Patient involvement in rheumatoid arthritis care to improve disease activity-based management in daily practice: A randomized controlled trial.

OBJECTIVE: To evaluate the effect of an intervention to improve disease activity-based management of RA in daily clinical practice by addressing patient level barriers. METHODS: The DAS-pass strategy aims to increase patients' knowledge about DAS28 and to empower patients to be involved in treatment (decisions). It consists of an informational leaflet, a patient held record and guidance by a specialized rheumatology nurse. In a Randomized Controlled Trial, 199 RA patients were randomized 1:1 to intervention or control group. Outcome measures were patient empowerment (EC-17; primary outcome), attitudes towards medication (BMQ), disease activity (DAS28) and knowledge about DAS28. RESULTS: Our strategy did not affect EC-17, BMQ, or DAS28 use. However it demonstrated a significant improvement of knowledge about DAS28 in the intervention group, compared to the control group. The intervention had an additional effect on patients with low baseline knowledge compared to patients with high baseline knowledge. CONCLUSION: The DAS-pass strategy educates patients about (the importance of) disease activity-based management, especially patients with low baseline knowledge. PRACTICE IMPLICATIONS: The strategy supports patient involvement in disease activity-based management of RA and can be helpful to reduce inequalities between patients in the ability to be involved in shared decision making.

Development and preliminary evaluation of a short self-report measure of generalized pain hypersensitivity.

PURPOSE: Generalized pain hypersensitivity is frequently observed in chronic pain conditions. Currently, identification is based on expert clinical opinion, and in very few cases combined with quantitative sensory testing. The objectives of this study were to develop and evaluate a short self-report measure of generalized pain hypersensitivity: a generalized pain questionnaire (GPQ). METHODS: Items for the GPQ were developed based on a literature review, followed by an interview study with ten rheumatic patients with suspected pain hypersensitivity. We examined the psychometric properties of the preliminary items in a sample of 212 outpatients suffering from either fibromyalgia (FM; n=98) or rheumatoid arthritis (n=114). Additionally, self-reported data were gathered on sociodemographics, fibromyalgia-survey criteria, health status, and neuropathic-like pain features. RESULTS: Mokken-scale analyses demonstrated a unidimensional seven-item scale with strong homogeneity (H=0.65) and high reliability (r=0.90). Correlations between total GPQ scores and relevant external measures, such as the FM-survey criteria and neuropathic-like pain features, were consistent with a priori expectations, supporting its external construct validity. Furthermore, the GPQ had good accuracy in distinguishing between patients with FM (generally assumed to be the result of central nervous system hypersensitization) and patients with RA (assumed to result mostly in local nociceptive or inflammatory pain), with an area under the receiver-operating characteristic curve of 0.89. A cutoff value >10 had the highest combination of sensitivity (82.7%) and specificity (77.2%). CONCLUSION: The GPQ is psychometrically sound and appears promising for measuring the presence and severity of generalized pain hypersensitivity in chronic pain patients.

Hyperuricaemia: a marker of increased cardiovascular risk in rheumatic patients: analysis of the ACT-CVD cohort.

BACKGROUND: Gout and hyperuricaemia may be associated with increased cardiovascular risk, but analyses in different populations show conflicting results. This study investigates the impact of serum uric acid, inflammation and traditional CV risk parameters on CV event risk in patients with gouty arthritis and patients with non-gouty rheumatic disease. METHODS: cross-sectional and prospective multivariate analysis of the relation between tertiles of serum uric acid and individual traditional CV risk factors in a cohort of gouty arthritis (GA, n=172), rheumatoid arthritis (RA, n=480) and osteoarthritis (OA, n=206) patients. MAIN OUTCOME MEASURES: systolic blood pressure, TC/HDL ratio, GlyHb, BMI and first CV events. RESULTS: Individual CV risk factors were significantly less favourable in GA (systolic blood pressure, TC/HDL ratio, BMI, p<0.05). In RA and OA, but not in GA, individual cardiometabolic parameters correlated with serum uric acid values (OA: RA: systolic blood pressure, TC/HDL ratio, BMI; systolic blood pressure, TC/HDL ratio, GlyHb, BMI; p<0.05). In non-GA individuals the highest tertile of serum uric acid (>0.34 mmol/L) and NT proBNP level were independent predictors of first CV events, against age and GlyHb level in GA (p<0.05). The hazard of first CV events was equally significantly increased in GA patients (HR 3.169, 95% CI 1.287-7.806) and non-GA individuals with a serum uric acid ≥ 0.34 mmol/L (HR 3.721, 95% CI 1.603-8.634) compared to non-GA individuals with a serum uric acid < 0.27. CONCLUSIONS: GA is associated with a 3.1-fold hazard of first CV events. In non-GA rheumatic patients increasing serum uric acid is associated with increased CV risk, whereas CV risk in GA is independent of serum uric acid values. The presence of GA or a baseline serum uric acid in the upper range are possibly stronger predictors of first CV events than some traditional CV risk factors or parameters of inflammation.

Acceptance of New Technology: A Usability Test of a Computerized Adaptive Test for Fatigue in Rheumatoid Arthritis.

BACKGROUND: Little is known about the acceptance and usability of computerized adaptive tests (CATs) among patients with rheumatoid arthritis (RA). The main difference between completing a CAT and a traditional questionnaire concerns item presentation. CATs only provide one item at a time on the screen, and skipping forward or backward to review and change already given answers is often not possible. OBJECTIVE: The objective of this study was to examine how patients with RA experience a Web-based CAT for fatigue. METHODS: In individual sessions, participants filled in the CAT while thinking aloud, and were subsequently interviewed about their experience with the new instrument. The technology acceptance model (TAM) was used to structure the results. RESULTS: The participants were 15 patients with RA. They perceived the CAT as clear, brief, and easy to use. They were positive about answering one question per screen, the changing response options, layout, progress bar, and item number. There were 40% (6/15) of the participants that also mentioned that they experienced the completion of the CAT as useful and pleasant, and liked the adaptive test mechanism. However, some participants noted that not all items were applicable to everybody, and that the wordings of questions within the severity dimension were often similar. CONCLUSIONS: Participants perceived the "CAT Fatigue RA" as easy to use, and also its usefulness was expressed. A 2.0 version has been improved according to the participants' comments, and is currently being used in a validation study before it will be implemented in daily clinical practice. Our results give a first indication that CAT methodology may outperform traditional questionnaires not merely on measurement precision, but also on usability and acceptance valuation.

Modern psychometrics applied in rheumatology--a systematic review.

BACKGROUND: Although item response theory (IRT) appears to be increasingly used within health care research in general, a comprehensive overview of the frequency and characteristics of IRT analyses within the rheumatic field is lacking. An overview of the use and application of IRT in rheumatology to date may give insight into future research directions and highlight new possibilities for the improvement of outcome assessment in rheumatic conditions. Therefore, this study systematically reviewed the application of IRT to patient-reported and clinical outcome measures in rheumatology. METHODS: Literature searches in PubMed, Scopus and Web of Science resulted in 99 original English-language articles which used some form of IRT-based analysis of patient-reported or clinical outcome data in patients with a rheumatic condition. Both general study information and IRT-specific information were assessed. RESULTS: Most studies used Rasch modeling for developing or evaluating new or existing patient-reported outcomes in rheumatoid arthritis or osteoarthritis patients. Outcomes of principle interest were physical functioning and quality of life. Since the last decade, IRT has also been applied to clinical measures more frequently. IRT was mostly used for evaluating model fit, unidimensionality and differential item functioning, the distribution of items and persons along the underlying scale, and reliability. Less frequently used IRT applications were the evaluation of local independence, the threshold ordering of items, and the measurement precision along the scale. CONCLUSION: IRT applications have markedly increased within rheumatology over the past decades. To date, IRT has primarily been applied to patient-reported outcomes, however, applications to clinical measures are gaining interest. Useful IRT applications not yet widely used within rheumatology include the cross-calibration of instrument scores and the development of computerized adaptive tests which may reduce the measurement burden for both the patient and the clinician. Also, the measurement precision of outcome measures along the scale was only evaluated occasionally. Performed IRT analyses should be adequately explained, justified, and reported. A global consensus about uniform guidelines should be reached concerning the minimum number of assumptions which should be met and best ways of testing these assumptions, in order to stimulate the quality appraisal of performed IRT analyses.

Construct validity of the interview time trade-off and computer time trade-off in patients with rheumatoid arthritis: a cross-sectional observational pilot study.

BACKGROUND: The Time Trade-Off (TTO) is a widely used instrument for valuing preference-based health-related quality of life (HRQoL). The TTO reveals preferences for own current health ('utilities') on a scale anchored between death (0) and perfect health (1). Limited information on the external validity of the TTO is available. Aim of this pilot study was to examine the construct validity of both an interview TTO and a computer-based TTO in patients with rheumatoid arthritis (RA). METHODS: Thirty patients visiting the outpatient rheumatology clinic participated. Construct validity was assessed by measuring convergent and discriminative validity. Convergent validity was assessed by calculating Spearman's correlations between the utilities obtained from the TTOs and pain, general health (rating scales), health-related quality of life (SF-36 and SF-6D) and functional status (HAQ-DI). Discriminative power of both TTO measures was determined by comparing median utilities between worse and better health outcomes. RESULTS: Correlations of both TTO measures with HRQoL, general health, pain and functional status were poor (absolute values ranging from .05 to .26). Both TTOs appeared to have no discriminative value among groups of RA patients who had a worse or better health status defined by six health outcome measures. About one-third of respondents were zero-traders on each of the TTO measures. After excluding zero-traders from analysis, the correlations improved considerably. CONCLUSIONS: Both the interview TTO and computer TTO showed poor construct validity in RA patients when using measures of HRQol, general health, pain and functional status as reference measures. Possibly, the validity of the TTO improves when using an anchor that is more realistic to RA patients than the anchor 'death'.

Dutch translation and cross-cultural adaptation of the PROMIS® physical function item bank and cognitive pre-test in Dutch arthritis patients.

INTRODUCTION: Patient-reported physical function is an established outcome domain in clinical studies in rheumatology. To overcome the limitations of the current generation of questionnaires, the Patient-Reported Outcomes Measurement Information System (PROMIS®) project in the USA has developed calibrated item banks for measuring several domains of health status in people with a wide range of chronic diseases. The aim of this study was to translate and cross-culturally adapt the PROMIS physical function item bank to the Dutch language and to pretest it in a sample of patients with arthritis. METHODS: The items of the PROMIS physical function item bank were translated using rigorous forward-backward protocols and the translated version was subsequently cognitively pretested in a sample of Dutch patients with rheumatoid arthritis. RESULTS: Few issues were encountered in the forward-backward translation. Only 5 of the 124 items to be translated had to be rewritten because of culturally inappropriate content. Subsequent pretesting showed that overall, questions of the Dutch version were understood as they were intended, while only one item required rewriting. CONCLUSIONS: Results suggest that the translated version of the PROMIS physical function item bank is semantically and conceptually equivalent to the original. Future work will be directed at creating a Dutch-Flemish final version of the item bank to be used in research with Dutch speaking populations.

Which dimensions of fatigue should be measured in patients with rheumatoid arthritis? A Delphi study.

OBJECTIVE: Rheumatoid arthritis (RA) patients experience fatigue as a multidimensional symptom. The aim of the present study was to use health professionals and patients alike to identify which dimensions of fatigue should be measured in RA. METHODS: Twelve fatigue dimensions were constructed, based on items from traditional questionnaires and items generated from interviews. Health professionals and patients evaluated these dimensions, related to an initial pool of 294 items, in a Delphi procedure. Dimensions were selected if rated important by at least 80% of the participants. RESULTS: Ten rheumatologists, 20 nurses and 15 patients participated. All fatigue dimensions were selected directly (severity, frequency, duration, changes in fatigue, perceived causes of fatigue, energy, sleep/rest, body feeling, cognition/concentration, coping, negative emotions/mood and consequences). No additional dimensions emerged from participants' comments and suggestions. CONCLUSIONS: This study revealed 12 fatigue dimensions. This underlines the multidimensionality of fatigue in RA and the need for comprehensive measurement.

Does the eHealth Literacy Scale (eHEALS) measure what it intends to measure? Validation of a Dutch version of the eHEALS in two adult populations.

BACKGROUND: The Internet increases the availability of health information, which consequently expands the amount of skills that health care consumers must have to obtain and evaluate health information. Norman and Skinner in 2006 developed an 8-item self-report eHealth literacy scale to measure these skills: the eHealth Literacy Scale (eHEALS). This instrument has been available only in English and there are no data on its validity. OBJECTIVES: The objective of our study was to assess the internal consistency and the construct and predictive validity of a Dutch translation of the eHEALS in two populations. METHODS: We examined the translated scale in a sample of patients with rheumatic diseases (n = 189; study 1) and in a stratified sample of the Dutch population (n = 88; study 2). We determined Cronbach alpha coefficients and analyzed the principal components. Convergent validity was determined by studying correlations with age, education, and current (health-related) Internet use. Furthermore, in study 2 we assessed the predictive validity of the instrument by comparing scores on the eHEALS with an actual performance test. RESULTS: The internal consistency of the scale was sufficient: alpha = .93 in study 1 and alpha = .92 in study 2. In both studies the 8 items loaded on 1 single component (respectively 67% and 63% of variance). Correlations between eHEALS and age and education were not found. Significant, though weak, correlations were found between the eHEALS and quantity of Internet use (r = .24, P = .001 and r = .24, P = .02, respectively). Contrary to expectations, correlations between the eHEALS and successfully completed tasks on a performance test were weak and nonsignificant: r = .18 (P = .09). The t tests showed no significant differences in scores on the eHEALS between participants who scored below and above median scores of the performance test. CONCLUSIONS: The eHEALS was assessed as unidimensional in a principal component analysis and the internal consistency of the scale was high, which makes the reliability adequate. However, findings suggest that the validity of the eHEALS instrument requires further study, since the relationship with Internet use was weak and expected relationships with age, education, and actual performance were not significant. Further research to develop a self-report instrument with high correlations with people's actual eHealth literacy skills is warranted.