Design of CRASH trial. Evidence shows that quality of trial by Faupel et al is good and therefore should not be excluded.
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Biomedical subjects
Publications and source records attributed to P Alderson.
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This discussion paper is drawn from a qualitative research project comparing the effect of special and ordinary schools on the lives of children, young people and their families. Special schools are recommended by health professionals who seldom know how ineffective these schools are. We question the beneficence and justice of health professionals' advice on education for children with disabilities and other difficulties. Cooperation with local education authorities (LEAs) plays a considerable part in the work of community paediatricians, clinical medical officers, therapists and other health professionals encountering children with "special needs". The "needs" range from physical disability and sensory impairment to learning difficulties and emotional or behavioural difficulties. This cooperation involves routine administrative problems, but it raises broad ethical issues too, particularly in respect of current tendencies in state schooling towards the integration or inclusion of these children in mainstream schools and classes.
OBJECTIVES: To assess the effectiveness of interventions routinely used in the intensive care management of severe head injury, specifically, the effectiveness of hyperventilation, mannitol, CSF drainage, barbiturates, and corticosteroids. METHODS: Systematic review of all unconfounded randomised trials, published or unpublished, that were available by August 1996. RESULTS: None of the interventions has been reliably shown to reduce death or disability after severe head injury. One trial of hyperventilation was identified of 77 participants. The relative risk for death was 0.73 (95% confidence interval (95% CI) 0.36-1.49), and for death or disability it was 1.14 (95% CI 0.82-1.58). One trial of mannitol was identified of 41 participants. The relative risk for death was 1.75 (95% CI 0.48-6.38), no data were available for disability. No randomised trials of CSF drainage were identified. Two randomised trials of barbiturate therapy were identified, including 126 participants. The pooled relative risk for death was 1.12 (95% CI 0.81-1.54). Disability data were available for one trial. The relative risk for death or disability was 0.96 (95% CI 0.62-1.49). Thirteen randomised trials of corticosteroids were identified, comprising 2073 participants. The pooled relative risk for death was 0.95 (0.84 to 1.07) and for death or disability it was 1.01 (95% CI 0.91 to 1.11). On the basis of the currently available randomised evidence, for every intervention studied it is impossible to refute either a moderate increase or a moderate decrease in the risk of death or disability. CONCLUSION: Existing trials have been too small to support or refute the existence of a real benefit from using hyperventilation, mannitol, CSF drainage, barbiturates, or corticosteroids. Further large scale randomised trials of these interventions are required.
Is it ever possible to give informed consent to treatment or research? Are the standards of consent set by ethicists and lawyers too high for ordinary people to reach? Should these standards be abandoned or modified? These questions are discussed in this paper mainly in relation to the extensive literature on consent in medicine, with examples about consent to children's treatment and research which raise extra dilemmas. Paradoxical meanings are considered: consent as an informed correct choice or a courageous best guess, and autonomy as isolated, uncompromised freedom or reasonably uncoerced self-realisation. Beyond being informed, consent involves evaluating, making and signifying a decision. It is better understood as a process than an event, in which reasoned understandings can be complemented by emotional insights. Ethical and legal standards of voluntary consent, although partly an unrealistic ideal, provide important guidelines for people who request and give consent to research.
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OBJECTIVE: To quantify the effectiveness and safety of corticosteroids in the treatment of acute traumatic brain injury. DESIGN: Systematic review of randomised controlled trials of corticosteroids in acute traumatic brain injury. Summary odds ratios were estimated as an inverse variance weighted average of the odds ratios for each study. SETTING: Randomised trials available by March 1996. SUBJECTS: The included trials with outcome data comprised 2073 randomised participants. RESULTS: The effect of corticosteroids on the risk of death was reported in 13 included trials. The pooled odds ratio for the 13 trials was 0.91 (95% confidence interval 0.74 to 1.12). Pooled absolute risk reduction was 1.8% (-2.5% to 5.7%). For the 10 trials that reported death or disability the pooled odds ratio was 0.90 (0.72 to 1.11). For infections of any type the pooled odds ratio was 0.92 (0.69 to 1.23) and for the seven trials reporting gastrointestinal bleeding it was 1.05 (0.44 to 2.52). With only those trials with the best quality of concealment of allocation, the pooled odds ratio estimates for death and death or disability became closer to unity. CONCLUSIONS: This systematic review of randomised controlled trials of corticosteroids in acute traumatic brain injury shows that there remains considerable uncertainty over their effects. Neither moderate benefits nor moderate harmful effects can be excluded. The widely practicable nature of the drugs and the importance of the health problem suggest that large simple trials are feasible and worth while to establish whether there are any benefits from use of corticosteroids in this setting.
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Equipoise is advocated as a means of achieving high scientific and ethical standards in randomised trials. As used in the context of research the word describes a state of uncertainty characterised by the belief that in a trial no arm is known to offer greater harm or benefit than any other arm. Clinicians who lack personal equipoise are advised to accept clinical or communal equipoise, based on current unresolved disagreement among the medical profession. Equipoise is mainly discussed in the literature as an issue for senior doctors and research directors. Limitations of professional equipoise are reviewed, and data on the neglected topic of patients' equipoise are reported using the example of breast cancer trials. In theory, a patient who gives informed and voluntary consent to enter a randomised trial has achieved the equilibrium of equipoise. In practice, equipoise among patients ranges from personal to proxy acceptance.
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A series of eight multidisciplinary conferences on consent to health care and research was held in London during the period 1992 to 1995. The aim was to present a rich and varied account of consent from the perspectives of academics (especially social scientists), practitioners, and people affected by personal experience. This report summarizes some of the main contributions.
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