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A Model for Implementing an Interoperable Electronic Consent Form for Medical Treatment Using HL7 FHIR
Abstract
Background: For ethical, legal and administrative reasons, patients have to give explicit consent to a medical treatment. Objectives: This paper identifies the design requirements for electronic treatment consent (eConsent) architecture, and subsequently proposes a model for the eConsent architecture based on the HL7 FHIR® standard. Methods: Six requirements for the eConsent architecture were identified. A conceptual model for the system was then developed to address the identified requirements using HL7 FHIR. Results: The proposed concept makes use of the existingconsent model of HL7 FHIR, and includes additional resources for presenting the information to the patient. Moreover, it uses the SNOMED CT terminology to enable semantic interoperability with other health information systems. Conclusions: The proposed eConsent architecture meets the identified requirements. That said, the system is limited by the low maturity of the implemented FHIR resources and the fact that the terminology is currently inexhaustive for the use case. Custom extensions of the used FHIR resources must be considered.
Background:
One mechanism to increase participation in research is to solicit potential research participants' general willingness to be recruited into clinical trials. Such research permissions and consents typically are collected on paper upon patient registration. We describe a novel method of capturing this information electronically.
Purpose:
The objective is to enable the collection of research permissions and informed consent data electronically to permit tracking of potential research participants' interest in current and future research involvement and to provide a foundation for facilitating the research workflow.
Methods:
The project involved systematic analysis focused on key areas, including existing business practices, registration processes, and permission collection workflows, and ascertaining best practices for presenting consent information to users via tablet technology and capturing permissions data. Analysis was followed by an iterative software development cycle with feedback from subject matter experts and users.
Results:
An initial version of the software was piloted at one institution in South Carolina for a period of 1 year, during which consents and permission were collected during 2524 registrations of patients. The captured research permission data were transmitted to a clinical data warehouse. The software was later released as an open-source package that can be adopted for use by other institutions.
Limitations:
There are significant ethical, legal, and informatics challenges that must be addressed at an institution to deploy such a system. We have not yet assessed the long-term impact of the system on recruitment of patients to clinical trials.
Conclusions:
We propose that by improving the ability to track willing potential research participants, we can improve recruitment into clinical trials and, in the process, improve patient education by introducing multimedia to informed consent documents.
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.
Patient understanding in clinical informed consent is often poor. Little is known about the effectiveness of interventions to improve comprehension or the extent to which such interventions address different elements of understanding in informed consent.
. To systematically review communication interventions to improve patient comprehension in informed consent for medical and surgical procedures. Data Sources. A systematic literature search of English-language articles in MEDLINE (1949-2008) and EMBASE (1974-2008) was performed. In addition, a published bibliography of empirical research on informed consent and the reference lists of all eligible studies were reviewed. Study Selection. Randomized controlled trials and controlled trials with nonrandom allocation were included if they compared comprehension in informed consent for a medical or surgical procedure. Only studies that used a quantitative, objective measure of understanding were included. All studies addressed informed consent for a needed or recommended procedure in actual patients. Data Extraction. Reviewers independently extracted data using a standardized form. All results were compared, and disagreements were resolved by consensus. Data Synthesis. Forty-four studies were eligible. Intervention categories included written information, audiovisual/multimedia, extended discussions, and test/feedback techniques. The majority of studies assessed patient understanding of procedural risks; other elements included benefits, alternatives, and general knowledge about the procedure. Only 6 of 44 studies assessed all 4 elements of understanding. Interventions were generally effective in improving patient comprehension, especially regarding risks and general knowledge. Limitations. Many studies failed to include adequate description of the study population, and outcome measures varied widely.
. A wide range of communication interventions improve comprehension in clinical informed consent. Decisions to enhance informed consent should consider the importance of different elements of understanding, beyond procedural risks, as well as feasibility and acceptability of the intervention to clinicians and patients. Conceptual clarity regarding the key elements of informed consent knowledge will help to focus improvements and standardize evaluations.
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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