Clare Dyer

Bio: Clare Dyer is an academic researcher. The author has contributed to research in topics: High Court & Medicine. The author has an hindex of 18, co-authored 1404 publications receiving 3639 citations.

Surgeon amputated healthy legs

Abstract: A surgeon in Scotland amputated the legs of two psychologically disturbed men who had nothing physically wrong with them but felt a “desperate” need to be amputees, it emerged this week. Both men, one from England and one from Germany, had a rare type of body dysmorphic disorder known as apotemnophilia, in which patients are convinced from childhood that they will be normal only once a limb has been removed. The obsession is always with the removal of a specific limb, and each patient had a leg amputated above the knee. The operations were carried out in …

Lancet retracts Wakefield's MMR paper.

Abstract: The Lancet has retracted the 12 year old paper that sparked an international crisis of confidence in the safety of the measles, mumps, and rubella (MMR) vaccine when its lead author suggested a link between the vaccine and autism. Andrew Wakefield was found guilty by the General Medical Council last week of dishonesty and flouting ethics protocols. The UK regulator held that Dr Wakefield abused his position, subjected children to intrusive procedures such as lumbar puncture and colonoscopy that were not clinically indicated, carried out research that breached the conditions of ethics committee approval, and brought the medical profession into disrepute. In a statement published online (www.thelancet.com) the editors of the Lancet said: “Following the judgment of the UK General Medical Council’s Fitness to Practise Panel on Jan 28, 2010, it has become clear that several elements of the 1998 paper by Wakefield et al are incorrect, contrary to the findings of an earlier investigation. “In particular, the claims in the original paper that children were ‘consecutively referred’ and that investigations were ‘approved’ by the local ethics committee have been …

Bristol inquiry condemns hospital's "club culture".

Abstract: Between 30 and 35 children undergoing heart surgery at Bristol Royal Infirmary died between 1991 and 1995 who would probably have survived if treated elsewhere, the long awaited report into children's heart surgery at Bristol has concluded. These “excess” deaths took place in a unit where mortality at the time for children aged under 1 was probably double that for England as a whole, and even higher for neonates. Around a third of children who underwent open heart surgery received less than adequate care. The inquiry report, published last week, painted a picture of a flawed system of care with poor teamwork between professionals, “too much power in too few hands,” and surgeons who lacked the insight to see that they were failing and to stop operating. But the failings were not those of the surgeons alone. An expert review of 80 cases carried out for the inquiry showed inadequacies at every point, from referral to diagnosis, surgery, and intensive care. The physical setup was “dangerous,” with surgeons on one site—at the Royal Infirmary—and paediatric cardiologists several hundred …

New watchdog given power to overturn GMC acquittals

Abstract: Doctors who are cleared of serious professional misconduct by the General Medical Council risk having their acquittals overturned by a court following a ruling this week from a High Court judge. The Council for the Regulation of Healthcare Professionals (CRHP), the new watchdog set up to oversee disciplinary bodies in the healthcare field, won a High Court test case this week against the General Medical Council over the extent of its powers. The GMC had argued that the CRHP's power to refer cases to the High Court when it believes regulators have acted too leniently applies …

English teenager given heart transplant against her will.

Abstract: A 15 year old girl in the north of England is recovering this week after a heart transplant operation sanctioned by a High Court judge despite her refusal to undergo it. The teenager, identified as M, had only a week to live, and her parents had consented to the operation. But M, who had been fit and healthy until she developed heart failure in May, had learnt only two days earlier that a transplant was her only chance of survival and insisted she did not want to have it. The …

CONSORT 2010 statement: extension to randomised pilot and feasibility trials.

Abstract: The Consolidated Standards of Reporting Trials (CONSORT) statement is a guideline designed to improve the transparency and quality of the reporting of randomised controlled trials (RCTs). In this article we present an extension to that statement for randomised pilot and feasibility trials conducted in advance of a future definitive RCT. The checklist applies to any randomised study in which a future definitive RCT, or part of it, is conducted on a smaller scale, regardless of its design (eg, cluster, factorial, crossover) or the terms used by authors to describe the study (eg, pilot, feasibility, trial, study). The extension does not directly apply to internal pilot studies built into the design of a main trial, non-randomised pilot and feasibility studies, or phase II studies, but these studies all have some similarities to randomised pilot and feasibility studies and so many of the principles might also apply. The development of the extension was motivated by the growing number of studies described as feasibility or pilot studies and by research that has identified weaknesses in their reporting and conduct. We followed recommended good practice to develop the extension, including carrying out a Delphi survey, holding a consensus meeting and research team meetings, and piloting the checklist. The aims and objectives of pilot and feasibility randomised studies differ from those of other randomised trials. Consequently, although much of the information to be reported in these trials is similar to those in randomised controlled trials (RCTs) assessing effectiveness and efficacy, there are some key differences in the type of information and in the appropriate interpretation of standard CONSORT reporting items. We have retained some of the original CONSORT statement items, but most have been adapted, some removed, and new items added. The new items cover how participants were identified and consent obtained; if applicable, the prespecified criteria used to judge whether or how to proceed with a future definitive RCT; if relevant, other important unintended consequences; implications for progression from pilot to future definitive RCT, including any proposed amendments; and ethical approval or approval by a research review committee confirmed with a reference number. This article includes the 26 item checklist, a separate checklist for the abstract, a template for a CONSORT flowchart for these studies, and an explanation of the changes made and supporting examples. We believe that routine use of this proposed extension to the CONSORT statement will result in improvements in the reporting of pilot trials. Editor’s note: In order to encourage its wide dissemination this article is freely accessible on the BMJ and Pilot and Feasibility Studies journal websites.

OECD guidelines for testing of chemicals

Abstract: Other methods and guidelines not included in this publication may be judged to be appropriate in testing chemicals in certain scientifi c, legal, and administrative contexts.The OECD Council Decision on Mutual Acceptance of Data (12th May 1981; C[81]30) affi rms that data generated in one country in accordance with the OECD Test Guidelines – and additionally in accordance with the OECD Principles of Good Laboratory Practice – should be accepted in OECD countries for purposes of assessment and other uses relating to protection of man and the environment. The full text of this Decision and the OECD Principles of Good Laboratory Practice may be found in the Appendix to the OECD Guidelines for Testing of Chemicals.

Guidelines for the use of fresh-frozen plasma, cryoprecipitate and cryosupernatant.

Abstract: The indications for transfusing fresh-frozen plasma (FFP), cryoprecipitate and cryosupernatant plasma are very limited. When transfused they can have unpredictable adverse effects. The risks of transmitting infection are similar to those of other blood components unless a pathogen-reduced plasma (PRP) is used. Of particular concern are allergic reactions and anaphylaxis, transfusion-related acute lung injury, and haemolysis from transfused antibodies to blood group antigens, especially A and B. FFP is not indicated in disseminated intravascular coagulation without bleeding, is only recommended as a plasma exchange medium for thrombotic thrombocytopenic purpura (for which cryosupernatant is a possible alternative), should never be used to reverse warfarin anticoagulation in the absence of severe bleeding, and has only a very limited place in prophylaxis prior to liver biopsy. When used for surgical or traumatic bleeding, FFP and cryoprecipitate doses should be guided by coagulation studies, which may include near-patient testing. FFP is not indicated to reverse vitamin K deficiency for neonates or patients in intensive care units. PRP may be used as an alternative to FFP. In the UK, PRP from countries with a low bovine spongiform encephalopathy incidence is recommended by the Departments of Health for children born after 1 January 1996. Arrangements for limited supplies of single donor PRP of non-UK origin are expected to be completed in 2004. Batched pooled commercially prepared PRP from donors in the USA (Octaplas) is licensed and available in the UK. FFP must be thawed using a technique that avoids risk of bacterial contamination. Plastic packs containing any of these plasma products are brittle in the frozen state and must be handled with care.