Patient-Reported Outcomes Measurement Information System Global Health Research Articles

Testing the Psychometric Properties of 9 Bolt-Ons for the EQ-5D-5L in a General Population Sample

ObjectivesWe aimed to assess the psychometric performance and added value of 9 existing bolt-ons (breathing problems, cognition, hearing, self-confidence, skin irritation, sleep, social relationships, tiredness, and vision) for the EQ-5D-5L in a general population sample. MethodsThe EQ-5D-5L, 9 bolt-ons, SF-6Dv1, Patient-Reported Outcomes Measurement Information System (PROMIS)-29+2, PROMIS Global Health, and Satisfaction with Life Scale were completed in an online cross-sectional survey among a general adult population sample in Hungary (n = 1587). The following psychometric properties were tested for the EQ-5D-5L + bolt-on(s): ceiling, divergent and convergent validity, structural validity, known-group validity, and explanatory power. ResultsAdding sleep (30%), tiredness (24%), or vision (21%) substantially reduced the ceiling of the EQ-5D-5L (41%). Cognition, sleep, social relationships, and tiredness correlated with corresponding PROMIS and SF-6D items (rs = ǀ0.32ǀ − ǀ0.73ǀ). All bolt-ons, except cognition and self-confidence, loaded on a different factor from the EQ-5D-5L dimensions. Breathing, hearing, skin irritation, and vision significantly improved known-group validity in relevant health condition groups. The sleep bolt-on improved known-group validity in 9 of 13 chronic health conditions. Tiredness had the largest impact on explaining EQ VAS score variance in 8 of 13 conditions. Hearing and vision improved the ability of the EQ-5D-5L to capture declining health with age, whereas self-confidence and social relationships were valuable for mental health assessment. ConclusionsThis study established the validity of multiple bolt-ons for the EQ-5D-5L and highlights the usefulness of including relevant bolt-ons in population-based and patient surveys. Our findings inform the further development of these bolt-ons and the bolt-on item selection for clinical studies.

Longitudinal Patient-Reported Outcomes (PROs) in a Prospective Registry of CAR T-Cell Therapy Recipients

Background Chimeric antigen receptor T-cell therapies (CAR-T) significantly improve survival and health-related quality of life (HRQoL) in clinical trials of relapsed hematologic malignancies. However, the impact of CAR-T on real-world longitudinal patient-reported outcomes (PROs), particularly in the immediate post-CAR-T period during which patients are hospitalized and at risk for acute CAR-T-related toxicities, has not been studied. Further, few CAR-T studies have utilized Patient-Reported Outcomes Measurement Information System (PROMIS) survey instruments, which are recommended to enable comparison of PROs across various CAR-T products and disease types. To characterize real-world HRQoL and symptom burden in patients receiving CAR-T, we integrated PROMIS PRO instruments into a prospective cellular therapy registry. Methods The University of Chicago Cellular Therapy Biobank prospectively administers the PROMIS v1.2 Global Health and PROMIS-29 Profile v2.1 instruments to CAR-T recipients. PRO instruments are administered at the following timepoints, anchored to the day (D) of CAR-T receipt: baseline (at time of apheresis), D+1, D+15, D+28, D+90, D+180, and then every 3 months until the 2-year timepoint. The Biobank was queried for all patients who completed a baseline and at least one post-CAR-T survey. PROMIS T-scores were analyzed by one-way repeated measures ANOVA up to the 12-month timepoint. PROMIS T-scores were longitudinally visualized as mean change from baseline. Minimally important differences (MID) that were clinically significant were defined as T-score changes of at least 2. Statistical analyses were performed in STATA, version 17.0. Results There were 68 patients available for PRO analysis. Median age was 65 years (range, 24-80) and 63% were male. Most patients had large B-cell lymphomas (n = 27, 40%) or multiple myeloma (n = 27, 40%). Median prior lines of therapy were 4 (range, 1-12), with only 3 patients receiving 1 prior therapy. The majority of patients received CD19-targeted products (n = 35, 51%), followed by BCMA-targeted products (n = 27, 40%). Patients lived a median of 36 miles from the CAR-T center (range, 2-544), with 65% living over 30 miles away. Survey completion rates at timepoints were as follows: 73% at D+15, 82% at D+28, 84% at D+90, 76% at D+180, and 95% at 12 months. For PROMIS Global Health, there was a significant longitudinal change in Global Physical Health (p = .002), with a clinically meaningful improvement by D+28 which was no longer observed by D+90 ( Figure 1), but no significant change in Global Mental Health (p = .09). For PROMIS-29 Profile, there were significant longitudinal changes in physical function (p = .0001), fatigue (p = .001), and social role functioning (p = .002), but not anxiety (p = .08), depression (p = .45), sleep (p = .92), or pain (p = .27). There were clinically meaningful improvements in both physical and social role functioning in the first 28 days after CAR-T which were no longer observed by D+90 ( Figure 1). Fatigue significantly worsened in the first 28 days after CAR-T to a clinically meaningful degree, but subsequently improved to better than baseline after D+90 ( Figure 2). With a median follow-up of 9 months (range, 1-28), 40% of patients had post-CAR-T disease progression. Relapses occurred a median of 4.9 months after CAR-T, with 31% of relapses (n = 8) occurring before D+90. There were 10 deaths (15%) at a median of 6.7 months after CAR-T. Conclusions In this real-world prospective PRO analysis, there were clinically meaningful improvements in several HRQoL domains in the first month after CAR-T, namely physical and social functioning, despite significantly worsening fatigue during the same time period. However, these HRQoL improvements diminished after D+28, concurrent with the transition of patients from the CAR-T center to home. These results suggest that intensive support by the inpatient and outpatient care teams may improve physical HRQoL during the immediate post-CAR-T period. In addition, given the low rate of relapses before D+90 in this cohort, worsening patient-reported functioning after D+28 may be driven by changes in care support after discharge to home. Interventions to optimize the post-CAR-T transition to home are warranted, as well as studies utilizing PROMIS PROs to identify patients with deteriorating HRQoL who may benefit from augmented support and/or closer surveillance for relapsed disease.

What is the Impact of Social Deprivation on Mental and Physical Health Before and After Primary Total Knee Arthroplasty?

The purpose of the present study was to investigate the relationship between socioeconomic status and Patient-Reported Outcomes Measurement Information System Global Health (PROMIS-GH) scores before and after primary total knee arthroplasty (TKA). We hypothesized that patients with greater social deprivation would have lower PROMIS-GH scores at 3 months and 1 year following primary TKA. We retrospectively reviewed data from patients who underwent unilateral primary TKA and completed PROMIS-GH preoperatively and at 3 months (n= 257) or 1year (n= 154) postoperatively. Area Deprivation Index (ADI), calculated from 9-digit zip codes, was used to measure social deprivation. Participants were grouped into quartiles by ADI score. Minimal clinically important difference in PROMIS-GH mental (PROMIS-MH) and physical health (PROMIS-PH) component scores were compared between ADI groups. Participants in the highest ADI quartile (most disadvantaged) had significantly lower PROMIS-MH and PROMIS-PH scores at every time point relative to the lowest ADI quartile (least disadvantaged) (P < .05 for all). Both ADI groups experienced significant improvements in PROMIS-PH following TKA (P < .001 for all), but not in PROMIS-MH (P > .05 for all) at 3-months and 1-year postoperatively. Magnitude of improvement in PROMIS-PH and rates of achievement of minimal clinically important difference did not significantly differ between ADI groups (P > .05 for all). Socially disadvantaged patients benefit equally from primary TKA but are more likely to have persistently lower 1-year postoperative PROMIS-GH scores relative to less disadvantaged patients. Social deprivation should be accounted for when using PROMIS-GH to assess clinical outcomes for research and quality measures. IV, retrospective cohort study.

Utilities Estimated from PROMIS Scales for Cost-Effectiveness Analyses in Stroke.

The EQ-5D and Health Utilities Index Mark 3 (HUI-3) are preference-based measures used in cost-effectiveness studies. The Patient Reported Outcomes Measurement Information System (PROMIS) Preference scoring system (PROPr) is a new preference-based measure. In addition, algorithms were previously developed to map PROMIS Global Health (PROMIS-GH) items to HUI-3 using linear equating (HUILE) and 3-level EQ-5D using linear (EQ5DLE). We sought to evaluate and compare estimated utilities based on PROPr and PROMIS-GH in adult stroke survivors. We performed a retrospective cohort study of adults diagnosed with 1 of ischemic stroke, intracerebral hemorrhage, or subarachnoid hemorrhage seen in an outpatient clinic between 2015 and 2019. Patients completed PROMIS scales and other measures. We computed a modified version of PROPr (mPROPr) and compared the distributional characteristics and correlations with stroke outcomes for mPROPr, HUILE, and EQ5DLE. T toal of 4,159 stroke survivors (average age 62.7 ± 14.7 y, 48.4% female, 77.6% ischemic stroke) were included. Mean utility estimates for mPROPr, EQ5DLE, and HUILE were 0.333 ± 0.244, 0.739 ± 0.201, and 0.544 ± 0.301, respectively. Correlations between the modified Rankin Scale and each of mPROPr and HUILE were both -0.48 and -0.43 for EQ5DLE. Regression analyses indicated that mPROPr scores may be too low for stroke patients in good health and that EQ5DLE scores may be too high for stroke patients in poor health. All 3 PROMIS-based utilities were associated with measures of stroke disability and severity, but the distributions of utilities were very different. Our study highlights the problem cost-effectiveness researchers face of valuing health states with certainty. For researchers using utilities estimated from PROMIS scales, our study indicates that mapping PROMIS-GH item scores to HUI-3 via linear equating may be most appropriate in stroke patients. A new preference-based measure has been developed from the Patient Reported Outcomes Measurement Information System (PROMIS), known as the PROMIS-Preference (PROPr) scoring system, and published equations mapping PROMIS Global Health (PROMIS-GH) items to the Health Utilities Index Mark 3 (HUI-3) and EQ-5D-3L are available for use in cost-effectiveness studies.Our study provides distributional characteristics and comparisons of utilities estimated using a modified version of PROPr and equations mapping PROMIS-GH items to EQ-5D-3L and HUI-3 in a sample of stroke survivors.The results of our study show large differences in the distributions of utilities estimated using the different health state measures, and these differences highlight the ongoing difficulty researchers face in valuing health states with certainty.

Randomized Controlled Trial of Isha Kriya versus Observation to Improve Quality of Life in Hematopoietic Cell Transplantation Recipients

Hematopoietic cell transplantation (HCT) impacts its recipients' quality of life (QoL). Few mindfulness-based interventions (MBI) in HCT recipients have shown feasibility, but heterogeneous practices and outcome measures have questioned the real benefit. We hypothesize that a self-guided meditation as a mobile app will improve QoL in the acute HCT setting. This single-center, open-label, randomized controlled trial was conducted in 2021-2022. The study was cleared by Institutional Ethics Committee and registered at the Clinical Trial Registry of India. Recipients were included after obtaining written informed consent. Recipients without access to smartphones or regular practitioners of yoga, meditation, or other mind-body practice were excluded. Autologous + allogeneic HCT recipients of age ≥ 18 years were included in the study. Recipients were randomized to the control arm or Isha kriya arm in a 1:1 ratio stratified by type of transplant. Patients in the Isha kriya arm were recommended to perform the kriya twice daily from pre-HCT to day+30 post-HCT. Isha Kriya is 12-minute guided meditation based on the principles of yoga, focussing on breath, awareness, and thought. The primary endpoint was the QoL summary scores assessed by the Functional Assessment of Cancer Therapy - Bone Marrow Transplantation (FACT-BMT) and the Patient-Reported Outcomes Measurement Information System–Global Health (PROMIS-GH) questionnaires. The secondary endpoints were the difference in QoL domain scores. The validated questionnaires were self-administered before the intervention, day +30, and day +100 after HCT. The analysis of endpoints was done on an intention-to-treat basis. Domain and summary scores were calculated for each instrument as recommended by the developers. A p-value <0.05 was used for statistical significance, and cohen's d effect size determined clinical significance. A total of 72 HCT recipients were randomized to the Isha kriya and the control arm. Patients in both arms were matched for age, gender, diagnosis, and type of HCT. Both arms had no difference in the pre-HCT QoL domain, summary, and global scores. Post-HCT at day+30, there was no difference in the mean FACT-BMT total scores (112.9 ± 16.8 vs.101.2 ± 13.9, p = 0.2) and the mean global health scores (Global mental health 45.1 ± 8.6 vs. 42.5 ± 7.2, p = 0.5, global physical health 44.1 ± 6.3 vs. 44.1 ± 8.3, p = 0.4) in the two groups. There was similarly no difference in the physical, social, emotional, and functional domain scores. However, the mean BMT-subscale scores, which addresses BMT-specific quality-of-life concerns, were statistically and clinically significantly higher in the Isha kriya arm than the control arm (27.9 ± 5.1 vs. 24.4 ± 9.2, p = 0.03, Cohen's d 0.5, medium effect size). This effect was transient as the day+100 scores showed no difference (28.3 ± 5.9 vs. 26.2 ± 9.4, p = 0.3). Isha kriya did not improve the FACT-BMT total and global health scores in the acute HCT setting. However, practicing Isha kriya for a month did show a transient improvement in the FACT-BMT subscale scores on day +30 but not on day +100 post-HCT.

Are We Considering the Whole Patient? The Impact of Physical and Mental Health on the Outcomes of Spine Care.

Retrospective, observational. To evaluate the influence of baseline health status on the physical and mental health (MH) outcomes of spine patients. Spine conditions can have a significant burden on both the physical and MH of patients. To date, few studies have evaluated the outcomes of both dimensions of health, particularly in nonoperative populations. At their first visit to a multidisciplinary spine clinic, 2668 nonoperative patients completed the Patient-reported Outcomes Measurement Information System-Global Health (PROMIS-GH) instrument and a questionnaire evaluating symptoms and goals of care. Patients were stratified by their baseline percentile score of the MH and physical health (PH) components of the PROMIS-GH. Four groups of patients were compared based on the presence or absence of bottom quartile PH or MH scores. The primary end point was the achievement of a minimal clinically important difference (MCID) on the MH or PH components at follow-up. Multivariate regression assessed the predictors of MCID achievement. After controlling for demographics, symptoms, and goals, each 1-point increase in baseline PROMIS-GH mental score reduced the odds of achieving MH MCID by 9.0% ( P <0.001). Conversely, each 1-point increase in baseline GH-physical score increased the odds of achieving MCID by 4.5% ( P =0.005). Each 1-point increase in baseline GH-physical score reduced the odds of achieving PH MCID by 12.5% ( P <0.001), whereas each 1-point increase in baseline GH-mental score increased the odds of achieving MCID by 5.0% ( P <0.001). Spine patients presenting with the lowest levels of physical or MH were most likely to experience clinically significant improvement in those domains. However, lower levels of physical or mental health made it less likely that patients would experience significant improvement in the alternative domain. Physicians should evaluate and address the complex spine population holistically to maximize improvement in both physical and mental health status.

Rotator cuff tendinopathy: magnitude of incapability is associated with greater symptoms of depression rather than pathology severity

Population-based studies have established that rotator cuff tendinopathy develops in most persons during their lifetimes, it is often accommodated, and there is limited correspondence between symptom intensity and pathology severity. To test the relationship between effective accommodation and mental health on its continuum, we studied the relative association of magnitude of capability with symptoms of anxiety or depression compared with quantifications of rotator cuff pathology such as defect size, degree of retraction, and muscle atrophy among patients presenting for specialty care. We analyzed a retrospective cohort of 71 adults seeking specialty care for symptoms of rotator cuff tendinopathy who underwent a recent magnetic resonance imaging scan of the shoulder and completed the following questionnaires: Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health questionnaire (a measure of symptom intensity and magnitude of capability, consisting of mental and physical health subscores), Generalized Anxiety Disorder questionnaire (measuring symptoms of anxiety), and Patient Health Questionnaire (measuring symptoms of depression). Two independent reviewers measured the sagittal length of the rotator cuff defect and tendon retraction in millimeters on magnetic resonance imaging scans (excellent reliability) and rated rotator cuff muscle atrophy and fatty infiltration (more limited reliability), and we used the average measurement or rating for each patient. Multivariable statistical models were used to identify factors associated with the PROMIS Global Health score and mental and physical health subscores. Accounting for potential confounding in multivariable analysis, lower PROMIS Global Health total scores and physical health subscale scores were independently associated with greater symptoms of depression but not with measures of pathology. Lower PROMIS mental health subscale scores were independently associated with greater symptoms of anxiety and greater muscle atrophy. The observation that magnitude of incapability among patients seeking care for symptoms of rotator cuff pathology is associated with symptoms of depression but not with measures of the severity of the rotator cuff pathology suggests that treatment strategies for patients who seek care for symptoms of rotator cuff tendinopathy may be incomplete if they do not anticipate and address mental health.

Feasibility of large scale distress screening at an academic center and associated network sites using an adapted patient-reported outcome instrument and reflexive suicide screening.

278 Background: Regular distress screening of patients with cancer is mandated by cancer care guidelines, with 25-50% of patients with cancer experiencing some level of distress. The COVID-19 pandemic amplified symptoms of distress and shifted oncologic care delivery towards telemedicine. In light of challenges faced with implementation of such screening, especially during this pandemic, we sought to assess the feasibility of implementing patient-focused distress screening at a large academic cancer center and its associated network sites. Methods: We designed a modified distress screening tool with reflexive suicidality and mental health screening consisting of 1) Wellness Reflection, a questionnaire that incorporates questions from Patient-Reported Outcomes Measurement Information System-Global Health (PROMIS-GH) to monitor patients’ physical, mental, and social health and to assess patients’ needs for extra support, and 2) modified Patient Health Questionnaire 2+9 (PHQ 2+9) tool to screen for depression and suicide risk. This tool was used to triage patients in need of further assessment by the clinical team, including consideration for referrals to cancer supportive services. The two-tiered distress screening tool was delivered to patients at Stanford Cancer Center and 5 affiliate sites for in-person clinic visits starting September 2019. The Wellness Reflection was launched starting June 2020 for video visits. Results: From October 1, 2019 to May 14, 2021, 147,165 questionnaires representing 46,341 patients were collected. The overall Wellness Reflection questionnaire response rate was 55%; the video visit questionnaire response rate was ̃70%, higher than the in-person visit response rate of ̃50%. About 6% of questionnaires analyzed showed a request for more support, most commonly emotional and physical/symptom support, and this was consistent during the COVID-19 pandemic. 18.6% of questionnaire responses screened positive for further assessment, and those that triggered reflexive suicidality screening had a 17% positive PHQ 2+9 rate. Following assessment, 13,631 referrals to cancer supportive services were generated. Conclusions: The adoption of commonly available patient-reported outcome tools, including PROMIS-GH and PHQ 2+9, as a large-scale distress screening method for both in-person and tele-health clinic visits during the COVID-19 pandemic is feasible at a large academic cancer center and network sites. The volumes of positive screens and referrals were lower than expected despite broader implementation of distress screening and amplified symptoms of distress due to the pandemic.

Osteoarthritic changes in the knees of recently retired male professional footballers: a pilot study.

Knee osteoarthritis (OA) is common amongst retired male professional footballers. There is limited understanding with respect to the interplay between imaging findings, clinical presentation and patient-reported outcome measures (PROMs) in retired professional footballers with knee OA. This pilot study aimed to evaluate the extent of radiological and clinical knee OA in a cohort of retired male professional footballers, and to explore the relationship between these findings and knee-related PROMs. Fifteen retired male professional footballers underwent knee radiographs and were surveyed on their history of clinical OA, severe knee injury and previous knee surgery. The Knee Injury and Osteoarthritis Outcome Score Physical Function Short Form (KOOS-PS) and the Patient-Reported Outcomes Measurement Information System Global Health (PROMIS-GH) were used to assess health outcomes, such as level of function and pain. Radiological knee OA was diagnosed in six out of 15 participants. Seven of the participants had a clinical diagnosis of knee OA. Evidence of clinical and radiological OA was present amongst four participants. Radiological knee OA and clinical OA was significantly associated with a history of severe knee injury and previous knee surgery. Low correlations (ρ<-0.40) were found between knee OA severity and knee-related PROMs. Moderate correlation (ρ=-0.65) was found between clinical knee OA and KOOS-SP. Clinical knee OA correlates with PROMs amongst retired professional footballers but radiological OA does not. Further studies are required to understand the relationship between imaging findings, clinical presentation and PROMs amongst retired professional footballers with knee OA.

Responsiveness of the Brief Michigan Hand Outcomes Questionnaire and Patient-Reported Outcomes Measurement Information System Pain Interference in the Context of Patient Mental Health

A patient-reported outcomes measure (PROM) is responsive if it is sensitive to clinical status changes. The minimal clinically important difference (MCID) is used to indicate meaningful change, helpful in designing studies and adding context to some study results, and is related to instrument responsiveness. Our purpose was to provide MCID estimates for the brief Michigan Hand Outcomes Questionnaire (bMHQ) and Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference (PI) in a hand and upper extremity surgery cohort within the context of varying patient-reported mental health. Data were analyzed from 1,262 adult patients who received surgical care at a single center between January 1, 2018, and December 31, 2019. Patients completed PROMIS PI, PROMIS Global Health (including global mental health [GMH] component), bMHQ, and a pain-focused anchor question before each clinic visit. Data were collected 8 ± 2 weeks before and after surgery. A distribution-based MCID then was calculated for the general patient population, lowest 10th percentile of GMH scores, and top 10th percentile of GMH scores. Minimal clinically important difference estimates were 10.4 for the bMHQ and 4.3 for PROMIS PI. Analysis of MCID across different GMH score groups showed a mean score of 11.5 forbMHQ for the lowest 10th percentile of GMH, 9.6 for bMHQ for the top 10th percentile, 4.5 for PI for the lowest 10th percentile, and 4.9 for PI for the top 10th percentile. Analysis of subgroups stratified by preoperative patient-reported mental health condition found that preoperative mental health status, as indicated by GMH score, does not have a meaningful impact on responsiveness of bMHQ or PROMIS PI. A patient's reported mental health condition does not meaningfully change how these common PRO instruments reflect the patient condition after hand and upper extremity surgery.

POSB380 General Population Reference Values for the Promis Global Health in Hungary

Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health, also referred to as PROMIS Global-10, is a generic health status measure that has two subscales capturing physical and mental health. This study aimed to (1) develop Hungarian reference values for the PROMIS Global Health instrument and to (2) compare the results with the Dutch and US reference values.

Longitudinal course and phenotypes of health-related quality of life in adults with atopic dermatitis.

The real-world course of health-related quality of life (HRQoL) in atopic dermatitis (AD) is not well established. To examine predictors, longitudinal course and phenotypes of HRQoL in adult patients with AD. This was a prospective dermatology-practice based study of 955 patients with AD (age 18-97 years). Patients were assessed at baseline and approximately 6, 12, 18 and 24 months. HRQoL was assessed using the 10-item short-form Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health (PGH). AD severity and impact was assessed by patient-reported global AD severity, Patient-Oriented Eczema Measure (POEM), Eczema Area and Severity Index (EASI), Objective SCORing Atopic Dermatitis (O-SCORAD), Investigator's Global Assessment (IGA), Numerical Rating Scale (NRS) average and worst itch, PROMIS sleep-related impairment (SRI), and nine-item Patient Health Questionnaire (PHQ)-9. Repeated-measures regression models were constructed to examine itch over time. In multivariable linear regression models controlling for age, race/ethnicity, history of asthma, hay fever and food allergy, baseline PGH-physical (PGH-P4) T scores were inversely associated with patient-reported global AD severity, POEM, EASI, objective SCORAD, IGA, NRS average and worst itch, PROMIS SRI and PHQ-9, with stepwise decreases of physical health with worsening severity. PGH-mental health (PGH-M4) T scores were associated with all aforementioned severity measures aside from POEM. In multivariable repeated measures linear regression models, decreased PGH-P4 and PGH-M4 T scores and mapped five-dimension EuroQoL over time were associated with self-reported global AD severity, NRS worst and mean itch, POEM, PROMIS sleep disturbance and SRI, EASI, objective SCORAD, IGA and PHQ-9. Latent class analysis identified six classes of HRQoL, which were associated with measures of AD severity, nonwhite race, Hispanic ethnicity and having only public health insurance, but not age or sex. Patients with AD have a heterogeneous longitudinal course and distinct patterns of HRQoL. Many patients had fluctuating HRQoL over time. Most patients with moderate to severe disease at baseline had persistent HRQoL impairment over time.

The change in postoperative opioid prescribing after lumbar decompression surgery following state-level opioid prescribing reform.

On August 31, 2017, the state of Ohio implemented legislation limiting the dosage and duration of opioid prescriptions. Despite the widespread adoption of such restrictions, few studies have investigated the effects of these reforms on opioid prescribing and patient outcomes. In the present study, the authors aimed to evaluate the effect of recent state-level reform on opioid prescribing, patient-reported outcomes (PROs), and postoperative emergency department (ED) visits and hospital readmissions after elective lumbar decompression surgery. This study was a retrospective cohort study of patients who underwent elective lumbar laminectomy for degenerative disease at one of 5 hospitals within a single health system in the years prior to and after the implementation of the statewide reform (September 1, 2016-August 31, 2018). Patients were classified according to the timing of their surgery relative to implementation of the prescribing reform: before reform (September 1, 2016-August 31, 2017) or after reform (September 1, 2017- August 31, 2018). The outcomes of interest included total outpatient opioids prescribed in the 90 days following discharge from surgery as measured in morphine-equivalent doses (MEDs), total number of opioid refill prescriptions written, patient-reported pain at the first postoperative outpatient visit as measured by the Numeric Pain Rating Scale, improvement in patient-reported health-related quality of life as measured by the Patient-Reported Outcomes Measurement Information System-Global Health (PROMIS-GH) questionnaire, and ED visits or hospital readmissions within 90 days of surgery. A total of 1031 patients met the inclusion criteria for the study, with 469 and 562 in the before- and after-reform groups, respectively. After-reform patients received 26% (95% CI 19%-32%) fewer MEDs in the 90 days following discharge compared with the before-reform patients. No significant differences were observed in the overall number of opioid prescriptions written, PROs, or postoperative ED or hospital readmissions within 90 days in the year after the implementation of the prescribing reform. Patients undergoing surgery in the year after the implementation of a state-level opioid prescribing reform received significantly fewer MEDs while reporting no change in the total number of opioid prescriptions, PROs, or postoperative ED visits or hospital readmissions. These results demonstrate that state-level reforms placing reasonable limits on opioid prescriptions written for acute pain may decrease patient opioid exposure without negatively impacting patient outcomes after lumbar decompression surgery.

The PROMISⓇ-Plus-Osteoarthritis of the Knee (OAK) profile measure integrates generic and condition-specific content to enhance relevance and efficiency

ObjectiveThe Patient-Reported Outcomes Measurement Information System (PROMIS)-Plus-Osteoarthritis of the Knee (OAK) profile integrates universal PROMIS items with knee-specific items across 13 domains. We evaluated the psychometric properties of a subset of six domains associated with quality of life in people with OAK. Study Design and SettingIn a cross-sectional study of OAK patients (n=600), we estimated reliability using Pearson and Spearman correlations with Knee Injury and Osteoarthritis Outcome Score (KOOS) subscores and known-groups validity with PROMIS Global Health. Measure responsiveness was tested via paired t-tests in a longitudinal study (n=238), pre/post total knee replacement. ResultsAcross the six domains, internal consistency reliability (Cronbach's alpha) was 0.77−0.95 and test-retest reliability (intraclass correlation coefficients) was ≥0.90. Correlations with Knee Injury and Osteoarthritis Outcome Score (KOOS) subscores and PROMIS Global supported convergent and divergent validity. Known-groups validity testing revealed better scores in all domains for high vs. low global status groups, and knee-specific items added value in physical function and pain. All domains reflected (p<0.001) better health status scores at follow up. ConclusionThe six PROMIS-Plus-OAK profile domains demonstrated good psychometric characteristics. The measure integrates universal and knee-specific content to provide enhanced relevance, measurement precision and efficient administration for patient care and clinical research.

Developing Workshops to Enhance Hope Among Patients With Metastatic Breast Cancer and Oncologists: A Pilot Study.

Hope is a modifiable entity that can be augmented. We evaluated the feasibility, acceptability, and efficacy of a short intervention to increase hopefulness in patients with advanced breast cancer and oncologists. We enrolled eligible participants to two cohorts: one for patients with metastatic breast cancer and one for medical, radiation, or surgical oncologists. The intervention, a half-day hope enhancement workshop, included groups of 10-15 participants within each cohort. Participants in both cohorts completed preworkshop, postworkshop, and 3-month evaluations, which included the Adult Hope Scale (AHS), Herth Hope Index (HHI), and Patient-Reported Outcomes Measurement Information System-Global Health (PROMIS-GH) measures in patients, and the AHS, HHI, and a burnout self-assessment tool in physicians. We consented 13 patients and 26 oncologists for participation in the workshop and 76.9% (n = 10) of consented patients and 100% (n = 26) of consented physicians participated. Postworkshop, all participants planned to incorporate what they learned into their daily lives. In patients, AHS scores increased from preworkshop to postworkshop, and the mean change of 5.90 was significant (range 0-15, SD: 4.7, t = 3.99, P = .0032). HHI scores also increased, although the mean change was not significant. AHS and HHI scores did not significantly change in oncologists from preworkshop to postworkshop. At 3 months, less than half of the participants responded to the evaluation. We found that conducting a hope-enhancement workshop for patients with metastatic breast cancer and oncologists was feasible, generally acceptable to both populations, and associated with increased hopefulness in patients. Next steps should focus on confirming this effect in a randomized study and maintaining this effect in the postworkshop interval.

Do Obese Children Have Poor Patient-reported Outcomes After Closed Reduction and Percutaneous Pin Fixation of Supracondylar Humerus Fractures?

Nearly 1 in 5 American children are obese. The primary purpose of this study is to evaluate the relationship between childhood obesity and perioperative complications, patient-reported outcomes (PRO), and functional recovery after closed reduction and percutaneous pinning (CRPP) of type II and III supracondylar humerus fractures. Retrospective review of patients treated operatively with CRPP of Wilkins modification of the Gartland classification type II and III supracondylar humerus fractures was performed over a 1-year timeframe (July 1, 2016 to July 1, 2017). One hundred forty-four patients under the age of 16 treated were identified. Obesity was defined as body mass index (BMI) at or above the 95th percentile for age. Obesity as a risk factor for poor outcomes was assessed. The primary outcome measure was postoperative PRO [quick-DASH, Patient Reported Outcomes Measurement Information System (PROMIS)-UE, PROMIS Global Health, and PROMIS Pain scores]. Mean age at surgery was 5.9 years (SD=2.1, 1.07 to 12.2) and mean age at final follow-up (3.3 y) was 8.8 (SD=2.14, 4 to 16). Mean patient BMI was 17.2 (SD=4.48, 12.4 to 56.2). Sixty-six patients were female (45.8%) and 78 patients were male (54.2%). In all, 31 of 144 patients (21.5%) met criteria for obesity. Obesity (95th percentile for BMI or above) was not associated with a higher rate of complications overall (χ2=1.29, P=0.256), range of motion loss (χ2=0.2, P=0.655) or requirement of postoperative physical therapy (χ2=0.17, P=0.678). Seventy-five patients were available and willing to participate in the outcomes score assessments. Mean follow-up for this cohort of 75 patients was 3.3 years (SD=0.31, 2.85 to 3.88). There were no differences in PROMIS pain, PROMIS upper extremity function, PROMIS general health, or quick-DASH scores when comparing obese with nonobese patients. Obesity is a growing concern in the United States and its effect on long-term outcomes after CRPP of supracondylar humerus fractures is unknown. The present study demonstrates no difference in complications or PRO among obese patients compared with nonobese patients. Level IV-retrospective cohort study.

The association between patient rating of their spine surgeon and quality of postoperative outcome.

The Clinician and Group Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) survey was developed by the Centers for Medicare and Medicaid Services as a result of their value-based purchasing initiative. It allows patients to rate their experience with their provider in the outpatient setting. This presents a unique situation in healthcare in which the patient experience drives the marketplace, and since its creation, providers have sought to improve patient satisfaction. Within the spine surgery setting, however, the question remains whether improved patient satisfaction correlates with improved outcomes. All patients who had undergone lumbar spine surgery between 2009 and 2017 and who completed a CG-CAHPS survey after their procedure were studied. Demographic and surgical characteristics were then obtained. The primary outcomes of this study include patient-reported health outcomes measures such as the Patient-Reported Outcomes Measurement Information System Global Health (PROMIS-GH) surveys for both mental health (PROMIS-GH-MH) and physical health (PROMIS-GH-PH), and the visual analog scale for back pain (VAS-BP). A multivariable linear regression analysis was used to assess whether patient satisfaction with their provider was associated with changes in each health status measure after adjusting for potential confounders. The study population included 647 patients who had undergone lumbar spine surgery. Of these, 564 (87%) indicated that they were satisfied with the care they received. Demographic and surgical characteristics were largely similar between the two groups. Multivariable linear regression demonstrated that patient satisfaction with their provider was not a significant predictor of change in two of the three patient-reported outcomes (PROMIS-GH-MH and PROMIS-GH-PH) assessed at 1 year. However, top-box patient satisfaction with their provider was a significant predictor of improvement in VAS-BP scores at 1 year. The authors found that after adjusting for patient-level covariates such as age, diagnosis of disc displacement, self-reported mental health, self-reported overall health, and preoperative patient-reported outcome measure status, a significant association was observed between top-box overall provider rating and 1-year improvement in VAS-BP, but no such association was observed for PROMIS-GH-PH and PROMIS-GH-MH. This suggests that pain-related outcome measures may serve as better predictors of patients' satisfaction with their spine surgeons. Furthermore, this suggests that the current method by which patient satisfaction is being assessed and publicly reported may not necessarily correlate with validated measures that are used within the spine surgery setting to assess surgical efficacy.

QOL-31. USE OF PATIENT-REPORTED OUTCOMES TO IDENTIFY YOUTH AT RISK FOR IMPAIRED OVERALL HEALTH

Pediatric brain tumor survivors often experience persistent and clinically significant late-effects following treatment. Critical to understanding morbidity is utilization of patient-reported outcomes (PROs). The current study evaluated PROs of individuals previously diagnosed with a pediatric brain tumor and identified risk factors for less optimal overall health. Participants included 127 youth 10.59±4.81 (M±SD) years old at survey completion and 4.45±3.82 years from diagnosis of a brain tumor (34.6% Pilocytic Astrocytoma, 9.4% Medulloblastoma, 9.4% Ependymoma, 7.9% Craniopharyngioma, 38.6% Other). Outcomes were assessed via Patient-Reported Outcomes Measurement Information System (PROMIS) parent-proxy measures. Overall health was assessed via PROMIS Global Health (i.e., a measure of general, physical, mental, and social health). Univariate and logistic regression analyses examined potential demographic, medical, and psychosocial factors (e.g., age, race, diagnosis, treatment) related to poor global health. Initial descriptive analyses suggested that most youth experienced anxiety symptoms (T-score M±SD=50.71±11.54), depressive symptoms (47.96±10.34), cognitive functioning (46.52±9.10), and fatigue (55.14±10.62) similar to their peers. However, 31.0% of youth experienced impaired global health (T-score<40). After adjusting for other potential covariates, the final model suggested that youth with significant anxiety (OR=6.20, CI=1.56–24.65), youth with significant fatigue (OR=3.96, CI=1.26–12.41), and youth who did not undergo a gross total resection (OR=0.25, CI=0.07–0.96) were at risk for impaired global health. Identifying those at-risk for impaired health is essential to reducing survivor morbidity and optimizing overall quality of life following treatment. Current data suggest potentially modifiable factors that may improve long-term outcomes for survivors of pediatric brain tumors.

Validation of PROMIS CATs and PROMIS Global Health in an Interdisciplinary Pain Program for Patients With Chronic Low Back Pain.

Retrospective cohort study. To (1) confirm validity of Patient-Reported Outcomes Measurement Information System (PROMIS) physical function and pain interference computer-adaptive tests (CATs) and (2) assess the validity of PROMIS Global Health (GH) and five additional PROMIS CATs: social role satisfaction, fatigue, anxiety, depression, and sleep disturbance in a population of patients with chronic low back pain (cLBP) who completed a 3-month Interdisciplinary Pain Program (IPP). Recent recommendations for assessing outcomes in patients with cLBP have included PROMIS scales; however, there is a need for further evaluation, and PROMIS GH has not been studied in this population. The study cohort included patients with cLBP who completed the entirety of a 3-month IPP between August 2016 and December 2018. Patient-reported outcome measures (PROMs) were analyzed before the start of the IPP and at graduation. Convergent and discriminant validity were evaluated using Pearson correlation coefficients. Known groups' validity assessed the change in PROMIS scores stratified by improvement on the Modified LBP Disability Questionnaire. Responsiveness was evaluated with standardized response means based on global impression of change. IPP was completed by 217 patients (67.7% women, age 53.8 ± 12.8). Convergent validity was supported (P < 0.01 for all pairwise PROMs comparisons). All PROMs improved significantly by graduation, with the largest improvement for PROMIS pain interference, physical function, social role satisfaction, and Modified LBP Disability Questionnaire. Known groups' validity demonstrated the greatest change on PROMIS physical function, social role satisfaction, pain interference, and depression. Responsiveness was supported for all PROMs in 170 (78.3%) patients who indicated at least minimal improvement (standardized response means 0.43-1.06). Our study provides support of PROMIS CATs, highlights the importance of including other meaningful outcome measures, such as social role satisfaction, and provides the first validation of PROMIS GH, in patients with cLBP. PROMs collection can be streamlined through the use of PROMIS CATs which offer advantages over legacy measures. 3.

Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Short Forms Demonstrate Responsiveness in Patients Undergoing Knee Arthroplasty

BackgroundThe Patient-Reported Outcomes Measurement Information System (PROMIS) is an alternative to legacy outcome metrics. We investigated the relationship between Knee Injury and Osteoarthritis Outcomes Score for Joint Replacement (KOOS-JR) and PROMIS Global Health forms of Physical Health (PH) and Mental Health (MH) in knee arthroplasty patients. MethodsThis is a retrospective cohort study of knee arthroplasty patients from December 2017 through April 2019 who had surveys collected preoperatively and postoperatively. We excluded patients undergoing revision surgery. Outcome scores were analyzed for responsiveness, effect size index (ESI), minimal clinically important difference (MCID), and correlation with each other through 12 months postoperatively. ResultsA total of 875 patients were included. Floor and ceiling effects were 0% for PROMIS-PH. Postoperative PROMIS-PH and KOOS-JR scores significantly correlated with one another and increased from baseline at each postoperative time point (P < .001 for all). PROMIS-MH did not change between time points (P > .05). PROMIS-PH showed moderate responsiveness at 1 and 3 months (ESI >0.2) and excellent responsiveness at 6 and 12 months (ESI >0.8), whereas KOOS-JR was responsive at all time points (ESI >0.8). The MCID of PROMIS-PH correlated significantly with KOOS-JR, and a preoperative PROMIS-PH score of less than 32.5 predicted achieving MCID with 97% specificity. ConclusionPROMIS global health forms are a valid metric which capture patient outcomes and correlate with KOOS-JR scores after knee arthroplasty. Although KOOS-JR may be more responsive in the early postoperative time period, both measures show excellent responsiveness at 6 and 12 months after knee arthroplasty.