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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.<ref>{{Cite web|url=https://www.cdc.gov/me-cfs/index.html | title = Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) {{!}} Myalgic Encephalomyelitis/Chronic Fatigue Syndrome | date = 2019-03-22 | website = [[Centers for Disease Control and Prevention]]|language=en-us|access-date=2019-05-06}}</ref> The main objective of the study was to characterize the physiologic status of subjects with CFS<ref>{{Cite web|url=https://www.cdc.gov/me-cfs/index.html | title = Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) {{!}} Myalgic Encephalomyelitis/Chronic Fatigue Syndrome | date = 2019-03-22 | website = [[Centers for Disease Control and Prevention]]|language=en-us|access-date=2019-05-06}}</ref>, and to test the application of the 1994 CFS criteria to standardized reproducible criteria.<ref name="Reeves,2005" /> The study results were published in the ''[[BMC Medicine]]'' in 2005.<ref name="Reeves,2005" /> The complete data set is available on the [http://www.cdc.gov/cfs/programs/wichita-data-access/index.html CDC Wichita Clinical Study Data Access website]. ==Study Groups== The study enrolled 227 people and classified them into five study groups based on specific criteria:<ref>http://www.cdc.gov/cfs/programs/wichita-data-access/index.html</ref> *CFS group - patients who met the [[Fukuda criteria|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 *[[Idiopathic chronic fatigue|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 [[Depression|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== Testing included: *Demographics *[[Multidimensional Fatigue Inventory-20]] ([[MFI]])<ref>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.</ref> *36-item Short-Form Health Survey ([[SF-36]])<ref>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.</ref> *[[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 - [[interleukin 6|IL-6]] (interleukin 6), [[TNF-alpha]] (tumor necrosis factor), and [[interleukin 1|IL-1]] beta *Cambridge Neuropsychological Test Automated Battery (CANTAB)<ref>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.</ref> *Wechsler Adult Intelligence Scale – Revised (WAIS-R)<ref>Reynolds CR, Wilson VI, Clark PL. A four-test shot form of the WAIS-R for clinical screening. Clin Neuropsychol 1983; 3: 111-116 </ref> *Reading Subtest of Wide-Range Achievement Test (WRAT3)<ref>Wilkinson GS. The Wide Range Achievement Test: Manual. 3rd ed. Wilmington, DE: Wide Range; 1993</ref> *Epworth Sleepiness Scale (ESS)<ref>Johns MW. A new method for measuring daytime [[sleepiness]]: the Epworth Sleepiness Scale. Sleep 1991; 50-55</ref> *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) [http://bmcneurol.biomedcentral.com/articles/10.1186/1471-2377-6-41 Published Results, 2006]<ref name="Reeves,2006" /> *Self-Rating Depression Scale (SDS)<ref>Zung WWK. A self-rating depression scale. Arch Gen Psychiatry 1965; 12: 371-379.</ref> *Davidson Trauma Scale (DTS)<ref>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.</ref> *General Health Questionnaire (GHQ-30)<ref>Goldberg D, Williams P. A user’s guide to the general health questionnaire. Windsor: NFER-Nelson, 1988</ref> *Childhood Trauma Questionnaire (CTQ)<ref>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.</ref> *Traumatic Life Events Questionnaire (TLEQ)<ref>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.</ref> *Life Experiences Survey (LES)<ref>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</ref> *Perceived Stress Scale (PSS)<ref>Cohen S, Kamarck T, Memslstein R: A global measure of perceived [[stress]]. J Health Soc Beh 1983; 24:385-396.</ref> *Ways of Coping Questionnaire (WCQ)<ref>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 </ref> *Spielberger State-Trait Anxiety Inventory (STAI)<ref>Spielberger CD. Manual for the State-Trait Anxiety Inventory (STAI). Palo Alto, CA: Consulting Psychologists Press 1983.</ref> *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== 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."<ref name="Reeves,2005" /> 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]], [[HIV/AIDS|AIDS]], end-stage [[Kidney|renal]] failure, [or] [[chronic obstructive pulmonary disease]]. The disability is equivalent to that of some well-known, very severe medical conditions.”<ref>http://www.cdc.gov/media/transcripts/t061103.htm</ref> ==References== <references> <ref name="Reeves,2005">{{Citation | last1 = Reeves | first1 = W. C. | authorlink1 = William Reeves | last2 = Wagner | first2 = D. | authorlink2 = | last3 = Nisenbaum | first3 = R. | authorlink3 = | last4 = Jones | first4 = J. F. | authorlink4 = | last5 = Gurbaxani | first5 = B. | authorlink5 = | last6 = Solomon | first6 = L. | authorlink6 = | last7 = Papanicolaou | first7 = D.A. | authorlink7 = | last8 = Unger | first8 = E. R. | authorlink8 = Elizabeth Unger | last9 = Vernon | first9 = S. D. | authorlink9 = Suzanne Vernon | last10 = Heim | first10 = C. | author-link10 = | title = Chronic Fatigue Syndrome – A clinically empirical approach to its definition and study | journal = BMC Medicine | volume = 3 | issue = 19 | date = 2005 | doi = 10.1186/1741-7015-3-19 }}</ref> <ref name="Reeves,2006">{{Citation | last1 = Reeves | first1 = W. C. | authorlink1 = William Reeves | last2 = Heim | first2 = C. | authorlink2 = | last3 = Maloney | first3 = E. M. | authorlink3 = | last4 = Youngblood | first4 = L. S. | authorlink4 = | last5 = Unger | first5 = E. R. | authorlink5 = Elizabeth Unger | last6 = Decker | first6 = M. J. | authorlink6 = | last7 = Jones | first7 = J. F. | authorlink7 = | last8 = Rye | first8 = D. B. | authorlink8 = | title = Sleep characteristics of persons with chronic fatigue syndrome and non-fatigued controls: results from a population-based study | journal = BMC Neurology | volume = 6 | issue = 41 | date = 2006 | doi = 10.1186/1471-2377-6-41 }}</ref> </references> [[Category:Notable studies]] [[Category:Seminal works]]
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