Systematic literature review of domains assessed in psoriatic arthritis to inform the update of the psoriatic arthritis core domain set A patient-initiated DMARD self-monitoring service for people with rheumatoid or psoriatic arthritis on methotrexate: a randomised controlled trial Quality of patient‐reported outcome reporting across cancer randomized controlled trials according to the CONSORT patient‐reported outcome extension: A pooled analysis of 557 trials Quality of reporting of harms in randomised controlled trials of pharmacological interventions for rheumatoid arthritis: a systematic review Patient-reported outcomes better discriminate active treatment from placebo in randomized controlled trials in rheumatoid arthritis. Which outcome measures should be used in rheumatoid arthritis clinical trials? Clinical and quality-of-life measures' responsiveness to treatment in a randomized controlled trial. Comparison of health-related quality of life in rheumatoid arthritis, psoriatic arthritis and psoriasis and effects of etanercept treatment Composing a new song for trials: the Standardized Outcomes in Nephrology (SONG) initiative. Evaluating the utility of a patient decision aid for potential participants of a prostate cancer trial (RAVES-TROG 08.03). Moving forward toward standardizing analysis of quality of life data in randomized cancer clinical trials The TICOPA protocol (TIght COntrol of Psoriatic Arthritis): a randomised controlled trial to compare intensive management versus standard care in early psoriatic arthritis Consensus on a core set of domains for psoriatic arthritis. Evaluation of Test Characteristics for Outcome Measures Used in Raynaud's Phenomenon Clinical Trials Content and Criterion Validity of the Preliminary Core Dataset for Clinical Trials in Fibromyalgia Syndrome The Utrecht cohort for Multiple BREast cancer intervention studies and Long-term evaLuAtion (UMBRELLA): objectives, design, and baseline results Risk of serious adverse events associated with biologic and nonbiologic psoriasis systemic therapy: patients ineligible vs eligible for randomized controlled trials. The development of candidate composite disease activity and responder indices for psoriatic arthritis (GRACE project)
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 Objective To determine the effectiveness of a patient-initiated disease-modifying antirheumatic drugs ( DMARD ) self-monitoring service for people with rheumatoid ( RA ) or psoriatic arthritis ( PsA ) on methotrexate .  Methods A two-arm , single-centre , r and omised controlled trial assessing superiority in relation to healthcare use , clinical and psychosocial outcomes . Participants were 100 adults with either RA or PsA on a stable dose of methotrexate , r and omly assigned to usual care or the patient-initiated service .  Intervention participants were trained how to underst and and interpret their blood tests and use this information to initiate care from their clinical nurse specialist ( CNS ) . The primary outcome was the number of outpatient visits to the CNS during the trial period . Differences between groups were analysed using Poisson regression models . Secondary outcomes were collected at baseline and after the third and sixth blood tests . Disease activity was measured using either the Disease Activity Score in 28 joints or Psoriatic Arthritis Response Criteria ( PsARC ) , pain and fatigue using a visual numeric scale and the Health Assessment Question -II , Hospital Anxiety and Depression Scale and SF12 were completed to assess disability , mood and quality of life , respectively . Differences between groups over time on secondary outcomes were analysed using multilevel models . Results The patient-initiated DMARD self-monitoring service was associated with 54.55 % fewer visits to the CNS ( p<0.0001 ) , 6.80 % fewer visits to the rheumatologist ( p=0.23 ) and 38.80 % fewer visits to the general practitioner ( p=0.07 ) , compared with control participants . There was no association between trial arm and any of the clinical or psychosocial outcomes . Conclusions The results suggest that a patient-initiated service that incorporates patients ’ self-monitoring DMARD therapy can lead to significant reductions in healthcare use , while maintaining clinical and psychosocial well-being . Trial registration number IS RCT N21613721 The main objectives of this study were to identify the number of r and omized controlled trials ( RCTs ) including a patient‐reported outcome ( PRO ) endpoint across a wide range of cancer specialties and to evaluate the completeness of PRO reporting according to the Consoli date d St and ards of Reporting Trials ( CONSORT ) PRO extension Background The quality of reporting of harms data in r and omised controlled trials ( RCTs ) has been reported to be suboptimal . Rheumatoid arthritis ( RA ) has seen a massive growth in novel pharmacotherapies in the last decade . Objective The aim of this study was to assess the quality of reporting of harms-related data  in RCTs evaluating pharmacological interventions for RA according to the CONSORT ( Consoli date d St and ards of Reporting Trials ) statement on harms reporting extension . Study selection RCTs published between January 2011 and August 2016 in the five highest impact factor journals in general medicine and two in rheumatology subject categories as per 2015 Journal Citation Reports were included . Reports of secondary , supplementary or exploratory analyses of RCTs and non-inferiority trials were excluded . Two review ers independently extracted data using a structured , pilot-tested , 18-item question naire developed based on CONSORT harms extension recommendations . Findings 68 RCTs were included in the review . Out of a maximum harms reporting score of 18 , the mean ( SD ) score was 8.51 ( 3.5 ) ( range=0–15 ) . More than half ( 56.5 % ) of the RCTs reported ≤50 % of items and only three ( 4.3 % ) RCTs reported more than 70 % ( score ≥14 ) of the items . Multilinear regression analyses found that region of trial origin ( p=0.01 ) , sample size ( p=0.001 ) and whether the study was a long-term extension of a trial or not ( p=0.04 ) were independent predictors associated with higher total harms reporting score . Conclusions The adherence to CONSORT harms extension was poor in recently published RCTs of pharmacological interventions for RA . There is a need to improve quality of harms reporting in RCTs to allow transparent and balanced assessment of the benefit-risk ratio in clinical decision making BACKGROUND Recent r and omized controlled trials ( RCTs ) in rheumatoid arthritis ( RA ) have used patient- and physician-reported outcomes , ESR and /or CRP as components of ACR response criteria to assess efficacy . OBJECTIVES Mean changes from baseline in patient- and physician-reported outcome measures , ESR and CRP were compared in two RCTs in patients with active RA . Comparisons between active and placebo treatment used mean percentage improvements and st and ard effect sizes ( SESs ) . RESULTS In both protocol s , patient-reported assessment s of disease activity , pain and physical function reflected little or no improvement with placebo , best discriminating between active and placebo therapy , as did ESR and CRP . CONCLUSION Improvements in signs and symptoms of active RA in placebo RCTs appear to be best reflected by patient-reported measures of physical function , as long as reported changes in global assessment s of disease activity and /or pain reflect similar benefit . Patient-reported outcome measures should be considered objective ; treatment-associated changes are congruent with measures of inflammation , and appear less susceptible to the placebo response OBJECTIVE To determine the discriminant validity of the core set of outcome measures proposed by the American College of Rheumatology ( ACR ) and the Outcome Measures in Clinical Trials ( OMERACT ) conference committee to be used in clinical trials of rheumatoid arthritis ( RA ) . METHODS Utilizing data from a multicenter r and omized double-blind clinical trial of low-dose cyclosporine and placebo in RA , we estimated the relative efficiency ( RE ) of measures to detect a treatment effect ( relative to tender joint count , which was assigned a value of 1 ) . Four pain measures ( 10-cm visual analog scale [ VAS ] , 5-point categorical scale , Health Assessment Question naire [ HAQ ] pain index , Arthritis Impact Measurement Scales [ AIMS ] pain score ) and 3 quality -of-life measures ( Problem Elicitation Technique [ PET ] , HAQ , AIMS )  were compared . RESULTS Physician and patient global measures were the most responsive instruments , although neither was statistically superior to tender joint count . Swollen joint count , grip strength , pain measured on a 10-cm VAS , and functional status as measured by the PET and HAQ were all of intermediate responsiveness . Morning stiffness , 5-point pain scale , and erythrocyte sedimentation rate were the least responsive instruments . CONCLUSION This study provides further evidence to support the core set of outcome measures proposed by the ACR and OMERACT Objectives To compare health-related quality of life ( HRQoL ) before and after treatment with etanercept in patients with moderate to severe rheumatoid arthritis ( RA ) , psoriatic arthritis ( PsA ) and psoriasis using spydergram representations . Methods Data from r and omised , controlled trials of etanercept in patients with RA , PsA and psoriasis were analysed . HRQoL was assessed by the medical outcomes survey short form 36 ( SF-36 ) physical ( PCS ) and mental ( MCS ) component summary and domain scores . Baseline comparisons with age and gender-matched norms and treatment-associated changes in domain scores were quantified using spydergrams and the health utility SF-6D measure . Results Mean baseline PCS scores were lower than age and gender-matched norms in patients with RA and PsA , but near normative values in patients with psoriasis ; MCS scores at baseline were near normal in PsA and psoriasis but low in RA . Treatment with etanercept result ed in improvements in PCS and MCS scores as well as individual SF-36 domains across all indications . Mean baseline SF-6D scores were higher in psoriasis than in RA or PsA ; clinical ly meaningful improvements in SF-6D were observed in all three patient population s following treatment with etanercept . Conclusions Patients with RA , PsA and psoriasis demonstrated unique HRQoL profiles at baseline . Treatment with etanercept was associated with improvements in PCS and MCS scores as well as individual domain scores in patients with RA , PsA and psoriasis R and omized trials provide the most reliable evidence about the safety and effectiveness of interventions to improve health care and patient outcomes . Unfortunately , the potential for trials to inform treatment decisions remains limited because the outcomes reported often do not resonate with what is directly meaningful and relevant to patients and their clinicians [ 1–3 ] . Further , inconsistent reporting of outcomes across trials prevents assessment of the comparative effect of interventions [ 4 ] . Outcome reporting bias , whereby authors cherry-pick the outcomes they report on the basis of favourable results , may also occur when there is not a st and ardized list of outcomes measured and reported [ 5 , 6 ] . Collectively these problems may undermine the reliability of published trials , leading to inefficient use of scarce research and health care re sources and unintended harm to patients [ 6 ] . Such dissonance in outcomes reported in trials is widespread and evident across all medical specialties . The growing recognition of the problem has prompted large-scale efforts to establish core outcome sets . Core outcome sets are an agreed st and ardized set of outcomes for a specific clinical area that are to be reported as a minimum in all trials in that area [ 7 ] . Outcomes are selected because they are critically important to all stakeholders — namely patients , their clinicians and policymakers— for decision making . Core outcome sets are not design ed to be comprehensive or exclusive . Typically they include only three to five outcomes . Other outcomes that are identified to be important ( i.e. to some stakeholder groups ) may also be recommended for some trials ( Figure 1 ) . The design ated primary outcome of any given trial may be outside the core outcome set and research ers may also opt to add other , trial-specific outcomes , chosen for reasons including responsiveness to the intervention and feasibility . Attempts to st and ardize outcomes began 50 years ago when the World Health Organization published recommendations for the minimum requirements for data collection in cancer trials [ 8 ] . In the 1990s , the Outcome Measures in Rheumatology ( OMERACT ) initiative was formed , and is perhaps the most widely recognized and largest initiative in the field of core outcome development . OMERACT engages patients and health professionals to st and ardize outcome measures for trials in rheumatology [ 9 ] and has pioneered method ologies for developing core outcome sets . The uptake of the OMERACT core outcome sets has improved the consistency of outcomes reported in trials [ 10 ] . In the past decade , core outcome sets in diverse medical specialties , including cardiology , dermatology , surgery , oncology , women ’s health and respiratory disease , have progressively been developed [ 7 , 9–11 ] . The use of core outcome sets is also increasingly being advocated by funders to ensure the relevance and potential impact of research . In the UK , funding organizations , including the National Institute for Health Research and the Health Research Board ( Irel and ) , advise research ers to include core outcome sets if they are available and highlight the  Core Outcome Measures in Effectiveness ( COMET ) data base of core outcomes as a key re source [ 7 ] . The COMET initiative was recently launched to facilitate the development , implementation and evaluation of core outcome sets [ 7 ] . There has been a long-st and ing need in nephrology to develop core outcomes [ 12–14 ] . More than 14 000 r and omized trials are available in the Cochrane Kidney and Transplant Specialised Register [ 15 ] and a search of Clinical Trials.gov trials for ‘ kidney disease ’ yields > 3000 ongoing trials . Despite this considerable investment in trials in nephrology , improvements in outcomes for patients with kidney disease have been modest at best . Across all stages of chronic kidney disease ( CKD ) , patients still have a markedly higher risk of mortality and serious comorbidities , including cardiovascular disease , diabetes , cancer and infection , compared with the general population [ 16–18 ] . Patients with CKD have poor quality of life , particularly if they are on dialysis , to the extent that many patients || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || R and omised controlled trials ( RCTs ) can be hampered by poor patient accrual and retention . Decision aids ( DAs ) containing simple , evidence -based information , may assist patients with decision-making regarding trial participation . The current DA was of use for 95 % of participants . Further evaluation of the DA in a RCT is currently underway Background There is currently a lack of consensus on how health-related quality of life and other patient-reported outcome measures in cancer r and omized clinical trials are analyzed and interpreted . This makes it difficult to compare results across r and omized controlled trials ( RCTs ) synthesize scientific research , and use that evidence to inform product labeling , clinical guidelines , and health policy . The Setting International St and ards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data for Cancer Clinical Trials ( SISAQOL ) Consortium aims to develop guidelines and recommendations to st and ardize analyses of patient-reported outcome data in cancer RCTs . Methods and Results Members from the SISAQOL Consortium met in January 2017 to discuss relevant issues . Data from systematic review s of the current state of published research in patient-reported outcomes in cancer RCTs indicated a lack of clear reporting of research hypothesis and analytic strategies , and inconsistency in definitions of terms , including “ missing data , ” “ health-related quality of life , ” and “ patient-reported outcome . ” Based on the meeting proceedings , the Consortium will focus on three key priorities in the coming year : developing a taxonomy of research objectives , identifying appropriate statistical methods to analyze patient-reported outcome data , and determining best practice s to evaluate and deal with missing data . Conclusion The quality of the Consortium guidelines and recommendations are informed and enhanced by the broad Consortium membership which includes regulators , patients , clinicians , and academics Background Psoriatic Arthritis ( PsA ) is estimated to occur in 10 - 15 % of people with psoriasis and accounts for 13 % of people attending early arthritis clinics . With an increasing awareness of the poor outcomes associated with PsA and the availability of new effective , but costly , treatments , there is an urgent need to research the optimal treatment for patients with PsA. The aim of the TICOPA study is to establish whether , in treatment naive early PsA patients , “ tight control ” intensive management with protocol driven therapies and pre-defined objective targets for treatment can improve clinical outcome compared to st and ard care alone . Methods / design TICOPA is a UK multicentre , open-label , r and omised controlled , parallel group trial of 206 patients with early PsA. Patients will be r and omised on a 1:1 basis to receive either st and ard care ( 12 weekly review ) or intensive management ( 4 weekly review ) for a period of 48 weeks . Patients assigned to the intensive management group will follow a strict treatment protocol whereby dose continuation/escalation is determined through the objective assessment of the minimal disease activity ( MDA ) criteria . Patients assigned to the st and ard care group will have treatment prescribed as felt appropriate by the treating clinician , with no set protocol . The primary objective of the trial is to compare intensive management with st and ard care  in terms of the proportion of patients achieving an ACR 20 response at 48 weeks post-r and omisation , in order to determine whether intensive management has superior clinical efficacy . Key secondary outcomes include ACR 50 and 70 , PASI 75 and X-ray Van der Heijde score at 48 weeks post-r and omisation along with cost-effectiveness at 12 , 24 and 28 weeks . Discussion The TICOPA trial will provide direct evidence as to whether the use of early and intensive treatment in PsA in routine clinical care leads to an improvement in patients ’ disease activity and a reduction in radiological joint damage . Trial registration IS RCT N30147736 , 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 . R and omized controlled trials ( RCTs ) in Raynaud 's phenomenon ( RP ) have shown conflicting efficacy data . Also , there is no consensus on the outcome measures that should be used . Our objectives were to assess the reliability of individual core set measures used in 3 RCTs , evaluate the placebo response for individual core set measures , and determine if a composite of individual core set measures will decrease the placebo response , which may improve our ability to see treatment effects in future trials Objective . Increasing research interest and emerging new therapies for treatment of fibromyalgia ( FM ) have led to a need to develop a consensus on a core set of outcome measures that should be assessed and reported in all clinical trials , to facilitate interpretation of the data and underst and ing of the disease . This aligns with the key objective of the Outcome Measures in Rheumatology ( OMERACT ) initiative to improve outcome measurement through a data driven , interactive consensus process . Methods . Through patient focus groups and Delphi processes , working groups at previous OMERACT meetings identified potential domains to be included in the core data set . A systematic review has shown that instruments measuring these domains are available and are at least moderately sensitive to change . Most instruments have been vali date d in multiple language s. This pooled analysis study aims to develop the core data set by analyzing data from 10 r and omized controlled trials ( RCT ) in FM . Results . Results from this study provide support for the inclusion of the following in the core data set : pain , tenderness , fatigue , sleep , patient global assessment , and multidimensional function/health related quality of life . Construct validity was demonstrated with outcome instruments showing convergent and divergent validity . Content and criterion validity were confirmed by multivariate analysis showing R square values between 0.4 and 0.6 . Low R square value is associated with studies in which one or more domains were not assessed . Conclusion . The core data set was supported by high consensus among attendees at OMERACT 9 . Establishing an international st and ard for RCT in FM should facilitate future metaanalyses and indirect comparisons Purpose In oncology , RCTs are often beset by slow recruitment , limited generalizability , and strong preferences for interventions by patients and physicians . The cohort multiple r and omized controlled trial ( cm RCT ) is an innovative design with the potential to overcome those challenges . In cm RCT , a prospect i ve cohort serves as an infrastructure for multiple RCTs . We implemented cm RCT in a clinical breast cancer setting by creating UMBRELLA — a large prospect i ve cohort of breast cancer and DCIS patients /survivors . Methods For all participants , clinical data and patient-reported outcomes ( PROs , i.e. , quality of life , fatigue , anxiety and depression , physical activity , work ability , and cosmetic satisfaction ) are being collected at regular time-intervals for a period of 10 years . These data are being used both for observational and r and omized studies . For each intervention to be tested against st and ard care , a subcohort of eligible patients is identified within UMBRELLA . From this subcohort , a r and om sample of patients is offered the intervention . Their outcomes are compared to the outcomes of patients receiving st and ard care . Results So far , between October 2013 and July 2016 , we have recruited 1308 participants . In this period , 1308/1486 ( 88 % ) patients who were invited for participation in UMBRELLA consented to cohort participation . Of these patients , 1138 ( 87 % ) gave broad consent for r and omization to future interventions . Return rate for PROs at baseline were 80 % , and varied from 67 to 74 % during follow-up . Several observational studies — and the first r and omized intervention study —are currently ongoing . Conclusions Results from UMBRELLA show that this novel study design is feasible and acceptable to patients in a clinical breast cancer setting . We invite research ers who are interested in conducting r and omized or observational studies within the UMBRELLA cohort to contact the UMBRELLA scientific advisory board OBJECTIVE To describe the use of systemic therapy for psoriasis  ( biologic and nonbiologic [ classic ] drugs ) in patients not adequately represented in r and omized controlled trials ( RCTs ) and the risk of serious adverse events ( SAEs ) in these patients . DESIGN A registry inception cohort was used . SETTING Thirteen dermatology departments in Spain participated . PATIENTS A consecutive sample of patients treated with biologics and a systematic sample of patients treated with classic systemic therapy  were evaluated . A total of 1042 patients ( 2179 person-years ) were included . EXPOSURE Inadequate representation in trials was defined as the presence of any of the following factors : elderly age ( > 70 years ) ; type of psoriasis other than chronic plaque psoriasis ; history of infection caused by hepatitis B , hepatitis C , or human immunodeficiency virus ; history of cancer ( excluding nonmelanoma skin cancer ) ; and chronic renal or hepatic disease . MAIN OUTCOME MEASURES Serious adverse events as defined by the International Conference on Harmonization were evaluated . RESULTS In all , 29.8 % of patients receiving systemic therapy for psoriasis would not have been eligible for RCTs . These individuals had an increased risk of SAEs ( incidence rate ratio , 2.7 ; 95 % CI , 1.5 - 4.7 ) . Patients exposed to biologics had an adjusted increased risk of SAEs ( incidence rate ratio , 2.3 ; 95 % CI , 1.1 - 4.8 ) that was similar in patients eligible and ineligible for RCTs . CONCLUSIONS Patients ineligible for RCTs are an important proportion ( 30 % ) of those receiving systemic therapy for psoriasis . These patients have a higher risk of SAEs and should be closely monitored . Patients exposed to biologics ( whether these patients are eligible for RCTs or ineligible ) are susceptible to the same increase in risk of SAEs , but biologics add to a higher baseline risk in patients who are ineligible for RCTs . The risk-benefit ratio in ineligible patients receiving biologics might be different from the ratio in eligible patients Objective To develop new composite disease activity indices for psoriatic arthritis ( PsA ) . Methods Data from routine clinic visits at multiple centres were collected in a systematic manner . Data included all domains identified as important in r and omised controlled trials in PsA. Decisions to change treatment were used as surrogates for high disease activity . New indices were developed by multiple linear regression ( psoriatic arthritis disease activity score : PASDAS ) and empirically , utilising physician-defined cut-offs for disease activity ( arithmetic mean of desirability functions : AMDF ) . These were compared with existing composite measures : Composite Psoriatic arthritis Disease Activity Index ( CPDAI ) , Disease Activity for PSoriatic Arthritis ( DAPSA ) , and Disease Activity Score for rheumatoid arthritis ( DAS28 ) . Results 161/503 ( 32 % ) subjects had treatment changes . Although all measures performed well , compared with existing indices , PASDAS was better able to discriminate between high and low disease activity ( area under receiver operating curves ( ROC ) ) curve with 95 % CI : PASDAS 0.773 ( 0.723 , 0.822 ) ; AMDF 0.730 ( 0.680 , 0.780 ) ; CPDAI 0.719 ( 0.668 , 0.770 ) ; DAPSA 0.710 ( 0.654 , 0.766 ) ; DAS28 0.736 ( 0.680 , 0.792 ) . All measures were able to discriminate between disease activity states in patients with oligoarthritis , although area under the receiver operating curves ( AUC ) were generally smaller . In patients with severe skin disease ( psoriasis area and severity index > 10 ) both nonparametric and AUC curve statistics were nonsignificant for all measures . Conclusions Two new composite measures to assess disease activity in PsA have been developed . Further testing in other data sets , including comparison with existing measures , is required to vali date these instruments
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 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 .