scholarly journals Qualitative and psychometric approaches to evaluate the PROMIS pain interference and sleep disturbance item banks for use in patients with rheumatoid arthritis

2021 ◽  
Vol 5 (1) ◽  
Author(s):  
Brandon Becker ◽  
Kimberly Raymond ◽  
Carol Hawkes ◽  
April Mitchell Foster ◽  
Andrew Lovley ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Sleep Disturbance ◽  
Content Validity ◽  
Sleep Disturbances ◽  
Measurement Precision ◽  
Pain Interference ◽  
Concept Elicitation ◽  
Short Forms ◽  
Item Banks ◽  
Patient Reported

Abstract Background Patients with rheumatoid arthritis (RA) commonly experience pain despite the availability of disease-modifying treatments. Sleep disturbances are frequently reported in RA, with pain often a contributing factor. The Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference and Sleep Disturbance item banks were initially developed to provide insights into the patient experience of pain and sleep, respectively, though they were not specifically intended for use in RA populations. This study evaluated the content validity of the PROMIS Pain Interference and Sleep Disturbance item banks in RA and identified relevant content for short forms for patients with RA that achieved high measurement precision across a broad range of health. Methods A qualitative approach consisting of hybrid concept elicitation and cognitive debriefing interviews was used to evaluate the content validity of the item banks in RA. Interviews were semi-structured and open-ended, allowing a range of concepts and responses to be captured. Findings from the qualitative interviews were used to select the most relevant items for the short forms, and psychometric evaluation, using existing item-response theory (IRT) item parameters, was used to evaluate the marginal reliability and measurement precision of the short forms across the range of the latent variables (i.e. pain interference and sleep disturbance). Results Thirty-two participants were interviewed. Participants reported that RA-related pain and sleep disturbances have substantial impacts on their daily lives, particularly with physical functioning. The PROMIS Pain Interference and Sleep Disturbance item banks were easy to understand and mostly relevant to their RA experiences, and the 7-day recall period was deemed appropriate. Qualitative and IRT-based approaches identified short forms for Pain Interference (11 items) and Sleep Disturbance (7 items) that had high relevance and measurement precision, with good coverage of the concepts identified by participants during concept elicitation. Conclusion Pain and sleep disturbances affect many aspects of daily life in patients with RA and should be considered when novel treatments are developed. This study supports the use of the PROMIS Pain Interference and Sleep Disturbance item banks in RA, and the short forms developed herein have the potential to be used in clinical studies of RA.

scholarly journals Measurement properties of the Dutch–Flemish patient-reported outcomes measurement information system (PROMIS) physical function item bank and instruments: a systematic review

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Inger L. Abma ◽  
Bas J. D. Butje ◽  
Peter M. ten Klooster ◽  
Philip J. van der Wees
Keyword(s):  
Patient Reported Outcomes ◽  
Measurement Precision ◽  
Item Bank ◽  
Measurement Properties ◽  
Structural Validity ◽  
Short Forms ◽  
Item Banks ◽  
High Quality Evidence ◽  
Patient Reported

Abstract Background Limitations in physical functioning are a big concern especially for patients with chronic or musculoskeletal diseases. Therefore, physical functioning is often used as a core outcome of treatments. The generic patient-reported outcomes information system (PROMIS) physical function (PF) item bank has shown potential to measure PF with better precision, interpretability and lower respondent burden compared with traditional patient-reported outcome measures. This study provides an overview of the current evidence on the quality of the measurement properties of the translated Dutch–Flemish PROMIS-PF item bank and its subdomains, and their derived short forms and computer adaptive tests (CATs). Methods PubMed was searched up to June 17th 2020 for validation studies of Dutch–Flemish PROMIS-PF in Dutch and Flemish adults. Quality assessment of the included studies was conducted using the COSMIN Risk of bias checklist. The COSMIN criteria for good measurement properties were used to judge the results of the studies, which were adjusted and added to where needed for this review, in the context of IRT instruments and item banks. The quality of evidence was summarized for each measurement property based on the Grading of Recommendation Assessment, Development, and Evaluation (GRADE) approach. Results Eleven studies were included, evaluating the PROMIS-PF item bank, the Upper Extremity (UE) subdomain, and/or their derived short forms and CATs in different clinical populations. There is evidence for sufficient structural validity, measurement precision, construct validity, and cross-cultural validity of the Dutch–Flemish PROMIS-PF item bank. The upper extremity subdomain item bank shows high quality evidence for structural validity and measurement precision. Content validity of these item banks has not been thoroughly demonstrated in a Dutch–Flemish population. Furthermore, the derived instruments have far less robust evidence: there are fewer validation studies available and none examined their performance as stand-alone administered instruments. Conclusions The first studies into the Dutch–Flemish PROMIS-PF item bank and the UE subdomain show promising results, with especially high quality evidence for sufficient structural validity and measurement precision. However, more studies, and with higher methodological quality, are needed to study the instruments derived from these item banks. These studies should also evaluate content validity, reliability and responsiveness.

scholarly journals Qualitative study: burden of menopause-associated vasomotor symptoms (VMS) and validation of PROMIS Sleep Disturbance and Sleep-Related Impairment measures for assessment of VMS impact on sleep

2021 ◽  
Vol 5 (1) ◽  
Author(s):  
Marci English ◽  
Boyka Stoykova ◽  
Christina Slota ◽  
Lynda Doward ◽  
Emad Siddiqui ◽  
...  
Keyword(s):  
Sleep Disturbance ◽  
Content Validity ◽  
Short Form ◽  
Work Productivity ◽  
The United States ◽  
Vasomotor Symptoms ◽  
Response Options ◽  
Short Forms ◽  
Patient Reported ◽  
The Impact

Abstract Purpose We evaluated the impact of menopause-associated vasomotor symptoms (VMS) on sleep. We also sought to establish the content validity of Patient-Reported Outcomes Measurement Information System (PROMIS) short form Sleep-Related Impairment and Sleep Disturbance measures in postmenopausal women with moderate to severe VMS. Methods Cross-sectional, in-person, qualitative interviews were conducted in the United States (Texas, Illinois) and European Union (UK, France) with women aged 40–64 years experiencing moderate to severe VMS (≥35/wk). Main outcomes were impact of VMS on sleep based on concept elicitation and content validity of PROMIS Sleep-Related Impairment and Sleep Disturbance short forms via cognitive debriefing. Results Thirty-two women (US: n = 16; EU: n = 16) participated. A majority (US: 93.8%; EU: 93.8%) said VMS affected sleep; specifically, they had sleep interrupted by sweating or overheating and had difficulty returning to sleep. Sleep disturbance was the most bothersome aspect of VMS (US: 75%; EU: 50%). VMS-associated sleep disturbance affected next-day work productivity, mood, relationships, daily activities, concentration, social activities, and physical health. Participants found both PROMIS sleep measures relevant and easy to answer; the Sleep Disturbance measure was considered the most relevant. Participants had no difficulty remembering their experiences over the 7-day recall period and found the response options to be distinct. Conclusion VMS associated with menopause significantly interferes with sleep and next-day functioning (e.g., work productivity), supporting assessment of sleep outcomes in studies evaluating treatment of VMS. Women with moderate to severe VMS found that the PROMIS Sleep-Related Impairment and Sleep Disturbance short forms assessed constructs important to understanding sleep in the context of menopause-associated VMS.

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

2020 ◽  
Vol 158 (3) ◽  
pp. S101-S102
Author(s):  
Julia Schuchard ◽  
Michael Kappelman ◽  
Andrew Grossman ◽  
Jennifer Clegg ◽  
Christopher Forrest
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Pediatric Patient ◽  
Patient Reported Outcome ◽  
Pain Interference ◽  
Short Forms ◽  
Patient Reported

scholarly journals Content validity of a sleep numerical rating scale and a sleep diary in adults and adolescents with moderate-to-severe atopic dermatitis

2020 ◽  
Vol 4 (1) ◽  
Author(s):  
Carla Dias-Barbosa ◽  
Rodolfo Matos ◽  
Margaret Vernon ◽  
Colleen E. Carney ◽  
Andrew Krystal ◽  
...  
Keyword(s):  
Atopic Dermatitis ◽  
Phase I ◽  
Sleep Disturbance ◽  
Content Validity ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Sleep Diary ◽  
Convenience Sample ◽  
Concept Elicitation ◽  
Numerical Rating

Abstract Background The intense itching associated with atopic dermatitis (AD) often causes patients to experience severe sleep disturbance. Here, we describe the results of a two-phase concept elicitation and cognitive interview study to establish the content validity of a sleep disturbance numerical rating scale (SD NRS) and a Consensus Sleep Diary adapted for adults and adolescents with moderate-to-severe AD (CSD-AD©). Results In phase I, a concept elicitation conducted in 20 adults and 10 adolescents with moderate-to-severe AD revealed that the following sleep-related issues were important and relevant: nighttime awakening (87%), trouble falling asleep (73%), feeling unrested (53%), daytime fatigue or sleepiness (53%), and feeling as if they did not get enough sleep (33%). The frequency and extent of sleep disturbance varied substantially from day to day due to varying degrees of itching and flares, medication use, and changes in the weather. All participants understood the SD NRS question, with most finding it easy or very easy to understand (100% of adults and 90% of adolescents) and most understanding the anchors as intended (95% of adults, and 100% of adolescents). Most participants (94% of adults, and 90% of adolescents) indicated that they would consider a one- or two-point change meaningful on the SD NRS. The CSD-AD© was revised based on participant feedback, and tested during phase II in a convenience sample of six adults and four adolescents from phase I. The changes made to the CSD-AD© were confirmed to be relevant and understandable. All patients were able to provide an answer to each item in the CSD-AD©, and most were able to estimate the duration of nighttime awakenings, daytime naps, and dozing. Conclusions The study supported the content validity of the SD NRS and CSD-AD© in adults and adolescents with moderate-to-severe AD. It also emphasized the importance of using these instruments daily when assessing the benefit of a new treatment on sleep quality in this population.

Sleep disturbance and quality of life in Rheumatoid Arthritis: a prospective mobile health study (Preprint)

2021 ◽  
Author(s):  
John McBeth ◽  
William G Dixon ◽  
Susan Mary Moore ◽  
Bruce Hellman ◽  
Ben James ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Rheumatoid Arthritis ◽  
Sleep Disturbance ◽  
Mobile Health ◽  
Sleep Disturbances ◽  
Total Sleep Time ◽  
Sleep Onset ◽  
Sleep Time ◽  
Domain Scores

BACKGROUND Sleep disturbance and poor health related quality of life (HRQoL) are common in people with rheumatoid arthritis (RA). Sleep disturbances, such as less total sleep time, more waking periods after sleep onset, and higher levels of non-restorative sleep, may be a driver of HRQoL. However, understanding if these sleep disturbances reduce HRQoL has, to date, been challenging due to the need to collect complex time-varying data in high resolution. Such data collection has now been made possible by the widespread availability and use of mobile health (mHealth) technologies. OBJECTIVE In a mobile health (mHealth) study we tested whether sleep disturbance (both absolute values and variability) caused poor HRQoL. METHODS The Quality of life, sleep and rheumatoid arthritis (QUASAR) study was a prospective mHealth study of adults with RA. Participants completed a baseline questionnaire, and for 30 days wore a triaxial accelerometer to objectively assess sleep, and provided daily reports via a smartphone app of sleep (Consensus Sleep Diary (CSD)), pain, fatigue, mood, and other symptoms. Participants completed the World Health Organization Quality of Life-Brief (WHOQoL-BREF) questionnaire every 10 days. Multi-level modelling tested the relationship between sleep variables and WHOQoL-BREF domains (physical, psychological, environment and social). RESULTS Of 268 recruited participants, 254 were included in this analysis. Across all WHOQoL-BREF domains, participant’s scores were lower than the population average. CSD sleep parameters predicted WHOQoL-BREF domain scores. For example, for each hour increase in the total time asleep physical domain scores increased by 1.11 points (β = 1.11 (0.07, 2.15)) and social domain scores increased by 1.65 points. These associations were not explained by sociodemographic and lifestyle factors, disease activity, medication use, levels of anxiety, sleep quality, or clinical sleep disorders. They were, however, attenuated and no longer significant when pain, fatigue and mood were included in the model. Increased variability in the total time asleep, was associated with poorer physical and psychological domain scores independently of all covariates. There were no patterns of association between actigraphy measured sleep and WHOQoL-BREF. CONCLUSIONS Optimising total sleep time, increasing sleep efficiency, decreasing sleep onset latency, and reducing the variability in total sleep time could improve HRQoL in people with RA.

scholarly journals Patient-Reported Outcomes Demonstrate The Value Of Non-Operative And Operative Orthopedic Treatments And Predict The Odds Of Improvement With Surgery

2017 ◽  
Vol 2 (3) ◽  
pp. 2473011417S0000
Author(s):  
Andrew Haskell ◽  
Todd S. Kim
Keyword(s):  
Pain Intensity ◽  
Patient Reported Outcomes ◽  
Pain Interference ◽  
Surgical Patients ◽  
Final Visit ◽  
Adaptive Tests ◽  
Item Banks ◽  
Patient Reported ◽  
Computer Adaptive Tests ◽  
Better Than

Category: Outcomes Measurement Introduction/Purpose: The importance of patient reported outcomes (PROs) has become increasingly recognized as an important tool to measure our clinical value. The National Institute of Health (NIH) created the Patient-Reported Outcomes Measurement Information System (PROMIS), a series of validated item banks, to help clinicians and researches measure key clinical domains. The PROMIS computer adaptive tests (CAT) may be administered with minimal resources or administrative burden. This study describes the results of administering computer adaptive tests (CAT) to every patient in a high volume Orthopedic Surgery practice. We test the hypotheses that both non-operative treatment and operative treatments improve PRO scores. Furthermore, we test the hypothesis that preoperative scores in these domains may be used to predict chances of improvement after surgery. Methods: The PROMIS CAT was administered prospectively for all patients as part of standard clinic intake and recorded in the patient’s electronic medical record (EMR) at each clinic visit. The PROMIS item banks are normalized to mean 50±10 for the US population. De-identified data was retrospectively extracted from the EMR including PROMIS scores, demographic information, as well as surgery specific information. As of this submission, 1688 PROMIS CATs from March 2015 to September 2016 have been analyzed. Data for initial and final clinic visits, as well as for the final preoperative visit for patients who had surgery, are compared using Wilcoxon Matched Pairs Test for paired samples and Mann-Whitney U Test for unpaired samples. Linear regression is used to assess the association of initial values to change in value after treatment. The effect of stratified initial clinic domain value on odds of improving with surgery is assessed using Analysis of Variance. Results: Non-surgical and surgical patients present with similar pain intensity (49.6±7.9 vs. 49.4±7.8). Surgical patients do not improve prior to surgery, but both improve by their final visit (45.7±7.5, 43.7±8.8, p<0.05). Non-surgical and surgical patients present with similar pain interference (60.0±8.4 vs. 60.3±8.9). Surgical patients do not improve prior to surgery, but both improve by their final visit (56.9±8.8, 54.3±9.4, p<0.05). For surgical patients, change in pain intensity and pain interference correlate with initial values (R2 0.32 and 0.27, p<0.05). The percentage whose pain intensity improves after surgery when initial value is over one SD worse than mean is 96%, within one SD worse than mean is 81%, within one SD better than mean is 56%, and over one SD better than mean is 40% (p<0.05). Conclusion: Both non-operative and operative orthopedic treatments improve patient reported pain intensity and pain interference. For patients that have surgery, patients that present with more severe symptoms tend to improve more with surgery. Furthermore, the odds of improving after surgery can be calculated based on preoperative PRO scores. This may allow surgeons to counsel patients about the potential benefits of surgery with personalized precision that is currently unavailable. Measuring PROs using PROMIS CATs demonstrates the value of both non-operative and operative Orthopedic Surgery care for our patients. Preoperative PRO scores may predict the odds of successful surgical intervention.

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

2021 ◽  
Vol 5 (1) ◽  
Author(s):  
Frida Carlberg Rindestig ◽  
Marie Wiberg ◽  
John Eric Chaplin ◽  
Eva Henje ◽  
Inga Dennhag
Keyword(s):  
Physical Activity ◽  
Patient Reported Outcomes ◽  
School Health ◽  
Factor Models ◽  
Pain Interference ◽  
Measurement Information ◽  
Outcomes Measurement ◽  
Item Banks ◽  
Patient Reported ◽  
Measurement Information System

Abstract Background The 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. Methods 12- 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. Results As 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. Conclusions We 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.

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