10/30/2013. Disclosures. Defining Flares in RA RA Flare Group

Transcription

1 Disclosures Using PROMIS Instruments to Identify Disease Flares in People with Rheumatoid Arthritis S Bartlett is the Canadian delegate for PROMIS International Recipient of CIHR planning award for Canada PRO network Susan J. Bartlett, PhD Ana-Maria Orbai, MD Trisha Duncan, MD Clifton O. Bingham, MD ACR Annual Meeting - 30 October, 2013 Defining Flares in RA RA Flare Group RA flares are common 1-4 Episodes of increased disease activity beyond normal day-to-day variation Flare may mean different things to patients and healthcare professionals 4,5 No standardized definition until recently Since 2006, an international collaboration of 40+ researchers, clinicians, epidemiologists, biostatisticians, health professionals, patients working to develop a standardized RA flare measure Understanding the RA flare experience from the patient perspective is fundamental 1 Bingham et al, J Rheum 2009, ; 2 Bykerk et al., Annals Rheum Dis 2012, ; Alten et al. J Rheum 2011; 5 Bartlett et al., Annals Rheum Dis, 2012 RA Flare Domain Core Set Identification Inflammatory Flare.. when RA is so active that the patient needs to see the doctor or requires a change/increase in medication Patient research partners involved in all aspects 14 focus groups in 5 countries with 67 patients to identify common features of RA flares Separate Patient and HCP Delphis were conducted Final combined Delphi with 125 patients and 108 providers (23 countries) Hewlett et al., 2011; Bartlett et al., 2012 PATIENT STREAM HCP WORKSTREAM OMERACT 9 (2008) OMERACT 9 (2008) FOCUS GROUPS Patient DELPHI OMERACT 10 (2010) HCP DELPHI 1 HCP DELPHI 2 Combined DELPHI (N=233) OMERACT 11 (2012) RA Flare Core Domain Set Ratified 1

2 The Tipping Point Associated with Flares The Patient Perspective SEEK HELP RA Patients and Providers have Different Perspectives of Important Characteristics of Disease Flares Defined as uncontrollable Normal for me Flare as: Single joint Self-induced External cause Few bad days Flare diverted Early warnings of uncontrollable flare: Patterns and intensity may alter Symptoms are: Persistent Impacting Intense Clustered Unprovoked Self-Management increasing Uncertainty decreasing Hewlett S, et al, Rheumatology (Oxford) Bartlett SJ et al, Ann Rheum Dis 2012 PCORI Pilot Project PROMIS ) Hypothesis: Integrating PROs into routine care of RA patients will improve the assessment of a broader range of symptoms which may influence shared decision-making Objective: To evaluate the feasibility and impact of integrating expanded PRO assessment in a busy clinical practice setting Acceptability to Patients and Providers Integration within Practice Workflow Patient Physician Communication, Shared Decision-Making Satisfaction (Physicians, Patients, Staff) Performance of PROs in RA clinical care Developed using rigorous modern psychometric methods to improve measurement of HRQL across multiple areas of physical, mental, and social health Available as both short forms and computerized adaptive tests (CATs) Tested mostly in research settings Limited evaluation in specific diseases or in clinical care settings From Domains to Instruments Patient Identified Domain Legacy Measure PROMIS Instruments Global Assessment VAS Health Rating Pain VAS Pain Impact Pain Interference Physical Function MHAQ Physical Function Participation --- Participation Satisfaction Fatigue VAS Fatigue Sleep --- Sleep Disturbance Sleep Interference Emotional Distress --- Depression Anxiety Anger Other Measures: Patient assessed disease change, Patient acceptable symptom state, Flare assessment, Stiffness, Self-management 2

3 Asking about RA Flare 3

4 Research Methods (1) Research Methods (2) RA patients enrolled in a clinical registry of routine clinical measures and legacy PROs In waiting room, patients given an ipad linked to Assessment Center website PROMIS and other PROs completed Routine visit with rheumatologist takes place; provider has results available in real-time to review with patient Provider and patient review results during visit After visit both rate value of information impact Results - Patients (N=125) Results - Flare Variable Value Range Sociodemographic Age (yrs; mean SD) 56 (13) Female 99 (79%) Minority race 18 (14%) Completed high school 65 (52%) RA Characteristics Disease duration (yrs.) 12 (9) 0-41 CDAI (mdn IQR) 6.5 (8.9) MD Global Assessment (mdn IQR) 10 (17) 0-75 Patient Reported Outcomes Patient Global (mdn IQR) 30 (40) 0-80 Pain (VAS) (mdn IQR) 23 (50) MHAQ.13 (.63) (20%) reported being in a flare at time of visit Mean (SD) severity of 6.0 (2.5) (0=none; 10=worst) 52% reported duration >14 days Flare was not associated with age, sex, race, education or RA duration In Patients Reporting Flare: RA Characteristics My RA is worse OR 8 (95% CI 3-20) My current level of symptoms is unacceptable OR 6; (95% CI 2-14) Flare (n=25) No Flare (n=100) Sig Patient Global 47 (24) 24 (26) <.01 AM Stiff >30 min (%) 52% 31%.05 CDAI 15 (11) 7 (7) <.01 Swollen joints (28) 5 (6) 2 (3) <.01 Tender joints (28) 3 (4) 1 (3).02 MD Global 26 (23) 13 (14).01 Values are mean (SD) unless otherwise stated. *0=none, 4=very severe; **0=never, 4=always 4

5 PROs by Flare Status PROs by Flare Status Flare (n=25) No Flare (n=100) Sig Pain 100 mm VAS 54 (26) 25 (27) <.01 PROMIS Pain Intensity 51 (7) 43 (8) <.01 PROMIS Pain Interference 60 (7) 51 (10) <.01 Physical Function MHAQ.5 (.4).3 (.4).01 PROMIS Physical Function 38 (6) 44 (9) <.01 Fatigue 100 mm VAS 60 (24) 35 (31) <.01 PROMIS Fatigue 58 (7) 53 (11).03 Values are the mean (SD); Higher scores reflect greater impairment. *0=none, 4=very severe; **0=never, 4=always Flare (n=25) No Flare (n=100) Sig Sleep PROMIS Sleep Disturbance 55 (7) 51 (10).04 PROMIS Sleep related Impairment 55 (9) 51 (10).03 Social Roles and Activities PROMIS Participation 46 (8) 51 (9).04 PROMIS Satisfaction 43 (10) 50 (10) <.01 Emotional Function PROMIS Depression 51 (9) 49 (9).29 PROMIS Anxiety 54 (9) 51 (8).11 PROMIS Anger 48 (10) 47 (9).67 Convergent validity PROMIS PROs Scale Spearman s rho PAIN 100 mm VAS PROMIS Pain Intensity.83 PROMIS Pain Interference.82 FATIGUE 100 mm VAS PROMIS Fatigue.86 Individual reports T scores / population norms Floor/ceiling effects Efficiency MHAQ PROMIS PF -.74 *all rho s p<.01 Example PROMIS Reports Distribution of Selected PROMIS CAT T-Scores in RA Patients High levels of impairment: Interference, Fatigue, Sleep Disturbance, Physical Function Low levels of impairment: of sleep-related impairment, emotional distress Better Worse * *Score for Physical Function transformed (100-T) for demonstration 5

6 Range, Floor & Ceiling Effects Preliminary Results PROMIS In Clinic: Feasibility Scale Range Floor Ceiling Patient Global (0-100) (18%) -- Pain VAS (0-100) (16%) 1 (1%) PROMIS Pain Intensity PROMIS Pain Interference Fatigue VAS (0-100) (11%) 1 (1%) PROMIS Fatigue CAT MHAQ (0-3) (43%) -- PROMIS PF CAT PROMIS Instruments: Global health, Pain (intensity, interference), Fatigue, Physical function, Sleep (disturbance, interference), Depression, Anxiety, Social roles (participation, satisfaction) Mean SD Min Max Time to Complete (minutes) Number of Questions Interviews in progress with patients, providers, and clinic staff to determine effect on clinic flow Conclusions Next Steps Patient reports of flare were associated with significantly higher PROMIS scores, legacy measures and clinical disease activity indicators Flaring patient scores reflected clinically significant impairments (0.4-1 SD) Strong correlations between PROMIS instruments with legacy measures Prospective studies are ongoing to assess responsiveness for RA improvement and worsening Beyond flare detection, PROMIS measures may aid in RA self-monitoring, and in the case of worsening, could signal the need for additional clinical assessment Acknowledgements Funding Provided By: Patient Centered Outcomes Research Institute (PCORI) Pilot Project NIH/NIAMS P30-AR (Rheumatic Diseases Research Core Center) Ira J. Fine Discovery Fund Sibley Hospital Foundation Johns Hopkins Arthritis Center Research Fund OMERACT Acknowledgements Johns Hopkins Rheumatology Trisha Duncan MD Ana-Maria Orbai MD Uzma Haque MD Grant Louie MD MHS Rebecca Manno MD MHS Thomas Grader-Beck MD Victoria Ruffing RN Laura Manning RN Marilyn Towns CCRC Michelle Jones Brandy Miles Tony Keyes Wes Linda Penny Athanasiou Candyce Salters Felicia Agen Joyce Kosmas Bonnie Hebden Johns Hopkins Bloomberg School of Public Health Katherine Clegg-Smith PhD Elaine DeLeon MPH Northwestern University Richard Gershon PhD David Cella PhD Monica Prudencio Arredondo Stakeholders/Advisors Kenneth Saag MD MPH Patience White MD James Witter MD PhD Laure Gossec MD PhD Sarah Hewlett RN PhD Enkeleida Nikai Amye Leong MBA Kelly Young Ernest Choy MD PhD Patient participants 6