Patient and Family-Initiated Safety Event Reporting: A Scoping Review

Background Patient- and family-initiated safety event reporting is increasingly recognized as a valuable complement to clinician-led reporting in healthcare. While patients and families frequently identify unique safety concerns, such as communication breakdowns, near misses, and care coordination failures, these insights remain underutilized in formal quality improvement efforts. Objective This scoping review aimed to synthesize existing literature on the implementation, use, and impact of patient- and family-initiated safety event reporting systems across healthcare settings. Methods Following the Arksey and O’Malley framework and PRISMA-ScR (Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews) guidelines, we conducted a comprehensive search of five databases (MEDLINE, CINAHL, Embase, Scopus, PsycINFO) for empirical studies published between 2000 and 2025. Eligible studies focused on systems enabling patients or families to report safety concerns, adverse events, or near misses. Two reviewers independently screened and extracted data, which were synthesized thematically. Results Twenty studies met the inclusion criteria. Four key themes emerged: (1) diverse but poorly integrated reporting mechanisms, (2) unique safety concerns identified by patients and families, (3) persistent barriers to reporting—such as fear of retaliation and limited awareness, and (4) limited evidence of systematic follow-up or impact on patient safety outcomes. Although reporting systems have expanded, most remain siloed, and few demonstrate clear links between patient reports and safety improvements. Conclusions Patient- and family-initiated reporting offers unique insights into safety but is hampered by fragmented implementation and lack of impact evaluation. Future efforts must prioritize integration, equity, and responsiveness to meaningfully engage patients and families in safety surveillance and system learning. Plain Language Summary Engaging patients and families in their own care is an important way of keeping them informed and involved, leading to better treatment and outcomes. Similarly, reporting about patient safety events is vital to driving change and preventing future harm. Event reports usually originate from clinical providers such as nurses and physicians, though there continue to be many challenges around underreporting. However, patients and their caregivers also play a central role in raising safety concerns, as they often notice breakdowns in communication and procedure, and potential errors that otherwise go undetected by healthcare staff. Patient participation in reviewing adverse events has been shown to foster learning at the organization and trust in healthcare, but patients’ ability to contribute to safety surveillance and processes is limited by lack of awareness or access to reporting systems, as well as cultural norms, insufficient buy-in at the institution, and other barriers. Moreover, there is limited evidence of whether their concerns resulted in changes or had any impact on patient safety. To better understand the state of patient- and family-initiated reporting and opportunities for improvement, this study reviewed existing literature in five major research databases for insights about mechanisms designed to allow patients and families to report safety concerns, adverse events, or near misses.