Using MedDRA for Data Entry

USING MedDRA FOR DATA ENTRY

The process of coding adverse event or other medi-cal information with MedDRA involves the use of computer software: either a ‘browser’ or an ‘autoencoder’. These are available commercially, or a browser may be downloaded from the MSSO website. A browser permits the user to search MedDRA for an LLT to match the verbatim or ‘as reported’ term. Most browsers provide some type of Boolean search facility, with ‘and/or’ commands, or the possibility to search for LLTs beginning with, or containing, selected parts of words. Many browsers also present a view of the MedDRA ‘tree’ and enable this to be searched starting with the SOC likely to contain the concept being searched, then drilling down through the HLGT, HLT and PT until appropriate LLTs can be viewed and selected. An illustration of the appearance of MedDRA using a browser is shown in Figures 13.2 and 13.3.

Autoencoders may have the additional capability of scanning narrative texts and presenting expressions likely to need coding. They will often store selec-tions of LLTs that closely match verbatim terms coded historically, in order to improve consistency of term selection. They can code long lists of verbatim terms, presenting the user with a list of identical or closely matching LLTs that can then be confirmed as being acceptable or rejected.

Guidelines on the selection of terms used to code adverse events have been published by the MSSO (MedDRA^® Term Selection, 2004), with the endorse-ment of ICH. These ‘Points to Consider’ guidelines cover the topics shown in Table 13.8. It is important that each MedDRA subscriber has its own written procedures that are consistent with these guidelines, in order to make coding as consistent as possible across the organisation concerned.

The general principles presented in the ICH-endorsed guidelines are as follows:

1.   Try to clarify ambiguous, confusing or unintelli-gible data.

2.   Promote quality through form design and by train-ing those involved in collection and follow-up.

3.   Select the LLT that most accurately reflects the reporter’s words.

4.   Use current LLTs only (unless for legacy data conversion).

5.   Use medical judgement if there is no exact match for a verbatim term, if there is an existing adequate representation in MedDRA.

6.     It is not appropriate to address deficiencies in MedDRA by developing organisation-specific solutions.

7.   If there is no adequate representation of a concept in MedDRA, submit a change request to the MSSO.

8.   If a specific medical concept (e.g. metastatic colon cancer) has no single MedDRA term, request a new term, and in the interim, use one or more existing terms (e.g. Colon cancer, or Metas-tases or use the two terms Colon cancer and Metastases)

9.   Do not subtract or add information: no medical concepts should be excluded from coding; code regardless of causality assessment.

10.            Do not invent diagnoses or mechanisms: use the information as provided by the reporter.

11.Documentation of selection strategies and Quality Assurance procedures are encouraged.

12.Human intervention is essential to ensure that the end result reflects the original information and makes medical sense.

13. Do  not  make  ad  hoc  structural  changes to  MedDRA:  the  assignment  of  SOCs  is pre-determined and should not be altered by users, although a change request may be made if terms are incorrectly placed.

The guidelines also suggest that if a report of an adverse event includes a diagnosis and its symptoma-tology, it is sufficient to select a term for the diagnosis and not for the signs and symptoms. It remains an option to code the signs and symptoms in addition. If there are signs and symptoms that are not usually part of the diagnosis, these should be coded as well as the diagnosis.

The guidelines make the following important point: ‘The MedDRA terminology is multiaxial and more complex than common terminologies previously used. Therefore, term selection should be reviewed by a qualified individual, a person with medical back-ground and/or training and who is also trained in the use of MedDRA’.

The reader of this chapter should refer to the guide-lines for examples and details. Accurate and consistent coding of data are vital for the appropriate analysis and evaluation of safety data.