Profiling and Mapping Quality Improvement and Patient Safety Research Frameworks: Protocol for a Scoping Review to Guide Integration

Siobhán E McCarthy; Jill Poots; John McCaffrey; Emily O'Dowd; Anna V Chatzi; Killian Walsh; Jennifer A Pallin; Clíodhna McGowan; Tommy Kyaw Tun; John Brennan; Samuel Cromie; Edward W Gregg

doi:10.12688/hrbopenres.14173.3

. 2026 Apr 28;8:92. Originally published 2025 Aug 18. [Version 3] doi: 10.12688/hrbopenres.14173.3

Profiling and Mapping Quality Improvement and Patient Safety Research Frameworks: Protocol for a Scoping Review to Guide Integration

Siobhán E McCarthy ^1,^a, Jill Poots ², John McCaffrey ³, Emily O'Dowd ⁴, Anna V Chatzi ⁵, Killian Walsh ⁶, Jennifer A Pallin ³, Clíodhna McGowan ³, Tommy Kyaw Tun ⁷, John Brennan ⁸, Samuel Cromie ², Edward W Gregg ^3,⁹

PMCID: PMC13044539 PMID: 41939513

Version Changes

Revised. Amendments from Version 2

Minor differences. Changes only to introduction providing increased conceptual clarity. For example, on what we mean by a framework, with examples, as well as justification of scoping review approach.

Background

A core remit of the Evidence Based QUality Improvement and Patient Safety (EQUIPS) Research Network (2024–2029) is to inform research priorities for the Irish healthcare system. Previously, research prioritisation exercises have treated quality improvement (QI) and patient safety research as separate fields. Given the growth of QI research, an integrated approach is required to generate a full view of the continuum of knowledge generation and translation activities in quality and safety contexts. The co-creation of a Conceptual Framework for Quality Improvement and Patient Safety Research among researchers, knowledge users and patient groups is required to outline important topics, research questions and methodologies, applicable to all areas of healthcare. A scoping review of the literature is first needed to examine existing QI and patient safety research frameworks to inform the development of a harmonised conceptual framework for the Irish context. Methods The scoping review will follow JBI guidelines for developing and co-creating scoping review protocols with knowledge users. The completed review will be reported according to the PRISMA extension for Scoping Reviews, and Guidance for Reporting Involvement of Patients and the Public 2 (GRIPP2) checklist which supports enhanced reporting of patient and public involvement in research. We will search the following databases from 2000–2025 focussing on literature sources from developed countries: Ovid MEDLINE, Embase, CINAHL, Scopus, Cochrane Library, Web of Science. We will map included papers using an extraction template developed to fulfil the study aims. Two reviewers will independently screen studies, and discrepancies will be addressed by consensus using a third reviewer. Dissemination Findings will be used to inform the development of a meta-framework that will be used to guide QI and patient safety research priority setting, measurement and monitoring, implementation, and knowledge translation activities in Ireland, at local and national levels. OSF https://doi.org/10.17605/OSF.IO/FGWUA

Keywords: quality improvement, patient safety, research priorities, co-design, conceptual framework, scoping review

Introduction

A core aim of the Evidence Based QUality Improvement and Patient Safety (EQUIPS) Research Network (2024–2029), a collaboration of Irish Universities, patient representatives, and the Health Service Executive (HSE) in Ireland, is to inform research priorities for the Irish healthcare system. A conceptual understanding of quality improvement (QI) and patient safety as individual and inter-related fields is required to inform a research agenda. Up to now, research prioritisation exercises in Ireland and internationally have treated these as separate fields. The co-creation of a harmonised Conceptual Framework for Quality Improvement and Patient Safety Research among researchers, knowledge users and patient groups is necessary to outline important topics, research questions and methodologies, applicable and relevant to all areas of healthcare. A framework is defined as ‘a structure, overview, outline, system or plan consisting of various descriptive categories, e.g. concepts, constructs or variables, and the relations between them that are presumed to account for a phenomenon’. ¹ Therefore we define a QI and patient safety research framework as a set of categories and relations which describe the research process leading to the production of generalisable new knowledge about QI and patient safety. The conceptual framework will enable tailoring of research priorities and methodologies to the needs of service users and staff at unit, organisational and national levels in Ireland. First, a scoping review of the literature is required to examine existing QI and patient safety research frameworks to inform the development of a harmonised conceptual framework for the Irish context. A scoping review is the most suitable approach, as it enables the collation, description, and synthesis of information from multiple heterogeneous fields that contribute to the study of QI and patient safety. This paper sets out the background, aims and methodology for the scoping review. The background section defines key concepts, identifies research gaps and discusses relevant health systems developments which inform the review protocol.

Background

Quality Improvement

QI is the systemic use of data-guided activities to bring about immediate improvements in healthcare delivery, and is considered a routine part of healthcare. 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 service. ³ Internationally, QI competency is perceived as essential for 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 healthcare. ⁸ According to a scoping review, most published QI initiatives conducted in Ireland (2015–2020) report use of an established QI methodology and achievement of aims. ⁹ The QI initiatives mainly aimed to improve the effectiveness, efficiency, and safety of care processes and outcomes, and few aimed to enhance patient-centredness, value for money, or staff well-being. ⁹ Initiatives rarely aimed to enhance the equity domain of quality, ⁹ an often ‘forgotten goal’ of QI internationally, ¹⁰ with some recent exceptions from the Irish context. ¹¹ Most QI initiatives are unpublished, however 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 together 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 improvement. ¹⁹ 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 recommended ¹⁸ with increasing emphasis on realist syntheses, ²⁰ ^, ²¹ implementation science, health economic evaluation and behavioural science methods. ²²

Quality Improvement research priorities for the Irish healthcare system

QI research is considered to be in its infancy in Ireland and globally. ⁸ 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 sustainability. ²³ 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 (e.g. small- and/or 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 care. ³¹ This is perhaps the most well-known Patient Safety Research Framework, and functions to guide the foci of researchers’ attention worldwide. 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 These and other 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 solutions. ³² ^, ³⁴

Patient safety research in Ireland

A 2023 scoping review identified only a modest amount of patient safety research studies conducted in Ireland. ³⁵ Most focussed on measuring past harm and safety culture and a minority evaluated patient safety solutions. ³⁵ 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 initiatives. ³⁵

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 diabetes. ³⁵ 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 reports. ³² These were summarised using Donabedian’s structure, process and outcome quality framework to identify research areas that were the results or consequences of care (outcomes), due to resourcing and organisational arrangements (structures) or influenced by the delivery of care (processes). ³⁶ It was expected that further knowledge in these substantial knowledge gaps would contribute to improving patient safety. ³² Priorities for developed countries like Ireland focussed on the underlying processes and organisational factors that lead to unsafe care, the cost-effectiveness of risk-reducing strategies, and the development of better safety indicators. ³²

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 equity. ³⁷ 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 priority. ³⁸ 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 UNSDGs. ³⁹ These SDGs reinforce new priority areas in the literature such as the impact of staff well-being on patient safety ⁴⁰ ^, ⁴¹ and the need for environmental sustainability and safety to co-exist, without additional risk to patients. ⁴² 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 disclosure. ⁴³ 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 place. ⁴⁴ Despite Ireland being a relatively late adopter of integrated digital technologies, ⁴⁵ the use of electronic health records, digital solutions and artificial intelligence is expected to increase over the next decade. ⁴⁶ For example, digitisation of data may create greater capacity for QI and patient safety research in Ireland and 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 reforms ⁴⁷ and digitisation of healthcare, ⁴⁸ 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.

Rationale for combining Quality Improvement and Patient Safety Research Frameworks

The US Institute of Medicine have long established patient safety, alongside timeliness, effectiveness, efficiency, equity and patient centredness, as core goals of quality in healthcare. ⁴⁹ Since QI methodologies utilise data to diagnose improvement opportunities, and implement and monitor system performance, there are natural conceptual overlaps between the study of improvement and patient safety research. For example, in healthcare settings, QI methodology (e.g. PDSA) is regularly used to help implement, monitor, and adapt patient safety interventions (e.g. safe surgery checklist) over time with the goal of improving safety. At the same time, using routine and additional data sources, researchers examine implementation and effectiveness outcomes (e.g. compliance with safe surgery checklist and surgical outcomes) to inform decision-making about adoption of policies and practices. For illustration and reflecting the literature above, Table 1, details multiple similarities and differences across QI, QI research and Patient Safety research.

Table 1. Similarities and differences in Quality Improvement, Quality Improvement Research, Patient Safety Research.

	QI	QI Research	Patient Safety Research
Purpose	Improvement of quality or patient safety in near-to-real in local settings	Creation of generalisable knowledge	Creation of generalisable knowledge
Guiding Principle	Pragmatism – what works here?	Pragmatism + scientific rigor	Scientific rigor – what are valid and reliable findings?
Rationale	Undesirable variation in one or more quality domains (STEEEP) ^*, including patient safety	Knowledge gap about how to create and sustain improvement across quality domains (STEEEP) ^*, including patient safety	Knowledge gap about the scale and causes of patient safety problems and their effective solutions
Data Sources	Routine data sources	Routine + research data sources	Routine + research data sources
Outcomes	Improved processes and/or staff or patient outcomes	Scientific publication about quality improvement, including patient safety	Scientific publication about patient safety
Relationship to Patient Safety	Intersectional - recognises and monitors the influence of other domains on patient safety	Intersectional – recognises and studies the influence of other domains on patient safety and vice versa	Exclusive patient safety focus – aware of other influences but the primary unit of analysis is patient safety (e.g. events, interventions)
Relationship to QI and QI Research	Interdependent – culture of QI required to attract and sustain funded QI research opportunities	Interdependent – QI research requires QI initiatives and programmes in place to study them	Independent – can be done without QI initiatives and programmes

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Safety, Timeliness, Effectiveness, Efficiency, Equity, Person-Centredness. ⁴⁹

To reflect these multiple approaches and interdependencies to improving safety in practice, researchers require guidance about selecting evaluation foci and research methodology. For example, a recent Canadian Patient Safety Institute publication, offers guidance on how to combine knowledge translation, quality improvement and implementation science research frameworks, such as the Capability Opportunity and Motivation Model of Behaviour in efforts to enhance patient safety. ⁵⁰ Such a framework could address a recent call for combining QI and PS in clinical education ⁵¹ and is likely a good example of what could be applied as hybrid research framework, due to its potential to guide the research process and inform knowledge on quality improvement and patient safety. Currently there is no known collated body of literature which profiles stand-alone QI Research Frameworks, Patient Safety Research Frameworks, and hybrid approaches (QI and Patient Safety Research Frameworks) and guides on how these may be best utilised.

Aims and objectives

The aim of this scoping review is to identify and describe the conceptual frameworks relating to stand-alone QI Research Frameworks, Patient Safety Research Frameworks, and hybrid approaches (QI and Patient Safety Research, QIPS-R, Frameworks) in healthcare. The research questions guiding this review are:

1.
What conceptual frameworks exist to guide Quality Improvement and/or Patient Safety Research and how have they been applied in healthcare?
2.
How are the concepts of QI and patient safety research defined in Quality Improvement and/or Patient Safety Research Frameworks?
3.
What are the reported objectives of Quality Improvement and/or Patient Safety Research frameworks?
4.
What domains and sub-domains are addressed in Quality Improvement and/or Patient Safety Research Frameworks?
5.
What structure-, process- and outcome-related indicators are used in Quality Improvement and/or Patient Safety Research Frameworks?
6.
What criteria for research priorities have been established?
7.
What research priorities have been established?

Scoping review findings will be used to inform the development of a meta-framework that will be used to guide QI and patient safety research (QIPS-R) related priority setting, measurement and monitoring, implementation, and knowledge translation activities in Ireland. The actual development of the meta-framework does not form part of the scoping review protocol. The development of the framework will take place in the follow-on phase of this research, as part of EQUIPS Research Network programme of work.

Methods

The review follows JBI methodological guidance for scoping reviews, ⁵² and will be reported in accordance with the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) guidelines. The review protocol was structured using JBI guidelines for developing and co-creating scoping review protocols with knowledge users ⁵³ ^, ⁵⁴ and adaption of the PRISMA extension for Scoping Reviews checklist (PRISMA-ScR). ⁵⁵ All review materials will be available on the Open Science Framework (OSF; https://doi.org/10.17605/OSF.IO/FGWUA).

Eligibility criteria

The eligibility criteria are informed by a Phenomenon of Interest, Concept, Context approach, as presented in Table 2. 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 countries. ³¹ Only English language sources will be reviewed due to language limitations of the review team. Similar to other reviews, ³⁵ 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. Inclusion thresholds include that papers must address one of the two central scoping review themes: (1) QI and/or patient safety research frameworks and (2) QI and/or patient safety research priorities. Where multiple papers describe the same research frameworks, all papers will be included in the review as supporting references, with the research framework itself only being described once in the scoping review findings.

Table 2. Scoping Review Focus.

Phenomenon of Interest	Quality Improvement and/or Patient Safety Research Frameworks used in healthcare
Concept	Quality improvement and patient safety research questions, priorities, and methodologies
Context	Healthcare settings across the globe

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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 3. The full search strategy for each database is available on OSF ( https://doi.org/10.17605/OSF.IO/FGWUA; see Supplementary File 1).

Table 3. Database Search Terms (Draft).

("Patient Safety" OR "Healthcare Safety" OR "Safety" OR "Quality
Improvement" OR "Improvement Science" Or "Human Factors"
Or "Resilience Engineering" Or "Safety I" Or "Safety II" Or "High
Reliability" Or "Ergonomics" Or "Socio-technical Systems") AND
("Healthcare") AND ("Research Priorities" OR "Research Framework"
OR "Research Methodologies" OR "Research Models" OR
"Implementation Science" OR "Behavioural
Science" OR "Behaviour Change" OR "Knowledge Translation")

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Data management and study selection

Identified records will be imported to Covidence to manage screening and extraction. Two reviewers will independently assess each of the retrieved records against eligibility criteria. To support inter-rater reliability, seven reviewers (SEM, JP, JMC, EOD, AVC, JAP, CMG) at the study selection stage comprise experienced researchers with PhDs in healthcare quality, human factors and/or health services research or equivalent experience. 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 (SEM plus one other 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

Working in teams of two across six reviewers (SEM, JP, EOD, AVC, JAP, CMG), two reviewers (with a balance of healthcare quality/human factors and health services research expertise) will use a piloted, standardised data extraction form, developed in Covidence, to independently extract data relevant to the scoping review aims (see Table 4 for draft template). To support consistency of the process and version control, the extraction template will be finalised and agreed prior to its use it the study. The approach to data extraction will be both deductive and inductive, with some open text extraction options included to enable the collection of concepts and information which may not have been anticipated at the outset ( Table 4). Disagreement among reviewers will be resolved by a third reviewer. To maintain consistency, all consensus decisions will be led be author SEM with at least two other reviewers present.

Table 4. Draft Data Extraction Template Headings.

1. General Information
1.1 Title of paper	Free text
1.2 Author(s)	Free text
1.3 Year of Publication	Free text
1.4 Study Digital Object Identifier (DOI)	DOI link
1.5 Country (sl/pl) in which study was conducted	Free text
1.6 Paper type	Theoretical/discursive Literature review Primary research Other
1.7 Quality Improvement and/or Patient Safety Research Definition(s)	Free text
2. Methods
2.1 Study Design	Randomised controlled trial Non-randomised experimental study Cohort study Cross sectional study Case control study Literature review Qualitative research Quantitative research Ethnographic research Quality Improvement research Behavioural Science research Implementation research Implementation effectiveness design Mixed-methods design Prevalence study Case series Case study Diagnostic test accuracy study Clinical prediction rule Health Economic evaluation Text and opinion Participatory Research Delphi Study Other
3. Theme 1: Quality Improvement (QI) and/or Patient Safety (PS) Research Frameworks
3.1 Presentation of a QI and/or PS Research Framework	Yes/No
3.2 Title of Framework	Free text
3.3 Type of QI and/or PS Research Framework	‘Pure Research’ (i.e. to produce generalisable knowledge only) ‘Hybrid Research Plus’ (i.e. to produce generalisable knowledge and other purposes e.g. implementation)
3.4 QI and/or PS Research Framework Focus	Quality Improvement Research Quality Improvement Initiatives Patient Safety Research Implementation Science Behaviour Change Sustainability (i.e. to embed change) Cost and Outcomes Other (free text)
3.5 QI and/or PS Research Framework Aims	Free text (stated aims/goals of framework)
3.6 QI and/or PS Research Framework Domains	Free text (list of domain names or category titles associated with the framework)
3.7 QI and/or PS Research Framework Sub-Domains	Free text (list of framework sub-domains or sub-category titles)
3.8 Framework Recommended Study Designs	Randomised controlled trial Non-randomised experimental study Cohort study Cross-sectional study Case control study Literature review Qualitative research Quantitative research Ethnographic research Quality Improvement research Behavioural science research Implementation research Implementation effectiveness (hybrid) designs Mixed methods designs Prevalence study Case series Case study Diagnostic test accuracy study Clinical prediction rule Health economic evaluation Text and opinion Participatory research Other (free text)
3.9 Recommended Research Methodologies (ie. stated recommended methodologies to measure the framework)	Literature Review Audit Participant Observation Surveys Routine Data Monitoring Run Charts Statistical Process Control Interviews Focus Groups Other (free text)
3.10 If Literature Review Recommend, what type?	Not specified Systematic Review Scoping Review Realist Synthesis Narrative Review Not applicable Other
4. Theme 2: QI and/or Patient Safety Research Priorities
4.1 Were research priorities established?	Yes No Other e.g. research needs/topic recommendations (free text)
4.2 Participants	Population type
4.3 Inclusion criteria	Free text
4.4 Exclusion criteria	Free text
4.5 Total number of participants	Number
4.6 Were criteria for establishing research priorities indicated?	Yes No
4.7 Name and definitions of criteria	Free text
4.8 Number of research priorities established	Number
4.9 Were the research priorities rank ordered?	Yes No Not applicable
4.10 Top 12 research priorities established	Name of each research priority (1-12, if applicable)
4.11 Other proxy priorities i.e. research needs/topic recommendations	Free text research topics Free text interventions Free text methodologies
4.12 Were structural indicators established? (i.e. building blocks of care, e.g. buildings, staff, equipment, policies)	Yes, please specify (free text) No
4.13 Were process indicators established? (i.e. management, organisational, and clinical processes, e.g. use of checklists)	Yes, please specify (free text) No
4.14 Were outcome indicators established? (i.e. outcomes of care, e.g. adverse events)	Yes, please specify (free text) No
4.15 Areas of Care (by Service) for which the priorities were established	All Primary Care Pre-Hospital Care Hospital Care Continuing & Community Care Other (free text)
5. End Matter
5.1 Limitations	Free text
5.2 Study funding sources	Free text
5.3 Possible conflicts of interest for study authors	Free text

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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. Scoping review findings will be presented at a dedicated QI and Patient Safety Research symposium at the RCSI University of Medicine & Health Sciences and other fora. Here consultation will take place with stakeholders (i.e. healthcare professionals, healthcare managers, researchers, academics, patient representatives, research funders, and EQUIPS members). Discussion will focus on how the findings may be used to develop Quality Improvement and Patient Safety Research Conceptual Framework and inform the prioritisation of research topics and methodologies within the context of the Irish healthcare system.

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 review. ⁵⁴ The knowledge users are the Lead Knowledge users who volunteered and self-selected to work together with the Researchers in the Strand 2 working group of the EQUIPS Research Network, and those who may join this strand of work as it develops. The first task in the network’s Strand 2 work package primarily concerns establishing relevant research priorities and methodologies, to better facilitate multi-disciplinary and applied research relevant to the HSE patient safety and quality 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 users. ⁵⁴ Then as part of the protocol development, all strand knowledge users were invited to help develop the research questions, search strategy, and review drafts of the protocol manuscript to ensure its helpfulness to their roles. Two such knowledge users in the strand group (TK, JB) supported with these elements. The remainder of the knowledge users could not participate due to constraints on their time from clinical/administrative responsibilities, however, it is anticipated, in accordance with the guidance, they will review results to ‘sense check’ findings and support the development and usability of a QI and Patient Safety Research Conceptual Framework relevant for the Irish context. ⁵⁴ 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 to their communities and healthcare settings (e.g. sharing on social media, via podcasts, in specific newsletters, or at journal clubs). ⁵⁴ 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 Criteria. ⁵⁶ The overall participatory mechanism for knowledge user engagement with the planned scoping review is the existing schedule of regular online meetings as part of EQUIPS Strand 2 work programme. The scoping review is a standing agenda item at these meetings, which are chaired by the EQUIPS Research Network Manager. The meetings are facilitated with the aim of giving equal voice to researchers and knowledge users. For example, using the meeting forum, knowledge users themselves continually decide how they would like to be included, and contribute to the review. Outputs from the Strand meetings are reported by the Network Manager to the wider network, including its steering committee, whom are responsible for ensuring that strand outputs are used to fulfil the network’s work programme. 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 research. ⁵⁷

In accordance with JBI guidance, ⁵⁴ there is no requirement to apply for research ethical approval for the scoping review. Knowledge users are being engaged to inform the process of how scoping review is done, and not as research participants. Nevertheless, as is best practice, ethical principles of beneficence and informed consent will be applied to the conduct of the scoping review. Knowledge users, have been informed during online Strand 2 meetings that they are free to share any relevant view and given the volunteer nature of their role in the study, are free to withdraw from participation in the scoping review team for any reason and without incurring any negative consequences from any of the individuals or organisations associated with the research.

Conclusion

In Ireland, there is a need for greater guidance for researchers involved in studying improvement work and patient safety. The completed review will provide a shared understanding of QI and patient safety research. Based on this understanding the review will enable production of practical tools to assist researchers and improvers. First, the development of a QI and Patient Safety Research Conceptual Framework suitable for the Irish context, that will enable users of the Framework to identify research priorities and methodologies relevant for their areas of work. Secondly, the review will inform a research prioritisation exercise among members of the EQUIPS Research Network, to best inform research funders and policy makers at national level of the key research areas that will make a difference to improving the safety and quality of care in the Irish healthcare system. These dual planned outputs will provide evidenced based priorities and methodologies, and a practical tool to support acceleration of QI and patient safety research in Ireland.

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. Review of grey literature is ongoing at the time of Version 3 submission (16 April 2026).

Ethics and consent

Ethical approval and consent were not required.

Data availability

Underlying data

No underlying data are associated with this article.

Extended data

Extended data associated with this article are available on OSF, under the project title “Profiling and Mapping Quality Improvement and Patient Safety Research Frameworks: A Scoping Review to Guide Integration”, https://doi.org/10.17605/OSF.IO/FGWUA (McCarthy, S et al. 2025) ⁵⁸

The following extended data are associated with this article:

•
PRISMA Scoping Review Checklist_Protocol
•
Supplementary File 1_Search strategy

Data are available under the terms of the Creative Commons Attribution 4.0 International Public License (CC BY 4.0).

Reporting guidelines

An adapted version of PRISMA Scoping Review checklist for the protocol is available on the OSF, under the project title “Profiling and Mapping Quality Improvement and Patient Safety Research Frameworks: A Scoping Review to Guide Integration”, https://doi.org/10.17605/OSF.IO/FGWUA (McCarthy, S et al. 2025) ⁵⁶

Data are available under the terms of the Creative Commons Attribution 4.0 International Public License (CC BY 4.0).

Acknowledgements

This research was completed as part of the HRB and HSE funded Evidence-Based Quality Improvement and Patient Safety Research Network work programme (PSRN-2023-001). EWG is supported by Research Ireland [22/RP/10091] and JMC, JAP, CMG supported by the RCSI Converge Programme.

Funding Statement

Health Research Board [PSRN-2023-001].

The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

[version 3; peer review: 1 approved, 2 approved with reservations, 2 not approved]

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HRB Open Res. 2026 Apr 1. doi: 10.21956/hrbopenres.15774.r54050

Reviewer response for version 2

Anthony J Montgomery ¹

I had the benefit of reading the reviews of three previous reviewers and the response of the authors. It's obvious that the authors have addressed the many technical questions posed by the previous reviewers. Therefore, I will comment on some of the conceptual issues.

The basic idea to conduct a scoping review on the research frameworks that guide patient safety and QI research is a worthy one. I am very happy to approve this study, and the following comments should be considered as suggestive, not obligatory.

1. It would be helpful for the reader to understand why a scoping review is the best way forward. I assume the scoping review approach reflects the fact that the area is heterogeneous and a little 'scattered', but it would be helpful to comment on this a little.

2. Some examples of the research frameworks that already exist would be helpful for the reader. Also, a 'tighter' definition of what is meant by a research framework would be helpful. It sounds a little generic at the moment. For example, what is not a research framework? Will the authors be using inductive/abductive methods to delineate what research frameworks exist?

3. The research aims are mostly clear. I was just wondering with regard to the first aim, how the authors meant by 'what conceptual frameworks are available' - what is meant by 'available'?

4. The authors intend to develop a meta-framework, but does this not depend on the quality of the frameworks in existence? For example, if the scoping review finds that the majority of frameworks are poorly described and vague - why try to make a meta-framework?

5. The constant use of and/or needs to be clarified a little. For example, what happens if they find many examples of QI that are not directly focused on patient safety issues?

I hope my comments have been helpful. As I said, the idea and method are sound, and it will be interesting to see how the authors deal with the heterogeneous nature of the information that they find.

Is the study design appropriate for the research question?

Yes

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

Partly

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

Reviewer Expertise:

Patient safety research, occupational health, burnout, emotional labour, psychological safety.

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.

HRB Open Res. 2026 Apr 22.

John McCaffrey ¹

Authors' response: Thank you very much for the peer review of our scoping review protocol paper. We appreciate the very helpful suggestions around conceptual issues and have responded to these below and incorporated edits in the paper.

Authors' response: Thank you for this helpful suggestion, we have added the below comment to the introductory section:

"A scoping review is the most suitable approach, as it enables the collation, description, and synthesis of information from multiple heterogeneous fields that contribute to the study of QI and patient safety."

Authors' response: Thank you for this helpful suggestion. We have now specified what we mean exactly by a QI and patient safety research framework. In the introduction, we have added:

"A framework is defined as ‘a structure, overview, outline, system or plan consisting of various descriptive categories, e.g. concepts, constructs or variables, and the relations between them that are presumed to account for a phenomenon’. ¹ Therefore we define a QI and patient safety research framework as a set of categories and relations which describe the research process leading to the production of generalisable new knowledge about QI and patient safety."

In relation to examples of research frameworks, we are reluctant to put potential findings in the scoping review protocol. However, we have in the existing manuscript, given two examples. To make these more explicit, we highlighted these to the reader a bit more, with the below edits:

"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 care. ³¹ This is perhaps the most well-known Patient Safety Research Framework, and functions to guide the foci of researchers’ attention worldwide.

For example, a recent Canadian Patient Safety Institute publication, offers guidance on how to combine knowledge translation, quality improvement and implementation science research frameworks, such as the Capability Opportunity and Motivation Model of Behaviour in efforts to enhance patient safety. ⁵⁰ Such a framework could address a recent call for combining QI and PS in clinical education ⁵¹ and is likely a good example of what could be applied as hybrid research framework, due to its potential to guide the research process and inform knowledge on quality improvement and patient safety."

In response to your helpful suggestion, we have now clarified in the methods section, that we will use both deductive and inductive methods approach to delineate what research frameworks exist. We have added the below to the methods section:

"The approach to data extraction will be both deductive and inductive, with some open text extraction options included to enable the collection of concepts and information which may not have been anticipated at the outset."

3. The research aims are mostly clear. I was just wondering with regard to the first aim, how the authors meant by 'what conceptual frameworks are available' - what is meant by 'available'?

Authors' response: Thank you for this query. By available, we mean, what frameworks ‘exist’? To be more clear, we have removed the word ‘available’ the list of objectives. For example, the first objective now reads:

1. What conceptual frameworks exist to guide Quality Improvement and/or Patient Safety Research and how have they been applied in healthcare?

Authors' response: Thank you for this question. This in an important consideration and we cannot pre-empt the findings of the scoping review or what other data sources may be required. This is a good reason why the development of the meta-framework does not form part of the scoping review aims and objectives itself. As indicated in the aims and objectives section, the primary aim of the scoping review itself is to profile existing frameworks. To make this more clear, we have added to the aims and objectives section:

"The actual development of the meta-framework does not form part of the scoping review protocol. The development of the framework will take place in the follow-on phase of this research, as part of EQUIPS Research Network programme of work."

5. The constant use of and/or needs to be clarified a little. For example, what happens if they find many examples of QI that are not directly focused on patient safety issues?

Authors' response: The use of ‘and/or’ is simply to denote that we are profiling a mixed array of frameworks, some may deal with QI or Patient Safety alone, some may deal with both. If we find a QI research framework that is not directly focussed on patient safety issues, that will form part of our findings. It could be that is focussed on other relevant issues that may be indirectly supportive of patient safety research, for example, methodologies for studying how improvement happens. This is explicit in the existing first sentence of the aims and objectives section:

"The aim of this scoping review is to identify and describe the conceptual frameworks relating to stand-alone QI Research Frameworks, Patient Safety Research Frameworks, and hybrid approaches (QI and Patient Safety Research, QIPS-R, Frameworks) in healthcare."

I hope my comments have been helpful. As I said, the idea and method are sound, and it will be interesting to see how the authors deal with the heterogeneous nature of the information that they find.

Authors' Response: Thank you

HRB Open Res. 2026 Apr 1. doi: 10.21956/hrbopenres.15774.r53513

Reviewer response for version 2

Mary Lavelle ¹

Thank you for the opportunity to review this paper. The topic is important, and the scoping review has the potential to offer valuable insights for those working both clinically and from a research perspective within healthcare settings, both in Ireland and beyond.

It is clear that the authors have made substantial revisions in response to earlier reviewer comments, and these changes have appreciably strengthened both the manuscript and the methodological description.

At this stage, I have only one remaining query. Will the proposed meta‑framework be presented as part of this review article? If so, it would be helpful to include additional detail on the planned process for co‑creating this framework, including how the development steps will be operationalised.

Is the study design appropriate for the research question?

Yes

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

Yes

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

Partly

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

Not applicable

Reviewer Expertise:

Patient safety and health services 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.

HRB Open Res. 2026 Apr 16.

John McCaffrey ¹

Thank you for your peer review and positive comments on our manuscript. In response to your query, we will not be including the proposed meta-framework as part of the scoping review article. To make this more clear, we have added the below statement at the end of the aims and objectives section:

The actual development of the meta-framework does not form part of the scoping review protocol. The development of the framework will take place in the follow-on phase of this research, as part of EQUIPS Research Network programme of work

HRB Open Res. 2026 Mar 4. doi: 10.21956/hrbopenres.15774.r53664

Reviewer response for version 2

Kassu Jilcha ¹

The study topic is highly relevant to the health sector, and I appreciate the focus on "Profiling and Mapping Quality Improvement and Patient Safety Research Frameworks: Protocol for a Scoping Review to Guide Integration." This work has the potential to serve as a valuable resource for health researchers and healthcare sectors alike. However, there are several areas where the protocol could be strengthened to enhance its scientific rigor and clarity.

Protocol Structure and Presentation:

A well-defined structure is essential for study protocols. The protocol should include a clear Abstract that summarizes the background, objectives, methodology, and anticipated implications, along with appropriate keywords. The Introduction should clearly present the concepts of quality improvement and patient safety, highlighting how these elements can be integrated to enhance patient health outcomes. It should also address the role of health professionals in maintaining quality while providing clinical services and cite recent studies to substantiate these ideas.

Literature Review and Conceptual Framework:

Following the Introduction, a comprehensive Literature Review section should address the specific objectives and research questions while identifying literature gaps. Importantly, this section should culminate in the development of a conceptual framework that currently appears to be missing from the protocol. This framework will be essential for guiding the scoping review methodology.

Methodology Clarity:

The Research Methodology section should comprehensively describe all study areas, including data sources, selection criteria, search strategies, tools to be used for data extraction and quality assessment, and data analysis techniques. This level of detail is crucial for ensuring the protocol's reproducibility and rigor.

Overall Assessment:

The protocol would benefit from more detailed and substantive content throughout, with clear delineation between sections using appropriate headings (Abstract, Introduction, Literature Review, Methodology, and Conclusion). This will help guide readers through the proposed study and facilitate understanding of how the integration of quality improvement and patient safety will be systematically explored.

Is the study design appropriate for the research question?

Yes

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

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?

Yes

Reviewer Expertise:

Occupational safety and health, ergonomics, Quality

HRB Open Res. 2026 Apr 16.

John McCaffrey ¹

Thank you for your peer review of our scoping review protocol.

We agree that the rationale for, and objectives of, the study are clearly described; that the study design is appropriate for the research question, and that sufficient details of the methods are provided to allow replication by others. Therefore we agree with your quantitative assessment, but is was mainly unclear how your qualitative assessment matched to this. Nevertheless, we have replied to the qualitative comments, and this supported the revised version.

Please see below responses to comments provided

Protocol Structure and Presentation:

The manuscript meets with requirements for structuring and describing scoping review protocols (as per JBI guidelines), and we disagree that any further amendments are needed, as the suggestions have already been met. For example, we have covered abstract, title, keywords, introduction, aims/objectives, methods (eligibility criteria, information sources, search strategy, data management, data extraction, data analysis and presentation, knowledge user engagement and co-creation), dissemination. These are all required by JBI standards, and are more reproducible and supportive of researchers than the generic Abstract, Introduction, Literature Review, Methodology, and Conclusion suggested. A heading ‘Literature Review’ is not recommended by JBI, as this would be more substantial than what would be expected for a scoping protocol, particularly when the scoping review itself, once completed, is a form of literature evidence synthesis.

Literature Review and Conceptual Framework:

Thank you for your comments on this. We have already included sufficient background literature in the introductory section, as per JBI guidelines for scoping review protocols. We have included definition of terms, why the research is needed, and what the gaps are. In response to your comments, we have added a specific statement on why a scoping review is indicated, to enhance clarity:

A scoping review is the most suitable approach, as it enables the collation, description, and synthesis of information from multiple heterogeneous fields that contribute to the study of QI and patient safety.

In response to your comments, we have clarified that the development of the conceptual framework does not form part of the scoping review aims and objectives. As per the aims and objectives, we aim to profile existing frameworks, and the development of the framework will form part of the next phase of the research. We have added the below statement:

Methodological Clarity: As per your quantitative assessment, and the reviewers 4 and 5, it is obvious the methodological clarity. Your qualitative comments formed a helpful checklist, but these elements – “data sources, selection criteria, search strategies, tools to be used for data extraction and quality assessment, and data analysis techniques” were included in the paper reviewed.

Overall Assessment: We agree with the overall quantitative assessment, as per the qualitative comments, we are satisfied that we have structured the protocol headings are per the well-established and internationally accepted and commonly used, JBI guidelines.

HRB Open Res. 2026 Jan 8. doi: 10.21956/hrbopenres.15586.r51963

Reviewer response for version 1

Adam B Sutherland ¹

Thanks so much for the opportunity to review this paper, which I have read with interest. My interest comes from your position of attempting to tie together safety science with implementation science. I am in agreement with the previous reviewer that this has not been achieved.

Theoretical Grounding

The manuscript is weakened by only offering a superficial theoretical exploration of the differences and alignments between improvement science and safety science. One of your review questions (Nr 5) is framed in Donabedian's "Structure-Process-Outcome" structure but there has been no exploration of this as a fundamental principle of quality improvement. Furthermore there has been no attempt to link improvement and safety science principles, which weakens the structure of your proposed analytical approach as it is unclear how you are going to ensure theoretical alignment between the concepts and the future framework you intend to develop.

End User Involvement

A core principle of scoping review methodology is the involvement of service users in the creation of the review and its questions. There is only a fleeting reference to service user involvement in the manuscript and I see no service users represented in the author list. I am very strongly on the opinion that where patient safety is involved, patients must be part of the research journey from start to end and this should be reconsidered.

Search Strategy

I've taken some time to look at your search strategies and have concerns that some of the terms you have used may skew your search results. I see behavioural science and implementation science included, human factors and sociotechnical systems but these are all very different concepts. Again,this is related to the lack of theoretical grounding of the proposal.

I also wonder about the feasibility of this review. Notwithstanding the theoretical weaknesses I can imagine that the initial search strategies will yield many hundreds of thousands of titles that require screening, and there may be insufficient resource available for this in the methods.

Data extraction

I think a bit more information is needed for the readers to understand what is meant by "QI/PS-R Focus" and "QI/PS-R Definitions" - perhaps this just relates to the theoretical positions taken? How will extractors manage those studies that report BOTH QI and PS factors? I would fully expect that there would be substantial overlap between patient safety and quality improvement. You would need to separate the two concepts and demonstrate how they align (or indeed sit in tension)

Is the study design appropriate for the research question?

Partly

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

Yes

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

Partly

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

Not applicable

Reviewer Expertise:

Human Factors; Patient Safety

I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above.

HRB Open Res. 2026 Jan 28.

John McCaffrey ¹

Response: Thank you for this observation. Please see reply to reviewer 1. Overall, we have updated the scoping review aims to profiling QI Research Frameworks, Patient Safety Research Frameworks, and Frameworks which may already combine QI and Patient Safety as part of an overall research framework. The paper title has been reorientated to reflect the aims of the scoping review and not a planned application of the findings, i.e. the development of a conceptual framework.

“Profiling and Mapping Quality Improvement and Patient Safety Research Frameworks: Protocol for a Scoping Review to Guide Integration

Theoretical Grounding

The manuscript is weakened by only offering a superficial theoretical exploration of the differences and alignments between improvement science and safety science.

Response: The paper has incorporated an additional paragraph on the rationale for combining QI and patient safety research frameworks as below. Since part of our data extraction concerns how frameworks define QI and/or patient safety research, the scoping review findings with further detail difference and alignments between these.

“ Rationale for combining Quality Improvement and Patient Safety Research Framework

The US Institute of Medicine have long established patient safety, alongside timeliness, effectiveness, efficiency, equity and patient centredness, as a core goal of quality in healthcare (IOM, 2001). Since QI methodologies use data for diagnosing improvement opportunities in healthcare systems and for implementing and monitoring improvements in system performance, there are natural conceptual overlaps between the study of improvement and patient safety research. For example, in healthcare settings, QI methodology (e.g. PDSA) is regularly used to help implement, monitor, and adapt patient safety interventions (e.g. safe surgery checklist) over time with the goal of improving safety. At the same time, using routine and additional data sources, researchers examine implementation and effectiveness outcomes (e.g. compliance with safe surgery checklist and surgical outcomes) to inform decision-making about adoption of policies and practices. To reflect the multiple approaches to improving safety in practice, researchers require guidance about selecting evaluation foci and research methodology. For example, a recent Canadian Patient Safety Institute publication, offers guidance on how to combine quality improvement and implementation science research frameworks in efforts to enhance patient safety (CPSI, 2020). Additionally, there was a recent call for QIPS to be combined in clinical education (Wong et al., 2022). Currently there is no known collated body of literature which profiles stand-alone QI Research Frameworks, Patient Safety Research Frameworks, and hybrid approaches (QI and Patient Safety Research Frameworks) and guides on how these may be best utilised.”

One of your review questions is framed in Donabedian's "Structure-Process-Outcome" structure but there has been no exploration of this as a fundamental principle of quality improvement.

Response: Thank you for this observation. An explanation of Donabedian’s Structure-Process-and Outcome Quality Framework is now provided in the introductory text. Additionally, examples of structures, processes and outcomes are now provided in the study data extraction table (Table 3) in the manuscript, and as identified below (4.12 – 4.14).

“Fifty identified research priorities for developed countries are detailed in WHO reports ³² . These were summarised using Donabedian’s structure, process and outcome quality framework to identify research areas that were the results or consequences of care (outcomes), due to resourcing and organisational arrangements (structures) or influenced by the delivery of care (processes). It was expected that further knowledge in these substantial knowledge gaps would contribute to improving patient safety (WHO, 2008) . Priorities for developed countries like Ireland focused on the underlying processes and organisational factors that lead to unsafe care, the cost-effectiveness of risk-reducing strategies, and the development of better safety indicators ^32”

4.12 Were structural indicators established? (i.e. building blocks of care, e.g. buildings, staff, equipment, policies)

4.13 Were process indicators established? (i.e. management, organisational, and clinical processes, e.g. use of checklists)

4.14 Were outcome indicators established? (i.e. outcomes of care, e.g. adverse events)

World Alliance for Patient Safety. Summary of the Evidence on Patient Safety: Implications for Research. Geneva: World Health Organization, 2008

Furthermore, there has been no attempt to link improvement and safety science principles, which weakens the structure of your proposed analytical approach as it is unclear how you are going to ensure theoretical alignment between the concepts and the future framework you intend to develop.

Response: Thank you for this observation. A table (Table 1) outlining similarities and differences across principles of quality improvement, quality improvement research and patient safety research has been included in the introductory section. Completion of the scoping review, profiling the frameworks, will identify within existing frameworks where synergies across aims, methodology and outcome are, and where there are opportunities for integration.

“For illustration and reflecting the literature above, Table 1, details multiple similarities and differences across QI, QI research and Patient Safety research. To reflect these multiple approaches and interdependencies in improving safety in practice, researchers require guidance about selecting evaluation foci and research methodology”.

End User Involvement

Response: Thank you for this observation. EQUIPS has a small but growing number of patient partners and collaborates regularly with other patient organisations (e.g., Patients for Patient Safety Ireland). All patient partners were invited to participate in scoping review development and we anticipate they will continue to play an active role in further stages of this research. Authors are listed according to the International Committee of Medical Journal Editors (ICMJE) Recommendations.

Please see reply to Reviewer 1 above. More detail has been added on sharing of findings:

“Scoping review findings will be presented at a dedicated QI and Patient Safety Research symposium at the RCSI University of Medicine & Health Sciences and other fora. Here, consultation will take place with stakeholders (i.e. healthcare professionals, healthcare managers, researchers, academics, patient representatives, research funders, and EQUIPS members). Discussion will focus on how the findings may be used to develop Quality Improvement and Patient Safety Research Conceptual Framework and inform the prioritisation of research topics and methodologies within the context of the Irish healthcare system”.

Search Strategy

I've taken some time to look at your search strategies and have concerns that some of the terms you have used may skew your search results. I see behavioural science and implementation science included, human factors and sociotechnical systems but these are all very different concepts. Again, this is related to the lack of theoretical grounding of the proposal.

Response: Thank you for this observation. We have clarified we are profiling stand-alone and or integrated QI and Patient Safety Frameworks, and have provided more theoretical grounding, I think these address the concerns. Moreover, details of expertise supporting the project are more clearly outlined, and this should instil confidence that papers addressing the theoretical aims of the study will be included.

Response: We are confident in the feasibility of the review, given our aim to profile research frameworks, specifically.

Data extraction

Response: Thank you for this observation. I think this had been addressed by our clarification of aims. Please see reply to reviewer 1 above and below

We have clarified our overall aim is identify stand-alone QI Research Frameworks, Patient Safety Research Frameworks, and hybrid approaches (QI and Patient Safety Research, QIPS-R, Frameworks), and not necessarily hybrid approaches only, which are in their infancy. Additionally, we have clarified that the results of the scoping review will be used to develop a meta-framework, the methodology for which is beyond the parameters of the scoping review protocol.

“The aim of this scoping review is to identify and describe the conceptual frameworks relating to stand-alone QI Research Frameworks, Patient Safety Research Frameworks, and hybrid approaches (QI and Patient Safety Research, QIPS-R, Frameworks) in healthcare. The research questions guiding this review are:

1. What conceptual frameworks are available for Quality Improvement and/or Patient Safety Research and how have they been applied in healthcare?

2. How are the concepts of QI and patient safety research defined in available Quality Improvement and/or Patient Safety Research Frameworks?

3. What are the reported objectives of available Quality Improvement and/or Patient Safety Research frameworks?

4. What domains and sub-domains are addressed in available Quality Improvement and/or Patient Safety Research Frameworks?

5. What structure-, process- and outcome- related indicators are used in available Quality Improvement and/or Patient Safety Research Frameworks?

6. What criteria for research priorities have been established?

7. What research priorities have been established?

Scoping review findings will be used to inform the development of a meta-framework that will be used to guide QI and patient safety research related priority setting, measurement and monitoring, implementation, and knowledge translation activities in Ireland.”

HRB Open Res. 2025 Nov 22. doi: 10.21956/hrbopenres.15586.r50211

Reviewer response for version 1

Olalekan John Okesanya ¹

The paper suffers from multiple deficiencies, as mentioned below, which diminish its academic value.

The paper aims to integrate quality improvement (QI) and patient safety (PS), though the scarcity of a clear theoretical model linking these concepts hinders the strength of the proposed meta-framework with insufficient explanation of their connection. Moreover, while “knowledge user engagement” is emphasised, the protocol offers minimal discussion on the participatory mechanisms involved. The omission of concrete example regarding decision-making structures leaves the co-creation assertion somewhat unsupported. Also, the authors state ethical approval is unnecessary yet moral considerations in stakeholder engagement and interpretation are overlooked parting the ethical structure incomplete. Equally, although dual independent reviewers are noted, key details about their training and calibration are left out this failure raises concerns regarding consistency in inclusion decisions and inter rater reliability. In addition, the draft extraction template is presented, though it is vague in relation to coding schemes and variable definitions, making it difficult to understand the way multi-domain data will be categorized. Furthermore, the review’s findings aim to contribute to a conceptual framework, but the process for developing this framework remains unaddressed, making it unclear whether it should be inductively derived or theoretically imposed. Meanwhile, covidence is mentioned, lacking elaboration on how data validation, version control and reviewer calibration will be managed raising concerns about internal consistency and data integrity. Then, the adherence to JBI and PRISMA-ScR guidelines is outlined though procedural details on how these frameworks will be executed remain inadequately clarified. The shortcoming of explicit inclusion thresholds and screening examples impacts the review’s reproducibility, rendering it questionable. Subsequently, the research plans to retrieve multiple frameworks addressing similar concepts, yet a method for reconciling duplicates as well as overlaps is absent which could result in data redundancy, distorting the synthesis. Finally, the Irish healthcare system is described in broad terms, without addressing system-specific factors that could influence the research, limiting its ability to provide contextually relevant recommendations.

Is the study design appropriate for the research question?

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

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

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

Reviewer Expertise:

IoT, Health care, AI and Cloud

HRB Open Res. 2026 Jan 28.

John McCaffrey ¹

Thank you for time and expertise in providing the peer review. We have reflected on each of the comments and provide the below clarifications and revisions, which have strengthened and clarified the academic value of our planned study.

Theoretical Rationale for Study Research Questions

The paper aims to integrate quality improvement (QI) and patient safety (PS), though the scarcity of a clear theoretical model linking these concepts hinders the strength of the proposed meta-framework with insufficient explanation of their connection.

Response: We have revised the study background to make clear the conceptual overlap between QI Research and Patient Safety Research and have clarified the study aims and objectives. We are aware that QI Research Frameworks exist in the literature, as do Patient Safety Research Frameworks. These are valid and are required to guide researchers in their fields. We have added a definition of a framework to the introductory paragraph:

A framework is considered ‘a structure, overview, outline, system or plan consisting of various descriptive categories, e.g. concepts, constructs or variables, and the relations between them that are presumed to account for a phenomenon’ ¹

Nilsen, P. Making Sense of Implementation Theories, Models, and Frameworks. In: Albers, B., Shlonsky, A., Mildon, R. (eds) Implementation Science 3.0. 2020. Springer, Cham. https://doi.org/10.1007/978-3-030-03874-8.

We are also aware that both QI research and Patient Safety research address overlapping goals (i.e. contributing to knowledge to enhance safety), and while we are aware of some recent frameworks that guide both QI and Patient Safety Research (e.g. Canadian Patient Safety Institute (2020) A Guide to Patient Safety Improvement: Integrating Knowledge Translation & Quality Improvement Approaches), there is no systematic collation of such frameworks available from the literature that we could identify. The availability of existing frameworks like this strengthens our proposal to develop a meta-framework, which could be used partially or in-full dependent on the needs of end-users such as those within our diverse network. For example, researchers may take guidance from a full meta-framework or elements of it, dependent on their context or the aims of their study. For health professionals, there has been a call to integrate quality improvement and patient safety research in clinical education ( Wong et al., 2020) which a meta-framework could support . In essence, individual QI and Patient Safety Research Frameworks are still required, but since they are part of the knowledge generation and translation continuum that aims to improve safety, a meta-research framework is required to reflect and understand the co-occurring approaches to improving patient safety in practice. As such, the primary aim of this scoping review is to profile stand-alone QI Research Frameworks, Patient Safety Research Frameworks, and hybrid approaches (QI and Patient Safety Research Frameworks). Thereafter, at the end of the scoping review study, we will use this understanding to inform the development of a meta-framework. We appreciate this was not sufficiently clear in the original submission. We have added the below paragraph on the rationale for combining the QI and patient safety research frameworks, and have clarified our review aims and objectives.

“ Rationale for combining Quality Improvement and Patient Safety Research Framework

Institute of Medicine, Committee on Quality of Health Care in America. Crossing the quality chasm: a new health system for the 21st century. National Academies Press; 2001.

Canadian Patient Safety Institute. A Guide to Patient Safety Improvement: Integrating Knowledge Translation & Quality Improvement Approaches. Edmonton, Alberta; 2020

1. What conceptual frameworks are available for Quality Improvement and/or Patient Safety Research and how have they been applied in healthcare?

2. How are the concepts of QI and patient safety research defined in available Quality Improvement and/or Patient Safety Research Frameworks?

3. What are the reported objectives of available Quality Improvement and/or Patient Safety Research frameworks?

4. What domains and sub-domains are addressed in available Quality Improvement and/or Patient Safety Research Frameworks?

5. What structure-, process- and outcome- related indicators are used in available Quality Improvement and/or Patient Safety Research Frameworks?

6. What criteria for research priorities have been established?

7. What research priorities have been established?

Participatory Mechanisms for Knowledge User Engagement

Moreover, while “knowledge user engagement” is emphasised, the protocol offers minimal discussion on the participatory mechanisms involved. The omission of concrete example regarding decision-making structures leaves the co-creation assertion somewhat unsupported.

Response: Thank you for this observation. We have added the below paragraph to the section on knowledge-user engagement and co-creation.

“The overall participatory mechanism for knowledge user engagement with the planned scoping review is the existing schedule of regular online meetings as part of EQUIPS Strand 2 work programme. The scoping review is a standing agenda item at these meetings, which are chaired by the EQUIPS Research Network Manager. The meetings are facilitated with the aim of giving equal voice to researchers and knowledge users. For example, using the meeting forum, knowledge users themselves continually decide how they would like to be included, and contribute to the review. Outputs from the Strand meetings are reported by the Network Manager to the wider network, including its steering committee, whom are responsible for ensuring that strand outputs are used to fulfil the network’s work programme”.

Ethical Considerations

Also, the authors state ethical approval is unnecessary yet moral considerations in stakeholder engagement and interpretation are overlooked parting the ethical structure incomplete

Response: Thank you for this observation, we have expanded the ethical considerations and have included the below paragraph:

“In accordance with JBI guidance ⁵⁰, there is no requirement to apply for research ethical approval for the scoping review. Knowledge users are being engaged to inform the process of how scoping review is done, and not as research participants. Nevertheless, as is best practice, ethical principles of beneficence and informed consent will be applied to the conduct of the scoping review. Knowledge users, have been informed during online Strand 2 meetings that they are free to share any relevant view and given the volunteer nature of their role in the study, are free to withdraw from participation in the scoping review team for any reason and without incurring any negative consequences from any of the individuals or organisations associated with the research.”

Methodology

Reviewers

Equally, although dual independent reviewers are noted, key details about their training and calibration are left out this failure raises concerns regarding consistency in inclusion decisions and inter rater reliability.

Response: Thank you for this observation. We have added the below to the methodology section.

“Two reviewers will independently assess each of the retrieved records against eligibility criteria. To support inter-rater reliability, seven reviewers (SEM, JP, JMC, EOD, AVC, JAP, CMG) at the study selection stage comprise experienced researchers with PhDs in healthcare quality, human factors and/or health services research or equivalent experience. 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 (SEM plus one other reviewer) to reach consensus.”

Additionally:

“Working in teams of two across six reviewers (SEM, JP, EOD, AVC, JAP, CMG), two reviewers (with a balance of healthcare quality/human factors and health services research expertise) will use a piloted, standardised data extraction form, developed in Covidence, to independently extract data relevant to the scoping review aims (see Table 4 for draft template).”

Data Extraction Template

In addition, the draft extraction template is presented, though it is vague in relation to coding schemes and variable definitions, making it difficult to understand the way multi-domain data will be categorized.

Response: Thank you for this observation. An updated draft extraction template is now presented, with better clarity and includes variable definitions where relevant. Please see Table 4 in the revised manuscript.

Review Findings

Furthermore, the review’s findings aim to contribute to a conceptual framework, but the process for developing this framework remains unaddressed, making it unclear whether it should be inductively derived or theoretically imposed.

Response: Thank you for this observation. We have now clarified that our aim is to identify and describe the conceptual frameworks relating to stand-alone QI Research Frameworks, Patient Safety Research Frameworks, and hybrid approaches (QI and Patient Safety Research, QIPS-R, Frameworks) in healthcare. While we indicate that the results will be used to contribute to a conceptual framework, describing the process for this is beyond the scope of the review protocol paper. However, we have added to the methodology section that the scoping review findings will be presented to stakeholders at a QI and Patient Safety Research Symposium and other for a. Here consultation about how the findings could be used to inform a framework for Irish context will take place. See paragraph below:

“Scoping review findings will be presented at a dedicated QI and Patient Safety Research symposium at the RCSI University of Medicine & Health Sciences and other fora. Here consultation will take place with stakeholders (i.e. healthcare professionals, healthcare managers, researchers, academics, patient representatives, research funders, and EQUIPS members). Discussion will focus on how the findings may be used to develop a QI and Patient Safety Research Conceptual Framework and inform the prioritisation of research topics and methodologies within the context of the Irish healthcare system.”

In addition, we have updated the title of the scoping review protocol to make this more clear.

“Profiling and Mapping Quality Improvement and Patient Safety Research Frameworks: Protocol for a Scoping Review to Guide Integration”

Covidence

Meanwhile, C ovidence is mentioned, lacking elaboration on how data validation, version control and reviewer calibration will be managed raising concerns about internal consistency and data integrity.

Response: Thank you for this observation. We have updated the data extraction section as below to address these concerns.

“To support consistency of the process and version control, the extraction template will be finalised and agreed prior to its use it the study. Disagreement among reviewers will be resolved by a third reviewer. To maintain consistency, all consensus decisions will be led be author SEM with at least two other reviewers present.”

Adherence to JBI and PRISMA-ScR

Then, the adherence to JBI and PRISMA-ScR guidelines is outlined though procedural details on how these frameworks will be executed remain inadequately clarified. The shortcoming of explicit inclusion thresholds and screening examples impacts the review’s reproducibility, rendering it questionable. Subsequently, the research plans to retrieve multiple frameworks addressing similar concepts, yet a method for reconciling duplicates as well as overlaps is absent which could result in data redundancy, distorting the synthesis.

Response: Thank you for this observation. We believe the inclusion of a detailed data extraction template addresses the concern about application of JBI and PRISMA-ScR guidelines. To address the issue of inclusion thresholds we have added the below statement under the study eligibility criteria

“Inclusion thresholds include that papers must address one of the two central scoping review themes: (1) QI and/or patient safety research frameworks and (2) QI and/or patient safety research priorities”.

To address the issue of duplicates, papers which address the same framework will be included as a supporting reference, but the framework will only be described once in the scoping review report.

“Where multiple papers describe the same research frameworks, all papers will be included in the review as supporting references, with the research framework itself only being described once in the scoping review findings”.

Contextual Relevance – Irish Healthcare System

Finally, the Irish healthcare system is described in broad terms, without addressing system-specific factors that could influence the research, limiting its ability to provide contextually relevant recommendations.

Response: Thank you for this observation which is well founded. As we have now revised the study aim (to produce a scoping review) over production of a conceptual framework, this critique means our scoping review findings ought to be contextualised with the context of the Irish healthcare system. Planned consultation with stakeholders at the QI and patient safety research symposium will enable this. We have updated the methodology as below:

“Scoping review findings will be presented at a dedicated QI and Patient Safety Research symposium at the RCSI University of Medicine & Health Sciences and other fora. Here consultation will take place with stakeholders (i.e healthcare. professionals, healthcare managers, researchers, academics, patient representatives, research funders, and EQUIPS members) on how the findings may be used to develop a research conceptual framework and inform research prioritisation exercises within the context of the Irish healthcare system”.

Associated Data

This section collects any data citations, data availability statements, or supplementary materials included in this article.

Data Availability Statement

Underlying data

No underlying data are associated with this article.

Extended data

The following extended data are associated with this article:

•
PRISMA Scoping Review Checklist_Protocol
•
Supplementary File 1_Search strategy

Data are available under the terms of the Creative Commons Attribution 4.0 International Public License (CC BY 4.0).

Reporting guidelines

Data are available under the terms of the Creative Commons Attribution 4.0 International Public License (CC BY 4.0).

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PERMALINK

Profiling and Mapping Quality Improvement and Patient Safety Research Frameworks: Protocol for a Scoping Review to Guide Integration

Siobhán E McCarthy

Jill Poots

John McCaffrey

Emily O'Dowd

Anna V Chatzi

Killian Walsh

Jennifer A Pallin

Clíodhna McGowan

Tommy Kyaw Tun

John Brennan

Samuel Cromie

Edward W Gregg

Roles

Version Changes

Revised. Amendments from Version 2

Background

Introduction

Background

Quality Improvement

Quality Improvement methodologies

Quality Improvement research

Quality Improvement research priorities for the Irish healthcare system

Patient safety research

Patient safety research in Ireland

Patient safety research priorities for the Irish healthcare system

Irish health system developments

Rationale for combining Quality Improvement and Patient Safety Research Frameworks

Table 1. Similarities and differences in Quality Improvement, Quality Improvement Research, Patient Safety Research.

Aims and objectives

Methods

Eligibility criteria

Table 2. Scoping Review Focus.

Information sources and search strategy

Table 3. Database Search Terms (Draft).

Data management and study selection

Data extraction

Table 4. Draft Data Extraction Template Headings.

Data analysis and presentation

Knowledge user engagement and co-creation

Conclusion

Dissemination

Study status

Ethics and consent

Data availability

Underlying data

Extended data

Reporting guidelines

Acknowledgements

Funding Statement

References

Reviewer response for version 2

Anthony J Montgomery

Roles

John McCaffrey

Reviewer response for version 2

Mary Lavelle

Roles

John McCaffrey

Reviewer response for version 2

Kassu Jilcha

Roles

John McCaffrey

Reviewer response for version 1

Adam B Sutherland

Roles

John McCaffrey

Reviewer response for version 1

Olalekan John Okesanya

Roles

John McCaffrey

Associated Data

Data Availability Statement

Underlying data

Extended data

Reporting guidelines

ACTIONS

PERMALINK

RESOURCES