Informed Consent Process Research Articles

WP8.15 - Systematic Review and Meta-Analysis of Non-Interactive multimedia interventions used In the Informed Consent Process

Abstract Introduction Non interactive multimedia interventions in the form of educational videos regarding a proposed intervention have been increasingly used to enhance information given during informed consent. This review aimed to assess the impact of this modality. Methods This was a subgroup analysis of a larger systematic review and meta-analysis conducted in accordance with a predefined protocol registered on PROSPERO (CRD42023380406). Five databases were searched using pre-defined search criterion in December 2022 for randomised trials of non-interactive multimedia interventions designed to improve the informed consent process. Adults > 18 years with the capacity to consent were included. The Cochrane risk of Bias (ROB) tool was used to assess study quality. Effect measurements were assessed using standard mean differences and risk ratios for continuous variables and dichotomous variables respectively. Meta- analyses were performed using Review Manager (RevMan) version 5.4. Results 49 studies contributing 6149 patients met the inclusion criteria. 43 studies were conducted in an elective setting across a variety of surgical, radiological, endoscopic, oncological, and medical disciplines. Statistically significant Improvement was demonstrated, in subjective understanding (SMD 0.31, 95% CI 0.07 to 0.54 I2 = 0%), immediate (SMD 0.97, 95% CI 0.78 to 1.17, I2=75%), short (SMD 0.77, 95% CI 0.21 to 1.34, I2 = 90% ), long-term knowledge (SMD 1.23, 95% CI 0.26 to 2.19, I2=86%) and satisfaction the informed consent process. (SMD 0.32, (95% CI 0.16 to 0.49, I2 = 74%). Conclusions This review provides a global overview of the impact of non-interactive multimedia interventions demonstrating improvement in numerous outcomes measures. These intervention types should be considered as an informational adjunct during the informed consent process.

WP7.15 - Surgical dogma… Why change?

Abstract Aims Surgical dogma still persists today despite up-to-date evidence. Implementation of evidence into clinical practice takes on average 17 years. Acute appendicitis is typically managed with surgery, despite evidence recommending a non-operative, antibiotic-only strategy as an appropriate first line treatment in uncomplicated cases. This study investigates barriers to, and facilitators of, changing practice with regards to management of acute appendicitis. Methods Surgeons involved in emergency general surgery in U.K. hospitals were invited to participate in online/telephone semi-structured interviews. Thematic analysis based on the theoretical domains framework was used to develop belief statements. Results 16 interviews were conducted to achieve data saturation. 8 consultant surgeons, 8 surgical trainees from secondary and tertiary centres participated. Numerous barriers and facilitators were identified. There is a lack of awareness of current research with variable interpretation of evidence and its practical applications. There were concerns regarding loss of training opportunities in a “benchmark” procedure; failure of treatment and subsequent complications; missed malignancy and cost implications. Surgeons identified a reluctance to change from long standing practice and recognised their communication may skew patients’ decision making. Decision making practice varied from paternalistic to shared/supported. Surgeons believe they undertake a fully informed consent process, despite some not offering non-operative management as an alternative treatment. Conclusions Numerous barriers and facilitators exist to implementing change and are often based on surgeons’ personal experiences rather than evidence. The identified factors will be used to develop an implementation strategy to drive evidence-based practice and may be transferable to other surgical conditions.

Patient and Physician Communication in the Allogeneic Transplantation Setting: Challenges and Potential Solutions

Allogeneic hematopoietic cell transplantation is a challenging treatment characterized by multiple morbidities, the need for long-term care, and a significant mortality risk. Consequently, close patient and physician communication throughout treatment is crucial. We aimed to review the literature examining patient and physician communication around critical aspects experienced by allogeneic survivors over the transplantation trajectory, such as the informed consent process, transplantation-related morbidity (eg, psychosocial distress, cognitive dysfunction, sexuality), adherence to treatment, and the use of complementary and alternative medicine, as well as interventions and strategies to improve patient and physician communication. We found a paucity of studies examining communication on these topics. Nevertheless, there is evidence of significant communication gaps around morbidities often experienced by allogeneic survivors, such as psychosocial distress, fatigue, and sexual functioning, due to both patient and physician barriers. Similarly, there is a concern that gaps also exist when addressing the informed consent process, cognitive dysfunction, adherence to treatment, and use of complementary and alternative medicine. The use and discussion of patient-reported outcome measures as part of clinical care is associated with patient and physician satisfaction with communication and better detection and management of symptoms. Although other strategies, such as decision aids, question prompt lists, and communication skills training, have improved communication in oncology, they have not been tested in the allogeneic setting. Future research is clearly needed to examine patient and physician communication in the allogeneic transplantation setting and test strategies to improve communication during this challenging treatment.

Assessment of awareness and knowledge of Good Samaritan Law in the general literate population - A cross-sectional study in Telangana.

Road traffic injuries are the eighth leading cause of death in India. The Law Commission of India report says that 50% of the victims who died of preventable injuries could have been saved had they received the medical care on time. To protect the people who help road accident victims, Good Samaritan Law was enacted. To assess awareness and knowledge about Good Samaritan Law among the general literate population and to assess the impact of awareness session on awareness score. In this cross-sectional study, adult participants of either gender, literate enough to read and comprehend the material provided, were included in the study through either an electronic or written informed consent process. The participants were asked to complete a questionnaire, watch/read the awareness video/material provided, and then complete the post-awareness session questionnaire. The participants were divided into the aware and unaware groups for further assessment of pre-awareness scores. The pre- and post-awareness session scores were compared in the participants using paired-t-test. In this study, 379 participants gave consent for participation; however, only 288 participants attempted the post-awareness questionnaire. The mean pre-awareness session score was significantly higher in the aware group (8.5) as compared to the unaware group (5.6). The pre-awareness scores were significantly high in doctors as compared to medical students in the aware group and as compared to medical students, graduates, teachers, and general public in the unaware group. Post-awareness session scores (9.2 ± 2.8) were observed to be significantly higher (p < 0.001) than pre-awareness session scores (6.4 ± 3.4). In this study, it was observed that the percentage of participants who were aware of the law was less. It demonstrated the impact of awareness session on increasing GSL awareness score in participants. These findings indicate the need of awareness programs to transform bystanders into good samaritans.

Distinguishing Therapeutic Misconception from Religious Belief.

In the context of early-phase clinical trials, research subjects often confuse the differences between clinical research and personal treatment. This phenomenon, known as therapeutic misconception, potentially undermines the validity of informed consent. Several interventions have been proposed to help mitigate therapeutic misconception, although few have considered the role of religious belief. This is a notable omission, given that an association between therapeutic misconception and religious belief has been shown to exist. This perspective calls for more research into the nature of the association between therapeutic misconception and religious belief and suggests a framework that may help clinicians and researchers distinguish between the two, thereby bolstering the informed consent process.

Individualized clinical decisions within standard-of-care pragmatic clinical trials: Implications for consent.

Pragmatic clinical trials of standard-of-care interventions compare the relative merits of medical treatments already in use. Traditional research informed consent processes pose significant obstacles to these trials, raising the question of whether they may be conducted with alteration or waiver of informed consent. However, to even be eligible, such a trial in the United States must have no more than minimal research risk. We argue that standard-of-care pragmatic clinical trials can be designed to ensure that they are minimal research risk if the random assignment of an intervention in a pragmatic clinical trial can accommodate individualized, clinically motivated decision-making for each participant. Such a design will ensure that the patient-participants are not exposed to any risks beyond the clinical risks of the interventions, and thus, the trial will have minimal research risk. We explain the logic of this view by comparing three scenarios of standard-of-care pragmatic clinical trials: one with informed consent, one without informed consent, and one recently proposed design called Decision Architecture Randomization Trial. We then conclude by briefly showing that our proposal suggests a natural way to determine when to use an alteration versus a waiver of informed consent.

“These Researchers Think They Come From Heaven with Analytical Superpowers When They Don’t”: A Qualitative Analysis of Research Experiences in Intersex-Related Studies

This article explores diverse ethical considerations related to the study of vulnerable population groups to produce meaningful project outcomes that avoid harm to the involved communities. In the specific context of the intersex community, previous analyses have encountered various challenges, including the medicalization of intersex people’s bodies, the use of pathologizing language, and misrepresentation of the population’s needs. The article explores some of the beliefs, experiences, and tools that experts in research ethics, researchers, and intersex research participants consider most important regarding research ethics in intersex-related studies. The article is based on original empirical research; semi-structured interviews were conducted with 21 participants, recruited through email and snowball sampling methods, and the data were examined using thematic analysis. It moves from issues related to the research design (positionality, researcher preparation, framing intersex within the LGBT acronym) to experiences related to the research development (ethical approval, informed consent process, language use, relationship of trust). The article describes some of the major concerns and raises discussions that could be relevant for the development of future research under human rights-based perspectives. The findings are aimed to be useful beyond the field of intersex-related studies, as they can be relevant to research about other communities that have endured violations of their human rights during research.

Enhancing patient informed consent in elective skin cancer surgeries: a comparative study of traditional and digital approaches in a German public hospital

BackgroundThis study aims to investigate the integration of modern sources of patient information, such as videos, internet-based resources, and scientific abstracts, into the traditional patient informed consent process in outpatient elective surgeries. The goal is to optimize the informed consent experience, enhance patient satisfaction, and promote shared decision making (SDM) between patients and surgeons. By exploring different patient informed consent formats and their impact on patient satisfaction, this research seeks to improve healthcare practices and ultimately enhance patient outcomes. The findings of this study will contribute to the ongoing efforts to improve the informed consent process in public hospitals and advance patient-centred care.MethodsData collection occurred at the day care clinic of a prominent German public hospital, forming an integral component of a prospective clinical investigation. The study exclusively focused on individuals who had undergone surgical intervention for skin cancer. For the purpose of meticulous data examination, the statistical software SPSS version 21 was harnessed. In the course of this study, a chi-square test was aptly employed. Its purpose was to scrutinize the nuances in patient experiences pertaining to informed consent across four distinct categories, viz., oral informed consent discussion (Oral ICD), written informed consent discussion (Written ICD), video-assisted informed consent discussion (video-assisted ICD), and digitally assisted informed consent discussion (digital-assisted ICD). The primary dataset of this inquiry was diligently gathered via a structured questionnaire administered to a targeted cohort of 160 patients. Within this sample, a balanced representation of genders was observed, encompassing 82 males and 78 females. Their collective age span ranged from 18 to 92 years, with an average age of 71 years. A randomized selection methodology was employed to include participants in this study during the period spanning from July 2017 to August 2018.ResultsSignificant differences were observed across the groups for all research questions, highlighting variations in patient responses. Video-assisted and digital-assisted IC were rated as superior in patient satisfaction with information compared to written and oral IC. Demographic profiles of the four study groups were found to be comparable.ConclusionThe findings of this study indicate that the incorporation of digital technologies in the informed consent process can enhance patient understanding during outpatient elective skin cancer surgeries. These results have important implications for increasing patient satisfaction and improving the SDM process within the hospital environment.

Complications of Hardware Removal in Pediatric Orthopaedic Surgery.

Hardware removal (HR) is one of the most common surgical procedures in pediatric orthopaedics. Surgeons advocate for HR for a variety of reasons, including to limit peri-implant fracture risk, restore native anatomy for adult reconstruction surgery, permit bone growth and development, and mitigate implant-related pain/irritation. To our knowledge, no recent study has investigated the characteristics and complications of HR in pediatric orthopaedics. The goal of this study is to report the prevalence and complications of hardware removals across all of pediatric orthopaedic surgery. A retrospective case series was conducted of all hardware removals from 2012 to 2023 performed at a single urban tertiary-care children's hospital. Cases were identified using CPT codes/billing records. Spinal hardware and cases for which hardware was either implanted or explanted at an outside hospital were excluded. Patient demographic and clinical data were recorded. For patients with multiple hardware removals, each case was recorded independently. A total of 2585 HR cases for 2176 children met study criteria (57.7% male; mean age 12.3±4.4y). The median postoperative follow-up time was 1.7 months (interquartile range: 0.6 to 6.9). The most common sites of hardware removal were the femur/knee (32.7%), tibia/fibula/ankle (19.3%), and pelvis/hip (18.5%). The most common complications included sustained, new-onset postoperative pain (2.6%), incomplete hardware removal (1.6%), and perioperative fracture (1.4%). The overall complication rate of hardware removal was 9.5%. Eighty-eight percent of patients who underwent hardware removal for pain experienced pain relief postoperatively. HR >18 months after insertion had a 1.2x higher odds of overall complication (P=0.002) and 3x higher odds of incomplete removal/breakage (P<0.001) than hardware removed 9 to 18 months after insertion. The overall complication rate of hardware removal across a large series in the pediatric population was 9.5%. Despite hardware removal being one of the most common and often routine procedures in pediatric orthopaedics, the complication rate is not benign. Surgeons should inform patients and families about the likelihood of success and the risks of incomplete removal during the informed consent process. IV.

Impact of Educational Videos on Patient Understanding of Interventional Radiology Procedures

Under-awareness of Interventional Radiology (IR) care by the public has been reported. The aim of this study is to evaluate the impact of educational videos to facilitate better patient understanding during the informed consent process. Educational videos for six common IR procedures including chemoembolization, radioembolization, ablation, tunneled central venous catheter placement, port placement, and port removal were developed for educating patients in the pre-procedural setting. One hundred and eighty patients referred to a tertiary academic institution were randomly selected to participate, including 30 patients per procedure type. Anonymous seven question, five-point Likert-scale assessments were administered to the participants before and after engaging with the videos. The survey evaluated patients' perceived understanding of IR procedures and satisfaction with the videos as educational tools. One hundred and eighty patients completed the survey. Comparing post-video to pre-video ratings, there was an increase in patients' understanding of the involved anatomy (4.5 vs 3.3; p<0.01), understanding of procedure benefits (4.6 vs 3.7; p<0.01), understanding of procedural risks (4.5 vs 3.3; p<0.01), understanding of procedural alternatives (3.4 vs 2.7; p<0.01), and overall procedural understanding (4.7 vs 3.4; p<0.01). Additionally, patients had a positive impression of the videos with a mean overall satisfaction rating of the video-assisted explanation of 4.80. A patient-centric video-assisted informed consent for IR procedures enhances patients' understanding and results in high patient satisfaction.

Should Obtaining Informed Consent Be Considered an Entrustable Professional Activity? Insights From Whether and How Attendings Entrust Surgical Trainees.

Because residents are frequently delegated the task of obtaining consent early in their training, the American Association of Medical Colleges describes "obtaining informed consent" as a core entrustable professional activity (EPA) for medical school graduates. However, prior studies demonstrated that residents frequently perform this task without receiving formal instruction or assessment of competency. This study sought to understand how attending physicians decide to delegate obtaining informed consent for surgical procedures to trainees. The authors conducted a survey of attending surgeons at a university-based health care system of 6 affiliated teaching hospitals (October-December 2020) to collect data about current entrustment practices and attendings' knowledge, experience, and attitudes surrounding the informed consent process. Summary statistics and bivariate analyses were applied. Eighty-five attending surgeons participated (response rate, 49.4%) from diverse specialties, practice types, and years in practice. Fifty-eight of 85 (68.2%) stated they "never" granted responsibility for the consent conversation to a trainee, and 74/81 (91.4%) reported they typically repeated their own consent conversation whenever a trainee already obtained consent. The most common reasons they retained responsibility for consent were ethical duty (69/82, 84.1%) and the patient relationship (65/82, 79.3%), while less than half (40/82, 48.8%) described concerns about trainee competency. Reflecting on hypothetical clinical scenarios, increased resident competency did not correspond with increased entrustment ( P = .27-.62). Nearly all respondents (83/85, 97.7%) believed residents should receive formal training; however, only 41/85 (48.2%) felt additional training and assessment of residents might change their current entrustment practices. Attendings view informed consent as an ethical and professional obligation that typically cannot be entrusted to trainees. This practice is discordant with previous literature studying residents' perspectives. Furthermore, resident competency does not play a predominant role in this decision, calling into question whether informed consent can be considered an EPA.

Factors Influencing the Quality and Extent of the Informed Consent Process in Patients Undergoing Surgical Procedures: A Cross-Sectional Study.

Background Informed consent is an essential component of medical practice, particularly in surgical procedures, as it guarantees that patients are thoroughly informed of the risks, benefits, and alternatives prior to receiving treatment. Nevertheless, research has demonstrated that patients frequently fail to recall critical information that was conveyed during the informed consent process, which emphasizes the potential for communication and comprehension deficiencies. Objective The objective of this study was to evaluate the quality of informed consent and the decision-making preferences of patients who are undergoing surgical procedures. Methodology A cross-sectional survey was conducted among 239 hospitalized patients who were scheduled for elective surgeries at a tertiary hospital in Muscat. The survey assessed patients' satisfaction with the process, preferences for decision-making, and comprehension of informed consent. Non-parametric correlation analysis was implemented to analyze the data. Results The consent form was signed by the majority of patients themselves (96.7%), with a median age range of 36-45 years and a relatively balanced gender distribution. For the remaining cases, where patients were unable to sign, the consent forms were signed by surrogates. The majority of patients were Omani nationals (96.7%), with a mixture of school and postgraduate education. The study did not identify any substantial disparities in the provision of informed consent between patients who received consent details in the outpatient clinic and those who received them in the ward. Although a small number of patients, particularly those with higher education, found the explanations unclear, the quality of the explanations was generally rated as explicit and sufficient. The ability to ask further questions, the degree of explanation, the explanation of alternative options, involvement in decision-making, the time to consider before making a decision, and the ability to repeat the explanation given were all positively correlated with satisfaction with the informed consent process. Conclusion The study emphasizes the significance of patient engagement and effective communication in the informed consent process. In order to improve patient satisfaction and comprehension, healthcare providers should prioritize interactive and comprehensive communication. It is imperative that policymakers establish policies that guarantee patients are afforded sufficient time and opportunity to comprehend the risks, advantages, and alternatives of surgical procedures.

Perceptions, experiences, and motivation of COVID-19 vaccine trial participants in South Africa: a qualitative study

BackgroundThe informed consent process is an important step in conducting ethical clinical trials, as it ensures that research participants are aware of their rights and responsibilities in clinical trials. This study explored participants’ perceptions, experiences and the factors motivating their participation in a COVID-19 vaccine trial in South Africa.MethodsThis descriptive qualitative study was conducted among twenty-five adult participants (18 to 64 years old) who participated in a COVID-19 vaccine trial in South Africa. Three focus group discussions and fifteen semi-structured interviews were carried out. Data were collected at a Clinical Research Site located in Prince Mshiyeni Memorial Hospital, in Umlazi Township, Durban, South Africa, where the COVID-19 vaccine trial participants were initially enrolled. Data were analysed iteratively using a thematic analysis approach.ResultsFour key findings emerged: 1) Participants who experienced an event (such as tested positive for COVID-19) during the clinical trial were more likely to talk about the informed consent more thoroughly compared to the other participants. 2) Participants understood the purpose of informed consent process better when it was repeated multiple times throughout the course of the trial. 3) Where participants did not recall or understand various elements of the informed consent, participants were likely to create their own interpretations. 4) Factors influencing participations in trials were reimbursement for participation, access to health care, protection of family members, and ability to socialize without fear of COVID-19.ConclusionOverall, the findings show that the informed consent process should be regarded as an ongoing process rather than a once-off event that only happens at the start of a clinical trial. An understanding of participants’ perspectives, experiences, and motivations for participating in clinical trials, can help trial staff strengthen the consent documents and processes.

Perspectives on Spare Embryos amongst IVF users: An Exploratory Study from a Selected District of the Southern Indian State of Karnataka.

Perspectives of IVF users on their spare embryos is a less explored subject in the Indian context despite the country's population and abundance of IVF clinics. We conducted a qualitative study using in-depth interviews in a selected district of the Indian state of Karnataka. Seven individuals were recruited independently of any assistance from an IVF clinic. The interviews explored participants' knowledge and perception of the spare embryos using a set of guiding questions exploring the theme of the informed consent process, views on research, preferences for embryo donation, the role of family and the dynamics of decision-making, amongst other things. The interviews were qualitatively analysed using Corbin and Strauss's grounded theory approach. Our findings reveal that the participants do not learn about the prospects of spare embryos from the very start of their IVF journeys, and they may not be informed about the various options available to decide the fate of the spare embryos. Irrespective of their views on research and moral perceptions of embryos, participants expressed a sense of responsibility and ownership towards their embryos and a general reluctance to donate them. Our findings have implications for guiding future inquiries on this subject, which can better the informed consent process and unravel the role of ownership in the ethics of spare embryos in the Indian context.

Quality of Informed Consent in Phase III Clinical Trials in Portugal: The Participants' Perspective.

Some studies show that participants do not always fully understand the informed consent form (ICF), which is one of the reasons for dropouts. This study aimed to adapt the Quality of Informed Consent (QuIC) questionnaire into a valid instrument to be applied to the Portuguese population and to measure its reliability and validity in the Portuguese population, by applying it to a sample of participants in controlled trials. The QuIC questionnaire was developed to assess the quality of informed consent in clinical trials and consists of two parts, addressing both the objective (part A) and the subjective (part B) understanding. After being translated and validated into Portuguese, it was implemented in 100 cardiac participants of phase III clinical trials in a University Hospital Center. The QuIC-PT questionnaire showed excellent stability over time and good validity. All patients evaluated their participation and their health positively and recognized the main purpose of the clinical trial. Almost all participants understood their role in helping future patients and the purpose of the trial and realized that, by signing the ICF, they were participating in a clinical trial. However, none of them knew that their experimental treatment was not proven to be the best alternative for their condition. The QuIC-PT questionnaire seems to be a valid and useful instrument to evaluate the participants' understanding of the ICF. In this study, we found that some concepts, like 'study protocol' or 'randomization', were not well understood by participants when signing the ICF, especially by participants with lower education levels. They also believed that the experimental intervention would solve their health condition. Greater awareness about the importance of the informed consent process and ICF is necessary so that participants can fully understand the protocol, especially the risks involved, and their rights as participants.

Surfactants and the importance of informed consent: Nurturing culturally competent care in healthcare settings.

Culturally competent healthcare improves patient satisfaction and clinical outcomes. Many drugs, dressings and implants have human or animal-derived content which may conflict with patients' religious beliefs, and may even have medicolegal implications. This cross-sectional study (anonymous web-based survey) was done to understand the informed consent process followed by paediatricians and neonatologists in India, their views regarding disclosure pertaining to the animal origin of exogenous surfactants to patients' families, and their willingness and ability to provide alternative surfactants based on parental preferences. A total of 114 neonatologists/paediatricians involved in neonatal care and using surfactants in their practice responded to the survey. Although 61(53.5%) neonatal care units stocked two or more brands of surfactant in their inventory, only 38(33.3%) units had both bovine and porcine preparations. Most (104, 91.2%) of the doctors always take parental consent before administering surfactants; but only a few (12,10.5%) said they always inform parents about its animal origin. None of the respondents offer parents a choice between bovine or porcine-origin surfactants, most (73, 64%) presuming that it would be irrelevant for the parents. However, many respondents (27, 23.7%) mentioned that they want to offer the choice to parents but are unable to do so because they do not stock both bovine and porcine preparations. Although most parents might agree to a life-saving medicine in emergency situations, this does not mean they do not want to be informed. Healthcare professionals should not have a dismissive attitude to parental belief systems. They must use the antenatal period to take the cultural/spiritual history and the necessary consent.

Care for sexual health in oncology survey: Discussions about sexual health with people with cancer in the context of the obligation to provide informed consent

PurposeThe purpose of this paper is to describe the impacts of cancer treatment on sexual health in a sample of people who had been treated for mixed types of cancer; to describe discussions they had with professionals about sexual health that occurred during cancer care; and to consider the extent to which these discussions were sufficient to enable participants to give informed consent for the sexual side effect of cancer treatment. MethodA cross-sectional, online survey using a convenience sample of people with cancer was recruited via UK cancer charities. Eligibility criteria included having received treatment and follow-up care for any type of cancer in the UK during the previous 10 years. Univariate analysis was conducted using SPSS. Results136 people with cancer participated in this survey. The majority of participants reported having experienced a worsening of their sexual lives, which bothered them. Whilst 33.6% of the sample (n = 125) reported having discussed sexual health during their cancer care, only 5.4% reported that a healthcare professional initiated a pre-treatment discussion about the sexual side effects of cancer treatment. ConclusionsThese results suggest that the proportion of participants who were provided with sufficient information to give informed consent for the sexual side effects of cancer treatment was very low. This indicates that healthcare professionals may require specific advice on how to include this topic during the informed consent process.

Interactive Health Technology Tool for Kidney Living Donor Assessment to Standardize the Informed Consent Process: Usability and Qualitative Content Analysis.

Kidney living donation carries risks, yet standardized information provision regarding nephrectomy risks and psychological impacts for candidates remains lacking. This study assesses the benefit of interactive health technology in improving the informed consent process for kidney living donation. The Kidney Hub institutional open portal offers comprehensive information on kidney disease and donation. Individuals willing to start the kidney living donation process at Helsinki University Hospital (January 2019-January 2022) were invited to use the patient-tailored digital care path (Living Donor Digital Care Path) included in the Kidney Hub. This platform provides detailed donation process information and facilitates communication between health care professionals and patients. eHealth literacy was evaluated via the eHealth Literacy Scale (eHEALS), usability with the System Usability Scale (SUS), and system utility through Likert-scale surveys with scores of 1-5. Qualitative content analysis addressed an open-ended question. The Kidney Hub portal received over 8000 monthly visits, including to its sections on donation benefits (n=1629 views) and impact on donors' lives (n=4850 views). Of 127 living kidney donation candidates, 7 did not use Living Donor Digital Care Path. Users' ages ranged from 20 to 79 years, and they exchanged over 3500 messages. A total of 74 living donor candidates participated in the survey. Female candidates more commonly searched the internet about kidney donation (n=79 female candidates vs n=48 male candidates; P=.04). The mean eHEALS score correlated with internet use for health decisions (r=0.45; P<.001) and its importance (r=0.40; P=.01). Participants found that the Living Donor Digital Care Path was technically satisfactory (mean SUS score 4.4, SD 0.54) and useful but not pivotal in donation decision-making. Concerns focused on postsurgery coping for donors and recipients. Telemedicine effectively educates living kidney donor candidates on the donation process. The Living Donor Digital Care Path serves as a valuable eHealth tool, aiding clinicians in standardizing steps toward informed consent. ClinicalTrials.gov NCT04791670; https://clinicaltrials.gov/study/NCT04791670. RR2-10.1136/bmjopen-2021-051166.

Improving Clinical Communication: a qualitative study on the Informed Consent

In the context of the Patient-Centred Care paradigm (Epstein et al., 2005; Suojanen et al., 2012) and the shift toward the psychobiological model (Dean &amp; Street, 2015; Muñoz &amp; García-Izquierdo, 2020), there is a growing demand for the patient to be an active agent in the management of their health. Clinical communication should be conveyed accurately and empathetically (Bellés Fortuño &amp; García-Izquierdo, forthcoming), especially in complex legal genres such as the Informed Consent (IC). The research carried out by the Gentt research group up-to-date has revealed that there is no specific monitoring with the use of IC protocols in clinical practice. In this paper, we present the results of a qualitative pilot study with a group of practitioners from the Valencian Community (Spain). A focus group was conducted where the articulation of communication with patients was analyzed. The study tries to define the practical insights of using the IC to draw conclusions that can improve clinical communication. Results show that MPs generally consider that the IC process needs improvement, especially when considering closeness with patients to enhance communication.

Coerced consent in clinical research: study protocol for a randomized controlled trial

BackgroundDespite the low-risk nature of participation in most clinical anesthesia trials, subject recruitment on the same day as surgery is often restricted due to the concerns of researchers and local research ethics boards that same-day consent may not afford adequate time and opportunity for patients to weigh and make decisions, as well as perceptions of patient vulnerability immediately prior to surgery that could impact the voluntary nature and the rigor of the informed consent process. However, specialties such as anesthesiology, critical care, interventional radiology, and emergency medicine have a varied pattern of practice and patient acquaintance that does not typically afford the luxury of time or, in many cases, advance consent for participation in research. Indeed, the initial encounter between anesthesiologists and patients undergoing elective procedures routinely occurs on the day of surgery. Concerns of coercion related to same-day consent for clinical anesthesia research trials have not been borne out in the literature, and represent a significant obstacle to clinical researchers, as well as to the patients who are denied opportunities for potential benefit through participation in research studies.MethodsWe describe the protocol for a prospective randomized controlled trial examining the voluntariness of patient consent, solicited either in advance of surgery or on the same day, to participate in an anesthesia research study at Women’s College Hospital. One hundred fourteen patients scheduled to undergo ambulatory anterior cruciate ligament repair facilitated by general anesthesia with an adductor canal block will be randomized for recruitment either (a) in the pre-operative assessment clinic before the day of surgery or (b) on the day of surgery, to be approached for consent to participate in a fabricated research study of adjunct medications in adductor canal blocks. Regardless of allocation, patients in both groups will receive the same routine standard of care and will complete a post-operative questionnaire to signal perceptions of undue influence in the process of providing informed consent for the fabricated trial.DiscussionThis study will inform trial design and practice guidelines surrounding the amount of time patients ought to be afforded in order to make durable decisions to participate (or not) in clinical research studies. This is expected to impact trial recruitment in a variety of clinical settings where researchers have only brief opportunities to interface with patients.Trial registrationThe trial was registered prospectively on the Open Science Framework (OSF), registration #46twc, on 2023-Mar-17.