Multi-centre Studies in the Context of the Metropolis Project: PACBIRTH

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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 dorientation -
• Immigration Métropoles (Montréal)

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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)

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Part I - Metropolis projects multi-centre
studies generally
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What is a Metropolis project?

• A Metropolis project one in which researchers
  or partners were identified through Metropolis

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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)

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What makes a research study policy relevant?

• 1. Research question is relevant
• 2. Sample is representative
• 3. Data are of high quality
• ? Good science

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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)

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What makes a research study policy
relevant?the sample

• 2. Sample
• Representative of the population of interest
• Individual / legislation / other

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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)

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Does policy relevant suggest that a
multi-centre study is required?

• No

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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

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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

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Part II - Metropolis projects multi-centre
studies of refugee women
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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

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My interest reproductive health of refugee
women Background - II

• Policy relevant population (contd)?
• 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)

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My interest reproductive health of refugee
women Background - III

• Policy relevant population (contd)?
• Yes

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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

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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

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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

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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

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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 _at_ cost 60,000)

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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

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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?

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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)?

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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)

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A multi-centre Metropolis study in the national
comparative phase NORMAP-ERS - IV

• Measurement (contd)
• 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

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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)

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Challenges in conducting multi-centre studies

• 1. Variation in organizational structures of the
  various Centres
• 2. Time (is there any?)
• 3. Funding
• 4. Optimizing good science
• 5. Ethical considerations

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Multi-centre challenges1. 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

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Multi-centre challenges2. 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!

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Multi-centre challenges3. 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

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Multi-centre challenges4. optimizing good
science - Ifrom Knatterud et al Guidelines
for quality assurance in multi-center trials A
position paper in Controlled Clinical Trials
19477-493 (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

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Multi-centre challenges4. optimizing good
science (contd)

• 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

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Multi-centre challenges4. optimizing good
science (contd)

• Quality assurance actions
• correction of errors
• retraining staff
• additional auditing
• report on protocol violations in publications

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Multi-centre challenges5. 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

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Conclusion

• Multi- vs single-centre studies should be driven
  by
• Science
• Feasibility
• Resources
• If a multi-centre study will be done
• CLOSE SURVEILLANCE

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Ah, if we were only an arm stretch away wouldnt
multi-centre studies be easy!

• but then they wouldnt be multi-centre!!