Globally Harmonized, Standardized and Accredited Training and Certification Program
When assessing outcome after stroke, the main issue that concerns patients or the regulatory authorities that license drugs or devices, is the degree of disability that the patient is left with. The degree of disability is usually assessed by an independent observer and can be scored according to a standardised scale.
The modified Rankin scale is a 6 point disability scale with possible scores for function ranging from 0 up to 5. A separate category (of 6) is usually added to classify patients who die before the assessment window. The modified Rankin scale has been used widely in both secondary prevention and acute stroke trials, including most of the thrombolysis trials and all of the thrombectomy trials; and is becoming standard for rehabilitation research alongside tailored scales.
Rankin training and certification has been in use since the beginning of the 21st century and almost every stroke clinician with a research or audit interest will hold certification. Although variations in Rankin scoring systems have been proposed from time to time - including focussed assessments, automated scoring etc - these may place unwarranted reliance on the skills of elderly, disabled patients in understanding the principles behind scoring and cannot replace the skilled judgement of an alert, trained clinician in matching functional ability to the mRS scoring rules.
In order to detect a treatment effect or to demonstrate clinical improvement, it is important that patients are rated in a consistent manner, minimising variability. This becomes especially important if patients are enrolled across multiple sites, if trial results need to be combined through meta-analysis, or if registries are used to judge outcomes from healthcare strategies or services. Use of a common ‘language’ to describe patient outcome is critical. The modified Rankin Scale has clearly defined thresholds for each level of function but both patients and clinicians inevitably perceive these in diverse ways, introducing inter-rater variation in scoring. This cannot be completely eradicated but can be minimised through working to a common protocol. The modified Rankin training program seeks to standardise the approach to scoring of mRS and the certification tools confirm that raters have understood and can apply these in practice, so that their scores fall within the same range as 90% of their peers for similar patients.
To modernize the global healthcare and clinical research system using global standards of care so that no patient is left behind, no matter what race, religion, socio-economic status, political affiliation or geographical location.
"The National Institutes of Health Stroke Scale (NIHSS) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. The NIHSS was originally designed as a research tool to measure baseline data on patients in acute stroke clinical trials. Now, the scale is also widely used as a clinical assessment tool to evaluate acuity of stroke patients, determine appropriate treatment, and predict patient outcome. The NIHSS can be used as a clinical stroke assessment tool to evaluate and document neurological status in acute stroke patients. The stroke scale is valid for predicting lesion size and can serve as a measure of stroke severity. The NIHSS has been shown to be a predictor of both short and long term outcome of stroke patients. Additionally, the stroke scale serves as a data collection tool for planning patient care and provides a common language for information exchanges among healthcare providers. The scale is designed to be a simple, valid, and reliable tool that can be administered at the bedside consistently by physicians, nurses or therapists."
"The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent’s ability to answer questions and perform activities. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items. The single patient assessment requires less than 10 minutes to complete. The evaluation of stroke severity depends upon the ability of the observer to accurately and consistently assess the patient."
Regulatory agencies, Ethical Review Committees and healthcare accreditation organizations now require that any healthcare professional, using the NIHSS as a patient diagnostic tool, must show continued competencies in the use of the tool in order to maximize inter-rater-reliability between diagnosticians and improve human subject protection and patient safety.
Investigators required to certify in use of the modified Rankin Scale often participate in several trials, running across institutions and countries. These trials may each have a different sponsor. It is important that the arrangements for certification remain consistent between trials and among investigators within trials. Investigators who hold a certificate from a source other than the BlueCloud Network cannot transfer their certificate to a new trial without undertaking full training and certification de novo. This ensures that certificates in existence were based on a common, validated and harmonized approach in order to have consistent inter-rater-reliability during clinical trials. The training and certification material on this network are constantly monitored and updated as necessary to ensure maintain validity.
NIH Stroke Scale
The NIH Stroke Scale (NIHSS) International is an initiative by national and international government entities as well as private and scholastic organizations. These bodies are dedicated to promoting wellness and better patient care in the field of stroke.
It is our vision to provide all patients the best opportunity for survival. We believe the “Know Stroke” program gives healthcare providers the necessary tools to obtain this objective.
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.
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).
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.
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