Remission and active disease in rheumatoid arthritis: defining criteria for disease activity states.
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OBJECTIVE: Several composite scores are available to assess the activity of rheumatoid arthritis (RA). Criteria for remission and active RA based on these continuous scores are important for use in clinical practice and clinical trials. We aimed to reevaluate or to define such criteria for the Disease Activity Score in 28 joints (DAS28) and the Simplified Disease Activity Index (SDAI). METHODS: We sampled patient profiles from an observational RA database that included clinical and laboratory variables. Thirty-five rheumatology experts classified these profiles into 1 of 4 categories: remission, low, moderate, or high disease activity. Cutoff values were estimated by mapping scores on the DAS28 and SDAI to these ratings, and analyses of agreement (kappa statistics) and a diagnostic testing approach (receiver operating characteristic curves) were used to validate the estimates. The final criteria were validated using 2 observational cohorts (a routine cohort of 767 patients and an inception cohort of 91 patients). RESULTS: Results from the 3 analyses were very similar and were integrated. The criteria for separating remission, low, moderate, and high disease activity based on the SDAI were scores of 3.3, 11, and 26, respectively; those based on the DAS28 were scores of 2.4, 3.6, 5.5, respectively. In the routine cohort, these cutoff values showed substantial agreement (weighed kappa = 0.70) and discriminated between groups of patients with clearly different functional capacities (P < 0.001). In the inception cohort, these cutoff scores differentiated responders (those with a 20% response on the American College of Rheumatology improvement criteria) from nonresponders (P < 0.01), as well as patients with and without radiologic progression (P < 0.05). CONCLUSION: New criteria for levels of RA disease activity were determined and internally validated. These criteria, which are based on current and explicit expert judgment, are valuable in this era of rapidly advancing therapeutic approaches. (+info)
Ultrasonography for rheumatologists: the development of specific competency based educational outcomes.
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BACKGROUND: A competency based approach to the education of rheumatologists in musculoskeletal ultrasonography (MSK US) ensures standards are documented, transparent, accountable, and defensible, with clear benefit to all stakeholders. Specific competency outcomes will facilitate informed development of a common curriculum and structured programme of training and assessment. OBJECTIVE: To determine explicit competency based learning outcomes for rheumatologists undertaking MSK US. METHODS: International experts in MSK US, satisfying specific selection criteria, were asked to define the minimum standards required by a rheumatologist to be judged competent in MSK US. They reviewed 115 MSK US skills, comprising bone and soft tissue pathology, in seven joints regions of the upper and lower limbs, and rated their relative importance according to specific criteria. These data are presented as specific educational outcomes within designated competency categories. RESULTS: 57 expert MSK US practitioners were identified and 35 took part in this study. Ten generic core competency outcomes were recognised including physics, anatomy, technique, and interpretation. Regarding specific regional competencies, 53% (61/115) were considered "must know" core learning outcomes, largely comprising inflammatory joint/tendon/bone pathology and guided procedures; 45% (52/115) were required at an intermediate/advanced level (18/115 "should know", 34/115 "could know"), and 2% (2/115) were deemed inappropriate/unnecessary for rheumatologist ultrasonographers. CONCLUSIONS: This is the first study to developing a competency model for the education of rheumatologists in MSK US based on the evidence of international experts. A specific set of learning outcomes has been defined, which will facilitate future informed education and practice development and provide a blueprint for a structured rheumatology MSK US curriculum and assessment process. (+info)
Junking good science: undoing Daubert v Merrill Dow through cross-examination and argument.
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For more than 40 years, the tobacco industry prevailed in lawsuits brought by injured smokers, despite overwhelming epidemiological evidence that smoking caused lung cancer. Tobacco lawyers were able to create doubt about causation. They sought to persuade jurors that "everybody knew" smoking was harmful but "nobody knows" what causes cancer by recreating in court the scientific debate resolved by the 1964 Surgeon General's Report. The particularistic structure of jury trials combined with the law's mechanistic view of causation enables a defendant to contest virtually any claim concerning disease causation. Despite judicial efforts to eliminate "junk science" from lawsuits, a well-financed defendant may succeed in persuading jurors of the epidemiological equivalent of the proposition that the earth is flat. (+info)
An alternative method of determining standard of care in alleged cases of malpractice.
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BACKGROUND: Physician experts hired and prepared by litigants provide most information on standard of care for medical malpractice cases. Because this information may not be objective or accurate, we examined the feasibility and potential value of surveying peer physicians to assess standard of care. METHODS: The survey method was evaluated for a medical malpractice case involving a patient hospitalized with abdominal pain. An abstract of the medical record was created that included the patient characteristics and physician decisions most likely to influence patient outcome. The abstract and questionnaire were sent to 16 academic family physicians and to 20 randomly chosen primary care physicians in Iowa who practiced in communities of similar size to the defendant's community. RESULTS: All 16 academic and 18 (90%) community physicians completed the survey. All respondents judged the patient as presenting with an acute abdomen, and 89% of the community physicians and 100% of the academic physicians judged the care as below standard. More than half the physicians surveyed listed the autopsy diagnosis (perforated ulcer) in their differential. CONCLUSION: Surveys of randomly selected physicians are feasible to perform for medical malpractice cases. A pro-physician bias has little if any influence on the results. (+info)
The joint food and agriculture organization of the United Nations/World Health Organization Expert Committee on Food Additives and its role in the evaluation of the safety of veterinary drug residues in foods.
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The Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO) recommended the evaluation of food additives at the international level through the establishment of an expert committee or committees. These committees evaluated the safety of food additives present as residues resulting from the use of pesticides or veterinary pharmaceuticals. The results of these meetings include international harmonization on acceptable daily intake of these compounds and the maximum residue limit that is permitted to be present within any food of animal or plant origin. The decisions rendered by these committees provide a key element in the elimination of international trade barriers associated with products intended for human consumption. (+info)
Cognitive functioning in patients with suspected chronic toxic encephalopathy: evidence for neuropsychological disturbances after controlling for insufficient effort.
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OBJECTIVES: Chronic toxic encephalopathy (CTE) caused by long term occupational exposure to organic solvents is still a controversial disorder. Neuropsychological testing is the cornerstone for diagnosing the syndrome, but can be negatively influenced by motivational problems. In this nationwide study, we investigated the neuropsychological functioning and psychological symptoms of a large group of patients with suspected CTE, and ruled out alternative explanations for their complaints, including suboptimal performance due to insufficient effort. METHODS: We studied participants with suspected CTE (n = 386) who were referred for further diagnosis to the Netherlands Centre of Occupational Diseases in the period 1998-2003 and who had completed the entire diagnostic protocol. Patients were excluded if there was the slightest suspicion that test performance had been negatively influenced by insufficient effort (n = 221), or if comprehensive assessment identified an alternative diagnosis (n = 80). Insufficient effort was defined by a combination of three indices. The neuropsychological test scores of the patient group (n = 85) were compared with those of a control group of building trade workers matched for sex, age, and educational level (n = 35). RESULTS: The patient group had significantly more psychological complaints and performed significantly worse than the control group on tests of speed of information processing and memory and learning. However, only a small percentage of the patients had clearly abnormal scores for cognitive speed (9%) or memory (8%). Attention, verbal abilities, and constructional functions were not disturbed. Exposure duration and cognitive complaints were significantly correlated, whereas the correlation between exposure duration and neuropsychological domain scores was not significant. CONCLUSIONS: Insufficient effort was present in a substantial part of the patient group. After minimising the likelihood that insufficient effort negatively influenced neuropsychological scores, we still found neuropsychological deficits in speed of cognitive processing and memory; however, these scores were clearly abnormal only in a minority of patients with suspected CTE. Screening instruments should focus on these domains. (+info)
Amikacin dosing and monitoring in spinal cord injury patients: variation in clinical practice between spinal injury units and differences in experts' recommendations.
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The objective of this article was to determine the current practice on amikacin dosing and monitoring in spinal cord injury patients from spinal cord physicians and experts. Physicians from spinal units and clinical pharmacologists were asked to provide protocol for dosing and monitoring of amikacin therapy in spinal cord injury patients. In a spinal unit in Poland, amikacin is administered usually 0.5 g twice daily. A once-daily regimen of amikacin is never used and amikacin concentrations are not determined. In Belgium, Southport (U.K.), Spain, and the VA McGuire Medical Center (Richmond, Virginia), amikacin is given once daily. Whereas peak and trough concentrations are determined in Belgium, only trough concentration is measured in Southport. In both these spinal units, modification of the dose is not routinely done with a nomogram. In Spain and the VA McGuire Medical Center, monitoring of serum amikacin concentration is not done unless a patient has renal impairment. In contrast, the dose/interval of amikacin is adjusted according to pharmacokinetic parameters at the Edward Hines VA Hospital (Hines, Illinois), where amikacin is administered q24h or q48h, depending on creatinine clearance. Spinal cord physicians from Denmark, Germany, and the Kessler Institute for Rehabilitation (West Orange, New Jersey) state that they do not use amikacin in spinal injury patients. An expert from Canada does not recommend determining serum concentrations of amikacin, but emphasizes the value of monitoring ototoxicity and nephrotoxicity. Experts from New Zealand recommend amikacin in conventional twice- or thrice-daily dosing because of the theoretical increased risk of neuromuscular blockade and apnea with larger daily doses in spinal cord injury patients. On the contrary, experts from Greece, Israel, and the U.S. recommend once-daily dosing and determining amikacin pharmacokinetic parameters for each patient. As there is considerable variation in clinical practice across spinal units and experts differ on ideal dosing and monitoring of amikacin therapy in spinal cord injury patients, there is an urgent need to develop best-practice guidelines. (+info)
The perception of rheumatoid arthritis core set measures by rheumatologists. Results of a survey.
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OBJECTIVE: To investigate the perception of values of individual core set measures by rheumatologists, and how it differs across measures and across physicians. METHODS: We designed a survey in which 44 international expert rheumatologists explicitly marked positions on the scales of seven core-set measures that in their opinion corresponded to cut-points between remission, low, moderate and high disease activity. The measures comprised swollen and tender joint counts (SJC, TJC), CRP, ESR, patient and evaluator global assessments of activity (PGA, EGA), and the Health Assessment Questionnaire Disability Index (HAQ). RESULTS: The interpretation of measures across physicians was most consistent for ESR and PGA, while for CRP and joint counts there was most variation. Joint counts and CRP implied active disease at lower relative values (using normalized scales) than did PGA, EGA or ESR (P < 0.01 for most comparisons; Bonferroni-adjusted Wilcoxon signed rank test), and most physicians tended to tolerate higher numbers of tender joints than swollen joints to define similar levels of disease activity. Given these cut-points, more RA patients in a typical cross-sectional cohort would be regarded as being in remission according to joint counts (SJC, 35%; TJC, 55%) than to global scores (PGA, 18%; EGA, 9%), and fewer patients would be regarded as being in remission by physician-derived or laboratory measures than by patient-derived ones. CONCLUSION: These data give insights into the integrative process of activity evaluation and will be informative for future survey designs, studies using physician opinion as the gold standard for criterion validity of disease activity, and allow 'activity mapping' of values on different scales based on expert opinion. (+info)