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Chronic Fatigue Syndrome Research: Definition and Medical Outcome Assessment FREE

Ann Schluederberg, ScD; Stephen E. Straus, MD; Phillip Peterson, MD; Susan Blumenthal, MD; Anthony L. Komaroff, MD; Susan B. Spring, PhD; Alan Landay, MD; and Dedra Buchwald, MD
[+] Article and Author Information

Requests for Reprints: Ann Schluederberg, ScD; Virology Branch, DMID, National Institute of Allergy and Infectious Diseases, Room 3A-16, Solar Building, National Institutes of Health, Bethesda, MD 20892.

Current Author Addresses: Drs. Schluederberg and Spring: Virology Branch, DMID, National Institute of Allergy and Infectious Diseases, Room 3A-16, Solar Building, National Institutes of Health, Bethesda, MD 20892.

Dr. Straus: Laboratory of Clinical Investigation, National Institute of Allergy and Infectious Diseases, Building 10, Room 11N-250, National Institutes of Health, Bethesda, MD 20892.

Dr. Peterson: Department of Medicine, Division of Infectious Diseases, Hennepin County Medical Center, University of Minnesota, 701 Park Avenue, Minneapolis, MN 55415.

Dr. Blumenthal: Behavioral Medicine Program, National Institute of Mental Health, ADAMHA, Parklawn Building, Room 11C-06, 5600 Fishers Lane, Rockville, MD 20857.

Dr. Komaroff: Division of General Medicine, Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115.

Dr. Landay: Department of Immunology/Microbiology, Rush University Medical Center, 1753 West Congress Park, Room 1113 Jelke, Chicago, IL 60612.

Dr. Buchwald: Department of Medicine, Harborview Medical Center, 325 Ninth Avenue, Seattle, WA 98104.


Ann Intern Med. 1992;117(4):325-331. doi:10.7326/0003-4819-117-4-325
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Abstract

▪A workshop was held 18 to 19 March 1991 at the National Institutes of Health to address critical issues in research concerning the chronic fatigue syndrome (CFS). Case definition, confounding diagnoses, and medical outcome assessment by laboratory and other means were considered from the perspectives of key medical specialties involved in CFS research. It was recommended that published Centers for Disease Control (CDC) case-definition criteria be modified to exclude fewer patients from analysis because of a history of psychiatric disorder.

Specific recommendations were made concerning the inclusion or exclusion of other major confounding diagnoses, and a standard panel of laboratory tests was specified for initial patient evaluation. The workshop emphasized the importance of recognizing other conditions that could explain the patient's symptoms and that may be treatable. It was viewed as essential for the investigator to screen for psychiatric disorder using a combination of self-report instruments followed by at least one structured interview to identify patients who should be excluded from studies or considered as a separate subgroup in data analysis. Because CFS is not a homogeneous abnormality and because there is no single pathogenic mechanism, research progress may depend upon delineation of these and other patient subgroups for separate data analysis.

Despite preliminary data, no physical finding or laboratory test was deemed confirmatory of the diagnosis of CFS. For assessment of clinical status, investigators must rely on the use of standardized instruments for patient self-reporting of fatigue, mood disturbance, functional status, sleep disorder, global well-being, and pain. Further research is needed to develop better instruments for quantifying these domains in patients with CFS.

References

Komaroff AL, Buchwald D . Symptoms and signs of chronic fatigue syndrome. Rev Infect Dis.. 1991; ;13:( (Suppl 1) ):S8--11. .
CrossRef
 
Holmes GP, Kaplan JE, Gantz NM, Komaroff AL, Schonberger LB, Straus SE et al. . Chronic fatigue syndrome: a working case definition. Ann Intern Med.. 1988; ;108::387--9. .
 
Holmes GP, Kaplan JE, Schonberger LB et al. . Definition of the chronic fatigue syndrome [Letter]. Ann Intern Med.. 1988; ;109::512..
 
Sharpe MC, Archard LC, Banatvala JE, Borysiewicz LK, Clare AW, David A et al. . A report-chronic fatigue syndrome: guidelines for research. J R Soc Med.. 1991; ;84::118--21. .
 
Lloyd AR, Hickie I, Boughton CR, Spencer O, Wakefield D . Prevalence of chronic fatigue syndrome in an Australian population. Med J Aust.. 1990; ;153::522--8. .
 
Katon W, Russo J . Chronic fatigue syndrome criteria: a critique of the requirement for multiple physical complaints. Arch Intern Med.. 1992.;[In press].
 
Lane TJ, Manu P, Mathews DA . Depression and somatization in the chronic fatigue syndrome. Am J Med.. 1991; ;91::334--44. .
 
Holmes GP . Defining the chronic fatigue syndrome. Rev Infect Dis.. 1991; ;13:( (Suppl 1) ):S53--5. .
 
Demitrack MA, Greden JF . Chronic fatigue syndrome: the need for an integrative approach. Biol Psychiatry.. 1991; ;30::747--52. .
 
Goldberg DP, Hillier VF . A scaled version of the General Health Questionnaire. Psychol Med.. 1979; ;9::139--45. .
 
Peterson PK, Schenck CH, Sherman R . Chronic fatigue syndrome in Minnesota. Minn Med.. 1991; ;74::21--6. .
 
Robins LN, Helzer JE .The NIMH Diagnostic Interview Schedule, Version III-A. Department of Psychiatry, Washington University School of Medicine;. May1985..
 
Spitzer RL, Williams JBW, Gibbon M, First MB .Structured Clinical Interview for DSM-III-R (9/1/89 version), Biometrics Research Department, New York State Psychiatric Institute;. 1989..
 
Buchwald D, Goldenberg DL, Sullivan JL, Komaroff AL . The "chronic, active Epstein-Barr virus infection" syndrome and primary fibromyalgia. Arthritis Rheum.. 1987; ;30::1132--6. .
 
Goldenberg DL, Simms RW, Geiger A, Komaroff AL . High frequency of fibromyalgia in patients with chronic fatigue seen in a primary care practice. Arthritis Rheum.. 1990; ;33::381--7. .
 
Wolfe F, Smythe HA, Yunus MB et al. . Criteria for fibromyalgia (Abstract). Arthritis Rheum. 1989; ;32:( (Supplement) ):S47..
 
Landay AL, Jessup C, Lennette ET, Levy JA . Chronic fatigue syndrome: clinical condition associated with immune activation. Lancet.. 1991; ;338::707--12. .
 
Demitrack MA, Dale JK, Straus SE, Laue L, Listwak SJ, Kruesi MJ et al. . Evidence for impaired activation of the hypothalamic-pituitary-adrenal axis in patients with chronic fatigue syndrome. J Clin Endocrin Metabolism.. 1991; ;73::1224--34. .
 
Buchwald D, Cheney PR, Peterson DL, Henry B, Wormsley SB, Geiger A et al. . A chronic illness characterized by fatigue, neurologic and immunologic disorders, and active human herpesvirus type 6 infection. Ann Intern Med.. 1992; ;116::103--13. .
 
Peterson PK, Shepard J, Macres M, Schenck C, Crosson J, Rechtman D et al. . A controlled trial of intravenous immunoglobulin G in chronic fatigue syndrome. Am J Med. 1990; ;89::554--60. .
 
Barofsky I, Legro MW . Definition and measurement of fatigue. Rev Infect Dis.. 1991; ;13:( (Suppl 1) ):S94--7. .
 
Lewis SF, Haller RG . Physiologic measurement of exercise and fatigue with special reference to chronic fatigue syndrome. Rev Infect Dis.. 1991; ;13:( (Suppl 1) ):S98--108. .
 
Krupp LB, LaRocca NG, Muir-Nash RN, Steinberg AD . The Fatigue Severity Scale: application to patients with multiple sclerosis and systemic lupus erythematosus. Arch Neurol.. 1989; ;48::1121--3. .
 
Stewart AL, Hays RD, Ware JE . The MOS short-form general health survey: reliability and validity in a patient population. Med Care.. 1988; ;26::724--35. .
 
Bergner M, Bobbin RA, Carter WB, Gilson BS . The Sickness Impact Profile: Development and Final Revision of a Health Status Measure. Med Care.. 1981; ;19::787--805. .
 
Colburn TR, Smith BM, Guarini J . An ambulatory activity monitor with solid state memory. ISA Trans.. 1976; ;15::149--54. .
 
Schulte PA . Validation of biologic markers for use in research on chronic fatigue syndrome. Rev Infect Dis.. 1991; ;13:( (Suppl 1) ):S87--9. .
 
Herberman R . Sources of confounding in immunologic data. Rev Infect Dis.. 1991; ;13:( (Suppl 1) ):S84--6. .
 
Redmond CK . Analysis of clinical, epidemiologic, and laboratory data on chronic fatigue syndrome. Rev Infect Dis.. 1991; ;13:( (Suppl 1) ):S90--3. .
 
Buchwald D, Komaroff AL . Review of laboratory findings for patients with chronic fatigue syndrome. Rev Infect Dis.. 1991; ;13:( (Suppl 1) ):S12--8. .
 
Miller AH, Silberstein C, Asnis GM, Munk G, Rubinson E, Spigland I et al. . Epstein-Barr virus infection and depression [Letter]. J Clin Psychiatry.. 1986; ;47::529..
 
Beyaert R, Schulze-Osthoff K, Roy FV, Fiers W . Lithium chloride otentiates tumor necrosis factor-induced and interleukin 1-induced cytokine and cytokine receptor expression. Cytokine.. 1991; ;3::284--91. .
 
Endres S, Cannon JG, Ghorbani R, Dempsey RA, Sisson SD, Lonnemann G et al. . In vitro production of IL-β, IL-1α TNFα and IL-2: Distribution, effect of cyclooxygenase inhibition and evidence of independent gene regulation. Eur. J. Immunol.. 1989; ;19::2327--33. .
 
Jones JF, Strauss SE . Chronic Epstein-Barr virus infection. Annu Rev Med.. 1987; ;38::195--209. .
 
Straus SE, Dale JK, Wright R, Metcalfe DD . Allergy and the chronic fatigue syndrome. J Allergy Clin Immunol.. 1988; ;81::91--5. .
 
Cannon JG, Dinarello CA . Increased plasma interleukin-1 activity in women after ovulation. Science.. 1985; ;227::1247--9. .
 
National Committee for Clinical Laboratory Standards .Clinical applications of flow cytometry: quality assurance and immunophenotyping of peripheral blood lymphocytes—proposed guidelines.. NCCLS publication H42-P, Villanova, Pennsylvania;1989..
 

Figures

Tables

References

Komaroff AL, Buchwald D . Symptoms and signs of chronic fatigue syndrome. Rev Infect Dis.. 1991; ;13:( (Suppl 1) ):S8--11. .
CrossRef
 
Holmes GP, Kaplan JE, Gantz NM, Komaroff AL, Schonberger LB, Straus SE et al. . Chronic fatigue syndrome: a working case definition. Ann Intern Med.. 1988; ;108::387--9. .
 
Holmes GP, Kaplan JE, Schonberger LB et al. . Definition of the chronic fatigue syndrome [Letter]. Ann Intern Med.. 1988; ;109::512..
 
Sharpe MC, Archard LC, Banatvala JE, Borysiewicz LK, Clare AW, David A et al. . A report-chronic fatigue syndrome: guidelines for research. J R Soc Med.. 1991; ;84::118--21. .
 
Lloyd AR, Hickie I, Boughton CR, Spencer O, Wakefield D . Prevalence of chronic fatigue syndrome in an Australian population. Med J Aust.. 1990; ;153::522--8. .
 
Katon W, Russo J . Chronic fatigue syndrome criteria: a critique of the requirement for multiple physical complaints. Arch Intern Med.. 1992.;[In press].
 
Lane TJ, Manu P, Mathews DA . Depression and somatization in the chronic fatigue syndrome. Am J Med.. 1991; ;91::334--44. .
 
Holmes GP . Defining the chronic fatigue syndrome. Rev Infect Dis.. 1991; ;13:( (Suppl 1) ):S53--5. .
 
Demitrack MA, Greden JF . Chronic fatigue syndrome: the need for an integrative approach. Biol Psychiatry.. 1991; ;30::747--52. .
 
Goldberg DP, Hillier VF . A scaled version of the General Health Questionnaire. Psychol Med.. 1979; ;9::139--45. .
 
Peterson PK, Schenck CH, Sherman R . Chronic fatigue syndrome in Minnesota. Minn Med.. 1991; ;74::21--6. .
 
Robins LN, Helzer JE .The NIMH Diagnostic Interview Schedule, Version III-A. Department of Psychiatry, Washington University School of Medicine;. May1985..
 
Spitzer RL, Williams JBW, Gibbon M, First MB .Structured Clinical Interview for DSM-III-R (9/1/89 version), Biometrics Research Department, New York State Psychiatric Institute;. 1989..
 
Buchwald D, Goldenberg DL, Sullivan JL, Komaroff AL . The "chronic, active Epstein-Barr virus infection" syndrome and primary fibromyalgia. Arthritis Rheum.. 1987; ;30::1132--6. .
 
Goldenberg DL, Simms RW, Geiger A, Komaroff AL . High frequency of fibromyalgia in patients with chronic fatigue seen in a primary care practice. Arthritis Rheum.. 1990; ;33::381--7. .
 
Wolfe F, Smythe HA, Yunus MB et al. . Criteria for fibromyalgia (Abstract). Arthritis Rheum. 1989; ;32:( (Supplement) ):S47..
 
Landay AL, Jessup C, Lennette ET, Levy JA . Chronic fatigue syndrome: clinical condition associated with immune activation. Lancet.. 1991; ;338::707--12. .
 
Demitrack MA, Dale JK, Straus SE, Laue L, Listwak SJ, Kruesi MJ et al. . Evidence for impaired activation of the hypothalamic-pituitary-adrenal axis in patients with chronic fatigue syndrome. J Clin Endocrin Metabolism.. 1991; ;73::1224--34. .
 
Buchwald D, Cheney PR, Peterson DL, Henry B, Wormsley SB, Geiger A et al. . A chronic illness characterized by fatigue, neurologic and immunologic disorders, and active human herpesvirus type 6 infection. Ann Intern Med.. 1992; ;116::103--13. .
 
Peterson PK, Shepard J, Macres M, Schenck C, Crosson J, Rechtman D et al. . A controlled trial of intravenous immunoglobulin G in chronic fatigue syndrome. Am J Med. 1990; ;89::554--60. .
 
Barofsky I, Legro MW . Definition and measurement of fatigue. Rev Infect Dis.. 1991; ;13:( (Suppl 1) ):S94--7. .
 
Lewis SF, Haller RG . Physiologic measurement of exercise and fatigue with special reference to chronic fatigue syndrome. Rev Infect Dis.. 1991; ;13:( (Suppl 1) ):S98--108. .
 
Krupp LB, LaRocca NG, Muir-Nash RN, Steinberg AD . The Fatigue Severity Scale: application to patients with multiple sclerosis and systemic lupus erythematosus. Arch Neurol.. 1989; ;48::1121--3. .
 
Stewart AL, Hays RD, Ware JE . The MOS short-form general health survey: reliability and validity in a patient population. Med Care.. 1988; ;26::724--35. .
 
Bergner M, Bobbin RA, Carter WB, Gilson BS . The Sickness Impact Profile: Development and Final Revision of a Health Status Measure. Med Care.. 1981; ;19::787--805. .
 
Colburn TR, Smith BM, Guarini J . An ambulatory activity monitor with solid state memory. ISA Trans.. 1976; ;15::149--54. .
 
Schulte PA . Validation of biologic markers for use in research on chronic fatigue syndrome. Rev Infect Dis.. 1991; ;13:( (Suppl 1) ):S87--9. .
 
Herberman R . Sources of confounding in immunologic data. Rev Infect Dis.. 1991; ;13:( (Suppl 1) ):S84--6. .
 
Redmond CK . Analysis of clinical, epidemiologic, and laboratory data on chronic fatigue syndrome. Rev Infect Dis.. 1991; ;13:( (Suppl 1) ):S90--3. .
 
Buchwald D, Komaroff AL . Review of laboratory findings for patients with chronic fatigue syndrome. Rev Infect Dis.. 1991; ;13:( (Suppl 1) ):S12--8. .
 
Miller AH, Silberstein C, Asnis GM, Munk G, Rubinson E, Spigland I et al. . Epstein-Barr virus infection and depression [Letter]. J Clin Psychiatry.. 1986; ;47::529..
 
Beyaert R, Schulze-Osthoff K, Roy FV, Fiers W . Lithium chloride otentiates tumor necrosis factor-induced and interleukin 1-induced cytokine and cytokine receptor expression. Cytokine.. 1991; ;3::284--91. .
 
Endres S, Cannon JG, Ghorbani R, Dempsey RA, Sisson SD, Lonnemann G et al. . In vitro production of IL-β, IL-1α TNFα and IL-2: Distribution, effect of cyclooxygenase inhibition and evidence of independent gene regulation. Eur. J. Immunol.. 1989; ;19::2327--33. .
 
Jones JF, Strauss SE . Chronic Epstein-Barr virus infection. Annu Rev Med.. 1987; ;38::195--209. .
 
Straus SE, Dale JK, Wright R, Metcalfe DD . Allergy and the chronic fatigue syndrome. J Allergy Clin Immunol.. 1988; ;81::91--5. .
 
Cannon JG, Dinarello CA . Increased plasma interleukin-1 activity in women after ovulation. Science.. 1985; ;227::1247--9. .
 
National Committee for Clinical Laboratory Standards .Clinical applications of flow cytometry: quality assurance and immunophenotyping of peripheral blood lymphocytes—proposed guidelines.. NCCLS publication H42-P, Villanova, Pennsylvania;1989..
 

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