1. 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)

2. 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)

3. Part I - Metropolis projects & multi-centre studies generally

4. What is a Metropolis project? A Metropolis project = one in which researchers or partners were identified through Metropolis

5. 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)

6. What makes a research study policy relevant? 1. Research question is relevant 2. Sample is representative 3. Data are of high quality Good science

7. 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)

8. What makes a research study policy relevant?…the sample 2. Sample: Representative of the population of interest Individual / legislation / other

9. 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)

10. Does policy relevant suggest that a multi-centre study is required? No

11. 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

12. 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

13. Part II - Metropolis projects & multi-centre studies of refugee women

14. 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

15. 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)

16. My interest = reproductive health of refugee women: Background - III Policy relevant population (contd)? Yes

17. 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

18. 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

19. 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

20. 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

21. 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)

22. 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

23. 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?

24. 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)?

25. 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)

26. 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

27. 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)

28. 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

29. 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

30. 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!

31. 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

32. 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

33. Multi-centre challenges: 4. 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

34. Multi-centre challenges: 4. optimizing good science (contd) Quality assurance: actions correction of errors retraining staff additional auditing report on protocol violations in publications

35. 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

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

37. Ah, if we were only an arm stretch away… wouldnt multi- centre studies be easy! …but then they wouldnt be multi-centre!!