Treating Rheumatoid Arthritis to Target : the patient version of the international recommendations

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1 Treating Rheumatoid Arthritis to Target : the patient version of the international recommendations Data presented from the publication: M. de Wit, et al. Ann Rheum Dis. 2011;70: Epub Apr 7, Please always quote this reference when presenting these data.

2 MAIN REASONS FOR DEVELOPING A PATIENT VERSION OF THE RECOMMENDATIONS The content of the T2T statements addresses the issue of communication between the patient and the rheumatologist. But the technical nature of the medical language makes it difficult to understand for patients. Overarching principle # A emphasizes the importance of a shared decision making process. Recommendation #10: this can only be achieved if the patient is well informed about the different treatment options The main outcomes expected from a patient version of the recommendations written in lay language: To improve understanding, adherence and acceptance of the treatment. To enable patients to make informed decisions about their treatment. To create the conditions of a real dialogue with the rheumatologist about the risks and benefits of treatments. 2 To encourage physicians to make decisions on an equal level.

3 METHODS (1) A core group (4 members of the T2T committee, including 1 patient) produced a draft version of the recommendations in lay language. This draft version was discussed, amended and reworded during a one day consensus meeting with nine RA patients. The meeting was moderated by two members of the T2T committee: M. de Wit (patient) and D. van der Heijde (clinician). The participating patients were recruited and selected with the help of the EULAR Standing Committee of Patients with Arthritis/Rheumatism in Europe (PARE). They were eight woman and one man from 9 countries representing all regions of Europe: Cyprus, Czech Republic, Denmark, Ireland, Norway, Portugal, The Netherlands, Romania, UK. The final patient version elaborated during this meeting was published in June 2011 (1). 3 (1) M. de Wit, et al. Ann Rheum Dis. 2011;70: Epub Apr 7, 2011.

4 METHODS (2) Main rule of the translation: no change in the content or meaning of the recommendations. The level of agreement with the translation and the content of the recommendations was assessed by all patient participants (including the patient moderator) using a numerical scale, from 0 (no agreement) to 10 (full agreement). The group gave suggestions for implementations. 4

5 RESULTS / STATEMENTS The group tried to stay as close as possible to the original meaning. Simplification was achieved by cutting long sentences in multiple short sentences or by looking for common synonyms or clarification in lay language. The word significant raised long discussions; it was kept and the group proposed that each country should explore its own synonyms or translations. The word validated was another subject of concern; no satisfactory solution was found; in the end, it was not seen as an element of crucial importance and was deleted. To avoid long sentences, the group identified a number of words and concepts calling for more explanations in lay language. These are presented in a glossary accompanying the original ARD publication. The glossary is composed of 21 notions. From adjustment of drug treatment to validated measurement instrument. 5

6 OVERARCHING T2T PRINCIPLES ORIGINAL (A) The treatment of RA must be based on a shared decision between patient and rheumatologist. (B) The primary goal of treating the patient with RA is to maximise long-term healthrelated quality of life through control of symptoms, prevention of structural damage, normalisation of function and social participation (C) Abrogation of inflammation is the most important way to achieve these goals (D) Treatment to target by measuring disease activity and adjusting therapy accordingly optimizes outcomes in rheumatoid arthritis. PATIENT VERSION (A) Decisions regarding the treatment of RA must be made by the patient and the rheumatologist together. (B) The most important goal of treatment is to maximise long-term health-related quality of life. This can be achieved throuhg control of disease symptoms like pain, inflammation, stiffness and fatigue; prevention of damage to joints and bones; regaining normal function and participation in daily-life activities. (C) The most important way to achieve to achieve these goals is to stop joint inflammation. (D) Treatment toward a clear target of disease activity gives the best results in RA. This can be achieved by measuring disease activity and adjusting therapy if the target is not achieved. 6

7 RECOMMENDATIONS (1) ORIGINAL (1) The primary target for treatment of rheumatoid arthritis should be a state of clinical remission. PATIENT VERSION (1) The primary target of treatment of RA should be clinical remission. (2) Clinical remission is defined as the absence of signs and symptoms of significant inflammatory disease activity. (2) Clinical remission means that significant signs and symptoms of the disease that are caused by inflammation are absent. (3) While remission should be a clear target, based on available evidence low disease activity may be an acceptable alternative therapeutic goal, particularly in established, long-standing disease. (3) Although remission should be the target, it is not possible for some patients, in particular those with long disease duration. Therefore, low disease activity may be an acceptable alternative. (4) Until the desired treatment target is reached, drug therapy should be adjusted at least every 3 months. (4) Until the desired treatment target is reached, drug therapy should be adjusted at least every 3 months. 7

8 RECOMMENDATIONS (2) ORIGINAL (5) Measures of disease activity must be obtained and documented regularly, as frequently as monthly for patients with high/moderate disease activity or less frequently (such as every 3 to 6 months) for patients in sustained low disease activity or remission. PATIENT VERSION (5) Disease activity must be measured and documented regularly. For patients with high or moderate disease activity this must be done every month. For patients in a sustained low disease activity state or remission, this can be done less frequently (eg, every 3-6 months). (6) The use of validated composite measures of disease activity, which include joint assessments, is needed in routine clinical practice to guide treatment decisions. (6) Combined disease activity measurements which include joint examinations are needed in routine clinical practice to guide treatment decisions. (7) Structural changes and functional impairment should be considered when making clinical decisions, in addition to assessing composite measures of disease activity. (7) Besides disease activity, treatment decisions in clinicial practice should also consider damage to the joints and restrictions in activities of daily living. 8

9 RECOMMENDATIONS (3) ORIGINAL PATIENT VERSION (8) The desired treatment target should be maintained throughout the remaining course of the disease. (8) The desired treatment target should be maintained throughout the remaining course of the disease. (9) The choice of the (composite) measure of disease activity and the level of the target value may be influenced by considerations of co-morbidities, patient factors and drug related risks. (10) The patient has to be appropriately informed about the treatment target and the strategy planned to reach this target under the supervision of the rheumatologist. (9) Selecting the appropriate measurement of disease activity and target may be influenced by the individual situation: presence of other diseases, patient related-factors or drug-related safety risks. (10) The patient has to be appropriately informed about the treatment target and the strategy planned to reach this target under the supervision of the rheumatologist. 9

10 RESULTS / EVALUATION OF THE PATIENT VERSION With a very high level of agreement (mean 9.3) the patient group has emphasized the importance of the T2T recommendations. A patient version of the recommendations is likely to help people who receive treatment by informing them about what they receive. It will empower patients with RA who do not receive treatment according to these recommendations. 10 Level of agreement with T2T recommendations patient version Overarching principles A to D and Recommendations 1 to 10

11 RESULTS / IMPLEMENTATION However the group assumed there is a substantial gap between daily practice and the recommended treatment strategy. This is why thoughtful implementation is still needed: Validation of the recommendations content by a larger group of patients is required. Translating the recommendations from english into the language of different countries, would be taking a major step forward. Disseminating the patient version through leaflets or booklets would help the patients to be aware of the importance of issues like: how often they should see the rheumatologist, personal involvement in the decision making process, what they should expect from the treatment. The absence of a clear and uniform definition of the target in RA treatment makes the education of patients more difficult and calls in particular for a clear overview of the definitions used for high, moderate, low disease activity and remission. 11

12 DISCUSSION (1) At the time of the publication, there were only two published initiatives incorporating the patients point of view in the development of recommendations in the field of rheumatology. 1. The patient version of the ASAS/EULAR recommendations for the management of ankylosing spondylitis. 18 patients representatives from 10 countries, 2 days consensus meeting. The group translated the recommendations, discussed their content and proposed a wish list for the updating of the recommendations Eular recommendations on the management of systemic glucocorticoid therapy in rheumatic diseases: A task force composed of rheumatologists from 8 countries and patients from 5 countries. No patient version, but an exploration of perspectives on both sides on how to enhance the implementation of the recommendations. The group provided suggestions to improve the implementation and a research agenda It also emphasized the need for an early incorporation of both sides perspectives in the formulation of the recommendations.

13 DISCUSSION (2) The T2T patient group pointed out to the fact that drug treatment, no matter how important it is, is not the only element that determines clinic outcomes. Still, the participants noticed T2T recommendations have a strong focus on body functions and structures. Patient-centred care in rheumatology also requires non pharmacological and psychological support. This assumption led the group to emphasize the importance of multidisciplinary teamwork in the management of RA. Rheumatologists need the support of other key professionals when carrying the scores and educating/empowering the patients. Unfortunately, nurse practitioners and physician assistants are not available in all countries. 13

14 DISCUSSION (3) The group members reported from their experience that they cannot absorb all the information provided, specifically at the first visit. However, patients should receive information about the risks of the disease and the expected outcomes of the treatment, so the treatment can be started as soon as possible once the diagnosis has been made. A patient version will provide a very useful support to this process. So would be a meeting with a specialized nurse. 14

15 DISCUSSION (4) Two consequences of the very high level of agreement with the T2T recommendations should be emphasized: The T2T group did not disagree with any of the recommendations, in contrast with the ASAS/EULAR patient version. The T2T group did not add any topic to the research agenda, as did the glucocorticoid patient group. This could result from the involvement of some patient representatives (n=5) in the development process of the original recommendations. However, the T2T group identified a number of barriers for implementation. First of all they referred to the limited access to rheumatology care: few countries offer the possibility for RA patients to see a rheumatologist every 3 months or more often. In most countries, people don t have access to their own data. Some advanced digital registration systems allowing for regular reports, on disease activity, monitoring, patient education, etc. do exist. But only a minority of patients have access to those systems. 15

16 DISCUSSION (5) This is why the Patient version of the T2T recommendations could be used by patients organizations for advocacy purposes like approaching politicians, regulators and healthcare payers in their country. They could make a claim for better legislation resulting in better health outcome for people with RA. 16

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