Rehabilitation Teaching and Research Unit, Wellington School of Medicine and Health Sciences Outcome measures in psoriatic arthritis Preliminary identification.

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Presentation transcript:

Rehabilitation Teaching and Research Unit, Wellington School of Medicine and Health Sciences Outcome measures in psoriatic arthritis Preliminary identification of core domains using Delphi methodology William Taylor FRACP FAFRM for the Psoriatic Arthritis Working Group

Rehabilitation Teaching and Research Unit, Wellington School of Medicine and Health Sciences Background No agreed core outcome domains or measures for clinical studies of PsA Other rheumatic diseases have standard criteria for determining improvement in disease activity or response to therapy Initiation of the process alongside CASPAR meeting Oct 2002, aiming for OMERACT 2004

Rehabilitation Teaching and Research Unit, Wellington School of Medicine and Health Sciences Objectives To arrive at a consensus-based list of core domains that should be used in outcome studies of PsA, including: –Disease controlling anti-rheumatic therapy trials –Symptom modifying anti-rheumatic therapy trials –Clinical record keeping and observational studies –Rehabilitation intervention studies

Rehabilitation Teaching and Research Unit, Wellington School of Medicine and Health Sciences Methods - outline Review of existing instruments used to assess health status in PsA (Gladman et al, Arthritis Rheum) Development of a list of potential domains via discussion amongst steering committee of Psoriatic Arthritis Working Group Delphi process to rank and prioritize these domains amongst members of CASPAR plus others nominated by the steering committee

Rehabilitation Teaching and Research Unit, Wellington School of Medicine and Health Sciences Methods – Delphi 1 Jones J, Hunter D. Qualitative Research: Consensus methods for medical and health services research. BMJ 1995;311(7001): The features of consensus methods are anonymity, iteration, controlled feedback, statistical group response Useful when evidence on an issue is lacking or contradictory Delphi involves some kind of questionnaire to indicate agreement with particular issues, the group average and variation are then fed back on subsequent rounds to permit changes in participants’ opinions

Rehabilitation Teaching and Research Unit, Wellington School of Medicine and Health Sciences Methods – Delphi 2 The questionnaire requested 100 points to be distributed amongst 26 possible outcome domains, under the four measurement contexts The point allocation reflects the relative importance of that domain to the measurement context Three rounds were held by or fax

Rehabilitation Teaching and Research Unit, Wellington School of Medicine and Health Sciences Results - outline 32 from 54 rheumatologists with an interest in PsA responded to the first round 32 responded to 2 nd round; 29 responded to 3 rd round (last observation carried forward) Clear reduction in variability over the three rounds, but the relative ranking of domains didn’t alter a great deal

Rehabilitation Teaching and Research Unit, Wellington School of Medicine and Health Sciences DCART – results #1

Rehabilitation Teaching and Research Unit, Wellington School of Medicine and Health Sciences DCART – results #2

Rehabilitation Teaching and Research Unit, Wellington School of Medicine and Health Sciences DCART – results #3

Rehabilitation Teaching and Research Unit, Wellington School of Medicine and Health Sciences Conclusion - DCART The following domains are ranked highest: –Active joint count, xray damage, patient global, pain, physical function, acute phase response (score 7-12) Several other possible domains –Dactylitis, enthesitis, damaged joint count, skin disease, physician global, quality of life (score 5)

Rehabilitation Teaching and Research Unit, Wellington School of Medicine and Health Sciences SMARD – results #1

Rehabilitation Teaching and Research Unit, Wellington School of Medicine and Health Sciences SMARD – results #2

Rehabilitation Teaching and Research Unit, Wellington School of Medicine and Health Sciences SMARD – results #3

Rehabilitation Teaching and Research Unit, Wellington School of Medicine and Health Sciences SMARD - conclusion Highest scored domains (score 10 to 18) –pain, patient global assessment, physical function, quality of life and active joint count Other possible domains (scored 4 to 5) –morning stiffness, physician global assessment, enthesitis, dactylitis and fatigue

Rehabilitation Teaching and Research Unit, Wellington School of Medicine and Health Sciences Clinical record keeping – results #2

Rehabilitation Teaching and Research Unit, Wellington School of Medicine and Health Sciences Clinical record keeping – results #2

Rehabilitation Teaching and Research Unit, Wellington School of Medicine and Health Sciences Clinical record keeping – results #3

Rehabilitation Teaching and Research Unit, Wellington School of Medicine and Health Sciences Conclusions – clinical record keeping Three domains score highly (score 10) –pain, patient global assessment and actively inflamed joints Large number of others (score 4 to 5) –radiological damage, physical function, quality of life, morning stiffness, physician global assessment, skin disease, acute phase reactant, damaged joint count, enthesitis, dactylitis

Rehabilitation Teaching and Research Unit, Wellington School of Medicine and Health Sciences Rehabilitation – results #1

Rehabilitation Teaching and Research Unit, Wellington School of Medicine and Health Sciences Rehabilitation – results #2

Rehabilitation Teaching and Research Unit, Wellington School of Medicine and Health Sciences Rehabilitation – results #3

Rehabilitation Teaching and Research Unit, Wellington School of Medicine and Health Sciences Conclusion - rehabilitation The following domains are ranked highest: –Pain, patient global, physical function, quality of life, morning stiffness (score 10-15) Several other possible domains –Work incapacity, work limitations, observed physical performance, physician global (score 5-7)

Rehabilitation Teaching and Research Unit, Wellington School of Medicine and Health Sciences Final conclusion List of possible domains for discussion has been significantly shortened Now requires involvement of patient groups, broader rheumatology group, and industry Next step should probably be face-to-face discussion to refine the core lists (?when)