Rheumatoid Arthritis: Singh G

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A digest of articles written 1999 and later, on the topic "Arthritis, Rheumatoid," originating from Planet Earth —» Singh G.  Display:  All Citations ·  All Abstracts
1 Editorial A proposal for developing a large patient population cohort for longterm safety monitoring in rheumatoid arthritis. 2000

Lipani JA, Strand V, Woodworth T, Furst D, Singh G, Johnson K, Day R, Brooks P. · No affiliation provided · J Rheumatol. · Pubmed #10782801 No free full text.

This publication has no abstract.

2 Review The problem with NSAIDs: what data to believe? 2007

McKellar G, Madhok R, Singh G. · Center for Rheumatic Diseases, Glasgow Royal Infirmary, Castle Street, Glasgow G4 0SF, UK. · Curr Pain Headache Rep. · Pubmed #18173976 No free full text.

Abstract: Patients with rheumatoid arthritis and osteoarthritis have relied upon NSAIDs as a cornerstone of their analgesic regime for decades. The choice of anti-inflammatory agents broadened for this group of patients when the selective inhibitors of cyclooxygenase-2 enzyme were developed. Much has been published in the past few years regarding the superior gastrointestinal safety of this class of drugs when compared with traditional NSAIDs. Their triumphant debut was swiftly followed by the emergence of data detailing their associated increased serious cardiovascular risks. This also led to a reevaluation of data concerning more traditional NSAIDs, and surprisingly, a similar trend was seen. The US Food and Drug Administration has recommended that both classes of drugs carry a black box warning with regard to gastrointestinal and cardiovascular risks.

3 Review A proposal for developing a large patient population cohort for longterm safety monitoring in rheumatoid arthritis. OMERACT Drug Safety Working Party. 2001

Lipani JA, Strand V, Johnson K, Woodworth T, Furst D, Singh G, Day R, Brooks P, Anonymous00241. · Department of Medicine, Standford Universiity, Palo Alto, CA, USA. · J Rheumatol. · Pubmed #11361208 No free full text.

Abstract: This paper proposes the creation of an objectively acquired reference database to more accurately characterize the incidence and longterm risk of relatively infrequent, but serious, adverse events. Such a database would be maintained longitudinally to provide for ongoing comparison with new rheumatologic drug safety databases collecting the occurrences and treatments of rare events. We propose the establishment of product-specific registries to prospectively follow a cohort of patients with rheumatoid arthritis (RA) who receive newly approved therapies. In addition, a database is required of a much larger cohort of RA patients treated with multiple second line agents of sufficient size to enable case-controlled determinations of the relative incidence of rare but serious events in the treated (registry) versus the larger disease population. The number of patients necessary for agent-specific registries and a larger patient population adequate to supply a matched case-control cohort will depend upon estimates of the detectability of an increased incidence over background. We suggest a system to carry out this proposal that will involve an umbrella organization, responsible for establishment of this large patient cohort, envisioned to be drawn from around the world.

4 Clinical Conference Nonsteroidal anti-inflammatory drug use does not affect short-term endoscopic and histologic outcomes after Helicobacter pylori eradication in patients with rheumatoid arthritis. 2007

Tanaka E, Kamitsuji S, Inoue E, Yamada T, Nakajima A, Takeuchi E, Yanagisawa A, Misaka R, Shigemoto M, Yamashita K, Imamura T, Hara M, Tomatsu T, Saito T, Lauren G, Triadafilopoulos G, Kamatani N, Singh G, Yamanaka H. · Institute of Rheumatology, Tokyo Women's Medical University, Tokyo 162-0054, Japan. · Mod Rheumatol. · Pubmed #17564779 No free full text.

Abstract: We evaluated the effects of the use of nonsteroidal anti-inflammatory drugs (NSAIDs) on endoscopic and histological findings in patients with rheumatoid arthritis (RA) before and after the eradication of Helicobacter pylori infection. Helicobacter pylori (H. pylori) eradication using lansoprazole 30 mg, amoxicillin 750 mg, and clarithromycin 200 mg twice daily for 1 week was conducted in 44 patients (mean age: 56.5 years) with RA. Using the updated Sydney system, endoscopic and histological findings of the greater curvature of the antrum, the greater curvature of the upper corpus, and the lesser curvature of the lower corpus were compared before and after eradication, for a mean follow-up period of 3.5 months. Overall, H. pylori eradication was successful in 32 patients (72.7%). Of these 32 patients, 23 were NSAID users. In the successful eradication group, (1) there was no significant change on endoscopic findings, including gastric erythema and erosion in all three regions irrespective of NSAIDs use; (2) of 17 active ulcers before eradication in NSAIDs users, all healed except for one duodenal ulcer that persisted, where one patient newly developed a gastric ulcer, one developed erosive duodenitis, and two developed reflux esophagitis, all in NSAID users; (3) neutrophil infiltration and chronic inflammation were significantly improved in all three regions after H. pylori eradication irrespective of use of NSAIDs, while atrophic change and intestinal metaplasia did not change. In the eradication failure group; (1) there was no significant change on endoscopic and histological findings in the three regions; (2) two of three ulcers present before eradication on NSAID users persisted even after eradication, and no new cases of gastric ulcer or erosive duodenitis occurred. In conclusion, over a mean follow-up period of 3.5 months, use of NSAIDs in Japanese patients with RA did not impair the healing process of gastric and duodenal ulcers nor did it affect the endoscopic and histological improvements associated with H. pylori eradication.

5 Article Efficient management of rheumatoid arthritis significantly reduces long-term functional disability. 2008

Tanaka E, Mannalithara A, Inoue E, Hara M, Tomatsu T, Kamatani N, Singh G, Yamanaka H. · Institute of Rheumatology, Tokyo Women's Medical University, 10-22 Kawada-cho, Shinjuku-ku, Tokyo 162-0054, Japan. · Ann Rheum Dis. · Pubmed #17971459 No free full text.

Abstract: OBJECTIVES: The aim of this study was to examine the effect of efficient management of rheumatoid arthritis (RA) in relation to disability levels in a large cohort of patients with RA over a period of 3 years. METHODS: We studied 2775 patients with RA who had continuous enrolment for at least 3 years from 7511 patients with RA enrolled in an observational cohort study (Institute of Rheumatology, Rheumatoid Arthritis (IORRA)) from October 2000 to April 2005. The 28-joint Disease Activity Scores (DAS28) were calculated at 6 month intervals for all the patients and a value <2.6 was considered as a tight control. We have set up a new variable for each patient, "Avg-Dscore", based on the transition of each patient's DAS28 value, taking the threshold level of 2.6 into consideration. The "Avg-DAS28" is the average of DAS28 values over all the phases. Functional disability status was assessed by J-HAQ, the validated Japanese version of the Health Assessment Questionnaire (HAQ). The relationship of "Avg-Dscore" and "Avg-DAS28" with the functional disability level was determined using Spearman correlation coefficients and multiple linear regression models. RESULTS: The baseline features of these 2775 patients were: female 83.7%, mean age 56.8 years, mean RA duration 9.5 years, mean initial DAS28 4.0, mean initial J-HAQ score 0.79, and mean final J-HAQ score 0.86. There was a statistically significant correlation between "Avg-DAS28" and final J-HAQ score (r = 0.57, p<0.001), indicating that tighter disease control has significant association with lower disability levels. A similar relationship was observed between "Avg-Dscore" and final J-HAQ score (r = 0.47, p<0.001). Multiple linear regression analysis, after adjusting for all the covariates, revealed that "Avg-Dscore" and "Avg-DAS28" were the most significant factors contributing to final J-HAQ score, and confirmed the strong relationship between disease activity and functional disability. CONCLUSIONS: In patients with RA efficient disease management, by maintaining the DAS28 values at a level under 2.6, has significant association with improving functional capability. The threshold DAS28 level of 2.6 may be useful in developing targeted treatment guidelines for patients with RA.

6 Article Improvement of disease activity of rheumatoid arthritis patients from 2000 to 2006 in a large observational cohort study IORRA in Japan. 2007

Yamanaka H, Inoue E, Singh G, Tanaka E, Nakajima A, Taniguchi A, Hara M, Tomatsu T, Kamatani N. · Institute of Rheumatology, Tokyo Women's Medical University, 10-22 Kawada-cho, Shinjuku-ku, Tokyo, 162-0054, Japan. · Mod Rheumatol. · Pubmed #17694260 No free full text.

Abstract: The objective of this study was to show whether the disease activity of rheumatoid arthritis (RA) patients had improved in Japan, and whether the improvement of disease activity had resulted in a better outcome of patients. In a single-institute-based prospective observational cohort of RA patients (Institute of Rheumatology, Rheumatoid Arthritis, IORRA), a total of 7512 patients were enrolled, and their information was collected biannually. A cross-sectional data set A that included all patients in each phase was analyzed. From October 2000 to April 2006, disease activity score DAS28 significantly improved from 4.15 to 3.63, and the frequency of patients in remission (DAS28 < 2.6) increased from 8.5% to 21.5%. During this period, the frequency of methotrexate users increased from 33.9% to 58.7% and the average dosage of methotrexate also increased from 5.59 mg/week to 6.94 mg/week; on the other hand, there was no increase in any adverse reaction among the methotrexate users. To investigate the relationship between longitudinal disease control and progression of disability, a longitudinal data set B that included 712 patients who completed all phases of the study from 2000 to 2006 was selected and was analyzed. The disability index JHAQ of a poorly controlled group (average DAS > 5.1) increased (+34.8%), that of a moderately controlled group (average DAS 3.2-5.1) also increased (+14.0%), but that of a well-controlled group (average DAS < 3.2) decreased (-13.0%). In conclusion, by using a prospective observational cohort IORRA in Japan, we demonstrate that RA disease activity improved from 2000 to 2006, which correlates with an increased use of methotrexate. The suppression of disease activity resulted in a better outcome for patients.

7 Article The adaptation, reliability and validity testing of the Estonian version of the Health Assessment Questionnaire's Disability Index. 2007

Tammaru M, Singh G, Hanson E, Maimets K. · Department of Internal Medicine, Faculty of Medicine, University of Tartu, Puusepa 6, Tartu 51014, Estonia. · Rheumatol Int. · Pubmed #17641894 No free full text.

Abstract: The aim of our study was the adaptation of the Health Assessment Questionnaire's Disability Index (HAQ-DI) for Estonia along with the assessment of its psychometric properties. The linguistic validation included phases of translation, back translation and testing on patients. Reliability and validity were tested on a sample of 50 rheumatoid arthritis patients by administering the HAQ-DI and the comparator instruments at two visits; disease activity and radiological stage were assessed. The participants were asked to comment on the questionnaires. The HAQ-DI was easily translatable into Estonian. It showed good test-retest reliability, internal consistency, and ability to discriminate between different levels of self-perceived severity. Comparison with the comparators and performed assessments demonstrated expected convergent and divergent validity. Still, the participants' comments revealed issues disregarded during the adaptation process. We recommend the Estonian HAQ-DI for rheumatoid arthritis clinical studies and trials; some aspects of the adaptation process are highlighted for further discussion.

8 Article Prevalence of Helicobacter pylori infection and risk of upper gastrointestinal ulcer in patients with rheumatoid arthritis in Japan. 2005

Tanaka E, Singh G, Saito A, Syouji A, Yamada T, Urano W, Nakajima A, Taniguchi A, Tomatsu T, Hara M, Saito T, Kamatani N, Yamanaka H. · Institute of Rheumatology, Tokyo Women's Medical University, 10-22 Kawada-cho, Shinjuku-ku, Tokyo, 162-0054, Japan. · Mod Rheumatol. · Pubmed #17029090 No free full text.

Abstract: We evaluated the prevalence of Helicobacter pylori infection and the association of H. pylori infection and/or nonsteroidal anti-inflammatory drug (NSAID) use with upper gastrointestinal (UGI) ulcers in a cohort of Japanese patients with rheumatoid arthritis (RA). Using the clinical database of the cohort of RA patients and the serum titers of H. pylori antibody, 1815 patients were analyzed. Clinical data were successfully collected for 1529 patients over 2 years, and the history of NSAID use and the occurrence of newly diagnosed UGI ulcer were ascertained by patient self-reports and confirmed by their medical records. A total of 871 patients (49.3%) were H. pylori antibody-positive. Rates of positivity for H. pylori in patients with and without NSAID use were 47.5% and 54.7%, respectively (odds ratio = 0.75, 95% confidence intervals [CI]: 0.58-0.96). The incidence of newly diagnosed UGI ulcer was 0% in the H. pylori-/NSAID- group, 1.24% in the H. pylori-/NSAID+ group, 1.06% in the H. pylori+/NSAID- group, and 3.46% in the H. pylori+/NSAID+ group. The odds ratios of H. pylori infection and NSAID for the occurrence of new UGI ulcers after adjusting for age and sex were 2.97 (95% CI: 1.19-7.38) and 4.31 (95% CI: 0.57-32.4), respectively. Although the prevalence of H. pylori antibody was low in patients with RA compared with that in healthy Japanese individuals, H. pylori infection was a significant risk factor for UGI ulcer in patients with RA.

9 Article Declines in mortality from acute myocardial infarction in successive incidence and birth cohorts of patients with rheumatoid arthritis. free! 2004

Krishnan E, Lingala VB, Singh G. · Stanford University, Division of Immunology, Department of Medicine, 1000 Welch Rd, Suite 203, Palo Alto, Calif, USA. · Circulation. · Pubmed #15381644 links to  free full text

Abstract: BACKGROUND: Patients with rheumatoid arthritis are at high risk for acute myocardial infarction (AMI). The treatment of rheumatoid arthritis has become more intensive over the past 2 decades, resulting in tighter control of inflammation and lower levels of disability. The impact of this on atherosclerotic cardiovascular diseases is not known. METHODS AND RESULTS: Death rates from AMI in a cohort of 3862 patients with rheumatoid arthritis followed up from 1980 to 1997 were studied. Time trends in AMI mortality among successive incidence and birth cohorts were examined by use of multivariable Poisson regression models and by comparing standardized mortality ratios. The mean age was 56 years in this predominantly female cohort (76%), and median disease duration was 6.5 years. During the period of observation, the use of methotrexate increased substantially, whereas that of prednisone was relatively stable. Over the 22,209 person-years of observation, there were 157 deaths as a result of AMI, with a death rate of 7.06 per 1000 person-years. Mortality rates were higher in older age groups and in men. After adjustment for age, sex, race, and disease duration, the risk of AMI declined in successive incidence years (relative risk, 0.94; 95% CI, 0.92 to 0.96). Patients with rheumatoid arthritis incident after 1990 did not have excess AMI mortality compared with general population. Declines in mortality trends were observed in successive birth cohorts as well. CONCLUSIONS: Mortality as a result of AMI among patients with rheumatoid arthritis has declined over time.

10 Article Attrition bias in rheumatoid arthritis databanks: a case study of 6346 patients in 11 databanks and 65,649 administrations of the Health Assessment Questionnaire. 2004

Krishnan E, Murtagh K, Bruce B, Cline D, Singh G, Fries JF. · Division of Rheumatology, Department of Medicine, Stanford University, Palo Alto, California, USA. · J Rheumatol. · Pubmed #15229950 No free full text.

Abstract: OBJECTIVE: Patient dropout (attrition) can bias and threaten validity of databank-based studies. Although there are several databanks of rheumatoid arthritis (RA) in operation, this phenomenon has not been well studied. METHODS: We studied the attrition patterns of patients with RA in 11 long-running databanks where patients were followed using semiannual Health Assessment Questionnaires. Attrition rates were calculated as the proportion of living patients who were in active followup at the cutoff date. Mantel-Haenszel methods and Weibull regression were used to model the relationship between attrition and age, sex, race, education, disease duration, functional disability, and other characteristics. RESULTS: Overall, 6346 patients with RA were recruited into the study cohorts and followed for 32,823 person-years with 65,649 observations. The crude attrition rate was 3.8% per cycle. Rates were lowest in community-based databanks. Smaller size of the centers, inner-city location, and university clinic settings were associated with worse attrition. In multivariable analyses, younger age, lower levels of education, and non-Caucasian race predicted attrition. Level of disability and disease duration were not associated with attrition. Conclusion. In terms of person-years of followup and observation-points, this may be the largest study on attrition to date. While it is possible to have very high overall retention rates, certain types of databanks (smaller, inner-city-based, and university-based) are more likely to be biased due to selective retention of older, more educated Caucasian patients.

11 Article Validation of a Japanese version of the Stanford Health Assessment Questionnaire in 3,763 patients with rheumatoid arthritis. free! 2003

Matsuda Y, Singh G, Yamanaka H, Tanaka E, Urano W, Taniguchi A, Saito T, Hara M, Tomatsu T, Kamatani N. · Institute of Rheumatology, Tokyo Women's Medical University, 10-22 Kawada-cho, Shinjuku-ku, Tokyo 162-0054, Japan. · Arthritis Rheum. · Pubmed #14673964 links to  free full text

Abstract: OBJECTIVE: To develop and validate a self-administered instrument for measuring functional status in Japanese-speaking rheumatoid arthritis patients. METHODS: We translated the Stanford Health Assessment Questionnaire (HAQ) into Japanese (original HAQ), and then made a tentative Japanese version of the HAQ (J-HAQ) with culturally appropriate modifications of the arising, eating, and reach category questions. The questionnaire was then administered to 3,763 RA patients (82.6% female; mean age 58.0 years; mean onset age 47.4 years; mean disease duration 10.5 years). RESULTS: This instrument showed excellent internal reliability (Cronbach's alpha = 0.927), with a mean interitem correlation of 0.60. For the arising category question, the J-HAQ asks about arising from a futon in addition to a bed because futons are still common in Japanese culture. Arising from a futon is generally more difficult for disabled individuals than is arising from a bed, so the arising score was higher in the J-HAQ (mean score 0.82) than in the original HAQ (0.48). The average scores for the eating and reach categories were virtually identical for the original HAQ and the J-HAQ, with correlation coefficients of 0.979 and 0.926, respectively. Thus, the overall disability index (average of the scores for all functional areas) was higher in the J-HAQ (0.81) than in the original HAQ (0.76), although the correlation coefficient was high (0.993). The test-retest reliability value (0.92), studied at a 1-week interval, revealed identical disability index scores measured on the 2 occasions. CONCLUSION: The final version of the J-HAQ is a valid and reliable instrument for measuring functional status in Japanese-speaking RA patients.

12 Article Consequences of increased systolic blood pressure in patients with osteoarthritis and rheumatoid arthritis. 2003

Singh G, Miller JD, Huse DM, Pettitt D, D'Agostino RB, Russell MW. · Medical Research International, Waltham, Massachusetts 02451-7341, USA. · J Rheumatol. · Pubmed #12672188 No free full text.

Abstract: OBJECTIVE: To estimate the potential effect on cardiovascular event occurrence and treatment costs associated with increases in systolic blood pressure (SBP) among patients with osteoarthritis (OA) and rheumatoid arthritis (RA). METHODS: We used cardiovascular risk prediction models from the Framingham Heart Study and data on risk factors from the Third National Health and Nutrition Examination Survey (NHANES III) to estimate occurrences of ischemic heart disease and stroke over one year among US adults with OA/RA. Separate analyses were conducted for treated hypertensive patients, and untreated hypertensive and normotensive patients, respectively. Published estimates were used to assign costs to these events and to follow care. The effect of incremental increases in SBP on events and costs was then assessed. Monte Carlo simulation was undertaken to assess the range of event occurrence and costs associated with alternative assumptions regarding the distribution of increased SBP in the at-risk population. RESULTS: Of the estimated 30 million adults in the US aged > or = 35 years with OA and RA, roughly 11.8 million (39%) receive pharmacologic treatment for hypertension. Increases in SBP of 1-5 mm Hg were associated with 7,100-35,700 additional ischemic heart disease and stroke events over one year, with corresponding costs (year 2000 USD) of 114-569 million year 2000 USD. A 20 mm Hg increase in SBP experienced by 15% of the at-risk population (equivalent to a population-average 3 mm Hg increase) is associated with about 21,700 additional events (95% CI 19,120, 24,221) and 346 million year 2000 USD (95% CI 305 year 2000 USD, 387 million) in associated costs. CONCLUSION: Relatively small changes in SBP associated with use of common arthritis medications can have a significant effect on the cardiovascular risk profile. It is important that clinicians who treat patients with OA/RA accurately weigh the potential risks of these medications against their benefits.

13 Article Estimating the cost-effectiveness of 54 weeks of infliximab for rheumatoid arthritis. 2002

Wong JB, Singh G, Kavanaugh A. · Division of Clinical Decision Making, Department of Medicine, Tupper Research Institute, Tufts-New England Medical Center, Tufts University School of Medicine, Boston, Massachusetts 02111, USA. · Am J Med. · Pubmed #12401535 No free full text.

Abstract: PURPOSE: To estimate the cost-effectiveness of infliximab plus methotrexate for active, refractory rheumatoid arthritis. METHODS: We projected the 54-week results from a randomized controlled trial of infliximab into lifetime economic and clinical outcomes using a Markov computer simulation model. Direct and indirect costs, quality of life, and disability estimates were based on trial results; Arthritis, Rheumatism, and Aging Medical Information System (ARAMIS) database outcomes; and published data. Results were discounted using the standard 3% rate. Because most well-accepted medical therapies have cost-effectiveness ratios below $50,000 to $100,000 per quality-adjusted life-year (QALY) gained, results below this range were considered to be "cost-effective." RESULTS: At 3 mg/kg, each infliximab infusion would cost $1393. When compared with methotrexate alone, 54 weeks of infliximab plus methotrexate decreased the likelihood of having advanced disability from 23% to 11% at the end of 54 weeks, which projected to a lifetime marginal cost-effectiveness ratio of $30,500 per discounted QALY gained, considering only direct medical costs. When applying a societal perspective and including indirect or productivity costs, the marginal cost-effectiveness ratio for infliximab was $9100 per discounted QALY gained. The results remained relatively unchanged with variation of model estimates over a broad range of values. CONCLUSIONS: Infliximab plus methotrexate for 54 weeks for rheumatoid arthritis should be cost-effective with its clinical benefit providing good value for the drug cost, especially when including productivity losses. Although infliximab beyond 54 weeks will likely be cost-effective, the economic and clinical benefit remains uncertain and will depend on long-term results of clinical trials.

14 Article Long-term morbidity, mortality, and economics of rheumatoid arthritis. 2001

Wong JB, Ramey DR, Singh G. · New England Medical Center, Boston, MA 02111, USA. · Arthritis Rheum. · Pubmed #11762934 No free full text.

Abstract: OBJECTIVE: To estimate the morbidity, mortality, and lifetime costs of care for rheumatoid arthritis (RA). METHODS: We developed a Markov model based on the Arthritis, Rheumatism, and Aging Medical Information System Post-Marketing Surveillance Program cohort, involving 4,258 consecutively enrolled RA patients who were followed up for 17,085 patient-years. Markov states of health were based on drug treatment and Health Assessment Questionnaire scores. Costs were based on resource utilization, and utilities were based on visual analog scale-based general health scores. RESULTS: The cohort had a mean age of 57 years, 76.4% were women, and the mean duration of disease was 11.8 years. Compared with a life expectancy of 22.0 years for the general population, this cohort had a life expectancy of 18.6 years and 11.3 quality-adjusted life years. Lifetime direct medical care costs were estimated to be $93,296. Higher costs were associated with higher disability scores. CONCLUSION: A Markov model can be used to estimate lifelong morbidity, mortality, and costs associated with RA, providing a context in which to consider the potential value of new therapies for the disease.

15 Article Cross-cultural adaptation and psychometric evaluation of the Childhood Health Assessment Questionnaire (CHAQ) and the Child Health Questionnaire (CHQ) in 32 countries. Review of the general methodology. 2001

Ruperto N, Ravelli A, Pistorio A, Malattia C, Cavuto S, Gado-West L, Tortorelli A, Landgraf JM, Singh G, Martini A, Anonymous00055. · Laboratorio di Informatica Medica, IRCCS San Matteo, University of Pavia, Pavia, Italy. · Clin Exp Rheumatol. · Pubmed #11510308 No free full text.

Abstract: The aim of this project was to cross-culturally adapt and validate the American English version of the Childhood Health Assessment Questionnaire (CHAQ) and of the Child Health Questionnaire (CHQ) in the 32 different member countries of the Paediatric Rheumatology International Trials Organisation (PRINTO). This effort forms part of an international study supported by the European Union to evaluate the health-related quality of life in children with juvenile idiopathic arthritis (JIA) as compared to their healthy peers. A total of 6,644 subjects were enrolled from 32 countries: Argentina, Austria, Belgium, Brazil, Bulgaria, Chile, Croatia, the Czech Republic, Denmark, Finland, France, Georgia, Germany, Greece, Hungary, Israel, Italy, Korea, Latvia, Mexico, the Netherlands, Norway, Poland, Portugal, Russia, Slovakia, Spain, Sweden, Switzerland, Turkey, the United Kingdom, and Yugoslavia. A total of 3,235 patients had JIA (20% systemic onset, 33% polyarticular onset, 17% extended oligoarticular subtype, and 30% persistent oligoarticular subtype) while 3,409 were healthy children. This introductory paper describes the methodology used by all the participants. The results and the translated version of both the CHAQ and the CHQ for each country are fully reported in the following papers. The results of the present study show that cross-cultural adaptation is a valid process to obtain reliable instruments for the different socio-economic and socio-demographic conditions of the countries participating in the project.

16 Article Gastrointestinal complications of prescription and over-the-counter nonsteroidal anti-inflammatory drugs: a view from the ARAMIS database. Arthritis, Rheumatism, and Aging Medical Information System. 2000

Singh G. · The Department of Medicine, Division of Immunology and Rheumatology, Stanford University School of Medicine, Palo Alto, California, USA. · Am J Ther. · Pubmed #11319579 No free full text.

Abstract: More than 30 million people worldwide consume prescription nonsteroidal anti-inflammatory drugs (NSAIDs) on a daily basis. Gastrointestinal (GI) toxicity owing to the use of NSAIDs is a well-recognized clinical problem, with approximately 25% of all reported adverse drug reactions being attributed to prescription NSAID use. In addition to prescription NSAIDs, the use of over-the-counter (OTC) formulations of these products is common. Although it has been suggested that OTC doses of NSAIDs may not lead to significant GI toxicity, the data confirming this have been lacking. Data on the GI risks of OTC doses of aspirin, ibuprofen, naproxen, paracetamol, and no drug from 4164 consecutively diagnosed patients with rheumatoid arthritis from eight ARAMIS (Arthritis, Rheumatism, and Aging Medical Information System) centers in North America are presented. Serious GI events were defined as GI bleeds and other clinically significant GI events requiring hospitalization. Relative risks were standardized for potential demographic confounders using Cox proportional hazard models. Although the relative risk of OTC doses of NSAIDs (3 to 4) is less than the previously published risk of prescription doses (6 to 7), it remains clinically significant and a matter of serious concern because of the widespread use of these medications and an underappreciation of the true risk. Paracetamol was not associated with increased risk of GI complications and should be considered first-line therapy.

17 Article Development of a Spanish (Castillian) version of the Childhood Health Assessment Questionnaire. Measurement of health status in children with juvenile chronic arthritis. 2000

García-García JJ, González-Pascual E, Pou-Fernández J, Singh G, Jiménez R. · Paediatric Department, Unitat Integrada Hospital Sant Joan de Déu-Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, University of Barcelona, Spain. · Clin Exp Rheumatol. · Pubmed #10728453 No free full text.

Abstract: OBJECTIVE: To demonstrate that the Spanish (Castillian) version of the Childhood Health Assessment Questionnaire (cHAQ-S) is a valid and reliable instrument for measuring the health status of children with juvenile chronic (or rheumatoid) arthritis (JCA) and is sensitive to change. METHODS: A conceptual translation of the original questionnaire into Spanish and two back-translations were performed. The cHAQ-S was completed by the parents of young children (aged 1 to 19 years) affected by JCA, and additionally by those children aged over 9. A second cHAQ-S was administered at least 15 months after the first one. RESULTS: The cHAQ-S was administered to 79 patients of patients affected by JCA. The test-retest reliability was evaluated among 16 patients, and no significant differences between the first and second administration were found (0.88 versus 0.84; p > 0.6; intraclass correlation coefficient R = 0.94). The Cronbach's alpha coefficient was 0.948, indicating an excellent internal reliability with a mean correlation between the different components of the questionnaire varying from 0.3557 to 0.7831. For the between-observer reliability, an intraclass correlation coefficient of 0.96 was obtained. Correlations between DI (Disability Index) and several measures of disease activity were all statistically significant (Spearman's R ranged from 0.42 to 0.87; p < 0.005). Patients who improved showed similar improvement in the DI (p = 0.015), while patients who worsened showed a worsening of the DI (p = 0.1) and patients whose condition was stable showed no change in DI (p = 0.6). CONCLUSION: The cHAQ-S is a feasible, reliable and valid instrument for the determination of the health status of Spanish children suffering from JCA. It is also sensitive to changes in the child's health status.