Systematic literature review of domains assessed in psoriatic arthritis to inform the update of the psoriatic arthritis core domain set A Preliminary Core Domain Set for Clinical Trials of Shoulder Disorders: A Report from the OMERACT 2016 Shoulder Core Outcome Set Special Interest Group Consensus on a core set of domains for psoriatic arthritis. Toward Development of a Fibromyalgia Responder Index and Disease Activity Score: OMERACT Module Update Content and Criterion Validity of the Preliminary Core Dataset for Clinical Trials in Fibromyalgia Syndrome Testing an OMERACT MRI Scoring System for Peripheral Psoriatic Arthritis in Cross-sectional and Longitudinal Settings Identifying Preliminary Domains to Detect and Measure Rheumatoid Arthritis Flares: Report of the OMERACT 10 RA Flare Workshop Patient Global Assessment in Psoriatic Arthritis: A Multicenter GRAPPA and OMERACT Study 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. Composing a new song for trials: the Standardized Outcomes in Nephrology (SONG) initiative. Preliminary core set of domains and reporting requirements for longitudinal observational studies in rheumatology. Development of a core outcome set for clinical trials in inflammatory bowel disease: study protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey Discriminant validity, responsiveness and reliability of the arthritis-specific Work Productivity Survey assessing workplace and household productivity in patients with psoriatic arthritis The TICOPA protocol (TIght COntrol of Psoriatic Arthritis): a randomised controlled trial to compare intensive management versus standard care in early psoriatic arthritis Safety and efficacy of adalimumab in treatment of patients with psoriatic arthritis who had failed disease modifying antirheumatic drug therapy. Predictors of unfavourable repeat biopsy results in men participating in a prospective active surveillance program. The development of candidate composite disease activity and responder indices for psoriatic arthritis (GRACE project) Development and validation of the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index Efficacy and safety of open-label etanercept on extended oligoarticular juvenile idiopathic arthritis, enthesitis-related arthritis and psoriatic arthritis: part 1 (week 12) of the CLIPPER study Clinical efficacy, radiographic and safety findings through 2 years of golimumab treatment in patients with active psoriatic arthritis: results from a long-term extension of the randomised, placebo-controlled GO-REVEAL study Protocol for the development of a core outcome set for pelvic girdle pain, including methods for measuring the outcomes: the PGP-COS study Influence of psoriatic arthritis on the efficacy of adalimumab and on the treatment response of other markers of psoriasis burden: subanalysis of the BELIEVE study. A randomized controlled trial of shared decision making for prostate cancer screening.
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 . The Outcome Measures in Rheumatology ( OMERACT ) Shoulder Core Outcome Set Special Interest Group ( SIG ) was established to develop a core outcome set ( COS ) for clinical trials of shoulder disorders . Methods . In preparation for OMERACT 2016 , we systematic ally examined all  outcome domains and measurement instruments reported in 409 r and omized trials of interventions for shoulder disorders published between 1954 and 2015 . Informed by these data , we conducted an international Delphi consensus study including shoulder trial experts , clinicians , and patients to identify key domains that should be included in a shoulder disorder COS . Findings were discussed at a stakeholder premeeting of OMERACT . At OMERACT 2016 , we sought consensus on a preliminary core domain set and input into next steps . Results . There were 13 and 15 participants at the premeeting and the OMERACT 2016 SIG meeting , respectively ( 9 attended both meetings ) . Consensus was reached on a preliminary core domain set consisting of an inner core of 4 domains : pain , physical function/activity , global perceived effect , and adverse events including death . A middle core consisted of 3 domains : emotional well-being , sleep , and participation ( recreation and work ) . An outer core of research required to inform the final COS was also formulated . Conclusion . Our next steps are to ( 1 ) analyze whether participation ( recreation and work ) should be in the inner core , ( 2 ) conduct a third Delphi round to finalize definitions and wording of domains and reach final endorsement for the domains , and ( 3 ) determine which instruments fulfill the OMERACT criteria for measuring each domain 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 . Following development of the core domain set for fibromyalgia ( FM ) in Outcome Measures in Rheumatology Clinical Trials ( OMERACT ) meetings 7 to 9 , the FM working group has progressed toward the development of an FM responder index and a disease activity score based on these domains , utilizing outcome indices of these domains from archived r and omized clinical trials in FM . Possible clinical domains that could be included in a responder index and disease activity score include pain , fatigue , sleep disturbance , cognitive dysfunction , mood disturbance , tenderness , stiffness , and functional impairment . Outcome measures for these domains demonstrate good to adequate psychometric properties , although measures of cognitive dysfunction need to be further developed . The approach used in the development of responder indices and disease activity scores for rheumatoid arthritis and ankylosing spondylitis represents heuristic models for our work , but FM is challenging in that there is no clear algorithm of treatment that defines disease activity based on treatment decisions , nor are there objective markers that define thresholds of severity or response to treatment . The process of developing c and i date dichotomous responder definitions and continuous quantitative disease activity measures is described , along with participant discussion s from OMERACT 10 . Final results of this work will be published in a separate report pending completion of analyses 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 Objective . Magnetic resonance imaging ( MRI ) is increasingly used to measure articular inflammation and damage in patients with psoriatic arthritis ( PsA ) . We evaluated the reliability of a new OMERACT PsA MRI scoring system  , PsAMRIS , in PsA fingers . Methods . In 2 separate studies , MRI scans were obtained from patients with clinical evidence of synovitis or dactylitis of the fingers . For the first cross-sectional study , images were obtained at one timepoint . For the second longitudinal study , images were obtained at 2 timepoints , 6 weeks apart . Scans were scored using PsAMRIS in an international multireader setting , for synovitis , tenosynovitis , periarticular inflammation , bone edema , bone erosions , and bone proliferation . Results . Global status scores from both data sets revealed moderate to high reliability for scoring most features , although reliability was poor for periarticular inflammation in the cross-sectional study . Change scores that reflected inflammatory activity also exhibited moderate to good reliability in the longitudinal exercise , despite there being very little absolute change in MRI synovitis or tenosynovitis observed in this data set . At the distal interphalangeal joints , reliability for change scores was acceptable only for synovitis and tenosynovitis . Conclusion . Further development and testing of the PsAMRIS is planned to improve its performance as a clinical and research tool to identify and measure pathology in peripheral joint Background . While disease flares in rheumatoid arthritis ( RA ) are a recognized aspect of the disease process , there is limited formative research to describe them . Methods . The Outcome Measures in Rheumatology Clinical Trials ( OMERACT ) RA Flare Definition Working Group is conducting an international research project to underst and the specific characteristics and impact of episodic disease worsening , or “ flare , ” so that outcome measures can be developed or modified to reflect this uncommonly measured , but very real and sometimes disabling RA disease feature . Patient research partners provided critical insights into the multidimensional nature of flare . The perspectives of patients and healthcare and research professionals are being integrated to ensure that any outcome measurement to detect flares fulfills the first OMERACT criteria of Truth . Through an iterative data -driven Delphi process , a preliminary list of key domains has been identified to evaluate flare . Results . At OMERACT 10 , consensus was achieved identifying features of flare in addition to the existing core set for RA , including fatigue , stiffness , symptom persistence , systemic features , and participation . Patient self-report of flare was identified as a component of the research agenda needed to establish criterion validity for a flare definition ; this can be used in prospect i ve studies to further evaluate the Discrimination and Feasibility components of the OMERACT filter for a flare outcome measure . Conclusion . Our work to date has provided better underst and ing of key aspects of the RA disease process as episodic , potentially disabling disease worsening even when a patient is in low disease activity . It also highlights the importance of developing ways to enhance communication between patients and clinicians and improve the ability to achieve “ tight control ” of disease 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 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 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 || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || Observational and longitudinal observational studies ( LOS ) provide essential information about the course and outcome of rheumatic disorders that can not be provided by r and omized controlled trials , and they constitute the major clinical scientific communication in rheumatology . There has been no consensus as to the full and appropriate content of LOS . This report defines a core set of domains and reporting requirements for LOS . At the 1998 OMERACT IV Conference a consensus process evaluated the literature of rheumatology in light of the constructs , variables , and outcomes of rheumatology by using introductory lectures , nominal groups , and plenary sessions . The result of this process was to identify 5 " core " domains that should be included in every LOS : Health Status , Disease Process , Damage , Mortality , and Toxicity/Adverse Reactions . Two additional domains , Work Disability and Costs , were recognized as important , but need not be used in all LOS . Eleven subdomains were identified that divided the domains into convenient clinical and conceptual units . A set of reporting requirements was also determined . The core recommendations , which follow on the WHO ICIDH-2 outline , are not disease-specific ; the substitution of different " disease process " and " damage " measures make them suitable for many rheumatic disorders . The core set is intended to serve as a core for LOS in almost all rheumatic conditions Introduction Crohn ’s disease ( CD ) and ulcerative colitis ( UC ) , the main forms of inflammatory bowel disease ( IBD ) , are chronic , progressive and disabling disorders of the gastrointestinal tract . Although data from r and omised controlled trials ( RCTs ) provide the foundation of evidence that vali date s medical therapy for IBD , considerable heterogeneity exists in the measured outcomes used in these studies . Furthermore , in recent years , there has been a paradigm shift in IBD treatment targets , moving from symptom-based scoring to improvement or normalisation of objective measures of inflammation such as endoscopic appearance , inflammatory biomarkers and histological and radiographic end points . The abundance of new treatment options and evolving end points poses opportunities and challenges for all stakeholders involved in drug development . Accordingly , there exists a need to harmonise measures used in clinical trials through the development of a core outcome set ( COS ) . Methods and analysis The development of an IBD-specific COS includes four steps . First , a systematic literature review is performed to identify outcomes previously used in IBD RCTs . Second , semistructured qualitative interviews are conducted with key stakeholders , including patients , clinicians , research ers , pharmaceutical industry representatives , healthcare payers and regulators to identify additional outcomes of importance . Using the outcomes generated from literature review and stakeholder interviews , an international two-round Delphi survey is conducted to prioritise outcomes for inclusion in the COS . Finally , a consensus meeting is held to ratify the COS and disseminate findings for application in future IBD trials . Ethics and dissemination Given that over 30 novel therapeutic compounds are in development for IBD treatment , the design of robust clinical trials measuring relevant and st and ardised outcomes is crucial . St and ardising outcomes through a COS will reduce heterogeneity in trial reporting , facilitate valid comparisons of new therapies and improve clinical trial quality 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 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 , OBJECTIVE To demonstrate the safety and efficacy of adalimumab for the treatment of active psoriatic arthritis ( PsA ) in patients with an inadequate response to disease modifying antirheumatic drugs ( DMARD ) . METHODS In a placebo controlled , double-blind , r and omized , multicenter study , patients were treated for 12 weeks with subcutaneous injections of adalimumab 40 mg every other week ( eow ) or placebo , followed by a period of open-label treatment with adalimumab 40 mg eow . The primary efficacy endpoint was the percentage of patients who met the American College of Rheumatology ( ACR20 ) core criteria at Week 12 . Secondary efficacy measures included the modified Psoriatic Arthritis Response Criteria ( PsARC ) and assessment s of disability , psoriatic lesions , and quality of life . For missing data , nonresponder imputation was used for ACR and PsARC scores and last observation carried forward for other measures . RESULTS A total of 100 patients received study drug ( 51  adalimumab  , 49 placebo )  . At Week 12 , an ACR20 response was achieved by 39 % of adalimumab patients versus 16 % of placebo patients ( p = 0.012 ) , and a PsARC response was achieved by 51 % with adalimumab versus 24 % with placebo ( p = 0.007 ) . At Week 12 , measures of skin lesions and disability were statistically significantly improved with adalimumab . After Week 12 , open-label adalimumab provided continued improvement for adalimumab patients and initiated rapid improvement for placebo patients , with ACR20 response rates of 65 % and 57 % , respectively , observed at Week 24 . Serious adverse events had similar frequencies during therapy with placebo ( 4.1 % ) , blinded adalimumab ( 2.0 % ) , and open-label adalimumab ( 3.1 % ) . No serious infections occurred during adalimumab therapy . CONCLUSION In this study of patients who had active PsA and a previous , inadequate response to DMARD therapy , adalimumab was well tolerated and significantly reduced the signs , symptoms , and disability of PsA during 12 weeks of blinded and 12 weeks of open-label therapy . Adalimumab also improved psoriasis in these patients BACKGROUND Active surveillance ( AS ) protocol s for low-risk prostate cancer ( PCa ) generally include repeat prostate biopsies at predefined follow-up intervals . OBJECTIVE To study the outcome of routinely obtained 1-yr repeat biopsies and factors predicting reclassification to higher risk , to contribute to risk stratification for men on AS . DESIGN , SETTING , AND PARTICIPANTS We analysed men with low-risk PCa ( clinical stage ≤ T2 , prostate-specific antigen ( PSA ) ≤ 10 ng/ml , PSA density < 0.2 ng/ml per millilitre , one or two positive biopsy cores , and Gleason score ≤ 6 ) who had been included in a prospect i ve AS protocol . INTERVENTIONS  PSA was measured 3-monthly and the first volume-dependent repeat biopsy was scheduled 1 yr after diagnosis , independent of PSA doubling time ( PSA-DT ) . Reclassification to higher risk disease on repeat biopsy was defined as Gleason score ≥ 7 or ≥ 3 positive cores . MEASUREMENTS We analysed whether baseline patient characteristics and PSA-DT were associated with reclassification to more aggressive PCa on repeat biopsy . RESULTS AND LIMITATIONS A first repeat biopsy was taken in 757 patients after median follow-up of 1.03 yr . The results of repeat biopsies were favourable ( no or low-risk PCa ) in 594 patients ( 78.5 % ) and led to reclassification of risk in 163 ( 21.5 % ) . Analysis showed that reclassification to higher risk was significantly influenced by the number of initial positive cores ( two vs one ) ( odds ratio [ OR ] : 1.8 ; p=0.002 ) and higher PSA density ( OR : 2.1 ; p=0.003 ) . The outcome was not significantly influenced by age , clinical stage , total number of biopsy cores , or PSA . Adding PSA-DT at time of repeat biopsy to the model showed PSA-DT <3 yr to be significantly associated with reclassification to higher risk ( OR : 1.7 ; p=0.015 ) . Data on tumour involvement per biopsy core were not available . CONCLUSIONS Clinical features at baseline and during follow-up in our AS cohort are significantly associated with short-term reclassification to higher risk on repeat biopsy . These characteristics can potentially be used for risk stratification of men with PCa who are apparently at favourable risk 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 Background : Enthesitis is a recommended core domain for assessment of ankylosing spondylitis ( AS ) , but no measurement has yet been vali date d according to Outcome Measures in Rheumatoid Arthritis Clinical Trials ( OMERACT ) criteria . Objective : The purpose of this study was to seek to vali date an enthesitis index for patients with AS according to OMERACT criteria . Methods : An enthesitis index was vali date d in two AS patient cohorts : ( 1 ) a longitudinal cohort ( n = 223 ) and ( 2 ) 22 patients from three Canadian sites participating in a 24-week r and omised placebo-controlled trial of adalimumab in AS . Construct validity was evaluated by correlation analysis with the Bath AS Disease Activity Index ( BASDAI ) , the Bath AS Functional Index ( BASFI ) and quality of life instruments . Reproducibility was assessed by intraclass correlation coefficient ( ICC ) , and responsiveness was assessed by Guyatt ’s effect size and st and ardised response mean . Results : The most frequently affected sites were the greater trochanter and supraspinatus insertion ( ∼20 % ) . Patients with enthesitis had significantly greater scores for the BASDAI , BASFI , patient global , AS-specific quality of life index ( ASQOL ) and the Short Form 36 ( SF-36 ) General Health Survey ( p<0.001 ) . The enthesitis score contributed significantly to variance in the BASDAI and BASFI . Interobserver ICCs were 0.96 in the longitudinal cohort and 0.89 and 0.77 in the adalimumab clinical trial cohort ( for status and change score , respectively ) . Significant differences in change scores were evident for all patients after 24 weeks of adalimumab treatment , ( p = 0.04 ) , this being more significant when a subset of the most commonly affected entheses were analysed ( p = 0.01 ) . Conclusion : AS patients with enthesitis constitute a more severe subset of disease , and the Spondyloarthritis Research Consortium of Canada ( SPARCC ) Enthesitis Index is feasible and reliable for measurement of this condition . Discrimination requires further study in larger trials Objective To investigate the efficacy and safety of etanercept ( ETN ) in paediatric subjects with extended oligoarticular juvenile idiopathic arthritis ( eoJIA ) , enthesitis-related arthritis ( ERA ) , or psoriatic arthritis ( PsA ) . Methods CLIPPER is an ongoing , Phase 3b , open-label , multicentre study ; the 12-week ( Part 1 ) data are reported here . Subjects with eoJIA ( 2–17 years ) , ERA ( 12–17 years ) , or PsA ( 12–17 years ) received ETN 0.8 mg/kg once weekly ( maximum 50 mg ) . Primary endpoint was the percentage of subjects achieving JIA American College of Rheumatology ( ACR ) 30 criteria at week 12 ; secondary outcomes included JIA ACR 50/70/90 and inactive disease . Results 122/127 ( 96.1 % ) subjects completed the study ( mean age 11.7 years ) . JIA ACR 30 ( 95 % CI ) was achieved by 88.6 % ( 81.6 % to 93.6 % ) of subjects overall ; 89.7 % ( 78.8 % to 96.1 % ) with eoJIA , 83.3 % ( 67.2 % to 93.6 % ) with ERA and 93.1 % ( 77.2 % to 99.2 % ) with PsA. For eoJIA , ERA , or PsA categories , the ORs of ETN vs the historical placebo data were 26.2 , 15.1 and 40.7 , respectively . Overall JIA ACR 50 , 70 , 90 and inactive disease were achieved by 81.1 , 61.5 , 29.8 and 12.1 % , respectively . Treatment-emergent adverse events ( AEs ) , infections , and serious AEs , were reported in 45 ( 35.4 % ) , 58 ( 45.7 % ) , and 4 ( 3.1 % ) , subjects , respectively . Serious AEs were one case each of abdominal pain , bronchopneumonia , gastroenteritis and pyelocystitis . One subject reported herpes zoster and another varicella . No differences in safety were observed across the JIA categories . Conclusions ETN treatment for 12 weeks was effective and well tolerated in paediatric subjects with eoJIA , ERA and PsA , with no unexpected safety findings Objectives To assess long-term golimumab efficacy/safety in patients with active psoriatic arthritis ( PsA ) . Methods Adult PsA patients ( ≥3 swollen , ≥3 tender joints , active psoriasis ) were r and omly assigned to subcutaneous injections of placebo , golimumab 50 mg or 100 mg every 4 weeks ( q4wks ) through week 20 . All patients received golimumab 50 or 100 mg beginning week 24 . Findings through 2 years are reported . Efficacy evaluations included ≥20 % improvement in American College of Rheumatology ( ACR20 ) response , good/moderate response in Disease Activity Scores incorporating 28 joints and C-reactive protein ( DAS28-CRP ) , ≥75 % improvement in Psoriasis Area and Severity Index ( PASI75 ) and changes in PsA-modified Sharp/van der Heijde scores ( SHS ) . Results Golimumab treatment through 2 years was effective in maintaining clinical response ( response rates : ACR20 63%–70 % , DAS28-CRP 77%–86 % , PASI75 56%–72 % ) and inhibiting radiographic progression ( mean change in PsA-modified SHS in golimumab-treated patients : −0.36 ) , with no clear difference between doses . No new safety signals were identified through 2 years . With the study 's tuberculosis screening and prophylactic measures , no patient developed active tuberculosis through 2 years . Conclusions Golimumab 50 and 100 mg for up to 2 years yielded sustained clinical and radiographic efficacy when administered to patients with active PsA. Increasing the golimumab dose from 50 to 100 mg q4wks added limited benefit . Golimumab safety through up to 2 years was consistent with other antitumour necrosis factor α agents used to treat PsA. Treatment of patients with latent tuberculosis identified at baseline appeared to be effective in inhibiting the development of active tuberculosis Background Pelvic Girdle Pain ( PGP ) is an important cause of disability and economic cost worldwide . There is a need for effective preventative and management strategies . Emerging studies measure a variety of outcomes rendering synthesis and translation to clinical practice difficult . A Core Outcome Set ( COS ) can address this problem by ensuring that data are relevant , useful and usable for making well-informed healthcare choices . The aim of this study is to develop a consensus-based PGP-COS , including agreement on methods ( e.g. instruments ) for measuring the construct outcomes in the COS for use in research and clinical practice . Furthermore , as there is uncertainty as to whether incorporating stakeholder interviews in addition to conducting a systematic review to determine an initial list of outcomes for the Delphi survey , or , whether using different rating scales in a Delphi survey impacts on the final COS , we propose to embed two method ological studies within the PGP-COS development process to address these questions . Methods The PGP-COS study will include five phases : ( 1 ) A systematic review of the literature and semi-structured interviews with 15 patients ( three countries ) to form the initial list of outcomes for the Delphi survey ; ( 2 ) A 3-round Delphi including patients , clinicians , research ers and service providers ; ( 3 ) A systematic review of methods for measuring the outcomes in the preliminary PGP-COS identified in the Delphi survey ; ( 4 ) A face-to-face consensus meeting to agree on the final PGP-COS and methods for measuring the COS ; ( 5 ) Global dissemination . To address the method ological questions , we will assess the number and type of outcomes , in the final PGP-COS , that were exclusively derived from the interviews . Secondly , we will r and omise Delphi survey participants to either a 5-point or 9-point importance rating scale , and examine potential differences in ‘ important ’ ratings between the groups . Discussion There is currently no COS for measuring/monitoring PGP in trials and clinical practice . A PGP-COS will ensure that relevant outcomes are measured using appropriate measurement instruments for patients with PGP globally . Core outcome set registration This PGP-COS was registered with COMET ( Core Outcome Measures for Effectiveness Trials ) in January 2017 ( http://www.comet-initiative.org/ studies /details/958 ) BACKGROUND Adalimumab is a fully human anti-TNF monoclonal antibody with demonstrated efficacy and safety in patients with moderate to severe psoriasis and psoriatic arthritis ( PsA ) . OBJECTIVE This study examined the effect of PsA on adalimumab treatment response in patients from the Phase IIIb BELIEVE trial ( NCT00574249 , Clinical Trials.gov registry ) , and response of other markers of disease burden to adalimumab  treatment . METHODS In this post hoc analysis , patients with or without a history of PsA and with moderate to severe psoriasis were r and omized to adalimumab plus adjunctive topical therapy ( calcipotriol/betamethasone dipropionate ) or monotherapy ( adalimumab plus matching topical vehicle ) . RESULTS Regardless of baseline PsA , improvement at Week 16 was seen in PASI 75 , pruritus , PSSI , and DLQI ( all patients ) , and mean NAPSI scores . Patients with PsA had HAQ improvement at Week 16 , and compared to patients without PsA , had higher VAS pain scores . This analysis represents the first publication of the influence of PsA and PsA plus body weight on patient response to adalimumab , and response of scalp psoriasis , nail psoriasis , and patient-reported outcomes to adalimumab . The incidence of AEs was similar among all patients ( 62 % ) , those with PsA ( 65 % ) and without PsA ( 60 % ) . The most common AEs were infections ( 27 % ) ; 4.2 % of all patients reported serious AEs . CONCLUSION Adalimumab treatment result ed in comprehensive , clinical ly relevant improvements from baseline PsA status , in skin , nails , quality of life , pain and pruritus . Despite having more severely affected disease and quality of life , patients with PsA did not respond to adalimumab significantly differently from patients without OBJECTIVE To evaluate a patient-educational approach to shared decision making for prostate cancer screening . DESIGN R and omized controlled trial with preoffice visit assessment and 2-week follow-up . SETTING University-based family practice center . PATIENTS Men aged 45 through 70 years with no history of prostate cancer or treatment for prostate disease ( N = 160 ) . Two patients were unavailable for follow-up . INTERVENTION Twenty-minute educational videotape on advantages and disadvantages of prostate-specific antigen ( PSA ) screening for prostate cancer . MAIN OUTCOME MEASURES A measure of patients ' core knowledge of prostate cancer developed for this study , reported preferences for PSA testing , and ratings of the videotape . RESULTS Patients '  core knowledge at baseline was poor . At 2-week follow-up , subjects undergoing videotape intervention showed a 78 % improvement in the number of knowledge questions answered correctly ( P = .001 ) , and knowledge increased about mortality due to early-stage prostate cancer , PSA screening performance , treatment-related complications , and disadvantages of screening . No overall change was observed for control subjects . At follow-up , 48 ( 62 % ) of 78 intervention patients planned to have the PSA test compared with 64 ( 80 % ) of 80 control patients ( 18.5 % absolute reduction ; 95 % confidence interval , 4.6%-32.4 % ; P = .009 ) . Intervention subjects rated favorably the amount of information provided and the clarity , balance , and length of the videotape and would recommend the videotape to others . CONCLUSIONS Patient education regarding the potential benefits and harms of early detection of prostate cancer can lead to more informed decision making . Incorporating the PSA videotape into the periodic health examination for asymptomatic men aged 50 years and older is recommended
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 .