Exploring the Significance of Medical History in Healthcare

In CDISC SDTM (Study Data Tabulation Model), "Medical History" refers to a specific domain used to systematically capture and structure information about a study participant's medical background, including any relevant medical conditions, prior illnesses, and pertinent medical events.

This domain is a standardized way to document a participant's health history, making it easier for researchers and regulators to analyze and interpret clinical trial data consistently. Variables within the Medical History domain may include details about medical diagnoses, start and end dates of conditions, severity, outcomes, and relationships to the investigational product or other therapies.

Concomitant Medication: CM

Concomitant medication refers to any medication or drug that a study participant in a clinical trial is taking concurrently with the investigational product being studied. These medications can include prescription drugs, over-the-counter medications, vitamins, supplements, or herbal remedies.

Concomitant medication recording is essential for clinical research and data collection because it enables researchers and medical professionals to evaluate possible drug interactions, side effects, and effects on study outcomes.

E.g. CMTRT: Paracetamol, CMDOS: 250, CMDOSU: mg, CMCAT: General.

Protocol Deviations: DV

Protocol deviations refer to instances in a clinical trial where procedures or actions do not align with the predetermined study protocol. These deviations can result from unintended errors, variations in participant adherence, or necessary deviations to ensure participant safety. Accurate recording and documentation of protocol deviations are essential for maintaining data integrity and regulatory compliance in clinical research.

E.g., Drug XXXX administered during the study treatment period.

Clinical Events: CE

Clinical events in clinical research refer to significant health-related incidents or occurrences that study participants encounter during a clinical trial. Adverse events, serious adverse events, and other medically relevant incidents such as hospitalizations or deaths are examples of such events. Proper clinical event documentation and reporting are critical for monitoring participant safety and assessing the impact of investigational treatments. This event could be pre-specified on CRF.

E.g. Rash, Nausea

ECG Results: EG

ECG (Electrocardiogram) results refer to the graphical representation of the electrical activity of the heart obtained through an ECG test. These results display the heart's rhythm, rate, and any potential abnormalities in the heart's electrical conduction system.

EGN- RIND: can be added to indicate where a result falls concerning the reference range defined by EGORNRLO( EG Original Normal low) and EGORNRHI. The Qualifiers: --MODIFY, --BODSYS, --SPEC is not used. e.g., EGTEST: Ventricular Rate, EGPOS: Supine, EGORRES: Abnormal.

Laboratory Test Results:

Laboratory test results are numerical or qualitative data from medical tests conducted on biological samples such as blood, urine, or tissue. These results provide essential information about a patient's health, including measures of various biomarkers, organ function, and specific conditions or diseases.

For lab tests that do not have continuous numeric results, LBSTNRC is populated. E.g. LBTEST: Glucose, LBCAT: Urine, LBORRESU: mg/dL

Physical Examination: PE

A physical examination is a methodical evaluation of an individual's general health and physiological processes carried out by a medical professional. A medical practitioner examines a patient's vital signs (blood pressure, heart rate, etc.), overall appearance, body systems (cardiovascular, respiratory, musculoskeletal, etc.), and any physical signs or symptoms during a physical examination.

E.g., PETESTCD: Head, PELOC: Face, PESTRESC: Normal.

Questionnaires: QS

A numerical scoring system is applied to question responses to analyze the questionnaires. Subject-reported results and validated or non-validated questionnaires are examples of questionnaire data, though they are not the only ones. When submitting a set of questions grouped on the CRF for the convenience of data capture, the QS domain is not intended for use.

E.g., QSTEST: Healthy as anybody, QSSCAT: General Health, QSORRES: True Subject Characteristics: SC

Subject Characteristics refer to information that has yet to be gathered from other subject-related domains.

Examples: subject initials, eye color, childbearing status, etc.

Based on the general observation class, the subject characteristics structure expands the demographic data. SC includes information that is either not expected to change during the trial or whose change is not significant once it has been gathered.

E.g., SCTEST: Eye Color, SCORRES: Brown, SCTESTCD: EYECD

Vital Signs: VS

Measurements like blood pressure, height, weight, pulse, and body temperature are recorded by CRF, along with deduced information like body mass index.

The allowed variable VSLOINC may be used when the LOINC dictionary is utilized for vital sign assessments. The reference range that VSORNRLO and VSORNRHI define can be used to determine a result's location using VSNRIND.

E.g., VSTEST: Systolic Blood Pressure, VSPOS: Sitting, VSORRES: 154, VSSORRESU: mmHg.

How are the domains captured on a case report form?

The corresponding variables for each domain are annotated on the Case Report form; for example, the subject's initials would be annotated as SUBJID. Annotation of the Study Number as STUDYID will be created. A USUBJID could be annotated by combining the STUDYID and the SUBJID.

SDTM Dates: Represented in ISO 8601 format as a complete date/time, a partial date/time, or an incomplete date/time i.e., YYYY-MM-DDThh:mm:ss

E.g., December 15, 2003 13:15:17 ? 2003-12-15T13:15:17

In conclusion, understanding and effectively utilizing a patient's medical history is of paramount importance in the field of healthcare. This comprehensive overview has highlighted the multifaceted significance of medical history, emphasizing its role in diagnosis, treatment planning, risk assessment, and patient-centered care. By harnessing the wealth of information in medical histories, healthcare professionals can make more informed decisions, improve patient outcomes, and enhance the overall quality of healthcare delivery.

As we continue to advance in healthcare technology and data integration, it becomes even more crucial to prioritize the accurate and thorough documentation and utilization of medical histories. Embracing the power of medical history can ultimately lead to a brighter and healthier future for both patients and healthcare systems alike.