Multi-centre Studies in the Context of the Metropolis Project: PACBIRTH & NORMAP-ERS Anita J. Gagnon, N, MPH, PhD Assistant Professor, McGill University.

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!!