Readability and understandability of clinical research patient information leaflets and consent forms in Ireland and the UK: a retrospective quantitative analysis
Original Research
Lydia O’Sullivan, Prasanth Sukumar, Rachel Crowley, Eilish McAuliffe, Peter Doran
Ethics, 3 September 2020
Abstract
Objectives
The first aim of this study was to quantify the difficulty level of clinical research Patient Information Leaflets/Informed Consent Forms (PILs/ICFs) using validated and widely used readability criteria which provide a broad assessment of written communication. The second aim was to compare these findings with best practice guidelines.
Design
Retrospective, quantitative analysis of clinical research PILs/ICFs provided by academic institutions, pharmaceutical companies and investigators.
Setting
PILs/ICFs which had received Research Ethics Committee approval in the last 5 years were collected from Ireland and the UK.
Intervention
Not applicable.
Main outcome measures
PILs/ICFs were evaluated against seven validated readability criteria (Flesch Reading Ease, Flesh Kincaid Grade Level, Simplified Measure of Gobbledegook, Gunning Fog, Fry, Raygor and New Dale Chall). The documents were also scored according to two health literacy-based criteria: the Clear Communication Index (CCI) and the Suitability Assessment of Materials tool. Finally, the documents were assessed for compliance with six best practice metrics from literacy agencies.
Results
A total of 176 PILs were collected, of which 154 were evaluable. None of the PILs/ICFs had the mean reading age of <12 years recommended by the American Medical Association. 7.1% of PILs/ICFs were evaluated as ‘Plain English’, 40.3%: ‘Fairly Difficult’, 51.3%: ‘Difficult’ and 1.3%: ‘Very Difficult’. No PILs/ICFs achieved a CCI >90. Only two documents complied with all six best practice literacy metrics.
Conclusions
When assessed against both traditional readability criteria and health literacy-based tools, the PILs/ICFs in this study are inappropriately complex. There is also evidence of poor compliance with guidelines produced by literacy agencies. These data clearly evidence the need for improved documentation to underpin the consent process.
Month: October 2020
Seven-step framework to enhance practitioner explanations and parental understandings of research without prior consent in paediatric emergency and critical care trials
Seven-step framework to enhance practitioner explanations and parental understandings of research without prior consent in paediatric emergency and critical care trials
Original Research
Louise Roper, Mark D Lyttle, Carrol Gamble, Amy Humphreys, Shrouk Messahel, Elizabeth D Lee, Joanne Noblet, Helen Hickey, Naomi Rainford, Anand Iyer, Richard Appleton
BMJ Emergency Medicine Journal, 29 August 2020
Abstract
Background
Alternatives to prospective informed consent enable the conduct of paediatric emergency and critical care trials. Research without prior consent (RWPC) involves practitioners approaching parents after an intervention has been given and seeking consent for their child to continue in the trial. As part of an embedded study in the ‘Emergency treatment with Levetiracetam or Phenytoin in Status Epilepticus in children’ (EcLiPSE) trial, we explored how practitioners described the trial and RWPC during recruitment discussions, and how well this information was understood by parents. We aimed to develop a framework to assist trial conversations in future paediatric emergency and critical care trials using RWPC.
Methods
Qualitative methods embedded within the EcLiPSE trial processes, including audiorecorded practitioner–parent trial discussions and telephone interviews with parents. We analysed data using thematic analysis, drawing on the Realpe et al (2016) model for recruitment to trials.
Results
We analysed 76 recorded trial discussions and conducted 30 parent telephone interviews. For 19 parents, we had recorded trial discussion and interview data, which were matched for analysis. Parental understanding of the EcLiPSE trial was enhanced when practitioners: provided a comprehensive description of trial aims; explained the reasons for RWPC; discussed uncertainty about which intervention was best; provided a balanced description of trial intervention; provided a clear explanation about randomisation and provided an opportunity for questions. We present a seven-step framework to assist recruitment practice in trials involving RWPC.
Conclusion
This study provides a framework to enhance recruitment practice and parental understanding in paediatric emergency and critical care trials involving RWPC. Further testing of this framework is required.
Participant Reactions to a Literacy-Focused, Web-Based Informed Consent Approach for a Genomic Implementation Study
Participant Reactions to a Literacy-Focused, Web-Based Informed Consent Approach for a Genomic Implementation Study
Research Article
Stephanie A. Kraft, Kathryn M. Porter, Devan M. Duenas, Claudia Guerra, Galen Joseph, Sandra Soo-Jin Lee, Kelly J. Shipman, Jake Allen, Donna Eubanks, Tia L. Kauffman, Nangel M. Lindberg, Katherine Anderson, Jamilyn M. Zepp, Marian J. Gilmore, Kathleen F. Mittendorf, Elizabeth Shuster, Kristin R. Muessig, Briana Arnold, Katrina A.B Goddard, Benjamin S. Wilfond
AJOB Empirical Bioethics, 26 September 2020
Abstract
Background
Clinical genomic implementation studies pose challenges for informed consent. Consent forms often include complex language and concepts, which can be a barrier to diverse enrollment, and these studies often blur traditional research-clinical boundaries. There is a move toward self-directed, web-based research enrollment, but more evidence is needed about how these enrollment approaches work in practice. In this study, we developed and evaluated a literacy-focused, web-based consent approach to support enrollment of diverse participants in an ongoing clinical genomic implementation study.
Methods
As part of the Cancer Health Assessments Reaching Many (CHARM) study, we developed a web-based consent approach that featured plain language, multimedia, and separate descriptions of clinical care and research activities. CHARM offered clinical exome sequencing to individuals at high risk of hereditary cancer. We interviewed CHARM participants about their reactions to the consent approach. We audio recorded, transcribed, and coded interviews using a deductively and inductively derived codebook. We reviewed coded excerpts as a team to identify overarching themes.
Results
We conducted 32 interviews, including 12 (38%) in Spanish. Most (69%) enrolled without assistance from study staff, usually on a mobile phone. Those who completed enrollment in one day spent an average of 12 minutes on the consent portion. Interviewees found the information simple to read but comprehensive, were neutral to positive about the multimedia support, and identified increased access to testing in the study as the key difference from clinical care.
Conclusions
This study showed that interviewees found our literacy-focused, web-based consent approach acceptable; did not distinguish the consent materials from other online study processes; and valued getting access to testing in the study. Overall, conducting empirical bioethics research in an ongoing clinical trial was useful to demonstrate the acceptability of our novel consent approach but posed practical challenges.
Research participant understanding and engagement in an institutional, self‐consent biobank model
Research participant understanding and engagement in an institutional, self‐consent biobank model
Original Article
Andrew Schmanski, Emily Roberts, Marilyn Coors, Stephen J. Wicks, Jaron Arbet, Rachel Weber, Kristy Crooks, Kathleen C. Barnes, Matthew R. G. Taylor
Journal of Genetic Counselling, 20 September 2020
Abstract
The number of institutional and governmental biobanks and the target enrollment sizes of modern biobanks are increasing, affording more opportunities for the public to participate in biobanking efforts. In parallel with these expansions are pressures to increase the efficiency of obtaining informed consent using shorter consent forms that cover a broader scope of research and increasingly include provisions for return of research or clinical genetic test results to participants. Given these changes, how well these participants understand genetics, their level of understanding of what they are consenting to, and their wishes to engage longitudinally and receive biobank results are not well understood. We surveyed participants in a large, medical system‐based biobank who had enrolled through a two‐page, self‐consent process about their baseline knowledge of genetics, understanding and recall of the consent process, wishes for future contact and engagement, and level of interest in receiving clinical genetic testing results. A total of 856 consented persons participated in the survey (67% women; 67% white). Participants’ general reported genetics knowledge was relatively high (mean 11.60 of 15 questions answered correctly) as was recall of key elements from the two‐page consent form. Overall participant enthusiasm for future contact by the biobank and for receiving clinical genetic testing results was high. The use of a two‐page, self‐consent process in a large, institutional biobank resulted in high levels of consent recall and enthusiasm for future ongoing engagement and receipt of genetic testing results by participants.
Informed Consent Smart Phone App Improved Level of Comfort and Knowledge Amongst Pediatric Residents
Informed Consent Smart Phone App Improved Level of Comfort and Knowledge Amongst Pediatric Residents
Cassandra Koid Jia Shin, Tania Lopez, Edwin Forman, Gwen Raphan
Academic Pediatrics, September–October 2020; 20(7) pp e12-e13
Abstract
Background
Obtaining informed consent is an integral part of medicine yet is a skill set that is not typically taught to residents formally. Lack of skill and confidence obtaining informed consent can have dire medical-legal consequences. Therefore, we created an informed consent smartphone app to give providers this information at their fingertips so they can successfully obtain informed consent on several common pediatric procedures in a more standardized fashion. Our objective was to assess if pediatric residents knowledge and comfort with obtaining informed consent would increase with an informed consent app.
Methods
A prototype smartphone app was designed on Adobe XD with a standardized approach to obtaining informed consent for pediatric procedures (RBC and platelet transfusions, LP, conscious sedation, central lines and vitamin K refusal). In 2020, an anonymous pre-intervention questionnaire was circulated amongst pediatric residents in Elmhurst Hospital Center. Participants were given an opportunity to navigate the informed consent app and given a post-intervention survey.
Results
Of the 25 residents who participated, all had previously obtained consent. Most learned how to obtain consent by observing another resident (72%) and surprisingly, 12% report that they obtained consent without any preparation at all. Self-reported level of comfort for procedures increased proportionally with every year of training. Residents’ comfort obtaining informed consent improved for every procedure after use of the informed consent app. 100% were comfortable obtaining informed consent with the app for all procedures with the exception of central lines which was not functioning on the app. 96% of residents agree that they would benefit from additional training in obtaining informed consent. 100% of residents agree that they would use the informed consent app.
Conclusions
With the informed consent app, residents’ level of comfort increased for all procedures. This quick intervention showed promise as an easy way for residency programs to standardize an approach to obtaining informed consent.
Effect of video-assisted education on informed consent and patient education for peripherally inserted central catheters: a randomized controlled trial
Effect of video-assisted education on informed consent and patient education for peripherally inserted central catheters: a randomized controlled trial
Perspective Clinical Research Report
Jia Li, Xue-fang Huang, Jie-lin Luo, Jiang-yun Zhang, Xiao-lin Liang, Chun-li Huang, Hui-ying Qin
Journal of International Medical Research, 10 September 2020; 48(9)
Open Access
Abstract
Objective
To evaluate the effects of a video-assisted education intervention on informed consent and patient education for peripherally inserted central catheters (PICCs).
Methods
We conducted a randomized controlled trial comparing the effects on informed consent of video-assisted patient education and traditional face-to-face discussion in a catheter outpatient ward of a cancer centre in Guangzhou, China, in 2018. Participants were 140 patients randomly allocated (1:1 ratio) to two groups: video-assisted or traditional intervention. General information, patient retention of PICC-related information, working time spent by nurses on the procedure, and patient and nurse satisfaction with the procedure were assessed.
Results
The time used for informed consent was significantly shorter in the experimental group (1.02 ± 0.24 minutes) than in the control group (6.87 ± 1.10 minutes). The time used for PICC-related education was significantly shorter in the experimental group (1.03 ± 0.28 minutes) than in the control group (5.11 ± 0.57 minutes). Nurses’ degree of satisfaction with the procedure was significantly higher in the experimental group (4.10 ± 0.57) than in the control group (2.60 ± 0.70).
Conclusion
The use of video-assisted informed consent and patient education in this cancer centre decreased nurses’ working time and improved nurses’ satisfaction.
Pictorial Consent in Cardiac Surgery: A far better option rather than Standard Informed Written Consent
Pictorial Consent in Cardiac Surgery: A far better option rather than Standard Informed Written Consent
Debmalya Saha, Pawan Singh, Soumyaranjan Das, Ravi Kumar Gupta, Satyajit Samal, Muhammad Abid Geelani
International Journal of Scientific and Research Publications, September 2020; 10(9)
Open Access
Abstract
Because of the complexity of the procedures, high level of clarification for the patients as well as their attendants while taking consent is a must as cardiac surgery is associated with significant morbidity and mortality. Pictorial consent with preoperative education is a far better option in this regard. We randomly took a total of 150 patients within the age group of 18 to 70 years, and they were explained with standard consent followed by pictorial consent and vice versa by the same informant. And they were given a preset questionnaire format after both consents. Later, based on their answers, comparison in relation to the level of clarity was done. Questionnaire was formatted after rigorous modification from the reviews of literature.
How do dementia researchers view support tools for informed consent procedures of persons with dementia?
How do dementia researchers view support tools for informed consent procedures of persons with dementia?
Original Contributions
Theresa S. Wied, Aoife Poth, Johannes Pantel, Frank Oswald, Julia Haberstroh
Zeitschrift für Gerontologie und Geriatrie, 19 September 2020
Open Access
Abstract
The study aimed to assess how dementia researchers view eight support tools that have been defined to enhance informed consent (IC) procedures for people with dementia (PwD). In an online survey, 19 dementia researchers from Germany and Portugal evaluated the tools in terms of 4 implementation criteria. Overall, they all had a very positive attitude towards the support tools, whereby the tools person-centered attitude of the researcher and elaborated plain language were the most highly rated of the eight tools. Our findings also indicated that familiar support tools were assessed more favorably than those that were previously unknown. Overall, the results of this study showed that the participating dementia researchers were open to the use of decision support measures in PwD and were willing to apply the support tools in practice.
Awareness and Understanding of Decision-Making Capacity and Its Relationship to Legally Valid Consent for Older Patients in Dentistry
Awareness and Understanding of Decision-Making Capacity and Its Relationship to Legally Valid Consent for Older Patients in Dentistry
Research Article
Amardeep Singh Dhadwal, Lwazi Sibanda, Igor R. Blum
Primary Dental Journal, 17 September 2020
Abstract
With a growing ageing population and increased life expectancy in the UK, oral healthcare professionals will be exposed to a greater number of patients with health conditions which may affect cognitive function, communication and capacity to consent to treatment. This often gives rise to a conundrum which clinicians may face when considering capacity, consent and the legal implications and frameworks surrounding this. Assessing patient capacity is encountered routinely in dental practice and so oral healthcare professionals should be well informed of their responsibilities in this context. This article summarises and introduces readers to key concepts regarding consent and capacity with reference to relevant cross-jurisdictional legislation.
Constructing authentic decisions: proxy decision-making for research involving adults who lack capacity to consent
Constructing authentic decisions: proxy decision-making for research involving adults who lack capacity to consent
Victoria Shepherd, Mark Sheehan, Kerenza Hood, Richard Griffith, Fiona Wood
BMJ Medical Ethics, 2 September 2020
Open Access
Abstract
Research involving adults who lack capacity to consent relies on proxy (or surrogate) decision-making. Proxy decisions about participation are ethically complex, with a disparity between normative accounts and empirical evidence. Concerns about the accuracy of proxies’ decisions arise, in part, from the lack of an ethical framework which takes account of the complex and morally pluralistic world in which proxy decisions are situated. This qualitative study explored the experiences of family members who have acted as a research proxy in order to develop an understanding of the ethical concepts involved, and the interactions between those concepts. Proxies described a complex process of respecting the wishes and preferences of the person they represented, whist integrating preferences with what they viewed as being in the interests of the person. They aimed to make a decision that was ‘best’ for the person and protected them from harm; they also aimed to make the ‘right’ decision, viewed as being authentic to the person’s values and life. Decisions were underpinned by the relationship between the person and their proxy, in which both trust and trustworthiness were key. Proxies’ decisions, based both on respect for the person and the need to protect their interests, arose out of their dual role as both proxy and carer. The findings raise questions about accounts which rely on existing normative assumptions with a focus on accuracy and discrepancy, and which fail to take account of the requirement for proxies to make authentic decisions that arise out of their caring obligations.
Center for Informed Consent Integrity 