{"id":971,"date":"2014-09-11T20:54:04","date_gmt":"2014-09-11T19:54:04","guid":{"rendered":"https:\/\/blogs.bmj.com\/adc\/?p=971"},"modified":"2014-09-07T22:47:40","modified_gmt":"2014-09-07T21:47:40","slug":"top-tips-for-detecting-adverse-events-in-paediatrics","status":"publish","type":"post","link":"https:\/\/blogs.bmj.com\/adc\/2014\/09\/11\/top-tips-for-detecting-adverse-events-in-paediatrics\/","title":{"rendered":"Top tips for detecting adverse events in paediatrics"},"content":{"rendered":"

\"\"How can we determine the safety if anything we do in paediatric prescribing?\u00a0For chronic conditions, we’re generally pretty sure that if we let it wind on, it will harm the child. If we treat it, we’ll be managing the disease but causing adversity. The balance is making this tip where the good stuff overwhelms the poor stuff.<\/p>\n

I think the commonest, extreme, example is chemotherapy. These agents are intended to treat a cancer to save a life. To do this, they may cause sufficient immunosupression to produce a fatal infection, or mucosal erosions to give a fatal intestinal perforation, or a thrombotic event that produces a cerebral infarct and death. The carefully measured doses of these drugs are placed to \u00a0make the tipping point\u00a0in favour of benefit over harm; and we have improved survival in childhood cancer by this treatment approach.<\/p>\n

<\/p>\n

Where the challenge becomes greater is where the condition we are treating may not be immediately life threatening, or where the side effects are less mortal and more morbid, or where a treatment is new and the uncertainties are greater. The challenges here are in determining what constitutes\u00a0benefit over harm;\u00a0how this might change in\u00a0eyes of different patients, and how to make such decisions without enough evidence.<\/p>\n

Let’s take a look at this latter question.\u00a0There are some data, particularly within adults, that have shown that knowledge of expected side effects changes the reports of adverse experiences, so we need to see how the reports very between placebo and new treatment group … and yet some very rare events won’t be adequately captured in randomised trials of generally small numbers and short duration, so we’ll need to look at open, uncontrolled, observational series to do that. Or data from adults. (And we’ll also need to remember that\u00a0we may not record things we don’t ask about and that some VERY NAUGHTY PEOPLE don’t report all trials<\/a>.)<\/p>\n

So:<\/p>\n

    \n
  1. Always examine trial data for adverse effects; consider very\u00a0much that lack of statistical significance is NOT evidence of no difference<\/a><\/li>\n
  2. If you can’t find something reported, it doesn’t mean it hasn’t happened<\/a>.<\/li>\n
  3. Data from adult studies might be really really helpful. Whisper it – but adult & paed data often are not that different<\/a><\/li>\n
  4. Listen to your patients and their families.<\/li>\n<\/ol>\n

    – Archi<\/p>\n","protected":false},"excerpt":{"rendered":"

    How can we determine the safety if anything we do in paediatric prescribing?\u00a0For chronic conditions, we’re generally pretty sure that if we let it wind on, it will harm the child. If we treat it, we’ll be managing the disease but causing adversity. The balance is making this tip where the good stuff overwhelms the […]<\/p>\n

    Read More…<\/a><\/p>\n","protected":false},"author":7,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[79],"tags":[],"class_list":["post-971","post","type-post","status-publish","format-standard","hentry","category-archimedes"],"yoast_head":"\nTop tips for detecting adverse events in paediatrics - ADC Online Blog<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/blogs.bmj.com\/adc\/2014\/09\/11\/top-tips-for-detecting-adverse-events-in-paediatrics\/\" \/>\n<meta property=\"og:locale\" content=\"en_GB\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Top tips for detecting adverse events in paediatrics - ADC Online Blog\" \/>\n<meta property=\"og:description\" content=\"How can we determine the safety if anything we do in paediatric prescribing?\u00a0For chronic conditions, we’re generally pretty sure that if we let it wind on, it will harm the child. 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