Should informed consent and information related to patient recruitment in clinical trials be available to the reader of scientific articles? A case study in dentistry
Research Article
Clovis Mariano Faggion Jr
Accountability in Research, 16 May 2022
Abstract
Ethical aspects in research should be transparently reported. This study aimed to investigate whether informed consent and information related to patient recruitment in clinical studies are well-reported in the scientific literature. Randomized clinical trials (RCTs) on root coverage procedures published between November 2016 to November 2021 were selected from the PubMed database. Items/questions were used to guide the extraction of data related to patient recruitment, with a focus on the detailed report of informed consent used to clarify the research to the patient. Data were extracted from the published article and the respective research protocol published in a public registry. Information related to potential selective outcome reporting (SOR) was also extracted. 187 documents were initially screened and 74 reports of RCTs were included. No informed consent was published in the article. Only one research protocol provided a link to the informed consent. Deviations from reporting in the research protocol and published article were found, suggesting SOR. Informed consent and information related to patient recruitment in RCTs on root covering procedures are severely underreported. The present findings may stimulate further discussion and debate on the need for making this information publicly available.
Patient and Proxy Recall After Providing Written or Oral Informed Consent to Participate in an Interventional Trial
Patient and Proxy Recall After Providing Written or Oral Informed Consent to Participate in an Interventional Trial
Research Letter Ethics
Angela Huttner, Elodie von Dach, Virginie Prendki, Stephan Harbarth, Laurent Kaiser
JAMA Network Open, 13 May 2022; 5(5)
Abstract
Introduction
Patients’ understanding and recall after granting written consent for trial participation are known to be suboptimal.1 A 2006 study among 44 hospitalized patients providing written consent to an interventional trial found that only 68% remembered the purpose of the trial 10 days later; one-fifth had no recollection of having consented to any study.2 Recall by patients granting oral consent, and by the healthy proxies granting written consent for patients without capacity, is underreported. We compared recall rates after 30 days for participation in a randomized clinical trial (RCT) among patients with capacity who had given written or oral consent and for proxies of patients without capacity who had given written consent.
Methods
The RCT and this nested cohort study were approved by the Geneva Cantonal Ethics Commission. All participants or their proxies provided informed consent. This study is reported following the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) reporting guideline. This nested prospective cohort study included all patients with capacity and all proxies of patients without capacity participating at a single site (Geneva University Hospital, Switzerland) of a multicenter RCT by von Dach et al3 comparing antibiotic durations for gram-negative bacteremia in adults hospitalized between 2017 and 2019. In line with Swiss law, consent could be granted in writing by the patient, orally with a witness’s signature (for patients who were illiterate or physically unable to sign), or in writing by the proxy of a patient without capacity. Our primary outcome was the 30-day recall rate for RCT participation among patients providing written or oral consent and proxies providing written consent. On day 30, patients and proxies were contacted for the RCT’s first clinical follow-up. They were asked whether they remembered (1) that they were (or their dependent was) participating in the RCT, (2) that they had granted consent, (3) the RCT’s purpose, and (4) potential risks. Data were analyzed in Stata statistical software version 16.0 (StataCorp). Comparisons were performed with Fisher exact test; associations were 2-sided with P = .05 considered significant. Univariate logistic regression was used to assess factors potentially associated with recall. Data were analyzed from November 1 to 30, 2021.
Results
The Geneva site enrolled 240 patients in the RCT. Consent was granted in writing by 167 patients (69%), orally by 16 patients (7%), and in writing by the proxies of 57 patients (24%) without capacity. At 30 days, data were available for 231 patients (96%): 4 patients (2%) had died, 3 patients (1%) had been otherwise lost to follow-up, and 2 patients (1%) were not asked the nested study’s questions. Median (IQR) patient age was 83 (74-89) years; 157 patients (65%) were women (Table 1). All proxies were next of kin. The time spent presenting the study and whether participants and proxies asked questions are detailed in Table 1. A total of 111 of 161 patients providing written consent (69%), 9 of 14 patients providing oral consent (64%), and 36 of 56 proxies (64%) remembered that they or their loved ones were participating in a trial. Furthermore, 60 patients providing written consent (37%), 5 patients providing oral consent (36%), and 21 proxies (37%) recalled granting consent; 40 patients providing written consent (25%), 5 patients providing oral consent (36%), and 20 proxies (36%) remembered the purpose of the trial. Few remembered the trial’s potential risks (Table 1). In linear and univariate regression models, neither the time spent with patients or proxies, whether they had questions, nor consent modality was associated with improved recall (Table 2).
Discussion
This cohort study among hospitalized patients, most of whom were elderly and all of whom had been acutely ill and hospitalized in the days prior, found that most patients had poor recall of their written consent to participate in an interventional trial (63%), a finding consistent with earlier studies.1,2 Yet recall after oral consent was no worse (64%), suggesting that the act of signing a document was not associated with improved retention or understanding. Perhaps most strikingly, recall by proxies, presumably healthy, providing written consent for their loved ones was as poor as that of patients who were seriously ill (63%). This study is limited by the impossibility of randomizing candidates or proxies to oral or written consent and by the small number of patients granting oral consent. The ability of patients—deemed competent by their physicians—to grant truly informed consent has long been in question.4,5 The ability of their proxies, physically healthy but emotionally stressed, to do the same requires further exploration. While these results require confirmation in larger studies, the act of signing consent, as opposed to granting it orally, was not associated with later recall or understanding.
Emergency department patients’ attitudes towards the use of data in their clinical record for research without their consent
Emergency department patients’ attitudes towards the use of data in their clinical record for research without their consent
Brief Report
Chase Schultz-Swarthfigure, Anne-Maree Kelly, Deborah Zion
Journal of Medical Ethics, 18 May 2022
Abstract
Background
Health research often uses health information, a subcategory of personal information, collected during clinical encounters. Conditions under which such health information can be used for the secondary purpose of research are set out in state, national and international law. In Australia, consent is required or the relevant conditions for a waiver of consent must be met and approved by a human research ethics committee (HREC). Consent for use of health information for research is rarely sought at an emergency department (ED) presentation. Research often occurs after the index visit and gaining consent can be difficult. Waiver of consent provisions are frequently used, but acceptability of this approach to patients is unclear.
Objective
To identify ED patients’ knowledge and attitudes towards the use of health information for research, consent preferences and acceptability of waiver of consent.
Methods
An online, anonymous survey of adult patients attending two large EDs in Melbourne, Australia.
Results
103 patients completed the survey. We found that 52% were unaware that health information might be used for research. A majority (77%) felt that HREC approval for use of health information without consent was acceptable. However, 36% would prefer to be contacted regarding consent.
Conclusion
These findings suggest a lack of awareness that health information can be used for research and that waiver of consent is acceptable, but not necessarily preferred, in most of the ED patient population. Efforts to increase awareness and provide opportunities to express preferences about health information use for research are needed.
Patient-centered cross-enterprise document sharing and dynamic consent framework using consortium blockchain and ciphertext-policy attribute-based encryption
Patient-centered cross-enterprise document sharing and dynamic consent framework using consortium blockchain and ciphertext-policy attribute-based encryption
Research Article
Liang Zhang, Haibin Kan, Honglan Huang
Proceedings of the 19th ACM International Conference on Computing Frontiers, 17 May 2022; pp 58–66
Abstract
Patient-centered healthcare data sharing and data usage consent are gaining popularity. Cross-enterprise document sharing (XDS) is the crucial system of sharing personalized healthcare data. Furthermore, dynamic consent is vital to the XDS system, because it respects people’s autonomy and achieves recognition of data sovereignty. Because of its transparency, blockchain is a powerful system for managing storage and computing without a trusted third party. Besides, ciphertext-policy attribute-based encryption (CP-ABE) extends public-key encryption by implying access control policies in ciphertexts, making it suitable for protecting the privacy of individual healthcare data in versatile cases. Particularly, we use hospital name, “date” and “department” as attribute strings in the access control policies. Consequently, based on consortium blockchain and CP-ABE, we propose a patient-centered XDS and a dynamic consent framework. Compared with previous related literature, we make the proposed framework consistent with current practices and achieve favorable criteria, such as data confidentiality, data recoverability and time-aware ciphertext. Further, we conduct comprehensive experiments to show the feasibility and practicality.
A Consent Tool for Secondary Use of Biomedical Data
A Consent Tool for Secondary Use of Biomedical Data
Simon Adams, Gausegan Uthayathas, Murat Sariyar
Studies in Health Technology and Informatics, 16 May 2022; 292 pp 107-110
Abstract
To pursue scientific goals with patient data usually requires informed consent from the data subjects. Such a consent constitutes a contract between the research institute and the patient. Several issues must be included in the consent to be valid, for example, how the data is processed and stored as well as specifics of the research questions for which the data is going to be used. Here, we describe the development and the implementation of a user-friendly IT solution that supports the process-oriented obtainment of consents. Current solutions often focus only on the benefits for the researcher. Our solution intends to add value to all participants and to reduce paperwork to a minimum. The consent Tool was evaluated by a usability test using the UEQ Method (User Experience Questionnaire) and received positive feedback – both efficiency and originality were rated above the average UEQ-Benchmark. Nevertheless, the lack of compatibility with the technical infrastructure of the hospital was a significant shortcoming. Hence, although there is a general interest in digitized solutions in the healthcare sector, there are still many hurdles to implement them and roll them out.
Health-related confidentiality and consent among minors: Data on adult perspectives from Belgium and The Netherlands
Health-related confidentiality and consent among minors: Data on adult perspectives from Belgium and The Netherlands
David De Coninck, Koen Matthijs. Peter de Winter, Jaan Toelen
Data in Brief, June 2022; 42
Open access
Abstract
The data presented in this article provide one of the first large-scale insights on adult preferences for confidentiality and consent with regards to medical decision-making for minors. We collected data on these preferences through 12 hypothetical scenario’s that were presented, for which each participant had to indicate if they would (not) follow the minor’s preferences. Data regarding family communication, relationship quality, and sociodemographic characteristics were also collected. The data were collected through an online survey in September and October 2020, which yielded responses from 1000 Belgian and 1000 Dutch participants between 35 and 55 years of age. We selected this age range because it increased the chances that they had a child near the age of the fictional minor in the hypothetical cases. These data can be of interest for family researchers and/or health workers who want to explore adults’ perceptions regarding confidentiality and consent among minors.
Getting parental consent when treating children
Getting parental consent when treating children
Feature
Rupert Hoppenbrouwers
BDJ Team, 20 May 2022; 9 pp 20–21
Excerpt
When treating young children, it may be necessary to get the authority of someone with parental responsibility. With complex family relationships however, it might not be clear to dental professionals who has parental responsibility, and this can create a dilemma. Here we explain the principles and procedures around parental responsibility when treating younger children…
Editor’s note: BDJ Team is a product of the British Dental Association.
Implementation of Surgical Education Video to Burn Patients Before the Informed Consent Process
Implementation of Surgical Education Video to Burn Patients Before the Informed Consent Process
Theses and Dissertations
Brian Piatkowski
Doctor of Nursing Practice, 28 May 2022
Open Access
Abstract
Purpose
Before the initiation of this evidence-based Doctor of Nursing Practice (DNP) project, a systematic review of literature set forth by other researchers regarding the informed consent process was done. The literature showed patient satisfaction scores increased, while anxiety decreased regarding surgical procedures after using a multimedia educational tool. The first goal of the project was to determine any gaps in knowledge of the burn surgical patient population. The second goal of the project was to determine gaps in knowledge and comfort levels with providers obtaining informed consent. The third goal was to determine the efficacy of implementing a surgical education video for patients and providers.
Background
The informed consent process is a daily task for providers with a surgical patient population. In the burn population, informed consent is often presented by an intern or resident physician. Consent is comprised of surgical debridement with a multitude of options for coverage of their wounds. The current state of practice is a verbal overview of all the possible procedures that may be done to the patient’s wound(s). Patients often verbalize feeling overwhelmed with the amount of information on the consent and often have questions related to their procedure just before the brief of the operative case.
Methods
An educational video was developed that detailed the surgical procedure and the potential burn wound coverings. A 3-question survey was given to patients who have already been through the informed consent process. Survey metrics examined knowledge of consent when signed, the satisfaction of verbal explanation, and if a video would increase understanding. The video was given to the same patients to watch. After the video was viewed, those patients were then again surveyed. Providers were also given a 3-question survey before viewing the video. Survey metrics examined comfort of consent, knowledge of procedures, and if the video would increase patient understanding of consent topics. The providers were then surveyed after watching the video.
Results
Initial post-implementation data shows that patients and providers have increased comfort and knowledge in the informed consent process. Patients show an 80% increase in understanding of consent, a 72% increase in satisfaction with video vs verbal overview, and a 97% increase in satisfaction with material viewed. Provider data shows a 65% increase in the comfort of consent, a 64% increase in knowledge of procedures, and a 97% increase that the video will help patients understand their consent. This shows that this evidence-based project is an improvement from the current standard of practice.
Evaluation
Implementation of a standardized audio/video teaching method for burn surgical patients is an effective way to increase patient and provider satisfaction regarding the informed consent process. This tool can easily be modified with practice changes for sustainability. Implementing this educational tool is a cost-effective and simple way to educate burn patients before their surgical procedures. There is an overall improvement in patient satisfaction and increased satisfaction in the providers who obtain the consent.
Participant comprehension and perspectives regarding the convenience, security, and satisfaction with teleconsent compared to in-person consent: A parallel-group pilot study among Danish citizens
Participant comprehension and perspectives regarding the convenience, security, and satisfaction with teleconsent compared to in-person consent: A parallel-group pilot study among Danish citizens
Anne Nyholm Gaarskjær, Meg Duroux, Rasmus Hogreffe
Contemporary Clinical Trials Communications, 27 May 2022
Abstract
Background
Teleconsent via video conferencing enables decentralized trials with remote consent and has the additional benefit of allowing a real-time reaction to potential misunderstandings. However, participant acceptance of and satisfaction with teleconsent versus in-person consent processes are unknown.
Methods
We conducted a parallel-group pilot study to evaluate participant comprehension and perspectives regarding the convenience, security, and satisfaction with teleconsent compared to in-person consent among Danish citizens for a hypothetical research study.
Results
There were no statistically significant differences in perceptions of security or satisfaction between teleconsent and in-person consent arms. However, participants viewed teleconsent as more convenient than in-person consent, as no transportation was needed and the process was less time-consuming. Recruitment was also faster in the teleconsent arm, and more people dropped out of the in-person arm, citing difficulties with transportation and time.
Conclusion
Decentralized clinical trials have been demonstrated to increase recruitment and enrollment rates, improve trial efficiency, and decrease dropout rates and trial delays. We add to this literature by suggesting that patients perceive teleconsent as similar to in-person consent, suggesting this is a feasible and acceptable substitution for in-person consent in multisite, decentralized trials. Future work should include patient perspectives from a larger, more diverse group of participants.
Video-assisted informed consent in a clinical trial of resuscitation of extremely preterm infants: Lessons learned
Video-assisted informed consent in a clinical trial of resuscitation of extremely preterm infants: Lessons learned
Namrita Jain Odackal, Catherine Grace Caruso, Melissa Klitzman, Mónica Rincón, Bobbi Byrne, Jameel Justin Winter, Gina Petroni, Karen D Fairchild, Jamie B Warren
American Journal of Perinatology, 26 May 2022
Abstract
Objective
Obtaining informed consent for clinical trials is challenging in acute clinical settings. For the VentFirst randomized clinical trial (assisting ventilation during delayed cord clamping for infants <29 weeks’ gestation), we created an informational video that sites could choose to use to supplement the standard in-person verbal and written consent. Using a post-consent survey, we sought to describe the impact of the video on subject recruitment, satisfaction with the consent process, and knowledge about the study.
Study design
Descriptive survey-based sub-study.
Results
Of the sites participating in the VentFirst trial that obtained IRB approval to allow use of the video to supplement the standard informed consent process, three elected to participate in the survey substudy. From February 2018 to January 2021, 82 women at these three sites were offered the video and completed the post-consent survey. Overall, 73 of these 82 women (89%) consented to participate in the primary study, 78 (95%) indicated the study was explained to them very well or extremely well, and the range of correct answers on 5 knowledge questions about the study was 63%-98%. Forty-six (56%) of the 82 women offered the video chose to watch it. There were no major differences in study participation, satisfaction with the consent process, or knowledge about the study between the women who chose to watch or not watch the video.
Conclusion
Watching an optional video to supplement the standard informed consent process did not have a major impact on outcomes in this small sub-study. The ways in which audiovisual tools might modify the traditional informed consent process deserve further study.
Center for Informed Consent Integrity 