Harms

  • What does it mean?
Most treatments come with a risk attached - they may lead to harms and side effects, even when they benefit patients. It is crucial to measure harms and side effects and show this information by treatment. This ensures patient's safety is always considered when running a trial and interpreting findings.
  • An example
As Emma starts using toothpaste A, she notices she has developed a strange side effect - she develops mouth ulcers and is concerned. She contacts her dentist who immediately reports this side effect to the trial team. The trial team keep note of this side effect, along with others that are reported from other patients. During the trial, and at the end, the trial team analyses and presents this information.

  • How can patients be involved?
Patients can help researchers when summarising and presenting data on safety, to ensure it is clear and can be discussed by the whole trial team. Patients can be involved in interpreting the safety analysis findings.

Comments

  1. And patients can contribute to discussions on what and how side-effects can be reported. They can give a different perspective on how people may view different side-effects - including those which may be seen as a 'nuisance' rather than a 'harm'.

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