Comparing the Measurement Properties and Preferability of Patient Reported Outcome Measures in Pediatric Rheumatology: PROMIS versus CHAQ

2020 ◽  
pp. jrheum.200943
Author(s):  
Joshua Craig ◽  
Brian M. Feldman ◽  
Lynn Spiegel ◽  
Saunya Dover

Objective The Childhood Health Assessment Questionnaire (CHAQ), though widely used for assessments in pediatric rheumatology, has drawbacks, including low correlation to disease activity and ceiling effects. We sought to determine if any tools from the Patient Reported Outcomes Measurement Information System (PROMIS) improve on these shortcomings and/or are preferred by patients. Methods Patients 5-17 years of age, with childhood arthritis (JIA) or juvenile dermatomyositis (JDM) were recruited from the rheumatology clinics at a Canadian children’s hospital. Participants completed the CHAQ, 3 PROMIS measures (pain interference, mobility, and physical activity), and underwent a standard clinical assessment. Results 52 patients participated, 25 with JIA and 27 with JDM. None of the PROMIS measures suffered from ceiling effects, while the CHAQ disability index (DI) and pain visual analog scales both did, with 50% and 20% of patients achieving the best possible scores respectively. The PROMIS mobility was moderately correlated CHAQ DI (rs = -0.60, 95%CI = -0.75--0.40) and the PROMIS pain interference was strongly correlated to the CHAQ pain score (rs = 0.65, 95%CI = 0.43-0.80). No measures correlated with disease activity. Patients preferred the PROMIS to the CHAQ. Conclusion The PROMIS pain interference, mobility and physical activity measures improve in some areas where the CHAQ is weak: they do not suffer from ceiling effects and patients prefer the PROMIS tools. More work is needed to determine the correlation and responsiveness of the PROMIS tools to changes in disease activity over time before they should be widely adopted for clinical use.

2019 ◽  
Vol 7 (7_suppl5) ◽  
pp. 2325967119S0026
Author(s):  
Anas Minkara ◽  
Michaela O’Connor ◽  
Robert W. Westermann ◽  
James T. Rosneck ◽  
Thomas Sean Lynch

Objectives: Patient-Reported Outcomes Measurement Information System (PROMIS) is an NIH-funded computerized adaptive test (CAT) developed to effectively assess patient outcomes in multiple domains, including physical function (PF), pain severity, and quality of life while minimizing patient burden. The purpose of this study is to validate PROMIS in patients undergoing hip arthroscopy for Femoroacetabular Impingement (FAI), including test-retest reliability and correlation with validated hip outcome measures. Methods: Patients undergoing elective hip arthroscopy for FAI were consecutively enrolled at a major academic center. Patients with chronic comorbidities, bilateral FAI with a staged approach, and lack of postoperative follow-up were excluded. Eligible patients completed the modified Hip Harris Score (mHHS), Hip Outcome Score Activities of Daily Living (HOS-ADL), International Hip Outcome Tool (iHOT-12), and PROMIS including PF, pain interference, and activity satisfaction. Questionnaires were completed preoperatively, two, and six weeks postoperatively. Ceiling effects were determined to be present if greater than 15% of patients scored the highest possible score on one of the patient reported outcome measurement tools in this study. The correlation of preoperative values with postoperative function were assessed utilizing the Pearson coefficient. Normality was evaluated using the Shapiro-Wilk test. Dependent sample t-tests were utilized to compare means in test-retest reliability. Results: There were 38 patients with a mean age of 29.3 ± 8.9 years (54% female) identified for the study. PROMIS demonstrated excellent correlation with HOS-ADL (Pearson coefficient of 0.81, Figure 1), as well as mHHS (0.80) and iHOT-12 (0.73). Patients with higher PROMIS-pain interference and pain intensity scores demonstrated a negative linear correlation with mHHS (r=-0.86, p<0.05), HOS-ADL (r=-0.71, p<0.05), and iHOT-12 (-0.71, p<0.01). PROMIS scores exhibited significant responsiveness to hip arthroscopy. Patients with higher activity satisfaction demonstrated excellent-good correlation with mHHS scores (r=0.66, p<0.05) and HOS-ADL (0.66, p<0.05). PROMIS also demonstrated excellent test-retest reliability with no variability in scores, including PF (55.5 ± 8.6 vs. 54.2 ± 10.5, p=0.74). No floor or ceiling effects were exhibited by PROMIS including the physical function, pain interference, pain intensity, social participation, and role satisfaction domain scores. Conclusion: PROMIS is a valid and efficient PRO in hip arthroscopy for FAI demonstrating excellent test-retest reliability and correlation with established hip outcome measures. No floor or ceiling effects were demonstrated by PROMIS. Subdomains also exhibit excellent prognostic ability in the clinical setting.


2021 ◽  
Vol 5 (1) ◽  
Author(s):  
Frida Carlberg Rindestig ◽  
Marie Wiberg ◽  
John Eric Chaplin ◽  
Eva Henje ◽  
Inga Dennhag

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.


2014 ◽  
Vol 41 (5) ◽  
pp. 931-937 ◽  
Author(s):  
Eoghan M. McCarthy ◽  
Paul A. MacMullan ◽  
Shibeb Al-Mudhaffer ◽  
Anne Madigan ◽  
Suzanne Donnelly ◽  
...  

Objective.We sought to prospectively examine the responsiveness of a number of patient-reported outcome (PRO) measures in polymyalgia rheumatica (PMR), as well as their relationship to the biomarkers erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and plasma fibrinogen.Methods.Sixty patients with PMR were divided into active (n = 25) or inactive (n = 35) disease groups based on symptoms; physician assessment; and the biomarkers ESR, CRP, and plasma fibrinogen. Groups underwent assessment at baseline and 6 weeks. Disease activity measures and relevant PRO measures were recorded. Measures of responsiveness were compared for all PRO and biomarkers.Results.Visual analog scale disease activity (VASDA) and VAS quality of life (VASQOL) are more responsive to change in disease activity than VAS pain, morning stiffness, Health Assessment Questionnaire (HAQ), and PMR-activity score (AS). Analysis of PMR-AS versus VASDA, VASQOL, and HAQ showed correlation coefficients of 0.87 (p < 0.001), 0.80 (p < 0.001), and 0.68 (p < 0.001), respectively. Receiver-operating curve (ROC) analysis revealed VASDA to be more specific than either HAQ (0.95 vs 0.85; p < 0.001) or VASQOL (0.95 vs 0.93; p < 0.001) for the detection of response to treatment in active PMR. Overall, fibrinogen showed superior correlation coefficients with the various PRO than either of the standard biomarkers ESR or CRP. In addition, standardized response means for fibrinogen, ESR, and CRP were 1.63, 1.2, and 1.05, respectively, indicating that plasma fibrinogen was the most responsive biomarker for assessment of change in disease activity.Conclusion.VASDA and VASQOL are the most responsive PRO to changes in disease activity in PMR. In addition, plasma fibrinogen demonstrated greater responsiveness to changes in disease activity and superior correlation with the various PRO measures recorded than did the standard biomarkers ESR and CRP.


2019 ◽  
Vol 33 (09) ◽  
pp. 875-883
Author(s):  
Vidushan Nadarajah ◽  
Elizabeth Glazier ◽  
Kenneth Miller ◽  
Julio J. Jauregui ◽  
Michael P. Smuda ◽  
...  

AbstractGiven that pain relief is often the primary goal of orthopaedic surgery, an accurate assessment of pain is paramount. The objectives of this cross-sectional analytical study were to (1) compare how the Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CT) performs against the Numeric Pain Scale (NPS) measure in evaluating pain, and (2) to determine demographic, clinical, and psychosocial correlates of PI in an urban population undergoing a variety of knee surgeries. We hypothesized that there would be a strong correlation between PI and NPS, with minimal floor and ceiling effects; and that a worse PI score would be associated with a worse general health profile. The sample consisted of 412 patients undergoing knee surgery at an urban academic center. Patients were preoperatively administered measures of health-related quality of life (HRQOL). Bivariate and multivariable statistical analyses were performed to identify significant independent predictors. The mean PI score was 60.3 ± 7.2 and had no floor or ceiling effects, whereas NPS demonstrated a greater percentage of patients scoring at the extremes of the measure. Worse PI scores were associated with older age, higher body mass index (BMI), greater comorbidity, lower income, smoking, female gender, Hispanic ethnicity, Black race, unemployment, opioid use, lower expectations, and greater American Society of Anesthesiologists score (p < 0.05). Compared with other procedures, total knee arthroplasty was associated with worse PI scores and anterior cruciate ligament reconstruction was associated with better PI scores. Furthermore, PI demonstrated significant associations with a wide range of HRQOL measures. After controlling for confounding variables, worse PI was independently associated with older age, lower income, higher BMI, and smoking.


Rheumatology ◽  
2021 ◽  
Author(s):  
Bonny Rockette-Wagner ◽  
Didem Saygin ◽  
Siamak Moghadam-Kia ◽  
Chester Oddis ◽  
Océane Landon-Cardinal ◽  
...  

Abstract Objective Idiopathic inflammatory myopathies (IIM) cause proximal muscle weakness, which affect activities of daily living. Wearable physical activity monitors (PAMs) objectively assess continuous activity with potential clinical usefulness in IIM assessment. We examined the psychometric characteristics for PAM outcomes in IIM. Methods Adult IIM patients were prospectively evaluated (baseline, 3 and 6-months) in an observational study. A waist-worn PAM (ActiGraph GT3X-BT) assessed average step counts/min, peak 1-min cadence, and vector magnitude/min. Validated myositis core set measures (CSM) including manual muscle testing (MMT), physician global disease activity (MD global), patient global disease activity (Pt global), extra-muscular disease activity (Ex-muscular global), HAQ-DI, muscle enzymes, and patient-reported physical function were evaluated. Test-retest reliability, construct validity, and responsiveness were determined for PAM measures and CSM using Pearson correlations and other appropriate analyses. Results 50 adult IIM patients enrolled [mean (SD) age, 53.6 (±14.6); 60% female, 94% Caucasian]. PAM measures showed strong test-retest reliability, moderate-to-strong correlations at baseline with MD global (r=-0.37- -0.48), Pt-global (r=-0.43- -0.61), HAQ-DI (r=-0.47- -0.59) and MMT (r = 0.37–0.52), and strong discriminant validity for categorical MMT and HAQ-DI. Longitudinal association with MD global (r=-0.38- -0.44), MMT (r = 0.50–0.57), HAQ-DI (r=-0.45- -0.55), and functional tests (r = 0.30–0.65) were moderate-to-strong. PAM measures were responsive to MMT improvement (≥10%) and moderate-to-major improvement on ACR/EULAR myositis response criteria. Peak 1-min cadence had the largest effect size and Standardized Response Means (SRMs). Conclusion PAM measures showed promising construct validity, reliability, and longitudinal responsiveness; especially peak 1-min cadence. PAMs provide valid outcome measures for future use in IIM clinical trials.


Hand ◽  
2021 ◽  
pp. 155894472097412
Author(s):  
Ali Aneizi ◽  
Dominique Gelmann ◽  
Dominic J. Ventimiglia ◽  
Patrick M. J. Sajak ◽  
Vidushan Nadarajah ◽  
...  

Background: The objectives of this study were to determine the baseline patient characteristics associated with preoperative opioid use and to establish whether preoperative opioid use is associated with baseline patient-reported outcome measures in patients undergoing common hand surgeries. Methods: Patients undergoing common hand surgeries from 2015 to 2018 were retrospectively reviewed from a prospective orthopedic registry at a single academic institution. Medical records were reviewed to determine whether patients were opioid users versus nonusers. On enrollment in the registry, patients completed 6 Patient-Reported Outcomes Measurement Information System (PROMIS) domains (Physical Function, Pain Interference, Fatigue, Social Satisfaction, Anxiety, and Depression), the Brief Michigan Hand Questionnaire (BMHQ), a surgical expectations questionnaire, and Numeric Pain Scale (NPS). Statistical analysis included multivariable regression to determine whether preoperative opioid use was associated with patient characteristics and preoperative scores on patient-reported outcome measures. Results: After controlling for covariates, an analysis of 353 patients (opioid users, n = 122; nonusers, n = 231) showed that preoperative opioid use was associated with higher American Society of Anesthesiologists class (odds ratio [OR], 2.88), current smoking (OR, 1.91), and lower body mass index (OR, 0.95). Preoperative opioid use was also associated with significantly worse baseline PROMIS scores across 6 domains, lower BMHQ scores, and NPS hand scores. Conclusions: Preoperative opioid use is common in hand surgery patients with a rate of 35%. Preoperative opioid use is associated with multiple baseline patient characteristics and is predictive of worse baseline scores on patient-reported outcome measures. Future studies should determine whether such associations persist in the postoperative setting between opioid users and nonusers.


Author(s):  
Michaela Gabes ◽  
Helge Knüttel ◽  
Gesina Kann ◽  
Christina Tischer ◽  
Christian J. Apfelbacher

Abstract Purpose To critically appraise, compare and summarize the quality of all existing PROMs that have been validated in hyperhidrosis to at least some extend by applying the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology. Thereby, we aim to give a recommendation for the use of PROMs in future clinical trials in hyperhidrosis. Methods We considered studies evaluating, describing or comparing measurement properties of PROMs as eligible. A systematic literature search in three big databases (MEDLINE, EMBASE and Web of Science) was performed. We assessed the methodological quality of each included study using the COSMIN Risk of Bias checklist. Furthermore, we applied predefined quality criteria for good measurement properties and finally, graded the quality of the evidence. Results Twenty-four articles reporting on 13 patient-reported outcome measures were included. Three instruments can be further recommended for use. They showed evidence for sufficient content validity and moderate- to high-quality evidence for sufficient internal consistency. The methodological assessment showed existing evidence gaps for eight other PROMs, which therefore require further validation studies to make an adequate decision on their recommendation. The Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) and the short-form health survey with 36 items (SF-36) were the only questionnaires not recommended for use in patients with hyperhidrosis due to moderate- to high-quality evidence for insufficient measurement properties. Conclusion Three PROMs, the Hyperhidrosis Quality of Life Index (HidroQoL), the Hyperhidrosis Questionnaire (HQ) and the Sweating Cognitions Inventory (SCI), can be recommended for use in future clinical trials in hyperhidrosis. Results obtained with these three instruments can be seen as trustworthy. Nevertheless, further validation of all three PROMs is desirable. Systematic review registration PROSPERO CRD42020170247


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 524.3-525
Author(s):  
M. Patanè ◽  
L. Carmisciano ◽  
E. Hysa ◽  
E. Gotelli ◽  
A. Signori ◽  
...  

Background:Rheumatoid arthritis (RA) is a long-term, progressive, and disabling autoimmune disease1. The disease activity can be quantified by the Disease Activity Score 28-joint count – C reactive protein (DAS28crp)2; the evaluation of disability function (DF) is actually mainly performed only by subjective Patient Reported Outcomes (PROs) like Health Assessment Questionnaire (HAQ)3; to investigate the functional aspects of RA hands it is usually used the grip strength (GS)4. However, in the scientific literature no tool, which objectively evaluates movement speed, has been reported. The Hand Test System (HTS, ETT) is an engineered glove (RAGLOVE), nowadays applied for neuroscience studies to evaluate hand motility5Objectives:To objectively evaluate the RA hand’s speed of the fine movements, through the HTS and to compared with a group of age and sex matched healthy controls. To verify the correspondence with the HAQ, DAS28, GS.Methods:55 consecutives RA patients (pts) (6 males, age 61 ± 16 years, mean duration of disease 12 ± 8 years), classified according to 2010 ACR/EULAR criteria6, and 50 matched healthy controls (HCs) were enrolled. After consent, all participants undergone HTS test that recognizes the touches between the finger tips during the opposition movements of the hands in standard sequences of movements, after dressed the glove. A multiple finger evaluation (MFE) and a single finger evaluation (SFE) were performed using a dedicated software that provided the physician the following quantitative parameters: Touch Duration (TD), Inter Tapping Interval (ITI) and Movement Rate (MR). Average time for hand 2 minutes. RA pts compiled the HAQ, performed the GS and a DAS28cpr was performed.The student’s t-test was used to compare the glove’s parameters between the groups whereas the analysis of variance (ANOVA) was utilized to verify potential differences between the populations. In order to evaluate the single correlations, the r and p values of Pearson were employed.Results:For MFE, glove parameters TD and ITI were significantly higher in RA pts than HCs, whereas; MR was significantly lower in RA pts compared to HCs (all p <0.001).For SFE non-affected fingers (not swollen and not tender) of RA pts performed better than a clinically affected fingers, but in any case significantly worse than average HCs fingers (p < 0.001).There is a statistically significant correlation between the GS and MR (r= 0.39 p=0.003) and TD (r=-0.33 p=0.015).TD, ITI e MR of RA pts showed a significant correlation with the total score of the HAQ (r = 0.56, r = 0.39, r = -0.56, all p < 0.001;). DAS28, considered as a continuous variable, proved to be significantly correlated with the TD (r = 0.36, p = 0.009). When the RA patients were grouped according to the disease activity by DAS28cpr7, there was an increase of one third of the TD’s logarithm for each increase in the activity class (linear regression with ordinal predictors, beta = 0.33; 95%CI 0.03, 0.63,p < 0.0297). Finally, even RA pts in remission showed a TD significantly higher compared with HCs (p= 0.034).Conclusion:The RAGLOVE is shown as a new safe and fast tool to evaluate a new objective parameter in the hand’s functionality: the speed of finger movements. In RA pts, an inversely proportional correlation emerges between the speed of movement and disease activity.The significant correlation found with HAQ, highlights the loss of motility of the hands as one of the main determinant of disability. The RAGLOVE is now tested in RA patients undergoing treatment.References:[1]Hakkinen et al Ann Rheum Dis. 2005;[2]Van Der Heijde et al J of Rheum. 1993;[3]Fries et al Arthritis Rheum. 1980;[4]Mathiowetz et al J Hand Surg Am. 1984;[5]Carmisciano et al Eur J Neurol. 2020;[6]Aletaha et al. Ann Rheum Dis. 2010;[7]Aletaha et al Arthritis Rheum 2005.Disclosure of Interests:None declared


Author(s):  
Rebecca McKeown ◽  
David R. Ellard ◽  
Abdul-Rasheed Rabiu ◽  
Eleni Karasouli ◽  
Rebecca S. Kearney

Abstract Background Ankle fractures are painful and debilitating injuries that pose a significant burden to society and healthcare systems. Patient reported outcome measures (PROMs) are commonly used outcome measures in clinical trials of interventions for ankle fracture but there is little evidence on their validity and reliability. This systematic review aims to identify and appraise evidence for the measurement properties of ankle specific PROMs used in adults with an ankle fracture using Consensus Based Standards for the Selection of Health Measurement Instrument (COSMIN) methodology. Methods We searched MEDLINE, Embase and CINAHL online databases for evidence of measurement properties of ankle specific PROMs. Articles were included if they assessed or described the development of the PROM in adults with ankle fracture. Articles were ineligible if they used the PROM to assess the measurement properties of another instrument. Abstracts without full articles and conference proceedings were ineligible, as were articles that adapted the PROM under evaluation without any formal justification of the changes as part of a cross-cultural validation or translation process. Two reviewers completed the screening. To assess methodological quality we used COSMIN risk of bias checklist and summarised evidence using COSMIN quality criteria and a modified Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Two reviewers assessed the methodological quality and extracted the data for a sample of articles. Results The searches returned a total of 377 articles. From these, six articles were included after application of eligibility criteria. These articles evaluated three PROMs: A-FORM, OMAS and AAOS. The A-FORM had evidence of a robust development process within the patient population, however lacks post-formulation testing. The OMAS showed sufficient levels of reliability, internal consistency and construct validity. The AAOS showed low quality evidence of sufficient construct validity. Conclusions There is insufficient evidence to support the recommendation of a particular PROM for use in adult ankle fracture research based on COSMIN methodology. Further validation of these outcome measures is required in order to ensure PROMs used in this area are sufficiently valid and reliable to assess treatment effects. This would enable high quality, evidenced-based management of adults with ankle fracture.


2021 ◽  
Vol 8 ◽  
pp. 237437352199883
Author(s):  
Yvonne Versluijs ◽  
Maartje Lemmers ◽  
Laura E. Brown ◽  
Amanda I. Gonzalez ◽  
Joost T. P. Kortlever ◽  
...  

This study assessed the correlation of 9 questions addressing communication effectiveness (the Communication Effectiveness Questionnaire [CEQ]) with other patient-reported experience measures (PREMs; satisfaction, perceived empathy) as well as patient-reported outcome measures (PROMs; pain intensity, activity tolerance) in patients with musculoskeletal illness or injury. In a cross-sectional study, 210 patients visiting an orthopedic surgeon completed the CEQ and measures of satisfaction with the visit, perceived empathy, pain intensity, and activity tolerance. We evaluated correlations between CEQ and other PREMs and CEQ and PROMs. We measured ceiling effects of the PREMs. Communication effectiveness correlated moderately with other PREMs such as satisfaction (ρ = 0.54; P < .001) and perceived empathy (ρ = 0.54; P < .001). Communication effectiveness did not correlate with PROMs: pain intensity (ρ = −0.01; P = .93) and activity tolerance (ρ = −0.05; P = .44). All of the experience measures have high ceiling effects: perceived empathy 37%, satisfaction 80%, and CEQ 46%. The observation of notable correlations of various PREMs, combined with their high ceiling effects, direct us to identify a likely common statistical construct (which we hypothesize as “relationship”) accounting for variation in PREMs, and then develop a PREM which measures that construct in a manner that results in a Gaussian distribution of scores. At least within the limitations of current experience measures, there seems to be no association between illness (PROMs) and experience (PREMs).


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