Parental experiences of the informed consent process in randomized clinical trials—A Nordic study
Research Article
Nina Mogensen, Ulrika Kreicbergs, Birgitte Klug Albertsen, Päivi Lähteenmäki, Mats Heyman, Arja Harila
Pediatric Blood & Cancer, 7 September 2023
Open Access
Abstract
Background
Randomized clinical trials (RCTs) are an essential part of improving acute lymphoblastic leukemia (ALL) treatment. This population-based questionnaire study investigated parents’ experiences of the informed consent process in the RCTs within the Nordic NOPHO (Nordic Society of Paediatric Haematology and Oncology) ALL2008 trial.
Procedure
Parents in Sweden, Denmark, and Finland whose child was alive and in first remission after end of therapy and who were asked to participate in any RCT in the ALL2008 protocol, were asked to complete 15 questions/items regarding their experience of the RCT consent process.
Results
A total of 483 parents of 279 children met the inclusion criteria and answered the study questionnaire. Most (91%) agreed/strongly agreed to having received sufficient information to make a well-informed decision, felt confidence in the study design (86%), and thought that the process was satisfactory (86%). Those who did not consent reported a generally more negative experience of the process. More than a third of all parents and over half of parents who had refused participation felt that it was burdensome to decide. Most parents (66%) in general, and one-third of those with children 8 years or older, reported that their child was not involved in the process.
Parental perspectives about information and deferred versus two-stage consent in studies of neonatal asphyxia
Parental perspectives about information and deferred versus two-stage consent in studies of neonatal asphyxia
Original Research
Christian A. Maiwald, Charlotte Rovers, Annie Janvier, Heidrun Sturm, Martina Michaelis, Georg Marckmann, Hans-Joerg Ehni, Christian F Poets, Mario Rüdiger, Axel R Franz
ADC Fetal & Neonatal, 30 August 2023
Abstract
Objective
The ALBINO Trial (NCT03162653) investigates effects of very early postnatal allopurinol on neurocognitive outcome following perinatal asphyxia where prenatal informed consent (IC) is impossible. Ethically and legally, waiver of consent and/or deferred consent (DC) is acceptable in such an emergency. Short oral/two-step consent (SOC, brief information and oral consent followed by IC) has recently been investigated.
Methods
Mixed-methods analysis of parental opinions on DC versus SOC in the context of neonatal asphyxia in a survey at two German centres. Prospective parents (ProP), parents of healthy newborns (PNeo) and parents of asphyxiated infants (PAx) born between 2006 and 2016 were invited.
Results
108 of 422 parents participated (ProP:43; PNeo:35; PAx:30). Most parents trusted physicians, wanted preinterventional information and agreed that in emergencies interventions should begin immediately. Intergroup and intragroup variability existed for questions about DC and SOC. In the ALBINO Trial situation, 55% preferred SOC, and 26% reported DC without information might adversely affect their trust. Only 3% reported to potentially take legal action after DC. PAx were significantly more likely to support DC. PAx more frequently expressed positive emotions and appreciation for neonatal research. In open-ended questions, parents gave many constructive recommendations.
Conclusion
In this survey, parents expressed diverse opinions on consent, but the majority preferred SOC over DC. Parents who had experienced emergency admission of their asphyxiated neonates were more trusting. Obtaining parental perspectives is essential when designing studies, while being cognisant that these groups of parents may not represent the opinion of all parents.
The use of e-consent in surgery and application to neurosurgery: a systematic review and meta-analysis
The use of e-consent in surgery and application to neurosurgery: a systematic review and meta-analysis
Original Article
Asfand Baig Mirza, Abbas Khizar Khoja, Fizza Ali, Mustafa El-Sheikh, Ammal Bibi-Shahid, Jandira Trindade, Brett Rocos, Gordan Grahovac, Jonathan Bull, Alexander Montgomery, Babak Arvin, Ahmed-Ramadan Sadek
Acta Neurochirurgica, 11 September 2023
Open Access
Abstract
Introduction
The integration of novel electronic informed consent platforms in healthcare has undergone significant growth over the last decade. Adoption of uniform, accessible, and robust electronic online consenting applications is likely to enhance the informed consent process and improve the patient experience and has the potential to reduce medico-legal ramifications of inadequate consent. A systematic review and meta-analysis was conducted to evaluate the utility of novel electronic means of informed consent in surgical patients and discuss its application to neurosurgical cohorts.
Methods
A review of randomised controlled trials, non-randomised studies of health interventions, and single group pre-post design studies in accordance with the PRISMA statement. Random effects modelling was used to estimate pooled proportions of study outcomes. Patient satisfaction with the informed consent process and patients’ gain in knowledge were compared for electronic technologies versus non-electronic instruments. A sub-group analysis was conducted to compare the utility of electronic technologies in neurosurgical cohorts relative to other surgical patients in the context of patient satisfaction and knowledge gain.
Results
Of 1042 screened abstracts, 63 studies were included: 44 randomised controlled trials (n = 4985), 4 non-randomised studies of health interventions (n = 387), and 15 single group pre-post design studies (n = 872). Meta-analysis showed that electronic technologies significantly enhanced patient satisfaction with the informed consent process (P < 0.00001) and patients’ gain in knowledge (P < 0.00001) compared to standard non-electronic practices. Sub-group analysis demonstrated that neurosurgical patient knowledge was significantly enhanced with electronic technologies when compared to other surgical patients (P = 0.009), but there was no difference in patient satisfaction between neurosurgical cohorts and other surgical patients with respect to electronic technologies (P = 0.78).
Conclusions
Novel electronic technologies can enhance patient satisfaction and increase patients’ gain in knowledge of their surgical procedures. Electronic patient education tools can significantly enhance patient knowledge for neurosurgical patients. If used appropriately, these modalities can shorten and/or improve the consent discussion, streamlining the surgical process and improving satisfaction for neurosurgical patients.
Using a chat-based informed consent tool in large-scale genomic research
Using a chat-based informed consent tool in large-scale genomic research
Sarah K Savage, Jonathan LoTempio, Erica D Smith, E Hallie Andrew, Gloria Mas, Amanda H Kahn-Kirby, Emmanuèle Délot, Andrea J Cohen, Georgia Pitsava, Robert Nussbaum, Vincent A Fusaro, Seth Berger, Eric Vilain
Journal of the American Medical Informatics Association, 4 September 2023
Abstract
Objective
We implemented a chatbot consent tool to shift the time burden from study staff in support of a national genomics research study.
Materials and Methods
We created an Institutional Review Board-approved script for automated chat-based consent. We compared data from prospective participants who used the tool or had traditional consent conversations with study staff.
Results
Chat-based consent, completed on a user’s schedule, was shorter than the traditional conversation. This did not lead to a significant change in affirmative consents. Within affirmative consents and declines, more prospective participants completed the chat-based process. A quiz to assess chat-based consent user understanding had a high pass rate with no reported negative experiences.
Conclusion
Our report shows that a structured script can convey important information while realizing the benefits of automation and burden shifting. Analysis suggests that it may be advantageous to use chatbots to scale this rate-limiting step in large research projects.
Counseling, informed consent, and debriefing for cesarean section in sub-Saharan Africa: A scoping review
Counseling, informed consent, and debriefing for cesarean section in sub-Saharan Africa: A scoping review
Faysal S, Penn-Kekana L, Day LT, Tripathi V, Khan F, Stafford R, Levin K, Campbell O, Filippi V
International Journal of Gynaecology and Obstetrics, 12 September 2023
Abstract
Background
Counseling as part of the informed consent process is a prerequisite for cesarean section (CS). Postnatal debriefing allows women to explore their CS with their healthcare providers (HCPs).
Objectives
To describe the practices and experiences of counseling and debriefing, the barriers and facilitators to informed consent for CS; and to document the effectiveness of the interventions used to improve informed consent found in the peer-reviewed literature.
Search strategy
The databases searched were PubMed, EMBASE, PsycINFO, Africa-wide information, African Index Medicus, IMSEAR and LILACS.
Selection criteria
English-language papers focusing on consent for CS, published between 2011 and 2022, and assessed to be of medium to
high quality were included.
Data collection and analysis
A narrative synthesis was conducted using Beauchamp and Childress’s elements of informed consent as a framework.
Main results
Among the 21 included studies reporting on consent for CS, 12 papers reported on counseling for CS, while only one reported on debriefing. Barriers were identified at the service, woman, provider, and societal levels. Facilitators all operated at the provider level and interventions operated at the service or provider levels.
Conclusions
There is a paucity of research on informed consent, counseling, and debriefing for CS in sub-Saharan Africa.
Informed Consent and Ethical Considerations in Assisted Reproductive Technology in Nigeria: Options and Challenges
Informed Consent and Ethical Considerations in Assisted Reproductive Technology in Nigeria: Options and Challenges
Book Chapter
Folakemi O. Ajagunna
Reproductive Health and Assisted Reproductive Technologies In Sub-Saharan Africa, 29 August 2023 [Springer]
Abstract
Informed consent, permission given by a patient in full knowledge of the consequences, risks or potential benefits of the medical procedure to be carried out is a sine qua non in the practice of Assisted Reproductive Technologies. This permission emanates from the right to autonomy which a patient should enjoy. Implicit within this right to informed consent is that the patient is given adequate information about the treatment he or she is to be subject to. Where informed consent is not obtained, it could result in jeopardy for both the medical practitioner and the patient. This chapter examines issues emanating from informed consent in assisted reproduction in Nigeria. It adopts a socio-legal approach to interrogate the practice of informed consent in Nigeria. In-depth and key-informant interviews were conducted with IVF doctors, embryologists and women patronising IVF clinics to ascertain practices in various IVF clinics in Nigeria. The research found that although there are guidelines on informed consent in the rules of professional conduct in Nigeria, this is not a true reflection of what obtains in the ART industry. The research recommends that in addition to the rules or ethos of the medical profession in Nigeria, a legal framework is essential to advance the rights of patients to full and adequate information in assisted reproduction.
Principles of consent in trauma and orthopaedics
Principles of consent in trauma and orthopaedics
Christopher Wilson, Qamar Mustafa, Tim Crook
Surgery (Oxford), 9 September 2023
Abstract
Consent is one of the essential elements of daily practice for clinicians working in Trauma and Orthopaedics. Autonomy is the right of competent adults to make informed decisions about their care. GMC guidance has placed a professional burden on surgeons to provide informed decision making. The Montgomery v Lanarkshire Health Board (2015) case set a precedent that has driven the modernization of consenting practice, raising the status of shared decision making from guidance to legal requirement. In a post-Montgomery landscape, consent is often the first focus for lawyers and insurers when medico-legal malpractice suit is concerned. Orthopaedic surgeons are at a higher risk of facing malpractice suites (Gould et al., 2003), yet there is a lack of formal training regarding obtaining and documenting informed consent. In this article we discuss the historical context, the current status of consent within UK medical practice, as well as strategies to ensure that consent is legally obtained within Trauma and Orthopaedics.
General Preoperative Workup, Informed Consent, Antibiotic Prophylaxis, and Anesthesia in Thyroid Surgery
General Preoperative Workup, Informed Consent, Antibiotic Prophylaxis, and Anesthesia in Thyroid Surgery
Book Chapter
Angela Gurrado, Lucia Ilaria Sgaramella, Elisabetta Poli, Walter Lavermicocca, Antonella Filoia, Mario Testini
Thyroid Surgery, 18 September 2023 [Springer]
Open Access
Abstract
Thyroidectomy is the treatment of choice for benign and malignant thyroid disease. The diagnostic workup has to define the thyroid disease, the therapeutic strategy, and the extension of the potential surgery. Providing patient education is a fundamental step in the surgeon-patient relationship and it is performed before any medical-surgical intervention with the aim of enabling the patient’s conscious self-determination. Patients should be adequately informed by the surgeon about the indications for surgery, alternative treatments, complications and possible permanent consequences. Thyroid surgery is considered a clean procedure, and hence antibiotic prophylaxis should not be routinely employed except under specific conditions. Anesthesia for thyroid surgery requires an experienced team in the recognition, assessment, and management of a potentially difficult airway, in a patient who may also have significant comorbidity. Neuromonitoring is effective for identifying and monitoring the function of the laryngeal nerves. The anesthetist is actively involved in this procedure, in particular as concerns correct positioning of the endotracheal tube and management of the neuromuscular blockade.
Issues of informed consent for non-specialists conducting colorectal cancer screenings
Issues of informed consent for non-specialists conducting colorectal cancer screenings
Forrest Bohler, Allison Garden
Journal Of Osteopathic Medicine, 12 September 2023
Abstract
The United States is currently facing a physician shortage crisis including a lack of specialist providers. Due to this shortage of specialists, some primary care providers offer colorectal cancer screenings in communities with few gastroenterologists, especially in under-resourced areas such as rural regions of the United States. However, discrepancies in training and procedural outcomes raise concerns regarding informed consent for patients. Because osteopathic physicians play a critical role in addressing the physician shortage in these under-resourced communities, this commentary may be especially useful because they are likely to encounter these ethical complexities in their day-to-day practice.
Informed consent for total knee arthroplasty: exploration of patient`s information acquisition and decision-making processes—a qualitative study
Informed consent for total knee arthroplasty: exploration of patient`s information acquisition and decision-making processes—a qualitative study
Research Article
Sandro Zacher, Julia Lauberger, Carolin Thiel, Julia Lühnen, Anke Steckelberg
BMC Health Services, 11 September 2023; 23(978)
Open Access
Abstract
Background
Total knee arthroplasty (TKA) is an option for the treatment of knee osteoarthritis (OA). Patients have high expectations regarding the benefits of the actual operation. Patients can seek a second opinion on the indication for TKA. In a study, less than half of recommended TKAs were confirmed by the second opinion and conservative treatments are not fully utilized. Informed consent forms that are used in Germany usually do not meet the requirements to support informed decision-making. Our aim was to describe the process from the diagnosis of knee OA through the decision-making process to the informed consent process for TKA, and to understand when, how, and by whom decisions are made. Moreover, we wanted to describe patients’ information needs and preferences about knee OA and its treatment, including TKA, and find out what information is provided. We also wanted to find out what information was important for decision-making and identify barriers and facilitators for the optimal use of evidence-based informed consent forms in practice.
Methods
We chose a qualitative approach and conducted semi-structured interviews with patients who were going to receive, have received, or have declined TKA, and with general practitioners (GP), office-based as well as orthopaedists and anaesthesiologists in clinics who obtain informed consent. The interviews were audio-recorded, transcribed and analysed using qualitative content analysis.
Results
We conducted interviews with 13 patients, three GPs, four office-based orthopaedists and seven doctors in clinics who had obtained informed consent. Information needs were modelled on subjective disease theory and information conveyed by the doctors. Patients in this sample predominantly made their decisions without having received sufficient information. Trust in doctors and experiences seemed to be more relevant in this sample than fact-based information. Office-based (GPs, orthopaedists) and orthopaedists in clinics had different understandings of their roles and expectations in terms of providing information.
Conclusions
We were able to identify structural barriers and assumptions that hinder the implementation of evidence-based informed consent forms.
Center for Informed Consent Integrity 