Validation of the ANCA-associated vasculitis patient-reported outcomes (AAV-PRO) questionnaire.

OBJECTIVES: To finalise and validate a disease-specific patient-reported outcome (PRO) measure: the ANCA-associated vasculitis patient-reported outcome (AAV-PRO) questionnaire. Using a 35-item candidate questionnaire developed following 50 qualitative interviews in the UK, USA and Canada, a longitudinal survey was conducted to determine the final scale structure and validate the AAV-PRO. METHODS: Participants were recruited via Vasculitis UK and the Vasculitis Patient-Powered Research Network. The 35-item candidate questionnaire was completed at baseline and 3 months; UK participants completed the EuroQol-5D-5L (EQ-5D-5L), while US participants completed a test-retest exercise, 3-5 days after baseline. Scale structure was defined using exploratory factor analysis (EFA) and Rasch analysis. Convergent and known groups validity, test-retest reliability and longitudinal construct validity were assessed. RESULTS: There were 626 participants with AAV; >25% reporting 'active disease'. EFA and Rasch analysis supported a 29-item profile measure comprising six domains: 'organ-specific symptoms', 'systemic symptoms', 'treatment side effects', 'social and emotional impact', 'concerns about the future' and 'physical function'. Mean domain scores were higher for participants with 'active disease' versus 'remission' (p<0.001). Construct validity was demonstrated by correlations between domain scores and the EQ-5D-5L (range r=-0.55 to 0.78), all p<0.0001. In participants reporting 'no change' (n=97) during the test-retest, intraclass correlation coefficient values were high (range 0.89-0.96) for each domain. CONCLUSIONS: The AAV-PRO, a new disease-specific PRO measure for AAV, has good face and construct validity, is reliable, feasible and discriminates among disease states.

Patient perceptions of glucocorticoids in anti-neutrophil cytoplasmic antibody-associated vasculitis.

Granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA), and eosinophilic granulomatosis with polyangiitis (EGPA) are multisystem diseases of small blood vessels, collectively known as the anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitides (AAV). This study explores the patient's perspective on the use of glucocorticoids, which are still a mainstay of treatment in AAV. Patients with AAV from the UK, USA, and Canada were interviewed, using purposive sampling to include a range of disease manifestations and demographics. The project steering committee, including patient partners, designed the interview prompts and cues about AAV, its treatment, and impact on health-related quality of life. Interviews were transcribed and analysed to establish themes grounded in the data. A treatment-related code was used to focus analysis of salient themes related to glucocorticoid therapy. Fifty interviews were conducted. Individual themes related to therapy with glucocorticoids emerged from the data and were analysed. Three overarching themes emerged: (1) Glucocorticoids are effective at the time of diagnosis and during relapse, and withdrawal can potentiate a flare, (2) glucocorticoids are associated with salient emotional, physical, and social effects (depression, anxiety, irritation, weight gain and change in appearance, diabetes mellitus, effect on family and work); and (3) patient perceptions of balancing the risks and benefits of glucocorticoids. Patients identified the positive aspects of treatment with glucocorticoids; they are fast-acting and effective, but, they voiced concerns about adverse effects and the uncertainty of the dose-reduction process. These results may be informative in the development of novel glucocorticoid-sparing regimens.

Updating OMERACT Core Set of Domains for ANCA-associated Vasculitis: Patient Perspective Using the International Classification of Function, Disability, and Health.

OBJECTIVE: Aspects of antineutrophil cytoplasmic antibodies-associated vasculitis (AAV) prioritized by patients with AAV were described using the International Classification of Function, Disability, and Health (ICF). METHODS: Items identified during 14 individual interviews were incorporated into an ICF-based questionnaire administered to participants of 2 vasculitis patient symposia: 36 in the United Kingdom and 63 in the United States. RESULTS: Categories identified as at least "moderately relevant" by ≥ 5% of subjects included 44 body functions, 14 body structures, 35 activities and participation, 31 environmental factors, and 38 personal factors. CONCLUSION: Identified categories differ from those identified by the current Outcome Measures in Rheumatology (OMERACT) core set and those prioritized by vasculitis experts.

Feasibility and Construct Validation of the Patient Reported Outcomes Measurement Information System in Systemic Vasculitis.

OBJECTIVE: The Patient Reported Outcome Measurement Information System (PROMIS) is a collection of item banks of self-reported health. This study assessed the feasibility and construct validity of using PROMIS instruments in vasculitis. METHODS: Data from a multicenter longitudinal cohort of subjects with systemic vasculitis were used. Instruments from 10 PROMIS item banks were selected with direct involvement of patients. Subjects completed PROMIS instruments using computer adaptive testing (CAT). The Medical Outcomes Study Short Form-36 (SF-36) was also administered. Cross-sectional construct validity was assessed by calculating correlations of PROMIS scores with SF-36 measures and physician and patient global scores for disease activity. Longitudinal construct validity was assessed by correlations of between-visit differences in PROMIS scores with differences in other measures. RESULTS: During the study period, 973 subjects came for 2306 study visits and the PROMIS collection was completed at 2276 (99%) of visits. The median time needed to complete each PROMIS instrument ranged from 40 to 55 s. PROMIS instruments correlated cross-sectionally with individual scales of the SF-36, most strongly with subscales of the SF-36 addressing the same domain as the PROMIS instrument. For example, PROMIS fatigue correlated with both the physical component score (PCS; r = -0.65) and with the mental component score (MCS; r = -0.54). PROMIS physical function correlated strongly with PCS (r = 0.81) but weakly with MCS (r = 0.29). Weaker correlations were observed longitudinally between change in PROMIS scores with change in PCS and MCS. CONCLUSION: Collection of data using CAT PROMIS instruments is feasible among patients with vasculitis and has some cross-sectional and longitudinal construct validity.

Assessment of the intraday variability of anthropometric measurements in the work environment: a pilot study.

Sitting for long periods of time, both during work and leisure times, is the typical behavior of the modern society. Especially at work, where there is not much flexibility, adopting the sitting posture for the entire day can cause some short-term and long-term effects. As workers' productivity and well-being relies on working conditions, evaluating the effects caused by work postures assumes a very important role. The purpose of this article was to evaluate the variation of some anthropometric measurements during one typical workday to understand whether the known long-term effects can also be seen and quantified in an 8-h period. Twenty participants were measured before and after work, using traditional anthropometry equipment. The data from the two repetitions were compared using statistical tests. The results showed a slight variation in the anthropometric measurements, some with a tendency to increase over time and others with a tendency to decrease.

A comparison of manual anthropometric measurements with Kinect-based scanned measurements in terms of precision and reliability.

BACKGROUND: Collecting anthropometric data for real-life applications demands a high degree of precision and reliability. It is important to test new equipment that will be used for data collectionOBJECTIVE:Compare two anthropometric data gathering techniques - manual methods and a Kinect-based 3D body scanner - to understand which of them gives more precise and reliable results. METHODS: The data was collected using a measuring tape and a Kinect-based 3D body scanner. It was evaluated in terms of precision by considering the regular and relative Technical Error of Measurement and in terms of reliability by using the Intraclass Correlation Coefficient, Reliability Coefficient, Standard Error of Measurement and Coefficient of Variation. RESULTS: The results obtained showed that both methods presented better results for reliability than for precision. Both methods showed relatively good results for these two variables, however, manual methods had better results for some body measurements. CONCLUSION: Despite being considered sufficiently precise and reliable for certain applications (e.g. apparel industry), the 3D scanner tested showed, for almost every anthropometric measurement, a different result than the manual technique. Many companies design their products based on data obtained from 3D scanners, hence, understanding the precision and reliability of the equipment used is essential to obtain feasible results.

Health-related quality of life in ANCA-associated vasculitis and item generation for a disease-specific patient-reported outcome measure.

OBJECTIVE: The antineutrophil cytoplasmic antibody (ANCA)-associated vasculitides (AAVs) are multisystem diseases of the small blood vessels. Patients experience irreversible damage and psychological effects from AAV and its treatment. An international collaboration was created to investigate the impact of AAV on health-related quality of life (HRQoL), and develop a disease-specific patient-reported outcome measure to assess outcomes of importance to patients. METHODS: Patients with AAV from the UK, USA, and Canada were interviewed to identify salient aspects of HRQoL affected by AAV. The study was overseen by a steering committee including four patient research partners. Purposive sampling of interviewees ensured representation of a range of disease manifestations and demographics. Inductive analysis was used to identify themes of importance to patients; these were further confirmed by a free-listing exercise in the US. Individual themes were recast into candidate items, which were scrutinized by patients, piloted through cognitive interviews and received a linguistic and translatability evaluation. RESULTS: Fifty interviews, conducted to saturation, with patients from the UK, USA, and Canada, identified 55 individual themes of interest within seven broad domains: general health perceptions, impact on function, psychological perceptions, social perceptions, social contact, social role, and symptoms. Individual themes were constructed into >100 candidate questionnaire items, which were then reduced and refined to 35 candidate items. CONCLUSION: This is the largest international qualitative analysis of HRQoL in AAV to date, and the results have underpinned the development of 35 candidate items for a disease-specific, patient-reported outcome questionnaire.

Validation study of a Kinect based body imaging system.

BACKGROUND: Understanding the reliability and precision of the data obtained using three-dimensional body scanners is very important if it is intended to replace the traditional data collection methods. If the collection of anthropometric data with three-dimensional body scanners is a fast and reliable process that produces precise data at a low price, it could be used for numerous applications worldwide. Many studies have addressed data collected by white light and laser based scanners. OBJECTIVE: This study provides a comparative analysis between the anthropometric data collected using a Kinect body imaging system with the data collected using traditional manual methods. Moreover, a comparison is also made between the results obtained in this study and the results of previous studies of different types of body scanners. METHODS: The Mean Absolute Difference was calculated and all the values were compared to the maximum allowable error defined in ISO 20685. Additionally, an analysis of the significant differences between the two acquisition methods was also applied to a physical mannequin, to understand how the body movement and body stance variation in human participants impacts the results obtained. RESULTS: There are few body measurements that are close to this restricted allowable error. The results were better when the mannequin was measured. Although they were still above the ISO 20685 limit, they were much closer than the results obtained for human participants. CONCLUSION: The main cause of the differences between the two methods is the time required for the 3D system to acquire the data. The involuntary body sway of human participants is more difficult to control when the time span is too long.

Exploration, Development, and Validation of Patient-reported Outcomes in Antineutrophil Cytoplasmic Antibody-associated Vasculitis Using the OMERACT Process.

OBJECTIVE: Antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) is a group of linked multisystem life- and organ-threatening diseases. The Outcome Measures in Rheumatology (OMERACT) vasculitis working group has been at the forefront of outcome development in the field and has achieved OMERACT endorsement of a core set of outcomes for AAV. Patients with AAV report as important some manifestations of disease not routinely collected through physician-completed outcome tools; and they rate common manifestations differently from investigators. The core set includes the domain of patient-reported outcomes (PRO). However, PRO currently used in clinical trials of AAV do not fully characterize patients' perspectives on their burden of disease. The OMERACT vasculitis working group is addressing the unmet needs for PRO in AAV. METHODS: Current activities of the working group include (1) evaluating the feasibility and construct validity of instruments within the PROMIS (Patient-Reported Outcome Measurement Information System) to record components of the disease experience among patients with AAV; (2) creating a disease-specific PRO measure for AAV; and (3) applying The International Classification of Functioning, Disability and Health to examine the scope of outcome measures used in AAV. RESULTS: The working group has developed a comprehensive research strategy, organized an investigative team, included patient research partners, obtained peer-reviewed funding, and is using a considerable research infrastructure to complete these interrelated projects to develop evidence-based validated outcome instruments that meet the OMERACT filter of truth, discrimination, and feasibility. CONCLUSION: The OMERACT vasculitis working group is on schedule to achieve its goals of developing validated PRO for use in clinical trials of AAV.