INTRODUCTION:11,4
On data collecting instruments (DCIs) known as Case Record Forms / Report Forms (CRFs) for paper-based trials or as electronic Case Record/ Report form (eCRF) for web-based clinical trials, data generated in all clinical trials are recorded. These studies gather and record data on adverse events (AE), medical histories (MH), and concomitant Medication (CM) administered in addition to the research drug on pertinent DCIs. A multicentric clinical study consists of numerous trial sites with various investigators from various ethnic backgrounds. It is predicted that there will be a chance for varied methods of capturing medical and scientific data since investigators and clinical research specialists from various nations and regions will be involved. In the end, additional analysis is performed on all the data collected throughout these trials. It is crucial that this data be analyzed consistently and in a standardized manner. As a result, adopting standardized medical dictionaries is necessary for medical coding. Data from the categories above, including AEs, SAEs, MH, CM, and any others, are often coded. However, it is required to code AEs, SAEs, and CM in every research experiment.
This article makes an attempt to:
· To describe how standard medical coding dictionaries are used in clinical trials for medical coding.
· To briefly discuss the two dictionaries that the majority of specialists in the pharmaceutical and CRO industries use the most.
· To explain the medical coding process and to highlight some of the usual issues that a coder runs with while coding.
Although there are many standardized medical coding dictionaries available, only the five listed below are utilized for coding.
1. COSTART: Coding Symbols for Thesaurus of Adverse Reaction Terms.
2. ICD9CM: International Classification of Diseases 9 Revision Clinical Modification.
3. MedDRA: Medical Dictionary for Regulatory Activities.
4. WHO-ART: World Health Organisation Adverse Reactions Terminology.
5. WHO-DDE: World Health Organisation Drug Dictionary Enhance
MedDRA and WHO-DDE are two popular medical coding dictionaries that are used to code medical terminology produced in clinical trials out of the five mentioned above. It is nearly hard to maintain consistency in reporting a term in any particular clinical experiment. However, it might be difficult for a coder to guarantee that the word "reported on data collection instrument" (CRF/eCRF) is correctly entered.
It is common knowledge that these dictionaries are expensive and that companies doing medical coding activities need to hold the necessary, active licenses. For each of the dictionaries, certain user groups have been granted distinct licenses.
Processes in medical coding:10,7,5
Precoding process: The database development team must properly import/load each and every revision of any medical coding dictionary into the appropriate coding tool. Thesaurus Management System (TMS) is the coding tool utilized in relation to Oracle Clinical (OC). The programming team verifies that all the tables and records are successfully loaded in the tool once the dictionaries have been imported or loaded into the appropriate tool. For the specific version of the dictionary, this procedure is only carried only once. For the specific version of the dictionary, this procedure is only carried only once. The operational team conducts user acceptance testing (UAT) to validate that the dictionary loaded in the tool is producing the desired output as expected after the development team has ensured accurate import tables and records in the tool. The chosen lexicon is made available for usage in a given project or research after the operational team passes UAT. Members of the operational team assigned to the new project or research must do UAT again if the same version of the lexicon is to be used for any other project or study in the future.
In order to assign a dictionary to a project or research, it is necessary to first ensure that the following conditions are met:
· At the start of the project, the coding tool had the most recent certified version accessible.
· Even though a newer version of the dictionary is available, there is a policy or requirement that it be used throughout the whole project.
· Updated version anticipated as and when available over the project's duration.
· During the course of a project, an updated version is applied retroactively as and when it becomes available.
Coding in live project:10,5
Data managers in charge of "Data Review and Discrepancy Management" should ideally code on verified and cleansed data. In each project, the words that need to be coded are coded by a procedure called "auto coding"; the terms that don't get "auto-coded" must be coded "manually" by the medical coder in charge of the project. Below is a quick description of the two coding procedures, manual and automatic:
Auto Coding: If the phrase entered by the researcher on the data collecting tool perfectly matches the relevant term listed in the medical lexicon, the term is automatically coded.
Manual Coding: When words do not correspond to the correct hierarchy level in the medical lexicon, auto coding fails. The medical coder assigned to the project must manually code each of these phrases. The medical coder will manually assign the code after selecting the most suitable match for the word from the terms in the designated vocabulary. This does not imply that every term reported and documented on the CRF or eCRF is correctly coded. There are certain terms that are ambiguous or difficult for a coder to locate a matching phrase in the dictionary. There might be several symptoms and indicators listed by the investigator. In these situations, the investigator or a team of medically certified professionals receives these words and requests clarification or further information from the medical coder or medical coding team. It aids the medical coder to locate terms in the coding dictionary that are extremely similar to such ambiguous or dubious terms so that the term(s) is properly coded. Terms that are automatically and manually coded are examined by the coding staff. Uncertain terms and terms with inadequate information are sent to the site. The investigator is required to submit the data management teams the relevant revisions and details along with a signed copy of the resolution. The database action is taken by the data management team in accordance with investigator resolution. The coder examines the data or update before properly coding the word.
Some fundamental principles of coding include:
· Clearly defined and documented process
· Quality assurance
· Quality of source data
· Level of term selection
· No addition or subtraction of information
Medical dictionary for regulatory activity (MedDRA):
Medical dictionary for regulatory activity (MedDRA) is a medical is a medical coding dictionary developed by maintenance and support services organization(MSSO) The International Conference on Harmonization's (ICH) Technical Requirements for Registration of Pharmaceuticals for Human Use are in support of MedDRA. There was no internationally recognized medical terminology for biopharmaceutical regulatory purposes prior to the creation of MedDRA.
MedDRA is used for coding:3,8
· Medical terms are established during all stages of clinical trials, with the exception of animal toxicity,
· therapeutic indications, including signs, symptoms, illnesses, disease diagnosis or prevention, and changes in function,
· Codes and quantitative findings from analyses, operations, and medical/social/family histories
In a given year, MedDRA releases two versions: the first in March and the second in September. The MedDRA terminology is available on an annual, constant subscription basis. Every MedDRA update that includes authorized modifications and additions is delivered with each subscriber.
As shown below, MedDRA has five hierarchical levels.
· Low level term (LLT)
· Preferred term (PT)
· High level term (HLT)
· High level group term (HLGT)
· System organ class (SOC)
LOW LEVEL TERM (LLT) is the lowest level of terminology Only ONE PT is connected to each LLT. A PT specifically characterizes a symptom, sign, condition, diagnostic, therapeutic indication, inquiry, surgery, or medical treatment, as well as factors related to health, society, or family history.6
High Level Term (HLT) is an apex description for PTs connected to it. A High-Level Group Term (HLGT) is a term used to describe two or more HLTs that are connected by their physiology, disease, etiology, or function. The System Organ Class (SOC) is the hierarchy's top tier. The genesis, manifestation place, and purpose of the SOCs are classified together.
Fig. 1: MedDRA Stage
Common Problem Faced by medical coding expert while coding:2
· Illegible verbatim term
· Spelling errors
· Use of abbreviations
· Multiple signs and symptoms recorded as separate events which may lead to same diagnosis (for example: signs and symptoms recorded as running nose, cough and fever may lead to diagnosis of Pneumonia)
· Multiple medical concepts recorded together.. To code we need to split the terms.
· Event is recorded without mentioning he site e.g. ulcer is recorded without additional information like mouth ulcer, leg ulcer etc.
· There were several medical notions that described the surgical technique and the cause of the damage. However, it is unclear what caused the injury, where it occurred, or why.
· A drug phrase is reported, but neither the allergy caused by the medicine nor the result of the allergy is made clear.
Other commonly used dictionary:12
World Health Organization Drug Dictionary (WHODD): This dictionary is one that the Uppsala Monitoring Center maintains updated (UMC). This dictionary is the most complete one with information on pharmaceutical products. Contract research organizations (CROs), different pharmaceutical corporations, and drug regulatory agencies all employ it. The dictionary includes names of pharmaceutical products from more than 90 different nations, both proprietary and non-proprietary. The WHODRUG lexicon has seen significant growth. There are now three different dictionary kinds.
· WHO Drug Dictionary (WHO-DD)
· WHO drug dictionary enhanced (WHO-DD Enhanced)
· WHO Herbal Dictionary (WHO-HD)
The WHO DD and WHO DD Enhanced primarily provide information on conventional pharmaceuticals, but also include the following additional product categories:
· Medicinal item
· herbal treatment
· A vaccine
· nutritional supplement
· pharmaceutical radioactivity
· Blood component Diagnostic tool
· Homeopathic treatment
Nearly all of the herbal entries that have been added to the WHO Drug Dictionary over time are included in the WHO Herbal Dictionary. Beginning in 2005, the WHO Herbal Dictionary will be the exclusive source of information on all herbals. According to the Herbal Anatomical Therapeutic Chemical (HATC) classification, the WHO Herbal Dictionary is categorized. Information on the medicinal products may be found in the WHO Drug Dictionaries. Using this data, it is possible to locate a phrase (a pharmaceutical product) that closely like the term reported on DCI.
Information on the medicinal products may be found in the WHO Drug Dictionaries. Using this data, it is possible to locate a phrase (a pharmaceutical product) that closely like the term reported on DCI.
LEVEL 1: Anatomical significant group
LEVEL 2: Therapeutic Subgroup
LEVEL 3: Pharmacological Subgroup
LEVEL 4: Chemical Subgroup
LEVEL 5: Chemical Substance
CONCLUSION:
Coding is therefore necessary to increase consistency when comparing "safety signals" with clinical data that has been gathered. Because this would have a direct influence on safety information, quality control should be used at every level of data processing to guarantee that all data are trustworthy and have been processed appropriately. To attain the highest level of coding and to guarantee that all the criteria for quality are satisfied, training should be made available to all programmers. Coding should not be considered an administrative task but rather one of the most crucial tasks in clinical research. Consider include your inferences, conclusions, and recommendations.
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Received on 18.04.2024 Revised on 02.07.2024 Accepted on 16.08.2024 Published on 14.12.2024 Available online on December 05, 2024 Research J. Science and Tech. 2024; 16(4):304-308. DOI: 10.52711/2349-2988.2024.00043 ©A and V Publications All right reserved
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