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Social licence and the general public’s attitudes toward research based on linked administrative health data: a qualitative study

Social licence and the general public’s attitudes toward research based on linked administrative... Background: Both the research literature and headline news stories indicate that the public cares about how their health data are used. The objective of this study was to learn more about the general public’s attitudes toward users and uses of linked administrative health data held by ICES in Ontario, Canada. Methods: Eight focus groups, with a total of 65 members of the general public, were conducted in urban and northern settings in Ontario, Canada, in 2015 and 2017 using qualitative market research panels established by a market research/public opinion research firm. Results: Three major themes emerged: (a) the need for assurance about privacy and security, (b) general support for research based on linked administrative health data with some conditions and (c) mixed and more negative reaction when there is private sector involvement. Two minor themes were also derived from the data: (a) low knowledge and understanding of how linked administrative health data are used for research and (b) mixed views on the need to obtain consent when health data do not include identifying information. Interpretation: The public generally supports research based on linked administrative health data, but there is no blanket approval. Researchers and organizations that hold health data should engage with members of the public to understand and address their concerns about privacy and security and to ensure that research is aligned with social licence, particularly where there is private sector involvement. round the world, specialized research centres have the public when considering expanded uses of, and access to, developed expertise related to the linkage and analy- population-wide health data holdings. sis of population-wide administrative health data. A social licence to operate is an informal agreement that is Canadian examples include ICES in Ontario, the Manitoba granted by communities and relevant stakeholders to an orga- 3 4 11 Population Data BC and the Organizations holding a social Centre for Health Policy, nization to do certain work. Canadian Institute for Health Information. These organiza- licence may not even recognize that they have one until it is In their analysis of negative public reaction to tions all work with data sets that are created by linking withdrawn. person-level data from different data sets (e.g., prescription care.data in the UK, Carter and colleagues note that “the con- drugs, hospital admissions, mortality) then removing or cod- cept of a social licence describes how the expectations of society ing identifying information so that research and analyses can regarding some activities may go beyond compliance with the be performed while protecting privacy. Recent high-profile requirements of formal regulation; those who do not fulfil the 6–8 reports and initiatives highlight the potential benefits that conditions for the social licence (even if formally compliant) This could be realized by increasing linkage of, and access to, may experience ongoing challenge and contestation.” Canadian health data from these centres and other sites. At the same time, substantial public debate has been generated about questionable practices related to health data, including Competing interests: None declared. concerns about private sector access to data under care.data This article has been peer reviewed. in the United Kingdom and concerns about privacy and 10 Correspondence to: Alison Paprica, alison.paprica@utoronto.ca As patient consent for My Health Record in Australia. stewards of health data that cover the entire population, it is CMAJ Open 2019. DOI:10.9778/cmajo.20180099 the responsibility of organizations like ICES to engage with E40 CMAJ OPEN, 7(1) © 2019 Joule Inc. or its licensors OPEN Research begs the question, What do we know about the boundaries of levels would be included. The screening process also included social licence for data-intensive health research in Canada? questions about level of trust in scientists and level of support Do members of the general public in Ontario support current for data-intensive health research to ensure that each focus and potential expanded uses of what they may reasonably con- group included participants with varying views on those topics. sider to be “their” data, and if yes, under what circumstances? As part of the recruitment process, participants were notified The objective of this qualitative research study was to gain of the purpose of the focus groups (i.e., to learn about the gen- insight into social licence and the general public’s attitudes eral public’s views on users and uses of linked administrative toward users and uses of linked administrative health data health data). Participants were also informed of the purpose of held by ICES in Ontario, Canada. each focus group, in writing, as part of the process to obtain their informed consent in writing immediately before each ses- Methods sion and verbally at the start of each focus group. At the end of each session, participants were provided with a cheque for $75 Study design as a token of appreciation for their time and participation. Focus groups were conducted using semistructured discussion Focus groups were moderated by a professional facilitator/ guides designed to prompt dialogue among participants researcher (Vanessa Chan, MA, female) who had more than (Appendix 1, available at www.cmajopen.ca/content/7/1/E40/ 5 years’ experience with Ipsos performing qualitative research suppl/DC1). Each 2-hour focus group had 3 parts: participant related to social and public affairs issues. This enabled the reaction to background information about data and ICES, research team to benefit from the experience of a highly participant views on specific scenarios and research case stud- skilled facilitator, provided an environment in which partici- ies, and time for questions with an ICES representative pants would be more likely to feel free to express negative (P.A.P.). The first set of focus groups in fall 2015 focused opinions about ICES than if a member of the ICES staff were mostly on data in general and public sector uses of health facilitating, and allowed the research team to focus on observ- data, with some discussion of private sector studies in the last ing and understanding the participant discussion. The ses- half of each session. In 2016, a decision was made to conduct sions took place in facilities designed for focus groups, with additional focus groups to learn more about the general pub- audio-recording capabilities and space for observation behind lic’s views about private sector involvement in research based a one-way mirror. The discussions followed semistructured on linked administrative data. Research case studies designed discussion guides (Appendix 1), which allowed for free- to represent ones that would interest and involve the private flowing discussion as well as facilitated discussion of written sector were developed, and a second set of focus groups con- examples, with prompts on certain questions. Members of the centrating on the private sector and linked administrative research team (P.A.P. in all focus groups, M.N.M. and M.J.S. health data was conducted in spring 2017. in some focus groups) and, sometimes, 1 or 2 additional staff from ICES observed the focus groups from behind a one-way Data collection mirror and took independent field notes (P.A.P., M.N.M.) Purposive sampling was used to select heterogeneous partici- during the sessions. Focus group participants were informed The pants with varying perspectives for each focus group. that researchers were in attendance behind the one-way mir- target group size of 8–10 people per focus group was selected ror and that sessions were audio-recorded. Audio-recordings so that groups would be large enough to include differing per- were transcribed verbatim by Ipsos. With the exception of spectives but not so large that group size inhibited some par- statements that were attributed to the facilitator, the tran- The team ticipants from contributing to the dialogue. scripts did not attribute the quotes to specific individuals. The decided to hold 2 sessions in each location in each study year purpose of the focus groups was to generate and analyze inter- and thus there was less need to to decrease the risk that a small number of vocal participants in actions between participants a single focus group would have a disproportionate or undue focus on the comments of any one individual. impact on the study findings. For practical reasons, we recruited participants for each set of 4 focus groups all at once Data analysis Preliminary analyses performed after the 2015 and 2017 data rather than recruiting participants 1 session at a time. The study team was open to the possibility of conducting additional collections were completed indicated that the reactions and focus groups if the sample size proved to be insufficient. There responses of participants were consistent across the 2 sets of was no crossover between focus groups, that is, no person par- focus groups, despite differences in the specific scenarios and ticipated in more than 1 focus group. The study made use of research case studies presented in 2015 and 2017. Accordingly, qualitative market research panels established by a market the data from 2015 and 2017 were analyzed as a whole by the research/public opinion research firm (Ipsos) according to the research team. Data were analyzed by P.A.P. and M.N.M. quality guidelines of the Marketing Research and Intelligence using a qualitative descriptive approach, which is a naturalistic Association. Potential participants from the panels were con- form of inquiry that aims to remain “data-near” while induc- tacted by telephone by Ipsos and screened using a recruitment tively interpreting and thematically grouping and detailing 15,16 P.A.P. led questionnaire to ensure that the perspectives of northern respondent experiences, beliefs and expectations. Ontario residents and urban residents would be reflected and the development of the descriptive coding framework on the that men and women of varying ages, education and income basis of the verbatim transcripts and field notes taken during CMAJ OPEN, 7(1) E41 OPEN Research the focus group sessions. The transcripts were read and reread themes; however, on the basis of the finding that themes were as coding was performed independently by P.A.P. and strong and pervasive across both the 2015 and 2017 focus M.N.M. using a combination of Microsoft Word and Micro- groups, no additional participants were recruited. soft Excel software. P.A.P. and M.N.M. used an inductive ana- Ethics approval lytic approach to derive themes and subthemes on the basis of the data, and themes and subthemes were socialized and The studies were approved by the Research Ethics Board of refined through discussion between P.A.P., M.N.M. and the Sunnybrook Research Institute in Toronto. M.J.S. M.J.S. reviewed portions of transcripts, with a focus on Results the key-coded statements that helped define the themes and subthemes. Differences in opinion between P.A.P., M.N.M. Eight focus groups were held with a total of 65 members of and M.J.M. were resolved through iterative discussions. Major themes were those that were prominent in the data from mul- the general public in 2015 and 2017 (Table 1). Four were tiple focus group sessions and multiple participants. Each held in northern Ontario (2 in Thunder Bay in 2015 and 2 in major theme had multiple subthemes. Minor themes were also Sudbury in 2017) and 4 in Toronto. Each session was 2 hours derived from the data from multiple focus groups and partici- long. The focus groups in 2015 focused mostly on data in pants, but these were less prominent and indirectly related to general, and public sector uses of health data, with some dis- the main objective of learning about the attitudes of the gen- cussion of private sector studies in the last half of each session. eral public toward research based on linked administrative The focus groups in 2017 discussed the general public’s views health data. Review and coding of transcripts stopped when about private sector involvement in research based on linked inductive thematic saturation was achieved, that is, when administrative data. P.A.P., M.N.M. and M.J.S. agreed that additional coding and Three major themes were identified: (a) the need for assur- thematic analysis would not result in any new codes or themes. ance about privacy and security, (b) general support for The research team was open to the possibility of recruiting research based on linked administrative health data with some additional participants if there were insufficient data to identify conditions and (c) mixed and more negative reaction when Table 1: Participants of focus groups Location and date, no. (%) Northern Ontario: Northern Ontario: Thunder Bay Urban: Toronto Sudbury Urban: Toronto Sept. 23, 2015 Sept. 24, 2015 Mar. 29, 2017 Mar. 30, 2017 (n = 17 across 2 focus (n = 14 across 2 focus (n = 18 across 2 focus (n = 16 across 2 focus Characteristic groups) groups) groups) groups) Male 8 (47) 5 (36) 8 (44) 8 (50) Female 9 (53) 9 (64) 10 (66) 8 (50) Age, yr 18–34 3 (18) 5 (36) 5 (28) 2 (13) 35–44 3 (18) 4 (29) 5 (28) 3 (19) 45–54 2 (12) 3 (21) 2 (11) 3 (19) ≥ 55 9 (53) 2 (14) 6 (33) 8 (50) Education High school or lower 5 (29) 1 (7) 6 (33) 2 (13) Community college 7 (41) 4 (29) 11 (61) 5 (31) University or higher 5 (29) 9 (64) 1 (6) 9 (56) Income (before taxes), $ ≤ 20 000 2 (12) 0 (0) 4 (22) 0 (0) 20 001–39 999 8 (47) 1 (7) 3 (17) 4 (25) 40 000–59 999 5 (29) 2 (14) 4 (22) 4 (25) 60 000–79 999 2 (12) 1 (7) 2 (11) 0 (0) 80 000–99 999 0 (0) 4 (29) 3 (17) 5 (31) 0 (0) 2 (14) 2 (11) 3 (19) ≥ 100 000 Unable to code 4 (29) E42 CMAJ OPEN, 7(1) OPEN Research there is private sector involvement (Box 1). As indicated in research team also identified 2 minor themes: (a) low knowl- Appendix 2 (available at www.cmajopen.ca/content/7/1/E40/ edge and understanding of research based on linked adminis- suppl/DC1), each major theme had multiple subthemes. The trative health data and (b) mixed views on the need to obtain consent when health data do not include identifying informa- tion (Box 2). No major differences were noted between the Box 1: Examples of verbatim statements illustrating major 2015 and 2017 focus groups or between the views of northern themes participants and Toronto urban participants. Major theme 1: the need for assurance about privacy and security Major theme 1: the need for assurance about • What was the last one [hacking incident], with the government. privacy and security Anybody recall that? … CRA, oh Canada Revenue [Agency], The main concerns about research based on linked administra- yeah, that’s what it was. It was a huge one, yeah. tive health data related to the security of personal data gener- Thunder Bay 2015 — Group 2 ally (e.g., the hacking of the Canada Revenue Agency). Partici- • I liked that the personal information is removed, but I have the same thought — like really? [disbelief] It’s great on paper, but pants responded positively to information about the ICES someone’s going to make a connection somewhere or process for removing or coding identifying information before something’s going to happen. Toronto 2015 — Group 1 data are made available to researchers, and about the legislated • Because it’s the digital age, now, too, and anything can be oversight provided by the Information and Privacy Commis- hacked. Look at the guy who just hacked Yahoo from here in sioner of Ontario. The process of removing names and other Ontario. Sudbury 2017 — Group 2 direct identifiers was appreciated, but many participants did • Well I think because it’s health data, it’s really important to not see it as sufficient assurance. Even when fully informed of keep it safeguarded. It’s not just some random information. It’s privacy and security safeguards, participants noted that risks personal information. Really personal information. Toronto 2015 — Group 2 unavoidably increase when there are more people and organi- • I found it encouraging that the information and privacy zations accessing data (Box 1 and Appendix 2). commissioner has an oversight over it and it renews every 3 years. I found that encouraging. Someone’s keeping an eye Major theme 2: general support for research based on it. Sudbury 2017 — Group 1 on health administrative data, with some conditions • Information can somehow slip out. Especially when there’s Generally, health data were viewed as an asset that should be more people involved. Thunder Bay 2015 — Group 2 used for research, and focus group participants supported Major theme 2: general support for research based on linked administrative health data with some conditions Box 2: Examples of verbatim statements illustrating minor • For me, I think this is a really great use of the information themes that’s already being collected. It’s sitting there, it’s waiting to be used. Sudbury 2017— Group 1 Minor theme 1: low knowledge and understanding of research based on linked administrative health data • It’s already been collected … it’s there and it can be used. So why shouldn’t they, if they can get access? It would be so • Is this actually happening today, where they’re collecting a lot helpful. Toronto 2015 — Group 2 of data? Toronto 2017 — Group 2 • If they’re collecting 25 years of data they’re going to discover • We don’t know them (ICES) so how can we trust them. We’ve that certain medications are unhealthy or not fit for people, so never heard of them until today, so we can’t possibly trust that’s — there’s a big benefit in this for sure. them. Thunder Bay 2015 — Group 1 Toronto 2017 — Group 2 • [Indicating that the participant has confused research based • [Indicating concern about potential for misuse of data] And on linked administrative health data with integration of data to then they combine all that together, and they say, okay, well, inform individual patient care] It’s like one-stop shopping. Once this person has got this and this and this. Wasting medication you get into the system, all your information is in one place, for or treatment or whatever on this person, beyond this age is your services or programs or health care, whatever that you useless. Let’s just let this person die. may need to link up to, to help you in your health. Thunder Bay 2015 — Group 1 Thunder Bay 2015 — Group 2 Major theme 3: mixed and more negative reaction when there Minor theme 2: mixed views on the need to obtain consent is private sector involvement when health data do not include identifying information • I’d rather not have a private company because I feel like • I don’t think consent is needed as much to gather data when they’re just out to make money. Sudbury 2017 — Group 2 it’s nameless and faceless. Toronto 2017 — Group 2 • People who are really good at this kind of work always tend to • So the first thing is no one really tells you when you go to the work for the private sector because the money’s better … doctor that your data will be shared, right? That’s number one. someone with a fresh idea can come in and see something We don’t know. They haven’t gotten anyone’s consent. that’s totally different. Toronto 2015 — Group 2 Toronto 2015 — Group 2 • I guess I just think maybe they [the private sector] could fund • And I think if it’s something the company’s doing because they their own research. I’m not sure the taxpayers should pay for want stats on how their drugs are being used, then I think it. But I guess, as you said, if they’re giving us an appropriate people should be consenting to it. I don’t need to make them price or a better drug being released, then I guess it’s okay. even more profitable than they are without my consent. Toronto 2017 — Group 1 Sudbury 2017 — Group 2 CMAJ OPEN, 7(1) E43 OPEN Research research based on linked administrative health data, with a study, who would have access to health data and whether some conditions. Support was strongest when people saw a there could be a potential downside or negative impact. public benefit and agreed with the purposes for which studies Repeated confusion about the nature and purpose of research were conducted (e.g., focus group participants strongly sup- based on linked population-wide data (i.e., distinct from anal- ported using administrative health data to study the long-term yses in which data are linked to inform the clinical care of an safety and efficacy of prescription drug products). In contrast, individual) suggests that the topic is hard to understand and participants expressed concerns when they thought the results that there is low awareness of research based on linked admin- of a study could be misused or disadvantage certain groups istrative health data among members of the general public in (e.g., seniors, people not adhering to their prescription drug Ontario at present. There were mixed views regarding medications) (Box 1 and Appendix 2). whether consent is required when health data sets do not con- tain identifying information. Major theme 3: mixed and more negative reaction The results of this research study are consistent with liter- 19,20,21 when there is private sector involvement and the themes identified in a recent systematic ature Some focus group participants expressed concerns about pri- review that included 25 publications from the UK, the vate sector involvement in studies based on linked administra- United States, Canada and other countries. Findings from tive health data (e.g., the concern that increased pharmaceuti- that systematic review that are reinforced by this study cal product sales and profit, not public benefit, would be the include the following: general widespread support for uses of primary motive). In contrast, others saw benefits of private data in health research with some conditions, concerns about sector involvement including more skilled people being able privacy and security, the requirement that there be a public to use the data and the potential development of new products benefit, more trust in public sector studies than in private and services. Several participants wanted some form of reci- sector studies, and varying views on the need for consent. procity when public data are used in studies funded by the pri- This study identified the new subtheme of administrative vate sector (e.g., in the form of lower drug prices [Box 1 and health data being an asset that should be used for public ben- Appendix 2]). efit, and it provides additional information about how public views are influenced by information about breaches, hacking Minor theme 1: low knowledge and understanding of and violation of trust outside of the health and research sec- research based on linked administrative health data tors. It also begins to identify the types of studies that the Most participants were not aware of studies based on linked public supports provided that appropriate controls are in administrative health data, despite regular media coverage of place (e.g., studies of the long-term safety and efficacy of a them. Several participants misunderstood the practice of link- prescription drug product). ing administrative health data sets for studies at the popula- Given the public’s concerns about uses of data generally, tion level and confused it with efforts to bring together data social licence for data-intensive health research is essential. from different health care service providers to improve care Carter and colleagues note that “poorly informed understand- for individual patients, even after the moderator provided ing of the social licence for secondary use of personal medical clarification. In some instances, participants’ lack of prior data, and a failure to recognise that legal authority might not knowledge about research based on linked administrative be enough to secure the social licence, seems to have been at There are health data led to them having concerns about transparency the heart of the controversy underlying care.data.” and trust (Box 2 and Appendix 2). indications that social licence for data-intensive health research varies by jurisdiction. For example, in Denmark, Minor theme 2: mixed views on the need to obtain where there is a long-standing history of citizen support for consent when health data do not include identifying the use of public data in research, Danish researchers information approach patients about participation in database-based trials The subset of focus group participants who expressed views directly with little to no involvement of health care provid- about consent had varying opinions. Some felt that consent ers, but in Scotland potential trial participants are generally should always be obtained even when study participants in contacted by someone within the circle of health care provid- data sets are not identifiable. Others were direct in stating ers that patients would reasonably expect to have access to Regarding informed consent, it is the authors’ their views that consent is not necessary if identifying infor- patient data. mation is removed before data are used for research (Box 2 view that informed consent can contribute to social licence, and Appendix 2). but it does not constitute the complete answer in all circum- stances because there are public benefits that can be realized Interpretation only through studies based on population-wide nonconsented data (e.g., the withdrawal of Vioxx from the market, restric- Generally, the participants in the Toronto and northern and the identifica- tions on mobile phone use while driving Ontario focus groups were supportive of research based on tion of the magnitude of the opioid epidemic all were based linked administrative health data providing that there was on studies of population-wide nonconsented data). Further, assurance about privacy and security, but they cared about consent may not be truly informed in cases where researchers details including whether there would be a public benefit from cannot describe all the potential future uses of health data. E44 CMAJ OPEN, 7(1) OPEN Research This research study, and the literature, indicate that the data, but there is no blanket approval. Researchers and orga- general public wants society to realize the benefits that can be nizations holding health data should engage with and derived from research based on linked administrative health involve members of the public to ensure that data-intensive data, but it is incumbent on the parties involved in research health research is trustworthy and within the bounds of and data sharing to be transparent and to involve and engage social licence. If researchers focus on conducting studies with members of the public in an ongoing and authentic man- that have a clear public benefit and respect and address pub- ner to ensure alignment with social licence. As illustrated by lic concerns about privacy and private sector involvement, news reports of growing concerns following Cambridge Ana- public support is likely to increase, enhancing the impact lack of trust in a lytica’s reported misuse of Facebook data, and the sustainability of research based on linked adminis- 29,30 sector or organization can spread and have consequences trative health data. for other practices that rely on data. Public involvement and transparency are essential to building and maintaining trust. References Informational transparency — publicizing information about 1. International Population Data Linkage Network Member Directory [homepage]. 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Available: https://www.theglobeandmail.com/world/ Acknowledgements: The authors thank Don Willison, who provided article-facebook-moves-to-improve-data-collection-transparency-as-zuckerberg/ helpful advice on how to structure focus groups to maximize the likelihood (accessed 2018 June 8). that participants would understand what research based on linked adminis- 29. Smee B. Facebook’s data changes will hamper research and oversight, academics warn. The Guardian [London] 2018 Apr. 25. Available: https://www.theguardian. trative health data is before being asked to comment on specific research com/technology/2018/apr/25/facebooks-data-changes-will-hamper-research-and case studies. Vanessa Chan is acknowledged for her expert facilitation skills -oversight-academics-warn (accessed 2018 June 8). and services. The authors also thank Mary Tully for her extensive contri- 30. Curry B. Ethics committee urged to look beyond Facebook with privacy butions to the research case studies presented in the 2017 focus groups and study. The Globe and Mail [Toronto] 2018 Apr. 16. Available: https://www. Fiona Miller for her advice on qualitative research methods. theglobeandmail.com/politics/article-ethics-committee-urged-to-look-beyond -facebook-with-privacy-study/ (accessed 2018 June 8). Disclaimer: This study was supported by ICES, which is funded by an 31. Aitken M, Tully M, Porteus C, et al. Consensus statement on public involve- annual grant from the Ontario Ministry of Health and Long-Term Care ment and engagement with data-intensive health research [abstract]. IJPDS (MOHLTC). The opinions, results and conclusions reported in this arti- 2018;3:246. cle are those of the authors and are independent from the funding sources. No endorsement by ICES or the Ontario MOHLTC is intented Affiliations: ICES (Paprica, Nunes de Melo, Schull), Toronto, Ont.; or should be inferred. The Marketing Research and Intelligence Associa- Institute for Health Policy, Management and Evaluation (Paprica, Schull), tion (MRIA) is a Canadian not-for-profit association representing the University of Toronto, Toronto, Ont.; Sunnybrook Health Sciences Centre market intelligence and survey research industry. The authors have no (Schull), Toronto, Ont. affiliation with the MRIA. The market research/public opinion research firm (Ipsos) that recruited participants and provided the facilities and Contributors: All authors contributed to the design and conception of facilitator for the focus groups is a member of the MRIA. the study, attended focus groups, critically reviewed drafts of the manu- script, discussed and refined the themes and subthemes, and approved the Supplemental information: For reviewer comments and the original final version submitted for publication. Magda Nunes de Melo led the lit- submission of this manuscript, please see www.cmajopen.ca/content/7/1/ erature review. Magda Nunes de Melo and Alison Paprica led the work to E40/suppl/DC1. E46 CMAJ OPEN, 7(1) http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png CMAJ Open Unpaywall

Social licence and the general public’s attitudes toward research based on linked administrative health data: a qualitative study

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2291-0026
DOI
10.9778/cmajo.20180099
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Abstract

Background: Both the research literature and headline news stories indicate that the public cares about how their health data are used. The objective of this study was to learn more about the general public’s attitudes toward users and uses of linked administrative health data held by ICES in Ontario, Canada. Methods: Eight focus groups, with a total of 65 members of the general public, were conducted in urban and northern settings in Ontario, Canada, in 2015 and 2017 using qualitative market research panels established by a market research/public opinion research firm. Results: Three major themes emerged: (a) the need for assurance about privacy and security, (b) general support for research based on linked administrative health data with some conditions and (c) mixed and more negative reaction when there is private sector involvement. Two minor themes were also derived from the data: (a) low knowledge and understanding of how linked administrative health data are used for research and (b) mixed views on the need to obtain consent when health data do not include identifying information. Interpretation: The public generally supports research based on linked administrative health data, but there is no blanket approval. Researchers and organizations that hold health data should engage with members of the public to understand and address their concerns about privacy and security and to ensure that research is aligned with social licence, particularly where there is private sector involvement. round the world, specialized research centres have the public when considering expanded uses of, and access to, developed expertise related to the linkage and analy- population-wide health data holdings. sis of population-wide administrative health data. A social licence to operate is an informal agreement that is Canadian examples include ICES in Ontario, the Manitoba granted by communities and relevant stakeholders to an orga- 3 4 11 Population Data BC and the Organizations holding a social Centre for Health Policy, nization to do certain work. Canadian Institute for Health Information. These organiza- licence may not even recognize that they have one until it is In their analysis of negative public reaction to tions all work with data sets that are created by linking withdrawn. person-level data from different data sets (e.g., prescription care.data in the UK, Carter and colleagues note that “the con- drugs, hospital admissions, mortality) then removing or cod- cept of a social licence describes how the expectations of society ing identifying information so that research and analyses can regarding some activities may go beyond compliance with the be performed while protecting privacy. Recent high-profile requirements of formal regulation; those who do not fulfil the 6–8 reports and initiatives highlight the potential benefits that conditions for the social licence (even if formally compliant) This could be realized by increasing linkage of, and access to, may experience ongoing challenge and contestation.” Canadian health data from these centres and other sites. At the same time, substantial public debate has been generated about questionable practices related to health data, including Competing interests: None declared. concerns about private sector access to data under care.data This article has been peer reviewed. in the United Kingdom and concerns about privacy and 10 Correspondence to: Alison Paprica, alison.paprica@utoronto.ca As patient consent for My Health Record in Australia. stewards of health data that cover the entire population, it is CMAJ Open 2019. DOI:10.9778/cmajo.20180099 the responsibility of organizations like ICES to engage with E40 CMAJ OPEN, 7(1) © 2019 Joule Inc. or its licensors OPEN Research begs the question, What do we know about the boundaries of levels would be included. The screening process also included social licence for data-intensive health research in Canada? questions about level of trust in scientists and level of support Do members of the general public in Ontario support current for data-intensive health research to ensure that each focus and potential expanded uses of what they may reasonably con- group included participants with varying views on those topics. sider to be “their” data, and if yes, under what circumstances? As part of the recruitment process, participants were notified The objective of this qualitative research study was to gain of the purpose of the focus groups (i.e., to learn about the gen- insight into social licence and the general public’s attitudes eral public’s views on users and uses of linked administrative toward users and uses of linked administrative health data health data). Participants were also informed of the purpose of held by ICES in Ontario, Canada. each focus group, in writing, as part of the process to obtain their informed consent in writing immediately before each ses- Methods sion and verbally at the start of each focus group. At the end of each session, participants were provided with a cheque for $75 Study design as a token of appreciation for their time and participation. Focus groups were conducted using semistructured discussion Focus groups were moderated by a professional facilitator/ guides designed to prompt dialogue among participants researcher (Vanessa Chan, MA, female) who had more than (Appendix 1, available at www.cmajopen.ca/content/7/1/E40/ 5 years’ experience with Ipsos performing qualitative research suppl/DC1). Each 2-hour focus group had 3 parts: participant related to social and public affairs issues. This enabled the reaction to background information about data and ICES, research team to benefit from the experience of a highly participant views on specific scenarios and research case stud- skilled facilitator, provided an environment in which partici- ies, and time for questions with an ICES representative pants would be more likely to feel free to express negative (P.A.P.). The first set of focus groups in fall 2015 focused opinions about ICES than if a member of the ICES staff were mostly on data in general and public sector uses of health facilitating, and allowed the research team to focus on observ- data, with some discussion of private sector studies in the last ing and understanding the participant discussion. The ses- half of each session. In 2016, a decision was made to conduct sions took place in facilities designed for focus groups, with additional focus groups to learn more about the general pub- audio-recording capabilities and space for observation behind lic’s views about private sector involvement in research based a one-way mirror. The discussions followed semistructured on linked administrative data. Research case studies designed discussion guides (Appendix 1), which allowed for free- to represent ones that would interest and involve the private flowing discussion as well as facilitated discussion of written sector were developed, and a second set of focus groups con- examples, with prompts on certain questions. Members of the centrating on the private sector and linked administrative research team (P.A.P. in all focus groups, M.N.M. and M.J.S. health data was conducted in spring 2017. in some focus groups) and, sometimes, 1 or 2 additional staff from ICES observed the focus groups from behind a one-way Data collection mirror and took independent field notes (P.A.P., M.N.M.) Purposive sampling was used to select heterogeneous partici- during the sessions. Focus group participants were informed The pants with varying perspectives for each focus group. that researchers were in attendance behind the one-way mir- target group size of 8–10 people per focus group was selected ror and that sessions were audio-recorded. Audio-recordings so that groups would be large enough to include differing per- were transcribed verbatim by Ipsos. With the exception of spectives but not so large that group size inhibited some par- statements that were attributed to the facilitator, the tran- The team ticipants from contributing to the dialogue. scripts did not attribute the quotes to specific individuals. The decided to hold 2 sessions in each location in each study year purpose of the focus groups was to generate and analyze inter- and thus there was less need to to decrease the risk that a small number of vocal participants in actions between participants a single focus group would have a disproportionate or undue focus on the comments of any one individual. impact on the study findings. For practical reasons, we recruited participants for each set of 4 focus groups all at once Data analysis Preliminary analyses performed after the 2015 and 2017 data rather than recruiting participants 1 session at a time. The study team was open to the possibility of conducting additional collections were completed indicated that the reactions and focus groups if the sample size proved to be insufficient. There responses of participants were consistent across the 2 sets of was no crossover between focus groups, that is, no person par- focus groups, despite differences in the specific scenarios and ticipated in more than 1 focus group. The study made use of research case studies presented in 2015 and 2017. Accordingly, qualitative market research panels established by a market the data from 2015 and 2017 were analyzed as a whole by the research/public opinion research firm (Ipsos) according to the research team. Data were analyzed by P.A.P. and M.N.M. quality guidelines of the Marketing Research and Intelligence using a qualitative descriptive approach, which is a naturalistic Association. Potential participants from the panels were con- form of inquiry that aims to remain “data-near” while induc- tacted by telephone by Ipsos and screened using a recruitment tively interpreting and thematically grouping and detailing 15,16 P.A.P. led questionnaire to ensure that the perspectives of northern respondent experiences, beliefs and expectations. Ontario residents and urban residents would be reflected and the development of the descriptive coding framework on the that men and women of varying ages, education and income basis of the verbatim transcripts and field notes taken during CMAJ OPEN, 7(1) E41 OPEN Research the focus group sessions. The transcripts were read and reread themes; however, on the basis of the finding that themes were as coding was performed independently by P.A.P. and strong and pervasive across both the 2015 and 2017 focus M.N.M. using a combination of Microsoft Word and Micro- groups, no additional participants were recruited. soft Excel software. P.A.P. and M.N.M. used an inductive ana- Ethics approval lytic approach to derive themes and subthemes on the basis of the data, and themes and subthemes were socialized and The studies were approved by the Research Ethics Board of refined through discussion between P.A.P., M.N.M. and the Sunnybrook Research Institute in Toronto. M.J.S. M.J.S. reviewed portions of transcripts, with a focus on Results the key-coded statements that helped define the themes and subthemes. Differences in opinion between P.A.P., M.N.M. Eight focus groups were held with a total of 65 members of and M.J.M. were resolved through iterative discussions. Major themes were those that were prominent in the data from mul- the general public in 2015 and 2017 (Table 1). Four were tiple focus group sessions and multiple participants. Each held in northern Ontario (2 in Thunder Bay in 2015 and 2 in major theme had multiple subthemes. Minor themes were also Sudbury in 2017) and 4 in Toronto. Each session was 2 hours derived from the data from multiple focus groups and partici- long. The focus groups in 2015 focused mostly on data in pants, but these were less prominent and indirectly related to general, and public sector uses of health data, with some dis- the main objective of learning about the attitudes of the gen- cussion of private sector studies in the last half of each session. eral public toward research based on linked administrative The focus groups in 2017 discussed the general public’s views health data. Review and coding of transcripts stopped when about private sector involvement in research based on linked inductive thematic saturation was achieved, that is, when administrative data. P.A.P., M.N.M. and M.J.S. agreed that additional coding and Three major themes were identified: (a) the need for assur- thematic analysis would not result in any new codes or themes. ance about privacy and security, (b) general support for The research team was open to the possibility of recruiting research based on linked administrative health data with some additional participants if there were insufficient data to identify conditions and (c) mixed and more negative reaction when Table 1: Participants of focus groups Location and date, no. (%) Northern Ontario: Northern Ontario: Thunder Bay Urban: Toronto Sudbury Urban: Toronto Sept. 23, 2015 Sept. 24, 2015 Mar. 29, 2017 Mar. 30, 2017 (n = 17 across 2 focus (n = 14 across 2 focus (n = 18 across 2 focus (n = 16 across 2 focus Characteristic groups) groups) groups) groups) Male 8 (47) 5 (36) 8 (44) 8 (50) Female 9 (53) 9 (64) 10 (66) 8 (50) Age, yr 18–34 3 (18) 5 (36) 5 (28) 2 (13) 35–44 3 (18) 4 (29) 5 (28) 3 (19) 45–54 2 (12) 3 (21) 2 (11) 3 (19) ≥ 55 9 (53) 2 (14) 6 (33) 8 (50) Education High school or lower 5 (29) 1 (7) 6 (33) 2 (13) Community college 7 (41) 4 (29) 11 (61) 5 (31) University or higher 5 (29) 9 (64) 1 (6) 9 (56) Income (before taxes), $ ≤ 20 000 2 (12) 0 (0) 4 (22) 0 (0) 20 001–39 999 8 (47) 1 (7) 3 (17) 4 (25) 40 000–59 999 5 (29) 2 (14) 4 (22) 4 (25) 60 000–79 999 2 (12) 1 (7) 2 (11) 0 (0) 80 000–99 999 0 (0) 4 (29) 3 (17) 5 (31) 0 (0) 2 (14) 2 (11) 3 (19) ≥ 100 000 Unable to code 4 (29) E42 CMAJ OPEN, 7(1) OPEN Research there is private sector involvement (Box 1). As indicated in research team also identified 2 minor themes: (a) low knowl- Appendix 2 (available at www.cmajopen.ca/content/7/1/E40/ edge and understanding of research based on linked adminis- suppl/DC1), each major theme had multiple subthemes. The trative health data and (b) mixed views on the need to obtain consent when health data do not include identifying informa- tion (Box 2). No major differences were noted between the Box 1: Examples of verbatim statements illustrating major 2015 and 2017 focus groups or between the views of northern themes participants and Toronto urban participants. Major theme 1: the need for assurance about privacy and security Major theme 1: the need for assurance about • What was the last one [hacking incident], with the government. privacy and security Anybody recall that? … CRA, oh Canada Revenue [Agency], The main concerns about research based on linked administra- yeah, that’s what it was. It was a huge one, yeah. tive health data related to the security of personal data gener- Thunder Bay 2015 — Group 2 ally (e.g., the hacking of the Canada Revenue Agency). Partici- • I liked that the personal information is removed, but I have the same thought — like really? [disbelief] It’s great on paper, but pants responded positively to information about the ICES someone’s going to make a connection somewhere or process for removing or coding identifying information before something’s going to happen. Toronto 2015 — Group 1 data are made available to researchers, and about the legislated • Because it’s the digital age, now, too, and anything can be oversight provided by the Information and Privacy Commis- hacked. Look at the guy who just hacked Yahoo from here in sioner of Ontario. The process of removing names and other Ontario. Sudbury 2017 — Group 2 direct identifiers was appreciated, but many participants did • Well I think because it’s health data, it’s really important to not see it as sufficient assurance. Even when fully informed of keep it safeguarded. It’s not just some random information. It’s privacy and security safeguards, participants noted that risks personal information. Really personal information. Toronto 2015 — Group 2 unavoidably increase when there are more people and organi- • I found it encouraging that the information and privacy zations accessing data (Box 1 and Appendix 2). commissioner has an oversight over it and it renews every 3 years. I found that encouraging. Someone’s keeping an eye Major theme 2: general support for research based on it. Sudbury 2017 — Group 1 on health administrative data, with some conditions • Information can somehow slip out. Especially when there’s Generally, health data were viewed as an asset that should be more people involved. Thunder Bay 2015 — Group 2 used for research, and focus group participants supported Major theme 2: general support for research based on linked administrative health data with some conditions Box 2: Examples of verbatim statements illustrating minor • For me, I think this is a really great use of the information themes that’s already being collected. It’s sitting there, it’s waiting to be used. Sudbury 2017— Group 1 Minor theme 1: low knowledge and understanding of research based on linked administrative health data • It’s already been collected … it’s there and it can be used. So why shouldn’t they, if they can get access? It would be so • Is this actually happening today, where they’re collecting a lot helpful. Toronto 2015 — Group 2 of data? Toronto 2017 — Group 2 • If they’re collecting 25 years of data they’re going to discover • We don’t know them (ICES) so how can we trust them. We’ve that certain medications are unhealthy or not fit for people, so never heard of them until today, so we can’t possibly trust that’s — there’s a big benefit in this for sure. them. Thunder Bay 2015 — Group 1 Toronto 2017 — Group 2 • [Indicating that the participant has confused research based • [Indicating concern about potential for misuse of data] And on linked administrative health data with integration of data to then they combine all that together, and they say, okay, well, inform individual patient care] It’s like one-stop shopping. Once this person has got this and this and this. Wasting medication you get into the system, all your information is in one place, for or treatment or whatever on this person, beyond this age is your services or programs or health care, whatever that you useless. Let’s just let this person die. may need to link up to, to help you in your health. Thunder Bay 2015 — Group 1 Thunder Bay 2015 — Group 2 Major theme 3: mixed and more negative reaction when there Minor theme 2: mixed views on the need to obtain consent is private sector involvement when health data do not include identifying information • I’d rather not have a private company because I feel like • I don’t think consent is needed as much to gather data when they’re just out to make money. Sudbury 2017 — Group 2 it’s nameless and faceless. Toronto 2017 — Group 2 • People who are really good at this kind of work always tend to • So the first thing is no one really tells you when you go to the work for the private sector because the money’s better … doctor that your data will be shared, right? That’s number one. someone with a fresh idea can come in and see something We don’t know. They haven’t gotten anyone’s consent. that’s totally different. Toronto 2015 — Group 2 Toronto 2015 — Group 2 • I guess I just think maybe they [the private sector] could fund • And I think if it’s something the company’s doing because they their own research. I’m not sure the taxpayers should pay for want stats on how their drugs are being used, then I think it. But I guess, as you said, if they’re giving us an appropriate people should be consenting to it. I don’t need to make them price or a better drug being released, then I guess it’s okay. even more profitable than they are without my consent. Toronto 2017 — Group 1 Sudbury 2017 — Group 2 CMAJ OPEN, 7(1) E43 OPEN Research research based on linked administrative health data, with a study, who would have access to health data and whether some conditions. Support was strongest when people saw a there could be a potential downside or negative impact. public benefit and agreed with the purposes for which studies Repeated confusion about the nature and purpose of research were conducted (e.g., focus group participants strongly sup- based on linked population-wide data (i.e., distinct from anal- ported using administrative health data to study the long-term yses in which data are linked to inform the clinical care of an safety and efficacy of prescription drug products). In contrast, individual) suggests that the topic is hard to understand and participants expressed concerns when they thought the results that there is low awareness of research based on linked admin- of a study could be misused or disadvantage certain groups istrative health data among members of the general public in (e.g., seniors, people not adhering to their prescription drug Ontario at present. There were mixed views regarding medications) (Box 1 and Appendix 2). whether consent is required when health data sets do not con- tain identifying information. Major theme 3: mixed and more negative reaction The results of this research study are consistent with liter- 19,20,21 when there is private sector involvement and the themes identified in a recent systematic ature Some focus group participants expressed concerns about pri- review that included 25 publications from the UK, the vate sector involvement in studies based on linked administra- United States, Canada and other countries. Findings from tive health data (e.g., the concern that increased pharmaceuti- that systematic review that are reinforced by this study cal product sales and profit, not public benefit, would be the include the following: general widespread support for uses of primary motive). In contrast, others saw benefits of private data in health research with some conditions, concerns about sector involvement including more skilled people being able privacy and security, the requirement that there be a public to use the data and the potential development of new products benefit, more trust in public sector studies than in private and services. Several participants wanted some form of reci- sector studies, and varying views on the need for consent. procity when public data are used in studies funded by the pri- This study identified the new subtheme of administrative vate sector (e.g., in the form of lower drug prices [Box 1 and health data being an asset that should be used for public ben- Appendix 2]). efit, and it provides additional information about how public views are influenced by information about breaches, hacking Minor theme 1: low knowledge and understanding of and violation of trust outside of the health and research sec- research based on linked administrative health data tors. It also begins to identify the types of studies that the Most participants were not aware of studies based on linked public supports provided that appropriate controls are in administrative health data, despite regular media coverage of place (e.g., studies of the long-term safety and efficacy of a them. Several participants misunderstood the practice of link- prescription drug product). ing administrative health data sets for studies at the popula- Given the public’s concerns about uses of data generally, tion level and confused it with efforts to bring together data social licence for data-intensive health research is essential. from different health care service providers to improve care Carter and colleagues note that “poorly informed understand- for individual patients, even after the moderator provided ing of the social licence for secondary use of personal medical clarification. In some instances, participants’ lack of prior data, and a failure to recognise that legal authority might not knowledge about research based on linked administrative be enough to secure the social licence, seems to have been at There are health data led to them having concerns about transparency the heart of the controversy underlying care.data.” and trust (Box 2 and Appendix 2). indications that social licence for data-intensive health research varies by jurisdiction. For example, in Denmark, Minor theme 2: mixed views on the need to obtain where there is a long-standing history of citizen support for consent when health data do not include identifying the use of public data in research, Danish researchers information approach patients about participation in database-based trials The subset of focus group participants who expressed views directly with little to no involvement of health care provid- about consent had varying opinions. Some felt that consent ers, but in Scotland potential trial participants are generally should always be obtained even when study participants in contacted by someone within the circle of health care provid- data sets are not identifiable. Others were direct in stating ers that patients would reasonably expect to have access to Regarding informed consent, it is the authors’ their views that consent is not necessary if identifying infor- patient data. mation is removed before data are used for research (Box 2 view that informed consent can contribute to social licence, and Appendix 2). but it does not constitute the complete answer in all circum- stances because there are public benefits that can be realized Interpretation only through studies based on population-wide nonconsented data (e.g., the withdrawal of Vioxx from the market, restric- Generally, the participants in the Toronto and northern and the identifica- tions on mobile phone use while driving Ontario focus groups were supportive of research based on tion of the magnitude of the opioid epidemic all were based linked administrative health data providing that there was on studies of population-wide nonconsented data). Further, assurance about privacy and security, but they cared about consent may not be truly informed in cases where researchers details including whether there would be a public benefit from cannot describe all the potential future uses of health data. E44 CMAJ OPEN, 7(1) OPEN Research This research study, and the literature, indicate that the data, but there is no blanket approval. Researchers and orga- general public wants society to realize the benefits that can be nizations holding health data should engage with and derived from research based on linked administrative health involve members of the public to ensure that data-intensive data, but it is incumbent on the parties involved in research health research is trustworthy and within the bounds of and data sharing to be transparent and to involve and engage social licence. If researchers focus on conducting studies with members of the public in an ongoing and authentic man- that have a clear public benefit and respect and address pub- ner to ensure alignment with social licence. As illustrated by lic concerns about privacy and private sector involvement, news reports of growing concerns following Cambridge Ana- public support is likely to increase, enhancing the impact lack of trust in a lytica’s reported misuse of Facebook data, and the sustainability of research based on linked adminis- 29,30 sector or organization can spread and have consequences trative health data. for other practices that rely on data. Public involvement and transparency are essential to building and maintaining trust. References Informational transparency — publicizing information about 1. International Population Data Linkage Network Member Directory [homepage]. 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The one-way mirror: public attitudes to commercial access to health may have affected their ability to understand and respond to data. London (UK): Ipsos MORI; 2016. the sample research case studies with which they were pre- 21. Aitken M, Cunningham-Burley S, Pagliari C. Moving from trust to trustwor- sented. Finally, there are uses of linked administrative health thiness: experiences of public engagement in the Scottish Health Informatics Programme. Sci Public Policy 2016;43:713-23. data (e.g., helping clinical trial recruitment focus on sites with 22. Aitken M, de St Jorre J, Pagliari C, et al. Public responses to the sharing and large numbers of eligible patients, artificial intelligence appli- linkage of health data for research purposes: a systematic review and thematic synthesis of qualitative studies. BMC Med Ethics 2016;17:73. cations) that were not presented to focus group participants 23. Best brains exchange — using administrative, electronic medical record and patient and warrant further study. health record data in clinical trials. Ottawa: Canadian Institutes of Health Research; 2016. Available: http://www.cihr-irsc.gc.ca/e/13931.html (accessed 2018 Oct. 16). Conclusion 24. Mamdani M, Rochon P, Juurlink DN, et al. Effect of selective cyclooxygenase This qualitative study found that members of the Ontario 2 inhibitors and naproxen on short-term risk of acute myocardial infarction in the elderly. Arch Intern Med 2003;163:481-6. public see data as an asset that should be used, and they gen- 25. Min ST, Redelmeier DA. Car phones and car crashes: an ecologic analysis. Can erally support research based on linked administrative health J Public Health 1998;89:157-61. CMAJ OPEN, 7(1) E45 OPEN Research 26. Gomes T, Juurlink DN, Dhalla IA, et al. Trends in opioid use and dosing design private sector example studies, independently coded transcripts among socio-economically disadvantaged patients. Open Med 2011;5:e13-22. and performed analyses to identify themes and subthemes. Alison Paprica 27. O’Doherty KC, Christofides E, Yen J, et al. If you build it, they will come: had the primary responsibility for the descriptive coding framework and unintended future uses of organised health data collections. BMC Med Ethics was the lead for preparation of the manuscript. All of the authors gave 2016;17:54. approval of the final version for publication and agreed to be accountable 28. McMahon T. Facebook broadens estimate of data misuse to 87 million peo- for all aspects of the work. ple, including more than 600 000 Canadians. The Globe and Mail [Toronto] updated 2018 Apr. 5. Available: https://www.theglobeandmail.com/world/ Acknowledgements: The authors thank Don Willison, who provided article-facebook-moves-to-improve-data-collection-transparency-as-zuckerberg/ helpful advice on how to structure focus groups to maximize the likelihood (accessed 2018 June 8). that participants would understand what research based on linked adminis- 29. Smee B. Facebook’s data changes will hamper research and oversight, academics warn. The Guardian [London] 2018 Apr. 25. Available: https://www.theguardian. trative health data is before being asked to comment on specific research com/technology/2018/apr/25/facebooks-data-changes-will-hamper-research-and case studies. Vanessa Chan is acknowledged for her expert facilitation skills -oversight-academics-warn (accessed 2018 June 8). and services. The authors also thank Mary Tully for her extensive contri- 30. Curry B. Ethics committee urged to look beyond Facebook with privacy butions to the research case studies presented in the 2017 focus groups and study. The Globe and Mail [Toronto] 2018 Apr. 16. Available: https://www. Fiona Miller for her advice on qualitative research methods. theglobeandmail.com/politics/article-ethics-committee-urged-to-look-beyond -facebook-with-privacy-study/ (accessed 2018 June 8). Disclaimer: This study was supported by ICES, which is funded by an 31. Aitken M, Tully M, Porteus C, et al. Consensus statement on public involve- annual grant from the Ontario Ministry of Health and Long-Term Care ment and engagement with data-intensive health research [abstract]. IJPDS (MOHLTC). The opinions, results and conclusions reported in this arti- 2018;3:246. cle are those of the authors and are independent from the funding sources. No endorsement by ICES or the Ontario MOHLTC is intented Affiliations: ICES (Paprica, Nunes de Melo, Schull), Toronto, Ont.; or should be inferred. The Marketing Research and Intelligence Associa- Institute for Health Policy, Management and Evaluation (Paprica, Schull), tion (MRIA) is a Canadian not-for-profit association representing the University of Toronto, Toronto, Ont.; Sunnybrook Health Sciences Centre market intelligence and survey research industry. The authors have no (Schull), Toronto, Ont. affiliation with the MRIA. The market research/public opinion research firm (Ipsos) that recruited participants and provided the facilities and Contributors: All authors contributed to the design and conception of facilitator for the focus groups is a member of the MRIA. the study, attended focus groups, critically reviewed drafts of the manu- script, discussed and refined the themes and subthemes, and approved the Supplemental information: For reviewer comments and the original final version submitted for publication. Magda Nunes de Melo led the lit- submission of this manuscript, please see www.cmajopen.ca/content/7/1/ erature review. Magda Nunes de Melo and Alison Paprica led the work to E40/suppl/DC1. E46 CMAJ OPEN, 7(1)

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