Evidence map›Paper›PMID 17615054›Full record

SynthesisBMC medical research methodology2007

Systematic reviews of adverse effects: framework for a structured approach.

Yoon K Loke, Deirdre Price, Andrew Herxheimer, Cochrane Adverse Effects Methods Group

Abstract readSystematic Review
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in BMC medical research methodology, 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 98 papers, 59 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
98citing papers in PubMed, 59 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

98 citing papers in PubMed, 59 syntheses or guidelines pooled it.

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  3. Serious adverse events associated with bowel preparation for colonoscopy in Japan: Systematic review.Digestive endoscopy : official journal of the Japan Gastroenterological Endoscopy Society · 2025
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  5. Side-effects of mdma-assisted psychotherapy: a systematic review and meta-analysis.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2024
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  6. Topical fluoride as a cause of dental fluorosis in children.The Cochrane database of systematic reviews · 2024
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  17. Seizures and quinolone antibiotics in children: a systematic review of adverse events.European journal of hospital pharmacy : science and practice · 2020
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38 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Yoon K LokeSchool of Medicine, Health Policy and Practice, University of East Anglia, Norwich, UK. Y.Loke@uea.ac.uk <Y.Loke@uea.ac.uk>
Deirdre Price
Andrew Herxheimer
Cochrane Adverse Effects Methods Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAs every healthcare intervention carries some risk of harm, clinical decision making needs to be supported by a systematic assessment of the balance of benefit to harm. A systematic review that considers only the favourable outcomes of an intervention, without also assessing the adverse effects, can mislead by introducing a bias favouring the intervention. Much of the current guidance on systematic reviews is directed towards the evaluation of effectiveness; but this differs in important ways from the methods used in assessing the safety and tolerability of an intervention. A detailed discussion of why, how and when to include adverse effects in a systematic review, is required.

methodsThis discussion paper, which presupposes a basic knowledge of systematic review methodology, was developed by consensus among experienced reviewers, members of the Adverse Effects Subgroup of The Cochrane Collaboration, and supplemented by a consultation of content experts in reviews methodology, as well as those working in drug safety.

resultsA logical framework for making decisions in reviews that incorporate adverse effects is provided. We explore situations where a comprehensive investigation of adverse effects is warranted and suggest strategies to identify practicable and clinically useful outcomes. The advantages and disadvantages of including observational and experimental study designs are reviewed. The consequences of including separate studies for intended and unintended effects are explained. Detailed advice is given on designing electronic searches for studies with adverse effects data. Reviewers of adverse effects are given general guidance on the assessment of study bias, data collection, analysis, presentation and the interpretation of harms in a systematic review.

conclusionReaders need to be able to recognize how strategic choices made in the review process determine what harms are found, and how the findings may affect clinical decisions. Researchers undertaking a systematic review that incorporates adverse effect data should understand the rationale for the suggested methods and be able to implement them in their review.

Indexed as

Decision Support Systems, ClinicalDrug-Related Side Effects and Adverse ReactionsMeta-Analysis as TopicPractice Guidelines as TopicConsensusDatabases, BibliographicDrug EvaluationHumansInformation Storage and RetrievalMedical Subject HeadingsRandomized Controlled Trials as TopicResearch DesignRisk Assessment

Identifiers

PMID17615054
PMCPMC1933432

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.