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UNLABELLED: This study reports the direct costs related to osteoporosis and hip fractures paid for governmental and private institutions in the Mexican health system and estimates the impact of these entities on Mexico. We conclude that the economic burden due to the direct costs of hip fracture justifies wide-scale prevention programs for osteoporosis (OP). METHODS: To estimate the total direct costs of OP and hip fractures in the Mexican Health care system, a sample of governmental and private institutions were studied. Information was gathered through direct questionnaires in 275 OP patients and 218 hip fracture cases. Additionally, a chart review was conducted and experts' opinions obtained to get accurate protocol scenarios for diagnoses and treatment of OP with no fracture. Microcosting and activity-based costing techniques were used to yield unit costs. RESULTS: The total direct costs for OP and hip fracture were estimated for 2006 based on the projected annual incidence of hip fractures in Mexico. A total of 22,233 hip fracture cases were estimated for 2006 with a total cost to the healthcare system of US$ 97,058,159 for the acute treatment alone ($4,365.50 per case). We found considerable differences in costs and the way the patients were treated across the different health sectors within the country. CONCLUSION: Costs of the acute treatment of hip fractures in Mexico are high and are expected to increase with the predicted increment of life expectancy and the number of elderly in our population.

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To review the available evidence that has used generic instruments alone or in comparison with disease specific instruments. A systematic review was carried out using the methods recommended by the Cochrane Collaboration. We used MEDLINE and EMBASE searches and we performed a hand search of the abstracts listed under "quality of life" at American College of Rheumatology (ACR) meetings. Selection was limited to randomized controlled trials (RCT) using generic instruments in populations older than 18 years with any of the following diseases: rheumatoid arthritis, fibromyalgia, osteoporosis, osteoarthritis, systemic lupus erythematosus, and ankylosing spondylitis. Language was restricted to English papers. Studies using only disease-specific instruments were excluded. From 488 articles retrieved, 13 reports of 10 randomized controlled trials were selected. There were 101 abstracts on quality of life in ACR abstract books; 78 abstracts contained data on generic instruments, and of these, 9 described their use in RCT. Despite a substantial increase in the number of papers and abstracts addressing different aspects of generic questionnaires, the majority of the papers were descriptive. The evidence is not yet available to document that any of the generic instruments pass the requirements of the OMERACT Filter.

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BACKGROUND: Osteoporosis (OP) and its fractures are a major problem due to their impact in morbidity and mortality in the elderly. Although this entity is well studied in other countries, OP and its fractures have not been evaluated carefully in our population. The objective was to assess risk factors for osteoporotic hip fracture in Mexicans. METHODS: A total of 295 subjects, 152 cases and 143 controls, were studied. Cases were patients with hip fracture, of both sexes and 45 years of age or older. Controls were healthy subjects who were in hospital waiting rooms accompanying patients without hip fractures. A questionnaire covering known possible risk factors for osteoporotic hip fracture was administered by the same evaluator to all subjects. Pelvic roentgenograms, anterior-posterior view, were obtained in both cases and controls to perform the Singh index and the cortical index of the femur. RESULTS: Fractures were present in (72.2%) of women. Weight and any alcohol ingestion were associated with an increased risk of hip fracture. The odds ratio (OR) for low weight by the Quetelet Index was 4.03 (95% CI 1.93-8.39) p < 0.001. Any alcohol intake was associated with an OR of 1.73 (95% CI 1.04-2.90) p < or = 0.03 for the total group, and 2.78 (95% CI 1.25-6.14) p < or = 0.003 for women. Controls had a significantly higher mean daily calcium intake compared to cases (mean, SD 575.9 +/- 297.2 vs. 490.4 +/- 245.5, p < or = (0.007). Family history, smoking, physical activity, pregnancies, breastfeeding or concomitant diseases were not associated with risk of hip fracture. CONCLUSIONS: This study confirmed the risk factors for osteoporotic hip fracture in Mexicans, previously shown for other ethnic groups. Further research in different factors, such as rate of bone turnover, anthropometric dimensions, and genetic studies (osteoporosis gene) are needed in order to define the differences among ethnic groups.

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Considerations in designing clinical trials of novel molecules are not different from those that should be considered in every rheumatoid arthritis clinical trial. This article raises some critical issues that clinicians have to face in the planning and design of clinical trials for new molecules in rheumatoid arthritis. The most frequent problems are related to outcome measures (core set of endpoints, improvement and remission), patient populations, characteristics of the study design, and economic evaluation. Although some of these issues have been resolved by consensus, further research needs to be carried out to support the use of different measurement techniques. Because clinical trials remain the most powerful investigative instrument for deciding about the benefits of new advances in medical therapy, their design should be based on an appropriate methodology.

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OBJECTIVE: (1) To adapt the Community Oriented Programme for the Control of Rheumatic Disease (COPCORD) Core Questionnaire (CCQ) for use as a rheumatic disease screening instrument in Spanish and Portuguese communities in Brazil, Chile, and Mexico, including translation and back translation, and assessment of cross cultural equivalence and reliability. (2) To determine the screening characteristics of the CCQ, specifically the sensitivity and specificity of Spanish and Portuguese versions for detecting cases of rheumatic disorder compared with a full clinical examination by a rheumatologist. (3) To determine the number of clinical examinations that could be avoided in population studies by applying the CCQ followed by a clinical examination in positive CCQ screenees. METHODS: Translation and assessment of cross cultural equivalence were conducted by practising rheumatologists in Brazil, Chile, and Mexico using standardized methods. Back translation was done by an independent rheumatologist (Brazil), a radiologist (Chile), and a general physician (Mexico). Interviewer agreement was assessed in all sites in a convenience sample. Sensitivity and specificity were assessed by independently administering the CCQ and a full clinical examination to a sample of 200 persons aged 15 years or older, randomly selected from communities in Sao Paulo, Brazil (n = 200), Temuco, Chile (n = 200), and Mexico City, Mexico (n = 200). RESULTS: (1) Cross cultural equivalence and back translation of the modified questionnaire were satisfactory. Interviewer agreement was acceptable. (2) In groups from Brazil, Chile, and Mexico, respectively, the overall prevalence of rheumatic disease based on clinical examination was 33.3, 45.1, and 46.3%. The sensitivity and specificity of 2 definitions of a positive CCQ screening for the presence of rheumatic disorder were: Definition 1 (no trauma, present pain, tenderness, swelling or stiffness in bones, joints or muscles): sensitivity, 91.8, 96.0, 84.0; specificity, 70.0, 35.5, 61.0; Definition 2 (Definition 1 plus pain intensity > or = 4 and 11 point category rating scale): sensitivity, 66.2, 86.3, 42.7; specificity, 82.3, 41.9, 80.0. (3) In groups from Brazil, Chile, and Mexico, respectively, positive screening by Definition 1 followed by a clinical examination avoids 499, 213, and 403 clinical examination per 1000 respondents screened and yields an overall prevalence of rheumatic disorder of 30, 43, and 40%. The addition of pain intensity (Definition 2) increased the total number of examinations avoided, but reduced the prevalence estimate compared to Definition 1 (22.0, 39.0, and 20.0%). CONCLUSION: The CCQ appears promising as a screening tool to detect rheumatic disorder in Spanish and Portuguese speaking communities in a developing country. The findings suggest that the CCQ followed by a full clinical examination in positive respondents can provide an acceptable estimate of prevalence of rheumatic disorder. The total number of clinical examinations that must be administered in population based prevalence surveys can be reduced by using the CCQ, while maintaining satisfactory accuracy. Our findings need to be confirmed in further applications of the CCQ.

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The three-stage World Health Organization-International League of Associations for Rheumatology Community Oriented Programme for Control of Rheumatic Disease (WHO-ILAR COPCORD) is described. Stage I results from Indonesia and Brazil are presented. This is a needs-based approach that offers efficiency in large-scale survey research that aims to estimate the prevalence of rheumatic diseases. It saves human resources, time, and cost in the collection of epidemiologic data. Awaited with interest are the results of the next two stages of COPCORD, which involve the development of educational programs on rheumatic disease and the evaluation of their impact on the burden of illness.

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At present there is no widely accepted therapy for ankylosing spondylitis (AS), a progressive debilitating disease. The effectiveness of sulfasalazine in AS still lacks strong evidence, as well, the magnitude of its benefit is unknown. A meta-analysis was carried out to assess the effectiveness of sulfasalazine in AS. A search of the literature was done using Medline, Index Medicus, the reference lists of articles located and contacting content experts to reveal unpublished studies. Five randomized controlled trials (RCT) comparing sulfasalazine to placebo were located and assessed methodologically. The methodologic quality of all 5 RCT was considered satisfactory and consequently these studies were included in the meta-analysis. The pooled estimate of clinical benefit (and its 95% confidence interval) favoring sulfasalazine, over and above that observed in the placebo group was as follows: Duration of morning stiffness -28.2% (-54.6 to -1.8%); severity of morning stiffness -30.6% (-52.5 to -8.7%); severity of pain -26.7% (-44.3 to -9.1%); general well being -7.1% (-24.3 to 10.0%); erythrocyte sedimentation rate -9.2% (-24.8 to 6.4%); and IgA -11.7% (-18.8 to -4.7%). Adverse effects, mostly mild, were more frequently observed in the sulfasalazine group (odds ratio [OR] = 1.5746, p = 0.1082). The occurrence of dropouts (OR = 1.1554, p = 0.6119) was similar in both groups. Sulfasalazine is a safe and effective drug in the short term treatment of AS.

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The assessment of a measure of chronic pain, should be reliable, valid and sensitive to change. Our study evaluated the reliability of 3 pain scales, visual analogue scale (VAS), numerical rating scale (NRS) and verbal rating scale (VRS) in literate and illiterate patients with rheumatoid arthritis (RA). Patients with RA attending an outpatient rheumatology clinic were interviewed and asked to score their pain levels on the 3 pain scales. The scales were presented in random order, twice, before and just after a regular medical consultation. Ninety-one patients were studied (25 illiterate and 66 literate). The Pearson product moment correlation between first and second assessment was 0.937 for VAS, 0.963 for NRS and 0.901 for VRS in the literate patient group and 0.712 for VAS, 0.947 for NRS and 0.820 for VRS in the illiterate patient group. These results indicate that the NRS has the higher reliability in both groups of patients.

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Functional ability evaluation constitutes an important outcome measurement in any proposed trial involving patients with rheumatoid arthritis (RA). We performed a crosscultural study directed at the translation into Portuguese of the Physical Ability Dimension of the Health Assessment Questionnaire (HAQ) and the evaluation of its reliability. Five questions were modified in the Portuguese version of the HAQ to suit Brazilian conditions. The test-retest correlation coefficient was 0.905 (p less than 0.001) and the interobserver correlation coefficient was 0.830 (p less than 0.001) Our results provide evidence of instrument reliability. The instrument kept its face and content validity and the evaluation of the longitudinal construct validity is now in progress.

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