Online unsupervised performance-based cognitive testing: a feasible and reliable approach to scalable cognitive phenotyping of Parkinson’s patients
Nasri Balit, Sophie Sun, Yilin Zhang, Madeleine Sharp
MedRxiv, 5 July 2024
Abstract
Introduction
A better understanding of the heterogeneity in the cognitive and mood symptoms of Parkinson’s disease will require research conducted in large samples of patients. Fully online and remote research assessments present interesting opportunities for scaling up research but the feasibility and reliability of remote and fully unsupervised performance-based cognitive testing in individuals with Parkinson’s disease is unknown. This study aims to establish the feasibility and reliability of this testing modality in Parkinson’s patients.
Methods
Sixty-seven Parkinson’s patients and 36 older adults completed two sessions of an at-home, online battery of five cognitive tasks and three self-report questionnaires. Feasibility was established by examining completion rates and data quality. Test-retest reliability was evaluated using the Intraclass Correlation Coefficient (ICC (2,1)).
Results
Overall completion rates and data quality were high with few participant exclusions across tasks. With regards to test-retest reliability, intraclass correlation coefficients were quite variable across measures extracted from a task as well as across tasks, but at least one standard measure from each task achieved moderate to good reliability levels. Self-report questionnaires achieved a higher test-retest reliability than cognitive tasks. Feasibility and reliability were similar between Parkinson’s patients and older adults.
Conclusion
These results demonstrate that remote and unsupervised testing is a feasible and reliable method of measuring cognition and mood in Parkinson’s patients that achieves levels of test-retest reliability that are comparable to those reported for standard in-person testing.

Designing Value-Centered Consent Interfaces: A Mixed-Methods Approach to Support Patient Values in Data-Sharing Decisions
David Leimstädtner, Peter Sörries, Claudia Müller-Birn
arXiv, 4 July 2024
Abstract
In the digital health domain, ethical data collection practices are crucial for ensuring the availability of quality datasets that drive medical advancement. Data donation, allowing patients to share their clinical data for secondary research use, presents a promising resource for such datasets. Yet, current consent interfaces mediating data-sharing decisions are found to favor data-collectors’ values by leveraging cognitive biases in data-subjects towards higher data-sharing rates. Seeking to establish patient-centered data collection practices in digital health, we investigate the design of consent interfaces that support end-users in making valuecongruent health data-sharing decisions. Focusing our research efforts on the situated context of health data donation at the psychosomatic unit of a German university hospital, we demonstrate how a human-centered design can ground technology within the perspective of a vulnerable group. We employed an exploratory sequential mixed-method approach consisting of five phases: (1) Participatory workshops explore patient values, informing the (2) design of a proposed Value-Centered Consent Interface. A (3) online experiment demonstrates our interface element’s effect, increasing value-congruence in data-sharing decisions. Our proposed consent interface design is then adapted to the research context through a (4) co-creation workshop with subject experts and (5) a user evaluation with patients. Our work contributes to recent discourse in CSCW concerning ethical implications of new data practices within their socio-technological context by exploring patient values on medical data sharing, introducing a novel consent interface leveraging reflection to support value-congruent decision-making, and providing a situated evaluation of the proposed consent interface with patients.

Consent Considerations for Generation and Sharing of Genomic Data
Review
Charles D. Warden
Preprints.org, 25 June 2024
Abstract
It is important to consider both requirements and limitations for the generation and sharing of genomic data. For example, human genomic sequence data should typically not be deposited publicly without the appropriate “explicit consent” to do so. This includes genetic identifying data that may exist within raw reads for bulk RNA Sequencing (RNA-Seq) data and genomic data from cell lines that are available to purchase. At the same time, data sharing is important for re-analysis and reproducibility/replication in the scientific community. A review of known rules and guidelines for genomic data sharing is provided. This includes specific rules for NIH-funded data for controlled access deposit of HeLa cell line data, including bulk RNASeq data. The ability to create “partial” Gene Expression Omnibus (GEO) public deposits with only processed data is described, with search criteria that can identify many “partial” GEO deposits for a variety of data types where reads were not made public for patient privacy concerns. However, it is the opinion of the author that this should be considered a short-term solution, and additional considerations and action should be carried out for genomic data generated in future experiments. Information about how to learn more about what is known for consent for cell line samples is also briefly provided, along with search results for genomic data from widely available cell lines that is deposited in controlled access databases. Finally, it should be made clear that this article presents some amount of opinion. Additionally, open feedback for this preprint is encouraged to further enhance knowledge and communication.

Informed Consent Practices Among Emergency Staff for Patients Undergoing Emergency Surgery in the Emergency Surgical Units of Two Tertiary Teaching Hospitals in Uganda: A Qualitative Study
Research Article
Olivia Kituuka, Ian Munabi, Moses Galukande, Adelline Twimukye, Erisa Mwaka
BMC Medical Ethics, 25 June 2024
Abstract
Background
Staff in low resourced emergency units of a low-income country face the challenge of obtaining informed consent for incapacitated patients or their next of kin in a time-constrained situation often in an overcrowded environment. Therefore, we aimed to establish the informed consent practices for emergency surgical care among healthcare professional at two emergency surgical units at two tertiary teaching hospitals in Uganda.
Methods
In October 2022 – February 2023we conducted key informant interviews in Uganda and purposively selected 16 staff in surgical emergency units at two tertiary teaching hospitals and directly observed the informed consent practices. Data was managed and analyzed inductively using NVivo version 12.
Results
Six themes emerged from key informant interviews including knowledge and perspectives no informed consent; processes, procedures, and practices regarding informed consent; communication strategies for informed consent; ethical considerations; benefits of informed consent during surgery; and challenges to emergency informed consent. Staff had adequate knowledge about informed consent but faced several challenges during the consent process due to lack of guiding institutional policies. Overall, the informed consent process was inadequate at both institutions with greeting of patients, disclosure of risks and assessment of understanding poorly done. Consent was conducted in a noisy environment at both institutions and there was no privacy in the public hospital.
Conclusion
Although knowledge about consent practices by emergency staff at both institutions was good, in practice there was inadequate disclosure of risks, inadequate knowledge about the surgical procedure, risks, and benefits. Emergency staff identified the need for procedure specific consent documents which capture the information that is given to the patient and guiding policies on consent for incapacitated patients who have no surrogates.

Designing e-consent protocols for pragmatic clinical trials: case studies from a UKCRC clinical trials unit
Matt Hammond, Polly Ashford, Juliet High, Lucy Clark, Gregory Howard, Megan Jones, Susan Stirling, Claire West
BMC Trials, 22 May 2024
Abstract
Background
Interest in and use of electronic consent (e-consent) in the conduct of academic clinical trials has increased since the COVID-19 pandemic. E-consent offers advantages including increased efficiency and accessibility, and reduced burden on site staff, which can be appealing to academic trialists anticipating challenges in recruitment to complex trial designs or with limited funding. However, there are many options to consider when using e-consent in a study protocol. This paper presents five case studies from Norwich Clinical Trials Unit, demonstrating how e-consent models can be effectively tailored to the needs of different trials. These examples illustrate the options around and benefits of e-consent, the acceptability of e-consent by participants, and the design considerations that were made during the development of the trial protocols.
Case Studies
Five randomised trials are presented, selected from a range of different trial designs, disease areas, interventions, and patient populations. E-consent was either offered as an alternative to paper consent, according to participant preference, or as the sole method of consent. E-consent was generally used to facilitate remote consent in decentralised trials but was also chosen to increase efficiency and reduce burden in an emergency department setting. The technical implementation of e-consent and detailed participant procedures were tailored to the needs of the trial settings and patient populations. For example, accompanying participant information sheets were provided in paper or electronic form, and electronic signatures could be typed or drawn. Administrative data on uptake of e-consent is presented where available.
Conclusion
This paper demonstrates that the operational and technical aspects of implementing e-consent in clinical trials can be influenced by the trial design, the needs and characteristics of the trial population, financial/efficiency considerations, and level of risk. E-consent is not a one-size-fits-all tool for trials, and its use should be carefully considered during the development of the trial protocol, in conjunction with patient and public involvement contributors, site staff and other trial stakeholders.

Development and validation of a stakeholder-driven, self-contained electronic informed consent platform for trio-based genomic research studies
Bethany Y Norton, James Liu, Sara A Lewis, Helen Magee, Tyler N Kruer, Rachael Dinh, Somayeh Bakhtiari, Sandra H. Nordlie, Sheetal Shetty, Jennifer Heim, Yumi Nishiyama, Jorge Arango, Darcy Johnson, Lee Seabrooke, Mitchell Shub, Robert Rosenberg, Michele Shusterman, Stephen Wisniewski, Blair Cooper, Erin Rothwell, Michael C Fahey, M. Wade Shrader, Nancy Lennon, Joyce Oleszek, Wendy Pierce, Hannah Fleming, Mohan Belthur, Jennifer Tinto, Garey Noritz, Laurie Glader, Kelsey Steffan, William Walker, Deborah Grenard, Bhooma Aravamuthan, Kristie Bjornson, Malin Joseph, Paul Gross, Michael C Kruer, the Cerebral Palsy Research Network
medRxiv, 3 May 2024
Abstract
    Increasingly long and complex informed consents have yielded studies demonstrating comparatively low participant comprehension and satisfaction with traditional face-to-face approaches. In parallel, interest in electronic consents for clinical and research genomics has steadily increased, yet limited data are available for trio-based genomic discovery studies. We describe the design, development, implementation, and validation of an electronic iConsent application for trio-based genomic research deployed to support genomic studies of cerebral palsy. iConsent development incorporated stakeholder perspectives including researchers, patient advocates, institutional review board members, and genomic data-sharing considerations. The iConsent platform integrated principles derived from prior electronic consenting research and elements of multimedia learning theory. Participant comprehension was assessed in an interactive teachback format. The iConsent application achieved nine of ten proposed desiderata for effective patient-focused electronic consenting for genomic research.

Overall, participants demonstrated high comprehension and retention of key human subjects’ considerations. Enrollees reported high levels of satisfaction with the iConsent, and we found that participant comprehension, iConsent clarity, privacy protections, and study goal explanations were associated with overall satisfaction. Although opportunities exist to optimize iConsent, we show that such an approach is feasible, can satisfy multiple stakeholder requirements, and can realize high participant satisfaction and comprehension while increasing study reach.

Piloting electronic informed consenting in a pneumococcal human infection study in Blantyre, Malawi
Research Article
Clara Ngoliwa, Chikondi Chakwiya, Joel Gondwe, Edna Nsomba, Vitumbiko Nkhoma, Modesta Reuben, Linda Chantunga, Pemphero Liwonde, Edward Mangani, Evaristar Kudowa, Lumbani Makhaza, Neema Toto, Tiferanji Sochera, Tarsizio Chikaonda, Ben Morton, Marc Y.R. Henrion, Dingase Dula, Stephen B. Gordon, Anthony E. Chirwa
Wellcome Open Research, 29 April 2024
Open Access
Abstract
Background
Electronic consent can potentially improve accuracy, workflow, and overall patient experience in clinical research but
has not been used in Malawi, owing to uncertainty about data security and technical support.
Objectives
We explored the feasibility of using electronic consent (e-consent) in an ongoing human infection study in Blantyre Malawi. We dual-consented participants by both electronic and paper methods to assess the feasibility of electronic consent, and then compared benefits and challenges of the two methods.
Methods
The approved paper consent forms were digitized using Open Data Kit (ODK). Following participant information giving by the research staff, healthy literate adult participants with no audio-visual impairments completed a self-administered e-consent and provided an electronic signature. Signed e-consent forms were uploaded to a secure study server. While the participants were in clinic, the signed electronic consent form was printed as a copy for the participant. The feasibility, advantages and disadvantages including data safety consideration for e-consenting were evaluated by exploring issues surrounding use of e-consenting versus paper-based consenting. Consent forms were analysed by research staff for errors such as overwriting and legibility.
Results
We piloted 109 participants to e-consenting. It was found to be user friendly, had 0% (n 0/109) errors compared to 43.1% (n 47/109) in paper based methods along with enhanced data safety. The challenges included difficult digitization of ethics stamped documents, volunteer unfamiliarity with tablet user interface and its requirement for a working internet and printer.
Conclusion
E-consenting was feasible but required additional resource investment. Benefits included error minimization and data security.