Picture from By Ernie Smith / Jul 14, 2015 (iStock/Thinkstock)
Three years ago, when I started my PhD about regulation and improvement in healthcare, if someone had told me that by the end of it I would end up defending the need for regulation, (specifically social regulation), I wouldn’t have believed them. Not one iota. At that point in time, regulation in healthcare was from my perspective a wholly unnecessary top-down burden. It adds to costs, it wastes time, it is rigid and inflexible, it leads to risk-adverse behaviours out of fear of non-compliance, it creates mountains of paperwork, it offers pointless inspection reports and external ‘support’ with only rare occasions of useful insight, and finally and most importantly for me, it obstructs and hinders improvement efforts through its need to ‘control’. Whereas I felt that improvement was its polar opposite. It was interested in understanding care from the patients view, it is a bottom up process with those closest to the work improving the work, it is creative, emergent, exciting and innovative and much better at delivering results (and from my perspective as a QI leader, I was in ‘control’ instead). I wonder now if my subconscious personal PhD aim was to ‘prove’ the futility of regulation and the superiority of improvement approaches. Yet, as I have delved into the academic regulatory and improvement literature I have had to quite radically modify this polarised, and biased viewpoint.
Let me clarify two things. First, what do I mean by social regulation – I use a broad definition, which indicates that regulators are bodies that have the authority on behalf of the public to influence behavioural change in organisations (Selznick, 1985). This means, that regulators don’t have to have ‘legal’ regulations to enforce and they can be a number of types of public bodies and are not limited to being a ‘regulator’ nor are they necessarily inspectorates. Using this broad definition means that even national or regional, or corporate improvement agencies can be argued to conduct regulatory activities. The regulatory literature also uses the word ‘enforce’ a lot. Unfortunately, it is a word that sounds rather ‘coercive’ especially to improvement practitioners yet, the literature is explicit that enforcement strategies can use a full range of approaches, from the stereotypical deterrence approach of punishing sanctions through to friendlier, persuasive strategies such as education, improvement support and training aiming for a more voluntary take up of new requirements (Hutter, 1989).
Second, why does social regulation arise? The literature indicates that there are two main reasons, market failure and public interest (Walshe, 2003). Social regulation such as that used in healthcare arises for both of these reasons. For example, market failure arises because in some geographical areas of the country or specific sub-sets of populations there is inequity in service provision, and public interest regulation arises because of the harm and safety impact of poor quality care. Self-regulation and/or local improvement activity has simply been inadequate to protect against these problems and given that much harm is caused by the health system rather than by individual healthcare organisations or individuals there is a need for an agency that takes a system rather than organisational view (Brennan and Berwick, 1996).
I used to argue that organisational improvement could resolve the poor care issues highlighted: ‘If only we could do it right’ and ‘if only they would let us’, just like other high performing organisations, say like Virginia Mason. Yet the evidence is growing that improvement approaches, whilst critical to develop learning to improve patient care; are insufficient to resolve the wide array of complex performance and quality issues in healthcare (regardless of whether they are industrial or clinical, lean or IHI-QI etc). Over the last eight years, at least eleven systematic reviews of such improvement approaches have taken place and indicate inconsistent evidence regarding the benefits of such approaches, frustratingly coupled with inadequate research quality (see for example: (DelliFraine et al., 2010; Nadeem et al., 2013; Taylor et al., 2014)). This is not to say that regulation as an alternative is without the problems I highlighted at the beginning. Those problems are still apparent, and similar evaluative work for regulation and its accreditation cousin, also finds inconsistent evidence of its benefits (see for example (Greenfield and Braithwaite, 2008; Flodgren et al., 2011; Mumford, 2013)). Further, both can have priorities ‘captured’ or distorted through vested interests or dominant groups overpowering patient perspectives.
What I have discovered though, is that there is a growing body of theory and evidence arguing that regulation and improvement should not be seen as an ‘either/or’ choice but instead as a complementary mix of interventions (Sinclair, 1997). This blends both the ‘benign big gun’ (Ayres and Braithwaite, 1992) from the regulatory enforcement menu with the supportive persuasive approaches, with local flexibility and experimentation of improvement approaches within and potentially across organisations. This ‘responsive regulation’ approach (ibid) can build on the best of both regulatory and improvement approaches. This can help to: ensure regulatory flexibility linked to the local circumstances, encourage and support improvement experiments with patients, develop learning networks and reduce the regulatory burden through collaboration between regulatory agencies and healthcare organisations. That said, this approach still has the potential to use punitive approaches of enforcement with organisations on the rarer occasion that this may be needed. An iron fist within a thick velvet glove.
This type of regulation was supported in the Berwick review (2013) of NHS care in England, and my research indicates that the trend towards variants of responsive regulation is continuing across devolved health systems in the UK but that this is not without its challenges. These link to regulatory roles, resources both financial and skills, and ensuring collaborative relationships (Furnival et al., 2016). This adaptive combination of regulation and improvement can focus on supporting healthcare organisations to develop their improvement capability and ensure delivery of better quality, performance outcomes and processes for patients depending on local circumstances.
Reflecting now, on my views from three years ago, I wish I had known more about regulation then and its relationship and indeed similarity with improvement. Some of the decisions and actions I took previously whilst in improvement roles may well have been different and may have led to much better care experiences and outcomes for patients. I also feel quite strongly that there is a huge opportunity to grow understanding and practice across the rich fields of regulation and improvement. There is much mis-conception of both, only by working together in collaboration can we truly improve care for patients, carers and their families.
Ayres, I. & Braithwaite, J. (1992) Responsive Regulation: Transcending the De-regulation Debate. New York: Oxford University Press.
Berwick, D. (2013) A Promise to Learn – A Commitment to Act. Improving the Safety of Patients in England. National Advisory Group on the Safety of Patients in England.
Brennan, T. A. & Berwick, D. (1996) New rules: regulation, markets and the quality of American health care. : Jossey Bass.
DelliFraine, J. L., Langabeer, J. R. & Nembhard, I. M. (2010) Assessing the evidence of Six Sigma and Lean in the health care industry. Quality Management in Healthcare, 19(3), 211-225.
Flodgren, G., Pomey, M. P., Taber, S. A. & Eccles, M. P. (2011) Effectiveness of external inspection of compliance with standards in improving healthcare organisation behaviour, healthcare professional behaviour or patient outcomes. Cochrane database of systematic reviews, (11).
Furnival, J., Boaden, R. & Walshe, K. (2016) Emerging hybridity: a comparative analysis of regulatory arrangements in the four countries of the United Kingdom. 10th International Organisational Behaviour in Healthcare Conference. Cardiff, UK: Society for Studies in Organizing Healthcare.
Greenfield, D. & Braithwaite, J. (2008) Health sector accreditation research: a systematic review. International Journal for Quality in Health Care, 20(3), 172-183.
Hutter, B. M. (1989) Variations in Regulatory Enforcement Styles. Law & Policy, 11(2), 153-174.
Mumford, V., Forde, K., Greenfield, D., Hinchcliff, R. and Braithwaite, J. (2013) Health services accreditation: what is the evidence that the benefits justify the costs? International Journal for Quality in Healthcare, 25(5), 606-620.
Nadeem, E., Olin, S. S., Hill, L. C., Hoagwood, K. E. & Horwitz, S. M. (2013) Understanding the Components of Quality Improvement Collaboratives: A Systematic Literature Review. Milbank Quarterly, 91(2), 354-394.
Selznick, P. (1985) Focusing organizational research on regulation. Regulatory policy and the social sciences, 363-367.
Sinclair, D. (1997) Self‐regulation versus command and control? Beyond false dichotomies. Law & Policy, 19(4), 529-559.
Taylor, M. J., McNicholas, C., Nicolay, C., Darzi, A., Bell, D. & Reed, J. E. (2014) Systematic review of the application of the plan–do–study–act method to improve quality in healthcare. BMJ quality & safety, 23(4), 290-298.
Walshe, K. (2003) Regulating Healthcare. A Prescription for Improvement? Maidenhead, UK: Open University Press.