Abstract
Objective: 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. Methods: 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. Results: 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. Significance: 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.
| Original language | English |
|---|---|
| Pages (from-to) | 20-31 |
| Number of pages | 12 |
| Journal | Epilepsia Open |
| Volume | 2 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - Mar 2017 |
Keywords
- Accreditation
- Clinical trials
- Diagnostic accuracy
- Multicenter collaboration
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EpiNet as a way of involving more physicians and patients in epilepsy research : Validation study and accreditation process. / Bergin, Peter S.; Beghi, Ettore; Sadleir, Lynette G.; Brockington, Alice; Tripathi, Manjari; Richardson, Mark P.; Bianchi, Elisa; Srivastava, Kavita; Jayabal, Jayaganth; Legros, Benjamin; Ossemann, Michel; McGrath, Nicole; Verrotti, Alberto; Tan, Hui Jan; Beretta, Simone; Frith, Richard; Iniesta, Ivan; Whitham, Emma; Wanigasinghe, Jithangi; Ezeala-Adikaibe, Birinus; Striano, Pasquale; Rosemergy, Ian; Walker, Elizabeth B.; Alkhidze, Maia; Rodriguez-Leyva, Ildefonso; Ramírez González, Jose Alfredo; D'Souza, Wendyl J.; on behalf of the EpiNet Study Group; Calle, Analía; Palacios, Claudio; Cairns, Anita; Carney, Patrick; Craig, Donald; Gill, Deepak; Gupta, Sachin; Lander, Cecilie; Laue-Gizzi, Hanka; Hitchens, Natalie; Kiley, Michelle; Lawn, Nicholas; Reyneke, Elizabeth; Riney, Kate; Tan, Meng; Tan, Michael; Thieban, Mark; Wong, Chong; van Rijckevorsel, Germain; Ferrari Strang, Ana Gabriela; Gifoni, Angela; Helio, Linden; Monnerat, Bruno; Brna, Paula; Donner, Elizabeth; Jacques, Stephanie; Jette, Nathalie; McLachlan, Richard; Mohamed, Ismail; Tran, Thi Phuoc Yen; Bo, Xiao; Fan, Song; Guang, Yang; Li, Ming; Wang, Kang; Zhang, Shouwen; Ladino, Lady; Christensen, Jakob; Kӧlmel, Margarethe Sophie; Nikanorova, Marina; Uusitalo, Annukka; Vieira, Paivi; Auvin, Stephane; Ediberidze, Tamar; Gogatishvili, Nino; Jishkariani, Tamar; Dennig, Dieter; Grimmer, Anja; Michaelis, Rosa; Schubert-Bast, Susanne; Stephani, Caspar; Stodieck, Stefan; Vollbrandt, Martin; Zellner, Andreas; Zafeiriou, Dimitrios; Fogarasi, Andras; Halasz, Peter; Chaurasia, Rameshwar Nath; Jain, Satish; Nair, Raj; Passi, Pravar; Rajadhyaksha, Surekha; Sattaluri, Sita Jayalakshmi; Shah, Harshuti; Udani, Vrajesh; Costello, Daniel; Aguglia, Umberto; Bartocci, Arnaldo; Benna, Paolo; Ferlazzo, Edoardo; Laino, Daniela; Spalice, Alberto; Zanchi, Clara; Ali, Amza; Lim, Kheng Seang; Ramirez, Alfredo; Anderson, Neil; Barber, Alan; Cariga, Pietro; Cleland, James; Child, Nicholas; Davis, Suzanne; Dayal, Viswas; Dickson, Cameron; Doran, John; Duncan, Roderick; Giri, Pratima; Herd, Michael; Hutchinson, David; Jones, Bethany; Kao, Justin; Kilfoyle, Dean; Mottershead, John; Muir, Colette; Nolan, Melinda; Pereira, Jennifer; Ranta, Anna; Sadani, Sneha; Simpson, Mark; Spooner, Claire; Timmings, Paul; Walker, Elizabeth; Wei, Diana; Willoughby, Ernest; Wong, Edward; Wu, Teddy; Olusola, Talabi; Mahmud, Hiba; Mogul, Zarine; Espinoza, Julio; Vizarreta, Jose Hernandez; Baeta, Elia Maria; Teotónio, Rute; Jocic-Jakubi, Bosanka; Lukic, Stevo; Korošec, Marko; Zgur, Tomaz; Eguílaz, María Gómez; Asztely, Fredrik; Sithinamsuwan, Pasiri; Anderson, Joseph; Auce, Pauls; Desurkar, Archana; Hamandi, Khalid; Kelso, Andrew; Sanchez, Violeta; Sidra, Aurangzeb; Smith, Phil; Wehner, Tim; Winston, Gavin; Andrade, Edgard; Bensalem-Owen, Meriem; Boudreau, Michelle; Caller, Tracie; Chapman, Kevin; Chari, Geetha; Davis, Kathryn; Droker, Brian; El-Hagrassy, Mirret; Eliashiv, Dawn; Eze, Chigolum; Heck, Christi; Kabir, Arif; Kolesnik, Dmitriy; Lam, Alice; Lopez, Jonathan; Maamoon, Tammaa; Cohen, Jennifer Madan; Maganti, Rama; Nwankwo, Chinasa; Park, Kristen; Proteasa, Simona; Sandok, Evan; Seinfield, Syndi; Toub, Julia; Wirrell, Elaine; Arbildi, Marcela; Thien, Truong Tran.
In: Epilepsia Open, Vol. 2, No. 1, 03.2017, p. 20-31.Research output: Contribution to journal › Article › peer-review
TY - JOUR
T1 - EpiNet as a way of involving more physicians and patients in epilepsy research
T2 - Validation study and accreditation process
AU - Bergin, Peter S.
AU - Beghi, Ettore
AU - Sadleir, Lynette G.
AU - Brockington, Alice
AU - Tripathi, Manjari
AU - Richardson, Mark P.
AU - Bianchi, Elisa
AU - Srivastava, Kavita
AU - Jayabal, Jayaganth
AU - Legros, Benjamin
AU - Ossemann, Michel
AU - McGrath, Nicole
AU - Verrotti, Alberto
AU - Tan, Hui Jan
AU - Beretta, Simone
AU - Frith, Richard
AU - Iniesta, Ivan
AU - Whitham, Emma
AU - Wanigasinghe, Jithangi
AU - Ezeala-Adikaibe, Birinus
AU - Striano, Pasquale
AU - Rosemergy, Ian
AU - Walker, Elizabeth B.
AU - Alkhidze, Maia
AU - Rodriguez-Leyva, Ildefonso
AU - Ramírez González, Jose Alfredo
AU - D'Souza, Wendyl J.
AU - on behalf of the EpiNet Study Group
AU - Calle, Analía
AU - Palacios, Claudio
AU - Cairns, Anita
AU - Carney, Patrick
AU - Craig, Donald
AU - Gill, Deepak
AU - Gupta, Sachin
AU - Lander, Cecilie
AU - Laue-Gizzi, Hanka
AU - Hitchens, Natalie
AU - Kiley, Michelle
AU - Lawn, Nicholas
AU - Reyneke, Elizabeth
AU - Riney, Kate
AU - Tan, Meng
AU - Tan, Michael
AU - Thieban, Mark
AU - Wong, Chong
AU - van Rijckevorsel, Germain
AU - Ferrari Strang, Ana Gabriela
AU - Gifoni, Angela
AU - Helio, Linden
AU - Monnerat, Bruno
AU - Brna, Paula
AU - Donner, Elizabeth
AU - Jacques, Stephanie
AU - Jette, Nathalie
AU - McLachlan, Richard
AU - Mohamed, Ismail
AU - Tran, Thi Phuoc Yen
AU - Bo, Xiao
AU - Fan, Song
AU - Guang, Yang
AU - Li, Ming
AU - Wang, Kang
AU - Zhang, Shouwen
AU - Ladino, Lady
AU - Christensen, Jakob
AU - Kӧlmel, Margarethe Sophie
AU - Nikanorova, Marina
AU - Uusitalo, Annukka
AU - Vieira, Paivi
AU - Auvin, Stephane
AU - Ediberidze, Tamar
AU - Gogatishvili, Nino
AU - Jishkariani, Tamar
AU - Dennig, Dieter
AU - Grimmer, Anja
AU - Michaelis, Rosa
AU - Schubert-Bast, Susanne
AU - Stephani, Caspar
AU - Stodieck, Stefan
AU - Vollbrandt, Martin
AU - Zellner, Andreas
AU - Zafeiriou, Dimitrios
AU - Fogarasi, Andras
AU - Halasz, Peter
AU - Chaurasia, Rameshwar Nath
AU - Jain, Satish
AU - Nair, Raj
AU - Passi, Pravar
AU - Rajadhyaksha, Surekha
AU - Sattaluri, Sita Jayalakshmi
AU - Shah, Harshuti
AU - Udani, Vrajesh
AU - Costello, Daniel
AU - Aguglia, Umberto
AU - Bartocci, Arnaldo
AU - Benna, Paolo
AU - Ferlazzo, Edoardo
AU - Laino, Daniela
AU - Spalice, Alberto
AU - Zanchi, Clara
AU - Ali, Amza
AU - Lim, Kheng Seang
AU - Ramirez, Alfredo
AU - Anderson, Neil
AU - Barber, Alan
AU - Cariga, Pietro
AU - Cleland, James
AU - Child, Nicholas
AU - Davis, Suzanne
AU - Dayal, Viswas
AU - Dickson, Cameron
AU - Doran, John
AU - Duncan, Roderick
AU - Giri, Pratima
AU - Herd, Michael
AU - Hutchinson, David
AU - Jones, Bethany
AU - Kao, Justin
AU - Kilfoyle, Dean
AU - Mottershead, John
AU - Muir, Colette
AU - Nolan, Melinda
AU - Pereira, Jennifer
AU - Ranta, Anna
AU - Sadani, Sneha
AU - Simpson, Mark
AU - Spooner, Claire
AU - Timmings, Paul
AU - Walker, Elizabeth
AU - Wei, Diana
AU - Willoughby, Ernest
AU - Wong, Edward
AU - Wu, Teddy
AU - Olusola, Talabi
AU - Mahmud, Hiba
AU - Mogul, Zarine
AU - Espinoza, Julio
AU - Vizarreta, Jose Hernandez
AU - Baeta, Elia Maria
AU - Teotónio, Rute
AU - Jocic-Jakubi, Bosanka
AU - Lukic, Stevo
AU - Korošec, Marko
AU - Zgur, Tomaz
AU - Eguílaz, María Gómez
AU - Asztely, Fredrik
AU - Sithinamsuwan, Pasiri
AU - Anderson, Joseph
AU - Auce, Pauls
AU - Desurkar, Archana
AU - Hamandi, Khalid
AU - Kelso, Andrew
AU - Sanchez, Violeta
AU - Sidra, Aurangzeb
AU - Smith, Phil
AU - Wehner, Tim
AU - Winston, Gavin
AU - Andrade, Edgard
AU - Bensalem-Owen, Meriem
AU - Boudreau, Michelle
AU - Caller, Tracie
AU - Chapman, Kevin
AU - Chari, Geetha
AU - Davis, Kathryn
AU - Droker, Brian
AU - El-Hagrassy, Mirret
AU - Eliashiv, Dawn
AU - Eze, Chigolum
AU - Heck, Christi
AU - Kabir, Arif
AU - Kolesnik, Dmitriy
AU - Lam, Alice
AU - Lopez, Jonathan
AU - Maamoon, Tammaa
AU - Cohen, Jennifer Madan
AU - Maganti, Rama
AU - Nwankwo, Chinasa
AU - Park, Kristen
AU - Proteasa, Simona
AU - Sandok, Evan
AU - Seinfield, Syndi
AU - Toub, Julia
AU - Wirrell, Elaine
AU - Arbildi, Marcela
AU - Thien, Truong Tran
PY - 2017/3
Y1 - 2017/3
N2 - Objective: 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. Methods: 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. Results: 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. Significance: 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.
AB - Objective: 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. Methods: 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. Results: 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. Significance: 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.
KW - Accreditation
KW - Clinical trials
KW - Diagnostic accuracy
KW - Multicenter collaboration
UR - http://www.scopus.com/inward/record.url?scp=85025158355&partnerID=8YFLogxK
U2 - 10.1002/epi4.12033
DO - 10.1002/epi4.12033
M3 - Article
AN - SCOPUS:85025158355
VL - 2
SP - 20
EP - 31
JO - Epilepsia Open
JF - Epilepsia Open
SN - 2470-9239
IS - 1
ER -