EP.WE.347An Audit On Our Procedural Consent Forms For Complication Of COVID-19 During The Pandemic

This poster presents a pilot study that analyzed a small corpus of informed consent forms used in research with children, adolescents, and adult early readers using Coh-Metrix, a readability measurement tool. Recommendations for increasing readability of consent forms in order to improve the informed consent process are also provided. Cette affiche présente une étude pilote qui a analysé un corpus restreint de formulaires de consentement éclairé utilisés dans la recherche avec les enfants, les adolescents et les lecteurs précoces adultes, utilisant Coh-Metrix, un outil de mesure de la lisibilité. Nous fournissons également des recommandations pour augmenter la lisibilité des formulaires de consentement afin d'améliorer le processus de consentement éclairé.

Download Full-text

Development, piloting, and evaluation of an evidence-based informed consent form for total knee arthroplasty (EvAb-Pilot): a protocol for a mixed methods study

Pilot and Feasibility Studies ◽

10.1186/s40814-021-00843-x ◽

2021 ◽

Vol 7 (1) ◽

Author(s):

Alina Weise ◽

Julia Lühnen ◽

Stefanie Bühn ◽

Felicia Steffen ◽

Sandro Zacher ◽

...

Keyword(s):

Total Knee Arthroplasty ◽

Informed Consent ◽

Adverse Events ◽

Knee Arthroplasty ◽

Evidence Based ◽

Nocebo Effect ◽

Legal Requirements ◽

Consent Forms ◽

Link Type ◽

Total Knee

Abstract Background Practitioners frequently use informed consent forms to support the physician-patient communication and the informed consent process. Informed consent for surgery often focuses on risk centered information due to high liability risks for treatment errors. This may affect patients’ anxiety of adverse events and the nocebo effect. This study focuses on the optimization of pre-surgical information on risks and complications, and at the same time reconciles these information with legal requirements. Methods The development, piloting, and evaluation of evidence-based informed consent forms for total knee arthroplasty (TKA) and related anesthesia procedures will follow the UK MRC Framework for developing and evaluating complex interventions. Conducting different sub-studies, we will (I) qualitatively explore the information acquisition and decision-making processes, (II) develop and pilot test evidence-based informed consent forms on the example of TKA and related anesthesia procedures, (III) conduct a monocentric interrupted time series (ITS) pilot study to evaluate the effects of evidence-based informed consent forms in comparison with standard consent forms, and (IV) perform a process evaluation to identify barriers and facilitators to the implementation of the intervention and to analyze mechanisms of impact. Discussion The evidence-based and understandable presentation of risks in informed consent forms aims at avoiding distorted risk depiction and strengthening the patients’ competencies to correctly assess the risks of undergoing surgery. This might reduce negative expectations and anxiety of adverse events, which in turn might reduce the nocebo effect. At the same time, the practitioners’ acceptance of evidence-based informed consent forms meeting legal requirements could be increased. Trial registration ClinicalTrials.gov, NCT04669483. Registered 15 December 2020. German Clinical Trials Registry, DRKS00022571. Registered 15 December 2020

Download Full-text

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

Journal of Empirical Research on Human Research Ethics ◽

10.1177/15562646211020160 ◽

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.

Download Full-text

Flaws in Revising Medical Consent Forms – Reply

Law Medicine and Health Care ◽

10.1017/s0277845900010812 ◽

1983 ◽

Vol 11 (5) ◽

pp. 228-229

Keyword(s):

Consent Forms

Download Full-text

515 How Has ‘Montgomery’ Changed the Way We Document Risks on Consent Forms for Deceased Donor Kidney Transplantation? A Single-Centre Audit and Re-Audit

British Journal of Surgery ◽

10.1093/bjs/znab134.443 ◽

2021 ◽

Vol 108 (Supplement_2) ◽

Author(s):

A M Hussein ◽

C J Callaghan

Keyword(s):

Gold Standard ◽

Deceased Donor ◽

Consent Form ◽

Donor Kidney ◽

Consent Forms ◽

Legal Case ◽

Deceased Donor Kidney ◽

Single Kidney ◽

Donor Kidney Transplantation ◽

Deceased Donor Kidney Transplantation

Abstract Introduction The 2015 Montgomery case changed the remit of risk discussions required during the consent process. This audit reviewed single kidney transplant (SKT) consent forms to establish which risks are documented, and whether this legal case affected discussions. Following the audit, we introduced a pre-printed consent form and closed the audit loop by assessing its uptake. Method Trust paper consent forms for all patients aged 50+ who received a deceased donor SKT in our centre in 2014 (n = 58; pre-Montgomery) and 2017 (n = 70; post-Montgomery) were reviewed to see if 20 perceived ‘gold standard’ risks were documented. A pre-printed procedure-specific consent form including all gold standard risks was then introduced in July 2019. A re-audit reviewed the case-notes of every alternate recipient aged 50+ of a deceased donor SKT from 01/08/19 to 29/02/20 to check if the pre-printed form was used. Results Overall, 53% of the 20 ‘gold standard’ risks were documented in 2014 versus 59% in 2017 (p = 0.55). There was a 91% uptake of the pre-printed consent form. Discussion This audit established the importance of using a pre-printed consent form to standardise risk discussions We propose that pre-printed procedure-specific forms should be encouraged throughout the NHS to support ‘Montgomery-appropriate’ consent discussions.

Download Full-text

Assessing Parent Decisions About Child Participation in a Behavioral Health Intervention Study and Utility of Informed Consent Forms

JAMA Network Open ◽

10.1001/jamanetworkopen.2020.9296 ◽

2020 ◽

Vol 3 (7) ◽

pp. e209296

Author(s):

Stephanie A. Kraft ◽

Kathryn M. Porter ◽

Devan M. Duenas ◽

Erin Sullivan ◽

Maya Rowland ◽

...

Keyword(s):

Informed Consent ◽

Behavioral Health ◽

Intervention Study ◽

Health Intervention ◽

Child Participation ◽

Consent Forms ◽

Behavioral Health Intervention ◽

Parent Decisions

Download Full-text

Consent and information giving in radiotherapy

Journal of Radiotherapy in Practice ◽

10.1017/s146039690700619x ◽

2007 ◽

Vol 6 (4) ◽

pp. 217-223

Author(s):

Gillian Thompson

Keyword(s):

Health Professional ◽

Quality Care ◽

Good Practice ◽

Consent Forms ◽

Policy Model ◽

Information Giving ◽

Department Of Health ◽

Radiotherapy Department ◽

Consent To Treatment ◽

To Receive

AbstractThis paper explores some of the issues around implementing a consent policy within the radiotherapy department. Consent can be defined as a patient’s agreement for a health care professional to provide care. The NHS Plan1 highlighted the need for quality care centred around the patient and for changes in the way patients are asked to give their consent to treatment. This led to the Department of Health (DoH) publishing a Good Practice in Consent Implementation Guide (2001)2 for use within all NHS Trusts from 1 April 2002, which aimed to provide consistency across the NHS and provides a policy model and generic consent forms.The policy recommends that the health professional carrying out the procedure is ultimately responsible for ensuring that the patient is genuinely consenting to what is being done, as it is they who would be held responsible in law should a case be made by a patient against a health professional. In radiotherapy, it is the Clinical Oncologist who obtains consent as they are responsible for prescribing courses of treatment; however, it is the Radiographer’s role to deliver this treatment. This paper discusses some of the issues around implementing a consent policy in terms of who can give and confirm consent, and what are the requirements for training if the patient is to receive the appropriate information before making the decision to consent to treatment.

Download Full-text