Bismark, Marie --- "An evidence-based approach to medical regulation" [2015] PrecedentAULA 17; (2015) 127 Precedent 4

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LEARNING FROM COMPLAINTS AND NOTIFICATIONS

AN EVIDENCE-BASED APPROACH TO MEDICAL REGULATION

By Dr Marie Bismark

Calls to improve the regulation of medical practitioners are not new. As far back as 1421, the parliament of King Henry V was petitioned over concerns that unqualified practitioners were causing ‘great harm and slaughter of many men’.^[1]

However, the environment in which medico-legal regulators, such as medical boards and complaints commissioners, operate has changed profoundly. This article outlines one recent development that is likely to have a significant impact on medico-legal regulators: the shift towards evidence-based regulation.

WHERE PATIENT SAFETY, CONSUMER VOICE AND DATA ANALYSIS MEET

Over recent decades, we have all witnessed the rise of the patient safety movement, the growing influence of the consumer voice, and the power of data analysis. The days when hospitals were thought to be safe, patients offered doctors their unquestioning trust, and data analysis was for maths geeks only are over. We now know that more people die in a given year as a result of medical errors than from motor vehicle accidents or breast cancer.^[2] Patients are increasingly aware of their right to complain and their complaints provide rich and nuanced information on opportunities for the health system to improve. And the advent of new technologies means that ‘big data’ – extremely large data sets that may be analysed to reveal patterns and associations – are now recognised as a valuable resource for identifying risks and resolving problems.

From the convergence of these three trends, comes the idea of empirical medico-legal research, which uses scientific methods, rather than traditional legal analyses, to make sense of patients’ claims and complaints.^[3]

EMPIRICAL MEDICO-LEGAL RESEARCH

In essence, empirical research encourages medico-legal regulators to ‘lift their gaze’ from the day-to-day business of case resolution to look at the bigger picture. Rather than simply reacting to harm after it has occurred, this approach seeks to understand patterns of claims and complaints in an evidence-based manner, thereby supporting a more proactive approach to protecting patients from harm.

Two examples come from studies conducted by my research group at the University of Melbourne: an analysis of complaint-prone practitioners and a review of mandatory notifications to the Australian Health Practitioner Regulation Agency (AHPRA).

COMPLAINT-PRONE PRACTITIONERS

Speak with almost any medico-legal regulator, and they will tell you that claims and complaints don’t rain on all practitioners equally: some practise under a darker cloud than others.^[4] However, to date, agencies have lacked reliable methods for systematically determining which doctors should be targeted for assistance and preventive action. Instead, employers, insurers, and regulators live with the fear that one day a patient will be seriously harmed after red flags were overlooked and someone will ask ‘why didn’t you act sooner?’

We sought to understand the distribution of complaints across Australia's medical workforce and to identify characteristics of doctors at high risk of incurring recurrent complaints. To do this, we assembled a national sample of nearly 19,000 patient complaints filed against doctors with health complaints commissioners in Australia over an 11-year period. We then analysed this data, looking for ‘hot-spots’ of risk among certain groups of practitioners.

While we expected to find some clustering, we were surprised by the extent to which some doctors were over-represented in complaints data. We found that fewer than 5 per cent of all doctors accounted for nearly half of all complaints. The number of prior complaints a doctor had experienced was the strongest predictor of subsequent events: doctors named in a third complaint had a nearly 60 per cent probability of being named in a further complaint within two years. Male doctors had a 40 per cent higher risk of recurrence than their female colleagues, and older doctors had a 30 to 40 per cent heightened risk of recurrence.^[5] At the practitioner level, the risk of a further complaint within two years varied widely, from less than 10 per cent risk among low-risk doctors to more than 80 per cent risk among high-risk doctors.

The insight that large numbers of complaints are concentrated among a small group of doctors, and that those doctors exhibit distinctive characteristics, has important policy implications. Detecting problems early opens up the possibility for early interventions to prevent or minimise harm. A tool for applying our method is still under development. However, several agencies are already beginning to explore new ways of identifying and responding to cases involving practitioners with multiple previous complaints.

MANDATORY REPORTING OF CONCERNS ABOUT HEALTH PRACTITIONERS

Of course, not all adverse events are readily apparent to patients, and many patients who suffer preventable harm do not complain.^[6] When health practitioners experience problems with their health, performance, or conduct, their peers may be aware of the problem long before the first patient complaint occurs.

Since 2010, Australian law has required health practitioners, employers and education providers to report certain concerns about the health, conduct or performance of a health practitioner to AHPRA.^[7] Mandatory reporting has sparked controversy and debate. Supporters believe that it facilitates the identification of high-risk practitioners and communicates a clear message that patient safety comes first. Critics claim that mandatory reporting fosters a culture of fear, deters help-seeking, and fuels vexatious reporting. Concerns have also been raised about the subjectivity of reporting criteria.^[8]

However, little evidence is available to evaluate the veracity of these different views. We sought to provide baseline information on how the regime is working by analysing an early sample of mandatory notifications. We reviewed all 819 such mandatory reports made to AHPRA over a 13-month period.

We found that concerns regarding professional standards, especially in relation to clinical care, accounted for nearly two-thirds of reports of notifiable conduct received by AHPRA. Men were twice as likely as women to be the subject of a report. Reports across different health practitioner groups (such as a nurse reporting a surgeon) were uncommon, suggesting that the new law has not overcome previously identified factors that make it difficult for nurses and allied health professions to report concerns about doctors. We also observed wide variation in reporting rates: for example, there was a nearly fivefold difference in the rate of mandatory reporting across states and territories. These results suggest that many practitioners remain unsure about the nature and scope of their obligations with respect to mandatory reporting.^[9]

Further research is exploring patterns of reporting by treating practitioners (those practitioners in a therapeutic relationship with a practitioner-patient who may be placing patients at risk of harm). Even under a mandatory reporting regime, it seems that important barriers restrict the likelihood that a practitioner will speak up about a peer whose performance is impaired: uncertainty regarding the legal requirement to report; fear of making the situation worse; lack of confidence that appropriate action would be taken; and loyalty to colleagues that supports a culture of ‘gaze aversion’.

CONCLUSIONS

Medico-legal agencies are a valuable source of data on risks to patient safety, because they concentrate cases of serious preventable harm from populations of millions. Yet, traditionally, medico-legal agencies have focused on the resolution of individual cases: reacting to the aftermath of adverse events and behaviours.^[10] When regulators do apply analytical tools, they are often drawn from legal scholarship with a focus on legal principles and precedent. While such tools have their place, they offer a narrow visual field, constraining the ability of agencies to see the patterns that are writ large across hundreds or thousands of cases.

A more evidence-based approach, using tools drawn from the fields of public health and epidemiology, can help medico-legal regulators to sharpen their senses: amplifying the voices of patients and practitioners and revealing larger patterns of concern. In practical terms, the application of epidemiological methods to medico-legal actions strengthens the ability of medico-legal agencies to ‘find important problems and fix them’.^[11]

Just as evidence-based medicine integrates an individual’s skills and assessment with the best available evidence from medical research, so too should evidence-based policy. Identifying the optimal balance between competing interests is an enduring challenge for regulators. Hopefully, the emergence of a more evidence-based approach will complement and enhance medico-legal agencies’ existing efforts to protect patients and support practitioners back into safe practice.

As medical practice and community expectations evolve, so too must medical regulation. Our research suggests that proactive approaches to preventing harm, and the curious mind of a scientist, are qualities that will stand the medico-legal regulators of the future in good stead.^[12]

Dr Marie Bismark is a public health physician and health lawyer who leads the Law and Public Health unit at the University of Melbourne. PHONE [phone] EMAIL [e-mail].

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^[1] JH Raach, ‘English medical licensing in the early 17th century’, (1944) 16(4) The Yale Journal of Biology and Medicine, at 267.

^[2] LT Kohn, JM Corrigan and MS Donaldson, To Err Is Human: Building A Safer Health System (2000), National Academies Press, Washington DC.

^[3] P Cane and H Kritzer, The Oxford Handbook of Empirical Legal Research (2010), Oxford University Press.

^[4] RM Wachter, In conversation with ... Gerald B Hickson MD, Agency for Healthcare Research and Quality Mortality and Morbidity (Dec 2009).

^[5] MM Bismark et al, 'Identification of doctors at risk of recurrent complaints: A national study of healthcare complaints in Australia', BMJ Quality & Safety (2013), at 1-9.

^[6] MM Bismark et al, ‘Relationship between complaints and quality of care in New Zealand: A descriptive analysis of complainants and non-complainants following adverse events’, (2006) 15(1), Quality and Safety in Health Care, at 17-22.

^[7] M Parker, ‘Embracing the new professionalism: Self-regulation, mandatory reporting and their discontents’, (2011) 18(3) Journal of Law and Medicine, at 456-66.

^[8] MM Bismark et al, ‘Mandatory reports of concerns about the health, performance and conduct of health practitioners’ (2014) 201(7) The Medical Journal of Australia, at 399-403.

^[9] Ibid.

^[10] MM Bismark et al, see note 5 above.

^[11] MK Sparrow, The Regulatory Craft: Controlling Risks, Solving Problems and Managing Compliance (2011), Brookings Institution Press.

^[12] M Bismark, ‘The seven qualities of highly effective regulators’, in M Bismark (ed), Public health, patient voice, good governance (2014), Melbourne. Blog post found at: http://mariebismark.com/2014/12/01/the-seven-qualities-of-highly-effective-regulators/.