**Appendix A: Subscales of the Clinical Trial Communication Inventory**

#### **Use of eye contact**

I use eye contact to try to figure out whether a patient understands a study through eye contact.

I use eye contact to assess a patient's state of mind while I talk with them about a study.

I find that most patients do not want to make eye contact when discussing study participation.

#### **Maintaining patient privacy**

If the patient is comfortable discussing a study in an area where privacy cannot be secured, I will still consent the patient.

Most patients don't care about being consented in a private location.

It is not practical to always consent patients in a private location.

If a private location in unavailable, I talk in a quiet voice to enhance a sense of privacy when discussing a study.

#### **Translation of medical and technical information**

I 'translate' information about a study to help patients.

I find ways of using lay language.

I believe that members of some minority/ethnic populations have specific preferences for words or research-related terminology.

I try to avoid certain words or medical terms when talking with members of certain cultural groups.

I try to use language that I think would be received well by members of the cultural group to which they belong.

When going through a consent form with a patient, I often say something like, 'so this means…' followed by a lay explanation.

Based on what I know about the educational level of the patient, I adapt my explanation of a study.

I explain the concept of beneficence (trials are conducted to determine whether there is a sig-

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211

I explain the concept of non-maleficence (there is evidence to suggest that being involved in a

I think it is more important to be warm and friendly with patients than to maintain a profes-

I slip into the same style and manner of speech as the person I am talking to about a study. Whether a person talks loud and fast or softly and slowly, I adjust the way I speak about a

When I am discussing a study participation, if a patient appears relaxed, I relax my body, too.

I make sure to give a patient the names of who to contact if they have additional questions

1 Department of Communication Studies, School of Communication, University of Miami,

2 Department of Communication Studies, Texas Christian University, Fort Worth, USA

4 STEM Translational Communication Center, University of Florida, Gainesville, USA

3 UT Health San Antonio, The University of Texas at Austin, San Antonio, USA

, Wei Peng<sup>1</sup>

and JoNell E. Potter<sup>5</sup>

, Aurora Occa1

\*,

I usually mirror a patient's body posture when I's discussing a study with them.

Based on my first impressions of a patient, I adapt how I talk about a study. I try to adjust my facial expressions to reflect the current situation they are in.

, Jessica Raley3

, Janice Krieger<sup>4</sup>

5 Miller School of Medicine, University of Miami, Miami, USA

nificant additional benefit from the experimental treatment).

clinical trial will in no way worsen the patient's chances).

sional distance.

study to how they talk.

**Question answering**

about the trial

**Author details**

Susan E. Morgan1

Miami, USA

Soroya Julian McFarlane1

**Nonverbal communication (reading, adapting, mirroring)**

I often mimic a patient's mannerisms when I talk about a study.

I enjoy answering a patient's questions about a study. I always invite patients to ask questions about a study.

, Amber Finn2

\*Address all correspondence to: axo132@miami.edu

#### **Reframing medical and technical information**

If it's a complex study, I often reframe information in medical terms that are more familiar to them.

I find that I often use analogies (that aren't part of the consent form) when explaining a study.

I frequently use examples as a way to explain technical information about a study.

I often give specific examples of what will happen to a patient if they join a study.

I frame unfamiliar or potentially scary concepts in terms that are more familiar or acceptable to patients.

I often use metaphors and analogies to explain randomization or other study concepts.

I use analogies to explain potentially scary tests or concepts.

#### **Fostering understanding of research**

I always begin a discussion with a patient by explaining the purpose of our conversation.

Before getting a patient's signature on a consent form, I always check their understanding of the study information.

I ask patients to 'teach back' (or summarize for me) the key points of a study to me before they consent to being in a study.

I offer patients the option of delaying their decision about study participation.

I explain to patients that the research study is being conducted to improve scientific knowledge about a particular disease, condition, or treatment.

I explain the general rationale for a randomized clinical trial (when appropriate).

When offering patients the opportunity to participate in a research study, I explain the researchers' motivations for conducting the study.

When offering patients the opportunity to participate in a research study, I tell them that all trials have to receive approval from ethics committees.

When offering patients the opportunity to participate in a research study, I acknowledge the uncertainty of treatment benefits.

#### **Explaining specific research concepts**

I explain the concept of equipoise (trials are conducted only when there is collective uncertainty that the benefit of an experimental treatment is better than the current best practice standard treatment).

I explain the concept of beneficence (trials are conducted to determine whether there is a significant additional benefit from the experimental treatment).

I explain the concept of non-maleficence (there is evidence to suggest that being involved in a clinical trial will in no way worsen the patient's chances).

#### **Nonverbal communication (reading, adapting, mirroring)**

I think it is more important to be warm and friendly with patients than to maintain a professional distance.

I slip into the same style and manner of speech as the person I am talking to about a study.

Whether a person talks loud and fast or softly and slowly, I adjust the way I speak about a study to how they talk.

I usually mirror a patient's body posture when I's discussing a study with them.

When I am discussing a study participation, if a patient appears relaxed, I relax my body, too.

I often mimic a patient's mannerisms when I talk about a study.

Based on my first impressions of a patient, I adapt how I talk about a study.

I try to adjust my facial expressions to reflect the current situation they are in.

#### **Question answering**

Based on what I know about the educational level of the patient, I adapt my explanation of a

If it's a complex study, I often reframe information in medical terms that are more familiar to

I find that I often use analogies (that aren't part of the consent form) when explaining a study.

I frame unfamiliar or potentially scary concepts in terms that are more familiar or acceptable

I often use metaphors and analogies to explain randomization or other study concepts.

I always begin a discussion with a patient by explaining the purpose of our conversation.

Before getting a patient's signature on a consent form, I always check their understanding of

I ask patients to 'teach back' (or summarize for me) the key points of a study to me before they

I explain to patients that the research study is being conducted to improve scientific knowl-

When offering patients the opportunity to participate in a research study, I explain the

When offering patients the opportunity to participate in a research study, I tell them that all

When offering patients the opportunity to participate in a research study, I acknowledge the

I explain the concept of equipoise (trials are conducted only when there is collective uncertainty that the benefit of an experimental treatment is better than the current best practice

I offer patients the option of delaying their decision about study participation.

I explain the general rationale for a randomized clinical trial (when appropriate).

I use analogies to explain potentially scary tests or concepts.

edge about a particular disease, condition, or treatment.

researchers' motivations for conducting the study.

trials have to receive approval from ethics committees.

**Fostering understanding of research**

the study information.

consent to being in a study.

uncertainty of treatment benefits.

standard treatment).

**Explaining specific research concepts**

I frequently use examples as a way to explain technical information about a study.

I often give specific examples of what will happen to a patient if they join a study.

study.

210 Clinical Trials in Vulnerable Populations

them.

to patients.

**Reframing medical and technical information**

I enjoy answering a patient's questions about a study.

I always invite patients to ask questions about a study.

I make sure to give a patient the names of who to contact if they have additional questions about the trial
