Open government?

NEWS unfair to concentrate on mistakes, and not point out the triumphs. But as one

LONDON PERSPECTIVE

Clinical confidentiality vs open audit Panorama, the BBC’s flagship documentary programme, had a go at hospital doctors last month. My journalist colleagues thought it was "a good effort"; my medical friends were more: ambivalent. The programme looked at a series of medical mistakes. The lessons the programme drew from these mistakes were sweeping: a need for accreditation before surgeons carry out new surgical techniques such as keyhole surgery; new and more open systems of medical audit; the right of patients to know a surgeon’s current performance record; the need for royal colleges to ensure their recommended procedures are followed; and even separate league tables for hospitals and doctors. All this may look as remote as the moon, yet the medical establishment would be wise not to ignore such proposals. In the USA, the BBC team interviewed patients who had had access to audit records before selecting the hospitals and doctors they wanted. An Oregon man drove down to California for his coronary bypass because the surgeon there was reputed to have the lowest death rate in America for the procedure. But the best quote came from a Pennsylvanian patient, also needing a heart bypass, who discovered that his local medical centre had a low rating in the state’s league table of hospitals. The programme showed him arguing with his local doctors and refusing to accept their explanation. Asked why he was sticking to the league table, the patient replied: wouldn’t you do the same if you were a parachutist and you discovered one packer was near perfect and another had a 10% failure rate? The programme made compelling viewing. There was a tape of the patient whose blocked bowel was mistakenly divided by the keyhole surgeons. Neither gynaecologist involved had received formal training in : clearing bowel obstructions. The programme quoted from a report by Prof Alfred Cushieri calling for stricter

Fleet Street editor has noted: bad news

is to journalism what manure is to rose trees. Even so the programme was a powerful challenge to clinical confidamning, the programme reported dentiality. John Yates, of Interthat although the surgeons’ and gynae- Authority Comparisons and Consulcologists’ royal colleges encouraged tancy, Birmingham, monitoring 100 :anonymous surgeons in an unknown training, they do not insist on it. Dr Donald Gibb explained the region discovers the predictable fourof London, protocol King’s Hospital, fold variation in mortality, but the for ensuring that side-effects with the surgeons are not identifiable. Clinical use of ritodrine with pregnant mothers confidentiality was meant to protect expecting premature babies were patients, not doctors. Less than two decades ago, Dr properly monitored. In the local Chatham hospital used by Debbie David Owen was at the Health Coram there was no protocol, and no Department. He was a minister readequate monitoring. Her husband puted to relish taking people on, but he Kevin explained how his pregnant refused to push medical audit. wife had died when the drug was used.Whenever I challenged him privately, He went on: "If you treat patients he would always say that it was imposwithout the full knowledge of the drug sible. The royal commission that rewhich you’re using, then you can’t be ported in 1979 ducked the issue. Now, doing your patients justice". Debbie’sjust 14 years on, medical audit is firmly family had carried out their own established albeit in a confidential research and discovered the risks had form. Thanks to Brendon Devlin, the been fully documented, "yet clinicalRoyal College of Surgeons Surgical freedom means there’s no way ofAudit Unit continues to gather steam. ensuring doctors take account of this Two reports, on ankle fractures and evidence". Gibb conceded that theupper gastrointestinal endoscopy, are royal college, which has drawn-up ’:due out any time. A dozen more are in labour ward protocols but not made :,the pipeline. If audit can spread so them mandatory, should do more. relatively quickly, then so can ending The journalists went to Liverpoolclinical confidentiality. This may not where Prof Richard Cooke in hisbe good news for doctors, but it should neonatal ward uses steroids, wherebe for patients. appropriate, for mothers expecting premature babies. The risk the babies Malcolm Dean run of lung disorders and brain

damage

was

effectiveness explained. So

and the steroids was was the fact that the of Obstetricians and

explained, of

Royal College Gynaecologists, despite encouraging its members to use the therapy, does

monitor whether its recommendations are being followed. The NHS is awash with statistics, but much of it in an unusable form. Just how unusable was shown by the Midlands hospital that was keeping its records in an outbuilding, known as the Dead House, where a tramp used records to help light fires. By its very nature, television journalism has to miss out many of the caveats, although the programme did point out the problems of introducing control on keyhole surgery, including American-style openness into the an accreditation procedure. Asked on UK-the genuine complications of camera whether this would be a breach league tables, the difficulties in interof clinical freedom, Cushieri replied: preting them, and the temptation of doctors to massage results if they were "Yes, but what is better, clinical freedom or patients’ safety?" More going to be exposed. And of course it is not

Open government? Patients agitating for greater access to information about UK doctors’ skills and performance, will take little comfort from the white paper published this week on Open Government. Historians will probably be pleased to read hitherto secret intelligence records concerning the Cuban Missile Crisis in 1962, and even "19th century administrative material inherited by the Secret Intelligence Service..."; but it will still be the government who decides what may be known about its activities: the citizen has few rights in law to such information. Nonetheless, the white paper announces some good intentions. The strictures of section 118 of the Medicines Act 1968 (intended to protect the pharmaceutical industry’s trade secrets) "... may need to be reconsidered... ". That section will, in fact, have to be reconsidered to conform with the drug-licensing pro-

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cedure due for enforcement throughout the Despite the claim that the government European Community in 1995, which will intends to show " ... much greater require more information from the industransparency in the aims, performance and try on the development of testing of phardelivery of government services", the susmaceuticals. The white paper admits thei picion remains that opacity could easily value of official statistics in "providing an supervene when expedient. Sooner or later . objective perspective of the changes taking the UK public will require their rights to place in national life... ", and makes a government information to be decided by commitment to "... introduce measures to law and not by those who may have the help ensure the consistency of release most to gain by concealment-the : practice for key official statistics", whichi government itself. : sounds like an admission that, in the past, the release practice for some statistics (such John Bignall as those suggesting poverty to be the main determinant of premature death) has been 1Open Government. London: HM Stationery influenced by political considerations. :Office, 1992. Pp 93. £11. ISBN 0-10-122902-X.

Flags in research Medical researchers who use data collected by the Office of Population Censuses and Surveys (for England and Wales) will be heartened by the recommendations of a working party that looked into the services provided to medical research making use of individual named records. Among the recommendations of the Working Group of the Registrar General’s Medical Advisory Committee are that OPCS continues to support and develop its services to medical researchers ; that it considers computerising historic records; that every effort be

records of

American Board of Emergency Medicine sued On July 16 over 170 physicians set a legal precedent by filing class-action claims against the American Board of Emergency Medicine (ABEM). The claims allege that the ABEM is violating the law by not letting these physicians sit the specialty board examination in emergency medicine, thus preventing them becoming "ABEM certified". The ABEM’s alleged sin was to set a deadline (June, 1988), after which practitioners who were not emergency medicine residency-trained would no longer qualify to sit the exam. Board-

certified in internal medicine but practising in emergency medicine, I am one of those

births, deaths, and mar- potential plaintiffs. riages, cancer registrations, census The case (Daniel vs ABEM) was initiated forms, data from ad hoc and regular by Dr Gregory F Daniel, a native of

health and social surveys, notifications Trinidad who graduated from a US mediof termination of pregnancy, and, in cal school and was practising emergency

anonymised form, hospital episode medicine in New York. He had repeatedly requested and been denied permission to statistics data, notifications of congenital malformations ascertained at take the ABEM certifying exam. Soon after filed the case in a New York State court birth, samples of coded general he in 1990 it was removed to a US District practice records, records of in-vitro Court, where the ABEM sought dismissal fertilisation (for some years), and new for technical reasons and on the basis that

certifications for the blind and parIt also maintains the Central Health Register Inquiry System (CHRIS) for England and Wales and has links with the Scottish register. The records have been very valuable for longitudinal studies-eg, that made to keep charges as low as possible of the smoking habits and health of (eg, by attracting more work so that doctors, for which Richard Doll and: costs per case are reduced); and that Austin Bradford Hill regularly rethe office looks into the demand for, ceived copies of drafts of death certiand costs of, setting up internally a ficates indicating that the deceased twin register for medical research. : had been medically qualified. Longitudinal studies of occupational health Records from the OPCS the General Register Office) have been hazards also rely heavily on OPCS used for medical research for the past data (table). For 1992-93, OPCS is 130 years, increasingly so especially expected to collect £500 000 for its: over the past two decades, during services to medical research. : which the number of "flags" (which indicate that the record is of an indiviVivien Choo dual in a medical research study and which enable subsequent deaths to be 1 Uses of OPCS records for medical research. notified to researchers) has grown A review of the Registrar General’s Medical Advisory Committee. OPCS Occasional Paper from about 50 000 in 1967 to about 2 41. London: OPCS, 1993. Pp 55. £6.25. ISBN million in 1992. The office holds v 0-904952-97-5.

tially sighted.

(formerly

*As of Jan 1993,

Number of studies by type and number of flags*

the

complaint, even if proved, would not justify any relief. The court named a special magistrate (a common procedure in federal courts) to evaluate the ABEM’s request. magistrate’s recommendations to the judge, accepted in August, 1992, were that The

part of the complaint on technicalities be dismissed but that the anti-trust allegations should stand. American anti-trust litigation is long and expensive. To prove "unreasonable restraint of trade" requires thousands of hours of research on economic, historic, and demographic factors involved. However, if a court finds illegal trade practices proven, an entire class of individuals may qualify for compensation. To prepare for battle, Daniel et al contracted with the antitrust specialist law firm of Shearman & Sterling, a global operation with 600 attorneys. The leading lawyer in the case was chairman of the American Bar Association’s Antitrust Law Section in the 1980s and before that was director of the Bureau of Competition at the Federal Trade Commission. The plan was to sign on at least 130 additional physicianplaintiffs, willing to invest around$3500 each to fund the administrative costs. The law firm accepted the case on a contingency basis. The addition of other names to back the enterprise might, it was hoped, give ABEM pause for thought. Daniel claims that the ABEM had economic motivations when setting its deadline. He says that some emergency physicians have become economic secondclass citizens’ due to their non-certified status, which in no way reflects upon their competence or experience. Over 50% of all the emergency doctors in the USA may be