Quality of Life

The Education Division of the Strelitz Diabetes Institute under the direction of Etta Vinik has pioneered and developed a quality of life Tool for detection and monitoring the progress of diabetic neuropathy. The tool has been licensed to several pharmaceutical companies and generated considerable income and support for the endeavor. It has been translated into 4 different languages and is now being tested in an African American version to document its validity. It is being used in multicenter worldwide clinical research studies in diabetic neuropathy. They propose to carry out several studies in 2006:

The development and validation of the Norfolk QOL-DN instrument was published in June in Diabetics Technology.  Therapeutics. (Reference 1.)  Because the importance of health-related quality of life is being recognized as an important outcome, requests to use the Norfolk QOL-DN in neuropathy studies are received on a regular basis.  This will provide extended collaboration as well as the opportunity to use it in different populations with different languages such as German and Spanish. Please contact Etta Vinik at vinikej@evms.edu for more information.

Study Description

Title: Utilization of the Norfolk quality of Life Diabetic Neuropathy (Norfolk QOl-DN) a patient-reported outcomes measure, sensitive to the different features of diabetic neuropathy (DN) - small fiber, large fiber and autonomic nerve function. To determine:

1. The ability of the tool to detect responses to an intervention using the anti oxidant alpha lipoic acid in a multinational, multicenter worldwide study.
2. Determine the relationship between the various components of the QOL-DN and objective measures of autonomic function using indices of heart rate variability that quantify the integrity of the sympathetic and parasympathetic nervous systems.

Background: The review of 1000 structured patient interviews guided the development of 28 items pertaining specifically to the symptoms and impact of large fiber, small fiber, and autonomic nerve function. These items, in addition to 14 generic health status items and 5 general information items formed the 47-item Norfolk Quality of Life Questionnaire –Diabetic Neuropathy (QOL-DN). Items are grouped according to small, large fiber and autonomic nerve function, symptoms, and activities of daily living (ADLs).

Differences between DN subjects and both DC and C subjects were significant (p< 0.05) for all item groupings. Total QOL scores correlated with total neuropathy scores (TNS). The activities of daily living (ADL), total quality of life (QOL), and autonomic scores were greater in DC than C (p<0.05). The positive scores for the DC group in the ADL and autonomic domains, suggests that diabetes per se impacts these aspects of QOL. It remained to be determined whether or not the tool was capable of showing an impact of an intervention on scores in the individual domains of the tool and if there were positive correlations between objective measures of autonomic nerve function and the autonomic domain of the tool.

Project 1:

Hypothesis: The Norfolk QOL-DN has sufficient accuracy and precision to be able to provide objective evidence that an intervention can be quantified using the tool.
Patients have been entered into a placebo controlled multicenter worldwide study to determine the effects of alpha lipoic acid, a powerful antioxidant on symptoms and signs as well as objective measures including quantitative sensory, autonomic and electrophysiologic tests. The Norfolk QOL-DN was administered at entry into the study and at intervals during treatment with either placebo or active drug. The study had now been completed and unblinded. This database is now available for the student to access and determine whether or not the tool is capable of quantifying an impact of treatment on measures of QOL and ADL. A great advantage to this analysis is that the study has shown effectiveness of the compound with objective measures of neuropathy and any changes in the QOL-DN scores can be correlated with indices of neurologic function.

Project 2:

Hypothesis: There will be a correlation between objective measures of heart rate variability (HRV) and the role of the sympathetic nervous system and parasympathetic nervous system on the measures of autonomic function domain of the Norfolk QOL-DN tool.

Autonomic neuropathy affects every system in the body and the symptoms are far ranging and the impact on morbidity and mortality are high. The integrity of the autonomic nervous system can be determined using the changes in heart rate variability (HRV) with deep respiration, a Valsalva maneuver (blowing into a sphygmomanometer cuff) and standing. We have a device (ANSAR) that not only quantifies HRV but also determines the different frequencies in HRV. Low frequencies correspond to sympathetic function and high frequencies to parasympathetic function. We have a cadre of patients who have been tested using the device and who have completed the Norfolk QOL-DN which contains an autonomic domain. The student will have access to the de-identified data to determine the relationship of these objective measures of AN with the QOL-DN autonomic domain questions and answers. This ostensible would validate the tool a s a means of quantifying the impact of AN on QOL as well as potentially provide a means of assessing responsiveness of AN to interventions designed to improve autonomic function.

References

1. Vinik, e., Hayes, R., Oglesby, A., Bastyr, E., Barlow, P., Ford-Molvik, S., Vinik, A., The Development and Validation of the Norfolk QOL-DN a New Measure of Patient Perception of the Effects of Diabetes and Diabetic Neuropathy, Diabetes Technology and Therapeutics, Vol 7(3), 497-508, 2005

2. Vinik AI, Mehrabyan A: Diabetic Neuropathies, Med Clin N Am 88:947-999, 2004

3. Vinik AI and Erbas T: Recognizing and Treating Diabetic Autonomic Neuropathy. Cleveland Clinic Journal of Medicine 68 (11), 928 – 944. 2001

4. Vinik EJ, Hayes RP, Oglesby A, Bastyr E, Vinik, AI: Identification of factors in the nerve fiber specific Norfolk Quality of Life (QOL-DN) inventory that reflect QOL and health status. (Abstract). Diabetes 64: (Supplement 1), 2004

5. Vinik EJ, Oglesby A, Bastyr E, Vinik, AI. : Norfolk Quality of Life (QOL) Tool: Relationship between indices of specific nerve fiber symptoms and neurologic disabilities. International Diabetes Federation Meetings, Paris 2003

6. Vinik EJ, Zarrabi L, Witherspoon CAG, McNitt PM, Vinik AI: Development of a sensitive, specific quality of life inventory for peripheral neuropathy (Abstract). Diabetes 49: Supplement 1, 2000

7. Vinik EJ, Stansberry KB, Ruck SM, Doviak MJ, and Vinik AI: Norfolk Neuropathy Quality of Life (QOL) Tool: Scoring and reproducibility in healthy people, diabetic controls and patients with neuropathy. (Abstract) Diabetes 52: (Supplement 1), 2002

8. Vinik EJ, Stansberry KB, Vinik AI: The Norfolk Neuropathy Quality of Life Instrument (Norfolk QOL-DN): Comparison with Symptom Scores (NSS), Nerve Impairment (NISS), Quantitative Sensory (QST), Autonomic (QAFT) Tests and Electrophysiology in a Large Clinical Trial Population. (Abstract). Late Breaking News. ADA Scientific Sessions 2003