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Digitalising Consent in Healthcare: Development of an eConsent Backend
Abstract
One of the key elements for protecting human subjects of research studies and patients
who receive medical treatment is obtaining informed consent. Not only is this about
giving the subject or patient freedom of choice, but it is a whole process that provides
sufficient information, asserts comprehension and later documents the decision made.
Currently, this is very often achieved by oral information sessions, in some cases supported with print-out material, and the later signature of a paper-based consent form.
Transforming it to a digital process of obtaining consent electronically (eConsent) has the
potential for increasing comprehension, data quality and patient empowerment while at
the same time reducing costs.
This thesis identifies eight requirements for an eConsent architecture for research studies
as well as for medical treatment. Subsequently, a backend model for this architecture
based on the HL7 FHIR standard is proposed and implemented as part of an open-source
prototype. The thesis was realised in cooperation with two stakeholders in Toronto,
Canada: The Centre for Global eHealth Innovation and Dr. Alvin Lin.
The proposed concept makes use of the existing consent model of HL7 FHIR, which has
been implemented for the privacy consent use case. Moreover, some extensions of the
standard help meet the requirements while focusing on the capability to auto-generate
a user interface (UI). To enable semantic interoperability with other health information
systems, SNOMED CT is used as an internationally standardised terminology for selected
predefined parts of the information.
The proposed eConsent architecture meets most of the identified requirements. That said, the system is limited by the low maturity of the implemented FHIR resources and the fact that the terminology for the use case is currently not exhaustive. Additional custom extensions of the used FHIR resources or switching to another digital source of information than the proposed FHIR QuestionnaireResponse must be considered.
... In some cases (e.g. where informed consent is obtained remotely using an eConsent system), it is important to verify whether participants understand what they are providing consent to; as such, it is necessary to confirm their knowledge using, for example, a multiple-choice quiz [1]. ...
... • performing studies and surveys such as Case Report Forms (CRF) [4,5] • templating for information display and generation of a user interface (UI) [6] • generation of dynamic forms and forums [7] • implementing scoring systems, e.g. for triage of patients in the emergency department [8] Aside from work published on eConsent [1], the literature does not show any implementations of performing a quiz with FHIR Questionnaires. This paper describes the options for quiz verification that are supported by FHIR. ...
... Listing 1: FHIR quiz Questionnaire using an Extension to identify the correct answers [1,2]. ...
Informed consent of patients to research studies is a cornerstone to modern healthcare, which has lead to considerable administrative effort. The purpose of this paper is to show how forms and questionnaires and their respective answers can be captured in a standardized, structured way, in order to enable automated verification. The use of the HL7 FHIR resources Questionnaire and QuestionnaireResponse is discussed with respect to the different implementation options of Extensions, POST Interceptors, FHIR Operations, and CDS Hooks. These four approaches are described and it is determined whether they produce standard-compliant results and how they can be integrated with other solutions. Since all approaches yield advantages and disadvantages, the choice amongst any option must be based on the actual use case.
A renewed interest by consumer information technology giants in the healthcare domain is focused on transforming smartphones into personal health data storage devices. With the introduction of the open source ResearchKit, Apple provides a framework for researchers to inform and consent research subjects, and to readily collect personal health data and patient reported outcomes (PRO) from distributed populations. However, being research backend agnostic, ResearchKit does not provide data transmission facilities, leaving research apps disconnected from the health system. Personal health data and PROs are of the most value when presented in context along with health system data. Our aim was to build a toolchain that allows easy and secure integration of personal health and PRO data into an open source platform widely adopted across 140 academic medical centers. We present C3-PRO: the Consent, Contact, and Community framework for Patient Reported Outcomes. This open source toolchain connects, in a standards-compliant fashion, any ResearchKit app to the widely-used clinical research infrastructure Informatics for Integrating Biology and the Bedside (i2b2). C3-PRO leverages the emerging health data standard Fast Healthcare Interoperability Resources (FHIR).
Informed consent is an ethical and legal requirement for research involving human participants. It is the process where a participant is informed about all aspects of the trial, which are important for the participant to make a decision and after studying all aspects of the trial the participant voluntarily confirms his or her willingness to participate in a particular clinical trial and significance of the research for advancement of medical knowledge and social welfare. The concept of informed consent is embedded in the principles of Nuremberg Code, The Declaration of Helsinki and The Belmont Report. Informed consent is an inevitable requirement prior to every research involving human being as subjects for study. Obtaining consent involves informing the subject about his or her rights, the purpose of the study, procedures to be undertaken, potential risks and benefits of participation, expected duration of study, extent of confidentiality of personal identification and demographic data, so that the participation of subjects in the study is entirely voluntary. This article provides an overview of issues in informed consent: The obligations of investigator, sponsor and Institutional Review Board to protect rights and welfare of human research subjects. It discusses about the basic elements of informed consent and the process to be followed while obtaining informed consent. Some of the circumstances under which informed consent can be waived and ethical challenges faced by physicians in obtaining informed consent from subjects are also highlighted in this article.
The purpose of this chapter is to illustrate the importance of using open source technologies and common standards for interoperability when implementing eHealth systems, and to illustrate this through case studies, where possible.
The sources used to inform this chapter draw from the implementation and evaluation of the eHealth Program in the context of the Millennium Villages Project (MVP).
As the eHealth Team was tasked to deploy an eHealth architecture, the Millennium Villages Global-Network (MVG-Net), across all 14 of the MVP sites in sub-Saharan Africa, the team not only recognized the need for standards and uniformity but also realized that context would be an important factor. Therefore, the team decided to utilize open source solutions.
The MVP implementation of MVG-Net provides a model for those looking to implement informatics solutions across disciplines and countries. Furthermore, there are valuable lessons learned that the eHealth community can benefit from.
By sharing lessons learned and developing an accessible, open source eHealth platform, we believe that we can more efficiently and rapidly achieve the health-related and collaborative Millennium Development Goals.
The Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009 that was signed into law as part of the "stimulus package" represents the largest US initiative to date that is designed to encourage widespread use of electronic health records (EHRs). In light of the changes anticipated from this policy initiative, the purpose of this paper is to review and summarize the literature on the benefits and drawbacks of EHR systems. Much of the literature has focused on key EHR functionalities, including clinical decision support systems, computerized order entry systems, and health information exchange. Our paper describes the potential benefits of EHRs that include clinical outcomes (eg, improved quality, reduced medical errors), organizational outcomes (eg, financial and operational benefits), and societal outcomes (eg, improved ability to conduct research, improved population health, reduced costs). Despite these benefits, studies in the literature highlight drawbacks associated with EHRs, which include the high upfront acquisition costs, ongoing maintenance costs, and disruptions to workflows that contribute to temporary losses in productivity that are the result of learning a new system. Moreover, EHRs are associated with potential perceived privacy concerns among patients, which are further addressed legislatively in the HITECH Act. Overall, experts and policymakers believe that significant benefits to patients and society can be realized when EHRs are widely adopted and used in a "meaningful" way.
This paper introduces a new client-server messaging engine used to exchange clinical data between various medical software applications. Our portal uses the HL7 (Health Level Seven) messaging standard to provide translated clinical data to HL7 and non-HL7 client applications. We used HL7 because this standard is worldwide used to facilitate the communication between clinical applications.
Informed consent is legally and ethically required before invasive non-emergent procedures. Language barriers make obtaining informed consent more complex.
Determine the impact of language barriers on documentation of informed consent among patients in a teaching hospital with on-site interpreter services.
Matched retrospective chart review study.
Eligible Chinese- and Spanish-speaking patients with limited English proficiency (LEP) who received a thoracentesis, paracentesis, or lumbar puncture were matched with eligible English-speaking patients by procedure, hospital service, and date of procedure.
Charts were reviewed for documentation of informed consent (IC), including a procedure note documenting an IC discussion and a signed consent form. For LEP patients, full documentation of informed consent also included evidence of interpretation, or a consent form in the patient's primary language.
Seventy-four procedures in LEP patients were matched with 74 procedures in English speakers. Charts of English-speaking patients were more likely than those of LEP patients to contain full documentation of informed consent (53% vs 28%; odds ratio (OR): 2.81; 95% CI, 1.42-5.56; p = 0.003). Upon multivariate analysis adjusting for patient and service factors, English speakers remained more likely than LEP patients to have full documentation of informed consent (Adj OR: 3.10; 95% CI, 1.49-6.47; p = 0.003). When examining the components of informed consent, charts of English-speaking and LEP patients were similar in the proportion documenting a consent discussion; however, charts of English speakers were more likely to contain a signed consent form in any language (85% vs 70%, p = 0.03).
Despite the availability of on-site professional interpreter services, hospitalized patients who do not speak English are less likely to have documentation of informed consent for common invasive procedures. Hospital quality initiatives should consider monitoring informed consent for LEP patients.
Objective:
To systematically review audio-visual (AV) interventions for promoting informed consent (IC) in clinical practice and to consider the impact of reading age adjustment.
Methods:
Systematic review of randomized controlled trials (RCTs) comparing AV interventions to standard IC in clinical practice. Outcomes included recall (immediate <1 day; intermediate 1-14 days; late >14 days), satisfaction and anxiety. Data were synthesized using random effects meta-analyses. Comparisons were made between studies that did and did not adjust for participant reading age.
Results:
Of 11,813 abstracts screened, 29 RCTs were eligible (30 intervention arms). Interventions included videos (n=17), computer programs (n=5), electronic presentations (n=3), compact discs (n=3) and websites (n=2). Meta-analysis showed AV interventions improved immediate recall (standardized mean difference [SMD] 0.64, 95% confidence interval [CI] 0.45-0.85). Results for intermediate and late recall were too heterogeneous to synthesize. AV interventions did not consistently affect either satisfaction or anxiety. Adjusting the reading age of interventions improved immediate recall (reading age interventions: adjusted SMD 1.21, 95%CI 0.81-1.61; non-reading age adjusted SMD 0.51, 95%CI 0.36-0.66).
Conclusion:
AV interventions, especially those adjusted for participant reading age, improve immediate information recall for IC. Practice implications Wider use of AV aids is justified when obtaining IC in clinical practice.
Evaluate the evidence regarding the relative effectiveness of multimedia and print as modes of dissemination for patient education materials; examine whether development of these materials addressed health literacy.
A structured literature review utilizing Medline, PsycInfo, and the Cumulative Index to the Nursing and Allied Health Literature (CINAHL), supplemented by reference mining.
Of 738 studies screened, 30 effectively compared multimedia and print materials. Studies offered 56 opportunities for assessing the effect of medium on various outcomes (e.g., knowledge). In 30 instances (54%), no difference was noted between multimedia and print in terms of patient outcomes. Multimedia led to better outcomes vs. print in 21 (38%) comparisons vs. 5 (9%) instances for print. Regarding material development, 12 studies (40%) assessed readability and 5 (17%) involved patients in tool development.
Multimedia appears to be a promising medium for patient education; however, the majority of studies found that print and multimedia performed equally well in practice. Few studies involved patients in material development, and less than half assessed the readability of materials.
Future research should focus on comparing message-equivalent tools and assessing their effect on behavioral outcomes. Material development should include explicit attention to readability and patient input.
To investigate whether SNOMED CT covers the terms used in pre-operative assessment guidelines, and if necessary, how the measured content coverage can be improved.
Pre-operative assessment guidelines were retrieved from the websites of (inter)national anesthesia-related societies. The recommendations in the guidelines were rewritten to "IF condition THEN action" statements to facilitate data extraction. Terms were extracted from the IF-THEN statements and mapped to SNOMED CT. Content coverage was measured by using three scores: no match, partial match and complete match. Non-covered concepts were evaluated against the SNOMED CT editorial documentation.
From 6 guidelines, 133 terms were extracted, of which 71% (n=94) completely matched with SNOMED CT concepts. Disregarding the vague concepts in the included guidelines SNOMED CT's content coverage was 89%. Of the 39 non-completely covered concepts, 69% violated at least one of SNOMED CT's editorial principles or rules. These concepts were categorized based on four categories: non-reproducibility, classification-derived phrases, numeric ranges, and procedures categorized by complexity.
Guidelines include vague terms that cannot be well supported by terminological systems thereby hampering guideline-based decision support systems. This vagueness reduces the content coverage of SNOMED CT in representing concepts used in the pre-operative assessment guidelines. Formalization of the guidelines using SNOMED CT is feasible but to optimize this, first the vagueness of some guideline concepts should be resolved and a few currently missing but relevant concepts should be added to SNOMED CT.
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