Noticias News Nouvelles

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1 Noticias News Nouvelles The Centre for Mother, Infant, and Child Research 7 th Floor, 790 Bay Street Toronto ON CANADA M5G 1N8 Tel: Fax: tbs@sw.ca website: V O L U M E 8, I S S U E 7 J U L Y 3 1, Overall Total: 2001 Total this month: 54 I N S I D E T H I S I S S U E Recruitment Record 2000 Recruits! 1 Reminder: Interim Analysis 1 Query Tutorial 2 Interim Analysis & Data Campaign 1 3 Recruitment Record! We have set a new monthly recruitment record! Thank you to all of our recruiting centres for making this milestone possible. Excellent work! 2000 Recruits! Congratulations to Dr George Carson and the team at Regina General Hospital in Regina, Canada for recruiting the 2000th patient into the Twin Birth Study. Let s aim to complete our recruitment goal of 2800 recruits by this time next year! Monthly Feature Congratulations Dr Raquel Martin Congratulations 1st Recruit Recruitment Excellence Recruitment Table 2yr Table Reminder: 2 nd Interim Analysis Please send any outstanding primary data to the Data Coordinating Centre by courier and send any queries by or fax today. The interim analysis begins at the end of August and the Data Safety and Monitoring Board will meet in November to review the results. Your help in sending the outstanding primary data is greatly appreciated!

2 P A G E 2 Query Tutorial Page 2 of the Clinical Neurodevelopmental Assessment Form, please note that if the child does not have cerebral palsy you do not need to complete the rest of the form. Please do not continue to question 7b.

3 P A G E 3 Data campaign for the interim analysis Again this month we are recognizing centres with 100% complete and clean data. We look forward to adding more centres to this list. If your centre has any outstanding data and/or queries, please send them to the Data Coordinating Centre as soon as possible. Congratulations to the following centres with 100% complete and clean data for the first 1800 recruits! COUNTRY CITY CENTRE ARGENTINA Bahia Blanca Hospital Penna Santiago del Estero Hospital Ramon Carrillo AUSTRALIA Adelaide Women's and Children's Hospital Clayton Monash Medical Centre Ipswich Ipswich Hospital Meadowbrook Logan Hospital Sydney St George Hospital Toowoomba Toowoomba Base Hospital Townsville Townsville Hospital BRAZIL Goiania Hospital Materno Infantil Porto Alegre ISCMPA-Maternidade Mario Totta CANADA Calgary Foothills Medical Centre Halifax IWK Health Centre Hamilton McMaster University Medical Centre London St Joseph's Health Care Mississauga Trillium Health Centre New Westminster Royal Columbian Hospital North Bay North Bay General Hospital Regina Regina General Hospital Saskatoon Royal University Hospital St John's Eastern Health Toronto Mount Sinai Hospital Vancouver Lions Gate Hospital CHILE Vina del Mar Hospital Dr Gustavo Fricke CROATIA Zagreb Sveti Duh Hospital ESTONIA Tartu Tartu University Hospital GERMANY Berlin CUB - Benjamin Franklin Munich Ludwig Maximilians University of Munich ISRAEL Afula HaEmek Medical Center Hadera Hillel Yaffe Medical Center Haifa Bnai Zion Medical Center Nazareth Nazareth Hospital (EMMS) (Continued on page 4)

P A G E 4 (Continued from Data Campaign for the Interim Analysis page 3) COUNTRY CITY CENTRE ISRAEL Tiberias Poriya Government Hospital SPAIN Barcelona Hospital Clinic-University of Barcelona THE

4 P A G E 4 (Continued from Data Campaign for the Interim Analysis page 3) COUNTRY CITY CENTRE ISRAEL Tiberias Poriya Government Hospital SPAIN Barcelona Hospital Clinic-University of Barcelona THE NETHERLANDS Amsterdam Sint Lucas Andreas Ziekenhuis Heerlen Maastricht Atrium Medical Center Academisch Ziekenhuis Maastricht UK Bradford Bradford Royal Infirmary London Nottingham Plymouth Lewisham Hospital Derriford Hospital USA Columbia University of South Carolina Iowa City Miami Nottingham City Hospital University of Iowa Hospitals and Clinics University of Miami Oakland Phoenix Monthly Feature East Bay Perinatal Medical Associates Maricopa Medical Center This month, we feature Laura Kennedy, the coordinator from St Joseph's Health Care in London, Canada. St Joseph s Health Centre became active in October 2008 and has already recruited 5 patients into TBS. We congratulate the team for a job well done! Laura writes: I am very excited to be a part of the Twin Birth Study! This is the first international clinical trial that I have been involved with and it was great to meet collaborators from around the world at the New Investigators Meeting in April. Although it can be difficult to recruit for this study, I know that each woman who joins is helping to answer a vital question that may change the practice of physicians around the world. That makes each recruitment at our site very rewarding. I enjoy meeting and developing a relationship with the patients and their families and look forward to enrolling many more women in this important study!

5 Congratulations! P A G E 5 We wish to congratulate Dr Raquel Martin at Hospital LC Lagomaggiore in Mendoza, Argentina for recruiting the centre s 150th patient! Great work! Congratulations on your first recruits We send congratulations to Dr Nelson Sass and the team at Maternidade Escola de Vila Nova Cachoeirinha in Sao Paulo, Brazil. Congratulations on recruiting four patients within one month of becoming active! Excellent job! Recruitment Excellence Congratulations to Dr Jesus Daniel Aguirre and the team at Hospital JR Vidal, Corrientes, Argentina; Dr Caio Coelho Marques and the team at University Hospital Sao Lucas, Porto Alegre, Brazil; Dr Danielly Scaranello Nunes Santana and the team at Hospital Universitario de Jundiai, Jundiai, Brazil; Dr George Carson and the team at Regina General Hospital, Regina, Canada; Dr Ramesh Kulkarni and the team at North Bay General Hospital, North Bay, Canada; Dr Fred Kirss and the team at Tartu University Hospital - Women s Clinic, Tartu, Estonia; Dr Dalia Mansour-Schwake and the team at Holy Family Hospital, Nazareth, Israel; and Prof Miroslava Gojnic and the team at University of Belgrade, Belgrade, Serbia. Keep up the excellent work! We will be sending a gold seal to place on your Certificate of Achievement.

6 Twin Birth Study Recruitment (Projected sample size of 2800) as of July 31, 2009 Annual Jun Jul - Apr May June July Grand Goal Total COUNTRY ARGENTINA BRAZIL CANADA POLAND ISRAEL EGYPT CHILE UK AUSTRALIA THE NETHERLANDS ESTONIA SERBIA USA SPAIN JAMAICA JORDAN HUNGARY ROMANIA BELGIUM GERMANY CROATIA GREECE Total CENTRES BY COUNTRY (Shaded area is prior to start-up) ARGENTINA Hospital LC Lagomaggiore, Mendoza Hospital Posadas, Buenos Aires Hospital Ramon Carrillo, Santiago del Estero Hospital Avellaneda, Tucuman Hospital JR Vidal, Corrientes Hospital Penna, Bahia Blanca Hospital Sarda, Buenos Aires Hospital Angela Iglesia de Llano, Corrientes Hospital Juan A Fernandez, Buenos Aires Hospital Alvarez, Buenos Aires Centres that are no longer recruiting 0 10 BRAZIL University of Campinas, Campinas Maternidade Escola da UFRJ, Rio de Janeiro University of Pernambuco, Recife Hospital Universitario Antonio Pedro, Niteroi Hospital Universitario de Jundiai, Jundiai Perinatal, Rio de Janeiro ISCMPA-Maternidade Mario Totta, Porto Alegre Hospital Sao Lucas, Porto Alegre Hospital das Clinicas da UFPE, Recife Botucatu Medical School, Botucatu Maternidade Escola de Vila Nova Cachoeirinha, Sao Paulo Hospital Materno Infantil, Goiania CANADA Sunnybrook Health Sciences Centre, Toronto McMaster University Medical Centre, Hamilton IWK Health Centre, Halifax Regina General Hospital, Regina Trillium Health Centre, Mississauga Lions Gate Hospital, Vancouver Mount Sinai Hospital, Toronto Foothills Medical Centre, Calgary SMBD Jewish General Hospital, Montreal Royal Columbian Hospital, New Westminster Royal University Hospital, Saskatoon St Joseph's Health Care, London North Bay General Hospital, North Bay Eastern Health, St John's Toronto East General, Toronto Children's & Women's Health Centre of BC, Vancouver Centres that are no longer recruiting 0 1 POLAND University School of Medical Sciences, Poznan Polish Mothers Memorial Hospital, Lodz Medical University of Gdansk, Gdansk ISRAEL Edith Wolfson Medical Center, Holon Ma'ayney HaYeshua Medical Center, Bnei Brak Nazareth Hospital (EMMS), Nazareth HaEmek Medical Center, Afula Poriya Government Hospital, Tiberias

7 Annual Jun Jul - Apr May June July Grand Goal Total Bnai Zion Medical Center, Haifa Hillel Yaffe Medical Center, Hadera Holy Family Hospital, Nazareth EGYPT Assiut University Hospital, Assiut CHILE Hospital Dr Gustavo Fricke, Vina del Mar Hospital Dr Sotero del Rio, Puente Alto UK Bradford Royal Infirmary, Bradford Nottingham City Hospital, Nottingham Basildon & Thurrock University, Basildon Queen Elizabeth Hospital, King's Lynn Queens Medical Centre, Nottingham Derriford Hospital, Plymouth University Hospital of North Staffordshire, Stoke-on-Trent Lewisham Hospital, London AUSTRALIA Ipswich Hospital, Ipswich Mater Mothers' Hospital, Brisbane St George Hospital, Sydney Toowoomba Base Hospital, Toowoomba Monash Medical Centre, Clayton Logan Hospital, Meadowbrook Townsville Hospital, Townsville Women's and Children's Hospital, Adelaide THE NETHERLANDS Atrium Medical Center, Heerlen Academisch Ziekenhuis Maastricht, Maastricht Sint Lucas Andreas Ziekenhuis, Amsterdam Maxima Medical Centre, Veldhoven Centres that are no longer recruiting 0 7 ESTONIA Tartu University Hospital - Women's Clinic, Tartu SERBIA University of Belgrade, Belgrade USA East Bay Perinatal Medical Associates, Oakland Maricopa Medical Center, Phoenix University of South Carolina, Columbia University of Miami, Miami University of Iowa Hospitals and Clinics, Iowa City Centres that are no longer recruiting 0 4 JORDAN Islamic Hospital, Amman JAMAICA University Hospital of the West Indies, Kingston SPAIN Hospital Clinic-University of Barcelona, Barcelona HUNGARY University of Debrecen, Debrecen ROMANIA University of Pharmacy and Medicine, Cluj-Napoca BELGIUM Vrije Universiteit Brussel, Brussels GERMANY Ludwig Maximilians University of Munich, Munich CUB - Virchow Klinikum, Berlin CUB - Benjamin Franklin, Berlin CROATIA Sveti Duh Hospital, Zagreb GREECE Alexandra Maternity, Athens Centres awaiting first patient: [COUNTRY: Hospital, City (annual goal)] [month/year start-up package sent] AUSTRALIA: Royal North Shore, St Leonards (3) [11/06]; CANADA:St Paul s Hospital, Vancouver (3) [01/09]; UK: Aberdeen Maternity, Aberdeen (6) [11/06], Liverpool Women's Hospital, Liverpool (12) [05/07]; USA: Washington University, St Louis (5) [01/07];

8 TBS 2 Year Follow-up The status of the TBS 2 Year Follow-up is displayed in the following table for centres that recruited patients. Centres are listed according to the total number of recruits by country and centre. See below for the number of follow-up assessments performed by your centre! Let's aim for 100% follow-up!! Status Totals As of July 2009 COUNTRY ARGENTINA BRAZIL CANADA POLAND ISRAEL EGYPT CHILE UK AUSTRALIA THE NETHERLANDS ESTONIA SERBIA USA JORDAN JAMAICA SPAIN HUNGARY ROMANIA GERMANY BELGIUM CROATIA GREECE Total % 89.6% 82.9% 75.9% 29.6% 42% CENTRES BY COUNTRY (Shaded area is prior to start-up) ARGENTINA Hospital LC Lagomaggiore, Mendoza Hospital Posadas, Buenos Aires Hospital Ramon Carrillo, Santiago del Estero Hospital Avellaneda, Tucuman Hospital JR Vidal, Corrientes Hospital Penna, Bahia Blanca Hospital Sarda, Buenos Aires Hospital Angela Iglesia de Llano, Corrientes Hospital Juan A Fernandez, Buenos Aires Hospital Ramos Mejia, Buenos Aires Hospital Alvarez, Buenos Aires BRAZIL University of Campinas, Campinas Maternidade Escola da UFRJ, Rio de Janeiro University of Pernambuco, Recife Hospital Universitario Antonio Pedro, Niteroi Hospital Universitario de Jundiai, Jundiai Perinatal, Rio de Janeiro ISCMPA-Maternidade Mario Totta, Porto Alegre Hospital Sao Lucas, Porto Alegre Hospital das Clinicas da UFPE, Recife Botucatu Medical School, Botucatu Maternidade Escola de Vila Nova Cachoeirinha, Sao Paulo 4 4 Hospital Materno Infantil, Goiania CANADA Sunnybrook Health Sciences Centre, Toronto McMaster University Medical Centre, Hamilton IWK Health Centre, Halifax Regina General Hospital, Regina Trillium Health Centre, Mississauga Lions Gate Hospital, Vancouver Mount Sinai Hospital, Toronto Foothills Medical Centre, Calgary SMBD Jewish General Hospital, Montreal Royal Columbian Hospital, New Westminster St Joseph's Health Care, London Royal University Hospital, Saskatoon North Bay General Hospital, North Bay 4 4 Eastern Health, St John's Toronto East General, Toronto York Central Hospital, Richmond Hill 1 1 Children's & Women's Health Centre of BC, Vancouver 1 1 POLAND Univ School of Medicine, Poznan Polish Mothers Memorial Hospital, Lodz Medical University of Gdansk, Gdansk ISRAEL Edith Wolfson Medical Center, Holon Ma'ayney HaYeshua Medical Center, Bnei Brak Nazareth Hospital (EMMS), Nazareth Poriya Government Hospital, Tiberias HaEmek Medical Center, Afula Bnai Zion Medical Center, Haifa

9 Status Totals As of July 2009 Hillel Yaffe Medical Center, Hadera Holy Family Hospital, Nazareth 5 5 EGYPT Assiut University Hospital, Assiut CHILE Hospital Dr Gustavo Fricke, Vina del Mar Hospital Dr Sotero del Rio, Puente Alto UK Bradford Royal Infirmary, Bradford Nottingham City Hospital, Nottingham Basildon & Thurrock University, Basildon Queen Elizabeth Hospital, King's Lynn Queens Medical Centre, Nottingham 4 4 Derriford Hospital, Plymouth University Hospital of North Staffordshire, Stoke-on-Trent Lewisham Hospital, London 3 3 AUSTRALIA Ipswich Hospital, Ipswich Mater Mothers' Hospital, Brisbane St George Hospital, Sydney Toowoomba Base Hospital, Toowoomba Monash Medical Centre, Clayton Logan Hospital, Meadowbrook Townsville Hospital, Townsville Women's and Children's Hospital, Adelaide 1 1 THE NETHERLANDS Atrium Medical Center, Heerlen Maaslandziekenhuis Sittard, Sittard Academisch Ziekenhuis Maastricht, Maastricht Sint Lucas Andreas Ziekenhuis, Amsterdam Maxima Medical Centre, Veldhoven 1 1 ESTONIA Tartu University Hospital - Women's Clinic, Tartu SERBIA University of Belgrade, Belgrade USA East Bay Perinatal Medical Associates, Oakland Maricopa Medical Center, Phoenix University of South Carolina, Columbia University of Miami, Miami Jamaica Hospital Medical Center, Jamaica Texas Tech UHSC, Lubbock 2 2 University of Iowa Hospitals and Clinics, Iowa City JAMAICA University Hospital of the West Indies, Kingston SPAIN Hospital Clinic-University of Barcelona, Barcelona JORDAN Islamic Hospital, Amman HUNGARY University of Debrecen, Debrecen ROMANIA University of Pharmacy and Medicine, Cluj-Napoca GERMANY Ludwig Maximilians University of Munich, Munich CUB - Virchow Klinikum, Berlin 3 3 CUB - Benjamin Franklin, Berlin BELGIUM Vrije Universiteit Brussel, Brussels CROATIA Sveti Duh Hospital, Zagreb GREECE Alexandra Maternity, Athens 1 3 4

Noticias News Nouvelles

Recruitment Tips Noticias News Nouvelles Volume 6 Issue 7 July 31, 2007 University of Toronto Maternal, Infant and Reproductive Health Research Unit at the Women s College Research Institute 7 th Floor,