scholarly journals Participants' Comprehension of the Informed Consent in an Epidemiological Study on Dementia Prevalence: A Qualitative Study

2021 ◽  
Vol 12 ◽  
Author(s):  
Ilaria Falvo ◽  
Maddalena Fiordelli ◽  
Rebecca Amati ◽  
Aliaa Ibnidris ◽  
Emiliano Albanese ◽  
...  
Keyword(s):  
Informed Consent ◽  
Qualitative Study ◽  
Epidemiological Study ◽  
Large Scale ◽  
Consent Form ◽  
Dementia Prevalence ◽  
Informed Consent Form ◽  
Dementia Research ◽  
Age Appropriate ◽  
Informed Consent Document

Aim: In the absence of an effective treatment, informed participation in dementia research can hardly be underestimated. However, although informed consent is key in biomedical research, it may become a barrier to participation. Whether informed consent may cause confusion and contribute to unfair participant selection in dementia research is not known. In preparation of a future epidemiological study on the prevalence and impact of dementia in Switzerland, we aimed to conduct a qualitative study to explore participants' comprehension of the purpose of informed consent form and process shortly after participation in the pilot and validation study that preceded the large scale survey.Methods: We conducted a qualitative study with 22 participants of the validation phase of an epidemiological study on the prevalence and impact of dementia in Switzerland to capture their understanding of both the nature and the content of the informed consent form and process. Participants were older adults (65 years or more) eligible for a dementia epidemiological study and their informant (a person who could provide information on their health and cognition). None of the participants reported to be suffering from dementia at the time of the interview.Results: We found that participants held inaccurate and potentially trust-threatening beliefs regarding the scope of the informed consent. Participants identified contradictory contextual, formal and content needs that are difficult to be fulfilled, and misperceived the clinical and research settings in terms of informed consent procedures.Conclusions: Participants and their proxies should be informed about both the scope of the informed consent process, and the content of the informed consent document in a focused, age-appropriate manner, while dispelling confusion about the purpose of research.

scholarly journals How Does the Patient React After Reading the Informed Consent Form of a Gynecological Surgery? A Qualitative Study

2018 ◽  
Vol 40 (02) ◽  
pp. 072-078
Author(s):  
Andrea Amorim ◽  
Luis Santos ◽  
Omero Poli-Neto ◽  
Luiz Brito
Keyword(s):  
Decision Making ◽  
Informed Consent ◽  
Qualitative Study ◽  
Abdominal Surgery ◽  
Consent Form ◽  
Decision Making Process ◽  
Gynecological Surgery ◽  
Previous Abdominal Surgery ◽  
Informed Consent Form ◽  
Made In

Objective To analyze the reaction of women after reading the Informed Consent Form (ICF) before undergoing elective gynecological/urogynecological surgeries. Methods A qualitative study with 53 women was conducted between September 2014 and May 2015. The analysis of the content was conducted after a scripted interview was made in a reserved room and transcribed verbatim. We read the ICF once more in front of the patient, and then she was interviewed according to a script of questions about emotions and reactions that occurred about the procedure and her expectations about the intra- and postoperative period. Results The women had a mean age of 52 years, they were multiparous, and most had only a few years of schooling (54.7%). The majority (60.4%) of them had undergone urogynecological surgeries. Hysterectomy and colpoperineoplasty were the most frequent procedures. Ten women had not undergone any previous abdominal surgery. Fear (34.6%) was the feeling that emerged most frequently from the interviews after reading the ICF, followed by indifference (30.8%) and resignation (13.5%). Nine women considered their reaction unexpected after reading the ICF. Three patients did not consider the information contained in the ICF to be sufficient, and 3 had questions about the surgery after reading the document. Conclusion Reading the ICF generates fear in most women; however, they believe this feeling did not interfere in their decision-making process.

scholarly journals Practice of informed consent in Guangdong, China: a qualitative study from the perspective of in-hospital patients

BMJ Open ◽  
2018 ◽  
Vol 8 (10) ◽  
pp. e020658 ◽  
Author(s):  
Ni Gong ◽  
Yinhua Zhou ◽  
Yu Cheng ◽  
Xiaoqiong Chen ◽  
Xuting Li ◽  
...  
Keyword(s):  
Informed Consent ◽  
Qualitative Study ◽  
Medical Information ◽  
Medical Knowledge ◽  
Information Provision ◽  
Clinical Decision ◽  
Clinical Settings ◽  
Clinical Practices ◽  
Informed Consent Form ◽  
Hospital Patients

ObjectiveThis study aimed to investigate the practice of informed consent in China from the perspective of patients.DesignA qualitative study using in-depth interviews with in-hospital patients focusing on personal experience with informed consent.SettingGuangdong Province, China.Participants71 in-hospital patients in rehabilitation after surgical operations were included.ResultsMedical information is not actively conveyed by doctors nor effectively received by patients. Without complete and understandable information, patients are unable to make an autonomous clinical decision but must sign an informed consent form following the doctor’s medical arrangement. Three barriers to accessing medical information by patients were identified: (1) medical information received by patients was insufficient to support their decision-making, (2) patients lacked medical knowledge to understand the perceptions of doctors and (3) patient–doctor interactions were insufficient in clinical settings.ConclusionsInformed consent is implemented as an administrative procedure at the hospital level in China. However, it has not been embedded in doctors’ clinical practices because, from the perspective of patients, doctors do not fulfil the obligation of medical information provision. As a result, the informed part of informed consent was neglected by individual doctors in China. Reforming medical education, monitoring the process of informed consent in clinical settings and redesigning medical institutional arrangements are pathways to restoring the practice of informed consent and patient-centred models in China.

scholarly journals Pelaksanaan Informed Consent pada Pemeriksaan Intra Vena Pyelografi di Instalasi Radiologi Rumah Sakit Umum Sukoharjo

2017 ◽  
Vol 3 (1) ◽  
pp. 199-203
Author(s):  
Rini Indrati ◽  
Meita Shinta Fatikhatul Laila ◽  
Andrey Nino Kurniawan
Keyword(s):  
Qualitative Research ◽  
Informed Consent ◽  
Consent Form ◽  
Radiology Department ◽  
Medical Council ◽  
Patient Understanding ◽  
Informed Consent Form ◽  
Descriptive Qualitative

Background: The implementation of informed consent at Radiology department of Sukoharjo Hospital was conducted by administrative officer and radiographer. The officer explained the preparation of pyelographic intra-venous examination to the patient then the patient was asked to fill out and sign the informed consent form. According to the Indonesian Medical Council and Regulation of the Minister of Health of Indonesia, the delivery of informed consent is carried out by doctors. The doctor explains all the information contained in the contents of informed consent before taking any medical action. The purpose of this research is to know the implementation of informed consent done in the radiology department and patient understanding of the contents of the informed consent form.Methods: The type of this research is descriptive qualitative research with the observational approach. Data were collected in March-June 2017 by observational of informed consent and interviews of 30 patients who will conduct intra vena pyelographic examination. Data analyzed by descriptively.Results: The results showed that the provision of informed consent to intravenous pyelographic examination patient at Sukoharjo Hospital was performed by administration officer and radiographer before conducting the examination. The patient's understanding of the contents of informed consent has not been in accordance with the content of the informed consent form because the information submitted by the radiologist only concerning the preparation of intravenous examination of pyelography does not include examination procedures, objectives, risks, complications, diagnoses, prognoses, alternative other measures and risks, and costs.Conclusions: In radiology department of Sukoharjo hospital at Intravenapyelography patient informed consent delivered by administrative officers and radiographer. Patients understanding the content of informed consent

Usability Testing

2001 ◽  
Vol 9 (2) ◽  
pp. 15-20
Author(s):  
Susan Waters ◽  
Melody Carswell ◽  
Eric Stephens ◽  
Ada Sue Selwit
Keyword(s):  
Informed Consent ◽  
Usability Testing ◽  
Consent Form ◽  
Research Project ◽  
Informed Consent Form ◽  
The Difference

How information is presented in an informed consent form can mean the difference between success and failure in a research project.

OHP-008 Waste in biomedical research due to informed consent form deficiencies

2017 ◽  
Author(s):  
E Villamañán ◽  
I Jiménez-Nácher ◽  
P Gómez-Salcedo ◽  
E Wagner ◽  
M Freire ◽  
...  
Keyword(s):  
Informed Consent ◽  
Biomedical Research ◽  
Consent Form ◽  
Informed Consent Form
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