Digitalizing the Clinical Research Informed Consent Process: Assessing the Participant Experience in Comparison With Traditional Paper-Based Methods
Michael T. Buckley, Molly R. O’Shea, Sangeeta Kundu, Allison Lipitz-Snyderman, Gilad Kuperman, Suken Shah, Alexia Iasonos, Collette Houston, Stephanie L. Terzulli, Joseph M. Lengfellner, Paul Sabbatini
JCO Oncology Practice, 19 December 2022
Abstract
Purpose
Consent processes are critical for clinical care and research and may benefit from incorporating digital strategies. We compared an electronic informed consent (eIC) option to paper consent across four outcomes: (1) technology burden, (2) protocol comprehension, (3) participant agency (ability to self-advocate), and (4) completion of required document fields.
Methods
We assessed participant experience with eIC processes compared with traditional paper-based consenting using surveys and compared completeness of required fields, over 3 years (2019-2021). Participants who consented to a clinical trial at a large academic cancer center via paper or eIC were invited to either pre-COVID-19 pandemic survey 1 (technology burden) or intrapandemic survey 2 (comprehension and agency). Consent document completeness was assessed via electronic health records.
Results
On survey 1, 83% of participants (n = 777) indicated eIC was easy or very easy to use; discomfort with technology overall was not correlated with discomfort using eIC. For survey 2, eIC (n = 262) and paper consenters (n = 193) had similar comprehension scores. All participants responded favorably to at least five of six agency statements; however, eIC generated a higher proportion of positive free-text comments (P < .05), with themes such as thoroughness of the discussion and consenter professionalism. eIC use yielded no completeness errors across 235 consents versus 6.4% for paper (P < .001).
Conclusion
Our findings suggest that eIC when compared with paper (1) did not increase technology burden, (2) supported comparable comprehension, (3) upheld key elements of participant agency, and (4) increased completion of mandatory consent fields. The results support a broader call for organizations to offer eIC for clinical research discussions to enhance the overall participant experience and increase the completeness of the consent process.
Animation supported consent before elective laparoscopic cholecystectomy
Animation supported consent before elective laparoscopic cholecystectomy
Emre Doganay, David Wald, Sam Parker, Frances Hughes
British Journal of Surgery, 7 December 2022
Abstract
Background
Patient understanding of surgical procedures is often incomplete at the time they are performed, invalidating consent, and exposing healthcare providers to complaints and claims of failure to inform. Remote consultations, language barriers and patient factors can hinder an effective consent pathway. New approaches are needed to support communication and shared decision-making.
Methods
Multi-language digital animations explaining laparoscopic cholecystectomy were introduced at The Royal London Hospital for patients who attended for elective surgery (www.explainmyprocedure.com). Patients completed questionnaires on the day of their procedure both before and after introduction of the animations. We assessed patient-reported understanding of the procedure, its intended benefits, the possible risks, and alternatives to treatment in 72 consecutive patients, 37 before (no animation group) and after 35 after introducing the animations into the consent pathway (animation group). Patient understanding in the two groups was compared.
Results
The two groups were well matched in respect of age, sex and whether English was their first spoken language. The proportions of patients who reported they completely understood the procedure, its benefits, risks, and alternatives in the no animation group were 54%, 57%, 38% and 24% and in the animation group, 91%, 91%, 74% and 77% respectively; p<0.01 for each comparison.
Conclusions
The integration of multi-language laparoscopic cholecystectomy video animations into the patient consent pathway was associated with substantial improvement in reported understanding of the procedure, benefits, risks, and alternatives to treatment. This approach can be applied across all surgical disciplines in a standardised manner in an era of accelerated elective work and remote consultations.
Digital Informed Consent: Modernising Information Sharing in Surgery to Empower Patients
Digital Informed Consent: Modernising Information Sharing in Surgery to Empower Patients
Original Scientific Report
Simon L. Parsons, Prita Daliya, Phil Evans, Dileep N. Lobo
World Journal of Surgery, 3 December 2022
Open Access
Abstract
Background
Despite the 2015 Montgomery Ruling highlighting key requisites for informed consent, little has changed to modernise data-sharing and documentation of the consent process. It can be difficult to gauge patient understanding and address all patient concerns in time-limited appointments. We aimed to assess the feasibility of a digital information-sharing platform to support a move towards a digital informed consent process.
Methods
All adult patients referred to a single centre with symptomatic gallstones were invited to use a digital information-sharing platform to support the informed consent process prior to their first surgical clinic appointment. The platform provided patients with multimedia information on gallstones and available treatment options. It recorded the time spent accessing information, asked patients multiple choice questions (MCQs) to allow a self-test of understanding, documented a summary medical history, and allowed free text for patient questions. This information was summarised into a clinical report to support outpatient clinic consultations.
Results
Of the 349 patients registered to use the digital platform, 203 (58.2%) [165 (81.3%) female, mean age 47.6 years (range 19–84 years)] completed all modules necessary to generate a clinical report. Some 130 patients (64.0%) answered all 10 MCQs correctly and spent a mean of 18.7 min (range 3–88 min) reading the consent information. Most patient-reported medical histories were deemed to be accurate.
Conclusion
Despite difficulties with access, resulting in drop-outs, patients welcomed the opportunity to receive information digitally, prior to their consultation. Patients described feeling empowered and better informed to be involved in decision-making.
Ethics of the fiduciary relationship between patient and physician: the case of informed consent
Ethics of the fiduciary relationship between patient and physician: the case of informed consent
Sophie Ludewigs, Jonas Narchi, Lukas Kiefer, Eva C Winkler
JME, 8 December 2022
Open Access
Abstract
This paper serves two purposes: first, the proposition of an ethical fiduciary theory that substantiates the often cited assertion that the patient–physician relationship is fiduciary in nature; and second, the application of this theory to the case of informed consent. Patients’ decision-making preferences vary significantly. While some seek fully autonomous decision-making, others prefer to delegate parts of their decision. Therefore, we propose an ethical fiduciary theory that allows physician and patient to jointly determine the physician’s role on a spectrum from fiduciary as advisor to fiduciary as agent. Drawing on legal concepts of the fiduciary relationship and on phenomenological accounts of obligation by Lévinas and Løgstrup, our theory relies on the key attributes of trust, vulnerability and otherness. Finally, practical implications of this theory for the informed consent process are developed: we propose a preassessment of patients’ risk and value profiles as well as a restructuring of the oral consent interview and the written consent materials.
A Comparative Analysis of Informed Consent Legistlation in Ukrainian and Latvia Legislation and Case Law
A Comparative Analysis of Informed Consent Legistlation in Ukrainian and Latvia Legislation and Case Law
Anatoliy A. Lytvynenko, Iryna Ya. Senyuta, Tatjana I. Jurkeviča, Volodymyr S. Makarchuk
International Comparative Jurisprudence, 18 October 2022; 8(2)
Open Access
Abstract
Informed consent is one of the key principles in safeguarding human rights in the sphere of healthcare. It presupposes the expression of the patient’s free will relating to his medical examinations, treatment and diagnostic procedures, as well as the physician’s duty to inform the patient on the forthcoming medical interventions, including the facts regarding the potential risks of these medical interventions. This principle is one of the elements of contemporary medical law, which has marked the transfer from paternalistic medicine to a modern model of medicine, where the patient is an active participant in the process of medical treatment. In this paper, the authors illustrate the legal aspects of safeguarding the patient’s right to informed consent in the legislation and legal practices of Ukraine and the Republic of Latvia. The institute of informed consent, which needs to be safeguarded, as a key element of the legitimacy of a medical intervention (such as surgery, or vaccination), requires a specific form of fulfillment, which is conducted in writing. A medical intervention, excluding cases of emergency, is legitimate only when the consent of the patient is provided; unconsented medical interventions frequently cause lawsuits, where plaintiffs seek to recover damages for performance of a medical intervention without their informed consent. The authors have highlighted these issues while commenting on the recent case law of the Supreme Court of Ukraine and the Supreme Court of the Republic of Latvia.
Age-of-consent requirements and adolescent HIV testing in low-and middle-income countries: multinational insights from 51 population-based surveys
Age-of-consent requirements and adolescent HIV testing in low-and middle-income countries: multinational insights from 51 population-based surveys
Joseph G Rosen, Elizabeth M Stone, Michael T Mbizvo
International Journal of STD & AIDS, 16 December 2022
Abstract
Background
Pervasive social and structural barriers—including national policies—inhibit HIV testing uptake among priority populations, including adolescents. We assessed the relationship between age-of-consent policies for HIV testing and adolescent HIV testing coverage in 51 low- and middle-income countries.
Methods
We pooled data from household surveys (2010–2020) and calculated the weighted country-level prevalence of lifetime HIV testing separately for adolescent girls and boys (ages 15–19). We then abstracted age-of-consent requirements for HIV testing across countries. Using multivariable linear regression, we estimated the average difference in national HIV testing coverage estimates for adolescent girls and boys by age-of-consent restrictions for HIV testing.
Results
National HIV testing coverage estimates ranged from 0.7% to 72.5% among girls (median: 18.0%) and 0% to 73.2% among boys (median: 7.5%) in Pakistan and Lesotho, respectively. In adjusted models, HIV testing coverage in countries requiring parental consent for individuals <18 years was, on average, 9.4 percentage-points (pp) lower (95% confidence interval [95%CI] −17.9pp to −0.9pp) among girls and 9.3pp lower (95%CI: −17.3pp to −1.2pp) among boys, relative to countries with less restrictive policies (age-of-consent: ≤16 years). Compared to countries with less restrictive (age-of-consent: ≤14 years) policies, HIV testing prevalence was significantly lower among girls (β −10.5pp, 95%CI: −19.7pp to −1.3pp) and boys (β −10.5pp, 95%CI –19.2pp to −1.8pp) in countries with more restrictive (age-of-consent: 18 years) parental consent requirements.
Conclusions
Age-of-consent policies are persistent obstacles to adolescent HIV testing. Repealing parental consent requirements for HIV testing is needed to expand coverage and accelerate progress towards global HIV treatment and prevention targets.
Remote consent approaches for mobile phone surveys of non-communicable disease risk factors in Colombia and Uganda: A randomized study
Remote consent approaches for mobile phone surveys of non-communicable disease risk factors in Colombia and Uganda: A randomized study
Research Article
Joseph Ali, Madhuram Nagarajan, Erisa S. Mwaka, Elizeus Rutebemberwa, Andres I. Vecino-Ortiz, Angelica Tórres Quintero, Mariana Rodriguez-Patarroyo, Vidhi Maniar, Gulam Muhammed Al Kibria, Alain B. Labrique, George W. Pariyo, Dustin G. Gibson
PLOS ONE, 21 December 2022
Open Access
Abstract
Introduction
Automated mobile phone surveys (MPS) can be used to collect public health data of various types to inform health policy and programs globally. One challenge in administering MPS is identification of an appropriate and effective participant consent process. This study investigated the impact of different survey consent approaches on participant disposition (response characteristics and understanding of the purpose of the survey) within the context of an MPS that measured noncommunicable disease (NCD) risk factors across Colombia and Uganda.
Methods
Participants were randomized to one of five consent approaches, with consent modules varying by the consent disclosure and mode of authorization. The control arm consisted of a standard consent disclosure and a combined opt-in/opt-out mode of authorization. The other four arms consist of a modified consent disclosure and one of four different forms of authorization (i.e., opt-in, opt-out, combined opt-in/opt-out, or implied). Data related to respondent disposition and respondent understanding of the survey purpose were analyzed.
Results
Among 1889 completed surveys in Colombia, differences in contact, response, refusal, and cooperation rates by study arms were found. About 68% of respondents correctly identified the survey purpose, with no significant difference by study arm. Participants reporting higher levels of education and urban residency were more likely to identify the purpose correctly. Participants were also more likely to accurately identify the survey purpose after completing several survey modules, compared to immediately following the consent disclosure (78.8% vs 54.2% correct, p<0.001). In Uganda, 1890 completed surveys were collected. Though there were differences in contact, refusal, and cooperation rates by study arm, response rates were similar across arms. About 37% of respondents identified the survey purpose correctly, with no difference by arm. Those with higher levels of education and who completed the survey in English were able to more accurately identify the survey purpose. Again, participants were more likely to accurately identify the purpose of the survey after completing several NCD modules, compared to immediately following the consent module (42.0% vs 32.2% correct, p = 0.013).
Conclusion
This study contributes to the limited available evidence regarding consent procedures for automated MPS. Future studies should develop and trial additional interventions to enhance consent for automated public health surveys, and measure other dimensions of participant engagement and understanding.
Knowledge about and attitudes toward medical informed consent: a Lebanese population survey
Knowledge about and attitudes toward medical informed consent: a Lebanese population survey
Research Article
Mary Deeb, Dana Alameddine, Rasha Abi Radi Abou Jaoudeh, Widian Laoun, Julian Maamari, Rawan Honeini, Alain Khouri,F adi Abou-Mrad, Nassib Elia, Aniella Abi-Gerges
Ethics & Behaviour, 19 December 2022
Abstract
As Medicine shifts from a paternalistic practice to a patient-centered approach, the concept of medical informed consent (IC) has evolved to safeguard patient autonomy. However, its current implementation still presents many challenges in clinical practice. We assessed the knowledge and attitudes of the general Lebanese population regarding the IC process as well as their sociodemographic and medical correlates. An anonymous online survey was distributed to the Lebanese population using social media channels. A sample of 500 adults with an average age of 36.2 ± 13.5 years, including 319 females and 181 males, was recruited. Most of the respondents had a university degree (85.8%), reported previous hospital admissions (75.9%) and had signed an IC for surgical procedures (40.7%). Few participants were knowledgeable about IC Lebanese law. Variability in knowledge level was significantly related to gender and a previous hospitalization history. Positive attitudes toward patient autonomy (53.1%) and shared decision-making (57.5%) correlated with older age, female gender, graduate education, and a previous history of signing an IC document. Males were more likely to believe that IC has positive effects on health than females. This is the first study that provides novel findings regarding Lebanese peoples’ awareness of the ethico-legal components of medical IC.
Analyzing online public commentary responding to the announcement of deemed consent organ donation legislation in the Canadian province of Nova Scotia
Analyzing online public commentary responding to the announcement of deemed consent organ donation legislation in the Canadian province of Nova Scotia
Alessandro R. Marcon, Darren N. Wagner, Christen Rachul, Matthew J. Weiss
Plos One, 15 December 2022
Open Access
Abstract
Background
The Canadian province of Nova Scotia recently became the first jurisdiction in North America to pass deemed consent organ donation legislation. The announcement of this legislation generated substantial online discussion, which we analyzed to provide insights on public perception.
Methods
We performed directed content analysis on 2663 user-generated comments appearing on two widely-shared Canadian Broadcasting Company (CBC) articles published online in April 2019. We determined levels of support and opposition in comments and described the specific rhetoric used for doing so. We also performed one-way ANOVA and Pearson chi-square tests to determine how the comments were being received and engaged by other users.
Results
A range of commentary was present in both support and opposition to the changes in legislation. There were more negative than positive comments, and negative commentary generated more replies. Positive comments were received more positively by other users while negative comments were received more negatively. The total sum of negative comments was greatly influenced by a small number of very active participants. Negative commentary focused more on broad concepts and principles related to government, power, and individual rights rather than specific issues in the Nova Scotian context. Substantial issues of trust in the government and healthcare system were evident.
Conclusions
There were strong positive and negative sentiments expressed in the comments, but the total sum of negativity in the comments was significantly influenced by a small number of commentators. Analysis on the presumed consent concerns can be helpful to inform public outreach efforts.
Nurse knowledge and attitudes towards organ donation and deemed consent: the Human Organ and Tissue Donation Act in Nova Scotia
Nurse knowledge and attitudes towards organ donation and deemed consent: the Human Organ and Tissue Donation Act in Nova Scotia
Reports of Original Investigations
Robin Urquhart, Nelofar Kureshi, Jade Dirk, Matthew Weiss, Stephen Beed
Canadian Journal of Anesthesia, 1 December 2022
Abstract
Purpose
In April 2019, the Human Organ and Tissue Donation Act (HOTDA) in Nova Scotia was modified to incorporate a deemed consent model. In this study, we sought to understand intensive care unit (ICU) and emergency department (ED) nurses’ knowledge of and confidence around organ donation and transplantation, experiences with organ donors and recipients, attitudes toward organ donation and deemed consent, and perceived opportunities and barriers to a deemed consent approach in view of the legislative change.
Methods
We sent an electronic, self-administered survey to all ICU and ED nurses in Nova Scotia. The survey queried respondents on their knowledge of, experience with, and attitudes around organ donation and HOTDA, and opportunities and barriers to the implementation of HOTDA in clinical practice. Survey results were analyzed using descriptive statistics.
Results
One-hundred and ninety-four nurses responded to the survey. Nearly all (98%) supported organ donation, with 86% having signed an organ donor card to donate organs and/or tissues after death. A considerable majority (89%) also supported the new legislation. Nevertheless, a minority of respondents (13%) believed that deemed consent legislation would be considered a violation of the general principles of freedom and autonomy. The three most identified topics for ongoing training were coordination of the donation process (70%), clinical management of donors (70%), and family issues in decision-making (70%).
Conclusion
Intensive care unit and ED nurses had positive attitudes toward organ donation, including deemed consent model. The findings should inform educational initiatives in Nova Scotia and beyond to optimize organ donation processes and outcomes.
Center for Informed Consent Integrity 