square analysis was used for categorical variables.Results:Thirty-one of 41 eligible patients were interviewed. The average age at surgery was 40 years old. Clinical and radiographic follow-up was a mean of 59.7 months and 31.2 months following TAA, respectively. General health as measured with the SF-36 was not significantly different from age/gender-matched norms. Eighty-seven percent of patients would choose to have a TAR again. While 58% reported being limited in vigorous activities, 61% were able to ambulate frequently for long periods of time. On average the patients did not report ongoing pain, and only 16% reported fatigue that hindered activities. Eighty-one percent reported returning to full employment and performing their duties without difficulty, and 84% reported they resumed all normal social activities. Primary implant survivorship was 88%.Conclusion:Despite a younger age and potentially increased demands, patients younger than 50 years of age undergoing primary total ankle arthroplasty are generally very satisfied with their index procedure at a mean follow-up of nearly 5 years. Our findings of positive outcomes on their health and well-being may improve surgeon insight for TAA as a preferred treatment for younger individuals with end-stage ankle arthritis.