CHIPS news. noticias nouvelles notícias nieuws. CHIPS Data Campaign. Please SEND US YOUR DATA and QUERY REPLIES today!

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1 CHIPS news noticias nouvelles notícias nieuws VOLUME 6 ISSUE 2 FEBRUARY 2013 CHIPS Data Campaign INSIDE THIS ISSUE: CHIPS Data Campaign 1 New Complete and Clean Data Report 1 Data tutorial: Recording proteinuria after randomisation 2 Translating responses for the Postpartum Questionnaire and other supporting documents 2 Current Complete and Clean Data Report 3 Please SEND US YOUR DATA and QUERY REPLIES today! Our goal is to achieve 100% complete and clean data for all CHIPS cases for our final analysis. Please help us accomplish this by continuing to send your primary data, query responses and supporting documentation to the Data Co-ordinating Centre, as you complete them. Please remember that ORIGINAL primary data must be MAILED to the DCC: CHIPS Data Co-ordinating Centre The Centre for Mother, Infant, and Child Research Sunnybrook Health Sciences Centre C Bayview Avenue Toronto, Ontario, CANADA M4N 3M5 ONLY data query responses (as completed on the CHIPS Data Query Table) may be sent to the DCC by or fax: chipsdata@sunnybrook.ca Fax: CHIPS Contacts: CHIPS Clinical Co ordinating Centre (CCC) chips@cw.bc.ca Ph: CHIPS Data Co ordinating Centre (DCC) chipsdata@sunnybrook.ca Ph: We appreciate your continued efforts to help us ensure that CHIPS has the best data quality possible! New Complete and Clean Data Report The Data Co-ordinating Centre has programmed a new report to track the number of cases that are considered complete (that is, we have all ) AND clean (have no outstanding queries). This Complete and Clean Data Report will provide updates on the status of data collection and cleaning as we move towards the final analysis. Our current overall standings (as of February 28, 2013) for returned and clean data are: Cases data : 84.1% Cases and : 69.7% Please turn to page 3 to find out the current status of your centre!

2 CHIPS Data Tutorial: Recording proteinuria after randomisation: Queries have been generated when a woman was recorded as having proteinuria, but her test results fall below the CHIPS criteria for proteinuria. Please note that the CHIPS Protocol definition for proteinuria is: "> 0.3 g/d by 24hr urine collection, or if a 24hr urine collection is not available, by a urinary protein:creatinine ratio of > 30 mg/mmol or urinary dipstick of > 2+". When recording proteinuria after randomisation on the Maternal Form, page 2, question 1, please ensure that the values meet the CHIPS criteria for proteinuria. Example: Maternal Form, page 2 question 1 Correct answer KT The maximum amount of protein recorded is below 0.3g/d, and therefore should not be recorded. Question 1 should be revised to no and sub-questions 1a-d should not be marked in. Translations required for the Postpartum Questionnaire and supporting documents: Please remember to translate the relevant text on the following documents into English before sending them to the DCC: 1. Postpartum Questionnaire Section D: Study Treatment Evaluation free-text responses given by patients. 2. Any supporting documents: a) Delivery Form Text that confirms a pregnancy loss reported b) Neonatal Form Text about admission and discharge information, reasons for high level neonatal care, and any other neonatal events reported c) Maternal Form Text that confirms any maternal outcomes and any other maternal events reported d) Postpartum Questionnaire i) Text that confirms hospital re-admission information for the baby and indication for re-admission ii) Text that confirms maternal complications after discharge from delivering hospital

3 CHIPS Primary Data Report for Forms Returned and Queries Resolved (Entry, Study Contact, Maternal, Delivery, Neonatal, PPQ) Country Centre # Patients # Patients and ARGENTINA AUSTRALIA BRAZIL CANADA CHILE COLOMBIA ESTONIA HUNGARY Hospital LC Lagomaggiore, Mendoza (68%) 1 (6%) Hospital Avellaneda, Tucuman 10 6 (60%) 5 (50%) Hospital JR Vidal, Corrientes 8 6 (75%) Hospital JM Cullen, Santa Fe 2 2 (100%) Ipswich Hospital, Ipswich (91%) 26 (72%) Women's and Children's Hospital, Adelaide (100%) 15 (83%) King Edward Memorial Hospital, Subiaco (100%) 13 (76%) Campbelltown Hospital, Penrith South 8 4 (50%) 3 (37%) Liverpool Hospital, Penrith South 5 4 (80%) 1 (20%) St John of God Hospital, Subiaco 1 1 (100%) Maternidade de Vila Nova Cachoeirinha, Sao Paulo 7 Hospital Universitario Antonio Pedro, Niteroi 6 4 (66%) Maternidade Escola da UFRJ, Rio de Janeiro 4 4 (100%) 2 (50%) Hospital Sao Lucas - PUCRS, Porto Alegre 3 Children's & Women's Health Centre of BC, Vancouver (100%) 32 (100%) Congratulations! Jim Pattison Outpatient Care and Surgery Centre, Surrey (92%) 23 (88%) St Michael's Hospital, Toronto (81%) 17 (77%) Calgary Health Region - Foothills Hospital, Calgary (95%) 18 (85%) IWK Health Centre, Halifax (94%) 18 (94%) Sunnybrook Health Sciences Centre, Toronto (100%) 18 (94%) Royal Alexandra Hospital, Edmonton (93%) 14 (87%) Hopital Sainte-Justine, Montreal (93%) 14 (93%) CHUS Fleurimont, Sherbrooke (100%) 13 (100%) Congratulations! Ottawa Hospital Civic Division, Ottawa (100%) 13 (100%) Congratulations! Mount Sinai Hospital, Toronto 8 7 (87%) Royal University Hospital, Saskatoon 6 6 (100%) 6 (100%) Congratulations! Ottawa Hospital General Division, Ottawa 5 5 (100%) 5 (100%) Congratulations! St Paul's Hospital, Vancouver 5 5 (100%) 5 (100%) Congratulations! Toronto East General Hospital, Toronto 5 5 (100%) London Health Sciences Centre, London 4 4 (100%) 4 (100%) Congratulations! Royal Victoria Hospital, Montreal 2 2 (100%) 2 (100%) Congratulations! Regina General Hospital, Regina 1 Women s Health Centre, St John's 1 1 (100%) 1 (100%) Congratulations! Hospital Dr Sotero del Rio, Puente Alto (95%) 25 (55%) Hospital Base Osorno, Osorno (91%) 9 (75%) Corporacion Comfenalco Valle - Universidad Libre, Cali (85%) 15 (75%) Clinica Versalles, Cali (90%) 4 (36%) Clinica Materno Infantil Farallones, Cali 5 2 (40%) 2 (40%) Tartu University Hospital - Women's Clinic, Tartu (94%) 14 (73%) University of Debrecen, Debrecen 5 4 (80%)

4 Country Centre # Patients # Patients and ISRAEL JORDAN NEW ZEALAND POLAND QATAR THE NETHERLANDS UK USA Hillel Yaffe Medical Center, Hadera 6 Ma'ayney Hayeshua Medical Center, Bnei Brak 3 2 (66%) Nazareth Hospital (EMMS), Nazareth 3 2 (66%) Islamic Hospital, Amman 13 8 (61%) 8 (61%) Christchurch Women's Hospital, Christchurch (93%) 12 (75%) Waitemata Health-North Shore Hospital, Auckland 1 1 (100%) 1 (100%) Congratulations! Medical University of Gdansk, Gdansk 9 9 (100%) 6 (66%) Polish Mothers Memorial Hospital, Lodz 9 8 (88%) 2 (22%) University School of Medical Sciences, Poznan 3 Women's Hospital Hamad Medical Corporation, Doha 43 2 (4%) Academic Medical Center, Amsterdam (92%) 26 (92%) OLVG, Amsterdam (84%) 11 (84%) UMCU, Utrecht 10 7 (70%) 6 (60%) VU Medical Center, Amsterdam 9 6 (66%) 5 (55%) Maxima Medical Centre, Veldhoven 8 4 (50%) 4 (50%) UMCG, Groningen 6 6 (100%) 5 (83%) Isala Klinieken Zwolle, Zwolle 5 Tergooiziekenhuizen, Hilversum 5 4 (80%) 4 (80%) MUMC Maastricht, Maastricht 4 4 (100%) 3 (75%) St Antonius Ziekenhuis, Nieuwegein 3 Kennemer Gasthuis Haarlem, Haarlem 2 2 (100%) Diakonessen Ziekenhuis, Utrecht 1 1 (100%) 1 (100%) Congratulations! Flevo ziekenhuis, Almere 1 Jeroen Bosch Hospital, 's-hertogenbosch 1 Guy's & St Thomas' Hospital, London (94%) 35 (92%) New Cross Hospital, Wolverhampton (93%) 27 (87%) Nottingham City Hospital, Nottingham (100%) 30 (100%) Congratulations! Queen's Medical Centre, Nottingham (100%) 21 (95%) Royal Victoria Infirmary, Newcastle upon Tyne (100%) 16 (72%) Liverpool Women's Hospital, Liverpool (81%) 9 (56%) Bradford Royal Infirmary, Bradford (92%) 12 (92%) Leicester Royal Infirmary, Leicester 12 6 (50%) 5 (41%) Wexham Park Hospital, Slough (91%) 9 (75%) City Hospitals Sunderland NHS Foundation Trust, Sunderland 10 9 (90%) 9 (90%) South Warwickshire NHS Trust, Warwick 9 8 (88%) 6 (66%) Derriford Hospital, Plymouth 8 7 (87%) 7 (87%) York District Hospital, York 8 8 (100%) Singleton Hospital, Swansea 7 7 (100%) 5 (71%) Chesterfield Royal Hospital, Chesterfield 6 4 (66%) 4 (66%) Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield 6 5 (83%) 4 (66%) St Mary's Hospital, Manchester 6 6 (100%) 6 (100%) Congratulations! Birmingham Women's Hospital, Birmingham 5 5 (100%) Lancashire Teaching Hospitals NHS Foundation Trust, Lancashire 3 3 (100%) 2 (66%) The Royal Derby Hospital, Derby 3 3 (100%) Basildon & Thurrock University Hospital, Basildon 1 1 (100%) 1 (100%) Congratulations! Cooper University Hospital, Camden (92%) 11 (84%) Medical University of South Carolina, Charleston 11 9 (81%) 8 (72%) Beth Israel Deaconess, Boston 8 7 (87%)

5 Country Centre # Patients # Patients and Yale-New Haven Hospital, New Haven 8 6 (75%) 3 (37%) Norton Hospital Downtown, Louisville 7 7 (100%) 7 (100%) Congratulations! East Carolina University, Greenville 6 6 (100%) 5 (83%) Meriter Hospital, Madison 6 6 (100%) 4 (66%) Oregon Health & Science University, Portland 5 5 (100%) 5 (100%) Congratulations! University of North Carolina, Chapel Hill 4 4 (100%) 3 (75%) Norton Suburban Hospital, Louisville 2 1 (50%) 1 (50%) Total: (84.1 %) 719 (69.7 %)