Quality of written informed consent forms for electroconvulsive therapy in Australia: a comparative analysis

2021 ◽  
pp. 103985622110092
Author(s):  
Karuppiah Jagadheesan ◽  
Frances Walker ◽  
Vinay Lakra
Keyword(s):  
Informed Consent ◽  
Electroconvulsive Therapy ◽  
Health Department ◽  
Consent Form ◽  
Missing Information ◽  
Consent Forms ◽  
The Right ◽  
Comparative Audit ◽  
Written Informed Consent

Objectives: We compared the quality of the written informed consent forms for electroconvulsive therapy (ECT) in Australian jurisdictions. Method: For this comparative audit-type study, a checklist was developed to compare informed consent forms from different jurisdictions. The main information sources for consent forms were government health department websites and Google. The directors of clinical services were contacted if a consent form was not available through a web source. Results: Majority of the informed consent forms covered information about ECT, general anaesthesia and alternative treatments, supports available for decision making, and a reference to the right to withdraw consent. Missing information affected information areas such as likely outcome if no ECT, lack of guaranteed response and cultural and linguistic supports. Conclusions: A standardised consent form that can be used across all jurisdictions can help improve the ECT practice.

Informed Consent for Online Research—Is Anybody Reading?: Assessing Comprehension and Individual Differences in Readings of Digital Consent Forms

2021 ◽  
pp. 155626462110201
Author(s):  
Caitlin Geier ◽  
Robyn B. Adams ◽  
Katharine M. Mitchell ◽  
Bree E. Holtz
Keyword(s):  
Individual Differences ◽  
Informed Consent ◽  
Research Process ◽  
The Other ◽  
Consent Form ◽  
Online Research ◽  
Consent Forms ◽  
Potential Benefits

Informed consent is an important part of the research process; however, some participants either do not read or skim the consent form. When participants do not read or comprehend informed consent, then they may not understand the potential benefits, risks, or details of the study before participating. This study used previous research to develop experimentally manipulated online consent forms utilizing various presentations of the consent form and interactive elements. Participants ( n = 576) were randomly exposed to one of six form variations. Results found that the highly interactive condition was significantly better for comprehension than any of the other conditions. The highly interactive condition also performed better for readability, though not significantly. Further research should explore the effects of interactive elements to combat habituation and to engage participants with the parts of the consent form unique to the study.

scholarly journals Written Informed Consent—Translating into Plain Language. A Pilot Study

Healthcare ◽  
2021 ◽  
Vol 9 (2) ◽  
pp. 232
Author(s):  
Agnieszka Zimmermann ◽  
Anna Pilarska ◽  
Aleksandra Gaworska-Krzemińska ◽  
Jerzy Jankau ◽  
Marsha N. Cohen
Keyword(s):  
Informed Consent ◽  
Plain Language ◽  
Consent Forms ◽  
Software Analysis ◽  
Informed Consent Form ◽  
Education Levels ◽  
Polish Language ◽  
University Degree ◽  
Study Participants ◽  
Written Informed Consent

Background: Informed consent is important in clinical practice, as a person’s written consent is required prior to many medical interventions. Many informed consent forms fail to communicate simply and clearly. The aim of our study was to create an easy-to-understand form. Methods: Our assessment of a Polish-language plastic surgery informed consent form used the Polish-language comprehension analysis program (jasnopis.pl, SWPS University) to assess the readability of texts written for people of various education levels; and this enabled us to modify the form by shortening sentences and simplifying words. The form was re-assessed with the same software and subsequently given to 160 adult volunteers to assess the revised form’s degree of difficulty or readability. Results: The first software analysis found the language was suitable for people with a university degree or higher education, and after revision and re-assessment became suitable for persons with 4–6 years of primary school education and above. Most study participants also assessed the form as completely comprehensible. Conclusions: There are significant benefits possible for patients and practitioners by improving the comprehensibility of written informed consent forms.

Assessment of the quality of patient information sheets and informed consent forms for clinical trials at a hospital neurology service

2020 ◽  
Vol 27 (10) ◽  
pp. 1825-1831
Author(s):  
A. G. Jaramillo Vélez ◽  
M. Aguas Compaired ◽  
M. Granados Plaza ◽  
E. L. Mariño ◽  
P. Modamio
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Patient Information ◽  
Consent Forms

Use, content, and readability of written informed consent forms for treatment.

1986 ◽  
Vol 17 (6) ◽  
pp. 514-518 ◽  
Author(s):  
Mitchell M. Handelsman ◽  
Melinda B. Kemper ◽  
Pamela Kesson-Craig ◽  
Joanne McLain ◽  
Cynthia Johnsrud
Keyword(s):  
Informed Consent ◽  
Consent Forms ◽  
Written Informed Consent

Personality, Sex of Participant, and Face-to-Face Interaction Affect Reading of Informed Consent Forms

2014 ◽  
Vol 114 (1) ◽  
pp. 297-313 ◽  
Author(s):  
Michael M. Knepp
Keyword(s):  
Informed Consent ◽  
Information Seeking ◽  
Consent Form ◽  
Research Support ◽  
Consent Forms ◽  
Face To Face ◽  
Informed Consent Form

Students ( N = 183) participated in a study designed to determine if each student read the informed consent form. Approximately 12% of students in the online condition followed the procedure compared with 38% in the laboratory phase. Participants with higher trait worry and those with lower emotion reappraisal were more likely to follow the procedure, while women were more likely to read the form than men. Across conditions, most students do not read informed consent documents, particularly in online formats. These findings of this research support the idea that women tend to be more information-seeking than men in health and research settings and those with higher trait worry tend to read the consent forms to alleviate uncertainty and trust concerns.

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.

Improving the quality of the consenting and education process for patients starting on oral oncology medications.

2016 ◽  
Vol 34 (7_suppl) ◽  
pp. 82-82
Author(s):  
Lauren Azure Zatarain ◽  
Jessica Ashford ◽  
David Bivens
Keyword(s):  
Informed Consent ◽  
Patient Education ◽  
Clinic Visit ◽  
Health Record ◽  
Management Problem ◽  
Safety Standards ◽  
Oral Oncology ◽  
Written Informed Consent ◽  
Education Process

82 Background: Oral oncology medication prescribing is on the rise nationwide. Given that these medications are self-administered, drug compliance is a concern. Appropriate patient education directly impacts drug adherence. Prior to the process improvement initiative in our community based medical oncology clinic, implied consent was obtained while educating patients on side effects and written informed consent was documented 0% of the time. This creates a patient safety and risk management problem. Methods: Our clinic implemented a new process for consenting and educating patients starting on new oral oncology medications from April – October 2015. The plan/do/study/act performance improvement technique was utilized. A new consent form was created for oral oncology medications meeting ASCO/ONS safety standards. The consent and education packets were placed centrally in the office and coincided with an initiative to improve consenting for IV chemotherapy. Providers were in-serviced to contact the nurse prior to patients exiting clinic to initiate the new prescription and begin the patient education process. Reminder checklists were placed in exam rooms to trigger the provider to communicate with nursing staff. Outcome measures included data on the percent of patients with written informed consent in health record and percent of patients with patient education handouts in health record prior to drug start. Data on percent of patients for whom the provider notified nurse prior to end of clinic visit were collected as a balance measure. Results: Over a 6 month period, 101 consecutive patients initiated on oral oncology drugs were included in the data analysis. The baseline mean improved from 0% to 75% for obtaining written informed consent (p chart, 3 sigma). The baseline mean improved from 37% to 80% for documenting patient education in health record prior to oral oncology medication start (p chart, 3 sigma). Conclusions: There was significant improvement in obtaining written informed consent and providing patient education prior to oral oncology drug start after implementation of new clinic processes.

scholarly journals Current ERCP practice in Belgium: the BSGIE survey

2021 ◽  
Vol 84 (1) ◽  
pp. 73-77
Author(s):  
C Snauwaert ◽  
X Dekoninck ◽  
T Moreels
Keyword(s):  
Informed Consent ◽  
Real Life ◽  
Daily Practice ◽  
Current Status ◽  
Case Volume ◽  
Belgian Society ◽  
Real Life Data ◽  
Measurement And Evaluation ◽  
Written Informed Consent

Background and study aims : Data on procedural outcome and quality of endoscopic retrograde cholangiopancreatography (ERCP) in Belgian practice are scarce. The aim of this study is to assess current status of ERCP-performance in Belgium. Methods : National multi-institutional survey (online question-naire) among members of the Belgian Society of Gastrointestinal Endoscopy (BSGIE), conducted in the period June-August 2018. The RIZIV/INAMI provided real-life data on the total number of ERCPs performed in Belgium. Results : Forty-five responders completed the survey (for43 centers performing ERCP), providing information for 8368 ERCPs performed in 45% (43/95) of institutions performing ERCP in Belgium. Fifty-eight percent of centers performed > 100 ERCPs/year and 7% of centers (n=3) performed < 50 ERCPs/year. According to the RIZIV/INAMI data, low case-volume centers are underrepresented in this survey. The most common ERCP-indication was stone extraction (52%). 74% of endoscopists had more than 10 years of experience in performing ERCP. The majority of centers had their own written protocol (84%) for microbiological duodenoscope surveillance. Monitoring of cannulation rate and post-ERCP pancreatitis (PEP) was only performed in a minority of centers (30%). The majority of centers (76%) provided verbal informed consent relating to the ERCP-procedure ; a minority also requested a written informed consent (23%). 65% of centers systematically use NSAIDs for PEP-prophylaxis. Conclusion : This is the first survey of ERCP performance in Belgium. There were wide variations in practice. Adherence to key performance measures and measurement and evaluation of ERCP performance in daily practice at center and endoscopist level are not uniformly widespread.

scholarly journals The Quality of Informed Consent Obtaining Before Electroconvulsive Therapy: A Report From a Referral, Academic Hospital

2021 ◽  
Vol 7 (1) ◽  
pp. 37-41
Author(s):  
Hossein Khoshrang ◽  
◽  
Morteza Rahbar Taramsari ◽  
Cyrus Emir Alavi3 ◽  
Robabeh Soleimani ◽  
...  
Keyword(s):  
Informed Consent ◽  
Electroconvulsive Therapy ◽  
Patient Relationship ◽  
Academic Hospital ◽  
Physician Patient Relationship ◽  
The North ◽  
North Of Iran ◽  
The Mean ◽  
Physician Patient

Background: In patients undergoing Electroconvulsive Therapy (ECT), obtaining written Informed Consent (IC) must be the standard measure before the procedure. The patient must be informed about the risks and benefits of the treatment and alternatives. Objectives: We aimed to investigate the quality of IC obtaining before the ECT course in an academic hospital in the North of Iran. Materials & Methods: This study was conducted at an academic center in the north of Iran during 2018-2019. Firstly the patients’ mental capacity was assessed, and if it was not adequate for giving informed consent, a patient’s relative was interviewed. The collected data were analyzed by SPSS V. 22. The Kolmogorov-Smirnov test was used to evaluate the normality assumption. To compare the mean scores in subgroups, we applied t-test. Results: A total of 259 people enrolled in the survey and were interviewed. Schizophrenia was the main cause of receiving ECT. The Mean±SD score of receiving information was 8.22±3.68 (0-16), understandability of IC 3.03±1.76 (0-6), patients’ voluntary acceptance of the treatment 1.38±0.68 (0-4) and physician-patient relationship 6.11±2.16 (0-12). The total Mean±SD score was 18.05±3.16 (0-38). Conclusion: IC process was not optimal in our center; however, great trust in the physicians was noticeable. The physician-patient relationship had the highest score while the intentional obtaining of informed consent achieved the lowest.

Consent

2018 ◽  
Author(s):  
Anna Rathmell
Keyword(s):  
Informed Consent ◽  
Medical Care ◽  
Patient Autonomy ◽  
Consent Form ◽  
English Law ◽  
Contemporary Medicine ◽  
The Right

In contemporary medicine, the traditional paternalistic model of healthcare has largely been replaced with a model which focuses on patient autonomy and the right of patients to have as much control as possible over decisions relating to their medical care. In English law, this has led to the concept of informed consent and the right of patients to withdraw their consent at any time, even if they have previously given consent or signed a consent form.

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