Rapid Responses to:
|
|
Rapid Responses: Rapid Responses published:
-
![[Read Rapid Response]](/icons/misc/sectionDOWN.gif)
Trial Problems and consent
- Brian Morgan (9 January 2001)
-
A reply to Brian Morgan
- Edmund Hey (11 January 2001)
-
Lending equipment justifies authorship
- Brian Morgan (13 January 2001)
-
Re: A reply to Brian Morgan
- Barbara Bryan (13 January 2001)
-
On the Defence
- Lisa Blakemore-Brown (13 January 2001)
-
Re: A reply to Brian Morgan
- Mark Struthers (14 January 2001)
-
Coauthorship of Drs Hey and Southall
- Jon Skinner (15 January 2001)
-
Re: On the Defence
- Brian Morgan (16 January 2001)
-
Trial experience and recollection of consent
- Heather Goodare (18 January 2001)
-
Patient records
- Brian Morgan (19 January 2001)
-
Re: Trial experience and recollection of consent
- Lisa Blakemore-Brown (20 January 2001)
|
|
|||
|
Brian Morgan, Freelance Journalist Cardiff
Send response to journal:
|
Your journal went very silent on the matter of the Griffiths Report after it was attacked by Hey and Chalmers so it is with some pleasure that I read more on the subject. (1) Elbourne and others have written before on patient feedback from trials. (2) Their previous paper was responded to by a parent from North Staffs. (3) Elbourne et al give suggestions as to why parents fail to recall phrases like 'randomisation' and 'trial'. However they exclude from their suggested reasons occasions when the researchers do not tell the parents that their children are being entered into a clinical trial. In the case of the North Staffs trial of CNEP in premature infants with RDS, I would like Elbourne et al to consider how a mother who was recovering from anaesthesia after caesarian delivery could (a) possibly recall being told about 'randomisation' and 'trial', (b) sign a consent form with a perfect signature and (c) no more than four hours after birth whilst still drowsy forecast the name of the baby she had just given birth to, a name neither she nor her husband would think of for several more days. This is just one of a number of carefully documented and researched related situations. The reason many of the parents do not recall being being told CNEP was a randomised trial was simply this - they were not told. And please while we are on the subject of the Griffiths Report, when is the BMJ going to act on Dr Edmund Hey's puzzling claim at the foot of his defence of Professor David Southall (4) that: 'Neither author knew any member of the research team at Stoke when asked to undertake this work for the Medical Defence Union.' when he had recently co-authored a paper with the professor? (5) References 1 http://www.bmj.com/cgi/content/full/322/7277/49 2 http://www.bmj.com/cgi/content/full/317/7150/21 3 http://www.bmj.com/cgi/eletters/317/7150/21 4 http://www.bmj.com/cgi/content/full/321/7263/752 5 Skinner JR, Hunter S, Poets CF, Milligan DW, Southall D, Hey EN. Haemodynamic effects of altering arterial oxygen saturation in preterm infants with respiratory failure. Arch Dis Child Fetal Neonatal Ed. 1999 Mar;80(2):F81-7. |
|||
|
|
|||
|
Edmund Hey, Retired Paediatrician
Send response to journal:
|
I see that Mr Morgan asks a second time, in his letter of January 9th, how it is that I could be an author of an article of which Professor Southall is also an author, and yet say I did not know any member of the research team in Stoke when first asked to undertake work on the Griffiths Enquiry for the Medical Defence Union (MDU). The answer is simple. I helped the main author of this paper, Dr Skinner, with certain aspects of the research he was reporting. Professor Southall also helped him in other, unconnected, ways (mostly by lending him some research equipment). Collaborative research is not infrequently like that nowadays. I had never spoken to, or written to, Professor Southall in my life before receiving the request for advice from the MDU. I would add, for the record, that my article in the BMJ on 23 September was a critique of the way the Griffiths Enquiry was conducted. It was not, and could not be, a defence of the Stoke clinicians, for the reasons I outlined in my letter on 25 November. Edmund Hey |
|||
|
|
|||
|
Brian Morgan, Freelance Journalist Cardiff
Send response to journal:
|
With the greatest of respect to Dr Hey, there were at least three attempts to get him to explain his apparent prior link with one of the researchers at North Staffs, twice by myself and at least once by another correspondent. His explanation is fair enough as far as it goes except that it is not supported by confirmation from either of the other two individuals mentioned in his response. I say this because it provides an interesting interpretation of 'co-authorship' in biomedical research, which is that lending research equipment qualifies, and he says this is what much of collaborative research is like these days - not infrequently. The authors of COPE ( http://www.bmj.com/misc/cope) might be surprised to hear this. According to them - there should be a balance between intellectual contributions, conception, design, analysis and writing on the one hand, and other routine work. Where exactly lending research equipment fits in this balance between authorship and mere acknowledgement I might leave readers to ponder. I stand to be corrected, but what Dr Hey seems to be saying is : 'Yes there was prior co-authorship, I didn't declare it as a conflict of interest because it wasn't really co-authorship at all - mostly what the other author did was to lend equipment. So my claim of not knowing one of the researchers still stands.' Perhaps this is acceptable in the cloistered medical world. |
|||
|
|
|||
|
Barbara Bryan, Communications Director, NCADRC (home branch office, located in Roanoke, Virginia, USA)
Send response to journal:
|
"Immaculate Connection," Dr Hey? Who would have guessed that researchers, whose combined conclusions affect many with their implications, might know neither each other nor each others' postulates and extent of participation in research studies seemingly conducted jointly? In America an exercise as simple as a tea-and-biscuit book club's intended unanimous vote is stopped by absentee votes. Only when all involved, all "present and voting," have opportunity to be fully informed on the latest arguments prior to lending their names will "informed consent" to unanimity be satisfied. That kind of professional care, competence, and scrutiny is implied by signatures, such as your own and those of other prominent professionals, to significant studies. Insisting on delineating minor and disparate parts of a research project--such as "I helped...with certain aspects" and "Professor Southall helped...unconnected...(mostly...lending...research equipment)"---seems to parallel "Gee, Your Honor, I just held the bag. How was I to know what was in it?" If your assertion is correct--that "collaborative research...nowadays" is conducted by people who neither know each other nor exchange and challenge postulates or specifics of their varying parts in the project--should we wonder more about each study's "main author" and signatories? Should we look askance at most published collaborative research as merely many names having Immaculate Connection? Conflict? Barbara Bryan began investigative reporting in 1961 and has researched the field of false allegations of child abuse/neglect since 1983. Her particular interest is in finding even one reputable study using accepted scientific methodology to validate the concept known as Munchausen Syndrome by Proxy. |
|||
|
|
|||
|
Lisa Blakemore-Brown, Independent Psychologist UK
Send response to journal:
|
If anything will stick in our minds about the NHS and the end of the century it must be the extraordianry number of complaints and the findings of underlying arrogance, paternalism and defensiveness. For the record, I would be very interested to know if Dr Hey, after his article, has heard anything which might just make him think that maybe - just maybe - he was not given the whole truth??? |
|||
|
|
|||
|
Mark Struthers, GP Leighton Buzzard, Bedfordshire
Send response to journal:
|
What extraordinary revelations Dr Hey! It's amazing to learn that people can put their name to a research paper as co-authors and then claim never to have communicated with one another. Surely the word 'collaboration' should be redefined. I may have a naive disposition but I find it very difficult to believe that the so called 'critique' of the Griffiths Enquiry offered by Sir Iain Chalmers and Dr Hey was not in some way meant to be a defence for the clinicians at Stoke. It was after all commissioned by a medical defence organisation representing at least one of those clinicians. The business of the MDU is to defend doctors against allegations of malpractice - nothing else. In the addendum to their 'scholarly analysis' Hey and Chalmers admit to a concern for the future of clinical research. Their aggressive foray against Griffiths was bound to be a risky strategy and I suspect it will backfire to everyones cost. It is not the Griffiths Report which will put research in serious jeopardy but the misjudgment of these authors and of course the arrogant and insensitive medical correspondence which followed the printing of their paper in September last year. The authors also state that their labours on behalf of the MDU were unpaid so at least I can be sure that as member of this medical defence organisation none of my enormous annual subscription will have contributed to this malarkey. |
|||
|
|
|||
|
Jon Skinner, Paediatric Cardiologist Auckland, New Zealand
Send response to journal:
|
As the first author of the article with both Dr Hey’s and Professor Southall’s names attached (1), perhaps I can clarify this situation. Dr Hey was one of my senior supervisors in Newcastle upon Tyne during a research project in neonatal haemodynamics, when I was a research Fellow. I met Dr Southall after I had given a paper at a meeting in York. He made some helpful and encouraging comments and observations about my research, and he mentioned he had a research fellow, Dr Poets, with overlapping research interests. I contacted Dr Poets and he came up to Newcastle from London to loan me a specially modified oximetry machine, and to show me how to operate it. We also discussed the design of the study. I wrote the results paper with the help of my supervisors in Newcastle (Hey, Milligan and Hunter), and sent it off to Dr Poets and Dr Southall for their comments and suggestions. They made many helpful suggestions as to the layout, content and discussion, and directed me to useful cross-referencing. I decided that their cumulative input warranted including them both as co-authors. Dr Hey and Dr Southall never met, nor, as far as I know, talked to each other, during this process. I coordinated the input of all of the authors into the design of the study and the writing of the paper, and found the combined intellectual and practical inputs helpful to me and important in the ultimate written report. Jon Skinner (1) Skinner JR, Hunter S, Poets CF, Milligan DW, Southall D, Hey EN. Haemodynamic effects of altering arterial oxygen saturation in preterm infants with respiratory failure. Arch Dis Child Fetal Neonatal Ed. 1999;80(2):F81-7 |
|||
|
|
|||
|
Brian Morgan, Freelance Journalist Cardiff
Send response to journal:
|
Ms Blakemore-Brown may yet see interesting revelations - we are now told that the Near Infra Red Spectroscopy that was supposed to have been used to confirm beforehand that CNEP was safe to use on these preterm babies was not actually available until after the study had begun - which is what I and others have been saying all along. If the CNEP study had been published in the UK, say in the BMJ or the Lancet, then there is a reasonable prospect that the editors of one of these two journals might take the issue of such a fraudulent claim seriously enough to require a correction or withdrawal. The paper was actually published in the USA in Pediatrics, the editor of which was informed when this was uncovered - but no positive action followed. If this were the only confusion concerning the CNEP study it would be enough to worry about - but it isn't. Who for example were the seven unidentified paediatricians and a statistician who specified the weightings in the unproven scoring system which held the key to whether the study continued or was halted early? Different weightings could have led to the study halting earlier than it did. A child who died before 28 days of age was allocated 30 points - more than a child who survived but still needed oxygen on the 28th day. I know what I would consider a preferable outcome and it's not the dead child. Were these experts the same ones as conducted the substantive research? We should be told. Why was the study terminated early at Queen Charlotte's after only 15 months but lasted 43 months at North Staffs - surely the same early termination criteria were in place at both centres? And going to the heart of the question of forged consent forms - how were mothers who were effectively non compos mentis after a caesarian section able to provide perfect signatures at between 2 and 4 hours after the birth? That's what the research paper says happened - and I've seen the supposedly genuine consent forms with their signatures on - it isn't possible. I am the eternal optimist and I believe we will get answers eventually - but I do think that only judicial inquiry will be totally effective - coroner's inquests on the deaths - public inquiry for the rest of it. Pronto. |
|||
|
|
|||
|
Heather Goodare
Send response to journal:
|
Editor - Diana Elbourne and colleagues (1) discuss a common, and entirely avoidable problem. People asked to sign consent forms, for both research and treatment,often do not recollect the exact details later. This is perfectly understandable. The courteous and common-sense thing to do is surely to give all trial participants, parents of children in trials, and ordinary patients not in trials, a copy of the consent form they have just signed. The form should be accompanied by an information sheet giving all relevant details (including randomisation if any). This should not replace oral explanation, but supplement it. This strategy would avoid much confusion, unhappiness, and even perhaps litigation. It is amazing to us that such a simple procedure, which is routine in business transactions, is still not observed routinely in clinical practice in the UK. Heather Goodare
Charlotte Williamson
1 Elbourne E, Snowdon C, Garcia J, Field D. Trial experience and problems of parental recollection of consent. BMJ 2001; 322:49-50. |
|||
|
|
|||
|
Brian Morgan, Freelance Journalist Cardiff
Send response to journal:
|
Goodare and Williamson have made such a sensible suggestion, I wonder what roadblocks the rearguard of the medical professions will erect this time. What this suggestion reminds me of is one of the differences between the US and NHS healthcare systems - which is that patients in the US leave any consultation or treatment session with the latest additions to their medical file. They have no comprehension of the secrecy of the UK system and out inability to see our records whenever we want to. I know that not all comparisons between the UK and USA healthcare systems are so favourable but in this respect they have something to commend. It is only a decade since UK patients acquired a statutory right to see their health records, but this is a lengthy and expensive procedure - still with the medical power of veto - and it happens that essential records disappear or are altered when complaint or litigation is mentioned. The individual or authority being complained about has effective control over the evidence needed to settle the matter. In two contentious cases I am currently following, the police force have fortunately seized medical records in one of them, and in another a security firm is holding original documents at the request of the police, pending possible criminal action. Patients in these cases are assured that at least what was available at the time of seizure will remain safe. There is a case to be made that (a) copies of health records should be given to patients at the completion of every period of treatment or consultation, and (b) that originals should be more securely held and accounted for than they are presently. This would severely limit the possibility of medical fraud or deception and attempts to cover up after the event. It would cost money, but save some of the money being diverted from patient care into litigation. |
|||
|
|
|||
|
Lisa Blakemore-Brown, Independent Psychologist UK
Send response to journal:
|
The concerns raised by the Griffiths Inquiry with respect to signed consent forms touch on two issues: whether people `forgot` that they had signed and whether Doctors `forgot` they had signed it for them. In other words, could there have been fraudulent action? Whilst in a normal world the idea of giving a copy of a signed form and a sheet of info would suffice, in a potentially corrupt world this would do nothing to erase the potential real problem. As Brian Morgan has revealed, in one case a signed consent form was found - unfortunately there are glaring facts which prove it could not possibly have been signed by the patient. If fraudulent action is found - and even if it is not found to be provable in the CNEP cases - I agree with this respondent that there need to be radical changes. However, the changes would need to recognise not just that an innocent patient could forget, with the innocent medic not realising. Sadly,they would also need to take into account that fraud and forgery could potentially occur(however rarely) on the part of the professionals as well as the possibility that lies could be told by a potentially litigious patient. Being rather poor on technological matters the only idea I could think of to get round this would be to film the process of patient signing with proof of time and date set within the equipment and resistant to tampering. |
|||