Evaluation of Physician Knowledge of Safety and Safe Use Information for Intravitreal Aflibercept Injection in Europe: A Second Survey of Physicians Following Dissemination of Updated Risk-Minimization Materials.

BACKGROUND: Materials have been distributed in the European Union to inform physicians on the safe use of intravitreal aflibercept (IVT-AFL) as part of the risk-minimization plan for IVT-AFL. OBJECTIVE: We aimed to measure physician knowledge and understanding of key safety information for IVT-AFL. METHODS: The current study was a follow-up cross-sectional survey ('wave 2') to an earlier survey ('wave 1') examining the effectiveness of the IVT-AFL educational materials by assessing physician knowledge of the key safety information. Based on wave 1 results, the educational materials were revised to focus more on items of key concern (e.g., use in women of childbearing potential, procedural information); physicians in France, Germany, Italy, Spain, and the UK completed a questionnaire to evaluate their knowledge of key safety information in the revised educational materials. RESULTS: Among 454 physician respondents (of 4715 invited; response rate 9.6%), most reported having received the IVT-AFL Summary of Product Characteristics (SmPC; 89%) and Prescriber Guide (82%). More than half reported receiving the Injection Procedure Video (54%) and Patient Booklet (65%). The highest percentage of correct answers was observed for questions concerning procedural steps, the most important risks, and safe use as emphasized by the educational materials and the SmPC. CONCLUSION: Physician knowledge and understanding of safe use of IVT-AFL, including for questions that prompted revisions to the educational materials, suggests the need to reconsider methods for developing educational materials to follow best practices (e.g., focusing on only key messages and pretesting with end users).

Physician and Patient Knowledge of Safety and Safe Use Information for Aflibercept in Europe: Evaluation of Risk-Minimization Measures.

BACKGROUND: As part of the risk-management plan for aflibercept in the European Union, materials have been developed to educate physicians and patients in Europe on the safe use of aflibercept. OBJECTIVES: The objectives of this study were to measure receipt of the educational materials and to evaluate understanding of key safety information for aflibercept. METHODS: An observational cross-sectional study among physicians and patients with recent aflibercept experience in France, Germany, Italy, Spain, and the UK was conducted. Eligible physicians and patients completed a brief questionnaire regarding their knowledge of key safety information. RESULTS: Among the 8424 physicians invited to participate in the survey, 428 physicians were eligible, completed the questionnaire, and were included in this analysis. Most physicians reported having received the aflibercept summary of product characteristics (87%) and prescriber guide (77%); approximately half reported receiving the injection procedure video (50%) and patient booklet (54%). Physician knowledge of the most important topics (i.e., side effects; preparing patients for aflibercept injection) was high. Physician knowledge of dosing was high for neovascular (wet) age-related macular degeneration and lower for less commonly prescribed indications. Most physicians knew the contraindications for aflibercept and recognized possible side effects. Among the 874 patients approached about participation in the study, 773 patients were eligible, completed the questionnaire, and were included in the analysis. Patients' reported receipt was relatively low for the aflibercept patient booklet (38%) and the audio CD (23%). Patient knowledge of the health conditions to discuss with a doctor prior to injection was generally high; knowledge about possible side effects varied. Most patients knew that they should speak to a physician immediately if they experienced a possible side effect of aflibercept. CONCLUSION: Most physicians reported receiving the summary of product characteristics, prescriber guide, and patient booklet; half reported receiving the intravitreal injection procedure video. Patient receipt of the educational material was variable. Observed patterns of knowledge indicated the greatest knowledge of the most important risks emphasized in the educational material and lower knowledge of more complex or less salient aspects of safe use.

Thyroid hormone and heart failure.

Thyroid hormone metabolic disarray has been identified as a risk factor for the progression of heart disease and the development of heart failure (HF). Both hyper- and hypothyroidism have been associated with a failing myocardium. Poor cardiac contractility and low cardiac output due to hyperthyroidism is a rare occurrence and is mostly seen in patients with preexisting heart disease. Referred to as a "rate related" phenomenon, hyperthyroid-induced sustained sinus tachycardia or atrial fibrillation may further reduce ventricular contractility. Increasingly, the hypothyroid state, and in particular a low triiodothyronine level, has been associated with a reduced cardiac performance and poor prognosis in HF, even in the presence of normal thyroid-stimulating hormone levels. Low thyroid hormone levels alter cardiac gene expression and increase systemic vascular resistance, both resulting in a reduction of cardiac contractility and cardiac output. This review summarizes current data on thyroid dysfunction and HF as well as the emerging implications of the "low triiodothyronine state."