PRE-EMPT NEWSLETTER: ISSUE 6; SEPT., 2012 Newslett… · PAGE 2 PRE-EMPT NEWSLETTER: ISSUE 6;...

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2012 CIHR Knowledge Translation prize Congratulations to Dr Peter von Dadelszen This package is, quite simply, an overwhelmingly impressive account of work of immense quality and far-reaching impact. The work in KT is exemplary in employing sound research methods and in evaluating the impact on health outcomes of the dissemination of the KT materials. This is, quite frankly, an outstanding application.” And, “The letters of nomination…are the strongest letters I have ever read about anyone for any award! They document the incredi- ble national and international impact that Dr von Dadelszen‟s contributions have had to women‟s health around the world, and the tremendous recognition he has received and is receiving.” These were the words of two Canadian Institutes of Health Research (CIHR) reviewers who chose our very own Dr Peter von Dadelszen‟s nomination over 16 others for the prestigious 2012 CIHR Knowledge Translation (KT) Prize of $100,000. The CIHR KT Prize honours and supports the exemplary KT efforts and activities of an exceptional individual, team, or organization that has made an outstanding contribution to increasing the application of research findings, improving the health of individuals, improving health services and products, or strengthening the health-care system. Dr Matthews Mathai, Coordinator for Epidemiology, Monitoring & Evaluation, Maternal & Perinatal Health Depart- ment, WHO and PI for PRE-EMPT Objective 5: KT, nominated Peter. His nomination letter outlines Peter‟s impressive international accomplishments related both to pre-eclampsia basic science and health services research KT activities. He wrote, “How has Peter achieved this remarkable track record of KT with such a broad range of international partners? In my opinion it is his patent knowledge of his topic, his respectful and open manner that invites con- tributions from global partners, and the esteem in which he is held by those partners, that has led to his international pre-eminence in the area of global woman‟s health, and pre-eclampsia especially. You hear his name mentioned everywhere.” The Society of Obstetricians and Gynecologists of Canada (SOGC) also supported Peter‟s nomination. They recognized Peter‟s pioneering achievements in development of the PIERS predictive models, co-authorship of numerous SOGC clinical practice guidelines, and numerous published strategic KT implementation studies that utilize pre-post implementation designs to measure guideline impact at population levels. What will Peter do with the $100,000 associated with the award? Peter states, “While a personal recognition, in my mind this award recognizes the creativity, immense amount of work, and attention to detail that our group has developed and maintained over the past 12 years. My plan is to use the funds to complete the fullPIERS modelling process (external validation), so that the fullPIERS model can be used to improve maternal and perinatal health outcomes interna- tionally. Through new and existing international partnerships, we will leverage these funds to create a fully powered fullPIERS validation data set, externally validate the existing model, and, if appropriate, recalibrate the fullPIERS model.” miniPIERS has been developed and validated as the primary focus of PRE-EMPT Objective 2.The PRE-EMPT and global pre-eclampsia community extend their warmest congratulations to Peter. We have all witnessed his com- mitment, service, personal sacrifice, time away from his family, and unending devotion to the cause of alleviating the global burden of pre-eclampsia. We also extend our gratitude to the CIHR for this award in recognition of Peter‟s ex- traordinary achievements and contributions. Dr. Diane Sawchuck, RN, PhD PRE-EMPT N EWSLETTER : I SSUE 6; S EPT ., 2012 PRE-EMPT News The logo focuses on the current WHO data on maternal mortality ratios in Africa and South Asia Recent Activity The PRE-EMPT newsletter is designed for those involved in this project. We hope this publication will keep you up to date on current and upcoming activities, important project changes and accom- plishments by the team. The newsletter will be distributed bimonthly, with the next issue scheduled for the end of No- vember. We welcome submissions of project updates by any team member for inclusion in the newsletter. Please sub- WHO Working Group Meeting on Maternal Mortality & Morbidity, Montreux, Switzerland August 28-31 Global Pregnancy CoLaboratory Second Annual Meeting, Oriel College, Oxford, United Kingdom September 3-6 Members at the Annual Global Pregnancy Colaboraotry meeting, Page.3

Transcript of PRE-EMPT NEWSLETTER: ISSUE 6; SEPT., 2012 Newslett… · PAGE 2 PRE-EMPT NEWSLETTER: ISSUE 6;...

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2012 CIHR Knowledge Translation prize

Congratulations to Dr Peter von Dadelszen

“This package is, quite simply, an overwhelmingly impressive account of

work of immense quality and far-reaching impact. The work in KT is exemplary

in employing sound research methods and in evaluating the impact on health

outcomes of the dissemination of the KT materials. This is, quite frankly, an

outstanding application.” And, “The letters of nomination…are the strongest

letters I have ever read about anyone for any award! They document the incredi-

ble national and international impact that Dr von Dadelszen‟s contributions

have had to women‟s health around the world, and the tremendous recognition

he has received and is receiving.”

These were the words of two Canadian Institutes of Health Research (CIHR)

reviewers who chose our very own Dr Peter von Dadelszen‟s nomination over

16 others for the prestigious 2012 CIHR Knowledge Translation (KT) Prize of

$100,000. The CIHR KT Prize honours and supports the exemplary KT efforts

and activities of an exceptional individual, team, or organization that has made

an outstanding contribution to increasing the application of research findings,

improving the health of individuals, improving health services and products, or

strengthening the health-care system. Dr Matthews Mathai, Coordinator for

Epidemiology, Monitoring & Evaluation, Maternal & Perinatal Health Depart-

ment, WHO and PI for PRE-EMPT Objective 5: KT, nominated Peter. His

nomination letter outlines Peter‟s impressive international accomplishments

related both to pre-eclampsia basic science and health services research KT

activities. He wrote, “How has Peter achieved this remarkable track record of

KT with such a broad range of international partners? In my opinion it is his

patent knowledge of his topic, his respectful and open manner that invites con-

tributions from global partners, and the esteem in which he is held by those

partners, that has led to his international pre-eminence in the area of global

woman‟s health, and pre-eclampsia especially. You hear his name mentioned

everywhere.” The Society of Obstetricians and Gynecologists of Canada

(SOGC) also supported Peter‟s nomination. They recognized Peter‟s pioneering

achievements in development of the PIERS predictive models, co-authorship of

numerous SOGC clinical practice guidelines, and numerous published strategic

KT implementation studies that utilize pre-post implementation designs to

measure guideline impact at population levels.

What will Peter do with the $100,000 associated with the award? Peter states,

“While a personal recognition, in my mind this award recognizes the creativity,

immense amount of work, and attention to detail that our group has developed

and maintained over the past 12 years. My plan is to use the funds to complete

the fullPIERS modelling process (external validation), so that the fullPIERS

model can be used to improve maternal and perinatal health outcomes interna-

tionally. Through new and existing international partnerships, we will leverage

these funds to create a fully powered fullPIERS validation data set, externally

validate the existing model, and, if appropriate, recalibrate the fullPIERS

model.” miniPIERS has been developed and validated as the primary focus of

PRE-EMPT Objective 2.The PRE-EMPT and global pre-eclampsia community

extend their warmest congratulations to Peter. We have all witnessed his com-

mitment, service, personal sacrifice, time away from his family, and unending

devotion to the cause of alleviating the global burden of pre-eclampsia. We also

extend our gratitude to the CIHR for this award in recognition of Peter‟s ex-

traordinary achievements and contributions.

Dr. Diane Sawchuck, RN, PhD

PRE-EMPT NEWSLETTER : ISSUE 6 ; SEPT . , 2012

PRE-EMPT News

The logo focuses on the current WHO data on maternal mortality ratios in Africa and

South Asia

Recent Activity

The PRE-EMPT newsletter is designed

for those involved in this project. We

hope this publication will keep you up to

date on current and upcoming activities,

important project changes and accom-

plishments by the team. The newsletter

will be distributed bimonthly, with the

next issue scheduled for the end of No-

vember. We welcome submissions of

project updates by any team member for

inclusion in the newsletter. Please sub-

WHO Working Group

Meeting on Maternal

Mortality & Morbidity,

Montreux, Switzerland

August 28-31

Global Pregnancy

CoLaboratory Second

Annual Meeting, Oriel

College, Oxford, United

Kingdom

September

3-6

Members at the Annual Global Pregnancy

Colaboraotry meeting, Page.3

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P R E - E M P T N E W S L E T T E R : I S S U E 6 ; S E P T . , 2 0 1 2 P A G E 2

drafted and is being reviewed by all co-authors.

Next up for the Monitoring group in PRE-EMPT will be to

work on secondary analysis of the PIERS data including assess-

ment of risk factors for perinatal outcomes, development of the

genPIERS model, and more in-depth assessment of site specific

data.

If any collaborator has an idea they think can be tested using the

PIERS data, please submit it to Beth at [email protected] . The

intent is to make the PIERS data as accessible as possible, but

all applications for use of the data must first be approved by the

Working Group.

How high risk are our participants?

We have looked at the previous pregnancy history of the first

186 women recruited (thanks to Tina Purnat for producing the

data). Of the women recruited, 59% had early onset pre-

eclampsia (< 30 weeks) in their previous pregnancy, 16% had

ecalmpsia, 60% had very preterm birth <34 weeks, and 49% had

stillbirths. This indicates that they are a very high risk group of

women. Of the first 7 pregnancies to end, there have been 3

miscarriages, 2 women with pre-eclampsia, and 2 women with

neither complication. While these numbers are too small to

draw any conclusions, they are consistent with our expectation

that we are selecting a high risk group of women, and that the

rate of pre-eclampsia in the placebo group may well be greater

than the 25% used for our sample size calculation.

Publications: Apart from publication of our protocol, we are

working on two further reports: a systematic review of low-

dose calcium supplementation in pregnancy; and a sub-study of

the effect of low-dose calcium supplementation on non-pregnant

women with previous pre-eclampsia.

(Pictures on Page 4)

The miniPIERS model development and validation study is

now complete. The final miniPIERS model included: gesta-

tional age on admission; chest pain/ dyspnoea; headache/

visual disturbances; vaginal bleeding with abdominal pain;

right upper quadrant pain; systolic blood pressure; and dip-

stick proteinuria. This model was well-calibrated and had

reasonable discrimination ability with an area under the curve

of the receiver operating characteristic of 0.760 (95% CI

0.715 – 0.804). A cut-off of predicted probability ≥25% to

define a positive test in the development cohort resulted in a

positive likelihood ratio of 7.04 (95% CI 5.10 – 9.72) and

classified women with 82.8% accuracy; results from the vali-

dation cohorts were similar. The final publication has been

In this randomized trial, women with previous pre-eclampsia

and planning another pregnancy receive calcium 500mg daily

versus placebo from before pregnancy until 20 weeks.

Recruitment: At the end of August, we achieved our second

milestone, recruitment of 180 women. More importantly,

recruitment shows a steady upward trend. Recruitment on 20

September was 193. Strategies to further improve recruit-

ment include:

Production of „Calcium trial research collaboration‟

coffee mugs to acknowledge the contribution of antenatal

clinics who assist with recruitment.

Additional research sites at Stellenbosch University,

South Africa, and 3 clinics in Argentina.

We plan to widen the inclusion criteria to include

women with previous pre-eclampsia and current non-

proteinuric hypertension. These women are at particularly

high risk, and stand to benefit from calcium supplementation

(if indeed calcium supplementation is effective) in terms of

recurrence of pre-eclampsia in the next pregnancy. Pre-

eclampsia will be diagnosed by development of new protein-

uria in the next pregnancy.

Data entry in Open Clinic is going well with 94% of

CRF‟s entered at the last count.

miniPIERS Development & Validation (PI: Peter von Dadelszen)

CAP (Calcium And Pre-eclampsia) Trial (PI:Justus Hofmeyr)

CLIP Feasibility and Trial (PI: Peter von Dadelszen)

CLIP will test the impact of a community-level package of

care to reduce adverse maternal and perinatal outcomes re-

lated to pre-eclampsia. CLIP is currently in the feasibility and

cRCT planning phase.

The CLIP Steering Committee has convened for two recent

teleconferences: August 8th and September 26th 2012. These

discussions focused on pre-eclampsia screening and triggers

for the CLIP trial.

The development of CLIP Trial pictograms is ongoing. The

images have been built on the feedback received from the CLIP

sites and Steering Committee. The CLIP Nigeria research team

has undertaken a thorough beta test with 41 women of reproduc-

tive age. Planning for beta testing in the other CLIP sites is

underway.

India has received ethics approval from the Indian Council of

Medical Research and is preparing for upcoming stakeholder

meetings to be held in Belgaum in October.

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P R E - E C L A M P S I A - E C L A M P S I A M ON I T ORI N G , P RE V E N T I ON & T RE A T M E N T P A G E 3

Annual Global Pregnancy CoLaboratory meeting, Oxford, September 3-6

The Global Pregnancy CoLaboratory continues to move forward with new projects including two large projects currently in process by

the entire group. The major event since our last report was the annual conference held at Oriel College in Oxford. Twenty members of

the steering committee attended as well as the several guests invited to present and

participate in the meeting.

The conference began with presentations from three new centers acquired since the

2011 Oxford meeting. The new members are: Stefan Hansson from Lund, Sweden;

Melissa Wilson from University of Southern California; and Yang-ling Wang from

Beijing, China. We also welcomed guests and heard presentations from the Maternal

Fetal Medicine Units network of the NICHD, Prebic, and GoNET.

Dr. Hannele Laivuori presented a brief overview of genetics in 2012 especially in

relation to preeclampsia research. She focused on how standard genetic approach,

which tends to loosen admission criteria to increase the number of subjects and im-

prove power, was absolutely counter to the principles of preeclampsia research. It

was her recommendation (and supported by discussion) that future studies of pree-

clampsia should address more homogeneous groups, such as early-onset preeclamp-

sia.

Donna Russell provided a presentation from the LINK database with a summary of information currently entered by the CoLab partici-

pants; 8 of 20 centers have entered their data. We have more than 5000 women who have biological samples drawn in early pregnancy

and who subsequently developed preeclampsia. Donna was available to work individually with the CoLab members to enter data into the

LINK database. We eagerly await the entry of the remaining data to demonstrate what a remarkable resource the CoLab provides.

Dr. Stephen Munjanja presented his views on how CoLab could help developing countries and developing countries could assist CoLab,

which has the potential to increase infrastructure in developing countries and to direct research to the areas where the need is greatest.

Les Myatt and Jim Roberts had been working on a manuscript addressing harmonization of preeclampsia research. Following a robust

discussion, members elected to form a working group that will collaborate with Dr. Myatt on harmonizing preeclampsia research. Annet-

ine Staff and her angiogenic factor data meta-analysis group reviewed progress and reported that they have data from over 14,000

women while emphasizing on the lessons learnt. Chris Redman emphasized that progress can be quite hindered if one makes a study too

complex. Finally, they established a data dictionary, which will serve as a guide towards formation of the core variable data dictionary

we are attempting to form for the CoLab.

In the discussion to attempt to identify subtypes of preeclampsia Dr. Redman emphasized the likelihood that there will be different types

of preeclampsia in developed and developing countries and Dr. Roberts stressed that there are also likely different subtypes within each

of these settings. The relevance of the subtypes is enormous. Identification of such subtypes could allow specific prediction and preven-

tion of preeclampsia subtypes. In developing countries this would be useful to risk stratify patients. A valuable resource for the studies is

a database established by the Intergrowth 21st Study of the BMFG. Dr. José Villar provided an overview, which will provide excellent

standardized data from 55,000 pregnancies from developed and developing countries. Dr. Redman reviewed the uses of this data that had

been suggested by the working group. He also presented preliminary data from Dr. Villar demonstrating that information from the data-

base was consistent with the established information about preeclampsia supporting our comfort with using this data.

In discussion about the sustainability, Dr. Per Magnus, principal investigator of MoBA, one of the largest cohorts in the CoLab, pre-

sented strategies that have been useful in maintaining this very large cohort. There was discussion of an RFA that will be announced in

the near future to study preterm birth (including preeclampsia). We concluded after extensive discussion that this RFA could, from a

scientific perspective, provide the CoLab with the opportunity to a “fill in the blanks” that were not available within the Intergrowth data

including the acquisition of biological materials. The suggested strategy was to apply for the pilot study portion of the RFA and in the 2

years of funding provided to work with investigators in the developing country to gather data to enable us to generate an algorithm for

stratifying risk or perhaps even identifying a preeclampsia subtype that might be amenable to intervention. In the next cycle we would

apply for the larger grant to do an intervention related to stratification or to prevention of preeclampsia in the selected subgroup.

One important outcome of the meeting was the decision to form working groups to address several issues which would take the direction

provided by the overall steering committee and work on specific issues and would include the current working groups in place including

those involved in the angiogenic factor study and the preeclampsia subtype study, and others but would also identify “timely topics”.

These groups would be assigned the task of facilitating research in the area that seems especially important and timely to the field, and

for which CoLab provides unique resources. The expertise in these groups would not be limited to the CoLab members but would consist

of experts recruited from around the world to work on these topics. Each working group would be assigned a specific project that would

need to be accomplished over the next 12 months. This might be the preparation of a research project but could also be a “white paper”

on appropriate approaches and targets for research. The two “timely topics” working groups for 2012 - 2013 will address the genetics of

preeclampsia and the placenta in preeclampsia. The formal sessions of the group were complemented by informal interactions greatly

facilitated by the lovely setting of Oriel College. The meeting was productive and successful, providing a vision for the near future and

we hope a viable plan for sustainability.

Members at the Global Pregnancy Colaboratory

meeting at Oxford

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UBC Department of Obstetrics & Gynaecology 2H30-4500

Oak Street, Vancouver, BC

Phone: 604-875-3054

Fax: 604-875-3212

PRE-EMPT Co-ordinating Centre

The Pre-eclampsia Foundation‟s Care Provider Page on their website ( http://www.preeclampsia.org/care-providers ) was set up over the past 12

months so as to make available and increase the visibility range of the WHO guidelines and other national guidelines. An analysis indicated that

visitors spent an average of 2:08 on the page (note the industry standard that, on average, most website visitors spend :30 on a webpage)!

In addition, Dr. You‟s Pre-ecamF-funded research on low literacy tool was published in May 2012. (You WB, Wolf MS, Bailey SC, et al. Improv-

ing patient understanding of preeclampsia: a randomized controlled trial. Am J Obstet Gynecol 2012;206:431.e1-5.)The Pre-eclampsia Foundation

also issued news about the 2012 Vision Grant winners and it can be found on their website.

Knowledge Translation (PI: Matthews Mathai)

XX FIGO World

Congress, Rome, Italy

October

7– 12,

2012

Karnataka State OB-

GYN Association

Meeting (KSOGA) &

UBC - JNMC

CLIP Planning Meeting,

Belgaum, India

October

17-22,

2012

PRE-EMPT Second

Annual Meeting, Van-

couver, Canada

November

5-8,

2012

Global Maternal Health

Conference, Arusha

International Conference

Center, Tanzania

January 15-

17, 2013

Upcoming

Activities

More updates in pictures

CAP Study: The collaboration coffee

mugs for clinics who assist with

recruitment (P.2)

CAP study: Research midwife Catherine

Parker with the first participant at

the Chris Hani Baragwanath site to

reach 32 weeks’ (P.2)

The second annual PRE-EMPT Meeting will be taking

place at the Fairmont Waterfront in Vancouver B.C.

from November 5-8th, 2012. The meeting will focus on

CLIP Feasibility Study and Trial. The first copy of the

draft agenda will be circulated shortly along with the

requests for chairs and presentations. The PRE-EMPT

Team in Vancouver is greatly looking forward to

welcoming all our esteemed guests and for engaging in

dialogue that helps us achieve our goals to improve

maternal health. If you have any questions or concerns,

please email [email protected] .

http://pre-empt.cfri.ca/

Annual PRE-EMPT Meeting, November 5-8, 2012

Fairmont Waterfront Vancouver. Photo credit:

http://www.fairmont.com/

Below: The Pre-eclampsia Founda-

tion’s Care Provider website page