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. 1986 Jan 4;292(6512):40–43. doi: 10.1136/bmj.292.6512.40

Standards for the use of ordinal scales in clinical trials.

C R MacKenzie, M E Charlson
PMCID: PMC1338986  PMID: 3080061

Abstract

Ordinal scales are frequently used in clinical trials to quantify outcomes which are non-dimensional. They may be regarded as either single state or transition measures based on whether they assess the outcome at a single point in time or directly examine change which has occurred between two points in time. Each has unique structural and operating characteristics, so that different methodological standards for their construction and utilisation are required. All trials employing ordinal scales published in three leading journals between 1980 and 1984 were examined. For both types of scales the individual ranks must be clearly defined, mutually exclusive, and ordered in a hierarchical progression. Further, both types must be able to detect equally both improvement and deterioration. For this to be ensured with the single state scales the population under study must not be clustered at one extreme of the scale at entry into the trial. With the transition scales internal symmetry must be achieved. Strategies for determining the comparisons to be performed should include emphasis on within patient analysis for crossover trials. Concordance between scale scores and the other measures of outcome employed in the trial must be evaluated. Frequent violations were uncovered in the studies reviewed, and it is hoped that the simple rules outlined will prove useful in the planning and evaluation of future trials.

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Selected References

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  1. Allen G. S., Ahn H. S., Preziosi T. J., Battye R., Boone S. C., Boone S. C., Chou S. N., Kelly D. L., Weir B. K., Crabbe R. A. Cerebral arterial spasm--a controlled trial of nimodipine in patients with subarachnoid hemorrhage. N Engl J Med. 1983 Mar 17;308(11):619–624. doi: 10.1056/NEJM198303173081103. [DOI] [PubMed] [Google Scholar]
  2. Anderson J. L., Marshall H. W., Bray B. E., Lutz J. R., Frederick P. R., Yanowitz F. G., Datz F. L., Klausner S. C., Hagan A. D. A randomized trial of intracoronary streptokinase in the treatment of acute myocardial infarction. N Engl J Med. 1983 Jun 2;308(22):1312–1318. doi: 10.1056/NEJM198306023082202. [DOI] [PubMed] [Google Scholar]
  3. Bergner M., Bobbitt R. A., Carter W. B., Gilson B. S. The Sickness Impact Profile: development and final revision of a health status measure. Med Care. 1981 Aug;19(8):787–805. doi: 10.1097/00005650-198108000-00001. [DOI] [PubMed] [Google Scholar]
  4. Brook R. H., Ware J. E., Jr, Rogers W. H., Keeler E. B., Davies A. R., Donald C. A., Goldberg G. A., Lohr K. N., Masthay P. C., Newhouse J. P. Does free care improve adults' health? Results from a randomized controlled trial. N Engl J Med. 1983 Dec 8;309(23):1426–1434. doi: 10.1056/NEJM198312083092305. [DOI] [PubMed] [Google Scholar]
  5. Bryson Y. J., Dillon M., Lovett M., Acuna G., Taylor S., Cherry J. D., Johnson B. L., Wiesmeier E., Growdon W., Creagh-Kirk T. Treatment of first episodes of genital herpes simplex virus infection with oral acyclovir. A randomized double-blind controlled trial in normal subjects. N Engl J Med. 1983 Apr 21;308(16):916–921. doi: 10.1056/NEJM198304213081602. [DOI] [PubMed] [Google Scholar]
  6. Carpenter W. T., Jr, Sadler J. H., Light P. D., Hanlon T. E., Kurland A. A., Penna M. W., Reed W. P., Wilkinson E. H., Bartko J. J. The therapeutic efficacy of hemodialysis in schizophrenia. N Engl J Med. 1983 Mar 24;308(12):669–675. doi: 10.1056/NEJM198303243081201. [DOI] [PubMed] [Google Scholar]
  7. Cooper D. S., Halpern R., Wood L. C., Levin A. A., Ridgway E. C. L-Thyroxine therapy in subclinical hypothyroidism. A double-blind, placebo-controlled trial. Ann Intern Med. 1984 Jul;101(1):18–24. doi: 10.7326/0003-4819-101-1-18. [DOI] [PubMed] [Google Scholar]
  8. Dwosh I. L., Giles A. R., Ford P. M., Pater J. L., Anastassiades T. P. Plasmapheresis therapy in rheumatoid arthritis. A controlled, double-blind, crossover trial. N Engl J Med. 1983 May 12;308(19):1124–1129. doi: 10.1056/NEJM198305123081903. [DOI] [PubMed] [Google Scholar]
  9. Ericsson C. D., DuPont H. L., Sullivan P., Galindo E., Evans D. G., Evans D. J., Jr Bicozamycin, a poorly absorbable antibiotic, effectively treats travelers' diarrhea. Ann Intern Med. 1983 Jan;98(1):20–25. doi: 10.7326/0003-4819-98-1-20. [DOI] [PubMed] [Google Scholar]
  10. Feinstein A. R., Wells C. K. A new clinical taxonomy for rating change in functional activities of patients with angina pectoris. Am Heart J. 1977 Feb;93(2):172–182. doi: 10.1016/s0002-8703(77)80308-6. [DOI] [PubMed] [Google Scholar]
  11. Finlay I. G., Scott R., McArdle C. S. Prospective double-blind comparison of buprenorphine and pethidine in ureteric colic. Br Med J (Clin Res Ed) 1982 Jun 19;284(6332):1830–1831. doi: 10.1136/bmj.284.6332.1830. [DOI] [PMC free article] [PubMed] [Google Scholar]
  12. Fischer B. H., Marks M., Reich T. Hyperbaric-oxygen treatment of multiple sclerosis. A randomized, placebo-controlled, double-blind study. N Engl J Med. 1983 Jan 27;308(4):181–186. doi: 10.1056/NEJM198301273080402. [DOI] [PubMed] [Google Scholar]
  13. Hauser S. L., Dawson D. M., Lehrich J. R., Beal M. F., Kevy S. V., Propper R. D., Mills J. A., Weiner H. L. Intensive immunosuppression in progressive multiple sclerosis. A randomized, three-arm study of high-dose intravenous cyclophosphamide, plasma exchange, and ACTH. N Engl J Med. 1983 Jan 27;308(4):173–180. doi: 10.1056/NEJM198301273080401. [DOI] [PubMed] [Google Scholar]
  14. Heddle R. J., Soothill J. F., Bulpitt C. J., Atherton D. J. Combined oral and nasal beclomethasone diproprionate in children with atopic eczema: a randomised controlled trial. Br Med J (Clin Res Ed) 1984 Sep 15;289(6446):651–654. doi: 10.1136/bmj.289.6446.651. [DOI] [PMC free article] [PubMed] [Google Scholar]
  15. Kirk A. P., Lennard-Jones J. E. Controlled trial of azathioprine in chronic ulcerative colitis. Br Med J (Clin Res Ed) 1982 May 1;284(6325):1291–1292. doi: 10.1136/bmj.284.6325.1291. [DOI] [PMC free article] [PubMed] [Google Scholar]
  16. Lee D. C., Johnson R. A., Bingham J. B., Leahy M., Dinsmore R. E., Goroll A. H., Newell J. B., Strauss H. W., Haber E. Heart failure in outpatients: a randomized trial of digoxin versus placebo. N Engl J Med. 1982 Mar 25;306(12):699–705. doi: 10.1056/NEJM198203253061202. [DOI] [PubMed] [Google Scholar]
  17. Morrow G. R., Morrell C. Behavioral treatment for the anticipatory nausea and vomiting induced by cancer chemotherapy. N Engl J Med. 1982 Dec 9;307(24):1476–1480. doi: 10.1056/NEJM198212093072402. [DOI] [PubMed] [Google Scholar]
  18. Nelson E., Conger B., Douglass R., Gephart D., Kirk J., Page R., Clark A., Johnson K., Stone K., Wasson J. Functional health status levels of primary care patients. JAMA. 1983 Jun 24;249(24):3331–3338. [PubMed] [Google Scholar]
  19. Nicotra M. B., Rivera M., Awe R. J. Antibiotic therapy of acute exacerbations of chronic bronchitis. A controlled study using tetracycline. Ann Intern Med. 1982 Jul;97(1):18–21. doi: 10.7326/0003-4819-97-1-18. [DOI] [PubMed] [Google Scholar]
  20. Roald O. K., Seem E. Treatment of Raynaud's phenomenon with ketanserin in patients with connective tissue disorders. Br Med J (Clin Res Ed) 1984 Sep 8;289(6445):577–579. doi: 10.1136/bmj.289.6445.577. [DOI] [PMC free article] [PubMed] [Google Scholar]
  21. Robson M. H., France R., Bland M. Clinical psychologist in primary care: controlled clinical and economic evaluation. Br Med J (Clin Res Ed) 1984 Jun 16;288(6433):1805–1808. doi: 10.1136/bmj.288.6433.1805. [DOI] [PMC free article] [PubMed] [Google Scholar]
  22. Rubenstein L. Z., Josephson K. R., Wieland G. D., English P. A., Sayre J. A., Kane R. L. Effectiveness of a geriatric evaluation unit. A randomized clinical trial. N Engl J Med. 1984 Dec 27;311(26):1664–1670. doi: 10.1056/NEJM198412273112604. [DOI] [PubMed] [Google Scholar]
  23. Veith R. C., Raskind M. A., Caldwell J. H., Barnes R. F., Gumbrecht G., Ritchie J. L. Cardiovascular effects of tricyclic antidepressants in depressed patients with chronic heart disease. N Engl J Med. 1982 Apr 22;306(16):954–959. doi: 10.1056/NEJM198204223061603. [DOI] [PubMed] [Google Scholar]
  24. Wagner D. P., Knaus W. A., Draper E. A. Statistical validation of a severity of illness measure. Am J Public Health. 1983 Aug;73(8):878–884. doi: 10.2105/ajph.73.8.878. [DOI] [PMC free article] [PubMed] [Google Scholar]
  25. Wallace D., Goldfinger D., Lowe C., Nichols S., Weiner J., Brachman M., Klinenberg J. R. A double-blind, controlled study of lymphoplasmapheresis versus sham apheresis in rheumatoid arthritis. N Engl J Med. 1982 Jun 10;306(23):1406–1410. doi: 10.1056/NEJM198206103062307. [DOI] [PubMed] [Google Scholar]
  26. Walter P., Neil-Dwyer G., Cruickshank J. M. Beneficial effects of adrenergic blockade in patients with subarachnoid haemorrhage. Br Med J (Clin Res Ed) 1982 Jun 5;284(6330):1661–1664. doi: 10.1136/bmj.284.6330.1661. [DOI] [PMC free article] [PubMed] [Google Scholar]

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