Dataset Information

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

ABSTRACT:

Background

As 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.

Methods

This 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.

Results

A 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.

Conclusion

Readers 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.

SUBMITTER: Loke YK

PROVIDER: S-EPMC1933432 | biostudies-literature | 2007 Jul

REPOSITORIES: biostudies-literature

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Publications

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

Loke Yoon K YK Price Deirdre D Herxheimer Andrew A

BMC medical research methodology 20070705

<h4>Background</h4>As 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 i ...[more]

PMID: 17615054

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Project description:BackgroundBefore implementing healthcare interventions, clinicians need to weigh the beneficial and adverse effects of interventions. However, a large body of evidence has demonstrated that seeking and reporting of adverse effects is suboptimal in clinical trials and in systematic reviews of interventions. This cross-sectional study will investigate the status of this problem in orthodontics. This study will assess whether adverse effects were sought and whether findings related to adverse effects were reported in systematic reviews of orthodontic interventions in the five leading orthodontic journals and in the Cochrane Database of Systematic Reviews.MethodsSystematic reviews of clinical orthodontic interventions published between 01 August 2009 and 31 July 2019 in the five leading orthodontic journals and in the Cochrane Database will be included. Empty reviews will be excluded. The reporting of outcomes on adverse effects will not determine eligibility, i.e., reviews will not be excluded, because they did not report usable data. Study selection and data extraction will be conducted independently by two authors. Our primary outcome will be the prevalence of systematic reviews of orthodontic interventions that sought any findings related to adverse effects in the included studies. Additional prevalence statistics will be calculated on a series of items related to seeking of adverse effects in the eligible reviews. All statistics will be calculated for (1) all journals together, (2) the group of five orthodontic journals and the Cochrane Database of Systematic Reviews separately, and (3) each individual journal separately. Chi-square tests of independence will be used to compare these groups.DiscussionThis study will assess whether adverse effects were sought in systematic reviews of orthodontic interventions. This knowledge is important, because reviews that present an incomplete picture on adverse effects can have unfavorable consequences for the end-users. Also not reporting that no adverse effects were assessed in eligible studies included in a systematic review can mislead pertinent stakeholders. Our findings could have policy implications for making judgments on accepting or rejecting an intervention systematic review for publication, for example, by directing editors and peer-reviewers to adopt the various items on adverse effects defined in the MECIR standards and in the PRISMA harm checklist.

Project description:ObjectivesTo examine the quality of reporting of harms in systematic reviews, and to determine the need for a reporting guideline specific for reviews of harms.DesignSystematic review.Data sourcesCochrane Database of Systematic Reviews (CDSR) and Database of Abstracts of Reviews of Effects (DARE).Review methodsDatabases were searched for systematic reviews having an adverse event as the main outcome, published from January 2008 to April 2011. Adverse events included an adverse reaction, harms, or complications associated with any healthcare intervention. Articles with a primary aim to investigate the complete safety profile of an intervention were also included. We developed a list of 37 items to measure the quality of reporting on harms in each review; data were collected as dichotomous outcomes ("yes" or "no" for each item).ResultsOf 4644 reviews identified, 309 were systematic reviews or meta-analyses primarily assessing harms (13 from CDSR; 296 from DARE). Despite a short time interval, the comparison between the years of 2008 and 2010-11 showed no difference on the quality of reporting over time (P=0.079). Titles in fewer than half the reviews (proportion of reviews 0.46 (95% confidence interval 0.40 to 0.52)) did not mention any harm related terms. Almost one third of DARE reviews (0.26 (0.22 to 0.31)) did not clearly define the adverse events reviewed, nor did they specify the study designs selected for inclusion in their methods section. Almost half of reviews (n=170) did not consider patient risk factors or length of follow-up when reviewing harms of an intervention. Of 67 reviews of complications related to surgery or other procedures, only four (0.05 (0.01 to 0.14)) reported professional qualifications of the individuals involved. The overall, unweighted, proportion of reviews with good reporting was 0.56 (0.55 to 0.57); corresponding proportions were 0.55 (0.53 to 0.57) in 2008, 0.55 (0.54 to 0.57) in 2009, and 0.57 (0.55 to 0.58) in 2010-11.ConclusionSystematic reviews compound the poor reporting of harms data in primary studies by failing to report on harms or doing so inadequately. Improving reporting of adverse events in systematic reviews is an important step towards a balanced assessment of an intervention.

Project description:Qualitative systematic reviews or qualitative evidence syntheses (QES) are increasingly recognised as a way to enhance the value of systematic reviews (SRs) of clinical trials. They can explain the mechanisms by which interventions, evaluated within trials, might achieve their effect. They can investigate differences in effects between different population groups. They can identify which outcomes are most important to patients, carers, health professionals and other stakeholders. QES can explore the impact of acceptance, feasibility, meaningfulness and implementation-related factors within a real world setting and thus contribute to the design and further refinement of future interventions. To produce valid, reliable and meaningful QES requires systematic identification of relevant qualitative evidence. Although the methodologies of QES, including methods for information retrieval, are well-documented, little empirical evidence exists to inform their conduct and reporting.This structured methodological overview examines papers on searching for qualitative research identified from the Cochrane Qualitative and Implementation Methods Group Methodology Register and from citation searches of 15 key papers.A single reviewer reviewed 1299 references. Papers reporting methodological guidance, use of innovative methodologies or empirical studies of retrieval methods were categorised under eight topical headings: overviews and methodological guidance, sampling, sources, structured questions, search procedures, search strategies and filters, supplementary strategies and standards.This structured overview presents a contemporaneous view of information retrieval for qualitative research and identifies a future research agenda. This review concludes that poor empirical evidence underpins current information practice in information retrieval of qualitative research. A trend towards improved transparency of search methods and further evaluation of key search procedures offers the prospect of rapid development of search methods.

Project description:BackgroundIt is critical that abstracts of systematic reviews transparently report both the beneficial and adverse effects of interventions without misleading the readers. This cross-sectional study assessed whether adverse effects of interventions were reported or considered in abstracts of systematic reviews of orthodontic interventions and whether spin on adverse effects was identified when comparing the abstracts with what was sought and reported in these reviews.MethodsThis cross-sectional study (part 2 of 2) used the same sample of 98 systematic reviews orthodontic interventions as used in part 1. Eligible reviews were retrieved from the Cochrane Database of Systematic Reviews and the 5 leading orthodontic journals between August 1 2009 and July 31 2021. Prevalence proportions were sought for 3 outcomes as defined in the published protocol. Univariable logistic regression models were built to explore associations between the presence of spin in the abstract and a series of predictors. Odds ratios (OR) 95% confidence intervals (95% CI) were used to quantify the strength of associations and their precision.Results76.5% (75/98) of eligible reviews reported or considered (i.e., discussed, weighted etc.) potential adverse effects of orthodontic interventions in the abstract and the proportion of spin on adverse effects was 40.8% (40/98) in the abstract of these reviews. Misleading reporting was the predominant category of spin, i.e., 90% (36/40). Our explorative analyses found that compared to the Cochrane Database of Systematic Reviews all 5 orthodontic journals had similar odds of the presence of spin on adverse effects in abstracts of systematic reviews of orthodontic interventions. The odds of the presence of spin did not change over the sampled years (OR: 1.03, 95% CI: 0.9 to 1.16) and did not depend on the number of authors (OR: 0.93, 95% CI: 0.71 to 1.21), or on the type of orthodontic intervention (OR: 1.1, 95% CI: 0.45 to 2.67), or whether conflicts of interests were reported (OR: 0.74, 95% CI: 0.32 to 1.68).ConclusionEnd users of systematic reviews of orthodontic interventions have to be careful when interpreting results on adverse effects in the abstracts of these reviews, because they could be jeopardized by uncertainties such as not being reported and misleading reporting as a result of spin.

Project description:BackgroundA structured approach involves systematic management of trauma patients. We aim to conduct an overview of reviews about the clinical efficacy and safety of structured approach (i.e., primary and secondary survey) by guideline checklist compared to non-structured approach (i.e. clinical examination); moreover, routine screening whole-body computer tomography (WBCT) was compared to non-routine WBCT in patients with suspected major trauma.MethodsWe systematically searched MEDLINE (PubMed), EMBASE and Cochrane Database of Systematic Reviews up to 3 May 2022. Systematic reviews (SRs) that investigated the use of a structured approach compared to a non-structured approach were eligible. Two authors independently extracted data, managed the overlapping of primary studies belonging to the included SRs and calculated the corrected covered area (CCA). The certainty of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology.ResultsWe included nine SRs investigating two comparisons in stable trauma patients: structured approach vs non-structured approach (n = 1) and routine WBCT vs non-routine WBCT (n = 8). The overlap of included primary studies was generally high across outcomes (CCA ranged between 20.85 and 42.86%) with some discrepancies in the directions of effects across reviews. The application of a structured approach by checklist may improve adherence to guidelines (e.g. Advanced Trauma Life Support) during resuscitation and might lead to a reduction in mortality among severely injured patients as compared to clinical examination (Adjusted OR 0.51; 95% CI 0.30-0.89; p = 0.018; low certainty of evidence). The use of routine WBCT seems to offer little to no effects in reducing mortality and time spent in emergency room or department, whereas non-routine WBCT seems to offer little to no effects in reducing radiation dose, intensive care unit length of stay (LOS) and hospital LOS (low-to-moderate certainty of evidence).ConclusionsThe application of structured approach by checklist during trauma resuscitation may improve patient- and process-related outcomes. Including non-routine WBCT seems to offer the best trade-offs between benefits and harm. Clinicians should consider these findings in the light of their clinical context, the volume of patients in their facilities, the need for time management, and costs.

Dataset Information

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

Background

Methods

Results

Conclusion

Publications

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

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