Informed consent in interventional radiology – are we doing enough?

2021 ◽  
pp. 20201368
Author(s):  
Akash Prashar ◽  
Saqib Butt ◽  
Davide Giuseppe Castiglione ◽  
Nadeem Shaida
Keyword(s):  
Interventional Radiology ◽  
Clinical Practice ◽  
Informed Consent ◽  
Blood Transfusion ◽  
Retrospective Analysis ◽  
Patient Information ◽  
Potential Risk ◽  
Current Model ◽  
Consent Form ◽  
Consent Process

Objectives: Obtaining informed consent is a mandatory part of modern clinical practice. The aim of this study was to identify how often complications relating to Interventional Radiology (IR) procedures were discussed with the patient prior to the procedure. Methods: A retrospective analysis of 100 patients who experienced a complication related to an IR procedure was performed. The patient’s procedure consent form was examined to identify whether the complication they experienced had been discussed as a possible risk. Other parts of the consent form relating to need for blood transfusion and the need for further procedures were also examined. Results: 39% of patients who experienced a complication did not have the complication documented as a potential risk on the consent form. 14% of patients required a blood transfusion but were not consented for this. 42% of patients required a further procedure or operation but were not warned of this. Conclusion: The model of gaining informed consent on the day of procedure is no longer valid. Better education and the use of clinics, patient information sheets and other resources is essential. Advances in knowledge: The paper highlights the inadequacies of the current model in gaining consent for IR procedures. A more comprehensive consent process making use of all available resources is essential.

scholarly journals Role of the consent form in UK veterinary practice

2020 ◽  
Vol 187 (8) ◽  
pp. 318-318
Author(s):  
Carol Gray
Keyword(s):  
Informed Consent ◽  
Thematic Analysis ◽  
Potential Role ◽  
Consent Form ◽  
Consent Process ◽  
Consent Forms ◽  
The Status ◽  
The Uk ◽  
Sufficient Space

BackgroundInformed consent from the client is required before veterinary professionals may administer treatment or perform surgery on an animal patient, except in an emergency. This study investigates the potential role(s) of the consent form in the consent process in the UK.MethodsThematic analysis was carried out on the text contained in 39 blank consent forms sourced from veterinary practices in the UK. Analysis was conducted at the levels of topical survey and thematic summary.ResultsConsent forms were used to authorise procedures, to define proposed treatment, to offer or recommend additional procedures, to convey the risks of treatment and to document the client’s financial obligations. None of the forms analysed provided sufficient space to document the accompanying conversation. Notable omissions from the submitted forms included options for treatment and benefits of treatment.ConclusionsThe consent form acts as a record of the procedure to be performed, the associated costs and the status of the person giving consent. However, from this analysis, it often fails to record the detail of the consent discussion, an essential part of the consent process. A proposal for an improved version of a veterinary consent form is provided.

Patient information through the informed consent form

2015 ◽  
Vol 145 (10) ◽  
pp. 458-459
Author(s):  
José María Prieto de Paula ◽  
Silvia Franco Hidalgo
Keyword(s):  
Informed Consent ◽  
Patient Information ◽  
Consent Form ◽  
Informed Consent Form

Effectiveness of consenting in Otorhinolaryngology

Open Medicine ◽  
2012 ◽  
Vol 7 (2) ◽  
pp. 198-202
Author(s):  
Nnaemeka Okpala ◽  
Amala Okpala ◽  
Gareth John ◽  
Hugh Cox
Keyword(s):  
Informed Consent ◽  
Therapeutic Alliance ◽  
Medical Practice ◽  
Consent Form ◽  
Consent Process ◽  
Pharyngeal Pouch ◽  
Consent Forms ◽  
Ethical Component ◽  
At Home

AbstractInformed consent in today’s medical practice has become a cornerstone and a routine ethical component playing a major role in forming a therapeutic alliance with the patient. The present study sought to analyse the effectiveness of the consent forms and the consenting process in Otorhinolaryngology. This three month questionnaire-based study covered varying operations which ranged from tonsillectomies, grommet insertions to pharyngeal pouch stapling. Twenty-nine percent of consent forms were signed on the day of the operation. Of the patients who received leaflets (51%) during the process of informed consent, a majority (88%) found it useful. The respondents were satisfied with the explanation of the procedure, benefits and complications (70–74%). Majority kept their consent forms at home (60%) and did not bother engaging in further search with regards to the information in the consent form (81%). Majority of the patients agreed that they had enough time to make an informed consent. Patients were satisfied with the consent process but more can be done to improve the consenting process.

Step 3: Obtaining Truly Informed Consent Before Disclosing Confidential Information Voluntarily

2013 ◽  
pp. 73-85
Author(s):  
Mary Alice Fisher
Keyword(s):  
Informed Consent ◽  
Patient Information ◽  
Informed Consent Process ◽  
Consent Process ◽  
Patient Specific ◽  
Confidential Information ◽  
Legal Requirement

Chapter 6 walks therapists through Step 3, and covers how to obtain truly informed consent before disclosing confidential information voluntarily. It emphasizes that ‘confidential’ is a reminder that every disclosure of patient information constitutes an exception to the rule of confidentiality, and how therapists are often tempted (or urged by others) to create their own ‘personal exceptions’, and this chapter is therefore a reminder that, ethically speaking, confidentiality is still the rule. It also examines how, in the absence of a legal requirement to disclose, information about a patient should ordinarily remain confidential, and therapists should not disclose it without first obtaining the patient’s consent, either as part of the informed consent process at intake or in preparation for a patient-specific disclosure.

A risk-specific anesthesia consent form may hinder the informed consent process

1991 ◽  
Vol 3 (6) ◽  
pp. 481 ◽  
Author(s):  
Scott K. Clark ◽  
Barbara L. Leighton ◽  
Joseph L. Seltzer
Keyword(s):  
Informed Consent ◽  
Informed Consent Process ◽  
Consent Form ◽  
Consent Process

A risk-specific anesthesia consent form may hinder the informed consent process

1991 ◽  
Vol 3 (1) ◽  
pp. 11-13 ◽  
Author(s):  
Scott K. Clark ◽  
Barbara L. Leighton ◽  
Joseph L. Seltzer
Keyword(s):  
Informed Consent ◽  
Informed Consent Process ◽  
Consent Form ◽  
Consent Process

Randomized comparison of two interventions to enhance understanding during the informed consent process for research

2021 ◽  
pp. 174077452110095
Author(s):  
Holly A Taylor ◽  
Daphne Washington ◽  
Nae-Yuh Wang ◽  
Hiten Patel ◽  
Daniel Ford ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Randomized Study ◽  
Informed Consent Process ◽  
Consent Form ◽  
Consent Process ◽  
P Value ◽  
Fact Sheet ◽  
Significant Difference ◽  
Participant Understanding

Background/Aims: Many investigators have tested interventions to improve research participant understanding of information shared during the informed consent process, using a variety of methods and with mixed results. A valid criticism of most consent research is that studies are often conducted in simulated research settings rather than ongoing clinical studies. The present study rigorously tested two simple and easily adoptable strategies for presenting key consent information to participants eligible to enroll in six actual clinical trials (i.e. six parent studies). Methods: In collaboration with the study team from each parent study, we developed two consent interventions: a fact sheet and an interview-style video. The content of each of the intervention was based on the information shared in the consent form approved for each parent study. Participants were randomized to the standard consent process, or to one of the two interventions. Once exposed to the assigned consent mode, participants were asked to complete an assessment of understanding. The study was powered to determine whether those exposed to the fact sheet or video performed better on the consent assessment compared to those exposed to the standard consent. We also assessed participant satisfaction with the consent process. Results: A total of 284 participants were randomized to one of the three consent arms. Assessments of understanding were completed with a total of 273 participants from July 2017 to April 2019. Participants exposed to the video had better understanding scores compared to those exposed to the standard consent form process ( p value = 0.020). Participants were more satisfied with the video when compared to the standard consent. Participants who received the fact sheet did not achieve higher overall understanding or satisfaction scores when compared to the standard consent process. Conclusion: This randomized study of two novel consent interventions across six different clinical trials demonstrated a statistically significant difference in participant understanding based on overall scores among those exposed to the video intervention compared to those exposed to the standard consent.

scholarly journals Clinical Research: Comprehension of the Patient Information Leaflet and the Consent Form

2012 ◽  
Vol 46 (3) ◽  
pp. 122-125
Author(s):  
Nusrat Shafiq ◽  
Samir Malhotra
Keyword(s):  
Developing Countries ◽  
Informed Consent ◽  
Clinical Research ◽  
Patient Information ◽  
Research Process ◽  
Informed Consent Process ◽  
Patient Information Leaflet ◽  
Consent Form ◽  
Information Leaflet ◽  
Informed Consent Form

ABSTRACT Informed consent process is an integral component of conducting clinical research ethically. Prior to giving an informed consent to participate in clinical research, it is important that the participant has fully understood all the components of a patient information leaflet and the consent form. The issue of comprehension of informed consent form and patient information leaflet has acquired particular importance in view of research being carried out in developing countries and in vulnerable population. The present review addresss this issue by discussing the need for addressing comprehension of research process by the participant, the tools for assessing the same and various ways in which these tools have been used. How to cite this article Shafiq N, Malhotra S. Clinical Research: Comprehension of the Patient Information Leaflet and the Consent Form. J Postgrad Med Edu Res 2012;46(3):122-125.

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