Patient-Reported Outcomes Measurement Information System Measures Research Articles

The influence of body mass index on patient-reported outcome measures following total hip arthroplasty: a retrospective study of 3,903 Cases.

The influence of obesity on patient-reported outcome measures (PROMs) following total hip arthroplasty (THA) is currently controversial. This study aimed to compare PROM scores for pain, functional status, and global physical/mental health based on body mass index (BMI) classification. Primary, elective THA procedures at a single institution between 2018 and 2021 were retrospectively reviewed, and patients were stratified into four groups based on BMI: normal weight (18.5-24.99kg/m2), overweight (25-29.99kg/m2), obese (30-39.99kg/m2), and morbidly obese (> 40kg/m2). Patient-Reported Outcome Measurement Information System (PROMIS) and Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS, JR) scores were collected. Preoperative, postoperative, and pre/post- changes (pre/post-Δ) in scores were compared between groups. Multiple linear regression was used to assess for confounders. We analyzed 3,404 patients undergoing 3,903 THAs, including 919 (23.5%) normal weight, 1,374 (35.2%) overweight, 1,356 (35.2%) obese, and 254 (6.5%) morbidly obese cases. HOOS, JR scores were worse preoperatively and postoperatively for higher BMI classes, however HOOS, JR pre/post-Δ was comparable between groups. All PROMIS measures were worse preoperatively and postoperatively in higher BMI classes, though pre/post-Δ were comparable for all groups. Clinically significant improvements for all BMI classes were observed in all PROM metrics except PROMIS mental health. Regression analysis demonstrated that obesity, but not morbid obesity, was independently associated with greater improvement in HOOS, JR. Obese patients undergoing THA achieve lower absolute scores for pain, function, and self-perceived health, despite achieving comparable relative improvements in pain and function with surgery. Denying THA based on BMI restricts patients from clinically beneficial improvements comparable to those of non-obese patients, though morbidly obese patients may benefit from additional weight loss to achieve maximal functional improvement.

Assessing quality of life in childhood cancer survivors at risk for hearing loss: a comparison of HEAR-QL and PROMIS measures.

Childhood cancer survivors (CCS) exposed to platinum chemotherapy are at an increased risk of developing hearing loss and reporting decreased quality of life (QOL). This study compared two QOL measures; one developed for children with hearing loss, The Hearing Environments and Refection on Quality of Life (HEAR-QL), and one validated in CCS, the Patient-Reported Outcomes Measurement Information System (PROMIS), to assess their ability to evaluate QOL deficits in this population. Subject eligibility were restricted to CCS exposed to platinum-based chemotherapy but who were free of known risk factors for cognitive impairment, (non-central nervous system tumor, no cranial radiation, or intrathecal chemotherapy). Participants had to be between 8-17 years, have completed anti-cancer therapy for at least 6 months, and have an audiogram within 1 year, Participants completed the HEAR-QL-26 (7-12 years) or the HEAR-QL-28 (13-18 years) and the PROMIS. Independent samples and/or one sample T-tests were utilized to compare participants with normal hearing and hearing loss, and to compare outcome measures to normative HEAR-QL and PROMIS data. Non-parametric correlations were utilized to evaluate the relationship between QOL and demographic and medical variables, and QOL and severity of hearing loss. Fifty-four CCS were evaluable. The mean age was 12.0 years. Twenty-eight participants (51.9%) received cisplatin, 30 (55.6%) carboplatin, and 4 (7.4%) received both. Twenty participants (37%) demonstrated hearing loss. Participants with hearing loss scored significantly lower on the HEAR-QL than those with normal hearing (mean: 70.3, SD: 21.7, vs mean: 88.0, SD: 9.3, p =.004 for the HEAR-QL-26; mean: 84.7, SD: 10.2 vs mean: 94.8, SD: 3.4, p =.040 for the HEAR-QL-28). Participants with normal hearing scored significantly lower on the HEAR-QL-26 than the normative mean (mean: 88, SD: 9.3, normative mean: 98, SD: 5, p =.000). The PROMIS failed to identify any differences in QOL between participants based on hearing status, or when compared to the normative mean. The HEAR-QL was more sensitive than the PROMIS in identifying QOL deficits in CCS at risk for hearing loss. The HEAR-QL should be considered in studies seeking to improve the QOL of CCS with hearing loss.

Using Patient-Reported Outcome Measures to Identify Factors Associated with Impaired Physical Function in Younger and Older Adults Living with Sickle Cell Disease

Background Improvements in disease management techniques have led to increases in the life expectancy of individuals with sickle cell disease (SCD). Despite the increasing number of older adults with SCD (defined as age ≥ 40 years), there is limited data on how symptoms experienced by this population such as pain, sleep, depression, and fatigue impact how they function day-to-day. In this study, we sought to determine which modifiable patient-reported factors most strongly correlate with patient reported physical function in adults with SCD. Understanding factors associated with impaired physical function will provide targets for future interventional studies to improve function. Methods We conducted a cross-sectional study at a single academic sickle cell center. Participants completed the Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me) Stiffness Impact and Sleep Impact surveys and the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function, Pain Intensity, Pain Interference, Fatigue, Cognitive Function, and Emotional Distress measures. For ASCQ-Me, higher scores imply better self-reported health. For PROMIS, higher scores mean higher levels of the concept being measured. Relationships between the variables thought to influence SCD experience were explored using analytical networks and centrality measures (INSIGHTS, Nanbar Health's data analysis and 3D visualization tool) that built upon calculated pairwise Spearman correlations of the non-normal variable set. Results Surveys were administered to 92 participants with 97% of participants completing all surveys. The mean score for each item was obtained across all participants. Scores were then stratified by age group and t-tests were performed to compare scores on results between groups for each ASCQ-Me and PROMIS measure. Across those who completed both surveys, the mean age was 43 (SD 13.7). The mean age for older adults was 54 (SD 8.6) and the mean age for younger adults was 30 (SD 5.5). More participants were female (58%) than male (42%). Genotypes included HbSS (58%), HbSβ 0-thalassemia (5%), HbSC, (24%), and HbSβ +-thalassemia (13%). The mean score on PROMIS Physical Function for all participants was 48.7 with 18% of responders reporting impaired physical function (score ≤ 40). Older adults had lower mean scores on PROMIS Physical Function (46.4) vs. for younger adults (51.6, p <0.05). The strongest correlations were between PROMIS Physical Function and ASQME Stiffness Impact (r s= 0.66; p<0.001), PROMIS Pain Intensity (r s= -0.61; p<0.001), PROMIS Pain Interference, (r s= -0.61; p<0.001), and ASCQ-Me Fatigue (r s = -0.55; p<0.001). There was a moderate positive correlation between PROMIS Physical Function and ASCQ-Me Sleep Impact (r s= 0.40; p<0.001) and PROMIS Cognitive Function (r s=0.36 p < 0.001) implying better sleep and better cognitive function were associated with better patient reported physical function. Lastly, better physical function had a low-moderate association with PROMIS Emotional Distress (r s= - 0.24; p < 0.05). We assessed relationships between all of the patient-reported outcome measures and found that the strongest relationships were between Pain Intensity and Pain Interference (r s= 0.69), Pain Intensity and Stiffness (r s= -0.67), and Fatigue and Cognitive Function (r s= -0.69). There was no central node identified (Figure). Conclusion Each factor evaluated in this study showed a statistically significant and clinically meaningful relationship to patient reported physical function. One of our major findings was that when mapped against each other, there was no central node explaining the identified correlations between the variables assessed. These results suggest that physical functioning is multifactorial and that there exist multiple modifiable factors that may influence function in people with SCD. Factors associated with physical function will serve as targets for future interventional studies to maintain and improve function in adults with SCD.

A multidisciplinary lifestyle program for metabolic syndrome-associated osteoarthritis: the "Plants for Joints" randomized controlled trial

To determine the effectiveness of the "Plants for Joints" multidisciplinary lifestyle program in patients with metabolic syndrome-associated osteoarthritis (MSOA). Patients with hip or knee MSOA were randomized to the intervention or control group. The intervention group followed a 16-week program in addition to usual care based on a whole food plant-based diet, physical activity, and stress management. The control group received usual care. The patient-reported Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) total score (range 0-96) was the primary outcome. Secondary outcomes included other patient-reported, anthropometric, and metabolic measures. An intention-to-treat analysis with a linear-mixed model adjusted for baseline values was used to analyze between-group differences. Of the 66 people randomized, 64 completed the study. Participants (84% female) had a mean (SD) age of 63 (6) years and body mass index of 33 (5) kg/m2. After 16 weeks, the intervention group (n=32) had a mean 11-point larger improvement in WOMAC-score (95% CI 6-16; p=0.0001) compared to the control group. The intervention group also lost more weight (-5kg), fat mass (-4kg), and waist circumference (-6cm) compared to the control group. Patient-Reported Outcomes Measurement Information System (PROMIS) fatigue, pain interference, C-reactive protein, hemoglobin A1c, fasting glucose, and low-density lipoproteins improved in the intervention versus the control group, while other PROMIS measures, blood pressure, high-density lipoproteins, and triglycerides did not differ significantly between the groups. The "Plants for Joints" lifestyle program reduced stiffness, relieved pain, and improved physical function in people with hip or knee MSOA compared to usual care.

Can Patient-Reported Outcome Measurement Information System Measures Estimate High Impact Chronic Pain After Total Joint Arthroplasty?

BackgroundHigh impact chronic pain (HICP) is not typically measured following orthopedic surgeries, but has a substantial negative impact on postoperative quality of life. This analysis determined which Patient-Reported Outcome Measurement Information System (PROMIS) measures accurately estimate HICP status following total joint arthroplasty (TJA). MethodsThis was a secondary analysis of a hip and knee TJA cohort. HICP status was determined by two items from the Graded Chronic Pain Scale-Revised. The cohort (n = 2,400) consisted of 47.5% hip (n = 1,142) and 52.5% knee TJA (n = 1,258). For total hip arthroplasty (THA), 53.7% were women (n = 615), 48.6% were 65 years or older (n = 557), 72.5% completed the survey more than 24 months after first surgery (n = 831), and 9.9% had HICP (n = 114). For total knee arthroplasty (TKA), 54.3% were women (n = 687), 59.3% were 65 years or older (n = 750), 72.3% survey completed the survey more than 24 months after first surgery (n = 915), and 11.5% had HICP (n = 145). Included PROMIS measures were pain interference, physical function, anxiety, and sleep disturbance. First, discriminant function analysis determined PROMIS measure contribution to HICP status. Then, area under the curve (AUC) calculated the accuracy of PROMIS measures to estimate HICP status. Influences of sociodemographic and surgical characteristics on AUC were explored in sensitivity analyses. ResultsResults for TKA and THA were similar so they are presented collectively for the sake of brevity. Mean differences were identified for all PROMIS measures for those with HICP (All P values < 0.01). Pain interference (β = 0.934) and sleep disturbance (β = 0.154) were independently correlated with HICP status in discriminant function analyses. The AUC (95% CIs) for HICP were as follows: pain interference (.952-.973), physical function (.921-.949), sleep (.780-.838), and anxiety (.687-.757). Sensitivity analyses revealed little change in AUC and HICP cutoff scores for PROMIS pain interference and physical function. ConclusionTwo PROMIS measures commonly administered as standard of care for orthopedics, pain interference, and physical function, can be used to estimate HICP status for THA and TKA, thereby refining assessment of TJA outcomes.

Abstract P4-05-04: Health-Related Quality of Life and Work Impairment Among Individuals Living with HER2+ Breast Cancer with Brain Metastases

Abstract Background: Roughly 20% of people diagnosed with breast cancer (BC) will be considered HER2+. HER2+ BC patients are among those at highest risk for developing brain metastases, with up to 50% developing brain metastases. Brain metastases are associated with faster disease progression, shorter survival, and myriad increased impairments. Despite the significant burden faced by HER2+ BC patients living with brain metastases (BMBC), there is little empirical research available regarding the unique experiences of this population. The goals of this exploratory study were to examine the feasibility of recruiting HER2+ BMBC patients to complete an online survey, and to describe their health-related quality of life (HRQOL) and experiences with work impairment. Methods: 62 women with HER2+ metastatic BC were recruited via advocacy partners, Living Beyond Breast Cancer and Metastatic Breast Cancer Alliance, and completed an online survey in January 2022. Participants reported sociodemographics, clinical history, current caregiving support received, physical health (Patient-Reported Outcomes Measurement Information System (PROMIS) Global Physical Health 2av1.2), HRQOL (PROMIS-29v2.0 and PROMIS Cognitive Function Short Form 8a) and work impairment (Work Productivity and Activity Impairment Questionnaire–Specific Health Problem (WPAI-SHPv2.0)). Descriptive statistics were calculated for study variables; PROMIS measures were converted to T scores (M=50, SD=10), enabling comparisons to established population benchmarks. Results presented in this study are restricted to the 30 HER2+ participants living with BMBC. Results: Participants were 47% White, 23% Hispanic, 23% Asian, 3% Black/African American, 3% American Indian/Alaska Native; mean age=43y (range: 33-72); 83% held a Bachelor degree or higher; 70% were married or partnered; mean years since BMBC diagnosis=2.7 (range: &amp;lt; 1-20); mean years between diagnosis and onset of metastatic disease=1.8 (range: 0-11). 67% of participants reported receiving constant care from a caregiver; the remaining participants reported receiving an average of 10.2 hours/week of care. 50% of participants reported physical health corresponding to poor levels (&amp;gt;2 SD on PROMIS). The majority of participants reported HRQOL impairments corresponding to moderate to severe levels (&amp;gt;1SD on PROMIS): Anxiety (84%); Physical Function (80%); Pain Interference (77%); Depression (70%); Fatigue (70%); Sleep Disturbance (67%); Cognitive Function (63%); and Ability to Participate in Social Roles and Activities (53%). Mean symptom burden T-scores (range: 60.4-67.7) and mean functional impairment T-scores (range: 36.0-39.9) were poorer relative to several reference groups (i.e., other women with HER2+ MBC, overall BC population benchmarks, general US population benchmarks). At the time of the survey, 73% of participants were not employed due to disability. Among those employed (n=7); 100% reported that BMBC negatively affected their employment in the past week: mean percent of scheduled work hours missed=37% (range: 14-74%); mean percent of reduced productivity while working=39% (range: 0-80%); and mean overall work impairment=60% (range: 39-95%). Conclusions: HER2+ BMBC patients experience substantial emotional, physical, social, and cognitive quality of life impairments, high work absenteeism, reduced productivity, and overall work impairment, suggesting significant unmet needs for this population. Efforts to recruit HER2+ BMBC patients were successful, suggesting high feasibility of future work with a more robust sample. Despite the small sample size, our descriptive results provide a key foundation for future research with HER2+ BMBC patients to formally test hypotheses and evaluate predictor variables impacting patient HRQOL and work impairment. Citation Format: Victoria G. Morris, Alexandra K. Zaleta, Heather Badt. Health-Related Quality of Life and Work Impairment Among Individuals Living with HER2+ Breast Cancer with Brain Metastases [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P4-05-04.

Validity of Patient-Reported Outcomes Measurement Information System Physical, Mental, and Social Health Measures After Left Ventricular Assist Device Implantation and Implications for Patient Care.

A better understanding is needed of the burdens and benefits of left ventricular assist device (LVAD) implantation on patients' physical, mental, and social well-being. The purpose of this report was to evaluate the validity of Patient-Reported Outcomes Measurement Information System (PROMIS) measures for LVAD patients and to estimate clinically important score differences likely to have implications for patient treatment or care. Adults from 12 sites across all US geographic regions completed PROMIS measures ≥3 months post-LVAD implantation. Other patient-reported outcomes (eg, Kansas City Cardiomyopathy Questionnaire-12 item), clinician ratings, performance tests, and clinical adverse events were used as validity indicators. Criterion and construct validity and clinically important differences were estimated with Pearson correlations, ANOVA methods, and Cohen d effect sizes. Participants' (n=648) mean age was 58 years, and the majority were men (78%), non-Hispanic White people (68%), with dilated cardiomyopathy (55%), long-term implantation strategy (57%), and New York Heart Association classes I and II (54%). Most correlations between validity indicators and PROMIS measures were medium to large (≥0.3; p<0.01). Most validity analyses demonstrated medium-to-large effect sizes (≥0.5) and clinically important differences in mean PROMIS scores (up to 14.8 points). Ranges of minimally important differences for 4 PROMIS measures were as follows: fatigue (3-5 points), physical function (2-3), ability to participate in social roles and activities (3), and satisfaction with social roles and activities (3-5). The findings provide convincing evidence for the relevance and validity of PROMIS physical, mental, and social health measures in patients from early-to-late post-LVAD implantation. Findings may inform shared decision-making when patients consider treatment options. Patients with an LVAD, their caregivers, and their clinicians should find it useful to interpret the meaning of their PROMIS scores in relation to the general population, that is, PROMIS may help to monitor a return to normalcy in everyday life.

Patient Experiences with a Tertiary Care Post-COVID-19 Clinic

Post-acute sequelae of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (PASC) is a complex condition with multisystem involvement. We assessed patients' experience with a PASC clinic established at University of Iowa in June 2020. A survey was electronically mailed in June 2021 asking about (1) symptoms and their impact on functional domains using the Patient-Reported Outcomes Measurement Information System (PROMIS) measures (Global Health and Cognitive Function Abilities) (2) satisfaction with clinic services, referrals, barriers to care, and recommended support resources. Survey completion rate was 35% (97/277). Majority were women (67%), Caucasian (93%), and were not hospitalized (76%) during acute COVID-19. As many as 50% reported wait time between 1 and 3 months, 40% traveled >1 h for an appointment and referred to various subspecialities. Participants reported high symptom burden-fatigue (77%), "brain fog" (73%), exercise intolerance (73%), anxiety (63%), sleep difficulties (56%) and depression (44%). On PROMIS measures, some patients scored significantly low (≥1.5 SD below mean) in physical (22.7%), mental (15.9%), and cognitive (17.6%) domains. Approximately 61% to 93% of participants were satisfied with clinical services. Qualitative analysis added insight to their experience with healthcare. Participants suggested potential strategies for optimizing recovery, including continuity of care, a co-located multispecialty clinic, and receiving timely information from emerging research. Participants appreciated that physicians validated their symptoms and provided continuity of care and access to specialists.

Stakeholder outcome prioritization in the Biologic Abatement and Capturing Kids' Outcomes and Flare Frequency in Juvenile Spondyloarthritis (BACK-OFF JSpA) trial.

The Biologic Abatement and Capturing Kids' Outcomes and Flare Frequency in Juvenile Spondyloarthritis (BACK-OFF JSpA) study is a randomized, pragmatic trial investigating different tumour necrosis factor inhibitor de-escalation strategies for children with sustained inactive disease. In this project, we elicited concept rankings that aided in the selection of the patient-reported outcome (PRO) measures that should be examined as part of the BACK-OFF JSpA trial. We conducted a discrete choice experiment to evaluate individuals' preferences regarding PROs. Stakeholders assessed a discrete list of 21 outcome concepts, each of which had a Patient-Reported Outcome Measurement Information System (PROMIS) measure associated with it. PROMIS measures are self- or proxy-reported instruments that are universally applicable to the general population and all chronic conditions. Stakeholders were required to make choices instead of expressing the strength of a preference. Fourteen caregivers, 12 patients (9-22 years old), 16 rheumatologists and three executives from health insurance companies completed the exercise, which took approximately 10 min. The discrete choice experiment resulted in an estimate of the relative importance of each outcome and rank. All stakeholder groups agreed that the primary PRO should be 'Pain Interference', a measure that evaluates the effect of pain on a child's everyday activities, including its impact on social, emotional, mental and physical functioning. Patients and caregivers were mostly aligned in their top priorities, with patients valuing physical health (50% of the top 10) whereas caregivers were more interested in mental health (60% of the top 10). Rheumatologists and health insurance executives were most interested in physical health outcomes, which were ranked 80% and 60% of their top 10 PROs, respectively. Overall, the patients had the most diverse set of prioritized outcomes, including at least one of each category in their top 10 rank order of importance. Patients were also the only stakeholders to prioritize 'social' health. Patients and caregivers were mostly aligned in their outcome priority rankings. The rank-order list directly informed the creation of a profile of PRO measures for our upcoming trial. Stakeholder partners helped with acquisition of data and lead parent partners helped interpret data.

Fatigue and Cognition During Remission in Adults with Immune Thrombotic Thrombocytopenic Purpura

Introduction: Although impaired cognitive function following recovery from immune-mediated thrombotic thrombocytopenic purpura (iTTP) has been well-described, the issue of fatigue is rarely addressed. In our qualitative studies, people with iTTP described fatigue significantly impacted their daily lives. It is unknown if the prevalence of fatigue in iTTP patients differs from the general population. The first aim of this study was to compare fatigue and cognitive scores of people with iTTP in clinical remission to both the United States (US) population and to people with other disorders. Our second aim was to describe clinical severity of fatigue and cognitive impairment among people with iTTP in remission. Methods: Patients were recruited from 9 US centers (8/2019 - 11/2021). Eligibility included: 1) age >18 years, 2) ADAMTS13 deficiency (<10% activity) at diagnosis or during a relapse and 3) being >1-year from the last episode. Fatigue and cognitive function were assessed with the validated NIH Patient-Reported Outcomes Measurement Information System (PROMIS) measures. PROMIS measures are disease cross-cutting instruments which allow for comparisons to not only the US population but also other disorders. Demographic information was also obtained. A one sample t-test was used to compare mean fatigue score of iTTP patients to the US population. iTTP patients were compared to other disorders using PROMIS mean scores and 95% confidence intervals (CI). To aid in clinical interpretation of PROMIS scores, severity thresholds ('No/Mild', 'Moderate', 'Severe') were created utilizing T-score ranges as described previously (Terrell DR, et al Blood 2021; 834). Patients were compared by severity categories and clinical characteristics. Results: 101 patients completed the study (83% female; 52% White; 36% Black; median age 49.5 years [range 26-85 years]). The mean fatigue score in the iTTP patients was 58 (95% CI 56.4, 60.3), significantly worse than the US population (mean 50), (p<0.0001) with higher scores indicating worse function. Comparisons to other disorders indicated that fatigue in iTTP patients was worse than breast cancer survivors and persons who had recovered from severe COVID-19, but similar to patients with systemic lupus erythematosus (SLE) and rheumatoid arthritis (Figure 1). The mean cognitive function score in iTTP patients was 45 (95% CI 43.2, 46.8), significantly worse than the US population (p<0.0001) with lower scores indicating worse function. iTTP cognitive function was worse than breast cancer patients and persons who have recovered from severe COVID-19, but similar to patients with SLE (Figure 1). Table 1 shows the overlap of clinical severity for cognitive and fatigue symptoms. 13% (13/101) of patients in remission had scores indicating 'Severe' impairment on both domains (cognitive and fatigue). Notably, the majority (62%) of patients with severe impairment on both measures were > 5 years since their last episode while only 38% had experienced a relapse. In contrast, 36% of patients with 'No/Mild' impairment on both measures were > 5 years from their last episode and 50% of them had relapsed. Yet, patients with moderate severity on both measures were the most likely to report surviving a relapse (68%) and 50% of these patients were > 5 years from their most recent episode. Conclusion: Fatigue and cognitive function in iTTP patients is worse than the US population but similar to chronic autoimmune disorders such as SLE. Further, 62% of people with severe impairment on both fatigue and cognitive measures were more than 5-years from their most recent episode, and a history of disease relapse was not associated with more severe symptoms. These data suggest that even in long-term 'remission', people with iTTP continue to struggle with severe fatigue and cognition, and whether this relates to the initial disease occurrence or continued sub-clinical disease activity is unknown. Strengths of this study included the large number of patients that were recruited from 9 US academic centers. Future studies should evaluate the impact of ADAMTS13 activity and subclinical microangiopathy on symptom clinical severity. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Using percentiles in the interpretation of Patient-Reported Outcomes Measurement Information System scores: Guidelines for autism.

The objectives of this study were to (1) demonstrate the application of percentiles to advance the interpretation of patient-reported outcomes and (2) establish autism-specific percentiles for four Patient-Reported Outcomes Measurement Information System (PROMIS) measures. PROMIS measures were completed by parents of autistic children and adolescents ages 5-17 years as part of two studies (n=939 parents in the first study and n=406 parents in the second study). Data from the first study were used to develop autism-specific percentiles for PROMIS parent-proxy sleep disturbance, sleep-related impairment, fatigue, and anxiety. Previously established United States general population percentiles were applied to interpret PROMIS scores in both studies. Results of logistic regression models showed that parent-reported material hardship was associated with scoring in the moderate-severe range (defined as ≥75th percentile in the general population) on all four PROMIS measures (odds ratios 1.7-2.2). In the second study, the percentage of children with severe scores (defined as ≥95th percentile in the general population) was 30% for anxiety, 25% for sleep disturbance, and 17% for sleep-related impairment, indicating a high burden of these problems among autistic children. Few children had scores at or above the autism-specific 95th percentile on these measures (3%-4%), indicating that their scores were similar to other autistic children. The general population and condition-specific percentiles provide two complementary reference points to aid interpretation of PROMIS scores, including corresponding severity categories that are comparable across different PROMIS measures.

Biomarker associations with insomnia and secondary sleep outcomes in persons with and without HIV in the POPPY-Sleep substudy: a cohort study.

We investigated associations between inflammatory profiles/clusters and sleep measures in people living with HIV and demographically-/lifestyle-similar HIV-negative controls in the Pharmacokinetic and clinical Observations in PeoPle over fiftY (POPPY)-Sleep substudy. Primary outcome was insomnia (Insomnia Severity Index [ISI]>15). Secondary sleep outcomes included 7-day actigraphy (e.g. mean/standard deviation of sleep duration/efficiency), overnight oximetry (e.g. oxygen desaturation index [ODI]) and patient-reported measures (Patient-Reported Outcomes Measurement Information System (PROMIS) sleep questionnaires). Participants were grouped using Principal Component Analysis of 31 biomarkers across several inflammatory pathways followed by cluster analysis. Between-cluster differences in baseline characteristics and sleep outcomes were assessed using Kruskal-Wallis/logistic regression/Chi-squared/Fisher's exact tests. Of the 465 participants included (74% people with HIV, median [interquartile range] age 54 [50-60] years), only 18% had insomnia and secondary sleep outcomes suggested generally good sleep (e.g. ODI 3.1/hr [1.5-6.4]). Three clusters with distinct inflammatory profiles were identified: "gut/immune activation" (n = 47), "neurovascular" (n = 209), and "reference" (relatively lower inflammation; n = 209). The "neurovascular" cluster included higher proportions of people with HIV, obesity (BMI>30 kg/m2), and previous cardiovascular disease, mental health disorder, and arthritis of knee/hip relative to the other two clusters. No clinically relevant between-cluster differences were observed in proportions with insomnia (17%, 18%, 20%) before (p = .76) or after (p = .75) adjustment for potential confounders. Few associations were observed among actigraphy, oximetry, and PROMIS measures. Although associations could exist with other sleep measures or biomarker types not assessed, our findings do not support a strong association between sleep and inflammation in people with HIV.

PROMIS Utilization in Pediatric Orthopaedics: A Scoping Review.

The lack of a common patient-reported outcome metric used among the orthopaedic population is a problem that has been previously identified by the American Academy of Orthopaedic Surgeons. The Patient-Reported Outcomes Measurement Information System (PROMIS) was developed by the National Institute of Health with the goal of creating a precise and efficient measurement tool for patient-reported symptoms, functioning, and health-related quality of life to be used in clinical research. A study summarizing its use in the pediatric orthopaedic population has not been previously performed. We performed a literature search of Ovid Medline, Embase, Scopus, and the Cochrane Central Register of Controlled Trials from 2010 to August 2021. There were 1961 unique citations included after the removal of 1756 duplicates. After initial screening, 183 studies were screened under full-text review leaving a final number of 51 studies included in this scoping review. Pediatric PROMIS studies were grouped by body part or sub-speciality: "Hand and Upper Extremity" (25.5%, n=13), "Sports" (23.5%, n=12), "Spine" (13.7%, n=7), "Trauma" (13.7%, n=7), "General Pediatric Orthopaedics" (11.8%, n=6), "Lower Extremity" (9.8%, n=5), and "Orthopaedic Oncology" (2%, n=1). An increase in studies utilizing PROMIS was seen throughout the study period with only 3 studies published from 2013 to 2016 to 39 in 2020 and 2021 alone. The 3 most frequently used pediatric PROMIS domains were Pain Interference (76.5%, n=39/51), Mobility (60.8%, n=31/51), and Upper Extremity (54.9%, n=28/51). 64.3% (n=9/14) of the included studies which reported on the floor effects of Pain Interference exhibited a significant floor effect. In all, 77.8% (n=7/9) of the included studies which reported on ceiling effects of Upper Extremity exhibited a significant ceiling effect. The use of PROMIS increased significantly since the first publication in 2013 suggesting orthopaedic providers have increasingly utilized PROMIS in their day-to-day practice as an outcome measure. Ceiling and floor effects were prominent in several of the included domains (Pain Interference and Upper Extremity). Overall, PROMIS measures are efficient, reliable, and effective to use. IV.

Relationship between balance confidence and social engagement in people with multiple sclerosis

ObjectiveTo evaluate the relationships among patient-reported balance confidence and social satisfaction and social participation in people with multiple sclerosis (pwMS). Methods75 ambulatory pwMS who had sustained at least two falls or near falls in the prior two months self-reported their balance confidence (Activities-specific Balance Confidence (ABC) questionnaire) and social satisfaction and participation (Patient Reported Outcomes Measurement Information System (PROMIS) measures). Correlations between the ABC and PROMIS measures were examined using Spearman's rank correlation. ResultsIn a cross-sectional analysis, ABC scores and PROMIS scores for social satisfaction and social participation were statistically significantly correlated (ρ 0.37–0.54, p ≤ 0.001). The correlation between balance confidence and social satisfaction was consistently stronger at each time point than between balance confidence and social participation. ConclusionSelf-reported balance confidence is associated with both social satisfaction and social participation in pwMS who fall. The causal direction of this relationship remains uncertain.

Moderate Weightbearing Restrictions Are Associated with Worse Depressive Symptoms and Anxiety in Children Aged 5 to 7 Years with Perthes Disease.

Moderate Weightbearing Restrictions Are Associated with Worse Depressive Symptoms and Anxiety in Children Aged 5 to 7 Years with Perthes Disease.

QS7: Does Genital Self-image Correspond With Sexual Health Before And After Vaginoplasty

Purpose:Improvements in mental health and quality of life are well documented for transgender patients following vaginoplasty. Patient-reported outcomes (PROs) regarding sexual health are lacking in this intervention, or have not been validated in transgender patients.Methods:A community advisory board of transgender women informed an anonymous online survey utilizing PROs for those who were contemplative of (pre-) and post-vaginoplasty. They were recruited on online platforms not associated with an individual institution. Survey measures included the Female Genital Self-Image Scale (FGSIS) and Patient-Reported Outcomes Measurement Information System (PROMIS) sexual health measures. Welch approximation t-tests were performed for FGSIS and PROMIS questions using Bonferroni correction.Results:687 transgender patients pre-vaginoplasty (n = 522, 76%) and post-vaginoplasty (n = 165, 24%) responded. In PROMIS measures, the postoperative cohort reported higher ability to orgasm (p = 0.0003), satisfaction with sex life (p = 0.001), pleasure in sex life (p = 0.002), use of lubricant (p < 0.0001), and scar interfere with sexual satisfaction (p < 0.0001). FGSIS total score was higher among postoperative patients (27.8 ± 6.0) than preoperative patients (17.8 ± 5.3) (p < 0.0001). Using Spearman’s rho, no significant correlation between FGSIS total score and any PROMIS sub-sectional measures was observed for either cohort. 193 patients (133 preoperative, 60 postoperative) reported their responses about sex being influenced by the Covid-19 crisis.Conclusion:Patients who are contemplating vaginoplasty have worse sexual health and genital self-image than those who have had vaginoplasty. FGSIS scores did not correlate with PROMIS sexual health measures when controlling for prior vaginoplasty, demonstrating that sexual health is multimodal for each individual patient.

Can PROMIS measures be used to create subgroups for patients seeking orthopaedic care?

AimsPatient-reported outcome measures have become an important part of routine care. The aim of this study was to determine if Patient-Reported Outcomes Measurement Information System (PROMIS) measures can be used to create patient subgroups for individuals seeking orthopaedic care.MethodsThis was a cross-sectional study of patients from Duke University Department of Orthopaedic Surgery clinics (14 ambulatory and four hospital-based). There were two separate cohorts recruited by convenience sampling (i.e. patients were included in the analysis only if they completed PROMIS measures during a new patient visit). Cohort #1 (n = 12,141; December 2017 to December 2018,) included PROMIS short forms for eight domains (Physical Function, Pain Interference, Pain Intensity, Depression, Anxiety, Sleep Quality, Participation in Social Roles, and Fatigue) and Cohort #2 (n = 4,638; January 2019 to August 2019) included PROMIS Computer Adaptive Testing instruments for four domains (Physical Function, Pain Interference, Depression, and Sleep Quality). Cluster analysis (K-means method) empirically derived subgroups and subgroup differences in clinical and sociodemographic factors were identified with one-way analysis of variance.ResultsCluster analysis yielded four subgroups with similar clinical characteristics in Cohort #1 and #2. The subgroups were: 1) Normal Function: within normal limits in Physical Function, Pain Interference, Depression, and Sleep Quality; 2) Mild Impairment: mild deficits in Physical Function, Pain Interference, and Sleep Quality but with Depression within normal limits; 3) Impaired Function, Not Distressed: moderate deficits in Physical Function and Pain Interference, but within normal limits for Depression and Sleep Quality; and 4) Impaired Function, Distressed: moderate (Physical Function, Pain Interference, and Sleep Quality) and mild (Depression) deficits.ConclusionThese findings suggest orthopaedic patient subgroups differing in physical function, pain, and psychosocial distress can be created from as few as four different PROMIS measures. Longitudinal research is necessary to determine whether these subgroups have prognostic validity.Cite this article: Bone Jt Open 2021;2(7):493–502.

PROMIS Global-10 poorly correlates with legacy outcomes for patients undergoing hip arthroscopy.

ABSTRACTThe Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 assesses generic-related quality of life, but has not been well studied in the orthopaedic literature. The purpose was to compare PROMIS Global-10 and legacy hip-specific patient-reported outcome measures (PROMs) in patients undergoing hip arthroscopy for femoroacetabular impingement syndrome (FAIS). This study included patients who underwent primary hip arthroscopy with complete preoperative and 6-month post-operative follow-up. PROMIS Global-10 Physical (PROMIS-P) and Mental (PROMIS-M) components, as well as the modified Harris hip score (mHHS) and International Hip Outcome Tool-33 (iHOT-33) were assessed. PROM analysis included: post-operative changes, correlations, floor and ceiling effects and responsiveness. Final analysis included 112 patients. Average age and body mass index were 36.1±11.7 years and 24.8±3.9 kg/m2, respectively. All 6-month PROMs, except PROMIS-M, were significantly improved compared to preoperative level (P<0.02). Preoperatively, PROMIS-P was poorly correlated with mHHS and iHOT-33 (rs <0.4) whereas PROMIS-M was only poorly correlated with iHOT-33 (rs <0.4, 95% CI of 0.02–0.37). Post-operatively, the iHOT-33 was poorly correlated with both PROMIS measures (rs <0.4). The mHHS was fairly correlated with both PROMIS measures (rs <0.6) post-operatively. The effect sizes for mHHS and iHOT-33 were high (d=1.2 and 1.40, respectively), whereas the effect sizes for PROMIS Global-10 were small (d<0.3). PROMIS Global-10 demonstrated lower effect sizes and poor to fair correlation with legacy hip-specific PROMs, and appears to have a limited role in the assessment of patients undergoing hip arthroscopy for FAIS. Therefore, the PROMIS Global-10 may have a limited role in assessing patients with FAIS.

Anxiety and Fear During the Covid-19 Pandemic: A Web-Based Survey of Thyroid Cancer Survivors

Background: The coronavirus (COVID-19) pandemic has led to rapid changes in our society and healthcare system. Cancer patients and survivors may be disproportionately affected by these changes, including decreased access to healthcare, increased infection risk, and economic challenges. We sought to determine the effects of the pandemic on thyroid cancer survivors’ quality of life. Methods: An anonymous web-based survey was administered in collaboration with ThyCa: Thyroid Cancer Survivors’ Association, consisting of questions about (1) demographics, (2) thyroid cancer clinical characteristics, (3) attitudes toward and impact of COVID-19, and (4) the Patient-Reported Outcomes Measurement Information System (PROMIS) 29-item profile. The survey was linked on the ThyCa homepage. PROMIS measures were scored using item response theory models with a T-score metric relative to U.S. reference data via the HealthMeasures Scoring Service (https://www.healthmeasures.net). T-scores were analyzed using Mann-Whitney U, Wilcoxon signed-rank, Kruskal-Wallis, and Spearman’s rank correlation tests. Results: From 5/6/2020 - 10/8/2020, 505 participants accessed the survey, and all completed surveys by U.S.-based thyroid cancer survivors were analyzed (n=378, 75%). Mean age was 53 years, 89% were female, 90% were white, 74% had papillary thyroid cancer, 97% had surgery, and 70% received radioactive iodine. The vast majority agreed or strongly agreed (83%) that their lives were very different during COVID-19, as was the way they interacted with their doctors (79%). Less than half (43%) agreed or strongly agreed that they were satisfied with the amount of information from their doctor’s office regarding COVID-19 changes. Compared to previously-published PROMIS data for this population, T-scores were significantly higher in the domain of anxiety/fear (57.8 vs. 56.5, p<0.01) and lower for ability to participate in social roles and activities (46.2 vs. 48.1, p<0.01). Younger age was weakly correlated with greater anxiety/fear (Spearman’s rho=-0.38, p<0.01), and greater anxiety/fear was associated with pending treatment (p<0.01), lower cancer stage (p=0.01), and female sex (p=0.02). Conclusions: During the COVID-19 pandemic, thyroid cancer survivors reported increased anxiety/fear and decreased social participation. In our efforts to care for patients both physically and mentally as the pandemic continues, we must better understand their fears and concerns and improve communication about potential changes to their care.

Patient-Reported Outcomes Measurement Information System (PROMIS) Assessment of Non-Motor Features in Deep Brain Stimulation Candidates: Relationship to the Beck Depression and Anxiety Inventories.

To compare Patient-Reported Outcomes Measurement Information System (PROMIS) measures of depression and anxiety to the Beck Depression Inventory-II (BDI-II), Beck Anxiety Inventory (BAI), and explore patterns of selected PROMIS measures in patients undergoing evaluation for Deep Brain Stimulation (DBS). BDI-II, BAI, and seven PROMIS measures were administered to 163 DBS candidates with diagnoses of Parkinson Disease (PD, n=102), Essential Tremor (ET, n=45), or Dystonia (n=16). Elevated PROMIS Depression using BDI-II Crosswalk equivalents predicted elevated BDI-II with 63% sensitivity and 94% specificity. On other PROMIS measures, 69 patients (42%) reported low Physical Function (T≤40) with Pain Interference being the next most frequent abnormal score (n=51, 31%). Group differences were present for PROMIS Physical Function, Sleep Disturbance, and Pain. These preliminary findings provide initial support for PROMIS Depression to assess mood disturbance in DBS candidates, and characterize other PROMIS measures in DBS candidates including group differences reflecting disease specific contribution to Quality of Life.