A Randomized Controlled Trial of Video-Assisted Electronic Consent Versus Standard Consent for Percutaneous Kidney Biopsy
Pedro H Franca Gois, Vera Y Miao, Rebecca B Saunderson, Marina Wainstein, Julia Jefferis, Rebecca Hudson, Shaun Chandler, Kylie-Ann Mallitt, Martin Wolley, Belinda Elford, Ann Bonner, Helen G Healy
Clinical Journal of the American Society of Nephrology, 9 April 2025
Abstract
Background
Informed consent is crucial in healthcare, as it respects and honors patient autonomy. However, the process of consenting a patient to a procedure or intervention is often unstandardized, leading to gaps in comprehension, which in turn affects decision-making. This study aimed to assess the patient-reported benefits of video-assisted electronic consent (eConsent) compared with the usual consent practices for percutaneous kidney biopsies (PKB).
Methods
In this single-center, open-label, randomized controlled trial, consecutive patients undergoing PKB between July 2021 and January 2024 were randomized (1:1) to either video-assisted eConsent (intervention) or usual practice of consent (control). The intervention group accessed an eight-minute explanatory animation on an online platform covering the procedure, its risks, and pre- and post-biopsy care before providing digital consent. The control group was consented to by clinicians in the usual manner and signed a paper form. The primary outcome was questionnaire-based patient comprehension, with secondary outcomes including patient-reported experience, anxiety, and satisfaction with the consent process.
Results
Of 178 eligible patients, 120 were enrolled (60 in each group), with a median age of 52 (IQR 34-65) years, 56% were female, and 59% had less than 12 years of education. Comprehension scores were significantly higher in the eConsent group, with participants answering on average three more questions correctly out of nine compared to the control group (p<0.001). Comprehension did not differ significantly by sex or education level, but younger patients scored higher. The eConsent group also had better comprehension of pre- and post-PKB care. No significant differences were observed in patient-reported experience, anxiety, or satisfaction between groups.
Conclusions
Video-assisted eConsent improves patient comprehension of PKB compared to usual consent practice without affecting patient experience, anxiety, or satisfaction.
Month: May 2025
An informational video for informed consent improves patient comprehension before total hip replacement- a randomized controlled trial
An informational video for informed consent improves patient comprehension before total hip replacement- a randomized controlled trial
Research
Sebastian von Hertzberg-Boelch, Konrad Fuchs, Johanna Schubring, Dominik Rak, Kilian List, Konstantin Horas, Axel Jakuscheit, Maximilian Rudert
International Orthopaedics, 2 April 2025
Open Access
Abstract
Purpose
Effective patient comprehension is critical for informed consent, particularly in Total Hip Arthroplasty (THA), a globally prevalent procedure. This study evaluates the efficacy of an informational video to improve the patients’ understanding, self-perceived knowledge, and emotional comfort in the context of THA informed consent. This randomized controlled trial investigates the impact of an additional informational video on (I) the patients’ understanding, (II) self-precepted knowledge and (III) emotional comfort during the informed consent process for THA.
Methods
Participants were randomized to receive either the standard informed consent procedure or the standard procedure supplemented with an informational video. The effect of the video was tested with post-consent questionnaires.
Results
The informational video significantly (p = 0.014) improved the patients’ understanding from 78.6% to 86.5%. Self-precepted knowledge and Emotional comfort was not effected by the video (p = 0.986; p = 0.333).
Conclusions
The informational video significantly improved patient comprehension during the informed consent process before THA.
Comprehension and Satisfaction with Informed Consent for Hip Arthroscopy Using Supplemental Online Educational Materials
Comprehension and Satisfaction with Informed Consent for Hip Arthroscopy Using Supplemental Online Educational Materials
Molly Piper, Kira Smith, Margaret Sinkler, Michael Salata, Jacob Calcei
Journal of Hip Preservation Surgery, 27 March 2025
Abstract
Background
Informed consent is a crucial component of building the patient-physician relationship, and it typically involves a conversation between patient and provider along with a written document. The purpose of this study was to determine whether the use of electronic educational resources in addition to paper handouts would improve patient comprehension and retention of informed consent for hip arthroscopy procedures.
Methods
Patients undergoing hip arthroscopy were enrolled prospectively, and they were randomized into two groups at their preoperative visit. The first group of patients received a handout discussing their procedure following the informed consent process with the physician, while the second group received the handout as well as access to an online educational forum. The online educational materials included information regarding the procedure, risks, benefits, and alternative options to surgery. The patient’s comprehension, retention, and satisfaction were assessed with a survey on their day of surgery prior to the hip arthroscopy procedure.
Results
There were 26 patients who completed the survey preoperatively, and 65% of those patients were females (n= 17). The average age was 30 ± 9.6 years. 13 of those patients accessed the online educational materials, and 13 patients only had a paper copy of the information. There was no significant difference in the proportion of patients who were very or extremely informed of their procedure (p > 0.99). Additionally, there was not a significant difference in the awareness of the risks, benefits, and alternatives to hip arthroscopy between patient groups (p > 0.99). Over 75% of patients in each group were very or extremely satisfied with the information and teaching they received during the informed consent, but there was not a significant difference between groups (p= 0.59). Of the patients who utilized the online educational materials, 62% agreed that the materials helped improve their understanding of the surgery (n= 8).
Conclusion
Despite an additional online educational forum, there was not a difference in patients’ comprehension of information from the informed consent process for those undergoing hip arthroscopy. There was also not a difference in patient satisfaction between patients receiving only a paper handout versus the additional online educational forum.
Pediatric Acute Appendicitis as a Model for Shared Decision-Making
Pediatric Acute Appendicitis as a Model for Shared Decision-Making
Book Chapter
Lindsay A. Gil, Loren Berman, Peter C. Minneci
Difficult Decisions in Pediatric Surgery, 28 March 2025 [Springer]
Abstract
Shared Decision-Making (SDM) in pediatric surgery is challenging given that the treatment decision typically involves three parties (surgeon, caregiver, and patient), and at least one of the treatment choices usually involves an operative intervention. There has been mounting evidence to support the safety and efficacy of non-operative management of pediatric uncomplicated acute appendicitis with antibiotics alone, making SDM an essential and valuable tool for pediatric surgeons. This chapter highlights both the importance and challenges of applying SDM in pediatric surgery by exemplifying its application to the treatment choice between non-operative and operative management of pediatric uncomplicated acute appendicitis. The appendicitis example is one of several in which SDM has the potential to reduce healthcare resource utilization and costs by increasing uptake of non-operative conservative treatments.
Ethical Considerations in the Surgical Care of Children: Balancing the Interests of the Child, the Family, and the Surgeon
Ethical Considerations in the Surgical Care of Children: Balancing the Interests of the Child, the Family, and the Surgeon
Book Chapter
Johnathan Kent, Miranda Ortega, Manish Tushar Raiji
Difficult Decisions in Pediatric Surgery, 28 March 2025 [Springer]
Abstract
Pediatric surgeons take part in the care of children across a wide spectrum of development and maturity. The relationships between patients, their families, and their surgeons can form an inclusive and supportive team to help children navigate complex health concerns. However, these relationships can also form the basis of complex ethical challenges. The care of children involves an understanding of the development of a child’s maturity and subsequent ability to participate in medical decision making. Under specific circumstances, adolescents can become fully independent to make medical decisions. But in the vast majority of instances, children and adolescents require surrogate decision makers to choose for them. This chapter explores several of the tensions that may arise when considering medical and surgical care for children.
Editor’s note: We note the authors’ assertion that “…in the vast majority of instances, children and adolescents require surrogate decision makers…” We express concern about the imprecision and underlying assumptions of this assertion and continue to examine issues around assent, capacity and children’s rights in our Center for Informed Consent Integrity work.
Navigating consent and dissent in early childhood research: An Australian perspective
Navigating consent and dissent in early childhood research: An Australian perspective
Katie Fielding, Karen Murcia, Madeleine Dobson, Geoffrey Lowe
Issues in Educational Research, March 2025; 35(1)
Open Access
Abstract
Notions of consent, including assent and dissent, are paramount ethical considerations in human research, but have different connotations in research involving young children (aged 3 to 8). While discussion surrounding consent in the early childhood literature has progressed from paternalistic views surrounding the need to protect the child, to recognising their capacity to make decisions in line with their rights, needs and interests, some studies suggest that the application of this change may still be problematic in practice. Many researchers still grapple with notions of who provides consent, what consent may look like, and how it is applied both before and during research. This article reports on the practical application of consent, framed by the hierarchy of Children’s Participation Rights (Mayne et al., 2018), within a study into young children’s demonstration of creative thinking behaviours when using digital technologies. It provides a brief overview of contemporary views of children’s rights and consent for context before outlining the study itself and how consent was applied throughout, informed by the Mayne et al. (2018) framework. It presents a series of vignettes describing elements of consent as they arose in practice and discusses them in relation to the literature. The article concludes by considering rights-based consent in contemporary early childhood research in terms of study design for future researchers to consider.
Readability of health research informed consent forms: case of the National Health Research Ethics Committee in Tanzania
Readability of health research informed consent forms: case of the National Health Research Ethics Committee in Tanzania
Renatha Kato, Renatha Joseph, Lazaro Haule, Mwanaidi Kafuye
BMC Medical Ethics, 22 April 2025
Open Access
Abstract
Background
Obtaining informed consent is the practice of respect for persons that gives the right to participants to make autonomous decisions about research participation. The difficult-to-read research informed consent forms (RICFs) hinder comprehension and can expose participants to harm. This study aims to assess the readability of health RICFs for studies approved by the National Health Research Ethics Committee (NatHREC) in Tanzania.
Methods
We used a retrospective cross-sectional study design. A total of 266 RICFs were sampled from the NatHREC database using stratified and systematic random sampling strategies. The readability of RICFs was assessed using the Flesch Reading Ease (FRE) and Flesch-Kincaid Readability Grade Level (FKRGL) formulas available in Microsoft Word Office and by manual check. Data were collected using the assessment checklist, analyzed, and presented with SPSS and MS Excel software.
Results
Out of 266 RICFs assessed, 65.4% had the recommended page numbers, 81.6% had longer sentences, and 80.5% were difficult to read, necessitating a person to acquire a US grade 10 (Form Four educational level in Tanzania) to understand the presented information. Pearson’s correlation coefficient with p-values of < 0.001 and 95% confidence level disclosed that sentence lengths in the RICFs had a statistical association with the difficult reading levels obtained.
Conclusion
Findings from this study showed that most of the RICFs were concise in terms of page numbers and word count but had long and difficult sentences. Researchers should assess the readability of RICFs before submitting them for ethical approval. Research Ethics Committees (RECs) should consider inclusion of RICFs readability measurements in the Ethics Guidelines for Health Research. The study recommends further studies to assess the Kiswahili versions of RICFs to determine if the results obtained in this study apply to Kiswahili texts.
Informed Consent in Tertiary Care Hospitals of Pakistan; The Moral Magic of Consent
Informed Consent in Tertiary Care Hospitals of Pakistan; The Moral Magic of Consent
Nargis Khan, Gul Hassan Sethar, Zia Ullah Khan, Lubna Meraj, Nadia Shams, Farhat Bashir
Journal of Rawalpindi Medical College, 29 March 2025
Abstract
Objective
This study aimed to assess whether standard international guidelines obtain informed consent and to identify potential contributing factors.
Methodology
This Questionnaire descriptive cross-sectional study was conducted at public sector hospitals of Karachi (October 2021-Aug. 2022) after ethical approval. A 12-point questionnaire was developed based on three categories, first to assess awareness & significance of IC, second regarding elements of IC & third for administrative part of IC. Indoor adult patients ≥18 years of age, who have undergone any surgical or medical procedures were included. The critically ill, unconscious and those unable to give consent were excluded. Data was analyzed by SPSS version 23.
Results
A total of 587 subjects were included, with a mean age of 43. There were 340(57.9%) males & 247(42.1%) females. 51.7% of respondents had an education level of <10 years. 51.1% & 48.9 % of subjects underwent medical related & surgical related procedures respectively. 426(72.6%) patients were aware of IC and 318(54.2%) responded affirmative to significance of IC. 407(69.3%) subjects were informed about treatment options prior to procedure, 349(59.5%) were informed about complications, while risks & benefits of procedure were discussed with 294(50.1%). 281(47.9%) of the patients were satisfied with the information about the procedure, and 288(49.1%) subjects understood the information. Of the respondents, 356(60.6%) stated that the language used wasn’t appropriate for comprehension, 200(34.1%) identified language as a barrier, 185(31.5%) pointed to cultural factors, and 202(34.4%) believed that both language and culture were barriers to IC. 368(62.7%) of the subjects signed the IC, while the IC was signed by a family member in 219(37.3%). Only a minority of patients, 199(33.9%), felt that the consent process was free and fair, while 388(66.1%) believed their decision was influenced. Among them, 233(39.7%) felt influenced by the doctor, and 155(26.4%) attributed the influence to a family member.
Conclusion
There is significant room for improvement in achieving legally and ethically valid informed consent (IC). Literacy, language barriers, and cultural beliefs are major factors influencing patient’s understanding of IC. Higher levels of education were associated with better comprehension of IC. The majority of patients reported that the consent process was neither free nor fair, with language and cultural barriers being significant obstacles. Enhancing the communication skills of healthcare professionals and incorporating formal training on obtaining IC at all levels, from undergraduate education to consultant training, is suggested.
Informed Consent as a Fundamental Principle of Medical Ethics: An Examination of its Application in Nigerian Healthcare Settings
Informed Consent as a Fundamental Principle of Medical Ethics: An Examination of its Application in Nigerian Healthcare Settings
Onyegbule Kelechi Goodluck
Journal of Commercial and Property Law, 23 March 2025
Abstract
The patient’s right of consent to any medical treatment recommended by a medical practitioner is now internationally recognised. This consent is required by the premise of the individual’s inviolable right to choose and control his own health-care situations. Consent must be free, prior, and informed. Free indicates that permission is invalid if obtained through manipulation or coercion. Consent gained unwillingly, under duress or coercion, may result in a battery lawsuit. The consent must be granted voluntarily by a patient who has capacity to so do. Prior means that consent must be obtained adequately in advance of any authorisation granted by medical or hospital authorities, or the initiation of hospital activities that influence the patient’s health. Informed means that the patient’s agreement must be obtained only after complete and legally accurate disclosure of information about the proposed medical operation. The disclosure must be in a form that is both accessible and clear to the patient, including the nature, scope, duration, potential hazards, and foreseeable consequences of the medical operation. There must be complete disclosure of information about the treatment, benefit, danger, complications, and repercussions of such a procedure. Regarding a procedure or therapy that needs to be administered to the patient, the doctor gives all the information that is required. In Nigeria, the idea of informed, prior, and free consent is not widely recognized in the medical field. This is caused by multiple variables. First, there is the issue of Nigeria’s low literacy rate. Patients with limited literacy typically depend solely on the doctor’s judgement. The second factor is the lack of enforcement of the right to informed consent. Under Nigerian law, patients whose rights to informed consent have been violated have little recourse options. Bureaucracy also hinders the processes that are in place to enforce the right to informed consent. This article makes the case that the legal and institutional regimes for Nigeria’s informed consent laws are insufficient.
Expectations for meaningful free, prior, and informed consent: an exploration by the Little Salmon/Carmacks First Nation
Expectations for meaningful free, prior, and informed consent: an exploration by the Little Salmon/Carmacks First Nation
Original Article
Emily Martin, The Little Salmon Carmacks First Nation, Ben Bradshaw
The Extractive Industries and Society, September 2025
Abstract
Indigenous self-determination plays an increasingly prominent role in lands and resources development decisions. One way of operationalizing self-determination is through the realization of free, prior, and informed consent (FPIC) for development impacting Indigenous Peoples and their lands, as recognized in the United Nations Declaration on the Rights of Indigenous peoples (UNDRIP). In the Yukon, Canada, where some consent and consent-like rights are held by First Nations, few First Nations have formally articulated their expectations for the meaningful expression of their consent. This paper begins to address this gap based on a case study by the Little Salmon/Carmacks First Nation (LS/CFN), a self-governing, Northern Tutchone Yukon First Nation located proximate to past, present, and potentially future mineral development. Though LS/CFN’s expectations of FPIC are not formalized today, this exploratory research presents that LS/CFN participants expect: early engagement; to be fully informed; space for self-defined internal processes; ongoing engagement with proponents and the Crown; mitigation of resource barriers; enforceability of commitments; contextually relevant processes; appropriate representation; agreed upon definitions of terminology; mitigation of power imbalances; and mutual agreement on the consent process itself. More broadly this article makes a case for a covenantal, rather than a solely contractual, approach to make FPIC meaningful.
Center for Informed Consent Integrity 