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1. Healthcare access and attitudes towards telehealth during the early phase of the <scp>COVID</scp> ‐19 pandemic among an Australian cohort with inflammatory arthritis

Author

Rischin, A., Liew, D., Black, R., Fletcher, A., Buchbinder, R., Lassere, M., March, L., Robinson, P.C., Hill, C., Barrett, C., Carroll, G., Marine, F., Schachna, L., Sinnathurai, P., and The ARAD Steering Committee

Subjects
medicine.medical_specialty, Telemedicine, telehealth, Inflammatory arthritis, education, Arthritis, Telehealth, 030204 cardiovascular system & hematology, Brief Communication, healthcare access, 03 medical and health sciences, 0302 clinical medicine, COVID‐19, Health care, Pandemic, Internal Medicine, medicine, Humans, 030212 general & internal medicine, Pandemics, inflammatory arthritis, health care economics and organizations, SARS-CoV-2, business.industry, Australia, COVID-19, medicine.disease, Mental health, Coronavirus, Attitude, Family medicine, Cohort, Brief Communications, business, physical health, mental health
Abstract

Community restrictions due to COVID‐19 have changed healthcare, including increased telehealth use. During the early pandemic phase, a cohort of Australian patients with inflammatory arthritis was surveyed. Self‐reported access to healthcare was maintained and physical health was more likely to be self‐rated poorly than mental health. There was a high level of support for telehealth during and after the pandemic.

Published
2021

3. Serum urate as a proposed surrogate outcome measure in gout trials: From the OMERACT working group

Author

Morillon M.B., Christensen R., Singh J.A., Dalbeth N., Saag K., Taylor W.J., Neogi T., Kennedy M.A., Pedersen B.M., McCarthy G.M., Shea B., Diaz-Torne C., Tedeschi S.K., Grainger R., Abhishek A., Gaffo A., Nielsen S.M., Noerup A., Simon L.S., Lassere M., Tugwell P., Stamp L.K., and Gout Working Group F.T.O.

Subjects
Patient Research Partners, Gout, Serum urate, Surrogate, OMERACT, Biomarker
Abstract

Serum urate (SU) is the most common primary efficacy outcome in trials of urate-lowering therapies for gout. Despite this, it is not formally considered a validated surrogate outcome. In this paper we will outline the definitions of biomarkers and surrogate outcome measures, respectively as well as the available frameworks and challenges in the assessment of the validity of serum urate as a surrogate in gout (i.e. a reasonable replacement for gout symptoms). © 2021 Elsevier Inc.

Published
2021

4. Healthcare access and attitudes towards telehealth during the early phase of the COVID-19 pandemic among an Australian cohort with inflammatory arthritis

Author

Rischin, A, Liew, D, Black, R, Fletcher, A, Buchbinder, R, Lassere, M, March, L, Robinson, PC, Hill, C, Rischin, A, Liew, D, Black, R, Fletcher, A, Buchbinder, R, Lassere, M, March, L, Robinson, PC, and Hill, C

Abstract

Community restrictions due to COVID-19 have changed healthcare, including increased telehealth use. During the early pandemic phase, a cohort of Australian patients with inflammatory arthritis was surveyed. Self-reported access to healthcare was maintained and physical health was more likely to be self-rated poorly than mental health. There was a high level of support for telehealth during and after the pandemic.

Published
2021

5. Information Maintenance as a Practice of Care

Author

Maintainers, The Information, Olson, D., Meyerson, J., Parsons, M. A., Castro, J., Lassere, M., Wright, D. J., Arnold, H., Galvan, A. S., Hswe, P, Nowviskie, B., Russell, A., Vinsel, L., Acker, A., Dillo, Ingrid, Abreu, A., Acey, C., Albert, K., Caron, B., Cifor, M., Dillo, I., Drabinski, E., Falcao, P., Ferraiolo, N. K., Gunn, S., Goodman-Wilson, D., Hudson, M., Jones, C., Ko, P., Lau, A., Mattern, S., Mayernik, M., McGovern, N., Ndumu, A., Neal, J. C., Owens, T., Rodriguez, S., Russo Carroll, S., Shorish, Y., Tansey, E., Tillman, R., Wickner, A., Weber, C., Williams, S., Yarmey, L., and Data Archiving and Networked Services (DANS)

Subjects
ComputingMilieux_THECOMPUTINGPROFESSION, education, ComputingMilieux_COMPUTERSANDSOCIETY
Abstract

An invitation to participate in a broad ranging discussion thatinfuses information maintenance with practices, relationships, and ways of thinking and being that represent a coherent ethic of care.

Published
2019
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14. Sensitivity and specificity of plain radiographic features of peripheral enthesopathy at major sites in psoriatic arthritis

Author

Helliwell, P. S., Porter, G., Lassere, M., Rappo, J., Mielants, H., Van De Berghe, M., Zmierczak, H. G., De Vlam, K., Russell, A., Gladman, D., Schentag, C., Fournie, B., Dougados, M., Dernis, E., Gossec, L., Zerkak, D., Veale, D., Fitzgerald, O., O'Rourke, M., Hajjaj-Hassouni, N., Lazrak Bentalha, N., Taylor, W., Healy, P., Marchesoni, A., Salvarani, C., Macchioni, P., Lubrano, E., Olivieri, I., Ali Kalla, A., Potts, J., Modi, G., Patel, N., Torre Alonso, J. C., Svensson, B., Lindqvist, U., Holmstrom, G., Theander, E., Dahlqvist, S. R., Alenius, G. M., Ek, K., Isdale, A., Mcgonagle, D., Holdsworth, J., Sharlala, H., Adebajo, A., K, L., Mchugh, N., Lewis, J., Owen, P., Barkham, N., Bejarano, V., Henry, J., Emery, P., Helliwell, P., Ibrahim, G., Ritchlin, C., Durham, R., Espinoza, L. R., Candia, L., Mease, P., Wang, L., and Gunter, L.

Subjects
Male, musculoskeletal diseases, medicine.medical_specialty, Pathology, Knee Joint, Spondyloarthropathy, Inflammatory arthritis, Arthritis, Sensitivity and Specificity, Arthritis, Rheumatoid, Tendons, Psoriatic arthritis, Sex Factors, Elbow Joint, medicine, Humans, Single-Blind Method, Spondylitis, Ankylosing, Radiology, Nuclear Medicine and imaging, Prospective Studies, Muscle, Skeletal, Pelvic Bones, Ankylosing spondylitis, Enthesopathy, Radiography, Rheumatoid arthritis, Undifferentiated spondyloarthropathy, Age Factors, Arthritis, Psoriatic, Case-Control Studies, Female, Heel, Ligaments, Articular, Middle Aged, Ossification, Heterotopic, Shoulder Joint, Spondylarthropathies, business.industry, medicine.disease, Enthesis, Dermatology, Psoriatic arthritis. Rheumatoid arthritis. Ankylosing spondylitis . Undifferentiated spondyloarthropathy . Enthesopathy . Radiography, business
Abstract

It has been proposed that the defining difference between rheumatoid arthritis and spondyloarthropathy (including psoriatic arthritis) is the initial pathological lesion where the emphasis in psoriatic arthritis is on the enthesis and in rheumatoid arthritis on the synovium. Classical radiological descriptions of seronegative spondyloarthropathy include enthesopathy at major entheseal insertions characterised by erosions and exuberant new bone formation. In this study, the plain radiographic features of spondyloarthropathy are compared between psoriatic arthritis, other spondyloarthropathies and rheumatoid arthritis. The CASPAR study collected clinical, radiological and laboratory data on 588 patients with physician diagnosed psoriatic arthritis and 525 controls with other inflammatory arthritis, 70% of which had rheumatoid arthritis. Plain radiographs of the pelvis and heels were part of the study protocol, although radiographs of other potential entheseal sites such as the knee, elbow and shoulder, were interpreted if available. All radiographs were read blind by two observers working in tandem. Significant differences in entheseal erosion and entheseal new bone formation were found between psoriatic arthritis, ankylosing spondylitis, undifferentiated spondyloarthropathy, rheumatoid arthritis and other diagnoses (entheseal erosion, chi-squared 20.8, p = 0.008; entheseal new bone formation, chi-squared 24.5, p = 0.001). These differences were mainly due to a higher proportion of these features in ankylosing spondylitis. No differences in the plain radiographic features of enthesopathy were found between psoriatic arthritis and rheumatoid arthritis except in the case of entheseal new bone formation at sites of attachment of inguinal ligament, sartorius and rectus femoris muscles to the ilium (OR 3.01, 95% CI 1.13–8.02). Very few subjects with symptomatic heel involvement had radiographic changes and minimal differences were found between those with and without symptoms in terms of new bone formation and erosion at either calcaneal site. New bone formation and erosion at major entheseal sites is most commonly seen in ankylosing spondylitis. Plain radiographic features of major enthesopathy are poor discriminators between psoriatic arthritis and rheumatoid arthritis.

Published
2007

15. Using serum urate as a validated surrogate end point for flares in patients with gout: protocol for a systematic review and meta-regression analysis

Author

Morillon, M.B., Stamp, L., Taylor, W., Fransen, J., Dalbeth, N., Singh, J.A., Christensen, R., Lassere, M., Morillon, M.B., Stamp, L., Taylor, W., Fransen, J., Dalbeth, N., Singh, J.A., Christensen, R., and Lassere, M.

Abstract

Contains fulltext : 171906.pdf (publisher's version ) (Open Access), INTRODUCTION: Gout is the most common inflammatory arthritis in men over 40 years of age. Long-term urate-lowering therapy is considered a key strategy for effective gout management. The primary outcome measure for efficacy in clinical trials of urate-lowering therapy is serum urate levels, effectively acting as a surrogate for patient-centred outcomes such as frequency of gout attacks or pain. Yet it is not clearly demonstrated that the strength of the relationship between serum urate and clinically relevant outcomes is sufficiently strong for serum urate to be considered an adequate surrogate. Our objective is to investigate the strength of the relationship between changes in serum urate in randomised controlled trials and changes in clinically relevant outcomes according to the 'Biomarker-Surrogacy Evaluation Schema version 3' (BSES3), documenting the validity of selected instruments by applying the 'OMERACT Filter 2.0'. METHODS AND ANALYSIS: A systematic review described in terms of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) reporting guidelines will identify all relevant studies. Standardised data elements will be extracted from each study by 2 independent reviewers and disagreements are resolved by discussion. The data will be analysed by meta-regression of the between-arm differences in the change in serum urate level (independent variable) from baseline to 3 months (or 6 and 12 months if 3-month values are not available) against flare rate, tophus size and number and pain at the final study visit (dependent variables). ETHICS AND DISSEMINATION: This study will not require specific ethics approval since it is based on analysis of published (aggregated) data. The intended audience will include healthcare researchers, policymakers and clinicians. Results of the study will be disseminated by peer-reviewed publications. TRIAL REGISTRATION NUMBER: CRD42016026991.

Published
2016

16. Malignancy risk in Australian rheumatoid arthritis patients treated with anti-tumour necrosis factor therapy: analysis of the Australian Rheumatology Association Database (ARAD) prospective cohort study

Author

Buchbinder, R, Van Doornum, S, Staples, M, Lassere, M, March, L, Buchbinder, R, Van Doornum, S, Staples, M, Lassere, M, and March, L

Abstract

BACKGROUND: Malignancy risk with tumour necrosis factor inhibitor (TNFi) therapy remains unclear. Our primary aim was to assess malignancy risk with TNFi therapy in a cohort of Australian patients with rheumatoid arthritis (RA). We also assessed risk in a biologic-naïve group. METHODS: Demographic data of all RA patients enrolled in the Australian Rheumatology Association Database before 25 October 2010 were matched to national cancer records in July 2010 (linkage complete to 2007). Verified self-reported malignancies occurring between 1 January 2008 and 25 October 2010 were also included in the analysis. Standardised incidence ratios (SIRs) were used to compare malignancy incidence in biologic-naïve and TNFi-exposed ARAD participants to the general population using site-, age- and sex-specific rates by calendar year. Rate ratios (RRs) were used to compare malignancy incidence in TNFi-exposed participants to biologic-naïve RA patients, and a composite RA cohort that included pre-TNFi person years, both adjusted for age, gender, smoking, methotrexate use and prior malignancy. RESULTS: Forty-four malignancies were reported after 5752 person-years in the TNFi-exposed group (N = 2145) and 32 malignancies were reported after 1682 person-years in the biologic-naïve group (N = 803). No overall increased risk of malignancy in TNFi-treated RA patients was found when compared with the general population or with biologic-naïve RA patients. Compared to the biologic naïve group, without the inclusion of pre-TNFi years in the comparator group, the relative risk of female breast cancer was reduced in TNFi-treated patients (RR 0.17 (95 % CI 0.03 to 0.95)). It was no longer significant when adding pre-TNFi years in the comparator group. The risk of melanoma was increased for both biologic naïve and TNFi-treated patients when compared with the general population (SIR 2.72 (95 % CI 1.13 to 6.53) and SIR 2.03 (95 % CI 1.09 to 3.78) respectively). The relative risk of melanoma was not i

Published
2015

17. Patient perceptions of carrying their own health information: Approaches towards responsibility and playing an active role in their own health-implications for a patient-held health file

Author

Forsyth, R, Maddock, CA, Iedema, RAM, and Lassere, M

Subjects
Male, Interviews as Topic, Patients, Health Records, Personal, Personal Autonomy, Humans, Female, Public Health, New South Wales, Attitude to Health
Abstract

To elicit patients' views on whether they could contribute to improvements in their care by carrying their own health information to clinician encounters; and to consider the implications for the development of a patient-held health file (PHF). Background Increasing rates of chronic disease lead to health care being delivered by multiple care providers often at distributed geographic locations. As a way of increasing the availability of patient information to care providers our project will trial a PHF. Patients carry these files to doctors' appointments where clinicians record data for other doctors or the patient. Increasing the availability of patient information is anticipated to enhance the safety and quality of care delivery and improve health outcomes. Study design Qualitative semi-structured interviews were conducted with 10 patients. Participants were evenly distributed in terms of genderaged 60 years or greater and visited at least two specialists and one general practitioner.Findings In this exploratory studypatients who were currently active in decision making about their own health already recorded some health information. They were receptive to carrying their information and thought they should take some responsibility for their health. Patients who were more passive in making decisions about their health did not perceive a need to carry their own information and felt that their doctors communicated adequately. Conclusion Patient-held health files provide an opportunity for patients to access their health information. Such files have the potential to improve health outcomes for patients who adopt both active and passive roles in relation to their own health and engaging with their health information. © 2010 The Authors. Health Expectations © 2010 Blackwell Publishing Ltd.

Published
2010

18. Treatment of psoriatic arthritis and rheumatoid arthritis with disease modifying drugs -- comparison of drugs and adverse reactions

Author

Helliwell, Philip, S, Taylor, Lassere M, William J., Rappo, J, Mielants, H, Van de Berghe, M, Zmierczak, Hg, de Vlam, K, Russell, A, Gladman, D, Schentag, C, Fournie, B, Dougados, M, Dernis, E, Gossec, L, Zerkak, D, Veale, D, Fitzgerald, O, O'Rourke, M, Hajjaj Hassouni, N, Bentalha, Nl, Taylor, W, Healy, P, Marchesoni, A, Salvarani, Carlo, Macchioni, P, Emilia, R, Lubrano, E, Olivieri, I, Kalla, Aa, Potts, J, Modi, G, Patel, N, Torre Alonso JC, Svensson, B, Lindqvist, U, Holmstrom, G, Theander, E, Dahlqvist, Sr, Alenius, Gm, Ek, K, Isdale, A, Mcgonagle, D, Holdsworth, J, Sharlala, H, Adebajo, A, Kay, L, Mchugh, N, Lewis, J, Owen, P, Barkham, N, Bejarano, V, Henry, J, Henshaw, K, Emery, P, Helliwell, P, Ibrahim, G, Ritchlin, C, Durham, R, Espinoza, Lr, Candia, L, Mease, P, Wang, L, and Gunter, L.

Subjects
Arthritis, Rheumatoid, Male, Cross-Sectional Studies, Methotrexate, Tumor Necrosis Factor-alpha, Antirheumatic Agents, Case-Control Studies, Arthritis, Psoriatic, Female, Humans, Middle Aged
Abstract

Rheumatoid arthritis (RA) and psoriatic arthritis (PsA) are chronic inflammatory diseases of the musculoskeletal system. Although it seems likely that these conditions have a different pathogenesis, the drugs used to treat them are the same. Our study used a cross-sectional clinical database to compare drug use and side-effect profile in these 2 diseases.The CASPAR study collected data on 588 patients with PsA and 536 controls, 70% of whom had RA. Data on disease modifying drug treatments used over the whole illness were recorded, together with their outcomes, including adverse events, for RA and PsA.For both diseases methotrexate (MTX) was the most frequently used disease modifying drug (39% of patients with PsA, 30% with RA), with over 70% of patients in both diseases still taking the drug. Other drugs were used with the following frequencies in PsA and RA, respectively: sulfasalazine 22%/13%, gold salts 7%/11%, antimalarial drugs 5%/14%, corticosteroids 10%/17%, and anti-tumor necrosis factor (TNF) drugs 6%/5%. Compared to RA, cyclosporine and anti-TNF agents were less likely to be ineffective in PsA. Compared to RA, subjects with PsA were less likely to be taking MTX and more likely to be taking anti-TNF agents. Hepatotoxicity with MTX was more common in PsA and pulmonary toxicity with MTX was found more often in RA.These data provide insight into prescribing patterns of disease modifying drugs in RA and PsA in a large international cohort, together with the differential adverse events of these drugs between these diseases.

Published
2008

19. Simulation studies of surrogate endpoint validation using single trial and multitrial statistical approaches

Author

Lassere, M, Johnson, K, Hughes, M, Altman, D, Buyse, M, Galbraith, S, and Wells, G

Abstract

OBJECTIVE: A schema was recently proposed for assessing the levels of evidence for surrogate validity that included 4 domains: Target, Study Design, Statistical Strength, and Penalties. This report examines one component of the schema. It surveys the literature on methods of statistical validation of surrogate markers and compares these methods head-to-head using simulated datasets. METHODS: Simulated datasets (continuous, multivariate normal) were generated to capture 3 possible relationships of surrogate (S) and true (T) outcome (none, weakly positive, strongly positive) each applied to 4 treatment effects (effect on both surrogate and true outcome, effect on neither, effect on surrogate only, and effect on true outcome only). These datasets were analyzed using single and multitrial statistical approaches, and the results were provided to participants for discussion. RESULTS: The multitrial surrogate threshold effect seemed to capture best the requirement that surrogate validation is demonstrated by a treatment-associated change in the surrogate predicting a treatment-associated change in the outcome. CONCLUSION: There was general agreement that neither a single trial nor any of the single trial statistical methods was adequate to establish surrogate validity. These exercises also showed that summary statistics developed specifically to establish surrogate validity, such as the proportion of the effect explained, were problematic. A sizable statistical research agenda remains, which includes investigating the additional advantage obtained with modeling subject-level data compared to modeling with only trial-level data; and developing and testing multitrial statistical approaches robust to settings with only a few trials.

Published
2007

20. Minimal disease activity for rheumatoid arthritis: A preliminary definition

Author

Wells, G. A., Boers, M., Shea, B., Brooks, P. M., Simon, L. S., Strand, C. V., Aletaha, D., Anderson, J. J., Bombardier, C., Dougados, M., Emery, P., Felson, D. T., Fransen, J., Furst, D. E., Hazes, J. M. W., Johnson, K. R., Kirwan, J. R., Landewé, R. B. M., Lassere, M. N. D., Michaud, K., Suarez-Almazor, M., Silman, A. J., Smolen, J. S., Heijde, D. M. F. M., Riel, P. L. C. M., Wolfe, F., Peter Tugwell, Rheumatology, and Other departments

Subjects
Pathogenesis and modulation of inflammation [N4i 1], Chronic inflammation and autoimmunity [UMCN 4.2], musculoskeletal diseases, Arthritis, Rheumatoid, Clinical Trials as Topic, Treatment Outcome, ROC Curve, Evaluation of complex medical interventions [NCEBP 2], Outcome Assessment, Health Care, Humans, skin and connective tissue diseases, Auto-immunity, transplantation and immunotherapy [N4i 4], Severity of Illness Index
Abstract

Contains fulltext : 48816.pdf (Publisher’s version ) (Closed access) Agreement on response criteria in rheumatoid arthritis (RA) has allowed better standardization and interpretation of clinical trial reports. With recent advances in therapy, the proportion of patients achieving a satisfactory state of minimal disease activity (MDA) is becoming a more important measure with which to compare different treatment strategies. The threshold for MDA is between high disease activity and remission and, by definition, anyone in remission will also be in MDA. True remission is still rare in RA; in addition, the American College of Rheumatology definition is difficult to apply in the context of trials. Participants at OMERACT 6 in 2002 agreed on a conceptual definition of minimal disease activity (MDA): "that state of disease activity deemed a useful target of treatment by both the patient and the physician, given current treatment possibilities and limitations." To prepare for a preliminary operational definition of MDA for use in clinical trials, we asked rheumatologists to assess 60 patient profiles describing real RA patients seen in routine clinical practice. Based on their responses, several candidate definitions for MDA were designed and discussed at the OMERACT 7 in 2004. Feedback from participants and additional on-site analyses in a cross-sectional database allowed the formulation of 2 preliminary, equivalent definitions of MDA: one based on the Disease Activity Score 28 (DAS28) index, and one based on meeting cutpoints in 5 out the 7 WHO/ILAR core set measures. Researchers applying these definitions first need to choose whether to use the DAS28 or the core set definition, because although each selects a similar proportion in a population, these are not always the same patients. In both MDA definitions, an initial decision node places all patients in MDA who have a tender joint count of 0 and a swollen joint count of 0, and an erythrocyte sedimentation rate (ESR) no greater than 10 mm. If this condition is not met: * The DAS28 definition places patients in MDA when DAS28 < or = 2.85; * The core set definition places patients in MDA when they meet 5 of 7 criteria: (1) Pain (0-10) < or = 2; (2) Swollen joint count (0-28) < or = 1; (3) Tender joint count (0-28) < or = 1; (4) Health Assessment Questionnaire (HAQ, 0-3) < or = 0.5; (5) Physician global assessment of disease activity (0-10) < or = 1.5; (6) Patient global assessment of disease activity (0-10) < or = 2; (7) ESR < or = 20. This set of 2 definitions gained approval of 73% of the attendees. These (and other) definitions will now be subject to further validation in other databases.

Published
2005

22. Towards imaging remission: Determining a MRI inflammatory activity acceptable state in rheumatoid arthritis.

Author

Haavardsholm, E.A., Gandjbakhch, F., Conaghan, P., Ejbjerg, B.J., Foltz, V., Brown, A., Møller Døhn, Uffe, Lassere, M., Freeston, J., Bøyesen, P., Bird, P., Fautrel, B., Hetland, Merete Lund, Emery, P., Bourgeois, P., Hørslev-Petersen, Kim, Olsen, I.C., Østergaard, Mikkel, Haavardsholm, E.A., Gandjbakhch, F., Conaghan, P., Ejbjerg, B.J., Foltz, V., Brown, A., Møller Døhn, Uffe, Lassere, M., Freeston, J., Bøyesen, P., Bird, P., Fautrel, B., Hetland, Merete Lund, Emery, P., Bourgeois, P., Hørslev-Petersen, Kim, Olsen, I.C., and Østergaard, Mikkel

Published
2012

23. Health-related quality of life and continuation rate on first-line anti-tumour necrosis factor therapy among rheumatoid arthritis patients from the Australian Rheumatology Association Database

Author

Staples, M., March, L., Lassere, M., Reid, Christopher, Buchbinder, R., Staples, M., March, L., Lassere, M., Reid, Christopher, and Buchbinder, R.

Abstract

Objectives: To describe changes in health-related quality of life (HRQoL) up to 60 months after commencing anti-TNF therapy for RA patients enrolled in the Australian Rheumatology Association Database (ARAD), and to determine the continuation rate and predictors of discontinuation of first-line anti-TNF therapy. Methods: Responses to the HAQ, Assessment of Quality of Life, Medical Outcomes Study Short Form-36 (SF-36) and European Quality of Life-5 Dimensions (EQ-5D) were extracted from ARAD for patients commencing anti-TNF therapy and analysed in 6-monthly intervals from the start date. Predictors of discontinuation of therapy were assessed using Cox regression. Results: Since September 2001, 2601 RA patients have enrolled in ARAD; 1801 have used anti-TNF therapy. Before starting the therapy, all HRQoL scores were below the population norms, but showed improvements in the first 6 months. From 12 to 60 months, HRQoL remained stable but below population means. Data to 60 months were available for 106 patients; 47% were still on first-line therapy at 5 years, all were using concurrent DMARDs and 55% were using concurrent prednisolone. Predictors of discontinuation of therapy were poorer HRQoL scores, a more recent therapy start date, concurrent prednisolone use and self-reported severe infection. Older patients and those with longer symptom duration were more likely to remain on therapy. Conclusions: In routine practice, HRQoL scores improve rapidly within 6 months of starting anti-TNFs and then remain stable for up to 60 months. Almost half remain on first-line therapy. © The Author 2010. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved.

Published
2011

26. Baseline comorbidities in a population-based cohort of rheumatoid arthritis patients receiving biological therapy: data from the Australian rheumatology association database.

Author

Briggs, AM, March, L, Lassere, M, Reid, C, Henderson, L, Murphy, B, van den Haak, R, Rischin, A, Staples, M, Buchbinder, R, Briggs, AM, March, L, Lassere, M, Reid, C, Henderson, L, Murphy, B, van den Haak, R, Rischin, A, Staples, M, and Buchbinder, R

Abstract

Aims. To describe the baseline characteristics of an Australian population-based cohort of rheumatoid arthritis (RA) patients commencing biological therapy. Methods. Descriptive analysis from the Australian Rheumatology Association Database (ARAD). Results. Up to October 2006, there were 681 RA patients taking biologics enrolled in ARAD. Baseline data were available for 624 (72% female, mean (SD) age 57.0 (12.5) years). Of these, 59.5% reported at least one comorbid condition, most commonly hypertension (35.7%) and osteoporosis (30.4%); 61 (9.8%) had a history of malignancy (35 nonmelanoma skin, 5 breast, 4 bowel, 5 cervix, 3 melanoma, 3 prostate and 1 each of lip, lung, myeloma, testis, uterus, vagina). Self-reported infections within the previous 6 months were common (71.5%). Conclusions. History of comorbidities, including recent infections, is common among Australian RA patients commencing biologics, and 10% have a history of malignancy. This may impact future evaluations of health outcomes among this population, including attribution of adverse events of biologic therapy.

Published
2009

27. Ankylosing spondylitis patients commencing biologic therapy have high baseline levels of comorbidity: a report from the Australian rheumatology association database.

Author

Oldroyd, J, Schachna, L, Buchbinder, R, Staples, M, Murphy, B, Bond, M, Briggs, A, Lassere, M, March, L, Oldroyd, J, Schachna, L, Buchbinder, R, Staples, M, Murphy, B, Bond, M, Briggs, A, Lassere, M, and March, L

Abstract

Aims. To compare the baseline characteristics of a population-based cohort of patients with ankylosing spondylitis (AS) commencing biological therapy to the reported characteristics of bDMARD randomised controlled trials (RCTs) participants. Methods. Descriptive analysis of AS participants in the Australian Rheumatology Association Database (ARAD) who were commencing bDMARD therapy. Results. Up to December 2008, 389 patients with AS were enrolled in ARAD. 354 (91.0%) had taken bDMARDs at some time, and 198 (55.9%) completed their entry questionnaire prior to or within 6 months of commencing bDMARDs. 131 (66.1%) had at least one comorbid condition, and 24 (6.8%) had a previous malignancy (15 nonmelanoma skin, 4 melanoma, 2 prostate, 1 breast, cervix, and bowel). Compared with RCT participants, ARAD participants were older, had longer disease duration and higher baseline disease activity. Conclusions. AS patients commencing bDMARDs in routine care are significantly different to RCT participants and have significant baseline comorbidities.

Published
2009

29. Ankylosing spondylitis patients commencing biologic therapy have high baseline levels of comorbidity: A report from the Australian Rheumatology Association database

Author

Oldroyd, J., Schachna, L., Buchbinder, R., Staples, M., Murphy, B., Bond, M., Briggs, Andrew, Lassere, M., March, L., Oldroyd, J., Schachna, L., Buchbinder, R., Staples, M., Murphy, B., Bond, M., Briggs, Andrew, Lassere, M., and March, L.

Abstract

Aims. To compare the baseline characteristics of a population-based cohort of patients with ankylosing spondylitis (AS) commencing biological therapy to the reported characteristics of bDMARD randomised controlled trials (RCTs) participants. Methods. Descriptive analysis of AS participants in the Australian Rheumatology Association Database (ARAD) who were commencing bDMARD therapy. Results. Up to December 2008, 389 patients with AS were enrolled in ARAD. 354 (91.0%) had taken bDMARDs at some time, and 198 (55.9%) completed their entry questionnaire prior to or within 6 months of commencing bDMARDs. 131 (66.1%) had at least one comorbid condition, and 24 (6.8%) had a previous malignancy (15 nonmelanoma skin, 4 melanoma, 2 prostate, 1 breast, cervix, and bowel). Compared with RCT participants, ARAD participants were older, had longer disease duration and higher baseline disease activity. Conclusions. AS patients commencing bDMARDs in routine care are significantly different to RCT participants and have significant baseline comorbidities.

Published
2009

30. Baseline comorbidities in a population-based cohort of rheumatoid arthritis receiving biological therapy: Data from the Australian Rheumatology Association database

Author

Briggs, Andrew, March, L., Lassere, M., Reid, C., Henderson, L., Murphy, B., van den Haak, R., Rischin, A., Staples, M., Buchbinder, R., Briggs, Andrew, March, L., Lassere, M., Reid, C., Henderson, L., Murphy, B., van den Haak, R., Rischin, A., Staples, M., and Buchbinder, R.

Abstract

Aims. To describe the baseline characteristics of an Australian population-based cohort of rheumatoid arthritis (RA) patients commencing biological therapy. Methods. Descriptive analysis from the Australian Rheumatology Association Database (ARAD). Results. Up to October 2006, there were 681 RA patients taking biologics enrolled in ARAD. Baseline data were available for 624 (72% female, mean (SD) age 57.0 (12.5) years). Of these, 59.5% reported at least one comorbid condition, most commonly hypertension (35.7%) and osteoporosis (30.4%); 61 (9.8%) had a history of malignancy (35 nonmelanoma skin, 5 breast, 4 bowel, 5 cervix, 3 melanoma, 3 prostate and 1 each of lip, lung, myeloma, testis, uterus, vagina). Self-reported infections within the previous 6 months were common (71.5%). Conclusions. History of comorbidities, including recent infections, is common among Australian RA patients commencing biologics, and 10% have a history of malignancy. This may impact future evaluations of health outcomes among this population, including attribution of adverse events of biologic therapy.

Published
2009

31. Comorbidities in an Australian population-based cohort of patients with ankylosing spondylitis commencing biological therapy : data from the Australian Rheumatology Association database (ARAD)

Author

Schnacha, L., Oldroyd, J., Buchbinder, R., Staples, M., Lassere, M., Reid, C., Briggs, A. M., Zochling, J., Murphy, B., Henderson, L., van den Haak, R., Hay, N., Bond, M., March, L., Schnacha, L., Oldroyd, J., Buchbinder, R., Staples, M., Lassere, M., Reid, C., Briggs, A. M., Zochling, J., Murphy, B., Henderson, L., van den Haak, R., Hay, N., Bond, M., and March, L.

Published
2008

33. Magnetic resonance imaging in psoriatic arthritis: a review of the literature.

Author

McQueen, F.M., Lassere, M., Østergaard, Mikkel, McQueen, F.M., Lassere, M., and Østergaard, Mikkel

Abstract

Psoriatic arthritis is a diverse condition that may be characterized by peripheral inflammatory arthritis, axial involvement, dactylitis and enthesitis. Magnetic resonance imaging (MRI) allows visualization of soft tissue, articular and entheseal lesions, and provides a unique picture of the disease process that cannot be gained using other imaging modalities. This review focuses on the literature on MRI in psoriatic arthritis published from 1996 to July 2005. The MRI features discussed include synovitis, tendonitis, dactylitis, bone oedema, bone erosions, soft tissue oedema, spondylitis/sacroiliitis and subclinical arthropathy. Comparisons have been drawn with the more extensive literature describing the MRI features of rheumatoid arthritis and ankylosing spondylitis.

Published
2006

34. An introduction to the EULAR-OMERACT rheumatoid arthritis MRI reference image atlas.

Author

Østergaard, Mikkel, Edmonds, J, McQueen, F, Peterfy, C, Lassere, M, Ejbjerg, B, Bird, P, Emery, P, Genant, H, Conaghan, P, Østergaard, Mikkel, Edmonds, J, McQueen, F, Peterfy, C, Lassere, M, Ejbjerg, B, Bird, P, Emery, P, Genant, H, and Conaghan, P

Abstract

This article gives a short overview of the development and characteristics of the OMERACT rheumatoid arthritis MRI scoring system (RAMRIS), followed by an introduction to the use of the EULAR-OMERACT rheumatoid arthritis MRI reference image atlas. With this atlas, MRIs of wrist and metacarpophalangeal joints of patients with rheumatoid arthritis can be scored for synovitis, bone oedema, and bone erosion, guided by standard reference images

Published
2005

35. Development of a new tool for standardised assessment of rheumatoid joint inflammation and destruction: The EULAR-OMERACT magnetic resonance imaging in rheumatoid arthritis reference film atlas.

Author

Østergaard, Mikkel, Bird, P, McQueen, F, Ejbjerg, B, Edmonds, J, Lassere, M, Peterfy, C, O'Connor, P, Shnier, R, Genant, H, Emery, P, Conaghan, P, Østergaard, Mikkel, Bird, P, McQueen, F, Ejbjerg, B, Edmonds, J, Lassere, M, Peterfy, C, O'Connor, P, Shnier, R, Genant, H, Emery, P, and Conaghan, P

Published
2004

36. OMERACT Rheumatoid Arthritis Magnetic Resonance Imaging Studies. Exercise 5: an international multicenter reliability study using computerized MRI erosion volume measurements.

Author

Bird, P, Ejbjerg, B, McQueen, F, Østergaard, Mikkel, Lassere, M, Edmonds, J, Bird, P, Ejbjerg, B, McQueen, F, Østergaard, Mikkel, Lassere, M, and Edmonds, J

Abstract

Scoring erosions on magnetic resonance imaging (MRI) is one method of estimating damage in patients with rheumatoid arthritis (RA), but it has limitations. The aim of this pilot study was to assess the feasibility and inter-reader reliability of computer assisted erosion volume estimation in patients with RA. Intra-reader and inter-occasion reliability was also assessed, and different slice thicknesses were compared in terms of erosion volume estimation. A 3 mm slice thickness 3D gradient-echo sequence followed by a 1 mm sequence was performed at baseline and repeated within 24 h with metacarpophalangeal (MCP) joints 2 to 5 of the dominant hand included in the field of view. Three readers were instructed to grade MCP 2 and 3 using the OMERACT grading system and then to measure the erosion volume of the same joints using OSIRIS software. The inter-reader reliability of the grading method and the volume method was calculated, as well as the inter-occasion reliability, by comparing results from each reader from baseline to the followup scan. One reader performed repeat volume measurements on 5 patients to assess the intra-reader reliability. Five patients were included in the study. Expressed in terms of intraclass correlation coefficients (ICC), the inter-reader and inter-occasion reliability of the volume method were comparable to the existing OMERACT scoring system, but large systematic differences in volume estimations were found between readers. The intra-reader reliability was excellent. Good correlation was demonstrated between the total erosion scores and the total erosion volumes. For both erosion volumes and erosion scores, 1 mm and 3 mm acquisitions produced variable results between readers, with no clear pattern of underestimation or overestimation for either slice thickness. The volume estimation method was more time consuming, taking roughly 5 times as long as the scoring method. Computerized MRI erosion volume measurements are feasible, with high intra-o

Published
2003

37. OMERACT Rheumatoid Arthritis Magnetic Resonance Imaging Studies. Exercise 3: an international multicenter reliability study using the RA-MRI Score.

Author

Lassere, M, McQueen, F, Østergaard, Mikkel, Conaghan, P, Shnier, R, Peterfy, C, Klarlund, Mette, Bird, P, O'Connor, P, Stewart, N, Emery, P, Genant, H, Edmonds, J, Lassere, M, McQueen, F, Østergaard, Mikkel, Conaghan, P, Shnier, R, Peterfy, C, Klarlund, Mette, Bird, P, O'Connor, P, Stewart, N, Emery, P, Genant, H, and Edmonds, J

Abstract

We examined inter-reader agreement of the revised OMERACT 5 Rheumatoid Arthritis MRI Score (RAMRIS v3). Magnetic resonance (MR) images of 10 sets of metacarpophalangeal (MCP) joints 2-5 and 8 sets of rheumatoid arthritis (RA) wrists [1.5 T, coronal and axial T1 and T2 spin-echo, +/- fat saturation (FS), +/- intravenous gadolinium (Gd)] were scored for (1) synovitis using a global score (0-3) and a direct measurement of synovial thickness (mm) and (2) three bone lesions: erosions, defects and edema, (score 0-10 by the volume of the lesion as a proportion of the 'assessed bone volume' by 10% increments). Six readers from 5 multinational centers performed all scoring. Three statistical methods were used to analyze the data: (1) single-measure fixed effects intraclass correlations (sICC) and average-measure fixed effects ICC (avICC), (2) percentage exact and close agreement, and (3) the smallest detectable difference (SDD). The sICC were moderate to good (between 0.60 and 0.91) for half of the joint sites for the 2 synovitis scoring methods, and for bone erosions and bone edema. After adjusting for 6 readers, the avICC was very good to excellent (0.80-0.98) for two-thirds of the joint sites by lesion, excluding bone defects that performed relatively poorly, primarily because few readers scored these lesions. The aggregated scores with the best reliability were those with a wide range of scores, high ICC, low SDD, and low percentage SDD (< 33%). The metacarpophalangeal (MCP) bone erosion (sICC 0.58, avICC 0.89, %SDD +/- 27), wrist bone erosion scores (0.72, 0.94, +/- 31%), the wrist synovitis global (0.74, 0.94, +/- 32%), and synovial maximal thickness (0.6, 0.94, +/- 32%) met these conditions. MCP joint synovitis global (0.76, 0.95, +/-35%), MCP joint bone edema (0.63, 0.91, +/- 34%), and wrist bone edema (0.78, 0.95, +/- 38%) performed marginally less well. Bone defects performed poorly (MCP joint 0.18, 0.46, +/- 56%; wrist 0.06, 0.24, +/- 55%). The revised OMERACT

Published
2003

38. OMERACT Rheumatoid Arthritis Magnetic Resonance Imaging Studies. Exercise 4: an international multicenter longitudinal study using the RA-MRI Score.

Author

Conaghan, P, Lassere, M, Østergaard, Mikkel, Peterfy, C, McQueen, F, O'Connor, P, Bird, P, Ejbjerg, B, Klarlund, Mette, Shnier, R, Genant, H, Emery, P, Edmonds, J, Conaghan, P, Lassere, M, Østergaard, Mikkel, Peterfy, C, McQueen, F, O'Connor, P, Bird, P, Ejbjerg, B, Klarlund, Mette, Shnier, R, Genant, H, Emery, P, and Edmonds, J

Published
2003

39. OMERACT Rheumatoid Arthritis Magnetic Resonance Imaging Studies. Core set of MRI acquisitions, joint pathology definitions, and the OMERACT RA-MRI scoring system.

Author

Østergaard, Mikkel, Peterfy, C, Conaghan, P, McQueen, F, Bird, P, Ejbjerg, B, Shnier, R, O'Connor, P, Klarlund, Mette, Emery, P, Genant, H, Lassere, M, Edmonds, J, Østergaard, Mikkel, Peterfy, C, Conaghan, P, McQueen, F, Bird, P, Ejbjerg, B, Shnier, R, O'Connor, P, Klarlund, Mette, Emery, P, Genant, H, Lassere, M, and Edmonds, J

Abstract

This article describes the 2002 OMERACT rheumatoid arthritis magnetic resonance image scoring system (RAMRIS) for evaluation of inflammatory and destructive changes in RA hands and wrists, which was developed by an international MRI-OMERACT group. MRI definitions of important RA joint pathologies, and a 'core set' of basic MRI sequences for use in RA are also suggested

Published
2003

40. OMERACT Rheumatoid Arthritis Magnetic Resonance Imaging Studies. Summary of OMERACT 6 MR Imaging Module.

Author

McQueen, F, Lassere, M, Edmonds, J, Conaghan, P, Peterfy, C, Bird, P, O'Connor, P, Ejbjerg, B, Klarlund, Mette, Stewart, N, Emery, P, Shnier, R, Genant, H, Østergaard, Mikkel, McQueen, F, Lassere, M, Edmonds, J, Conaghan, P, Peterfy, C, Bird, P, O'Connor, P, Ejbjerg, B, Klarlund, Mette, Stewart, N, Emery, P, Shnier, R, Genant, H, and Østergaard, Mikkel

Abstract

Magnetic resonance image (MRI) scanning is a new method for imaging and quantifying joint inflammation and damage in rheumatoid arthritis (RA). Over the past 4 years, the OMERACT MR Imaging Group has been developing and testing the RA-MRI scoring system (RAMRIS) for use in RA. The OMERACT filter demands that an ideal outcome measure satisfy the elements of truth, discrimination, and feasibility. The RAMRIS as it currently stands incorporates measures of joint inflammation and damage including bone erosion, edema, and synovitis. Tendonitis has not been scored because of feasibility issues; joint space narrowing, reflecting cartilage damage, has also been excluded as reliability was low at the small joints of the hands. Anatomical coverage of the score is currently restricted to the wrists and hands but can provide a basis for a more comprehensive score. The MR measurement of synovitis correlates closely with histological evidence and work continues on validating MR erosions with reference to radiographic techniques. The RAMRIS has demonstrated good reliability for bone erosion and synovitis at the wrists and metacarpophalangeal joints subject to reader training, with slightly lower levels of reader agreement for bone edema. Reliability was less satisfactory in discriminating between 2 time points, and further work is required if the score is to be used to monitor change. Feasibility also needs to be considered for the practical application of the score, including the time taken for scanning and scoring, as well as cost and safety issues. The OMERACT RAMRIS provides a framework for scoring inflammation and damage in RA upon which further modifications can be built. It has been endorsed by the MRI working group and OMERACT 6 participants as useful for inclusion as an outcome measure in clinical trials

Published
2003

42. MRI in Rheumatoid Arthritis at OMERACT 2002: Suggested 'core set' of MRI acquisitions, definitions of important joint pathologies, and scoring system (OEMRACT 2002 RAMRIS).

Author

Østergaard, Mikkel, McQueen, F, Peterfy, C, Conaghan, P, Lassere, M, Bird, P, Ejbjerg, B, Shnier, R, O'Connor, P, Klarlund, Mette, Emery, P, Genant, H, Edmonds, J, Østergaard, Mikkel, McQueen, F, Peterfy, C, Conaghan, P, Lassere, M, Bird, P, Ejbjerg, B, Shnier, R, O'Connor, P, Klarlund, Mette, Emery, P, Genant, H, and Edmonds, J

Published
2002

43. Interreader agreement in the assessment of magnetic resonance images of rheumatoid arthritis wrist and finger joints--an international multicenter study.

Author

Østergaard, Mikkel, Klarlund, Mette, Lassere, M, Conaghan, P, Peterfy, C, McQueen, F, O'Connor, P, Shnier, R, Stewart, N, McGonagle, D, Emery, P, Genant, H, Edmonds, J, Østergaard, Mikkel, Klarlund, Mette, Lassere, M, Conaghan, P, Peterfy, C, McQueen, F, O'Connor, P, Shnier, R, Stewart, N, McGonagle, D, Emery, P, Genant, H, and Edmonds, J

Abstract

Magnetic resonance imaging (MRI) allows direct visualization of inflammation and destruction in rheumatoid arthritis (RA) joints. However, MRI scoring methods have not yet been standardized or appropriately validated. Our aim was to examine interreader agreement for a simple system of scoring RA changes on MRI among 5 centers that had not undertaken intergroup calibration. MRI of RA wrist and metacarpophalangeal (MCP) joints were scored by experienced readers in 5 centers in different countries. In substudy 1, 5 sets of 2nd-5th MCP joints from UK [Technique A: 1.5 T, coronal and axial T1 and T2 spin-echo, -/+ fat saturation (FS), -/+ iv gadolinium (Gd)] were scored for synovitis (score 0-3) and bone lesions (0-3). In substudy 2, we evaluated 19 sets of 2nd-5th MCP joints [10 sets from UK (Technique A) and 9 sets from the US (Technique B: 1.5 T; coronal T1 spin-echo and T2* gradient-echo + FS, no Gd)] and 19 wrist joints [9 from the US (Technique B) and 10 from Denmark (Technique C: 1.0 T; coronal and axial T1 spin-echo, no FS, -/+ Gd)]. Synovitis (0-3), bone lesions (0-3), and joint space narrowing (JSN, 0-3) were scored in each MCP joint and in 3 different regions of the wrist. Bone erosions and lesions in each bone were scored 0-5. Substudy 1 served to test and redesign the score sheets. In substudy 2, the scores of synovitis and bone lesions by the 5 groups were the same or differed by only one grade in 73% and 85% of joints, respectively. On MRI that included 2 imaging planes and iv Gd (Techniques A and C), these rates were 86% (synovitis) and 97% (bone lesions). Corresponding intraclass correlation coefficients (quadratic weighted kappas) were 0.44-0.68, mean 0.58 (synovitis), and 0.44-0.69, mean 0.62 (bone lesion), i.e., in the moderate to good range. Unweighted kappa values were in the low to moderate range, generally lowest for JSN (< 0.20), better for synovitis and bone erosions, and best for bone lesions, being generally highest for MRI with 2 planes pr

Published
2001

44. Magnetic resonance imaging in rheumatoid arthritis: summary of OMERACT activities, current status, and plans.

Author

Conaghan, P, Edmonds, J, Emery, P, Genant, H, Gibbon, W, Klarlund, Mette, Lassere, M, McGonagle, D, McQueen, F, O'Connor, P, Peterfy, C, Shnier, R, Stewart, N, Østergaard, Mikkel, Conaghan, P, Edmonds, J, Emery, P, Genant, H, Gibbon, W, Klarlund, Mette, Lassere, M, McGonagle, D, McQueen, F, O'Connor, P, Peterfy, C, Shnier, R, Stewart, N, and Østergaard, Mikkel

Published
2001

45. Assessment of the radioanatomic positioning of the osteoarthritic knee in serial radiographs: comparison of three acquisition techniques

Author

H. Le Graverand, M.-P., primary, Mazzuca, S., additional, Lassere, M., additional, Guermazi, A., additional, Pickering, E., additional, Brandt, K., additional, Peterfy, C., additional, Cline, G., additional, Nevitt, M., additional, Woodworth, T., additional, Conaghan, P., additional, and Vignon, E., additional

Published
2006
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46. Patient perceptions of carrying their own health information: approaches towards responsibility and playing an active role in their own health - implications for a patient-held health file.

Author

Forsyth R, Maddock CA, Iedema RAM, and Lassere M

Abstract

Objective To elicit patients' views on whether they could contribute to improvements in their care by carrying their own health information to clinician encounters; and to consider the implications for the development of a patient-held health file (PHF). Background Increasing rates of chronic disease lead to health care being delivered by multiple care providers often at distributed geographic locations. As a way of increasing the availability of patient information to care providers our project will trial a PHF. Patients carry these files to doctors' appointments where clinicians record data for other doctors or the patient. Increasing the availability of patient information is anticipated to enhance the safety and quality of care delivery and improve health outcomes. Study design Qualitative semi-structured interviews were conducted with 10 patients. Participants were evenly distributed in terms of gender, aged 60 years or greater and visited at least two specialists and one general practitioner. Findings In this exploratory study, patients who were currently active in decision making about their own health already recorded some health information. They were receptive to carrying their information and thought they should take some responsibility for their health. Patients who were more passive in making decisions about their health did not perceive a need to carry their own information and felt that their doctors communicated adequately. Conclusion Patient-held health files provide an opportunity for patients to access their health information. Such files have the potential to improve health outcomes for patients who adopt both active and passive roles in relation to their own health and engaging with their health information. [ABSTRACT FROM AUTHOR]

Published
2010
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47. Documenting damage progression in a two-year longitudinal study of rheumatoid arthritis patients with established disease (the DAMAGE Study Cohort): is there an advantage in the use of magnetic resonance imaging as compared with pain radiography?

Author

Bird P, Kirkham B, Portek I, Shnier R, Joshua F, Edmonds J, and Lassere M

Abstract

OBJECTIVE: In early rheumatoid arthritis (RA), longitudinal studies have demonstrated that magnetic resonance imaging (MRI) is more sensitive than radiography in demonstrating progressive erosive joint damage. The present study evaluated the progression of erosive damage in patients with established RA by using limited field of view MRI and comparing the results with those obtained by radiography. METHODS: MRI and radiographic studies were available from 47 of 60 patients enrolled in a 2-year RA observational study. MRI of the metacarpophalangeal (MCP) joints was performed at baseline and 2 years later, and a single observer scored all of the MR images with the use of an MRI scoring method developed by the Outcome Measures in Rheumatology Clinical Trials MRI RA study group. MR images from 14 patients were reread by the same observer after 1 week to assess intraobserver reliability. Radiographs were obtained at baseline and at 2 years, and were scored by an observer using the Scott modification of the Larsen score. Radiographs from 14 patients were reread after 1 week to assess the intraobserver reliability. The smallest detectable difference (SDD) was calculated for the MRI scores, the total Larsen scores, and the Larsen scores of the dominant-hand MCP joints (MCPs 2-5) for direct comparison with the MRI results. RESULTS: The median disease duration was 5.1 years (range 0.5-29 years). Evidence of erosion progression was identified by MRI in 30 patients (64%). The SDD based on the intraobserver scores was calculated as +/-3.25 units. Using this result, 11 patients (23%) showed evidence of erosion progression on MRI that was greater than the SDD. The SDD for progression based on the intraobserver total Larsen radiographic scores was 0.77 units, and the SDD for the Larsen scores of the dominant-hand MCP joints was 1.55 units. On the basis of these results, radiographic progression was noted in 19 patients (40%) by the total Larsen score and 7 patients (15%) by the dominant-hand MCP Larsen score. The most striking finding was that although MRI and radiograph scores identified a similar group of patients as having progression of joint damage, the radiographs of both hands appeared to be more responsive to change, albeit with the caveat that radiographic progression was most marked outside the dominant-hand MCP joints. CONCLUSION: There was no clear advantage of MRI with a limited field of view as compared with radiographic imaging of both hands in detecting progression of joint damage over 2 years in this group of patients with established RA. The conclusion drawn from this study is not that radiographs are better than MRI or vice versa, but that careful analysis is required to determine the optimal imaging method, or combination of imaging methods, for each study population, depending on the objective and duration of the study. [ABSTRACT FROM AUTHOR]

Published
2004
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49. Definitions and validation criteria for biomarkers and surrogate endpoints: Development and testing of a quantitative hierarchical levels of evidence schema

Author

Lassere, M. N., Johnson, K. R., Boers, M., Tugwell, P., Brooks, P., Simon, L., Strand, V., Conaghan, P. G., Østergaard, M., Walter Maksymowych, Landewé, R., Bresnihan, B., Tak, P. -P, Wakefield, R., Mease, P., Bingham Iii, C. O., Hughes, M., Altman, D., Buyse, M., Galbraith, S., Wells, G., Other departments, Amsterdam institute for Infection and Immunity, and Clinical Immunology and Rheumatology

Subjects
Evidence-Based Medicine, National Institutes of Health (U.S.), Predictive Value of Tests, Rheumatic Diseases, Terminology as Topic, Outcome Assessment, Health Care, Humans, Reproducibility of Results, Biomarkers, United States
Abstract

OBJECTIVE: There are clear advantages to using biomarkers and surrogate endpoints, but concerns about clinical and statistical validity and systematic methods to evaluate these aspects hinder their efficient application. Our objective was to review the literature on biomarkers and surrogates to develop a hierarchical schema that systematically evaluates and ranks the surrogacy status of biomarkers and surrogates; and to obtain feedback from stakeholders. METHODS: After a systematic search of Medline and Embase on biomarkers, surrogate (outcomes, endpoints, markers, indicators), intermediate endpoints, and leading indicators, a quantitative surrogate validation schema was developed and subsequently evaluated at a stakeholder workshop. RESULTS: The search identified several classification schema and definitions. Components of these were incorporated into a new quantitative surrogate validation level of evidence schema that evaluates biomarkers along 4 domains: Target, Study Design, Statistical Strength, and Penalties. Scores derived from 3 domains the Target that the marker is being substituted for, the Design of the (best) evidence, and the Statistical strength are additive. Penalties are then applied if there is serious counterevidence. A total score (0 to 15) determines the level of evidence, with Level 1 the strongest and Level 5 the weakest. It was proposed that the term "surrogate" be restricted to markers attaining Levels 1 or 2 only. Most stakeholders agreed that this operationalization of the National Institutes of Health definitions of biomarker, surrogate endpoint, and clinical endpoint was useful. CONCLUSION: Further development and application of this schema provides incentives and guidance for effective biomarker and surrogate endpoint research, and more efficient drug discovery, development, and approval.

50. Is blood pressure reduction a valid surrogate endpoint for stroke prevention? an analysis incorporating a systematic review of randomised controlled trials, a by-trial weighted errors-in-variables regression, the surrogate threshold effect (STE) and the biomarker-surrogacy (BioSurrogate) evaluation schema (BSES)

Author

Lassere Marissa N, Johnson Kent R, Schiff Michal, and Rees David

Subjects
Blood pressure, Stroke, Surrogate Endpoint, Biomarker, Medicine (General), R5-920
Abstract

Abstract Background Blood pressure is considered to be a leading example of a valid surrogate endpoint. The aims of this study were to (i) formally evaluate systolic and diastolic blood pressure reduction as a surrogate endpoint for stroke prevention and (ii) determine what blood pressure reduction would predict a stroke benefit. Methods We identified randomised trials of at least six months duration comparing any pharmacologic anti-hypertensive treatment to placebo or no treatment, and reporting baseline blood pressure, on-trial blood pressure, and fatal and non-fatal stroke. Trials with fewer than five strokes in at least one arm were excluded. Errors-in-variables weighted least squares regression modelled the reduction in stroke as a function of systolic blood pressure reduction and diastolic blood pressure reduction respectively. The lower 95% prediction band was used to determine the minimum systolic blood pressure and diastolic blood pressure difference, the surrogate threshold effect (STE), below which there would be no predicted stroke benefit. The STE was used to generate the surrogate threshold effect proportion (STEP), a surrogacy metric, which with the R-squared trial-level association was used to evaluate blood pressure as a surrogate endpoint for stroke using the Biomarker-Surrogacy Evaluation Schema (BSES3). Results In 18 qualifying trials representing all pharmacologic drug classes of antihypertensives, assuming a reliability coefficient of 0.9, the surrogate threshold effect for a stroke benefit was 7.1 mmHg for systolic blood pressure and 2.4 mmHg for diastolic blood pressure. The trial-level association was 0.41 and 0.64 and the STEP was 66% and 78% for systolic and diastolic blood pressure respectively. The STE and STEP were more robust to measurement error in the independent variable than R-squared trial-level associations. Using the BSES3, assuming a reliability coefficient of 0.9, systolic blood pressure was a B + grade and diastolic blood pressure was an A grade surrogate endpoint for stroke prevention. In comparison, using the same stroke data sets, no STEs could be estimated for cardiovascular (CV) mortality or all-cause mortality reduction, although the STE for CV mortality approached 25 mmHg for systolic blood pressure. Conclusions In this report we provide the first surrogate threshold effect (STE) values for systolic and diastolic blood pressure. We suggest the STEs have face and content validity, evidenced by the inclusivity of trial populations, subject populations and pharmacologic intervention populations in their calculation. We propose that the STE and STEP metrics offer another method of evaluating the evidence supporting surrogate endpoints. We demonstrate how surrogacy evaluations are strengthened if formally evaluated within specific-context evaluation frameworks using the Biomarker- Surrogate Evaluation Schema (BSES3), and we discuss the implications of our evaluation of blood pressure on other biomarkers and patient-reported instruments in relation to surrogacy metrics and trial design.

Published
2012
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