Medical ethics and law for doctors of tomorrow: the 1998 Consensus Statement updated.

Knowledge of the ethical and legal basis of medicine is as essential to clinical practice as an understanding of basic medical sciences. In the UK, the General Medical Council (GMC) requires that medical graduates behave according to ethical and legal principles and must know about and comply with the GMC's ethical guidance and standards. We suggest that these standards can only be achieved when the teaching and learning of medical ethics, law and professionalism are fundamental to, and thoroughly integrated both vertically and horizontally throughout, the curricula of all medical schools as a shared obligation of all teachers. The GMC also requires that each medical school provides adequate teaching time and resources to achieve the above. We reiterate that the adequate provision and coordination of teaching and learning of ethics and law requires at least one full-time senior academic in ethics and law with relevant professional and academic expertise. In this paper we set out an updated indicative core content of learning for medical ethics and law in UK medical schools and describe its origins and the consultative process by which it was achieved.

Autonomy in medical ethics after O'Neill.

Following the influential Gifford and Reith lectures by Onora O'Neill, this paper explores further the paradigm of individual autonomy which has been so dominant in bioethics until recently and concurs that it is an aberrant application and that conceptions of individual autonomy cannot provide a sufficient and convincing starting point for ethics within medical practice. We suggest that revision of the operational definition of patient autonomy is required for the twenty first century. We follow O'Neill in recommending a principled version of patient autonomy, which for us involves the provision of sufficient and understandable information and space for patients, who have the capacity to make a settled choice about medical interventions on themselves, to do so responsibly in a manner considerate to others. We test it against the patient-doctor relationship in which each fully respects the autonomy of the other based on an unspoken covenant and bilateral trust between the doctor and patient. Indeed we consider that the dominance of the individual autonomy paradigm harmed that relationship. Although it seems to eliminate any residue of medical paternalism we suggest that it has tended to replace it with an equally (or possibly even more) unacceptable bioethical paternalism. In addition it may, for example, lead some doctors to consider mistakenly that unthinking acquiescence to a requested intervention against their clinical judgement is honouring "patient autonomy" when it is, in fact, abrogation of their duty as doctors.

Ethics and evidence based surgery.

Traditionally, surgical practice has been experiential and based on the contemporary understanding of basic mechanisms of disease. It was both a science and an art and depended to far too great an extent on the individualism and self belief of its main exponents. "Evidence based medicine" (EBM) emerged in the 1980s and a new gospel of "Rules of Evidence" was introduced. There is no doubt that the net effect of EBM has been beneficial, but over reliance on randomised controlled trials and the lack of generalisability of scientific evidence to individual patients has perhaps led to less enthusiasm for its tenets among surgeons. There are valid and spurious reasons for this that are discussed. The situation is improving but inevitable tensions remain between the surgeon committed to the individual patient here and now, and the clinical researcher whose focus is the benefit of future patients in the larger community.

The relationship between Caesarean section and subfertility in a population-based sample of 14 541 pregnancies.

BACKGROUND: There has been a threefold increase in the rate of Caesarean section over the past 25 years. The long-term consequences of Caesarean section may include subsequent subfertility. METHODS: We investigated the relationship between Caesarean section and subfertility within a cohort of 14 541 pregnant women. RESULTS: A history of previous Caesarean section was associated with an increased risk of taking >1 year to conceive from the time of planning a pregnancy, adjusted odds ratio (OR) 1.53 [95% confidence interval (CI) 1.09, 2.14]. This association was stronger for women of parity > or =2, adjusted OR 2.97 (95% CI 1.72, 5.10). Nulliparous women with a history of subfertility were at increased risk of delivery by Caesarean section, adjusted OR 1.56 (1.22, 2.00) and OR 2.33 (1.64, 3.30) for durations of >1 and >3 years respectively. CONCLUSIONS: These findings suggest a complex relationship between Caesarean section and subfertility where subfertility may both precede and be a consequence of Caesarean section.

Mortality and morbidity associated with early-onset preeclampsia.

OBJECTIVE: To examine the management of early-onset preeclampsia and its maternal and fetal morbidity and mortality. DESIGN: Retrospective cohort study of 49,812 births at a university teaching hospital between June 1986 and March 1997. Seventy-one women were identified with a diagnosis of preeclampsia with an onset at less than 30 completed weeks of gestation. RESULTS: The incidence of very preterm preeclampsia was 1 in 682 total births. The mean diagnosis to delivery interval (range) was 14 days (0-49 days). There were no maternal deaths. Fifteen women (21%) had developed HELLP/ELLP syndrome, 9 (13%) had renal failure, 1 (1.4%) had eclampsia, and 11 (15%) had an abruption. Five women (7%) had a termination of pregnancy, 57 (80%) were delivered by cesarean section, and 4 (5%) required a classical incision. There were 12 intrauterine deaths (16%), 9 neonatal deaths (12%), and 52 neonatal survivors (72%). Two of the survivors were known to have neurological impairment at the 2-year follow-up. CONCLUSIONS: A conservative approach to the management of early-onset preeclampsia results in a good obstetric outcome for the majority of fetuses, but this must be balanced against the significant risk of morbidity to the mothers.

Randomised trial comparing hysterectomy and transcervical endometrial resection: effect on health related quality of life and costs two years after surgery.

OBJECTIVE: To compare the impact of endometrial resection and abdominal hysterectomy on a range of health outcomes and health service costs, based on longer term follow up of patients randomised to a clinical trial. DESIGN: A parallel group of randomised control trial. SETTING: The gynaecology department of a teaching hospital. PARTICIPANTS: 196 women requiring surgical treatment for menorrhagia were randomised and received surgery (88 underwent resection and 97 hysterectomy). Longer term follow up was undertaken using a postal questionnaire sent to all 196 women. MAIN OUTCOME MEASURES: Longer term assessment was on the basis of menstrual symptoms, health related quality of life using the Short Form 36 (SF36) and the EuroQol visual analogue scale, patient satisfaction and health service resource cost. RESULTS: Of 196 women who were sent a questionnaire, 155 (79%) responded at an average interval of 2.8 years after initial surgery. All aspects of health outcomes were as good or better in patients randomised to hysterectomy. Among patients randomised to resection, 57% had experienced no improvement in premenstrual symptoms following surgery and 23% had taken time off work due to menstrual problems; among hysterectomy patients, these rates were 23% and 4%, respectively. Women randomised to hysterectomy had better mean scores on seven of the eight dimensions of the SF36 health related quality of life instrument, with the greatest difference being on the pain dimension (P = 0.01). Women randomised to hysterectomy were generally more satisfied with treatment (P = 0.002). By two years after initial surgery, women randomised to resection had a 12% probability of having had a repeat resection and a 16% chance of having had a hysterectomy. As a percentage of the mean total cost associated with women randomised to hysterectomy, the mean total cost of resection was 53% based on four months follow up; this proportion had increased to 71%, based on an average overall follow up of 2.2 years. CONCLUSIONS: These results show that, at an average follow up of 2.8 years among responders to a questionnaire, women randomised to hysterectomy experienced more of an improvement in menstrual symptoms and higher rates of satisfaction with treatment. There is also some evidence of superior health related quality of life amongst hysterectomy patients. However, the health service cost of endometrial resection remains lower than that of hysterectomy. An assessment of the relative cost effectiveness of the two procedures awaits further research.

The biological activity of the corticotropin-releasing hormone receptor-adenylate cyclase complex in human myometrium is reduced at the end of pregnancy.

We recently suggested that placentally derived CRH might influence human parturition via specific receptor mechanisms. We identified a human myometrial CRH receptor that changes to a high affinity state in the later stages of pregnancy and becomes coupled to the adenylate cyclase system. The purpose of this study was to investigate the functional capacity of this receptor in myometrial tissue obtained from women being delivered electively by cesarian section at term (38-40 weeks gestation) and preterm (30-35 weeks gestation) before the onset of labor. Myometrial membrane suspensions were prepared by differential centrifugation, and the production of cAMP after stimulation with various test substances was measured by RIA. In preterm myometrium, both human CRH and cholera toxin stimulated cAMP production. This effect was significantly reduced in term myometrium. The adenylate cyclase was functionally active in term myometrium, as demonstrated by the use of forskolin. Furthermore, pertussis toxin pretreatment of term myometrial membranes did not increase the response to CRH. These results suggest that in human pregnant myometrium at term, there is a modification in the coupling mechanisms between CRH receptors and the catalytic component of adenylate cyclase, resulting in a reduction of CRH-stimulated cAMP production.

Abu Dhabi third stage trial: oxytocin versus Syntometrine in the active management of the third stage of labour.

OBJECTIVE: To compare the effect of oxytocin and Syntometrine when used as part of active management of third stage of labour on postpartum haemorrhage, hypertension, nausea/vomiting and retained placenta. STUDY DESIGN: A randomised double blind trial was conducted in the Obstetric Unit of Corniche Hospital, Abu Dhabi in the United Arab Emirates. Between 1 January 1991 and 30 June 1991, 2040 women were randomly allocated either to the oxytocin (n = 1017) or the Syntometrine (n = 1023) group. Twelve patients had to be excluded from the trial (oxytocin, 5; Syntometrine, 7) after randomisation because they no longer fulfilled the inclusion criteria. All women in the trial received either oxytocin 10 units or Syntometrine 1 ml (oxytocin 5 units+ergometrine (ergonovine) 0.5 mg) by intramuscular injection with delivery of the anterior shoulder of the baby. Relative risk with 95% confidence intervals was calculated for each variable. RESULTS: Oxytocin (10 units) alone was as effective as Syntometrine (1 ml) in preventing post-partum haemorrhage without an increase in the incidence of retained placenta. Median blood loss was similar in both groups. The incidences of nausea, vomiting and headache were significantly lower in the oxytocin group, as was the occurrence of a mean rise in diastolic and systolic blood pressures of 20 and 30 mmHg or more, respectively. CONCLUSION: Prophylactic administration of oxytocin 10 U in the third stage of labour, as part of active management, reduces the incidence of maternal nausea, vomiting, headache and rise in blood pressure than does Syntometrine 1 ml without adversely affecting the rate of post partum haemorrhage.

An economic evaluation of transcervical endometrial resection versus abdominal hysterectomy for the treatment of menorrhagia.

OBJECTIVE: To evaluate the relative health service cost of endometrial resection versus abdominal hysterectomy for the treatment of menorrhagia and the value women attach to their health state before and after surgery. DESIGN: A prospective economic evaluation running alongside a randomised controlled trial. SETTING: The gynaecology department of a teaching hospital. SUBJECTS: 200 women requiring surgical treatment of menorrhagia between January 1990 and May 1991; after withdrawals, 97 women underwent hysterectomy and 99 underwent endometrial resection. MAIN OUTCOME MEASURES: The total health service cost of managing women in the two arms of the trial until 4 months after their operation. The change in women's valuation of their health state a fortnight after and a minimum of 4 months after surgery relative to that 1 month prior to their operation. RESULTS: Total health service costs are significantly higher amongst abdominal hysterectomy patients (mean 1059.73 pounds) than amongst endometrial resection patients with a mean difference of 499.68 pounds (95% CI 432 pounds-567 pounds). This significant difference exists under alternative assumptions about the difference in lengths of stay in hospital between the two treatment groups and the hotel cost per in-patient day. On a scale of 0 to 100, relative to a month before surgery, there is a statistically significant difference in favour of endometrial resection between the two groups in the increase in value women attach to their health state at a fortnight after surgery (mean difference 11.2; 95% CI 0.6-21.7), but not at a minimum of 4 months after surgery (mean difference 7; 95% CI -17.4 to 3.4). CONCLUSIONS: On the basis of health service resource cost up to 4 months after surgery, endometrial resection has a cost advantage over abdominal hysterectomy. However, given the fact that a subgroup of women requires retreatment due to resection failure and that this study considers a relatively short period of follow up, the long term costs and benefits of endometrial resection need to be evaluated before widespread diffusion is justified.

Randomised controlled trial comparing endometrial resection with abdominal hysterectomy for the surgical treatment of menorrhagia.

OBJECTIVE: To evaluate the effectiveness of endometrial resection as a surgical treatment for menorrhagia. DESIGN: Randomised controlled trial. SETTING: Gynaecology department at a teaching hospital. SUBJECTS: Two hundred women needing surgical treatment for menorrhagia between January 1990 and May 1991. After withdrawal of four women 97 underwent hysterectomy and 99 underwent endometrial resection. MAIN OUTCOME MEASURES: Patient satisfaction 4 months after surgery; post-operative complications; length of hospital stay; duration of time before return to work, normal daily activities and sexual intercourse; change in premenstrual symptoms. RESULTS: The difference in patient satisfaction between endometrial resection (84 out of 99) and abdominal hysterectomy (89 out of 95) just reached statistical significance in favour of abdominal hysterectomy at 4 months after surgery (difference = 9%, 95% confidence intervals (CI) 1.1%-17.5%). Post-operative morbidity, length of hospital stay and time taken to return to work, normal daily activities and sexual intercourse were significantly less in the endometrial resection group. However, the premenstrual symptoms of dysmenorrhoea, bloating and breast tenderness were less frequent after hysterectomy. CONCLUSION: In the short term, endometrial resection was almost as satisfactory as abdominal hysterectomy for the surgical treatment of menorrhagia, and was associated with less morbidity. However, even at 4 months after surgery, there was a failure rate of at least 10% in those in whom endometrial resection appeared complete. Longer term comparative studies are necessary before the widespread introduction of endometrial resection as an alternative to abdominal hysterectomy for the surgical treatment of menorrhagia.