High prevalence of spin was found in pharmacovigilance studies using disproportionality analyses to detect safety signals: a meta-epidemiological study

Mouffak, Amelle; Lepelley, Marion; Revol, Bruno; Bernardeau, Claire; Salvo, Francesco; Pariente, Antoine; Roustit, Matthieu; Cracowski, Jean‐Luc; Khouri, Charles

doi:10.1016/j.jclinepi.2021.06.022

Cited by 29 publications

(14 citation statements)

References 23 publications

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“…We defined spin as the “use of specific reporting strategies, from whatever motive, to highlight that the experimental treatment is beneficial, despite a statistically nonsignificant difference for the primary endpoint, or to distract the reader from statistically nonsignificant results,” as proposed by Boutron et al 6 We used this definition to evaluate the presence of spin in the results and conclusion sections in the abstracts, as well as the results, discussion, and conclusion sections in the main text of each report. The spin strategies were identified according to the type of research, 18 , 19 , 20 , 21 and we identified spin strategies for noninferiority RCTs. Spin was considered to be present if the report corresponded to the strategies of spin specified in advance and improperly emphasized the benefit of the experimental treatment.…”

Section: Methodsmentioning

confidence: 99%

Misleading Reporting (Spin) in Noninferiority Randomized Clinical Trials in Oncology With Statistically Not Significant Results

et al. 2021

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Key Points Question Is the interpretation and reporting of noninferiority trials with primary end point results that are not statistically significant correct, and what are the associated factors of misleading reporting? Findings This systematic review of 52 noninferiority randomized clinical trials of cancer treatments with results for primary end points that are not statistically significant, 75% included misleading reporting. Multivariable analysis found that the prevalence of misleading reporting was significantly lower in reports with funding from for-profit sources and higher in reports of novel experimental treatments. Meaning These findings suggest that authors should carefully consider noninferiority cancer clinical trial result interpretation and reporting, especially for primary outcome results that are not statistically significant.

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Section: Methodsmentioning

confidence: 99%

Misleading Reporting (Spin) in Noninferiority Randomized Clinical Trials in Oncology With Statistically Not Significant Results

et al. 2021

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“…Inherent limitations in this study type include, underreporting and selective reporting, which can cause underestimation or overestimation ROR values due to factors such as reaction severity, training of the reporter in identifying a reaction, drug notoriety, etc 21 . Furthermore, disproportionality analysis do not establish a causal link between the adverse event and drug of interest, therefore, the results cannot be interpreted as such 28 . These studies are useful in identifying associations for further study and estimating risk.…”

Section: Discussionmentioning

confidence: 99%

Severe cutaneous adverse reactions associated with the immune checkpoint inhibitors: A case/non‐case analysis using the Food and Drug Administration Adverse Event Reporting System

Godfrey,

Jedlowski,

Thiede

2024

Aust J Dermatology

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Background/ObjectivesThe immune checkpoint inhibitors (ICIs) have been increasingly associated with severe cutaneous adverse reactions (SCARs). These reactions, including Stevens–Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP) are uncommon but potentially lethal. Despite the severity of these reactions and growing association with the ICIs, their specific risk and mortality rates have been largely unexplored.MethodsA case/non‐case analysis was performed using data from the United States Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) to examine the reporting odds ratios (RORs) for ICI‐associated SCARs cases under two conditions: (1) ICIs compared with all drugs in FAERS and (2) ICIs compared with a reference group of pooled anticancer drugs to control for underlying malignancy.ResultsA statistically significant ROR for SJS (ROR: 5.44), TEN (ROR: 5.81) and DRESS (ROR: 1.38) were identified under Condition 1. Under Condition 2, this significance was maintained for SJS (ROR: 7.31), TEN (ROR: 7.40) and DRESS (ROR: 3.90), and mild significance was identified for AGEP (ROR: 1.89). Mortality rates for the ICIs were increased compared with the anticancer medications (28.5% vs. 24.5% for SJS, 55.3% vs. 46% for TEN, 3.0% vs. 2.1% for AGEP and 7.1% vs. 6.1% for DRESS).ConclusionsOur results suggest an association between SCARs and the ICIs independent of cancer status.

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“…We have shown that, despite a five-fold increase in DAs in recent years, regulators seldom rely on DAs alone and that some DAs lack information on prior documentation of ADRs. Earlier research has shown that DAs alone rarely support and may follow/confirm regulatory decisions [ 32 ], in addition to suffering from spin or overinterpretation [ 33 ], and that determining if SDRs merit further action further demands substantial resources [ 34 ].…”

Section: Discussionmentioning

confidence: 99%

Signals of Adverse Drug Reactions Communicated by Pharmacovigilance Stakeholders: A Scoping Review of the Global Literature

et al. 2022

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Introduction and Objective Signals of adverse drug reactions (ADRs) can be supported by reports of ADRs and by interventional and non-interventional studies. The evidence base and features of ADR reports that are used to support signals remain to be comprehensively described. To this end, we have undertaken a scoping review. Methods We searched the following databases: PubMed, EMBASE, PsycINFO, Web of Science, and Google Scholar, without language or time restrictions. We also hand searched the bibliographies of relevant studies. We included studies of any design if the results were described as signals . We assessed the levels of evidence using the Oxford Centre for Evidence-Based Medicine (OCEBM) criteria and coded features of reports of ADRs using the Bradford Hill guidelines. Results Overall, 1974 publications reported 2421 studies of signals; 1683/2421 were clinical assessments of anecdotal reports of ADRs, but only 225 (13%) of these included explicit judgments on which features of the ADR reports were supportive of a signal. These 225 studies yielded 228 signals; these were supported by features, which were: ‘experimental evidence’ (i.e., positive dechallenge or rechallenge, 154 instances [68%]), ‘temporality’ (i.e., time to onset, 130 [57%]), ‘exclusion of competing causes’ (49 [21%]), and others (40 [17%]). Positive dechallenge/rechallenge often co-occurred with temporality (77/228). OCEBM 4 (i.e., case series and case-control studies) was the most frequent level of evidence (2078 studies). Between 2013 and 2019, there was a three-fold increase in clinical assessments of reports of ADRs compared with a less than two-fold increase in studies supported by higher levels of evidence (i.e., OCEBM 1–3). We identified an increased rate between 2013 and 2019 in disproportionality analyses (about 15 studies per year), mostly from academia. Conclusions Most signals were supported by temporality and dechallenge/rechallenge, but clear reporting of judgments on causality remains infrequent. The number of studies supported only by anecdotal reports of ADRs increased from year to year. The impact of a growing number of signals of disproportionate reporting communicated without an accompanying clinical assessment should be evaluated.

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High prevalence of spin was found in pharmacovigilance studies using disproportionality analyses to detect safety signals: a meta-epidemiological study

Cited by 29 publications

References 23 publications

Misleading Reporting (Spin) in Noninferiority Randomized Clinical Trials in Oncology With Statistically Not Significant Results

Misleading Reporting (Spin) in Noninferiority Randomized Clinical Trials in Oncology With Statistically Not Significant Results

Severe cutaneous adverse reactions associated with the immune checkpoint inhibitors: A case/non‐case analysis using the Food and Drug Administration Adverse Event Reporting System

Signals of Adverse Drug Reactions Communicated by Pharmacovigilance Stakeholders: A Scoping Review of the Global Literature

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