Research inefficiencies in external validation studies of the Framingham Wilson coronary heart disease risk rule: A systematic review.

Background: External validation studies create evidence about a clinical prediction rule's (CPR's) generalizability by evaluating and updating the CPR in populations different from those used in the derivation, and also by contributing to estimating its overall performance when meta-analysed in a systematic review. While most cardiovascular CPRs do not have any external validation, some CPRs have been externally validated repeatedly. Hence, we examined whether external validation studies of the Framingham Wilson coronary heart disease (CHD) risk rule contributed to generating evidence to their full potential.

Methods: A forward citation search of the Framingham Wilson CHD risk rule's derivation study was conducted to identify studies that evaluated the Framingham Wilson CHD risk rule in different populations. For external validation studies of the Framingham Wilson CHD risk rule, we examined whether authors updated the Framingham Wilson CHD risk rule when it performed poorly. We also assessed the contribution of external validation studies to understanding the Predicted/Observed (P/O) event ratio and c statistic of the Framingham Wilson CHD risk rule.

Results: We identified 98 studies that evaluated the Framingham Wilson CHD risk rule; 40 of which were external validation studies. Of these 40 studies, 27 (67.5%) concluded the Framingham Wilson CHD risk rule performed poorly but did not update it. Of 23 external validation studies conducted with data that could be included in meta-analyses, 13 (56.5%) could not fully contribute to the meta-analyses of P/O ratio and/or c statistic because these performance measures were neither reported nor could be calculated from provided data.

Discussion: Most external validation studies failed to generate evidence about the Framingham Wilson CHD risk rule's generalizability to their full potential. Researchers might increase the value of external validation studies by presenting all relevant performance measures and by updating the CPR when it performs poorly.