Patient and Health Professional Perspectives about Engaging Patients in Addressing Patient Safety: A Systematic Review Protocol.

BACKGROUND: Patient safety is crucial to the provision of quality healthcare and has become increasingly important with the world health organisation recognising the significance of patient engagement in safety issues. Despite an increasing amount of literature examining the engagement of patients in addressing their safety, there has been little research examining the perspectives of patients and health professionals regarding the engagement of patients in safety issues. AIM: This protocol aimed to explore the perspectives of patients and health professionals regarding the engagement of patients in safety issues.
METHODS: During February 2019, a literature search was conducted using four databases, PubMed/MEDLINE, Embase, Web of Science and Scopus. There were no limits on the year of publication. Two authors were screening the titles, abstracts and full texts of all the studies independently of each other and potential discrepancies will be resolved in consultation with the third author. Studies identified in the literature search were assessed using the Mixed Methods Appraisal Tool (MMAT), and a 'best fit' framework synthesis approach was adopted to combine evidence from studies that have used qualitative and mixed methods.
CONCLUSION: The results from this study can be used to develop interventions to increase patient engagement with patient safety.

Introduction

Over the last ten years, patient safety has been a key priority for both governments and healthcare providers, and patient engagement has become a key element in the design of health care processes and has been successfully applied to some aspects of patient care [1], [2], [3], [4]. Health policymakers believe that encouraging patients to play an active role at all levels of health care provision can improve efficiency, quality, and health outcomes [5]. Patients and their families are best placed to identify what it is that can be done to ensure patient safety and their role has been recognized by the World Alliance for Patient Safety (WAPS) which is actively promoting the value of involving patients and their families in measures to improve health care [6], [7].

The term “patient engagement” is used to refer to a process whereby patients, their carers and their families are encouraged by healthcare providers to be actively involved in the delivery of health care services on the basis that their involvement puts the patient at the centre. It is considered that with the patient at the centre both safety and quality will be improved [8]. While there is no agreed definition of patient engagement, those definitions found in the literature all reflect a single underlying theme, that through patient engagement the role of those using health services is facilitated and strengthened, enabling them to be active contributors in the development of health care policy and practice [9].

Different examples of patient engagement in patient safety can be found in the existing literature. A starting point for patient engagement is the point at which information is collected from the patient about their experience of care and of the outcomes that have been achieved. Such information can provide valuable insight into patient needs, their preferences and their values, information which may ultimately support improvements in both the quality and the safety of healthcare [8]. Other examples of patient engagement can be found at an organisational level. For example, patients and their families, as members of advisory committees, can be involved in designing and developing processes and systems which have the patient at the centre [10], or they may be involved in the development and dissemination of tools, information and educational materials that support patient safety [11].

It is also clear that patient engagement can extend from the patient being the source of data in a research study to the patient as a “co-researcher”, contributing to the design, planning and execution of the research studies themselves [12]. Other examples of patient engagement include situations where patients are involved in monitoring and updating their medication and treatment plans or where patients and their families and carers are encouraged to ask questions or to raise any concerns they might have [8].

In recent years, the value of engaging patients and their carers in patient safety planning has been highlighted [13] and the World Health Organization (WHO), most recently, has emphasised patient and community participation in patient safety through the “patient for patient safety” program [14]. Several studies have also demonstrated an association between patient engagement and patient trust [15] and patient satisfaction [16], [17]. Patient engagement has also been shown to improve treatment outcomes [18] and to decrease the number of adverse events [19].

Given these findings, it would be reasonable to conclude that the volume of patient safety incidents and the question of what interventions might be adopted to reduce them should be considered as one of the principal functions of the patient engagement process. It seems that if patients are well-informed about their condition and about the medical procedures they are undergoing and they feel empowered and involved in their care, they will have a positive experience of health services [14]. However, this key role that patients can play is often ignored in patient safety programs with the result that these plans rely less on patients than they might [20].

Patient engagement in health care is a relatively new approach, and studies in this area are still very limited [21]. A review of the literature shows that little has been written on how patients can contribute to the processes that ensure their safety [22]. Given this scarcity of evidence, it appears that more work is needed to explore the views of health professionals and of patients concerning the role that patients can play in addressing the safe provision of care [23]. The perspectives brought by health professionals and by patients are crucial if we are to understand the setting in which health interventions will be performed [24]. However, most health interventions focus on the views of healthcare providers [25] even though including a patient perspective has been shown to result in better health decisions and outcomes [26] as well as improving levels of patient satisfaction with their health care [27], [28].

This review will, therefore, address the following question: ’what perspective do patients and health professionals have about engaging patients in addressing issues relating to patient safety?’ It is hoped that by answering this question a more comprehensive understanding of the issue might be achieved.

Methods

Study method

The systematic review was registered with the International Database of Prospectively Registered Systematic Reviews (PROSPERO): CRD42018104822 [29]. The protocol for the systematic review is based on the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols (PRISMA-P) reporting guidelines [30] and the review will adopt the ‘best fit’ framework synthesis approach [31] and will be reported according to the PRISMA guidelines [32].

Eligibility criteria

This review will examine qualitative studies and the qualitative element of mixed methods studies. Only those that investigated the views of patients and health professionals regarding the engagement of patients in addressing patient safety will be included, and no restriction will be placed on the form of that patient engagement. Conference abstracts, theses, books, and opinions were excluded from the study although such material may be used to identify further studies. Studies, where the full text is not available, were excluded. Eligibility criteria for inclusion in this review have been defined using PICOD components (participants, interventions, comparators, and outcomes and design) and are described below (Table 1):

Table 1

PICOD indicator and Eligibility criteria

PICOD indicator	Inclusion criteria
Population/Participants	1) Patients
	2) Health professionals to include, according to the WHO definition, those people in a health system who are engaged in actions the primary intent of which is to enhance health [33] (e.g. physician, clinician, midwife, nurse, laboratory technician, etc.).
Indicators/phenomenon of Interest	Perspectives of patients and health professionals regarding the engagement of patients in addressing issues of patient safety.
Context	Any country and in any hospital
Outcome	The probable outcome will include a greater understanding of the impact of patient engagement on patient safety and of any factors, barriers or facilitators which impede or ease the engagement of patients in addressing patient safety issues.
Design	Qualitative and mixed methods studies

Search strategy and data sources

A search of the PubMed/Medline, Embase, Web of Science and Scopus databases will be conducted during February 2019, and no restrictions will be placed on the years of publication nor the language of publication. For Persian articles, we will search the Farsi databases such as SID and Magiran using Persian equivalents words. The search strategy proposed for the PubMed database is shown below, and this strategy will be used with some modification for other databases (Table 2).

Table 2

Search strategy for the PubMed database

Search number	Search string
#1	Patient safety [MeSH Term] OR‘Medical errors’ [ti,ab] OR ‘Patient harm’ [ti,ab] OR ‘Safe care’
#2	‘Patient Engage*’ [ti,ab] OR ‘Patient Involv*’[ti,ab] OR ‘Patient Participat*’ [ti,ab] OR Patient Center*’ [ti,ab]
#3	Perspective* [ti,ab] OR Opinion* [ti,ab] OR View* [ti,ab] OR Experience* [ti,ab]
#4	Patient* [ti,ab] OR Provider* [ti,ab] OR ‘Health Personnel’ [MeSH Term] OR ‘Healthcare Professional*’ [ti,ab] OR ‘Healthcare Staff’ [ti,ab] OR Physician* [ti,ab] OR Clinician* [ti,ab] Doctor* [ti,ab] OR Nurse* [ti,ab]
#5	Qualitative [ti,ab] OR ‘Mixed method’[ti,ab]
#6	#1 AND #2 AND #3 AND #4 AND #5

To capture grey literature, a search will be conducted of the greylist database, and the reference lists of the included studies will be searched.

Study selection process and data extraction

Search results will be uploaded, and any duplicates are removed by ZCH using EndNote X8 (Clarivate Analytics). Relevant studies will be identified by ZCH and MA-Z who, independently of each other, will apply the inclusion and exclusion criteria to screen the titles, abstracts and full-texts of all of the studies. Any disagreements between ZCH and MA-Z during the screening process will be resolved by consensus or, if consensus is not possible, by consulting with AJ. A flow diagram will be used to report the study selection process by the PRISMA guidelines [32].

ZCH and MA-Z will, independently of each other, extract data from those studies identified at the screening stage. This will be done using a data extraction form having adopted an unblended standardized manner. The data extraction form will be based on the seven constructs in the Vincent’ framework [34] and will record key study information and key findings. Key study information will include source, year, country, design and method, participants, and data analysis. Key result information will include those factors, challenges and facilitators that were found to influence patient engagement in addressing patient safety. The data extraction form will be piloted on a sample of five studies and, should this pilot identify the need for modification, necessary modifications will be made to the form. The final modified form will be used in respect of the remaining studies. Any discrepancies that may arise during the data extraction process will be resolved by achieving a consensus between ZCH and MA-Z and by a discussion with AJ if a consensus cannot be reached.

Quality appraisal

Both the qualitative and mixed methods studies identified during this review will be appraised using the Mixed Methods Appraisal Tool (MMAT) [35], a tool that has established content validity and which has been piloted across all methodologies [36]. Initial assessment of each study will be conducted using two screening questions the answers to which will determine whether or not further appraisal is feasible. An overall quality score will be calculated for those studies deemed feasible for further appraisal by categorising them within a methodological domain using the MMAT scoring metrics descriptors. The critical appraisal of the studies identified during the review will be carried out independently of each other by ZCH and MA-Z with any disagreements will be resolved through consensus.

Data synthesis

Data synthesis will be carried out by ZCH and MA-Z using the “best fit” framework synthesis method [31]. Vincent’s ‘framework of contributory factors influencing clinical practice’ [34] was selected to describe the data obtained from studies included in the review and to complete the initial step required by the ‘best fit’ framework synthesis approach [31]. Units of analysis included data described in the studies under review as ‘findings’ or ‘results’, as well as findings in the abstract [37]. Only the qualitative results from the mixed method studies will be synthesised and any quantitative findings from these studies will be ignored. Line-by-line coding [38] will be carried out by one author who will re-organise concepts or factors until they can be “translated into one another” [39], [40]. Hierarchies of subcategories and higher order categories will be created by organising the codes into groups that share common features [37].

Ethics and Dissemination

The results of this review will be disseminated through publication in a peer-reviewed journal or by a presentation at a relevant conference. This study was approved by the Tabriz University of Medical Sciences (ethical code: IR.TBZMED.REC.1397.617).

Author contributions

AJ and ZCH contributed to the concept of the study. The manuscript protocol was drafted by ZCH and was revised by AJ and MA-Z. The search strategy was developed by all three authors and MA-Z and ZCH, independently of each other, will search, screening the studies, extracting data from those identified for inclusion and completing the data synthesis. The publication of the protocol was approved by all three authors.