Clinical characteristics, visceral involvement, and mortality in at-risk or early diffuse systemic sclerosis: a longitudinal analysis of an observational prospective multicenter US cohort
Sara JaafarAlain LescoatSuiyuan HuangJessica GordonMonique HinchcliffAmi A. ShahShervin AssassiRobyn T. DomsicElana J. BernsteinVirginia SteenSabrina ElliottFaye N. HantFlavia V. CastelinoVictoria K. ShanmugamChase CorreiaJohn VargaVivek NagarajaDavid RoofehTracy FrechDinesh Khanna
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Early diffuse cutaneous systemic sclerosis (dcSSc) has the highest case fatality among rheumatic diseases. We report baseline characteristics, current immunosuppressive therapies, progression of skin and internal organ involvement, and mortality in a multicenter prospective cohort from the United States (US) of America.Keywords:
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Utilizing a multicenter approach in observational clinical research allows for improved generalizability of the results, a larger sample size, and, consequently, improved efficiency. This paper highlights important issues with regard to the organization of multicenter observational studies in orthopaedic research. Specifically, we emphasize the development of trial committees, stress the importance of having a methods center for the purpose of coordinating day-to-day study activities, and describe the roles of the participating clinical sites. The successful conduct of multicenter studies requires careful study organization, a dedicated and experienced methods center, and motivated participating surgeons and study staff at the clinical sites. To illustrate the organization of a multicenter initiative, we use the example of a total hip arthroplasty collaborative.
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72 preschoolers and 72 school children observed the original discrimination of nonreversal shift (NRS) followed by 14 NRS trials by themselves. The observational trials were 10 or 30 in each age group. The correct (_??_) or incorrect (×) responses on the 1st (unchanged pair) and the 2nd (changed pair) trials of NRS were mainly measured. In preschoolers, both dependent observational-learning mode (_??_-× responses: DOL) and independent observational-learning mode (_??_-_??_ and ×-×: IOL) were found, but no observational-trial effects on the modes were found. In school children, DOL occurred significantly more than IOL in both groups, and the observational-trial effect was also found. Subproblem analyses suggested that the _??_-× responses were indeed the “dependent” mode rather than the “independent” one.
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The purposes of this study were to develop and implement an observational training program and to assess the effects of a video observational training program on video and live observational proficiency. Physical education majors took a pretest in both a video and a live environment to assess observational proficiency. The task was observing children batting and answering questions regarding the critical features of the movement. The students were then placed into either a treatment ( n = 12) or a control ( n = 11) group. There were no differences between groups on either assessment ( p > .05). The treatment group then participated in a video observational training program. After the training, all subjects took a posttest in each environment to assess observational proficiency. The training was found to be effective in improving video observational proficiency ( p < .05) but not live observational proficiency ( p > .05). These results provide support for the effectiveness of video observational training in developing video observational proficiency but not live observational proficiency.
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Observational methods such as OW AS. RULA. and REBA have been widely used to identify posture-related risks of musculoskeletal disorders in industry, since they are useful and efficient in evaluating postural stresses. However. there are few studies comparing the methods and providing guidelines for selecting and using the methods. They have been developed based on different backgrounds and with different application areas. Each method has its own characteristics. which must be considered in selecting and using them. In this study. 17 male subjects evaluated 42 different working postures that frequently assumed in the automobile assembly line using a psychophysical method. The postures were then evaluated by different observational methods. The results of the observational methods were compared with psychophysically evaluated stresses. The observational methods resulted in different values of stresses for certain postures. For some postures showing high values of perceived discomfort. the observational methods showed different values of stresses. These results showed that the observational methods should be used differently according to application area and they have some weak points to be improved.
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Studies can be observational or experimental. With an observational study, the investigator does not determine the assignment of subjects, and there might not be a control group. If there is a control group, assignment of the independent variable (exposure or intervention) is not under the control of the investigator. Observational studies can be rigorously conducted, but the lack of random assignment of the exposure/intervention introduces confounding and bias. Thus, the quality of evidence resulting from observational studies is lower than that of experimental randomized controlled trials (RCTs). An observational study might be performed if an RCT is unethical, impractical, or outside the control of the investigator. There are many types of prospective and retrospective observational study designs. However, an observational study design should be avoided if an experimental study is possible. Sophisticated statistical approaches can be used, but this does not elevate an observational study to the level of an RCT. Regardless of quality, an observational study cannot establish causality.
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Journal Article Potential impact of observational cohort studies in Japan on rheumatoid arthritis research and practice Get access Hisashi Yamanaka, Hisashi Yamanaka Institute of Rheumatology, Tokyo Women's Medical University, 10-22 Kawada-cho, Shinjuku-ku, Tokyo 162-0054, Japan Correspondence to: Hisashi Yamanaka, Institute of Rheumatology, Tokyo Women's Medical University, 10-22 Kawada-cho, Shinjuku-ku, Tokyo 162-0054, Japan Tel. +81-3-5269-1725; Fax +81-3-5269-1726 e-mail: yamanaka@ior.twmu.ac.jp Search for other works by this author on: Oxford Academic Google Scholar Shigeto Tohma Shigeto Tohma Clinical Research Center for Allergy and Rheumatology, National Hospital Organization, Sagamihara National Hospital, Sagamihara, Japan Search for other works by this author on: Oxford Academic Google Scholar Modern Rheumatology, Volume 16, Issue 2, 1 April 2006, Pages 75–76, https://doi.org/10.3109/s10165-006-0464-8 Published: 01 April 2006 Article history Received: 24 January 2006 Accepted: 20 February 2006 Published: 01 April 2006
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