Contextual determinants of adverse event reporting: an evidence map and methods proposal to reduce misclassification in E2B(R3) individual case safety report narratives

Purpose: Individual case safety reports (ICSRs) are central to post-marketing pharmacovigilance, yet their narrative sections often lack the contextual information needed to differentiate pharmacologic adverse drug reactions from expectancy- and stress-related symptom formation. We mapped how psychophysiological/nocebo mechanisms are addressed in current pharmacovigilance standards and narrative analytics, and developed a minimal, E2B(R3)-compatible enhancement of ICSR narratives. Methods: We conducted an evidence map using scoping-review methods (PRISMA-ScR). On 18 February 2026, we searched PubMed (MEDLINE), Europe PMC, OpenAlex and IEEE Xplore (2005-17 February 2026) using pre-specified queries combining pharmacovigilance/ICSR narrative concepts with NLP/signal detection and psychophysiology/nocebo terms; we additionally screened the first 200 Google Scholar results (sorted by relevance). Records were exported to Zotero, deduplicated, and screened in Rayyan; full texts were retrieved where available and assessed for eligibility. Results: We identified 966 records; 660 unique records were screened, 350 full texts were assessed, and 250 sources were included for charting. Included sources clustered into narrative analytics/NLP (n=125), narrative data quality and standards (n=87), operationalization of context determinants (n=33), and nocebo/psychophysiology mechanisms (n=5). Conclusions: We propose a short micro-template placed in existing narrative fields plus a 3-level CPD flag (unlikely/possible/likely) as a context covariate for pharmacovigilance workflows. The proposal aims to reduce misclassification and spurious signals while remaining compatible with E2B(R3), low-burden for reporters, and safeguarded against stigmatizing interpretations.