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Abstract
Objectives External inspections are widely used to improve the quality of care. The effects of inspections remain unclear and little is known about how they may work. We conducted a narrative synthesis of research literature to identify mediators of change in healthcare organisations subject to external inspections.
Methods We performed a literature search (1980–January 2020) to identify empirical studies addressing change in healthcare organisations subject to external inspection. Guided by the Consolidated Framework for Implementation Research, we performed a narrative synthesis to identify mediators of change.
Results We included 95 studies. Accreditation was the most frequent type of inspection (n=68), followed by statutory inspections (n=19), and external peer review (n=9). Our findings suggest that the regulatory context in which the inspections take place affect how they are acted on by those being inspected. The way inspections are conducted seem to be critical for how the inspection findings are perceived and followed up. Inspections can engage and involve staff, facilitate leader engagement, improve communication and enable the creation of new networks for reflection on clinical practice. Inspections can contribute to creating an awareness of the inspected organisation’s current practice and performance gaps, and a commitment to change. Moreover, they can contribute to facilitating the planning and implementation of change, as well as self-evaluation and the use of data to evaluate performance.
Conclusions External inspections can affect different mediators of organisational change. The way and to what extent they do depend on a range of factors related to the outer setting, the way inspections are conducted and how they are perceived and acted on by the inspected organisation. To improve the quality of care, the organisational change processes need to involve and impact the way care is delivered to the patients.
- change management
- clinical governance
- health policy
- quality in health care
- organisational development
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Strengths and limitations of this study
This is the first review addressing how external inspections can contribute to improve the quality of care.
We used a theoretical framework to extract and analyse heterogeneous data to explore mediators of change in the inspected health organisations.
For some of the theoretical constructs, we did not identify relevant studies and some of the review findings were graded low confidence, partly because of concerns about adequacy of data.
Background
External inspections are widely used in healthcare.1 2 They are a core element in accreditation, certification and regulation.3 These heterogeneous, complex processes consist of a set of activities that are introduced into varying organisational contexts and share a common ground in that ‘some dimensions or characteristics of a healthcare provider organisation and its activities are assessed or analysed against a framework of ideas, knowledge or measures derived or developed outside that organisation’.4 The phrase ‘external inspection’ also implies that the inspection is initiated and conducted by an organisation external to the one being inspected. External inspections can serve different purposes like promoting accountability and transparency in a regulated society.1 A key purpose of external inspections is that they are conducted to reveal possible substandard performance. When they reveal substandard performance, the inspected organisations are expected to implement necessary change, thereby improving the quality of care delivery.5
Evidence on the effect of external inspections on the quality of care remains unclear and contradictory.6–10 The way in which external inspections might mediate change in organisations is poorly understood.11 12 Better knowledge of how external inspections can contribute to improve quality of care may increase our understanding of why the effects of external inspections seem to vary and facilitate more effective ways of conducting inspections.6 11 13
We conducted a systematic review and performed a narrative synthesis to explore how external inspections can contribute to mediate change and improve the quality of care in healthcare organisations.
Theoretical framework
Quality of care is understood as a property of healthcare systems delivering care.14 15 Accordingly, improving the quality of care depends on changing the performance of the healthcare system, which implies change in organisational behaviour.16 17 Change in organisational behaviour can be understood as a complex social process that involves individuals or groups with the capacity to initiate activities that can contribute to producing change in their organisation in the presence of the appropriate antecedent conditions.18–20
If external inspection is to contribute to improving the quality of care, it needs to impact organisational change, defined as ‘any modification in organisational composition, structure or behaviour’.21 Change activities take place in an organisation of social actors; thus, these activities are accompanied by communication among these actors. Following Schmidt,22 we suggest that the communication within the organisation can affect organisational ideas, which can be understood as the substantive content of the communication about the activities that are undertaken. These ideas represent a cognitive frame for how the organisational actors view and understand their organisation and the change activities that take place within it.22 We refer to the communication about organisational ideas as organisational discursive activities. Figure 1 shows our study framework.
Study framework.
We need to explore how external inspections can affect the change and discursive activities involved in organisational change aimed at improving the quality of care. Accordingly, we need to identify the related theoretical constructs and explore how these constructs can be affected by external inspections.
The Consolidated Framework for Implementation Research (CFIR) is a metatheoretical framework based on the synthesis of constructs from existing theories, which identifies and defines key constructs involved in effective implementation of organisational change (see online supplementary file 1).23 The CFIR encompasses five main domains: intervention characteristics, outer setting, inner setting, characteristics of the individuals involved and the process of implementation. We regard these theoretical constructs as conceptualisations that may be impacted by external inspections during the process of implementing organisational change.
Supplemental material
Methods
Literature review
We performed a systematic literature search (1980–January 2020) to identify empirical studies addressing changes in healthcare organisations subject to external inspection. Our inclusion criteria were quantitative and qualitative studies about external inspections that included empirical data about mediators of change at an organisational level for care delivery. The studies also needed to include a method section describing how data were obtained and analysed. Because the purpose of our study was to explore mediators of change rather than assessing effect sizes of inspections, we found it expedient to include both qualitative and quantitative studies.
We searched the following electronic databases for studies: the Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effectiveness, Medline, Embase, The Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsychINFO and Web of Knowledge. A detailed description of the searches in all of the databases is provided in online supplementary file 2.
Supplemental material
Data extraction and analysis
An overview of the article selection process is shown in figure 2. EHo performed an initial screening of the article titles and the abstracts, focusing on relevance. EHo, GSB and EHa independently reviewed the full text articles and then discussed which articles that should be included in the review.
Flow chart of article selection process.
The main reasons for exclusion were that articles did not include an external inspection, did not address how the external inspection affected the organisation, were not based on empirical findings or did not address clinical care. We included 95 articles for further analysis.
The articles used a range of study designs addressing different types of external inspections in different settings. Thus, we used narrative synthesis as our analytical strategy.24 Narrative synthesis comprises four main elements: developing an initial theory of how the intervention works, developing a preliminary synthesis of findings from the included studies, exploring relationships in the data and assessing the robustness of synthesis. Our initial theory of how external inspections might affect the involved organisations was built around the CFIR. This framework defines key constructs involved in effective implementation of change in an organisation. Accordingly, we explored how external inspections could affect the theoretical constructs identified in the framework.
For each of the included studies, EHo extracted data about the study aim, study method, participants, setting, type of inspection and main findings. EHo conducted the preliminary synthesis of the data for how external inspection affected the involved organisations. The data extraction was guided by the theoretical constructs in the CFIR and comprised written summaries of key findings, excerpts of results from the included studies that addressed the constructs in the CFIR, including illustrative quotations used in qualitative studies. GSB read the included articles to validate the data extraction.
To analyse and explore relationships in the extracted data, we conducted a thematic content analysis of all data included in the preliminary synthesis. We used a combination of direct and indirect approaches as described by Hsieh and Shannon.25 Our initial coding scheme was guided by theory and comprised the theoretical constructs in the CFIR. During the analysis, we added codes derived from the data. Using an iterative process of coding, reflecting on the codes and condensing, we identified themes describing how external inspections could affect organisational change.26 The extracted data and analysis were shared and discussed among all authors.
GRADE (Grading of Recommendations, Assessment, Development and Evaluations)-Confidence in the Evidence from Reviews of Qualitative Research (GRADE-CERQual) was developed to assess the confidence of review findings from qualitative evidence synthesis and is based on four components: methodological robustness, relevance, adequacy of data and coherence of findings. Because most of our included studies used a descriptive design and were based on qualitative data, we found it expedient to apply the GRADE-CERQual principles to assess the confidence of our review findings.
To determine the methodological robustness of the included studies, we applied previously used assessment criteria27 which were adapted from criteria developed by Cunningham et al28 and the Australian National Health and Medical Research Council.29 These criteria were developed to assess the methodological quality of a range study designs. Based on the criteria, studies were scored from 1 to 3, where 3 denotes the most robust study methodology.
The criteria and the rating scheme are displayed in online supplementary file 3. EHo and GSB independently rated all of the included studies and then discussed each article to reach consensus on a CERQual statement for each review finding. Our review is based on previously published and publicly available data; therefore, ethical approval was not needed.
Supplemental material
Patient and public involvement
No patients involved.
Results
Table 1 presents the characteristics of the included studies. In total, 95 studies met the eligibility criteria. Accreditation was the most frequent type of inspection (n=68), followed by statutory inspections (n=19), and external peer review (n=9). A descriptive design was used in 46 of the studies, implying that the data were collected merely to describe and characterise the study population. An analytical design was used in 49 of the studies, implying that the data were collected to test a hypothesis or associations between the variables. Five of the analytical studies included an intervention and randomisation. Data collection methods included surveys, performance indicators based on administrative data or patient records, interviews, focus group interviews, document analysis and observation. None of the studies used an experimental design to test the meditators of change in organisations subject to external inspections.
Characteristics of the included studies, Consolidated Framework for Implementation Research (CFIR) constructs addressed and quality rating
The presentation of the findings is structured according to the mediators of change identified in our analysis guided by the theoretical constructs in the CFIR. For clarity, some of the mediators of change are presented together. The theoretical constructs, the mediators of change identified in our analysis and the corresponding articles are shown in table 2.
Consolidated Framework for Implementation Research (CFIR) constructs, mediators of change identified in our analysis and the relevant articles
Self-assessment
Survey and interview data suggest that the self-assessment tools were considered useful and initiated critical reflection on the organisation’s current practice.30–34 Four other studies reported that the self-assessment tool was confusing and time consuming and was concerned with finding and producing documentation rather than reviewing practice.35–38 Four case studies, three using interview data and one using time series analysis of performance indicators found that most substantial changes were made during the self-assessment phase,36 39–41 where as one study using interview data found that the organisation did not make improvements during the self-assessment phase because it was considered sufficient just to identify improvement needs.42 Another case study found that changes made before the site visit were superficial and sought to achieve ritual compliance, focusing more on getting through the inspection process than on really improving the quality of care.43
Importance of valid and relevant inspection standards
Survey and interview data suggest that the standards used for inspections must be valid, focused on clinical practice and benefits for the patients, and should be translated into something perceived as relevant and useful for the services in their improvement work.36 44–50 To be perceived as relevant, the standards should be adapted to the local context.51 52 Development and revision of standards require a collaborative approach and the expertise of a range of stakeholders including the patients.53–55
Guidance on how to follow up inspection findings
Qualitative data indicate that inspected organisations want guidance on how to improve following an inspection,44 50 56 and two studies using survey data and interview data found that organisations receiving support and guidance from a consultant were more successful in implementing changes after the inspection.43 57
Complexity of inspections
Interview data suggest that the inspection teams gather large amounts of qualitative and quantitative data during the inspections, and that it can challenging to synthesis, weigh and make sense of all the gathered information for the inspection team.42
Knowledge and skills of surveyors and credibility of inspections schemes
Ensuring trust and credibility of assessment schemes requires collaboration between regulators, assessment agencies and health services.58 A key factor for credibility is surveying reliability,59 and qualitative and quantitative date suggest that reliability and validity of surveyor judgements and how they interpret and apply the standards can be a challenge.44 49 59–63 The relationship between surveyors and the staff in the organisations being inspected fundamentally affect the way inspections work.43 Qualitative data indicate that the inspection teams should be multiprofessional, and that they need specific knowledge about the services being inspected along with good communication skills, because such knowledge and skills were considered important for the inspected organisations’ confidence in the inspection findings.31 43 50 64–68 Skill and competence of surveyors along with active collaboration and consensus meetings between surveyors can improve reliability and validity of their judgements.60 63 69
Choosing whom to inspect
Inspecting agencies can rely on a risk-based approach for choosing whom to inspect. Data from one case study suggest that the quantitative dataset used to risk assess provider performance and prioritise inspections did not correlate with the subsequent ratings of general practices and acute trusts.43
Unannounced inspections
Interview and survey data suggest that unannounced inspections could limit the time spent preparing for the inspection, and could contribute to enhance the credibility of the inspection findings.42 66 70 Two trials using actual performance data from inspections did not find any difference between regular inspections and unannounced/short-notice (48 hours) inspections in their ability to identify quality problems,71 72 while survey data from stakeholders indicate that short-notice (48 hours) surveys more effectively identified true organisational performance.70
Increased costs
Survey and interview data along with cost indicators suggest that inspections could increase costs during accreditation and inspections. The increased costs related to staff doing different type of work, for example, participating in meetings, producing new documentation and collecting evidence to fulfil documentation requirements, and smaller facilities seemed to have higher costs.35 38 43 46 52 56 73
Patient focus
Three cross-sectional studies using interview and survey data found that the inspection process and recommendations following the inspection should be more directed towards patient care and clinical practice in order to contribute to improvement.32 45 61 Interview and survey data suggest that accreditation can contribute to increase the focus on patient needs, and promote patient involvement in care.55 74–76 Qualitative data suggest that inputs from patients during inspections are valuable, but more work is needed on how to incorporate such inputs in a meaningful way in the inspection processes.42 46
Relations and communication with external stakeholders
Data from two case studies suggest that findings from inspections can be aggregated and used to identify systemic and interorganisational issues which can influence stakeholders and wider systems other than the inspected organisations themselves.43 77 Interview and survey data suggest that inspection processes can contribute to improve the relationship and communication with community partners by sharing experiences and receiving input on how to improve, and that achieving accreditation was viewed as a way to gain prestige and recognition.30 31 41–43 50 78–83 One case study indicated that inspection does not improve relations with community partners.40
External pressure
Interview and survey data suggest that being reviewed by someone external and independent can be viewed as positive because external feedback can provide a stimulus for change which is based on credible evidence.30 43 44 47 61 83 84 Social pressure from stakeholders in the community was viewed as an external pressure to participate in accreditation.48 78
Public confidence in services
Survey and interview data indicate that results from the inspection processes can be made publicly available, and that such publication can demonstrate that the quality of the services meet a certain standard, thereby contributing to public confidence in the services.30 40 41 43 46 55 66 78 85
External incentives
Interview data suggest that health organisations can participate in multiple accreditation programmes, and that resources are directed towards mandatory programmes with public disclosure of results.56 80 Participation in accreditation and inspections are resource demanding, and to promote effective implementation of accreditation and inspections expectations to participate should be aligned and supported by other regulatory incentives.35 49 75 76
Role of mass media
Interview data indicate that mass media are more likely to report bad news and shortcomings following inspection and accreditation than positive news, thereby giving the public an unbalanced picture of the current situation.35 43 66 Two case studies suggest that media coverage can contribute to the implementation of improvement measures following inspections.48 77
Government involvement
Qualitative data suggest that government can play an active role in developing accreditation schemes by incorporating them as requirements in their strategies for improving quality and safety, by facilitating collaboration between regulators and services, and through financial incentives.48 51 54 86–88
Intrinsic motivation
A cluster randomised trial indicated that accreditation contributed to foster intrinsic motivation for staff, especially for those who perceived accreditation as an instrument for quality improvement prior to accreditation.89
Structural characteristics
A cross-sectional study using data from 4400 hospitals did not find differences in outcomes to be associated with type of accreditation programme.90 Performance data from two cohort studies suggest that hospital size and type did not predict effects of accreditation91; however, lower performing hospitals improved at a greater rate than moderate and higher performing hospitals.92 Two case studies indicate that degree of improvement can depend on improvement capability of the inspected organisation,43 and that accreditation can be easier to implement in smaller facilities.76
Creation of networks, and improved communications
Qualitative data indicate that inspections can contribute to improved teamwork and communication within existing networks in the sense that these can become more focused around how the organisation delivers clinical care.40 42 43 48 51 66 76 80 82 83 93–96 Involved staff members reported that inspections can expand existing networks by facilitating the creation of new meeting places.40 41 43 78 80 97
Awareness of current practice, performance gaps and a more desirable practice, and commitment to change
Interview and survey data suggest that an inspection can highlight problem areas needing improvement.31 43 47 67 76 77 82 86 93 95 96 98–103 Case studies suggest that external inspections rarely identify problems previously unknown in the inspected organisation, but the inspections still serve the purpose of confirming these problems and bringing them into the open so that they can be addressed.42 61 104
Other case studies suggest that inspections should not only address deficits in organisational performance but also be used to recognise and validate success30 41 so that the inspected organisation can maintain what it is currently doing well.30 42 66 Qualitative research indicate that the inspection can draw attention to and provide feedback about a more desirable practice and how this can be achieved.30 31 48 82 83 93 95 97 103
Data from interviews suggest that the authority of the inspecting organisation along with organisational reflections on performance gaps that take place during the inspection can contribute to creating an understanding of the necessity of improving and commitment to change.41 61 76 80 96 104
Inspection findings and goal setting
Data from surveys and interviews suggest that the inspection process should be translated into something meaningful and understandable for the front line in order to contribute to involvement in improvement work.32 35 49 61 66 76 96 105 Problem areas identified during inspections can receive increased attention by the inspected organisation.8 41 42 51 56 77 95 Qualitative studies indicate that feedback from the inspection can be used to define improvement goals for the inspected organisation.56 66 80 103
Organizational incentives and rewards
Survey data suggest that internal recognition and rewards were associated with perceived quality results in accreditation.106
Learning climate, reflection on clinical practice and understanding the clinical system
Findings from case studies and three survey studies using organisational context measures suggest that interprofessional collaboration and reflection can contribute to improving the organisational climate during inspection38 42 51 83 93 94 107 108 and strengthening the social relationships between staff members.80 109 However, interview and survey data also suggested that inspection can lower staff morale by focusing solely on what is wrong.43 66 81 96
A key feature of the new meeting places that can be created during an inspection seems to be that they can bring together a broad range of professionals and disciplines to discuss and reflect on clinical processes in a way that they had not done previously.31 32 41–43 45 66 76 80
Staff members report that communication and interprofessional reflection during the inspection process can contribute to enhancing their understanding of the clinical system and its interdependencies.35 38 95 96 Qualitative data suggest that interprofessional reflection can promote the breakdown of organisational silos and contribute to improving individuals’ understanding of the organisation as a whole, when clinicians learn about practices other than those in which they are usually involved.31 40 41 80 108
Engage leaders in improvement
Leader involvement and engagement in inspection are reported to be important because they give a direction to the improvement process and can facilitate the involvement and motivation of other staff members.47 49 Survey and interview data indicate that inspections can facilitate leader engagement in the area that is being inspected.43 51 66 77 81 102 110 111 However, survey data also indicate that accreditation has no effect—or even a negative impact—on leadership.108 Qualitative case studies report that inspections can provide leaders with a platform that can enable them to act to improve clinical work.40 47 80 Four cross-sectional studies using survey data support the idea that leadership engagement in accreditation can be associated with perceived quality results106 112 113 and accreditation performance.94
Allocation of resources
Qualitative data indicate that preparing for the inspection and being inspected can be burdensome and time consuming, and that the efforts do not necessarily match the outcomes.35 36 38 42 49 66 76 86 95 96 112 Survey and interview data suggest that inspections can have negative consequences for the time spent on clinical work.31 37 66 75 96 114 Interview data indicate that there is an inherent risk that staff members who are involved in accreditation processes without sufficient resources and competence in place can become less enthusiastic about future engagement because of the constraints under which their involvement takes place.35 Findings from qualitative studies suggest that resources may be allocated to areas needing improvement following the inspection.41 61 66 80 93
Planning improvement interventions
Interview data indicate that external inspections can provide an opportunity to reflect on current practice and performance gaps, and to plan actions for improvements in these areas.30 31
Staff members report that feedback from the inspection teams can also be used to plan improvement measures, and that perceived accreditation results were associated with quality improvement planning.31 42 61 76 86 96 100 101 104 Interview data suggest that the feedback following an inspection can provide a sense of direction and validity to the planning process by requesting the inspected organisation to produce a formal action plan addressing how non-conformities should be corrected.30 31 104
Engage and involve staff in improvement activities
Qualitative data indicate that the involvement of those being inspected can be a critical factor for change,45 108 and staff involvement in the accreditation process has been shown to be associated with perceived quality results.86 97 106 112 113 Case studies suggest that inspections can contribute to involving clinicians in improvement work,42 43 48 51 76 80 96 but there were also data indicating that an inspection only involves part of the organisation,41 108 with the risk of those not sufficiently involved not buying into its potential for real change.66
Implementing improvement interventions
Findings from case studies and quantitative cross-sectional studies combining survey data and performance indicators indicate that inspections can contribute to the implementation of planned changes, addressing substandard performance identified during the inspections.30 41–43 49 51 66 76 79 82 86 96 97 101 102 104 115 The inspected organisation can implement changes derived from new models of thought developed during the inspection.40 80
In accreditation, qualitative data and time series analyses of performance indicators suggest that the most substantial changes are implemented during the self-assessment phase prior to the actual inspection.39–41 116 In statutory inspections, survey and interview data indicate that changes were implemented throughout the inspection cycle.42 43 65 66 99
Interview and observational survey data in combination with performance indicators indicate that the feedback and recommendation provided to inspected organisations can facilitate the implementation of change.30 41 42 49 51 66 79 86 97 115 Staff members report that recommendations need to be explicit and realistic about what needs to be changed, and these should be cast in a way that eases implementation by being explicit about the aim of the change and its relevance for patient care.61 104
The inspected organisation can be held accountable for implementing changes,41 and this is reported to contribute to creating momentum to speed up the implementation process.42 43 61 66 104
Findings from qualitative studies, surveys and one randomised controlled trial indicate that inspections can contribute to organisational change, but the change does not necessarily affect quality of care.32 37 41 42 100 101 117 118 Interview and survey data, and one randomised controlled trial indicate that changes can be implemented to make the organisation comply with the standard without actually improving patient care.37 40 45 66 118 According to qualitative data, non-conformities identified during inspections and the corresponding feedback can address shortcomings in the quality management system and support processes.44 50 61 100 However, quality management systems are not always implemented systematically and clinicians question to what degree they actually support and impact clinical work.44 Qualitative findings suggest that there is a risk that corrective changes made to the management system will not have any impact on the quality of care.61 100
Use of measurement systems and data, and evaluation and continuous improvement
Staff members report that external inspections can contribute to reinforcing a healthcare organisation’s self-evaluation, which can impact the organisation’s long-term performance.30 43 66 76 The inspecting body can express expectations as to how the inspected organisation should monitor performance and progress of improvement, and what data they can use for this purpose following the inspection.48 51 82 Qualitative data suggest that such expectations should be stated in a way that makes it possible to follow-up and monitor the progress of the implementation, as well as the effects of the changes on the quality of care.43 61 Survey data and performance data indicate that accreditation can promote continuous improvement, and sustain improvements over time.46 116 However, a challenge is that the standard used for inspection is not necessarily sensitive to improvement over time, and it might not include requirements on how to use measurements to inform continuous evaluation and improvement over time.46 48 85
Cross-sectional studies based on survey and performance data indicate that the inspection process can facilitate the development of measurement systems, which can be used to evaluate performance,51 61 82 85 108 113 119 120 and survey and interview data suggest that inspection can have a positive influence on clinicians’ understanding of the necessity of measuring and evaluating improvement progress.56 121 122 However, contradictory findings based on survey data indicate that inspection does not affect the way the inspected organisation uses and processes data to evaluate its performance.108 Survey and interview data indicate that inspection can facilitate reflection on practice in a way that can provide inspiration for further changes beyond the theme of the inspection.31 50 79 93
Assessment of review findings
The assessment of confidence in our findings is shown in table 3. Nine findings were rated as high, 19 moderate and 8 low.
Assessment of confidence of review findings
Discussion
Our review suggests that the mechanisms by which external inspections might contribute to improve the quality of care are dependent on complex interactions between factors related to the outer setting, how the inspections are conducted and how they are perceived and acted on by the inspected organisations.
Inspections serve different purposes including accountability and transparency in the services.1 Our findings indicate that public disclosure of inspection findings can contribute towards transparency about the standard of the service, and thereby public trust by ensuring that the services meet a certain minimum standard.66 85 Healthcare organisations serve the public, and the review findings suggest that the inspection process can contribute to accountability by creating an opportunity for community partners to provide input on how the inspected organisations should improve.30 41
Regulatory guidance
The regulatory context in which the inspections take place affect how they are perceived and acted on by the organisations being inspected. An active regulator along with incentives, disclosure of inspection results and mandatory programmes seem to promote participation and increase resource allocation towards the inspected area.49 56 Our findings indicate that inspected organisations value guidance on how to follow up inspection findings, and that such guidance can facilitate implementation of changes.50 57 Another key reason for doing inspections is to promote quality improvement. Our findings suggest that the standards used during the inspections should focus on patient needs and be translated into something that is perceived as meaningful by the front-line staff.45 61
Use of self-assessment tools
Most external inspections include a self-assessment phase in which the inspected organisations are expected to prepare and review their own practice prior to the external assessment. Our findings about this phase are contradictory; the perceived usefulness and relevance of the available tools seem to have great impact on the outcome of this phase. Self-assessment tools that address patient care and that help the front-line staff to review their clinical practice are perceived as useful and can contribute to change.30 39 Self-assessment tools primarily concerned with providing documentation and that do not address patient care are perceived as burdensome and do not seem to contribute to changes in care delivery.31 35
Credible, predictable and transparent inspection processes
External inspections represent an assessment of the inspected organisations’ performance, and an evaluation of how the staff do their work. If substandard performance is identified, the performance, and consequently the way the staff do their work needs to be changed. In order to engage in change processes, the inspection scheme and the findings must be perceived as valid and reliable by the relevant stakeholders. The interaction between the surveyors and the inspected organisation is critical for establishing a credible inspection scheme in which the findings are acted on. The inspection teams’ knowledge about the inspected area and their communication skills are reported to be a prerequisite for confidence in the inspection findings.50 65 Inspection processes should be predictable and transparent. The surveyors therefore need to ensure that the inspection findings and the judgement of them are reliable across different organisations.54 59
Measures to bring about change in clinical processes
Our findings suggest that external inspections can affect different mediators of organisational change. The main activities of the improvement process following an inspection include planning and implementing improvement measures, evaluation and continuous improvement.23 123 The findings suggest that when substandard performance is identified, the inspected organisation is expected to plan and implement improvement measures that address the identified performance gaps and evaluate their effects. Inspections can affect all steps in this basic improvement process.
Organisational change is a precondition for improved quality of care, but it is possible to implement organisational change that does not affect the way care is delivered.124 Our findings indicate that there is as an inherent danger that improvement measures following an inspection mainly address deficiencies in management systems and support processes, that is, updating or creating new written guidelines and educational activities. Structural changes of this kind can be a precondition for making changes in the corresponding clinical processes.125 However, structural changes not sufficiently linked to corresponding changes in the clinical processes can have limited effect on the quality of care.126 127
We found evidence that inspections can affect other organisational change and discursive activities beside the basic steps in the improvement process. Our findings indicate that the change and discursive activities can interact and affect the improvement process in complex ways. Based on our theoretical framework, we argue that the way and to what extent inspections affect these change and discursive activities can be crucial for whether the inspection actually leads to organisational change that improve the quality of care.
Strengthening networks and promoting learning
Inspections can contribute to enhancing communication about clinical work and facilitating the development of networks through which organisational members meet and reflect on their own clinical practice and the findings of the inspection, thereby improving the learning climate. Involvement and engagement from leaders and staff can be a prerequisite for such multiprofessional reflection, which can be key to shaping a shared organisational understanding of the organisation’s actual performance and of areas needing improvement, thus contributing to readiness and acceptance for change. Moreover, the reflection can improve the organisational members’ understanding of their clinical system and its interdependencies, on which they can base their planning and implementation of improvement measures. We argue that improvement measures that are planned and implemented based on a new and enhanced understanding of the clinical system and its interdependencies are more likely to produce organisational change that change the way clinical care is delivered and thereby improve the quality of care.
Strengths and limitations
The strength of our study is that we conducted a systematic literature search to identify relevant studies and used a theoretical framework to extract and analyse heterogeneous data to identify possible mediators of change. Our theoretical framework does not represent a complete list of all possible constructs that might contribute to explaining how external inspection affects organisational change and the quality of care. Nevertheless, the theoretical framework was sufficiently comprehensive to include a wide range of constructs for exploring how inspections affect organisations, which in turn can advance our understanding of how inspections can contribute to improving the quality of care.
We assessed nine of our findings to have high confidence and 19 of our findings to have moderate confidence, which indicates that it is highly likely or likely that our findings represent the phenomenon of interest (table 3). The fact that we assessed a finding to have high confidence does not necessarily imply that inspections always will have that particular impact, because they are complex and context dependent. Two of the findings assessed to have high confidence were external inspections’ contribution towards awareness of current practice and performance and implementing improvement interventions. These findings might seem contradictory to previous research suggesting that external inspections have limited impact on the quality of care.128 We argue that these findings illustrate what seem to be a key challenge for external inspections. Even though they might contribute to discover substandard performance and facilitate implementation of organisational change, the quality of care is not improved unless the change processes affect care delivery to patients. Eight findings were assessed to have low confidence, indicating that it is possible that the review findings are a reasonable representation of the phenomenon at interest. One of the main reasons for grading a finding as low was inadequacy of data and inconsistent findings, which can partly be explained by the fact that external inspections are complex interventions introduced into different organisational contexts.129
Implications and future research
In order to contribute to quality improvement, inspections need to affect organisational change activities involved in improving care delivery. We found that inspections can affect different mediators of organisational change, and our findings can thereby enhance our understanding of why inspections seem to have varying effects. Our findings can provide guidance for policy makers and inspectors on how future inspections should be designed and conducted to be more effective. Organisational change to improve clinical services may be promoted by regulatory guidance, use of self-assessment tools as part of the inspection, a credible, predictable and transparent inspection process, and development of measures to bring about change in clinical processes.
This is the first review addressing how external inspections can contribute to improve the quality of care. Future studies should further explore relationships between how the inspections are carried out, their contextual setting and the way they can mediate change in care delivery in the inspected organisations.
Conclusion
External inspections can affect different mediators of organisational change. The way and to what extent they do depend on a range of factors related to the outer setting, the way inspections are conducted and how they are perceived and acted on by the inspected organisation. They can affect the key activities involved in planning, implementing and evaluating organisational change and the organisational discourse about these ongoing change activities. To improve the quality of care, the organisational change processes need to involve and affect the way care is delivered to the patients.
Acknowledgments
The authors thank Signe Romuld, Lise Vik-Haugen and Gerd Vik, librarians at the Norwegian Board of Health Supervision and Western Norway University of Applied Sciences, for valuable help in developing and conducting the database search.
References
Footnotes
Contributors EHo and GSB contributed to developing the study design, screening articles, data extraction, data synthesis, assessing quality of included articles and confidence in review findings, and drafting of the manuscript and revisions. EHa contributed to developing the study design, screening articles and drafting of the manuscript and revisions. KW, OB, SF, PS and JCF contributed to developing the study design, and drafting of the manuscript and revisions.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests None declared.
Patient consent for publication Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data sharing not applicable as no datasets generated and/or analysed for this study. This is a systematic review, and all the data that we have used are taken from previously published material.