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Joseph M. Plasek,1,2 David S. Pieczkiewicz,1,2 Andrea N. Mahnke,1 Catherine A. McCarty,1 Justin B. Starren,1 and also Bonnie L. Westra2

Joseph M. Plasek

1Marshfield Clinic study Foundation, Marshfield, Wise., USA

2University of Minnesota, Minneapolis, Minn., USA


David S. Pieczkiewicz

1Marshfield Clinic study Foundation, Marshfield, Wise., USA

2University the Minnesota, Minneapolis, Minn., USA


Objective

Nonverbal and verbal communication facets enhance and also reinforce the consent kind in the notified consent procedure and should be transferred as necessary to multimedia styles using interaction style when re-designing the process.

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Methods

Observational, inquiry asking behavior, and content analyses were supplied to analyze nonverbal and verbal facets of an informed consent process.


Conclusion

In convert a verbal conversation about a textual document to multimedia formats, all elements of the original procedure including verbal and nonverbal variation must be one part of an communication community-centered design approach.


1. Introduction

An educated consent process usually includes a conventional IRB authorized textual document, i m sorry is commonly described come a participant by a research study coordinator utilizing variable linguistic language and also body gestures. Previous studies focused on enhancing the textual document, or changing the presentation medium <1–12>, but tiny research has actually been conducted to recognize the variability natural in the linguistic consent process. Small research has focused specifically on how written consent develops are incorporated into a verbal dialogue between a potential research participant and the human administering the consent.

Marshfield Clinic’s Personalized medication Research project (PMRP) conducts genetic studies in which they collection blood, and also plasma samples, and also requires written educated consent because that participation. A current study of PMRP participants mirrors that return the participants construed the overall goals of the project, numerous were unsure or incorrect about key factors that the research <13>. Outcomes of this study imply that incorrect responses were as result of a absence of comprehension, rather than a loss of storage of certain details, due to the fact that the percent of exactly responses was not regarded the time since consenting to the PMRP project <13, 14>.

Marshfield Clinic determined a require to improve their approaches of notified consent come ensure the participants are completely informed as soon as they consent to be in the study and that they retain the information. This examine is one phase of a larger project to construct a multi-media notified consent procedure that is acceptable to potential study participants and improves the retention the information. The function of this step of the study was to recognize the relationship in between the nonverbal and also verbal facets of the educated consent procedure for PMRP prior to determining just how to transform the content and process to a multi-media format. This examine fills a gap in knowledge by formally evaluating the current consent procedure in a novel means using human factors methods that encompass observational, inquiry asking behaviors and also content analyses. The application of this study is a proof-of-concept guide to the organization of both nonverbal and verbal communication aspects in a multi-media informed consent application.


2. Background

The researchers’ function in the informed consent process is to educate participants regarding the true nature, aims, and intent the the research by explicate what to intend if lock agree come participate, and also through full disclosure of the purpose, anticipated benefits, risks, alternatives, and also expected outcomes that the study; come answer any questions the participant may have; and also to respect the participants consent or disagreement <7–10>. Based on previous research, potential examine subjects are much more likely come actually check out the consent type if that is given to them to review at your leisure; thus, it follows that multimedia education and learning materials, which room self-paced, room also more likely to be reviewed <15>.

Multimedia education consists of a range of combinations of text, audio, video, interactive questionnaires, visualizations, graphics, or also immersion into a online 3D atmosphere <7>. Agre and also Rapkin measured understanding of consent information amongst 204 participants randomized to one of four consent processes: standard, video, computer-assisted instruction, or booklet, and also reported that comprehension was unchanged throughout all groups on the write-up test regardless of the delivery method, arguing that the media supplied to existing the informed consent procedure does not issue <1, 12>.

A multimedia tool has the potential come standardize the quality of notified consent; however, ahead studies have actually failed to produce a generalised solution <7>. These researches fail come assess either the competence of the patient, the appropriateness of the education level of the material, or the efficiency of the digital consent process <7>. Back a computer-based informed consent procedure adds a level the standardization, it must be tailored to the separation, personal, instance participants’ learning layout as one-size-fits-all interventions may not be universally generalize-able <16>. Agre and Rapkin argue that a successful consent process must, at a minimum, encompass both a written and also a verbal component, perhaps even using the method of asking the participant to repeat what the or she understands, and the participant should communicate one on one v someone knowledgeable about the study at some point in time <1, 12>. A counterintuitive result identified in Agre and also Rapkin’s study is the participant comprehension of an notified consent type increases as soon as participants had a greater level of formal education, or as soon as the study protocol to be very complicated (i.e. The study had much more risks, next effects, or steps to explain), requiring a simplified, much longer explanation <1, 12>. However, the german of verbal and also nonverbal communication aspects to multimedia modern technologies is impeded by the tacit nature of this elements.


3. Methods

Data was obtained by conducting “mock” notified consent sessions with a convenience sample of 6 Marshfield Clinic employees and also six Biomedical Informatics study Centers’ usability neighborhood volunteers. Because the PRMP project is a population-based biobank that recruits from the community, consisting of Marshfield Clinic employees, these topics were typical of PRMP subjects. The sample size is taken into consideration adequate for a proof-of-concept paper. The nonverbal and verbal aspects were captured by videotaping and also digitally recording twelve mock consent sessions.

All 12 “mock” sessions were conducted by the same research study coordinator, who was additionally responsible because that administering really PRMP consents and was well acquainted through the process, with subjects as despite they were enrolling in a study. Subjects were consented come the videotaping of the research of the consent process, and also were conscious that the objective of the research study was to research the consent process itself fairly than to enroll them right into the PMRP project. Certified medical transcriptionists in ~ the Marshfield Clinic professionally spelling audio native the twelve sessions.


3.1. Analysis

The nonverbal aspects of the informed consent process were analyzed utilizing an observational analysis <17>, where the investigator it was observed the videos and documented the nonverbal habits of the research coordinator. Eleven videos to be analyzed because that gesture, eye gaze, and also body posture for nonverbal cues that the research study coordinator supplied within the consent procedure in interaction with the study participant. Because that the observational analysis, one session was excluded because of technical worries that caused the ns of the video. Observational evaluation was supplied to generate a perform of gestures through classifications similar to Bickmore et al. And also Whishaw et al <18, 19>. Analysis of eye gaze and also body attitude is used to present how the study coordinator supplies the written consent type as a form of exterior scaffolding, wherein one places expertise in the environment that the research coordinator depends on to assist their thoughts in stimulate to remind the coordinator come cover aspects of the consent kind within their verbal explanation <20>. Gestures are likewise used as perceptual-motor info scaffolding because that perceptual-motor information, whereby their hand gestures reflect properties of the specific objects and also the actions they have previously used to remember and also convey the principles in a linguistic consent <21>. Analysis of gestures is offered to describe and also make inferences around the characteristics of interaction to analyze style and also techniques of persuasion.

The verbal facets of the informed consent process were analyzed for concern asking actions initiated by the participant that developed dialogue making use of a content evaluation <22, 23>. Concern asking behavior analysis highlights the important function of the study coordinator in answering questions from the research participant and also shows the usefulness of supplementary materials in a multimedia variation as a method of tailoring to the demands of a certain participant. The inquiry asking behavior evaluation uses frequency of inquiries asked by the participants together a method to analysis the flow of information. The composed consent form consists of 20 particular sections or contents areas.

A content evaluation was supplied to explain trends in communication content, come analyze methods in persuasion, and also to identify the balance that personalized narrative for paraphrasing within the present verbal consent procedure <23>. The content evaluation is a qualitative an approach used to analyze the content of communication and also is validated utilizing inter-rater reliability. A content analysis was performed on 4 transcripts come determine just how the verbal process compliments and extends the written consent kind in regards to content and also style the delivery. One transcript was analyzed by a second coder to develop interrater integrity using Cohen’s Kappa. In this study, the focus was top top the words provided by the research coordinator that can be a paraphrasing of information in the consent type or a personalized narrative to attach to the separation, personal, instance participant’s instance or also a joke to elicit participant response.


4. Results

The data for non-verbal observational evaluation included 1,903 monitorings that to be classified, and analyzed native the 11 videotaped sessions. The species of observations that to be gathered in ~ the observational analysis include:


General hand gestures refers to any waving of the hand, conducting, paddling, arcing, or tapping in air gestures that are not specific.


Specific conversational hand gestures are actions made by the research study coordinator that communicate much more than a tide of the hand come the participant, which may add value come the consent procedure by representing a ide or by re-assuring the participant.


Highlighting gestures space where the research study coordinator points to, traces, or taps a sentence or word.


Resting gestures space where the study coordinator’s hands room folded or placed confront down top top the table or follow me the corners in ~ the top of the consent document, which add value come the consent process by removed unnecessary movement and by inviting the participant to ask questions of the study coordinator.


Repositioning gestures space where the study coordinator go something v the file document, by either straightening the consent document, or turning to a new page, which are important to aid the participant follow in addition to the document consent process.


Other details hand gestures room actions whereby the research study coordinator, for example, is: emotional their chest, counting, ‘what-ever’, slide hands across the table, simulating a needle prick in the arm vein, create a circle, create a crossing out or avoiding gesture to cancel something out, or gift something as ‘door number 1 vs. Door number 2’.


Head gestures space where the research study coordinator is nodding or shaking their very own head in ~ the conversation and also may be used to relief the participant.


Eye gaze ad to when the research coordinator gazes under at the written consent document, or right into the participant’s eyes, i m sorry is crucial for communicating ideas or focusing attention elsewhere.


Body posture refers to where the research study coordinator leans forward towards the participant, or leans back against the chair.


Transition patterns are combinations the gestures that type a usual pattern that occur in the shift at the beginning of a brand-new section whereby the study coordinator leans front gazing under at the page and also either points come or traces the necessary text.

Of the 1,903 monitorings presented in ►Figure 1,77% were hand gestures (29% general hand waving, 13% certain hand waving, 20% highlighting, 10% resting, and also 5% repositioning), 12% to be head gestures, 5% were body posture shifts, and also 5% were eye gazes.


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Fig. 1

Observations by type


For the verbal analysis of the mock educated consent, there to be a complete of 61 concerns asked through participants over the 12 sessions, corresponding to 14 of the 20 part on the consent form that to be analyzed using inquiry asking behavior analysis. ►Figure 2 presents the frequency that questions organized by ar of the consent type where the participant interrupted the research study coordinator to ask a question or to get additional clarification on one idea. Content in ►Figure 2 is gift in the very same order together the 20 part of the consent form, not included the final section ~ above “statement of consent” (i.e., where the participant is inquiry to authorize the consent form).


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Number the observations, questions, and also sentences by section of the personalized medicine research project (PMRP) consent kind ordered temporally


The educated consent sections through the many questions in decreasing order were: what will take place if friend agree come take component in PMRP, exactly how will privacy and also confidentiality it is in protected, who may have accessibility to your examine information, what space the possible risks and also discomforts that the project and, will you ever be re-contacted for additional information. The sections v no inquiries are: what is notified consent, what space the possible benefits that the research task to you, what are the costs for taking component in this project, will any kind of commercial commodities be emerged from PMRP, perform you have to take component in this project, and the statement of consent.

Paraphrased explanations were generally followed through a personalized interaction style to alleviate the intricacy of the post into much more simplified variation to enhance the comprehension of the participant. The research study coordinator never read the text of the consent type verbatim and only come close to doing so when at first describing the consent kind section why they to be asked come take component in the research study study. ►Table 1 shows the break down of the content analysis between paraphrased and personalized sentences. Inter-rater dependability was calculate on one transcript making use of a Cohen’s Kappa v a “good agreement” result of 73.8%.


Communication MethodTranscript ATranscript BTranscript CTranscript DReviewer 1Reviewer 2nnnnn
Personalization/Narrative2527213532
Error11202
Joke03221
Question58856
Subtotal: Personalized3139334241
Paraphrased7163227961
Total Sentences10210255121102

5. Discussion

The function of this the examine was to determine the relationship in between the nonverbal and verbal aspects of the educated consent process for PMRP prior to determining just how to transform the contents and procedure into a multi-media format. The written informed consent is reinforced v a procedure that requires both nonverbal and also verbal communication. Our key finding was to identify which part of the educated consent were complicated for participants to understand based upon the frequency of concerns asked. We likewise identified that different varieties of gestures, body postures, and verbal interaction were provided to reinforce the consent process.

The vital finding the the observational evaluation is the variability in types and frequency that gestures, human body posture, and also eye gaze. The results of this study are comparable to results by Bickmore et al, which confirmed that face-to-face consents are effective because researchers usage verbal and nonverbal behaviors, such together head nods, hand gesture, eye gaze cues and also facial screens to connect factual info to patients, and to interact empathy and also immediacy come elicit participant to trust <18>. A transition pattern may indicate where the study coordinator uses the record consent together a means to jog their own memory to ensure the important elements of the consent room covered. The implication of these findings for the style of multi-media informed consent applications is the developers should ensure the the new application replace instead replace the nonverbal communication with appropriate interaction techniques.

Information the is currently conveyed in gestures need not be changed with video clip of the very same gestures. The information could be presented using textual cues, pictures, or multimedia to improve the consent form. For example, highlighting gestures like pointing, tapping, or tracing can be changed with a stylized text that is bolded or italicized, or with a larger font size. In the exact same line of thought, counting gestures, which indicate a perform of items, might be changed with bullet points or numbers. By virtue of the brand-new presentation medium, certain species of gestures including: basic hand waving, resting gestures, posture, and eye gaze would certainly be irrelevant and thus can be discarded.

Other species of specific hand waving gestures could similarly be replaced or discarded as appropriate. Repositioning gestures space generally because of the boundaries of the paper medium where web page turns are essential to carry forward new content, and can most likely be discarded. However, the concept of repositioning will must be changed by a “next” button at appropriate intervals.

Another application to the replace-ability of nonverbal interaction might it is in to use a animated conversational avatar with a selection of nonverbal behaviors, including: hand gestures, body attitude shifts, gazing at and also away native the patient, raising and lowering eyebrows, head nods, various facial expressions and variable proximity, i m sorry is explained in greater information in Bickmore et al., <18>.

The benefits of utilizing conversational avatars include: usage of verbal and also nonverbal conversational behaviors that denote understanding and mark significance, and also convey information in redundant channels of information (e.g., hand gestures, such together pointing, facial screen of emotion, and eye gaze); use of verbal and also nonverbal communicative habits to maximize comprehension; use of verbal and also nonverbal communicative behaviors used by suppliers to develop trust and rapport v their patient in order to increase satisfaction and adherence to treatment regimens; and also adaptation of your messages to the specific needs that patients and to the immediate context of the conversation <18>.

The ar of the most daunting concepts in ~ the consent form are visually shown in ►Figure 2, indicating locations where added material need to be made available at the inquiry of the participant in the form of a generally Asked concern (FAQ) handout or additional on-demand content. Similar to Bickmore et al., outcomes in this study demonstrate that face-to-face interaction permits researchers come dynamically assess a participant"s level of understanding based upon the participant"s verbal and nonverbal behavior and to repeat or sophisticated information as vital <18>.

The services of using a FAQ for more clarifying information on the consent form is that it presents details in consistent manner in a low-pressure environment in which patients are complimentary to take it as lot time together they need to thoroughly recognize it <18>. Although research study coordinators encourage participants come ask questions, they typically fail to elicit participant’s questions and also participants with minimal health proficiency are also less most likely than rather to ask concerns <18>.

Research coordinators rarely, if ever, check out the message of the consent form verbatim. The key finding of the content analysis is that researcher coordinator supplied both paraphrased and personalized communications and also the level the paraphrasing vs. Personalization is change by transcript and also by ar of the consent form. The communication evaluation suggests that details is tailored come the participant making use of non-legalistic conversational language. Tailoring details to a specific research participant within a computer-based maintain environment might be done using a understanding test as a part of the educated consent process similar come that used by Taub et al. V the examine of the result of vocabulary level and also corrected feedback <7>.

There room several restrictions to this research that impact the generalizability the the results. The research was performed with a little convenience sample in a solitary lab setup where entrants were not actually enrolling in the study and also were motivated to asking questions. The limitation of having actually subjects who weren’t enrolling in the PMRP project may have affected the number and species of questions participants asked, yet this is mitigated by the fact that all subjects were eligible come enroll in PMRP with the conventional protocol.

Despite the camera’s being unobtrusively mounted in the ceiling, there is still a opportunity that power anxiety impacted the nonverbal habits of the research coordinator as they attempted to habituate come the setting. Future studies have to balance the researcher’s services of a naturalistic setting (e.g., potentially better quality interactions) versus the research subject’s protections in a “mock” lab setting (e.g., far better privacy and blinding that researchers). Having only one study coordinator administer all of the consents gift a predisposition due to the little sample size, and personal nature of nonverbal and also verbal behaviors, yet this might be counter by your familiarity and expertise v administering the PMRP consent procedure that enables them to habituate to the setting far better than someone that is less familiar with administering the consent, and also to define things in a much more consistent method due to enhanced practice. An additional limitation for the observational evaluation was that inter-rater dependability was not formally calculated, together a 2nd reviewer did watch a similar collection of gestures for 2 transcripts however at a coarser granularity 보다 the first reviewer did. Because that the content analysis, only 4 transcripts to be used as result of availability.

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This study offers several unique methods of evaluation to reinforce the importance of recording the nonverbal and verbal communication of the informed consent procedure in a much more complete way than previous study studies demonstrate.