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Principles and Practice of Research pp 151–168Cite as

Endpoints for Clinical Studies: Conventional and Innovative Variables

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Abstract

Two well-dressed gentlemen were on their way home from a party where they had obviously dined and wined too well. One was on his knees systematically examining the sidewalk beneath a streetlight. His friend volunteered, helpfully: “I’m sure I heard your keys drop back here where it’s dark!” The searcher replied: “I know, but what’s the use of looking back there where I can’t see when it’s so much easier here in the light?”

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References

  1. Spitzer WO, Feinstein AR, Sackett DL. What is a health care trial? J Am Med Assoc 1975; 233: 161–63.

    CAS  Google Scholar 

  2. White KL. Improved medical care statistics and health services system. Pub Health Rep 1967; 82: 847–54.

    CAS  Google Scholar 

  3. Graham C, Bond S, Gerkovich M, Cook M. Use of McGill Pain Questionnaire in assessment of cancer pain replicability and consistency. Pain 1980; 8: 377–87.

    PubMed  CAS  Google Scholar 

  4. Melzack R, O’Fiesh JG, Mount BM. The Bromp-tom mixture: effects on pain in cancer patients. Can Med Assoc J 1976; 115: 125–29.

    PubMed  CAS  Google Scholar 

  5. World Health Organization. International Classification of Impairments, Disabilities, and Handicaps. Geneva: WHO, 1980.

    Google Scholar 

  6. Criteria Committee of the New York Heart Association. Diseases of the Heart and Blood Vessels. Nomenclature and Criteria for Diagnosis. Boston: Little, Brown 1964: 112–13.

    Google Scholar 

  7. Karnofsky DA, Burchenal JH. Clinical evaluation of chemotherapeutic agents in cancer. In: Evaluation of Chemotherapeutic Agents, Macleod CM, ed. New York: Columbia University Press, 1949; 191–205.

    Google Scholar 

  8. Visick AH. A study of the failures after gastrectomy. Edinburgh: Ann R Coll Surg, 1948; 3: 266–84.

    CAS  Google Scholar 

  9. Fries JF. Toward an understanding of patient outcome measurement. Arthritis Rheum 1983; 26: 697–704.

    PubMed  CAS  Google Scholar 

  10. Gough R, Furnival CM, Schilder L, Grove W. Assessment of the quality of life of patients with advanced cancer. Eur J Cancer Clin Oncol 1983; 19: 1161–65.

    PubMed  CAS  Google Scholar 

  11. Sugarbaker PH, Barofsky I, Rosenberg SA, Gianola FJ. Quality of life assessment of patients in extremity sarcoma clinical trials. Surgery 1982; 91: 17–23.

    PubMed  CAS  Google Scholar 

  12. Troidl H, Kusche J. Lebensqualität nach Gastrek-tomie: Ergebnisse einer randomisierten Studie zum vergleich Oesophago-jujunostomie nach Schlatter mit dem Hunt-Laurence-Rodino Pouch. In: Das Magenkarzinom. Methodik klinischer Studien and therapeutischer Ansätze, Rohde H, Troidl H, eds. Stuttgart: Thieme, 1984.

    Google Scholar 

  13. LaMendola WF, Pellegrini RV. Quality of life and coronary artery bypass surgery patients. Soc Sei Med 1979; 13A: 457–61.

    CAS  Google Scholar 

  14. Williams NS, Johnston D. The quality of life after rectal excision for low rectal cancer. Br J Surg 1983; 70: 460–62.

    PubMed  CAS  Google Scholar 

  15. Lebow JL. Consumer assessment of the quality of medical care. Med Care 1974; 12: 328–37.

    PubMed  CAS  Google Scholar 

  16. Hulka BS, Zyzanski SJ, Cassel JC, Thompson SJ. Scale for the measurement of attitudes toward physicians and primary medical care. Med Care 1970; 5: 429–35.

    Google Scholar 

  17. Mangelsdorff AD. Patient satisfaction questionnaire. Med Care 1979; 17: 86–90.

    PubMed  CAS  Google Scholar 

  18. Taylor PW, Nelson-Wernick E, Currey HS, Woodbury ME, Conley LE. Development and use of a method of assessing patient perception of care. Hosp Health Serv Admin 1981; 26: 89–103.

    CAS  Google Scholar 

  19. Light HK, Solheim JS, Hunter GW. Satisfaction with medical care during pregnancy and delivery. Am J Obstet Gynecol 1976; 122: 827–31.

    Google Scholar 

  20. Pineault R, Contandriopoulos A-P, Valois M, Bastian M-L, Lance J-M. Randomized clinical trial of one-day surgery: patient satisfaction, clinical outcomes, and costs. Med Care 1985; 23: 171–82.

    PubMed  CAS  Google Scholar 

  21. Feinstein AR. An additional basic science for clinical medicine: IV. The development of clinimetrics. Ann Intern Med 1983; 99: 843–48.

    CAS  Google Scholar 

  22. Fletcher RH, Fletcher SW. Clinical research in general medical journals. A 30-year perspective. N Engl J Med 1979; 301: 180–83.

    PubMed  CAS  Google Scholar 

  23. Fletcher RH, Fletcher SW, Wagner EH. Clinical epidemiology—the essentials. Baltimore: Williams & Wilkins, 1982.

    Google Scholar 

  24. Feinstein AR. An additional basic science for clinical medicine: II. The limitations of randomized trials. Ann Intern Med 1983; 99: 544–50.

    CAS  Google Scholar 

  25. Feinstein AR. Clinical biostatistics: XLI. Hard science, soft data, and the challenges of choosing clinical variables in research. Clin Pharmacol Ther 1977; 22: 485–98.

    PubMed  CAS  Google Scholar 

  26. Koran LM. The reliability of clinical methods, data and judgments. N Engl J Med 1975;293:642–46, 695–701.

    Google Scholar 

  27. Feinstein AR. Clinical biostatistics: XLV. The purposes and functions of criteria. Clin Pharmacol Ther 1978; 24: 479–92.

    Google Scholar 

  28. Feinstein AR. Clinical biostatistics: XLVI. What are the criteria for criteria? Clin Pharmacol Ther 1979; 25: 108–16.

    PubMed  CAS  Google Scholar 

  29. Department of Clinical Epidemiology and Biostatistics, McMaster University. Clinical disagreement: II. How to avoid it and how to learn from one’s mistakes. Can Med Assoc J 1980; 123: 613–17.

    Google Scholar 

  30. Sackett DL, Haynes RE, Tugwell P. Clinical Epidemiology. A Basic Science for Clinical Medicine. Toronto: Little, Brown, 1985.

    Google Scholar 

  31. Riddell RH, Goldman H, Ransohoff DF, Appelman HD, Fenoglio CM, Haggett R, Ahren C, Correa P, Hamilton SR, Morson BC, Sammers SC, Yardky JH. Dysplasia in inflammatory bowel disease: standardized classification with provisional clinical applications. Human Pathol 1983; 14: 931–68.

    CAS  Google Scholar 

  32. Smythe H, Helewa A, Goldsmith CH. Selection and combination of outcome measures. J Rheumatol 1982; 9: 770–74.

    PubMed  CAS  Google Scholar 

  33. Guyatt GH, Veldhuyzen Van Zanten SJO, Feeny DH, Patrick DL. Measuring quality of life in clinical trials. Can Med Assoc J 1989; 140: 1441–47.

    CAS  Google Scholar 

  34. Abramson JH. Survey methods in community medicine. Edinburgh: Churchill-Livingston, 1979.

    Google Scholar 

  35. Pocock SJ. Current issues in the design and interpretation of clinical trials. Br Med J 1985; 290: 39–42.

    CAS  Google Scholar 

  36. Bombardier C, Tugwell P. A methodological framework to develop and select indices for clinical trials: statistical and judgmental approaches. J Rheumatol 1982; 9: 753–57.

    PubMed  CAS  Google Scholar 

  37. Jette AM. Concepts of health and methodological issues in functional assessment. In: Functional assessment in rehabilitation medicine, Granger CV, Gresham GA, ed. Baltimore: Williams & Wilkins, 1984: 46–64.

    Google Scholar 

  38. Sackett DL, Chambers LW, MacPherson AS, Goldsmith CH, Maculey RG. The development and application of indices of health: general methods and a summary of results. Am J Public Health 1977; 67: 423–28.

    PubMed  CAS  Google Scholar 

  39. Ware JE, Brook RH, Davies AR, Lohr KN. Choosing measures of health status for individuals in general populations. Am J Public Health 1981; 71: 620–25.

    PubMed  Google Scholar 

  40. Department of Clinical Epidemiology and Biosta-tistics, McMaster University. Clinical disagreement: I. How often it occurs and why. Can Med Assoc J 1980; 123: 499–504.

    Google Scholar 

  41. Haynes RB, Sackett DL, Tug well P. Problems in the handling of clinical and research evidence by medical practitioners. Arch Intern Med 1983; 143: 971–75.

    Google Scholar 

  42. Fleiss JL. The design and analysis of clinical experiments. New York. Wiley, 1986.

    Google Scholar 

  43. Makrides L, Richman J, Prince B. Research methodology and applied statistics: 3. Measurement procedures in research. Physiother Can 1980; 32: 253–57.

    Google Scholar 

  44. Whitehead TP. Quality control techniques in laboratory services. Br Med Bull 1974; 30: 237–42.

    PubMed  CAS  Google Scholar 

  45. Deyo RA, Inui TS. Toward clinical applications of health status measures: sensitivity of scales to clinically important changes. Health Serv Res 1984; 19: 275–89.

    PubMed  CAS  Google Scholar 

  46. Guyatt G, Walter S, Norman G. Measuring change over time: assessing the usefulness of evaluative instruments. J Chronic Dis 1987; 40: 171–78.

    PubMed  CAS  Google Scholar 

  47. Deyo RA, Centor RM. Assessing the responsiveness of functional scales to clinical change: an analogy to diagnostic test performance. J Chronic Dis 1986; 39: 899–906.

    Google Scholar 

  48. Spitzer WO, Dobson AJ, Hall J, Chesterman E, Levi J, Shepherd R, Battista RN, Catchlove BR. Measuring the quality of life of cancer patients. A concise QL-Index for use by physicians. J Chronic Dis 1981; 34: 585–97.

    PubMed  CAS  Google Scholar 

  49. Stewart AL, Ware JE, Brook RH. Construction and Scoring of Aggregate Functional Status Measures: Vol. I, Rand Health Insurance Experiment Series, R-225 1–1-HHS. Santa Monica, CA: Rand, 1982.

    Google Scholar 

  50. Reading AE. Testing pain mechanisms in persons in pain. In: Textbook of Pain, Wall PD, Melzack R, ed. New York: Churchill-Livingstone, 1989: 269–80.

    Google Scholar 

  51. Sriwatanakul K, Kelvie W, Lasagna L, Calimlim JF, Weis OF, Mehta G. Studies with different types of visual analogue scales for measurement of pain. Clin Pharmacol Ther 1983; 34: 234–39.

    PubMed  CAS  Google Scholar 

  52. Melzack R, Torgerson WS. On the language of pain. Anesthesiology 1971; 24: 50–59.

    Google Scholar 

  53. Melzack R. The McGill Pain Questionnaire: major properties and scoring methods. Pain 1975; 1: 277–99.

    PubMed  CAS  Google Scholar 

  54. Melzack R. The Short-Form McGill Pain Questionnaire. Pain 1987; 30: 191–97.

    PubMed  CAS  Google Scholar 

  55. Reading AE, Hand DJ, Sledmere CM. A comparison of response profiles obtained on the McGill Pain Questionnaire and an adjective checklist. Pain 1982; 6: 375–83.

    Google Scholar 

  56. Van Buren J, Kleinknecht RA. An evaluation of the McGill Pain Questionnaire for use in dental pain assessment. Pain 1979; 6: 23–33.

    PubMed  Google Scholar 

  57. Cohen MM, Tate RB. Using the McGill Pain Questionnaire to study common postoperative complications. Pain 1989; 39: 275–79.

    PubMed  CAS  Google Scholar 

  58. Taenzer P. Postoperative pain: relationships among measures of pain, mood and narcotic requirements. In: Pain Measurement and Assessment, Melzack R, ed. New York: Raven Press, 1983: 111–18.

    Google Scholar 

  59. Finch L, Melzack R. Objective pain measurement: a case for increased clinical usage. Physiother Can 1982; 34: 343–46.

    Google Scholar 

  60. McDowell I, Newell C. Measuring Health. A Guide to Rating Scales and Questionnaires. New York: Oxford University Press, 1987.

    Google Scholar 

  61. Huskisson EC. Measurement of pain. Lancet 1974; 2: 1127–31.

    PubMed  CAS  Google Scholar 

  62. Pilowsky I, Spence ND. Manual for the Illness Behavior Questionnaire (IBQ), 2nd ed. Adelaide, Australia: University of Adelaide, 1983.

    Google Scholar 

  63. Pilowsky I, Spence ND, Waddy JL. Illness behavior and coronary artery bypass surgery. J Psycho-som Res 1979; 23: 39–44.

    CAS  Google Scholar 

  64. Black RG, Chapman CR. SAD Index for clinical assessment of pain. In: Advances in Pain Research and Therapy, Vol. I, Bonica JJ, Albe-Fessard D, eds. New York: Raven Press, 1976: 301–5.

    Google Scholar 

  65. Tursky B, Jammer LD, Friedman R. The Pain Perception Profile: a psychological approach to the assessment of pain report. Behav Ther 1982; 13: 376–94.

    Google Scholar 

  66. Zung WWK. A self-rating pain and distress scale. Psychosomatics 1983; 24: 887–94.

    PubMed  CAS  Google Scholar 

  67. Morrow GR. The assessment of nausea and vomiting. Past problems, current issues and suggestions for future research. Cancer 1984; 53 (Suppl): 2267–80.

    Google Scholar 

  68. Melzack R, Rosberger Z, Hillingsworth ML, Thirlwell M. New approaches to measuring nausea. Can Med Assoc J 1985; 133: 755–59.

    CAS  Google Scholar 

  69. Spielberger CD, Gorsuch RL, Lushene RE, Manual for the State-Trait Anxiety Inventory (Self- Evaluation Questionnaire). Palo Alto, CA: Consulting Psychologists Press, 1970.

    Google Scholar 

  70. Johnston M. Anxiety in surgical patients. Psychol Med 1980; 10: 145–52.

    PubMed  CAS  Google Scholar 

  71. Auerbach SM. Trait-state anxiety and adjustment to surgery. J Consult Clin Psychol 1973; 40: 264–71.

    PubMed  CAS  Google Scholar 

  72. Martinez-Urrutia A. Anxiety and pain in surgical patients. J Consult Clin Psychol 1975; 4: 437–42.

    Google Scholar 

  73. Johnston M, Carpenter L. Relationship between preoperative anxiety and postoperative state. Psychol Med 1980; 10: 361–67.

    PubMed  CAS  Google Scholar 

  74. Rule WR, Traver MD. Test-retest reliabilities of State-Trait Anxiety Inventory in a stressful social analogue situation. J Pers Assess 1983; 47: 276–77.

    PubMed  CAS  Google Scholar 

  75. Goligher JC, Pulvertaft CN, de Dombal FT, Conyers JH, Duthie HL, Feather DB, Latchmore AJC, Shoesmith JH, Smiddy FG, Willson-Pepper J. Five-to-eight-year results of Leeds/York controlled trial of elective surgery for duodenal ulcer. Br Med J 1968; 2: 781–87.

    PubMed  CAS  Google Scholar 

  76. Emas S, Fernstrom M. Prospective, randomized trial of selective vagotomy with pyloroplasty and selective proximal vagotomy with and without pyloroplasty in the treatment of duodenal, pyloric and prepyloric ulcers. Am J Surg 1985; 149: 236–43.

    PubMed  CAS  Google Scholar 

  77. Troidl H, Menge K-H, Lorenz W, Vestweber K-H, Barth H, Hamelmann H. Quality of life and stomach replacement. In: Gastric Cancer, Herfarth CH, Schlag P, eds. Berlin: Springer Verlag, 1979: 312–17.

    Google Scholar 

  78. Hall R, Horrocks JC, Clamp SE, de Dombal FT. Observer variation in results of surgery for peptic ulceration. Br Med J 1976; 1: 814–16.

    PubMed  CAS  Google Scholar 

  79. Katz S, Ford AB, Moskowitz RW, Jackson BA, Jaffe MW, Cleveland MA. Studies of illness in the aged. The Index of ADL: a standardized measure of biological and psychosocial function. JAMA 1963; 185: 914–19.

    PubMed  CAS  Google Scholar 

  80. Katz S, Downs TD, Cash HR, Grotz RC. Progress in the development of the Index of ADL. Gerontol-ogist 1970; 10: 20–30.

    CAS  Google Scholar 

  81. Sherwood SJ, Morris J, Mor V, Gutkin C. Compendium of measures for describing and assessing long-term care populations. Boston: Hebrew Rehabilitation Center for the Aged. In: Assessing the Elderly. A Practical Guide to Measurement, Kane RA, Kane RL, eds.. Lexington, MA: Lexington Books, D.C. Heath, 1981: 45.

    Google Scholar 

  82. Donaldson SW, Wagner CC, Gresham CE. A unified ADL evaluation form. Arch Phys Med Rehabil, 1973; 54: 175–80.

    PubMed  CAS  Google Scholar 

  83. Mahoney FI, Barthel DW. Functional evaluation: the Barthel Index. MD State Med J 1965; 14: 61–65.

    PubMed  CAS  Google Scholar 

  84. Schoening HA, Iversen IA. Numerical scoring of self-care status: a study of the Kenny Self Care Evaluation. Arch Phys Med Rehabil 1968; 49: 221–29.

    PubMed  CAS  Google Scholar 

  85. Harris WH. Traumatic arthritis of the hip after dislocation and acetabular fractures: treatment by mold arthroplasty. J Bone Joint Surg 1969;51-A: 737–55.

    Google Scholar 

  86. Larson CB. Rating scale for hip disabilities. Clin Orthop Relat Res 1963; 31: 85–92.

    PubMed  CAS  Google Scholar 

  87. Neer CS, Watson KC, Stanton FJ. Recent experience in total shoulder replacement. J Bone and Joint Surg 1982; 64: 319–37.

    Google Scholar 

  88. Kettlekamp DB, Thompson C. Development of a knee scoring scale. Clin Orthop Related 1975; 107: 93–99.

    Google Scholar 

  89. Hejgaard N, Sandberg H, Hide A, Jacobsen K. Prospective stress radiography in 38 old injuries of the ligaments of the knee joint. Acta Orthop Scand 1983; 54: 119–25.

    PubMed  CAS  Google Scholar 

  90. Murray DG, Webster DA. The variable axis knee prosthesis. J Bone Joint Surg 1981;63-A:687–94.

    Google Scholar 

  91. Short WH, Hootnick DR, Murray DG. Ipsilateral supracondylar femur fractures following knee arthroplasty. Clin Orthop Relat Res 1981; 158: 111–16.

    PubMed  Google Scholar 

  92. Yates JW, Chalmer B, McKegney FP. Evaluation of patients with advanced cancer using the Karnofsky Performance Status. Cancer 1980; 45: 2220–24.

    PubMed  CAS  Google Scholar 

  93. Hutchinson TA, Boyd NF, Feinstein AR. Scientific problems in clinical scales as demonstrated in the Karnofsky Index of Performance Status. J Chronic Dis 1979; 32: 661–66.

    PubMed  CAS  Google Scholar 

  94. World Health Organization: Constitution of the World Health Organization. Basic Documents. Geneva: WHO, 1948: 2.

    Google Scholar 

  95. Boyle MH, Torrance GW. Developing multiattrib-ute health indexes. Med Care 1984; 22: 1045–57.

    PubMed  CAS  Google Scholar 

  96. Brook RH, Ware JE, Davies-Avery A, Stewart AL, Donald CA, Rogers WH, Williams KN, Johnston SA. Overview of adult health status measures fielded in Rand’s Health Insurance Study. Med Care 1979; 17 (Suppl 7): 1–131.

    Google Scholar 

  97. Gilson BS, Gilson JS, Bergner M, Bobbitt RA, Kressel S, Pollard WE, Vesselago M. The Sickness Impact Profile. Development of an outcome measure of health care. Am J Public Health 1975; 65: 1304–10.

    PubMed  CAS  Google Scholar 

  98. Grogono AW, Woodgate DJ. Index for measuring health. Lancet 1971; 2: 1024–26.

    PubMed  CAS  Google Scholar 

  99. Kaplan RM, Atkins CJ, Timms R. Validity of a quality of well-being scale as an outcome measure in chronic obstructive pulmonary disease. J Chronic Dis 1984; 37: 85–95.

    PubMed  CAS  Google Scholar 

  100. Patrick DL, Bush JW, Chen MM. Toward an operational definition of health. J Health Soc Behav 1973; 14: 6–23.

    PubMed  CAS  Google Scholar 

  101. Bergner M, Bobbitt RA, Carter WB, Gilson, BS. The Sickness Impact Profile: development and final revision of a health status measure. Med Care 1981; 19: 787–805.

    PubMed  CAS  Google Scholar 

  102. Carter WB, Bobbitt RA, Bergner M, Gilson BS. Validation of an interval scaling: the Sickness Impact Profile. Health Serv Res 1976; 11: 516–28.

    PubMed  CAS  Google Scholar 

  103. Gilson BS, Erickson D, Chavez CT, Bobbitt RA, Bergner M, Carter WB. A Chicano version of the Sickness Impact Profile (SIP). Cult Med Psychiatr 1980; 4: 137–50.

    CAS  Google Scholar 

  104. Deyo RA, Diehl AK. Measuring physical and psychosocial function in patients with low-back pain. Spine 1983; 8: 635–42.

    PubMed  CAS  Google Scholar 

  105. Deyo RA, Inui TS, Leininger J, Overman S. Physical and psychosocial function in rheumatoid arthritis. Arch Intern Med 1982; 142: 879–82.

    PubMed  CAS  Google Scholar 

  106. Deyo RA, Inui TS, Leininger JD, Overman SS. Measuring functional outcomes in chronic disease: a comparison of traditional scales and a self-administered health status questionnaire in patients with rheumatoid arthritis. Med Care 1983; 21: 180–92.

    PubMed  CAS  Google Scholar 

  107. Bergner M, Bobbitt RA, Pollard WE, Martin DP, Gilson BS. The Sickness Impact Profile: validation of a health status measure. Med Care 1976; 14: 57–67.

    PubMed  CAS  Google Scholar 

  108. Pollard WE, Bobbitt RA, Bergner M, Martin DP, Gilson BS. The Sickness Impact Profile: reliability of a health status measure. Med Care 1976; 14: 146–55.

    PubMed  CAS  Google Scholar 

  109. Schipper H. Why measure quality of life? Can Med Assoc J 1983; 128: 1367–70.

    PubMed  CAS  Google Scholar 

  110. Wood-Dauphinee S, Troidl H. Assessing quality of life in surgical studies. Theor Surg 1989; 4: 35–44.

    Google Scholar 

  111. McLeod RS, Fazio VW. Quality of life with continent ileostomy. World J Surg 1984; 8: 90–95.

    PubMed  CAS  Google Scholar 

  112. Bennett RC. Long-term follow-up of surgical adrenalectomy for breast cancer. Aust NZ J Surg, 1983; 53: 415–519.

    CAS  Google Scholar 

  113. Meyers S. Assessing quality of life. Mt Sinai J Med 1983; 50: 190–92.

    PubMed  CAS  Google Scholar 

  114. Scharschmidt BF. Human liver transplantation: analyses of data on 540 patients from four centers. Hepathology 1984; 4 (Suppl I): 958–1019.

    Google Scholar 

  115. Westaby S, Sapsford RN, Bentall HH. Return to work and quality of life after surgery for coronary artery disease. Br Med J 1979; 2: 1028–31.

    PubMed  CAS  Google Scholar 

  116. Drettner B, Ahlbom A. Quality of life and state of health for patients with cancer of the head and neck. Acta Otolaryngol 1983; 96: 307–14.

    PubMed  CAS  Google Scholar 

  117. Trudel L, Fabia J, Bouchard J-P. Quality of life of 50 carotid endarterectomy survivors: a long-term follow-up study. Arch Phys Med Rehabil 1984; 65: 310–12.

    PubMed  CAS  Google Scholar 

  118. Schipper H, Levitt M. Measuring quality of life: risks and benefits. Cancer Treatment Rep 1985; 69: 1115–25.

    CAS  Google Scholar 

  119. Priestman TJ, Baum M. Evaluation of quality of life in patients receiving treatment for advanced breast cancer. Lancet 1976; 2: 899–901.

    Google Scholar 

  120. Coates A, Dillenbeck CF, McNeil DR, Kaye SB, Sims K, Fox RM, Woods RL, Milton GW, Solomon J, Tattersall MH. On the receiving end: II. Linear Analogue Self Assessment (LASA) in the evaluation of aspects of the quality of life of cancer patients receiving therapy. Eur J Cancer Clin Oncol 1983; 19: 1633–37.

    PubMed  CAS  Google Scholar 

  121. Selby PJ, Chapman J-A-W, Etazadi-Amoli J, Dalley D, Boyd NF. The development of a method for assessing the quality of life of cancer patients. Br J Cancer 1984; 50: 13–22.

    PubMed  CAS  Google Scholar 

  122. Schipper H, Clinch J, McMurray A, Levitt M. Measuring the quality of life of cancer patients: the Functional Living Index—Cancer: development and validation. J Clin Oncol 1984; 2: 472–83.

    PubMed  CAS  Google Scholar 

  123. Wood-Dauphinee S, Williams JI. The Spitzer Quality of Life Index: its performance as a measure. In: The Effect of Cancer on Quality of Life, Osaba D, ed. Boca Raton, FL: CRC Press, submitted.

    Google Scholar 

  124. Köster R, Gebbensleben H, Stützen B, Salzberger B, Ahrens P, Rhode H. Quality of life in gastric cancer. Karnofsky’s scale and Spitzer’s index in comparison at the time of surgery in a cohort of 1081 patients. Scand J Gastroenterol 1987; 22 (Suppl 133): 102–6.

    Google Scholar 

  125. Parfrey PS, Vavasour H, Bullock M, Henry S, Harnett JD, Gault HM. Symptoms in end stage renal diseases: dialysis vs transplantation. Transplant Proc 1987; 19: 3407–09.

    PubMed  CAS  Google Scholar 

  126. Nakache R, Tyden G, Groth CG. Quality of life in diabetic patients after combined pancreas-kidney or kidney transplantation. Diabetes 1989; 38: 40–42.

    PubMed  Google Scholar 

  127. Troidl H, Kusche J, Vestweber K-H, Eypasch E, Maul V. Pouch versus esophagojejunostomy after total gastrectomy. World J Surg 1987; 11: 699–712.

    PubMed  CAS  Google Scholar 

  128. Kusche J, Vestweber K-H, Troidl H. Quality of life after total gastrectomy for stomach cancer. Results of three types of evaluative methods. Scand J Gastroenterol 1987; 22 (Suppl 133): 96–102.

    Google Scholar 

  129. Guyatt GH, Bombardier C, Tugwell P. Measuring disease-specific quality of life in clinical trials. Can Med Assoc J 1986; 134: 889–95.

    CAS  Google Scholar 

  130. Guyatt GH, Mitchell A, Irvine EJ, Singer J, Williams N, Goodacre R, Tompkins C. A new measure of health status for clinical trials in inflammatory bowel disease. Gastroenterology 1989; 96: 804–10.

    PubMed  CAS  Google Scholar 

  131. Guyatt GH, Berman L, Townsend M, Pugsley SO, Chambers LW. A measure of quality of life for clinical trials in chronic lung disease. Thorax 1987; 43: 773–78.

    Google Scholar 

  132. Levine MN, Guyatt GH, Gent M, DePauw S, Goodyear MD, Hryniuk WM, Arnold A, Findlay B, Skillings JR, Bramwell VH, Levin L, Bush H, Abu-Zahra H, Kotalik J. Quality of life in stage II breast cancer: an instrument for clinical trials. J Clin Oncol 1988; 6: 1798–1810.

    PubMed  CAS  Google Scholar 

  133. Aaronson NK, Bullinger M, Ahmedzia S. A modular approach to quality-of-life assessment in cancer clinical trials. Recent Results Can Res 1988; 111: 231–49.

    CAS  Google Scholar 

  134. Williams JI, Wood-Dauphinee S. Assessing quality of life: measures and utility. In: Quality of Life and Technology Assessment, Mosteller F, Falotico-Taylor J, eds. Washington, DC: National Academy Press, 1989: 65–115.

    Google Scholar 

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Authors
  1. S. Wood-Dauphinée
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  2. H. Troidl
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Editor information

Editors and Affiliations

  1. Department of Surgery, University of Cologne, Surgical Clinic Merheim, D-5000, Cologne 91, Federal Republic of Germany

    Hans Troidl

  2. Department of Epidemiology and Biostatistics, McGill University, H3A 1A2, Montreal, Quebec, Canada

    Walter O. Spitzer

  3. Department of Anaesthesia, Harvard University, Massachusetts General Hospital, 02114-2696, Boston, Massachusetts, USA

    Bucknam McPeek

  4. Department of Surgery, McGill University, Montreal General Hospital, H3G 1A4, Montreal, Quebec, Canada

    David S. Mulder

  5. Division of Thoracic Surgery, Toronto General Hospital, Eaton North 10-226, M5G2C4, Toronto, Ontario, Canada

    Martin F. McKneally

  6. Department of Surgery, Medical College of Virginia, Virginia Commonwealth University, 23298-0645, Richmond, Virginia, USA

    Andrew S. Wechsler

  7. Department of General Surgery, MD Anderson Cancer Center, 77030, Houston, Texas, USA

    Charles M. Balch

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Wood-Dauphinée, S., Troidl, H. (1991). Endpoints for Clinical Studies: Conventional and Innovative Variables. In: Troidl, H., et al. Principles and Practice of Research. Springer, New York, NY. https://doi.org/10.1007/978-1-4684-0371-8_17

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  • DOI: https://doi.org/10.1007/978-1-4684-0371-8_17

  • Publisher Name: Springer, New York, NY

  • Print ISBN: 978-1-4684-0373-2

  • Online ISBN: 978-1-4684-0371-8

  • eBook Packages: Springer Book Archive

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