Framework to help design and review research involving children.

This is the third of a series of four articles addressing ethical approaches and issues in undertaking clinical research with children and young people (CYP). This paper addresses the major ethical aspects of studies with CYP, where they vary from studies in adults.

Drawing blood from peripheral intravenous cannula compared with venepuncture: A systematic review and meta-analysis.

AIMS: To synthesize the evidence evaluating if blood samples are similar when obtained from peripheral intravenous cannula compared with venepuncture. DESIGN: A systematic review and meta-analysis was undertaken. DATA SOURCES: Searches were conducted in databases for English language studies between January 2000-December 2018. REVIEW METHODS: The search adhered to the Meta-analysis of Observational Studies in Epidemiology guidelines. The methodological quality of studies was assessed using Joanna Briggs critical appraisal instruments. The overall quality of the evidence was assessed using the GRADE. RESULTS: Sixteen studies were identified. Findings suggest haemolysis rates are higher in blood sampled from peripheral intravenous cannula. However, haemolysis rates may be lower if a peripheral intravenous cannula blood sampling protocol is followed. For equivalence of blood test results, even though some results were outside the laboratory, allowable error and were outside the Bland-Altman Level of Agreement, none of these values would have required clinical intervention. With regard to the contamination rates of blood cultures, the results were equivocal. CONCLUSION: Further research is required to inform the evidence for best practice recommendations, including, if a protocol for drawing blood from a peripheral cannula is of benefit for specific patient populations and in other settings. IMPACT: Venepuncture can provoke pain, anxiety and cause trauma to patients. Guidelines recommend blood samples from peripheral intravenous cannula be taken only on insertion. Anecdotal evidence suggests drawing blood from existing cannulas may be a common practice. Further research is required to resolve this issue.

Making research central to good paediatric practice.

There is evidence abroad of a cautious if not protective approach to research involving children and young people (CYP). We are sensitive to these views but believe they are based on a misconception that we must address together. In this introductory article we look at the complexities and risks of this research, how we must involving CYP and their families in the all aspects of research, how to seek valid consent and assent and how research findings should be reported. Considering how we should conduct this ongoing debate, we outline seven principles that we believe should underpin the necessary dialogue between all with legitimate interest. Our debate should be: (1) evidence informed: arguments should be supported by appropriate and reasonably accurate factual claims; (2) transparent about the grounds for decisions; (3) balanced: arguments should be met by contrary arguments; (4) conscientious: we must be willing to talk and listen, with civility and respect; (5) substantive: arguments should be considered sincerely on their merits, not on how they are made or by who is making them; (6) comprehensive: all points of view held by significant portions of the population should receive attention; and (7) with procedures for revising decisions in light of challenges, and it should be our responsibility to ensure we have met all of these.

A syllabus for research ethics committees: training needs and resources in different European countries.

This paper reports a European Forum for Good Clinical Practice workshop held in 2011 to consider a research ethics committee training syllabus, subsequent training needs and resources. The syllabus that was developed was divided into four competencies: committee working; scientific method; ethical analysis and the regulatory framework. Appropriate training needs for each, with possible resources, were discussed. Lack of funding for training was reported as a major problem but affordable alternatives were debated. Strengths and weaknesses of this approach were discussed and the resultant proposal will be disseminated through the European Forum for Good Clinical Practice and the research ethics committees of member states.

Intermittent versus continuous renal replacement therapy: a matter of controversy.

BACKGROUND: Acute Renal Failure (ARF) requiring some form of replacement therapy is a frequent complication in the critically ill patient. Despite potential therapeutic advantages the expectation of an improvement in patient outcomes using Continuous Renal Replacement Therapy (CRRT) compared to conventional Intermittent Haemodialysis (IHD) remains controversial. AIMS AND METHOD: This article will review the literature on the issues surrounding the use of IHD versus CRRT in the management of the critically ill patient. Articles were selected according to level of evidence with priority given to meta-analyses and randomised controlled trials. DISCUSSION: Several operational features of CRRT allow this technique to be tolerated more easily in critical illness than IHD. The gradual removal of fluid reduces the incidence of hypotension and the risk of volume overload. Decreased variability in the concentration of solutes enables greater azotemia control. However, CRRT is required to operate uninterrupted to achieve a treatment dose that is equivalent to a conventional IHD treatment schedule. In the absence of definitive evidence to validate superior patient survival and return of renal function there is disagreement as to the most appropriate form of Renal Replacement Therapy (RRT) for the critically ill patient. The introduction of 'hybrid' therapies offers a further alternative treatment strategy, which combine favourable aspects of IHD and CRRT. CONCLUSION: The decision to use IHD or CRRT should be guided by the therapeutic needs of the patient rather than the operational differences between the two techniques. The resources and expertise available at the organisation are also important in determining the mode best able to manage the critically ill patient at any stage and may change according to the severity of illness. The emergence of hybrid therapies provides a compromise option which encompasses many of the features of both systems, but does not embrace all options of either approach.