Adverse effects in systematic reviews: challenges for formulating the question and searching for different studies and sources of information

Tags: Workshop
Golder S1
1Cochrane Adverse Effects Methods Group

Objectives: To give guidance for review authors on formulating the question, the available data sources on adverse effects, and how to retrieve data for incorporation into a systematic review. This will include the development of optimal search techniques and discussion of the diverse formats of adverse effects data sources.

Description: Participants will receive a number of scenarios, and will then work together in small groups to plan a search strategy for a comprehensive evaluation of adverse effects. The scenarios will be drawn from real-life situations to cover a wide range of potential adverse effects, such as:

1. There have been safety concerns arisen about the risk of fractures with thiazolidinediones.

2. Patients with epilepsy often have to take long-term medication to control their symptoms, and there are concerns over the safety and tolerability of the drugs.

3. Human bone morphogenic protein-2 (rhBMP-2) is used in orthopaedic and spinal surgery to promote fusion. In 2011, questions were raised about the product’s safety.

At the end, groups will feedback on their search protocols, and any points raised will be discussed further. Examples from existing reviews will be provided by the facilitator, as well as tips and tricks to solve specific issues and give examples of sources of support and help available. The workshop will mostly focus on drug effects but the issues faced in identifying adverse effects for all types of interventions will be touched upon.