The added value of ordinal analysis in clinical trials: an example in traumatic brain injury

Table 4 Analysis of the Glasgow Outcome Scale with the sliding dichotomy approach

		Dead	SD	MD	GR	Worse than expected	Better than expected	Odds ratio (95% CI)	Wald statistic	P-value
Best prognosis	Corticosteroid	67	86	274	1,162	427	1,162	1.22 (1.03 to 1.43)		0.017
	Placebo	59	84	228	1,227	371	1,227
Intermediate prognosis	Corticosteroid	282	215	365	748	497	1,113	1.06 (0.91 to 1.23)		0.45
	Placebo	225	241	357	749	466	1106
Worst prognosis	Corticosteroid	899	280	212	210	899	702	1.28 (1.11 to 1.47)		0.0006
	Placebo	791	328	228	237	791	793
Pooled odds ratio, unadjusted	1.17 (1.07 to 1.27)								3.67	0.0003
Pooled odds ratio, adjusted^	1.19 (1.08 to 1.30)								3.69	0.0002

The prognosis bands were created with model containing the variables age, GCS, pupillary reactivity and major extracranial injury. Odds ratios were given by prognosis band, for the unadjusted treatment effect. Pooled odds ratios were given for the unadjusted and adjusted treatment effect. An odds ratio > 1 indicates an adverse effect of corticosteroids. Patients with better outcome than expected are underlined. Data from the CRASH trial (n = 9,554).
^ Adjustment for age; GCS, pupillary reactivity and major extracranial injury.
GCS, Glasgow Coma Scale; SD, Severe Disability (including Vegetative State); MD, Moderate Disability; GR, Good Recovery; OR, odds ratio.

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