Japan CCCIDM SMIS: Medical History, Family History, and Age of Symptom Onset

Illustrates Domains

MH
APMH
FAMH

Illustrates Variables

ABLFL

Illustrates Data Structures

ADAM OTHER

Content

Example 1a

The following example is for medical history or conditions using prespecified terms. The use of the MHPRESP variable means the participant was specifically asked about these conditions (on a form or by the clinician), versus being spontaneously reported by the subject/participant. MHOCCUR is used to indicate that the subject did (Y) or did not (N) have a history of the condition indicated in MHTERM. The use of MHCAT is optional. Note that the "age or date diagnosed as" items (Rows 1, 2, 5 and 8) are represented below as specified in the SMIS, which requested responses be expressed in the format of decade of life. Example 1c shoes how to represent actual age of diagnosis.

SMIS Item Numbers include: 11 - Age diagnosed as diabetes, 14 - Diabetic retinopathy, 15 - Age diagnosed as hypertension, 17 - Abnormality on ECG, 19 - Age diagnosed as dyslipidemia, 20 - History of coronary artery disease, 21 - Age diagnosed as CKD, 30 - Diabetic neuropathy

Rows 1, 2, 5, 8:	Show how to represent the decade of life during which the participant was diagnosed with these conditions, using the non-standard variable MHLDECDX. Other timing information regarding when the diagnosis was made (if available) is represented as either a start date or start year of the medical history event (in the variable MHSTDTC), or as a value of "BEFORE" in the variable MHSTRF (start of the event relative to the current study reference start date).
Row 3:	Shows history of coronary artery disease. The non-standard variable MHSOURCE (Source of Information) shows that the diagnosis information came from a contrast study.
Row 4:	Shows the participant was diagnosed with an abnormality on ECG, the timing of this event was not known, only that it had resolved before the current study had started. Thus, MHENRF (end relative to the study reference period) = BEFORE.
Rows 6-7:	Show the prespecified conditions diabetic retinopathy and diabetic neuropathy. Note in row six that the participant (or the review of the participant's medical record) indicated they had not been diagnosed with diabetic retinopathy (MHOCCUR = N).

mh.xpt

Row	STUDYID	DOMAIN	USUBJID	MHSEQ	MHTERM	MHDECOD	MHCAT	MHPRESP	MHOCCUR	MHSTDTC	MHSTRF	MHENRF	MHLDECDX	MHSOURCE
1	ABCDE	MH	ABCDE-001	1	Hypertension	Hypertension	RISK FACTOR FOR SEVERE ILLNESS	Y	Y	2002-04-20			40s
2	ABCDE	MH	ABCDE-001	2	Dyslipidaemia	Dyslipidaemia	RISK FACTOR FOR SEVERE ILLNESS	Y	Y	1994			30s
3	ABCDE	MH	ABCDE-001	3	Coronary artery disease	Coronary artery disease	RISK FACTOR FOR SEVERE ILLNESS	Y	Y	2009				CONTRAST STUDY
4	ABCDE	MH	ABCDE-001	4	Abnormality on ECG	Electrocardiogram abnormal	RISK FACTOR FOR SEVERE ILLNESS	Y	Y			BEFORE
5	ABCDE	MH	ABCDE-001	5	Diabetes	Diabetes	RISK FACTOR FOR SEVERE ILLNESS	Y	Y		BEFORE		<10
6	ABCDE	MH	ABCDE-001	6	Diabetic retinopathy	Diabetic retinopathy	RISK FACTOR FOR SEVERE ILLNESS	Y	N
7	ABCDE	MH	ABCDE-001	7	Diabetic neuropathy	Diabetic neuropathy	RISK FACTOR FOR SEVERE ILLNESS	Y	Y	2009
8	ABCDE	MH	ABCDE-001	8	Chronic kidney disease	Chronic kidney disease	RISK FACTOR FOR SEVERE ILLNESS	Y	N	2008			60s

MH NSV Metadata

Variable	Label	Type	Codelist	Role	Origin
MHLDECDX	Decade of Life of Diagnosis	text		Non-standard Record Qualifier	CRF
MHSOURCE	Source of Information	text		Non-standard Record Qualifier	CRF

This example uses the Associated Persons Medical History (APMH) domain to show how to represent family history of renal failure using the SREL variable (Name/Subject, Device or Study Relationship) for first and second degree relatives. For more information about the Associated Persons domain, refer to the Study Data Tabulation Model Implementation Guide: Associated Persons (SDTMIG-AP) v1.0. The controlled terminology for the SREL variable uses the "Relationship to Subject"/RELSUB codelist. In the Associated Persons domains such as APMH, each person associated with the participant/subject also must be assigned a unique identifier, the Associated Person Identifier (APID).

Row 1:	Shows how to represent family history of renal failure in any first-degree relative (SREL = "RELATIVE, FIRST DEGREE").
Row 2:	Shows how to represent family history of renal failure in any second-degree relative (SREL = "RELATIVE, SECOND DEGREE").

apmh.xpt

Row	STUDYID	DOMAIN	APID	MHSEQ	RSUBJID	SREL	MHTERM	MHCAT	MHPRESP	MHOCCUR	MHDTC
1	ABCDE	APMH	0003-1st	1	ABCDE-003	RELATIVE, FIRST DEGREE	Renal Failure	FAMILIAL DISEASE HISTORY	Y	Y	2020-06-20
2	ABCDE	APMH	0004-2nd	1	ABCDE-004	RELATIVE, SECOND DEGREE	Renal Failure	FAMILIAL DISEASE HISTORY	Y	Y	2020-06-20

For illustration purposes, this example (corresponding to item numbers 11, 15, 19 and 21) shows how to represent the actual age at disease onset in FAMH, if this information is available and useful to researchers. FATEST = "Age At Disease Onset" was used. Controlled terminology has been requested for this concept, but is currently unpublished and subject to change.

Rows 1-4:	Show how to represent the age at disease onset for the same participant and the same diseases.

Row Captions Debug Message

There seems to be only one row caption. Please rephrase as narrative.

famh.xpt

Row	STUDYID	DOMAIN	USUBJID	FASEQ	FATESTCD	FATEST	FAOBJ	FACAT	FAORRES	FAORRESU	FASTRESN	FASTRESU	FADTC
1	ABCDE	FAMH	ABCDE-001	5	AGEDONST	Age At Disease Onset	Hypertension	DISEASE HISTORY	47	YEARS	47	YEARS	2020-06-19
2	ABCDE	FAMH	ABCDE-001	6	AGEDONST	Age At Disease Onset	Dyslipidaemia	DISEASE HISTORY	39	YEARS	39	YEARS	2020-06-19
3	ABCDE	FAMH	ABCDE-001	7	AGEDONST	Age At Disease Onset	Diabetes	DISEASE HISTORY	<10	YEARS	35	YEARS	2020-06-19
4	ABCDE	FAMH	ABCDE-001	8	AGEDONST	Age At Disease Onset	Chronic kidney disease	DISEASE HISTORY	62	YEARS		YEARS	2020-06-19