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Multi-centre Studies in the Context of the Metropolis
Project: PACBIRTH & NORMAP-ERS
Anita J. Gagnon, N, MPH, PhDAssistant Professor, McGill University
Nurse Scientist, MUHC- Royal Victoria HospitalMember, 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 issuescrossing 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 / communitiesserious or could have serious sequelaecan 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 interestIndividual / legislation / other
What makes a research study ‘policy relevant’?…the data
3. Data:Reliable and valid high qualityPermits 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
sitesDifficult 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 statusreduced social supporthistories 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 pregnancyeffects 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-centreUltimate 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 -IIGeneral 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 post- birth 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 multi-centre studies
1. Variation in organizational structures of the various Centres
2. Time (is there any?)3. Funding4. Optimizing good science5. 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 involvementto discuss / develop before fundingto 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 problemswell-written protocol / proceduresdata collection of essential items onlypretest of forms / procedurescommitment of investigators to follow protocol training - test records/cases/videossite visitsdefinition of quality control re: datadocumentation of changes
Multi-centre challenges:4. optimizing good science
(cont’d)
Quality assurance: detection of problemscentral monitoringsite visits record auditingperformance-monitoring reportsstatistical investigations review of data from quality checkschecks on data analysis
Multi-centre challenges:4. optimizing good science
(cont’d)
Quality assurance: actionscorrection of errors retraining staffadditional auditing report on protocol violations in publications
Multi-centre challenges:5. ethics
Local regulations differprovince / metro area / site
Informed consenttime required to go through various IRBIRB requirements will differ by site
Anonymity of data
Conclusion
Multi- vs single-centre studies should be driven by:ScienceFeasibilityResources
If a multi-centre study will be done:CLOSE SURVEILLANCE
Ah, if we were only an arm stretch away… wouldn’t
multi-centre studies be easy!
…but then they wouldn’t be multi-centre!!