Tag Archives: Mid Staffs

Public inquiries versus systematic collection of the evidence

The Francis Report1 has had a great influence on British public life – from the Cabinet, through the boardroom and down to the shop floor. The report will be widely quoted for many years to come. The report is 1,782 pages long and contains no fewer than 290 recommendations. But how much can one really learn from such an in-depth analysis of just one site? Contrast the Francis Report with a recent systematic overview of the evidence on quality improvement from the Agency for Healthcare, Research and Quality (AHRQ) in Washington, recently summarised in Annals of Internal Medicine2. This AHRQ study is based on a systematic and intellectually grounded analysis of the entire high quality, world literature. It builds on a similar review conducted on behalf of AHRQ by the Stanford Evidence-based Practice Center over a decade ago. And a very interesting and active decade this has been with an exponential increase in research in the areas of quality and safety of healthcare.

Service delivery interventions to improve quality and safety can be divided, from a methodological point of view, into two classes3. Interventions applied close to the patient, with a specific objective in mind, are ‘targeted interventions.’ Interventions applied more upstream of the patient, with multiple objectives in mind are called ‘generic interventions.’ Generic interventions have much broader or diffuse effects on quality. An example of a targeted intervention is the use of ultrasound to guide the placement of intravenous cannulae. Examples of generic interventions include improving the nurse-to-patient ratio or changing the human resources policy.

Targeted interventions are much easier to study – for example they are much more amenable to evaluation through randomised trials. The AHRQ report shows that a number of targeted interventions are effective, including use of peroperative checklists, outlawing use of hazardous abbreviations, medication reconciliation and various types of guideline such as those concerned with ventilator-associated pneumonia, prolonged use of urinary catheters and thromboembolism prophylaxis.

Generic interventions with diffuse effects, are more difficult to study than targeted interventions. Nevertheless, a compelling case for or against generic interventions can often be built systematically by triangulating various sorts of evidence between and within studies.3 It is in this way, for example, that the authors of the overview conclude that improving the nurse-patient ratio leads to better outcomes (including hospital mortality). The report also produces reasonably convincing evidence in favour of rapid response teams, which can be called out from the intensive care unit to attend patients who are deteriorating on the wards. There is very strong evidence for simulation training, especially for complicated technical procedures, but the case for specific team training (as opposed to training in teams) was somewhat less convincing. There is evidence that surgical ‘score cards’ – that is to say a system where surgeons collect detailed data on their cases – leads to improved care when this is owned by the surgical societies and where individual hospitals are put in charge of improvement efforts. This result would seem to vindicate my recent post on how the outcomes of surgical procedures should influence practice. One ‘old chestnut’ is a question of top down cultural change. The evidence that top down cultural change can be produced through ‘heroic’ leadership is extremely unconvincing. A dispersed model of leadership, combined with bottom up specific improvement practices, seems to be the way to go. The report does not treat safety interventions as a black box, but seeks to understand what makes an intervention work or fail. For instance, rapid response teams are dependent on both good monitoring of patients’ conditions on the ward (the afferent arm) and a rapid, efficient response (the efferent arm). Many guidelines, such as checklists, will merely elicit ritualistic displays of compliance unless practitioners have first been convinced of their rationale.

The above are just a small sample of the extensive evidence in the overview. It is a rich source of high quality evidence, based, wherever possible, on comparative studies. It should be essential reading for clinicians and health service managers.

1. Francis R. Report of the Mid Staffordshire NHS Foundation Trust Public Inquiry. Available from http://www.midstaffspublicinquiry.com/report. Accessed 14 March 2013.

2. Shekelle PG, Pronovost PJ, Wachter RM, Taylor SL, Dy SM, Foy R, Hempel S, McDonald KM, Ovretveit J, Rubenstein LV, Adams AS, Angood PB, Bates DW, Bickman L, Carayon P, Donaldson L, Duan N, Farley DO, Greenhalgh T, Haughom J, Lake ET, Lilford R, Lohr KN, Meyer GS, Miller MR, Neuhauser DV, Ryan G, Saint S, Shojania KG, Shortell SM, Stevens DP, Walshe K.. Advancing the Science of Patient Safety. Ann Intern Med.2011;154(10):693-696

3. Lilford RJ, Chilton PJ, Hemming K, Girling AJ, Taylor CA, Barach P. Evaluating policy and service interventions: framework to guide selection and interpretation of study end points. BMJ 2010; 341 doi: http://dx.doi.org/10.1136/bmj.

Who will look after the patients when all the doctors have been locked up?

Professionals, doctors included, live in an increasingly regulated environment: not only is performance monitored on a regular basis, but doctors are subject to individual sanction. They may be scrutinised by the complaints procedure in the health service, they may be taken to the regulator (the General Medical Council), and they may be sued in the civilian courts under tort. On top of all this, they are subject to criminal prosecution.

Criminal prosecution implies a criminal act, and of course doctors should not be immune from prosecution for criminality, including crime perpetrated in the workplace. There was a famous case where a French anaesthetist sought revenge on a colleague by misconnecting the gas pipes in the operating theatre. The idea was that his colleague would be sanctioned for harm to a patient, but the ruse backfired and the guilty anaesthetist was quite properly locked up.

But what about acts of misjudgement? That is, acts where there is no question of criminal intent. The law, of course, does not require criminal intent for a deed to be punishable. For example, a drunk driver may still go to jail for running over a pedestrian even though he never set out to cause harm. The point here is that, by driving under the influence of alcohol, others were placed in harm’s way. The equivalent in healthcare would be criminal negligence – negligence so gross that harm could be foreseen, even if the specific harm that materialised was not intended. Thus, a doctor who operates drunk, or against the clock, can properly be found criminally negligent if a patient suffers. Things get more tricky, however, when there is no such turpitude – when there was simply a terrible mistake. It is quite difficult to argue this point in abstract so let us take a real example. I have heard of two cases where criminal prosecutions were started against a doctor when a patient, having been declared fit in accident and emergency, then died from heart attack on the way home. Yet, the diagnosis of heart attack is notoriously tricky in many cases. While it might seem to a lay person that there is a prima facie case of criminal negligence in such a scenario, this is most unlikely to withstand scrutiny. In cases above, prosecutions were not brought in the end. Nevertheless, doctors were suspended and lived under a cloud for many years. Having a criminal case hanging over you is no joke.

It seems to me that the criminal code should not be invoked in the first instance, unless there is some reason to believe there was real criminal intent, or that the clinicians had risked a patient’s safety by working in a general way which put patients at risk. My proposal is that more contentious cases should first be pursued through regulatory or civil processes. Only if these expose negligence to a criminal degree should the prosecution service get involved.

Of course it is not just doctors and other clinicians who are in the firing line; professionals of all types may be prosecuted. A recent case applied to six seismologists from the National Commission for the Forecast and Prevention of Major Risks (Franco Barberi, Enzo Boschi, Gianmichele Calvi, Mauro Dolce, Claudio Eva and Giulio Selvaggi) and the vice director of Italy’s Civil Protection Agency (Bernadro Bernardis) who have been sentenced to six years in prison in a criminal court for failing to provide adequate warning about a potential earthquake. In the event, a large earthquake followed, resulting in approximately 300 deaths, 1,500 injuries and left over 65,000 homeless, and the judge found that some people’s lives might have been saved, had a stronger warning been given.1 In fact, the judge in this case gave a harsher sentence than the prosecutor had requested (four years).2 Here is a case which was prosecuted in the criminal courts and where the accused were found guilty. Such a case is at enormous risk of hindsight bias. Predicting earthquakes is extremely tricky. Finding the right form of words to convey this uncertain risk is also extremely difficult. I have to confess sympathy with the convicted seismologists. They are currently appealing their harsh sentences, and it will be interesting to see if the appeal judge agrees.

Returning to healthcare, criminal prosecutions have escalated since the 1990s but convictions seldom follow.3 Misdiagnosis, the most important medical ‘error’, and the most common cause of civil litigation4 seldom forms the basis of prosecution, less a successful prosecution.

Robert Francis’ report has been interpreted in the media as saying: “Hospital staff and managers should face prosecution if patients are harmed or killed as a result of poor care”5 and indeed the report says: “Non-compliance with a fundamental standard leading to death or serious harm of a patient should be capable of being prosecuted as a criminal offence, unless the provider or individual concerned can show that it was not reasonably practical to avoid this. Reliance might be placed for that purpose on effective implementation of the procedures devised by NICE, but this would offer no defence to those who had not followed such a procedure.”6

So if you don’t follow a process laid down by the National Institute for Health and Clinical Excellence (NICE), then the criminal law can be invoked. This seems a high standard indeed given evidence on uptake of guidelines.7,8 The recommendation will need to be thought through rather carefully, I think.

1. Nature (2011). Scientists on trial: At fault? 14 Sep 2011. Available at: http://www.nature.com/news/2011/110914/full/477264a.html [Accessed 7 Feb 2013].

2. Nature (2012b). Italian court finds seismologists guilty of manslaughter. 22 Oct 2012. Available at: http://www.nature.com/news/italian-court-finds-seismologists-guilty-of-manslaughter-1.11640 [Accessed 7 Feb 2013].

3. Ferner RE, McDowell E. Doctors charged with manslaughter in the course of medical practice, 1795 – 2005: a literature review. J R Soc Med. 2006;99:309-314

4. Ferner RE. Medication errors that have led to manslaughter charges. BMJ. 2000;321:1212-1216

5. Guardian. Mid Staff report calls for sweeping changes to improve patient safety. http://www.guardian.co.uk/society/2013/feb/06/mid-staffordshire-report-sweeing-changes (accessed 7 Feb 2013).

6. Francis R. Report of the Mid Staffordshire NHS Foundation Trust Public Inquiry Executive Summary. http://cdn.midstaffspublicinquiry.com/sites/default/files/report/Executive%20summary.pdf (accessed 7 Feb 2013).

7. Benning A, Dixon-Woods M, Nwulu U, Ghaleb M, Dawson J, Barber N, Franklin BD, Girling A, Hemming K, Carmalt M, Rudge G, Naicker T, Kotecha A, Derrington MC, Lilford R. Multiple component patient safety intervention in English hospitals: controlled evaluation of second phase. BMJ. 2011;342:d199.

8. Asch SM, Kerr EA, Keesey J, Adams JL, Setodji CM, Malik S, McGlynn EA. N Engl J Med 2006; 354:1147-1156