Tag Archives: hospitals

End of Year Blog: Reflections on my Time as a Non-Executive Director

I must apologise for the hiatus in blogging. This coincided with the Collaboration for Leadership in Applied Health Research and Care (CLAHRC) grant application – a £10 million grant from the National Institute for Health Research (NIHR), with over £20 million of matched funds. Following this, I successfully applied for a job to lead a Centre for International Research at the University of Warwick, and so I have been a bit busy.

I have had the privilege of serving as a non-executive director on the Sandwell and West Birmingham Hospitals NHS Trust Board for the last year and a half. Regrettably, I now have to resign this important post to pursue the above opportunities. This is a good time to reflect on my time on the Board.

Seventeen years had passed since I last served on a hospital board – the United Leeds Teaching Hospitals Group. I was an executive director in Leeds and this is, of course, a different role to that of non-executive director. The biggest change, however, was in the balance of topics discussed in the board.

Firstly, discussion of finance makes up a relatively small proportion of the business of a current board whereas it was a principle topic for discussion in the earlier epoch. Secondly, quality metrics now take up a large portion of board time and this was certainly not the case two decades ago. Ironically, the number of external groups who scrutinise the hospital has also increased dramatically. The Care Quality Commission, Monitor (or the Trust Development Authority), Litigation Authority, Health and Wellbeing Boards, various types of commissioning organisation, and many other bodies scrutinise hospital ‘performance’. The hospital is now a veritable goldfish bowl, and so the board is but one of many organisations providing ‘assurance’.

I shall return to my own views on the implications of all this external scrutiny in just a moment. In the meantime, I can report that during my brief 18 months on the Board, two very important developments took place, which many board members may not encounter during a complete period of tenure.

Firstly, our Chief Executive, John Adler, moved to the big and turbulent Leicester Teaching Hospital Group and so we had to find a replacement. Appointment of a chief executive is the biggest single decision that a board can make. It was fascinating to participate in this crucially important process, and very gratifying to watch the new Chief Executive, Toby Lewis, take control of the tiller. I think that to be a leader one has to want to lead and it has been a joy to watch Toby take charge. He is also an unusually, or should I say particularly, ‘cerebral’ chief executive. Intellectual curiosity is a safeguard against complacency and error. Hospital consultants are a clever lot (mean IQ above 125?) and they respect a leader who is more than a match for them. It was a delight to observe the constructive, but sometimes piquant, interaction between Toby and one of my peer non-executive directors, herself something of a force of nature.

The other big event was recognition, by the government, that a long-standing proposed new hospital scheme would be a suitable candidate for consideration under HM Treasury’s new model, Public Finance Initiative (PFI). With the exception of Chair Richard Samuda, who had previously been chief executive of a property company, my non-executive colleagues and I had to undergo a steep learning curve. The axioms behind the PFI are fiendishly complicated, yet it is essential for all non-executive directors to have a clear understanding of the decisions involved. Modelling future financial and clinical consequences of a new hospital obviously involves a large number of assumptions, including the amount of risk that can be transferred, whether the cost of transferring that risk is reasonable (given the alternatives), what would happen to ‘market share’, how much patient care will be transferred to the community (and with what financial and clinical consequences), and many other factors to which the model is sensitive. The important principle is that it is not just the future under the new building that must be modelled, but also the counterfactual under a scenario where the building does not go ahead – in other words there is no status quo. I came away with the idea that, quite apart from its impact on the nation’s financial position, PFI is not such a disastrous vehicle for hospital finance as many think, especially if, as expected, some Public Dividend Capital is added to the mix. Indeed, it was also prudent to model the consequences of methods to raise capital other than PFI. Architectural issues are also important. For example, I understand that time and motion studies show that single wards reduce staff efficiency by about 6%, compared to multiple occupancy wards. It is also extremely important that the design can accommodate future expansion. As our accomplished Director of Strategy and Organisational Development, Mike Sharon, put it, “the only thing we can be sure of is that we cannot be sure of the optimum size for a hospital 20 years hence.”

I will return now to the question of the role of the board in a time of increasing external scrutiny. To my mind, the corollary is obvious – the board needs to think less of itself as critical and more as friend. That is to say, it can (notwithstanding its statutory responsibility) place itself more on the side of the poacher than the gamekeeper, with respect to assurance. To my mind, executive directors need another scrutiny body like the proverbial ‘hole in the head’.

So what is the role of non-executive directors, given that their scrutiny role has been, at least partially, subsumed by others? The obvious answer is to assist the executive directors in their tasks. This begs the question of whether the executives need such assistance! Here, I think the answer is somewhat nuanced. Firstly, there’s obvious need for a group who can hire and fire the chief executive. That indispensable role cannot be left to one individual. The second role of non-executives is in developing strategy for the organisation. Here, their primary role is to supply external ‘ballast’ in the form of clever and committed people who can contribute by increasing total brain power and by bringing in the perspective of someone who does not have their nose to the coal face. Their last role is to bring specialist expertise. However, I think that this is the least important role because expertise can always be brought in. Nevertheless, non-executive directors with legal and accountancy backgrounds definitely add something to discussions and may spot ‘unknown unknowns’. In my own small way, I tried to bring an academic perspective to bear and to form something of a bridge between the Hospital and the University. As a researcher, I pushed the Board to go beyond simply scrutinising data with which they were presented and scrutinise the method by which the data are collected. This is important to detect and mitigate bias. Statistical control charts should be used to allow for the play of chance. I hope these ideas have been taken to heart. In my opinion, however, too much is made of lessons that can be learnt from other industries – experience of commanding a ship at sea or running a biscuit factory is not much use in a hospital. Returning ambassadors and captains of industry are valuable because they are intelligent people (mainly) who naturally take a strategic perspective, rather than because they bring specific knowledge from these domains. Part and parcel of taking a greater role in strategy is the importance of finance. I do not go along with the fashion of criticising boards that emphasise money. Firstly, money is the language of choice and I would like to see more, not less, emphasis on value for money. Secondly, the surest way to undermine the care of future patients is to overspend in the current year. Maintaining financial probity is the bedrock of patient safety, as our excellent Director of Finance and Performance Management, Robert White, well understood.

Given my sense that boards of NHS hospitals should take a more prominent role in strategy rather than in simply conducting an assurance function, I was interested to see that this is precisely what is advocated in a new business book “Boards that Lead: When to Take Charge, When to Partner, and When to Stay Out of the Way” by Charan, Carey and Useem. These authors use a huge amount of experience and empirical observation to reach the conclusion that non-executives should be “strategic partners”. They also make the point that non-executives can subtract as well as add value to a company and a lot depends on the personality of the individuals concerned. Large egos, hobby horses, low intelligence and unwillingness to engage with detail can get in the way. For me, the hardest thing was finding enough time to fulfil my duties on the Board while holding down a highly competitive day job. But I leave with thanks to my Board colleagues, and a special “thank you” to our sure-footed Chair, Richard Samuda, and diligent Trust Secretary, Simon Grainger-Payne, who helped me settle in. I will miss working with such a committed and talented group of people, and wish them and the hospital all the very best.

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.
References

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.

References
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

Using individual surgeons’ outcome data for quality control purposes

I have to start this blog with an anti-blog. Some of my “immense following” thought I was having a dig at qualitative researchers in general in my previous blog. On re-reading my blog, I can see how it could have been interpreted in this way, so let me hurry to reassure qualitative researchers that I did not mean to impugn the method; on the contrary, I’m an acolyte of qualitative research. My target was phenomenology and constructivism, and of course it is the ideas, not the people I wish to attack. Incidentally, Kuper said in her BMJ article on qualitative research that most qualitative researchers are constructivists.1 She produced no evidence to back up this assertion which I think and hope is wrong.

But today’s blog is about the Government’s announcement that it will publish the results of individual surgeons. As always with data, making them available is one thing; what people do with them is another. As a libertarian I can find no grounds for supressing the availability of data. But what are we to make of comparisons of the performance of different surgeons?

First of all, a lot will depend on the outcome in question. Below is a graph from my published work which examines standardised mortality ratios (SMRs) as a diagnostic test for preventable mortality.2 Even if risk adjustment can explain a massive 80 per cent of the variance between hospitals, you can see that SMRs are a rubbish diagnostic test; SMRs are neither sensitive nor specific at hospital level because less than 20% of mortality is preventable. False positives are not neutral and no one who has been properly brought up would ever use a test this bad, not even for screening.

Graph2

But hang about, these are hospital mortality rates, not the mortality rates of individual surgeons. Overall hospital mortality represents the interaction of tens of hundreds of different variables – different doctors, different nurses, different pharmacists. Surgical mortality is likely to be much more dependent on the individual surgeon, especially when it is a technically demanding operation, such as the management of leaking aneurysms and removal of inaccessible giblets, such as pancreas or oesophagus. However, we still need to proceed with great caution for the following reasons:

  1. Surgeons attract different case loads and those with a black belt are often sent the most tricky cases. And remember, case mix adjustment is an imperfect art. The technique can sometimes even exaggerate the very bias that it is designed to counteract.3
  2. The number of operations of a given type that a surgeon carries out can be rather small, yielding wide confidence limits. The data should be entered on a funnel plot, since studies by David Spiegelhalter and others show that that this is better than other methods at helping people to understand natural variability.4
  3. As practice improves, so league tables will vitiate their own success and become less useful diagnostically. This is because the greater the variance between surgeons, the greater the signal in the noise and the steeper the slope of the curve in the above diagram.2 As surgeons with the worst rates improve or desist, so variance between them decreases and the information content of SMRs declines. The graph in the figure assumes that the coefficient of variation of the preventability rate is twice that of the outcome overall.

Of course surgeons can be compared with respect to outcomes other than mortality; revision rates for hip replacement for instance. However, the above caveats, especially the one about the best surgeons attracting the most difficult cases, still apply.

As an aside, it is sometimes said that using individual surgeon outcomes in performance management does not result in cherry picking on the grounds that league tables in cardiac surgery have not resulted in selection of progressively lower risk cases over time. However, a moment’s thought shows that this is a logical fallacy because there is no counter-factual. The natural method of medical advancement is to progressively stretch indications as knowledge and experience accrue.

I do, however, understand the concern generated by high profile cases where internal hospital procedures have not spotted incompetent surgeons. My prescription would be “to investigate the investigators.” I would make it the medical director’s job to look at the figures and to probe the explanations. The medical director can triangulate the figures with other data. If a surgeon is an outlier and anaesthetists and theatre sisters corroborate technical incompetence – then that is one thing. However, if the outlier turns out to be an acknowledged virtuoso surgeon, who attracts the most difficult cases for that reason, then that is another thing altogether. The Care Quality Commission should not jump on the individual surgeon in a draconian fashion but check that the medical director is doing his or her investigative job. Indeed, this was precisely the route followed by my colleagues and I with respect to an outlier in a surgical trial and I commended it to the government as a suitable model for routine practice as well.5

References
01. Kuper A, Reeves S, Levinson W. An introduction to reading
and appraising qualitative research. BMJ. 2008;337:404-7.

02. Girling AJ, Hofer TP, Wu J, Chilton PJ, Nicholl JP, Mohammed MA, Lilford RJ. Case-mix adjusted hospital mortality is a poor proxy for preventable mortality: a modelling study. BMJ Qual Saf. 2012. Available from: http://qualitysafety.bmj.com/content/early/2012/10/12/bmjqs-2012-001202.full

03. Mohammed MA, Deeks JJ, Girling A, Rudge G, Carmalt M, Stevens AJ, Lilford RJ. Evidence of methodological bias in hospital standardised mortality ratios: retrospective database study of English hospitals. BMJ 2009. Available from: http://www.bmj.com/content/338/bmj.b780

04. Spiegelhalter D. Funnel plots for comparing institutional performance. Stat Med 2005. Available from http://www.ncbi.nlm.nih.gov/pubmed/15568194.

05. Mason S, Nicholl J, Lilford R. What to do about poor clinical performance in clinical trials. BMJ 2002. Available from http://www.bmj.com/content/324/7334/419.

Can well-minded infection control procedures be subverted?

While infection control procedures on hospital wards should be praised for making them safer places for patients, is it possible that many of these routines have made their way into our mindset and become detached from their original purpose? If you don’t believe this can happen, then may I refer you to Leviticus?

In many hospitals these days, visitors are banned from bringing in flowers for patients, supposedly because there is a risk of water carrying infections. But there is no evidence to prove this as long as water is changed regularly. On the contrary, Simon Cohn says that “studies have emphatically concluded that bedside flowers pose no particular threat to health.”1 Emphatically may be a bit strong, given that science cannot prove a null but the evidence may be taken as reassuring. One cannot but suspect that safety and the precautionary principle do not by themselves explain the ban on flowers. Frequently emptying vases can add to the already busy schedules of ward staff, as can clearing up any unexpected spillages caused by vases being knocked over, so perhaps the infection control agenda has taken on a meaning beyond its original intentions.

Visitors to hospitals may also find restrictions on the types of items allowed in waiting rooms. To reduce the risk of infection, soiled magazines would certainly have to be removed and toys should have hard surfaces to facilitate easy cleaning but if you ban these items altogether, it eliminates the need to spend time cleaning and disinfecting.

Another frustration for people coming in to a hospital hoping to visit their loved ones is the restrictions on visitor numbers. Curtailing visitors during cold and flu season reduces the risk of illnesses being brought in to hospital from the community but what about healthy family members coming to a maternity ward to meet their new brother or sister? My grandson Sammy was inconsolate when denied access to his mother and newborn sibling in the maternity ward of the Homerton Hospital earlier this month.

Sadly, these measures can lead to hospitals becoming soulless and leave patients feeling miserable. Has managing infections taken on a social role and become a means of control or a pointless exercise, rather than evidence-based practice? Us researchers are accused of ending every paper with the self-perpetuating plea “more research needed.” However, with the powerful sequencing tools now available, perhaps we really do need to establish the provenance of hospital infections once and for all2 and not give up the comfort of flowers, or visitors and cuddly toys without a fight.

 

01. Cohn S. Where have all the flowers gone? BMJ 2009;339:b5406 http://www.bmj.com/content/339/bmj.b5406?view=long&pmid=20015906#ref-1

02. Hospital Microbiome http://hospitalmicrobiome.com/ (accessed 7 December 2012)