Barthel Index

 

This index measures the extent to which somebody can function independently and has mobility in their activities of daily living (ADL) i.e. feeding, bathing, grooming, dressing, bowel control, bladder control, toileting, chair transfer, ambulation and stair climbing. The index also indicates the need for assistance in care.  The Barthel Index (BI) is a widely used measure of functional disability. The index was developed for use in rehabilitation patients with stroke and other neuromuscular or musculoskeletal disorders, but may also be used for oncology patients.

Fugl-Meyer Assessment (FMA) (coming soon)

 

The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia (Fugl-Meyer, Jaasko, Leyman, Olsson, & Steglind, 1975; Gladstone, Danells, & Black, 2002). It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment.

Columbia-Suicide Severity Rating Scale (C-SSRS)

 

The C-SSRS is used extensively across primary care, clinical practice, surveillance, research, and institutional settings.  It is available in over 100 country-specific languages, and is part of a national and international public health initiative involving the assessment of suicidality, including general medical and psychiatric emergency departments, hospital systems, managed care organizations, behavioral health organizations, medical homes, community mental health agencies, primary care, clergy, hospices, schools, college campuses, US Army, National Guard, VAs, Navy and Air Force settings, frontline responders (police, fire department, EMTs), substance abuse treatment centers, prisons, jails, juvenile justice systems, and judges to reduce unnecessary hospitalizations. Of note, the CDC adopted the Columbia definitions (referenced in CDC document) and there is a link to the C-SSRS in the new CDC surveillance document.

Beck Depression Inventory® (BDI)

 

The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression (Beck, et al., 1961). The BDI has been developed in different forms, including several computerized forms, a card form (May, Urquhart, Tarran, 1969, cited in Groth-Marnat, 1990), the 13-item short form and the more recent BDI-11 by Beck, Steer & Brown, 1996. (See Steer, Rissmiller & Beck , 2000 for information on the clinical utility of the BDI-11.) The BDI takes approximately 10 minutes to complete, although clients require a fifth – sixth grade reading level to adequately understand the questions (Groth-Marnat, 1990).

 

Internal consistency for the BDI ranges from .73 to .92 with a mean of .86. (Beck, Steer, & Garbin, 1988). Similar reliabilities have been found for the 13-item short form (Groth-Marnat, 1990). The BDI demonstrates high internal consistency, with alpha coefficients of .86 and .81 for psychiatric and non-psychiatric populations respectively (Beck et al., 1988).

 

References

 

Beck, A.T., Ward, C. H., Mendelson, M., Mock, J., & Erbaugh, J. (1961) An inventory for measuring depression. Archives of General Psychiatry, 4, 561-571.

 

Beck, A. T., Steer, R.A., & Garbin, M.G. (1988) Psychometric properties of the Beck Depression Inventory: Twenty-five years of evaluation. Clinical Psychology Review, 8(1), 77-100.

 

Groth-Marnat G. (1990). The handbook of psychological assessment (2nd ed.). New York: John Wiley & Sons.

 

Hojat, M., Shapurian, R., Mehrya, A.H., (1986). Psychometric properties of a Persian version of the short form of the Beck Depression Inventory for Iranian college students, Psychological Reports, 59(1), 331-338.

 

Steer, R. A., Rissmiller, D. J.& Beck, A.T., (2000) Use of the Beck Depression Inventory with depressed geriatric patients. Behaviour Research and Therapy, 38(3), 311-318.

 

ADaM, BRIDG, CDASH, SDTM

 

Analysis Data Model (ADaM)

ADaM defines dataset and metadata standards that support:

• efficient generation, replication, and review of clinical trial statistical analyses, and
• traceability between analysis results, analysis data, and data represented in the Study Data Tabulation Model (SDTM).

 

BRIDG

The BRIDG Model is a Domain Analysis Model (DAM) that is being developed through a collaborative effort of stakeholders from CDISC, the HL7 Regulated Clinical Research Information Management Technical Committee (RCRIM TC), the National Cancer Institute (NCI), and the US Food and Drug Administration (FDA).

 

Clinical Data Acquisition Standards Harmonization (CDASH)

Developed with participation from organizations in all three ICH (International Conference on Harmonization) regions (US, Europe and Japan), CDASH v1.1 describes the recommended data collection fields for 16 domains, including demographics, adverse events, and other domains common to most therapeutic areas and clinical research phases. Additionally, CDASH v1.1 includes implementation guidelines, best practice recommendations, regulatory references.

 

Study Data Tabulation Model (SDTM)

SDTM provides a standard for organizing and formatting data to streamline processes in collection, management, analysis and reporting. Implementing SDTM supports data aggregation and warehousing; fosters mining and reuse; facilitates sharing; helps perform due diligence and other important data review activities; and improves the regulatory review and approval process. SDTM is also used in non-clinical data (SEND), medical devices and pharmacogenomics/genetics studies.