Eliciting adverse effects data from participants in clinical trials

Abstract

This review supports concerns that methods to elicit participant-reported AEs influence the detection of these data. There was a risk for under-detection of AEs in studies using a more general elicitation method compared to those using a comprehensive method. These AEs may be important from a clinical perspective or for patients. This under-detection could compromise ability to pool AE data. However, the impact on the nature of the AE detected by different methods is unclear. The wide variety and low quality of methods to compare elicitation strategies limited this review. Future studies would be improved by using and reporting clear definitions and terminology for AEs (and other important variables), frequency and time period over which they were ascertained, how they were graded, assessed for a relationship to the study drug, coded, and tabulated/reported. While the many potential AE endpoints in a trial may preclude the development of general AE patient-reported outcome measurement instruments, much could also be learnt from how these employ both quantitative and qualitative methods to better understand data elicited. Any chosen questioning method needs to be feasible for use by both staff and participants.

Real-world effectiveness and tolerability of erenumab: A retrospective cohort study

“…A review of FDA documents also notes that this could not be determined (17). It is possible that adverse event ascertainment in erenumab clinical trials involved asking open-ended questions only, which is known to be suboptimal and in particular may lead to underreporting of psychiatric, sexual, or other adverse events (18). Clinical trials are typically designed to focus on efficacy endpoints rather than adverse event endpoints.…”

The prevalence, characteristics and treatment of hemorrhoidal disease: results of an international web-based survey

“…Second, our survey used a multiple-choice format to ask participants about their symptoms, which may have prompted them to report pain, thus leading to a higher incidence. Analyses of methods to elicit adverse event information suggest that questioning patients about specific events or symptoms usually results in higher rates of reporting than open-ended questions that rely on patients spontaneously reporting that event [15,16]. A similar effect may be at play in surveys using multiple-choice questions to elicit symptom information.…”

Probiotics: If It Does Not Help It Does Not Do Any Harm. Really?

“…Safety is further complicated by the fact that various companies use duplicate cultures of the original strains, by applying fingerprinting techniques, potentially increasing the risk of detrimental effects [149]. To fill the gap in reliability and transparency in probiotics effectiveness and safety the following need to be considered: eliciting side effects data from participants [198], suboptimal adherence to reporting guidelines [199,200,201], over food industry funding mounting to 60% of the screened studies [202], lack of long-term effects in normal and vulnerable populations [203], and occasional lack of viable organisms [204]. Most recently, skepticism was raised concerning the labeled number of bacteria in probiotic preparations, publication bias, the generalizability of findings, and the safety in immune deficient hosts [13].…”