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ARTICLE |

What is a Health Care Trial? FREE

Walter O. Spitzer, MD, MHA, MPH; Alvan R. Feinstein, MD; David L. Sackett, MD, MScEpid
[+] Author Affiliations

Reprint requests to Department of Clinical Epidemiology and Biostatistics, School of Medicine, McMaster University, 1200 Main St W, Hamilton, Ontario, Canada L8S 4J9 (Dr. Spitzer).


JAMA. 1975;233(2):161-163. doi:10.1001/jama.1975.03260020047024
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ALTHOUGH most people know what to expect as topics of the research conducted in such domains as biochemistry, microbiology, or epidemiology, the domain of health care research has not been clearly delineated. It sometimes seems to include a chaotic variety of activities, ranging from polemic debates about medical ethics to quantitative accounts of hospital finances to biostatistical experiments with randomized therapy. The heterogeneous components and varieties of such research create special problems for peer review committees and for administrators of agencies that support health care research. Because the distinctive features of the research have not been precisely demarcated, it is often difficult to reach a consensus about the merit or even the eligibility of projects under consideration.

To help clarify some of the confusion, we have written this article for the taxonomic purpose of defining and classifying the kinds of investigation that constitute health care research. Health care research is

REFERENCES

Daniels M, Hill AB:  Chemotherapy of pulmonary tuberculosis in young adults . Br Med J 1:1162-1168, 1952;.
D'Arcy HP:  History of randomized controlled trials . Lancet 1:965, 1972;.
Armitage P:  History of randomized controlled trials . Lancet 1:1388, 1972;.
Green FHK:  The clinical evaluation of remedies . Lancet 2:1085-1090, 1954;.
Feinstein AR:  The architecture of clinical research . Clin Pharmacol Ther 11:432-441, 1970;.
Lewis CE, Resnick B, Schmidt G, et al:  Activities, events and outcomes in ambulatory patient care . N Engl J Med 280:645-649, 1969;.
Spitzer WO, Kergin DJ, Yoshida MA, et al:  Nurse practitioners in primary care: III. The southern Ontario randomized trial . Can Med Assoc J 108:1006-1016, 1973;.
Spitzer WO, Sackett DL, Sibley JC, et al:  The Burlington randomized trial of the nurse practitioner . N Engl J Med 290:251-256, 1974;.
Sackett DL, Spitzer WO, Gent M, et al:  The Burlington randomized trial of the nurse practitioner: Health outcomes of patients . Ann Intern Med 80:137-142, 1974;.
Charney E, Kitzman H:  The child-health nurse (pediatric nurse practitioner) in private practice . N Engl J Med 285:1353-1358, 1971;.
Fletcher SW, Appel FA, Bourgois M:  Improving emergency room patient follow-up in a metropolitan teaching hospital: Effect of a follow-up clerk . N Engl J Med 291:385-388, 1974;.
Colcher IS, Bass JW:  Penicillin treatment of streptococcal pharyngitis . JAMA 222:657-659, 1972;.
Glogow E:  Effects of health education methods on appointment breaking . Public Health Rep 85:441-449, 1970;.
Fink D, Malloy MJ, Cohen M, et al:  Effective patient care in the pediatric ambulatory setting: A study of the acute care clinic . Pediatrics 43:927-935, 1969;.
Katz S, Vignos PJ Jr, Moskowitz RW, et al:  Comprehensive outpatient care in rheumatoid arthritis . JAMA 206:1249-1254, 1968;.
Mather HG, Pearson NG, Read KLQ, et al:  Acute myocardial infarction: Home and hospital treatment . Br Med J 3:334-338, 1971;.
Fletcher RH:  Auditing problem-oriented records and traditional records: A controlled comparison of speed, accuracy and identification of errors in medical care . N Engl J Med 290:829-833, 1974;.
Singer E:  Social costs of Parkinson's disease . J Chronic Dis 26:243-254, 1973;.
Isaacs B:  Geriatric patients: Do their families care? Br Med J 4:282-286, 1971;.
Brewerton DA, Daniel JW:  Factors influencing return to work . Br Med J 4:277-281, 1971;.
Mawson SR, Adlington P, Evans M:  A controlled study evaluation of adeno-tonsillectomy in children . J Laryngol Otol 81:777-790, 1967;.
McKee WJE:  A controlled study of the effects of tonsillectomy and adenoidectomy in children . Br J Prev Soc Med 17:49-69, 1963;.
Harpur JE, Conner WT, Hamilton M, et al:  Controlled trial of early mobilisation and discharge from hospital in uncomplicated myocardial infarction . Lancet 2:1331-1334, 1971;.
Hutter AM, Sidel VW, Shine KI, et al:  Early hospital discharge after myocardial infarction . N Engl J Med 288:1141-1144, 1973;.
Piachaud D, Weddell JM:  The economics of treating varicose veins . Int J Epidemiol 1:287-294, 1972;.
Anderson TW, Reid DBW, Beaton GH:  Vitamin C and the common cold: A double blind trial . Can Med Assoc J 107:503-508, 1972;.
Feinstein AR:  The need for humanized science in evaluating medication . Lancet 2:421-423, 1972;.

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Daniels M, Hill AB:  Chemotherapy of pulmonary tuberculosis in young adults . Br Med J 1:1162-1168, 1952;.
D'Arcy HP:  History of randomized controlled trials . Lancet 1:965, 1972;.
Armitage P:  History of randomized controlled trials . Lancet 1:1388, 1972;.
Green FHK:  The clinical evaluation of remedies . Lancet 2:1085-1090, 1954;.
Feinstein AR:  The architecture of clinical research . Clin Pharmacol Ther 11:432-441, 1970;.
Lewis CE, Resnick B, Schmidt G, et al:  Activities, events and outcomes in ambulatory patient care . N Engl J Med 280:645-649, 1969;.
Spitzer WO, Kergin DJ, Yoshida MA, et al:  Nurse practitioners in primary care: III. The southern Ontario randomized trial . Can Med Assoc J 108:1006-1016, 1973;.
Spitzer WO, Sackett DL, Sibley JC, et al:  The Burlington randomized trial of the nurse practitioner . N Engl J Med 290:251-256, 1974;.
Sackett DL, Spitzer WO, Gent M, et al:  The Burlington randomized trial of the nurse practitioner: Health outcomes of patients . Ann Intern Med 80:137-142, 1974;.
Charney E, Kitzman H:  The child-health nurse (pediatric nurse practitioner) in private practice . N Engl J Med 285:1353-1358, 1971;.
Fletcher SW, Appel FA, Bourgois M:  Improving emergency room patient follow-up in a metropolitan teaching hospital: Effect of a follow-up clerk . N Engl J Med 291:385-388, 1974;.
Colcher IS, Bass JW:  Penicillin treatment of streptococcal pharyngitis . JAMA 222:657-659, 1972;.
Glogow E:  Effects of health education methods on appointment breaking . Public Health Rep 85:441-449, 1970;.
Fink D, Malloy MJ, Cohen M, et al:  Effective patient care in the pediatric ambulatory setting: A study of the acute care clinic . Pediatrics 43:927-935, 1969;.
Katz S, Vignos PJ Jr, Moskowitz RW, et al:  Comprehensive outpatient care in rheumatoid arthritis . JAMA 206:1249-1254, 1968;.
Mather HG, Pearson NG, Read KLQ, et al:  Acute myocardial infarction: Home and hospital treatment . Br Med J 3:334-338, 1971;.
Fletcher RH:  Auditing problem-oriented records and traditional records: A controlled comparison of speed, accuracy and identification of errors in medical care . N Engl J Med 290:829-833, 1974;.
Singer E:  Social costs of Parkinson's disease . J Chronic Dis 26:243-254, 1973;.
Isaacs B:  Geriatric patients: Do their families care? Br Med J 4:282-286, 1971;.
Brewerton DA, Daniel JW:  Factors influencing return to work . Br Med J 4:277-281, 1971;.
Mawson SR, Adlington P, Evans M:  A controlled study evaluation of adeno-tonsillectomy in children . J Laryngol Otol 81:777-790, 1967;.
McKee WJE:  A controlled study of the effects of tonsillectomy and adenoidectomy in children . Br J Prev Soc Med 17:49-69, 1963;.
Harpur JE, Conner WT, Hamilton M, et al:  Controlled trial of early mobilisation and discharge from hospital in uncomplicated myocardial infarction . Lancet 2:1331-1334, 1971;.
Hutter AM, Sidel VW, Shine KI, et al:  Early hospital discharge after myocardial infarction . N Engl J Med 288:1141-1144, 1973;.
Piachaud D, Weddell JM:  The economics of treating varicose veins . Int J Epidemiol 1:287-294, 1972;.
Anderson TW, Reid DBW, Beaton GH:  Vitamin C and the common cold: A double blind trial . Can Med Assoc J 107:503-508, 1972;.
Feinstein AR:  The need for humanized science in evaluating medication . Lancet 2:421-423, 1972;.
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