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All rapid responses

Rapid responses are electronic letters to the editor. They enable our users to debate issues raised in articles published on thebmj.com. Although a selection of rapid responses will be included online and in print as readers' letters, their first appearance online means that they are published articles. If you need the url (web address) of an individual response, perhaps for citation purposes, simply click on the response headline and copy the url from the browser window. Letters are indexed in PubMed.

Re: Clinical governance and the drive for quality improvement in the new NHS in England Gabriel Scally, Liam J Donaldson. 317:doi 10.1136/bmj.317.7150.61

Clinical governance is an important first step and certainly a natural next step from heightened concern over clinical efficacy and reduction of practice variance.

I remain concerned that we are not fully addressing the organisational dimension of clinical, aka medical, practice. The structure of medical specialist practice in hospitals continues to advantage the doctors and not the patients.

This means that junior doctors continue to revolve through a system which fragments their clinical learning, and may actually hamper their ability to adopt current practice. After all, the younger, new doctors are more likely to be the most up to date on current practices, but are at the whim of individual consultants when it comes to rewards for their learning. Where, after all, are the bad habits learned?

I am still convinced that we should investigate further the US/Canada system of hospital privileges (approved areas of clinical practice) for hospital-based consultants, with appropriate reviews of clinical practice, including the clinical supervision of specialists in the first year of appointment at a hospital, regardless of how many years they have been practising. This general approach has the additional advantage of ensuring that post-graduate education is the reponsibility of the clinical service area more generally, not individual consultants.

More widely, responsibility for clinical and service quality is opened up to scrutiny at the board level, with wider managerial responsibility to manage the distribution of the patient case load. (There are areas which have adopted this pooled approach and been very successful in reducing waiting; its a pity though, that waiting is seen as the important quality variable....)

Important steps have been take through clinical governance, and as we all know, what gets measured gets done. However, clinical governance as an idea to reduce variance and enhance better/best practice will still require more than measured good intentions. I for one am still waiting for the "governance" to be developed further.

Competing interests: No competing interests

06 July 1998
Mike Tremblay
health policy consultant
anywhere
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Re: Getting evidence into practice Fiona Godlee. 317:doi 10.1136/bmj.317.7150.6

Great article! This is such an important area of medicine that has been too long overlooked. It is important to help physicians use evidence as the basis of their clinical decisions and to help insurers (US) base their decisions on evidence rather than "standard of care" which may be based on no evidence. Thank you for your excellent coverage of this topic. In teaching residents, these advances will be invaluable.

Competing interests: No competing interests

06 July 1998
Delia Pratt
Ass Clin Prof -- FP
Sutter Med Ctr
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Re: Qualitative study of patients' perceptions of doctors' advice to quit smoking: implications for opportunistic health promotion Christopher C Butler, Roisin Pill, Nigel C H Stott. 316:doi 10.1136/bmj.316.7148.1878

Sir
The paper by Butler et al1 challenges current practice regarding unsolicited antismoking advice from GPs. It potentially provides a basis for the development of patient centred approaches. Before this can be done the suggested typologies need to be reliably reproducible in a practical setting. Observers independent of the study have not as yet attempted to place the study’s subjects into the specified categories. To do so would reduce concerns that classification could vary between practitioners. We also need to demonstrate that this typology can be reliably applied to the wider population, including people from social class V and the unemployed (who were not included in the study).

The idea of typologies raises the important issue that the same intervention may not be suitable for all patients. Current practice relies on the insight of GPs to give acceptable antismoking advice. Typologies would provide GPs with guidance, enabling them to tailor advice to individual patients more effectively, making the advice more acceptable. However the authors’ assumption that that this advice would therefore be more effective in terms of smoking cessation is an hypothesis that requires further investigation. It has been estimated that GP advice to stop smoking costs £270 per QALY2. The use of this more complex, new intervention would increase the associated cost. Thus we need to be sure that the intervention will be of sufficient benefit to maintain cost-effectiveness.

This study does not address the effectiveness of opportunistic antismoking advice but it does provide important information about the acceptability of this intervention to different patients. If the effectiveness of more acceptable antismoking advice is proven in the future this will be of mutual benefit to patients and doctors.

Malcolm Lawson Third year medical student
Linda Waddilove Third year medical student
Jacqui Mascall Third year medical student
Department of Epidemiology and public Health, Medical School, University of Newcastle upon Tyne, Newcastle upon Tyne, NE2 4HH.

1. Butler CC, Pill R, Stott NCH. Qualitative study of patients’ perceptions of doctors’ advice to quit smoking: implications for opportunistic health promotion. BMJ 1998; 316:1878-81 (20 June)
2. Maynard A. Developing the Health Care Market. The Economic Journal 1991; 101:1277-86 (September)

Competing interests: No competing interests

06 July 1998
Malcolm Lawson
Third Year Medical Students
Linda Waddilove, Jacqui Mascall
Dept. of Epidemiology and Public Health Medicine, University of Newcastle
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Re: Government row flares up over vitamin B-6 John Warden. 317:doi 10.1136/bmj.317.7150.12

I feel that if many studies were critically reviewed before being placed into legislation or regulations there would be far less of these restrictions on the books. Do we really need government to be such a close watch dog on our everyday lives??

Competing interests: No competing interests

06 July 1998
Michael R Rano
private practice
binghamton, ny usa
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Re: Interpreting treatment effects in randomised trials Roger S Goldstein, et al. 316:doi 10.1136/bmj.316.7132.690

Editor – The proposal for analysing randomised trials by Guyatt et al1 is misguided, flies in the face of elementary statistical theory and is to be resisted. There are three obvious sources of variability in clinical trials. First, we have pure differences between patients: some are more seriously ill than others. Second, we have variability within patients: even given the same treatment regime they, or their measurements, may vary from period to period. Third, we have treatment by patient interaction: some patients may react more favourably to a given treatment than will other patients. The parallel group trial does not and cannot distinguish between the three types of variability unless we can find meaningful ways of classifying sub-groups2,3. The standard cross-over trial will distinguish between the first type of variability and the other two but not easily between the second and third4 and certainly not in the form of analysis suggested by Guyatt et al.

Guyatt et al have implicitly assumed in this paper1 that whether a patient is better treated on one treatment than another can be determined by comparing one period of treatment on each. This is at complete variance to advice that Guyatt and co-authors have give elsewhere5. There they have suggested, that if efficacy for individual patients is to be established, they should be randomised to repeated periods of treatment and control: the so-called 'n-of-1’ methodology.

Nothing from the two clinical trials as presented by Guyatt et al is inconsistent with the theory that all patients benefitted equally. If we wish to establish what proportion of patients benefit from treatments, rather than merely being satisfied with average effects, then we need random effect models and sequences of n-of-1 trials3,6. Since the methodology which they propose does not correctly partition the sources of random variability, it will simply produce random results.

1Guyatt GH, Juniper EF, Walter SD, Griffith LE, Goldstein RS. Interpreting treatment effects in randomised trials. BMJ 1998; 316:690-3
2Senn SJ. Letter to the editor: testing for individual and population equivalence based on the proportion of similar responses, Stat Med 1997; 15: 1303-5.
3 Senn SJ. Statistical Issues in Drug Development. Chichester: Wiley, 1997.
4 Senn SJ. Cross-over Trials in Clinical Research. Chichester: Wiley, 1993.
5Guyatt GH, Heyting A, Jaeschke R, Keller J, Adachi JD, Roberts RS. N of 1 randomized trials for investigating new drugs. Controlled Clin Trials 1990; 11:88-100.
6 Senn SJ. Suspended judgment: n-of-1 trials. Controlled Clin Trials, 1993; 14:1-5.

Stephen Senn Professor of pharmaceutical and health statistics
Department of Epidemiology and Public Health, Department of Statistical Science,
University College London, London WC1E 6BT
stephens@public-health.ucl.ac.uk

Competing interests: No competing interests

06 July 1998
Stephen Senn
Professor of Pharmaceutical and Health Statistics
University College London
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Re: Infant mortality falls among Israeli Muslims Judy Siegel-Itzkovich. 315:doi 10.1136/bmj.315.7100.75f

Could the decrease in Infant mortality seen in the Israeli Muslims be due to any broad change in behavior.....say 1) increased exclusive breastfeeding over bottle feeding?
2) increased caesarian birth rates?
3) decreased milk substitutes?
4) decreased cultural sucking utensils?
5) change in custom of administering uvulectomy?

Competing interests: No competing interests

06 July 1998
David C Page
Independent
Private Practice
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Re: Prescribing patient information leaflets may be better than prescribing drugs T Kenny, R Wilson, I N Purves. 317:doi 10.1136/bmj.317.7150.80b

This article agrees with my observations. Adult onset diabetics are often very resistant to diet, exercise and stress-reduction counsel. Many simply want a pill and a quick discharge from care.
By preparing PIL's which are appropriately personalized, complete with physician's and counsellor's signatures, we have achieved better compliance and healthier pts. It is almost always helpful to furnish the PIL for the "requested" drug [some pts. even specify dosages!] and highlight the indications and esp. the adverse effects. We have reduced some pts. from multiple meds with no exercise or dietary restraint to no meds and planned exercise with mild dietary restraint. The hard core pts. with long-term problems are helped the least, but most receive some benefit if we see them before neuropathy and gangrene set in.

Competing interests: No competing interests

03 July 1998
James L Keyes
Diabetic Nutritional Counsellor
Marion County, Arkansas, USA
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Re: Electromagnetic fields may be carcinogenic Terri Rutter. 317:doi 10.1136/bmj.317.7150.12a

I only had this comment because my mother, Edwina Moody, had breast cancer which spread through out her body. I asked her how many other women in her office had breast cancer. Most of the women in her office that she started working with in 1960...has either died with cancer...or has it now...or it is in remission...but they all had breast cancer.

This was in a small town, where there was very little turn over in personnel. These ladies all worked together for some 20 years. The generator used to be outside of the building where they worked...then as the company expanded, they moved the electric plant away from the building where they worked.

I mention this since you would not want to place people in this environment to study them...but there are places where the information can be gathered, where people were placed in these positions out of ignorance of the harm that could be caused.

Thank you for listening. Lynda Gayle Roberts

Competing interests: No competing interests

03 July 1998
Lynda Gayle Roberts
None
None
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Re: Depression as a risk factor for ischaemic heart disease in men: population based case-control study Julia Hippisley-Cox, Katherine Fielding, Mike Pringle. 316:doi 10.1136/bmj.316.7146.1714

Sir,
Hippisley-Cox et al. conducted a case control study suggesting that depression is linked to ischaemic heart disease (IHD). It is obviously important to consider whether this link actually exists. We do, however, question the validity of the result of this study. Our two main concerns are: firstly, considering all important confounding variables, and, secondly, the relative timing of the two diagnoses.
There is some evidence that obesity is linked to both depression and IHD, and thus omitting BMI from the multivariate analysis may confound the results. Obviously, collection of data on BMI has been a limitation of a case control study. Another problem with the design has been the exact timing of diagnosis of IHD and depression, where the diagnosis of IHD and depression was assumed to precede that of depression if both occurred in the same year.
Therefore, we suggest that a prospective study following patients with depression will be a more appropriate study design. This will enable all relevant data to be collected, accounting for differences in BMI and other factors such as exercise, family history and serum lipids. This will also ensure that for each case the diagnosis of depression precedes that of IHD.

Bisher Kawar, Richard Latham and Alison Macrae
Department of Epidemiology and Public Health, University of Newcastle.
Tel. 0191 222 8754
Fax. 0191 222 8211

References
1. Comings DE. Gade R. MacMurray JP. Muhleman D. Peters WR. Genetic variants of the human obesity (OB) gene: association with body mass index in young women, psychiatric symptoms, and interaction with the dopamine D2 receptor (DRD2) gene. Molecular Psychiatry. 1(4):325-35, 1996 Sep.
2. Solomon CG. Manson JE. Obesity and mortality: a review of the epidemiologic data. American Journal of Clinical Nutrition. 66(4 Suppl):1044S-1050S, 1997 Oct.
3. Wurtman JJ. Depression and weight gain: the serotonin connection. Journal of Affective Disorders. 29(2-3):183-92, 1993 Oct-Nov.

Competing interests: No competing interests

03 July 1998
Bisher Kawar
3rd year medical students
Richard Latham, Alison Macrae
Department of Public Health and Epidemipology, The Medical School, University of Newcastle
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Re: Effect of educational leaflets and questions on knowledge of contraception in women taking the combined contraceptive pill: randomised controlled trial Carolyn Sadler, et al. 316:doi 10.1136/bmj.316.7149.1948

Dear Sir

Little et al (1) conclude that provision of information to women on the combined oral contraceptive pill enhances their knowledge.

This lends valuable support to current opinion and encourages practice which aims to inform Pill-users.

Whilst they draw a valid conclusion from their research, it is already widely accepted that providing information makes people better informed. What their study fails to consider is whether having this knowledge actually affects women's Pill-using behaviour:
Does better Pill knowledge reduce unwanted pregnancies?
As of July 1st 1998, a Medline search failed to show any studies dealing with this issue. We believe that future research could usefully investigate this area.

Yours faithfully

Sarah Brown
Heather Forsyth
Ruth Sutton
Zoe Wright

3rd year Medical Students
Medical School
University of Newcastle, Newcastle-upon-Tyne

Competing interests: No competing interests

03 July 1998
Sarah Brown
3rd year Medical Student
Marion Hancock
Dept of Epidemiology and Public Health
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