Development of a Quality Improvement and Patient Safety Research Conceptual Framework to Inform Research Priorities for the Irish Healthcare System: Protocol for a Scoping Review

Quality Improvement

QI is the systemic use of data-guided activities to bring about immediate improvements in healthcare delivery¹, and is considered a routine part of healthcare^1,2. In Ireland, the HSE Quality and Patient Safety Competency Navigator outlines the expectation for all healthcare staff to engage in QI activities, to a level commensurate with their role and function in the health service³. Internationally, QI is perceived as essential for achieving competency in supporting quality and safety^4–6 and United Nations (UN) Sustainable Development Goals (SDGs)⁷.

Quality Improvement methodologies

QI methodologies include any suite of tools (e.g. process maps, driver diagrams, statistical process control charts) and methods (e.g. model for improvement, lean, six-sigma) which provide a structured scientific approach to making improvements in healthcare⁸. According to a scoping review, most published QI initiatives conducted in Ireland (2015–2020) report use of an established QI methodology and achievement of aims⁹. The aims of the QI initiatives mainly related to improving the effectiveness, efficiency, and safety of care processes and outcomes, and few aimed to enhance patient-centredness, value for money, or staff well-being⁹. Initiatives rarely aimed to enhance the equity domain of quality⁹, an often ‘forgotten goal’ of QI internationally¹⁰. One example from the Irish context is available from the literature¹¹. However, most QI initiatives are unpublished. The conceptual framework is required to support research questions about all levels of QI work, irrespective of whether the QIs are published and available in the public domain.

Quality Improvement research

The primary purpose of QI is improved care and outcomes near to the time of data collection whereas research primarily aims to generate and disseminate new knowledge^12,13. The term ‘QI research’ brings these activities together and is defined as ‘the pursuit of generalizable new knowledge related to creating and sustaining improvement in health care delivery in real world settings’¹⁴. Additionally, terms such as ‘QI evaluation studies’ and ‘improvement science’ have been use to describe the study of improvement work^15–18.

The conduct of QI research, like conventional research studies, requires alignment between the study questions and methodology. However, the intervention and the context are primary parts of the effectiveness of improvement, making traditional high-status methodologies such as randomised control trials an inappropriate fit for the study of improvement¹⁹. General questions important to the field are (a) how can we attain improvement in complex systems?, and (b) how can we improve the way we improve?⁸. Dependent on the research question, multiple designs are recommended¹⁸ with increasing emphasis on realist syntheses^20,21, implementation science, health economic evaluation and behavioural science methods²².

Quality Improvement research priorities for the Irish healthcare system

QI research is considered to be in its infancy in Ireland and globally⁸. There is a need to align designs to important questions, which address a QI knowledge gap, and in particular a QI research priority. General knowledge gaps include the when, why and how of effective adaptation of improvement initiatives to context, and impacts on effectiveness and sustainability²³. In Ireland, even though, the National Patient Safety Strategy has established thirteen ‘patient safety improvement priorities’²⁴, criteria for establishing ‘QI research priorities’ are not yet known. In addition, there is a lack of co-ordination between established improvement priorities and research strategy for the healthcare system^24,25. There is also no current guidance on prioritising QI activities across quality domains, settings, and populations, and on selecting appropriate research methodologies and frameworks. Additionally, there is no guidance for identifying which QI initiatives (small- and large- scale) would make a valid and important contribution to generalisable new knowledge about creating and sustaining improvement.

A conceptual framework aligning research questions about improvement, with appropriate designs, allied to improvement priorities for the Irish Health System is needed. This framework should integrate fundamentally with patient safety research, given QI’s role in enhancing safe processes and outcomes and the focus of the EQUIPS Research Network.

Patient safety research

Patient safety is considered an attribute of healthcare systems^26,27, and safe systems seek to avoid, prevent and ameliorate adverse outcomes or injuries stemming from care^28,29. Patient safety, as a discipline of study, applies ‘safety science methods toward the goal of achieving a trustworthy health system of care’²⁶. Research is core to enabling the acquisition and application of knowledge to create fail safe and resilient systems^26,30. In the early 2000s, the World Health Organisation (WHO) published the Patient Safety Research Cycle which outlined the core research functions of patient safety research. These were 1) measuring harm, 2) understanding the causes of harm, 3) identifying locally affordable solutions, 4) evaluating impact and 5) translating evidence into safer care³¹. The 2017 Organisation for Economic Co-operation and Development (OECD) Report ‘The Economics of Patient Safety’ highlighted multiple patient safety solutions which require evaluation and tailoring to local contexts^32,33. Together, these reports highlight the applied and evaluative nature of patient safety research which aims to lead to the development or adaptation of locally effective, appropriate and affordable solutions³². In a similar vein, the European Medicines Agency have highlighted the role of perceptions and behavioural research to enhance adherence and strengthen safety³⁴.

Patient safety research in Ireland

A 2023 scoping review identified only a modest amount of patient safety research studies conducted in Ireland³⁵. Most focussed on measuring past harm and safety culture and a minority evaluated patient safety solutions³⁵. The review called for the availability of patient record data, tailored to distinct aspects of patient harm (e.g. specific care-related injuries, missed diagnoses that lead to harm) to address HSE strategic goals to measure and monitor safety, and establish and evaluate safety improvement initiatives³⁵.

Limitations of the review were a hospital focus, and exclusion of studies which focussed on the safety of one process e.g. medication errors, or patients with a particular medical condition e.g. patients with diabetes³⁵. For practicality, the scoping review examined safety in the generic sense and studies which addressed many of the 13 HSE patient safety improvement priorities (e.g., falls, pressure ulcers, sepsis etc.) were excluded.

Patient safety research priorities for the Irish healthcare system

Criteria for establishing patient safety research priorities have evolved over time. In the early 2000s, relevant WHO criteria were ‘the frequency of the safety issue; the magnitude of harm and its distribution within the population; the effect on the efficiency of the health system; the availability, feasibility, and sustainability of solutions; and the urgency or political backing required to tackle the problem’³². Fifty identified research priorities for developed countries are detailed in WHO reports³². It was expected that further knowledge in these substantial knowledge gaps would contribute to improving patient safety³². Priorities for developed countries like Ireland focussed on the underlying processes and organisational factors that lead to unsafe care and the cost-effectiveness of risk-reducing strategies³².

Recently, safety prioritisation exercises have included equity as a key criterion. For example, a 2017 WHO exercise, which consulted global experts, identified research priorities/questions for medication safety research based on the criteria of answerability, effectiveness, innovativeness, implementation, burden reduction and equity³⁶. In England, an inductive approach to the development of patient safety research priorities for primary care among healthcare staff and patients identified concern for the most vulnerable in society as a key priority³⁷. The equity emphasis is underpinned by the WHO Global Action Plan for Patient Safety 2021–2030, which has aligned patient safety with United Nation’s Sustainable Development Goals UNSDGs³⁸. These SDGs reinforce new priority areas in the literature such as the impact of staff well-being on patient safety^39,40 and the need for environmental sustainability and safety to co-exist, without additional risk to patients⁴¹. Yet, in Ireland, the current criteria for establishing patient safety research priorities have yet to be agreed, as well as the mode for establishing the criteria.

Irish health system developments

In recent years, new infrastructural developments in the Irish Health System, have linked QI and safety goals, making the current integrated assessment of research priorities timely to inform future policy and practice. For example, Ireland established a National Patient Safety Agency and introduced a new Patient Safety Act, mandating open disclosure⁴². Healthcare regions have recently been redefined with the aim of integrating hospital and community care and facilitating the right care at the right time and place⁴³. Despite Ireland being a relatively late adopter of integrated digital technologies⁴⁴, the use of electronic health records, digital solutions and artificial intelligence is expected to increase over the next decade. For example, a new digitally-powered National Patient Safety Surveillance System is soon to be developed, which will draw on existing HSE Quality and Safety Signals data sources and the National Centre for Clinical Audit data⁴⁵. The system will be pro-actively engaged in risk management and improvement work, and will generate greater capacity for QI and patient safety research in Ireland. This enhanced capacity may in turn impact the feasibility of certain research priorities. However, if not carefully implemented, a digital strategy could also contribute to harm and inequities.

Therefore, given the strategic reforms⁴⁶ and digitisation of healthcare⁴⁷, now is an ideal time to ‘design in’ quality and safety into new models of care, and identify relevant quality and safety challenges, and consequent research priorities for the Irish health system. A scoping review is needed to collate all the relevant evidence and inform discussions about harmonised QI and patient safety research priorities for the Irish context.

Eligibility criteria

The eligibility criteria are informed by a Phenomenon of Interest, Concept, Context approach, as presented in Table 1. We will include all study types across peer reviewed and grey literature. Editorials, book chapters and conference proceedings will be excluded. Since we want to identify frameworks and research priorities applicable to the Irish healthcare context, we will focus on papers from developed countries only, as these will have similar healthcare challenges and research needs. For example, a prior global WHO patient research prioritisation exercise took the approach of identifying priorities for developed, transitional and developing countries³¹. Only English language sources will be reviewed due to language limitations of the review team. Similar to other reviews⁴¹, for practicality reasons and to avoid duplication with other research areas, we will exclude papers that focus on the improvement and safety of singular medical processes (e.g. medication safety) and particular patient groups (e.g. patients with diabetes), unless their primary focus is on discussion of research definitions, frameworks, models and/or priorities for QI and/or patient safety research. All healthcare settings will be included.

Information sources and search strategy

A search strategy was developed in consultation with an information specialist (KW) for the selected databases (2000–2025): Ovid MEDLINE, Embase, CINAHL, Scopus, Cochrane Library, Web of Science. Grey literature sources will include international and national government and agency reports, relevant to QI and patient safety research and will be purposively selected from established agencies websites (e.g., World Health Organisation, Agency for Healthcare Research and Quality Patient Safety Network) known to the authors. The search strategy for an example database is presented in Table 2. The full search strategy for each database is available on OSF (https://doi.org/10.17605/OSF.IO/FGWUA; see Supplementary File 1).

Data management and study selection

Identified records will be imported to Covidence to manage screening and extraction. Two reviewers will independently assess retrieved records against eligibility criteria. Titles and abstracts will be screened for relevance, followed by full-text review to examine if eligibility criteria are met. Disagreement among reviewers will be resolved by consulting a third reviewer to reach consensus. A PRISMA flow diagram will be generated to map out the number of records identified, included and excluded, and the reasons for exclusion.

Data extraction

Two reviewers will use a piloted, standardised data extraction form, developed in Covidence, to independently extract data relevant to the scoping review aims (see Table 3 for draft template). Disagreement among reviewers will be resolved by a third reviewer.

Data analysis and presentation

Tables and graphs will be used to present data which address the study research questions. Findings will demonstrate the breadth of QI and patient safety research frameworks, and will indicate synergies and gaps. Researchers and Knowledge Users will be involved in the analysis and presentation of findings, which will be used to develop a research conceptual framework and to inform a research prioritisation exercise among EQUIPS members.

Knowledge user engagement and co-creation

In accordance with the JBI guidance and operating principles of the EQUIPS Research Network, knowledge users (i.e., healthcare staff and patient partners) will co-create all elements of the scoping review⁵⁰. The knowledge users are the Lead Knowledge users who volunteered and self-selected to work together with the Researchers in Strand 2.1 of EQUIPS Research Network, and those who may join this strand of work as it develops. The work of Strand 2.1 primarily concerns establishing relevant research priorities and methodologies, to better facilitate multi-disciplinary and applied research relevant to the HSE patient safety and improvement priorities. As such, prior to the development of the scoping review protocol, pre-planning meetings for the conceptualisation of the review took place with knowledge users⁵⁰. Then as part of the protocol development, knowledge users (TK, JB) helped develop the research questions, search strategy, and reviewed drafts of the protocol manuscript to ensure its helpfulness to their role. Due to time and resource constraints, knowledge users have decided not to take an active role in prospective scoping review screening, selecting and extracting articles, though this option was available if desired. Knowledge users will, in accordance with the guidance, review results to see if these ‘make sense’ and how they may best contribute to the planned development and usability of a QI and Patient Safety Research Conceptual Framework relevant for the Irish context⁵⁰. Using their unique experiences, context and perspectives, after the scoping review is published, knowledge users will alongside the researchers, support dissemination activities, and in ways uniquely relevant in their communities and healthcare settings (e.g. sharing on social media or at journal clubs)⁵⁰. Where researchers and knowledge users contribute substantially to the work, authorship rights will be applied in accordance with the International Committee of Medial Journal Editors Criteria⁵². The actual process of the co-creation of the scoping review will be reported in the final study manuscript using the Guidance for Reporting Involvement of Patients and the Public 2 (GRIPP2) short form checklist, a tool which supports improved reporting of patient and public involvement in research⁵³.

Dissemination

The paper will be submitted for publication in a peer-reviewed journal, and presented at national and international quality and safety conferences.

Study status

Between 12 June 2025 and 18 July 2025, the search strategy was developed, piloted, and refined, in consultation with an information specialist. The final search was conducted on 18 July 2025. Title and abstract screening commenced on 21 July 2025 and is ongoing at the time of submission.