Clinical case reporting
You can now apply for the Reckeweg Clinical Case Award 2024.
The deadline for eligible cases is Feb 28, 2024.
Get started: Anonymization
We’ll provide you with all the information you need to know before writing a clinical case report. Like any clinical study, a case report has to follow ethical and scientific standards. To write a high-quality clinical case report, you should inform yourself about current data protection regulations and the CARE guidelines.
The Clinical Case Report is the oldest form of medical communication. Even then, the report served as a means of disseminating new findings from clinical practice. A clinical case report is intended to describe the signs, symptoms, diagnosis and treatment of a disease. It usually describes unusual or novel patient cases, e.g. a previously unknown disease, a complication of a known disease, an unusual side effect or adverse reaction to a treatment method, or a new approach to a common disease.
In clinical case studies, consideration is given to preserving the anonymity of the patient. Case reports follow a standard structure and format that differs from that of original research articles.
All cases must be thoroughly anonymized
Omit any identifying patient data. All authors must follow the rules for anonymization.
It is vital to understand that clinical case reports are stories about single individuals. By definition, they provide information about health issues and may contain personal data. Current laws in Europe, the USA, and many other regions protect people by restricting access to their personal data.
Europe’s General Data Protection Regulation (GDPR), America’s Health Insurance Portability and Accountability Act (HIPAA), California’s Consumer Privacy Act, the UK’s Data Protection Act (DPA), and similar regulations impose substantial penalties for breaching data privacy. Because medical records contain personal patient data, they are protected by these laws. Information from medical records cannot be published without consent in a case report or any other medium, such as a web page or social blog.
Clinicians who have access to patients’ medical records and are using them to write a clinical case report have the responsibility to comply with these regulations and ensure that they are not breaching patients’ data privacy!
How can I ensure that I’m not breaking the law?
If you’re a healthcare professional and want to write a scientific clinical case report to publish, you must do TWO things:
- Inform patients that you want to write and publish a case report based on their medical records, and ask for written consent. Such consent should be written in the patient’s preferred language, be understandable to the patient, explain how the patient’s personal health information will be used, and inform of possible confidentiality issues. Both the patient and the healthcare professional must sign the consent document.
- Anonymize all personal data in your case report. Anonymization is the process of removing any identifying personal data from your case report in such a way that nobody can identify the patient. This process includes removing all personal data, such as names, birthdate, height, weight, ethnicity, address, country, city, hospital, and gender. Particular attention should be paid to removing identifying information from images, such as photos of patients or of distinctive parts of their body, x-rays, laparoscopic images, ultrasound images, pathology slides, and scans of their lab data.
Are there any tools that can help me?
Below you can find the example of the patient consent form template.
You can use this or any other similar template to obtain patient consent, but you MUST have it in your files BEFORE submitting your case to a publisher or a journal. A publisher or a journal may ask you to confirm that you have obtained written patient consent.
You can read about anonymization of case reports in the article of Rafelson W, Bruno J, Dizon DS. Protecting patient privacy in narratives: The Lifespan-Brown Checklist for Appropriate Use of Patient Narratives. Oncologist. 2019;24(3):285–7. doi:10.1634/theoncologist.2018-0659.
To make it easier for you, we provide a guide you can use to assess whether your case report still contains potential personal data in the images.
Please be warned, however, that this guide does not constitute legal advice and does not remove your responsibility to ensure that the case is appropriately anonymized so that patients cannot be identified under any circumstances.
Where can I find additional information about anonymization?
For additional information, see these Open Access resources:
- The Royal College of Radiologists. Guidance on the use of patient images obtained as part of standard care for teaching, training and research. London: The Royal College of Radiologists, 2017.
- TransCelerate Biopharma. Protection of personal data in clinical documents – a model approach. TransCelerate Biopharma, 2016.
- Cornock M. How the writers of case reports need to consider and address consent and the General Data Protection Regulation (GDPR). Case Rep Womens Health. 2018;19(Jul):e00060. doi:10.1016/j.crwh.2018.e00060.
- Neavyn M, Murphy C. Coming to a consensus on informed consent for case reports. J Med Toxicol. 2014;10(4):337–9. doi:10.1007/s13181-014-0421-4.
Writing up a case report
You can write the case report without using a template. However, we recommend using the CARE-writer™ to comply with scientific standards for case report writing. This online tool was developed to include all requirements for a well-written scientific case report and is free to use. Check Step 2 for more information.
You may write your clinical case in English or your native language, though you should keep in mind that English is considered the language of science worldwide, and more people will be able to read your work in English. Also, regardless of which language you choose to write in, an abstract in English is mandatory.
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