CPR Methodological Standards

Methodological Standards for CPRs

1. Laupacis, A., N. Sekar, et al. (1997). "Clinical prediction rules. A review and suggested modifications of methodological standards." Jama 277(6): 488-94.

2. Wasson, J. H., H. C. Sox, et al. (1985). "Clinical prediction rules. Applications and methodological standards." N Engl J Med 313(13): 793-9.

3. McGinn, T. G., G. H. Guyatt, et al. (2000). "Users' guides to the medical literature: XXII: how to use articles about clinical decision rules." Jama 284(1): 79-84.

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Outcome

Should be clearly defined and clinically important. If a surrogate outcome is used, it must have a definite relationship with a clinically important outcome.
Blind Assessment - The presence or absence of an outcome should ideally be determined without knowledge of the status of the predictor.

Predictive Variables
- Clear, clinically sensible, and reproducible definition of the variables.
- List of all variables considered, but not included in the rule.
- Blind Assessment - assessment of the predictors without knowledge of the outcome.
Patient Population
- Patient characteristics that are likely to affect the performance of the rule should be described.
Description of Study Site
- office, clinic, ER, hospital
Prospective Validation: Level of Evidence
- Prospectively validate the rule in a group of patients different from the group in which it was derived.
Effects of Clinical Use Prospectively Measured (Impact Analysis)
- Are physicians actually willing to use the rule and does it affect clinical outcomes.
Mathematical Techniques Described
- multivariate analysis
Describing the Results of a Clinical Prediction Rule
- sensitivity, specificity, likelihood ratio, positive and negative predictive value
Reproducibility
- Interobserver reliability of the clinical predictors
Sensibility
- Does the rule have face validity?