Quality improvement in New Zealand healthcare Part 3: achieving effective care through clinical audit By Mary Seddon and John Buchanan Summary and HTML coding for Brilliant New Zealand Ltd by Malcolm Macpherson Abstract This article examines effectiveness of healthcare. Two facets must be attended to: the best available evidence must be sought through research; and that evidence must be applied. This second function is the domain of quality improvement activities generally and clinical audit in particular. Clinical audit compares actual practice to a standard of practice, identifies gaps between what is done and what should be done, and rectifies deficiencies in the processes of care. In this article, the steps involved in a clinical audit, how it is different to research, and the question of whether clinical audit requires ethical approval are explored. Article Effectiveness is achieving an expected and measurable benefit. It is a fundamental dimension of quality in the patient-clinician partnership and it involves making appropriate decisions based on the best available evidence. To provide effective care requires attention to its two facets. The first involves using research to determine: 1 The best evidence for therapeutic decisions 2 Which drug regimen is superior 3 Which test will provide the closet approximation of the truth with the fewest false positives. Some call this doing the right thing. Advances in the methodology of clinical research and in the critical appraisal and collation of research evidence have extended the boundaries of contemporary knowledge and our ability to determine the right thing in a given clinical situation. The other facet is ensuring that the best evidence, is applied to every day practice, doing it right, and is the domain of quality improvement projects. Note by summariser Macpherson The difference between doing the right thing and doing it right are also applied in other areas of performance assessment and improvement. It is common to say that a standards approach - focusing on compliance - is doing it right, while a continuous improvement, performance excellence focus, is about doing the right thing. It is possible - according to cliche - to certify concrete lifejackets (to make them right), even though this would not be doing the right thing! Quality improvement has received less attention and certainly less resources than biomedical research, but it is at least as important in ensuring effective care is delivered to patients. How well we deliver care was first challenged by Jack Wennberg when he and others at Dartmouth University uncovered unexplained variation in the frequency of common operations in neighbouring regions of the United States. Some operations (such as tonsillectomy in children) varied 10-fold in the same state. The researchers could not explain the variation on differences in patient need, and concluded that most of the variation related to the doctors; where they trained, how long since they graduated, and historical practice patterns (how we have always done it). The degree of variation was a revelation to the medical community and directly challenged the effectiveness of care; although Wennberg and his colleagues could not determine which rate was right, it was clear that the extremes of variation could not both be right. Wennberg has gone on to develop maps of the United States for several surgical operations which continue to show variation in care and confirm that at least some people are getting ineffective care. This notion was taken up by Mark Chassin in his taxonomy of overuse, and underuse of health services. Overuse refers to patients receiving ineffective care, or care where the risks outweigh the benefits. Overuse is particularly common in chronic care conditions but almost any medical condition is prone to overuse especially in a developed country. New Zealand examples of overuse include antibiotics being prescribed for the common cold, and the medicalisation of common problems. Such medicalisation has been labelled disease mongering by some, who give examples of turning ordinary aliments into diseases (e.g. drugs to treat baldness), treating personal problems as medical problems (e.g. drug companies promoting antidepressants to treat social phobia otherwise known as shyness), and labelling risk factors as diseases (e.g. high cholesterol). Overuse also has important implications for patient safety, not only because of the inherent and inevitable risks of any treatment, but also because of the risks of error in a procedure that was not needed. Underuse, or patients not receiving known effective care, care where the benefits far outweigh the risks such that all patients should be offered such care. Examples of underuse also abound in New Zealand. For example in cardiology (a specialty rich in evidence about effective treatments), underuse is evident with the delays and barriers to cardiac intervention for people living in rural areas; underuse of warfarin in patients with atrial fibrillation; and the poor referral rates to cardiac rehabilitation for patients surviving an acute myocardial infarction. The extent of overuse and underuse has been systematically studied in the United States and published in Beth McGlynn's seminal work The First National Report Card on Quality of Health Care in America. In this study of 12 metropolitan areas in the US it was found that only half of adult Americans received recommended care, there is widespread underuse of effective care and overuse of ineffective care. For example, only 45% of patients with acute myocardial infarctions received beta-blockers and only 61% got aspirin, therapies that research has told us could decrease such patients’ risk of death by 20%. It also showed that such underuse was endemic and not confined to any one sociodemographic group or condition. Clinical audit Clinical audit and clinical indicators are the basic quality improvement methods for assessing and improving effectiveness in practice. In this article, we explore clinical audit, what it is, what it is not, and what steps are involved. The essence of audit is that it compares actual practice to a standard of practice and as a result of this comparison, any deficiencies in actual practice may be identified and rectified. The word audit is thrown around with abandon in the health service but clinical audit has a very specific meaning as described above, whereas most calls to audit something in healthcare mean nothing more than to have a look at it, or perhaps do a survey. However, clinical audit is more than a critical review or a survey (which can define problems but cannot in themselves solve them). In embarking on a clinical audit, it is explicit that processes or outcomes of care will be measured and compared with pre-set standards. If deficiencies in process are identified then changes will be made and followed by further measurement to ensure that the change has lead to improvement. Clinical audit attempts to answer the 3 questions that are central to any quality improvement work: 1 What are we trying to accomplish? 2 What changes can we make to produce an improvement? 3 How will we know that such changes have produced such improvement? A further feature of clinical audit is the interdisciplinary nature of the activity, and the Introduction to Clinical Audit (by the Ministry of Health) has this to say: Clinical audit allows for the systematic, critical review of the quality of clinical practice by a multidisciplinary team. It includes the procedures used for diagnosis, treatment and care of patients, the associated use of resources and the effect of care on the outcome and quality of life for the patient. The steps of clinical audit There are many different diagrams and descriptions of the audit cycle or quality cycl but the essential tasks in the process of clinical audit are generic. Basic clinical audit cycle Step 1 Identify the area that may need improvement. The decision of what to audit is usually based on clinical experience, literature review ,or data collection and should preferably be an area that is important. This may, for example, be an area that has high clinical importance, an area that is known to impact on patient safety or because poor management in this area may have high financial costs. Step 2 Develop the standards that are to be achieved in the area (based on guidelines, literature review, and consensus). This will then define the agreed target for excellent performance. Standards for clinical audit should be SMART specific (use precise language) measurable (identify a target standard to measure practice against) achievable (use performance levels that can actually be used in practice) related (to the aims and objectives of the project) theoretically sound (based on best practice) and time-bound. Step 3 Collect data and comparing against standards. If there is no gap the audit may be terminated. If there is a gap then the audit proceeds. Step 4 Develop an action plan. This may require discussions with staff as the team looks for possible solutions. Occasionally the answer is obvious but most solutions impact on delivery of care and will need acceptance. Document plans to bring current practice into line with the standards. Step 5 Implement the plan. Step 6 Monitor and evaluate the new process. Re-measure the impact and compare with Step 2. Measurement and recording of the results of clinical indicators over time as part of the monitoring process may give early confirmation that the changes made have resulted in improvement. The problem can then be further refined with monitoring of the gains made or the audit cycle re-entered if there is need for further improvement. It is important to also watch out for unexpected consequences of change (which may be positive or negative) and to be flexible enough to manage these as well. Note by summariser Macpherson This step-wise closed-circle process is also generically known as a PDCA (Plan Do Check Act) cycle, and is widely employed as a core process in many TQM-like process interventions. It emerges in LEAN interventions, in people-based standards schemes, and in almost every sphere of human activity where systematic improvement is a priority. It is usually accompanied by a suite of aligned activities that enable process diagnosis and the prioritization of improvement strategies: fishbone or Ishikawa diagrams, simple statistical analysis using Pareto principles and so on. Clinical audit versus clinical research There is confusion between clinical audit and clinical research; both aim to improve the quality of healthcare, and there are methodological similarities. Clinical research fills the gap between what is known and what needs to be known (extending the frontiers of current professional knowledge) while audit measures the gap between best practice and what actually happens. Randomised clinical trials, the gold standard for research, have no place in clinical audit. A clinical study of any sort in which groups of patients are compared is research, and not audit. Audit is no less rigorous than research, but audit must accommodate the real life situations of small numbers of cases and the possibility of confounding. There is also confusion about whether clinical audit requires ethical approval. The National Ethics Committee has stated that most observational research requires ethics committee review whereas most audit and audit related activity does not, and that ethical review is not required for clinical audit where the activity met the following criteria: 1 conducted either internally or externally by persons who are under a professional obligation to preserve confidentiality 2 does not include the collection of new or additional information from patients/consumers 3 does not include anything being done to (or withheld from) patients beyond their normal clinical management. Summary Effectiveness is about appropriate decision-making based on the best available evidence, avoiding both overuse and underuse. Clinical audit is the chief method for measuring effectiveness and ensuring that best practice is indeed being practised.