Using a Multimedia Tool for Informed Consent in Mohs Surgery: A Randomized Trial Measuring Effects on Patient Anxiety, Knowledge, and Satisfaction
Macey Delcambre, Dylan Haynes, Tamar Hajar, Spring Golden, Anna Bar, Emile Latour, Justin J. Leitenberger
Dermatologic Surgery, 11 October 2019
Abstract
Background
Multimedia educational materials have been found to improve aspects of informed consent, although data in the context of Mohs micrographic surgery (MMS) is limited.
Objective
To assess whether a preoperative educational video decreases anxiety, increases comprehension, and improves overall satisfaction for patients undergoing same-day office consultation and MMS.
Materials and Methods
This single-center randomized controlled trial included patients above the age of 18 years undergoing MMS for skin cancer between October 2015 and December 2015. Patients were randomized to view a short preoperative video on MMS in addition to traditional informed consent versus informed consent without video viewing. Questionnaires were used to assess preoperative anxiety, knowledge, and satisfaction.
Results
From 231 consecutively enrolled subjects, there were no significant differences in anxiety (p = .626) or satisfaction (p = .065) between groups. Subjects receiving the intervention were able to more accurately recognize risks of MMS (88% vs 69% of controls, p < .001) and had improved subject-reported confidence in understanding procedural risks and benefits (89% vs 71% of controls, p = .049). Composite comprehension scores were similar between groups (p = .131).
Conclusion
A preoperative MMS educational video increased recognition of procedural risks, but did not improve patient anxiety or satisfaction.

Improving the chemotherapy consent: From paper to tablet
Aarti Sonia Bhardwaj, Jessica Parra, Kavita Rampertaap, Katherine FitzPatrick, Raina Caridi, Mark Liu, Victoria Casani, Donna Berizzi, Luis M. Isola, Cardinale B. Smith
Journal of Clinical Oncology, 20 September 2019; 37(27) pp 298-298
Abstract
Background
A comprehensive chemotherapy informed consent process improves shared decision-making. Additionally, the Oncology Care Model (OCM) emphasizes providing patients with a documented care plan that contains the 13 components in the Institute of Medicine Care Management Plan. Within our health system, we incorporated the care plan into our existing chemotherapy consent process and utilized technology to increase compliance and reduce administrative burden.
Methods
Our 2 phase PDSA included: 1) updating our existing paper chemotherapy form with the 13 components of the IOM care plan and then 2) piloting an electronic version of the chemotherapy consent form. We updated our new chemotherapy consent with the addition of Prognosis, Expected Response to Treatment, Potential Effect on Quality of Life, Potential Benefits/Goals of Treatment, and added more options for potential side effects/harm. Given the increased administrative burden, we created and piloted the use of an electronic version of the consent form in our breast oncology program.
Results
Baseline, monthly random chart audit of 20-40 patients revealed compliance with completing every question of the paper chemotherapy consent at 30% of all patients receiving IV chemotherapy at our cancer center that month- 7/2018. When the new chemotherapy consent incorporating the IOM elements was rolled out, compliance initially rose to 50% (8/2018), however the following months dropped to 10-20% (9-11/2018) and then back up to 41% briefly (12/2018). The results were low and inconsistent. A pareto chart confirmed that redundancy and too many questions were the reasons for under-completion. By auto-populating fields for certain questions on the paper consent, compliance increased to 75% (2/2019). Finally within our breast cancer pilot group our compliance rose to 100% (3-4/2019), by converting to an electronic form with the maximum options for auto-population and drop-down selections for certain fields.
Conclusions
Incorporating regulatory requirements into an existing workflow can reduce administrative burden. The use of innovative technology can further increase clinician and OCM compliance while delivering value to patients.

HealthLit4Kids Animation: inclusive and informed participants [Conference Extract]
eCite Digital Repository
C Mainsbridge, R Nash, S Elmer, K Patterson, V Cruickshank, A McDonald, E Burke, R Dick
Engagement Transforms 2019 (ET19), 6 September 2019, Hobart, Tasmania
Abstract
HealthLit4Kids is an education program designed for use in schools. Teachers invite children to participate in classroom-based health literacy development activities. The learning culminates with the development of an Artefact (creative piece accompanied with a description). Consent must be obtained from a parent or guardian and the child prior to uploading the HealthLit4Kids Artefact to the Open Education Resource and prior to the inclusion of each Artefact in research and evaluation. English is an additional language for 30% of the families at 2 of the 5 schools currently engaged with HealthLit4Kids, and limited literacy made it difficult to engage with “traditional” information sheets and informed consent processes. In response to these identified needs, the researchers developed a short, animated resource to support an informed consent process: 1. HealthLit4Kids Information Video 2. Parent/Child Information and Consent Video 3. Parent Term 1 Focus Group Information and Consent Video 4. Parent Term 3 Focus Group Information and Consent Video

The Effect of an Educational and Interactive Informed Consent Process on Patients with Cervical Spondylotic Myelopathy Caused by Ossification of the Posterior Longitudinal Ligament
Young-Seok Lee, Dae-Chul Cho, Joo-Kyung Sung, Inbo Han, Chi-Heon Kim, Ji-Yoon Kim, Kyoung-Tae Kim
Spine, 6 September 2019
Open Access
Abstract
Objective 
In this study, an educational and interactive informed consent (EIC) program was proposed for patients with OPLL-CSM to improve their comprehension level during the informed consent process.
Summary of Background Data
Cervical spondylotic myelopathy caused by ossification of the posterior longitudinal ligament (OPLL-CSM) is a slow progressive disease, and it is difficult for patients to understand the disease. Few studies have evaluated very specific programs to improve the informed consent process for these patients.
Methods
This prospective study evaluated patients with OPLL-CSM who either underwent the proposed EIC process (n=63) or the standard consent process (n = 124). The standard consent process only included a physician-patient interview. During the EIC process, information was provided regarding OPLL-CSM through information booklets, a video, verbal information, and initial and second physician-patient interviews. After the second physician-patient interview, the patient was requested to answer 14 medical questions to assess their knowledge about OPLL-CSM. The proposed EIC process took approximately 90 minutes. They were asked to report the most useful educational method and the most effective method of reinforcing verbal communication.
Results
The mean questionnaire scores were higher in the EIC group than in the control group (p < 0.001). Video was selected by 50/63 patients (79.4%) as the most useful EIC process method, and the most effective method of reinforcing verbal communication was video (n = 61; 96.8%). Patients in the EIC group reported having higher satisfaction with surgery (p = 0.024) than did those in the control group.
Conclusions
The proposed EIC process was shown to result in good patient comprehension and recall regarding OPLL-CSM. Using a video was the most informative and effective reinforcement of verbal communication. The enhanced educational group had better knowledge and improved satisfaction following surgery. The EIC process might help physicians educate and counsel patients regarding OPLL-CSM and its treatment.

Editor’s note: Spine is an international, peer-reviewed, bi-weekly periodical which describes itself as the leading subspecialty journal for the treatment of spinal disorders

A video decision aid improves informed decision-making in patients with advanced cancer considering palliative radiation therapy
Brief Report
Kavita V. Dharmarajan, Chasity B. Walters, Tomer T. Levin,  Carol Ann Milazzo, Christopher Monether,  Robin Rawlins-Duell,  Roma Tickoo,  Daniel E. Spratt, Shona Lovie, Gina Giannantoni-Ibelli, Beryl McCormick
Journal of Pain and Symptom Management, 28 August 2019
Abstract
Context
Advanced cancer patients have unrecognized gaps in their understanding about palliative radiation therapy (PRT).
Objectives
To build a video decision aid for hospitalized patients with advanced cancer referred for PRT and prospectively test its efficacy in reducing decisional uncertainty, improving knowledge, increasing treatment readiness and readiness for palliative care consultation, and its acceptability among patients.
Methods
Forty patients with advanced cancer hospitalized at Memorial Sloan Kettering Cancer Center watched a video decision aid about PRT and palliative care. Patients’ conceptual and logistical knowledge of PRT, decisional uncertainty, treatment readiness, and readiness for palliative care consultation were assessed before and after watching the video with a 6-item knowledge survey, the decisional uncertainty subscale of the Decisional Conflict Scale, and Likert instruments to assess readiness to accept radiation treatment and/or palliative care consultation, respectively. A post-video survey assessed the video’s acceptability among patients.
Results
After watching the video, decisional uncertainty was reduced (28.3 vs. 21.7, p=0.02); knowledge of PRT improved (60.4 vs. 88.3, p<0.001); and PRT readiness increased (2.0 vs. 1.3, p=0.04). Readiness for palliative care consultation was unchanged (p=0.58). Patients felt very comfortable (70%) watching the video and would highly recommend it (75%) to others.
Conclusion
Among hospitalized patients with advanced cancer, a video decision aid reduced decisional uncertainty, improved knowledge of PRT, increased readiness for PRT, and was well-received by patient viewers.

Characteristics of patients having telemedicine versus in-person informed consent visits before abortion in Utah
Sara Daniel, Sarah Raifman, Shelly Kaller, Daniel Grossman
Contraception, 4 September 2019
Abstract
Objective
This study aimed to evaluate demographic and service delivery differences between patients using telemedicine relative to an in-person visit to satisfy Utah’s state-mandated informed consent visit, which must occur at least 72 h before the abortion.
Study design
We conducted a retrospective cohort study with data from Planned Parenthood Association of Utah (PPAU), which included all informed consent and abortion encounters from January 1, 2015 – March 31, 2018. We evaluated the following for each encounter by informed consent type (telemedicine vs. in-person): demographics, distance to a PPAU facility, length of time between informed consent and abortion visits, and gestational age at time of abortion.
Results
Of the 9175 informed consent visits, 91% were in-person (n=8395) and 9% were via telemedicine (n=780), which ranged from 5% in 2015 to 16% in 2018. Compared to in-person patients, telemedicine patients were slightly older (27 vs. 25 median years, p<.001), more likely to live out of state (47% vs. 4%, p<.001) and further away from PPAU clinics offering informed consent visits (104 miles vs. 10 median miles, p<.001). Among those who received abortion care at PPAU (6233), telemedicine informed consent patients were more likely to have medication abortions (adjusted odds ratio 1.68, 95% confidence interval 1.28–2.19) compared to in-person informed consent patients.
Conclusions
PPAU’s telemedicine option for completing the abortion informed consent visit appears to be of particular interest to patients who live further from clinics, including out of state, as it could help reduce travel burdens imposed by Utah’s mandatory delay law.
Implications
Telemedicine provision of state-mandated informed consent is feasible and could be used in other states where similar mandatory delays before abortion are required and where telemedicine is allowed.

Legal authorized representative experience with smartphone-based electronic informed consent in an acute stroke trial
Original research
Diogo C Haussen, Leah Craft, Shannon Doppelheuer, Gabriel Martins Rodrigues, Alhamza R Al-Bayati, Krishnan Ravindran, Meagan Schultz, Loretta Sutherly, Kiva M Schindler, Michael R Frankel, Raul G Nogueira
BMJ Journal of Neurointerventional Surgery, 17 September 2019
Open Access
Abstract
Background 
The pilot use of a smartphone platform for electronic informed consent (e-Consent) in large vessel occlusion acute stroke (LVOS) trials has recently been reported. The degree of satisfaction from Legal Authorized Representatives (LARs) with regard to this process remains to be established.
Methods 
A single-center study evaluating the experience of LARs with the use of e-Consent in a LVOS randomized trial of an investigational drug administered within 12 hours of last known normal was carried out. A structured survey was used to evaluate the experience of the LARs with the e-consenting process.
Results 
From February to November 2018, 60 consecutive patients were e-Consented. Of these, 53 LARs completed the survey. The median (IQR) age of the patients was 63 (53–70) years, baseline/discharge National Institutes of Health Stroke Scale score was 17 (12–20)/3(1–12), and 45% were independent at discharge. The survey was applied in person in 43% of cases and via telephone in 57%. Median LAR age was 48 (39–59) years, 64% were female, and a multi-ethnic composition was observed. Forty percent of LARs had less than tertiary level of education (high-school or less). Regarding the e-Consent, 98% of LARs reported to be ‘clear’ and 83% felt ‘very comfortable’ in signing. The overall experience was ‘excellent/good’ in 91%. Despite the positive general impression regarding the use of e-Consent, 12 LARs (22%) would have preferred paper consent. Multivariable regression indicated that lower educational status (tertiary education or less: OR 5.09, 95% CI 1.02 to 25.48; p=0.04) and lower baseline ASPECTS score (OR 0.63, 95% CI 0.41 to 0.96; p=0.03) were independently associated with preference for paper consent.
Conclusions 
e-Consent was overall very well perceived by LARs in a randomized clinical trial of LVOS. A minority of proxies, who were more commonly less formally educated, would have preferred paper consenting.

Consent for mobile phone surveys of non-communicable disease risk factors in low-resource settings: an exploratory qualitative study in Uganda
Original Article
Erisa Mwaka, Janet Nakigudde, Joseph Ali, Joseph Ochieng, Kristina Hallez, Raymond Tweheyo, Alain Labrique, Dustin G. Gibson, Elizeus Rutebemberwa, George Pariyo
mHealth, 5 July 2019; 5(26)
Open Access
Abstract
Background
Lack of data for timely decision-making around the prevention and control of non-communicable diseases (NCDs) presents special challenges for policy makers, especially in resource-limited settings. New data collection methods, including pre-recorded Interactive Voice Response (IVR) phone surveys, are being developed to support rapid compilation of population-level disease risk factor information in such settings. We aimed to identify information that could be used to optimize consent approaches for future mobile phone surveys (MPS) employed in Uganda and, possibly, similar contexts.
Methods
We conducted an in-depth qualitative study with key stakeholders in Uganda about consent approaches, and potential challenges, for pre-recorded IVR NCD risk factor surveys. Semi-structured interviews were conducted with 14 key informants. A contextualized thematic approach was used to interpret the results supported by representative quotes.
Results
Several potential challenges in designing consent approaches for MPS were identified, including low literacy and the lack of appropriate ways of assessing comprehension and documenting consent. Communication with potential respondents prior to the MPS and providing options for callbacks were suggested as possible strategies for improving comprehension within the consent process. “Opt-in” forms of authorization were preferred over “opt-out”. There was particular concern about data security and confidentiality and how matters relating to this would be communicated to MPS respondents.
Conclusions
These local insights provide important information to support optimization of consent for MPS, whose use is increasing globally to advance public health surveillance and research in constructive ways.

Editor’s note: mHealth covers “clinical telemedicine practice, advances in health technology, health services research, highlights of emerging products, public health implications of health technology, health policy and regulation and management of health care systems and other related fields”

Usability Inspection of Multipurpose Scalable Informed Consent Platform
Finkelstein J, Robins D, Liu J
Studies in health technology and informatics, 4 July 2019
Abstract
We developed a multipurpose scalable electronic informed consent platform (E-Consent) which is reusable for any informed consent in a multitude of settings. The platform allows research staff to easily upload multimedia information about a research protocol with an approved informed consent into the system, which delivers this content interactively for prospective study candidates in a user-friendly way. Consistent with user-centered design, E-Consent underwent usability inspection via cognitive walkthroughs accompanied by surveys that captured task complexity on a 5-point Likert-type scale. The System Usability Scale (SUS) provided a standardized reference for usability and satisfaction. Overall, the E-Consent framework was considered by participants to be easy-to-use, satisfying, and timely, while delivering complex information such as that on a consent form. E-Consent ranked in the top 10th percentile for usability as measured by SUS. This extensible framework successfully delivered complex information and recorded user consents, all in an easy-to-understand and highly usable fashion.

Digitizing the Informed Consent: the Challenges to Design for Practices [CONFERENCE PAPER]
Michela Assale, Erica Barbero, Federico Cabitza
2019 IEEE 32nd International Symposium on Computer-Based Medical Systems, 5-7 June 2019; Spain
Abstract
This paper reports a user study performed to assess the usability of a Web-based electronic informed consent application called DICE, which is aimed at supporting patients in the process of reading, understanding and using the informed consent as a trigger for further interaction with the team of care givers. In particular, we performed a questionnaire-based study and a series of individual semi-structured interviews to understand whether the application is usable and can be used in real-world settings, respectively. We found that patients could appreciate the availability of interactive tools like DICE, but health professionals believe that its actual adoption in current workflows and practices could be hampered by the chronic lack of time and health operators who could timely address the licit requests that such a tool could bring to light.