Scleroderma Information » Scleroderma » Criteria re:UCTD in U of M Study/CD
Question:
***Worse!! In one document pertaining to either the UM or the NYU study, they were talking about pulling records from hospitals in the area of women with and without implants…..the document does not say that they obtained permission from any woman affected or not. I would think this would be a violation of your privacy for any coporate enity to pull a persons medical records without permission from that person to do so. Linda Dintino http://members.aol.com/dowlied/page/index.htm Document Index http://members.aol.com/wisgroup/webring/
Response:
March 20, 1992 To: File Status: U of MI Case-control Study Revisions This memo provides a synopsis of two telephone calls. 1. Thursday, March 19, 1991 – Telephone call from Brian Keroack, M.D. Rheumatology Fellow The outcome of the meeting of Carol Burns, Brian Keroack, M.D. and Maureen Mayes, M.D. was as follows. A positive ANA will not be used as a part of the case definition for UCTD, as it is most likely associated with an undiagnosed SLE case. Rather that create a case definition for UCTD, the U of MI will most likely use a case definition which is based on the one published by Alarcon et al, J. Rheum 18(9).:1332, 1991. Copy attached. 2. Friday, March 20, 1992 – Telephone call to David Schottenfeld, M.D. Principal Investigator A proposal and budget to speed up the U of MI study will be submitted to Dow Corning, if possible, next week. A letter facsimile will be sent to Dow Coming as soon as possible, requesting official sanction from DC to provide additional resources of approximately $65,000 in incentive money for hospitals participating in the study. Healthcare Knowledge Resources believes that offering an incentive will significantly speed up the process and lead to a better participation rate. The proposal will be to pay each hospital $5 per record abstracted plus $10 For a patient contact, if one is made. U of MI is asking for immediate approval as they are ready to send the letters out to the hospitals right now. A second proposal for expansion of the study into Ohio will be submitted to DC 4 to 6 weeks from now. U of MI will provide a revised estimate of the relative risk that their study may detect for systemic scleroderma based on various assumptions. Assumptions will vary on DCC 0010000774 CD image# DCC00774.001 the estimated incidence of systemic scleroderma, beta and a two sided versus a one sided test. The U of MI can expect to receive a letter requesting that their research proposal, abstract forms, and pretest questionnaire be provided to the FDA. The letter making this request will most likely come from DC. DCC 010000775 Image #DCC 0074.002 3/19/92 11:20 313-763-1253 RHEUMATOLOGY DC CORP MEDICAL Undifferentiated Connective Tissue Disease Critera: Adapted from Alarcon et al J. Rheum 18(9):1331 1991 UCTD defined as follows: At least one of the three MAJOR criteria (1) Raynauds (2) Isolated Kerato conjectivitis Scicca (3) Unexplained Polyarthritis (including possible and probable RA) and (4) at least 3 other criteria that could not be attributed to other disease proceses including: Raynauds Myalgia Rash Kerato-conjunctivitis Pleuritis Pericarditis CNS symptoms Pulmonary symtoms Peripheral neuropathy elevated ESR False + VDRL DCC 010000776 Image # DCC00774.003 Linda Dintino http://members.aol.com/dowlied/page/index.htm Document Index http://members.aol.com/wisgroup/webring/
Response:
Does this make you feel like a lab rat or what? – Hide quoted text — Show quoted text – March 20, 1992 To: File Status: U of MI Case-control Study Revisions This memo provides a synopsis of two telephone calls. 1. Thursday, March 19, 1991 – Telephone call from Brian Keroack, M.D. Rheumatology Fellow The outcome of the meeting of Carol Burns, Brian Keroack, M.D. and Maureen Mayes, M.D. was as follows. A positive ANA will not be used as a part of the case definition for UCTD, as it is most likely associated with an undiagnosed SLE case. Rather that create a case definition for UCTD, the U of MI will most likely use a case definition which is based on the one published by Alarcon et al, J. Rheum 18(9).:1332, 1991. Copy attached. 2. Friday, March 20, 1992 – Telephone call to David Schottenfeld, M.D. Principal Investigator A proposal and budget to speed up the U of MI study will be submitted to Dow Corning, if possible, next week. A letter facsimile will be sent to Dow Coming as soon as possible, requesting official sanction from DC to provide additional resources of approximately $65,000 in incentive money for hospitals participating in the study. Healthcare Knowledge Resources believes that offering an incentive will significantly speed up the process and lead to a better participation rate. The proposal will be to pay each hospital $5 per record abstracted plus $10 For a patient contact, if one is made. U of MI is asking for immediate approval as they are ready to send the letters out to the hospitals right now. A second proposal for expansion of the study into Ohio will be submitted to DC 4 to 6 weeks from now. U of MI will provide a revised estimate of the relative risk that their study may detect for systemic scleroderma based on various assumptions. Assumptions will vary on DCC 0010000774 CD image# DCC00774.001 the estimated incidence of systemic scleroderma, beta and a two sided versus a one sided test. The U of MI can expect to receive a letter requesting that their research proposal, abstract forms, and pretest questionnaire be provided to the FDA. The letter making this request will most likely come from DC. DCC 010000775 Image #DCC 0074.002 3/19/92 11:20 313-763-1253 RHEUMATOLOGY DC CORP MEDICAL Undifferentiated Connective Tissue Disease Critera: Adapted from Alarcon et al J. Rheum 18(9):1331 1991 UCTD defined as follows: At least one of the three MAJOR criteria (1) Raynauds (2) Isolated Kerato conjectivitis Scicca (3) Unexplained Polyarthritis (including possible and probable RA) and (4) at least 3 other criteria that could not be attributed to other disease proceses including: Raynauds Myalgia Rash Kerato-conjunctivitis Pleuritis Pericarditis CNS symptoms Pulmonary symtoms Peripheral neuropathy elevated ESR False + VDRL DCC 010000776 Image # DCC00774.003 Linda Dintino http://members.aol.com/dowlied/page/index.htm Document Index http://members.aol.com/wisgroup/webring/
no comment untill now