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- An adverse event is harm that occurs while a patient is taking a drug, irrespective of whether the drug is suspected to be the cause. A side-effect is any effect caused by a drug other than the intended therapeutic effect, whether beneficial, neutral or harmful.
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Jun 22, 2023 · Introduction: Adverse events refer to any unexpected or harmful reaction to medical treatment, medication, or healthcare intervention. These events can range from mild to severe and can have long-lasting effects on a patient's health.
- 1 Introduction to Issues in Addressing Adverse Effects#Section-19-1
- 2 Formulation of The Review#Section-19-2
- 3 Identification of Evidence#Section-19-3
- 4 Appraisal of Evidence#Section-19-4
- 5 Synthesis and Interpretation of Evidence#Section-19-5
- 6 Chapter Information#Section-19-6
- 7 References#Section-19-7
Every healthcare intervention comes with the risk, great or small, of harmful or adverse effects. 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. All reviews should try...
A starting point for assessing adverse effects of an intervention is to consider whether a review will evaluate both beneficial and adverse effects of an intervention, or just the adverse effects. Although most Cochrane Reviews look at both beneficial and adverse effects, review authors may decide to conduct a separate review of only the adverse ef...
19.3.1 Search methods for adverse effects data#section-19-3-1
When considering the search process, review authors may decide to perform a single search to retrieve studies evaluating both benefits and harms. If so, the search strategy should be designed to take account of the selected approach, either confirmatory, exploratory or hybrid, and any differences in eligibility criteria for addressing beneficial and adverse effects. A single search may be reasonable if it is sufficiently broad (e.g. if it captures all studies containing a specific drug name o...
19.3.2 Allocating resources for the search#section-19-3-2
Despite significant improvements in reporting of adverse effects in primary studies, specific terms relating to adverse effects may not feature in the title, abstract, keywords or bibliographic database indexing systems. To determine the necessary work and resources involved, careful scoping when drafting the review question is recommended. This may need to account for the inclusion of unpublished data (see Section 19.3.4 and Chapter 4) and non-randomized studies (see Chapter 24).
19.3.3 Sources to search #section-19-3-3
Due to the variable content and indexing techniques of healthcare databases, it is important not to restrict adverse effect review searches to a single source, nor to a limited combination of the primary clinical research databases. Performing a search in MEDLINE alone is not recommended. A case study reviewing adverse effects of thiazolidinedione use in patients diagnosed with type 2 diabetes mellitus tested over 60 sources (Golder and Loke 2012).The results indicated that the minimum combin...
19.4.1 Challenges in assessing risk of bias for adverse effects data#section-19-4-1
Assessing risk of bias for pre-specified adverse effects that are actively monitored in included studies is generally the same as for the pre-specified beneficial effects. However, adverse effects are seldom specified as primary outcomes, and often are not pre-specified at all, so there is often lack of clarity in the methods used to obtain adverse effects data. Thus, different susceptibilities to bias can arise for adverse effects due to the way in which they are measured, recorded and repor...
19.4.2 Recommended tools for assessing risk of bias in adverse effects data#section-19-4-2
Review authors should use the currently recommended risk-of-bias tools,the RoB 2 tool for randomized trials (see Chapter 8), and the ROBINS-I tool for non-randomized studies (see Chapter 25). Although these tools are most easily directed atoutcomes that have been pre-specified by the review team, they are suitable for any type of quantitative outcome analysed in a review. Where adverse effects are extracted post hoc from included trials in an exploratory approach, it may not be possible to li...
19.4.3 Selective outcome reporting bias of adverse effects data#section-19-4-3
Selective outcome reporting refers to authors reporting a subset of variables, based on the results, from among all the outcomes originally analysed (see Chapter 7). Selective outcome reporting distorts the body of available evidence on which to conduct data synthesis and can lead to a high risk of bias (Kicinski et al 2015). Missing or partially reported adverse effects data are common in systematic reviews evaluating adverse effects (Saini et al 2014). There is evidence that Cochrane Review...
19.5.1 Estimating intervention effects from adverse effects#section-19-5-1
Review authors can have greater confidence in their interpretation of adverse effects data when outcomes are defined, monitored and reported as pre-specified outcomes in the research studies. In contrast, where the adverse effects are unexpected or ascertained ad hoc through spontaneous reporting, review authors will have to make more cautious interpretations regarding perceived safety or lack of harm, unless there is evidence that monitoring and reporting were sufficiently robust to have acc...
19.5.2 Synthesizing and interpreting ‘zero events’#section-19-5-2
It can be difficult, or unwise, to determine that there were no adverse events of a specific type. Although trial reports may provide tables detailing withdrawals (and reasons) or serious adverse effects, they will not necessarily include all events of interest to the review authors. New or unexpected adverse events may have been missed if ascertainment relied solely on spontaneous reporting. Furthermore, trials may report statements such as “no serious harms were found” without specifying th...
Authors: Guy Peryer, Su Golder, Daniela Junqueira, Sunita Vohra, Yoon Kong Loke; on behalf of the Cochrane Adverse Effects Methods Group Acknowledgements:We thank Julian Higgins, Jamie Kirkham and Barbara Jennings. Funding:This work was supported by Cochrane Methods Innovation Fund.
Chou R, Fu R, Carson S, Saha S, Helfand M. Methodological shortcomings predicted lower harm estimates in one of two sets of studies of clinical interventions. Journal of Clinical Epidemiology 2007; 60: 18-28. Chou R, Aronson N, Atkins D, Ismaila AS, Santaguida P, Smith DH, Whitlock E, Wilt TJ, Moher D. AHRQ series paper 4: assessing harms when comp...
An adverse effect is an undesired harmful effect resulting from a medication or other intervention, such as surgery. [ 1 ] . An adverse effect may be termed a " side effect ", when judged to be secondary to a main or therapeutic effect.
Aug 13, 2023 · The term adverse event is a broad term that can encompass any negative effect. However, a sentinel event is a term used when the result is serious harm or death. Healthcare providers must report adverse events that result in serious harm or death to the patient as sentinel events.
- 2023/08/13
Mar 26, 2021 · An adverse drug reaction (ADR) is any undesirable or unintended effect of the drug that occurs during its proper use. However, an adverse event is the occurrence of an undesirable event during or following the exposure to the drug, but not necessarily caused by the drug itself. An adverse event (AE) may be: A physical event; for example, rash
Adverse drug reaction (ADR, or adverse drug effect) is a broad term referring to unwanted, uncomfortable, or dangerous effects that drugs (including medications ) may have.
Nov 30, 2020 · The comparator arm provides an opportunity to compare rates of adverse events (AEs) which enables signals for potential adverse drug reactions (ADRs) to be identified [1, 2]. 1 Whilst statistical analysis methods for efficacy outcomes in clinical trials are well established the same cannot be said for the analysis of harm outcomes [3, 4, 5].
