Fondazione Arturo Pinna Pintor SIQuAS VRQ
From perceived quality to perception of medical error - For an integrated methodology to detect medical errors
Saturday October 15, 2005
Arturo Pinna Pintor Foundation Hall
Via Vespucci 61 – Torino, Italy

 Introduction

P. Pinna Pintor

President Pinna Pintor Clinic and Arturo Pinna Pintor Foundation

Today’s symposium is taking place at a time in which the press has been reporting as never before on fatal incidents that have occurred to patients in hospitals in various Italian regions (slide 3)
The emphasis given by the daily press (Sole 24 Ore – Sanità) to the high frequency of mistakes made on patients in hospitals has raised, in our country too, the issue of patient safety and of the prevention of medical errors. 210,000 deaths were recorded by the Lombardy Region Work Team between 1994 and 2004, and the Fourth Symposium on Public Health organised by the Varese Medical Association (slide 4), which reported deaths estimated at between 15,000 and 50,000 cases in Italy (2001 data) [1], dramatically raised the alarm in our country also as regards the safety of patients in hospitals.
Dying in hospital because of doctors or because of hospital inefficiency, rather than because of disease, is nothing new, albeit these facts, for years and years, have been suppressed.
Suffice to think of the fate of the eminent US surgeon, Codman, who in 1911 established the “end result theory”,  with the idea of tracking the outcomes of patient treatments as an opportunity to identify clinical misadventures. He also believed the information should be made public and for this he faced ostracism from the surgeon community. He was compelled to abandon Massachusetts General Hospital (a public hospital) and in 1915 he was obliged to close the private clinic he had opened a few years earlier. His initiative, however, was not wasted, given that two years later the American College of Surgeons (ACS), in order to guarantee better quality of treatment in the USA, developed a set of minimum standard requirements for hospitals, whence came the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) in 1953.
Years later, however, malpractice in the USA remained an issue for insurance claims and meant a continuous rise in premium costs and in the cost of health services.
A long dossier drafted by the Institute of Medicine under the title “To Err is Human” was published on 30th November 1999 and got international visibility thanks to an NBC scoop. The dossier reported estimated mortality in the USA and was an extrapolation of data from research conducted 20 years earlier (Slide 5)(Slide 6). The figure was between 44,000 and 98,000. The news sent a shock wave through Government,  public opinion, the medical community and health administrators in the USA.
However, such high death rates and the wide frequency range of events raised big doubts on the validity of the figures after their publication. Some considered them overestimated [2] [3] [4] [5], other Authors, on the contrary, argued they were underestimated [6] [7].
Something not very different occurred recently in Italy too, where the epidemiology of malpractice and of mortality was contested [8] [9] by many sides a few months ago, on the grounds that the survey methodology was not specific enough and mainly based on insurance claims for damages.
Further confirmation of the uncertain and contradictory character of epidemiological data based on civil liability litigation comes from the following: according to ANIA “In 70% of the medical liability claims made to the Observatory established at  Naples University, the responsibility was attributed to the professional (doctor/nurse)".
AMAMI data state quite the opposite: out of the 15,000 doctors charged for  malpractice  and sued  for damages, 65% are discharged.
However, even without trustworthy epidemiological data, in the past 5 years medical malpractice and its deleterious consequences, (impact on the media and the new awareness of government  institutions, professional associations and insurance companies), has led to a search for ways of containing and preventing risks in hospitals and in the community (slide 7) (slide 8).
Last but not least is the establishment, last August, of a Centre for collaboration between WHO, JCAHO and JCI, exclusively dedicated to patient safety and to the reduction of an unacceptable number of cases of malpractice throughout the world every day (slide 9).
In Italy too, the initiatives taken for the same endeavour are ever more numerous : detect, prevent and reduce medical malpractice (slide 10).
Health policies which aim  at creating tools and training staff to reduce the increasingly serious risk of medical malpractice in our country are welcome and pragmatic, and this even without the epidemiological data which, as we have just said, are extremely variable  and in many ways unreliable.
However, there are good reasons for ascertaining, as precisely as possible, how prevalent errors are, what gives rise to them and what damage they cause; even though, when a house is on fire, putting it out must take precedence over finding its causes. Prevention, which is nowadays considered the front-line method to ensure safety, requires us to know the risk of error in any given context, and, as we all know, risk is calculated by multiplying the frequency by the gravity of incidents. The JCAHO studies of ‘sentinel’ events have provided interesting data for the distribution of the causes of the more serious errors – sentinel events – and this is useful but not sufficient to implement prevention of them. The lack of data for frequency means lack of the element that allows risk assessment as nowadays understood in Italy too (Law 626)
It is in fact possible that the distribution of hidden errors and root causes of the kind JCAHO lists under the name of “sentinel events”, be different (just as the barriers to their detection are different) from the distribution of the events reported by JCAHO.
For this reason, any extrapolation obtained by applying the same cause distribution found by JCAHO for different error types to undetected events should be considered arbitrary. There is no proof that the same barriers to detection are to be found for each error type, and this might represent a bias thwarting the selection of the causes and the relevant shift of resources necessary for the prevention in areas that would otherwise be neglected.
In the case of root causes of events due to infection (slide 12), for example, a somewhat small sample (57 cases), given the long period of observation (1995-2004), communication flaws are less than 10% of reported events, against over 70% in the much larger numbers for surgery and post-surgery events (slide 13). We don't know what the prevalence of communication flaws would have been with a larger and more representative sample.
The search for the most accurate method (or methods) for the identification of the largest possible number of errors and events is not a merely academic exercise (slide 11).
In sociological research, surveys of public perception are increasingly used, as a more or less important point of view, depending on what kind of information one requires. The quality of treatment as perceived by patients, doctors and  health authorities for years now has been an indispensable point of reference for performance in the field of health services.
If error is the negative side of quality, one doesn’t quite see why the perception of error by patients, doctors or the population should not give us – within the same framework – a more reliable appraisal of reality and why it should not represent a new way of ascertaining error and the damage that may derive from it.
This approach represents an innovative model in the methodology for the search for “esse” according to Berkeley (slide 14), in getting as close as possible to reality. It was first taken by the Harvard School in comparing perception, or, if you wish, the experience the population had of the frequency of  foreseeable errors and their consequences in the USA.
This is the thought which animates our symposium. We hope the discussion amongst a number of top experts is going to be useful in setting the trend for new research work on medical malpractice and on safe treatments in our country too.


BIBLIOGRAPHY
 
  1. Marcon G: Editoriale e Errori e danni nelle cure mediche. USA e Regno Unito lanciano l’allarme. Rischio Sanità 2001:1-16
  2. McDonald C e coll.: Death due to medical errors are exaggerated in Institute of Medicine Report. JAMA 2000; 284:93-4
  3. Sox HC, Woloshin S: How many deaths are due to medical error? Getting the number right. Eff Clin Pract 2000; 6:277-83
  4. Brennan JA: The Institute of Medicine Report on medical errors – could it do arm? NEJM 2000; 342:1123
  5. Dentzer S: Media mistakes in coverage of the Institute of Medicine’s Error Report. Effective Clinical Practice, Nov./Dec. 2000
  6. Leape LL: Institute of Medicine Medical Error Figures are not exaggerated. JAMA 2000; 284:95-97
  7. Starfield B: Is US health really the best in the world? JAMA 2000; 284:483-485
  8. Bevilacqua L: L’errore medico esiste ma i dati sono inattendibili. MedWeb Corriere Medico 21 Ottobre 2004
  9. Bianco A: Così si tutela l’azienda più del paziente. Il Sole 24 Ore -5 Settembre 2005, n. 243- pag. 47

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last update: 2005/12/29 Document made with Nvu