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医生参与眼部黑色素瘤的随机临床试验。

Physician participation in a randomized clinical trial for ocular melanoma.

作者信息

Taylor K M

机构信息

Centre for Health Studies, York University, Ontario, Canada.

出版信息

Ann Ophthalmol. 1992 Sep;24(9):337-44.

PMID:1471822
Abstract

One substudy of the Collaborative Ocular Melanoma Study (COMS) is a randomized trial examining surgery versus radiation therapy for ocular melanoma. To understand the perspective of the physician investigators, a survey of the 101 COMS physicians from 29 major institutions in the United States and Canada was completed before randomization of the first patient. A 95% response rate was obtained, and follow-up interviews were conducted with 87% of the physicians. The study found that (1) COMS physicians identified significant differences between incentives and disincentives to participate in any trial compared with participating in COMS, (2) COMS physicians could be differentiated and had a stronger clinical rather than research orientation, and (3) COMS physicians exhibited a high intention to recruit an identifiable subset of eligible patients. These data suggest that continued support of individual investigators and a close examination of incentives and disincentives to physician participation would be useful in enhancing accrual in this study. A follow-up of this group is planned throughout the anticipated ten-year duration of patient recruitment of this COMS trial.

摘要

协作性眼黑色素瘤研究(COMS)的一项子研究是一项随机试验,旨在比较手术与放射治疗对眼黑色素瘤的疗效。为了解参与研究的医生的观点,在第一位患者随机分组之前,对来自美国和加拿大29个主要机构的101位COMS医生进行了一项调查。获得了95%的回复率,并对87%的医生进行了后续访谈。研究发现:(1)与参与COMS相比,COMS医生认为参与任何试验的激励因素和阻碍因素存在显著差异;(2)COMS医生可以被区分,且具有更强的临床导向而非研究导向;(3)COMS医生表现出很高的意愿招募符合条件的特定患者子集。这些数据表明,持续支持个体研究者并仔细审查医生参与研究的激励因素和阻碍因素,将有助于提高该研究的入组率。计划在这项COMS试验预计为期十年的患者招募期间,对该组医生进行随访。

相似文献

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Physician participation in a randomized clinical trial for ocular melanoma.医生参与眼部黑色素瘤的随机临床试验。
Ann Ophthalmol. 1992 Sep;24(9):337-44.
2
Comparison of survival among eligible patients not enrolled versus enrolled in the Collaborative Ocular Melanoma Study (COMS) randomized trial of pre-enucleation radiation of large choroidal melanoma.未纳入与纳入脉络膜黑色素瘤术前放疗协作眼黑色素瘤研究(COMS)随机试验的符合条件患者的生存情况比较。
Ophthalmic Epidemiol. 2007 Jul-Aug;14(4):251-7. doi: 10.1080/01658100701473275.
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Ten-year follow-up of fellow eyes of patients enrolled in Collaborative Ocular Melanoma Study randomized trials: COMS report no. 22.协作性眼黑色素瘤研究随机试验中入组患者对侧眼的十年随访:COMS报告第22号
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Arch Ophthalmol. 2003 Aug;121(8):1156-62. doi: 10.1001/archopht.121.8.1156.
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The Collaborative Ocular Melanoma Study (COMS) randomized trial of pre-enucleation radiation of large choroidal melanoma: IV. Ten-year mortality findings and prognostic factors. COMS report number 24.脉络膜黑色素瘤协作组(COMS)关于大脉络膜黑色素瘤眼球摘除术前放疗的随机试验:IV. 十年死亡率研究结果及预后因素。COMS报告第24号。
Am J Ophthalmol. 2004 Dec;138(6):936-51. doi: 10.1016/j.ajo.2004.07.006.
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Incidence of cataract and outcomes after cataract surgery in the first 5 years after iodine 125 brachytherapy in the Collaborative Ocular Melanoma Study: COMS Report No. 27.协作性眼黑色素瘤研究中碘125近距离放射治疗后前5年白内障的发病率及白内障手术后的结局:COMS报告第27号
Ophthalmology. 2007 Jul;114(7):1363-71. doi: 10.1016/j.ophtha.2006.10.039. Epub 2007 Mar 6.
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The collaborative ocular melanoma study.协作性眼黑色素瘤研究
Ophthalmol Clin North Am. 2005 Mar;18(1):129-42, ix. doi: 10.1016/j.ohc.2004.11.004.
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Quality of life assessment in the collaborative ocular melanoma study: design and methods. COMS-QOLS Report No. 1. COMS Quality of Life Study Group.协作性眼黑色素瘤研究中的生活质量评估:设计与方法。COMS-QOLS报告第1号。COMS生活质量研究组。
Ophthalmic Epidemiol. 1999 Mar;6(1):5-17. doi: 10.1076/opep.6.1.5.1565.
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The Collaborative Ocular Melanoma Study (COMS) randomized trial of pre-enucleation radiation of large choroidal melanoma II: initial mortality findings. COMS report no. 10.脉络膜黑色素瘤协作组(COMS)大型脉络膜黑色素瘤眼球摘除术前放疗随机试验II:初步死亡率结果。COMS报告第10号。
Am J Ophthalmol. 1998 Jun;125(6):779-96. doi: 10.1016/s0002-9394(98)00039-7.
10
The Collaborative Ocular Melanoma Study (COMS) randomized trial of pre-enucleation radiation of large choroidal melanoma I: characteristics of patients enrolled and not enrolled. COMS report no. 9.脉络膜黑色素瘤摘除术前放疗协作组研究(COMS)大型脉络膜黑色素瘤随机试验I:入组和未入组患者的特征。COMS报告第9号。
Am J Ophthalmol. 1998 Jun;125(6):767-78. doi: 10.1016/s0002-9394(98)00038-5.

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