What is the best method to ensure informed consent is valid for orthodontic treatment? A trial to assess long-term recall and comprehension
Summary Review
Carter, H. Al-Diwani
Evidence-Based Dentistry, 24 June 2022; 23 pp 52–53
Abstract
Design
Single-blind randomised controlled trial.
Intervention
Patient and parent pairs were randomly assigned via a random number generator to Group A or B. Both groups were given ten minutes to read a modified consent document. Group A (rehearsal) were given printouts that showed images of four core and four custom risks with handwritten descriptions of each risk and consequences. Group B were given an audio-visual presentation instead (PowerPoint). Interviews of each group were completed immediately after the informed consent and at six-month follow-up to assess recall and comprehension of information provided.
Case selection
Patients aged 11-18 years old and their parents attending for comprehensive orthodontic treatment at Ohio State University graduate orthodontic clinic. All subjects needed to be able to communicate in English, have no developmental disabilities or urgent medical conditions and neither the patients or parents or subjects’ siblings were to have had orthodontic treatment in the last five years.
Data analysis
1) Exploratory analysis to test for differences in demographics and anxiety between the two groups; 2) Multiple linear regression analysis was used to assess percentage of accurate responses at baseline and six months and the change between the two different groups, with differing baseline characteristics (p <0.05 was considered statistically significant); and 3) Intra- and inter-rater reliability was assessed using intra-class correlation.
Results
There were no significant differences in information retention and understanding between the two methods at six-month follow-up. For both groups, recall was significantly lower six months following consent-taking. Specific domains whereby information recall and comprehension are poor include: treatment method, risks, resorption and discomfort.
Conclusions
There is no superior method of consent-taking to ensure patients’ and parents’ information retention in the months following commencement of treatment. However, the study highlighted that current consent practices which are considered ‘best practice’ may be deficient.
Month: July 2022
Comparing shared decision making using a paper and digital consent process. A multi-site, single centre study in a trauma and orthopaedic department
Comparing shared decision making using a paper and digital consent process. A multi-site, single centre study in a trauma and orthopaedic department
Rory Dyke, Edward St-John, Hemina Shah, Joseph Walker, Dafydd Loughran, Raymond Anakwe, Dinesh Nathwani
The Surgeon, 11 June 2022
Abstract
Introduction
The importance of shared decision making (SDM) for informed consent has been emphasised in the updated regulatory guidelines. Errors of completion, legibility and omission have been associated with paper-based consent forms. We introduced a digital consent process and compared it against a paper-based process for quality and patient reported involvement in shared decision making.
Methods
223 patients were included in this multi-site, single centre study. Patient consent documentation was by either a paper consent form or the Concentric digital consent platform. Consent forms were assessed for errors of legibility, completion and accuracy of content. Core risks for 20 orthopaedic operations were pre-defined by a Delphi round of experts and forms analysed for omission of these risks. SDM was determined via the ‘collaboRATE Top Score’, a validated measure for gold-standard SDM.
Results
72% (n = 78/109) of paper consent forms contained ≥1 error compared to 0% (n = 0/114) of digital forms (P < 0.0001). Core risks were unintentionally omitted in 63% (n = 68/109) of paper-forms compared to less than 2% (n = 2/114) of digital consent forms (P < 0.0001). 72% (n = 82/114) of patients giving consent digitally reported gold-standard SDM compared to 28% (n = 31/109) with paper consent (P < 0.001).
Conclusion
Implementation of a digital consent process has been shown to reduce both error rate and the omission of core risks on consent forms whilst increasing the quality of SDM. This novel finding suggests that using digital consent can improve both the quality of informed consent and the patient experience of SDM.
Characteristics of Electronic Informed Consent Platforms for Consenting Patients to Research Studies: A Scoping Review
Characteristics of Electronic Informed Consent Platforms for Consenting Patients to Research Studies: A Scoping Review
Jennifer Guarino, Irena Parvanova, Joseph Finkelstein
Studies in Health Technology and Informatics, 6 June 2022; 290 pp 777-781
Abstract
Informed consent process assures that research study participants are properly informed about the study prior to their consent. Due to the increasing significance of electronic informed consent (eIC) platforms, particularly during the COVID-19 pandemic, we conducted a scoping review of eIC systems to address the following characteristics: 1) technological features of current eIC platforms, 2) eIC platforms usability and efficacy, and 3) areas for future eIC research. We performed a literature search using publicly available PubMed repository, where we included studies discussing an eIC platform or multimedia educational module given to patients prior to signing a consent form. In addition, we tracked first author, year of publication, sample size, study location, eIC procedure, methodology, and eIC’s comparison to paper consent. Our results showed that with a few noted exceptions, electronic consent improves patient usability, satisfaction, knowledge, and trust scores when compared to traditional paper consent.
Informed consent: more than just a signature
Informed consent: more than just a signature
Parker O’Neill, Sierra Schaffer, Fallon O’Neill, Andrew Poullis
Gut, 19 June 2022; 71
Abstract
Introduction
Informed consent is a core component of ethical medical practice and is vital to ensure patient autonomy is upheld. However, consent is not a static concept and physicians need to remain engaged with the literature to ensure they minimise their liability. This study aims to clarify the legal duties of gastroenterologists when gaining informed consent by analysing the current literature and past legal precedents.
Methods
A bibliometric analysis of the Web of Science (WoS) Core Collection database was performed with the MeSH terms ‘gastroenterology’ AND ‘informed consent’. The top 50 most-cited articles were extracted and analysed. A scoping review was performed of the case law surrounding informed consent in the UK and the USA.
Results
A total of 383 articles were identified on the WoS, with 228 articles excluded due to not meeting the inclusion criteria. of the top 50 articles, 48% were from American institutions and 16% were from the UK. The American Journal of Gastroenterology had published 20% and the Journal of Digestive Diseases had published 8% of the top 50 articles. Since 1970, there has been a steady rise in citations of articles pertaining to informed consent in gastroenterology with the record of 63 citations occurring in 2015. Thematic analysis showed 72% of the top 50 articles discussed informed consent in relation to diagnostic procedures, 14% regarding treatment, and 14% regarding research participation. of the articles discussing diagnostic procedures, half specified the type of diagnostic tool evaluated. Thirty-three percent of articles focused on colonoscopy, 26% on OGD, 22% on ERCP, 11% on flexible sigmoidoscopy, and 7% on genetic testing. The UK has progressed from what was previously a paternalistic Bolam’s test with the Bolitho addendum to the Montgomery test 2015 which demands physicians establish what is relevant to their specific patient when gaining informed consent. The USA experienced a similar evolution, progressing from the Natanson case holding physicians to the standard of a ‘reasonable and prudent medical doctor’ to the Canterbury case 1972 requiring physicians to disclose what would be important to a ‘reasonable patient’. Exponentially more articles have been published since the American Canterbury case came into effect. Most articles focused on invasive procedures and discussed complex ethical questions seeking to increase patient autonomy.
Conclusion
Physicians in both the UK and USA now have a legal duty to ensure their patients are fully informed to a standard that their individual patient deems appropriate. Most articles published are American-based and focus on informed consent in the context of diagnostic colonoscopy. Physicians may benefit from international guidelines on consenting patients for invasive procedures in gastroenterology.
The need for a standard for informed consent for collection of human fetal material
The need for a standard for informed consent for collection of human fetal material
Commentary
Roger A. Barker, Gerard J. Boer, Elena Cattaneo, R. Alta Charo, Susana M. Chuva de Sousa Lopes, Yali Cong, Misao Fujita, Steven Goldman, Göran Hermerén, Insoo Hyun, Steven Lisgo, Anne E. Rosser, Eric Anthony, Olle Lindvall
Stem Cell Reports, 14 June 2022; 17(6) pp 1245-1247
Summary
The ISSCR has developed the Informed Consent Standards for Human Fetal Tissue Donation and Research to promote uniformity and transparency in tissue donation and collection. This standard is designed to assist those working with and overseeing the regulation of such tissue and reassure the wider community and public.
How Informed is Informed Consent? Experiences of Research Participants at the KAVI-Institute of Clinical Research, Kenya
How Informed is Informed Consent? Experiences of Research Participants at the KAVI-Institute of Clinical Research, Kenya
Emily Nyariki, Robert R. Lorway, Omu Anzala, Joyce M. Olenja
African Journal of Health Sciences, 20 June 2022; 35(2)
Abstract
Introduction
Informed consent (IC) is a key yardstick for the ethical and legal conduct of clinical research involving human subjects. However, the extent to which it meets its obligations in low-income settings remains under-examined. This study explored the views and experiences of informed consent among research participants at the KAVI-Institute for Clinical Research, Nairobi, Kenya.
Materials and Methods
A mixed-methods study was conducted between March and June 2014. Participants were drawn from six selected KAVI-ICR studies. Data collection involved a survey questionnaire with 164 participants and in-depth interviews with 44 participants purposively selected from the survey questionnaire respondents. Descriptive statistics via SPSS and thematic analysis via Atlas Ti were used, for quantitative and qualitative data analysis respectively.
Results
The majority of participants had learnt about the KAVI studies from friends (41%) and community mobilisers/ peer educators (47%). The information relayed by these relations regarding participation had led some participants to reach their decisions before undergoing the informed consent process. All participants reported attending information meetings, passed the assessment of understanding tests, and autonomously gave their written consent. Incomplete understanding of research concepts such as randomization and associated terminologies, placebo, and vaccine-induced positivity were expressed.
Conclusion
Beyond understanding the information received before enrolment, participants’ decisions are shaped by individual and community factors as well as trust relations with trial staff and own friends. There is, therefore, a need for innovative approaches to implementing and evaluating informed consent in low-resource settings.
Informed consent: an empty promise? A comparative analysis between Italy and England, Wales, and Scotland
Informed consent: an empty promise? A comparative analysis between Italy and England, Wales, and Scotland
Research Article
Caterina Milo
Medical Law International, 16 June 2022
Open Access
Abstract
Informed consent (IC), as the process of sharing information between patients and clinicians before undertaking a medical treatment, signals a number of ‘good intentions’. IC, in its theoretical formulation, can be seen as valuing the expertise and contributions of both clinicians and patients, giving expression to the aspirations of both promoting patient autonomy and facilitating doctors to work in partnership with their patients. The Supreme Court judgement in Montgomery v Lanarkshire Health Board1 and the Italian legislation on IC2 are, in this respect, worthy of analysis as both provide valid examples of these ‘good intentions’. However, the reality of how IC has been translated in courtrooms does not always match the expectations. This article, through a comparative reflection, will claim that a gap between the ‘law in theory’ and the ‘law in practice’ is common to both legal systems. The article ultimately claims that changes in both legal and policy approach are needed in order to better safeguard IC.
Clinical adolescent decision-making: parental perspectives on confidentiality and consent in Belgium and The Netherlands
Clinical adolescent decision-making: parental perspectives on confidentiality and consent in Belgium and The Netherlands
Research Article
Jana Vanwymelbeke, David De Coninck, Koen Matthijs, Karla Van Leeuwen, Steven Lierman, Ingrid Boone, Peter de Winter, Jaan Toelen
Ethics & Behavior, 15 June 2022
Abstract
This study investigated Belgian and Dutch parental opinions on confidentiality and consent regarding medical decisions about adolescents. Through an online survey, we presented six cases (three on confidentiality, and three on consent) to 1,382 Belgian and Dutch parents. We studied patterns in parental confidentiality and consent preferences across and between cases through binomial logistic regressions and latent class analysis. Participants often grant the right to consent for a treatment to the adolescent, but the majority diverges from the adolescent’s preferences regarding confidentiality. More educated participants would rather not be informed about cases regarding a sexually transmitted disease or depression than lower educated participants. Further analysis shows that participants’ preferences correspond to authoritative (47%), permissive (30%) and authoritarian (17%) parenting styles. Belgian and Dutch parents are willing to grant some degree of autonomy, but they want to be informed about specific health issues. Parental views on confidentiality and granting consent appear to mirror existing parenting styles.
Evaluating Knowledge, Practice, and Barriers to Informed Consent Among Professional and Staff Nurses in South Africa: An Empirical Study
Evaluating Knowledge, Practice, and Barriers to Informed Consent Among Professional and Staff Nurses in South Africa: An Empirical Study
Sylvester C. Chima
Canadian Journal of Bioethics, 13 June 2022; 5(2) pp 44-70
Abstract
Background
Informed consent (IC) is an ethical and legal obligation protected by constitutional rights to bodily integrity, well-being, and privacy in South Africa. The National Health Act 2003 codified IC regulations, requiring that all healthcare professionals inform patients about diagnosis, risks, benefits, options, and refusal rights while factoring in patients’ language and literacy levels.
Objectives
This study’s primary aim was to determine the extent of South African professional/staff nurses’ compliance with current IC regulations and ascertain socio-cultural impediments impacting proper IC practice.
Methods
A cross-sectional survey using semi-structured questionnaires was used to evaluate knowledge and practice of IC among nurses in KwaZulu-Natal province. Data were analyzed using SPSS, v.21. Descriptive statistics, chi-squared tests, and content analysis were used to compare nursing domains.
Results
Three hundred fifty-five (355) nurses, 92% females, with 1 to 41 years of professional experience, completed this study. Information disclosed by nurses to patients included diagnosis (77%), treatment benefits (71%), risks (69%), recommendations (65%), risks of refusal (80%), and right of refusal (67%). Nurses (80%) felt information disclosure was adequate, while 85% reported that patients understood disclosed information.
Conclusions
Nurses practicing in local public hospitals had moderate knowledge of IC regulations. Practical implementation appeared deficient. Barriers to IC included language, workload, time constraints, lack of interpreters, and skewed gender norms in the nursing profession. Nurses require continuing professional education in healthcare law and ethics, a “corps of trained interpreters”, and gender transformation in the nursing profession to improve IC practice and overall quality of healthcare service delivery in South Africa.
Informed Consent: The Surgical Patient’s Experience in a Tertiary Hospital in Northwest Nigeria
Informed Consent: The Surgical Patient’s Experience in a Tertiary Hospital in Northwest Nigeria
B A Grema, S T Tanimu, G C Michael, I Aliyu, S A Aji, I U Takai, A I Sulaiman
West African Journal of Medicine, 27 May 2022; 5 pp 471-478
Abstract
Background
Obtaining informed consent (IC) before a surgical procedure is the cornerstone of medical practice. The practice of IC continues to evolve as litigations increase. Most studies on patients’ perspectives of IC are either old or were done in southern Nigeria. This study assessed the surgical patients’ IC experience in a tertiary hospital in northwest Nigeria.
Methods
This cross-sectional study assessed 244 consecutive patients who had elective surgeries in surgical departments of a tertiary hospital. Pretested questionnaires were used to collect data regarding their perception of the meaning of IC, the process of obtaining it, satisfaction with how it was obtained, and factors associated with satisfaction on how consent was obtained.
Results
Most were females (61.9%); their mean age was 34.8±14.3 years; 52.9% and 61.9% of respondents did not believe that IC enables patient-clinician shared decision-making or patient’s self-decision making, respectively. Most were allowed to ask questions (83.2%), received information on the surgical procedure (91.4%), diagnosis (97.9%); however, 38.5% and 48.8% did not receive information about surgical procedures’ immediate and long-term complications, respectively. Surgical procedure explanation was mostly provided by Resident Doctors (53.7%). Most (88.9%) were satisfied with how IC was obtained; satisfaction was associated with being allowed to ask questions, receiving explanations on diagnosis, surgical-procedure, complications of surgery, available alternative treatments, and when the resident/ consultants gave the explanation (all P<0.05).
Conclusion
Deficiencies exist in the process of getting IC. Satisfaction with this process was high though associated with following the recommended strategies. Improving the IC process will require appropriate interventions in this and similar settings.
Center for Informed Consent Integrity 