Mini Mental Status Examination Scores As Eligibility Criteria for Patients With Primary Brain Tumors Entering Clinical Trials

2.50
Hdl Handle:
http://hdl.handle.net/10755/165427
Category:
Abstract
Type:
Presentation
Title:
Mini Mental Status Examination Scores As Eligibility Criteria for Patients With Primary Brain Tumors Entering Clinical Trials
Author(s):
Powers, P.
Author Details:
P. Powers, Johns Hopkins University, School of Nursing, Baltimore, Maryland, USA
Abstract:
A standard eligibility criteria for patients entering clinical trial is that patients must be able to give informed consent. Obtaining informed consent is a process that depends on the patient’s ability to understand the proposed trial, its potential risks, benefits, and requirements, as well as alternative treatment options. This process is more difficult if the patient is cognitively impaired. New Approaches to Brain Tumor Therapy (NABTT) CNS Consortium conducts Phase I/II clinical trials for patients with CNS malignancies. Even though it is not a formal eligibility criterion, Mini Mental Status Exam (MMSE) scores are obtained on all patients entering NABTT trials. This is a reliable standardized tool used to measure mental status that has been studied as a predictor of comprehension in other settings. The MMSE scores of 504 patients with brain tumors entering NABTT trials were retrospectively reviewed. Although 83% of the patients had scores that were >25 out of a possible 30, 6.5% of patients had scores that were less than 18, which is usually considered indicative of severe cognitive impairment. A subsequent retrospective review of the eligibility criteria for the 79 brain tumor protocols listed on the NCI website revealed that none of these protocols required MMSE or any other quantitative measure of mental status to be enrolled in a research study. The presence of a low MMSE score indicates a potential area of concern for the patient’s ability to give informed consent. The addition of an objective measurement of patient’s mental capacity would help ensure that appropriate patients are being entered into clinical trials. NABTT will include a MMSE of >15 as an additional eligibility criterion for patients to join a protocol. The score of 15, rather than 18, was selected because of the motor deficits that prevent some patients from performing all parts of the exam. It is believed that this will provide an additional measure of the patient’s ability to give informed consent. Use of the MMSE as eligibility criteria for clinical trials in generalizable to other studies and an asset in assuring patient knowledge and understanding of treatment.
Repository Posting Date:
27-Oct-2011
Date of Publication:
27-Oct-2011
Conference Date:
2003
Conference Name:
28th Annual Oncology Nursing Society Congress
Conference Host:
Oncology Nursing Society
Conference Location:
Denver, Colorado, USA
Note:
This is an abstract-only submission. If the author has submitted a full-text item based on this abstract, you may find it by browsing the Virginia Henderson Global Nursing e-Repository by author. If author contact information is available in this abstract, please feel free to contact him or her with your queries regarding this submission. Alternatively, please contact the conference host, journal, or publisher (according to the circumstance) for further details regarding this item. If a citation is listed in this record, the item has been published and is available via open-access avenues or a journal/database subscription. Contact your library for assistance in obtaining the as-published article.

Full metadata record

DC FieldValue Language
dc.type.categoryAbstracten_US
dc.typePresentationen_GB
dc.titleMini Mental Status Examination Scores As Eligibility Criteria for Patients With Primary Brain Tumors Entering Clinical Trialsen_GB
dc.contributor.authorPowers, P.en_US
dc.author.detailsP. Powers, Johns Hopkins University, School of Nursing, Baltimore, Maryland, USAen_US
dc.identifier.urihttp://hdl.handle.net/10755/165427-
dc.description.abstractA standard eligibility criteria for patients entering clinical trial is that patients must be able to give informed consent. Obtaining informed consent is a process that depends on the patient’s ability to understand the proposed trial, its potential risks, benefits, and requirements, as well as alternative treatment options. This process is more difficult if the patient is cognitively impaired. New Approaches to Brain Tumor Therapy (NABTT) CNS Consortium conducts Phase I/II clinical trials for patients with CNS malignancies. Even though it is not a formal eligibility criterion, Mini Mental Status Exam (MMSE) scores are obtained on all patients entering NABTT trials. This is a reliable standardized tool used to measure mental status that has been studied as a predictor of comprehension in other settings. The MMSE scores of 504 patients with brain tumors entering NABTT trials were retrospectively reviewed. Although 83% of the patients had scores that were >25 out of a possible 30, 6.5% of patients had scores that were less than 18, which is usually considered indicative of severe cognitive impairment. A subsequent retrospective review of the eligibility criteria for the 79 brain tumor protocols listed on the NCI website revealed that none of these protocols required MMSE or any other quantitative measure of mental status to be enrolled in a research study. The presence of a low MMSE score indicates a potential area of concern for the patient’s ability to give informed consent. The addition of an objective measurement of patient’s mental capacity would help ensure that appropriate patients are being entered into clinical trials. NABTT will include a MMSE of >15 as an additional eligibility criterion for patients to join a protocol. The score of 15, rather than 18, was selected because of the motor deficits that prevent some patients from performing all parts of the exam. It is believed that this will provide an additional measure of the patient’s ability to give informed consent. Use of the MMSE as eligibility criteria for clinical trials in generalizable to other studies and an asset in assuring patient knowledge and understanding of treatment.en_GB
dc.date.available2011-10-27T12:18:21Z-
dc.date.issued2011-10-27en_GB
dc.date.accessioned2011-10-27T12:18:21Z-
dc.conference.date2003en_US
dc.conference.name28th Annual Oncology Nursing Society Congressen_US
dc.conference.hostOncology Nursing Societyen_US
dc.conference.locationDenver, Colorado, USAen_US
dc.description.noteThis is an abstract-only submission. If the author has submitted a full-text item based on this abstract, you may find it by browsing the Virginia Henderson Global Nursing e-Repository by author. If author contact information is available in this abstract, please feel free to contact him or her with your queries regarding this submission. Alternatively, please contact the conference host, journal, or publisher (according to the circumstance) for further details regarding this item. If a citation is listed in this record, the item has been published and is available via open-access avenues or a journal/database subscription. Contact your library for assistance in obtaining the as-published article.-
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