Get One At A Time; Producing Patient Profiles And Narratives

ICH GUIDANCE ON CLINICAL STUDY REPORTS As Per ICH E3 guidelines, a patient safety narrative should describe the following: the nature, intensity, and outcome of the event. the clinical course leading to the event. an indication of timing relevant to study drug administration.

A typical patient narrative report or warning should be written in a specific way: The exact nature, the intensity of the medical issue and the final outcome of the event. The medical course that led to the event. Drug administration regularity.

A medical professional may outline details of an accident victim's injuries as well as their treatment, disability impairment, if any, and prognosis in a written document referred to as a medical narrative.

The purpose of writing patient narratives is to provide a concise summary of identified/specific adverse events (AEs) occurring in a patient to conclude causal relationship between the investigational drug and AE.

A Medical Narrative Summary is a concise yet compelling report that provides a summary of all the medical treatment in a manner that is easy to understand.

In medicine, we are engaged in patient profiling when we make biased assumptions regarding our patients, their health status, and their risk factors based on their demographics or appearance. Profiling can fracture the patient-provider relationship and contribute to inequitable care.

Your story should be 1 – 3 pages in length. Review your story with a colleague who also cared for the patient. This may help you identify additional details and information that should be included.

It should make your audience want to read more. If it's a person, begin with a description of the person and then say why that person mattered. If it's an event, begin with the action or begin by reflecting back on why the event mattered, then go into the narrative.