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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 Bonnie L. Westra2

Joseph M. Plasek

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

2University that Minnesota, Minneapolis, Minn., USA


David S. Pieczkiewicz

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

2University the Minnesota, Minneapolis, Minn., USA


Objective

Nonverbal and also verbal communication aspects enhance and also reinforce the consent type in the educated consent process and should be transferred appropriately to multimedia styles using interaction design when re-designing the process.

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Methods

Observational, inquiry asking behavior, and also content analyses were used to analyze nonverbal and verbal facets of an notified consent process.


Conclusion

In converting a verbal conversation about a textual paper to multimedia formats, all aspects of the original process including verbal and nonverbal variation need to be one part of an communication community-centered design approach.


1. Introduction

An educated consent process usually contains a standard IRB approved textual document, i m sorry is typically described to a participant by a research coordinator utilizing variable linguistic language and also body gestures. Vault studies concentrated on improving the textual document, or transforming the presentation medium <1–12>, but small research has been carried out to recognize the variability inherent in the verbal consent process. Small research has focused specifically on how written consent creates are incorporated into a linguistic dialogue between a potential research participant and the human being administering the consent.

Marshfield Clinic’s Personalized medicine Research task (PMRP) conducts genetic studies in which they collection blood, and also plasma samples, and requires written notified consent because that participation. A current study the PMRP participants mirrors that back the participants interpreted the as whole goals that the project, many were unsure or untrue about an essential factors that the study <13>. Outcomes of this study indicate that incorrect responses were as result of a lack of comprehension, rather than a loss of storage of particular details, since the percentage of exactly responses was not concerned the time since consenting come the PMRP task <13, 14>.

Marshfield Clinic identified a require to boost their approaches of informed consent come ensure that participants are totally informed once they consent to be in the study and also that lock retain that 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 also improves the retention of information. The purpose of this phase of the research was to identify the relationship between the nonverbal and verbal elements of the informed consent process for PMRP before determining just how to transform the contents and procedure to a multi-media format. This research fills a gap in understanding by formally evaluating the present consent procedure in a novel means using human determinants methods that incorporate observational, concern asking behaviors and also content analyses. The application of this study is a proof-of-concept overview to the organization of both nonverbal and verbal communication facets in a multi-media educated consent application.


2. Background

The researchers’ function in the educated consent process is to notify participants regarding the true nature, aims, and intent of the examine by explicate what to intend if castle agree come participate, and through full disclosure of the purpose, suspect benefits, risks, alternatives, and also expected outcomes the the study; to answer any kind of questions the participant might have; and to respect the attendees consent or disagreement <7–10>. Based on previous research, potential examine subjects are an ext likely to actually check out the consent kind if the is provided to lock to review at their leisure; thus, it follows that multimedia education and learning materials, which room self-paced, room also an ext likely to it is in reviewed <15>.

Multimedia education is composed of a range of combine of text, audio, video, interactive questionnaires, visualizations, graphics, or also immersion into a virtual 3D setting <7>. Agre and Rapkin measured understanding of consent information among 204 attendees randomized to one of four consent processes: standard, video, computer-assisted instruction, or booklet, and also reported that understanding was unchanged throughout all teams on the write-up test regardless of the delivery method, arguing that the media provided to existing the educated consent process does not matter <1, 12>.

A multimedia tool has the potential to standardize the top quality of informed consent; however, vault studies have actually failed to produce a generalised solution <7>. These research studies fail come assess one of two people the competence that the patient, the appropriateness of the educational level the the material, or the effectiveness of the electronic consent procedure <7>. Back a computer-based notified consent process adds a level of standardization, it should be tailored to the separation, personal, instance participants’ learning style as one-size-fits-all interventions might not it is in universally generalize-able <16>. Agre and also Rapkin argue that a effective consent procedure must, at a minimum, encompass both a written and also a verbal component, perhaps even using the an approach of asking the participant to repeat what he or she understands, and also the participant should communicate one on one with someone knowledgeable about the research at some point in time <1, 12>. A counterintuitive result identified in Agre and Rapkin’s study is that participant understanding of an notified consent form increases as soon as participants had actually a greater level of official education, or as soon as the examine protocol was very complicated (i.e. The examine had an ext risks, side effects, or procedures to explain), inquiry a simplified, longer explanation <1, 12>. However, the transferability of verbal and nonverbal communication facets to multimedia innovations is shackles by the tacit nature of these elements.


3. Methods

Data was derived by conducting “mock” informed consent sessions through a convenience sample of 6 Marshfield Clinic employees and also six Biomedical Informatics study Centers’ usability ar volunteers. Because the PRMP job is a population-based biobank that recruits from the community, including Marshfield Clinic employees, these subjects were typical of PRMP subjects. The sample dimension is considered adequate for a proof-of-concept paper. The nonverbal and verbal facets were recorded by videotaping and digitally record twelve mock consent sessions.

All 12 “mock” sessions were conducted by the same study coordinator, that was additionally responsible for administering really PRMP consents and was well acquainted v the process, with topics as despite they were enrolling in a study. Subjects were consented to the videotaping of the study of the consent process, and also were conscious that the function of the research study was to examine the consent procedure itself rather than come enroll them right into the PMRP project. Certified medical transcriptionists at the Marshfield Clinic professionally spelling audio indigenous the twelve sessions.


3.1. Analysis

The nonverbal facets of the informed consent procedure were analyzed making use of an observational evaluation <17>, whereby the investigator observed the videos and documented the nonverbal habits of the research coordinator. Eleven videos were analyzed because that gesture, eye gaze, and body attitude for nonverbal cues that the research coordinator supplied within the consent procedure in communication with the research study participant. For the observational analysis, one session to be excluded due to technical issues that caused the ns of the video. Observational analysis was provided to generate a perform of gestures through classifications comparable to Bickmore et al. And Whishaw et al <18, 19>. Evaluation of eye gaze and body attitude is supplied to show how the study coordinator offers the composed consent kind as a kind of exterior scaffolding, whereby one places expertise in the atmosphere that the study coordinator depends on to help their thoughts in order to remind the coordinator to cover facets of the consent kind within their linguistic explanation <20>. Gestures are also used as perceptual-motor info scaffolding for perceptual-motor information, where their hand gestures reflect nature of the details objects and also the action they have actually previously used to remember and also convey the ideas in a linguistic consent <21>. Analysis of gestures is offered to describe and also make inferences around the attributes of interaction to analyze style and techniques of persuasion.

The verbal aspects of the informed consent process were analyzed for concern asking actions initiated through the participant that created dialogue making use of a content evaluation <22, 23>. Inquiry asking behavior evaluation highlights the important function of the study coordinator in answering inquiries from the research study participant and also shows the usefulness that supplementary products in a multimedia variation as a method of tailoring to the needs of a particular participant. The inquiry asking behavior evaluation uses frequency of questions asked by the participants as a method to analysis the circulation of information. The written consent form consists that 20 details sections or contents areas.

A content analysis was supplied to describe trends in interaction content, come analyze techniques in persuasion, and also to determine the balance the personalized narrative because that paraphrasing within the present verbal consent procedure <23>. The content evaluation is a qualitative technique used to analysis the content of communication and is validated using inter-rater reliability. A content evaluation was conducted on four transcripts come determine exactly how the verbal procedure compliments and extends the composed consent form in regards to content and style of delivery. One transcript was analyzed through a 2nd coder to establish interrater reliability using Cohen’s Kappa. In this study, the emphasis was ~ above the words offered by the research coordinator that could be a paraphrasing of info in the consent form or a personalized narrative to attach to the individual participant’s case or even a hoax to elicit participant response.


4. Results

The data for non-verbal observational analysis included 1,903 observations that were classified, and also analyzed indigenous the 11 videotaped sessions. The types of monitorings that were gathered within the observational evaluation include:


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


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


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


Resting gestures space where the research coordinator’s hands room folded or placed confront down ~ above the table or follow me the corners in ~ the height of the consent document, which include value to the consent process by removing unnecessary movement and by inviting the participant to ask concerns of the research study coordinator.


Repositioning gestures are where the research study coordinator walk something through the paper document, by one of two people straightening the consent document, or transforming to a brand-new page, i beg your pardon are vital to aid the participant follow along with the paper consent process.


Other details hand gestures are actions whereby the research coordinator, for example, is: poignant their chest, counting, ‘what-ever’, slide hands across the table, simulating a needle prick in the eight vein, create a circle, creates a crossing out or protecting against gesture to cancel other out, or presents something together ‘door number 1 vs. Door number 2’.


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


Eye gaze advert to once the research coordinator gazes down at the written consent document, or right into the participant’s eyes, i m sorry is important for communicating ideas or focusing attention elsewhere.


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


Transition patterns room combinations the gestures that kind a common pattern that take place in the change at the beginning of a new section whereby the study coordinator leans forward gazing under at the page and also either points to or traces the crucial text.

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


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Fig. 1

Observations by type


For the verbal evaluation of the mock informed consent, there was a total of 61 inquiries asked by participants end the 12 sessions, corresponding to 14 that the 20 sections on the consent form that to be analyzed using concern asking habits analysis. ►Figure 2 presents the frequency the questions organized by ar of the consent type where the participant interrupted the research coordinator come ask a concern or to get further clarification on an idea. Contents in ►Figure 2 is presented in the exact same order as the 20 sections of the consent form, excluding the last section ~ above “statement of consent” (i.e., wherein the participant is request to authorize the consent form).


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Number of observations, questions, and sentences by ar of the personalized medication research task (PMRP) consent type ordered temporally


The educated consent sections through the most questions in decreasing bespeak were: what will happen if you agree come take component in PMRP, how will privacy and also confidentiality it is in protected, who may have access to your study information, what space the possible risks and discomforts the the project and, will certainly you ever before be re-contacted for extr information. The sections through no inquiries are: what is notified consent, what space the possible benefits the the research task to you, what are the costs for taking component in this project, will any commercial commodities be emerged from PMRP, execute you have to take part in this project, and also the declare of consent.

Paraphrased explanations were commonly followed by a personalized communication style to reduce the intricacy of the message into more simplified variation to enhance the comprehension of the participant. The study coordinator never ever read the message of the consent kind verbatim and only come close come doing for this reason when initially describing the consent form section why they were asked come take part in the research study. ►Table 1 reflects the break down of the content evaluation between paraphrased and also personalized sentences. Inter-rater dependability was calculated on one transcript using a Cohen’s Kappa through a “good agreement” an outcome of 73.8%.


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

5. Discussion

The objective of this the study was to identify the relationship in between the nonverbal and also verbal facets of the educated consent procedure for PMRP before determining just how to change the contents and procedure into a multi-media format. The written notified consent is reinforced v a process that entails both nonverbal and also verbal communication. Our main finding was to determine which sections of the notified consent were complicated for participants to understand based on the frequency of questions asked. We likewise identified the different varieties of gestures, body postures, and verbal interaction were supplied to reinforce the consent process.

The key finding that the observational evaluation is the variability in types and frequency of gestures, human body posture, and eye gaze. The outcomes of this study are similar to results by Bickmore et al, which proved that face-to-face consents space effective since researchers use verbal and nonverbal behaviors, such together head nods, hand gesture, eye rigid cues and also facial displays to communicate factual information to patients, and also to connect empathy and immediacy come elicit participant to trust <18>. A transition pattern may suggest where the study coordinator provides the record consent as a method to jog their own memory come ensure that important elements of the consent are covered. The implicit of this findings for the style of multi-media notified consent applications is the developers have to ensure that the brand-new application replace instead replace the nonverbal communication with appropriate interaction techniques.

Information that is right now conveyed in gestures need not be changed with video of the same gestures. The information can be presented using textual cues, pictures, or multimedia to enhance the consent form. Because that example, highlighting gestures prefer pointing, tapping, or tracing could be replaced with a stylized text that is bolded or italicized, or through a enlarge font size. In the exact same line that thought, counting gestures, which suggest a list of items, could be replaced with cartridge points or numbers. By virtue that the new presentation medium, certain varieties of gestures including: general hand waving, resting gestures, posture, and eye gaze would certainly be irrelevant and also thus could be discarded.

Other species of specific hand waving gestures could an in similar way be replaced or discarded together appropriate. Repositioning gestures room generally due to the boundaries of the file medium where page turns are important to carry forward new content, and can probably be discarded. However, the concept of repositioning will should be changed by a “next” button at proper intervals.

Another application to the replace-ability that nonverbal interaction might it is in to use a animated conversational avatar through a range of nonverbal behaviors, including: hand gestures, body posture shifts, gazing at and also away indigenous the patient, raising and also lowering eyebrows, head nods, various facial expressions and also variable proximity, which is explained in greater detail in Bickmore et al., <18>.

The benefits of using conversational avatars include: usage of verbal and also nonverbal conversational actions that represent understanding and mark significance, and convey information in redundant channels of details (e.g., hand gestures, such together pointing, facial display screen of emotion, and eye gaze); usage of verbal and also nonverbal communicative habits to maximize comprehension; use of verbal and also nonverbal communicative habits used by carriers to create trust and rapport through their patient in bespeak to boost satisfaction and also adherence to therapy regimens; and also adaptation of your messages come the details needs the patients and to the prompt context the the conversation <18>.

The place of the most complicated concepts in ~ the consent type are visually displayed in ►Figure 2, indicating locations where added material must be made accessible at the inquiry of the participant in the kind of a frequently Asked inquiry (FAQ) handout or extr on-demand content. Comparable to Bickmore et al., results in this study show that face-to-face interaction allows researchers come dynamically evaluate a participant"s level the understanding based on the participant"s verbal and nonverbal behavior and also to repeat or intricate information as vital <18>.

The services of utilizing a FAQ for further clarifying details on the consent type is the it presents information in continual manner in a low-pressure atmosphere in which patient are free to take as lot time as they should thoroughly understand it <18>. Although study coordinators encourage participants come ask questions, they commonly fail come elicit participant’s questions and also participants with limited health proficiency are even less likely than others to ask questions <18>.

Research coordinators rarely, if ever, check out the text of the consent form verbatim. The vital finding of the content evaluation is that researcher coordinator supplied both paraphrased and personalized communications and also the level of paraphrasing vs. Personalization is variable by transcript and by ar of the consent form. The communication evaluation suggests that info is tailored come the participant making use of non-legalistic conversational language. Tailoring info to a specific research participant within a computer-based training environment could be done making use of a comprehension test as a component of the informed consent process similar to that used by Taub et al. Through the examine of the result of vocabulary level and also corrected feedback <7>.

There space several limitations to this study that impact the generalizability that the results. The study was carried out with a tiny convenience sample in a solitary lab setting where attendees were not actually enrolling in the study and were urged to asking questions. The limitation of having actually subjects who weren’t enrolling in the PMRP project might have impacted the number and species of questions participants asked, however this is mitigated by the reality that all subjects were eligible to enroll in PMRP with the standard protocol.

Despite the camera’s gift unobtrusively mounted in the ceiling, over there is tho a chance that power anxiety influenced the nonverbal actions of the research study coordinator together they attempted come habituate to the setting. Future studies must balance the researcher’s services of a naturalistic setup (e.g., potentially better quality interactions) against the research study subject’s protections in a “mock” lab setup (e.g., far better privacy and also blinding that researchers). Having only one study coordinator administer all the the consents presents a prejudice due come the small sample size, and personal nature of nonverbal and also verbal behaviors, yet this may be offset by your familiarity and also expertise through administering the PMRP consent procedure that enables them come habituate to the setting far better than someone that is less familiar with administering the consent, and also to explain things in a an ext consistent means due to raised practice. Another limitation because that the observational evaluation was the inter-rater integrity was not formally calculated, together a 2nd reviewer did observe a similar collection of gestures for two transcripts but at a coarser granularity than the first reviewer did. For the content analysis, only four transcripts were used due to availability.

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This study uses several unique methods of analysis to reinforce the prestige of recording the nonverbal and verbal interaction of the informed consent procedure in a more complete means than previous study studies demonstrate.