Rapid Responses to:

EDITORIALS:
Sharon E Straus
What's the E for EBM?
BMJ 2004; 328: 535-536 [Full text]
*Rapid Responses: Submit a response to this article

Rapid Responses published:

[Read Rapid Response] It's just cookbook medicine
David Topps   (8 March 2004)
[Read Rapid Response] Two more Es..
P Owe Petersson   (10 March 2004)
[Read Rapid Response] Deadline Bias
Alastair J Munro, Ninewells Hospital and Medical School, Dundee DD1 9SY   (17 March 2004)
[Read Rapid Response] Incidence-based Medicine
Devinder S Chauhan   (23 March 2004)
[Read Rapid Response] EBM - bridging the gap to the user
Graham Ellis, Lynn Legg, Peter Langhorne   (25 March 2004)
[Read Rapid Response] E stands for Eqivocal in EBM
Matthew R Kiln   (29 March 2004)
[Read Rapid Response] Re: E stands for Eqivocal in EBM
Adam Jacobs   (31 March 2004)
[Read Rapid Response] Evidence!
Malvinder S. Parmar   (17 May 2004)
[Read Rapid Response] 30 - year old evidence
S Anuradha, S Suresh   (19 May 2004)
[Read Rapid Response] GPs say evidence-based information is changing practice
David Tovey, Fiona Godlee   (20 October 2004)

It's just cookbook medicine 8 March 2004
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David Topps,
Assistant Professor
Family Medicine, University of Calgary

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Re: It's just cookbook medicine

The commonest rebuttal that I hear from my colleagues in practice, especially those less connected with academic practice, is that they resent the way that EBM places implied strictures on practice, limiting their "art of medicine", and is rarely relevant to their actual patients. "I have no intention of practising cookbook medicine" seems to be the oft heard cry.

And yet, when we look at the frightening numbers seen when considering medical error rates and the huge amount of death and destruction attributable to medical practice, it is hard to reconcile this view. Our patients worry about safety in the flying industry but are so far blithely unaware of the very real dangers involved in medical transactions. This will change, and if so, will we be forced to adopt the very rigid safety structures of the flying industry, with all its checklists and redundancy?

Perhaps this is taking an unnecessarily bleak standpoint, but if we don't get our own house in order, we will all be the worse for having this done for us and to us. I look forward to this October issue and the debates that may ensue.

Competing interests: None declared

Two more Es.. 10 March 2004
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P Owe Petersson,
MD PhD Prof (ajd)em
Sankt Mikaelsgatqan 2 b S-45140 Uddevalla Sweden

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Re: Two more Es..

It seems as it is in the air with some reflections on the EBM theme! Some of us with clinical and research roots from the late half of last century are still involved in lifelong learning and, more specific so , in various teaching processes! As for myself it means courses for GPs – not that much, for obvious reasons, in modern medicine but, for likewise obvious reasons, in the art of medicine!

Concerning medical treatment it seems not to be much problem in accepting the role of evidenced based medicine. Younger as well as older GPs are well “on line” with recent development - in principle!

However- when it comes to medical practise the picture may be somewhat different! Not the least in to days general practice when some times patients with subjective signs of illness, quite often lifestyle related and psychosocial in type, are becoming more frequent in numbers than those with objective signs of disease! Not that easy to be an GP there - in spite of all evidenced based medicine which usually does not include that much of evidence concerning “softer” modern lifestyle related problems!

In certain situations confidence in medicine may have to compensate for the lack of evidence. Such confidence that has to be developed between the patient and the GP, as prerequisite for further treatment , is likely to be inspired by the GPs earlier experience and likewise influenced by some ethical considerations: his logical, evidence based professional ego would perhaps tell and guide him no to offer much support as it would have no evidence based effect but again his experiences from years of clinical praxis would lead him to bypass the knowledge of evidence and offer help he feels could help! In accordance to the more traditional ethical code most doctors always have tried to adhere to !

One is here almost coming close to a somewhat “alternative attitude”- indeed sometimes in a rather “alternative “ clinical situation as well - from purely evidence point of view! In that respect there are perhaps to more E to consider E as in Experience and E as in Ethics!

Competing interests: None declared

Deadline Bias 17 March 2004
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Alastair J Munro,
Professor of Radiation Oncology
Department of Surgery and Molecular Oncology,
Ninewells Hospital and Medical School, Dundee DD1 9SY

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Re: Deadline Bias

I am frustrated by this editorial. As an academic clinician, who spends at least 5 days each week directly involved in the care of patients with cancer, I may have acquired some insights into the issues raised by Professor Straus. However, precisely because the care of patients is my primary concern, it is unlikely that I will be able to contribute to the debate. Where might I, and others like me, find the time within the next six weeks to write an article and navigate it through the maze that is the BMJ’s process for online submission? The imposition of this tight deadline will bias the contributions in your special issue against those from active clinicians and in favour of submissions from those with less direct responsibility for the care of patients. I realise that this is a testable (and perhaps unjustified) assumption. With this in mind, it will be interesting to study the authorship of the papers that do eventually appear in the special issue

Competing interests: Editor, Cochrane Colorectal Cancer Group

Incidence-based Medicine 23 March 2004
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Devinder S Chauhan,
Vitreoretinal Fellow
Moorfields Eye Hospital London EC1V 2PD

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Re: Incidence-based Medicine

Dear Editor,

Following a recent journal club, at which we discussed Smith and Pell's article on the lack of evidence for the assumed beneficial effects of parachutes (1), and Prof. Strauss's call for opinion (3), I should like to offer an alternative overview of levels of evidence.

There seem to be three fundamental types of medicine practised: evidence-based medicine, eminence-based medicine (3) and incidence-based medicine. A discussion of the first is best left to the forum proposed by Prof. Strauss and involves an attempt at empirical guidance of one's practice. The second is often quoted with a preamble such as "John Smith always used to 'because he thought that'". This depends, ideally, on an eminent teacher having collated evidence of all types with his or her (usually long) personal experience and understanding or intuition. Such paradigms may either be passed down on tablets of stone or as seeds for discussion or further study.

Incidence-based medicine is that which is predicated on infrequent incidents, usually negative with n less than or equal to 2. Most doctors, particularly surgeons, when asked why they do something in a particular way will launch into the relevant case history accompanied by either nervous laughter or resurrected horror.

Whilst it may seem logical that the evidence types should be in reducing order of importance, as listed above, when it comes to guiding one's clinical practice, it is apparent that the single disaster may have the greatest effect. This may even be more influential than the teachings of one's mentor and certainly the results of a prospective controlled randomised clinical trial with several hundred patients in each arm of the study. Of course, I have no evidence for this, but everyone I've asked seems to agree.

Devinder Chauhan MD FRCOphth

(1) Smith GCS, Pell JP. BMJ 2003; 327: 1459-1461

(2) Strauss SE. BMJ 2004;328:535-536

(3) Stahl SM. Acta Psychiatr Scand. 2002 Nov;106(5):321-2.

Competing interests: None declared

EBM - bridging the gap to the user 25 March 2004
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Graham Ellis,
Clinical Research Fellow
Stroke Therapy Evaluation Programme, Glasgow Royal Infirmary, Castle Street, Glasgow G4 0SF,
Lynn Legg, Peter Langhorne

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Re: EBM - bridging the gap to the user

Editor – Evidence-based medicine frequently encounters barriers to its translation into evidence-based practice1. These stand both at an individual level and at an organisational or national level. The failure of individual clinicians to practice evidence-based medicine is well described and may centre around the accessibility of the evidence, relevance of the information retrieved, accuracy of available information and difficulties with understanding or interpreting the evidence2. Adult learning theory suggests that adults learn best experientially; that is in context, with clear or explicit information delivered timeously in a problem-oriented approach3. Information technology coupled with an increasing body of available evidence can help to bridge some of these gaps4. For many clinicians, pre-appraised evidence provides a useful and accessible resource where time and appraisal skills may be lacking2,4. The challenge for continuing medical education and the delivery of high standards of medical care will be using modern media to reflect best available evidence with accuracy, understandability and applicability5.

The Stroke Therapy Evaluation Programme (STEP) is developing an initiative to develop and regulate a website of best current evidence for stroke care. It is organised in a problem-oriented structure with accurate pre- appraised evidence available to the end user. This process needs to be transparent, unbiased and of high quality. Additionally we are aware that users including patients may vary in their terminology and approach to evidence, and an adequate ontology of end users will be a valuable part of the development process. The website is expected to “go live” in October 2004 and feedback would be welcome. (www.effectivestrokecare.org)

PS. The Stroke Therapy Evaluation Programme has developed over several years with supported from Chest Heart and Stroke Scotland, The Healthcare Foundation, the Jeffrey Trust and the New Opportunities Fund

Graham Ellis, Clinical Research Fellow

Lynn Legg, Co-ordinator

Peter Langhorne Professor of Stroke Care

Stroke Therapy Evaluation Programme, Glasgow Royal Infirmary, Castle Street, Glasgow G4 0SF

1 Straus SE What’s the E for EBM? BMJ 2004;328:535-6

2 Young JM, Ward JE Evidence-based medicine in general practice: beliefs and barriers among Australian GPs

3 Knowles M. The Adult Learner: A Neglected Species (3rd Ed). Houston, TX: Gulf Publishing

4 Guyatt GH, Meade MO, Jaeschke RZ, Cook DJ, Haynes RB. Practitioners of evidence based care. BMJ 2000;320:954-5

5 Kunst H, Groot D, Latthe PM, Latthe M, Khan KS. Accuracy of information on apparently credible websites: survey of five common health topics. BMJ 2002;324:581-.2

Competing interests: Graham Ellis and Lynn Legg are employed by the Stroke Therapy Evaluation Project

E stands for Eqivocal in EBM 29 March 2004
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Matthew R Kiln,
Principal in General Practice
Rosendale Surgery, 103a Rosendale Road, London, SE21 8EZ

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Re: E stands for Eqivocal in EBM

I know this request was for submissions for a theme issue to be published in October in the BMJ (1),but because the evidence used in EBM is sometimes fundamentally flawed I felt I should write a letter as well.

The E in EBM stands for 'Equivocal', because that's the best value that can ever be given to the majority of published, controlled, double blind research studies (no matter what medical journal it is in). The reasons for why the 'evidence' for EBM is inherently unreliable are as follows;

a). The large volume of research funded by drug companies that is not allowed by them, to be submitted for publication (2.3).

b). Totally unsuitable patients are sometimes into sensitive drug trials,(personal observation from legal work that I do)one only needs a few such patients to invalidate the conclusions of studies. There is no way when doing peer reviewing, or reading the paper after publication that this can be detected. I have only noticed this from reading the paper, carefully going through the patients notes and talking to the patient at length. I have seen this in diabetes research, but it could be commom in areas of medical research, because no one usually has the time,the position, and the information to check for such practices.

c). Ghost-writing,(34)we will never know how many research papers this happens in but it is likely to be quite a few. As well as this the choosen 'well known' professors or doctors that put their names on research papers have never even seen the raw data, let alone know how accurately it has been the written up !

d). Effect of Bias. Whether it is intentionally or unintentionally introduced by researchers, doctors, stitisticians, ghost-writers the effect is difficult to quantify. Declared and undeclared interest id sone element (5). However, there are so many other ways that bias occurs, that to publish a double blind research paper without bias seems virtually impossible.

EBM has a small role in practcing medicine, and it is important to remember how eqvivocal the E can be.

Yours faithfully
Dr Matthew Kiln.

Ref:1. Straus S. What's the E for EBM?. BMJ 2004;328:535-36.

2.Kiln M. Industry-Sponsored Research. Lancet 2001;357:1209-10

3.Moynihan R.Who pays for the pizza? Re defining the relationships between doctors and drug companies. BMJ 2003;326:1189-92.

4. Reeves S. Who actually wrote the research paper?How to find out.(rapid response to : Smith R.medical Journals and pharmaceutical companies: uneasy bed fellows. BMJ 2003; 326:1202-25.

5. Barnes DF, Bero LA. Why review articles on health effects on smoking reach different conclusions. JAMA 1998;279:1566-70.

Competing interests: I am Co-Chairman of a patient support charity

Re: E stands for Eqivocal in EBM 31 March 2004
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Adam Jacobs,
Director
Dianthus Medical Limited, London SW19 3TZ

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Re: Re: E stands for Eqivocal in EBM

Matthew Kiln cites ghostwriting as one of the reasons why medical evidence is inherently unreliable. This statement is itself not very evidence-based.

Is there any evidence to show that ghostwriting makes a paper any more unreliable than a paper written by its named authors? Not to my knowledge. In fact, a systematic review published last year found that remarkably little research has been done on this subject [1]. However, as a professional medical writer, I resent the suggestion that the papers I write are unreliable. I take great care to ensure that the papers I write are scientifically valid, as I am sure do the overwhelming majority of professional medical writers.

There is no reason why the named authors of ghostwritten papers should not know how accurately their research has been written up, as Kiln suggests. Discussions between the named author and the ghostwriter are integral part of the ghostwriting process. As for seeing the raw data, it is true that authors often do not see it, but what would they do with it anyway? Raw data by itself is not usually very helpful: it is only after a statistician has processed it into meaningful tables and graphs that it becomes useful. I would always expect the named author of any paper that I ghostwrite to have access to the statistical output.

Kiln is absolutely correct, however, to point out that we do not know how many research papers are ghostwritten. Further research on this and on the quality of ghostwritten papers is urgently needed. I hope that the recently-established Ghostwriting Task Force of the European Medical Writers Association will be able to make some progress in this area in due course. Anyone with ideas about how such research could best be done is welcome to contact me by email.

References:

1. Lagnado M. Professional writing assistance: effects on biomedical publishing. Learned Publishing 2003;1:21–27

Competing interests: I make a substantial portion of my living from ghostwriting. I am also vice-president of the European Medical Writers Association and head of its Ghostwriting Task Force.

Evidence! 17 May 2004
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Malvinder S. Parmar,
Medical Director, Internal Medicine
Timmins & District Hospital, Timmins, Ontario, Canada

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Re: Evidence!

Effectiveness of agents (caustion, diagnostic or therapeutic)

Validated

Independently,

Decorously

Evaluated,

Neutral [without any bias or influence] and

Confirmed

Elegantly

Competing interests: None declared

30 - year old evidence 19 May 2004
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S Anuradha,
Staff Grade
Department of Ophthalmology, Royal Gwent Hospital, Newport NP20 2UB,
S Suresh

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Re: 30 - year old evidence

Systematic reviews of evidence summarise scientific evidence addressing questions of treatment, causation, diagnosis and prognosis. They help health professionals to keep abreast of their speciality of interest as well as remain literate in the broader aspects of medicine. Researchers use them to identify and refine their hypotheses leading to better primary research. Health policy makers formulate guidelines and legislation based on the conclusions of the reviews. They also provide high quality information to patients as the evidence in them is not just added but multiplied.

A landmark example is the review of trials that compared intravenous streptokinase with a placebo or no therapy in patients with acute myocardial infarction from 1959 -1988. Though the effect of treatment was favourable on mortality in 25 of the 33 trials, it was statistically significant only in six studies. The overall pooled effect favoured the treatment significantly. When the same data were used to perform a new or cumulative meta-analysis each time the results of a new trial were reported, statistical significance was attained for a positive effect in 1973 for a two-sided P value of < 0.01.1,2 The evidence for the beneficial effect of intravenous streptokinase on mortality was available 20 years before it was put into regular use.

Evidence based medicine has provided an easily accessible, vital tool in the form of systematic review. It is a simple, transparent approach that gives credibility to studies where due and assimilates good evidence along the way. ‘Where is the wisdom we have lost in knowledge? Where is the knowledge we have lost in information?’ asked T S Eliot. The Cochrane Database of Systematic Reviews has created an oasis for knowledge in the age of information. It is up to us to get the wisdom from it.

1 Lau J, Antman EM, Jiminez-Silva J, Kupelnick B, Mosteller F, Chalmers TC. Cumulative meta-analysis of therapeutic trials for myocardial infarction. N Engl J Med 1992;327:248-54.

2 Mulrow CD. Rationale for systematic reviews. BMJ 1994;309:597-99

Competing interests: None declared

GPs say evidence-based information is changing practice 20 October 2004
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David Tovey,
Deputy Editor, Clinical Evidence
BMJ Publishing Group, London, WC1H 9JR,
Fiona Godlee

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Re: GPs say evidence-based information is changing practice

As the publishers of the BMJ’s Clinical Evidence we have more than a passing interest in the extent to which the provision of evidenced-based information changes clinical practice. In this context, the results of an evaluation of Clinical Evidence assumed some importance, and were awaited with some nervousness.

5960 GPs in England were contacted by Stingray Research, an independent market research company, and asked to provide some broad perceptions about the role of evidence in their day to day practice and to pass judgement on Clinical Evidence. The response rate was 838/5960 (14.1%).

Some findings were not surprising. 75% of GP respondents reported that their patients were likely to demonstrate interest in the latest research findings. 97% of the GPs had used an information resource to find the latest evidence and 45% expected to do so at least once every fortnight. Subject matter ranged across the broad spectrum of disease. Clinical Evidence was mainly used around clinical consultations – before, during and after. However, other uses, such as education and teaching, and assisting the development of practice guidelines, were also reported by 77% and 52% of respondents respectively.

The most crucial findings related to the proportion of doctors, 75%, who reported that they had changed their practice as a result of using Clinical Evidence. Two thirds of these had done so in the previous 6 months. Change of practice in response to Clinical Evidence was most likely in younger doctors, but was also reported by 56% of respondents aged over 55.

Quotes from respondents underlined the message; that provision of evidence from an independent, trusted source supported them in developing their practice and improved the quality of their consultations.

There are limitations to this evaluation. We don’t know what the non- respondents thought for example. However, the evidence does seem to imply that there is a substantial body of clinicians of all ages – in this case English GPs, but we know that similar results have been found amongst Italian (1) and US doctors – who are motivated to use evidence based sources to improve their care for patients.

1. Clinical Evidence: a useful tool for promoting evidence-based practice? Giulio Formoso, Lorenzo Moja, Francesco Nonino, Pietro Dri, Antonio Addis, Nello Martini, Alessandro Liberati

Competing interests: Both authors are Clinical Evidence authors