Hypothermia or Machine Perfusion in Kidney Donors.

BACKGROUND: Therapeutic hypothermia in brain-dead organ donors has been shown to reduce delayed graft function in kidney recipients after transplantation. Data are needed on the effect of hypothermia as compared with machine perfusion on outcomes after kidney transplantation. METHODS: At six organ-procurement facilities in the United States, we randomly assigned brain-dead kidney donors to undergo therapeutic hypothermia (hypothermia group), ex situ kidney hypothermic machine perfusion (machine-perfusion group), or both (combination-therapy group). The primary outcome was delayed graft function in the kidney transplant recipients (defined as the initiation of dialysis during the first 7 days after transplantation). We also evaluated whether hypothermia alone was noninferior to machine perfusion alone and whether the combination of both methods was superior to each of the individual therapies. Secondary outcomes included graft survival at 1 year after transplantation. RESULTS: From 725 enrolled donors, 1349 kidneys were transplanted: 359 kidneys in the hypothermia group, 511 in the machine-perfusion group, and 479 in the combined-therapy group. Delayed graft function occurred in 109 patients (30%) in the hypothermia group, in 99 patients (19%) in the machine-perfusion group, and in 103 patients (22%) in the combination-therapy group. Adjusted risk ratios for delayed graft function were 1.72 (95% confidence interval [CI], 1.35 to 2.17) for hypothermia as compared with machine perfusion, 1.57 (95% CI, 1.26 to 1.96) for hypothermia as compared with combination therapy, and 1.09 (95% CI, 0.85 to 1.40) for combination therapy as compared with machine perfusion. At 1 year, the frequency of graft survival was similar in the three groups. A total of 10 adverse events were reported, including cardiovascular instability in 9 donors and organ loss in 1 donor owing to perfusion malfunction. CONCLUSIONS: Among brain-dead organ donors, therapeutic hypothermia was inferior to machine perfusion of the kidney in reducing delayed graft function after transplantation. The combination of hypothermia and machine perfusion did not provide additional protection. (Funded by Arnold Ventures; ClinicalTrials.gov number, NCT02525510.).

Issues and challenges for research in major trauma.

The starting point for evidence-based guidelines is the systematic review and critical appraisal of the relevant literature. This review highlights the risk of bias identified while critically appraising the evidence to inform the National Institute of Health and Care Excellence guideline on the assessment and initial management of major trauma.

Impact of a quality improvement project on deceased organ donor management.

CONTEXT: Donors showed poor glucose control in the period between declaration of brain death and organ recovery. The level of hyperglycemia in the donors was associated with a decline in terminal renal function. OBJECTIVE: To determine whether implementation of a quality improvement project improved glucose control and preserved renal function in deceased organ donors. METHODS: Data collected retrospectively included demographics, medical history, mechanism of death, laboratory values, and data from the United Network for Organ Sharing. RESULTS: After implementation of the quality improvement project, deceased donors had significantly lower mean glucose concentrations (mean [SD], 162 [44] vs 212 [42] mg/dL; P<.001) and prerecovery glucose concentration (143 [66] vs 241 [69] mg/dL; P<.001). When the donor cohorts from before and after the quality improvement project were analyzed together, mean glucose concentration remained a significant predictor of terminal creatinine level (P<.001). Multivariate analysis of delayed graft function in kidney recipients matched to donors indicated that higher terminal creatinine level was associated with delayed graft function in recipients (P<.001). CONCLUSION: The quality improvement project improved donor glucose homeostasis, and the data confirm that poor glucose homeostasis is associated with worsening terminal renal function.

Therapeutic Hypothermia in Deceased Organ Donors and Kidney-Graft Function.

BACKGROUND: Delayed graft function, which is reported in up to 50% of kidney-transplant recipients, is associated with increased costs and diminished long-term graft function. The effect that targeted mild hypothermia in organ donors before organ recovery has on the rate of delayed graft function is unclear. METHODS: We enrolled organ donors (after declaration of death according to neurologic criteria) from two large donation service areas and randomly assigned them to one of two targeted temperature ranges: 34 to 35°C (hypothermia) or 36.5 to 37.5°C (normothermia). Temperature protocols, which were initiated after authorization was obtained for the organ to be donated and for the donor's participation in the study, ended when organ donors left the intensive care unit for organ recovery in the operating room. The primary outcome was delayed graft function in the kidney recipients, which was defined as the requirement for dialysis during the first week after transplantation. Secondary outcomes were the rates of individual organs transplanted in each treatment group and the total number of organs transplanted from each donor. RESULTS: The study was terminated early, on the recommendation of an independent data and safety monitoring board, after the interim analysis showed efficacy of hypothermia. At trial termination, 370 organ donors had been enrolled (180 in the hypothermia group and 190 in the normothermia group). A total of 572 patients received a kidney transplant (285 kidneys from donors in the hypothermia group and 287 kidneys from donors in the normothermia group). Delayed graft function developed in 79 recipients of kidneys from donors in the hypothermia group (28%) and in 112 recipients of kidneys from donors in the normothermia group (39%) (odds ratio, 0.62; 95% confidence interval, 0.43 to 0.92; P=0.02). CONCLUSIONS: Mild hypothermia, as compared with normothermia, in organ donors after declaration of death according to neurologic criteria significantly reduced the rate of delayed graft function among recipients. (Funded by the Health Resources and Services Administration; ClinicalTrials.gov number, NCT01680744.).

Cost-effectiveness analysis of serial measurement of circulating natriuretic peptide concentration in chronic heart failure.

OBJECTIVE: To assess the cost-effectiveness of three monitoring strategies for optimising medical therapy in chronic heart failure (CHF). DESIGN: This analysis was based on six randomised controlled trials. Costs were measured from a UK NHS perspective and estimated for patients' lifetime. The health outcome was the quality-adjusted life-year (QALY). SETTING: Hospital and community. PATIENTS: Patients with CHF. INTERVENTIONS: Serial measurement of natriuretic peptide (NP) by a specialist, clinical assessment by a specialist, and usual care in the community. MAIN OUTCOME MEASURES: Costs, QALYs, and incremental cost-effectiveness ratio (ICER). RESULTS: Serial NP measurement by a specialist was the most cost-effective option in patients with CHF due to left ventricular systolic dysfunction (LVSD), showing an ICER of £3304 compared with clinical assessment. Serial NP measurement by a specialist was strongly favoured in patients with CHF from any cause, for all patients (ICER of £14 694 compared with clinical assessment by a specialist) and for the age subgroup ≤75 years (ICER of £2517 compared with usual care). However, serial NP measurement by a specialist was dominated (less effective and more costly) by alternative strategies in the subgroup age >75 years with CHF from any cause. Clinical assessment by a specialist of patients >75 years of age with CHF from any cause was cost-effective compared with usual care (ICER of £11 508). CONCLUSIONS: Serial measurement of NP concentration by a specialist is the most cost-effective strategy for CHF due to LVSD and from any cause, except in the subgroup of patients >75 years with CHF from any cause, where treatment guided by NP measurement may be harmful and not cost-effective.

Assessment and management of alcohol dependence and withdrawal in the acute hospital: concise guidance.

Alcohol dependence is common among patients attending acute hospitals. It can be the major reason for attendance or a significant cofactor. Assessment of these patients in the acute setting can be challenging owing to the multidisciplinary approach required. Doctors in acute hospitals are often inexperienced in managing dependence, a mental health problem. They might focus on the physical harms or the withdrawal, a consequence of the dependence. For this reason, assessment of dependence and prevention and management of acute alcohol withdrawal are often suboptimal. There is little existing guidance on how to manage this patient population, especially in non-specialist settings. With recently published National Institute for Health and Clinical Excellence (NICE) guidance on the management of dependence and withdrawal, now is the perfect time to produce concise guidelines in the hope that a more succinct suite of guidance can reach a larger audience.

Management of chronic heart failure in adults: synopsis of the National Institute For Health and clinical excellence guideline.

DESCRIPTION: The National Institute for Health and Clinical Excellence released its first clinical guideline on heart failure in 2003. This synopsis describes the update of that guideline, which was released in August 2010 and discusses the diagnosis, treatment, and monitoring of heart failure. METHODS: Guideline developers considered clinical evidence, health economic analyses, clinical expert opinion, and patient views. Systematic literature searches were performed, and an original decision model assessed the cost-effectiveness of serial measurement of serum natriuretic peptide to monitor patients with chronic heart failure. RECOMMENDATIONS: First, this guideline update describes the role of serum natriuretic peptide measurement, echocardiography, and specialist assessment in the diagnosis of heart failure. Second, it presents a pathway for pharmacologic treatment, rehabilitation, and pacing therapy (including implantable cardioverter-defibrillator and cardiac resynchronization therapy) for patients with heart failure and left ventricular systolic dysfunction and patients with heart failure and preserved ejection fraction. Finally, it explains the recommendation to monitor patients with heart failure by using serial measurement of serum natriuretic peptide.

The role of clinical nurse educators in organ procurement organizations.

Clinical nurse educators are advanced practice nurses with preparation at the master's level or higher. Such nurses play an important role in organ procurement organizations. As leaders and members of the team, they provide structure and design to the training process. These educators oversee orientation of new employees, serve as mentors to preceptors, assess the learning needs of the organization, and provide ongoing training to veteran staff. Clinical nurse educators also contribute to continuous quality improvement for the organization and help to comply with regulatory standards.

Diagnosis and initial management of transient ischaemic attack.

Transient ischaemic attack (TIA) is the sudden onset of focal neurological dysfunction of presumed vascular origin that, by definition, resolves within 24 hours (usually much sooner). Its importance as a predictor of completed stroke has only recently been recognised. Updated guidance on the recognition and management of TIA has recently been published as part of the National Clinical Guideline for Stroke. This is a concise version of the TIA component of the full guideline that recommends an urgent response to TIA to prevent subsequent stroke.

The acceptability of computer-aided cognitive behavioural therapy: a pragmatic study.

The clinical and cost-effectiveness of a computer-aided cognitive behavioural therapy (CCBT) programme, Beating the Blues, is indicated by a number of studies, but relatively little is known about its acceptability for patients with depression, anxiety, or both. This study investigated the acceptability of Beating the Blues offered on eight scheduled clinic visits with brief face-to-face support. Pre and posttreatment measures explored the relationship among programme acceptability, treatment continuation, and outcomes for people accessing the programme in routine care. Two hundred and nineteen patients with depression, anxiety, or both were offered Beating the Blues in 11 primary and secondary care practices. One hundred and ninety-one (87%) completed the pretreatment measures and 84 (38%) completed a treatment feedback questionnaire. Analysis of treatment acceptability for CCBT indicated a positive patient experience with the programme. Pretreatment expectancies predicted CCBT treatment completion but not outcomes. No differences were found between men and women on pretreatment measures. Posttreatment, women reported more favourable responses to the therapy, finding the programme more helpful and more satisfactory, than did men. No relationship between treatment acceptability and age was found. Study limitations, including research methods and attrition rates, and implications for future research are discussed. It is concluded that the Beating the Blues CCBT programme is an acceptable treatment for common mental health problems in routine care.

The role of a telephone helpline in provision of patient information.

AIM: To explore why individuals contacted a telephone helpline specialising in neurological conditions and their level of satisfaction with the service. METHOD: Callers were asked to complete a confidential postal questionnaire. RESULTS: The majority of callers found the helpline useful and all respondents would use the service again. The main reasons for contacting the helpline were to obtain medical information or request an information booklet. Health professionals and the internet were the other main sources of information and support. CONCLUSION: A telephone helpline is important in the provision of information and support on neurological conditions. Through close collaboration, the NHS and voluntary organisations can fulfil many of the needs of patients with complex medical conditions.