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The burdens imposed by Crohn’s disease: messages for clinicians?
Digestive and Liver Disease 35 (2003) 849–850
Commentary
The burdens imposed by Crohn’s disease: messages for clinicians? M.J.S. Langman∗ Department of Medicine, Queen Elizabeth Hospital, University of Birmingham, Birmingham B15 2TH, UK See related article on pages 853–861.
Health economic data do not usually form part of the prime reading of clinicians, who generally are more interested, of necessity and by inclination, in the most effective ways of managing disease and preventing its recurrence. In this issue of the journal Juan and colleagues [1] report a set of studies which bridge the gap for clinicians from econometric data by simultaneously enquiring about treatment costs, indirect costs and quality of life in patients with Crohn’s disease. The study size was substantial, with efforts made to include a cross-sectional sample of patients with the disease attending health service hospitals in Spain. Data was collected from structured enquiries of clinicians, which allowed calculation of direct disease costs, such as drug costs and those related to hospital admission. In addition, enquiries of patients allowed the elucidation of indirect costs, such as the need for extra help at home, and the consequences of inability to work. The overall effects on patients were measured as health-related quality of life in areas such as social function, and mental health and physical function. Elsewhere [2] health-related quality of life has been claimed to enquire into all those things one might want to measure in clinical trials beyond the traditional outcomes of death and measures of disease activity. This may be over-emphatic in suggesting that clinical trials fail to take account of symptoms and their effects. In fact, health-related quality-of-life estimates in Crohn’s disease seem to correlate consistently with disease activity indices such as the Crohn’s Disease Activity Index, or its summarizing relative the Harvey–Bradshaw index [3]. Juan and colleagues explore further by looking at specific sub-sets of clinical data, and the possible correlations with subsets of quality of life data. Here, proceeding, as they must, with multiple examinations it is hard to be sure that what emerges represents
∗
Fax: +44-121-627-2384. E-mail address: [email protected] (M.J.S. Langman).
true and meaningful data relationships rather than a play of chance. Having shown, as expected, a high degree of correlation of the Crohn’s Disease Activity Index with summary mental and (separately) physical health indices, they find that the physical health index correlates highly significantly with age, relapse and inability to work, whereas the mental health index correlates with chronic active disease, the need for emergency and routine visits, and with surgical relapse, but less well with relapse overall, and not at all with age. The reasons for divergence are unclear, and it would require additional studies to confirm replicability before there is unequivocal acceptance. In favour of accepting the current results at face value are the large study size and the considered attempt to work on a national scale. Apart from the vagaries of chance, there may be explanations such as a greater robustness of mental health in the face of acute rather than chronic disease. Note in this context that patients had to give informed consent to inclusion and those with poor mental health might either had not been approached or, more likely, refused to consent. Selection factors which might, nevertheless, influence outcome include data collection within a 3-month time window, so that infrequent attendees, presumably with well-controlled disease, would be less likely to be included. Although the national scale is a clear strength of the study, we do not seem to have hospital or individual non-participation numbers; those who refuse are often significantly different from compliers. Elsewhere it has been concluded that quality of life is more impaired in patients with Crohn’s disease than in those with ulcerative colitis. But it is difficult to tell whether this has been due to differing severities of illness in patients chosen for study, a tendency for Crohn’s disease to be harder to manage successfully, or some other feature, or features. Cost analyses yield some interesting data. That costs are lower than generally prevail in the United States may simply
1590-8658/$30 © 2003 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved. doi:10.1016/j.dld.2003.09.002
850
M.J.S. Langman / Digestive and Liver Disease 35 (2003) 849–850
reflect the high general expense of treating any disease in that country. However, the high recorded usage, and cost, of aminosalicylates is noteworthy. Such drugs have relatively modest efficacy in managing Crohn’s disease, though greater if large bowel disease is present, as here in two-thirds of cases [4]. Evidence, admittedly based largely on treatment in ulcerative colitis, also suggests that relative safety in relation to severe adverse reactions may not differ greatly overall between mesalazine and sulfasalazine [5]. One could also speculate on the cost savings which might be achieved with active quit-smoking campaigns. Smokers are more likely to develop Crohn’s disease and to suffer from relapsing disease [6,7]. Thus, with 210 patients hospitalized at a total cost of over 600,000 a reduction in admissions of, say, 10% would be expected to reduce hospital costs by 60,000. How many clinics treating Crohn’s disease have active anti-smoking programmes? As a further question, if disease is so costly in terms of quality of life, and its treatment so expensive, then can we be sure that adequate use is being made of immunosuppressants in relapse prevention? In some ways this article may be more important to clinicians for the questions it poses than for the answers it gives, but that is a virtue, not a drawback.
Conflict of interest statement Research support has been received from AstraZeneca, Merck Sharp Dohme and Novartis and advice given in return. Prof. Langman receives no personal fees or support. References [1] Juan J, Estiarte R, Colome E, Artes M, Jimenez FJ, Alonso J. Burden of Crohn’s disease in Spain. Dig Liver Dis 2003;35:853– 61. [2] Guyatt G, Feeny D, Patrick D. Issues in quality-of-life measurement in clinical trials. Control Clin Trials 1991;12(Suppl 4):81S–90. [3] Cohen RD. The quality of life in patients with Crohns disease. Aliment Pharmacol Ther 2002;16:1603–9. [4] Sanborn WJ, Feagan BG. Review article: mild to moderate Crohns disease—defining the basis of a new treatment algorithm. Aliment Pharmacol Ther 2003;18:263–77. [5] Ransford R, Langman MJS. Sulfasalazine and mesalazine: serious adverse reactions re-evaluated. Gut 2002;51:536–9. [6] Somerville KW, Logan RFA, Edmond M, Langman MJS. Smoking and Crohns disease. Br Med J 1984;289:954. [7] Hilsden RJ, Hodgkins DC, Timmer A, Sutherland L. Helping patients with Crohns disease quit smoking. Am J Gastroenterol 2000;95: 352–8.
Commentary
The burdens imposed by Crohn’s disease: messages for clinicians? M.J.S. Langman∗ Department of Medicine, Queen Elizabeth Hospital, University of Birmingham, Birmingham B15 2TH, UK See related article on pages 853–861.
Health economic data do not usually form part of the prime reading of clinicians, who generally are more interested, of necessity and by inclination, in the most effective ways of managing disease and preventing its recurrence. In this issue of the journal Juan and colleagues [1] report a set of studies which bridge the gap for clinicians from econometric data by simultaneously enquiring about treatment costs, indirect costs and quality of life in patients with Crohn’s disease. The study size was substantial, with efforts made to include a cross-sectional sample of patients with the disease attending health service hospitals in Spain. Data was collected from structured enquiries of clinicians, which allowed calculation of direct disease costs, such as drug costs and those related to hospital admission. In addition, enquiries of patients allowed the elucidation of indirect costs, such as the need for extra help at home, and the consequences of inability to work. The overall effects on patients were measured as health-related quality of life in areas such as social function, and mental health and physical function. Elsewhere [2] health-related quality of life has been claimed to enquire into all those things one might want to measure in clinical trials beyond the traditional outcomes of death and measures of disease activity. This may be over-emphatic in suggesting that clinical trials fail to take account of symptoms and their effects. In fact, health-related quality-of-life estimates in Crohn’s disease seem to correlate consistently with disease activity indices such as the Crohn’s Disease Activity Index, or its summarizing relative the Harvey–Bradshaw index [3]. Juan and colleagues explore further by looking at specific sub-sets of clinical data, and the possible correlations with subsets of quality of life data. Here, proceeding, as they must, with multiple examinations it is hard to be sure that what emerges represents
∗
Fax: +44-121-627-2384. E-mail address: [email protected] (M.J.S. Langman).
true and meaningful data relationships rather than a play of chance. Having shown, as expected, a high degree of correlation of the Crohn’s Disease Activity Index with summary mental and (separately) physical health indices, they find that the physical health index correlates highly significantly with age, relapse and inability to work, whereas the mental health index correlates with chronic active disease, the need for emergency and routine visits, and with surgical relapse, but less well with relapse overall, and not at all with age. The reasons for divergence are unclear, and it would require additional studies to confirm replicability before there is unequivocal acceptance. In favour of accepting the current results at face value are the large study size and the considered attempt to work on a national scale. Apart from the vagaries of chance, there may be explanations such as a greater robustness of mental health in the face of acute rather than chronic disease. Note in this context that patients had to give informed consent to inclusion and those with poor mental health might either had not been approached or, more likely, refused to consent. Selection factors which might, nevertheless, influence outcome include data collection within a 3-month time window, so that infrequent attendees, presumably with well-controlled disease, would be less likely to be included. Although the national scale is a clear strength of the study, we do not seem to have hospital or individual non-participation numbers; those who refuse are often significantly different from compliers. Elsewhere it has been concluded that quality of life is more impaired in patients with Crohn’s disease than in those with ulcerative colitis. But it is difficult to tell whether this has been due to differing severities of illness in patients chosen for study, a tendency for Crohn’s disease to be harder to manage successfully, or some other feature, or features. Cost analyses yield some interesting data. That costs are lower than generally prevail in the United States may simply
1590-8658/$30 © 2003 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved. doi:10.1016/j.dld.2003.09.002
850
M.J.S. Langman / Digestive and Liver Disease 35 (2003) 849–850
reflect the high general expense of treating any disease in that country. However, the high recorded usage, and cost, of aminosalicylates is noteworthy. Such drugs have relatively modest efficacy in managing Crohn’s disease, though greater if large bowel disease is present, as here in two-thirds of cases [4]. Evidence, admittedly based largely on treatment in ulcerative colitis, also suggests that relative safety in relation to severe adverse reactions may not differ greatly overall between mesalazine and sulfasalazine [5]. One could also speculate on the cost savings which might be achieved with active quit-smoking campaigns. Smokers are more likely to develop Crohn’s disease and to suffer from relapsing disease [6,7]. Thus, with 210 patients hospitalized at a total cost of over 600,000 a reduction in admissions of, say, 10% would be expected to reduce hospital costs by 60,000. How many clinics treating Crohn’s disease have active anti-smoking programmes? As a further question, if disease is so costly in terms of quality of life, and its treatment so expensive, then can we be sure that adequate use is being made of immunosuppressants in relapse prevention? In some ways this article may be more important to clinicians for the questions it poses than for the answers it gives, but that is a virtue, not a drawback.
Conflict of interest statement Research support has been received from AstraZeneca, Merck Sharp Dohme and Novartis and advice given in return. Prof. Langman receives no personal fees or support. References [1] Juan J, Estiarte R, Colome E, Artes M, Jimenez FJ, Alonso J. Burden of Crohn’s disease in Spain. Dig Liver Dis 2003;35:853– 61. [2] Guyatt G, Feeny D, Patrick D. Issues in quality-of-life measurement in clinical trials. Control Clin Trials 1991;12(Suppl 4):81S–90. [3] Cohen RD. The quality of life in patients with Crohns disease. Aliment Pharmacol Ther 2002;16:1603–9. [4] Sanborn WJ, Feagan BG. Review article: mild to moderate Crohns disease—defining the basis of a new treatment algorithm. Aliment Pharmacol Ther 2003;18:263–77. [5] Ransford R, Langman MJS. Sulfasalazine and mesalazine: serious adverse reactions re-evaluated. Gut 2002;51:536–9. [6] Somerville KW, Logan RFA, Edmond M, Langman MJS. Smoking and Crohns disease. Br Med J 1984;289:954. [7] Hilsden RJ, Hodgkins DC, Timmer A, Sutherland L. Helping patients with Crohns disease quit smoking. Am J Gastroenterol 2000;95: 352–8.