Wednesday, February 11, 2015

HSMR dead and buried?

HSMR dead and buried?

The use of HSMRs for assessing the quality of healthcare or even comparing mortality rates has been much questioned in the academic community. Dr Foster is a commercial concern, who naturally have an interest in selling their product. The Academy of Medical Royal Colleges (AoMRC) have no such conflict of interest, and they published their report on international HSMRs yesterday.

The AoMRC have been looking at the comparison made by Professor Sir Brian Jarman between UK and US healthcare, where he stated there was a 45% difference in mortality. That figure was striking, and gave rise to a number of salacious headlines. A difference of that magnitude based on such a large database would be beyond the vagaries of mere statistical chance. 

However, the AoMRC noted a number of factors that made any direct comparison unreliable:
Choice of factors included in the risk adjustment model
Choice of data used to derive the model
Choice of hospitals included from each country
Choice of assuming the same level of underlying risk in each country
There were also a number of differences in coding which affected comparisons:
Differences in diagnostic practices
Differences in the number of secondary diagnoses
Differences in severity
Proportion of population deaths in acute hospitals

Their conclusion?


"We do not believe that the comparisons are valid because of the reasons we have given. More rigorous analyses using more clinically sophisticated data need to be used. This reflects the conclusion of a recent paper from the Dr Foster Unit which stated: ‘There are considerable challenges in combining administrative databases across countries, with decisions to be made regarding definitions of inpatient admissions and diagnosis and procedure groups. Interpreting the resulting case mix-adjusted in-hospital outcome rates across international boundaries is hampered by differing discharge policies and intermediate care facilities. Standard statistical models cannot take account of this without valid and complete post discharge information’.

One of the key issues is that we have no measure of the uncertainty attached to the estimate of 45%. On a simplistic level, it is quite accurate because it is based on large numbers, but uncertainty in almost all the key assumptions used in its derivation mean that we cannot have much credence that this estimate is even close to the actual value.

We would advocate comparisons of outcomes of care for specific conditions or interventions
based on high quality clinical data that enables adequate risk adjustment. Such comparisons are difficult as they require data from the two countries that are sufficiently similar as regards variable definitions, patient inclusion criteria, similar professional judgement regarding diagnostic labelling etc. Despite these challenges we would recommend that some studies be commissioned to establish if there are systematic differences in the quality of hospital care between the two countries."

So how and why did this study with such precarious findings become headline news? The usual reasons I suspect. An eye-catching headline, a chance to bash the NHS, and further validation of the utility of HSMR. Only that might just have backfired.

Monday, February 9, 2015

Case Note Review The "Rolls Royce" Form of Patient Safety Analysis?

Case Note Review The "Rolls Royce" Form of Patient Safety Analysis?

The flaws of using various statistical techniques to estimate the numbers of avoidable deaths in hospitals have been documented in this blog and elsewhere ad nauseum. Thus it should be no surprise that the DoH will be assessing avoidable deaths by the far more reliable methodology of the case note review (disparaged by Julie Bailey for her own reasons). The only superior method would be widespread post-mortems accompanied by coroner's inquests, with all the resource implications. 

This would be an exciting advance in the monitoring of hospital mortality, although it would fail to pick up the major issue of quality of care (which as previously discussed is not reflected well by mortality). It also fails to address the massive falls in post-mortem rates, despite the recognition that post-mortems (whether virtual or orthodox) continue to pick up a high rate of diagnostic error. 

Nonetheless, this move demonstrates a welcome move away from the Dr Foster model of statistical analysis. The avoidable mortality in British NHS hospitals is on a par with that of healthcare systems across the developed world, despite the apocalyptic headlines from tabloid newspapers. 

Wednesday, February 4, 2015

FGM prosecutions - where now?

FGM prosecutions - where now?

The criminalisation of female genital mutilation (FGM), also known as female circumcision, has not yet resulted in any successful prosecutions. This could be lauded as a great success if the evidence suggested this was because FGM had ceased. All the pointers are that this practice continues. Thus the failure of a single prosecution to be brought prompted rising criticism, until 16 months ago the first prosecution was announced. The acquittal this week of Dr Dharmasena brings some of the difficulties into focus.

Firstly, the woman did not want the prosecution brought. 
That is not necessarily a problem. The cultural conditioning of victims of particular crimes may often mean that they do not view themselves as victims. Neither is the victim's cooperation nor consent necessary for prosecution - it is the Crown who prosecutes. However, it does make a prosecution more difficult.

Secondly, the doctor claims that the suture inserted was on the grounds of medical necessity, and he did not realise that it might be illegal. 
Ignorance of the law is no excuse, although it can establish lack of the necessary mens rea in certain circumstances. However, it might affect the decision-making of the jury. The jurors might have considered that even though the offence was technically made out, the doctor's actions were not sufficiently wrong as to merit criminal punishment. In legal language, a perverse acquittal such as happened with Clive Ponting, prosecuted for revealing official secrets about the General Belgrano sinking.
Here the communication between the midwives and the doctor would be crucial. The jury when faced with judging whether that single stitch was reinfibulation (restoring the genitals to the state of genital mutilation that existed prior to childbirth) or a bona fide medical repair, may simply have been able to state with certainty that the former was the case.

So is this acquittal a sign that the law is essentially unenforceable, or simply a sign of an overzealous CPS trying to prove that it is on top of the job? 

Tuesday, February 3, 2015

CQC again fails to conform to the standards of transparency it sets for others

CQC again fails to conform to the standards of transparency it sets for others

I asked the Care Quality Commission what I assumed would be a fairly easy question for them to answer. Do they have a policy that gives clear and explicit instructions to inspectors not to interrupt staff involved in emergency interventions?

Apparently it is not. After several attempts, I have still not had a straight answer. The answers have ranged from the evasive ("Our inspectors have guidelines to suspend inspections during major incidents" - no, thats not the question I asked) to the outright defensive ("Inspectors are often medical staff, including from A&E's. They wouldn't interrupt an emergency procedure"). Do they have a policy or not? If not, why not? If they do, what measures do they take to ensure compliance? If an inspector has placed a patient potentially at risk by interrupting staff during an emergency medical intervention, what would be the procedure for investigating? 

Quis custodiet ipsos custodes? Who can ensure that the CQC do not blunder through a hospital causing disruption? After all, any complaints to the CQC about the conduct of their staff risk prejudicing the CQC's report on that hospital. I hope the CQC will see fit to make a proper response; after all, this is an important issue which the public and press would be rightly interested in.

Monday, February 2, 2015

How to galvanize opposition to a bill

How to galvanize opposition to a bill

I have to admit, it is a masterstroke of pure genius. If I were a practising lawyer who stood to lose a lot of work from a bill going through Parliament, how would I galvanize opinion? If I start talking about the intricacies of the law, people will probably turn off as the debate gets bogged down in arguments and opinions. The simplest and best tactic is to say that there is no debate. This is what the opponents of the Saatchi Bill have done.

The non-legal opponents of the bill have accepted this at face value. This means that the entire debate about the law is bypassed on a false premise. There are several authoritative legal opinions that the current tests for the standard of medical care are prejudicial to innovation, one example being an article by the Samantas. So the anti-bill camp should accept there are arguments for a change in the law, rather than steamroller the debate by pretending there is no intellectual support for the premise of the bill that the law can stifle innovation. Of course, even if there is a need for the law to be changed, this does not mean that the bill currently proposed is right or could not be improved. But it would entail a shift in position from the current absolutism of the anti-bill camp.

Sunday, February 1, 2015

Prospective trials

Prospective trials

One of the most problematic elements of the civil trial is the retrospective analysis of the appropriateness of actions, which is inevitably influenced by hindsight. It is well known that the recollections of patients and families is influenced by outcomes, for example. The outcome of medical treatment will also influence the judgment of the medical treatment given. We see this time after time in medico-legal suits, as my recent blog about Davies v UHNS demonstrates. Although this action failed, its origins lie in the eventual diagnosis of a brain tumour. Such actions tend to encourage positive defensive medicine. 

It's ironic that those who believe so strongly in the prospective randomised controlled trial have so much faith in the retrospective legal trial. Simms v Simms is a rare instance of an innovative treatment being judged appropriate by the court prior to its administration to sufferers from nvCJD. It is a reasonable inference that one of the reasons that the hospital trust were reluctant to administer the treatment despite the families' ardent wish that the treatment be tried was the potential for medico-legal liability. 

In this respect, the approach of the Medical Innovation Bill makes sense. The appropriateness of an innovative treatment is judged prospectively, prior to the outcome.