Validity and measurement precision of the PROMIS physical function item bank and a content validity–driven 20-item short form in rheumatoid arthritis compared with traditional measures

A patient history is far more prominent in diagnosis and management of rheumatoid arthritis (RA) than in many chronic diseases, such as hypertension and diabetes, in which biomarkers dominate clinical decisions. A patient history traditionally has been termed ‘subjective’, based on narrative descriptions, in contrast to ‘objective’ high-technology laboratory and other measures. Self-report questionnaires provide standard, quantitative, reproducible medical history data, which meet criteria for the ‘scientific method’. Patient self-report scores for physical function distinguish active from control treatment results in RA clinical trials as effectively as laboratory tests, joint counts, or indices which include these measures. Self-report physical function generally is more reproducible than joint counts, and more significant than radiographic scores or laboratory tests in the prognosis of severe RA outcomes of work disability and mortality, providing a prognostic indicator analogous to blood pressure or haemoglobin A1C. Four prominent, feasible self-report questionnaires are the Health Assessment Questionnaire (HAQ), its multidimensional version (MDHAQ), the 36-item Short Form (SF-36), and Patient-Reported Outcomes Measurement Information System (PROMIS). The MDHAQ also includes ‘medical’ information (i.e. self-report joint count, symptom checklist, and medical history). Despite documentation of their scientific value and pragmatic advantages to document relevant information while saving time, patient questionnaires remain regarded primarily as providing ancillary rather than essential information to inform clinical decisions, based in part on perceived barriers concerning feasibility and complexities to interface with electronic medical records. Quantitative assessment of physical function on patient questionnaires prior to every routine rheumatology encounter could improve patient care and outcomes.

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Participation in Committed and Discretionary Activities and Quality of Life in Women with Rheumatoid Arthritis

British Journal of Occupational Therapy ◽

10.4276/030802212x13418284515794 ◽

2012 ◽

Vol 75 (7) ◽

pp. 313-320 ◽

Cited By ~ 2

Author(s):

Lillian Reinseth ◽

Ingvild Kjeken ◽

Till Uhlig ◽

Geir Espnes

Keyword(s):

Quality Of Life ◽

Rheumatoid Arthritis ◽

Physical Function ◽

Short Form ◽

Occupational Therapists ◽

Psychological Wellbeing ◽

High Participation ◽

Related Quality ◽

Health Related

Purpose: This study explored participation in committed activities (activities that we are obliged to perform), discretionary activities (activities for recreation and pleasure) and health-related quality of life (HRQoL) in women with rheumatoid arthritis (RA). Method: The study involved 238 females with RA. Self-reported participation in activities was measured by the Interest Checklist. The activities on the checklist were divided into committed and discretionary activities participated in during the past 10 years, the previous year and at the present time. HRQoL was measured by the Short-Form 36 (SF-36). Results: The results showed significant decreases in participation in both committed and discretionary activities over the 10-year period. Multivariate analysis showed that high participation in committed activities was associated significantly with good physical function, whereas high participation in discretionary activities was associated significantly with psychological wellbeing and good physical function. Respectively, the significant associations accounted for 30% of the variance of committed activities and 41% of the variance of discretionary activities. Higher education was associated significantly with high participation in activities, particularly in discretionary activities. Conclusion: Occupational therapists and other health professionals should assist females with RA, and especially those with less education, to maintain essential discretionary activities because this is associated with psychological wellbeing.

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Effect of Golimumab on Patient-reported Outcomes in Rheumatoid Arthritis: Results from the GO-FORWARD Study

The Journal of Rheumatology ◽

10.3899/jrheum.111195 ◽

2012 ◽

Vol 39 (6) ◽

pp. 1185-1191 ◽

Cited By ~ 25

Author(s):

MARK C. GENOVESE ◽

CHENGLONG HAN ◽

EDWARD C. KEYSTONE ◽

ELIZABETH C. HSIA ◽

JACQUELINE BUCHANAN ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Physical Function ◽

General Health ◽

Short Form ◽

Health Assessment ◽

Medical Outcomes ◽

Chronic Illness Therapy ◽

Sf 36 ◽

Patient Reported ◽

Questionnaire Disability

Objective.To evaluate the effect of golimumab on physical function, general health, and fatigue in patients with active rheumatoid arthritis (RA) despite methotrexate (MTX) therapy.Methods.In the multicenter, randomized, placebo-controlled GO-FORWARD study, 444 adults with active RA despite MTX received subcutaneous placebo + MTX (crossover to golimumab 50 mg at Week 24), golimumab 100 mg + placebo, golimumab 50 mg + MTX, or golimumab 100 mg + MTX every 4 weeks. Physical function and general health were assessed using the Health Assessment Questionnaire-Disability Index (HAQ-DI) and Physical and Mental Component Summary (PCS, MCS) scores of the Medical Outcomes Study Short Form-36 questionnaire (SF-36), respectively, through Week 52. Fatigue was measured through Week 24 using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) questionnaire.Results.Mean improvements from baseline in HAQ-DI, SF-36 PCS, and FACIT-Fatigue scores (Weeks 14 and 24) were significantly greater for golimumab 50 mg + MTX and 100 mg + MTX versus placebo + MTX. Significantly greater proportions of patients treated with golimumab + MTX achieved clinically meaningful improvements from baseline to Weeks 14 and 24 in HAQ-DI, PCS, and FACIT-Fatigue scores. Mean improvements in SF-36 PCS (Week 14), MCS (Week 24), and FACIT-Fatigue (Weeks 14 and 24) scores were significantly greater for golimumab 100 mg + placebo versus placebo + MTX. Mean improvements from baseline in HAQ-DI, SF-36 PCS, and MCS scores through Week 24 were sustained through Week 52.Conclusion.Patients with active RA despite MTX had significant improvement in physical function, general health, and fatigue following golimumab + MTX therapy; improvements in physical function and general health were maintained through Week 52. (Clinical Trials Registration NCT00264550)

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Effects of Language, Insurance, and Race/Ethnicity on Measurement Properties of the PROMIS Physical Function Short Form 10a in Rheumatoid Arthritis

Arthritis Care & Research ◽

10.1002/acr.23723 ◽

2019 ◽

Vol 71 (7) ◽

pp. 925-935 ◽

Cited By ~ 4

Author(s):

Zara Izadi ◽

Patricia P. Katz ◽

Gabriela Schmajuk ◽

Julie Gandrup ◽

Jing Li ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Physical Function ◽

Short Form ◽

Measurement Properties ◽

Race Ethnicity

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

Journal of Patient-Reported Outcomes ◽

10.1186/s41687-021-00318-w ◽

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.

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Calibration of the PROMIS Physical Function Item Bank in Dutch Patients with Rheumatoid Arthritis

PLoS ONE ◽

10.1371/journal.pone.0092367 ◽

2014 ◽

Vol 9 (3) ◽

pp. e92367 ◽

Cited By ~ 20

Author(s):

Martijn A. H. Oude Voshaar ◽

Peter M. ten Klooster ◽

Cees A. W. Glas ◽

Harald E. Vonkeman ◽

Erik Taal ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Physical Function ◽

Item Bank

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Certolizumab pegol plus methotrexate provides broad relief from the burden of rheumatoid arthritis: analysis of patient-reported outcomes from the RAPID 2 trial

Annals of the Rheumatic Diseases ◽

10.1136/ard.2010.143586 ◽

2011 ◽

Vol 70 (6) ◽

pp. 996-1002 ◽

Cited By ~ 44

Author(s):

Vibeke Strand ◽

Josef S Smolen ◽

Ronald F van Vollenhoven ◽

Philip Mease ◽

Gerd R Burmester ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Disease Activity ◽

Physical Function ◽

Clinical Outcomes ◽

Patient Reported Outcomes ◽

Short Form ◽

Certolizumab Pegol ◽

Number Needed To Treat ◽

Patient Reported ◽

The Impact

ObjectiveTo assess the impact of certolizumab pegol (CZP) on patient-reported outcomes (PROs) in rheumatoid arthritis (RA), and to interpret these results using number needed to treat (NNT), and associations between PRO responses and longer term outcomes.MethodsA total of 619 patients with active RA were randomised to CZP 200 or 400 mg, or placebo plus methotrexate (MTX). PROs assessed included pain, patient's global assessment of disease activity (PtGA), physical function, fatigue and health-related quality of life. Treatment impact on PROs, NNT to achieve simultaneous improvements in multiple PROs and correlations between PROs were calculated. Times to onset of improvements greater than or equal to minimum clinically important differences (MCIDs) in pain as a determinant of clinical outcomes at week 24 were compared between week 6 and 12 responders, and in patients with improvements in pain ≥MCID at week 12 (week 12 responders/non-responders).ResultsCZP 200 and 400 mg plus MTX were associated with rapid, clinically meaningful improvements in all PROs. The NNT for subjects to report changes ≥MCID in up to five PROs was two to three, and five for all six PROs (pain, PtGA, physical function, fatigue and short-form 36-item Physical and Mental Component Summary Scores). More patients with improvements ≥MCID in pain at week 6 than those at week 12 had lower disease activity at week 24. Week 12 pain responders had better clinical outcomes at week 24 than non-responders.ConclusionsThe data demonstrate that CZP provides broad relief from the burden of RA.Trial registration numberNCT00160602.

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Customizing CAT administration of the PROMIS Misuse of Prescription Pain Medication Item Bank for patients with chronic pain

Pain Medicine ◽

10.1093/pm/pnab159 ◽

2021 ◽

Author(s):

Dokyoung S You ◽

Karon F Cook ◽

Benjamin W Domingue ◽

Maisa S Ziadni ◽

Jennifer M Hah ◽

...

Keyword(s):

Short Form ◽

Pain Medication ◽

Measurement Precision ◽

Item Bank ◽

Stopping Rules ◽

Rule Based ◽

Medication Misuse ◽

Health Response ◽

Response Burden ◽

Response Rule

Abstract Objective The 22-item PROMIS®-Rx Pain Medication Misuse item bank (Bank-22) imposes a high response burden. This study aimed to characterize the performance of the Bank-22 in a computer adaptive testing (CAT) setting based on varied stopping rules. Methods The 22 items were administered to 288 patients. We performed a CAT simulation using default stopping rules (CATPROMIS). In 5 other simulations, a “best health” response rule was added to decrease response burden. This rule stopped CAT administration when a participant selected “never” to a specified number of initial Bank-22 items (2-6 in this study, designated CATAlt2-Alt6). The Bank-22 and 7-item short form (SF-7) scores were compared to scores based on CATPROMIS, and the 5 CAT variations. Results Bank-22 scores correlated highly with the SF-7 and CATPROMIS, Alt5, Alt6 scores (rs=.87-.95) and moderately with CATAlt2- Alt4 scores (rs=.63-.74). In all CAT conditions, the greatest differences with Bank-22 scores were at the lower end of misuse T-scores. The smallest differences with Bank-22 and CATPROMIS scores were observed with CATAlt5 and CATAlt6. Compared to the SF-7, CATAlt5 and CATAlt6 reduced overall response burden by about 42%. Finally, the correlations between PROMIS-Rx Misuse and Anxiety T-scores remained relatively unchanged across the conditions (rs=.31-.43, ps < .001). Conclusions Applying a stopping rule based on number of initial “best health” responses reduced response burden for respondents with lower levels of misuse. The tradeoff was less measurement precision for those individuals, which could be an acceptable tradeoff when the chief concern is in discriminating higher levels of misuse.

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Turkish Adaptation of Diabetic Foot Ulcer Scale–Short Form

The International Journal of Lower Extremity Wounds ◽

10.1177/1534734620921036 ◽

2020 ◽

Vol 19 (3) ◽

pp. 269-274 ◽

Cited By ~ 2

Author(s):

İsmail Toygar ◽

Sadık Hançerlioğlu ◽

Selden Gül ◽

Tülün Utku ◽

Ilgın Yıldırım Şimşir ◽

...

Keyword(s):

Factor Analysis ◽

Diabetic Foot ◽

Content Validity ◽

Short Form ◽

University Hospital ◽

Validity And Reliability ◽

Turkish Version ◽

Patient Identification ◽

Validity Index ◽

Content Validity Index

The purpose of this study was to evaluate the validity and reliability of the Turkish version of the Diabetic Foot Scale–Short Form (DFS-SF). The study was cross-sectional and conducted between January and October 2019 in a diabetic foot council of a university hospital. A total of 194 diabetic foot patients participated in the study. A Patient Identification Form and DFS-SF were used for data collection. Forward and backward translations were used in language validity. Expert opinions were obtained to determine the Content Validity Index. To determine construct validity, exploratory factor analysis and confirmatory factor analysis were used. Cronbach’s α internal consistency coefficient, item-scale correlation, and test-retest reliability were used to evaluate reliability. It was found that Content Validity Index was 0.97 (0.86-1.00), the factor loading of scale varied from 0.378 to 0.982, Cronbach’s α value varied from 0.81 to 0.94, and item-total correlations were between 0.30 and 0.75. The Turkish version of the DFS-SF was found valid and reliable to measure the quality of life of diabetic foot patients.

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