Actinic keratoses are a chronic condition in ultraviolet-damaged skin, with a risk of progressing to invasive skin cancer. The aim of this study was to investigate the preventive potential of field-directed repetitive daylight photodynamic therapy for actinic keratoses. A randomized trial was performed, including 58 patients with ≥5 actinic keratoses on photodamaged facial skin, who received either 5 full-face sessions of day-light photodynamic therapy within a period of 2 years or lesion-directed cryosurgery. Primary outcome was the mean cumulative number of new actinic keratoses developed between visits 2 and 6 (visit 6 being a follow-up). This outcome was lower after daylight photodynamic therapy (7.7) compared with cryosurgery (10.2), but the difference did not reach significance (–2.5, 95% confidence interval –6.2 to 1.2;
p
=0.18). Several signs of photoageing (fine lines, pigmentation, roughness, erythema, sebaceous gland hyperplasia) were significantly reduced after daylight photodynamic therapy, but not after cryosurgery. Significantly less pain and fewer side-effects were reported during day-light photodynamic therapy than during cryosurgery. This study found that repetitive daylight photodynamic therapy had photo-rejuvenating effects. However, the prevention of actinic keratoses by this therapy could not be proven in a statistically reliable manner.
Purpose: Aim of our study was to assess understanding of risks associated with intravascular application of contrast media in patients undergoing CT examination. We wanted to evaluate epidemiologic and socioeconomic prognostic factors for a higher understanding of risks. Additionally, we evaluated a possible correlation between an extensive, outcomeoriented oral informed consent and better understanding of risks. Materials and Methods: 120 patients distributed in 2 study arms participated in this prospective study. In study arm I, the treating physician was not informed that his patients participated in a study whereas the physician in study arm II knew about the survey. After the informed consent we performed a standardized, semi-structured interview to enquire the 3 most frequent risks of intravascular application of contrast agents (anaphylactoid reactions, nephropathy and thyrotoxic crisis) and epidemiologic data. The understanding of the risks was evaluated using a 6 point scale. Results: Patients scored 3.73 points in study arm I and 4.93 points in arm II on average. The statistical difference between both study arms was highly significant (p <0.001). In a combined logistic regression analysis, only "higher education" (p = 0.001) and participation in study arm II (p =0 .001) showed a significant connection to a better understanding of risks. Conclusion: Patients profit from an outcomeoriented and individualized informed consent. Due to the significant correlation between educational level and understanding of risks, informed consent should be adjusted to the educational status of the individual patient, e. g. by using didactic aids or individualized information sheets.
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