Faculty Bibliography

OBJECTIVES: The concordance of patient reported outcomes in rheumatoid arthritis (RA) among different countries has not been studied in detail. We tried to determine the differences in pain and fatigue perception among a group of RA patients in the US and in Turkey who had similar disease activity and functional score in multidimensional health assessment questionnaire (MDHAQ FN). METHODS: One hundred and thirty seven RA patients from Turkey and 129 from the US were studied. An MDHAQ was obtained and a DAS28 was calculated for each patient. Pain and fatigue perception was compared between the two groups after adjusting for age, sex, MDHAQ FN and DAS 28. RESULTS: Turkish patients had less pain than their US counterparts when adjusted for MDHAQ FN, DAS 28, age and sex (3.56 (2.24) vs. 4.35 (2.23), p=0.005) whereas there was no difference in fatigue between the two groups (3.85 (2.44) vs. 4.25 (2.45), p=0.194). When the patients with a DAS28 score of above 5.1 and below 2.6 were compared in both groups, Turkish patients had again less pain albeit less in the high disease activity group. CONCLUSIONS: This study suggests that Turkish patients have less pain than the US patients when controlled for age, gender and MDHAQFN and DAS28 scores. This is at odds to the conventional wisdom that pain perception is increased among the non-Western cultures

Golimumab is a human anti-tumor necrosis factor (TNF)-alpha monoclonal antibody that was recently approved for the treatment of patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. This review covers the published clinical trial data on the use of golimumab for the approved indications mentioned above with respect to efficacy and safety. The various ongoing trials for golimumab have yielded promising results in terms of efficacy and safety in methotrexate-naive and -resistant patients with rheumatoid arthritis, as well as in patients who were previously treated with other anti-TNF agents. In addition, the efficacy of golimumab in psoriatic arthritis and ankylosing spondylitis has also been demonstrated. The real safety information will be available only once the drug has been used in many more patients, who frequently have comorbid conditions

OBJECTIVE: To compare the Routine Assessment of Patient Index Data 3 (RAPID3) on a Multidimensional Health Assessment Questionnaire (MDHAQ) with the Disease Activity Score (DAS28), Clinical Disease Activity Index (CDAI), and individual core data set measures for correlations, agreement of activity levels, and time to score. METHODS: Four rheumatologists each assessed 50 patients with rheumatoid arthritis in 'real-time' clinical care. Patients completed an MDHAQ. The rheumatologist then calculated RAPID3 (physical function, pain, patient global estimate), performed a 28-joint count, assigned a physician global estimate, and scored a CDAI, each timed by an observer. Erythrocyte sedimentation rate (ESR) was tested on the same date, and the DAS28-ESR was computed later, again timed by an observer. Spearman's rank-order correlations and comparisons of patients classified as high activity, moderate activity, low activity, and remission according to the DAS28, CDAI, and RAPID3 were computed and compared with kappa statistics. A second study of 25 'paper patients' was also performed to compare time to score the DAS28, CDAI, and RAPID3 on a 0-10 versus 0-30 scale. Mean and median times to score each index were computed. RESULTS: The 3 indices were correlated significantly, including agreement for >80% of patients for high/moderate activity. The mean time to perform a 28-joint count was 94 seconds, and the mean times to score the DAS28, CDAI, RAPID3 on a 0-10 scale, and RAPID3 on a 0-30 scale were 114, 106, 9.6, and 4.6 seconds, respectively. CONCLUSION: RAPID3 scores provide similar quantitative information to DAS28 and CDAI, while calculated on a 0-30 scale in about 5% of the time

ABSTRACT : Informed consent is not only for documenting a patient's acceptance of enrolling in a clinical trial. It currently is the patient's and, we propose, should also be the public's main source of information regarding the reasons for the planned study, what is known in the field about the proposed trial, and what to expect as far as efficacy and harm. Informed consent is not currently part of the clinical trial registries. For purposes of full disclosure to the patients and the public, the informed consent should be part of the required documents for such registries

Informed consent is a legal document that summarizes what will take place in a study in a language the study subjects can understand and is the process by which a person decides whether or not to participate in a study. The document is not limited to explaining the intervention or potential risks and benefits but is also the source of understanding why the study is being done and what the particular study will add to what is already known. Overall, informed consent is a document providing important transparency and clarity about the study. While consent forms are mandatory prior to study approval by internal review boards, they are not published as part of study results and are not part of clinical trial registries. The central role of an informed consent document in any study could be vitally expanded and enhanced with inclusion and full disclosure of its content through clinical trial registries and published reports in the literature, bringing improved transparency to the entire clinical trial process. Transparency is important for the maintenance of high standards in clinical research and for public trust of the process, a sometimes underrecognized factor in healthcare initiatives