Reporting of Adverse Events in Published and Unpublished Studies of Health Care Interventions : A Systematic Review

BACKGROUND: We performed a systematic review to assess whether we can quantify the underreporting of adverse events (AEs) in the published medical literature documenting the results of clinical trials as compared with other nonpublished sources, and whether we can measure the impact this underreporting has on systematic reviews of adverse events. METHODS AND FINDINGS: Studies were identified from 15 databases (including MEDLINE and Embase) and by handsearching, reference checking, internet searches, and contacting experts. The last database searches were conducted in July 2016. There were 28 methodological evaluations that met the inclusion criteria. Of these, 9 studies compared the proportion of trials reporting adverse events by publication status. The median percentage of published documents with adverse events information was 46% compared to 95% in the corresponding unpublished documents. There was a similar pattern with unmatched studies, for which 43% of published studies contained adverse events information compared to 83% of unpublished studies. A total of 11 studies compared the numbers of adverse events in matched published and unpublished documents. The percentage of adverse events that would have been missed had each analysis relied only on the published versions varied between 43% and 100%, with a median of 64%. Within these 11 studies, 24 comparisons of named adverse events such as death, suicide, or respiratory adverse events were undertaken. In 18 of the 24 comparisons, the number of named adverse events was higher in unpublished than published documents. Additionally, 2 other studies demonstrated that there are substantially more types of adverse events reported in matched unpublished than published documents. There were 20 meta-analyses that reported the odds ratios (ORs) and/or risk ratios (RRs) for adverse events with and without unpublished data. Inclusion of unpublished data increased the precision of the pooled estimates (narrower 95% confidence intervals) in 15 of the 20 pooled analyses, but did not markedly change the direction or statistical significance of the risk in most cases. The main limitations of this review are that the included case examples represent only a small number amongst thousands of meta-analyses of harms and that the included studies may suffer from publication bias, whereby substantial differences between published and unpublished data are more likely to be published. CONCLUSIONS: There is strong evidence that much of the information on adverse events remains unpublished and that the number and range of adverse events is higher in unpublished than in published versions of the same study. The inclusion of unpublished data can also reduce the imprecision of pooled effect estimates during meta-analysis of adverse events

Are citations from clinical trials evidence of higher impact research? An analysis of ClinicalTrials.gov

An important way in which medical research can translate into improved health outcomes is by motivating or influencing clinical trials that eventually lead to changes in clinical practice. Citations from clinical trials records to academic research may therefore serve as an early warning of the likely future influence of the cited articles. This paper partially assesses this hypothesis by testing whether prior articles referenced in ClinicalTrials.gov records are more highly cited than average for the publishing journal. The results from four high profile general medical journals support the hypothesis, although there may not be a cause-and effect relationship. Nevertheless, it is reasonable for researchers to use citations to their work from clinical trials records as partial evidence of the possible long-term impact of their research

Supply of medicines: paternalism, autonomy and reality.

Radical changes are taking place in the United Kingdom in relation to the classification of, and access to, medicines. More and more medicines are being made available over the counter both in local pharmacies and in supermarkets. The provision of more open access to medicines may be hailed as a triumph for patient autonomy. This paper examines whether such a claim is real or illusory. It explores the ethical and legal implications of deregulating medicines. Do patients benefit? What is the impact on pharmacists? Are the true beneficiaries of change largely the pharmaceutical industries

P125 Online survey of perspectives on lung imaging use in cystic fibrosis

ObjectivesAs an emerging technology in cystic fibrosis (CF), there is potential for misunderstanding of lung magnetic resonance imaging (MRI) scan results. As the initial stage of a project to develop a results communication toolkit, we sought to explore experiences of lung imaging in CF.MethodsAn online survey of UK people with CF (pwCF), carers and healthcare professionals took place in early 2024. The survey had two areas of focus – the communication of scan results and use of lung MRI. A stepped design asked respondents about MRI, computed tomography (CT) or X-ray, depending on personal experience. The analysis incorporated both descriptive statistics and a tailored thematic approach.ResultsThe survey received 100 responses (n=50 pwCF / carers; n=50 healthcare staff). The results indicated general satisfaction from pwCF / carers around receiving results, who reported a fair-very good understanding (n=40/44) and that the process could not have been improved (n=35/50). However, healthcare staff identified areas for improvement around interpretation and understanding (n=40/43), and communication (n=36/41). Although few respondents had MRI experience (n=24), just over half (n=52) felt it was useful in CF or were unsure (n=48).Three themes were identified. 1) The role of imaging in CF explored the focus for pwCF / carers in comparing results, particularly in relation to modulator therapy impact. 2) The process of communication considered what was communicated to pwCF / carers, in particular image visualisation. 3) Considerations and challenges around imaging included time pressures around communication, the emotional impact of results and potential benefit of structured clinical imaging training.ConclusionThe results indicated the value of imaging and communication of findings, and general positivity towards MRI. They identified areas for focus in subsequent activity, such as supporting better clinical imaging understanding and the emotional burden