EpiNet as a way of involving more physicians and patients in epilepsy research: Validation study and accreditation process.
EpiNet as a way of involving more physicians and patients in epilepsy research: Validation study and accreditation process.
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DOI：
10.1002/epi4.12033
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发表时间：
2017-03
期刊：
影响因子：
3
通讯作者：
EpiNet Study Group
中科院分区：
文献类型：
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作者：
Bergin PS;Beghi E;Sadleir LG;Brockington A;Tripathi M;Richardson MP;Bianchi E;Srivastava K;Jayabal J;Legros B;Ossemann M;McGrath N;Verrotti A;Tan HJ;Beretta S;Frith R;Iniesta I;Whitham E;Wanigasinghe J;Ezeala-Adikaibe B;Striano P;Rosemergy I;Walker EB;Alkhidze M;Rodriguez-Leyva I;Ramírez González JA;D'Souza WJ;EpiNet Study Group
EpiNet的建立是为了鼓励癫痫研究。EpiNet用于多中心队列研究和研究者主导的试验。医生必须经过认证才能招募病人参加试验。在这里，我们描述了EpiNet - First试验的认证过程。对癫痫感兴趣的医生被邀请对30个病例进行评估，以确定以下情况：患者是否患有癫痫；癫痫发作的性质（全身性、局灶性）；病因学。对23个病例分两步提供了资料。EpiNet指导委员会确定有21例患有癫痫。指导委员会以协商一致方式确定每种情况下可接受的答复。我们选择了18个病例的子集来授权研究者进行EpiNet - First试验。我们最初专注于12个案例；为了获得认可，调查人员不能在指导委员会确定没有癫痫的任何病例中诊断癫痫。如果调查人员在评估12个病例后没有获得认可，则再考虑6个病例。在评估这18个病例时，如果他们在6名非癫痫患者中诊断出1名可能患有癫痫，但不能出现其他假阳性错误，并且在癫痫发作分类方面只能出现1个错误，则调查人员可以获得认可。在2013年12月至2014年12月期间，189名医生评估了30例病例。在第1步，与指导委员会就诊断达成一致的比例从47%到100%不等，在第2步提供有关检测的信息后，这一比例有所提高。189名医生中有105名（55%）获得了EpiNet - First试验的认证。经认证的医生对所有30例癫痫诊断的kappa值为0.70。我们已经建立了认证使用EpiNet的医生的标准。新调查员可以通过评估18种情况来获得认可。我们鼓励对癫痫感兴趣的医生成为EpiNet认证，并参与这些研究者主导的临床试验。
EpiNet was established to encourage epilepsy research. EpiNet is used for multicenter cohort studies and investigator‐led trials. Physicians must be accredited to recruit patients into trials. Here, we describe the accreditation process for the EpiNet‐First trials. Physicians with an interest in epilepsy were invited to assess 30 case scenarios to determine the following: whether patients have epilepsy; the nature of the seizures (generalized, focal); and the etiology. Information was presented in two steps for 23 cases. The EpiNet steering committee determined that 21 cases had epilepsy. The steering committee determined by consensus which responses were acceptable for each case. We chose a subset of 18 cases to accredit investigators for the EpiNet‐First trials. We initially focused on 12 cases; to be accredited, investigators could not diagnose epilepsy in any case that the steering committee determined did not have epilepsy. If investigators were not accredited after assessing 12 cases, 6 further cases were considered. When assessing the 18 cases, investigators could be accredited if they diagnosed one of six nonepilepsy patients as having possible epilepsy but could make no other false‐positive errors and could make only one error regarding seizure classification. Between December 2013 and December 2014, 189 physicians assessed the 30 cases. Agreement with the steering committee regarding the diagnosis at step 1 ranged from 47% to 100%, and improved when information regarding tests was provided at step 2. One hundred five of the 189 physicians (55%) were accredited for the EpiNet‐First trials. The kappa value for diagnosis of epilepsy across all 30 cases for accredited physicians was 0.70. We have established criteria for accrediting physicians using EpiNet. New investigators can be accredited by assessing 18 case scenarios. We encourage physicians with an interest in epilepsy to become EpiNet‐accredited and to participate in these investigator‐led clinical trials.