Research in Health Related Quality of Life

Research in Health Related Quality of Life

The Research Unit at the Strelitz Diabetes Center and Neuroendocrine Unit has a special interest in health related quality of life (QOL) and has focused attention on patients with neuropathy and neuroendocrine tumors, resulting in research in these areas and in the development and validation of two questionnaires:

  1. Norfolk QOL-DN
  2. Norfolk QOL-NET

 

Neuropathy Quality of Life Questionnaire (Norfolk QOL-DN)

To fulfill the need for a comprehensive questionnaire that would capture the entire spectrum of diabetic neuropathy we developed the Norfolk QOL-DN that includes the concentration of symptoms in the extremities, subtle loss of function such as fine motor impairments and slight sensory changes, unique problems with proprioception and balance, and autonomic symptoms that are not captured in existing instruments.

  • Description: The Norfolk QOL-DN is a self-administered questionnaire, which captures and quantifies the impact of diabetic neuropathy on the quality of life of individual patients with diabetic neuropathy. Fourteen of the items are of a health-related, biographical nature and are not scored. These are on the front page, and they are not numbered nor scored. The remaining 35 scored questions are numbered items that comprise the entire scale, and they are arranged thematically so that the wording of the questions and the type of response is grouped together. The content and topic of each individual question concerns particular functions or symptoms that are related to the following themes:

Total Quality of Life Score; Physical Functioning/Large Fiber Neuropathy; Activities of Daily Living (ADLs); Symptoms; Small Fiber Neuropathy; Autonomic Neuropathy

Norfolk QOL-DN was copyrighted in August 1997 by Eastern Virginia Medical School. The questionnaire is available for use by academic institutions from the authors: Etta J. Vinik, MA(Ed) and Aaron I. Vinik, MD, PhD.

Norfolk QOL-DN, together with a scoring manual, is also available to industry for clinical trials by licensing it from Eastern Virginia Medical School’s office of Intellectual Property through contact with the authors (see above).

The questionnaire has been used in multicenter, multinational clinical trials and was translated into the following languages in 2002 as a 47-item tool: Canadian French, Canadian English, UK English, German, and Spanish.

In 2006, as a 35-item tool, the Norfolk QOL-DN was translated into Portuguese for Portugal, Portuguese for Brazil, Spanish for Argentina, French for France, Italian and Swedish.

The development and validation of Norfolk QOL-DN has been published:

  • Etta J. Vinik, Risa P. Hayes, Alan Oglesby, Edward Bastyr, Patricia Barlow, Stephanie L. Ford-Molvik, Aaron I. Vinik, “The Development and Validation of the Norfolk QOL-DN, a New Measure of Patients' Perception of the Effects of Diabetes and Diabetic Neuropathy.” Diabetes Technology & Therapeutics. Vol. 7, No. 3: 497-508, Jun 2005.
  • Vinik EJ, Paulson JF, Ford-Molvik SL, Vinik AI., “German-Translated Norfolk Quality of Life (QOL-DN) Identifies the Same Factors as the English Version of the Tool and Discriminates Different Levels of Neuropathy Severity”. Journal of Diabetes Science and Technology. Vol 2, Issue 6, Nov 2008.

Neuroendocrine Quality of Life Questionnaire (Norfolk QOL-NET)

Due to the need for a specific (non-generic) questionnaire to evaluate the impact of neuroendocrine tumors (NETS) on the quality of life of patients with this disease, we developed the Norfolk QOL-NET.

  • Description: The Norfolk QOL-NET is a self-administered questionnaire, designed to capture and quantify the impact of carcinoid disease or neuroendocrine tumors on the quality of life of individual patients with neuroendocrine tumors. The first page of the tool asks questions about the individual’s medical history of carcinoid and neuroendocrine tumors. The quantitative portion of the questionnaire consists of 72 numbered items that comprise the entire scale, and is arranged thematically so that the wording of the question concerns particular functions or symptoms that are related to the following themes: Symptom Frequency; Symptom Severity; Activities of Daily Life; Sandostatin Injection Scale; Feelings Scale

These scales and the administration of the questionnaire are described in detail in a scoring manual available on request from the authors.

Norfolk QOL-NET was copyrighted October 3, 2005 by Eastern Virginia Medical School. It is available for use by academic institutions from the authors: Etta J. Vinik, MA(Ed) vinikej@evms.edu and Aaron Vinik, MD, PhD vinikai@evms.edu.

The questionnaire is available for use by industry for clinical trials from Eastern Virginia Medical School through contact with the authors (see above).

The development and validation of Norfolk QOL-NET has been published in the journal Pancreas:

  • Vinik, E, Carlton C, Silva M, Vinik A. “Development of the Norfolk Quality of Life Tool for Assessing Patients with Neuroendocrine Tumors”, Pancreas, Vol 38:3, 2009.

The following abstracts on the relationship between quality of life and health-related measures, encompassing the serotonin paradox that high blood serotonin levels relate to depression in patients with neuroendocrine tumors, were presented as posters in 2009:

  • Vinik Etta, Maria Silva, Aaron Vinik. Relationship Between Quality of Life and Health-Related Measures, Including Symptoms, Biochemical Markers and Tumor Burden. ISPOR (International Society for Pharmacoeconomics and Outcomes Research), May 2009; NANETS (National Association of Neuroendocrine Tumors), October 2009.