Multi-centre Studies in the
Context of the Metropolis Project:
PACBIRTH & NORMAP-ERS
Anita J. Gagnon, N, MPH, PhD
Assistant Professor, McGill University
Nurse Scientist, MUHC- Royal Victoria Hospital
Member, Conseil d’orientation Immigration & Métropoles (Montréal)
Acknowledgements
 Dr.
Jacqueline Oxman-Martinez
drawing me into the Health Sector of
Immigration and Metropolis (of which she is
the coordinator) & providing me the
opportunity to present to you today
 Dr.
Marie McAndrew
encouraging me to be part of the
administrative structure of the Metropolis
Centre of Excellence in Montreal (IM)
Part I - Metropolis projects &
multi-centre studies generally
What is a Metropolis project?
A
“Metropolis” project = one in which
researchers or partners were
identified through Metropolis
Why a Metropolis project?
 Similar
interests: researchers & partners
 Forum for discussion:
immigration issues
crossing disciplinary & academic boundaries
 Challenged
to be policy relevant (often
difficult for health researchers who may
simultaneously have clinical interests)
What makes a research study
‘policy relevant’?
1. Research question is relevant
2. Sample is representative
3. Data are of high quality
 Good science
What makes a research study
‘policy relevant’?… the question
1. Research question is based on public
health relevance:
Factor of interest (or its effect):
is experienced by many individuals / communities
serious or could have serious sequelae
can be influenced by changes in policy
Answer to the research question:
will provide new knowledge (i.e., expands on what
is already known)
What makes a research study
‘policy relevant’?…the sample
2. Sample:
Representative of the population of interest
Individual / legislation / other
What makes a research study
‘policy relevant’?…the data
3. Data:
Reliable and valid  high quality
Permits comparisons across different groups /
sites / cities / provinces / countries - (e.g., use
or creation of provincial / national databases)
Can be gathered (feasible) - (e.g, ethical,
other considerations)
Does ‘policy relevant’ suggest that a
multi-centre study is required?
No
Why a Multi-centre project?
(i.e., Why would anyone do this to themselves voluntarily?)
 Data
are not currently available to
inform policy on the issue
 Research question is relevant to
several centres
 Key  only a multi-centre study will
enable the research question to be
answered
Why NOT a Multi-centre project?
 Difficult
to organize
 Data must be comparable across sites
Difficult to accomplish in the context of
immigration research due to cultural &
linguistic translation issues
 Expensive
Part II - Metropolis projects &
multi-centre studies of refugee women
My interest = reproductive health of
refugee women: Background - I
 Policy
relevant population?
Refugees: at higher risk for several
known determinants of health:
poor nutritional status
reduced social support
histories of abuse
Refugees: identified by Health Canada
as a priority sub-population of
immigrants to be studied
My interest = reproductive health of
refugee women: Background - II
 Policy
relevant population (cont’d)?
Small studies and anecdotal reports:
health problems identified in refugees
during pregnancy
effects of lack of social support particularly
acute in refugees during pregnancy,
childbirth, and postpartum
Development from 0 to 6 months of life
key to future health outcomes for all
infants (see - Health Forum)
My interest = reproductive health of
refugee women: Background - III
 Policy
relevant population (cont’d)?
Yes
My interest = reproductive health of
refugee women: Background - IV
 Are
multi-centre studies required?
Yes
Extent of occurrence of health events in
refugee women during pregancy and
birth and their infants in Canada & what
is done about them- not yet reported & no
national databases to provide the answer
Multi-centre studies to address reproductive
health issues of refugee women
 PACBIRTH:
Pregnancy And Child Bearing In
Refugees: Transitional Health
 NORMAP-ERS:
Needs Of Refugee Mothers After
Pregnancy - Early Response Services
A multi-centre Metropolis study in
the feasibility phase: PACBIRTH - I
 Pregnancy
And Child Bearing In Refugees:
Transitional Health (PACBIRTH) - AJ
Gagnon & coll  phases  multi-centre
Ultimate objective:
examine health determinants/events of refugee
women in Canada and their infants during
pregnancy, at birth, and during the post-birth
e.g., maternal age; parity; maternal nutrition; infectious
diseases; hx torture; hx abuse & SGBV; FGM (female genital
mutilation); migration history; social isolation
A multi-centre Metropolis study in
the feasibility phase : PACBIRTH -II
General objective of this feasibility study:
To obtain information necessary for the
development of a larger research project
Specific objectives:
(1) ensure instruments are accurately translated
and reflect concepts relevant to refugee women's
health
(2) determine the acceptability of administering
the proposed battery of questionnaires to refugee,
non-refugee immigrant, and Canadian-born women
A multi-centre Metropolis study in
the feasibility phase: PACBIRTH -III
 Design:
Prospective cohort study
 Instruments
and measurement:
6 questionnaires will be translated into
the 10 most common languages of female
refugees to Canada
known translation principles will be
applied to ensure cultural equivalence
(= 16 separate steps @ cost = $60,000)
A multi-centre Metropolis study in
the feasibility phase: PACBIRTH -IV
 Sampling
procedures/participants:
100 refugee, 25 non-refugee immigrant, 25
Canadian-born women will be recruited on
hospital postpartum units in Montreal
Questionnaires will be administered in
hospital and at two weeks and 4 months postbirth data management centre via
dedicated fax and computer
A multi-centre Metropolis study in the national
comparative phase: NORMAP-ERS - I
 Needs
Of Refugee Mothers After
Pregnancy - Early Response Services
(NORMAP-ERS) - AJ Gagnon & coll
Primary Research Question:
Are postpartum concerns with refugee
mothers or their infants addressed by
hospital / community services?
A multi-centre Metropolis study in the national
comparative phase: NORMAP-ERS - II
Secondary Research Question:
Does the percentage of women with
addressed concerns differ by migration
history (refugee versus non-refugee) or
province of residence (Ontario, Quebec,
British Columbia)?
A multi-centre Metropolis study in the national
comparative phase: NORMAP-ERS - III
 Design:
Cross-sectional
 Instruments
and measurement:
Registered nurses will make home visits
at 1 week post-birth to assess families for
health and psychosocial concerns &
determine care received/planned at that
time (via maternal report)
A multi-centre Metropolis study in the national
comparative phase: NORMAP-ERS - IV
 Measurement
(cont’d):
Information on the nurses' records and the
maternal diaries of care which could suggest
group status will be removed
These records will be categorized by an
independent nurse expert (blinded to the
research questions), as an 'unaddressed' or
'addressed' concern
In cases where categorization is difficult for this
expert alone, the decision will be made by an
expert panel
A multi-centre Metropolis study in the national
comparative phase: NORMAP-ERS - V
 Sampling
procedures and
participants:
300 refugee and 300 non-refugee women
on the postpartum units of participating
hospitals/ birthing centres in Toronto,
Montreal, and Vancouver (200 in each
city)
Challenges in conducting multicentre studies
1. Variation in organizational
structures of the various Centres
2. Time (is there any?)
3. Funding
4. Optimizing good science
5. Ethical considerations
Multi-centre challenges:
1. Centre structures vary
 existence
/ number of researchers in the
health section differs by centre
 too few members or too busy
 some interested researchers are not part
of existing centres
Multi-centre challenges:
2. time
 Investigator
/ partner involvement
to discuss / develop before funding
to maximize the participation of the greatest
number of people versus representation from
the various sites at meetings
 To
write (and re-write!) the proposals
 To think!
Multi-centre challenges:
3. funding
 Metropolis
‘seed money’:
small for cross-Canada studies
 External
agencies:
Correct committee/ reviewer?
Do their priorities match ours?
Criteria for review?
clear understanding of translation requirements?
views of investigator travel & costs
Multi-centre challenges:
4. optimizing good science - I
[from : Knatterud et al “Guidelines for quality assurance in multi-center trials: A position paper” in
Controlled Clinical Trials 19:477-493 (1998)]

Quality assurance: prevention of problems
well-written protocol / procedures
data collection of essential items only
pretest of forms / procedures
commitment of investigators to follow protocol
training - test records/cases/videos
site visits
definition of quality control re: data
documentation of changes
Multi-centre challenges:
4. optimizing good science (cont’d)

Quality assurance: detection of problems
central monitoring
site visits
record auditing
performance-monitoring reports
statistical investigations
review of data from quality checks
checks on data analysis
Multi-centre challenges:
4. optimizing good science (cont’d)

Quality assurance: actions
correction of errors
retraining staff
additional auditing
report on protocol violations in publications
Multi-centre challenges:
5. ethics
 Local
regulations differ
province / metro area / site
 Informed
consent
time required to go through various IRB
IRB requirements will differ by site
 Anonymity
of data
Conclusion
 Multi-
vs single-centre studies should
be driven by:
Science
Feasibility
Resources
 If
a multi-centre study will be done:
CLOSE SURVEILLANCE
Ah, if we were only an arm
stretch away… wouldn’t multicentre studies be easy!
…but then they wouldn’t be multi-centre!!