Letter to the Editor: Patients' Knowledge and Decisional Conflict Regarding Tamoxifen Use: Scientific Views

No abstract available.

The Author's Response: Assessment of Breast Cancer Patients' Knowledge and Decisional Conflict Regarding Tamoxifen Use

No abstract available.

Assessment of Breast Cancer Patients' Knowledge and Decisional Conflict Regarding Tamoxifen Use

Breast cancer is the most common type of female cancer. Tamoxifen, a selective estrogen receptor modulator, is widely used to decrease breast cancer recurrence and mortality among patients. However, it also increases the risk of endometrial cancer. This study aimed to assess knowledge and decisional conflict regarding tamoxifen use. Between June and October 2014, breast cancer patients using tamoxifen were consecutively screened and requested to complete a survey including the EQ-5D, Satisfaction with Decision Scale (SWD), Decisional Conflict Scale (DCS), and a self-developed, 15-item questionnaire measuring tamoxifen-related knowledge. The study sample comprised 299 patients. The mean total knowledge score was 63.4 of a possible 100.0 (range, 13.3-93.3). While 73.9% of the participants knew that tamoxifen reduces the risk of breast cancer recurrence, only 57.9% knew that the drug increases endometrial cancer risk. A higher education level (> or =college) was associated with a higher, total knowledge score (beta = 4.291; P = 0.017). A higher knowledge score was associated with a decreased DCS score (beta = -0.366; P < 0.001). A higher SWD score was also associated with decreased decisional conflict (beta = -0.178; P < 0.001). In conclusion, the breast cancer patients with higher levels of tamoxifen-related knowledge showed lower levels of decisional conflict regarding tamoxifen use. Clinicians should provide the exact information about tamoxifen treatment to patients, based on knowledge assessment results, so as to aid patients' decision-making with minimal conflict.

Evaluación de la calidad de estructura y contenido de los formatos de consentimiento médico informado de los hospitales de la Región Lambayeque: marzo-junio 2010 / An assessment of structure and contents quality of informed consent forms in Lambayeque Region: March-June 2010

Objetivo: Determinar la calidad de estructura y de contenido de los formatos de consentimiento médico informado utilizados en los diferentes hospitales de la región Lambayeque. Material y método: Estudio descriptivo, transversal y observacional. Obtenidos los formatos de CMI de los hospitales de la región de Lambayeque; se evaluó su calidad de estructura y de contenido constatándola con los Comités de Ética. Se establecieron dos categorías: Cumple (si figuraba de manera completa y detallada); o, No Cumple (por omisión o tergiversación). Para el análisis, los formatos fueron divididos por número de requisitos cumplidos: más del 75 (cumple 19-24 requisitos); entre el 50-75 (de 12 a18) y menos del 50 (de 0 a 11). Resultados: De los 8 formatos estudiados de los Hospitales de la Región de Lambayeque se encontró que en ningún (0) hospital cumplían con los requisitos del modelo al no lograr más del 75 (19-24 requisitos); 1 (12,5) hospitales se halló entre el 50 y 75 (12-18 requisitos) y en 7 hospitales (75) cumplían menos del 50 (0-11 requisitos). Conclusiones: La calidad de los formatos de CMI de los hospitales de la Región Lambayeque en cuanto a su estructura y contenido: Deficiente.

Objective: To determine the quality of informed medical consent forms (ICFs) used in different hospitals in Lambayeque region with respect to their structure and contents Material and method: This was a descriptive, cross-sectional and observational study. ICFs used in Lambayeque hospitals were assessed with respect to their quality of structure and contents with the participation of Ethics Committees. Two categories were established: complied (if the forms were complete and detailed); or non-compliant (because of omission or confounding). Forms were divided according to the number of requisites complied with: more than 75 (complying with 19-24 requisites); between 50 to 75 (12 to 18 requisites) and less than 50 (0 to 11 requisites). Results: Of the eight forms studied in the Hospitals of the Region Lambayeque found in no (0) were eligible hospital of failing to model more than 75 (19-24 requirements), 1 (12.5) hospitals was found between 50 and 75 (12-18 requirements) and in six hospitals (75) had less than 50 (0-11 requirements). Conclusions: The quality of ICFs in Lambayeque region in terms of their structure and contents is poor.

Reasons for resubmission of research projects to the research ethics committee of a University Hospital in São Paulo, Brazil

INTRODUCTION: It is important to know the reasons for resubmitting research projects to the Research Ethics Committee in order to help researchers to prepare their research projects, informed consent forms and needed research documentation. OBJECTIVES: To verify the reasons for resubmitting projects that were previously rejected by the Ethics Committee. METHOD: This is a cross-sectional study that evaluated research projects involving human beings. Research projects were submitted in 2007 to the Research Ethics Committee of the Hospital das Clínicas, Faculdade de Medicina da Universidade de São Paulo. RESULTS: One thousand two hundred and fifty six research projects were submitted to the ethics committee and the average time for evaluating the research projects and related documents until a final decision was reached was 49.95 days. From the total, 399 projects were reviewed in 2 or more meetings until a final decision was reached. Of these, 392 research projects were included in the study; 35 projects were subsequently excluded for involving animals. Among the research projects included, 42.5 percent concerned research with new drugs, vaccines and diagnostic tests, 48.5 percent consisted of undergraduate students' research projects, 68.9 percent of the research had no sponsorship, and 97.5 percent were eventually approved. The main reasons for returning the projects to the researchers were the use of inadequate language and/or difficulty of understanding the informed consent form (32.2 percent), lack of information about the protocol at the informed consent form (25.8 percent), as well as doubts regarding methodological and statistical issues of the protocol (77.1 percent). Other reasons for returning the research projects involved lack of, inaccuracy on or incomplete documentation, need of clarification or approval for participation of external entities on the research, lack of information on financial support. CONCLUSION: Among the ...