Characterization of Informed Consent Forms Posted on ClinicalTrials.gov

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.

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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

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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.

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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

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Information Sheets and Informed Consent Forms for Clinical Study Participants: Towards Standardised Recommendations?

Therapies ◽

10.2515/therapie/2009035 ◽

2009 ◽

Vol 64 (3) ◽

pp. 179-186 ◽

Cited By ~ 1

Author(s):

Olivier Chassany ◽

Micheline Bernard-Harlaut ◽

Gilles Guy ◽

Nathalie Billon ◽

Bernard Alberola ◽

...

Keyword(s):

Clinical Study ◽

Informed Consent ◽

Consent Forms ◽

Study Participants

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

Healthcare ◽

10.3390/healthcare9020232 ◽

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.

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Readability of informed consent forms for whole-exome and whole-genome sequencing

Journal of Community Genetics ◽

10.1007/s12687-017-0324-6 ◽

2017 ◽

Vol 9 (2) ◽

pp. 143-151 ◽

Cited By ~ 10

Author(s):

Emilia Niemiec ◽

Danya F. Vears ◽

Pascal Borry ◽

Heidi Carmen Howard

Keyword(s):

Informed Consent ◽

Whole Genome Sequencing ◽

Genome Sequencing ◽

Whole Genome ◽

Consent Forms ◽

Whole Exome

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MON-004.0: Developing Informed Consent Forms

Handbook of SOPs for Good Clinical Practice ◽

10.1201/9780203492062-5 ◽

2004 ◽

pp. 27-30

Keyword(s):

Informed Consent ◽

Consent Forms

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1229 Standardising Consent for General Surgical Patients

British Journal of Surgery ◽

10.1093/bjs/znab259.135 ◽

2021 ◽

Vol 108 (Supplement_6) ◽

Author(s):

M Mamun ◽

E Charles

Keyword(s):

Informed Consent ◽

Hernia Repair ◽

General Surgery ◽

Case Note ◽

Surgical Patients ◽

Standards Of Care ◽

Retrospective Case ◽

Incision And Drainage ◽

Consent Forms ◽

Surgical Practice

Abstract Aim Informed consent requires all material risks to be discussed, as per Montgomery vs Lanarkshire 2015. This audit was based on the latest RCS England guidelines on consenting patients. We aimed to assess our adherence and to introduce standardised procedure-specific consent stickers to ensure the highest standards of care, which were reproducible. Method We undertook two retrospective case note reviews of patients undergoing emergency and elective general surgery procedures from 01/01-15/06 and 01/10-30/11 in 2020. RCS Good Surgical Practice 3.5.1 “Consent” details the standards for this audit. We included patients undergoing appendicectomy, cholecystectomy, incision and drainage and hernia repair (inguinal, umbilical, and incisional). We did not audit laparotomy due to variability in procedural risks precluding a specific sticker and we excluded patients unable to give consent. Results Our initial audit of 82 patients highlighted the variability between practitioners in the material risk discussion. Different patients undergoing the same procedures were being consented differently with significant omissions. We designed procedure specific-consent stickers to be used when consenting to address this imbalance and made these stickers available on surgical wards. A re-audit of 50 patients showed increase from 41% to 88% in documentation of material risks. While only 34% of the audited consent forms featured the stickers, those forms that did have the stickers on had 100% material risk documentation. Conclusions We saw an improvement in material risk discussion by implementing procedure-specific consent stickers. This supports the growing need for standardising consent across General Surgery to reduce variability. We will next aim to design laparotomy stickers.

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