title: Psychometric validation of the Psoriasis Symptom Diary using Phase III study data from patients with chronic plaque psoriasis. The Worst Itch Numeric Rating Scale for patients with moderate to severe plaque psoriasis or psoriatic arthritis. Discriminant validity, responsiveness and reliability of the arthritis-specific Work Productivity Survey assessing workplace and household productivity in patients with psoriatic arthritis Development of a methodological PubMed search filter for finding studies on measurement properties of measurement instruments Patient Global Assessment in Psoriatic Arthritis: A Multicenter GRAPPA and OMERACT Study Minimally Important Difference of Health Assessment Questionnaire in Psoriatic Arthritis: Relating Thresholds of Improvement in Functional Ability to Patient-rated Importance and Satisfaction The impact of a revised EQ-5D population scoring on preference-based utility scores in an inflammatory arthritis cohort. Is ASDAS better than BASDAI as a measure of disease activity in axial psoriatic arthritis? Use of “spydergrams” to present and interpret SF-36 health-related quality of life data across rheumatic diseases Responsiveness of health status instruments to changes in articular status and perceived health in patients with psoriatic arthritis. Consensus on a core set of domains for psoriatic arthritis. Validation of the Psoriasis Symptom Inventory (PSI), a patient-reported outcome measure to assess psoriasis symptom severity Systematic literature review of domains assessed in psoriatic arthritis to inform the update of the psoriatic arthritis core domain set
abstract: OBJECTIVES This analysis aim ed to confirm the reliability , validity , and responsiveness of the Psoriasis Symptom Diary ( PSD ) using data from two Phase III studies in patients with moderate to severe chronic plaque psoriasis . METHODS Data from two r and omized , double-blind , double-dummy , placebo-controlled , multicenter Phase III studies ( n = 820 ) assessing the efficacy and safety of secukinumab  were used . The PSD ( 24-h recall ; 0 - 10 numeric rating scale ) was electronically administered each evening . Test-retest reliability was determined using intraclass correlations . Construct validity hypotheses were evaluated via correlations with the Psoriasis Area and Severity Index ( PASI ) , Investigator 's Global Assessment ( IGA ) , Dermatology Life Quality Index ( DLQI ) , EuroQoL 5-Dimension Health Status Question naire , and Patient Global Impression of Change ( PGIC ) . Discriminating ability and responsiveness were evaluated by estimating mean differences and effect sizes between known groups ( using the PASI and IGA ) . Phase II-derived , anchor-based PGIC thresholds and cumulative distribution function ( CDF ) plots described meaningful change . RESULTS Items on the PSD yielded high intraclass coefficients ( > 0.90 ) . Correlations were in the anticipated direction and by week 12 were moderate to strong ( 0.41 - 0.73 ) in magnitude , demonstrating construct validity . Average PSD item scores differed predictably and significantly between known groups . Responsiveness effect size estimates were moderate to large ( 0.6 - 1.5 ) , and CDF plots showed the percentage of responders to be consistently higher in treatment than in placebo arms across the range of change in PSD scores . CONCLUSIONS The PSD is reliable , valid , and responsive , and represents a valid tool to enhance treatment decisions in patients with moderate to severe plaque psoriasis Plaque psoriasis ( PP ) and psoriatic arthritis ( PsA ) are autoinflammatory chronic conditions associated with skin involvement . Pruritus , or itching , is a prevalent and bothersome symptom in patients with PP and is associated with reduced health-related quality of life . The Worst Itch Numeric Rating Scale ( WI-NRS ) has been developed as a simple , single item with which to assess the patient-reported severity of this symptom at its most intense during the previous 24-hour period . Qualitative research was undertaken to assess the content validity of the WI-NRS . Patients with moderate to severe PP and patients with PsA were recruited from clinical sites in the USA . The qualitative research entailed two-part interviews , which began with concept elicitation to gain underst and ing of patients ' experiences of itching , followed by cognitive debriefing of the WI-NRS to assess the instrument 's underst and ability , clarity , and degree of appropriateness from the patient 's perspective . Twelve patients with PP and 22 with PsA participated in the study . Patients reported that itching was an important and relevant symptom of their psoriatic disease . The WI-NRS was reported to be complete and easy to underst and ; the recall period was considered appropriate , the response scale was familiar , and , overall , the instrument was found to be appropriate for assessing itching severity . Patient responses support the content validity of the WI-NRS . The psychometric properties of the tool will be evaluated in future studies Introduction The novel arthritis-specific Work Productivity Survey ( WPS ) was developed to estimate patient productivity limitations associated with arthritis within and outside the home , which is an unmet need in psoriatic arthritis ( PsA ) . The WPS has been vali date d in rheumatoid arthritis . This report assesses the discriminant validity , responsiveness and reliability of the WPS in adult-onset PsA. Methods Psychometric properties were assessed using data from the RAPID-PsA trial ( NCT01087788 ) investigating certolizumab pegol ( CZP ) efficacy and safety in PsA. WPS was completed at baseline and every 4 weeks until Week 24 . Validity was evaluated at baseline via known-groups defined using first and third quartiles of patients ’ Disease Activity Score 28 based on C-reactive protein ( DAS28(CRP ) ) , Health Assessment Question naire-Disability Index ( HAQ-DI ) , Short Form-36 ( SF-36 ) items and  PsA Quality of Life ( PsAQoL ) scores . Responsiveness and reliability were assessed by comparing WPS mean changes at Week 12 in American College of Rheumatology 20 % improvement criteria ( ACR20 ) or HAQ-DI Minimal Clinical ly Important Difference ( MCID ) 0.3 responders versus non-responders , as well as using st and ardized response means ( SRM ) . All comparisons were conducted on the observed cases in the R and omized Set , regardless of the r and omization group , using a non-parametric bootstrap-t method . Results Compared with patients with a better health state , patients with a worse health state had on average 2 to 6 times more household work days lost , more days with reduced household productivity , more days missed of family/social/leisure activities , more days with outside help hired and a significantly higher interference of arthritis per month . Among employed patients , those with a worse health state had 2 to 4 times more workplace days lost , more days with patient workplace productivity reduced , and a significantly higher interference of arthritis on patient workplace productivity versus patients with a better health state . WPS was also responsive to clinical changes , with responders having significantly larger improvements at Week 12 in WPS scores versus non-responders . The effect sizes for changes in productivity in ACR20 or HAQ-DI MCID responders were moderate ( 0.5 < SRM < 0.8 ) or small . Conclusions These analyses demonstrate the validity , responsiveness and reliability of the WPS , as an instrument for the measurement of patient productivity within and outside the home in an adult-onset PsA population Objectives For the measurement of  patient-reported outcomes , such as ( health-related ) quality of life , often many measurement instruments exist that intend to measure the same construct . To facilitate instrument selection , our aim was to develop a highly sensitive search filter for finding studies on measurement properties of measurement instruments in PubMed and a more precise search filter that needs less abstract s to be screened , but at a higher risk of missing relevant studies . Methods A r and om sample of 10,000 PubMed records ( 01 - 01 - 1990 to 31 - 12 - 2006 ) was used as a gold st and ard . Studies on measurement properties were identified using an exclusion filter and h and search ing . Search terms were selected from the relevant records in the gold st and ard as well as from 100 systematic review s of measurement properties and combined based on sensitivity and precision . The performance of the filters was tested in the gold st and ard as well as in two validation sets , by calculating sensitivity , precision , specificity , and number needed to read . Results We identified 116 studies on measurement properties in the gold st and ard . The sensitive search filter was able to retrieve 113 of these 116 studies ( sensitivity 97.4 % , precision 4.4 % ) . The precise search filter had a sensitivity of 93.1 % and a precision of 9.4 % . Both filters performed very well in the validation sets . Conclusion The use of these search filters will contribute to evidence -based selection of measurement instruments in all medical fields Objective . During OMERACT 8 , delegates selected patient global assessment ( PGA ) of disease as a domain to be evaluated in r and omized controlled trials in psoriatic arthritis ( PsA ) . This study assessed the reliability of the PGA , measured by means of 0–100 mm visual analog scale ( VAS ) , and the additional utility of separate VAS scales for joints ( PJA ) and skin ( PSA ) . Methods . In total , 319 consecutive patients with PsA ( 186 men , 133 women , mean age 51 ± 13 yrs ) were enrolled .  PGA , PJA , and PSA were administered at enrolment ( W0 ) and after 1 week ( W1 ) . Detailed clinical data , including ACR joint count , Psoriasis Area and Severity Index ( PASI ) , and Hospital Anxiety and Depression Scale , were recorded . Results . Comparison of W0 and W1 scores showed no significant variations ( intraclass correlation coefficients for PGA 0.87 , PJA 0.86 , PSA 0.78 ) , demonstrating the reliability of the instrument . PGA scores were not influenced by patient anxiety or depression , but were dependent on PJA and PSA ( p = 0.00001 ) . PJA was dependent on the number of swollen and tender joints ( p < 0.00001 ) . PSA scores were influenced by the extent of skin psoriasis and by h and skin involvement ( p = 0.00001 ) . Joint and skin disease were found not to correlate in terms of disease activity as evidence d by the swollen joint count compared to PASI ( r = 0.11 ) and by the PJA compared to PSA ( r = 0.38 ) . Conclusion . PGA assessed by means of VAS is a reliable tool related to joint and skin disease activity . Because joint and skin disease often diverge it is suggested that in some circumstances both PJA and PSA are also assessed Objective . To evaluate changes in function as measured by Health Assessment Question naire Disability Index ( HAQ-DI ) and the meaningfulness of the changes , in importance and satisfaction , in patients with psoriatic arthritis ( PsA ) . Methods . HAQ-DI was assessed at baseline and at Weeks 4 , 12 , and 24 in a r and omized double-blind study of 205 patients with active PsA receiving etanercept 25 mg twice weekly or placebo .  Concurrently , patients rated the importance of and satisfaction with their change in function on a 7-point scale ( 1 = not at all important/satisfied ; 7 = extremely important/satisfied ) . Mean HAQ-DI improvement corresponding to ratings of minimally ( 2–3 ) or very ( 6–7 ) important or satisfied was determined using a posthoc linear mixed-model analysis . Patient importance ratings were used as an anchor to estimate minimally important difference ( MID ) for HAQ-DI ; distribution-based estimates were also calculated . Results . A total of 161 patients ( 69 placebo ; 92 etanercept ) had ≥ 1 HAQ-DI scores showing improvement from baseline and a corresponding importance or satisfaction rating . HAQ-DI improvements corresponding to importance scale ratings of 2 or 3 were 0.335 ( 95 % CI 0.214 , 0.455 ) and 0.360 ( 95 % CI 0.263 , 0.456 ) , respectively , suggesting an MID of about 0.35 . HAQ-DI improvements corresponding to satisfaction scale ratings of 2 and 3 were 0.293 ( 95 % CI 0.230 , 0.357 ) and 0.360 ( 95 % CI 0.307 , 0.413 ) . For a given change in HAQ-DI , nearly two-thirds of patients indicated a lower rating for satisfaction than for importance . This trial was registered in the Clinical Trials.gov registry ( NCT00317499 ) . Conclusion . Our study suggests the MID for HAQ-DI in PsA is about 0.35 . The results may also provide insight into patient satisfaction with changes in function and expectations for therapy BACKGROUND AND OBJECTIVE It is well established that there are problems with the EQ-5D . This is due to the original scoring methods used and how negative time trade-off ( TTO ) values were treated . A revised scoring method has been published . This article applies this to an inflammatory arthritis cohort . The objective is to examine the impact of a revised scoring system for the EQ-5D ( UK ) TTO on the utility estimates and in the case of rheumatoid arthritis , to explore the impact of using different utility metrics on the incremental cost-effectiveness ratio ( ICER ) results of an economic model . METHODS A total of 504 patients with inflammatory arthritis were rescored using revised EQ-5D scoring , which uses an episodic r and om utility model to deal with negative TTO values . Differences in utility scores were compared and the new mapping coefficients were obtained . These were then used in an economic model to examine the impact on the ICER . RESULTS In rheumatoid arthritis , the overall change is less for the revised EQ-5D scoring than with the original EQ-5D ( TTO ) but greater than the SF-6D : EQ-5D UK -0.22 ( 95 % confidence interval [ CI ] -0.30 to -0.15 ) , revised EQ-5D UK -0.16 ( 95 % CI -0.21 to -0.10 ) and SF-6D -0.08 ( 95 % CI -0.11 to -0.05 ) . A similar trend is seen in the psoriatic arthritis group . The economic model produced different ICERs , when different utility measures were used ; EQ-5D ( TTO ) € 42,402 , SF-6D € 111,788 , and revised EQ-5D ( TTO ) € 57,747 . CONCLUSION In the context of inflammatory arthritis , this article demonstrates that a revised scoring for EQ-5D may have a significant impact on utility estimates and on the output of the economic model Objective To assess the discriminative ability and correlation of the Ankylosing Spondylitis Disease Activity Score ( ASDAS ) and Bath Ankylosing Spondylitis Activity Disease Activity Index ( BASDAI ) with disease activity in axial psoriatic arthritis ( AxPsA ) . Methods Patients with AxPsA were selected from a large prospect i ve cohort study of psoriatic arthritis . Patient and physician global scores were used as constructs of disease activity . Patients were categorised into high and low disease activity states based on patient and physician global assessment scores and physician 's decision to change treatment . Statistical analysis included descriptive statistics , linear and logistic regression . Results 201 patients with AxPsA were included in the study . ASDAS and BASDAI showed good correlation with disease activity as reflected by the patient global score ( correlation coefficients ( r ) for BASDAI 0.84 , ASDAS-B 0.77 , ASDAS-C 0.81 , p<0.001 ) and the physician global score ( r=0.53 for BASDAI , r=0.50 for ASDAS-B , r=0.55 for ASDAS-C , p<0.001 ) . Both scores showed good discriminative ability between high and low disease activity states . However , there were no significant differences between areas under the curve for the models that compared ASDAS with BASDAI for each definition of disease activity state . Conclusions In patients with AxPsA , ASDAS and BASDAI scores show similar good to moderate discriminative ability and correlation with different constructs of disease activity . ASDAS was not superior to BASDAI in its ability to discriminate between high and low disease activity states in The Medical Outcomes Study Short Form-36 ( SF-36 ) is a generic measure of health-related quality of life ( HRQOL ) , vali date d and cross-culturally translated , which has been extensively utilised in rheumatology . In r and omised controlled trials and observational studies , SF-36 provides rich data regarding HRQOL ; but as typically portrayed , patterns of disease and treatment-associated effects can be difficult to discern . “ Spydergrams ” offer a simplified means to visualise complex results across all domains of SF-36 in a single figure : depicting disease and population -specific patterns of decrements in HRQOL compared with age and gender-matched normative data , as well as providing a tool for interpreting complex treatment-associated or longitudinal changes . Utilising spydergrams as a st and ard format to illustrate and report changes in SF-36 across different rheumatic diseases can greatly facilitate analyses and interpretations of clinical trial results , as well as providing patients an accessible means to compare baseline scores and treatment-associated improvements with normative data from individuals without arthritis . Furthermore , SF-6D utility scores based on mean changes across all eight domains of SF-36 are suggested as a quantitative means of summarising changes illustrated by spydergrams , offering a universal metric for cost-effectiveness analyses of therapeutic interventions OBJECTIVE To compare the responsiveness of the Health Assessment Question naire ( HAQ ) , Arthritis Impact Measurement Scale 2 ( AIMS 2 ) , and Medical Outcome Study Short Form Health Survey ( SF-36 ) to changes in articular status and perceived health in out patients with psoriatic arthritis ( PsA ) . METHODS The 3 health status instruments were administered in r and om order on 2 occasions , about 12 - 18 months apart , to 70 patients attending the University of Toronto psoriatic arthritis clinic . St and ardized assessment s of disease activity , disease severity , and general health perceptions were also performed at each clinic visit . To assess responsiveness we used : ( 1 ) linear regression analyses to relate change scores for perceived health , the number of actively inflamed , and damaged joints to change scores for selected dimensions of the HAQ , AIMS 2 , and SF-36 ; ( 2 ) logistic regression analyses to relate both improvement in disease activity and disease progression to health status change scores ; and ( 3 ) st and ardized response means ( SRM ) . RESULTS There were 43 men and 27 women with a mean age of 46 years and arthritis duration of 13 years . Univariate regression analyses showed that the individual instruments were responsive to perceived changes in health , but relatively insensitive to detect changes in articular status . Multivariate regression analyses , in which the common dimensions of the instruments were jointly entered , indicated the SF-36 was equally or more responsive to changes in number of actively inflamed joints , clinical improvement in disease activity , and perceived health than the HAQ and AIMS 2 . The SRM analysis also suggested that the SF-36 was the most responsive . CONCLUSION The SF-36 proved equally or more responsive to short term changes in perceived health and inflammatory disease activity ; however , none of the instruments showed responsiveness to disease progression A  psoriatic arthritis ( PsA ) module was convened at OMERACT 8 in order to achieve consensus on the core domains that should be included in r and omized controlled trials and longitudinal observational cohorts of subjects with PsA. Following a plenary session at which current status of measures used to assess PsA were review ed , and discussion at breakout groups , the group achieved consensus on 6 core domains : peripheral joint activity , skin activity , pain , patient global assessment , physical function , and health-related quality of life . In addition the following domains were considered important but not m and atory : spinal disease , dactylitis , enthesitis , fatigue , nail disease , radiography , physician global assessment , and acute-phase reactants . A research agenda was proposed to include development and validation of instruments for the domains where none existed , and in particular further research was recommended for the following areas : magnetic resonance imaging and ultrasound of joints , enthesitis , skin and synovial tissue analysis , and " participation . Background : The objective of this study was to evaluate the measurement properties of the Psoriasis Symptom Inventory ( PSI ) , an eight-item patient-reported outcome measure for assessing severity of plaque psoriasis symptoms . Methods : In this prospect i ve , r and omized study using data from adults with moderate-to-severe plaque psoriasis , patients completed the PSI , Dermatology Life Quality Index ( DLQI ) , SF-36v2 Acute , and Patient Global Assessment ( PtGA ) . PSI construct validity was assessed using Spearman rank correlations between PSI and DLQI and SF-36 ; test-retest reliability and sensitivity to change were evaluated using PtGA as an anchor . Daily 24-h and weekly 7-day PSI versions were evaluated . Results : Eight US sites enrolled 143 patients ; 139 ( 97.2 % ) completed the study . All symptoms ( itch , redness , scaling , burning , cracking , stinging , flaking , and pain ) were reported across all response options ( not at all severe , mild , moderate , severe , very severe ) . Test-retest reliability was acceptable ( intraclass correlation coefficients range = 0.70–0.80 ) . A priori hypotheses of convergent and discriminant validity were confirmed by correlations of PSI with DLQI items and SF-36 domains . The PSI demonstrated good construct validity and was sensitive to within-subject change ( p < 0.0001 ) . Conclusions : The PSI is brief , valid , reproducible , and responsive to change and has the potential to be a useful PRO measure in psoriasis clinical trials The objectives of this systematic literature review ( SLR ) were to identify domains and outcome measures used in psoriatic arthritis ( PsA ) studies in the past 5 years , and to compare the measurement of the Outcome Measures in Rheumatology ( OMERACT ) 2006 PsA Core Domain Set in studies published in 2010–2015 vs those published in 2006–2010 . We performed a systematic literature search in two data bases , PubMed and Embase , to identify r and omised controlled trials ( RCTs ) in PsA. We also identified PsA longitudinal observational studies ( LOS ) . Three patient research partners provided input into study conception , and data collection and interpretation . We identified 41 studies representing 22 unique RCTs , 27 LOS and 12 registries . Across all studies , we identified 24 domains and 169 outcome measures . In addition to the PsA Core Domain Set ( 6 domains ) , the following domains were also assessed in more than 30 % of RCTs : acute phase reactants , dactylitis , enthesitis , fatigue and work productivity . We identified a range of 1–15 outcome measures per domain with a mean ( SD ) of 7 ( 4.7 ) per domain . The complete PsA Core Domain Set was assessed in 59 % of RCTs in 2010–2015 compared to 23.5 % RCTs in 2006–2010 . There has been increased measurement of the PsA Core Domain Set in RCTs and LOS in the past 5 years . Numerous additional outcomes were also measured . The PsA Core Domain Set needs an up date to st and ardise PsA outcome assessment s. This SLR will inform the development of an up date d PsA Core Domain Set with patient research partner input
target: CONCLUSIONS At least one PROM with some evidence for aspects of validity and reliability was available for six of the eight m and atory domains of the PsA COS
background: BACKGROUND An up date d psoriatic arthritis ( PsA ) core outcome set ( COS ) for r and omized controlled trials ( RCTs ) was endorsed at the Outcome Measures in Rheumatology ( OMERACT ) meeting in 2016 .
  OBJECTIVES To synthesize the evidence on measurement properties of patient reported outcome measures ( PROMs ) for PsA and thereby contribute to development of a PsA core outcome measurement set ( COMS ) as described by the OMERACT Filter 2.0 .