Wichita Clinical Study

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The Wichita Clinical Study was a research study conducted by William Reeves and his chronic fatigue syndrome (CFS) program department at the Centers for Disease Control and Prevention. From December 2002 to July 2003 in Wichita, Kansas, US, a 2-day in-hospital clinical assessment study was undertaken.[1] The main objective of the study was to characterize the physiologic status of subjects with CFS[2], and to test the application of the 1994 CFS criteria to standardized reproducible criteria.[3] The study results were published in the BMC Medicine in 2005.[3]

The complete data set is available on the CDC Wichita Clinical Study Data Access website.

Study Groups[edit | edit source]

The study enrolled 227 people and classified them into five study groups based on specific criteria:[4]

  • CFS group - patients who met the 1994 CFS case definition, also known as the Fukuda criteria case definition - 58 subjects
  • CFS-MDDm group - patients who met the 1994 CFS case definition except that a major depressive disorder with melancholic features was identified - 27 subjects
  • ISF group - patients who are chronically fatigued but not meeting the CFS case definition because of insufficient number of symptoms or fatigue severity - 59 subjects
  • ISF-MDDm group - patients who are chronically fatigued but with an insufficient number of symptoms or fatigue severity and a major depressive disorder with melancholic features - 28 subjects
  • NF group - patients who are non-fatigued controls matched to CFS subjects on age, race/ethnicity, sex, and body mass index - 55 subjects

Each participant's group assignment was blinded (that is, not known) to the researcher performing the evaluations.

Assessment[edit | edit source]

Testing included:

  • Demographics
  • Multidimensional Fatigue Inventory-20 (MFI)[5]
  • 36-item Short-Form Health Survey (SF-36)[6]
  • CDC 2005 Symptom Inventory for CFS
  • Physical Examination including a 30-minute recumbent blood pressure and heart rate, and 5-minute standing blood pressure and heart rate.
  • Laboratory Tests including a complete blood count with differential, c-reactive protein, alanine aminotransferase, albumin, alkaline phosphatase, asparatate aminotransferase, serum glutamic aminotransferase, total bilirubin, calcium, carbon dioxide, chloride, creatinine, glucose, potassium, total protein, sodium, blood urea nitrogen, and urinalysis.
  • Gynecological History
  • Medication Usage, including current prescribed and over-the-counter medications and dietary supplements
  • Tobacco Questionnaire - smoking status and the use of tobacco products
  • Endocrine and cortisol levels
  • Catecholamines - Plasma basal catecholamine, metanephrine, normetanephrine and neuropeptide; and morning plasma rennin and serum aldosterone
  • Cytokine levels - IL-6 (interleukin 6), TNF-alpha (tumor necrosis factor), and IL-1 beta
  • Cambridge Neuropsychological Test Automated Battery (CANTAB)[7]
  • Wechsler Adult Intelligence Scale – Revised (WAIS-R)[8]
  • Reading Subtest of Wide-Range Achievement Test (WRAT3)[9]
  • Epworth Sleepiness Scale (ESS)[10]
  • Nap Questionnaire- collected information related to four 20-minute naps that were part of the study
  • Sleep Questionnaire - pre-sleep questionnaire and post-sleep questionnaire, which collected information regarding subjects’ first and second overnight sleep study.
  • Polysomnographic and Multiple Sleep Latency Test (MSLT) Published Results, 2006[11]
  • Self-Rating Depression Scale (SDS)[12]
  • Davidson Trauma Scale (DTS)[13]
  • General Health Questionnaire (GHQ-30)[14]
  • Childhood Trauma Questionnaire (CTQ)[15]
  • Traumatic Life Events Questionnaire (TLEQ)[16]
  • Life Experiences Survey (LES)[17]
  • Perceived Stress Scale (PSS)[18]
  • Ways of Coping Questionnaire (WCQ)[19]
  • Spielberger State-Trait Anxiety Inventory (STAI)[20]
  • Single Nucleotide Polymorphism (SNP)- selected polymorphisms in a small set of genes representing immune and central nervous system functions, particularly Hypothalamic-pituitary-adrenal axis (HPA) to identify genetic variants associated with CFS or quantitative measures of major domains of CFS.
  • Gene Expression - Subjects’ peripheral blood mononuclear cells were analyzed to examine global gene expression.

Conclusion[edit | edit source]

The conclusion of the Wichita Clinical Study published in 2005 stated: "The empirical definition includes all aspects of CFS specified in the 1994 case definition and identifies persons with CFS in a precise manner that can be readily reproduced by both investigators and clinicians."[3]

In 2006, Reeves spoke at The National Press Club as part of a "Chronic Fatigue Syndrome Awareness Campaign". Using results from the Wichita Clinical Study, he stated: "When we completed the medical workups of people in Wichita to confirm that they had CFS, we found that only half of those with the illness had consulted a physician for the illness. We found that only 16 percent had been diagnosed and treated for CFS...We found that a quarter of the people with CFS are either unemployed or receiving disability...We’ve documented, as have others, that the level of functional impairment in people who suffer from CFS is comparable to multiple sclerosis, AIDS, end-stage renal failure, [or] chronic obstructive pulmonary disease. The disability is equivalent to that of some well-known, very severe medical conditions.”[21]

References[edit | edit source]

  1. ↑ "Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) | Myalgic Encephalomyelitis/Chronic Fatigue Syndrome". Centers for Disease Control and Prevention. March 22, 2019. Retrieved May 6, 2019.
  2. ↑ "Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) | Myalgic Encephalomyelitis/Chronic Fatigue Syndrome". Centers for Disease Control and Prevention. March 22, 2019. Retrieved May 6, 2019.
  3. ↑ 3.0 3.1 3.2 Reeves, W. C.; Wagner, D.; Nisenbaum, R.; Jones, J. F.; Gurbaxani, B.; Solomon, L.; Papanicolaou, D.A.; Unger, E. R.; Vernon, S. D.; Heim, C. (2005), "Chronic Fatigue Syndrome – A clinically empirical approach to its definition and study", BMC Medicine, 3 (19), doi:10.1186/1741-7015-3-19
  4. ↑ http://www.cdc.gov/cfs/programs/wichita-data-access/index.html
  5. ↑ Smets EM, Garssen Bj, Bonke B, De Haes JC. The multidimensional fatigue inventory (MFI) psychometric qualities of an instrument to assess fatigue. J Psychosom Res 1995; 39: 315-325.
  6. ↑ Ware JE, Sherbourne CD. The MOS 36-item short-form health survey (SF-36): conceptual framework and item selection. Med Care 1992;30: 473-483.
  7. ↑ Robbins TW, Sahakian BJ. Computer methods of assessment of cognitive function. In Principles and Practice of Geriatric Psychiatry, Copeland JRM, Abou-Saleh MT, Blazers DG (eds), John Wiley & Sons Ltd., Chichester, 1994, pp 205-209.
  8. ↑ Reynolds CR, Wilson VI, Clark PL. A four-test shot form of the WAIS-R for clinical screening. Clin Neuropsychol 1983; 3: 111-116
  9. ↑ Wilkinson GS. The Wide Range Achievement Test: Manual. 3rd ed. Wilmington, DE: Wide Range; 1993
  10. ↑ Johns MW. A new method for measuring daytime sleepiness: the Epworth Sleepiness Scale. Sleep 1991; 50-55
  11. ↑ Reeves, W. C.; Heim, C.; Maloney, E. M.; Youngblood, L. S.; Unger, E. R.; Decker, M. J.; Jones, J. F.; Rye, D. B. (2006), "Sleep characteristics of persons with chronic fatigue syndrome and non-fatigued controls: results from a population-based study", BMC Neurology, 6 (41), doi:10.1186/1471-2377-6-41
  12. ↑ Zung WWK. A self-rating depression scale. Arch Gen Psychiatry 1965; 12: 371-379.
  13. ↑ JR, Book SW, Colket JT, et al. Assessment of a new self-rating scale for post-traumatic stress disorder. Psychology Medicine 1997; 27: 153-160.
  14. ↑ Goldberg D, Williams P. A user’s guide to the general health questionnaire. Windsor: NFER-Nelson, 1988
  15. ↑ Bernstein DP, Fink L, Handelsman L, Lovejoy M, Wenzel K, Sapareto E, Gurriero J. Initial reliability and validity of a new retrospective measure of child abuse and neglect. Am J Psychiatry 1994; 151: 1132-1136.
  16. ↑ Kubany ES, Haynes SN, Leisen MB, et al. Development and preliminary validation of a brief broad-spectrum measure of trauma exposure: The Traumatic Life Events Questionnaire. Psychol Assess 2000; 12: 210-224.
  17. ↑ Sarason IG, Johnson JH, Siegel JM. Assessing the impact of life changes: development of the Life Experiences Survey. J Consult Clin Psychol 1978; 46: 932-946
  18. ↑ Cohen S, Kamarck T, Memslstein R: A global measure of perceived stress. J Health Soc Beh 1983; 24:385-396.
  19. ↑ Folkman S., Fazarus RS. If it changes it must be a process: Study of emotion and coping during three stages of a college examination. Journal of Personality and Social Psychology. 1985;48:150-170
  20. ↑ Spielberger CD. Manual for the State-Trait Anxiety Inventory (STAI). Palo Alto, CA: Consulting Psychologists Press 1983.
  21. ↑ http://www.cdc.gov/media/transcripts/t061103.htm

blinded trial A clinical trial is blinded if either the participants or the researchers don't know which treatment group they are allocated to until after the results are interpreted. (Learn more: www.nottingham.ac.uk)

heart rate (HR) - the number of times the heart beats within a certain time period, usually a minute

serum The clear yellowish fluid that remains from blood plasma after clotting factors have been removed by clot formation. (Blood plasma is simply blood that has had its blood cells removed.)

plasma The liquid part of blood, lymph, or milk after removing any suspended material. Most of the time, "plasma" simply refers to blood, after all the blood cells have been removed. If you also remove the clotting factors, then the plasma is referred to as "serum".

β β / Β. Greek letter beta (a symbol used in science), equivalent to "b".

stress Stress can by either physical or psychological, or both. Stress is either 1) a state of emotional or psychological strain or 2) the physical stress (pressure or tension) that a physical object such the human body is placed under, e.g., a stress test is a medical test that monitors the cardiovascular system during strenuous exercise.

single nucleotide polymorphism (SNP) - A single nucleotide polymorphism (SNP, pronounced "snip") is a potential genetic mutation that occurs in a single spot in the human genome; a difference in a single DNA building block. SNPs are often represented by an "rs" number, such as "rs53576".

single nucleotide polymorphism (SNP) - A single nucleotide polymorphism (SNP, pronounced "snip") is a potential genetic mutation that occurs in a single spot in the human genome; a difference in a single DNA building block. SNPs are often represented by an "rs" number, such as "rs53576".

central nervous system (CNS) - One of the two parts of the human nervous system, the other part being the peripheral nervous system. The central nervous system consists of the brain and spinal cord, while the peripheral nervous system consists of nerves that travel from the central nervous system into the various organs and tissues of the body.

Short Form 36-Item Health Survey (SF-36) - A 36-item patient-reported questionnaire, used to determine patient health status and quality of life.

cognition Thought processes, including attention, reasoning, and memory.

creatine (CR) - A natural substance that turns into creatine phosphate in the body, which helps make ATP. ATP provides the energy for muscles Often taken as a supplement to improve sports performance. (Learn more: www.webmd.com)

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