Clinical correlates of the ability to consent to research participation in brain metastasis

Clinical correlates of the ability to consent to research participation in brain metastasis
Adam Gerstenecker, Meredith Gammon, Dario Marotta, John Fiveash, Burt Nabors, Kyler Mulhauser, Kristen Triebel
Psycho-Oncology, 20 July 2020
Abstract
Objective
Impairment in the ability to provide informed consent is common in persons with brain metastasis. However, little is known about what factors contribute to this impairment in the patient group. Our objective is to determine if the associations between demographic, cognitive, and clinical variables correlate with the ability to provide informed consent in persons with brain metastasis.
Methods
We administered a comprehensive neuropsychological battery to a group of 61 persons with brain metastasis. Demographic and clinical information was also collected. All diagnoses were made by board‐certified oncologists and were verified histologically. Statistical analyses included Pearson’s product‐moment correlations, point biserial correlations, and linear regression.
Results
Results indicated that combinations of education, verbal memory, executive function, whole brain radiation therapy, and chemotherapy affected various aspects of the ability to provide informed consent. Subsequent regression models demonstrated that these variables contributed a significant amount of shared variance to the ability to provide informed consent.
Conclusion
We found that the ability of persons with brain metastasis to provide informed consent is a cognitively-complex ability that is also affected by education and treatment variables. This information can help clinical researchers in identifying persons with brain metastasis at risk of an impaired ability to provide informed consent and aid in the consenting process.

Enabling data sovereignty for patients through digital consent enforcement

Enabling data sovereignty for patients through digital consent enforcement
Arno Appenzeller, Ewald Rode profile imageEwald Rode, Erik  Krempel profile imageErik Krempel, Jürgen Beyerer profile imageJürgen Beyerer
PETRA ’20: Proceedings of the 13th ACM International Conference on PErvasive Technologies Related to Assistive Environments, June 2020; 33 pp 1-4
Abstract
Digital medical data offers an opportunity to improve medical diagnosis and caregiving. While a single doctor might not have enough patients to spot significant factors, data becomes much more evaluable once different doctors combine their data. Data evaluation across multiple data sources will be more practical with the increasing level of digitalization. While the potential benefits of a broad data analysis are enormous, there is a huge potential privacy impact for patients. To cope with legal regulations, for example the European General Data Protection Regulation (GDPR) and to give patients more control over the usage of their data, new tools are needed. Digital distributed patient records need a mechanism to manage a digital declaration of consent. There are some concepts how to digitize medical consent, but still there is no complete workflow that automatically evaluates and enforces consent for the usage of personal medical data. In this paper we will present a continuous digital consent enforcement workflow. Patients can define a detailed declaration of consent for their medical data and researchers can request data through a dedicated interface that enforces that consent. We show the feasibility of this workflow by presenting a prototype implementation and evaluating the system against defined requirements for informed consent.

Processes of consent in research for adults with impaired mental capacity nearing the end of life: systematic review and transparent expert consultation (MORECare_Capacity statement)

Processes of consent in research for adults with impaired mental capacity nearing the end of life: systematic review and transparent expert consultation (MORECare_Capacity statement)
Research Article
J. Evans, E. Yorganci, P. Lewis, J. Koffman, K. Stone, I. Tunnard, B. Wee, W. Bernal, M. Hotopf, I. J. Higginson, Deborah Tanner, Claire Henry, Gunn Grande, Steve Dewar, Gareth Owen, Rachel Burman, Dimitrios Adamis, Michael Dunn, Scott Kim, Simon Woods & Rowena Vohora
BMC Medicine, 22 July 2020; 18(221)
Open Access
Abstract
Background
Involving adults lacking capacity (ALC) in research on end of life care (EoLC) or serious illness is important, but often omitted. We aimed to develop evidence-based guidance on how best to include individuals with impaired capacity nearing the end of life in research, by identifying the challenges and solutions for processes of consent across the capacity spectrum.
Methods
Methods Of Researching End of Life Care_Capacity (MORECare_C) furthers the MORECare statement on research evaluating EoLC. We used simultaneous methods of systematic review and transparent expert consultation (TEC). The systematic review involved four electronic databases searches. The eligibility criteria identified studies involving adults with serious illness and impaired capacity, and methods for recruitment in research, implementing the research methods, and exploring public attitudes. The TEC involved stakeholder consultation to discuss and generate recommendations, and a Delphi survey and an expert ‘think-tank’ to explore consensus. We narratively synthesised the literature mapping processes of consent with recruitment outcomes, solutions, and challenges. We explored recommendation consensus using descriptive statistics. Synthesis of all the findings informed the guidance statement.
Results
Of the 5539 articles identified, 91 met eligibility. The studies encompassed people with dementia (27%) and in palliative care (18%). Seventy-five percent used observational designs. Studies on research methods (37 studies) focused on processes of proxy decision-making, advance consent, and deferred consent. Studies implementing research methods (30 studies) demonstrated the role of family members as both proxy decision-makers and supporting decision-making for the person with impaired capacity. The TEC involved 43 participants who generated 29 recommendations, with consensus that indicated. Key areas were the timeliness of the consent process and maximising an individual’s decisional capacity. The think-tank (n = 19) refined equivocal recommendations including supporting proxy decision-makers, training practitioners, and incorporating legislative frameworks.
Conclusions
The MORECare_C statement details 20 solutions to recruit ALC nearing the EoL in research. The statement provides much needed guidance to enroll individuals with serious illness in research. Key is involving family members early and designing study procedures to accommodate variable and changeable levels of capacity. The statement demonstrates the ethical imperative and processes of recruiting adults across the capacity spectrum in varying populations and settings.

Ethical and Regulatory Issues for Embedded Pragmatic Trials Involving People Living with Dementia

Ethical and Regulatory Issues for Embedded Pragmatic Trials Involving People Living with Dementia
Emily A. Largent, Spencer Phillips Hey, Kristin Harkins, Allison K. Hoffman, Steven Joffe, Julie C. Lima, Alex John London, Jason Karlawish
Journal of the American Geriatrics Society, 26 June 2020
Abstract
Embedded pragmatic clinical trials (ePCTs) present an opportunity to improve care for people living with dementia (PLWD) and their care partners, but they also generate a complex constellation of ethical and regulatory challenges. These challenges begin with participant identification. Interventions may be delivered in ways that make it difficult to identify who is a human subject and therefore who needs ethical and regulatory protections. The need for informed consent, a core human subjects protection, must be considered but can be in tension with the goals of pragmatic research design. Thus it is essential to consider whether a waiver or alteration of informed consent is justifiable. If informed consent is needed, the question arises of how it should be obtained because researchers must acknowledge the vulnerability of PLWD due in part to diminished capacity and also to increased dependence on others. Further, researchers should recognize that many sites where ePCTs are conducted will be unfamiliar with human subjects research regulations and ethics. In this report, the Regulation and Ethics Core of the National Institute on Aging Imbedded Pragmatic Alzheimer’s disease (AD) and AD‐related dementias (AD/ADRD) Clinical Trials (IMPACT) Collaboratory discusses key ethical and regulatory challenges for ePCTs in PLWD. A central thesis is that researchers should strive to anticipate and address these challenges early in the design of their ePCTs as a means of both ensuring compliance and advancing science.

Adolescent Barriers to HIV Prevention Research: Are Parental Consent Requirements the Biggest Obstacle?

Adolescent Barriers to HIV Prevention Research: Are Parental Consent Requirements the Biggest Obstacle?
Original Article
Seema K. Shah, Zaynab Essack, Katherine Byron, Catherine Slack, Daniel Reirden, Heidi van Rooyen, Nathan R. Jones, David S. Wendler
Journal of Adolescent Health, 5 July 2020
Abstract
Purpose
One third of people newly living with HIV/AIDS are adolescents. Research on adolescent HIV prevention is critical owing to differences between adolescents and adults. Parental permission requirements are often considered a barrier to adolescent enrollment in research, but whether adolescents view this barrier as the most important one is unclear
Methods
Adolescents were approached in schools in KwaZulu-Natal, South Africa, and at a sexually transmitted infection clinic at the Children’s Hospital of Aurora, Colorado. Surveys with a hypothetical vignette about participation in a pre-exposure prophylaxis trial were conducted on smartphones or tablets with 75 adolescents at each site. We calculated descriptive statistics for all variables, using 2-sample tests for equality of proportions with continuity correction. Statistical significance was calculated at p < 0.05. Multivariate analyses were also conducted.
Results
Most adolescents thought side effects (77%) and parental consent requirements (69%) were very important barriers to research participation. When asked to rank barriers, adolescents did not agree on a single barrier as most important, but the largest group of adolescents ranked parental consent requirements as most important (29.5%). Parental consent was seen as more of a barrier for adolescents in South Africa than in the United States. Concerns about being experimented on or researchers’ mandatory reporting to authorities were ranked much lower. Finally, most (71%, n = 106) adolescents said they would want to extra support from another adult if parental permission was not required.
Conclusion
Adolescents consider both parental permission requirements and side effects important barriers to their enrollment in HIV prevention research. Legal reform and better communication strategies may help address these barriers.

Level of education and preferred language of informed consent for clinical research in a multi-lingual community

Level of education and preferred language of informed consent for clinical research in a multi-lingual community
Grace Muzanyi, Isaac Sekitoleko, John L Johnson, Jane Lunkuse, Gladys Nalugwa, Joanita Nassali, David Kaawa Mafigiri
African Health Sciences, June 2020; 20(2)
Open Access
Abstract
Background
Low education levels and language barriers present challenges in obtaining informed consent for clinical research.
Objective
To describe and correlate the association between the level of education and the participant’s preferred language of consent.
Design
Descriptive-analytical cross-sectional study.
Participants
Adults being consented for participation in tuberculosis (TB) research studies in an East African community with varying levels of education.
Procedures
We analyzed data on demographic and educational characteristics collected from adults being consented for participation in TB studies. Only participants who could understand and speak Luganda (the main local language) or English (the official language of Uganda) were included in this analysis.
Results
A total of 523 participants were consented between April 2015 and December 2017 and included in this analysis; 250 below Senior four ( 13yrs of education). We noted that the preference for English rises with the rising levels of education and peaked at beyond senior six (83%Vs17%,OR=49,95%CI:22.8-106.3,p<0.001).Participants below senior four preferred Luganda Vs senior four and above(OR=16.9,95%CI:9.9-28.8,p<0.001)
Conclusion
Rising education levels of participants were associated with preference for English language usage during initial consent for clinical research studies.

Training Surgeons and the Informed Consent Discussion in Paediatric Patients: A Qualitative Study Examining Trainee Participation Disclosure

Training Surgeons and the Informed Consent Discussion in Paediatric Patients: A Qualitative Study Examining Trainee Participation Disclosure
Chang, K. Bhanot, S. Grant, A. Fecteau, M. Camp
Orthopaedic Proceedings, 17 July 2020; 102-B supplement 6
Open Access
Excerpt
The process of obtaining informed consent is an important and complex pursuit, especially within a paediatric setting. Medical governing bodies have stated that the role of the trainee surgeon must be explained to patients and their families during the consent process. Despite this, attitudes and practices of surgeons and their trainees regarding disclosure of the trainee’s participation during the consent process has not been reported in the paediatric setting.

Nineteen face-to-face interviews were conducted with surgical trainees and staff surgeons at a tertiary level paediatric hospital in Toronto, Canada. These were transcribed and subsequently thematically coded by three reviewers…

Evaluating the Patient and Setting-Specific Factors That Influenced the Quality of Informed Consent in a Retrospective Cohort of Subtotal Cholecystectomy Patients

Evaluating the Patient and Setting-Specific Factors That Influenced the Quality of Informed Consent in a Retrospective Cohort of Subtotal Cholecystectomy Patients
Mina Mesri, Ikemsinachi C. Nzenwa, Raimundas Lunevicius
Journal of Laparoendoscopic & Advanced Surgical Techniques, 13 July 2020
Abstract
Introduction
Cholecystectomy is the most frequently performed procedure in general surgery. The consent procedure for cholecystectomy needs to inform patients about the possibility of subtotal cholecystectomy (STC) as an alternative procedure used for “difficult gallbladders” as it is associated with increased postoperative morbidity. We sought to determine the quality of informed consent for patients who were scheduled for cholecystectomy but underwent STC, and evaluate whether patient or procedural factors influenced the information discussed in consenting.
Materials and Methods
We classified 57 components of information necessary for a patient to give informed consent for cholecystectomy. We retrospectively reviewed the consent forms of patients scheduled for conventional cholecystectomy but instead undergoing STC between 2011 and 2017. Consent quality was measured as the percentage of components completed. Subgroup analyses were conducted to determine whether age, gender, American Society of Anesthesiologists grade, setting (elective/nonelective), operation mode (open/laparoscopic), or the responsible surgeon affected consent quality.
Results
Across 174 patients, just 9 (5.2%) had been informed about the possibility of undergoing STC, whereas the overall quality of consent was 37.5%. Patient and setting-specific factors affected the completion of specific consent components. Patients were more likely to receive a patient information leaflet if they were female (relative risk [RR] 2.76; 95% confidence interval [CI] 1.09–7.00), <60 years (RR 3.32; 95% CI 1.39–7.90) or undergoing laparoscopic surgery (RR 8.04; 95% CI 2.50–25.88).
Conclusion
The suboptimal quality of consent and multiple inconsistencies in the information disclosed to different patient cohorts emphasize the need for a more transparent and consistent consenting process.

The patient and clinician experience of informed consent for surgery: a systematic review of the qualitative evidence

The patient and clinician experience of informed consent for surgery: a systematic review of the qualitative evidence
Research Article
J. Convie, E. Carson, D. McCusker, R. S. McCain, N. McKinley, W. J. Campbell, S. J. Kirk & M. Clarke
BMC Medical Ethics, 11 July 2020; 21(58)
Open Access
Abstract
Background
Informed consent is an integral component of good medical practice. Many researchers have investigated measures to improve the quality of informed consent, but it is not clear which techniques work best and why. To address this problem, we propose developing a core outcome set (COS) to evaluate interventions designed to improve the consent process for surgery in adult patients with capacity. Part of this process involves reviewing existing research that has reported what is important to patients and doctors in the informed consent process.
Methods
This qualitative synthesis comprises four phases: identification of published papers and determining their relevance; appraisal of the quality of the papers; identification and summary of the key findings from each paper while determining the definitiveness of each finding against the primary data; comparison of key themes between papers such that findings are linked across studies.
Results
Searches of bibliographic databases returned 11,073 titles. Of these, 16 studies met the inclusion criteria. Studies were published between 1996 and 2016 and included a total of 367 patients and 74 health care providers. Thirteen studies collected data using in-depth interviews and constant comparison was the most common means of qualitative analysis. A total of 94 findings were extracted from the primary papers and divided into 17 categories and ultimately 6 synthesised findings related to: patient characteristics, knowledge, communication, the model patient, trust and decision making.
Conclusions
This qualitative meta-aggregation is the first to examine the issue of informed consent for surgery. It has revealed several outcomes deemed important to capture by patients and clinicians when evaluating the quality of a consent process. Some of these outcomes have not been examined previously in research comparing methods for informed consent. This review is an important step in the development of a COS to evaluate interventions designed to improve the consent process for surgery.

Readability of the informed consent forms in Flanders using the Douma index: Analyzing the documents that help patients make decisions

Readability of the informed consent forms in Flanders using the Douma index: Analyzing the documents that help patients make decisions
Research Article
María del Valle Ramírez-Durán, María del Valle Coronado-Vázquez, María Isabel Mariscal-Crespo
Clinical Ethics, 9 July 2020
Abstract
Informed consent forms have been useful in clinical practice and they constitute a part of the shared decision making in the informed consent process. They provide information to patients about clinical procedures and techniques. They also act as a remainder of the information discussed after the medical interview. Sometimes these documents are not readable to everybody. Belgian law specifies that all information that patients receive has to be proportionate verbally, but written information is also handled. The present research analyzes the readability of the Flemish informed consent forms located in the webs of all General Hospitals using a simple random sample of 75 informed consent forms.

By using the Douma tool, which bases its analysis in the length of words and sentences, the readability mean of the sample was 46, level “Difficult”. The 59% of them had a difficult level. The 11% were normal. It is a fact, then, that the 59% of the informed consent forms evaluated in this study are not suitable for everybody in Flanders, especially those people with low literacy. There were some researches made in other countries that agreed with these results. Written clinical information was poorly written so the informed consent forms were not working helping patients to recall information nor helping patients to become a part in the shared decision making about their health. The use of readability formulas represented a simple way to discriminate those informed consent forms that had normal readability scores from those that should be adapted.