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Original research
Electronic consent in clinical care: an international scoping review
  1. Susan Chimonas1,
  2. Allison Lipitz-Snyderman1,
  3. Konstantina Matsoukas2 and
  4. Gilad Kuperman3
  1. 1Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York, USA
  2. 2MSK Library, Memorial Sloan Kettering Cancer Center, New York, New York, USA
  3. 3Health Informatics, Memorial Sloan Kettering Cancer Center, New York, New York, USA
  1. Correspondence to Dr Susan Chimonas; chimonas{at}mskcc.org

Abstract

Objective Digital technologies create opportunities for improvement of consenting processes in clinical care. Yet little is known about the prevalence, characteristics or outcomes of shifting from paper to electronic consenting, or e-consent, in clinical settings. Thus questions remain around e-consent’s impact on efficiency, data integrity, user experience, care access, equity and quality. Our objective was to scope all known findings on this critical topic.

Materials and methods Through an international, systematic scoping review, we identified and assessed all published findings on clinical e-consent in the scholarly and grey literatures, including consents for telehealth encounters, procedures and health information exchanges. From each relevant publication, we abstracted data on study design, measures, findings and other study features.

Main outcome measures Metrics describing or evaluating clinical e-consent, including preferences for paper versus e-consenting; efficiency (eg, time, workload) and effectiveness (eg, data integrity, care quality). User characteristics were captured where available.

Results A total of 25 articles published since 2005, most from North America or Europe, report on the deployment of e-consent in surgery, oncology and other clinical settings. Experimental designs and other study characteristics vary, but nearly all focus on procedural e-consents. Synthesis reveals relatively consistent findings around improved efficiency and data integrity with, and user preferences for, e-consent. Care access and quality issues are less frequently explored, with disparate findings.

Discussion and conclusion The literature is nascent and largely focused on issues that are immediate and straightforward to measure. As virtual care pathways expand, more research is urgently needed to ensure that care quality and access are advanced, not compromised, by e-consent.

  • Informed consent
  • telemedicine
  • digital technology

Data availability statement

Data are available upon reasonable request. All data relevant to the study are included in the article or uploaded as supplementary information. All data are available upon reasonable request, and have also been included as supplementary materials.

http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjhci-2022-100726

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    What is already known on this topic

    • Automation promises to improve consenting processes in clinical care. Yet little is known about the consequences of moving from paper to electronic consenting, or e-consent, in clinical settings.

    What this study adds

    • The literature is nascent but indicates improved efficiency, data integrity and user experience with e-consent. Care access, equity and quality issues are seldom explored, with disparate findings.

    How this study might affect research, practice or policy

    • As telehealth and other virtual care pathways expand, efforts are needed to ensure that e-consent promotes, rather than undermines, care quality, access and equity.

    Introduction

    The advent of digital capabilities is impacting all aspects of healthcare delivery, a trend accelerated by the COVID-19 pandemic.1–3 Electronic health records are now the norm, and interactions between patients and providers increasingly are electronic. Implementing electronic consenting (e-consent) for procedures, health information exchanges and other clinical purposes represents another opportunity for automation.4 While consent processes are designed to protect patient rights and assure the integrity of ethical principles,5 6 paper-based consents can suffer from quality and efficiency problems. For example, paper forms can be illegible, incomplete or lost, which creates rework and delays. Additionally, paper forms can be in only one location at a time. Paper forms also present a hurdle to remote or hybrid care models.

    Software applications for clinical e-consent are available, but the prevalence of such applications among healthcare providers is unknown. In a recent survey, the prevalence of clinical e-consenting in leading US oncology organisations was 68%7; the prevalence in other healthcare provider organisations is likely less. However, as with the expansion of digital technologies more broadly, e-consent can be expected to become more widespread as well. It is therefore vital to understand e-consent’s impacts on efficiency, data integrity, user experience, care access, equity and quality. Moreover, consent processes are complex and varied.8–10 Consent workflows can differ from setting to setting and from provider to provider. Different members of the clinical team can be involved and in some circumstances, a witness signature must be obtained. To accelerate the adoption of clinical e-consent, assessments of implementation best practices, benefits and unintended consequences are needed.

    Although literature reviews have assessed e-consent for research purposes, nothing equivalent yet exists for clinical e-consenting.11 We, therefore, conducted a scoping review to inform and guide provider organisations around the value of clinical e-consenting. Notably, our focus was on efforts to replace or compare paper-based consents with electronic ones, rather than on electronic or multimedia tools to support educational aspects of the consent process, per se. We thus sought to assemble all published findings about clinical e-consent, including implementation, adoption, benefits and challenges. We also aimed to identify knowledge gaps that may present hurdles to further progress.

    Materials and methods

    We conducted a scoping review to catalogue and characterise all documented findings on clinical e-consent in the scholarly and grey literatures. We chose to conduct a scoping review rather than a systematic review because we sought to assess a relatively large body of literature covering a potentially broad range of topics (eg, implementation, adoption, benefits, challenges). We defined clinical e-consents to include consents for procedural, telehealth, administrative or health information exchange purposes. Our methods are reported according to Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews (figure 1).12

    Figure 1
    Figure 1

    PRISMA flow diagram. PRISMA, Preferred Reporting Items for Systematic reviews and Meta-Analyses.

    Protocol

    Scoping reviews are not eligible for registration in Prospero; nonetheless, we used Prospero’s systematic review protocol for planning and reporting purposes (online supplemental appendix B).

    Supplemental material

    Eligibility criteria

    The scoping review included qualitative and quantitative experimental and observational studies. This includes surveys, interviews, case reports, commentaries, research reports and letters, and conference proceedings for which abstracts and/or full text where available. We also included reports by journalists, policymakers and other investigators publishing in the grey literature. We did not include opinion pieces/letters or editorials. Searches were open internationally, provided an English-language translation was available. Included studies documented the use of electronic forms in place of or as compared with paper-based consent forms in clinical settings (remote or in-person).

    Information sources and search strategy

    Using controlled search terms and keywords describing the concepts of electronic informed consent and clinical care, including “electronic consent” “e-consent”, “virtual consent”, “remote consent”, “teleconsent”, “mobile consent” and “digital consenting”, we conducted a comprehensive search (via PubMed, Scopus and Embase) of the medical, scientific and grey literatures from inception through 3 June 2022. To supplement our search, we also included relevant records from our initial, manual searches and by browsing the reference lists of included publications (see online supplemental files A and B for database search methodology).

    Supplemental material

    Supplemental material

    Study selection process

    All search results were imported into Covidence, an online systematic review software programme.13 The eligibility criteria were imported into Covidence as a set of codes for screening. To ensure reliability, each item was screened independently by at least tworeviewers (SC, AL-S, KM and GK), with all differences resolved through discussion.

    Data items and data collection process

    For all included articles, we abstracted data on year and location of study, type of publication (grey, peer-reviewed, conference abstract), study funding, author disclosures, clinical area, patient population, consenting professionals, consent type (procedural, administrative/health information exchange, other), study aim, study design, themes, measures and findings. The data abstraction form (online supplemental appendix C) was piloted on a sample of five included studies and modified as needed using feedback from the team. The remaining studies were then abstracted independently by two authors, with discrepancies resolved through team discussions.

    Supplemental material

    Methodological quality appraisal

    We did not appraise methodological quality or risk of bias of the included articles, which is consistent with guidance on scoping review conduct.

    Synthesis

    We used Microsoft Excel to create descriptive statistics to characterise the publications identified in our scoping review along the extracted domains. We used data from our scoping results to characterise and assess study themes, measures, findings and other relevant content in the literature.

    Patient and public involvement

    Many of the studies in our scoping review include patients as participants, and patients’ views, preferences and experiences are a major focus of the published literature and, by extension, this analysis.

    Results

    Characteristics of included studies

    The literature search resulted in 2128 citations (figure 1), after elimination of duplicates. Following title/abstract screening and full-text eligibility assessment, we included 25 for data abstraction and synthesis (table 1, online supplemental files C and D). These were published between 2005 and 2022, with about half appearing after 2020. Most were peer-reviewed research studies (14) or conference abstracts (10). A minority disclosed study funding sources (8) or authors’ potential conflicts of interest (10). All but one (4%) were based in North America and Europe.

    Supplemental material

    Supplemental material

    View this table:
    Table 1

    Characteristics of publications meeting inclusion criteria (n=25)

    Study methods

    Study designs varied widely, but more than half (15, 60%) used non-randomised experimental methods. All but one included controls, such as comparing electronic to paper consenting concurrently (11) or in a pre/post comparison (10) (table 1).

    Consent types

    Nearly all articles in our analysis focused on procedural consents (24), with only one addressing consents for health information exchanges (table 1).

    Study participants

    Nearly all studies (18) focused on consenting by adult patients. Consenting professionals ranged from physicians (8) and other clinicians (5) to administrators overseeing school immunisation programmes (2). Six studies included multiple types of consenting professionals (table 1).

    Clinical areas

    Included studies spanned diverse clinical areas, with the plurality (8) addressing e-consents in surgery. Other fields of inquiry included oncology (5) and reproductive health (4) (table 1).

    Emergent themes, measures and findings

    Seven themes, spanning 82 measures, emerged from the analysis of the included articles: adoption, efficiency and workflow, data quality, patient experience, provider experience, care access and equity and care quality (online supplemental files C and D).

    Adoption

    Seven studies reported seven findings around adoption and use of e-consent (online supplemental files C and D). Two of these addressed technical and legal preconditions for adoption, with mixed results. One study reported that, in a sample of 575 UK patients consenting to breast or general surgery, nearly all had internet access. However, a survey of 903 physicians, nurses and other medical professionals found that legal barriers across 47 European countries may prevent e-consenting for paediatric procedures. Other studies explored rates of use of e-consent in varying contexts: two studies—one Canadian, one Korean—described marked shifts away from paper after the introduction of e-consent options, and a study of 28 fertility nurses in the USA and the UK reported that e-consent use doubled during the COVID-19 pandemic. A fourth study, however, found that, among UK parents of over 3200 children eligible for HPV vaccination, use rates (measured by timely consent form return) were lower with e-consent than with paper. Similarly, a fifth study showed that, among 25 UK schools, return rates were lower with e-consent than with paper when implemented at scale.

    Efficiency and workflow

    Six studies described seven metrics around organisational or clinical workflow and efficiency (online supplemental files C and D). By three metrics, e-consent was found to make the consenting process ‘easier’, ‘more efficient’ or ‘less work’ for consenting professionals. Additionally, three metrics showed that e-consent saved time for patients or consenting professionals. However, one metric indicated that, compared with paper, e-consent form completion was more time-consuming for patients.

    Data quality

    A total of 12 publications reported 32 outcomes around data integrity (online supplemental files C and D). These frequently addressed missing consent forms or data items (seven studies, 22 metrics) or general consent form quality (10 studies, 10 metrics). E-consent compared favourably to paper by 31 measures and similarly to paper by one measure. No studies found data integrity to be higher with paper consenting.

    Patient experience

    Nine publications offered 17 measures of patient experience with e-consent (online supplemental files C and D). Three articles reported a patient preference for electronic over paper consenting, excepting among patients with low comprehension of health information exchanges, who preferred paper. Four articles also explored patient comprehension of the consenting process: in three, e-consent performed as well as or better than paper. A fourth study, which replaced a human explanation of health information exchange with an electronic interactive explanation, had lower comprehension in patients with low education. In another publication, paper and electronic consenting fared equally in terms of patients’ decisional conflict and satisfaction with care.

    Provider experience

    Five publications explored the experiences of consenting professionals around e-consent (online supplemental files C and D). These reported a total of seven measures of provider satisfaction with the consent process—five favoring e-consent, one favoring paper and one showing equivalence. While three studies described consenting professionals’ preferences for e-consent over paper, one also reported a preference among some clinicians for in-person, paper consents.

    Care access and equity

    Two publications touched on issues of care access by exploring the characteristics of patients choosing e-consent over paper (online supplemental files C and D). Notably, both focused on patients seeking abortions in USA that require an additional, separate visit for consent several days prior to the procedure. In these studies, patients choosing remote e-consent visits over in-person, paper consent visits were more likely to live out of state or further from the clinic. Similarly, one also found that patients choosing e-consent did so for reasons of convenience. We found no studies explicitly discussing the impact of e-consent on equity.

    Care quality

    Four studies examined associations between e-consent use and care quality, with disparate topics and results (online supplemental files C and D). In one publication, patient ratings of shared decision making were higher with e-consent than for paper. Another found electronic and paper consenting yielded similar vaccination and consent-to-vaccination rates, while a third study found that the vaccination rate was lower for e-consent, when implemented at scale, compared with paper. In a fourth study, providers reported that e-consenting had changed how they care for patients; however, the nature or desirability of this change was unspecified.

    Discussion

    This scoping review identified 25 articles assessing clinical e-consenting applications. We sought to understand the dimensions by which these publications characterised or evaluated clinical e-consent. We found that publications most commonly focused on the impact of electronic processes on consent data quality and patients’ experiences, with lesser attention paid to providers’ experiences, adoption, efficiency and workflow, and care quality, access and equity.

    A plurality of studies addressed the quality of clinical consent data. Overall, data completeness, legibility and accuracy were consistently improved by electronic processes as compared with paper-based ones. This is an important and hoped-for benefit, with implications for healthcare quality and safety as well as organisational efficacy.14–17 These critical findings should assure provider institutions that there is immediate and concrete value to automating clinical consent processes.

    Many studies examined dimensions of patient experience in a variety of settings. Almost uniformly, e-consenting was acceptable to patients and did not result in a loss of comprehension. These encouraging findings are consistent with results from the literature on research e-consent, in which patients similarly find electronic consenting systems comparable, or even preferable, to paper-based ones.18 19 A notable exception among the articles we examined was a study of consent for health information exchange, where an attempt to communicate risks and benefits entirely via computer (as opposed to paper plus human interaction) resulted in a decreased comprehension by some patients. This suggests that complex consents, whether electronic or paper-based, may always require human interaction. Another important consideration is the continued emergence of new e-consent technologies (eg, videos, apps). While early evidence in the research e-consent literature suggests patients generally find these, too, acceptable, even greater technological changes may emerge over time.18 20–22 It will be vital to ensure that these developments do not compromise patients’ comprehension or experience of the consent process.

    Similar to patients, providers were generally positively inclined towards clinical e-consenting and reported multiple benefits. Again, however, more research is needed, as we found very few articles addressing this topic. Assuring provider satisfaction will be a critical enabler of widespread adoption.23–25

    Notably, several studies explored enablers, barriers and other adoption issues, with mixed results. To promote greater uptake among providers and patients, more research around these vital topics is needed. Better evidence could also spur wider implementation of clinical e-consent by healthcare institutions, which need assurance that technology development costs will yield returns on investment.26 27

    Our scoping review found that additional—and particularly crucial—aspects of clinical e-consent remain largely unexplored. Measures of efficiency and workflow, for instance, are understudied. While one would expect improvements in these areas to be among the foremost benefits of automation, evidence either way remains scant. This may be because these issues can be difficult to measure, or there may be a lack of interest or opportunity among researchers. In any case, efficiency and workflow will be important topics for future study. For institutions to prioritise clinical e-consenting initiatives, these benefits must be well-established.

    Similarly, we found almost no data on the impact of clinical e-consent on care quality, access or equity. Further research in these areas will be crucial to ensure that potential harms to patients are avoided and existing disparities by age, race and other key characteristics are mitigated rather than exacerbated.28–30

    On the whole, the literature on clinical e-consent is nascent. While the findings thus far are nearly all positive, the number of research publications is relatively low and reflects a limited number of geographic locations and practice settings. More, several publications came from the same setting, so the range of locations and settings is even smaller than the number of publications. Thus, the data at present are insufficient to guide institutional efforts around clinical e-consent. To save provider organisations from needing to reinvent the wheel or rely on vendors’ marketing claims, additional studies should explore a larger variety of settings, particularly in locations beyond North America and the UK, with an eye for advancing more generalisable knowledge and best practices. Similarly, only one study examined consents for health information exchange, and few studies examined paediatric or proxy consents. More research is needed to explore these vital topics. It is also notable that fewer than half of the studies included information about funding or conflicts of interest, so undisclosed bias in the reported results is possible.

    Our study has some limitations. In our literature search, we may have missed relevant articles. However, we developed a comprehensive search strategy with a professional librarian (KM), reviewed additional reference lists from key articles and had two reviewers screen each article for fit. There also is potential subjectivity in review and data abstraction practices; however, we had two reviewers use explicit criteria for all procedures.

    Conclusion

    This scoping review indicates that clinical e-consent can deliver multiple kinds of value to patients and providers alike. Additional studies in a wider variety of settings are needed to inform effective implementation and ensure that clinical e-consent promotes care access, equity and quality.

    Data availability statement

    Data are available upon reasonable request. All data relevant to the study are included in the article or uploaded as supplementary information. All data are available upon reasonable request, and have also been included as supplementary materials.

    Ethics statements

    Patient consent for publication

    Ethics approval

    Not applicable.

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    Supplementary materials

    Footnotes

    • Contributors SC, AL-S, KM and GK participated in the planning, conduct and reporting of this study. SC is responsible for the overall content as guarantor.

    • Competing interests None declared.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.