Patient-Reported Outcomes Measurement Information System Item Research Articles

Abstract 10892: Cross-Cultural Validation and Psychometric Testing of the Heart Failure Somatic Perception Scale in Japan

Background: The assessment of symptoms experienced by patients with heart failure (HF) has important contextual implications for self-care and allows for early recognition of signs of worsening HF. The Heart Failure Somatic Perception Scale (HFSPS) is a measurement tool developed in the U.S. to assess symptoms experienced by patients with HF, but it is expected to be applicable to patients in countries with different cultural backgrounds. Objectives: To evaluate the psychometric properties (validity and reliability) of the HFSPS in Japanese HF patients. Methods: This study assessed the factor structure of the HFSPS using confirmatory factor analysis in 320 HF outpatients in Japan. Criterion-related validity of the HFSPS was evaluated by correlating its factor scores with Patient-Reported Outcomes Measurement Information System (PROMIS) scores using Pearson's correlation coefficient. Internal consistency reliability of the HFSPS was evaluated using the factor score coefficient of determination, Cronbach's alpha, and the model-based internal consistency index. Results: The sample (n=320) was 72% male, mean age 72.9±12.8 years. Confirmatory factor analysis examining the four-factor structure of the HFSPS (dyspnea, chest discomfort, early and subtle, and edema), resulted in resulted in the following fit indices: χ2= (129, N=310), P<0.001, comparative fit index =0.825, Tucker-Lewis index =0.793, root mean square error of approximation =0.131. For criterion-related validity, all domains of the PROMIS items (physical health, mental health, global health, and social role satisfaction) were negatively correlated (-0.07 to -0.37) and statistically significant indicating higher symptom burden was associated with worse global health. HFSPS reliability resulted in Cronbach's alpha 0.878 for dyspnea, 0.607 for chest discomfort, 0.772 for early and subtle, 0.777 for edema, and 0.921 for the entire scale. Conclusion: This study suggests the HFSPS is a reliable and valid tool among Japanese with HF. Using this scale will provide accurate assessment of symptoms experienced by HF patients in research testing educational interventions to improve HF symptom recognition and response.

Psychometrics of three Swedish physical pediatric item banks from the Patient-Reported Outcomes Measurement Information System (PROMIS)\xae: pain interference, fatigue, and physical activity

BackgroundThe Patient-Reported Outcomes Measurement Information System (PROMIS®) aims to provide self-reported item banks for several dimensions of physical, mental and social health. Here we investigate the psychometric properties of the Swedish pediatric versions of the Physical Health item banks for pain interference, fatigue and physical activity which can be used in school health care and other clinical pediatric settings. Physical health has been shown to be more important for teenagers’ well-being than ever because of the link to several somatic and mental conditions. The item banks are not yet available in Sweden.Methods12- to 19-year-old participants (n = 681) were recruited in public school settings, and at a child- and psychiatric outpatient clinic. Three one-factor models using CFA were performed to evaluate scale dimensionality. We analyzed monotonicity and local independence. The items were calibrated by fitting the graded response model. Differential Item analyses (DIF) for age, gender and language were calculated.ResultsAs part of the three one-factor models, we found support that each item bank measures a unidimensional construct. No monotonicity or local dependence were found. We found that 11 items had significant lack of fit in the item response theory (IRT) analyses. The result also showed DIF for age (seven items) and language (nine items). However, the differences on item fits and effect sizes of McFadden were negligible. After considering the analytic results, graphical illustration, item content and clinical relevance we decided to keep all items in the item banks.ConclusionsWe translated and validated the U.S. PROMIS item banks pain interference, fatigue and physical activity into Swedish by applying CFA, IRT and DIF analyses. The results suggest adequacy of the translations in terms of their psychometrics. The questionnaires can be used in school health and other pediatric care. Future studies can be to use Computerized Adaptive Testing (CAT), which provide fewer but reliable items to the test person compared to classical testing.

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.

Abstract OT3-19-02: Introducing an electronic platform to collect patient reported outcomes in the I-SPY 2 trial, a neoadjuvant clinical trial

Abstract Background: While the side effects of anthracycline and taxane based chemotherapy are well characterized, introduction of experimental agents and immunotherapy in the neoadjuvant and adjuvant setting may significantly alter the toxicity profiles of these regimens, resulting in short and long-term changes in patient quality of life (QOL). Trial Design: I-SPY 2 is a phase 2 trial investigating novel targeted therapies and immunotherapy in combination with standard chemotherapy in the neoadjuvant setting for Mammaprint high-risk stage 2 and 3 breast cancers. A QOL sub-study was introduced into the I-SPY 2 trial platform in 2012. All patients who consent to screen for the I-SPY 2 trial receive a baseline QOL questionnaire. Patients who consent to the treatment phase of I-SPY 2 also complete questionnaires on the first day of treatment, mid-way through neoadjuvant treatment, prior to surgery, and then 1, 6, 12 and 24 months post-surgery. Instruments have included the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC) QLQ C30 and BR23, as well as NCI Patient-Reported Outcomes Measurement Information System (PROMIS) measures, the National Comprehensive Cancer Network (NCCN) Distress Thermometer, and a Fear of Recurrence (FOR) instrument. We are currently implementing an electronic platform for survey collection and modifying the survey instruments to incorporate 31 items from the Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) measurement system along with previously included PROMIS items in domains of physical, psychological, cognitive, and sexual function, the Distress Thermometer, and the FOR instrument. During neoadjuvant treatment, patients will also complete weekly abbreviated surveys containing PRO-CTCAE items only. We are using the data from these measures to generate a Clinical Benefit Index (CBI), a single composite score that integrates a PROMIS Preference (PROPr) score with a clinical efficacy assessment (residual cancer burden- RCB index) to provide new insight into the overall impact that therapeutic agents in I-SPY2 have on cancer recurrence risk, general health, and QOL. Specific Aims: The primary objective of the QOL study is to evaluate the short- and long-term impact on QOL of novel agents added to standard treatment in high-risk breast cancer patients receiving neoadjuvant therapy. Factors including patient age, hormone receptor and HER2 status, and response to treatment by residual cancer burden will be evaluated to understand their impact on a patients’ QOL trajectory over time. A secondary objective is to compare patient reported toxicities (using PRO-CTCAE measures) with clinician-reported adverse events. Accrual: The I-SPY 2 trial has registered 2729 patients to date and there are 18 sites open across the US. Since the initiation of the QOL study, at least one QOL survey has been collected from 1066 patients. Given the adaptive design, enrollment for each agent varies based on patient outcomes, but collection of PRO measures on all patients will continue as new agents enter the trial. Clinical trial information: NCT01042379. Citation Format: Hila Ghersin, Aheli Chattopadhyay, Anne Blaes, Tara Sanft, Dawn Hershman, Amrita Basu, Ruby Singhrao, Susie Brain, Diane Heditsian, Hope S Rugo, Laura Esserman, Michelle Melisko. Introducing an electronic platform to collect patient reported outcomes in the I-SPY 2 trial, a neoadjuvant clinical trial [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr OT3-19-02.

P041 DEVELOPMENT OF PROMIS PEDIATRIC PATIENT-REPORTED OUTCOME SHORT FORMS FOR FATIGUE AND PAIN INTERFERENCE IN CHILDREN WITH CROHN’S DISEASE

Abstract Introduction There is a need for reliable, valid patient-reported outcome (PRO) measures to assess the health and quality of life in pediatric Crohn’s disease (PCD). The development of PROs for this population may be facilitated by using Patient-Reported Outcomes Measurement Information System (PROMIS) item banks, which were developed using rigorous psychometric methods. We aimed to develop disease-specific PROMIS short forms by conducting qualitative research to identify the items that are most relevant to children with PCD. Methods Participants in an initial card sorting study included 42 children with CD (ages 8–17), 70 parents of children with CD, and 26 clinicians with expertise in CD. Using an online program, participants rated the importance of PROMIS items for pediatric CD patients. This exercise indicated that children, parents, and clinicians endorse Fatigue and Pain Interference items as important for PCD. In a separate study, trained research coordinators conducted one-on-one semi-structured interviews with 37 children with CD to further explore their experiences with fatigue and pain. Research coordinators also conducted one-on-one cognitive interviews with 14 children with CD. Each participant completed a questionnaire and then was interviewed about the reasoning for their answers. All interviews were transcribed and coded for meaning units, defined as conceptually distinct statements in the words of the participant. Results In semi-structured interviews, highly reported facets of fatigue and its impact included feelings of tiredness, friendships, and sports/exercise. Highly reported facets of pain and its impact included feelings of hurt, friendships, family, attention, and sports/exercise. Participants’ responses revealed the same breadth and types of lived experiences of fatigue and pain as children from the development samples drawn from the general population. Ratings of children’s reasoning and logic in cognitive interviews showed strong understanding of PROMIS items. Final item selection for the PCD-specific PROMIS short forms involved consideration of the concepts that participants identified as important, item understandability, psychometric evaluation of precision and coverage, and balance across different facets of each domain. Conclusions Results support the content validity and comprehensibility of PROMIS Pediatric Fatigue and Pain Interference measures in PCD. This work contributed to the development of 8-item short forms that are tailored to assess the lived experiences of fatigue and pain interference in PCD.

Content validity of the National Comprehensive Cancer Network \u2013 Functional Assessment of Cancer Therapy \u2013 Breast Cancer Symptom Index (NFBSI-16) and Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form with advanced breast cancer patients

BackgroundThe purpose of this study is to evaluate the content validity of the National Comprehensive Cancer Network – Functional Assessment of Cancer Therapy – Breast Cancer Symptom Index (NFBSI-16) and the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 10b among patients with hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer.MethodsCognitive debriefing interviews sought to evaluate patients’ ability to read, understand, and meaningfully respond to the questionnaires, as well as to evaluate the questionnaires’ relevance in the target patient population. Interviews were conducted by telephone and lasted approximately 90 min. Audio recordings were transcribed, anonymized, and analyzed using qualitative data analysis software.ResultsFifteen cognitive debriefing interviews were conducted with women (mean age 66.0 years [standard deviation = 12.4]). Patients reported metastases in the bone (86.7%), liver (20.0%), lung (13.3%), skin (6.7%), and lymph node (6.7%) (not mutually exclusive). All patients for whom data were available demonstrated understanding of the instructions and the recall period of the NFBSI-16 (n = 14/14, 100.0%) and the PROMIS (n = 14/14, 100.0%). Greater than 90% of patients demonstrated understanding of each of the items in the NFBSI-16 and the PROMIS. Greater than 70% of patients demonstrated understanding of the response options of the NFBSI-16, > 90% understood response options of PROMIS Items 1–6, and ≥ 50% understood response options of PROMIS Items 7–10. Conceptual relevance was supported for most items in both questionnaires based on patients’ reports of experiencing the concepts as part of their breast cancer experience.ConclusionsThe results of the cognitive debriefing interviews provide evidence that the NFBSI-16 and PROMIS Physical Function Short Form 10b have content validity in the HR+/HER2- advanced breast cancer patient population. Patients may benefit from additional instructions at the point the response options reverse direction in the PROMIS.

Abstract 101: The Development and Initial Validation of PROMIS-Plus-HF Profile Measure

Background: Bringing together generic and heart failure (HF)-specific items in a publicly-available, patient-reported outcome measure may facilitate better health status comparisons across groups and within individuals longitudinally in learning health systems and clinical research studies. Methods and Results: We performed a mixed-methods study to develop and validate the PROMIS ® -Plus-HF profile measure, a HF-specific instrument based on the generic The Patient-Reported Outcomes Measurement Information System (PROMIS). We conducted eight focus groups with 61 HF patients and phone interviews with 10 HF clinicians. The measure was developed via an iterative process of reviewing existing PROMIS items and developing and testing new HF items. In 600-patient sample, we estimated reliability (internal consistency; test-retest, with n=100 participants). We conducted validity analyses using Pearson r and Spearman rho correlations with Kansas City Cardiomyopathy Questionnaire (KCCQ) subscores. In a longitudinal sample, we performed responsiveness testing (paired t-tests) with 75 HF patients receiving interventions with expected health status improvement. The PROMIS-Plus-HF measure comprises 86 items (64 existing; 22 new) across 18 domains. Internal consistency reliability (Cronbach’s alpha) coefficients ranged from 0.52-0.96, with alpha≥0.70 in 12/17 domains. Test-retest intraclass correlation coefficients were ≥0.90. Correlations with KCCQ subscores supported expected convergent ( r/rho &gt;0.60) and divergent validity ( r/rho &lt;0.30). In the longitudinal sample, 10/18 domains had improved (P&lt;0.05) scores from baseline to follow-up. Conclusions: The PROMIS-Plus-HF profile measure—a complete assessment of physical, mental, and social health—exhibited good psychometric characteristics and may facilitate patient-centered care and research. Subsets of domains, or the entire measure, can be used, depending on the clinical or research purpose.

Validation of two PROMIS item banks for measuring social participation in the Dutch general population

BackgroundThe Patient-Reported Outcomes Measurement Information System (PROMIS) item banks ‘Ability to Participate in Social Roles and Activities’ (35 items) and ‘Satisfaction with Social Roles and Activities’ (44 items) were developed to measure (satisfaction with) participation more efficiently and precisely than current instruments, by using Computerized Adaptive Testing (CAT). We validated these item banks in a Dutch general population.MethodsParticipants in an internet panel completed both item banks. Unidimensionality, local dependence, monotonicity, Graded Response Model item fit, Differential Item Functioning (DIF) for age, gender, education, region, ethnicity, and language (Dutch compared to US Social Supplement), and reliability were assessed.ResultsA representative Dutch sample of 1002 people participated. We found for the Ability to Participate and Satisfaction with Participation item banks, respectively, sufficient unidimensionality (CFI: 0.971, 0.960; TLI: 0.970, 0.958; RMSEA: 0.108, 0.108), no local dependence, sufficient monotonicity (H: 0.75, 0.73), good item fit (2 out of 35 items, 1 out of 44 items with S-X2p-value < 0.001). No DIF was found. We found a reliability of at least 0.90 with simulated CATs in 86% and 94% of the participants with on average 4.7 (range 2–12) and 4.3 (range 3–12) items, respectively.DiscussionThe PROMIS participation item banks showed sufficient psychometric properties in a general Dutch population and can be used as CAT. PROMIS CATs allow reliable and valid measurement of participation in an efficient and user-friendly way with limited administration time.

Use of Cognitive Interviews to Adapt PROMIS Measurement Items for Spanish Speakers Living with HIV.

Purpose. To use cognitive interviewing techniques to assess comprehension of existing Patient-Reported Outcomes Measurement Information System (PROMIS) items among Latinos living with HIV and then refine items based on participant feedback. Methods. Latino monolingual Spanish speakers living with HIV (n = 56) participated in cognitive interviews. Items from four PROMIS domains, including depression, anxiety, fatigue, and alcohol use, were assessed for comprehension. Audiotaped interviews and handwritten notes were subjected to content analysis to identify problems specific to each instrument for each domain. Results. The assessments from the cognitive interviews identified areas for improvement in each domain. We present data on the type of items that were difficult to comprehend and provide examples for how items were refined based on participants' and PROMIS Statistical Coordinating Center (PSCC) feedback. Six out of 48 depression items, 7 out of the 61 anxiety items, 18 out of 42 fatigue items, and 7 out of 44 alcohol use items were found to have poor comprehension. These items were refined based on participant feedback; the items were then submitted to the PSCC for additional guidance on linguistics and grammar to improve comprehension. Conclusions. Cognitive interviews may be used to enhance comprehension of PROMIS items among Latinos.

Measuring anxiety after spinal cord injury: Development and psychometric characteristics of the SCI-QOL Anxiety item bank and linkage with GAD-7

ObjectiveTo develop a calibrated item bank and computer adaptive test to assess anxiety symptoms in individuals with spinal cord injury (SCI), transform scores to the Patient Reported Outcomes Measurement Information System (PROMIS) metric, and create a statistical linkage with the Generalized Anxiety Disorder (GAD)-7, a widely used anxiety measure.DesignGrounded-theory based qualitative item development methods; large-scale item calibration field testing; confirmatory factor analysis; graded response model item response theory analyses; statistical linking techniques to transform scores to a PROMIS metric; and linkage with the GAD-7.SettingFive SCI Model System centers and one Department of Veterans Affairs medical center in the United States.ParticipantsAdults with traumatic SCI.Main Outcome MeasuresSpinal Cord Injury-Quality of Life (SCI-QOL) Anxiety Item BankResultsSeven hundred sixteen individuals with traumatic SCI completed 38 items assessing anxiety, 17 of which were PROMIS items. After 13 items (including 2 PROMIS items) were removed, factor analyses confirmed unidimensionality. Item response theory analyses were used to estimate slopes and thresholds for the final 25 items (15 from PROMIS). The observed Pearson correlation between the SCI-QOL Anxiety and GAD-7 scores was 0.67.ConclusionsThe SCI-QOL Anxiety item bank demonstrates excellent psychometric properties and is available as a computer adaptive test or short form for research and clinical applications. SCI-QOL Anxiety scores have been transformed to the PROMIS metric and we provide a method to link SCI-QOL Anxiety scores with those of the GAD-7.

Measuring depression after spinal cord injury: Development and psychometric characteristics of the SCI-QOL Depression item bank and linkage with PHQ-9

ObjectiveTo develop a calibrated spinal cord injury-quality of life (SCI-QOL) item bank, computer adaptive test (CAT), and short form to assess depressive symptoms experienced by individuals with SCI, transform scores to the Patient Reported Outcomes Measurement Information System (PROMIS) metric, and create a crosswalk to the Patient Health Questionnaire (PHQ)-9.DesignWe used grounded-theory based qualitative item development methods, large-scale item calibration field testing, confirmatory factor analysis, item response theory (IRT) analyses, and statistical linking techniques to transform scores to a PROMIS metric and to provide a crosswalk with the PHQ-9.SettingFive SCI Model System centers and one Department of Veterans Affairs medical center in the United States.ParticipantsAdults with traumatic SCI.Main Outcome MeasuresSpinal Cord Injury – Quality of Life (SCI-QOL) Depression Item BankResultsIndividuals with SCI were involved in all phases of SCI-QOL development. A sample of 716 individuals with traumatic SCI completed 35 items assessing depression, 18 of which were PROMIS items. After removing 7 non-PROMIS items, factor analyses confirmed a unidimensional pool of items. We used a graded response IRT model to estimate slopes and thresholds for the 28 retained items. The SCI-QOL Depression measure correlated 0.76 with the PHQ-9.ConclusionsThe SCI-QOL Depression item bank provides a reliable and sensitive measure of depressive symptoms with scores reported in terms of general population norms. We provide a crosswalk to the PHQ-9 to facilitate comparisons between measures. The item bank may be administered as a CAT or as a short form and is suitable for research and clinical applications.

Pain Assessment: A Practical Guide for Researchers and Clinicians

Pain is one of the most universal experiences of humankind, affecting all populations across the globe. In the United States over 100 million individuals are reported to be suffering with chronic pain (Institute of Medicine in Relieving pain in America: a blueprint for transforming prevention, care, education and research, The National Academies Press, Washington, 2011) and approximately 80 % of all medical visits stem directly from pain complaints (Quartana et al. in Expert Rev Neurother 9:745–758, 2009). This paper discusses a recent movement toward standardization of the pain assessment process to improve the quality of patient reported outcomes in clinical trials through the work of the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) workgroup and the National Institutes of Health Patient-Reported Outcomes Measurement Information System (PROMIS) Roadmap Initiative. We review pain assessment from the framework of the recommendations of IMMPACT including the key assessment domains and the specific instruments recommended for use. We also review the PROMIS item banks and their usefulness in fulfilling the spirit of the IMMPACT recommendations. Finally, we discuss important assessment domains that could be a part of all comprehensive pain assessments that were not addressed by IMMPACT or PROMIS and make recommendations for adoption for clinical practice.

U.S. General Population Estimate for "Excellent" to "Poor" Self-Rated Health Item.

The most commonly used self-reported health question asks people to rate their general health from excellent to poor. This is one of the Patient-Reported Outcomes Measurement Information System (PROMIS) global health items. Four other items are used for scoring on the PROMIS global physical health scale. Because the single item is used on the majority of large national health surveys in the U.S., it is useful to construct scores that can be compared to U.S. general population norms. To estimate the PROMIS global physical health scale score from the responses to the single excellent to poor self-rated health question for use in public health surveillance, research, and clinical assessment. A cross-sectional survey of 21,133 individuals, weighted to be representative of the U.S. general population. The PROMIS items were administered via a Web-based survey to 19,601 persons in a national panel and 1,532 subjects from PROMIS research sites. The average age of individuals in the sample was 53 years, 52 % were female, 80 % were non-Hispanic white, and 19 % had a high school degree or lower level of education. PROMIS global physical health scale. The product-moment correlation of the single item with the PROMIS global physical health scale score was 0.81. The estimated scale score based on responses to the single item ranged from 29 (poor self-rated health, 2.1 SDs worse than the general population mean) to 62 (excellent self-rated health, 1.2 SDs better than the general population mean) on a T-score metric (mean of 50). This item can be used to estimate scores for the PROMIS global physical health scale for use in monitoring population health and achieving public health objectives. The item may also be used for individual assessment, but its reliability (0.52) is lower than that of the PROMIS global health scale (0.81).

Dutch-Flemish translation of nine pediatric item banks from the Patient-Reported Outcomes Measurement Information System (PROMIS)®.

PurposeThe Patient-Reported Outcomes Measurement Information System (PROMIS®) is a new, state-of-the-art assessment system for measuring patient-reported health and well-being of adults and children. It has the potential to be more valid, reliable, and responsive than existing PROMs. The items banks are designed to be self-reported and completed by children aged 8–18 years. The PROMIS items can be administered in short forms or through computerized adaptive testing. This paper describes the translation and cultural adaption of nine PROMIS item banks (151 items) for children in Dutch–Flemish.MethodsThe translation was performed by FACITtrans using standardized PROMIS methodology and approved by the PROMIS Statistical Center. The translation included four forward translations, two back-translations, three independent reviews (at least two Dutch, one Flemish), and pretesting in 24 children from the Netherlands and Flanders.ResultsFor some items, it was necessary to have separate translations for Dutch and Flemish: physical function—mobility (three items), anger (one item), pain interference (two items), and asthma impact (one item). Challenges faced in the translation process included scarcity or overabundance of possible translations, unclear item descriptions, constructs broader/smaller in the target language, difficulties in rank ordering items, differences in unit of measurement, irrelevant items, or differences in performance of activities. By addressing these challenges, acceptable translations were obtained for all items.ConclusionThe Dutch–Flemish PROMIS items are linguistically equivalent to the original USA version. Short forms are now available for use, and entire item banks are ready for cross-cultural validation in the Netherlands and Flanders.