Shared Decision-Making in Femoral Versus Radial Cardiac Catheterization.

Shared decision-making is a strategy to assist with patient involvement in medical decisions. One of its pillars is patient knowledge and understanding of the risks and benefits associated with specific procedures. We studied patient knowledge about transradial (TRA) and transfemoral (TFA) cardiac catheterization. A prospective study was conducted in 100 patients hospitalized following diagnostic and therapeutic cardiac catheterization-TRA in 71% of patients and remaining TFA. All patients were presented a standard balanced informed consent outlining risks and benefits. Following catheterization, patients were verbally administered an 11-item open-ended questionnaire to assess knowledge of cardiac catheterization and the associated risks and benefits. A patient knowledge index (PKI) was developed with 1 point given for: identifying the procedure; correctly describing the procedure; identifying at least 1 risk of TRA; and/or TFA; and at least 1 benefit of TRA; and/or TFA. Maximum PKI score was 6. The mean PKI score was 2.6 ± 1.1. A PKI score ≥4 was observed in 21% of patients with only 1 patient obtaining the maximum 6 points. Over 80% of patients were unable to recall procedure risks provided at the time of informed consent. The majority of patients were unable to discriminate between TRA and TFA risks and benefits, PKI 2.52 versus 2.60, respectively (p = 0.718). On multivariate analysis, higher education levels were correlated with increased PKI scores (odds ratio = 0.65, p = 0.014) whereas black race was associated with lower PKI scores (odds ratio = -0.48, p = 0.045). In conclusion, patient retention of information from the informed consent was low. The majority of patients had no preference or deferred to their physician's expertise when deciding TRA compared with TFA. This study identifies challenges with implementing shared decision-making and the need for improved patient education and involvement regarding cardiac catheterization.

Global geographical variation in patient characteristics in percutaneous coronary intervention clinical trials: A systematic review and meta-analysis.

BACKGROUND: We sought to determine whether there are differences in enrolled patients' risk factors in published percutaneous coronary intervention (PCI) trials between various continents. METHODS: We systematically identified clinical trials evaluating PCI interventions through PubMed. We reviewed 701 studies between 1990 and 2014 from North America (N=135), Europe (N=403), and Asia (N=163), examining the prevalence of cardiovascular risk factors-hypertension (HTN), diabetes mellitus (DM), hyperlipidemia (HL), smoking, sex, and body mass index. We performed meta-regression with random- and mixed-effects models to compare patient baseline characteristics between continents and linear meta-regression analysis to test trends over time. RESULTS: In meta-regression with random-effects model, North American trials recruited the lowest proportion of male participants (71.32%), followed by Asian (74.41%) and European trials (76.47%; P<.0001). North American trials enrolled the highest proportion of patients with HTN (63.17%, P=.0035) and HL (63.72%, P<.0001), whereas Asia enrolled the highest proportion of DM patients (29.64%, P<.0001) and smoking (38.41%, P=.0144). When adjusting for other moderators such as publication date, body mass index, and sex in meta-regression with mixed-effects model, age was significantly positively correlated with HTN, HL, DM, and smoking (P<.001). Body mass index was significantly higher in Europe and North America than in Asia. All enrollment risk factors demonstrated (ß<0.02) statistically significant temporal trends over time, except for sex. CONCLUSIONS: There are major continental differences in risk factors among patients enrolled in PCI trials from various continents. Clinical trial results may not be applicable to patient populations from another region.