Building public trust and confidence in secondary use of health data for healthcare improvement and research: a qualitative study pre-protocol

Tina Bedenik; Caitriona Cahir; K. Bennett

doi:10.12688/hrbopenres.13711.2

Home Browse Building public trust and confidence in secondary use of health data...

ALL Metrics

Views

Downloads

Get PDF

Get XML

Export

▬

✚

Study Protocol

Revised

Building public trust and confidence in secondary use of health data for healthcare improvement and research: a qualitative study pre-protocol

[version 2; peer review: 2 approved]

Tina Bedenik ^1,2, Caitriona Cahir¹, K. Bennett^1,2

PUBLISHED 17 Jun 2024

Author details Author details

¹ School of Population Health, RCSI University of Medicine and Health Sciences, Dublin, D02 DH60, Ireland
² Science Foundation Ireland (SFI) FutureNeuro Research Centre, Dublin, D02 YN77, Ireland

Tina Bedenik
Roles: Conceptualization, Investigation, Methodology, Project Administration, Writing – Original Draft Preparation, Writing – Review & Editing

Caitriona Cahir
Roles: Methodology, Writing – Review & Editing

K. Bennett
Roles: Conceptualization, Funding Acquisition, Methodology, Project Administration, Writing – Review & Editing

OPEN PEER REVIEW

REVIEWER STATUS

This article is included in the Public and Patient Involvement collection.

Abstract

Background

Secondary use of health data provides opportunities to drive improvements in healthcare provision, personalised medicine, comparative effectiveness research, health services innovation, and policy and practice. However, secondary data use requires compliance with relevant legislation, implementation of technical safeguards, ethical data management, and respect for data sharers. Existing evidence suggests widespread support for secondary use of health data among the public, which co-exists with concerns about privacy, confidentiality and misuse of data. Balancing the protection of individuals’ rights against the use of their health data for societal benefits is of vital importance, and trust underpins this process. The study protocol explores how to build public trust and confidence in the secondary use of health data through all key stakeholder groups in Ireland, towards developing a culture that promotes a safe and trustworthy use of data.

Methods

This study will adopt a qualitative cross-sectional approach conducted in accordance with the Consolidated Criteria for Reporting Qualitative Research COREQ guidelines. Participants in the study will include academics and researchers; healthcare professionals, data protection, ethics and privacy experts and data controllers; pharmaceutical industry and patients and public. Purposive and convenience sampling techniques will be utilised to recruit the participants, and data will be collected utilizing focus groups that may be supplemented with semi-structured interviews. Data will be coded by themes using reflexive thematic analysis (TA) and collective intelligence (CI) will be convened post-analysis to explore the preliminary findings with the participants.

Ethics and Dissemination

Ethical approval was obtained from the Royal College of Surgeons in Ireland Research Ethics Committee (REC202208013). Final data analysis and dissemination is expected by Q1 2024. Findings will be disseminated through peer-reviewed journal publications, presentations at relevant conferences, and other academic, public and policy channels. Lay summaries will be designed for Public and Patient Involvement (PPI) contributors and general public.

Keywords

Qualitative research, health data, secondary use, trust, public and patient involvement, eHealth

Corresponding author: Tina Bedenik

Competing interests: No competing interests were disclosed.

Grant information: This research was conducted with the financial support of Science Foundation Ireland under Grant Agreement Nos. 16/RC/3948 and 20/SP/8955 at the FutureNeuro SFI Research Centre at the RCSI University of Medicine and Social Sciences. FutureNeuro, the SFI Research Centre for neurological diseases is funded by Science Foundation Ireland through the SFI Research Centres Programme.
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Copyright: © 2024 Bedenik T et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

How to cite: Bedenik T, Cahir C and Bennett K. Building public trust and confidence in secondary use of health data for healthcare improvement and research: a qualitative study pre-protocol [version 2; peer review: 2 approved]. HRB Open Res 2024, 6:47 (https://doi.org/10.12688/hrbopenres.13711.2) First published: 11 Sep 2023, 6:47 (https://doi.org/10.12688/hrbopenres.13711.1) Latest published: 17 Jun 2024, 6:47 (https://doi.org/10.12688/hrbopenres.13711.2)

Revised Amendments from Version 1

Revisions made for this version include edits, clarifications and inclusion of additional information based on the items raised by the reviewers. We added information about the study setting in body text, to increase clarity. We also clarified how we decided on the number of focus groups, and we referenced relevant literature on focus group discussions and saturation in qualitative research. We added information regarding researcher’s previous experience with collecting qualitative data, and we clarified that all data is collected via focus group discussions.

See the authors' detailed response to the review by Aileen Grant
See the authors' detailed response to the review by Masoud Mohammadnezhad

Introduction

The proliferation of digital health data and the increasing adoption of electronic health records (EHR) and electronic patient registers will allow interrogation of large volumes of individual or population-level health data for secondary purposes. Secondary use of health data can be defined as “any use of health data for reasons other than those for which they were collected in the first place” (Perrin & Mathieu, 2021), which is sometimes used interchangeably with the use of data for ‘purposes beyond the direct care’ of the patient, such as quality improvement, health service planning and research (The Health Information and Quality Authority, 2021). Secondary use of health data can drive improvements in healthcare provision and health outcomes, personalised medicine, comparative effectiveness research, health services innovation and policy and practice. However, secondary use requires compliance with relevant legislation, implementation of appropriate policies, procedures and technical safeguards, safe and ethical data management, and importantly respect for the privacy and confidentiality rights of data subjects.

International evidence on the public attitudes towards the use or sharing of health data for secondary purposes has increased in recent years, with a focus on the general knowledge, opinions and attitudes, as well as benefits and concerns related to secondary data use. This includes both systematic reviews (Aitken et al., 2016a; Aitken et al., 2016b; Garrison et al., 2016; Hill et al., 2013; Howe et al., 2018; Hutchings et al., 2020; Hutchings et al., 2021) and primary qualitative and mixed-methods studies (Audrey et al., 2016; Cheah et al., 2018; Grant et al., 2013; Haddow et al., 2011; Hate et al., 2015; Hill et al., 2013; Papoutsi et al., 2015; Spencer et al., 2016; Stevenson et al., 2013). The existing evidence base suggests a widespread support for secondary use of health data amongst the public, which co-exists with concerns and fears about breaches of privacy, confidentiality, misuse of data, sharing data for profit, discrimination and stigma that may affect data sharers. Earlier research especially indicated a low level of understanding and a lack of knowledge amongst the public about the existing practices, security and safeguards, and uses of health data for secondary purposes, suggesting that public education and information provision may increase public’ willingness to share their health data for secondary purposes (Aitken et al., 2016a; Carson et al., 2019; Haddow et al., 2011; Hill et al., 2013). Despite this, there is an identified widespread support amongst the public for using health data for secondary purposes, with altruism – also referred to as common, greater or social good – and a sense of moral responsibility reported as the central motives for sharing data (Aitken et al., 2016a; Garrison et al., 2016; Howe et al., 2018; Hutchings et al., 2020; Hutchings et al., 2021; Kalkman et al., 2022; Platt & Kardia, 2015; Spencer et al., 2016). The evidence also suggests that the public’s willingness to share health data for secondary purposes is not contingent only upon the perceived actual or potential benefits resulting from data use, but also upon real or perceived concerns about risks and harms resulting from data use. This includes concerns about the security and privacy of data sharers, data sharing with commercial entities and pharmaceutical industries specifically, lack of transparency and accountability around data sharing practices, data falling into the ‘wrong’ hands such as marketing agencies, employers and banks, misuse of information, unwanted impact of data disclosure, and stigma and discrimination related to disclosure of health data and sensitive health data specifically (Aitken et al., 2016a; Garrison et al., 2016; Hill et al., 2013; Howe et al., 2018; Kalkman et al., 2022; Papoutsi et al., 2015; Spencer et al., 2016; Stevenson et al., 2013). These multiple concerns around data sharing may be mitigated through enhanced individual control over who, how and which reasons uses one’s health data for secondary analysis (Haddow et al., 2011; Kalkman et al., 2022; McGuire et al., 2008; Spencer et al., 2016), which is intricately tied with building and nurturing public trust in the individuals or organization that manage and use health data (Aitken et al., 2016a; Baird et al., 2009; Carson et al., 2019; Howe et al., 2018; Hutchings et al., 2020; Papoutsi et al., 2015).

Empirical studies of the public attitudes towards the use of health data for secondary purposes in Ireland remain scant; however, the extant body of research supports the international evidence. A survey of public attitudes towards the use of health data from the general practitioners’ (GP) medical records found general support for the sharing of anonymous personal health data with researchers without the need for consent on individual study basis (Buckley et al., 2011), and these findings were subsequently corroborated by a smaller qualitative study (Clerkin et al., 2013). A more recent systematic review of the UK and Irish public attitudes towards use of health data for research identified widespread support for the sharing of health data for altruistic reasons, alongside concerns about patients’ privacy (Stockdale et al., 2019). The willingness to share data was closely connected to public trust in the individual or the organisation that managed their data, and their perceived competence to keep the data safe. Trust also emerged as a major theme from a recent qualitative study that examined the factors that influenced the public’s willingness to share their health data (Flaherty et al., 2022). The three identified factors that shaped participants’ level of trust were: (i) their ability to exercise control over personal data that they believed belongs to them, (ii) the perceived transparency of the data sharing processes, and (iii) the perceived confidentiality of the healthcare service. This study (Flaherty et al., 2022) was part of a wider mixed methods study of national public engagement on health information carried out by the Health Information and Quality Authority (HIQA) in partnership with the Department of Health and the Health Service Executive (HSE) (2021), conducted following the Conti cyber attack (PwC, 2021) on the HSE in Ireland. This mixed methods study (HIQA, 2021) suggested that the Irish public is overwhelmingly in support of using health data for secondary purposes, upon the condition that appropriate safeguards are in place. The study also found that the public wanted to be informed about how their health data is collected, used and shared by healthcare professionals, and for which purposes. Similar attitudes were echoed in the verdict from a citizens’ jury on access to health information published by the Irish Platform for Patient Organisations, Science and Industry (IPPOSI) (2021). The results captured a belief that health data belongs to the citizens, who need to be able to individually and regularly decide on how their information is accessed, used and shared. Advocating for a model of consent that is co-designed with the citizen, the citizens’ jury emphasised the need to put the citizens in control of the management of their health data and build public trust regarding health data collection and use.

With some exceptions (Grant et al., 2013) both the international and national research rarely explored perspectives of patients and public regarding secondary use of health data in conjunction with key stakeholders, which indicates the need for this particular study. In addition, the forthcoming legislative and policy changes in the European Union and Ireland further underscore the need to understand and secure public support regarding secondary health data use. The draft European Declaration on Digital Rights and Principles (2022) recommended by the European Commission will serve as a guide for policy makers and companies when dealing with new technologies, whilst the proposed European Health Data Space (EHDS) will provide a health specific ecosystem that supports the free movement of health data for secondary purposes. In Ireland, the upcoming Health Information and Patient Safety Bill will support the ongoing eHealth initiatives such as rolling out the individual health identifier and electronic health records, leading to a radical transformation of the national health information services. Building on the body of research, and in light of these legislative changes, the aims of the proposed study are twofold: (i) to explore the rationale for and means of using secondary health data for healthcare improvement and research, and (ii) to explore how to develop a culture of trust that promotes safe use of health data. Specifically, the study will focus on the key stakeholders’ knowledge, experiences and attitudes related to secondary health data use; their perceptions of risks, benefits and ethical challenges; internal components and processes underpinning public trust; as well as barriers and enablers to building trust and confidence in using health data for healthcare improvement and research.

Methods

The study will be conducted and reported in accordance with the Consolidated Criteria for Reporting Qualitative Research COREQ: 32-Item Checklist (Tong et al., 2007) to ensure methodological rigor, transparency and credibility of the findings.

Study design

This study adopts a qualitative cross-sectional approach utilizing focus groups and/or semi-structured interviews in exploring how to build public trust and confidence in the secondary use of health data for healthcare improvement and research in Ireland. A qualitative approach was chosen in order to elicit and interpret a diversity of views and perspectives, and to allow the participants the necessary time to engage with and reflect on the subject matter through facilitative questioning (Ritchie & Lewis, 2003). The qualitative design has previously been used in studies of people’s attitudes regarding health data use and sharing (Baird et al., 2009; Cheah et al., 2018; Evans et al., 2020; Grant et al., 2013; Hate et al., 2015; Spencer et al., 2016; Stevenson et al., 2013). Previous qualitative studies of health data use and sharing have used focus groups (Clerkin et al., 2013; Haddow et al., 2011; Hill et al., 2013), interviews (Audrey et al., 2016) or alternatively a combination of different data collection techniques such as focus group and survey (Papoutsi et al., 2015) and focus group and a workshop (Aitken et al., 2016b). Qualitative data collection techniques are a common approach in researching people’s perspectives on health data use and sharing, and focus groups provide the opportunity to collect rich in-depth information in a less-intense environment (Smithson, 2000; Then et al., 2014).

Stakeholders and Patient and Public Involvement (PPI)

In order to ensure that the study is aligned with the standards and strategies regarding secondary use of health data endorsed by the key organisations in Ireland, individual remote meetings with the Irish Platform for Patient Organisations, Science and Industry (IPPOSI), Health Information and Quality Authority (HIQA) and Health Service Executive (HSE) took place in November and December 2022. These meetings provided an opportunity to inform the respective organisations about the study, discuss the study design and receive suggestions on the additional topics and questions that may be explored, and to exchange knowledge and information regarding the changing national policy landscape on health data. A Patient and Public Involvement (PPI) Panel for health research was also involved in the design of this study. Two older male adults reviewed research materials including the Participant Information Leaflet, Consent Form and topic guide and they provided written feedback on these materials, which was followed up with a video-call with one panel member. The research materials were subsequently amended prior to submission to the RCSI Research Ethics Committee.

Research team and reflexivity

To increase the rigor, clarity and transparency of the qualitative process (Jootun et al., 2009; Probst, 2015) researchers’ respective professional backgrounds and roles are outlined. Tina Bedenik (TB) is a Postdoctoral Fellow in the RCSI University of Medicine and Health Sciences, School of Population Health. She has an interdisciplinary background focusing on the intersection of health and social justice, and she specialises in qualitative research and participatory methodologies. Caitriona Cahir (CC) is a Lecturer in the RCSI Data Science Centre in the School of Population Health with research interests in epidemiology and psychology. She has experience in both quantitative and qualitative methodologies, and she collaborates with a wide range of academic disciplines. Kathleen Bennett (KB) is an Associate Professor in Biostatistics and Head of the Data Science Centre in RCSI. She has over twenty-five years’ experience in undertaking medical research, mainly quantitative research as well as qualitative and mixed methods studies.

The focus groups and any semi-structured interviews will be organised and conducted by TB, and a support person will be present to take notes. Data analysis will be conducted by TB, with support from KB and CC. We are cognizant that our respective backgrounds, experiences and knowledge may influence the research process, in particular data collection and analysis. In order to reduce researcher bias, the research team will review emerging themes in a collaborative manner, explore differences in coding, and critically reflect on any bias that may occur in this process. This will subsequently strengthen the quality of the analysis, and increase trustworthiness and validity of the research findings.

Participants and recruitment

Participants in this study will be clustered into five homogeneous groups: Study Group 1 (SG1): Academics and Researchers using secondary data for research; Study Group 2 (SG2): Healthcare Professionals from primary care and hospital settings; Study Group 3 (SG3): Data Protection, Ethics and Privacy Experts and Data Controllers involved in health data; Study Group 4 (SG4): Pharmaceutical Industry; Study Group 5 (SG5): Patients and Public. Participants will be selected based on the following inclusion criteria: belonging to one of the five identified groups, experience with secondary health data use (applicable to SG1-4), and an interest in participating in the exploration of this topic regardless of their prior knowledge of secondary health data use (SG5). The study will only include participants aged 18+ years who are able to provide written, informed consent. The study will exclude those who cannot communicate fluently in English language. Eligibility criteria was based on the literature review of qualitative and mixed methods studies (Aitken et al., 2016b; Baird et al., 2009; Buckley et al., 2011; Cheah et al., 2018; Damschroder et al., 2007; Evans et al., 2020; Grant et al., 2013; Haddow et al., 2011; Hill et al., 2013; McGuire et al., 2008; Papoutsi et al., 2015; Spencer et al., 2016; Stevenson et al., 2013; Trinidad et al., 2010), and it was further informed by discussion within the research team and with the key stakeholders.

The aim is to facilitate one focus group for SG1-4 and up to four focus groups for SG5. It is anticipated that each focus group will consist of four-eight participants, and the proposed sample size will range between 36 and 64 participants. The sample size is based on the literature review of qualitative studies of health data use and sharing that utilised a combination of focus groups and interviews (Baird et al., 2009; Cheah et al., 2018; Evans et al., 2020; Grant et al 2013; Hate et al., 2015; Spencer et al., 2016; Stevenson et al., 2013), a focus group and a workshop (Aitken et al., 2016b) and just focus groups (Clerkin et al., 2013; Haddow et al., 2011; Hill et al., 2013; McGuire et al., 2008; Trinidad et al., 2010). The sample size in the above cited studies ranges from fifteen participants (McGuire et al., 2008) to sixty-six participants (Hate et al., 2015), with the mean number across these thirteen qualitative studies being forty-five participants. However, it should be noted that some of these studies were multi-team and longer-lasting research projects. In addition, some challenges with organizing focus groups are anticipated, and they may need to be supplemented with semi-structured interviews. Therefore, the final sample size in this study will be contingent upon the success of the recruitment process, responsiveness of the invited individuals and resource availability.

This project will utilise purposive and convenience sampling techniques, which is in line with other extant qualitative research on health data use and sharing (Cheah et al., 2018; Grant et al., 2013; Hate et al., 2015; Spencer et al., 2016). Relevant representative bodies and organizations in Ireland will be approached in writing with a request to invite their members and/or representatives to take part in the study through their (social) media channels. In relation to recruitment for the SG5 (Patients and Public), non-governmental organisations that advocate for and support specific social groups, including disadvantaged and under-represented ones, will be approached. This is to ensure diversity of viewpoints and representation of different communities in this study, especially those that may have particular needs or concerns regarding access, use and sharing of individual health data. Specifically, focus will be on the organisations working in the following fields: mental health; reproductive and sexual health; gender and LGBTQI; disability; homelessness and addiction. We also aim to include representatives and/or service users of organizations that work with and support ethnic minorities, migrants and asylum seekers and the Travelling community. In addition, we will use advertisements on websites associated with the research area, social media (e.g. Twitter, Facebook), newsletters and research flyers to ensure that all representative groups are included. Some potential participants for SG1-4 have already been identified through participation in online and in-person seminars and workshops on health data in Ireland, such as Epilepsy Ireland National Conference 2022.

Data collection

It is anticipated that between five and eight focus groups (four for SG1 to SG4, and up to four for SG5) will take place in early and mid-2023 online. There will be separate focus groups for different categories of participants, and each individual focus group will meet once. Participants who are unable to attend their assigned focus group, will be invited for an individual interview. The focus groups are expected to last between one-two hours and interviews around one hour. Once consent had been obtained, basic demographic data will be collected from all participants including information about their gender, age range, ethnicity, educational level and field of work (if applicable). This information will be presented in an aggregate form in order to provide context to the findings.

Both focus groups and/or interviews will be conducted using a topic guide. The topic guide for all the Study Groups will include questions pertaining to participants’ knowledge, experiences and attitudes related to secondary health data use; their perceptions of risks, benefits and ethical challenges regarding secondary health data use; internal components and processes underpinning public trust; and barriers and enablers to building trust and confidence in using health data for healthcare improvement and research. Not all questions in the topic guide will be relevant or applicable to all five Study Groups and the guide is tailored for each individual Study Group. The topic guide was informed by the literature review and it had been discussed with the RCSI PPI Panel, Industry Partner IQVIA Ireland and HIQA, IPPOSI and the HSE. The topic guide tailored for SG5 (Patients and Public) will be piloted in an online semi-structured interview with a female PPI Panel member, and the topic guide tailored for SG1-4 will be piloted in an online semi-structured interview with a qualitative researcher in the RCSI School of Population Health. The topic guide is flexible yet focused in its nature, which enables the research team to gather information that is relevant and adequate the purpose of the study, whilst keeping data collection at minimum

Cognizant that not all participants in SG5 (Patients and Public) may have prior knowledge about secondary use of health data, a short presentation at the start of this focus group will be facilitated in order to enable an informed discussion. It is anticipated that during focus groups some participants may respond to questions in a way that they believe is socially acceptable. In order to reduce the chance of participant bias, the research team will introduce open-ended question that cannot be addressed with a simple yes/no answer. Furthermore, questions may be asked in an indirect way to prevent from participants feeling pressured to respond, and prompts may be used to approach one subject from various angles. Specific emphasis will be placed on mutual respect and confidentiality, and participants will be explicitly asked not to talk about their own medical conditions.

Focus groups and/or interviews will be audio-recorded and video recorded. Video recordings, however, will be deleted immediately after data collection, and only audio recordings will be retained. All audio recordings will be sent to a transcribed by a third-party party transcription service for transcription, and subsequently shared with those participants who expressed their wish to receive them. Any changes that participants make pertaining to their own statements will be implemented, and the transcriptions will be de-identified and uploaded to NVivo 12 qualitative data analysis software to enable analysis. The original transcripts and audio recordings will be destroyed immediately following de-identification.

Data analysis

Qualitative data will be transcribed verbatim, de-identified and imported into NVivo 12 software to organise the data and conduct analysis. The transcripts will be scrutinised and data will be coded by themes using an inductive and iterative approach. Commonly used in qualitative health research, reflexive thematic analysis (TA) (Braun & Clarke, 2006; Braun & Clarke, 2019) is chosen for its flexible and adaptable approach that enables a production of a rich and detailed account of data. The analysis will be a data-driven process, which means that the research team will search for recurrent patterns of meanings from the data and generate themes, rather than using a pre-existing coding framework to guide their analysis (Braun & Clarke, 2006; Braun & Clarke, 2019). Six phases of analysis (Braun & Clarke, 2006; Braun & Clarke, 2019) will be used a guide to this process: familiarization with the data; generating initial codes; searching for themes; reviewing themes; defining and naming themes and producing the report. However, reflexive TA is not a linear process, and some movement back and forth between these six phases is anticipated. Adherence to the 15-Point Checklist of Criteria for Good Thematic Analysis (Braun & Clarke, 2006) will support the methodological rigor during the analysis and writing up the research findings. The term reflexive TA captures the philosophical foundation upon which this method is based and highlights the crucial role that the researchers play in the process of knowledge production. This method replies upon an awareness that the coding process requires “a continual bending back on oneself” (Braun & Clarke, 2019:6), which includes an interrogation of researchers’ assumptions that that shape this process. In light of that cognition, the two members of the research team will independently code two interviews at the start of the analysis, and subsequently compare and discuss results to develop a coding index. Finally, attention will be devoted to the researchers’ positionality in the attempt to identify and reduce any bias, and to enable a production of more trustworthy knowledge (Nowell et al., 2017).

Collective intelligence

Upon the completion of data analysis, the aim is to convene an assembly of all study participants to present the preliminary findings, and to explore these in a group setting. This participatory research method is knowns as collective intelligence (CI), which can be broadly defined as “groups of individuals doing things collectively that seem intelligent” (Malone et al., 2009). This method enables interaction amongst a range of individuals in order to enable a production of shared insight and more accurate study outcomes (Kurvers et al., 2015; Wolf et al., 2015). The underlying idea driving this approach is that the access to a wide social group, in which knowledge is distributed, implies access to wide epistemic resources (Broadbent & Nicholas, 2015). In addition, research indicates that this CI may be increasingly employed because research problems are becoming more complex, and traditional research methods anchored in one discipline no longer fit researchers’ needs (Nguyen et al., 2019). In recent years, this method has been gaining more traction in medical and healthcare research. For instance, a recent systematic scoping of studies utilising CI in medical decision-making revealed that CI helps resolve uncertainty in decision-making, it can improve metacognitive activities (awareness of one’s own thinking process) and collective insight, and thus results in more accurate outcomes (Radcliffe et al., 2019). In addition, the CI approach was employed in a study of barriers and needs of adults using eHealth for chronic pain self-management (O’Reilly et al., 2022), assessment of the citizens’ interpretation of public health information (Guilbeault & Centola, 2020), exploration of challenges and barriers to accessing, understanding and using open data (Hogan et al., 2017), and it was argued to be a valuable method in eliciting insights into the values and preferences of citizens regarding design of wellbeing measures and policies (Hogan et al., 2015). Adoption of CI enables triangulation, increases credibility and validity of the research findings, and allows the research team to base the study recommendations on a group consensus.

Ethics

Ethical approval for the qualitative study was obtained from the RCSI Research Ethics Committee (REC) on 8 November 2022. Interested individuals will receive the Participant Information Leaflet (PIL) and the Consent Form in an electronic form or hard copy, depending on the mode of data collection, prior to the focus groups/interviews taking place. A one-week time interval will be allowed between providing research materials and seeking consent, which provides the individuals with time to reflect on the study, consider their involvement and ask further questions. All participants will be required to sign the Consent Form in person or electronically prior to any data collection.

The participants may withdraw from the study at any stage up and up until they have the opportunity to review the transcript and make changes to their statements. Following data collection, the audio recordings of focus groups and interviews will be transcribed by an external service provider, with whom a data processing agreement has been put in place. Different mechanisms will be in place to protect participants’ privacy and confidentiality rights. Specifically, the transcriptions will be de-identified, and all names, locations and other potentially identifiable data will be replaced with number, letter or participant ID. De-identified transcripts will be uploaded to NVivo 12 software to enable data analysis, and the original transcripts and audio or video recordings will be deleted. The de-identified data will be stored on the RCSI OneDrive and password-protected computers, which are only accessible only to the research team. Upon the completion of the study, the de-identified transcripts of those participants who gave consent will be deposited with Zenodo, an open repository developed under the European OpenAIRE program that covers all types of research output including qualitative data.

All participants in this study will have their travel expenses reimbursed for travelling to RCSI for focus groups and/or interviews. Participants in the Patients and Public focus group will receive an honorarium (voucher) for their time participating in the focus group or interview, irrespective of whether in-person or virtual participation. This is standard practice for Public and Patient involvement in research (www.ppinetwork.ie).

Dissemination

Final data analysis and dissemination is expected by Q1 2024. The results will be written up in aggregated form for publication through a range of academic, public and policy channels including conferences, presentations, peer-reviewed journals, scientific reports, newsletters, websites, podcasts and social media, and lay summaries and infographics will be designed for general public. Those participants that expressed their interest in the final report will receive a copy upon study completion.

Study status

At the time of publication, the research team is planning to pilot the topic guide and start with the recruitment in Q1 2023.

Conclusion

The international and Irish literature and the upcoming legislative changes (The Health information and Patient Safety Bill and The European Health Data Space) demonstrate an increasing importance for the support for secondary use of health data amongst the public, and an awareness of benefits for sharing health data. Enhanced knowledge and awareness about this topic is positively associated with the willingness to share health data, and the public wishes to be informed about who is using their data, which is being data, and for what purpose. Nonetheless, concerns about sharing data remain widespread and these include fears about breaches of privacy, confidentiality and misuse of data and discrimination. In the light of these competing priorities, the central dilemma emerging from the evidence is how to balance the protection of individuals’ rights against the use of their health data for societal benefits. No qualitative study on secondary use of health data that explores the aforesaid issues and includes all relevant stakeholders and PPI has been conducted in Ireland to date. Encompassing the general public, patients, healthcare practitioners, researchers, and data and ethics experts, one significant strength of this study is the inclusivity and representation of different social groups, including disadvantaged or under-represented groups. Potential anticipated challenges include participant recruitment and generalisability of the study findings. This research will produce novel insights and knowledge to help inform policy and further research on the barriers and enablers to building trust and confidence in the access, sharing and use data for secondary purposes. The study will contribute to the debates and advance the methodology related to eliciting people’s views and perspectives in a safe, collaborative and efficient manner. Finally, the findings may be used to help promote a culture of trust that is mindful of peoples’ concerns about how their health data is used and shared.

Data availability

No underlying data are associated with this article

Acknowledgments

We wish to thank the study funders SFI and IQVIA Solutions Ireland LTD, and the FutureNeuro Research Centre for their support. Thank you to HIQA, HSE and IPPOSI for the valuable conversations on this subject, and members of the RCSI PPI Panel and colleagues in RCSI for their involvement.

Faculty Opinions recommended

References

Aitken M, Cunningham-Burley S, Pagliari C: Moving from trust to trustworthiness: Experiences of public engagement in the Scottish Health Informatics Programme. Sci Public Policy. 2016b; 43(5): 713–723. PubMed Abstract | Publisher Full Text | Free Full Text
Aitken M, de St Jorre J, Pagliari C, et al.: Public responses to the sharing and linkage of health data for research purposes: a systematic review and thematic synthesis of qualitative studies. BMC Med Ethics. 2016a; 17(1): 73. PubMed Abstract | Publisher Full Text | Free Full Text
Audrey S, Brown L, Campbell R, et al.: Young people's views about consenting to data linkage: findings from the PEARL qualitative study. BMC Med Res Methodol. 2016; 16(34): 34. PubMed Abstract | Publisher Full Text | Free Full Text
Baird W, Jackson R, Ford H, et al.: Holding personal information in a disease-specific register: the perspectives of people with multiple sclerosis and professionals on consent and access. J Med Ethics. 2009; 35(2): 92–96. PubMed Abstract | Publisher Full Text
Braun V, Clarke V: Using thematic analysis in psychology. Qual Res Psychol. 2006; 3(2): 77–101. Publisher Full Text
Braun V, Clarke V: Reflecting on reflexive thematic analysis. Qual Res Sport Exerc Health. 2019; 11(4): 589–597. Publisher Full Text
Broadbent S, Nicholas L: Collective intelligence in patient organisations. Nesta. London, 2015. Reference Source
Buckley BS, Murphy AW, MacFarlane AE: Public attitudes to the use in research of personal health information from general practitioners' records: a survey of the Irish general public. J Med Ethics. 2011; 37(1): 50–55. PubMed Abstract | Publisher Full Text
Carson C, Hinton L, Kurinczuk J, et al.: ‘I haven’t met them, I don’t have any trust in them. It just feels like a big unknown’: a qualitative study exploring the determinants of consent to use Human Fertilisation and Embryology Authority registry data in research. BMJ Open. 2019; 9(5): e026469. PubMed Abstract | Publisher Full Text | Free Full Text
Cheah PY, Jatupornpimol N, Hanboonkunupakarn B, et al.: Challenges arising when seeking broad consent for health research data sharing: a qualitative study of perspectives in Thailand. BMC Med Ethics. 2018; 19(1): 86. PubMed Abstract | Publisher Full Text | Free Full Text
Clerkin P, Buckley BS, Murphy AW, et al.: Patients' views about the use of their personal information from general practice medical records in health research: a qualitative study in Ireland. Fam Pract. 2013; 30(1): 105–12. PubMed Abstract | Publisher Full Text
Damschroder LJ, Pritts JL, Neblo MA, et al.: Patients, privacy and trust: patients' willingness to allow researchers to access their medical records. Soc Sci Med. 2007; 64(1): 223–235. PubMed Abstract | Publisher Full Text
Evans EA, Delorme E, Cyr K, et al.: A qualitative study of big data and the opioid epidemic: recommendations for data governance. BMC Med Ethics. 2020; 21(1): 101. PubMed Abstract | Publisher Full Text | Free Full Text
Flaherty SJ, Duggan C, O'Connor L, et al.: What influences a person’s willingness to share health information for both direct care and uses beyond direct care? Findings from a focus group study in Ireland [version 2; peer review: 4 approved]. HRB Open Res. 2022; 5: 36. PubMed Abstract | Publisher Full Text | Free Full Text
Garrison NA, Sathe NA, Antommaria AHM, et al.: A systematic literature review of individuals' perspectives on broad consent and data sharing in the United States. Genet Med. 2016; 18(7): 663–671. PubMed Abstract | Publisher Full Text | Free Full Text
Guilbeault D, Centola D: Networked collective intelligence improves dissemination of scientific information regarding smoking risks. PLoS One. 2020; 15(2): e0227813. PubMed Abstract | Publisher Full Text | Free Full Text
Grant A, Ure J, Nicolson DJ, et al.: Acceptability and perceived barriers and facilitators to creating a national research register to enable 'direct to patient' enrolment into research: the Scottish Health Research Register (SHARE). BMC Health Serv Res. 2013; 13: 422. PubMed Abstract | Publisher Full Text | Free Full Text
Haddow G, Bruce A, Sathanandam S, et al.: 'Nothing is really safe': a focus group study on the processes of anonymizing and sharing of health data for research purposes. J Eval Clin Pract. 2011; 17(6): 1140–1146. PubMed Abstract | Publisher Full Text
Hate K, Meherally S, Shah More N, et al.: Sweat, skepticism, and uncharted territory: a qualitative study of opinions on data sharing among public health researchers and research participants in Mumbai, India. J Empir Res Hum Res Ethics. 2015; 10(3): 239–250. PubMed Abstract | Publisher Full Text | Free Full Text
Hill EM, Turner EL, Martin RM, et al.: "Let's get the best quality research we can": public awareness and acceptance of consent to use existing data in health research: a systematic review and qualitative study. BMC Med Res Methodol. 2013; 13: 72. PubMed Abstract | Publisher Full Text | Free Full Text
Hogan M, Ojo A, Harney O, et al.: Governance, transparency and the collaborative design of open data collaboration platforms: understanding barriers, options, and needs. In: Ojo, A., Millard, J. (eds) Government 3.0 – next generation government technology infrastructure and services, Public Administration and Information Technology. Springer, Cham; 2017; 32. Publisher Full Text
Hogan MJ, Johnston H, Broome B, et al.: Consulting with citizens in the design of wellbeing measures and policies: lessons from a systems science application. Soc Indic Res. 2015; 123: 857–877. Publisher Full Text
Howe N, Giles E, Newbury-Birch D, et al.: Systematic review of participants' attitudes towards data sharing: a thematic synthesis. J Health Serv Res Policy. 2018; 23(2): 123–133. PubMed Abstract | Publisher Full Text
Hutchings E, Loomes M, Butow P, et al.: A systematic literature review of health consumer attitudes towards secondary use and sharing of health administrative and clinical trial data: a focus on privacy, trust, and transparency. Syst Rev. 2020; 9(1): 235. PubMed Abstract | Publisher Full Text | Free Full Text
Hutchings E, Loomes M, Butow P, et al.: A systematic literature review of attitudes towards secondary use and sharing of health administrative and clinical trial data: a focus on consent. Syst Rev. 2021; 10(1): 132. PubMed Abstract | Publisher Full Text | Free Full Text
Jootun D, McGhee G, Marland GR: Reflexivity: promoting rigour in qualitative research. Nurs Stand. 2009; 23(23): 42–46. PubMed Abstract
Kalkman S, van Delden J, Banerjee A, et al.: Patients’ and public views and attitudes towards the sharing of health data for research: a narrative review of the empirical evidence. J Med Ethics. 2022; 48(1): 3–13. PubMed Abstract | Publisher Full Text | Free Full Text
Kurvers RH, Wolf M, Naguib M, et al.: Self-organized flexible leadership promotes collective intelligence in human groups. R Soc Open Sci. 2015; 2(12): 150222. PubMed Abstract | Publisher Full Text | Free Full Text
Malone TW, Laubacher R, Dellarocas CN: Harnessing Crowds: mapping the genome of collective intelligence. MIT Sloan Research Paper No. 4732-09, 2009. Publisher Full Text
McGuire AL, Hamilton JA, Lunstroth R, et al.: DNA data sharing: research participants' perspectives. Genet Med. 2008; 10(1): 46–53. PubMed Abstract | Publisher Full Text | Free Full Text
Nguyen VT, Young B, Ravaud P, et al.: Overcoming barriers to mobilizing collective intelligence in research: qualitative study of researchers with experience of collective intelligence. J Med Internet Res. 2019; 21(7): e13792. PubMed Abstract | Publisher Full Text | Free Full Text
Nowell LS, Norris JM, White DE, et al.: Thematic analysis: striving to meet the trustworthiness criteria. Int J Qual Meth. 2017; 16(1).
O'Reilly PM, Harney OM, Hogan MJ, et al.: Chronic pain self-management in middle-aged and older adults: A collective intelligence approach to identifying barriers and user needs in eHealth interventions. Digit Health. 2022; 8: 20552076221105484. PubMed Abstract | Publisher Full Text | Free Full Text
Papoutsi C, Reed JE, Marston C, et al.: Patient and public views about the security and privacy of Electronic Health Records (EHRs) in the UK: results from a mixed methods study. BMC Med Inform Decis Mak. 2015; 15: 86. PubMed Abstract | Publisher Full Text | Free Full Text
Perrin Z, Mathieu L: Exploratory literature review - Citizens’ perceptions of and involvement in health data secondary use and sharing in Europe (Milestone M8.1). Joint Action Towards the European Health Data Space - TEHDAS. 2021. Reference Source
Platt J, Kardia S: Public trust in health information sharing: implications for biobanking and electronic health record systems. J Pers Med. 2015; 5(1): 3–21. PubMed Abstract | Publisher Full Text | Free Full Text
Probst B: The eye regards itself: benefits and challenges of reflexivity in qualitative social work research. Social Work Research. 2015; 39(1): 37–48. Publisher Full Text
PwC: Conti cyber attack on the HSE: Independent Post Incident Review. 2021. Reference Source
Radcliffe K, Lyson HC, Barr-Walker J, et al.: Collective intelligence in medical decision-making: a systematic scoping review.  BMC Med Inform Decis Mak.   2019; 19(1): 158. PubMed Abstract | Publisher Full Text | Free Full Text
Ritchie J, Lewis J: Qualitative Research Practice. A Guide for Social Science Students and Researchers.  London/Thousand Oaks/New Delhi: SAGE Publications. 2003. Reference Source
Smithson J: Using and analysing focus groups: limitations and possibilities. Int J Soc Res Methodol. 2000; 3(2): 103–119. Publisher Full Text
Spencer K, Sanders C, Whitley EA, et al.: Patient Perspectives on Sharing Anonymized Personal Health Data Using a Digital System for Dynamic Consent and Research Feedback: A Qualitative Study. J Med Internet Res. 2016; 18(4): e66. PubMed Abstract | Publisher Full Text | Free Full Text
Stevenson F, Lloyd N, Harrington L, et al.: Use of electronic patient records for research: views of patients and staff in general practice. Fam Pract. 2013; 30(2): 227–232. PubMed Abstract | Publisher Full Text
Stockdale J, Cassell J, Ford E: "Giving something back": A systematic review and ethical enquiry into public views on the use of patient data for research in the United Kingdom and the Republic of Ireland [version 2; peer review: 2 approved]. Wellcome Open Res. 2019; 3: 6. PubMed Abstract | Publisher Full Text | Free Full Text
The Health Information and Quality Authority: Findings from the national public engagement on health information. Dublin, Ireland: Health Information and Quality Authority. 2021. Reference Source
The Irish Platform for Patient Organisations, Science and Industry: Verdict from a citizens’ jury on access to health information. Dublin, Ireland: The Irish Platform for Patient Organisations, Science and Industry, 2021. Reference Source
Tong A, Sainsbury P, Craig J: Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. Int J Qual Health Care. 2007; 19(6): 349–357. PubMed Abstract | Publisher Full Text
Then KL, Rankin J, Ali E: Focus group research: what is it and how can it be used? Can J Cardiovasc Nurs. 2014; 24(1): 16–22. PubMed Abstract
Trinidad SB, Fullerton SM, Bares JM, et al.: Genomic research and wide data sharing: views of prospective participants. Genet Med. 2010; 12(8): 486–495. PubMed Abstract | Publisher Full Text | Free Full Text
Wolf M, Krause J, Carney PA, et al.: Collective intelligence meets medical decision-making: the collective outperforms the best radiologist. PLoS One. 2015; 10(8): e0134269. PubMed Abstract | Publisher Full Text | Free Full Text

Comments on this article Comments (0)

Version 2

VERSION 2 PUBLISHED 11 Sep 2023

Author details Author details

¹ School of Population Health, RCSI University of Medicine and Health Sciences, Dublin, D02 DH60, Ireland
² Science Foundation Ireland (SFI) FutureNeuro Research Centre, Dublin, D02 YN77, Ireland

Tina Bedenik
Roles: Conceptualization, Investigation, Methodology, Project Administration, Writing – Original Draft Preparation, Writing – Review & Editing

Caitriona Cahir
Roles: Methodology, Writing – Review & Editing

K. Bennett
Roles: Conceptualization, Funding Acquisition, Methodology, Project Administration, Writing – Review & Editing

Competing interests

No competing interests were disclosed.

Grant information

This research was conducted with the financial support of Science Foundation Ireland under Grant Agreement Nos. 16/RC/3948 and 20/SP/8955 at the FutureNeuro SFI Research Centre at the RCSI University of Medicine and Social Sciences. FutureNeuro, the SFI Research Centre for neurological diseases is funded by Science Foundation Ireland through the SFI Research Centres Programme.
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Article Versions (2)

version 2

Revised

Published: 17 Jun 2024, 6:47

https://doi.org/10.12688/hrbopenres.13711.2

version 1

Published: 11 Sep 2023, 6:47

https://doi.org/10.12688/hrbopenres.13711.1

© 2024 Bedenik T et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Download

Export To

metrics

VIEWS

783

downloads

Citations

SEE MORE DETAILS

CITE

how to cite this article

Bedenik T, Cahir C and Bennett K. Building public trust and confidence in secondary use of health data for healthcare improvement and research: a qualitative study pre-protocol [version 2; peer review: 2 approved]. HRB Open Res 2024, 6:47 (https://doi.org/10.12688/hrbopenres.13711.2)

NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article.

track

receive updates on this article

Track an article to receive email alerts on any updates to this article.

Open Peer Review

Version 2

VERSION 2

PUBLISHED 17 Jun 2024

Revised

Views

Reviewer Report 28 Jun 2024

Masoud Mohammadnezhad, Birmingham City University, Birmingham, England, UK

Approved

https://doi.org/10.21956/hrbopenres.15264.r40778

Thank you for ... Continue reading

CITE

Report a concern

Respond or Comment

Version 1

VERSION 1

PUBLISHED 11 Sep 2023

Views

Reviewer Report 07 Jun 2024

Masoud Mohammadnezhad, Birmingham City University, Birmingham, England, UK

Approved with Reservations

https://doi.org/10.21956/hrbopenres.14997.r39425

This is a good study that applied a qualitative cross-sectional approach to explore how to build public trust and confidence in the secondary use of health data through all key stakeholder groups in Ireland. It is a very relevant study that can help decision makers to support for secondary use of health data amongst the public, and an awareness of benefits for sharing health data. My decision to advise the authors to address these major comments.

In the abstract and its method section- please put COREQ in the parenthesis.
Please do the same in the method section of main text (put COREQ in the parenthesis).
Explain the study setting. From where the study participants will be chosen and why?
Please write all the inclusion and exclusion criteria. Do they need to be from Ireland? Will you exclude those who are not willing to participate?
PIn the abstract and its method section- please put COREQ in the parenthesis.
Please do the same in the method section of main text (put COREQ in the parenthesis).
Explain the study setting. From where the study participants will be chosen and why?
Please write all the inclusion and exclusion criteria. Do they need to be from Ireland? Will you exclude those who are not willing to participate?
Please explain how did you measured the number of FGD? You mentioned one FGD from SG1-4 and 5 FGDs for the SG5. How did you reach to this number?
How did you develop the study tool/questionnaire? Any pilot study before applying in the main study?
Who will conduct interviews? Any previous experience?
Why you easily change the FGD to in-depth interview for those who are not able to attend FGD. Don’t you think this may affect the quality of response?
How about study trustworthiness? The credibility, transferability, dependability,..?
lease explain how did you measured the number of FGD? You mentioned one FGD from SG1-4 and 5 FGDs for the SG5. How did you reach to this number?
How did you develop the study tool/questionnaire? Any pilot study before applying in the main study?
Who will conduct interviews? Any previous experience?
Why you easily change the FGD to in-depth interview for those who are not able to attend FGD. Don’t you think this may affect the quality of response?
How about study trustworthiness? The credibility, transferability, dependability,..?

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Yes
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Public Health Research, Qualitative and quantitative design, Social Determinants of Health and cross cultural research

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

CITE

Report a concern

Author Response 17 Jun 2024

Tina Bedenik, School of Population Health, RCSI University of Medicine and Health Sciences, Dublin, D02 DH60, Ireland

17 Jun 2024

Author Response

We wish to thank the reviewer for the feedback. We respond to each of the points below.

In the abstract and its method section- please put COREQ in the ... Continue reading We wish to thank the reviewer for the feedback. We respond to each of the points below.

In the abstract and its method section- please put COREQ in the parenthesis.

Response: We have placed COREQ in the parenthesis.

Please do the same in the method section of main text (put COREQ in the parenthesis).

Response: We have placed COREQ in the parenthesis.

Explain the study setting. From where the study participants will be chosen and why?

Response: We added information regarding study setting in the Abstract/Background of the revised version, and this information is present in the ‘Study design’ section of the former version. The participants are chosen because of their prior knowledge, experiences and interest in secondary health data use, which we outlined in ‘Participants and recruitment’ section of the paper.

Please write all the inclusion and exclusion criteria. Do they need to be from Ireland? Will you
exclude those who are not willing to participate?

Response: Both inclusion and exclusion criteria have been outlined in the section ‘Participants and recruitment’:
“Participants will be selected based on the following inclusion criteria: belonging to one of the five identified groups, experience with secondary health data use (applicable to SG1-4), and an interest in participating in the exploration of this topic regardless of their prior knowledge of secondary health data use (SG5). The study will only include participants aged 18+ years who are able to provide written, informed consent. The study will exclude those who cannot communicate fluently in English language.”
We added that all participants will be recruited from Ireland in ‘Participants and recruitment’ section of the revised version to increase clarity.

Please explain how did you measured the number of FGD? You mentioned one FGD from SG1-4 and 5 FGDs for the SG5. How did you reach to this number?

Response: We decided on five study groups to facilitate a discussion among all relevant stakeholders in Ireland regarding secondary use of health data. In addition, the literature suggests that in qualitative studies 4–8 focus group discussions are sufficient to reach saturation (Hennink & Kaiser, 2022). We included this information in the revised version.

How did you develop the study tool/questionnaire? Any pilot study before applying in the main
study?

Response: We provided information on the topic guide and the pilot in the ‘Data collection’ section of the article:
“The topic guide was informed by the literature review and it had been discussed with the RCSI PPI Panel, Industry Partner IQVIA Ireland and HIQA, IPPOSI and the HSE. The topic guide tailored for SG5 (Patients and Public) will be piloted in an online semi-structured interview with a female PPI Panel member, and the topic guide tailored for SG1-4 will be piloted in an online semi-structured interview with a qualitative researcher in the RCSI School of Population Health.”

Who will conduct interviews? Any previous experience?

Response: Information is provided in the article, under section ‘Research team and reflexivity’:
“The focus groups and any semi-structured interviews will be organised and conducted by TB.”
We added the information regarding researcher’s previous experience in the revised version.

Why you easily change the FGD to in-depth interview for those who are not able to attend FGD.
Don’t you think this may affect the quality of response?

Response: Thank you for the comment. We did not conduct any in-depth interviews, and all data is collected via focus group discussions. We have amended the article to reflect this more accurately.

How about study trustworthiness? The credibility, transferability, dependability,..?

Response: In order to increase trustworthiness and methodological rigor we outlined in the article that two members of the research team will independently code two focus group transcripts, and discuss the results. This is to ensure intercoder reliability, and we added this information in the revised version. We also outlined researchers’ positionality to identify and reduce any bias, and therefore enable a production of more trustworthy knowledge. Finally, we will also refer to and contrast with any published literature in the area when reporting the study findings, to increase the credibility, transferability and dependability.
We wish to thank the reviewer for the feedback. We respond to each of the points below.

In the abstract and its method section- please put COREQ in the parenthesis.

Response: We have placed COREQ in the parenthesis.

Please do the same in the method section of main text (put COREQ in the parenthesis).

Response: We have placed COREQ in the parenthesis.

Explain the study setting. From where the study participants will be chosen and why?

Response: We added information regarding study setting in the Abstract/Background of the revised version, and this information is present in the ‘Study design’ section of the former version. The participants are chosen because of their prior knowledge, experiences and interest in secondary health data use, which we outlined in ‘Participants and recruitment’ section of the paper.

Please write all the inclusion and exclusion criteria. Do they need to be from Ireland? Will you
exclude those who are not willing to participate?

Response: Both inclusion and exclusion criteria have been outlined in the section ‘Participants and recruitment’:
“Participants will be selected based on the following inclusion criteria: belonging to one of the five identified groups, experience with secondary health data use (applicable to SG1-4), and an interest in participating in the exploration of this topic regardless of their prior knowledge of secondary health data use (SG5). The study will only include participants aged 18+ years who are able to provide written, informed consent. The study will exclude those who cannot communicate fluently in English language.”
We added that all participants will be recruited from Ireland in ‘Participants and recruitment’ section of the revised version to increase clarity.

Please explain how did you measured the number of FGD? You mentioned one FGD from SG1-4 and 5 FGDs for the SG5. How did you reach to this number?

Response: We decided on five study groups to facilitate a discussion among all relevant stakeholders in Ireland regarding secondary use of health data. In addition, the literature suggests that in qualitative studies 4–8 focus group discussions are sufficient to reach saturation (Hennink & Kaiser, 2022). We included this information in the revised version.

How did you develop the study tool/questionnaire? Any pilot study before applying in the main
study?

Response: We provided information on the topic guide and the pilot in the ‘Data collection’ section of the article:
“The topic guide was informed by the literature review and it had been discussed with the RCSI PPI Panel, Industry Partner IQVIA Ireland and HIQA, IPPOSI and the HSE. The topic guide tailored for SG5 (Patients and Public) will be piloted in an online semi-structured interview with a female PPI Panel member, and the topic guide tailored for SG1-4 will be piloted in an online semi-structured interview with a qualitative researcher in the RCSI School of Population Health.”

Who will conduct interviews? Any previous experience?

Response: Information is provided in the article, under section ‘Research team and reflexivity’:
“The focus groups and any semi-structured interviews will be organised and conducted by TB.”
We added the information regarding researcher’s previous experience in the revised version.

Why you easily change the FGD to in-depth interview for those who are not able to attend FGD.
Don’t you think this may affect the quality of response?

Response: Thank you for the comment. We did not conduct any in-depth interviews, and all data is collected via focus group discussions. We have amended the article to reflect this more accurately.

How about study trustworthiness? The credibility, transferability, dependability,..?

Response: In order to increase trustworthiness and methodological rigor we outlined in the article that two members of the research team will independently code two focus group transcripts, and discuss the results. This is to ensure intercoder reliability, and we added this information in the revised version. We also outlined researchers’ positionality to identify and reduce any bias, and therefore enable a production of more trustworthy knowledge. Finally, we will also refer to and contrast with any published literature in the area when reporting the study findings, to increase the credibility, transferability and dependability.
Competing Interests: No competing interests were disclosed. Close
Report a concern
Respond or Comment

COMMENTS ON THIS REPORT

Author Response 17 Jun 2024

Tina Bedenik, School of Population Health, RCSI University of Medicine and Health Sciences, Dublin, D02 DH60, Ireland

17 Jun 2024

Author Response

We wish to thank the reviewer for the feedback. We respond to each of the points below.

In the abstract and its method section- please put COREQ in the ... Continue reading We wish to thank the reviewer for the feedback. We respond to each of the points below.

In the abstract and its method section- please put COREQ in the parenthesis.

Response: We have placed COREQ in the parenthesis.

Please do the same in the method section of main text (put COREQ in the parenthesis).

Response: We have placed COREQ in the parenthesis.

Explain the study setting. From where the study participants will be chosen and why?

Response: We added information regarding study setting in the Abstract/Background of the revised version, and this information is present in the ‘Study design’ section of the former version. The participants are chosen because of their prior knowledge, experiences and interest in secondary health data use, which we outlined in ‘Participants and recruitment’ section of the paper.

Please write all the inclusion and exclusion criteria. Do they need to be from Ireland? Will you
exclude those who are not willing to participate?

Response: Both inclusion and exclusion criteria have been outlined in the section ‘Participants and recruitment’:
“Participants will be selected based on the following inclusion criteria: belonging to one of the five identified groups, experience with secondary health data use (applicable to SG1-4), and an interest in participating in the exploration of this topic regardless of their prior knowledge of secondary health data use (SG5). The study will only include participants aged 18+ years who are able to provide written, informed consent. The study will exclude those who cannot communicate fluently in English language.”
We added that all participants will be recruited from Ireland in ‘Participants and recruitment’ section of the revised version to increase clarity.

Please explain how did you measured the number of FGD? You mentioned one FGD from SG1-4 and 5 FGDs for the SG5. How did you reach to this number?

Response: We decided on five study groups to facilitate a discussion among all relevant stakeholders in Ireland regarding secondary use of health data. In addition, the literature suggests that in qualitative studies 4–8 focus group discussions are sufficient to reach saturation (Hennink & Kaiser, 2022). We included this information in the revised version.

How did you develop the study tool/questionnaire? Any pilot study before applying in the main
study?

Response: We provided information on the topic guide and the pilot in the ‘Data collection’ section of the article:
“The topic guide was informed by the literature review and it had been discussed with the RCSI PPI Panel, Industry Partner IQVIA Ireland and HIQA, IPPOSI and the HSE. The topic guide tailored for SG5 (Patients and Public) will be piloted in an online semi-structured interview with a female PPI Panel member, and the topic guide tailored for SG1-4 will be piloted in an online semi-structured interview with a qualitative researcher in the RCSI School of Population Health.”

Who will conduct interviews? Any previous experience?

Response: Information is provided in the article, under section ‘Research team and reflexivity’:
“The focus groups and any semi-structured interviews will be organised and conducted by TB.”
We added the information regarding researcher’s previous experience in the revised version.

Why you easily change the FGD to in-depth interview for those who are not able to attend FGD.
Don’t you think this may affect the quality of response?

Response: Thank you for the comment. We did not conduct any in-depth interviews, and all data is collected via focus group discussions. We have amended the article to reflect this more accurately.

How about study trustworthiness? The credibility, transferability, dependability,..?

Response: In order to increase trustworthiness and methodological rigor we outlined in the article that two members of the research team will independently code two focus group transcripts, and discuss the results. This is to ensure intercoder reliability, and we added this information in the revised version. We also outlined researchers’ positionality to identify and reduce any bias, and therefore enable a production of more trustworthy knowledge. Finally, we will also refer to and contrast with any published literature in the area when reporting the study findings, to increase the credibility, transferability and dependability.
We wish to thank the reviewer for the feedback. We respond to each of the points below.

In the abstract and its method section- please put COREQ in the parenthesis.

Response: We have placed COREQ in the parenthesis.

Please do the same in the method section of main text (put COREQ in the parenthesis).

Response: We have placed COREQ in the parenthesis.

Explain the study setting. From where the study participants will be chosen and why?

Response: We added information regarding study setting in the Abstract/Background of the revised version, and this information is present in the ‘Study design’ section of the former version. The participants are chosen because of their prior knowledge, experiences and interest in secondary health data use, which we outlined in ‘Participants and recruitment’ section of the paper.

Please write all the inclusion and exclusion criteria. Do they need to be from Ireland? Will you
exclude those who are not willing to participate?

Response: Both inclusion and exclusion criteria have been outlined in the section ‘Participants and recruitment’:
“Participants will be selected based on the following inclusion criteria: belonging to one of the five identified groups, experience with secondary health data use (applicable to SG1-4), and an interest in participating in the exploration of this topic regardless of their prior knowledge of secondary health data use (SG5). The study will only include participants aged 18+ years who are able to provide written, informed consent. The study will exclude those who cannot communicate fluently in English language.”
We added that all participants will be recruited from Ireland in ‘Participants and recruitment’ section of the revised version to increase clarity.

Please explain how did you measured the number of FGD? You mentioned one FGD from SG1-4 and 5 FGDs for the SG5. How did you reach to this number?

Response: We decided on five study groups to facilitate a discussion among all relevant stakeholders in Ireland regarding secondary use of health data. In addition, the literature suggests that in qualitative studies 4–8 focus group discussions are sufficient to reach saturation (Hennink & Kaiser, 2022). We included this information in the revised version.

How did you develop the study tool/questionnaire? Any pilot study before applying in the main
study?

Response: We provided information on the topic guide and the pilot in the ‘Data collection’ section of the article:
“The topic guide was informed by the literature review and it had been discussed with the RCSI PPI Panel, Industry Partner IQVIA Ireland and HIQA, IPPOSI and the HSE. The topic guide tailored for SG5 (Patients and Public) will be piloted in an online semi-structured interview with a female PPI Panel member, and the topic guide tailored for SG1-4 will be piloted in an online semi-structured interview with a qualitative researcher in the RCSI School of Population Health.”

Who will conduct interviews? Any previous experience?

Response: Information is provided in the article, under section ‘Research team and reflexivity’:
“The focus groups and any semi-structured interviews will be organised and conducted by TB.”
We added the information regarding researcher’s previous experience in the revised version.

Why you easily change the FGD to in-depth interview for those who are not able to attend FGD.
Don’t you think this may affect the quality of response?

Response: Thank you for the comment. We did not conduct any in-depth interviews, and all data is collected via focus group discussions. We have amended the article to reflect this more accurately.

How about study trustworthiness? The credibility, transferability, dependability,..?

Response: In order to increase trustworthiness and methodological rigor we outlined in the article that two members of the research team will independently code two focus group transcripts, and discuss the results. This is to ensure intercoder reliability, and we added this information in the revised version. We also outlined researchers’ positionality to identify and reduce any bias, and therefore enable a production of more trustworthy knowledge. Finally, we will also refer to and contrast with any published literature in the area when reporting the study findings, to increase the credibility, transferability and dependability.
Competing Interests: No competing interests were disclosed. Close
Report a concern

Views

Reviewer Report 31 Oct 2023

Aileen Grant, School of Nursing and Midwifery, Robert Gordon University, Aberdeen, UK

Approved

https://doi.org/10.21956/hrbopenres.14997.r36560

This is a well written protocol for a study which will provide important data about perspectives of sharing digital health data in Ireland. Given the lack of research in this area I think the findings will be important internationally.

It is not clear what organisations or people will be explored for data sharing. I assumed it was within health care organisations but this could be clearer. In the UK with post- pandemic health care access issues there is anecdotal evidence patients would like access to their records to help with the work of being a multimorbid patient. I think it would being an interesting dimension if patients were asked about this too.

Apart from this everything was clear.

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Yes
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Qualitative methods

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.

CITE

Report a concern

Author Response 17 Jun 2024

Tina Bedenik, School of Population Health, RCSI University of Medicine and Health Sciences, Dublin, D02 DH60, Ireland

17 Jun 2024

Author Response

We would like to thank the reviewer for the helpful comment.

We have outlined in the section ‘Participants and recruitment’ who are the people that will take part in ... Continue reading We would like to thank the reviewer for the helpful comment.

We have outlined in the section ‘Participants and recruitment’ who are the people that will take part in the study:
Study Group 1 (SG1): Academics and Researchers using secondary data for research;
Study Group 2 (SG2): Healthcare Professionals from primary care and hospital settings;
Study Group 3 (SG3): Data Protection, Ethics and Privacy Experts and Data Controllers involved in health data;
Study Group 4 (SG4): Pharmaceutical Industry;
Study Group 5 (SG5): Patients and Public.
We added information that all participants will be recruited from Ireland, to increase clarity.

Thank you for the suggestion regarding the inclusion of perspectives of patients with multimorbidity. In the patients and public study group we include both persons with comorbidity and multimorbidity, and their views on the interactions with multiple healthcare providers and the impact on data sharing and use.
We would like to thank the reviewer for the helpful comment.

We have outlined in the section ‘Participants and recruitment’ who are the people that will take part in the study:
Study Group 1 (SG1): Academics and Researchers using secondary data for research;
Study Group 2 (SG2): Healthcare Professionals from primary care and hospital settings;
Study Group 3 (SG3): Data Protection, Ethics and Privacy Experts and Data Controllers involved in health data;
Study Group 4 (SG4): Pharmaceutical Industry;
Study Group 5 (SG5): Patients and Public.
We added information that all participants will be recruited from Ireland, to increase clarity.

Thank you for the suggestion regarding the inclusion of perspectives of patients with multimorbidity. In the patients and public study group we include both persons with comorbidity and multimorbidity, and their views on the interactions with multiple healthcare providers and the impact on data sharing and use.
Competing Interests: No competing interests were disclosed. Close
Report a concern
Respond or Comment

COMMENTS ON THIS REPORT

Author Response 17 Jun 2024

Tina Bedenik, School of Population Health, RCSI University of Medicine and Health Sciences, Dublin, D02 DH60, Ireland

17 Jun 2024

Author Response

We would like to thank the reviewer for the helpful comment.

We have outlined in the section ‘Participants and recruitment’ who are the people that will take part in ... Continue reading We would like to thank the reviewer for the helpful comment.

We have outlined in the section ‘Participants and recruitment’ who are the people that will take part in the study:
Study Group 1 (SG1): Academics and Researchers using secondary data for research;
Study Group 2 (SG2): Healthcare Professionals from primary care and hospital settings;
Study Group 3 (SG3): Data Protection, Ethics and Privacy Experts and Data Controllers involved in health data;
Study Group 4 (SG4): Pharmaceutical Industry;
Study Group 5 (SG5): Patients and Public.
We added information that all participants will be recruited from Ireland, to increase clarity.

Thank you for the suggestion regarding the inclusion of perspectives of patients with multimorbidity. In the patients and public study group we include both persons with comorbidity and multimorbidity, and their views on the interactions with multiple healthcare providers and the impact on data sharing and use.
We would like to thank the reviewer for the helpful comment.

We have outlined in the section ‘Participants and recruitment’ who are the people that will take part in the study:
Study Group 1 (SG1): Academics and Researchers using secondary data for research;
Study Group 2 (SG2): Healthcare Professionals from primary care and hospital settings;
Study Group 3 (SG3): Data Protection, Ethics and Privacy Experts and Data Controllers involved in health data;
Study Group 4 (SG4): Pharmaceutical Industry;
Study Group 5 (SG5): Patients and Public.
We added information that all participants will be recruited from Ireland, to increase clarity.

Thank you for the suggestion regarding the inclusion of perspectives of patients with multimorbidity. In the patients and public study group we include both persons with comorbidity and multimorbidity, and their views on the interactions with multiple healthcare providers and the impact on data sharing and use.
Competing Interests: No competing interests were disclosed. Close
Report a concern

Comments on this article Comments (0)

Version 2

VERSION 2 PUBLISHED 11 Sep 2023

Open Peer Review

Reviewer Status

Reviewer Reports

	Invited Reviewers
	1	2
Version 2 (revision) 17 Jun 24		read
Version 1 11 Sep 23	read	read

Aileen Grant, Robert Gordon University, Aberdeen, UK
Masoud Mohammadnezhad, Birmingham City University, Birmingham, UK

Comments on this article

All Comments(0)

Add a comment

Back to all reports

Reviewer Report

5 Views

28 Jun 2024 | for Version 2

Masoud Mohammadnezhad, Birmingham City University, Birmingham, England, UK

5 Views Cite this report Responses(0)

Approved

Thank you for addressing all my comments.

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Public Health Research, Qualitative and quantitative design, Social Determinants of Health and cross cultural research

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.

Respond to this report

Responses (0)

Back to all reports

Reviewer Report

15 Views

07 Jun 2024 | for Version 1

Masoud Mohammadnezhad, Birmingham City University, Birmingham, England, UK

15 Views Cite this report Responses(1)

Approved With Reservations

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Yes
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Public Health Research, Qualitative and quantitative design, Social Determinants of Health and cross cultural research

Respond to this report

Responses (1)

Author Response

17 Jun 2024

Tina Bedenik, School of Population Health, RCSI University of Medicine and Health Sciences, Dublin, D02 DH60, Ireland

We wish to thank the reviewer for the feedback. We respond to each of the points below.

In the abstract and its method section- please put COREQ in the parenthesis.

Response: We have placed COREQ in the parenthesis.

Please do the same in the method section of main text (put COREQ in the parenthesis).

Response: We have placed COREQ in the parenthesis.

Explain the study setting. From where the study participants will be chosen and why?

Response: We added information regarding study setting in the Abstract/Background of the revised version, and this information is present in the ‘Study design’ section of the former version. The participants are chosen because of their prior knowledge, experiences and interest in secondary health data use, which we outlined in ‘Participants and recruitment’ section of the paper.

Please write all the inclusion and exclusion criteria. Do they need to be from Ireland? Will you
exclude those who are not willing to participate?

Response: Both inclusion and exclusion criteria have been outlined in the section ‘Participants and recruitment’:
“Participants will be selected based on the following inclusion criteria: belonging to one of the five identified groups, experience with secondary health data use (applicable to SG1-4), and an interest in participating in the exploration of this topic regardless of their prior knowledge of secondary health data use (SG5). The study will only include participants aged 18+ years who are able to provide written, informed consent. The study will exclude those who cannot communicate fluently in English language.”
We added that all participants will be recruited from Ireland in ‘Participants and recruitment’ section of the revised version to increase clarity.

Please explain how did you measured the number of FGD? You mentioned one FGD from SG1-4 and 5 FGDs for the SG5. How did you reach to this number?

Response: We decided on five study groups to facilitate a discussion among all relevant stakeholders in Ireland regarding secondary use of health data. In addition, the literature suggests that in qualitative studies 4–8 focus group discussions are sufficient to reach saturation (Hennink & Kaiser, 2022). We included this information in the revised version.

How did you develop the study tool/questionnaire? Any pilot study before applying in the main
study?

Response: We provided information on the topic guide and the pilot in the ‘Data collection’ section of the article:
“The topic guide was informed by the literature review and it had been discussed with the RCSI PPI Panel, Industry Partner IQVIA Ireland and HIQA, IPPOSI and the HSE. The topic guide tailored for SG5 (Patients and Public) will be piloted in an online semi-structured interview with a female PPI Panel member, and the topic guide tailored for SG1-4 will be piloted in an online semi-structured interview with a qualitative researcher in the RCSI School of Population Health.”

Who will conduct interviews? Any previous experience?

Response: Information is provided in the article, under section ‘Research team and reflexivity’:
“The focus groups and any semi-structured interviews will be organised and conducted by TB.”
We added the information regarding researcher’s previous experience in the revised version.

Why you easily change the FGD to in-depth interview for those who are not able to attend FGD.
Don’t you think this may affect the quality of response?

Response: Thank you for the comment. We did not conduct any in-depth interviews, and all data is collected via focus group discussions. We have amended the article to reflect this more accurately.

How about study trustworthiness? The credibility, transferability, dependability,..?

Response: In order to increase trustworthiness and methodological rigor we outlined in the article that two members of the research team will independently code two focus group transcripts, and discuss the results. This is to ensure intercoder reliability, and we added this information in the revised version. We also outlined researchers’ positionality to identify and reduce any bias, and therefore enable a production of more trustworthy knowledge. Finally, we will also refer to and contrast with any published literature in the area when reporting the study findings, to increase the credibility, transferability and dependability.

View more View less

Competing Interests

No competing interests were disclosed.

Back to all reports

Reviewer Report

46 Views

31 Oct 2023 | for Version 1

Aileen Grant, School of Nursing and Midwifery, Robert Gordon University, Aberdeen, UK

46 Views Cite this report Responses(1)

Approved

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Yes
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Qualitative methods

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.

Respond to this report

Responses (1)

Author Response

17 Jun 2024

Tina Bedenik, School of Population Health, RCSI University of Medicine and Health Sciences, Dublin, D02 DH60, Ireland

We would like to thank the reviewer for the helpful comment.

We have outlined in the section ‘Participants and recruitment’ who are the people that will take part in the study:
Study Group 1 (SG1): Academics and Researchers using secondary data for research;
Study Group 2 (SG2): Healthcare Professionals from primary care and hospital settings;
Study Group 3 (SG3): Data Protection, Ethics and Privacy Experts and Data Controllers involved in health data;
Study Group 4 (SG4): Pharmaceutical Industry;
Study Group 5 (SG5): Patients and Public.
We added information that all participants will be recruited from Ireland, to increase clarity.

Thank you for the suggestion regarding the inclusion of perspectives of patients with multimorbidity. In the patients and public study group we include both persons with comorbidity and multimorbidity, and their views on the interactions with multiple healthcare providers and the impact on data sharing and use.

View more View less

Competing Interests

No competing interests were disclosed.

Alongside their report, reviewers assign a status to the article:

Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested

Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.

Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions

[1] Aitken M, Cunningham-Burley S, Pagliari C: Moving from trust to trustworthiness: Experiences of public engagement in the Scottish Health Informatics Programme. Sci Public Policy. 2016b; 43(5): 713–723. PubMed Abstract | Publisher Full Text | Free Full Text

[2] Aitken M, de St Jorre J, Pagliari C, et al.: Public responses to the sharing and linkage of health data for research purposes: a systematic review and thematic synthesis of qualitative studies. BMC Med Ethics. 2016a; 17(1): 73. PubMed Abstract | Publisher Full Text | Free Full Text

[3] Audrey S, Brown L, Campbell R, et al.: Young people's views about consenting to data linkage: findings from the PEARL qualitative study. BMC Med Res Methodol. 2016; 16(34): 34. PubMed Abstract | Publisher Full Text | Free Full Text

[4] Baird W, Jackson R, Ford H, et al.: Holding personal information in a disease-specific register: the perspectives of people with multiple sclerosis and professionals on consent and access. J Med Ethics. 2009; 35(2): 92–96. PubMed Abstract | Publisher Full Text

[5] Braun V, Clarke V: Using thematic analysis in psychology. Qual Res Psychol. 2006; 3(2): 77–101. Publisher Full Text

[6] Braun V, Clarke V: Reflecting on reflexive thematic analysis. Qual Res Sport Exerc Health. 2019; 11(4): 589–597. Publisher Full Text

[7] Broadbent S, Nicholas L: Collective intelligence in patient organisations. Nesta. London, 2015. Reference Source

[8] Buckley BS, Murphy AW, MacFarlane AE: Public attitudes to the use in research of personal health information from general practitioners' records: a survey of the Irish general public. J Med Ethics. 2011; 37(1): 50–55. PubMed Abstract | Publisher Full Text

[9] Carson C, Hinton L, Kurinczuk J, et al.: ‘I haven’t met them, I don’t have any trust in them. It just feels like a big unknown’: a qualitative study exploring the determinants of consent to use Human Fertilisation and Embryology Authority registry data in research. BMJ Open. 2019; 9(5): e026469. PubMed Abstract | Publisher Full Text | Free Full Text

[10] Cheah PY, Jatupornpimol N, Hanboonkunupakarn B, et al.: Challenges arising when seeking broad consent for health research data sharing: a qualitative study of perspectives in Thailand. BMC Med Ethics. 2018; 19(1): 86. PubMed Abstract | Publisher Full Text | Free Full Text

[11] Clerkin P, Buckley BS, Murphy AW, et al.: Patients' views about the use of their personal information from general practice medical records in health research: a qualitative study in Ireland. Fam Pract. 2013; 30(1): 105–12. PubMed Abstract | Publisher Full Text

[12] Damschroder LJ, Pritts JL, Neblo MA, et al.: Patients, privacy and trust: patients' willingness to allow researchers to access their medical records. Soc Sci Med. 2007; 64(1): 223–235. PubMed Abstract | Publisher Full Text

[13] Evans EA, Delorme E, Cyr K, et al.: A qualitative study of big data and the opioid epidemic: recommendations for data governance. BMC Med Ethics. 2020; 21(1): 101. PubMed Abstract | Publisher Full Text | Free Full Text

[14] Flaherty SJ, Duggan C, O'Connor L, et al.: What influences a person’s willingness to share health information for both direct care and uses beyond direct care? Findings from a focus group study in Ireland [version 2; peer review: 4 approved]. HRB Open Res. 2022; 5: 36. PubMed Abstract | Publisher Full Text | Free Full Text

[15] Garrison NA, Sathe NA, Antommaria AHM, et al.: A systematic literature review of individuals' perspectives on broad consent and data sharing in the United States. Genet Med. 2016; 18(7): 663–671. PubMed Abstract | Publisher Full Text | Free Full Text

[16] Guilbeault D, Centola D: Networked collective intelligence improves dissemination of scientific information regarding smoking risks. PLoS One. 2020; 15(2): e0227813. PubMed Abstract | Publisher Full Text | Free Full Text

[17] Grant A, Ure J, Nicolson DJ, et al.: Acceptability and perceived barriers and facilitators to creating a national research register to enable 'direct to patient' enrolment into research: the Scottish Health Research Register (SHARE). BMC Health Serv Res. 2013; 13: 422. PubMed Abstract | Publisher Full Text | Free Full Text

[18] Haddow G, Bruce A, Sathanandam S, et al.: 'Nothing is really safe': a focus group study on the processes of anonymizing and sharing of health data for research purposes. J Eval Clin Pract. 2011; 17(6): 1140–1146. PubMed Abstract | Publisher Full Text

[19] Hate K, Meherally S, Shah More N, et al.: Sweat, skepticism, and uncharted territory: a qualitative study of opinions on data sharing among public health researchers and research participants in Mumbai, India. J Empir Res Hum Res Ethics. 2015; 10(3): 239–250. PubMed Abstract | Publisher Full Text | Free Full Text

[20] Hill EM, Turner EL, Martin RM, et al.: "Let's get the best quality research we can": public awareness and acceptance of consent to use existing data in health research: a systematic review and qualitative study. BMC Med Res Methodol. 2013; 13: 72. PubMed Abstract | Publisher Full Text | Free Full Text

[21] Hogan M, Ojo A, Harney O, et al.: Governance, transparency and the collaborative design of open data collaboration platforms: understanding barriers, options, and needs. In: Ojo, A., Millard, J. (eds) Government 3.0 – next generation government technology infrastructure and services, Public Administration and Information Technology. Springer, Cham; 2017; 32. Publisher Full Text

[22] Hogan MJ, Johnston H, Broome B, et al.: Consulting with citizens in the design of wellbeing measures and policies: lessons from a systems science application. Soc Indic Res. 2015; 123: 857–877. Publisher Full Text

[23] Howe N, Giles E, Newbury-Birch D, et al.: Systematic review of participants' attitudes towards data sharing: a thematic synthesis. J Health Serv Res Policy. 2018; 23(2): 123–133. PubMed Abstract | Publisher Full Text

[24] Hutchings E, Loomes M, Butow P, et al.: A systematic literature review of health consumer attitudes towards secondary use and sharing of health administrative and clinical trial data: a focus on privacy, trust, and transparency. Syst Rev. 2020; 9(1): 235. PubMed Abstract | Publisher Full Text | Free Full Text

[25] Hutchings E, Loomes M, Butow P, et al.: A systematic literature review of attitudes towards secondary use and sharing of health administrative and clinical trial data: a focus on consent. Syst Rev. 2021; 10(1): 132. PubMed Abstract | Publisher Full Text | Free Full Text

[26] Jootun D, McGhee G, Marland GR: Reflexivity: promoting rigour in qualitative research. Nurs Stand. 2009; 23(23): 42–46. PubMed Abstract

[27] Kalkman S, van Delden J, Banerjee A, et al.: Patients’ and public views and attitudes towards the sharing of health data for research: a narrative review of the empirical evidence. J Med Ethics. 2022; 48(1): 3–13. PubMed Abstract | Publisher Full Text | Free Full Text

[28] Kurvers RH, Wolf M, Naguib M, et al.: Self-organized flexible leadership promotes collective intelligence in human groups. R Soc Open Sci. 2015; 2(12): 150222. PubMed Abstract | Publisher Full Text | Free Full Text

[29] Malone TW, Laubacher R, Dellarocas CN: Harnessing Crowds: mapping the genome of collective intelligence. MIT Sloan Research Paper No. 4732-09, 2009. Publisher Full Text

[30] McGuire AL, Hamilton JA, Lunstroth R, et al.: DNA data sharing: research participants' perspectives. Genet Med. 2008; 10(1): 46–53. PubMed Abstract | Publisher Full Text | Free Full Text

[31] Nguyen VT, Young B, Ravaud P, et al.: Overcoming barriers to mobilizing collective intelligence in research: qualitative study of researchers with experience of collective intelligence. J Med Internet Res. 2019; 21(7): e13792. PubMed Abstract | Publisher Full Text | Free Full Text

[32] Nowell LS, Norris JM, White DE, et al.: Thematic analysis: striving to meet the trustworthiness criteria. Int J Qual Meth. 2017; 16(1).

[33] O'Reilly PM, Harney OM, Hogan MJ, et al.: Chronic pain self-management in middle-aged and older adults: A collective intelligence approach to identifying barriers and user needs in eHealth interventions. Digit Health. 2022; 8: 20552076221105484. PubMed Abstract | Publisher Full Text | Free Full Text

[34] Papoutsi C, Reed JE, Marston C, et al.: Patient and public views about the security and privacy of Electronic Health Records (EHRs) in the UK: results from a mixed methods study. BMC Med Inform Decis Mak. 2015; 15: 86. PubMed Abstract | Publisher Full Text | Free Full Text

[35] Perrin Z, Mathieu L: Exploratory literature review - Citizens’ perceptions of and involvement in health data secondary use and sharing in Europe (Milestone M8.1). Joint Action Towards the European Health Data Space - TEHDAS. 2021. Reference Source

[36] Platt J, Kardia S: Public trust in health information sharing: implications for biobanking and electronic health record systems. J Pers Med. 2015; 5(1): 3–21. PubMed Abstract | Publisher Full Text | Free Full Text

[37] Probst B: The eye regards itself: benefits and challenges of reflexivity in qualitative social work research. Social Work Research. 2015; 39(1): 37–48. Publisher Full Text

[38] PwC: Conti cyber attack on the HSE: Independent Post Incident Review. 2021. Reference Source

[39] Radcliffe K, Lyson HC, Barr-Walker J, et al.: Collective intelligence in medical decision-making: a systematic scoping review.  BMC Med Inform Decis Mak.   2019; 19(1): 158. PubMed Abstract | Publisher Full Text | Free Full Text

[40] Ritchie J, Lewis J: Qualitative Research Practice. A Guide for Social Science Students and Researchers.  London/Thousand Oaks/New Delhi: SAGE Publications. 2003. Reference Source

[41] Smithson J: Using and analysing focus groups: limitations and possibilities. Int J Soc Res Methodol. 2000; 3(2): 103–119. Publisher Full Text

[42] Spencer K, Sanders C, Whitley EA, et al.: Patient Perspectives on Sharing Anonymized Personal Health Data Using a Digital System for Dynamic Consent and Research Feedback: A Qualitative Study. J Med Internet Res. 2016; 18(4): e66. PubMed Abstract | Publisher Full Text | Free Full Text

[43] Stevenson F, Lloyd N, Harrington L, et al.: Use of electronic patient records for research: views of patients and staff in general practice. Fam Pract. 2013; 30(2): 227–232. PubMed Abstract | Publisher Full Text

[44] Stockdale J, Cassell J, Ford E: "Giving something back": A systematic review and ethical enquiry into public views on the use of patient data for research in the United Kingdom and the Republic of Ireland [version 2; peer review: 2 approved]. Wellcome Open Res. 2019; 3: 6. PubMed Abstract | Publisher Full Text | Free Full Text

[45] The Health Information and Quality Authority: Findings from the national public engagement on health information. Dublin, Ireland: Health Information and Quality Authority. 2021. Reference Source

[46] The Irish Platform for Patient Organisations, Science and Industry: Verdict from a citizens’ jury on access to health information. Dublin, Ireland: The Irish Platform for Patient Organisations, Science and Industry, 2021. Reference Source

[47] Tong A, Sainsbury P, Craig J: Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. Int J Qual Health Care. 2007; 19(6): 349–357. PubMed Abstract | Publisher Full Text

[48] Then KL, Rankin J, Ali E: Focus group research: what is it and how can it be used? Can J Cardiovasc Nurs. 2014; 24(1): 16–22. PubMed Abstract

[49] Trinidad SB, Fullerton SM, Bares JM, et al.: Genomic research and wide data sharing: views of prospective participants. Genet Med. 2010; 12(8): 486–495. PubMed Abstract | Publisher Full Text | Free Full Text

[50] Wolf M, Krause J, Carney PA, et al.: Collective intelligence meets medical decision-making: the collective outperforms the best radiologist. PLoS One. 2015; 10(8): e0134269. PubMed Abstract | Publisher Full Text | Free Full Text

Building public trust and confidence in secondary use of health data for healthcare improvement and research: a qualitative study pre-protocol

Abstract

Keywords

Revised Amendments from Version 1

Introduction

Methods

Study design

Stakeholders and Patient and Public Involvement (PPI)

Research team and reflexivity

Participants and recruitment

Data collection

Data analysis

Collective intelligence

Ethics

Dissemination

Study status

Conclusion

Data availability

Acknowledgments

References

Comments on this article Comments (0)

Open Peer Review

Comments on this article Comments (0)

Open Peer Review

Reviewer Status

Reviewer Reports

Comments on this article

Are you a HRB-funded researcher?

Thank you!

Building public trust and confidence in secondary use of health data for healthcare improvement and research: a qualitative study pre-protocol

Abstract

Keywords

Revised Amendments from Version 1

Introduction

Methods

Study design

Stakeholders and Patient and Public Involvement (PPI)

Research team and reflexivity

Participants and recruitment

Data collection

Data analysis

Collective intelligence

Ethics

Dissemination

Study status

Conclusion

Data availability

Acknowledgments

References

Comments on this article Comments (0)

Open Peer Review

Comments on this article Comments (0)

Open Peer Review

Reviewer Status

Reviewer Reports

Comments on this article

Competing Interests Policy

Stay Updated

Are you a HRB-funded researcher?

Thank you!