Users' guides to the medical literature. XII. How to use articles about health-related quality of life. Evidence-Based Medicine Working Group.

CLINICAL SCENARIO You are a physician following a 35-year-old man who has had active Crohn disease for 8 years. The symptoms were severe enough to require resectional surgery 4 years ago, and despite treatment with sulfasalazine and metronidazole, the patient has had active disease requiring oral steroids for the last 2 years. Repeated attempts to decrease the prednisone have failed, and the patient has required doses of greater than 15 mg per day to control symptoms. You are impressed by both the methods and results of a recent article1documenting that such patients benefit from oral methotrexate and suggest to the patient that he consider this medication. When you explain some of the risks of methotrexate, particularly potential liver toxicity, the patient is hesitant. How much better, he asks, am I likely to feel while taking this medication? INTRODUCTION There are 3 reasons we offer treatment to our patients.

[1]  J. Hornberger,et al.  The hemodialysis prescription and cost effectiveness. Renal Physicians Association Working Committee on Clinical Guidelines. , 1993, Journal of the American Society of Nephrology : JASN.

[2]  G. Kok,et al.  Randomized Controlled Multicentre Evaluation of an Education Programme for Insulin‐treated Diabetic Patients: Effects on Metabolic Control, Quality of Life, and Costs of Therapy , 1991, Diabetic medicine : a journal of the British Diabetic Association.

[3]  G H Guyatt,et al.  Measuring health status: what are the necessary measurement properties? , 1992, Journal of clinical epidemiology.

[4]  P. K. Tandon,et al.  Analysis of quality of life data from a randomized, placebo-controlled heart-failure trial. , 1989, Journal of clinical epidemiology.

[5]  G H Guyatt,et al.  Determining a minimal important change in a disease-specific Quality of Life Questionnaire. , 1994, Journal of clinical epidemiology.

[6]  B Kirshner,et al.  A methodological framework for assessing health indices. , 1985, Journal of chronic diseases.

[7]  J. Rochon,et al.  Quality of life: a valid and reliable measure of therapeutic efficacy in the treatment of inflammatory bowel disease. Canadian Crohn's Relapse Prevention Trial Study Group. , 1994, Gastroenterology.

[8]  J. Reisch,et al.  Slow-Release Sodium Fluoride in the Management of Postmenopausal Osteoporosis , 1994, Annals of Internal Medicine.

[9]  P. Tugwell,et al.  Combination therapy with cyclosporine and methotrexate in severe rheumatoid arthritis. The Methotrexate-Cyclosporine Combination Study Group. , 1995, The New England journal of medicine.

[10]  G. Guyatt,et al.  Randomised controlled trial of respiratory rehabilitation , 1994, The Lancet.

[11]  T. Rector Patients' self-assessment of their congestive heart failure : Content, reliability, and validity of a new measure, the Minnesota Living with Heart Failure Questionnaire , 1987 .

[12]  G. Guyatt,et al.  Quality of life issues in women with vertebral fractures due to osteoporosis. , 1993, Arthritis and rheumatism.

[13]  I. Wiklund,et al.  The relationship between exercise tolerance and quality of life in angina pectoris , 1991, Clinical cardiology.

[14]  M. Chesney,et al.  The impact of diuretic therapy on reported sexual function. , 1991, Archives of internal medicine.

[15]  G. Greenberg,et al.  Oral budesonide for active Crohn's disease. Canadian Inflammatory Bowel Disease Study Group. , 1994, The New England journal of medicine.

[16]  S. Tyring,et al.  Famciclovir for the Treatment of Acute Herpes Zoster: Effects on Acute Disease and Postherpetic Neuralgia: A Randomized, Double-Blind, Placebo-Controlled Trial , 1995, Annals of Internal Medicine.

[17]  D. Naylor Cost-effectiveness analysis: are the outputs worth the inputs? , 1996, ACP journal club.

[18]  N. Hollenberg,et al.  Quality of Life and Antihypertensive Therapy in Men -- A Comparison of Captopril with Enalapril , 1993 .

[19]  D. Cook,et al.  Health status, quality of life, and the individual. , 1994, JAMA.

[20]  G. Guyatt,et al.  Measurement of health status. Ascertaining the minimal clinically important difference. , 1989, Controlled clinical trials.

[21]  T M Gill,et al.  A critical appraisal of the quality of quality-of-life measurements. , 1994, JAMA.

[22]  D. DeMets,et al.  Effect of oral milrinone on mortality in severe chronic heart failure. The PROMISE Study Research Group. , 1991, The New England journal of medicine.

[23]  G. Guyatt,et al.  Measuring quality of life in asthma. , 1993, The American review of respiratory disease.

[24]  G. Baker,et al.  Outcomes of Add‐on Treatment with Lamotrigine in Partial Epilepsy , 1993, Epilepsia.

[25]  Huth Ej Turmoil in medical education: Peking, Paris, and points west. , 1969 .

[26]  J H Wasson,et al.  A comparison of transurethral surgery with watchful waiting for moderate symptoms of benign prostatic hyperplasia. The Veterans Affairs Cooperative Study Group on Transurethral Resection of the Prostate. , 1995, The New England journal of medicine.

[27]  I Grant,et al.  Psychologic effects of continuous and nocturnal oxygen therapy in hypoxemic chronic obstructive pulmonary disease. , 1983, Archives of internal medicine.

[28]  C. Wells,et al.  The measurement of dyspnea. Contents, interobserver agreement, and physiologic correlates of two new clinical indexes. , 1984, Chest.

[29]  G. Guyatt,et al.  Quality of life in patients with inflammatory bowel disease. , 1988, Journal of clinical gastroenterology.

[30]  G W Torrance,et al.  Economic evaluation of neonatal intensive care of very-low-birth-weight infants. , 1983, The New England journal of medicine.

[31]  Osteoporosis Targeted Quality of Life Study Group Measuring Quality of Life in Women with Osteoporosis , 1997, Osteoporosis International.

[32]  A. Laupacis,et al.  The use of generic and specific quality-of-life measures in hemodialysis patients treated with erythropoietin. The Canadian Erythropoietin Study Group. , 1991, Controlled clinical trials.

[33]  G. Greenberg,et al.  Oral Budesonide for Active Crohn's Disease , 1994 .

[34]  Loyd,et al.  Methotrexate for the treatment of Crohn's disease. The North American Crohn's Study Group Investigators. , 1995, The New England journal of medicine.

[35]  G H Guyatt,et al.  How should we measure function in patients with chronic heart and lung disease? , 1985, Journal of chronic diseases.

[36]  G. Guyatt,et al.  A new measure of health status for clinical trials in inflammatory bowel disease. , 1989, Gastroenterology.

[37]  Is high-flux dialysis cost-effective? , 1993, International journal of technology assessment in health care.

[38]  D. Osoba,et al.  Measuring health-related quality of life. , 1999, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[39]  G. Guyatt,et al.  Assessing the minimal important difference in symptoms: a comparison of two techniques. , 1996, Journal of clinical epidemiology.

[40]  J. Zerwekh,et al.  Perspective slow‐release sodium fluoride in osteoporosis , 1996, Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research.

[41]  T. Aro,et al.  The treatment of acute low back pain--bed rest, exercises, or ordinary activity? , 1995, The New England journal of medicine.

[42]  I. Wilson,et al.  Linking clinical variables with health-related quality of life. A conceptual model of patient outcomes. , 1995, JAMA.

[43]  M. Bergner,et al.  The Sickness Impact Profile: Development and Final Revision of a Health Status Measure , 1981, Medical care.

[44]  C. Mulrow,et al.  Relative efficacy of vasodilator therapy in chronic congestive heart failure. Implications of randomized trials. , 1988, JAMA.

[45]  G. Guyatt,et al.  A measure of quality of life for clinical trials in chronic lung disease. , 1987, Thorax.

[46]  J. Kirwan,et al.  The effect of glucocorticoids on joint destruction in rheumatoid arthritis. The Arthritis and Rheumatism Council Low-Dose Glucocorticoid Study Group. , 1995, The New England journal of medicine.

[47]  M. Guttadauria,et al.  Methotrexate in Rheumatoid Arthritis: Impact on Quality of Life Assessed by Traditional Standard-Item and Individualized Patient Preference Health Status Questionnaires , 1990 .

[48]  S. Greenfield,et al.  The Medical Outcomes Study. An application of methods for monitoring the results of medical care. , 1989, JAMA.

[49]  S. Silberstein,et al.  Migraine prophylaxis with divalproex. , 1995, Archives of neurology.

[50]  G. Guyatt,et al.  Randomized Controlled Trial of Respiratory Rehabilitation , 1995 .

[51]  W H Rogers,et al.  Comparison of methods for the scoring and statistical analysis of SF-36 health profile and summary measures: summary of results from the Medical Outcomes Study. , 1995, Medical care.