Chapter One: Introduction
Background Information
Enhancing patient safety and other healthcare quality dimensions often requires implementation of changes at all the four levels of healthcare system such as patient experience when interacting with the healthcare practitioners, functionality of care delivery units including nursing units, practices of organisations which house the microsystems, and environment of payment, policy, authorisation among other factors which are external to the actual care delivery process involved in the shaping of the context within which healthcare organisations can deliver care. According to WHO (2021), the patient safety often emerges as a result of the evolving complexity within the healthcare system leading to the rise of patient harm within the healthcare facilities, and it aims at preventing or reducing the risks, errors and harm which occur to the patients during the care delivery process. Similarly, NHS England (2020) reported that patient safety is fundamental in the delivery of quality vital care services and that there is a clear consensus that the quality of care from a global perspective should be safe, effective and patient-centred.
In addition to the realisation of key benefits of quality healthcare, Bukoh and Siah (2020), Cheng et al. (2020) and Zenati, Kennedy-Metz and Dias (2020) noted that quality healthcare services must be equitable, timely, efficient and integrated. Therefore, there is need for formulating clear policies, enhancing leadership capacity and collection of appropriate data for driving safety improvement plans, skilled and competent healthcare teams as well as effective involvement of patients in the care delivery process as key strategies for successfully implementing patient safety programme. As reported in the previous studies by Cheng et al. (2020), Di Pietro et al. (2021) and Danzer et al. (2020), an effective healthcare system should consistently account for the increasing complexity within the healthcare settings which make healthcare practitioners and other people within the healthcare system prone to mistakes which may compromise the quality of care delivered to the patients. AHRQ (2020) noted that a patient might be prescribed with wrong medications as a result of a mix-up that took place due to similar packaging. In such case, prescription often passes through varying levels of care staring with the practitioner, doctor, in the ward section, pharmacist involving in the dispensing of drugs and finally the nurses who administer wrong medication to the patient. Specifically, lack of standard procedures for medication storage, ineffective communication system among the healthcare team, lack of verification standards prior to the medication administration as well as lack of involvement of patient in the care delivery process could be associated with the occurrence of patient safety problem registered in the case described by AHRQ (2020).
Adverse events are injuries or harm resulting from medical care errors and they probably represent a significant source of infections and death universally (NHS England, 2020). Even though there is still imprecise estimate about the side of this problem, there are higher chances that millions of people are often experiencing disabling injuries or deaths which are directly attributed to the medical care (Di Pietro et al., 2021). According to Bukoh and Siah (2020) and Zenati, Kennedy-Metz and Dias (2020), injuries within the healthcare setting can take place in association with many medical interventions ranging from the tainted blood supplies, healthcare-related infections to administration of substandard drugs. Even though most of these adverse events are often preventable, successful realisation of a totally safe health care is often compromised by the longstanding healthcare principle of “first, do no harm” which limit the ability of most of the care practitioners in making appropriate decision during the patient management process. Comprehensive understanding of the types of adverse events which take place in the hospital setting, their precise scopes, frequency and preventability are key in the formulation of effective policies for reducing incidences of harm from the medical care (Danzer et al., 2020). Nonetheless, most of the health care facilities are still unable to meet all the patient safety standards because of the varying patient needs and complexities of the healthcare conditions to be managed.
The World Health Organisation (WHO) has in the recent years launched series of activities focused on defining the precise topics for research into patient safety in a global perspective as a strategy for facilitating the identification of interventions for reducing incidences of harm and enhancing the quality of care offered to billions of people worldwide who come into contact with the healthcare system (WHO, 2021). The relationship between nurse staffing and the incidences of adverse outcomes among patients has been extensively researched, with previous studies providing varying results among this correlation. For example, Cheng et al. (2020) and Di Pietro et al. (2021 noted that nurse competency helps in reducing the occurrence of adverse events on patients, while Bukoh and Siah (2020) and Zenati, Kennedy-Metz and Dias (2020) on the contrary established that healthcare practitioner competency alone cannot ensure reduced or completely eliminate adverse events as other stakeholders in the healthcare system, including patients and pharmaceutical companies should also actively play their role. With reference to the evidence provided in these studies, it is important to note that realisation of an effective patient safety culture does not only depend on the management philosophies of the healthcare organisation but competency levels of all stakeholders within the general healthcare system, such as the pharmaceutical companies, legislative agencies, healthcare practitioners, patients and their families.
Problem Statement
Unsafe and care services of poor quality are key influencers of injuries and deaths among large number of patients globally (Danzer et al., 2020; Bukoh & Siah, 2020). According to Zenati, Kennedy-Metz and Dias (2020), most of the therapeutic practices and risks linked with healthcare are increasingly emerging as important challenge for patient safety and meaningfully contributing to the burden of harm. Existing evidence outlined factors such as medical errors, hospital-acquired infections, diagnostic errors, radiation errors to be directly involved in compromising the quality of patient safety and should be appropriately addressed (Cheng et al., 2020; NHS England, 2020; Zenati, Kennedy-Metz & Dias, 2020). Specifically, Zenati, Kennedy-Metz and Dias (2020) reported that the adverse events caused by risky care are among the top ten influencers of disability and death globally and should be addressed. Among the high-income countries such as the US, UK, Germany and France, the WHO (2021) reported that at least 10% of the total patient population are often vulnerable to receive unsafe care, with 50% of the adverse events leading to such harms are preventable.
From a global perspective, at least 40% of the patients are often harmed in primary healthcare setting, with up to 85% of the adverse events leading to such harms are preventable. Specifically, most of the detrimental errors reported in the primary and outpatient care settings are resulting from misdiagnosis, prescription errors and inappropriate use of medications. Despite the growing efforts for enhancing patient safety, there is still limited knowledge regarding the most appropriate strategies for ensuring positive patient culture (Bukoh & Siah, 2020; Di Pietro et al., 2021). According to Cheng et al. (2020), healthcare organisations with positive patient safety culture are often characterised with open communication among the team members, with nurses and other healthcare practitioners directly involved in the magnification of the significance of patient safety, incessant training for patient safety practice. Existing literature, such as Bukoh and Siah (2020) and Zenati, Kennedy-Metz and Dias (2020), has described patient safety culture as an effective approach for reducing medical error incidences in all types of healthcare settings. Nonetheless, the degree of patient safety has not been assessed within hospital settings with either strong or weak patient safety culture. Exploring patient safety culture is a fundamental requirement for realising improved patient safety as well as for reducing the incidences of medical errors which compromise care quality.
Research Aim, Questions and Objectives
Research Aim
The principal aim of this scoping review is to critically evaluate existing evidence about the patient safety implications and outcomes among healthcare organisations with either weak or string patient safety culture. Therefore, this review would lead to the identification of key gaps in knowledge about patient safety culture which can be addressed by future research.
Research Questions
- What are the effects of organisational leadership on patient safety?
- What are the strategies for enhancing patient safety culture?
- What are the implications of patient safety culture in different healthcare settings?
Research Objectives
- To assess and report the operative leadership approach for enhancing patient safety culture.
- To explore the role of healthcare information technology and communication system in enhancing patient safety culture.
- To assess and report the effects of adverse events on patient safety.
Significance of The Research
Despite the growing number of studies focusing on strategies for enhancing patient safety, most of such studies have focused on healthcare organisations with either strong or weak patient safety culture no studies collecting data from both groups of hospital settings hence the generated outcomes from such studies cannot be applied within a general hospital setting. Therefore, this scoping review focused on critically appraising evidence from studies involving healthcare organisations with both strong and weak patient safety culture leading to the generation of comprehensive knowledge that can be as a guide for developing an effective patient safety culture across all healthcare settings. Similar to other contemporary organisations, hospital leadership plays an important role in enhancing the quality of care provided to the patients. Therefore, successful completion of this review would lead to the identification the most appropriate leadership style in enhancing patient safety culture and delivery of safe and sustainable care services to the patients. The review would also facilitate the identification of factors influencing the occurrence of high incidences of adverse events which interfere with the quality of care and patient safety as well as the role of healthcare information technology as a key component of patient safety culture. In addition to critically appraising existing evidence about the patient safety culture within different types of hospital settings, this review would also lead to the identification of key gaps in literature which can be addressed by future research. Therefore, the results from this scoping review would be used as a guideline for motivating future research about the patient safety culture.
Research Outline
The present scoping review is organised into four chapters; introduction, methodology, literature review, conclusions and recommendations. After describing the background information, research questions, aim and objectives in the introduction chapter, research methods used in the literature search, identification and selecting for scoping review are outlined and their selection justified in the second chapter, methodology. Thereafter, evidence from the papers included in this scoping review was thematically analysed leading to the development of key themes to be critically appraised in order to facilitate identification of key gaps in knowledge which can be addressed by future research studies. The last chapter is organised into two key sections; conclusion which provide overall summary of the conducted scoping review and recommendations which provide suggestions for both future research and how the newly developed knowledge can be used for enhancing patient safety practice.
Chapter Two: Methodology
Introduction
In this chapter, the employed research methods and methodologies would be stated, explicated and its selection justified. Furthermore, the literature search strategy used during the identification and selection of most appropriate literature for review in this study would also be described in this chapter. Specifically, the inclusion criteria to be met by all the studies selected for the scoping review would be described and their practicality in the context of the research phenomenon explained. Some of the key aspects of the literature search process described in this chapter include identification of the keywords, selection of appropriate databases for literature search and eligibility criteria used for selecting appropriate literature for review.
Methodology Selection
The present study used a secondary research methodology involving collection and analysis of existing literature about the impacts of safety culture on care quality. The selection of a secondary methodology was influenced by the need to assess the nature of evidence presented in the previous studies about the research phenomenon and identify gaps in knowledge to motivate further research in this context. Specifically, a scoping review design of the secondary research methodology was used to critically appraise existing evidence about patient safety implications and outcomes within healthcare organisations with strong or weak patient safety culture. A scoping review is used for giving an extensive impression of the evidence about the research phenomenon, irrespective of the quality of previous studies involved and are useful during the examination of research areas which are emerging for key concept clarification and research gap identification (Munn et al., 2018). Patient safety is an imperative goal for all healthcare organisations and practitioners hence the adoption of a scoping review design allowed for collection and critical appraisal of existing evidence about this phenomenon from a general perspective.
Scoping review design enhanced generation of comprehensive information about the impacts of safety culture on patient outcomes as the synthesised data were collected from studies which adopted a wide variety of methodologies, such as qualitative, quantitative and mixed-methods approach. Such outcomes could not have been achieved if a systematic literature review or meta-analysis methodology were employed as they involve critical appraisal of only qualitative and quantitative evidence presented in the previous studies respectively. Therefore, the scoping review methodology widened the general scope of the research phenomenon being investigated leading to the identification of a wide variety of knowledge gaps which can be addressed by future research. Consistent with Colquhoun et al. (2017), Pham et al. (2016) and Tricco et al. (2016), scoping reviews can be used for identifying research phenomenon for future systematic review while systematic reviews on the other hand are used for addressing more specific research questions which are based on specific criteria of interest such as population, intervention and outcome. Therefore, adoption of a scoping review methodology allowed for selection and critical appraisal of evidence about patient safety within the general healthcare domain contrary to what could have been achieved using the other literature review methodologies such as systematic reviews and meta-analysis where the generated knowledge could have been specific to a particular healthcare organisation, department or profession.
Literature Search Strategy
Formulation of reporting guidelines is among the essential components of developing a standard methodology for scoping reviews (Eriksen & Frandsen, 2018; Li et al., 2019). Specifically, a reporting guideline is a tool or checklist that is formulated using explicit methods and is used by literature reviewers, including scoping reviewers, to report findings from the research studies they included in their reviews (Li et al., 2019). Therefore, reporting checklist helps in increasing the transparency of methods, enables readers to judge reliability and validity of the selected studies for review as well as to use newly generated knowledge from the scoping review appropriately, including in enhancing realisation of an informed decision-making process (Li et al., 2019). Consistent with Eriksen and Frandsen (2018) and Mendes et al. (2019), literature search strategy includes an organised structure of keywords employed during database search process for identification of syndicating essential concepts of the research phenomenon. Adoption of a well-defined literature search strategy facilitated the determination of extraneous variables impacting the quality of review outcomes and the identification of lacunae or faults which may compromise the quality of evidence to be selected for review if not properly managed. The employed literature search strategy involved defined keywords and search terms, outlining the databases used for literature search process and eligibility criteria used for determining the suitability each literature to be reviewed.
Keywords and Databases for Literature Search
The initial phase in literature search involves identification of keywords to be used for selecting the most appropriate literature from the databases. According to Pearce and Chang (2017), the quality of evidence selected for review is largely dependent on the types of keywords and search terms used during the literature search process. From this perspective, inability to recognise the most apposite keywords and search terms may compromise the overall quality of evidence selected for synthesis and the ability of the scoping review to generate new knowledge. In line with the clarifications by Ho et al. (2016) and Pearce and Chang (2017), the comprehensiveness of literature search process can be increased by using search methods such as wildcards, truncation and adjacency. Furthermore, the Boolean operators “AND”, “NOT” and “OR” were used for combining different keywords and search terms imputed into the search boxes as a strategy for restricting search results to only those studies containing the specific search terms and keywords hence facilitating improved homogeneity of evidence collected for knowledge synthesis and research gap identification.
The literature search process was performed on three databases which include CINHAL, Medline and ProQuest Health Management databases, which was selected because of their high reputations in indexing up-to-date and high-quality literature on general healthcare and patient welfare practices. Literature search was performed on the separate databases using the defined keywords, interconnected using Boolean operators, so as to facilitate identification of research papers with most appropriate evidence about the phenomenon of interest. With reference to the explanations by Ho et al. (2016) and Pearce and Chang (2017), keywords must define the context of the research phenomenon under investigation and that the literature search process must be evidently and expansively explained so as to allow easy replication by future reviewers. Keywords and search terms such as “patient safety OR patient safety culture” were keyed into the initial search lane of each of the three databases, then “patient safety implications OR patient safety outcomes” were entered into the second search lane while the keywords “healthcare organisation OR hospital setting OR primary care setting OR ambulatory setting OR infirmary OR nursing home OR hospice OR clinics” were inputted into the third search lane. Successive search lanes were interconnected using the Boolean operator “AND”, a technique which allowed for the inclusion of only research papers with the specified keywords and search terms.
Eligibility Criteria
Inclusion Criteria
Connelly (2020) defined inclusion criteria as key standards that which every literature must meet to be chosen for the knowledge synthesis, and that they mainly involve purpose and primary outcomes of the studies targeted for new knowledge development, and identification of research gaps in the case of a scoping review. Precisely, the patient outcomes of interest for this review were defined as a strategy for ensuring homogeneity and comprehensiveness of knowledge generated from the scoping review and that the findings can be used to enhance patient care culture as well as the identification of key gaps in knowledge which can be addressed by future research. The approach was consistent with the clarifications by Connelly (2020) and Meline (2016) which noted that the reviewers have responsibility of guaranteeing that every literature for review has comparable research aim so as to enhance homogeneousness of the newly developed knowledge. Furthermore, only studies which assessed effects of patient safety culture on patient outcomes were selected for the review. Therefore, the primary patient outcomes that were considered during the review include mortality rates, readmissions, effectiveness safety of care, length of hospital stays and patient experience.
The second inclusion criterion was limited to only studies originally published in English language. Even though Connelly (2020) supported the use of language conversion services for decoding evidence from original language to preferred ones by the reviewer, Patino and Ferreira (2018) conversely criticised the efficiency of this technique by arguing that it can compromise the general quality of evidence as not every content would be successfully translated. Therefore, only originally published research papers in English language were selected for review. From a methodological perspective, the literature search process was limited to only primary studies irrespective of the methodological approach they adopted. Therefore, qualitative, quantitative and mixed-methods research papers were included in this scoping review. The approach is consistent with the evidence in the study by Meline (2016) which noted that scoping reviews always include research papers with large variety of methodological approaches hence reviewers must include methodological approaches for primary studies to be selected for review within the search protocol. Specifically, this approach led to the generation of more comprehensive knowledge about the research phenomenon as well as identification of key gaps in knowledge which should be addressed by future research. The last inclusion criterion was based on the publication timeline of literature, with only studies published in 2015-2021 selected for review.
Exclusion Criteria
Exclusion criteria are standards for disregarding studies in terms of quality, research purpose, outcomes and type of methodological approach adopted (Connelly, 2020; Patino & Ferreira, 2018). Therefore, a study which fails to meet any of the inclusion criteria should be excluded during the literature search and selection process. Specific to the present review, studies which explored the strategies for increasing quality of patient outcomes without focusing on patient safety culture were excluded. The approach was necessary for enhancing homogeneity and comprehensiveness of evidence to be collected for new knowledge synthesis. With reference to the explanations by Meline (2016), authenticity and quality of evidence in secondary studies are not certain. Furthermore, a scoping review is mainly focused on identifying key gaps in knowledge that can be used to advise further research within the research context, including execution of meta-analysis or systematic literature review which are important types of secondary research methodologies. The next exclusion criterion was based on the studies’ full-text availability where all the research papers without full-text accessible were excluded. The inclusion of only studies with full-text formats allowed for critical assessment of quality of evidence presented in the whole literature rather than only those provided in the abstract section as in the case of studies with no full-text formats. Summary of the eligibility criteria used in this study is presented in the Table 1 below.
Table 1: Eligibility Criteria Used for Selecting Most Appropriate Studies for Scoping Review
| Eligibility Criteria | Inclusion Criteria | Exclusion Criteria |
| Research Aim | Impacts of patient safety culture on patient implications and outcomes | Assessing patient outcomes without focusing on the impacts of patient safety culture Exploring safety cultures in non-healthcare organisation settings such as general manufacturing industries. |
| Publication Variables | Published in 2015-prsent (2021) Originally published in English language Research papers with full-texts available. | Published in 2014 and earlier Published in non-English languages Research papers with only abstracts or no full-text available |
| Methodological Choice | Primary qualitative, quantitative or mixed-methods research studies, grey literatures, policies, reports | Secondary methodologies such as systematic review, meta-analysis, narrative reviews or scoping reviews |
Results from the Literature Search Process
The preliminary literature search process generated 2729 records which were further assessed using the defined eligibility criteria to facilitate the documentation of most appropriate studies for scoping review. The first step involved assessment and removal duplicates, with 504 records being excluded. The resulting 2225 records were further taken through eligibility assessment based on their year and language of publication and primary purpose of the study. Specifically, a total of 407 records were eliminated as they were published in non-English language, 797 excluded as they were published in 2014 and earlier while 693 records involved assessment of patient outcomes without focusing on the implications of patient safety culture. The process therefore led to the elimination of 1897 records, with the remaining 328 records being subjected to further eligibility assessment. Thereafter, all studies with no full-text formats (123 records) and secondary research papers (97 records) were eliminated. The resulting 108 full-text studies were then taken through the manual quality assessment process which led to the elimination of 29 studies and inclusion of 79 full-text studies in the present scoping review.
Data Analysis Method
A thematic data analysis approach was used in the present study for analysing collected secondary data from the existing literature. According to Meline (2016) and Patino and Ferreira (2018), thematic analysis is a methodological approach used for recognising, scrutinising and exploring patterns of meaning, referred to as themes, within the collected data. Contrary to the content analysis which simply focuses on assessing the number of phrases and words in the text, thematic analysis emphasises on the explicit and implicit analysis of meanings within the collected data (Patino & Ferreira, 2018). Precisely, themes reported as final results from the thematic analysis were generated through coding process which involved identification of items of analytical interest within the collected data and tagging them with the coding labels. Therefore, data collected from the selected studies for review were grouped into different categories based on their contents, subthemes, which were later regrouped to develop themes describing the phenomenon of interest. Consistent with the explanations by Meline (2016), thematic analysis is an appropriate approach for exploring data about lived experiences, behaviour, perspectives and practices about the phenomenon of interest. Therefore, thematic analysis method was suitable for this study as the review primarily focused on collecting data about the impacts of patient safety culture on patient outcomes, which are mainly based on the lived experiences, practices and perceptions of healthcare practitioners.
Chapter Summary
The chapter has successfully explained methodological approaches used during the literature search, identification and selection process. At total of 2729 records were identified from the initial literature search process, with 1009 hits, 872 hits and 848 hits being registered from CINHAL, Medline and ProQuest Health Management databases respectively. However, only 94 studies met all the inclusion criteria hence selected for evidence synthesis and knowledge gap identification regarding the impacts of patient safety culture on patient outcomes. Selected studies in this scoping review employed multiple types of primary research methodologies, a criterion which facilitated collection and critical appraisal of detailed evidence about the implications of patient safety culture on patient outcomes within different types of healthcare settings or organisations. In the subsequent chapter, evidence from the studies selected for scoping review would be critically appraised in order to explore the quality of knowledge in the previous literature about the research phenomenon of interest and identification of knowledge gaps to be addressed by future research in this context.
