Improving comprehension, recall and attention using multimedia-informed assent among pediatric oncology patients: A comparative randomized controlled trial

Improving comprehension, recall and attention using multimedia-informed assent among pediatric oncology patients: A comparative randomized controlled trial
Psychosocial and Supportive Care: Research Article
Passara Wongthai, Apichat Photia, Chanchai Traivaree, Chalinee Monsereenusorn, Nawachai Lertvivatpong, Khemika Khemakanok Sudnawa, Piya Rujkijyanont
Pediatric Blood & Cancer, 25 May 2022
Abstract
Background
Assent should be obtained in all children involved in research in keeping with their level of maturity. Traditional assent forms contain too much information and are difficult to read. The study aimed to identify an effective tool to enhance children’s comprehension during the assent process and focused on those with cancer who are likely more engaged in research involving greater than minimal risk.
Methods
In all, 116 children with cancer were randomized to receive either a paper-based assent document or a multimedia-based assent document. Open-ended and multiple-choice questions were used to assess comprehension and recall. Time spent on the documents and children’s behavior during the assent process was recorded to determine their attention and satisfaction.
Results
Children randomized to a multimedia-based assent document achieved significant higher comprehension and recall assessment scores (p-values <.001). The high score achievement significantly correlated with the child’s age with adjusted odds ratio (OR) of 1.90 (p-value <.001; 95% confidence interval [CI]: 1.35–2.66) for comprehension assessment and 1.59 (p-value .001; 95% CI: 1.20–2.12) for recall assessment. Children randomized to a multimedia-based assent document had significant longer time spent on the document (p-value .001) with less numbers of inattention (p-value <.001) and expressed more signs of enjoyment during the assent process (p-values <.001).
Conclusion
Multimedia-based assent document successfully enhanced comprehension, recall, and attention with more satisfaction compared with a traditional paper-based document among children with cancer. This approach may be considered as an alternative format for children engaging in research involving greater than minimal risk.

Context, Prioritization, and Unexpectedness: Factors Influencing User Attitudes About Infographic and Comic Consent

Context, Prioritization, and Unexpectedness: Factors Influencing User Attitudes About Infographic and Comic Consent
Xengie Doan, Annika Selzer, Arianna Rossi, Wilhelmina Maria Botes, Gabriele Lenzini
WWW ’22 Companion, 25-29 April 2022; Lyon, France [Virtual Event]
Open Access
Abstract
Being asked to agree to data disclosure is a ubiquitous experience in digital services – yet it is rare to encounter a well-designed consent experience. Considering the momentum for a European data space where personal information easily flows across organizations, sectors, and nations, solving the thorny issue of “how to get consent right” cannot be postponed any further. In this paper, we describe the first findings from a study based on 24 semi-structured interviews investigating participants’ expectations and opinions toward a consent form redesigned as a comic and an infographic in a data-sharing scenario. We found that time, information prioritization, tone, and audience fit are crucial when individuals are invited to disclose their information and the infographic is a better fit in biomedical scenarios.

Effective Communication of Personalized Risks and Patient Preferences During Surgical Informed Consent Using Data Visualization: Qualitative Semistructured Interview Study With Patients After Surgery

Effective Communication of Personalized Risks and Patient Preferences During Surgical Informed Consent Using Data Visualization: Qualitative Semistructured Interview Study With Patients After Surgery
Undina Gisladottir, Drashko Nakikj,  Rashi Jhunjhunwala, Jasmine Panton, Gabriel Brat, Nils Gehlenborg
JMIR Hum Factors, 1 April 2022; 9(2)
Abstract
Background
There is no consensus on which risks to communicate to a prospective surgical patient during informed consent or how. Complicating the process, patient preferences may diverge from clinical assumptions and are often not considered for discussion. Such discrepancies can lead to confusion and resentment, raising the potential for legal action. To overcome these issues, we propose a visual consent tool that incorporates patient preferences and communicates personalized risks to patients using data visualization. We used this platform to identify key effective visual elements to communicate personalized surgical risks.
Objective
Our main focus is to understand how to best communicate personalized risks using data visualization. To contextualize patient responses to the main question, we examine how patients perceive risks before surgery (research question 1), how suitably the visual consent tool is able to present personalized surgical risks (research question 2), how well our visualizations convey those personalized surgical risks (research question 3), and how the visual consent tool could improve the informed consent process and how it can be used (research question 4).
Methods
We designed a visual consent tool to meet the objectives of our study. To calculate and list personalized surgical risks, we used the American College of Surgeons risk calculator. We created multiple visualization mock-ups using visual elements previously determined to be well-received for risk communication. Semistructured interviews were conducted with patients after surgery, and each of the mock-ups was presented and evaluated independently and in the context of our visual consent tool design. The interviews were transcribed, and thematic analysis was performed to identify major themes. We also applied a quantitative approach to the analysis to assess the prevalence of different perceptions of the visualizations presented in our tool.
Results
In total, 20 patients were interviewed, with a median age of 59 (range 29-87) years. Thematic analysis revealed factors that influenced the perception of risk (the surgical procedure, the cognitive capacity of the patient, and the timing of consent; research question 1); factors that influenced the perceived value of risk visualizations (preference for rare event communication, preference for risk visualization, and usefulness of comparison with the average; research question 3); and perceived usefulness and use cases of the visual consent tool (research questions 2 and 4). Most importantly, we found that patients preferred the visual consent tool to current text-based documents and had no unified preferences for risk visualization. Furthermore, our findings suggest that patient concerns were not often represented in existing risk calculators.
Conclusions
We identified key elements that influence effective visual risk communication in the perioperative setting and pointed out the limitations of the existing calculators in addressing patient concerns. Patient preference is highly variable and should influence choices regarding risk presentation and visualization.

Impact of Informed Consent and Education on Care Engagement After Opioid Initiation in the Veterans Health Administration

Impact of Informed Consent and Education on Care Engagement After Opioid Initiation in the Veterans Health Administration
Tigran Avoundjian, Lara Troszak, Jennifer Cohen, Mary Beth Foglia, Jodie Trafton, Amanda Midboe
Journal of Pain Research, 25 May 2022; 15 pp 1553-1562
Abstract
Objective
To ensure all patients receiving long-term opioid therapy (LTOT) understand the risks, benefits and treatment alternatives, the Veterans Health Administration (VHA) released a national policy in 2014 to standardize a signature informed consent (SIC) process. We evaluated the impact of this policy on medical follow-up after LTOT initiation, a guideline recommended practice.
Methods
Using VHA administrative data, we identified patients initiating LTOT between May 2013 and May 2016. We used an interrupted time series design to compare the monthly rates of medical follow-up within 30 days and primary care visits within 3 months after LTOT initiation across three periods: 12 months before the policy (Year 1); 12 months after policy release (Year 2); and 12– 24 months after policy release, when the SIC process was mandatory (Year 3).
Results
Among the 409,895 patients who experienced 758,416 LTOT initiations, medical follow-up within 30 days and primary care engagement within 3 months increased by 4% between Year 1 and Year 3. Compared to Year 1, patients in Year 3 were 1.12 times more likely to have any medical follow-up (95% CI: 1.10, 1.13) and 1.13 times more likely to have a primary care visit (95% CI: 1.12, 1.15). Facilities with a greater proportion of patients receiving SIC had increased medical follow-up (RR: 1.04, 95% CI: 1.01, 1.07) and primary care engagement (RR: 1.06, 95% CI: 1.03, 1.10).
Conclusion
The VHA’s SIC policy is associated with increased medical follow-up among patients initiating LTOT, which may result in improved patient safety and has implications for other healthcare settings.

The Conceptual Legal Structure of The Patient’s Right to Informed Consent

The Conceptual Legal Structure of The Patient’s Right to Informed Consent
Noelia Martínez-Doallo
European Journal of Health Law, 12 May 2022
Abstract
Informed consent has been inconsistently conceptualised as a right, an immunity or even a power in the hands of the patient, which leaves its legal definition as partially indefinite. From the norms of the CHRB, a legal theory stance and the proposals of celebrated authors — namely, W.N. Hohfeld, H. Kelsen and R. Alexy, I will provide a steady conceptual structure for the subjective legal positions of the parties involved in the healthcare relationship regarding informed consent.

Informed Consent in Pringsewu Regional General Hospital: Legal Evidence Perspective

Informed Consent in Pringsewu Regional General Hospital: Legal Evidence Perspective
Samino Samino, Agung Aji Perdana, Selamet Kuntoro
Jounral Ilmu Kesehatan, 2022; 7(1)
Abstract
Quality health care is the right of every patient and his family. One of the indicators of quality services is the fulfillment of informed consent in accordance with the laws and regulations. Preliminary studies of several informed consent documents at Pringsewu Hospital found that all of them were not filled out completely. This study aims to analyze informed consent documents from the perspective of legal evidence.The study was conducted at Pringsewu Hospital in July 2021. The research method used a qualitative descriptive analysis approach, with 75 informed consent documents and two informants. How to collect data by reviewing the informed consent document that has been filled in at the hospital medical record installation, by checking the completeness of filling out the informed consent document for the five most types of actions, and in-depth interviews with the responsible leadership.The results showed that 75 informed consent documents were reviewed, none of which were filled out completely. The five most important indicators were not filled in completely, consecutively: name and signature of witness II, name and signature of witness I, gender of the patient, and gender of the giver of consent. To improve the completeness of filling out documents, the hospital will provide education to doctors, nurses, and administrative staff, as well as strict supervision. It was concluded that incomplete informed consent documents, as legal evidence, were low quality. The hospital leaders should conduct socialization to doctors, nurses and administrative staff regarding the importance of filling out the medical treatment approval form properly and completely.

The Extraction Industry in Latin America and the Protection of Indigenous Land and Natural Resource Rights: From Consultation Toward Free, Prior, and Informed Consent

The Extraction Industry in Latin America and the Protection of Indigenous Land and Natural Resource Rights: From Consultation Toward Free, Prior, and Informed Consent
Kylah Staley
Hastings Law Journal, May 2022; 73(4)
Open Access
Abstract
Resource extraction and exploitation threaten the survival of Indigenous and tribal peoples, who are amongst the most marginalized communities in the world. This is both a human rights issue and an environmental issue. There are around 300 million people that make up Indigenous communities worldwide, the majority of whom live in forests. Furthermore, Indigenous customary lands contain 80% of the world’s biodiversity. Traditionally, Indigenous communities have been stewards of their lands, where they regard the land as means for their own physical, spiritual, and cultural survival rather than a commodity to be exploited. The only protection Indigenous Peoples have against resource extraction in international law, under the Indigenous and Tribal Peoples (ILO) Convention 169, is the right to consultation and participation. Effectively, Indigenous communities have limited decision-making power in this context. This narrow protection of Indigenous Peoples’ lands and natural resources under ILO Convention 169 is inadequate and informed by a colonial past. For there to be adequate protections of Indigenous Peoples’ land and resource rights, Indigenous Peoples must hold actual decision-making power, not just participatory power. Free, prior, and informed consent (FPIC) is the principle and right that is critical to safeguarding Indigenous lands and resources as it is grounded in the foundational right of self-determination. Thus, I argue operationalizing FPIC would provide a comprehensive protection of Indigenous rights by ensuring that affected Indigenous communities (1) design the procedures for obtaining their consent (2) retain negotiating power and (3) actually agree to proposed projects.

Principle of Free, Prior and Informed Consent as a Resolution of Land Conflicts Between Oil Palm Plantation Companies and Indigenous Peoples in Kampar Regency

Principle of Free, Prior and Informed Consent as a Resolution of Land Conflicts Between Oil Palm Plantation Companies and Indigenous Peoples in Kampar Regency
Rahmad Hendra, Firdaus Firdaus, Samariadi Samariadi
Advances in Social Science, Education and Humanities Research, 2021; 659
Open Access
Abstract
The research was conducted in Bencah Kelubi Village and Subarak Village. In both villages there are oil palm plantation companies. In Subarak Village, oil palm plantation investors implement the principle of free, prior and informed consent (FPIC) at the beginning before the start of investment, while in Bencah Kelubi Village the oil palm plantation companies that make investments do not follow the FPIC principle. The writing method used by the author is descriptive analysis with a qualitative research pattern. The author found that FCPIC is significantly reduces the conflict between oil palm plantation companies and indigenous peoples.

Ethical obligation and legal requirements: On informed consent practices in Bangladesh

Ethical obligation and legal requirements: On informed consent practices in Bangladesh
Original Article
Sonia Mannan, Jobair Alam, K. M. Ashbarul Bari, S. M. A. A. Mamun, Rehnuma Mehzabin Orin
Developing World Bioethics, 19 May 2022
Abstract
Informed consent to medical intervention is fundamental in both ethics and law. But in practice it is often not taken seriously in developing countries. This paper provides an appraisal of informed consent practices in Bangladesh. Following a review of the ethical and legal principles of informed consent, it assesses the degree to which doctors adhere to it in Bangladesh. Based on findings of non-compliance, it then investigates the reasons for such non-compliance through an appraisal of informed consent practices in Bangladesh and provides recommendations aimed at improving such practices. The significance of this paper lies in unveiling the interdependence between the ethical and legal traits of informed consent and their ramifications on strengthening the patient-oriented approach of duty to care.

Understanding of Critical Elements of Informed Consent in Genomic Research: A Case of a Paediatric HIV-TB Research Project in Uganda

Understanding of Critical Elements of Informed Consent in Genomic Research: A Case of a Paediatric HIV-TB Research Project in Uganda
Research Article
Francis Anyaka Amayoa, Frederick Nelson Nakwagala, John Barugahare, Ian Guyton Munabi, Erisa Sabakaki Mwaka
Journal of Empirical Research on Human Research Ethics, 12 May 2022
Abstract
Several studies have reported inadequate comprehension of informed consent for genomic research. This study aimed to assess research participants’ understanding of critical elements of informed consent for genomic research. A cross-sectional survey involving 123 parents/caregivers of children participating in a paediatric genomic TB/HIV study was conducted. Only 47.2% of the participants had adequate understanding of consent information. The mean objective (actual) and subjective (perceived) understanding scores were 78.7% and 91.7% respectively. Participants adequately understood most elements of consent however, some elements were poorly understood including foreseeable risks, protection of confidentiality and compensation for research related injury. Overall there was inadequate comprehension of critical elements of informed consent and there was dissonance between actual and perceived comprehension of informed consent.