The medication self-management work system of patients and informal carers from a human factors & ergonomics perspective: A scoping review protocol

Background: Healthcare is increasingly delivered closer to the patients’ homes, which increases the level of responsibility that patients and informal carers take for managing their medication-taking, although this is associated with hazards. Medication self-management has been conceptualised as work taking place in non-formal settings ( e.g., households), which are complex systems. Human factors and ergonomics (HFE) models provide a framework for studying such systems. The Systems Engineering Initiative for Patient Safety (SEIPS) is one framework that considers work system elements and how they interact with each other to shape processes that lead to outcomes ( e.g., safety). Given the increasing amount of diverse research on patient and carer work and on system-shaping factors, the objectives of this review are to: (i) identify available evidence in a structured and systems-oriented way, (ii) explore approaches that have been applied and (iii) highlight research gaps. Methods: An evidence-informed patient, public and carer involvement (PPCI) approach will be implemented at all post-protocol stages to ensure the relevance, uptake and translation of the scoping review. The review will systematically search MEDLINE, Embase, PsycInfo, CINAHL and Web of Science to identify relevant qualitative studies. The methodological approach will be guided by Johanna Briggs Institute methodology and will be reported according to the PRISMA-ScR standards. Data charting and qualitative content analysis directed by SEIPS will explore how the work system and its constituting elements have been described in the literature and identify specific gaps and opportunities for future research. Borrowing from realist approaches, included studies will be assessed in terms of richness and relevance to our review question. Discussion: Strengths of this scoping review include PPCI and a converging focus on medication safety, medication self-management and HFE. Ultimately, this approach will advance our understanding of this complex system and guide opportunities to broaden and strengthen the evidence base.


Introduction
There is a global drive to deliver healthcare as close to home as appropriate 1,2 , and to reduce exposure to unnecessary hospital admission. In this context, patients and their carers are taking on increasing levels of responsibility and burden of medication management 3,4 . Both positive and negative outcomes have been associated with lay medication practices in the home. For example, patients may sometimes successfully and conveniently integrate medication work into the structure of their daily lives 3 . However, many hazards have been identified, including the sharing of prescribed medication 5,6 , non-adherence 7 , hoarding 8 , unsafe storage 9 , inappropriate disposal 10 , inappropriate dosage 11 and errors made by patients and their carers 12,13 . This medication management by patients or their carers has been conceptualised as work, that is, effort expended to complete tasks associated with all aspects of medication use to achieve the desired beneficial effects and reduce the likelihood of undesirable effects 3,4,14 . Such medication work is self-managed in non-formal settings (e.g., households), which are complex systems that can be explored using human factors and ergonomics (HFE) approaches. HFE seeks to understand how people and other elements within a system interact 15 , and to apply systems-thinking models to "optimise human well-being and overall system performance" 16 . The Systems Engineering Initiative for Patient Safety (SEIPS) is one such model 17 . SEIPS considers how work system elements (people, tools, tasks, technologies, environments and their organisation) and the interaction between these elements shape work processes (at social, physical or cognitive levels), which in turn produce work outcomes that may strengthen or weaken safety. For instance, SEIPS has been used to explore household medication safety 14,18 . Further, a recent scoping review exploring contributory factors related to patient work identified a substantial number of publications on the topic of medication management 4 , indicating that a dedicated review adopting a HFE perspective on the topic is needed. Therefore, given the increasing body of work that patients and informal carers perform to self-manage medication in non-formal settings, there is a need to gather the evidence about this work in a structured, systems-oriented way, in order to identify research gaps and opportunities to advance research, policy and practice.
The present need for research Preliminary searches suggested the current body of literature is heterogenous, which reflects a need to unify and structure this knowledge to take a considerate HFE approach to study lay medication management. Moreover, the increasing prevalence and global burden of polypharmacy 19 add complexity to the work carried out by patients and carers in managing their medication. Finally, the need to research lay medication management is emphasised by the fact that pre-existing health inequalities can widen even more during public health emergencies such as the COVID-19 pandemic 20 , as evidenced by outcomes such as medication-related harm.

Objectives
This scoping review aims to describe and categorise the available evidence about non-formal medication self-management work systems. The scoping review aims to (i) use a HFE perspective to identify and structure studies about medication self-management as practiced by patients and informal carers in non-formal settings, (ii) to explore the data analytical approach applied in these studies and (iii) to identify gaps in the available body of evidence and opportunities for future research.

Methods
Patient, public and carer involvement Patient, public and carer involvement (PPCI) in research is important to optimise the relevance and meaning of the research to those affected by the topic and to increase the uptake and translation of research into sustainable practice 21,22 . PPCI supports stakeholders, such as end users and professional or non-professional providers, to have parity with researchers. This helps stakeholders, patients and carers maintain a central status in the three domains of quality in healthcare, namely clinical effectiveness, patient safety and patient experience 23,24 .
This scoping review will incorporate and report on PPCI in line with the Authors and Consumers Together Impacting on eVidencE (ACTIVE) framework 22 . Contributors will be invited to participate on a continuous basis at the following stages: selection of studies, data collection, qualitative analysis, interpretation of findings, writing and publishing, knowledge translation and impact, including outreach activities and the co-design of lay summary materials. A suitable level of engagement (leading, controlling, influencing, contributing or receiving) will be jointly decided with PPCI contributors identified on each occasion, having regard to their preferences and the resources available at each stage. Training will be provided to support the learning needs required to meet the tasks.

Protocol development
The methodological approach is informed by scoping review guidelines published by the Joanna Briggs Institute (JBI) 25 and by recommendations on implementing PPCI according to the ACTIVE framework 22 . Further, the reporting of this protocol observes the items on the Preferred Reporting Items for Systematic Reviews and Meta Analyses extension for Scoping Reviews (PRISMA-ScR) checklist that are relevant to a protocol 26 . Additionally, a PRISMA extension for protocols (PRISMA-P) checklist 27 has been completed (access is detailed in the Data Availability section 28 ).

Eligibility criteria
The eligibility criteria were developed around a modified version of the PCC tool (participants, concept, context) 25 , presented below. Relevant peer-reviewed primary studies will be included while secondary studies will not, although references cited therein will be screened. This approach will help prevent inadvertent double counting of data originating from primary studies 25 . There is no restriction on the date of study publication. We will attempt to translate studies published in languages other than English.

Participants.
Studies with a primary focus on lay participants such as patients and their non-professional carers (e.g., family members or laypeople who may or may not have received training) will be included. Studies focusing on healthcare practitioners, formally employed caregivers or professional carers will be excluded.

Concept.
Studies addressing any aspect of medication self-management are eligible for inclusion. For the purpose of this review, we consider medication self-management as any task undertaken by the patient, or their carer, for the purpose of using their medication, at any stage of the medication management process. Medication will be defined as an authorised allopathic product that may be prescribed or non-prescribed (available over-the-counter).
Context. Studies exclusively addressing household, domestic or other non-formal healthcare settings will be included. Studies that have an element of professional or semi-professional service provision will be excluded.

Study design.
Eligible studies will include those that analysed or presented qualitative data by considering principles of human factors or ergonomics, systems engineering, sociotechnical or socioecological systems, or other relevant theories or frameworks, which enabled the identification of at least one of the following concepts: work system elements (e.g., people, environments, tasks, tools, technologies), work processes (e.g., obtaining supply, administering, monitoring), work outcomes (e.g., humanistic, organisational, clinical or economic) and factors (facilitators and barriers to safe and effective medicines management) associated with the work system.

Information sources
Five databases will be used to retrieve relevant literature, namely MEDLINE, Embase, PsycInfo, CINAHL and Web of Science.

Search strategy
The search strategy, shown in Table 1, was constructed for the MEDLINE and Embase databases using the Embase interface and was endorsed by a subject librarian. The systematic search will be tailored to the interface for PsycINFO, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), and Web of Science.
Each search string will focus on four key concepts: 1) medication use; 2) by a population of patients or informal carers; 3) within non-formal settings; as reported by 4) studies related to the field of HFE which can provide details around work systems, processes and outcomes. The four strings will be combined with the 'AND' operator to yield relevant results.

Selection of studies
Search results from each database will be uploaded to EndNote (Clarivate, London, UK) and de-duplicated. This body of citations will be imported to the Covidence systematic review software (Veritas Health Innovation, Melbourne, Australia), where further de-duplication and screening will be performed. All reviewers will independently review a proportion of titles and abstracts to ensure a common understanding of the application of eligibility criteria. In round one, two reviewers will then independently screen each study by title and abstract. Selected studies from round one will advance to round two where two reviewers will independently screen the article full text to determine final eligibility. Where differences in opinion arise or when a decision cannot be made at either round one or two, consensus will be reached ideally by discussion or through arbitration by another reviewer. A PRISMA flow diagram detailing study selection will be presented in the review 26 .

Data charting process
The review will employ the SEIPS model 17 to structure the charting of reported work system elements (persons, tasks, tools, internal and external environments, organisation), work processes and work outcomes.
A predefined list of elements, shown below, will be used to chart data 25 . Data charting will be piloted on three included studies independently by two authors and will be iteratively adapted to ensure all relevant items are collected 25 . One reviewer will then undertake data charting on the remaining studies. When 10% of studies are charted, a cross-check will be performed by a second reviewer to ensure all meaningful semantic units were charted and classified appropriately, and to enable early diagnosis and repair of issues. If inconsistencies arise, a subsequent cross-check will be performed when 25% of all studies are charted. Should discrepancies persist, all included studies will be cross-checked.
The data charting form will record the following elements, which will be analysed to meet the corresponding review objectives 25 : 1. Study characteristics including country and date of publication, study aims, design, sample size and participant characteristics, 2. Methodological details related to the use of conceptual or theoretical frameworks or methods of data analysis or synthesis, 3. Data that have been analysed or presented from a human factors or systems-based perspective, and which relate to medication self-management as practised by patients and informal carers in non-formal settings. This includes data relevant to work systems, processes, outcomes and related factors (facilitators and barriers), 4. Reported knowledge gaps and recommendations for future work.

Data analysis
Descriptive statistics will be used to characterise the body of studies (e.g., date and place of publication and participant demographics) and will be carried out using Microsoft Excel (Microsoft Corporation, Redmond, Washington). Further, the analytical approaches applied in the included studies will be described.
Basic deductive qualitative content analysis 25 , directed by the SEIPS model, will be employed to report a list of the work system elements, interactions and outcomes reported in the body of studies, thereby exploring medication self-management as practiced by patients and informal carers. This will also facilitate the identification of research gaps in the current body of evidence and opportunities for future research. An appropriate data analysis/management tool e.g., Microsoft Excel or NVivo (QSR International) will be used to support qualitative data analysis and management.
Included studies will be assessed during data charting in terms of their richness (adequacy of data in the included studies) and relevance (the degree of fit of the included studies to our review questions). Borrowing from the realist paradigm and guidance for assessing the confidence in evidence from reviews of qualitative research 29 , a five-point richness scale will be used to estimate the depth of theoretical application of human factors theories and perspectives, and a five-point relevance scale will be used to determine how relevant each study is to our review objectives. This assessment of richness and relevance will complement the above-mentioned method in meeting the objective to identify research gaps and direct future studies.
This deductive coding approach may not accommodate all charted data, as some may fall outside of SEIPS categories, including data that can help contextualise phenomena 30 . Nevertheless, this can be addressed by accommodating inductive approaches that are sensitive enough, especially with respect to subsequent analyses of these data.

Data presentation
Charted data units will be aggregated and analysed. Findings related to the categorisation of data will be presented in a tabulated form for each research objective. Gaps in the available body of evidence and opportunities for future research will be identified by deductively coding the data using SEIPS and then mapping the aggregated coded data against SEIPS 25 . Descriptive summaries will accompany each resulting data set and will respond to each research question.

Risk of bias and quality assessment
Consistent with guidance for scoping reviews, which aim to describe, summarise and present available data 25 , quality or risk of bias assessments about how well each included study addressed its objective will not be performed.

Research ethics committee approval
Approval from a research ethics committee is not necessary in line with scoping review methodology, because the data being used are available in the public domain.

Study status
The literature search has been completed and screening by title and abstract is underway.

Discussion
This scoping review aims to describe and categorise the available evidence about non-formal medication self-management work systems. Using the SEIPS model 17 , the scoping review will map the available evidence to describe each concept e.g., work system elements, the relevant processes and resulting outcomes, the relevance and the richness of the available data to address the research objectives, and will facilitate the identification of research gaps and opportunities for future work. The findings will inform whether a future systematic review or primary studies would best contribute to the construction or validation of a framework to support research and development about a systems-based analysis of non-formal medication self-management.
The proposed review has a number of strengths. The suggested PPCI approach will enhance the likelihood that patients and their representatives are at the centre of the review, that the research is relevant and meaningful and that it will be utilised to inform subsequent research, policy or practice. Adherence to the ACTIVE framework 22 will enhance the PPCI approach employed. The review team have experience across the relevant fields of medication management, medication safety, human factors and ergonomics, and systematic reviewing. The convergence of these and the PPCI experiences will enhance the rigour of the data charting and interpretation.

Data availability
Underlying data No data are associated with this article. should be clarified.

Reporting guidelines
The ACM Digital Library would also need to be considered, especially regarding technology-based approaches to medication management. There are also quite a few papers from the human factors area.
provides a novel approach for exploring medication management in informal settings.
The first sentence in the abstract and introduction is correct in that healthcare is increasingly being delivered closer to the patient's homes (e.g. monitoring blood pressure at home, remote care delivery, etc.) but I think this link to medicine management and taking medicines at home needs a better explanation. Haven't patients always taken their medication in the home? Could the authors please expand on how medicine management has become more burdensome because of the push to deliver care closer to home? Or has medicines management work become more burdensome because of the increase in prescribing behaviour and polypharmacy (as the authors allude to)?
I understand that the focus is on medication management in the home/informal setting and the hazards this can create. But I was surprised not to see more mentioned about the source of medication which requires management -i.e. prescribing by health care professionals and the relationship between work as prescribed by professionals to patients and patients' capacity to carry out this work (see the work of Carl May and colleagues 1 , and Ian Maidment and colleagues 2 ). How will the authors address the treatment burden which is surely not solely the responsibility of patients?
The review will adopt comprehensive patient, public and carer involvement, and from what I understood from the protocol, PPCI will occur from the study selection stage and onwards in the review process. But I wondered if patients and carers had been involved in the identification of the review questions and if so how their involvement shaped the resulting review.
conditions, polypharmacy 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.