...if we are looking at clinical trials, adverse events only tend to be collected and reported if they are ‘serious’ (this tends to mean ‘got the patient admitted to hospital’). ...even if collected, ...it is very unusual for a paper to publish an extensive list of adverse effects. Methods of assessing even rare effects are being advanced,1 patient-centred outcome reporting is becoming increasingly used2 and data repositories mean the older limits on what could fit into a publication are being less problematic (as is the benefit of prospective registration where you can see what was intended to be collected).3 There is much more inclusion of patients/public in setting up trials, and so capturing really key outcomes, and intriguing work in using social media posts where people describe their experiences too.4 Currently, as with much of our work, we need to remain open to listening to patient experience, evaluating any studies that come our way and presenting a balanced view of possible unwanted effects when discussing treatment options.
BackgroundFebrile neutropenia (FN) is a common complication of cancer treatment in children and young people, and many episodes are over-treated. Procalcitonin, may be an appropriate tool to guide ...the stopping of antibiotics in those at low risk of serious bacterial infection. Supportive care trials in this population have proven to be difficult to undertake. This single-arm pilot study aimed to evaluate whether a study using a procalcitonin-guided stopping-rule for antibiotics in paediatric FN is possible.MethodsDaily procalcitonin levels were performed during episodes of FN and clear guidance given for antibiotic discontinuation. Episode data and quantitative feasibility data were collected alongside interviews with professionals and ethnographic observations. Analysis was descriptive.ResultsOf 32 patients and families approached, 28 patients consented, and 13 had febrile neutropenia. In total, 16 episodes were included in the study. All relevant FN episodes had data captured, with adequate data collection. There were no significant safety events. In 4/8 (50%) of episodes without clear microbiologically documented or clinical infection, antibiotics were reduced in duration or in spectrum. Interviews with professionals revealed the importance of the research, the value of key individuals in the study team, particular challenges of this protocol and suggestions for study improvements.ConclusionsStudies to evaluate procalcitonin-guided approaches to stopping antibiotics in paediatric FN are possible.
