Canadian C-Spine Rule study for alert and stable trauma patients: I. Background and rationale

This paper is Part I of a 2-part series to describe the background and methodology for the Canadian C-Spine Rule study to develop a clinical decision rule for rational imaging in alert and stable trauma patients. Current use of radiography is inefficient and variable, in part because there has been a lack of evidence-based guidelines to assist emergency physicians. Clinical decision rules are research-based decision-making tools that incorporate 3 or more variables from the history, physical examination or simple tests. The Canadian CT Head and C-Spine (CCC) Study is a large collaborative effort to develop clinical decision rules for the use of CT head in minor head injury and for the use of cervical spine radiography in alert and stable trauma victims. Part I details the background and rationale for the development of the Canadian C-Spine Rule. Part II will describe in detail the objectives and methods of the Canadian C-Spine Rule study.     

Canadian CT head rule study for patients with minor head injury: methodology for phase II (validation and economic analysis)

Prospective validation on a new set of patients is an essential test of a new decision rule. However, many clinical decision rules are not prospectively assessed to determine their accuracy, reliability, clinical sensibility, or potential impact on practice. This validation process is important because many statistically derived rules or guidelines do not perform well when tested in a new population. The methodologic standards for a validation study are similar to those described in the article on phase I for derivation studies in the August 2001 issue of Annals of Emergency Medicine. The goal of phase II is to prospectively assess the accuracy, reliability, and acceptability of the decision rule in a new set of patients with minor head injury. This will determine the clinical utility of the rule and is essential if such a rule is to be widely adopted into clinical practice.     

The Canadian C-spine rule performs better than unstructured physician judgment

STUDY OBJECTIVES: We compare the predictive accuracy of emergency physicians' unstructured clinical judgment to the Canadian C-Spine rule. METHODS: This prospective multicenter cohort study was conducted at 10 Canadian urban academic emergency departments. Included in the study were alert, stable, adult patients with a Glasgow Coma Scale score of 15 and trauma to the head or neck. This was a substudy of the Canadian C-Spine and CT Head Study. Eligible patients were prospectively evaluated before radiography. Physicians estimated the probability of unstable cervical spine injury from 0% to 100% according to clinical judgment alone and filled out a data form. Interobserver assessments were done when feasible. Patients underwent cervical spine radiography or follow-up to determine clinically important cervical spine injuries. Analyses included comparison of areas under the receiver operating characteristic (ROC) curve with 95% confidence intervals (CIs) and the kappa coefficient. RESULTS: During 18 months, 6265 patients were enrolled. The mean age was 36.6 years (range 16 to 97 years), and 50.1% were men. Sixty-four (1%) patients had a clinically important injury. The physicians' kappa for a 0% predicted probability of injury was 0.46 (95% CI 0.28 to 0.65). The respective areas under the ROC curve for predicting cervical spine injury were 0.85 (95% CI 0.80 to 0.89) for physician judgment and 0.91 (95% CI 0.89 to 0.92) for the Canadian C-Spine rule (P <.05). With a threshold of 0% predicted probability of injury, the respective indices of accuracy for physicians and the Canadian C-Spine rule were sensitivity 92.2% versus 100% (P <.001) and specificity 53.9% versus 44.0% (P <.001). CONCLUSION: Interobserver agreement of unstructured clinical judgment for predicting clinically important cervical spine injury is only fair, and the sensitivity is unacceptably low. The Canadian C-Spine rule was better at detecting clinically important injuries with a sensitivity of 100%. Prospective validation has recently been completed and should permit widespread use of the Canadian C-Spine rule.     

The Canadian CT Head Rule Study for patients with minor head injury: rationale, objectives, and methodology for phase I (derivation)

Head injuries are among the most common types of trauma seen in North American emergency departments, with an estimated 1 million cases seen annually. "Minor" head injury (sometimes known as "mild") is defined by a history of loss of consciousness, amnesia, or disorientation in a patient who is conscious and talking, that is, with a Glasgow Coma Scale score of 13 to 15. Although most patients with minor head injury can be discharged without sequelae after a period of observation, in a small proportion, their neurologic condition deteriorates and requires neurosurgical intervention for intracranial hematoma. The objective of the Canadian CT Head Rule Study is to develop an accurate and reliable decision rule for the use of computed tomography (CT) in patients with minor head injury. Such a decision rule would allow physicians to be more selective in their use of CT without compromising care of patients with minor head injury. This paper describes in detail the rationale, objectives, and methodology for Phase I of the study in which the decision rule was derived. [Stiell IG, Lesiuk H, Wells GA, McKnight RD, Brison R, Clement C, Eisenhauer MA, Greenberg GH, MacPhail I, Reardon M, Worthington J, Verbeek R, Rowe B, Cass D, Dreyer J, Holroyd B, Morrison L, Schull M, Laupacis A, for the Canadian CT Head and C-Spine Study Group. The Canadian CT Head Rule Study for patients with minor head injury: rationale, objectives, and methodology for phase I (derivation). Ann Emerg Med. August 2001;38:160-169.]     

Canadian C-Spine Rule study for alert and stable trauma patients: II. Study objectives and methodology

Clinical prediction rules are decision-making tools that incorporate three or more variables from the history, physical examination or simple tests. They help clinicians make diagnostic or therapeutic decisions by standardizing the collection and interpretation of clinical data. There is growing interest in the methodological standards for their development and validation. This article describes the methods used to derive the Canadian C-Spine Rule and provides a valuable reference for investigators planning to develop future clinical prediction rules.