Community views on the secondary use of general practice data: Findings from a mixed-methods study.

INTRODUCTION: General practice data, particularly when combined with hospital and other health service data through data linkage, are increasingly being used for quality assurance, evaluation, health service planning and research. In this study, we explored community views on sharing general practice data for secondary purposes, including research, to establish what concerns and conditions need to be addressed in the process of developing a social licence to support such use. METHODS: We used a mixed-methods approach with focus groups (November-December 2021), followed by a cross-sectional survey (March-April 2022). RESULTS: The participants in this study strongly supported sharing general practice data with the clinicians responsible for their care, and where there were direct benefits for individual patients. Over 90% of survey participants (N = 2604) were willing to share their general practice information to directly support their health care, that is, for the primary purpose of collection. There was less support for sharing data for secondary purposes such as research and health service planning (36% and 45% respectively in broad agreement) or for linking general practice data to data in the education, social services and criminal justice systems (30%-36%). A substantial minority of participants were unsure or could not see how benefits would arise from sharing data for secondary purposes. Participants were concerned about the potential for privacy breaches, discrimination and data misuse and they wanted greater transparency and an opportunity to consent to data release. CONCLUSION: The findings of this study suggest that the public may be more concerned about sharing general practice data for secondary purposes than they are about sharing data collected in other settings. Sharing general practice data more broadly will require careful attention to patient and public concerns, including focusing on the factors that will sustain trust and legitimacy in general practice and GPs. PATIENT AND PUBLIC CONTRIBUTION: Members of the public were participants in the study. Data produced from their participation generated study findings. CLINICAL TRIAL REGISTRATION: Not applicable.

Development and implementation of a national online application system for cross-jurisdictional linked data.

The Population Health Research Network (PHRN) is an Australian national data linkage infrastructure that links a wide range of health and human services data in privacy-preserving ways. The data linkage infrastructure enables researchers to apply for access to routinely collected, linked, administrative data from the six states and two territories which make up the Commonwealth of Australia, as well as data collected by the Australian Government. The PHRN is a distributed network where data is collected and managed at the respective jurisdictional and/or cross-jurisdictional levels. As a result, access to linked data from multiple jurisdictions requires complex approval processes. This paper describes Australia's approach to enabling access to linked data from multiple jurisdictions. It covers the identification of, and agreement to, a minimum set of data items to be included in a unified national application form, the development and implementation of a national online application system and the harmonisation of business processes for cross-jurisdictional research projects. Utilisation of the online application system and the ongoing challenges of data linkage across jurisdictions are discussed. Changes to the data custodian and ethics committee approval criteria were out of scope for this project.

Data Linkage in Australia: The First 50 Years.

Population-based data linkage has a long history in Australia from its beginnings in Western Australia in the 1970s to the coordinated national data linkage infrastructure that exists today. This article describes the journey from an idea to a national data linkage network which has impacts on the health and well-being of Australians from preventing developmental anomalies to responding to the COVID-19 pandemic. Many enthusiastic and dedicated people have contributed to Australia's data linkage capability over the last 50 years. They have managed to overcome a number of challenges including gaining stakeholder and community support; navigating complex legal and ethical environments; establishing cross-jurisdictional collaborations, and gaining ongoing financial support. The future is bright for linked data in Australia as the infrastructure built over the last 50 years provides a firm foundation for further expansion and development, ensuring that Australia's linked health and human services data continues to be available to address the evolving challenges of the next half century.

Sharing administrative health data with private industry: A report on two citizens' juries.

BACKGROUND: There is good evidence of both community support for sharing public sector administrative health data in the public interest and concern about data security, misuse and loss of control over health information, particularly if private sector organizations are the data recipients. To date, there is little research describing the perspectives of informed community members on private sector use of public health data and, particularly, on the conditions under which that use might be justified. METHODS: Two citizens' juries were held in February 2020 in two locations close to Sydney, Australia. Jurors considered the charge: 'Under what circumstances is it permissible for governments to share health data with private industry for research and development?' RESULTS: All jurors, bar one, in principle supported sharing government administrative health data with private industry for research and development. The support was conditional and the juries' recommendations specifying these conditions related closely to the concerns they identified in deliberation. CONCLUSION: The outcomes of the deliberative processes suggest that informed Australian citizens are willing to accept sharing their administrative health data, including with private industry, providing the intended purpose is clearly of public benefit, sharing occurs responsibly in a framework of accountability, and the data are securely held. PATIENT AND PUBLIC CONTRIBUTION: The design of the jury was guided by an Advisory Group including representatives from a health consumer organization. The jurors themselves were selected to be descriptively representative of their communities and with independent facilitation wrote the recommendations.

Authorising the Release of Data without Consent for Health Research: The Role of Data Custodians and HRECs in Australia.

In Australia, access to administrative data for research without consent invokes a plethora of governance requirements. Whether these requirements are met is assessed by at least one human research ethics committee (HREC) and each of the custodians of the relevant data collections. In this article, we examined and compared the decision-making processes of data custodians and HRECs. These processes were investigated using three case studies and qualitative interviews with data custodians around Australia. The investigation demonstrated that there was significant overlap and duplication in the review of applications for access to data without consent between HRECs and data custodians. This was the result of overlapping requirements in the relevant legislation and policies with those in the National Statement for Ethical Conduct in Human Research 2007 (updated 2018) as well as confusion about the distinct roles of HRECs and data custodians.

Maximising data value and avoiding data waste: a validation study in stroke research.

OBJECTIVES: To determine the feasibility of linking data from the Australian Stroke Clinical Registry (AuSCR), the National Death Index (NDI), and state-managed databases for hospital admissions and emergency presentations; to evaluate data completeness and concordance between datasets for common variables. DESIGN, SETTING, PARTICIPANTS: Cohort design; probabilistic/deterministic data linkage of merged records for patients treated in hospital for stroke or transient ischaemic attack from New South Wales, Queensland, Victoria, and Western Australia. MAIN OUTCOME MEASURES: Descriptive statistics for data matching success; concordance of demographic variables common to linked databases; sensitivity and specificity of AuSCR in-hospital death data for predicting NDI registrations. RESULTS: Data for 16 214 patients registered in the AuSCR during 2009-2013 were linked with one or more state datasets: 15 482 matches (95%) with hospital admissions data, and 12 902 matches (80%) with emergency department presentations data were made. Concordance of AuSCR and hospital admissions data exceeded 99% for sex, age, in-hospital death (each κ = 0.99), and Indigenous status (κ = 0.83). Of 1498 registrants identified in the AuSCR as dying in hospital, 1440 (96%) were also recorded by the NDI as dying in hospital. In-hospital death in AuSCR data had 98.7% sensitivity and 99.6% specificity for predicting in-hospital death in the NDI. CONCLUSION: We report the first linkage of data from an Australian national clinical quality disease registry with routinely collected data from several national and state government health datasets. Data linkage enriches the clinical registry dataset and provides additional information beyond that for the acute care setting and quality of life at follow-up, allowing clinical outcomes for people with stroke (mortality and hospital contacts) to be more comprehensively assessed.

The role of data custodians in establishing and maintaining social licence for health research.

In this article we explore the role of data custodians in establishing and maintaining social licence for the use of personal information in health research. Personal information from population-level data collections can be used to make significant contributions to health and medical research, but this use is dependent on community acceptance or a social licence. We conducted semi-structured interviews with data custodians across Australia to better understand data custodians' views on their roles and responsibilities. This inductive, thematic analysis of the interview data focuses on three factors that contribute to social licence - reciprocity, non-exploitation and the public good. While the data custodians interviewed did not explicitly frame their role in the context of social licence, their descriptions of their roles and responsibilities clearly indicated that they did have some role to play in building and maintaining social licence.

Data Custodians and the Decision-making Process: Releasing Data for Research.

The empirical research presented in this article was prompted by concerns expressed by researchers about the decision-making processes of government data custodians. Data custodians are responsible for the collection, use and disclosure of vast collections of personal information, including the release of data from these collections for research. Researchers were concerned that the decision-making processes were time-consuming, complex and not transparent. The authors sought the views of data custodians in response, exploring the issues from the other side of the data divide. The majority of the 13 data custodians interviewed for this project were located in government sector agencies and their decision-making process was thus highly regulated and constrained by principles of administrative law. They did, however, have many thoughtful suggestions for change to improve the experience for all the stakeholders involved in the process of seeking and granting access to government-held data collections for research.

Recent trends in the use of linked data in Australia.

Objective The aim of this study was to quantify the use of linked data for health and human services research in Australia since the establishment of the Population Health Research Network (PHRN) in 2009. Methods A systematic literature search was performed using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2009 checklist to search for all publications involving the use of Australian linked data between 2009-10 and 2016-17. Publications were categorised by subject, data linked and data linkage unit involved. Results In all, 7153 articles were identified from the initial search, and 1208 were included in the final analysis. An increase in the number of publications involving linked data was observed from 2009-10 through to 2015-16. Most articles (82%) featured data linked by at least one PHRN-funded data linkage unit. The research areas of 86% of publications were able to be classified according to the International Statistical Classification of Diseases and Related Health Problems 10th Revision Australian Modification (ICD-10-AM). The number of publications involving cross-sectoral linked data also increased. Conclusions Investment in Australian data linkage infrastructure has seen an increase in the number of research publications involving the use of linked health and human services data. This study identified areas where linked data is commonly used and those where use could be improved. What is known about the topic? Data linkage is a method of bringing together information about individual people, places and events from different sources in a way that protects individual privacy. Individual jurisdictions have reported benefits from research conducted using linked data, including the generation of new knowledge and supporting improvements in the delivery of a wide range of health and human services. There has been significant investment in national data linkage infrastructure in Australia over the past 8 years. To date, there has been no systematic investigation of the effect of this investment on the use of linked population data by the research community. What does this paper add? This paper provides evidence of the increased use of high-quality population-based linked data in research over the 8-year period studied. It demonstrates the application of data linkage across a wide range of health areas and highlights the small but growing number of studies using cross-sectoral data to investigate complex conditions. What are the implications for practitioners? It is important to demonstrate to funders, policy makers, data custodians and researchers the value of robust data linkage capacity as an important national resource. Its use by researchers can bring enormous social and economic benefits by providing a more complete picture of the health and well-being of the community. The range of data collections routinely linked is increasing, as is the pool of researchers experienced in handling and analysing the data. Continued investment in Australia's data linkage infrastructure and the inclusion of other collections including general practice data will augment the use of this infrastructure in expanding the evidence base for policy makers and practitioners.

Addressing the challenges of cross-jurisdictional data linkage between a national clinical quality registry and government-held health data.

OBJECTIVE: To describe the challenges of obtaining state and nationally held data for linkage to a non-government national clinical registry. METHODS: We reviewed processes negotiated to achieve linkage between the Australian Stroke Clinical Registry (AuSCR), the National Death Index, and state held hospital data. Minutes from working group meetings, national workshop meetings, and documented communications with health department staff were reviewed and summarised. RESULTS: Time from first application to receipt of data was more than two years for most state data-sets. Several challenges were unique to linkages involving identifiable data from a non-government clinical registry. Concerns about consent, the re-identification of data, duality of data custodian roles and data ownership were raised. Requirements involved the development of data flow methods, separating roles and multiple governance and ethics approvals. Approval to link death data presented the fewest barriers. CONCLUSION: To our knowledge, this is the first time in Australia that person-level data from a clinical quality registry has been linked to hospital and mortality data across multiple Australian jurisdictions. Implications for Public Health: The administrative load of obtaining linked data makes projects such as this burdensome but not impossible. An improved national centralised strategy for data linkage in Australia is urgently needed.

Evaluation in health promotion: thoughts from inside a human research ethics committee.

Health promotion research, quality improvement and evaluation are all activities that raise ethical issues. In this paper, the Chair and a member of human resear ch ethics committees provide an insiders' point of view on how to demonstrate ethical conduct in health promotion research and quality improvement. Several common issues raised by health promotion research and evaluation are discussed including researcher integrity, conflicts of interest, use of information, consent and privacy.

An evaluation of a data linkage training workshop for research ethics committees.

BACKGROUND: In Australia research projects proposing the use of linked data require approval by a Human Research Ethics Committee (HREC). A sound evaluation of the ethical issues involved requires understanding of the basic mechanics of data linkage, the associated benefits and risks, and the legal context in which it occurs. The rapidly increasing number of research projects utilising linked data in Australia has led to an urgent need for enhanced capacity of HRECs to review research applications involving this emerging research methodology. The training described in this article was designed to respond to an identified need among the data linkage units in the Australian Population Health Research Network (PHRN) and HREC members in Australia. METHODS: Five one-day face to face workshops were delivered in the study period to a total of 98 participants. Participants in the workshops represented all six categories of HREC membership composition listed in the National Health and Medical Research Centres' (NHMRC) National Statement on Ethical Conduct in Human Research. Participants were assessed at three time points, prior to the training (T1), immediately after the training (T2) and 8 to 17 months after the training (T3). RESULTS: Ninety participants completed the pre and post questionnaires; 58 of them completed the deferred questionnaire. Participants reported significant improvements in levels of knowledge, understanding and skills in each of the eight areas evaluated. The training was beneficial for those with prior experience in the area of ethics and data linkage as well as those with no prior exposure. CONCLUSIONS: Our preliminary work in this area demonstrates that the provision of intensive face to face ethics training in data linkage is feasible and has a significant impact on participant's confidence in reviewing HREC applications.

Susceptibility of children to environmental pollutants.

Children are more vulnerable to adverse environmental exposures. The unique ways in which they interact with their environment and their dynamic developmental physiology mean that they generally receive a higher dose of toxicant for a given level of environmental exposure. In addition, children are frequently more likely to suffer adverse health outcomes from exposures. The developmental stage of the child during which the exposure occurs has a major influence on the consequences of the exposure. For example, exposures during organogenesis may result in permanent structural changes, whereas exposures once organogenesis is complete are more likely to result in functional consequences. The immune, respiratory, and central nervous systems are immature at birth and have a prolonged period of postnatal maturation. Thus, these organ systems are vulnerable to postnatal exposures.