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Study investigators may use active monitoring or surveillance, which directs enquiry towards pre-defined adverse events of interest, usually following protocol-defined procedures for data collection, case definitions and adjudication. There are two broad strategies for collecting information on adverse events. Third, many adverse events are too uncommon or too long-term to be observed within randomized trials.ġ9.1.2.1 Diversity in defining and monitoring of adverse eventsĪ huge range of adverse events can occur in a research study, and there are multiple ways in which adverse effects can be ascertained and categorized by study investigators (Smith et al 2015).
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Second, adverse effects may not be known when studies were planned, so data collection processes and analytic strategies may not be in place. First, there can be wide diversity across studies in how adverse events are defined, ascertained, analysed and reported. In this section we discuss some of the particular challenges when addressing adverse effects. In this chapter we use the term adverse event for an unfavourable or harmful outcome that occurs during, or after, the use of a drug or other intervention, but is not necessarily caused by it, and an adverse effect (or harm) as an adverse event for which the causal relation between the intervention and the event is at least a reasonable possibility.ġ9.1.2 Special issues for addressing adverse effects Common, and closely related, terms include adverse event, adverse effect, serious adverse event, serious adverse effects, adverse drug reaction, side effect, complications and harms (Zorzela et al 2016). Poor standardization and usage of adverse effects terminology in study reports can produce challenges for review authors. It focuses on methodological differences when assessing adverse effects compared with other outcomes. This chapter addresses special issues about adverse effects in Cochrane Reviews. All reviews should try to consider the adverse aspects of interventions. A Cochrane Review that considers only the favourable outcomes of the interventions that it examines, without also assessing the adverse effects, will lack balance and may make the intervention look more favourable than it should. Available from 19.1 Introduction to issues in addressing adverse effectsĮvery healthcare intervention comes with the risk, great or small, of harmful or adverse effects.
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Cochrane Handbook for Systematic Reviews of Interventions version 6.3 (updated February 2022). In: Higgins JPT, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA (editors). The approach may be confirmatory (focused on particular adverse effects of interest), exploratory (opportunistic capture of any adverse effects that happen to be reported), or a hybrid (combination of both).ĭepending on the approach used and outcomes of interest to the review, identification of relevant adverse effects data may require a bespoke search process that includes a wider selection of sources than that required to identify data on beneficial outcomes.īecause adverse effects data are often handled with less rigour than the primary beneficial outcomes of a study, review authors must recognize the possibility of poor case definition, inadequate monitoring and incomplete reporting when synthesizing data.Ĭite this chapter as: Peryer G, Golder S, Junqueira D, Vohra S, Loke YK. Review authors should pre-specify their approach to reviewing studies of adverse effects within the review protocol. This is due to high diversity in the number and type of possible adverse effects, as well as variation in their definition, methods of ascertainment, incidence and time-course.
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There are major challenges in specifying relevant outcomes and study designs for systematic reviews evaluating adverse effects. To achieve a balanced perspective, all reviews should try to consider adverse aspects of interventions.Ī detailed analysis of adverse effects is particularly relevant when evidence on the potential for harm has a major influence on treatment or policy decisions.