Legal and ethical implications of NICE guidance aimed at optimising organ transplantation after circulatory death.

Increasing the number of organ transplants is a priority for most governments. While potential new legislation for donor registration, such as the Welsh Government white paper on establishing an opt-out system for Welsh residents, is the focus of most ethical and legal scrutiny, there are also other approaches to increase the number of patients receiving organ transplants. The then National Institute for Health and Care Excellence (NICE) published guidance on this issue in 2011, but subsequent debate in this journal has suggested that the guidance was presumptuous and might encourage unethical practice. This paper addresses these concerns and concludes that the NICE guidance provides a legal, ethical and clinically relevant way forward in a complex and developing public health issue.

Trial of management of borderline and other low-grade abnormal smears (TOMBOLA): Trial design.

Cervical screening reduces the risk of cervical cancer by detecting and treating cervical intraepithelial neoplasia (CIN). The management of women with low-grade cervical abnormalities is controversial. Two management policies exist: repeat smears in primary care and colposcopy examination. It is not clear which of these is the more effective and efficient. There is also uncertainty as to the most effective and efficient management of women at colposcopy when an area of abnormality is seen on the cervix - immediate treatment or biopsy and selective recall for treatment if the biopsy result suggests this is necessary. The result of a human papillomavirus (HPV) test might assist in deciding the appropriate management of women with low-grade abnormalities. TOMBOLA, a pragmatic randomised-controlled trial set within the cervical screening programmes in Scotland and England, addresses these three areas of uncertainty. Almost four and a half thousand women aged 20-59 with a low-grade cervical abnormality have been recruited and randomised to either repeat smears or colposcopy examination. Women in the colposcopy arm of the trial are further randomised to a policy of either immediate treatment or biopsy and selective recall for treatment if they have an abnormal transformation zone. Women are followed up to an exit examination at 3 years. HPV testing is undertaken at recruitment and at the exit examination. The primary endpoint is cumulative incidence of CIN2/3. A range of other clinical, psychosocial and economic outcomes is being considered. This paper describes the design of the trial, and discusses the rationale underlying aspects of the design and the challenges faced in designing and implementing the trial.

Pulse oximetry error in a patient with a Santa Ana haemoglobinopathy.

A young man with a rare unstable haemoglobinopathy presented with a high fever, worsening shortness of breath and abdominal pain. At triage his pulse oximetry (SpO2) suggested that his blood oxygen saturation was 84% at room air. However, an arterial blood gas (ABG) oxygen saturation reading (SaO2) was 100%. The significant disparity between the two measurements demonstrates that using pulse oximetry in some unstable haemoglobinopathies may significantly underestimate the actual reading. This error is most probably due to the structural differences in the variant haemoglobin causing light to be absorbed at a different wavelength beyond the normal range of the oximeter. Haemoglobinopathies affect about 7% of the world's population and is often asymptomatic; so, there may be many more undiagnosed cases. Therefore, clinicians may confirm low SpO2 readings with an ABG and, where there is significant disparity with no obvious extrinsic cause, they should consider haemoglobinopathies.