Over the past decades, quality and safety issues have become increasingly important in health care, having a direct effect on both clinical outcomes and patient satisfaction. Health care suffers from a quality gap, referring to a difference between the practice according to the best available medical evidence and the practice that is observed in daily clinical practice (Shojania, McDonald, Wachter, & Owens, 2004). To close this gap, health authorities and organizations are currently giving high priority to quality improvement strategies, which are systematic, data-driven activities for immediate monitoring and improvement of health care quality (Shojania et al., 2004). A widely used quality improvement strategy is audit and feedback. In this proposal we focus on quality audits.
Defining quality audit in health care
Audits are commonly used to promote quality improvement by changes in healthcare processes, in healthcare provider behaviour and thereby in patient outcomes (Spencer & Walshe, 2009). A major advantage of auditing is that, unlike registered hospital data and mortality rates, it might uncover latent causes of quality issues to which improvements should be made to prevent threats to the quality of health care.
The range of audits can be broadly divided into external audits (e.g. accreditation, certification, external peer reviews) and internal audits (e.g. internal audits in preparation for an external audit or clinical audits) (Bohigas & Heaton, 2000; Spencer & Walshe, 2009). Although there are differences in for example the scope and the approach of the various types of audits, in fact, they serve the same objective, that is, quality improvement.
External audits are defined as ‘a system, process or arrangement in which 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’ (Walshe, Freeman, Latham, Wallace, & Spurgeon, 2000). Specifically, external audits need an external standard and collaboration from outside the hospital to be implemented, which distinguishes them from internal audits.
‘Internal’ means that local practitioners of the hospital’s own organisation perform the audit. It might be expected that – compared with external audits – more essential details of threats to quality can be revealed in an early stage, allowing the organisation to constantly adapt its processes for quality improvement at a local level. In its broad outlines, two types of internal audits can be distinguished: Internal audits focused on the auditing of quality systems and internal audits focused on quality improvement of health care, known as clinical audits. Internal audits in the context of auditing the quality systems are assessments in between external audits conducted by independent internal auditors, such as quality officers or healthcare professionals from another department to guarantee some level of independent judgement. These internal audits are initiated by third parties and are designed to evaluate and improve the effectiveness of the organisations’ quality management system (Bohigas & Heaton, 2000).
Compared with internal audits in the context of auditing the quality systems, clinical audits are mostly executed with a multidisciplinary team of healthcare professionals evaluating their own practice and are not necessarily related to external criteria (Dixon, 2014). Clinical audits are part of the continuous quality improvement process that focuses on specific issues or aspects of health care and clinical practice. In this research clinical audit is defined as ‘a quality improvement process that seeks to improve patient care and outcomes through systematic review of care against explicit criteria and the implementation of change’ (Scrivener et al., 2002). According to Dixon (2014) a clinical audit provides a structured, relatively simple, and effective method for local quality improvement and is normally carried out by a group of peers working in the same healthcare service or organization (Dixon, 2014). In contrast to internal audits, clinical audits are mostly bottom-up approaches which are initiated by healthcare professionals in their own practice.
A considerable amount of literature has been published on the effectiveness of audits. External audits have been adopted in North America, Europe and other countries around the world (Greenfield et al., 2015; Walshe et al., 2000; World Health Organization, 2003). The evidence for external audits improving healthcare quality is mixed (Brubakk, Vist, Bukholm, Barach, & Tjomsland, 2015; Flodgren, Pomey, Taber, & Eccles, 2011; Greenfield & Braithwaite, 2008). In addition, a systematic literature review on audit and feedback demonstrates variability in the effects on healthcare quality, with no evidence of increasing effect sizes over time (Ivers et al., 2012). However, audits in this review focus more on improving professional practice and guideline compliance of healthcare professionals and less on organisational conditions and quality systems. This variety of audits, coupled with the heterogeneity in contexts, suggest that it is unlikely that audits can be similarly effective in all settings. Therefore, the findings of these reviews are difficult to interpret and apply to clinical practice. Without clear evidence that audits contribute to quality improvement, it is difficult to justify the widespread use of audits. For these reasons, the theoretical basis for audits (how, when and why audits might lead to sustainable quality improvement) becomes more important than its empirical performance (whether audits works) and might be crucial to provide valuable information on audits and its relationship to the outcomes achieved (Shepperd et al., 2009; Walshe, 2007). A detailed understanding of the factors – or so-called determinants – that influence the effectiveness of audits is prerequisite to understand the mechanisms through which audits can lead to quality improvement. However, this specific insight is currently lacking.
Based on previous research on quality improvement strategies, a number of determinants which positively influence the effectiveness of quality improvement strategies are defined, namely determinants such as continuous improvement oriented audits, a bottom-up approach and active involvement of healthcare professionals (Fixsen, Naoom, Blase, Friedman, & Wallace, 2005; Greenhalgh, Robert, Macfarlane, Bate, & Kyriakidou, 2004; Johnston, Crombie, Davies, Alder, & Millard, 2000; Power & Terziovski, 2007; Weber & Joshi, 2000). Although these determinants seem contributing to the effectiveness of quality improvement strategies, no clear evidence can be found in the literature that these also influence the effectiveness of audits. Therefore, in the first place, this study will investigate if these determinants also influence the effectiveness of audits. Secondly, it will be investigated if additional determinants are essential in using audit as an effective strategy to improve the quality of health care.
Auditing for compliance versus continuous improvement
Audits can be categorized by their focus on compliance or on continuous improvement. Power and Terziovski (2007) indicated that compliance oriented audits do not deliver the results they promise and may be restricted due to the static audit standards (Power & Terziovski, 2007). In other words, the effectiveness of audits may be limited by the strong focus on compliance rather than on continuous improvement.
Within the context of health care, auditing for compliance has traditional support, while an emerging view is that improvement of processes and quality systems through continuous improvement generally provides a more appropriate goal (Groene, Sunol, & DUQuE Project Consortium, 2014). Auditing for continuous improvement differs from auditing for compliance primarily because the first type of auditing emphasizes understanding and improving the underlying work processes and systems. Therefore, auditing for continuous improvement adds value to standards rather than merely ensuring compliance with standards (McLaughlin & Kaluzny, 2006). Most of the compliance oriented audits are focused on rules, discipline and control which can be perceived as an external threat (e.g. exposing one’s mistakes to others) that may lead to mistrust, discouragement and risk avoidance of healthcare professionals (Johnston et al., 2000; Spencer & Walshe, 2009; Walshe, Wallace, Freeman, Latham, & Spurgeon, 2001; Wilkinson, Powell, & Davies, 2011).
From this viewpoint, it may be questioned if compliance oriented audits are sufficiently able to ensure quality or that a more improvement focused type of audit would be more appropriate for continuous quality improvement in health care. For that reason, this research examines if a focus on continuous improvement is contributory to the effectiveness of audits.
Bottom-up approach versus top-down approach
Many audits are top-down initiated and monitor centralized and formal standards and processes (e.g. external hospital accreditation surveys and programmes). One of the challenging issues of top-down initiated audits is actual organisational change (Flodgren et al., 2011). For organisational change to be successful, all stakeholders have to see the change as relevant (i.e. sense of urgency) and have to acknowledge that the proposed improvements have a clear, unambiguous advantage over current practices in terms of effectiveness or cost-effectiveness (i.e. relative advantage) (Greenhalgh et al., 2004). Moreover, consensus on perceived advantages by healthcare professionals themselves is important as a prerequisite for ownership. Within the top-down approach, the limited involvement of healthcare professionals tends to focus on adhering to procedures devised and imposed by non-clinical personnel (Bohigas & Heaton, 2000). As a consequence, top-down initiated audits may be enforced, but may lack the ownership necessary for the achievement of its goal.
The rationale of bottom-up initiated audits concerns the opposite process. The adoption of bottom-up initiated audits comes from healthcare professionals and represents the driver for change from within, rather than from outside the organization, process or department. Therefore, it could be argued that greater improvements in quality are likely to be achieved if healthcare professionals were more actively involved in developing, implementing and monitoring of audits (Fixsen et al., 2005). Accordingly, this research investigates if a bottom-up approach is contributory to the effectiveness of audits.