Rheumatoid Arthritis: Heiberg T

Wells G, Anderson J, Boers M, Felson D, Heiberg T, Hewlett S, Johnson K, Kirwan J, Lassere M, Robinson V, Shea B, Simon L, Strand V, van Riel P, Tugwell P. · Department of Clinical Epidemiology and Community Medicine, University of Ottawa, Ottawa, Ontario, Canada. · J Rheumatol. · Pubmed #12734920 No free full text.

Abstract: The OMERACT 6 Minimal Clinically Important Difference/Low Disease Activity Workshop was organized with the aim of meeting the many challenges that exist in determining a low disease activity in rheumatoid arthritis (RA). This article presents an overview of that workshop, including results of the voting, a summary of associated discussions, recommendations, and a proposed research agenda.

Kvien TK, Heiberg T. · Oslo City Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway. · J Rheumatol. · Pubmed #12672219 No free full text.

Abstract: Health status measures constitute an essential part of outcome assessments in patients with rheumatic diseases. Currently used health status measures typically assess patient perceptions within various dimensions of health. The issue of widening patient perspective in outcome assessments was raised at OMERACT 2000 and further activities were initiated at the subsequent American College of Rheumatology meetings. Measuring patient perceptions of health is considered the standard approach in clinical practice, controlled clinical trials, and longitudinal observation studies, as well as in other types of epidemiological research. However, the traditionally used instruments also have limitations based on the relevance of the questionnaire items, sensitivity to change in longitudinal observational studies, and intraindividual variations over time. Patient priorities or preferences for improvement in health may be an alternative for the assessment of important patient outcomes. Data support that patient priorities for improvement in health are associated with their perception, but that overlap is incomplete and that complimentary information may be achieved. Expectations about future health and satisfaction with health may also represent alternative approaches. Thus, an open research agenda is required for the future, including different approaches regarding both endpoints and methodological issues.

Kirwan J, Heiberg T, Hewlett S, Hughes R, Kvien T, Ahlmèn M, Boers M, Minnock P, Saag K, Shea B, Suarez Almazor M, Taal E. · University of Bristol Rheumatology Unit, Bristol Royal Infirmary, Bristol, UK. · J Rheumatol. · Pubmed #12672218 No free full text.

Abstract: The objective of the Patient Perspective Workshop at OMERACT 6 was to address the question of assessing the outcomes of intervention in rheumatoid arthritis (RA) from the perspective of those who experience the disease themselves. This was done by reviewing the current state of research in the area, identifying the requirements for the development of valid instruments, delineating a research agenda that can attain these requirements, and motivating participants to undertake the appropriate research. Through a series of meetings and discussion sessions a research agenda emerged that includes: exploring subjective experiences of RA identified by patients as important but not encompassed within the current "core set" of outcome measures (such as a sense of well being, fatigue, and disturbed sleep); clarifying terminology; and empowering patients to be more effective partners in outcomes research. These were supported by the OMERACT plenary session. Specific actions were required by both patient participants and organizers to ensure the nature of the conference, its focus and method of working were understood, and that the patient participants were sufficiently confident to make their contribution.

Mowinckel P, Hagen KB, Heiberg T, Kvien TK. · National Resource Centre for Rehabilitation in Rheumatology, Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway. · J Clin Epidemiol. · Pubmed #18538992 No free full text.

Abstract: OBJECTIVES: To investigate whether repeated measures in patients with rheumatoid arthritis will reduce the between subject variation and if so, to determine the optimal number of measures to effectively reduce the number of participants required in controlled clinical trials. STUDY DESIGN AND SETTING: A prospective observational study. Thirty-eight rheumatoid arthritis patients with a stable disease reported level of joint pain, fatigue and patient global assessment of disease activity on VAS scales as well as the Rheumatoid Arthritis Disease Activity Index (RADAI) daily during a total of 42 days. RESULTS: In all measures, the variation within each individual was substantial over a 42-day period. By increasing the number of measurements from one to five, the standard deviation (SD) decreased from 5.5% (RADAI score) to 11% (Pain VAS) resulting in a reduction in the number of patients needed in a clinical trial from 11% to 22%, respectively. When we used from 6 to 42 individual measurements, the decrease continued but the reduction was of a smaller magnitude. CONCLUSION: The use of up to five repeated measurements per patient will decrease the number of patients required in a two armed clinical trial by as much as 22%.

Uhlig T, Heiberg T, Mowinckel P, Kvien TK. · Department of Rheumatology, Diakonhjemmet Hospital, N-0319 Oslo, Norway. · Ann Rheum Dis. · Pubmed #18218667 No free full text.

Abstract: OBJECTIVES: During the last decades major advances have occurred in the treatment of patients with rheumatoid arthritis (RA), and improvements in the burden of the disease have been suggested. We examined whether there was a secular change towards less severe disease from 1994 to 2004 among patients within the representative setting of the Oslo Rheumatoid Arthritis Register (ORAR). METHODS: All living patients in the ORAR received a postal questionnaire in 1994, 1996, 2001 and 2004, including the Modified Health Assessment Questionnaire (MHAQ), SF-36, Arthritis Impact Measurement Scales 2 (AIMS2) and visual analogue scales for the patient global assessment of disease severity, pain and fatigue. A mixed model approach was used for longitudinal analysis adjusting for sex, age, co-morbidity, and for disease duration and DMARD if indicated. RESULTS: The numbers of respondents aged between 20 and 79 years in 1994, 1996, 2001 and 2004 were 931, 1025, 829 and 914 patients with similar demographic characteristics (mean age in 1994 was 60.6 years, mean disease duration 12.6 years, 78% females). Health status in the population with RA was consistently improved in all dimensions of health, and this improvement was statistically significant for the physical dimension, global health and pain over the 10-year period until 2004. Both year of examination and year of disease onset had an effect on measures of longitudinal health status outcome. CONCLUSIONS: Health status in RA improved from 1994 to 2004, probably due to access to better and more aggressive treatments.

Heiberg T, Kvien TK, Mowinckel P, Aletaha D, Smolen JS, Hagen KB. · Department of Research and Education, Ullevål University Hospital, N- 0407 Oslo, Norway. · Ann Rheum Dis. · Pubmed #17965118 No free full text.

Abstract: BACKGROUND: Established thresholds for low levels of disease activity need to be examined from a patients' perspective. OBJECTIVE: To identify new cut-off points for patients' perception of satisfactory condition (patient acceptable symptom state (PASS)) in composite indices and patient-reported outcomes, and to examine the agreement between the new PASS cut-off points for composite indices and existing thresholds for remission, low and moderate disease activity. METHODS: Patients with rheumatoid arthritis from a treatment register (n = 1496, 72.1% women, mean (SD) age 53.9 (13.5) years, disease duration 7.6 (9.1) years, 28-joint Disease Activity Score (DAS28) 4.98 (1.36)) responded during follow-up (12, 24 and 52 weeks) to a global dichotomised question on satisfactory condition (PASS). New PASS cut-off points were identified with the 75th centile estimation and receiver operating characteristic analyses for a variety of outcome measures, and cut-off points for composite indices were examined for agreement with the low disease activity threshold (1.625) of the Patient Activity Scale (PAS) and thresholds for remission, low and moderate disease activity in DAS28, Simplified Disease Activity Index (SDAI) and Clinical Disease Activity Index (CDAI). RESULTS: New PASS cut-off points for DAS28, SDAI and CDAI were in the moderate range of disease activity, and the cut-off point was 3.56 for PAS. Agreement between thresholds for disease activity levels and the PASS cut-off points was best for low disease activity (accuracy 64.5-74.6), and better for moderate disease activity (accuracy 61.3-67.2) than for remission (accuracy 30.7-45.8). CONCLUSION: The current PASS concept seems to be in the range of moderate disease activity.

Heiberg T, Kvien TK, Dale Ø, Mowinckel P, Aanerud GJ, Songe-Møller AB, Uhlig T, Hagen KB. · Centre for Education and Skill Training, Ulleval University Hospital, Oslo, Norway. · Arthritis Rheum. · Pubmed #17394232 links to  free full text

Abstract: OBJECTIVE: The patient perspective workshops at the Outcome Measures in Rheumatology Clinical Trials have included daily measures of health status (patient diary) and use of electronic tools for data collection in the research agenda. The objective of this study was to compare daily and weekly registrations of self-reported health status measures between personal digital assistant (PDA) and paper-pencil (PP) format regarding scores, variation, and feasibility. METHODS: Thirty-eight patients with stable rheumatoid arthritis recorded their health status during 84 days in a repeated crossover design, using PDA or PP format during four 21-day periods. Visual analog scales (VAS) for pain, fatigue, and global disease and the Rheumatoid Arthritis Disease Activity Index were scored daily; the Short Form 36 and Modified Health Assessment Questionnaire were scored weekly. RESULTS: The average scores and measures of variation of the 4 daily health status measures over 21 days did not differ significantly between PDA and PP formats in either of the 2 crossover periods. The values for the average range between the maximum and minimum values for daily measures were similar between the 2 formats, but showed considerable variation (e.g., range for pain VAS was 19-28 mm over each 21-day period). The time to complete the instruments was similar between the 2 formats. Missing daily data entries were generally low for both periods and somewhat higher for PDA. The majority of patients (82.9%) preferred using PDA. CONCLUSION: Daily assessments with PDA may be efficiently used for frequent data collection because this format performs similarly to the traditional PP format.

Kirwan JR, Hewlett SE, Heiberg T, Hughes RA, Carr M, Hehir M, Kvien TK, Minnock P, Newman SP, Quest EM, Taal E, Wale J. · University of Bristol Academic Rheumatology Unit, Bristol Royal Infirmary, Bristol, UK. · J Rheumatol. · Pubmed #16265712 No free full text.

Abstract: The Patient Perspective Workshop at OMERACT 7 addressed the question of assessing the outcomes of intervention in rheumatoid arthritis (RA) from the perspective of those who experience the disease. A particular emphasis at this workshop was placed on fatigue, but other areas included well-being, real-time assessment, patient priorities, and needs in early and late disease. Through a series of overview presentations, discussion groups, and plenary sessions, workshop participants (who included 19 patients) clarified what is known and what are the outstanding issues for future research. The importance of further work on clarifying the validity of fatigue measurements in RA has been confirmed, and with at least one suitable instrument available there will be strong pressure to include fatigue in a redefined core set of outcome measures in RA. In the other 4 areas covered there are important issues that can be addressed by enquiry and experiment and that together provide a challenging research agenda. At the final plenary session the OMERACT conference endorsed, by a large majority, the proposal that fatigue may warrant consideration for inclusion in the OMERACT core set for RA.

Kirwan JR, Ahlmén M, de Wit M, Heiberg T, Hehir M, Hewlett S, Katz PP, Minnock P, Quest EM, Richards P. · University of Bristol, Academic Rheumatology Unit, Bristol Royal Infirmary, Bristol, UK. · J Rheumatol. · Pubmed #16265711 No free full text.

Abstract: The first OMERACT Patient Perspective Workshop took place at OMERACT 6 in 2002. Through a series of meetings and discussion sessions a research agenda emerged and this report outlines progress made on this agenda. Work on identifying novel outcomes, instruments, and methods has shown similarities across European countries in the importance patients with rheumatoid arthritis (RA) attach to specific outcomes, in particular fatigue. Validation of an appropriate instrument to measure fatigue in patients with RA is currently being investigated. Frequent or repeated real-time assessment of symptoms such as pain and fatigue is becoming possible using electronic systems. An OMERACT Patient Panel has been established, and has produced a glossary for patients involved in supporting clinical research. In some centers, efforts are being made to provide Patient Research Partners with knowledge and skills that will enhance their contribution, and some of these approaches will be incorporated into OMERACT 7. The research agenda that was developed during the first Patient Perspective Workshop has stimulated new work in several areas. In addition, international attention has been drawn to the need to make sure that the patient's perspective is not lost among the technical expertise of rheumatology.

Kvien TK, Mowinckel P, Heiberg T, Dammann KL, Dale Ø, Aanerud GJ, Alme TN, Uhlig T. · Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway. · Ann Rheum Dis. · Pubmed #15843456 links to  free full text

Abstract: BACKGROUND: Increasing use of self reported health status in clinical practice and research, as well as patient appreciation of monitoring fluctuations of health over time, suggest a need for more frequent collection of data. Electronic use of health status measures in the follow up of patients is a possible way to achieve this. OBJECTIVE: To compare self reported health status measures in a personal digital assistant (PDA) version and a paper/pencil version for test-retest reliability, agreement between scores, and feasibility. METHODS: 30 patients with stable rheumatoid arthritis (mean age 61.6 years, range 49.8 to 70.0; mean disease duration, 16.7 years; 63% female; 67% rheumatoid factor positive; 46.6% on disease modifying antirheumatic drugs) completed self reported health status measures (pain, fatigue, and global health on visual analogue scales (VAS), rheumatoid arthritis disease activity index, modified health assessment questionnaire, SF-36) in a conventional paper based questionnaire version and on a PDA (HP iPAQ, model h5450). Completion was repeated after five to seven days. RESULTS: Test-retest reliability was similar, as evaluated by the Bland-Altman approach, the coefficient of variation, and intraclass correlation coefficients. The scores showed acceptable agreement, but with a slight tendency to higher scores on VAS with the PDA than the paper/pencil version. No significant differences were seen for measures of feasibility (time to complete, satisfaction score), but 65.5% preferred PDA, 20.7% preferred paper, and 13.8% had no preference. CONCLUSIONS: The clinimetric performance of paper/pencil versions of self reported health status measures was similar to an electronic version, using an inexpensive PDA.

Heiberg T, Finset A, Uhlig T, Kvien TK. · Department of Administration, Ullevål University Hospital, N-0407 Oslo, Norway. · Ann Rheum Dis. · Pubmed #15647426 links to  free full text

Abstract: OBJECTIVES: To examine possible changes in priorities for improvement in health and health status from 1994 to 2001 within the setting of the Oslo Rheumatoid Arthritis (RA) Register, which provides representative data for the entire RA population in the county. METHODS: All living patients in the Oslo RA Register area received a postal questionnaire in 1994 and 2001, including the Arthritis Impact Measurement Scales 2 (AIMS2), Short Form-36, the modified Health Assessment Questionnaire, and pain and fatigue visual analogue scales (VAS). Priorities for improvement in health were examined through question 60 in AIMS2, where patients are asked to indicate three of 12 areas of health where they would most like to see improvement. RESULTS: The number of respondents aged 20-79 years in 1994/2001 was 932/830, with similar demographic characteristics (78.8/78.3% were female, mean age 60.6/60.8, and disease duration 12.6/13.9 years). Health status was improved in all dimensions, with statistical improvement for the physical dimension, global health and pain, from 1994 to 2001. The profile of priorities remained mostly unchanged. Improvement in pain had the highest priority in both cohorts. Both symptom modifying and disease modifying drugs were more extensively used in 2001. CONCLUSIONS: Health status had improved from 1994 to 2001, probably because of access to better and more aggressive treatments. Pain remained the area of highest priority for improvement among patients with RA-despite an improved level of pain in 2001.

Heiberg T, Kvien TK. · Ullevål University Hospital, Oslo, Norway. · Arthritis Rheum. · Pubmed #12209485 links to  free full text

Abstract: OBJECTIVE: To examine preferences for improved health in patients with rheumatoid arthritis (RA). METHODS: A survey was mailed to patients with RA enrolled in a county-based register. The questionnaire comprised a variety of health status measures (Medical Outcome Study Short Form-36, Arthritis Impact Measurement Scales 2 [AIMS2], Modified Health Assessment Questionnaire, and visual analog scale for pain and fatigue). The patients were asked to check 3 of 12 areas in which they would most like to see improvement (item 60 AIMS2). The number of respondents was 1,024 (mean age/disease duration 63.4/12.7 years, 78.7% female). RESULTS: Pain was the preferred area for improvement in all subgroups of patients. Preference for improvement in pain was associated with lower age, higher levels of perceived pain, and lower scores for self efficacy related to pain. One-third of the patients with this preference did not report use of pain-relieving medication. CONCLUSION: Pain is the area of health in which almost 70% of the patients would like to see improvement. This study suggests that more attention should be paid to the examination of patient preferences for improvement in health.