Patients' Experience of Myositis and Further Validation of a Myositis-specific Patient Reported Outcome Measure - Establishing Core Domains and Expanding Patient Input on Clinical Assessment in Myositis. Report from OMERACT 12.
OBJECTIVE
The Outcome Measures in Rheumatology (OMERACT) myositis working group was established to examine patient-reported outcomes (PRO) as well as to validate patient-reported outcome measures (PROM) in myositis.


METHODS
Qualitative studies using focus group interviews and cognitive debriefing of the myositis-specific Myositis Activities Profile (MAP) were used to explore the experience of adults living with polymyositis (PM) and dermatomyositis (DM).


RESULTS
Preliminary results underscore the importance of patient input in the development of PROM to ensure content validity. Results from multicenter focus groups indicate the range of symptoms experienced including pain, fatigue, and impaired cognitive function, which are not currently assessed in myositis. Preliminary cognitive debriefing of the MAP indicated that while content was deemed relevant and important, several activities were not included; and that questionnaire construction and wording may benefit from revision. A research agenda was developed to continue work toward optimizing PRO assessment in myositis with 2 work streams. The first would continue to conduct and analyze focus groups until saturation in the thematic analysis was achieved to develop a framework that encompassed the patient-relevant aspects of myositis. The second would continue cognitive debriefing of the MAP to identify potential areas for revision. There was agreement that further work would be needed for inclusion body myositis and juvenile dermatomyositis, and that the inclusion of additional contributors such as caregivers and individuals from the pharmaceutical/regulatory spheres would be desirable.


CONCLUSIONS
The currently used PROM do not assess symptoms or the effects of disease that are most important to patients; this emphasizes the necessity of patient involvement. Our work provides concrete examples for PRO identification.
From the Department of Occupational Therapy, Karolinska University Hospital; Department of Learning, Informatics and Medical Education, Karolinska Institutet, Stockholm, Sweden; Division of Rheumatology, Department of Medicine, Johns Hopkins University, Baltimore, Maryland, USA; Division of Rheumatology, Rheumatology Unit, Department of Medicine, Karolinska University Hospital in Solna, Stockholm, Sweden; Division of Rheumatology, Department of Internal Medicine, Medical Research Center, College of Medicine, Department of Molecular Medicine and Biopharmaceutical Sciences, Seoul National University, Seoul, Korea; Department of Care Science and Society, Division of Physiotherapy, Karolinska Institutet; and Department of Physical Therapy, Karolinska University Hospital, Stockholm, Sweden.M. Regardt, PhD, Occupational Therapist, Department of Occupational Therapy, Karolinska University Hospital, and Department of Learning, Informatics and Medical Education, Karolinska Institutet; P. Basharat, MD; L. Christopher-Stine, MD, Division of Rheumatology, Department of Medicine, Johns Hopkins University; C. Sarver, Patient Research Partner, Baltimore, Maryland, USA; A. Björn, Patient Research Partner, Stockholm, Sweden; I.E. Lundberg, MD, Division of Rheumatology, Rheumatology Unit, Department of Medicine, Karolinska University Hospital in Solna, Karolinska Institutet; Y. Wook Song, MD, Division of Rheumatology, Department of Internal Medicine, Medical Research Center, College of Medicine, Department of Molecular Medicine and Biopharmaceutical Sciences, Seoul National University; C.O. Bingham 3rd, MD, Division of Rheumatology, Department of Medicine, Johns Hopkins University; H. Alexanderson, Associate Professor, Physiotherapist, Department of Care Science and Society, Division of Physiotherapy, Karolinska Institutet, and Department of Physical Therapy, Karolinska University Hospital. malin.regardt@karolinska.se.
Malin
M
Regardt
From the Department of Occupational Therapy, Karolinska University Hospital; Department of Learning, Informatics and Medical Education, Karolinska Institutet, Stockholm, Sweden; Division of Rheumatology, Department of Medicine, Johns Hopkins University, Baltimore, Maryland, USA; Division of Rheumatology, Rheumatology Unit, Department of Medicine, Karolinska University Hospital in Solna, Stockholm, Sweden; Division of Rheumatology, Department of Internal Medicine, Medical Research Center, College of Medicine, Department of Molecular Medicine and Biopharmaceutical Sciences, Seoul National University, Seoul, Korea; Department of Care Science and Society, Division of Physiotherapy, Karolinska Institutet; and Department of Physical Therapy, Karolinska University Hospital, Stockholm, Sweden.M. Regardt, PhD, Occupational Therapist, Department of Occupational Therapy, Karolinska University Hospital, and Department of Learning, Informatics and Medical Education, Karolinska Institutet; P. Basharat, MD; L. Christopher-Stine, MD, Division of Rheumatology, Department of Medicine, Johns Hopkins University; C. Sarver, Patient Research Partner, Baltimore, Maryland, USA; A. Björn, Patient Research Partner, Stockholm, Sweden; I.E. Lundberg, MD, Division of Rheumatology, Rheumatology Unit, Department of Medicine, Karolinska University Hospital in Solna, Karolinska Institutet; Y. Wook Song, MD, Division of Rheumatology, Department of Internal Medicine, Medical Research Center, College of Medicine, Department of Molecular Medicine and Biopharmaceutical Sciences, Seoul National University; C.O. Bingham 3rd, MD, Division of Rheumatology, Department of Medicine, Johns Hopkins University; H. Alexanderson, Associate Professor, Physiotherapist, Department of Care Science and Society, Division of Physiotherapy, Karolinska Institutet, and Department of Physical Therapy, Karolinska University Hospital.
Pari
P
Basharat
From the Department of Occupational Therapy, Karolinska University Hospital; Department of Learning, Informatics and Medical Education, Karolinska Institutet, Stockholm, Sweden; Division of Rheumatology, Department of Medicine, Johns Hopkins University, Baltimore, Maryland, USA; Division of Rheumatology, Rheumatology Unit, Department of Medicine, Karolinska University Hospital in Solna, Stockholm, Sweden; Division of Rheumatology, Department of Internal Medicine, Medical Research Center, College of Medicine, Department of Molecular Medicine and Biopharmaceutical Sciences, Seoul National University, Seoul, Korea; Department of Care Science and Society, Division of Physiotherapy, Karolinska Institutet; and Department of Physical Therapy, Karolinska University Hospital, Stockholm, Sweden.M. Regardt, PhD, Occupational Therapist, Department of Occupational Therapy, Karolinska University Hospital, and Department of Learning, Informatics and Medical Education, Karolinska Institutet; P. Basharat, MD; L. Christopher-Stine, MD, Division of Rheumatology, Department of Medicine, Johns Hopkins University; C. Sarver, Patient Research Partner, Baltimore, Maryland, USA; A. Björn, Patient Research Partner, Stockholm, Sweden; I.E. Lundberg, MD, Division of Rheumatology, Rheumatology Unit, Department of Medicine, Karolinska University Hospital in Solna, Karolinska Institutet; Y. Wook Song, MD, Division of Rheumatology, Department of Internal Medicine, Medical Research Center, College of Medicine, Department of Molecular Medicine and Biopharmaceutical Sciences, Seoul National University; C.O. Bingham 3rd, MD, Division of Rheumatology, Department of Medicine, Johns Hopkins University; H. Alexanderson, Associate Professor, Physiotherapist, Department of Care Science and Society, Division of Physiotherapy, Karolinska Institutet, and Department of Physical Therapy, Karolinska University Hospital.
Lisa
L
Christopher-Stine
From the Department of Occupational Therapy, Karolinska University Hospital; Department of Learning, Informatics and Medical Education, Karolinska Institutet, Stockholm, Sweden; Division of Rheumatology, Department of Medicine, Johns Hopkins University, Baltimore, Maryland, USA; Division of Rheumatology, Rheumatology Unit, Department of Medicine, Karolinska University Hospital in Solna, Stockholm, Sweden; Division of Rheumatology, Department of Internal Medicine, Medical Research Center, College of Medicine, Department of Molecular Medicine and Biopharmaceutical Sciences, Seoul National University, Seoul, Korea; Department of Care Science and Society, Division of Physiotherapy, Karolinska Institutet; and Department of Physical Therapy, Karolinska University Hospital, Stockholm, Sweden.M. Regardt, PhD, Occupational Therapist, Department of Occupational Therapy, Karolinska University Hospital, and Department of Learning, Informatics and Medical Education, Karolinska Institutet; P. Basharat, MD; L. Christopher-Stine, MD, Division of Rheumatology, Department of Medicine, Johns Hopkins University; C. Sarver, Patient Research Partner, Baltimore, Maryland, USA; A. Björn, Patient Research Partner, Stockholm, Sweden; I.E. Lundberg, MD, Division of Rheumatology, Rheumatology Unit, Department of Medicine, Karolinska University Hospital in Solna, Karolinska Institutet; Y. Wook Song, MD, Division of Rheumatology, Department of Internal Medicine, Medical Research Center, College of Medicine, Department of Molecular Medicine and Biopharmaceutical Sciences, Seoul National University; C.O. Bingham 3rd, MD, Division of Rheumatology, Department of Medicine, Johns Hopkins University; H. Alexanderson, Associate Professor, Physiotherapist, Department of Care Science and Society, Division of Physiotherapy, Karolinska Institutet, and Department of Physical Therapy, Karolinska University Hospital.
Catherine
C
Sarver
From the Department of Occupational Therapy, Karolinska University Hospital; Department of Learning, Informatics and Medical Education, Karolinska Institutet, Stockholm, Sweden; Division of Rheumatology, Department of Medicine, Johns Hopkins University, Baltimore, Maryland, USA; Division of Rheumatology, Rheumatology Unit, Department of Medicine, Karolinska University Hospital in Solna, Stockholm, Sweden; Division of Rheumatology, Department of Internal Medicine, Medical Research Center, College of Medicine, Department of Molecular Medicine and Biopharmaceutical Sciences, Seoul National University, Seoul, Korea; Department of Care Science and Society, Division of Physiotherapy, Karolinska Institutet; and Department of Physical Therapy, Karolinska University Hospital, Stockholm, Sweden.M. Regardt, PhD, Occupational Therapist, Department of Occupational Therapy, Karolinska University Hospital, and Department of Learning, Informatics and Medical Education, Karolinska Institutet; P. Basharat, MD; L. Christopher-Stine, MD, Division of Rheumatology, Department of Medicine, Johns Hopkins University; C. Sarver, Patient Research Partner, Baltimore, Maryland, USA; A. Björn, Patient Research Partner, Stockholm, Sweden; I.E. Lundberg, MD, Division of Rheumatology, Rheumatology Unit, Department of Medicine, Karolinska University Hospital in Solna, Karolinska Institutet; Y. Wook Song, MD, Division of Rheumatology, Department of Internal Medicine, Medical Research Center, College of Medicine, Department of Molecular Medicine and Biopharmaceutical Sciences, Seoul National University; C.O. Bingham 3rd, MD, Division of Rheumatology, Department of Medicine, Johns Hopkins University; H. Alexanderson, Associate Professor, Physiotherapist, Department of Care Science and Society, Division of Physiotherapy, Karolinska Institutet, and Department of Physical Therapy, Karolinska University Hospital.
Anita
A
Björn
From the Department of Occupational Therapy, Karolinska University Hospital; Department of Learning, Informatics and Medical Education, Karolinska Institutet, Stockholm, Sweden; Division of Rheumatology, Department of Medicine, Johns Hopkins University, Baltimore, Maryland, USA; Division of Rheumatology, Rheumatology Unit, Department of Medicine, Karolinska University Hospital in Solna, Stockholm, Sweden; Division of Rheumatology, Department of Internal Medicine, Medical Research Center, College of Medicine, Department of Molecular Medicine and Biopharmaceutical Sciences, Seoul National University, Seoul, Korea; Department of Care Science and Society, Division of Physiotherapy, Karolinska Institutet; and Department of Physical Therapy, Karolinska University Hospital, Stockholm, Sweden.M. Regardt, PhD, Occupational Therapist, Department of Occupational Therapy, Karolinska University Hospital, and Department of Learning, Informatics and Medical Education, Karolinska Institutet; P. Basharat, MD; L. Christopher-Stine, MD, Division of Rheumatology, Department of Medicine, Johns Hopkins University; C. Sarver, Patient Research Partner, Baltimore, Maryland, USA; A. Björn, Patient Research Partner, Stockholm, Sweden; I.E. Lundberg, MD, Division of Rheumatology, Rheumatology Unit, Department of Medicine, Karolinska University Hospital in Solna, Karolinska Institutet; Y. Wook Song, MD, Division of Rheumatology, Department of Internal Medicine, Medical Research Center, College of Medicine, Department of Molecular Medicine and Biopharmaceutical Sciences, Seoul National University; C.O. Bingham 3rd, MD, Division of Rheumatology, Department of Medicine, Johns Hopkins University; H. Alexanderson, Associate Professor, Physiotherapist, Department of Care Science and Society, Division of Physiotherapy, Karolinska Institutet, and Department of Physical Therapy, Karolinska University Hospital.
Ingrid E
IE
Lundberg
From the Department of Occupational Therapy, Karolinska University Hospital; Department of Learning, Informatics and Medical Education, Karolinska Institutet, Stockholm, Sweden; Division of Rheumatology, Department of Medicine, Johns Hopkins University, Baltimore, Maryland, USA; Division of Rheumatology, Rheumatology Unit, Department of Medicine, Karolinska University Hospital in Solna, Stockholm, Sweden; Division of Rheumatology, Department of Internal Medicine, Medical Research Center, College of Medicine, Department of Molecular Medicine and Biopharmaceutical Sciences, Seoul National University, Seoul, Korea; Department of Care Science and Society, Division of Physiotherapy, Karolinska Institutet; and Department of Physical Therapy, Karolinska University Hospital, Stockholm, Sweden.M. Regardt, PhD, Occupational Therapist, Department of Occupational Therapy, Karolinska University Hospital, and Department of Learning, Informatics and Medical Education, Karolinska Institutet; P. Basharat, MD; L. Christopher-Stine, MD, Division of Rheumatology, Department of Medicine, Johns Hopkins University; C. Sarver, Patient Research Partner, Baltimore, Maryland, USA; A. Björn, Patient Research Partner, Stockholm, Sweden; I.E. Lundberg, MD, Division of Rheumatology, Rheumatology Unit, Department of Medicine, Karolinska University Hospital in Solna, Karolinska Institutet; Y. Wook Song, MD, Division of Rheumatology, Department of Internal Medicine, Medical Research Center, College of Medicine, Department of Molecular Medicine and Biopharmaceutical Sciences, Seoul National University; C.O. Bingham 3rd, MD, Division of Rheumatology, Department of Medicine, Johns Hopkins University; H. Alexanderson, Associate Professor, Physiotherapist, Department of Care Science and Society, Division of Physiotherapy, Karolinska Institutet, and Department of Physical Therapy, Karolinska University Hospital.
Yeong
Y
Wook Song
From the Department of Occupational Therapy, Karolinska University Hospital; Department of Learning, Informatics and Medical Education, Karolinska Institutet, Stockholm, Sweden; Division of Rheumatology, Department of Medicine, Johns Hopkins University, Baltimore, Maryland, USA; Division of Rheumatology, Rheumatology Unit, Department of Medicine, Karolinska University Hospital in Solna, Stockholm, Sweden; Division of Rheumatology, Department of Internal Medicine, Medical Research Center, College of Medicine, Department of Molecular Medicine and Biopharmaceutical Sciences, Seoul National University, Seoul, Korea; Department of Care Science and Society, Division of Physiotherapy, Karolinska Institutet; and Department of Physical Therapy, Karolinska University Hospital, Stockholm, Sweden.M. Regardt, PhD, Occupational Therapist, Department of Occupational Therapy, Karolinska University Hospital, and Department of Learning, Informatics and Medical Education, Karolinska Institutet; P. Basharat, MD; L. Christopher-Stine, MD, Division of Rheumatology, Department of Medicine, Johns Hopkins University; C. Sarver, Patient Research Partner, Baltimore, Maryland, USA; A. Björn, Patient Research Partner, Stockholm, Sweden; I.E. Lundberg, MD, Division of Rheumatology, Rheumatology Unit, Department of Medicine, Karolinska University Hospital in Solna, Karolinska Institutet; Y. Wook Song, MD, Division of Rheumatology, Department of Internal Medicine, Medical Research Center, College of Medicine, Department of Molecular Medicine and Biopharmaceutical Sciences, Seoul National University; C.O. Bingham 3rd, MD, Division of Rheumatology, Department of Medicine, Johns Hopkins University; H. Alexanderson, Associate Professor, Physiotherapist, Department of Care Science and Society, Division of Physiotherapy, Karolinska Institutet, and Department of Physical Therapy, Karolinska University Hospital.
Clifton O
CO
Bingham
From the Department of Occupational Therapy, Karolinska University Hospital; Department of Learning, Informatics and Medical Education, Karolinska Institutet, Stockholm, Sweden; Division of Rheumatology, Department of Medicine, Johns Hopkins University, Baltimore, Maryland, USA; Division of Rheumatology, Rheumatology Unit, Department of Medicine, Karolinska University Hospital in Solna, Stockholm, Sweden; Division of Rheumatology, Department of Internal Medicine, Medical Research Center, College of Medicine, Department of Molecular Medicine and Biopharmaceutical Sciences, Seoul National University, Seoul, Korea; Department of Care Science and Society, Division of Physiotherapy, Karolinska Institutet; and Department of Physical Therapy, Karolinska University Hospital, Stockholm, Sweden.M. Regardt, PhD, Occupational Therapist, Department of Occupational Therapy, Karolinska University Hospital, and Department of Learning, Informatics and Medical Education, Karolinska Institutet; P. Basharat, MD; L. Christopher-Stine, MD, Division of Rheumatology, Department of Medicine, Johns Hopkins University; C. Sarver, Patient Research Partner, Baltimore, Maryland, USA; A. Björn, Patient Research Partner, Stockholm, Sweden; I.E. Lundberg, MD, Division of Rheumatology, Rheumatology Unit, Department of Medicine, Karolinska University Hospital in Solna, Karolinska Institutet; Y. Wook Song, MD, Division of Rheumatology, Department of Internal Medicine, Medical Research Center, College of Medicine, Department of Molecular Medicine and Biopharmaceutical Sciences, Seoul National University; C.O. Bingham 3rd, MD, Division of Rheumatology, Department of Medicine, Johns Hopkins University; H. Alexanderson, Associate Professor, Physiotherapist, Department of Care Science and Society, Division of Physiotherapy, Karolinska Institutet, and Department of Physical Therapy, Karolinska University Hospital.
Helene
H
Alexanderson
D000223:Adaptation, Psychological; D000328:Adult; D003245:Consensus Statements as Topic; D005221:Fatigue / Q000453:epidemiology / Q000503:physiopathology; D005260:Female; D017144:Focus Groups; D006801:Humans; D007407:Interviews as Topic; D008297:Male; D008875:Middle Aged; D009220:Myositis / Q000175:diagnosis / Q000523:psychology* / Q000628:therapy*; D010147:Pain Measurement; D063868:Patient Outcome Assessment; D011788:Quality of Life; D012720:Severity of Illness Index; D013315:Stress, Psychological; D013548:Sweden
MYOSITIS; OMERACT; OUTCOME AND PROCESS ASSESSMENT; PATIENT-REPORTED OUTCOMES