First do no harm: how can systematic reviews do justice to adverse effects? The challenges of deciding which adverse effects to search for and how

Tags: Workshop
Golder S1, Goodare H2
1University of York, 2Cochrane Consumer Representative for breast cancer and stroke

Background:

Formulating the systematic review question is a key step in the review process. Review teams need to decide whether to focus on specific adverse effects (and if so which ones) or whether to have a broader objective. Balancing the quest for an answerable, useful question with resources can be challenging.

Searching for included studies for a systematic review of adverse effects can also be difficult and often requires a different approach to searching for an effectiveness review. A problem has been the lack of information about adverse effects in primary research. Adverse effects tend to be secondary or even tertiary outcomes in primary research and this leads to poor reporting in the title, abstract and indexing of bibliographic records. In addition, inconsistent terminology and indexing is often applied to adverse effects studies. A range of study designs beyond randomised controlled trials (RCTs) and a wide variety of sources can prove invaluable.

Objectives:

To give guidance to review authors on formulating the question, signposting the available data sources on adverse effects and retrieving 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:

We will facilitate discussion on the advantages and disadvantages of a range of approaches to question formulation in systematic reviews incorporating adverse effects.

Next, participants will receive a number of scenarios and will 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.

At the end, the groups will feed back 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 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. Problems faced by patients seeking information about adverse effects will also be illustrated.