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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 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 reinforce the consent form in the notified consent process and have to be transferred appropriately to multimedia formats using interaction design when re-designing the process.

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Methods

Observational, question asking behavior, and content analyses were offered to analysis nonverbal and verbal aspects of an informed consent process.


Conclusion

In convert a verbal conversation about a textual file to multimedia formats, all facets of the original process including verbal and nonverbal variation should be one component of an interaction community-centered architecture approach.


1. Introduction

An educated consent process usually consists of a traditional IRB approved textual document, which is commonly described come a participant by a study coordinator using variable verbal language and body gestures. Ahead studies concentrated on improving the textual document, or changing the presentation tool <1–12>, but little research has been carried out to recognize the variability innate in the linguistic consent process. Little research has concentrated specifically on just how written consent creates are incorporated into a linguistic dialogue between a potential research participant and also the human administering the consent.

Marshfield Clinic’s Personalized medication Research job (PMRP) conducts genetic studies in i m sorry they collect blood, and also plasma samples, and requires written notified consent for participation. A current study the PMRP participants reflects that return the participants taken the all at once goals of the project, numerous were unsure or not correct about vital factors of the examine <13>. Outcomes of this study suggest that untrue responses were as result of a lack of comprehension, quite than a lose of memory of certain details, since the percentage of correct responses to be not related to the time since consenting come the PMRP task <13, 14>.

Marshfield Clinic determined a require to boost their techniques of informed consent come ensure that participants are fully informed as soon as they consent to it is in in the study and also that they retain the information. This study is one phase of a bigger project to develop a multi-media informed consent process that is agree to potential research participants and also improves the retention of information. The objective of this step of the research was to determine the relationship in between the nonverbal and verbal aspects of the notified consent procedure for PMRP before determining exactly how to change the content and process to a multi-media format. This examine fills a space in understanding by formally evaluating the current consent process in a novel way using human determinants methods that include observational, inquiry asking behaviors and content analyses. The application of this study is a proof-of-concept overview to the organization of both nonverbal and verbal communication elements in a multi-media notified consent application.


2. Background

The researchers’ function in the notified consent process is to educate participants as to the true nature, aims, and intent the the examine by describing what to mean if castle agree to participate, and through full disclosure that the purpose, suspect benefits, risks, alternatives, and also expected outcomes the the study; come answer any questions the participant may have; and to respect the attendees consent or dissent <7–10>. Based on previous research, potential study subjects are more likely come actually review the consent kind if that is offered to them to testimonial at their leisure; thus, it adheres to that multimedia education materials, which space self-paced, space also an ext likely to be reviewed <15>.

Multimedia education is composed of a variety of combine of text, audio, video, interaction questionnaires, visualizations, graphics, or also immersion right into a online 3D setting <7>. Agre and also Rapkin measured understanding of consent information among 204 attendees randomized to one of 4 consent processes: standard, video, computer-assisted instruction, or booklet, and reported that understanding was unchanged across all groups on the article test nevertheless of the shipment method, saying that the media supplied to present the informed consent procedure does not issue <1, 12>.

A multimedia tool has the potential to standardize the quality of educated consent; however, ahead studies have actually failed to create a generalized solution <7>. These researches fail come assess one of two people the competence of the patient, the appropriateness the the educational level the the material, or the efficiency of the electronic consent procedure <7>. Back a computer-based notified consent procedure adds a level that standardization, it need to be tailored come the individual participants’ learning format 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, in ~ a minimum, incorporate both a written and also a verbal component, perhaps also using the technique of questioning the participant come repeat what the or she understands, and the participant should connect one on one through someone knowledgeable around the research at some suggest in time <1, 12>. A counterintuitive result identified in Agre and Rapkin’s study is that participant comprehension of an educated consent form increases as soon as participants had a higher level of official education, or when the examine protocol to be very facility (i.e. The study had much more risks, next effects, or procedures to explain), inquiry a simplified, much longer explanation <1, 12>. However, the transferability of verbal and nonverbal communication facets to multimedia innovations is impeded by the tacit nature of these elements.


3. Methods

Data was derived by conducting “mock” educated consent sessions with a convenience sample of six Marshfield Clinic employees and six Biomedical Informatics study Centers’ usability community volunteers. Since the PRMP project is a population-based biobank that recruits indigenous the community, consisting of Marshfield Clinic employees, these topics were typical of PRMP subjects. The sample size is considered adequate because that a proof-of-concept paper. The nonverbal and verbal elements were recorded by videotaping and digitally recording twelve mock consent sessions.

All 12 “mock” sessions were carried out by the same study coordinator, that was also responsible because that administering yes, really PRMP consents and was fine acquainted with the process, with topics as though they were enrolling in a study. Subjects were consented to the videotaping of the study of the consent process, and also were aware that the objective of the research study was to examine the consent process itself rather than to enroll them right into the PMRP project. Certified medical transcriptionists at the Marshfield Clinic professionally transcribed audio native the twelve sessions.


3.1. Analysis

The nonverbal elements of the informed consent procedure were analyzed using an observational evaluation <17>, whereby the investigator it was observed the videos and documented the nonverbal actions of the research coordinator. Eleven videos to be analyzed for gesture, eye gaze, and also body attitude for nonverbal cues the the research study coordinator offered within the consent process in interaction with the study participant. For the observational analysis, one session was excluded because of technical issues that led to the lose of the video. Observational evaluation was supplied to create a list of gestures with classifications comparable to Bickmore et al. And also Whishaw et al <18, 19>. Evaluation of eye gaze and body attitude is supplied to display how the research coordinator provides the created consent kind as a kind of outside scaffolding, where one places understanding in the setting that the study coordinator counts on to assist their thoughts in order to remind the coordinator come cover elements of the consent kind within their linguistic explanation <20>. Gestures are likewise used as perceptual-motor details scaffolding because that perceptual-motor information, whereby their hand gestures reflect nature of the particular objects and also the actions they have previously supplied to remember and also convey the principles in a verbal consent <21>. Evaluation of gestures is provided to describe and make inferences around the characteristics of interaction to analyze style and techniques that persuasion.

The verbal elements of the informed consent process were analyzed for question asking habits initiated by the participant that developed dialogue making use of a content evaluation <22, 23>. Question asking behavior analysis highlights the important role of the research study coordinator in answering concerns from the research study participant and also shows the usefulness the supplementary materials in a multimedia version as a way of tailoring come the needs of a specific participant. The inquiry asking behavior evaluation uses frequency of concerns asked by the participants together a way to analyze the circulation of information. The written consent type consists the 20 details sections or content areas.

A content evaluation was provided to define trends in communication content, to analyze techniques in persuasion, and to determine the balance that personalized narrative because that paraphrasing in ~ the present verbal consent procedure <23>. The content analysis is a qualitative an approach used to analyze the contents of communication and is validated using inter-rater reliability. A content analysis was conducted on four transcripts to determine how the verbal process compliments and extends the created consent form in terms of content and style that delivery. One transcript was analyzed by a 2nd coder to establish interrater integrity using Cohen’s Kappa. In this study, the focus was ~ above the words provided by the research coordinator that might be a paraphrasing of info in the consent type or a personalized rigid to attach to the separation, personal, instance participant’s instance or even a joke to elicit participant response.


4. Results

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


General hand gestures ad to any type of waving of the hand, conducting, paddling, arcing, or tapping in wait gestures that space not specific.


Specific conversational hand gestures room actions do by the research study coordinator the communicate much more than a tide of the hand come the participant, which may add value come the consent process by representing a principle or through re-assuring the participant.


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


Resting gestures room where the research coordinator’s hands room folded or placed confront down on the table or along the corners in ~ the top of the consent document, which include value come the consent procedure by removed unnecessary movement and by inviting the participant to ask concerns of the study coordinator.


Repositioning gestures are where the research study coordinator walk something v the record document, by either straightening the consent document, or transforming to a new page, i m sorry are essential to aid the participant follow along with the paper consent process.


Other certain hand gestures room actions wherein the research coordinator, for example, is: emotional their chest, counting, ‘what-ever’, sliding hands throughout the table, simulating a needle prick in the eight vein, creates a circle, create a crossing out or protecting against gesture to cancel other out, or gift something together ‘door number 1 vs. Door number 2’.


Head gestures room where the study coordinator is nodding or shower their own head in ~ the conversation and also may be supplied to reassure the participant.


Eye gaze ad to as soon as the research study coordinator gazes under at the composed consent document, or into the participant’s eyes, i beg your pardon is crucial for interacting ideas or concentrating 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 typical pattern that occur in the transition at the beginning of a new section wherein the research study coordinator leans front gazing under at the page and either points come or traces the crucial 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 5% repositioning), 12% were head gestures, 5% to be body posture shifts, and also 5% were eye gazes.


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Fig. 1

Observations through type


For the verbal evaluation of the mock educated consent, there to be a total of 61 concerns asked by participants over the 12 sessions, matching to 14 of the 20 sections on the consent kind that were analyzed using question asking actions analysis. ►Figure 2 gift the frequency of questions organized by ar of the consent form where the participant interrupted the research coordinator to ask a question or to get more clarification on an idea. Content in ►Figure 2 is presented in the exact same order together the 20 sections of the consent form, excluding the final section ~ above “statement of consent” (i.e., whereby the participant is request to sign the consent form).


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


The notified consent sections with the many questions in decreasing stimulate were: what will happen if friend agree to take component in PMRP, exactly how will privacy and confidentiality it is in protected, who may have access to your examine information, what room the possible risks and discomforts that the project and, will certainly you ever before be re-contacted for extr information. The sections with no questions are: what is educated consent, what room the possible benefits the the research job to you, what space the prices for taking part in this project, will any commercial commodities be arisen from PMRP, carry out you need to take part in this project, and the explain of consent.

Paraphrased explanations were typically followed by a personalized communication style to minimize the complexity of the blog post into much more simplified variation to improve the understanding of the participant. The research study coordinator never read the text of the consent form verbatim and only comes close to doing so when initially describing the consent type section why they to be asked to take component in the research study study. ►Table 1 mirrors the failure of the content evaluation between paraphrased and personalized sentences. Inter-rater integrity was calculation on one transcript utilizing a Cohen’s Kappa v 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 purpose of this the study was to determine the relationship in between the nonverbal and also verbal facets of the informed consent procedure for PMRP prior to determining just how to change the contents and procedure into a multi-media format. The written informed consent is reinforced with a procedure that involves both nonverbal and also verbal communication. Our key finding to be to determine which sections of the educated consent were complicated for participants to understand based on the frequency of concerns asked. We also identified the different types of gestures, human body postures, and verbal interaction were provided to reinforce the consent process.

The crucial finding the the observational analysis is the variability in types and frequency of gestures, body posture, and eye gaze. The results of this examine are similar to results by Bickmore et al, which verified that face-to-face consents room effective since researchers use verbal and also nonverbal behaviors, such as head nods, hand gesture, eye rigid cues and facial displays to interact factual info to patients, as well as to interact empathy and immediacy to elicit participant to trust <18>. A shift pattern may suggest where the research study coordinator uses the document consent together a means to jog their own memory to ensure the important aspects of the consent space covered. The implicit of these findings for the design of multi-media educated consent applications is the developers should ensure the the brand-new application replaces the nonverbal communication with appropriate interaction techniques.

Information that is currently conveyed in gestures require not be replaced with video clip of the very same gestures. The information could be presented using textual cues, pictures, or multimedia to boost the consent form. For example, highlighting gestures favor pointing, tapping, or tracing can be changed with a stylized text that is bolded or italicized, or through a enlarge font size. In the very same line of thought, count gestures, which show a perform of items, might be changed with cartridge points or numbers. Through virtue of the new presentation medium, certain types of gestures including: general hand waving, resting gestures, posture, and also eye gaze would certainly be irrelevant and also thus could be discarded.

Other types of particular hand waving gestures could similarly be replaced or discarded together appropriate. Repositioning gestures room generally due to the boundaries of the paper medium where page turns are important to lug forward brand-new content, and also can probably be discarded. However, the ide of repositioning will need to be changed by a “next” button at appropriate intervals.

Another applications to the replace-ability the nonverbal communication might be to use a man conversational avatar v a variety of nonverbal behaviors, including: hand gestures, body attitude shifts, gazing at and away from the patient, raising and lowering eyebrows, head nods, different facial expressions and variable proximity, i m sorry is explained in greater detail in Bickmore et al., <18>.

The services of utilizing conversational avatars include: usage of verbal and also nonverbal conversational actions that represent understanding and mark significance, and also convey details in redundant channels of details (e.g., hand gestures, such together pointing, facial display of emotion, and also eye gaze); usage of verbal and nonverbal communicative actions to maximize comprehension; use of verbal and nonverbal communicative actions used by service providers to develop trust and rapport with their patients in bespeak to rise satisfaction and also adherence to treatment regimens; and adaptation of your messages come the certain needs of patients and also to the prompt context of the conversation <18>.

The ar of the most daunting concepts within the consent form are visually presented in ►Figure 2, indicating areas where extr material must be made accessible at the request of the participant in the type of a typically Asked inquiry (FAQ) handout or added on-demand content. Comparable to Bickmore et al., outcomes in this study demonstrate that face-to-face interaction permits researchers to dynamically assess a participant"s level the understanding based on the participant"s verbal and also nonverbal behavior and to repeat or intricate information as essential <18>.

The services of making use of a FAQ for more clarifying details on the consent type is that it presents information in constant manner in a low-pressure atmosphere in which patient are totally free to take as much time as they should thoroughly know it <18>. Although study coordinators encourage participants to ask questions, they commonly fail to elicit participant’s questions and also participants with restricted health proficiency are also less likely than rather to ask concerns <18>.

Research coordinators rarely, if ever, read the message of the consent kind verbatim. The crucial finding that the content analysis is that researcher coordinator offered both paraphrased and personalized communications and also the level of paraphrasing vs. Personalization is change by transcript and by ar of the consent form. The communication analysis suggests that details is tailored come the participant using non-legalistic conversational language. Tailoring details to a certain research participant within a computer-based cultivate environment can be done using a understanding test as a part of the educated consent process similar to that supplied by Taub et al. With the study of the effect of vocabulary level and corrected feedback <7>.

There space several restrictions to this examine that affect the generalizability the the results. The examine was carried out with a tiny convenience sample in a single lab setup where attendees were no actually enrolling in the study and also were urged to ask questions. The limitation of having actually subjects that weren’t enrolling in the PMRP project might have affected the number and varieties of questions participants asked, however this is mitigated through the truth that all subjects were eligible to enroll in PMRP v the conventional protocol.

Despite the camera’s being unobtrusively mounted in the ceiling, over there is tho a possibility that power anxiety affected the nonverbal actions of the study coordinator as they attempted come habituate come the setting. Future studies must balance the researcher’s benefits of a naturalistic setting (e.g., potentially better quality interactions) against the study subject’s protections in a “mock” lab setting (e.g., much better privacy and blinding of researchers). Having actually only one research study coordinator provide all of the consents gift a bias due come the little sample size, and personal nature of nonverbal and also verbal behaviors, however this may be counter by their familiarity and also expertise with administering the PMRP consent process that permits them come habituate to the setting far better than someone who is less acquainted with administering the consent, and also to define things in a more consistent way due to raised practice. One more limitation for the observational analysis was that inter-rater integrity was not formally calculated, together a 2nd reviewer did observe a similar set of gestures for 2 transcripts however at a coarser granularity 보다 the first reviewer did. For the contents analysis, only 4 transcripts to be used because of availability.

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This study supplies several distinctive methods of evaluation to reinforce the importance of capturing the nonverbal and also verbal communication of the educated consent process in a much more complete means than previous research studies demonstrate.