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What is the legal recourse open to doctors who do not accept that the guidelines are. 'systematically developed, evidence-based or clinically workable'? Finally ...
LETTERS TO THE EDITOR

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Preference is given to letters commenting on contributions published recently in the JRSM. They should not exceed 300 words and should be typed double spaced

Legal considerations of clinical guidelines

Dr Ash Samanta and his colleagues (March 2003 JRSM 1) have produced a clear and valuable account of the place of clinical guidelines in the conduct of clinical negligence cases. Inevitably their message is principally directed at lawyers, including judges who have the conduct of cases. Two matters arising from their article give me concern— namely, prevention of medical errors which lead to litigation, and the provision of the National Institute of Clinical Excellence (NICE) recommendations to clinicians. There needs to be much greater emphasis on prevention rather than investigating possible changes that would reduce costs. I think clinical guidelines and NICE reports have a very important part to play in reducing the number of claims. I think also they will lead to more successful outcomes for deserving claimants. Nothing will change unless clinicians receive the NICE reports and guidelines. I suggest it is for the specialty associations to send this material regularly to all trainees and consultants. It would be sensible also to provide medical students with this information during their clinical training. It would I am sure have a long-term beneficial effect. N H Harris 72 Harley Street, London W1G 7HG, UK

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1 Samanta A, Samanta J, Gunn M. Legal considerations of clinical guidelines: will NICE make a difference? J R Soc Med 2003;96:133–8

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In their otherwise excellent review Dr Samanta and his colleagues (March 2003 JRSM1) assert that ‘clinical guidelines are systematically developed, evidence-based, clinically workable statements that aim to provide consistent and high quality care for patients’, and that because ‘guidelines from NICE . . . may be seen as the cre`me de la cre`me of authoritative bodies’ it follows that their pronouncements are increasingly likely to inform the standard of care in negligence’. This is a dangerously illogical assumption to make: for all the diversity of lay and medical expertise available to NICE, the content of their guidelines is becoming increasingly proscriptive, and, in some cases, advocates a radical departure from pragmatic medical practice. The recent furore over the use of ultrasound locating devices for placing central venous catheters is a case in point.2–4 There are any number of criticisms that could be made of this document and its practical implementation,5 but with regard to the quasi-

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legal nature of the guidelines, several important questions arise. Who owes the duty of informing doctors of new guidelines? Who is responsible for their execution—the hospital, the doctor, or both? Who is responsible for failing to follow the guidelines—the doctor, the hospital (either primarily, or vicariously), or both? Does obtaining specific consent from the patient vitiate the pseudo-legal requirement to follow the guideline? What is the legal recourse open to doctors who do not accept that the guidelines are ‘systematically developed, evidence-based or clinically workable’? Finally, should the courts be asked in every case to determine whether the guidelines are reasonable and rational before relying on them as the standard of acceptable medical practice? NICE and CHAI are valuable agencies for improving the quality of care in the NHS, but their authority depends on the soundness of their decrees. It is ultimately for the courts to decide, case by case, whether such decrees should inform the standard of care in negligence. Guidelines should continue to inform, rather than prescribe, medical practice. S M White Department of Anaesthesia, St Thomas’ Hospital, London SE1 7EH, UK E-mail: [email protected]

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1 Samanta A, Samanta J, Gunn M. Legal considerations of clinical guidelines: will NICE make a difference? J R Soc Med 2003;96:133–8 2 National Institute for Clinical Excellence. Guidance on the use of ultrasound locating devices for placing central venous catheters. In: Technology Appraisal Guidance—No. 49. [http://www.nice.org.uk/pdf/ Ultrasound_49_GUIDANCE.pdf] 3 Muhm M. Ultrasound guided central venous access. BMJ 2002;325: 1373–4 4 Chalmers N. NICE has taken sledgehammer to crack nut. BMJ 2003; 326:712 5 White SM. Not NICE advice. Anaesthesia 2003;58:295–6

Autonomy of the pregnant woman

Dr Beveridge and colleagues (February 2003 JRSM1) describe a patient whose behaviour put her unborn child at risk but who could not be detained under the Mental Health Act. It was cases of this sort that in the 1990s led to a spate of court-authorized caesarean sections which drew criticism from the lay, legal and medical press.2 Guidelines laid down following the cases of Re MB3 and Re S4 have been adopted by the Department of Health and it is now quite clear that the pregnant woman if competent can decide what treatment to accept or refuse. Her reasons may be rational or irrational, and she may offer no reasons whatever—more so since the fetus is not a legal entity in English law. Beveridge et al. rightly obeyed the law as it stands, but there is no gainsaying that the unborn children of such vulnerable adults are at excess risk of an adverse outcome,

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including death, when they choose to distance themselves from healthcare. In South Tyneside we take the care of these individuals to their homes as much as possible and build up a relationship through a named midwife liaising with an obstetrician. The hope is that, by term, sufficient trust and rapport will have been established to achieve a supervised delivery. This is not always successful but is worth a try. Umo I Esen Department of Obstetrics and Gynaecology, South Tyneside District Hospital,

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REFERENCES

1 Montague M, Musheer Hussain SS, Blair RL. Three cases of atypical mycobacterial cervical adenitis. J R Soc Med 2003;96:129–31 2 Ghebremichael S, Svenson SB, Kallenius G, Hoffner SE. Antimycobacterial synergism of clarithromycin and rifabutin. Scand J Infect Dis 1996;28:387–90 3 Correa AG, Starke JR. Nontuberculous mycobacterial disease in children. Semin Respir Infect 1996;11:262–71 4 Piersimoni C, Nista D, Bornigia S, De Sio G. Evaluation of a new method for rapid drug susceptibility testing of Mycobacterium avium complex isolates by using the mycobacteria growth indicator tube. J Clin Microbiol 1998;36:64–7

South Shields, Tyne and Wear NE34 0PL, UK

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Myths and mandrakes

1 Beveridge EAJ, Anath H, Scurlock HG. What protection for the unborn child of a psychologically vulnerable adult? J R Soc Med 2003;96:92–3 2 Esen UI. Are court-authorised caesarean sections still possible? New Law J 2001;151:1324–5 3 Re MB (medical treatment) [1997] FLR 426 4 St George’s Health Care NHS Trust v S; R v Collins, ex parte S [1998] FLR 526

I must take issue with Dr Carter (March 2003 JRSM 1) over his assertion that the book of Genesis makes an association between mandrakes and fertility. First, the Hebrew word rendered mandrake (dudaim) is not necessarily referring to what we would understand as a mandrake. The word is only used in one other place in the Bible (Song of Solomon 7:13), where they are said to give a good smell. Is it not more likely that Leah’s son Reuben (who would only have been four or five years of age after all) brought her a flower in from the field than a root? Secondly, if there is any association, it is a negative one. After giving the mandrakes away, Leah bare two sons and a daughter before Rachel had any children at all. Thirdly, both Rachel and Leah’s children are said to be answers to prayer (Genesis 30:17 and 22).

Atypical mycobacterial infections

Ms Montague and her colleagues (March 2003 JRSM1) are unsure about the value of chemotherapy in atypical mycobacterial cervical adenitis. They refer to encouraging results with the macrolide clarithromycin, but both primary and secondary resistance to this agent are well recognized. There is evidence that combination therapy with rifabutin or rifampicin alongside clarithromycin has a synergistic effect, particularly against Mycobacterium avium-intracellulare complex.2 This not only ensures maximum antimycobacterial activity but also may protect against the development of secondary clarithromycin resistance. Multidrug regimens employing standard antimycobacterials (isoniazid, ethambutol and/or streptomycin) used with the above combination have proven effective in cases of disseminated atypical mycobacterial infections, particularly in patients with AIDS.3 With excision biopsy early diagnosis is feasible with tools such as the polymerase-chain-reaction linked ELISA with mycobacterial DNA probes. The antimicrobial susceptibility of atypical mycobacteria can be assessed rapidly in tissue specimens by use of mycobacteria growth indicator tubes, which also give an indication of minimum inhibitory concentrations.4 These tools for rapid diagnosis, not yet widely available, can be helpful in decisions about postoperative chemotherapy.

John Purkis 2 Crown House, Crown Lane, Wickham Market, Suffolk IP14 3ED, UK E-mail: [email protected]

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1 Carter AJ. Myths and mandrakes. J R Soc Med 2003;96:144–7

I greatly enjoyed Anthony Carter’s paper (March 2003 JRSM1) but feel that he should be aware that at least in the USA mandrake and medicine are still relatively recent bedfellows. While driving through Texas last month I went into a chemist shop in Hondo, near San Antonio, and found

S Venkatesh Karthik Department of Paediatrics, Warrington Hospital, Warrington WA5 1QG

Kalyani V Mulay St James’s University Hospital, Leeds, UK Correspondence to: Dr S V Karthik E-mail: [email protected]

Figure 1 Mandrake in the pharmacy

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a display of old medicine bottles on the shelf. The pharmacist explained it was his hobby and was happy for me to photograph them (Figure 1). I was unable to date the bottle shown but its condition and style did not suggest great age. There was nothing on the label to show the indications for its use. David J Wilkinson Boyle Department of Anaesthesia, St Bartholomew’s Hospital, London EC1A 3RA, UK

REFERENCE

1 Carter AJ. Myths and mandrakes. J R Soc Med 2003;96:144–7

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REFERENCES

1 Strauss R, Marzo-Ortega H. Michelangelo and medicine. J R Soc Med 2002;95:514–15 2 Stark JJ, Nelson JK. The breasts of ‘Night’: Michelangelo as oncologist. N Engl J Med 2000;343:1577–8 3 Espinel CH. The portrait of breast cancer and Raphael’s La Fornaria. Lancet 2002;360:2061–3 4 Wolff J. The Science of Cancerous Disease from Earliest Times to the Present (transl Ayoub B Canton). Science History Publications, 1987:3–45 5 Haagensen CD. Physicians’ role in the detection and diagnosis of breast disease. In: Haagensen CD, ed. Diseases of the Breast, 3rd edn. Philadelphia: W B Saunders, 1986:516–76 6 Meyer-Steineg Th, Sudhoff K. Geschichte der Medizin, 3rd edn. Jena: Fischer Verlag, 1927:49 7 Zimmerman S. Theodor Meyer-Steineg (1873–1936) Medizinhistoriker und Angenarzt in Jena. In: Wu¨rzburger Medizinhistorische Mitteilungen, Vol. 10. Wurzburg: Verlag Dr Johannes Ko¨nigshausen & Dr Thomas Neumann, 1991:90,194

Michelangelo and medicine

Dr Strauss and Dr Marzo-Ortega (October 2002 JRSM 1), discussing the work of Michelangelo (1475–1584) in relation to medicine, refer to a suggestion2 that the left breast in the sculpture Notte has features of locally advanced breast cancer.2 Michelangelo’s contemporary Raphael Sanzio (1483–1520) is thought to be the first to have depicted an advanced stage of breast cancer in the painting La Fornaria.3 Breast cancer has probably been prevalent since antiquity, but the search for historical evidence is difficult for lack of verifiable descriptions or graphic representations of the disease.4,5 In the chapter on pre-Hippocratic medicine in Meyer-Steineg’s Geschichte der Medizin I found an illustration showing a female torso (Figure 1) with contracted cancer in the left breast.6 The torso dates from 2nd to 1st century BC and was found in Izmir, Turkey. A plaster cast of the original terracotta torso is in the collections of the Institute for Medical History at the Friedrich-Schiller University in Jena, Germany.7 Figure 1 Female torso, 2-1 century BC This torso is perhaps not in the same artistic league as the work of Michelangelo, but it may well be the earliest historical evidence of breast cancer. Atti-La Dahlgren Department of Community Medicine, Travel and Migration Unit,

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University of Geneva, 1211 Geneva, Switzerland E-mail: [email protected]

Supporting individuals with disabling multiple sclerosis

Commenting on our paper,1 Dr Ryle (February 2003, JRSM 2) describes his experience of the absence of overall management and of patchy (albeit expert) advice. We have received similar messages in private correspondence. One woman in her seventies with MS had been unable to secure physiotherapy or rehabilitation, and there was a suggestion of a lack of concern for those who may be perceived as ‘too old to help’. Another correspondent felt that general practitioners were unable to give helpful advice on the management of symptoms related to MS. This might reflect limited clinical exposure to such cases, since a typical practice in the UK (about 2000) will have only 2–3 patients with MS on the list.3 He praised the Multiple Sclerosis Society for providing social contacts and for the useful information provided through MS Matters and other publications. The new National Service Framework (NSF) for Longterm Conditions will have a ‘particular focus on needs of people with neurological conditions and brain and spinal injury’ because of the unacceptable variations in the quality of care across the country and the need for urgent improvements. Where possible it will tap into existing NSFs but specific issues relating to this NSF will include: . User-centred interprofessional health and social care assessment and support . Specialist, community and vocational rehabilitation services . Community equipment services . Help with a range of common symptoms including pain and movement disorders . Information and support for carers and families

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. Support and services that help people with long-term conditions fulfil their own responsibilities as partners, parents and carers . Developing the concept of the expert patient.

One of the greatest challenges in rehabilitation service development is to make community-based management proactive and to coordinate contributions from professionals of different disciplines.4 We feel that multidisciplinary rehabilitation teams with appropriate medical support have much to contribute to those with disabling MS, in terms not only of symptom control but also of helping individuals to live with the condition. Close working relationships between community rehabilitation and neurological services could overcome some of the failings noted by Dr Ryle and others. It is hoped that the NSF will support such ventures. J C Gibson A O Frank1 Royal National Orthopaedic Hospital, Brockley Hill, Stanmore HA7 4LP; 1

Northwick Park Hospital, Harrow HA1 3UJ, UK

Correspondence to: Dr J C Gibson E-mail: [email protected]

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1 Gibson J, Frank A. Supporting individuals with disabling multiple sclerosis. J R Soc Med 2002;95:580–6 2 Ryle A. Supporting individuals with disabling multiple sclerosis. J R Soc Med 2003;96:104 3 Barnes MP. Multiple sclerosis. In: Greenwood R, Barnes MP, McMillan TM, Ward CD, eds. Neurological Rehabilitation. Edinburgh: Churchill Livingstone, 1993:485–504 4 Harvey AR. Working in Teams. In: Goodwill CJ, Chamberlain MA, Evans C, eds. Rehabilitation of the Physically Disabled Adult. Cheltenham: Stanley Thornes, 1997:335–51

Doctors’ knowledge about consent and capacity

Dr Jackson and Dr Warner (December 2002 JRSM 1) point to large gaps in doctors’ knowledge of consent and capacity. Two aspects of their project should, however, be questioned. First, the concept of a patient in whom capacity issues may be relevant is problematic. As White has pointed out,2 even if legal and ethical standards support a positive assumption regarding the decision-making competence of the patient, a physician, when seeking approval of a treatment plan, should always make sure that the patient possesses adequate decision-making abilities. Second, whatever the legal position, physicians and other healthcare professionals remain the ones who are responsible for the first-hand evaluation. When a court must decide on a decision-making-capacity issue, the judge depends almost exclusively on the evaluation made by the physician. Research must then look to the process of decision-making

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capacity of the patient as affected by special diseases. Marson et al. did this in Alzheimer’s disease.3–5 Other researchers, myself included, are turning their attention to the ethico-clinical judgment of the physician. Doctors evaluate, almost daily, decision capacity issues. Taking into account the work of Scho¨n, we hypothesize that physicians have expert knowledge of these matters, even if it is unconscious. Issues on ability to consent represent a challenge to every physician on a clinical ward, since all healthcare professionals are engaged in what should be an informed consent procedure with their patients. Ste´phane P Ahern De´ partement de me´ decine, Universite´ de Montre´ al, Porte S-757, C.P. 6128, Sucoursale Centre-Ville, Montre´ al, Que´ bec H3C 3J7, Canada E-mail: [email protected]

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1 Jackson E, Warner J. How much do doctors know about consent and capacity? J R Soc Med 2002;95:601–3 2 White BC. Competence to Consent. Washington: Georgetown University Press, 1994 3 Marson DC, Ingram KK, Cody HA, Harrell LE. Assessing the competency of patients with Alzheimer’s disease under different legal standards: a prototype instrument. Arch Neurol 1995;52:949–54 4 Marson DC, Cody HA, Ingram KK, Harrell LE. Neuropsychological predictors of competency in Alzheimer’s disease using a rational reasons legal standard. Arch Neurol 1995;52:955–9 5 Marson DC, Chatterjee A, Ingram KK, Harrell LE. Toward a neurological model of competency. Cognitive predictors of capacity to consent in Alzheimer’s disease using three different legal standards. Neurology 1996;46:666–72

Lymphocytic hypophysitis

Dr Masding and his colleagues (January, JRSM1) report a case in which visual defects arising in pregnancy were probably due to displacement of a non-secretory pituitary adenoma by the physiologically enlarged pituitary. They do not mention hypophysitis. While adenomas are the commonest pituitary disorder affecting pregnancy, inflammatory disease of the pituitary does need to be considered in any pregnant or postpartum patient with an intrasellar or suprasellar mass.2 Lymphocytic hypophysitis can mimic pituitary adenoma,3 with headache and visual field defects. Infertility, the presenting feature in the case described by Masding et al., can also be due to lymphocytic hypophysitis.4 Such a diagnosis is supported by mononuclear infiltration on histology, and immunohistochemistry, immunocytochemistry and immunoelectronmicroscopy may reveal inflammatory cells (CD20 or CD3) amongst the pituitary cytoarchitecture.5 Why this condition typically presents in pregnancy is uncertain. Lymphocytic hypophysitis may be part of a spectrum of inflammatory pituitary conditions, possibly autoimmune.

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Two types have been observed—lymphocytic adenohypophysitis (typically presenting in the third trimester or at delivery) and lymphocytic infundibulohypophysitis. Treatment options for lymphocytic hypophysitis include steroids and hormonal therapy. Early surgical intervention may not be necessary. Andreas K Demetriades Andrew W McEvoy Michael Powell Department of Neurosurgery, National Hospital for Neurology and Neurosurgery, Queen Square, London, UK Correspondence to: Mr Michael Powell

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1 Masding MG, Lees PD, Gawne-Cain ML, Sandeman DD. Visual field compression by a non-secreting pituitary tumour during pregnancy. J R Soc Med 2003;96:27–8

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2 Stelmach M, O’Day J. Rapid change in visual fields associated with suprasellar lymphocytic hypophysitis. J Clin Neuroophthalmol 1991;11: 19–24 3 Flanagan DE, Ibrahim AE, Ellison DW, Armitage M, Gawne-Cain M, Lees PD. Inflammatory hypophysitis—the spectrum of disease. Acta Neurochir (Wien) 2002;144:47–56 4 McCutcheon IE, Oldfield EH. Lymphocytic adenohypophysitis presenting as infertility. Case report. J Neurosurg 1991;74: 821–6 5 Horvath E, Vidal S, Syro LV, Kovacs K, Smyth HS, Uribe H. Severe lymphocytic adenohypophysitis with selective disappearance of prolactin cells: a histologic, ultrastructural and immunoelectron microscopic study. Acta Neuropathol (Berl) 2001;101:631–7 6 Miyagi K, Shingaki T, Ito K, et al.Lymphocytic infundibulo-hypophysitis with diabetes insipidus as a new clinical entity: a case report and review of the literature. No Shinkei Geka 1997;25:169–75 7 Ikeda H, Okudaira Y. Spontaneous regression of pituitary mass in temporal association with pregnancy. Neuroradiology 1987;29: 488–92

Further to the reproduction of an item from Anthony A Wood’s Fasti of May 19 1649 (JRSM, February 2003, p. 104) by chance I came across a painting by an unknown artist in the Tangye Collection of the Museum of London portraying Charles I after death, and illustrating how the head was stitched back by Dr Trapham [reproduced with permission, Museum of London]. It must be unique for a doctor to be a regicide, to disembowel his dead sovereign and to stitch back his severed head. Ben Cohen

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