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

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 d’orientation - 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 (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)

16. My interest = reproductive health of refugee women: Background - III • Policy relevant population (cont’d)? 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 (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

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 (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

34. 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

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… wouldn’t multi-centre studies be easy! …but then they wouldn’t be multi-centre!!