Patient safety is the first priority when conducting clinical trials. It is critical to assure that patient meets the eligibility criteria for the clinical trial protocol and that the safety risks are minimal. This is why patient medical history is very important part of data collection for each clinical trial but quite often this is a big challenge as well.
What are the common issues with obtaining patient medical history information?
One of the ideas of the electronic medical records (EMRs) is to provide assess to health care staff to patient history and help them make better diagnostics and treatment decisions. However, due to different limitations, like costs of EMRs, transferring current paper database into electronic records, adoption, etc., it is still not widely implemented. This means that health care staff does not have access yet to the medical history of majority of their patients.
It is easy when the patient has been treated in the same hospital and the whole medical history is available but these cases are very rare. In reality majority of the patients have been treated in different hospital, sometimes in different cities or even countries. In some cases collecting patient medical history from different health care providers sounds almost like mission impossible.
So how to collect patient medical history in this case?
- Contact patient`s GP – GPs are very good source of information. Even if they are not the first GP for the patient, GPs tend to see their patients more often and will have more information regarding medical history. This is why it is important GP to be informed at the very beginning when the patient starts in a clinical trial. Good relationship with the GP networks is very important for every clinical trials team and could contribute significantly to the success of the clinical trial.
- Contact local hospital that the patient is visiting – If you patient is visiting regularly local hospital or community center, it will be helpful to have contacts for the treatment team and request information.
- Ask the patient – This sounds as the easiest option but it could be a tricky one as well. Often patients are under lots of stress and very vulnerable and they may forget to tell you important information. Make sure you have considered the situation, always ask them simple questions and if you have doubts ask them again later when they feel more confortable.
- Ask relatives, care assistants or social workers – Some patients are not able to provide the information that you need due to varies reasons (medical condition; fail to mention important disease or procedure; etc.). In this case it may be helpful to speak to relative or care assistant (or social worker) who is looking after the patient or may have more details.
- Ask your colleagues in the hospital – Sometimes different physicians and nursing team in the same hospital have seen the patients. They may be able to help with some important details regarding patient medical history.
The information required for clinical trials can vary significant depends on the medical condition – some clinical trials require full medical history, some need only medical history for the last 5 years. Often clinical trial teams have difficulties obtaining all relevant information. One of the best approaches is to make everyone, who is looking after the patient, aware of the importance of having as complete as possible patient medical history. At the end of the day patient safety and well-being is main priority for all parties involved in patient`s treatment.
Author: Olga Peycheva
Olga is a clinical research professional who has been working in clinical research since 2005. She has extensive experience in clinical research in Eastern and Western Europe.
Originally published on 14 Apr 2014