A symptom is a sensation or perception of change related to health function experienced by an individual. Symptoms such as fatigue, pain and nausea can be classified according to their severity and perceived impact on function. Symptoms add to the burden of having a chronic disease, such as cancer, and they affect virtually all aspects of life. Symptoms interfere with a person's mood, level of activity and ability to relate to others.
Symptoms are best understood through self-report from patients at specific stages of specific disease types. Such patient-reported outcomes (PROs) have been recognized by the US Food and Drug Administration as legitimate primary outcome variables for clinical trials.
The Symptom Research department designs and licenses the following PRO-based assessment questionnaires to measure the symptoms experienced by cancer patients, to determine their severity and how they affect quality of life.
Don't see what you need? Our team of experts can help you build a fit-for-purpose questionnaire that captures symptoms specific to a given disease or treatment, including drugs in development. Read more...
Did You Know?
The FDA’s 2009 guidance on the use of patient-reported outcomes in drug labeling claims states that the optimal time to understand symptomatic impact and to design assessment questionnaires is early in drug development.
Experts in the Symptom Research department can help you build a fit-for-purpose assessment questionnaire that captures symptoms specific to a given disease or treatment, including drugs in development. Your questionnaire will:
- Provide early information about symptomatic impact and tolerability
- Identify reduction in symptomatic impact compared to standard of care
- Document delayed onset of symptom progression
- Show symptom palliation in combination with approved chemotherapy
- Support clinical meaningfulness of progression-free survival through symptomatic benefit
We are interested in collaborating with other investigators to develop and validate new language versions of our questionnaires. Contact us at email@example.com for more information.
NOTE: Our questionnaires may not be modified or translated into another language without the express written consent of the copyright holder (see Notice of Copyright below).
The MD Anderson Symptom Inventory (MDASI), Brief Pain Inventory (BPI), Brief Fatigue Inventory (BFI), Treatment-Induced Neuropathy Assessment Scale (TNAS), and the Alopecia Areata Symptom Impact Scale (AASIS), along with all of their variants, derivatives, and modules, are copyrighted questionnaires. The copyright applies to all language versions of these instruments.
The MDASI, BPI, BFI, TNAS, AASIS, and their derivatives may not be used or reproduced without permission. Failure to comply may result in legal action. Please use our order form to request the instrument(s) you need. Fees may apply.
The MDASI, BPI, BFI, TNAS, AASIS, and their derivatives may not be modified or translated into another language without express written consent. Failure to comply may result in legal action. Contact us at firstname.lastname@example.org to request permission to alter or translate the questionnaire.
Our symptom assessment questionnaires are understandable even by grade-school children, according to the Flesch scoring systems described below.
Flesch Reading Ease score: Rates text on a 100-point scale; the higher the score, the easier it is to understand the document. Most standard documents aim for a score of approximately 60 to 70.
Flesch-Kincaid Grade Level score: Rates text on a U.S. grade-school level. For example, a score of 8.0 means that an eighth grader can understand the document. Most standard documents aim for a score of approximately 7.0 to 8.0.
|Flesch Reading Ease||Flesch-Kincaid Grade Level|
|BPI (short form)||83.5||5.1|
The simplicity of our questionnaires facilitates cross-cultural studies of pain and other patient-reported cancer-related symptoms. Other than for the MDASI, validation studies have not been conducted using our assessment questionnaires in the pediatric population, aged 18 years and younger.