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Rheumatology outcome measures in principle and practice in India: So near and yet so far
i n d i a n j o u r n a l o f r h e u m a t o l o g y 8 ( 2 0 1 3 ) S 8 eS 1 0
ScienceDirect Available online at www.indianjrheumatol.com and www.sciencedirect.com
Perspective
Rheumatology outcome measures in principle and practice in India: So near and yet so far Vinod Ravindran MES Medical College, Perinthalmanna 679338, Kerala, India
Keywords: Rheumatology Outcome measures OMERACT India
Rheumatology is at the forefront of modern medicine not only in the fully industrialised world but also in India thanks to the shifting priorities in health care delivery and also due to the tremendous advances made in the understanding of the rheumatological diseases and to the significant and dramatic augmentation of therapeutic armamentarium against them. With its myriad manifestations with often a waxing a waning course; the impact of rheumatological diseases could be assessed fully only when all aspects are considered such as disease activity, chronic damage resulting from the disease activity, effect of treatment on the disease activity, drug related adverse events, impact of disease and management related aspects on quality of life and the economic impact of the disease both to the patient and to the society. Driven by a desire to more objectively assess the disease to guide the therapy; there has been a relatively recent focus on developing tools to measure the various aspects of disease (outcome measures).1,2 It was recognised that an ideal outcome measure should be suitable to be used in the clinical trials setting and in the routine clinical practice alike. In the foregoing pages of this supplement in his perspective my coguest editor Dr Kirwan has documented the pivotal role played by the Outcome Measures in Rheumatology (OMERACT; www.omeract.org) group in the development of “outcome measures”. In subsequent pages our international colleagues from the OMERACT in their respective reviews of outcome
measures in several important rheumatological diseases have elegantly written what could be truly described as the “state of the art” in the field of “rheumatology outcome measures”. They have highlighted the developments in this field and have also discussed strengths and limitations of existing outcome measures from the “developer’s” perspective. My colleagues from India have also excelled themselves by giving an honest and forthright assessment of the use of outcome measures in rheumatology in India. They have bought to our notice the practical difficulties of such outcome measures being used effectively in both clinical practice and research setting in India. Representing centres both academic and non-academic their views could be considered representing other countries of Asia as well; many of which share similar social and cultural traits and also to some extent economic scenarios and demographic features with India. In the first Indian commentary, Dr Shankar mentions that in gout, assessments of disease from an Asian and Indian perspective by and large remains an unexplored field and existing measures assessing certain disease domains particularly activity limitation and health-related quality of life (HRQoL) needs suitable adaptation. Dr Dharmanand while highlighting that current patient reported outcome measures (PROM) are typically western culture oriented laments the lack of patient participation in many clinical studies at the study conceptualization stage. He strongly advocates
E-mail address: [email protected]. 0973-3698/$ e see front matter Copyright ª 2013, Indian Rheumatology Association. All rights reserved. http://dx.doi.org/10.1016/j.injr.2013.11.020
i n d i a n j o u r n a l o f r h e u m a t o l o g y 8 ( 2 0 1 3 ) S 8 eS 1 0
appropriate representation of patients in the institutional ethics committees in India. Dr Aggarwal points out that an assessment of a multi-faceted disease like psoriatic arthritis could be difficult in view of the heavy case load in typical outpatient clinics and that an assessment of skin involvement might be difficult or inadequate in females due to social reasons. Giving an Indian perspective on the outcome measures used in rheumatoid arthritis, Dr Malaviya comments that culturally, people in India are not used to thinking in terms of a ‘scale’, probably because this is not taught in schools and this poses a great difficulty when patients are asked to assess their disease in absolute terms. He like several other authors also stresses on the need of modifications/revisions of outcome measures to ensure/enhance their cultural suitability. Dr Jois touches raw nerves by highlighting that most of our patients with axial spondyloarthritis (SpAs) are unable to afford biological agents so what is the point in measuring outcome? This thought provoking view appears to be particularly relevant for SpAs as the biological agents such as antiTNF therapy is the only effective therapy that has been shown to improve both clinical and to some extent radiological outcomes in axial SpA. While appealing for a greater collaboration between colleagues in OMERACT and Indian rheumatologists for developing fully “Indianised” outcome measures Dr Narsimulu points out certain unique problems which complicates the outcome assessment in systemic lupus erythematosus in India e.g. rampant and indiscriminate glucocorticoid usage, infections, cost of medications, poor adherence to the therapy, delayed presentation etc. Systemic sclerosis (SSc) is a complex and often frustrating disease to treat; Dr Shenoy brings to our notice the fact that to assess the pulmonary arterial pressure (PAH), right heart catheterisation (RHC) is not performed in most of the centres due to different perception of risk benefit ratio for this procedure by many cardiology colleagues; the additional cost of RHC acting as a further barrier. Finally, Dr Sharma exhorts the need for international collaboration in the field of primary systemic vasculitis with a view to develop and validate suitable outcome measures. As a way forward he mentions the success of Indian Rheumatology Association Vasculitis group (IRAVAS) group in developing Indian Takayasu’s Arteritis Activity Score (ITAS2010) which is probably the best validated disease activity measure in Takayasu’s arteritis to date. While there are several concerns (Box 1) the scenario is far from bleak. Researchers in India have successfully worked on developing and validating outcome measures such as Indian versions of HAQ and validation of vasculitis disease index (VDI) and the Birmingham vasculitis activity score (BVAS).3,4,5 Manpower (formally trained indigenously or aboard) in rheumatology has increased, there has been more collaborative research and certain areas such as patient education and the performance of rheumatoid arthritis classification criteria in the Indian context have also been now more formally studied.6,7 With increasing focus on ascertaining what is really good for our patients the limitations of using outcome measures primarily developed in other countries are being increasingly recognised, and the thrust is towards international collaboration to resolve and rectify the issues. One such collaborative effort of Toronto based rheumatologist Dr
S9
Box 1 Limitations of the existing rheumatology outcome measures and barriers in their effective use in the Indian setting Not culturally and socially sensitive. Importance of some measures not understood by other specialities. Patients have difficulty understanding the concept of visual analogue scale. Patients can not measure their disease in absolute terms. Non affordability of certain therapeutic agents renders the measurement of “outcome” futile. Costs of investigations necessary for certain outcome measures may not be acceptable to patients. Low education background of patients makes it difficult to administer patient reported outcome measures. In a patient with comorbidities, ‘global health’ might also indicate burden it. Poor patient participation at the study design level. Self reported disability and pain have multiple influences. Validation in several different Indian languages might be necessary. Lack of patient self help/advocacy groups. Inadequate international collaboration. Focus only on the therapeutic aspect of management of diseases mainly necessitated by a heavy case load. An “inward looking” approach. Inadequate trained manpower in rheumatology. Time consuming. Lack of motivation to work in this filed limited also by the infrastructure and adequate financial compensation.
Chandran with Indian rheumatologists at 5 sites in India is aimed at doing standardised assessment of SpA patients and using this cohort to test the available measures and develop new measures suitable to India (personal communication). The development of ITAS 2010 which is also a result of international collaboration has already been mentioned.8 In this regard it would be important for Indian rheumatologists to work together with their experienced colleagues in the OMERACT to develop and validate outcome measures true the need of Indian setting. It is an opportunity which one would hope that we of the Indian rheumatology community would only be too eager to grab and make full use of. We could consider having “workshops” on outcome measures in our annual meetings (IRACONs); the awareness among its users may lead to removal of yet another potential barrier and can also be a motivator. To gain from the first hand experience of their colleagues working with OMERACT, the IRACON platform could also be used by the interested groups on “outcome measures” of different diseases to avail the opportunity to interact with them. OMERACT international meetings remain unrepresented by India so far and this should also change in very near future. It is imperative that we take part in developing outcome measures “of the people, by the people and for the people”-our patients need and deserve that!
S10
i n d i a n j o u r n a l o f r h e u m a t o l o g y 8 ( 2 0 1 3 ) S 8 eS 1 0
Conflicts of interest 4.
The author has none to declare.
references
5.
6. 1. Bombardier C, Tugwell P, Sinclair A, Dok C, Anderson G, Buchanan WW. Preferences for endpoint measures in clinical trials: result of structured workshops. J Rheumatol. 1982;9:798e801. 2. Scott DL, Spector TD, Pullar T, McConkey B. What should we hope to achieve when treating rheumatoid arthritis? Ann Rheum Dis. 1989;48:256e261. 3. Kumar A, Malaviya AN, Pandhi A, Singh P. Validation of an Indian version of the health assessment questionnaire in
7.
8.
patients with rheumatoid arthritis. Rheumatology (Oxford). 2002;41:1457e1459. Chopra A, Saluja M. Validation and usefulness of Indian version (CRD Pune) health assessment questionnaire: Drug trails, community practice and COPCORD Bhigwan population study (1994-2012). Indian J Rheumatol. 2012;7(2):74e82. Misra R, Sivakumar MR, Bambery P, et al. Validation of BVAS and VDI: Indian Rheumatology Association core group experience. J Indian Rheumatol Assoc. 2004;12:78e81. Ravindran V, Jadhav R. The effect of rheumatoid arthritis disease education on adherence to medication and follow ups in Kerala, India. J Rheumatol. 2013;40:1460e1461. Ravindran V, Abdulaziz A. Performance of the 2010 ACR/ EULAR classification criteria for rheumatoid arthritis in a prospective early arthritis cohort. Indian J Rheumatol. 2012;7(SII):s31. Misra R, Danda D, Rajappa SM, et al. Development and initial validation of the Indian Takayasu clinical activity score (ITAS2010). Rheumatology (Oxford). 2013;52:1795e1801.
ScienceDirect Available online at www.indianjrheumatol.com and www.sciencedirect.com
Perspective
Rheumatology outcome measures in principle and practice in India: So near and yet so far Vinod Ravindran MES Medical College, Perinthalmanna 679338, Kerala, India
Keywords: Rheumatology Outcome measures OMERACT India
Rheumatology is at the forefront of modern medicine not only in the fully industrialised world but also in India thanks to the shifting priorities in health care delivery and also due to the tremendous advances made in the understanding of the rheumatological diseases and to the significant and dramatic augmentation of therapeutic armamentarium against them. With its myriad manifestations with often a waxing a waning course; the impact of rheumatological diseases could be assessed fully only when all aspects are considered such as disease activity, chronic damage resulting from the disease activity, effect of treatment on the disease activity, drug related adverse events, impact of disease and management related aspects on quality of life and the economic impact of the disease both to the patient and to the society. Driven by a desire to more objectively assess the disease to guide the therapy; there has been a relatively recent focus on developing tools to measure the various aspects of disease (outcome measures).1,2 It was recognised that an ideal outcome measure should be suitable to be used in the clinical trials setting and in the routine clinical practice alike. In the foregoing pages of this supplement in his perspective my coguest editor Dr Kirwan has documented the pivotal role played by the Outcome Measures in Rheumatology (OMERACT; www.omeract.org) group in the development of “outcome measures”. In subsequent pages our international colleagues from the OMERACT in their respective reviews of outcome
measures in several important rheumatological diseases have elegantly written what could be truly described as the “state of the art” in the field of “rheumatology outcome measures”. They have highlighted the developments in this field and have also discussed strengths and limitations of existing outcome measures from the “developer’s” perspective. My colleagues from India have also excelled themselves by giving an honest and forthright assessment of the use of outcome measures in rheumatology in India. They have bought to our notice the practical difficulties of such outcome measures being used effectively in both clinical practice and research setting in India. Representing centres both academic and non-academic their views could be considered representing other countries of Asia as well; many of which share similar social and cultural traits and also to some extent economic scenarios and demographic features with India. In the first Indian commentary, Dr Shankar mentions that in gout, assessments of disease from an Asian and Indian perspective by and large remains an unexplored field and existing measures assessing certain disease domains particularly activity limitation and health-related quality of life (HRQoL) needs suitable adaptation. Dr Dharmanand while highlighting that current patient reported outcome measures (PROM) are typically western culture oriented laments the lack of patient participation in many clinical studies at the study conceptualization stage. He strongly advocates
E-mail address: [email protected]. 0973-3698/$ e see front matter Copyright ª 2013, Indian Rheumatology Association. All rights reserved. http://dx.doi.org/10.1016/j.injr.2013.11.020
i n d i a n j o u r n a l o f r h e u m a t o l o g y 8 ( 2 0 1 3 ) S 8 eS 1 0
appropriate representation of patients in the institutional ethics committees in India. Dr Aggarwal points out that an assessment of a multi-faceted disease like psoriatic arthritis could be difficult in view of the heavy case load in typical outpatient clinics and that an assessment of skin involvement might be difficult or inadequate in females due to social reasons. Giving an Indian perspective on the outcome measures used in rheumatoid arthritis, Dr Malaviya comments that culturally, people in India are not used to thinking in terms of a ‘scale’, probably because this is not taught in schools and this poses a great difficulty when patients are asked to assess their disease in absolute terms. He like several other authors also stresses on the need of modifications/revisions of outcome measures to ensure/enhance their cultural suitability. Dr Jois touches raw nerves by highlighting that most of our patients with axial spondyloarthritis (SpAs) are unable to afford biological agents so what is the point in measuring outcome? This thought provoking view appears to be particularly relevant for SpAs as the biological agents such as antiTNF therapy is the only effective therapy that has been shown to improve both clinical and to some extent radiological outcomes in axial SpA. While appealing for a greater collaboration between colleagues in OMERACT and Indian rheumatologists for developing fully “Indianised” outcome measures Dr Narsimulu points out certain unique problems which complicates the outcome assessment in systemic lupus erythematosus in India e.g. rampant and indiscriminate glucocorticoid usage, infections, cost of medications, poor adherence to the therapy, delayed presentation etc. Systemic sclerosis (SSc) is a complex and often frustrating disease to treat; Dr Shenoy brings to our notice the fact that to assess the pulmonary arterial pressure (PAH), right heart catheterisation (RHC) is not performed in most of the centres due to different perception of risk benefit ratio for this procedure by many cardiology colleagues; the additional cost of RHC acting as a further barrier. Finally, Dr Sharma exhorts the need for international collaboration in the field of primary systemic vasculitis with a view to develop and validate suitable outcome measures. As a way forward he mentions the success of Indian Rheumatology Association Vasculitis group (IRAVAS) group in developing Indian Takayasu’s Arteritis Activity Score (ITAS2010) which is probably the best validated disease activity measure in Takayasu’s arteritis to date. While there are several concerns (Box 1) the scenario is far from bleak. Researchers in India have successfully worked on developing and validating outcome measures such as Indian versions of HAQ and validation of vasculitis disease index (VDI) and the Birmingham vasculitis activity score (BVAS).3,4,5 Manpower (formally trained indigenously or aboard) in rheumatology has increased, there has been more collaborative research and certain areas such as patient education and the performance of rheumatoid arthritis classification criteria in the Indian context have also been now more formally studied.6,7 With increasing focus on ascertaining what is really good for our patients the limitations of using outcome measures primarily developed in other countries are being increasingly recognised, and the thrust is towards international collaboration to resolve and rectify the issues. One such collaborative effort of Toronto based rheumatologist Dr
S9
Box 1 Limitations of the existing rheumatology outcome measures and barriers in their effective use in the Indian setting Not culturally and socially sensitive. Importance of some measures not understood by other specialities. Patients have difficulty understanding the concept of visual analogue scale. Patients can not measure their disease in absolute terms. Non affordability of certain therapeutic agents renders the measurement of “outcome” futile. Costs of investigations necessary for certain outcome measures may not be acceptable to patients. Low education background of patients makes it difficult to administer patient reported outcome measures. In a patient with comorbidities, ‘global health’ might also indicate burden it. Poor patient participation at the study design level. Self reported disability and pain have multiple influences. Validation in several different Indian languages might be necessary. Lack of patient self help/advocacy groups. Inadequate international collaboration. Focus only on the therapeutic aspect of management of diseases mainly necessitated by a heavy case load. An “inward looking” approach. Inadequate trained manpower in rheumatology. Time consuming. Lack of motivation to work in this filed limited also by the infrastructure and adequate financial compensation.
Chandran with Indian rheumatologists at 5 sites in India is aimed at doing standardised assessment of SpA patients and using this cohort to test the available measures and develop new measures suitable to India (personal communication). The development of ITAS 2010 which is also a result of international collaboration has already been mentioned.8 In this regard it would be important for Indian rheumatologists to work together with their experienced colleagues in the OMERACT to develop and validate outcome measures true the need of Indian setting. It is an opportunity which one would hope that we of the Indian rheumatology community would only be too eager to grab and make full use of. We could consider having “workshops” on outcome measures in our annual meetings (IRACONs); the awareness among its users may lead to removal of yet another potential barrier and can also be a motivator. To gain from the first hand experience of their colleagues working with OMERACT, the IRACON platform could also be used by the interested groups on “outcome measures” of different diseases to avail the opportunity to interact with them. OMERACT international meetings remain unrepresented by India so far and this should also change in very near future. It is imperative that we take part in developing outcome measures “of the people, by the people and for the people”-our patients need and deserve that!
S10
i n d i a n j o u r n a l o f r h e u m a t o l o g y 8 ( 2 0 1 3 ) S 8 eS 1 0
Conflicts of interest 4.
The author has none to declare.
references
5.
6. 1. Bombardier C, Tugwell P, Sinclair A, Dok C, Anderson G, Buchanan WW. Preferences for endpoint measures in clinical trials: result of structured workshops. J Rheumatol. 1982;9:798e801. 2. Scott DL, Spector TD, Pullar T, McConkey B. What should we hope to achieve when treating rheumatoid arthritis? Ann Rheum Dis. 1989;48:256e261. 3. Kumar A, Malaviya AN, Pandhi A, Singh P. Validation of an Indian version of the health assessment questionnaire in
7.
8.
patients with rheumatoid arthritis. Rheumatology (Oxford). 2002;41:1457e1459. Chopra A, Saluja M. Validation and usefulness of Indian version (CRD Pune) health assessment questionnaire: Drug trails, community practice and COPCORD Bhigwan population study (1994-2012). Indian J Rheumatol. 2012;7(2):74e82. Misra R, Sivakumar MR, Bambery P, et al. Validation of BVAS and VDI: Indian Rheumatology Association core group experience. J Indian Rheumatol Assoc. 2004;12:78e81. Ravindran V, Jadhav R. The effect of rheumatoid arthritis disease education on adherence to medication and follow ups in Kerala, India. J Rheumatol. 2013;40:1460e1461. Ravindran V, Abdulaziz A. Performance of the 2010 ACR/ EULAR classification criteria for rheumatoid arthritis in a prospective early arthritis cohort. Indian J Rheumatol. 2012;7(SII):s31. Misra R, Danda D, Rajappa SM, et al. Development and initial validation of the Indian Takayasu clinical activity score (ITAS2010). Rheumatology (Oxford). 2013;52:1795e1801.