Dataset Information

Meta-consent for the secondary use of health data within a learning health system: a qualitative study of the public's perspective.

ABSTRACT:

Background

The advent of learning healthcare systems (LHSs) raises an important implementation challenge concerning how to request and manage consent to support secondary use of data in learning cycles, particularly research activities. Current consent models in Quebec were not established with the context of LHSs in mind and do not support the agility and transparency required to obtain consent from all involved, especially the citizens. Therefore, a new approach to consent is needed. Previous work identified the meta-consent model as a promising alternative to fulfill the requirements of LHSs, particularly large-scale deployments. We elicited the public's attitude toward the meta-consent model to evaluate if the model could be understood by the citizens and would be deemed acceptable to prepare for its possible implementation in Quebec.

Methods

Eight focus groups, with a total of 63 members of the general public from various backgrounds were conducted in Quebec, Canada, in 2019. Explicit attention was given to literacy levels, language spoken at home and rural vs urban settings. We assessed attitudes, concerns and facilitators regarding key components of the meta-consent model: predefined categories to personalized consent requests, a dynamic web-based infrastructure to record meta-consent, and default settings. To analyse the discussions, a thematic content analysis was performed using a qualitative software.

Results

Our findings showed that participants were supportive of this new approach of consent as it promotes transparency and offers autonomy for the management of their health data. Key facilitators were identified to be considered in the implementation of a meta-consent model in the Quebec LHSs: information and transparency, awareness campaigns, development of educational tools, collaboration of front-line healthcare professionals, default settings deemed acceptable by the society as well as close partnerships with recognized and trusted institutions.

Conclusions

This qualitative study reveals the openness of a sample of the Quebec population regarding the meta-consent model for secondary use of health data for research. This first exploratory study conducted with the public is an important step in guiding decision-makers in the next phases of implementing the various strategies to support access and use of health data in Quebec.

SUBMITTER: Cumyn A

PROVIDER: S-EPMC8240433 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:Introduction:A major consideration for the implementation of a learning health system (LHS) is consent from participants to the use of their data for research purposes. The main objective of this paper was to identify in the literature which types of consent have been proposed for participation in research observational activities in a LHS. We were particularly interested in understanding which approaches were seen as most feasible and acceptable and in which context, in order to inform the development of a Quebec-based LHS. Methods:Using a scoping review methodology, we searched scientific and legal databases as well as the gray literature using specific terms. Full-text articles were reviewed independently by two authors on the basis of the following concepts: (a) LHS and (b) approach to consent. The selected papers were imported in NVivo software for analysis in the light of a conceptual framework that distinguishes various, largely independent dimensions of consent. Results:A total of 93 publications were analysed for this review. Several studies reach opposing conclusions concerning the best approach to consent within a LHS. However, in the light of the conceptual framework we developed, we found that many of these results are distorted by the conflation between various characteristics of consent. Thus, when these characteristics are distinguished, the results mainly suggest the prime importance of the communication process, by contrast to the scope of consent or the kind of action required by participants (opt-in/opt-out). We identified two models of consent that were especially relevant for our purpose: metaconsent and dynamic consent. Conclusions:Our review shows the importance of distinguishing carefully the various features of the consent process. It also suggests that the metaconsent model is a valuable model within a LHS, as it addresses many of the issues raised with regards to feasibility and acceptability. We propose to complement this model by adding the modalities of the information process to the dimensions relevant in the metaconsent process.

Project description:BackgroundSecondary use of health data has reached unequaled potential to improve health systems governance, knowledge, and clinical care. Transparency regarding this secondary use is frequently cited as necessary to address deficits in trust and conditional support and to increase patient awareness.ObjectiveWe aimed to review the current published literature to identify different stakeholders' perspectives and recommendations on what information patients and members of the public want to learn about the secondary use of health data for research purposes and how and in which situations.MethodsUsing PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines, we conducted a scoping review using Medline, CINAHL, PsycINFO, Scopus, Cochrane Library, and PubMed databases to locate a broad range of studies published in English or French until November 2022. We included articles reporting a stakeholder's perspective or recommendations of what information patients and members of the public want to learn about the secondary use of health data for research purposes and how or in which situations. Data were collected and analyzed with an iterative thematic approach using NVivo.ResultsOverall, 178 articles were included in this scoping review. The type of information can be divided into generic and specific content. Generic content includes information on governance and regulatory frameworks, technical aspects, and scientific aims. Specific content includes updates on the use of one's data, return of results from individual tests, information on global results, information on data sharing, and how to access one's data. Recommendations on how to communicate the information focused on frequency, use of various supports, formats, and wording. Methods for communication generally favored broad approaches such as nationwide publicity campaigns, mainstream and social media for generic content, and mixed approaches for specific content including websites, patient portals, and face-to-face encounters. Content should be tailored to the individual as much as possible with regard to length, avoidance of technical terms, cultural competence, and level of detail. Finally, the review outlined 4 major situations where communication was deemed necessary: before a new use of data, when new test results became available, when global research results were released, and in the advent of a breach in confidentiality.ConclusionsThis review highlights how different types of information and approaches to communication efforts may serve as the basis for achieving greater transparency. Governing bodies could use the results: to elaborate or evaluate strategies to educate on the potential benefits; to provide some knowledge and control over data use as a form of reciprocity; and as a condition to engage citizens and build and maintain trust. Future work is needed to assess which strategies achieve the greatest outreach while striking a balance between meeting information needs and use of resources.

Project description:BackgroundDigital health solutions have great potential to change the way health care is delivered, including better clinical outcomes and improved processes and access to health services. However, the adoption of mobile health (mHealth) solutions for patient monitoring has been rather slow in Switzerland. The reasons are complex, and a better understanding is needed to leverage the full potential of mHealth.ObjectiveThis study aimed to deepen the understanding of the potential relevance and influence of mHealth for the health system and health care provision, and factors influencing its adoption. The findings will be used to provide an outlook on feasible recommendations for action.MethodsWe conducted a qualitative survey using a maximum variation sample of a heterogeneous group of stakeholders (N=50) in the Swiss health care system with a profound knowledge of digital health and medical devices. A semistructured interview guide including open- and closed-ended questions was used to address questions around mHealth relevance and its influence on the health system, the relevance of selected determinants for mHealth adoption, and important influencing factors. A content analysis method was applied.ResultsOverall, respondents thought that mHealth would have a beneficial impact on the Swiss health system but that its adoption would evolve slowly. We derived 23 key opportunities regarding patient and patient pathway, treatment of disease, and diseases and health conditions. High consistency in answers among respondents was observed for treatment of disease. Stakeholders' attitudes toward mHealth adoption along the relevance of 23 preselected determinants were relatively consistent. However, we obtained diverging attitudes regarding the influence of trends, enablers, and restraints in Switzerland and translated them into 26 key themes influencing mHealth adoption. Relevant trends comprise changing needs and expectations of patients, a rising need for efficient health care delivery, growing interest in improved outpatient care, and emerging technologies and progressing digitization. Important enablers include growing demand for new financing schemes and incentive concepts, rising demand for comprehensive information on and stronger body of evidence for mHealth use cases, and increasing need for easy to use alternate care approaches. Challenging restraints are rigidness of thinking and siloed actions of health system actors, complexity of changing the existing regulations and structures, little understanding of mHealth use and the role of clinicians, and risk of further polarization of the population.ConclusionsThis study provides a comprehensive look at mHealth in the Swiss health system. It becomes apparent that strong governance is inevitable to foster a sustainable data strategy and to reconcile the different interests of stakeholders. The use of mHealth will add value but will not necessarily reduce the burden on the system caused by emerging societal needs and changing disease prevalence.

Project description:ObjectiveA mixed-methods study exploring the UK general public's views towards consent for the use of biosamples for biomedical research.SettingCross-sectional population-based focus groups followed by an online survey.Participants12 focus groups (81 participants) selectively sampled to reflect a range of demographic groups; 1110 survey responders recruited through a stratified sampling method with quotas set on sex, age, geographical location, socioeconomic group and ethnicity.Main outcome measures(1) Views on the importance of consent when donating residual biosamples for medical research; (2) preferences for opt-in or opt-out consent approaches and (3) preferences for different consent models.ResultsParticipants believed obtaining consent for use of residual biosamples was important as it was 'morally correct' to ask, and enabled people to make an active choice and retain control over their biosamples. Survey responders preferred opt-in consent (55%); the strongest predictor was being from a low socioeconomic group (OR 2.22, 95% CI 1.41 to 3.57, p=0.001) and having a religious affiliation (OR 1.36, 95% CI 1.01 to 1.81, p=0.04). Focus group participants had a slight preference for opt-out consent because by using this approach more biosamples would be available and facilitate research. Concerning preferred models of consent for research use of biosamples, survey responders preferred specific consent with recontact for each study for which their biosamples are eligible. Focus group participants preferred generic consent as it provided 'flexibility for researchers' and reduced the likelihood that biosamples would be wasted. The strongest predictor for preferring specific consent was preferring opt-in consent (OR 4.58, 95% CI 3.30 to 6.35, p=0.015) followed by non-'White' ethnicity (OR 2.94, 95% CI 1.23 to 7.14, p<0.001).ConclusionsThere is a preference among the UK public for ongoing choice and control over donated biosamples; however, increased knowledge and opportunity for discussion is associated with acceptance of less restrictive consent models for some people.

Project description:BackgroundDespite progress in developing learning health systems (LHS) and associated metrics of success, a gap remains in identifying measures to guide the implementation and assessment of the impact of an oncology LHS. Our aim was to identify a balanced set of measures to guide a person-centered oncology LHS.MethodsA modified Delphi process and clinical value compass framework were used to prioritize measures for tracking LHS performance. A multidisciplinary group of 77 stakeholders, including people with cancer and family members, participated in 3 rounds of online voting followed by 50-minute discussions. Participants rated metrics on perceived importance to the LHS and discussed priorities.ResultsVoting was completed by 94% of participants and prioritized 22 measures within 8 domains. Patient and caregiver factors included clinical health (Eastern Cooperative Oncology Group Performance Status, survival by cancer type and stage), functional health and quality of life (Patient Reported Outcomes Measurement Information System [PROMIS] Global-10, Distress Thermometer, Modified Caregiver Strain Index), experience of care (advance care planning, collaboRATE, PROMIS Self-Efficacy Scale, access to care, experience of care, end-of-life quality measures), and cost and resource use (avoidance and delay in accessing care and medications, financial hardship, total cost of care). Contextual factors included team well-being (Well-being Index; voluntary staff turnover); learning culture (Improvement Readiness, compliance with Commission on Cancer quality of care measures); scholarly engagement and productivity (institutional commitment and support for research, academic productivity index); and diversity, equity, inclusion, and belonging (screening and follow-up for social determinants of health, inclusivity of staff and patients).ConclusionsThe person-centered LHS value compass provides a balanced set of measures that oncology practices can use to monitor and evaluate improvement across multiple domains.

Project description:BackgroundData collected during routine health care and ensuing analytical results bear the potential to provide valuable information to improve the overall health care of patients. However, little is known about how patients prefer to be informed about the possible usage of their routine data and/or biosamples for research purposes before reaching a consent decision. Specifically, we investigated the setting, the timing and the responsible staff for the information and consent process.MethodsWe performed a quasi-randomized controlled trial and compared the method by which patients were informed either in the patient admission area following patient admission by the same staff member (Group A) or in a separate room by another staff member (Group B). The consent decision was hypothetical in nature. Additionally, we evaluated if there was the need for additional time after the information session and before taking the consent decision. Data were collected during a structured interview based on questionnaires where participants reflected on the information and consent process they went through.ResultsQuestionnaire data were obtained from 157 participants in Group A and 106 participants in Group B. Overall, participants in both groups were satisfied with their experienced process and with the way information was provided. They reported that their (hypothetical) consent decision was freely made. Approximately half of the interested participants in Group B did not show up in the separate room, while all interested participants in Group A could be informed about the secondary use of their routine data and left-over samples. No participants, except for one in Group B, wanted to take extra time for their consent decision. The hypothetical consent rate for both routine data and left-over samples was very high in both groups.ConclusionsThe willingness to support medical research by allowing the use of routine data and left-over samples seems to be widespread among patients. Information concerning this secondary data use may be given by trained administrative staff immediately following patient admission. Patients mainly prefer making a consent decision directly after information is provided and discussed. Furthermore, less patients are informed when the process is organized in a separate room.