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首页> 外文期刊>The American Journal of Psychiatry >Frequency of Provider Contact After FDA Advisory on Risk of Pediatric Suicidality With SSRIs
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Frequency of Provider Contact After FDA Advisory on Risk of Pediatric Suicidality With SSRIs

机译:FDA关于SSRI引起儿童自杀风险的咨询后,提供者联系的频率

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The Food and Drug Administration (FDA) issued a public health advisory in October 2003 on the risk of suicide in pediatric patients taking antidepressants and advised maintaining "close supervision" of such patients. In this study, the authors compared trends in the frequency of provider contacts for patients with depression before and after the advisory was issued. Retrospective cohorts of children (N=27,370) and adults (N=193,151) with new episodes of depression treated with antidepressants were created from a national claims database of managed care plans (1998-2005). Two standards were used in measuring patient monitoring: the Health Plan Employer Data and Information Set (HEDIS) quality-of-care criterion calling for three contacts in 3 months and the FDA-recommended contact schedule totaling seven visits in 3 months. Time-series models compared postadvisory trends to the expected trend based on preadvisory measures. Less than 5% of all patients met FDA contact recommendations before the advisory, and the rate did not change after the advisory. A greater proportion of patients met the HEDIS contact criterion before the advisory (60% for children and 40% for adults), and the rate did not change after the advisory. A greater proportion of pediatric patients seen by a psychiatrist (80%) met the HEDIS criterion than those seen by a pediatrician (60%) or a non-pediatrician primary care physician (54%), and than adults seen by a psychiatrist (65%) or a primary care physician (37%). The proportions of pediatric patients who met the FDA recommendations did not differ by specialty. Contrary to expectations, the frequency of visits by patients with new episodes of depression treated with antidepressants did not increase after the October 2003 FDA advisory was issued.
机译:美国食品药品监督管理局(FDA)于2003年10月发布了有关服用抗抑郁药的小儿患者自杀风险的公共卫生咨询,并建议对此类患者进行“密切监督”。在这项研究中,作者比较了在咨询发布之前和之后抑郁症患者的提供者联系频率的趋势。根据管理治疗计划的国家索赔数据库(1998-2005年),对儿童(N = 27,370)和成人(N = 193,151)患有抗抑郁药新发抑郁发作的回顾性队列进行了研究。测量患者监测时使用了两个标准:《健康计划雇主数据和信息集(HEDIS)护理质量标准》,要求在3个月内进行三次联系,而FDA推荐的联系时间表在3个月内共进行7次就诊。时间序列模型根据咨询前的措施将咨询后的趋势与预期趋势进行了比较。在咨询之前,只有不到5%的患者达到了FDA的联系建议,咨询后比率没有变化。咨询前有更大比例的患者达到HEDIS接触标准(儿童为60%,成人为40%),并且咨询后这一比率没有变化。符合HEDIS标准的精神科医生所见的儿科患者比例(60%)或非儿科初级保健医师所见的患者比例(54%),以及精神科医生所见的成年人比例(65) %)或初级保健医师(37%)。符合FDA建议的儿科患者比例在专业方面没有差异。与预期相反,在2003年10月FDA咨询发布之后,用抗抑郁药治疗的新发抑郁症患者的就诊频率并未增加。

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    《The American Journal of Psychiatry》 |2008年第1期|p.42-50|共9页
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    Elaine H. Morrato, Dr.P.H.Anne M. Libby, Ph.D.Heather D. Orton, M.S.Frank V. deGruy III, M.D.David A. Brent, M.D.Richard Allen, M.S.Robert J. Valuck, Ph.D.Received Jan. 30, 2007, revisions received April 13, and May 8, 2007, accepted May 21, 2007 (doi: 10.1176/appi.ajp.2007.07010205). From the University of Colorado at Denver and Health Sciences Center, Denver, and the Western Psychiatric Institute and Clinics, University of Pittsburgh, Pittsburgh. Address correspondence and reprint requests to Dr. Valuck, University of Colorado, 4200 E. 9th Ave., Campus Box C238, Denver, CO 80262, robert.valuck@uchsc.edu (e-mail).Dr. Morrato, Dr. Libby, Ms. Orton, Mr. Allen, and Dr. Valuck report an unrestricted investigator-initiated research grant from Eli Lilly and Company. Dr. Valuck is an advisory board member for Eli Lilly and has received research support from Pfizer. Dr. Morrato has received research support from Janssen and Pfizer. Mr. Allen has received research support from GlaxoSmithKline. Dr. Brent and Dr. deGruy report no competing interests.Supported by an investigator-initiated grant from Eli Lilly and Company to fund the access fees to the independent PharMetrics database and salary support for the investigators. Eli Lilly did not provide data, was not involved in the original design of the study, and did not participate in the analysis of the data. Dr. Libby was also supported in part for this work by the W.T. Grant Foundation. Drs. Tamminga and Freedman reviewed the funding documents and the study and did not discern any evidence of bias from these funding sources.,;

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