Using Medical Dictionaries

Medical dictionaries often need to be referenced when creating various analysis data sets For instance, perhaps the raw adverse event database in your clinical data management system contains only the MedDRA code. The code is worth having, but you would need the adverse event body system and preferred medical term to provide a useful summary of events. 

There are hundreds of proprietary medical dictionaries in circulation. Fortunately, a number of medical dictionaries are headed for retirement. The pharmaceutical industry along with regulators and standards groups is actively working to reduce the number of coding dictionaries. So we will discuss MedDRA for adverse events and WHODrug for 

The Medical Dictionary for Regulatory Activities (MedDRA) is a creation of the International Conference on Harmonization, and it is used to categorize and code diseases, disorders, and adverse events. The five levels and associated codes to the MedDRA coding hierarchy are as follows  

The essential pieces of MedDRA to have in SAS are the preferred term and body system, as this is what most clinical summaries and analyses require. The following is a piece of simplified SAS code that brings the lowest-level terms, preferred terms, and body systems together into one data set. 

Program 4.9 Bringing the MedDRA Dictionary Tables Together 

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Categorical Data and Why Zero and Missing Results Differ Greatly 102 Performing Many-to-Many Comparisons/Joins 106 Using Medical Dictionaries 108 Other Tricks and Traps in Data Manipulation 112 Common Analysis Data Sets 118 Critical Variables Data Set 118 Change-from-Baseline Data Set 118 Time-to-Event Data Set 121... 

The Internet provides access to a number of free-to-use medical dictionaries. The National Library of Medicine has compiled the following list of online dictionaries ... 

Adverse events need to be coded consistently with respect to letter case. Problems can occur when there is discordant coding using all capital letters, all lower-case letters, or combinations thereof, as computer software will interpret these capitalization variations as different events. Letter case sensitivity can be important when two or more words are used to describe an adverse event. For example, some databases utilizing the Medical Dictionary for Regulatory Activities (MedDRA) coding dictionary employ a coding system in which only the first letter of the first word of an adverse event is capitalized (e.g., Atrioventricular block complete ). Failing to adhere to uniform letter case conventions across the data can result in severe errors in data analysis. 

Figure 27.4 Sector map display of the MGPS data mining profile for each drug, using a dictionary of medical terms. For full caption see page 673.

Medical Dictionary for Regulatory Activities a creation of the International Conference on Harmonisation used to categorize and code diseases, disorders, and adverse events. 

Toxicology reports require a surprisingly limited vocabulary. Simple terms should always be preferred over complicated ones. Jargon should be avoided. Abbreviations and acronyms should be defined the first time they are used in each section of the report. Some technical or medical terms are unavoidable, but the author should ensure that all of the terms used can be found in a basic medical dictionary. Do not assume that the reader has an in-depth knowledge of the subject. 

Methods for handling the safety and tolerability data the safety data will usually be coded using the MedDRA (Medical Dictionary for Regulatory Activities, www.meddramsso.com) coding system in order to aid summary and presentation... 

Pharmaceutical companies, individual regulatory authorities and the WHO have databases which facilitate this overview. The use of a standard coding dictionary of adverse event terms is essential for this sort of analysis, and one, MedDRA (Medical Dictionary for Regulatory Activities) has been accepted as the gold standard to be used. Nevertheless, routine review of individual cases by responsible, experienced reviewers is the most essential factor in identifying new signals and ensuring patient protection. 

Those pronunciations of which the reader is unsure should be determined from a medical dictionary. Repeated spoken use of the terms is the most helpful tool in acquiring mastery of expression. 

MedDRA the Medical Dictionary for Regulatory Activities terminology is the international medical terminology developed imder the auspices of the International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use 2012. 

The medical literature of the past twenty-five years contains over 2000 papers on the clinical uses of vitamin E. These represent the ideas of the medical profession on the clinical disorders in which this group of substances has therapeutic value. The list reads rather like a medical dictionary. 

Biocompatibility should be considered for each ionic liquid and in the context of its application. For that reason, several views of their biocom-patibility may arise. General understanding of biocompatibility is a quality of not having toxic or injurious effects on biological systems (Dorland s medical dictionary). This term is now essentially applied to materials used for medical devices (ISO 10993). Biocompatibility evaluation can however be analyzed accordingly to different areas of research and application, and discussed within regulatory and environmental requirements. 

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