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CHIPS news

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Recruitment Update

I N S I D E T H I S I S S U E :

CHIPS Contacts: CHIPS Clinical Co-ordinating Centre (CCC)

Email: chips@cw.bc.ca

Ph: +1-604-875-2959 CHIPS Data Co-ordinating Centre (DCC)

Email: chipsdata@sunnybrook.ca

Ph: +1-416-480-5629

Recruits

936

The countdown for the final 100 recruits is well underway!

Thank you to all our Collaborators for bringing us to this point!!

Recruitment Status Total this month: 464646 Overall Total: 936!936!936! Only 929292 more to go! Recruitment Update 1

Second Interim Analysis Data Campaign! 1

In all this excitement… 1

Maintaining Differential dBP Control - Site Feedback 2

Data Form and Translation Updates 2

Recruitment Graph 2

Data Tutorial:

Maternal Complications on the PPQ 3

Site Achievements 3

Recruitment Table 4

Second Interim Analysis Data Campaign! The data campaign for the 2nd interim analysis is in full swing. Thank you in advance for making it priority to return data forms and queries for participants in the first 685!

Just one outstanding data form will result in the case being considered incomplete. Please check your latest overdue data report and inform us immediately if there are:

Forms listed in error, OR Forms which you cannot complete (please also advise the reason in this case.)

Returning Queries? Fill-in the query table directly and send via email.

Returning Data Forms? Keep a photocopy for your records and post the original to:

The CHIPS Data Co-ordinating Centre

The Centre for Mother, Infant, and Child Research (CMICR)

C8-2075 Bayview Avenue

Toronto ON M4N 3M5

Canada

In all this excitement... As we get closer to our overall recruitment goal, there is a tendency for recruitment to speed up. While consenting women during these exciting times, please take extra care to ensure that the woman understands the trial completely before she is enrolled. In particular, it is important to confirm that she understands that medication may be stopped, started, or adjusted in dose depending on allocated group AND that she has an equal chance of being randomised to ‘Less Tight’ or ‘Tight’ control.

Do NOT randomise a woman if either she, an influential family member, or her care provider(s) indicate any hesitancy about either type of dBP control or any other aspect of the trial, or if you have reason to believe that she may not stay in the trial once enrolled.

CHIPS Recruitment Graph

June 2012 Targeted Recruitment Goal: 797

Actual Recruitment: 936!

Maintaining Differential dBP Control - Site Feedback

We are pleased to announce that ALL translations of the Postpartum Questionnaire are complete and available for download at www.chipsdata.ca This now includes the Hebrew and Arabic translations.

Data Form and Translation Updates

“It’s the old saying communicate, communicate and tell them again!!!” This tip, shared by Di Leishman at Christchurch Women’s Hospital in New Zealand, is one of the many valuable pieces of feedback we have received from sites over the last few months. Here are a few of the common themes around which we have heard feedback:

Visibility is key: The co-ordinator should be visible to practitioners (in person at the clinic before or during participants’

visits, or by prompts prior to participants’ visits by letter, phone, email, or text message) The study and your contact information should be visible in participants’ charts (copies of letters,

flowcharts on coloured paper, labels, and/or ‘sticky notes’)

Importance of maintaining a personal relationship with CHIPS women: Taking every opportunity to check-in, even between study contacts. The extra attention is usually appreciated and encourages the women to play an active

role in her participation in the study.

Office/clinic visits: If adjustments are made to antihypertensive therapy to bring a woman’s dBP on to target, consider

bringing her back earlier than usual to check whether the change in medication has been successful in bringing her dBP into the ‘no change’ range. This would be consistent with usual clinical practice.

Continued diligence is needed to ensure that the ‘first office/clinic visit after randomisation’ is with the primary care provider who is comfortable making adjustments according to the flow diagrams. In addition, at least one site in the UK books this visit with the consultant rather than a registrar or GP.

Another site (Women’s Hospital HMC in Doha, Qatar) even opened a new antenatal clinic called “The Hypertension in Pregnancy Clinic” just for CHIPS! All CHIPS ladies are referred here, with consultations by both the physician and the study coordinator, and followed up closely on a regular basis.

Please contact the DCC directly at chipsdata@sunnybrook.ca should you have any questions about sending or completing the CHIPS data forms.

Data Tutorial: Maternal Complications on the PPQ Sometimes a mother will verbally report a maternal complication on Section B, but her condition will not meet our definition as listed on Section E3. For example, the mother may report “ difficulty controlling her blood pressure” on section B, question 1a of the Postpartum Questionnaire (PPQ), but her condition will not meet our definition of having uncontrolled hypertension, as captured in section E, question 3b of the PPQ.

In these cases, you should still answer “yes” to the question in section B, and “no” to the question 3b in section E. How-ever, we ask that you please write a note of explanation/confirmation on the form so that you are not queried.

In CHIPS, ‘uncontrolled hypertension’ is defined as “hypertension requiring administration of 3 or more different parenteral [intravenous or intramuscular] antihypertensive agents within a 12 hour period.” This means that the woman must have received 3 injectable antihypertensive agents in a relatively short span of time to meet the CHIPS definition.

Please visit the CHIPS website www.utoronto.ca/cmicr/chips/ and the CHIPS Trial Research Forum www.chipsstudy.com for more useful CHIPS information

Site Achievements We would like to recognise and congratulate the following CHIPS teams:

For recruiting their first patients:

University School of Medical Sciences (Poznan, Poland)

For meeting or multiplying their annual recruitment goals:

Academic Medical Center (Amsterdam, The Netherlands); Hospital Universitario Antonio Pedro (Niteroi, Brazil); Jim Pattison Outpatient Care and Surgery Centre (Surrey, Canada); New Cross Hospital (Wolverhampton, UK); Royal Alexandra Hospital (Edmonton, Canada); Yale-New Haven Hospital (New Haven, USA)

Well done everyone! Thank you so much for your outstanding performance!Well done everyone! Thank you so much for your outstanding performance!Well done everyone! Thank you so much for your outstanding performance!

Recruitment table continued on next page→

CHIPS Recruitment Table

Thank-you to all CHIPS collaborators for another month of recruitment excellence in June! Let’s see what we can do in July!

CHIPS Recruitment (Projected sample size of 1028)

as of June 30, 2012

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CHIPS Recruitment Table (cont’d)

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Recruitment table continued from previous page

CHIPS Recruitment Table (cont’d)