Patient-Reported Outcomes Measurement Information System Instruments Research Articles

Assessment of post-concussion emotional symptom load using PCSS and PROMIS instruments in pediatric patients

ABSTRACT Objectives The purpose of this study is to evaluate the utility of the Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety and depressive symptom domains in conjunction with the Post-Concussion Symptom Scale (PCSS)for identifying pediatric patients with emotional symptoms following a concussion, and to identify predictors of higher emotional symptom loads. Methods We recruited English-speaking patients aged 8–17 years presenting to a tertiary-care concussion clinic from 2014 to 2018 (n = 458). Demographics and clinical data including PCSS, injury date, previous history of anxiety/depression, and Vestibular/Ocular-Motor Screen (VOMS) were collected from patients’ electronic medical records. Participants completed surveys in the PROMISTM Pediatric Item Bank v1.1-Anxiety and Depressive Symptoms domains at their initial clinic visit. Multivariable linear regression identified predictors of higher emotional symptom loads. Results Overall, 425 (92.8%) reported ≥1 emotional symptom on either PROMIS or PCSS. Predictors of higher emotional symptom loads were abnormal VOMS, female sex, history of anxiety or depression, and longer time since injury. Conclusion Our results suggest that adding PROMIS anxiety and depressive symptom surveys to pediatric concussion evaluations may identify more children with emotional symptoms, allowing clinicians to better direct post-concussion treatment and incorporate psychological support for patients if necessary. Future studies should examine whether earlier identification of emotional symptoms with these tools facilitates recovery and improves short- and/or long-term psychological outcomes in pediatric concussion.

Comparison of Psychometric Properties of Patient-Reported Outcomes Measurement Information System With Traditional Outcome Metrics in Spine Surgery

Patient-Reported Outcomes Measurement Information System (PROMIS) was developed to address certain shortcomings of traditional, or legacy patient-reported outcome measures (PROMs). Because the use of PROMIS across orthopedic populations continues to increase, the purpose of this study was to provide a comprehensive overview of the use and validation of PROMIS in spine surgery. PubMed and Google Scholar were searched for relevant articles reporting on the use and validation of PROMIS in spine surgery. The PROMIS formats and individual domains used by investigators were noted. Additionally, psychometric properties reported in validation studies were evaluated. Both individual studies and systematic reviews have demonstrated the convergent validity of PROMIS domains, reporting moderate-to-strong correlations with legacy measures in a variety of spine patient populations. Across spine surgery patient populations, PROMIS instruments are consistently efficient, demonstrating decreased question burden compared with legacy PROMs. PROMIS domains overall exhibit responsiveness comparable with legacy measures, and the normalization of PROMIS scores to a general population allows for broad coverage, resulting in acceptable floor and ceiling effects. Despite the many strengths of PROMIS, there remain some populations where PROMIS is not suited to be used in isolation. PROMIS is widely used as an outcome measure in spine surgery and has been validated in a range of patient populations. Although PROMIS domains cannot fully replace legacy measures in spine patients, they can be used in certain settings to provide an efficient and psychometrically sound PROM.

Responsiveness of PROMIS Instruments for Trigger Digit After Corticosteroid Injection or A1 Pulley Release

The purpose of the study was to determine if the patient-reported outcomes measurement information system (PROMIS) is sufficiently sensitive to detect improvement after 2 common treatments of trigger finger: corticosteroid injection or A1 pulley release. This retrospective cohort study included 72 patients in the injection group and 51 in the A1 pulley release group. PROMIS physical function (PF), pain interference (PI), and upper extremity (UE) scores were collected at baseline and 6 weeks after injection for the injection group and at baseline, and 1 week, 6 weeks, and 3 months after surgery for A1 pulley release patients. Descriptive statistics and paired t tests were used to compare PROMIS scores within each cohort. Standardized response means (SRMs) were calculated for each PROMIS domain to gauge instrument responsiveness. Average age was 62 years, 65% were female patients, and 86% were White for the steroid injection cohort, compared to 60 years, 71%, and 88%, respectively, for the A1 pulley release cohort. For the steroid injection group, mean PROMIS PI scores (-4.0 points; SRM=-0.6) and PROMIS UE scores (+3.3 points; SRM= 0.5) improved significantly at 6 weeks after injection compared to baseline. Meanwhile, A1 pulley release patients improved significantly in mean PI scores (-3.7 points; SRM=-0.5) and in UE scores (+4.9 points; SRM= 0.7) at 3 months after surgery compared to baseline. Clinical improvements after trigger digit treatments are reflected in improved PROMIS PI and UE scores that reach previously accepted minimum clinically important difference values for hand patients. PROMIS PI and UE also are more responsive than PROMIS PF in capturing improvement for trigger digit treatments. As health care payers continue to emphasize patient-reported outcomes to determine treatment value and set reimbursement rates, this study helps establish that clinical improvement after trigger digit treatments are reflected in PROMIS PI and UE domains by reaching previously established minimum clinically important difference values for hand patients.

Reviewing Patient-Reported Outcomes 1 Year after Orthotopic Liver Transplantation.

With improved survivorship in liver transplantation (LT), there is an emerging focus on functional recovery and health-related quality of life (HRQoL) after surgery. The present study aimed to assess HRQoL after LT using the Patient-Reported Outcomes Measurement Information System (PROMIS). This was a prospective analysis of LT recipients between 2020 and 2021. A total of 238 patients were contacted by phone at 3, 6, and 12 months postoperatively using the PROMIS 29-Profile. Scores were recorded and computed using the HealthMeasures Scoring Service. PROMIS was available for 174 patients at 3 (n = 58), 6 (n = 57), and 12 months (n = 59). Overall, mean PROMIS scores were 47.6 ± 3, 47.6 ± 3, and 47.6 ± 3 at 3, 6, and 12 months, respectively. Most domains improved postoperatively by 12 months except for anxiety and sleep disturbance measures. The lowest domain in the immediate postoperative period was physical functioning, but this had the closest return to normative population values. Pain interference was above the population reference during the initial postoperative period, improving by 12 months where they were below mean population values. Depression and fatigue scores improved by 6 months and appeared to stabilize by 12 months post-LT. Patients demonstrated increased social participation, and scores were remarkably higher than general population means at each timepoint. LT can impact physical, mental, and social health which, in this setting, remains largely unexplored using PROMIS instruments. We report that although overall patient well being can improve, some mental health domains require further consideration during the postoperative period.

P73. Evaluating the concurrent validity of PROMIS PF, PI, and depression domains with the SOSG-OQ in metastatic spine tumor patients

<h3>BACKGROUND CONTEXT</h3> While there remains a significant movement towards incorporating PROMs (patient-reported outcome measures) into clinical spine practice to improve patient-centered care, a commonly used PROM in practice remains elusive. This is especially true in the case of patients with metastatic spine disease. The SOSG-OQ (Spine Oncology Study Group-Outcomes Questionnaire) was designed and validated for metastatic spine tumor patients. The use of general symptom-based PROMs, such as PROMIS (Patient-Reported Outcomes Measurement Information System) domains, may reduce both patient and physician burden and improve interdisciplinary care if shown to be concurrently valid. <h3>PURPOSE</h3> To evaluate the concurrent validity of PROMIS PF (Physical Function), PI (Pain Interference), and Depression domains with the SOSG-OQ in patients with metastatic spine disease. <h3>STUDY DESIGN/SETTING</h3> Cross-sectional study at a single academic medical center. <h3>PATIENT SAMPLE</h3> Metastatic spine tumor patients. <h3>OUTCOME MEASURES</h3> SOSG-OQ; PROMIS PF, PI, and Depression domains. <h3>METHODS</h3> Metastatic spine tumor patients from 1/2017 to 1/2021 at a single academic medical center were asked to complete PROMIS PF, PI, and Depression domains and the SOSG-OQ. Only patients who completed both the SOSG-OQ and PROMIS instruments were included in the analysis. Spearman correlation (ρ) coefficients were calculated, and the absolute value of each correlation was taken for ease of analysis. Patients missing a single question in the SOSG-OQ were excluded from the correlation analysis of the corresponding section. Significance was set at p<0.05. <h3>RESULTS</h3> A total of 73 unique visits, representing 55 patients met our inclusion criteria. A majority were men (39; 53%) and Caucasian (66; 91%), and the average age was 64 years (range: 34-87). There were 11 different types of tumors reported, with multiple myeloma, breast cancer, and lung cancer representing 22 (30%), 21 (29%), and 7 (9.6%), respectively. Additional cancers included prostate, colon, renal cell, thyroid, esophageal, non-Hodgkin's lymphoma, large B cell lymphoma, and metastatic spindle cell sarcoma. SOSG-OQ was strongly correlated with PROMIS PI (ρ = 0.83, p<0.0001; n = 68) and moderately correlated with both PROMIS PF (ρ = 0.76, p<0.0001; n = 68) and PROMIS Depression (ρ = 0.65, p<0.0001; n = 68). <h3>CONCLUSIONS</h3> PROMIS PF, PI, and Depression appear to capture similar clinical insight as the SOSG-OQ. Thus, spine surgeons can consider using these PROMIS domains in lieu of the SOSG-OQ in metastatic spine tumor patients. This is important for establishing broader, more interdisciplinary clinical care for this complex patient population, as PROMIS domains are symptom-based and can also be used by oncologists and other health care providers to deliver improved care. <h3>FDA DEVICE/DRUG STATUS</h3> This abstract does not discuss or include any applicable devices or drugs.

Comparison of patient-reported outcomes measurement information system and legacy instruments in multiple domains among older veterans with chronic back pain

BackgroundChronic low back pain (cLBP) results in significant physical, psycho-social and socioeconomic burden. Identifying efficient and reliable patient reported outcome measures is critical for research and clinical purposes. The NIH’s Patient Reported Outcomes Measurement Information System (PROMIS) instruments have not been compared to validated “legacy” instruments in older adults with cLBP. This study evaluates construct (convergent and discriminant) validity and time to complete (TTC) PROMIS as compared to legacy instruments.MethodsWe enrolled older Veterans (age 60+) with cLBP with/without leg pain scheduled for lumbar epidural steroid injections. Subjects completed PROMIS computer adaptive test item banks and corresponding legacy instruments in the following domains: pain intensity, interference, and behavior; functional status; depression and anxiety; fatigue; sleep and social functioning. Convergent and discriminant validity between PROMIS and legacy instruments was evaluated using Spearman rank order correlations; Mann-Whitney U tests compared TTC.ResultsOf the 71 Veterans recruited, the median (IQR) age was 67 (63–71) years old, 94% were men, 76% were White, 17% Black, and 96% were Non-Hispanic. Spearman correlations between PROMIS and legacy instruments showed moderate to very strong convergent validity in all domains (r = 0.4–1.0), except for social functioning and pain behavior (PROMIS Pain Behavior with Fear Avoidance Belief Questionnaire). The total median TTC for all PROMIS items was significantly shorter than legacy items, 8 min 50 s vs 29 min 14 s respectively, p < 0.001.ConclusionsGiven time efficiency of using PROMIS, along with strong construct validity, PROMIS instruments are a practical choice for measuring multidimensional PROs in older Veterans with cLBP for both research and clinical purposes.

Assessing Rheumatoid Arthritis Disease Activity With Patient-Reported Outcomes Measurement Information System Measures Using Digital Technology.

Health information technology has enabled efficient measurement of patient-reported outcomes (PROs). The National Institutes of Health Patient-Reported Outcomes Measurement Information System (PROMIS) is becoming more widely adopted for research and routine care, and some PROMIS instruments might be substituted for lengthier, legacy PRO instruments. Four PROMIS computer-adaptive testing (CAT) instruments (pain interference, physical function, sleep disturbance, and fatigue) and the Routine Assessment of Patient Index Data 3 (RAPID3), along with pain intensity and patient global assessment score, were administered to participants in the ArthritisPower registry. The RAPID3 was predicted using different combinations of these variables to create a new score (CAT-PROMIS RAPID3). Kappa statistics and Bland-Altman 95% limits of agreement were used to measure agreement between the observed versus predicted RAPID3. A total of 6,154 eligible patients contributed 11,275 observations. The mean ± SD age was 52.7 ± 10.5years, and 93% of patients were women. The median assessment times ranged from 29 seconds (PROMIS sleep disturbance) to 116 seconds (RAPID3). As single pairwise comparisons, the PROMIS CATs examined were modestly correlated (r approximately 0.4-0.7) to one other and RAPID3. Together with the pain intensity and patient global assessment, the PROMIS instruments explained a high fraction of total variance (R2 = 0.97) of the RAPID3 score. In the model with the highest agreement (κ = 0.93) between the observed RAPID3 and the CAT-PROMIS predicted RAPID3, Bland-Altman 95% limits of agreement showed minimal residual differences and no systematic biases. There was excellent agreement between the observed RAPID3 and predicted RAPID3 scores estimated using several PROMIS instruments. The Multidimensional Health Assessment Questionnaire and patient global assessment components of RAPID3 may be unnecessary if PROMIS scores are available.

A comparison of computer adaptive tests (CATs) and short forms in terms of accuracy and number of items administrated using PROMIS profile.

In the Patient-Reported Outcomes Measurement Information System (PROMIS), seven domains (Physical Function, Anxiety, Depression, Fatigue, Sleep Disturbance, Social Function, and Pain Interference) are packaged together as profiles. Each of these domains can also be assessed using computer adaptive tests (CATs) or short forms (SFs) of varying length (e.g., 4, 6, and 8 items). We compared the accuracy and number of items administrated of CAT versus each SF. PROMIS instruments are scored using item response theory (IRT) with graded response model and reported as T scores (mean = 50, SD = 10). We simulated 10,000 subjects from the normal distribution with mean 60 for symptom scales and 40 for function scales, and standard deviation 10 in each domain. We considered a subject's score to be accurate when the standard error (SE) was less than 3.0. We recorded range of accurate scores (accurate range) and the number of items administrated. The average number of items administrated in CAT was 4.7 across all domains. The accurate range was wider for CAT compared to all SFs in each domain. CAT was notably better at extending the accurate range into very poor health for Fatigue, Physical Function, and Pain Interference. Most SFs provided reasonably wide accurate range. Relative to SFs, CATs provided the widest accurate range, with slightly more items than SF4 and less than SF6 and SF8. Most SFs, especially longer ones, provided reasonably wide accurate range.

Patient-Reported Outcomes Measurement Information System (PROMIS) Instruments: Reliability and Validity in Veterans Following Orthopedic Surgery.

The patient-reported outcomes measurement information system (PROMIS) offers standardized assessment measures of clinically relevant patient-reported outcomes. This study evaluated the reliability and validity of select PROMIS measures with U.S. military veterans following orthopedic surgery. Data for the current study were collected as part of a pilot randomized control trial assessing the efficacy of a 1-day Acceptance and Commitment Therapy workshop on persistent postsurgical pain in at-risk veterans undergoing orthopedic surgery. Sixty-seven participants completed surveys 3 months after surgery. Participants completed the following PROMIS instruments: PROMIS Anxiety Short Form 8a, PROMIS Depression Short Form 8b, and PROMIS Pain Interference Short Form 8a. PROMIS measures were compared to the Generalized Anxiety Disorder 7-Item Scale, the Patient Health Questionnaire 9-Item Scale, and the Brief Pain Inventory Pain Interference subscale, respectively. All three PROMIS measures demonstrated excellent internal consistency (Cronbach's αs ranged from .93 to .96) and each loaded onto a single factor. The PROMIS measures were moderately correlated with their respective comparison measures (r = .69 to .76). The PROMIS anxiety and PROMIS depression measures were highly correlated to one another (r = .91). Findings highlight the potential utility of these PROMIS measures in veterans following orthopedic surgery and the overlap between the PROMIS depression and anxiety measures in this sample.

Performance of the PROMIS in Patients Undergoing 3 Common Elbow Procedures.

Background:Ulnar collateral ligament (UCL) reconstruction, distal biceps tendon repair, and elbow arthroscopic surgery are common elbow procedures performed in active patients.Hypothesis:We hypothesized (1) good to excellent correlation between Patient-Reported Outcomes Measurement Information System (PROMIS) instruments and traditional orthopaedic upper extremity patient-reported outcome (PRO) measures; (2) that PROMIS instruments would demonstrate ceiling effects; and (3) that the PROMIS physical function computer adaptive test (PF CAT) would demonstrate a low question burden compared with other PRO instruments.Study Design:Cohort study (diagnosis); Level of evidence, 2.Methods:A total of 76 patients undergoing UCL repair/reconstruction, distal biceps tendon repair, or elbow arthroscopic surgery filled out the Short Form–36 Health Survey (SF-36) Physical Function subscale, EuroQol–5 Dimensions (EQ-5D) questionnaire, PROMIS PF CAT, and PROMIS upper extremity item bank (UE). Excellent correlation between PROs was defined as ≥.70.Results:The PROMIS PF CAT had excellent correlation with the SF-36 (r = 0.74; P < .0001), Disabilities of the Arm, Shoulder and Hand (DASH) survey (r = –0.76; P < .0001), and PROMIS UE (r = 0.73; P < .0001). The PROMIS UE demonstrated excellent correlation with the SF-36 (r = 0.73; P < .0001) and DASH survey (r = –0.81; P < .0001). The PROMIS UE had ceiling effects in 33% of patients. The SF-36 showed ceiling effects in 20% of patients. On average, patients answered 5.1 ± 2.2 questions on the PROMIS PF CAT.Conclusion:The PROMIS PF CAT and PROMIS UE are valid in patients undergoing distal biceps tendon repair, elbow arthroscopic surgery, and UCL repair. The PROMIS UE demonstrated high ceiling effects in younger, higher functioning patients and should be used with caution in this group. A further evaluation and modification of the PROMIS UE in younger, high-functioning patients are warranted. Finally, the PROMIS PF CAT exhibited a low question burden relative to traditional PRO instruments without the loss of reliability.

Patient-Reported Outcomes Measurement Information System physical function and pain interference in spine surgery.

The Patient-Reported Outcomes Measurement Information System (PROMIS) is an adaptive, self-reported outcomes assessment tool that utilizes item response theory and computer adaptive testing to efficiently and precisely evaluate symptoms and perceived health status. Efforts to implement and report PROMIS outcomes in spine clinical practice remain limited. The objective of this retrospective cohort study is to evaluate the performance and psychometric properties of PROMIS physical function (PF) and pain interference (PI) among patients undergoing spine surgery. The authors identified all patients who underwent spine surgery at their institution between 2016 and 2018, and for whom there was retrievable PROMIS data. Descriptive statistics were calculated to summarize demographics, operative characteristics, and patient-reported outcomes. Assessments were evaluated preoperatively, and postoperatively within 2 months (early), 6 months (intermediate), and up to 2 years (late). Pairwise change scores were calculated to evaluate within-subjects differences and construct responsiveness over time. Pearson's correlation coefficients were used to evaluate the association between PROMIS PF and PI domains. Subgroup analysis was performed based on the primary diagnoses of cervical radiculopathy, cervical myelopathy, or lumbar degenerative disease. A total of 2770 patients (1395 males, 50.4%) were included in the analysis. The mean age at the time of surgery was 57.3 ± 14.4 years. Mean postoperative follow-up duration was 7.6 ± 6.2 months. Preoperatively, patients scored an average 15.1 ± 7.4 points below the normative population (mean 50 ± 10 points) in PF, and 15.8 ± 6.8 points above the mean in PI. PROMIS PF required a mean of 4.1 ± 0.6 questions and median 40 seconds (interquartile range [IQR] 29-58 seconds) to be completed, which was similar to PI (median 4.3 ± 1.1 questions and 38 seconds [IQR 27-59 seconds]). Patients experienced clinically meaningful improvements in PF and PI, which were sustained throughout the postoperative course. PROMIS instruments were able to capture anticipated changes in PF and PI, although to a lesser degree in PF early postoperatively. There was a strong negative correlation between PROMIS PF and PI scores at baseline (Pearson's r = -0.72) and during follow-up appointments (early, intermediate, and late |r| > 0.6, each). Subgroup analysis demonstrated similar results within diagnostic groups compared to the overall cohort. However, the burden of PF limitations and PI was greater within the lumbar spine disease subgroup, compared to patients with cervical radiculopathy and myelopathy. Patients receiving care at a tertiary spine surgery outpatient clinic experience significant overall disability and PI, as measured by PROMIS PF and PI computer adaptive tests. PROMIS PF and PI health domains are strongly correlated, responsive to changes over time, and facilitate time-efficient evaluations of perceived health status outcomes in patients undergoing spine surgery.

Comparison of the Michigan Hand Outcomes Questionnaire, Boston Carpal Tunnel Questionnaire, and PROMIS Instruments in Carpal Tunnel Syndrome

Patient-reported outcomes are important to assess improvement after surgery. Commoninstruments for carpal tunnel syndrome include the Michigan Hand Outcomes Questionnaire (MHQ) and Boston Carpal Tunnel Questionnaire (CTQ). The Patient-Reported Outcomes Measurement Information System (PROMIS) are newer measures. We evaluated how the PROMIS Pain Interference (PI) and Upper Extremity (UE) scores change after carpal tunnel release. All adult patients with carpal tunnel syndrome treated surgically were asked to participate in this prospective study. PROMIS instruments, MHQ, and CTQ were completed by 101 patients. Estimated means and standard errors were calculated, and piecewise linear fixed effects regression models were applied to the data. Standardized response means were calculated for each outcome measure. The MHQ Total Score did not show a considerable change from the preoperative to 1-week postoperative visit but improved from the 1-week to 3-month postoperative visit (55 to 80). The CTQ Functional Status Score (FSS) worsened from 2.3 preoperatively to 2.6 at the 1-week postoperative visit before improving through the 3-month postoperative visit (1.6). PROMIS UE showed responsiveness similar to the CTQ FSS with a decline at the 1-week visit, 38 to 33, followed by improvement (45 at 3 mo). However, the standardized response mean values were greater for the CTQ FSS compared with PROMIS UE. The average administration time was shortest for PROMIS UE. The CTQ Symptom Severity Scale and MHQ Pain Scores showed improvements as early as the 1-week visit. The CTQ Symptom Severity Scale improved from 3.1 to 2.3, and MHQ Pain Scores improved from 55 to 46. PROMIS PI did not change at the 1-week visit but improved at 6 weeks and 3 months, from 56 to 52 and 49. The standardized response means for PROMIS PI achieved a large effect size only at 3 months. The CTQ FSS is more responsive than PROMIS UE and the MHQ, with the CTQ FSS showing the largest effect sizes. PROMIS PI does not show the responsiveness seen in the CTQ Symptom Severity Scale and MHQ Pain Score. PROMIS instruments require less time to complete. This study demonstrates the change in PROMIS scores after carpal tunnel release and how they compare with legacy outcome instruments.

Can Routine Use of Patient-Reported Outcomes Help Guide Systemic Sclerosis Chronic Disease Care?

Background The implementation of patient reported outcome measures (PROMs) is increasingly recognized as a critical aspect of clinical practice. The use of PROMs is particularly important in patients with complex, chronic medical disease that have heterogeneous, subjective symptoms. In this report, we examine the association of traditional markers of disease severity in the systemic sclerosis (SSc) patient population with PROMs that focus on mental health and physical function. Methods SSc patients seen in the University of Utah Chronic Disease Clinic were offered a personal health assessment that included a current health visual analog scale (VAS), PROMs that assessed mental health [Patient-Reported Outcomes Measurement Information System (PROMIS) Bank v1.0 depression], and physical function (PROMIS Bank v1.2 physical function). All PROMIS instruments are normed such that an average person has a score of 50. The assessment was administered on a tablet while patients waited to see the physician(s) for SSc care visits and uploaded in real-time to the electronic medical record for physician review. Results During a six-month period, 137 unique SSc patients began a PROM assessment. All 137 patients completed the VAS and PROMIS physical function; 133 completed the PROMIS depression scales. Overall, scores were 53.1 and 43.2 for depression and physical function, respectively. Relatively mild patients without end-organ damage or disease activity due to SSc did not have significant differences in perceived reduction in general health, physical function, or depression when compared to SSc patients with digital ulcerations, interstitial lung disease, pulmonary arterial hypertension, inflammatory arthritis, inflammatory myositis, or joint contractures. Conclusions Patients with chronic disease report depression and physical health scores that are independent of traditional physician-perceived disease activity or damage. Disease burden associates with the presence of a chronic disease, but is independent of severity. Assessment of PROMs provides an additional perspective on health status for chronic disease care.

First use of patient reported outcomes measurement information system (PROMIS) measures in adults with neurofibromatosis.

The patient reported outcomes measurement information system (PROMIS) provides clinicians and researchers access to reliable, validated measures of physical, mental, and social well-being. The use of PROMIS can facilitate comparisons among clinical subpopulations and with the U.S. general population. We report on the first study using PROMIS measures in patients with neurofibromatosis (NF). Eighty-six adult patients (mean age = 44; 55% female; 87% white; 50% NF1, 41% NF2 and 9% schwannomatosis) completed a battery of PROMIS computerized adaptive tests (CATs). Across all PROMIS instruments, mean scores for each CAT were between 48.97 and 52.60, which is within ±0.5 SD of the U.S. general population norms. However, scores were distributed across a broad range for each PROMIS measure (±3 SDs). Clinically meaningful scores (defined >1 SD impairment) were observed in 20% (pain interference), 17% (pain behavior), 16% (physical function), 16% (anxiety), 16% (depression), 15% (satisfaction with social roles), 13% (fatigue), 6% (anger), and 5% (satisfaction with discretionary social activities) of the sample. All PROMIS measures were highly interrelated in bivariate analysis (P ≤ .001). There were no differences in PROMIS scores by disease type (NF1, NF2 and schwannomatosis), or self reported learning disabilities, or compared with the US population. Scores suggest a broad continuum of symptoms and functioning in patients with NF that is not affected by NF type, as well as interrelation among the physical and psychosocial domains as measured by PROMIS. PROMIS measures may be useful in clinical practice to monitor changes in symptoms and functioning over time, as well as in clinical trials to determine patient reported changes during drug and psychosocial clinical trials.

Demographic correlates of fatigue in the US general population: Results from the patient-reported outcomes measurement information system (PROMIS) initiative

ObjectiveTo investigate demographic correlates of fatigue in the US general population using a new instrument developed by the Patient-Reported Outcome Measurement Information System (PROMIS). First, we examined correlations between the new PROMIS instrument and the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) and the SF-36v2 Vitality subscale. Based on prior findings, we further examined several demographic correlates of fatigue: whether women would report higher levels of fatigue compared to men, and whether married people would experience lower levels of fatigue compared to unmarried people. We also explored the relationship between age, education, and fatigue. MethodsAnalyses were based on fatigue ratings by 666 individuals from the general population. Fatigue was assessed with the new PROMIS instrument, the FACIT-F, and the SF-36v2 Vitality subscale. Differences in fatigue were examined with independent samples t-tests and univariate ANOVAs. ResultsThe three fatigue instruments were highly intercorrelated. Confirming prior reports, women reported higher levels of fatigue than men. Married participants reported significantly less fatigue than their unmarried counterparts. Univariate ANOVAs yielded a main effect for participants' age; younger participants gave significantly higher fatigue ratings. We also found a main effect for participants' education. Participants with a masters or doctoral degree had significantly lower ratings of fatigue than participants with some college education and education up to high school. ConclusionFemale gender, not being married, younger age and lower educational attainment were each associated with increased fatigue in the general population and the three fatigue instruments performed equally well in detecting the observed associations.