Invisible harm in patient safety: a framework and definition for preventable psychological harm in cancer care.

Background: While patient safety is receiving increasing attention in healthcare services research and policies, it is mainly centred around prevention of physical harm. Preventable psychological harm (PPH) remains invisible in reports and quality measurements. As patients with cancer are particularly vulnerable due to the severity of their condition and therapies, they are exposed to risks such as non-physical adverse events. Recently, incidents of psychological harm have gained more attention in patient safety research, but a common and accepted definition and classification are missing.

Aim: We aimed to develop a common definition of PPH and a corresponding framework to classify events, settled within patient safety concepts and terminology.

Methods: Through a literature review, expert interviews from various healthcare backgrounds and workshops with patient representatives, we gathered information on PPH, which was reviewed and structured by an interdisciplinary research team (patient safety, psycho-oncology, palliative care research, nursing, organisational psychology). The final definition and framework were iteratively developed taking into account existing patient safety concepts.

Results: The definition broadens the classification of PPH to include a wide range of commissions and omissions by individuals or organizational practices within the health care system. These actions and inactions result in consequences of varying severity for patients and their close ones. The framework complements the definition of PPH, including those impacted by PPH, types of PPH, potential causes and contributing factors, vulnerabilities influencing severity and occurrence, moderating factors for mitigation and negative consequences of PPH.

Conclusions: Defining and classifying PPH is the first step to make it accessible for measurement, analysis and prevention. Its integration within patient safety terminology is important to ensure uptake and integration in research and practice.