Narrative Writing In Clinical Research
Narrative writing in clinical research involves an approach to communicating the finding of a study. Instead of simply presenting data results in a dry, technical format, we can use narrative writing to create a compelling and accessible story that engages readers and make the research more relatable. In practice, this might involve structuring the research report in a way that follows a narrative arc, with a clear beginning, middle, and end.
Researchers can use language that is easy to understand and avoid technical jargon as much as possible. They can also include anecdotes and examples to illustrate their findings and make them more tangible. Narrative writing in clinical research can help to humanize the research and make it more relevant to a wider audience
It can also help researchers to highlight the real-world implications of their findings and show how their work can have positive impact on people’s lives 9
Components of Patient Narrative:
As per International Conference on Hormonisation (ICH) E3 Guidelines,a patient narrative must contain the following
Nature,intensity and outcome of the event
Clinical course of the event
Timing of the study of drug administration
Relevant laboratory measures
How the event was treated
Action taken with respect to the study drug
Post mortem findings
Investigators and sponsor opinion on casuality
Patient identifier
His age,sex,and general clinical condition.
Disease being treated
Medical history of patient
Medication taken in the past or taking currently
Tips for writing an effective patient narrative:
Always use hard space and hard hyphens for days, dates, and laboratory values to avoid splitting on the next page or next line except at the beginning of a sentence (hard hyphen: ctrl + shift + hyphen; hard space: ctrl + shift + space)
Be consistent while using the patient throughout the narrative.
Tag the narrative template against the information available in data sources to help the reviewer track the information easily.
Always use generic names for the patient’s concomitant medications or treatment medications for adverse events. However, for combination drugs, the generic drug name should be provided along with the trade name in brackets; for example, lisinopril-hydrochlorothiazide (Zestoretic)
For describing the adverse event and medical history or ongoing condition of the patient, always use the preferred terms like pain in extremity should be reported as pain in hands or pain in legs.
Quick-check your narrative before submitting it to the scientific reviewer.
Benefits Of Narrative Medical Writting
Narrative medical writing provides several important benefits relevant to internists. While research and policy generate data that inform changes in population health management and care delivery, narrative vehicles deliver knowledge and meaning to larger constituencies. Because stories are an essential component of how humans use evidence, utilizing them to discuss policy issues can improve the dissemination and uptake that are vital to the adoption of best practices. Leaders in systems redesign and policy have leveraged narrative work to tether the urgency of policy issues to the broader public consciousness. A number of internists and trainees have published narrative accounts in academic journals that advance discussions about policy related to care delivery and population health.
Types Of Narrative:
The type of narratives depends on whether the trial is ongoing (interim analysis) or completed. For completed studies, if the number of narratives is large (approximately >150–200), narrative writing activity usually starts along with cleaning of database. These are usually referred to as Predatabase lock (DBL) narratives. If the number of narratives is less (<150), narrative writing activity may start along with CSR preparation. If the narratives are written based on pre-DBL data, these narratives will be updated/modified based on post-DBL data which is considered clean and final. Final narratives are submitted with the CSR as an appendix. For studies under interim analysis (ongoing studies), it is advisable to initiate narrative writing activities well before the data cutoff date and per protocol recommendations. In such cases, only the events which occurred before the cutoff date will have the narratives written for. Narratives may be written in text or tabular format depending on the requirement.
Patient and safety (pharmacovigilance) narratives
Data source
Therapeutic areas
Regulatory requirements
Need of Narrative Writing
To identify and closely examine AEs/SAEs that require further monitoring
To identify and monitor frequency, severity, and seriousness of unexpected AEs
To identify the factors which affect and predict for the occurrence of adverse drug reactions including patient-related factors such as age, gender, ethnicity, race, target illness, abnormalities of renal or hepatic function, comorbid diseases, genetic characteristics such as metabolic status, environment, and drug-related factors such as dose, plasma concentration, duration of exposure, and concomitant medication
To evaluate whether the data are suitable for support of the safety analysis
To identify the limitations of the drug on the basis of data
To evaluate and analyze drug–drug interaction, if applicable.
Step by step process of narrative writing:
Narrative writing is a complex process that involves various stakeholders . The process begins with template finalization which is a crucial step in the NWP as it avoids subjectivity.
It is advisable to write sample narratives for all possible criteria, which usually ranges between three and five narratives; however, this may vary based on the total number of narratives for that study and the team's preference. Finalized sample narratives need to be clean, concise, and appropriate, as they form the basis for drafting further batches. Thus, an agreement with all the stakeholders/reviewers on the content/template of sample narratives is desirable. Finally, the compiled batch of narratives is shared with the respective stakeholders before publishing. For the purpose of audit trail, all versions of the narrative document should be stored in the repository/document management system
Challenges in narrative writing process
The most common challenges observed while drafting a patient narrative are:
Large number of resources required for the project
Maintaining consistency in the narratives
Timely delivery of high quality narratives
Lack of standardized data sources or patient profiles
High variability in template finalization before and after sample narratives due to differences in opinion of reviewers
Change in reviewers in intermediate or later stages of the project
Delay in review cycles
Delay in receiving consensus on comments and queries from the clinical team
References:
Student Name: Hiba Ahmed
Student ID: 047/0323
Qualification: M Pharm
E-mail:hibaahmedmarch27@gmail.com
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