Pansie Zhang

MSD R&D (China) Co., Ltd

23Apr2015

Encoding Skill in Clinical Trials

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Part B, Exercise

Part A, Encoding considerations in clinical trials: encoding skill

Introduction, What is encoding

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What is encoding？

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Encoding is the process of matching the closest medical terms entered by investigator with the standard dictionaries.

In other words, encoding is used to standardize the terminology that is used to describe the clinical information such as AE’s, disease, drugs, vaccines…

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Auto vs Manual Encoding

If the verbatim terms exactly match the dictionary terms – Autoencoded by the system

If the verbatim terms do not match dictionary terms – Manually encoded by encoders

Human oversight of term selection performed by IT tools (such as an autoencoder) is needed to assure that the end result fully reflects the reported information and makes medical sense!

General encoding guidance – i.e., MedDRA Term Selection: Points to consider?

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Part A: Coding Skill

1. MedDRA Coding Guidance

Is any protocol/product specific encoding

guidance necessary to develop by safety and

encoding staff?

2, read study related documents, i.e., protocol, Data entry guidance, understand what data should be entered on what eCRFs

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3, familiar with the dictionaries, the coding system, the data entry/review system and term flow

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4, establish a coding QC process

• Sometimes encoding

is subjective and the

same verbatim may

be seen differently by

several encoders,

• Consistency concerns,

• Possible auto-

encoding error

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Assessing the

reported information,

First, try using actual

words from reporter

5, Choose an appropriate dictionary term when perform encoding

– Clinical condition:

Diagnosis, sign or

symptom?

– Indication?

– Test result?

– Injury?

– Procedure?

– Medication error?

– Product quality issue?

– Social circumstance?

– Device issue?

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Example:

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Swelling

(forearms/ankles)

Viral sinus infection

6，A combination term may be challenging

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- Is it Condition + condition?

Separate concepts or causal

association?

- Is it condition + procedure?

- Is a MedDRA combination term

available?

- Is one condition more specific than

the other

- ...

Example verbatim:

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MH: Uterine

cancer remove

MH: prostate

cancer remove

MH: Ablation of a

accessory pathway

because of Wolff-

Parkinson-White

syndrom

7, Helpful Hints: Prefixes/Suffixes, and Synonymous Terms

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Left tongue resection

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Example:

8, Be careful with the similar terms

- Cervical VS. Cervix

- Dilation VS. Dilatation

- Drainage VS. Discharge

- Lump, Mass, Tumour, Cancer

- Occulation VS. Obstruction

- Mole, Naevus

- Bruise, laceration

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Reactive T.B

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example

9, Check the hierarchy above a selected LLT (PT, HLT, HLGT, SOC) to ensure placement accurately reflects meaning of reported term.

Example verbatim:

allergic

parotitis

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10, If no exact match in MedDRA, use medical judgment to match to an existing term that adequately represents the concept.

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Procedure: Trigger point injection

The reason for the procedure is ‘Arthralgia(righr hand)’.

LLT: Angina tonsillaris

LLT: Angina pectoris

Anginal pain

Angina

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11, Terminology spelling consistently follows Dorland’s Illustrated Medical Dictionary, Dorland’s online and standard medical literature for all medical terms. Nonmedical terms included in the terminology follow Merriam-Webster® English Dictionary.

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Example

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Form Verbatim Term LLT PT SOC

MH acute renal insufficiency Acute renal insufficiency Renal failure acute Renal and urinary disorders

MH chronic renal disease Chronic kidney disease Renal failure chronic Renal and urinary disorders

MH chronic renal insufficiency Chronic renal insufficiency Renal failure chronic Renal and urinary disorders

an example of one of the MSSO’s rejection justifications: The proposal to Link (move) an LLT Renal insufficiency from PT Renal failure to another PT Renal impairment is not approved. The issue about placement of failure, insufficiency and impairment terms was extensively discussed by international user community, a blue ribbon panel and the MSSO and its board and a consensus was reached and recorded in the introductory guide as follows : "In MedDRA, for the major body systems of cardiac, hepatic, pulmonary, and renal, the words “failure” and “insufficiency” are used synonymously. In SOC Cardiac disorders, SOC Hepatobiliary disorders, SOC Renal and urinary disorders, and SOC Respiratory, thoracic and mediastinal disorders, the “failure” term is at the PT level and the “insufficiency” term is at the LLT level (e.g., PT Cardiac failure and LLT Cardiac insufficiency)."

12, In China local study, how to enter the data described in Chinese Medical terminology?

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Example: shanghuo(上火)

muscle suan(肌肉酸)

Report symptoms/diagnosis in Western

Medicine

13, Use available resources for difficult verbatim terms

Web search

Medical dictionaries

Clinical Scientist

Other encoders

Contact MSSO

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1, standard query wording

2, communicate with CRAs and help site understand terminology - Encourage investigator to use accepted medical terminology

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14, Train site to provide good quality data

Part B exercise

Hyperglycaemia (blood glucose = 200 mg/dL)

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* Blood glucose abnormal?

* Blood glucose increased?

* Hyperglycaemia ?

Obstructive arteriopathy of leg

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• Arteriopathic disease?

• Arterial occlusion?

• Peripheral arterial occlusive

disease

AE: Inflammation of right ear lobe (post ear piercing)

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* Post procedural inflammation?

* External ear inflammation?

Acute arthritis knees and hips

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* Acute arthritis?

* Gonarthritis?

* Coxarthritis?

* Polyarthritis?

Skin abrasion wound

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* Skin abrasion?

* Skin injury?

* Skin wound?

Nicotinism

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* Nicotine abuse？

* Nicotine Addition？

* Nicotine dependence？

* Nicotine poisoning？

Left & right loss of hearing

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Deafness bilateral

Hearing loss

Oophorectomy bilateralBilateral orchidectomy

Salpingo-oophorectomy bilateral …

SURGICAL ARTHROSCOPY HIP JOINT

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* Arthroscopic surgery？

* Hip surgery？

acute asthmatic bronchitis

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* Acute bronchitis?

* Asthmatic bronchitis?

asthmatoid bronchopneumonia

* Bronchopneumonia？

* Asthmatic bronchitis?

dermopathy

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Skin disorder?

Dermatosis?

is any disorder of the skin.

is any skin disease,

especially one not

characterized by

inflammation.

Practice more, you can become a dictionary expert!

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