Summary of the impact

In 2005/6, Allsop (and Jones) undertook research for the Chief Medical Officer (CMO) on comparative systems of medical governance to assess how doctors' continuing competence was assured. Their research drew on new data and built upon earlier research by Allsop on complaints and professional regulation. The study found that many countries had begun to replace self-governance by systems based on partnership with stakeholders to ensure accountability, although methods differed. The findings informed a subsequent report from the CMO and were carried forward in a White Paper and in 2008 through legislation. The research had an impact on UK policy makers by providing research-based evidence. The governance of the General Medical Council (GMC) has been reformed and periodic revalidation introduced. This will have a continuing impact on the practice of doctors and on patients.

Underpinning research

In 2005/6 Allsop led a research project (with Jones, De Montfort University) on how doctors were regulated in other countries, for the then Chief Medical Officer, which led to the impact outlined below. She had previously undertaken research on patient and health professionals' perspectives on complaints at South Bank University London (with grants from the Department of Health, ESRC and local NHS bodies between 1993 and 1999), and at De Montfort University (with Baggott and Jones on patient and carer groups (ESRC) and health professional regulation for the Council for Health Regulatory Excellence, from 2000 to 2004).

Most Recent Grant: Medical Regulation in an international context, April - October 2005, awarded to Professor Judith Allsop, University of Lincoln, Department of Health, £30,000.

The aim of this research was to examine key elements in the structures of regulation in a system context, identifying how the competence of doctors was assured and the arrangements for dealing with poorly performing doctors. Seven countries with contrasting health states were selected for data collection and analysis. Three had a similar system of regulation to the UK (Australia, Canada and New Zealand), three were in Europe (Finland, France and the Netherlands) and the seventh was the USA.

Data were drawn from research interviews, a systematic review of web-based documents and literature in English, and reports commissioned from experts in the non-English speaking countries to a pre-determined structure. The country reports showed the characteristics of the health state, the structure of medical governance, and recent changes, and how the quality of doctors' medical knowledge and practice was assured. They were sent to a senior regulator, or academic specialist, to crosscheck for accuracy, clarity and interpretation. A report was prepared that provided descriptive data on each country and an analysis of trends in key indicators of change, presented in the form of a grid. The analysis showed clear trends:

• most countries stated in their objectives that patient safety was a priority;
• most were moving from self-regulation by the medical profession to greater partnership with key stakeholders and transparency to the public;
• governing bodies were appointed, not elected by the profession, had increased lay representation, and enhanced democratic accountability;
• all countries had introduced more rigorous licensing checks at registration and had a planned programme for periodic revalidation of doctors' competence. Some used a `learning model', based on continuing professional education and colleague review; at the other end of the spectrum, periodic appraisal was based on externally validated, specialtyled formal assessment using standardised measures. The administration of tests was through either computer-based `objective' instruments to assess knowledge and practice (as in the USA), or through face-to-face assessments by a visiting team (as in the Netherlands). In 2006, no country had a fully costed and functioning system for regular revalidation.

Methods for identifying poor practice varied widely. They included selective appraisal according to particular risk factors (such as age), or investigating doctors where practice statistics showed that they deviated significantly from a norm. In most jurisdictions, complaints to the governing body could be investigated and lead to further action. For the most part, such processes were not transparent and public access was limited. The research identified the New Zealand ombudsman system as the most thorough in terms of investigation and learning, and suggested that pro-active, extensive informal co-operation between health regulators was a key factor in identifying problems early. The research showed that many countries had introduced a separation between the function of investigation of a complaint by the professional body, and that of adjudication, by establishing an external, lawyer-led tribunal.

References to the research

Details of the impact

The report from the research on medical governance across selected countries (2005/6) was peer reviewed and rated as good. It had a clear impact on the Chief Medical Officer's report (Donaldson 2006). The CMO wrote to Allsop saying, `I found your report on medical regulation in its international context rigorous, stimulating and useful and feel it added to the richness of my report'. The research report was made available on the CMO's website and, by agreement, the University of Lincoln website (Allsop and Jones 2006). The research was supported by, and has been referred to and used by, Sir Donald Irvine, lately president of the Picker Institute, a European-wide agency that promotes patient-centred health care.

The research had a distinct and material impact on the CMO's report (Department of Health 2006). Chapter Six reported the research and its findings, as well as the recommendations drawn from it. On page 112, the CMO's (2006) report states: `Much of the content... is based on Professor Allsop's findings'. The report itself is still available on the Department of Health website, as well as the re-publication in 2012. Specific recommendations in the report that used the research findings were:

• recommendation 11 (in dealing with poor performance the investigatory functions of the GMC should be separated from adjudication);
• recommendation 26 (a system for regular revalidation should be introduced to assure doctor's competence);
• recommendation 42 (the GMC should be more open and accountable).

The recommendations in the CMO's report follow from the research findings, in terms of what was shown to be a general trend in the governance of medicine in other countries towards greater accountability and transparency. The CMO's recommendations were then put forward in the White Paper (Secretary of State for Health, 2007) that followed, and were subsequently incorporated into legislation. Reforms to the General Medical Council took place between 2008 and 2013, namely: a smaller appointed Council; parity between lay and professional members; the separation of the investigatory and adjudicative functions; greater Parliamentary accountability; and increased scrutiny of competence with annual relicensing and periodic revalidation of practising doctors. The main reason for the impact made by this research was that it showed that reforms to medical regulation were taking place elsewhere. This challenged the GMC's view of itself as a world leader in medical regulation.

The research findings had an impact on the views of groups within the profession, including following dissemination through a series of presentations and question and answer sessions: to the CMO's Advisory Group in September 2005; to medical leaders at the Royal College of Physicians September 2005; to the full General Medical Council in October 2005. These presentations were part of the process of informing professionals of what was happening elsewhere, and of reaching a consensus on reform.

In addition, as part of the dissemination process, during 2008/9 Allsop gave presentations based on the research at conferences in Canada, Portugal and France, and published a number of articles in peer-reviewed international journals with various academic colleagues from other countries.

From 2008 to 2013, Allsop's research continued to be useful to policy makers and academics. For example, she published a further article on complaints in 2009 that reviewed the different models for complaint handling. With permission, this was drawn on by a regulator presenting a paper on complaint handling to the International Association of Medical Regulatory Authorities' bi-annual conference in Ottawa (2012). Together with Professor Robert Dingwall, in January 2011 Allsop was asked to discuss current research findings on complaints and medical negligence at an informal meeting with the Parliamentary Health Select Committee, in order to advise the Committee whether or not to carry out a further inquiry at that time. In 2012, access to the initial report was also widened, following a request to publish it by Lap Lambert Publishing in Germany. It is also available as an eBook on Amazon.

There has also been an impact on health regulators and the medical profession in other countries. The report has been cited in other publications on regulatory reform, and Allsop has, for example, given advice and support to a research project in British Colombia, Canada, and presented a paper based on the research to Italian doctors and academics who aim to address institutional governance arrangements in Italy to deal with incidents of poor practice and harm to patients (Alghero, Sardinia 2010).

Sources to corroborate the impact

1. Department of Health (2006) Good Doctors, Safer Patients. Proposals to strengthen the system to assure and improve the performance of doctors and to protect the safety of patient (Donaldson Report Archive).
2. Secretary of State for Health (2007) Trust, Assurance and Safety: The regulation of health professionals in the 21st century, Cm 7013, London: The Stationery Office.
3. Letter from Professor Sir Liam Donaldson deposited with University of Lincoln.
4. Allsop, J., Kuhlmann, E. and Saks, M. (2009) `Professional governance and public control: A comparison of healthcare in the United Kingdom and Germany', Current Sociology, 57 (4) pp. 511-528.
5. Parliamentary Health Select Committee records, Meeting with Professor Allsop and Professor Dingwall January 2011.
6. References to Allsop et al, Complaint Investigation and Adjudication Best Practices for the Health Colleges (in British Columbia, Canada) Policy Report 598, Bruce Dayman, University of Victoria, 2012.
7. Conference list of presentations March 2010 Laboratorio su Professione Medicie Proforma legge Institutitiva Legge Ordine die Medici (on request).