Dataset Information

Digitalizing the Clinical Research Informed Consent Process: Assessing the Participant Experience in Comparison With Traditional Paper-Based Methods.

ABSTRACT:

Purpose

Consent processes are critical for clinical care and research and may benefit from incorporating digital strategies. We compared an electronic informed consent (eIC) option to paper consent across four outcomes: (1) technology burden, (2) protocol comprehension, (3) participant agency (ability to self-advocate), and (4) completion of required document fields.

Methods

We assessed participant experience with eIC processes compared with traditional paper-based consenting using surveys and compared completeness of required fields, over 3 years (2019-2021). Participants who consented to a clinical trial at a large academic cancer center via paper or eIC were invited to either pre-COVID-19 pandemic survey 1 (technology burden) or intrapandemic survey 2 (comprehension and agency). Consent document completeness was assessed via electronic health records.

Results

On survey 1, 83% of participants (n = 777) indicated eIC was easy or very easy to use; discomfort with technology overall was not correlated with discomfort using eIC. For survey 2, eIC (n = 262) and paper consenters (n = 193) had similar comprehension scores. All participants responded favorably to at least five of six agency statements; however, eIC generated a higher proportion of positive free-text comments (P < .05), with themes such as thoroughness of the discussion and consenter professionalism. eIC use yielded no completeness errors across 235 consents versus 6.4% for paper (P < .001).

Conclusion

Our findings suggest that eIC when compared with paper (1) did not increase technology burden, (2) supported comparable comprehension, (3) upheld key elements of participant agency, and (4) increased completion of mandatory consent fields. The results support a broader call for organizations to offer eIC for clinical research discussions to enhance the overall participant experience and increase the completeness of the consent process.

SUBMITTER: Buckley MT

PROVIDER: S-EPMC10022878 | biostudies-literature | 2023 Mar

REPOSITORIES: biostudies-literature

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Publications

Digitalizing the Clinical Research Informed Consent Process: Assessing the Participant Experience in Comparison With Traditional Paper-Based Methods.

Buckley Michael T MT O'Shea Molly R MR Kundu Sangeeta S Lipitz-Snyderman Allison A Kuperman Gilad G Shah Suken S Iasonos Alexia A Houston Collette C Terzulli Stephanie L SL Lengfellner Joseph M JM Sabbatini Paul P

JCO oncology practice 20221219 3

<h4>Purpose</h4>Consent processes are critical for clinical care and research and may benefit from incorporating digital strategies. We compared an electronic informed consent (eIC) option to paper consent across four outcomes: (1) technology burden, (2) protocol comprehension, (3) participant agency (ability to self-advocate), and (4) completion of required document fields.<h4>Methods</h4>We assessed participant experience with eIC processes compared with traditional paper-based consenting usin ...[more]

PMID: 36534933

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Project description:ObjectiveObtaining informed consent is a cornerstone requirement of conducting ethical research. Traditional paper-based consent is often excessively lengthy and may fail to achieve the desired participant understanding of study requirements. Multimedia tools including video and audio may be a useful alternative. This study aimed to determine the efficacy, usability and acceptability of self-directed multimedia delivery of participant consent.DesignIt is a single-centre, randomised, prospective study to determine the efficacy, usability and acceptability of a self-directed multimedia consent process (intervention) compared with the traditional paper-based approach (control). The intervention was free of research staff, with computer-based finger-signed consent.SettingPathology blood collection services in Tasmania, Australia.Participants298 participants (63±8 years; 51% female individuals) referred from general practice were randomised to intervention (n=146) and control (n=152).Outcome measuresEfficacy, usability and acceptability of the allocated consent process were assessed by a questionnaire.ResultsAll participants successfully completed the allocated interventions. Efficacy parameters were higher among intervention participants, including a better understanding of study requirements compared with controls (p<0.05 all). Intervention participants were more likely to engage with the study information and spend more time on the consent process (p=<0.001 and p=0.006, respectively). Both groups reported similar levels of acceptability, although more control participants reported that the study information was too long (24% vs 14%; p=0.020).ConclusionA self-directed multimedia consent process is effective for achieving participant understanding and obtaining consent free of research staff. Thus, multimedia represents a viable method to reduce the burden on researchers, meet participant needs and achieve informed consent in clinical research.

Project description:BackgroundThe traditional informed consent (IC) process rarely emphasizes research participants' comprehension of medical information, leaving them vulnerable to unknown risks and consequences associated with procedures or studies.ObjectiveThis paper explores how we evaluated the feasibility of a digital health tool called Virtual Multimedia Interactive Informed Consent (VIC) for advancing the IC process and compared the results with traditional paper-based methods of IC.MethodsUsing digital health and web-based coaching, we developed the VIC tool that uses multimedia and other digital features to improve the current IC process. The tool was developed on the basis of the user-centered design process and Mayer's cognitive theory of multimedia learning. This study is a randomized controlled trial that compares the feasibility of VIC with standard paper consent to understand the impact of interactive digital consent. Participants were recruited from the Winchester Chest Clinic at Yale New Haven Hospital in New Haven, Connecticut, and healthy individuals were recruited from the community using fliers. In this coordinator-assisted trial, participants were randomized to complete the IC process using VIC on the iPad or with traditional paper consent. The study was conducted at the Winchester Chest Clinic, and the outcomes were self-assessed through coordinator-administered questionnaires.ResultsA total of 50 participants were recruited in the study (VIC, n=25; paper, n=25). The participants in both groups had high comprehension. VIC participants reported higher satisfaction, higher perceived ease of use, higher ability to complete the consent independently, and shorter perceived time to complete the consent process.ConclusionsThe use of dynamic, interactive audiovisual elements in VIC may improve participants' satisfaction and facilitate the IC process. We believe that using VIC in an ongoing, real-world study rather than a hypothetical study improved the reliability of our findings, which demonstrates VIC's potential to improve research participants' comprehension and the overall process of IC.Trial registrationClinicalTrials.gov NCT02537886; https://clinicaltrials.gov/ct2/show/NCT02537886.

Project description:BackgroundInformed consent (IC) is constitutionally protected in South Africa based on individual rights to bodily integrity and well-being. In terms of the law, patients cannot be involved in medical treatment or research without IC. This study explored patients' experience on practice and applicability of IC in African traditional medicine (ATM) in Msunduzi and eThekwini municipalities, KwaZulu-Natal province, South Africa, to evaluate whether important elements of IC such as full information disclosure, capacity, understanding, and volition are considered or being applied during ATM.MethodsThis cross-sectional quantitative study was conducted using semistructured questionnaires administered to patients attending traditional health practitioners' (THPs') treatment centres. Stata V15.1 was used to analyse variables including descriptive and inferential data analysis.ResultsOne hundred and twenty-nine (129) participants completed this study, of which 62% were females. Most participants were in the age range of 26-35 (38.8%). All respondents were IsiZulu home-language speakers, single (62.8%), employed (48%), and with some tertiary education (48.8%). Most patients were informed about their diagnosis (58.9%), treatment benefits (79.8%), and recommended treatment (79.8%). Fewer were informed about risks of treatment (36.4%), right of refusal (3.1%), and risks of refusing recommended treatment (0.8%). All participants reported satisfaction with information disclosed by the THPs and did not feel coerced to accept treatment. Consent was obtained verbally in all cases. The majority of participants (76.7%) sought surrogate assistance when consulting THPS, and 81.4% preferred being informed about all treatment risks. Most respondents also preferred involvement in healthcare decision-making during ATM.ConclusionThis study reveals that most patients consulting THPs in the KwaZulu-Natal province for treatment are aware of their right to information disclosure and the need to reach agreement before involvement in ATM treatment procedures. The study also showed that some key elements of IC are currently being applied during ATM practice in South Africa.

Project description:BackgroundThe informed consent process is a vital component of daily medical practice. It involves providing patients with sufficient, accurate, and understandable information to decide on a contemplated therapy. The study aims to evaluate the patient experience and satisfaction with the preoperative informed consent process.MethodsA cross-sectional study was performed on adult women admitted for elective gynecologic surgery in a tertiary training hospital. Participants were recruited on their second postoperative day and were asked to answer a structured questionnaire assessing decisional satisfaction and experience with the informed consent process. Satisfaction was measured using a 6-item Satisfaction with Decision Scale. Knowledge of the surgery and experience with the informed consent were measured using an Informed Consent Questionnaire. Bivariate associations between highly satisfied and not highly satisfied groups were tested using Fisher exact test.ResultsA total of 150 patients were enrolled in the study with a mean age of 44.5 years. The resident-in-charge provided the information and assisted in the documentation of the informed consent in 86.7% and 67.3% of patients, respectively. There was an overall high decisional satisfaction with a mean score of 27.4 and 52.7% of patients strongly agreeing to all statements of the Satisfaction with Decision Scale. The majority of the respondents were informed and acknowledged comprehension of the surgery including its risks, benefits, and alternative treatment options. Knowing the success rate and benefits of the procedure as well as being informed of the need for postoperative catheterization were significantly associated with high satisfaction.ConclusionKnowledge and understanding of the key components of informed consent influence patient satisfaction. The current study highlights the high decisional satisfaction rates of patients who underwent elective gynecologic surgery. Strategies to further improve this patient-physician encounter include the establishment of standard policies on personnel involved, timing, and quality of information given to patients. Patient satisfaction should serve as an indicator of the quality of healthcare rendered and guide for continuous improvement of services.

Dataset Information

Digitalizing the Clinical Research Informed Consent Process: Assessing the Participant Experience in Comparison With Traditional Paper-Based Methods.

Purpose

Methods

Results

Conclusion

Publications

Digitalizing the Clinical Research Informed Consent Process: Assessing the Participant Experience in Comparison With Traditional Paper-Based Methods.

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