**3. Results**

Because of the high ratio of survey items to number of participants, an exploratory factor analysis that included all survey items did not yield meaningful results. Breaking the survey down into smaller groups of conceptually linked items proved to be a more useful strategy. All reported exploratory factor analyses used an oblimin rotation because items representing, for example, different dimensions of nonverbal communication necessarily have a strong relationship with each other. An item was considered to be an indicator of a factor if it had a loading of .5 and a loading of no more than .4 on any other factor. The results of the exploratory factor analyses for four sets of items appear in **Table 2** (nonverbal communication), **Table 3** (translation, simplification, and lay language), **Table 4** (reframing medical information), and **Table 5** (fostering understanding of medical research). Appendix A contains the items retained for each scale.

The results of the factor analyses (where viable results were obtained) were used to construct final versions of the scales. Descriptive statistics for each of the final subscales and Cronbach's alpha appear as **Table 6**. Pearson correlations between all of the CTCI subscales appear in **Table 7**.

The relationships between the final CTCI subscales and other variables in the survey were examined. Specifically, we sought to look for possible difference in responses by gender, race/


ethnicity, and type of trial recruited for. We also looked for correlations between responses to the CTCI subscales and job satisfaction and years of experience. None of these analyses produced a significant pattern of results except for years of experience. The number of years of experience as a research professional correlated significantly with use of eye contact (r(62) = .45, *p* < .001); efforts to preserve patient privacy (r(61) = .47, *p* < .001); translation of medical and research terminology into lay language (r(56) = .55, *p* < .001); the use of reframing to explain research (r(51) = .52, *p* < .001); fostering understanding of research concepts (r(49) = .43, *p* = .002); and attitudes toward answering patient questions (r(54) = .67, *p* < .001). The correlation between years of experience and fostering understanding of medical research was nearly significant, r(52) = .27, *p* = .06. However, correlations between years of experience and the measure of mirroring and adapting to patients' nonverbal communication was non-

**Table 3.** Translation, simplification, and lay language use item factor loadings for exploratory factor analysis with

**Item 1 2 3 4** I 'translate' information about a study to help patients **.69** .00 .38 −.18 I find ways of using lay language **.67** −.08 .31 −.21

Assessing Communication Practice during Clinical Trial Recruitment and Consent: The Clinical...

I simplify the language of the consent form .58 −.25 .28 .56 I substitute simple words for complicated medical terminology .54 −.38 .11 .58

**.68** .10 −.45 .18

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205

**.73** .30 −.44 .06

**.78** .01 −.42 −.02

**.70** .03 −.02 −.38

**.75** −.16 −.04 −.24

.59 −.15 .41 −.22

.15 .71 .50 .18

.08 .84 .12 .04

.16 .82 −.11 .11

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

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

I break down the study protocol into smaller steps to make the prospect of participating in the study less intimidating

I make sure that all of my explanations of a study can be found

Because the consent form must be approved by the IRB, I keep to the

I do not diverge from the information and explanations offered in the

I try to use language that I think would be received well by members

members of certain cultural groups

adapt my explanation of a study

directly on the consent form

oblimin rotation.

language that is specified in the consent form

consent form even when I understand a study well

of the cultural group to which they belong

significant, r(54) = −.05, *p* = n.s.

**Table 2.** Nonverbal communication (reading, adapting, mirroring) factor loadings for exploratory factor analysis with oblimin rotation.


**3. Results**

204 Clinical Trials in Vulnerable Populations

too.

study.

a study to how they talk.

professional distance

oblimin rotation.

kind of mood they are in.

Because of the high ratio of survey items to number of participants, an exploratory factor analysis that included all survey items did not yield meaningful results. Breaking the survey down into smaller groups of conceptually linked items proved to be a more useful strategy. All reported exploratory factor analyses used an oblimin rotation because items representing, for example, different dimensions of nonverbal communication necessarily have a strong relationship with each other. An item was considered to be an indicator of a factor if it had a loading of .5 and a loading of no more than .4 on any other factor. The results of the exploratory factor analyses for four sets of items appear in **Table 2** (nonverbal communication), **Table 3** (translation, simplification, and lay language), **Table 4** (reframing medical information), and **Table 5** (fostering under-

standing of medical research). Appendix A contains the items retained for each scale.

**Item 1 2 3** I usually mirror a patient's body posture when I'm discussing a study with them. **.85** −.14 .25 I try to adjust my facial expressions to reflect the current situation they are in. **.75** .12 .13

I often mimic a patient's mannerisms when I talk about a study. **.74** −.07 .18 Based on my first impressions of a patient, I adapt how I talk about a study. **.69** .00 .07

I am very good at 'reading' a patient before I start talking about study details. .42 .38 −.6 I always maintain a highly professional tone and demeanor when I talk to a patient. .06 .77 .32 I act the same way with every patient regardless of their mood. −.03 .67 .40

**Table 2.** Nonverbal communication (reading, adapting, mirroring) factor loadings for exploratory factor analysis with

**.74** −.23 .06

**.69** −.05 .18

**.68** −.13 .20

**.67** .02 −.45

.46 .36 −.54

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

Whether a person talks loud and fast or softly and slowly, I adjust the way I speak about

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

I think it's more important to be warm and friendly with patients than to maintain

When I walk into the exam room (or waiting area) with patients, I try to figure out what

The results of the factor analyses (where viable results were obtained) were used to construct final versions of the scales. Descriptive statistics for each of the final subscales and Cronbach's alpha appear as **Table 6**. Pearson correlations between all of the CTCI subscales appear in **Table 7**. The relationships between the final CTCI subscales and other variables in the survey were examined. Specifically, we sought to look for possible difference in responses by gender, race/

> **Table 3.** Translation, simplification, and lay language use item factor loadings for exploratory factor analysis with oblimin rotation.

> ethnicity, and type of trial recruited for. We also looked for correlations between responses to the CTCI subscales and job satisfaction and years of experience. None of these analyses produced a significant pattern of results except for years of experience. The number of years of experience as a research professional correlated significantly with use of eye contact (r(62) = .45, *p* < .001); efforts to preserve patient privacy (r(61) = .47, *p* < .001); translation of medical and research terminology into lay language (r(56) = .55, *p* < .001); the use of reframing to explain research (r(51) = .52, *p* < .001); fostering understanding of research concepts (r(49) = .43, *p* = .002); and attitudes toward answering patient questions (r(54) = .67, *p* < .001). The correlation between years of experience and fostering understanding of medical research was nearly significant, r(52) = .27, *p* = .06. However, correlations between years of experience and the measure of mirroring and adapting to patients' nonverbal communication was nonsignificant, r(54) = −.05, *p* = n.s.


**Table 4.** Reframing medical information factor loadings for exploratory factor analysis with oblimin rotation.


**4. Discussion**

\* p = .05. \*\*p = .01. \*\*\*p < .001.

and eye contact.

This chapter presents the development and analysis of an instrument designed to evaluate the communication behaviors of professionals who recruit for clinical trials and research studies. Of the original 133 items, 44 items were retained in 8 subscales. These subscales include maintaining patient privacy; translation of medical and technical information; reframing medical and technical information; fostering understanding of research; explaining specific research concepts; question answering; nonverbal communication, including reading patients, adapting to patients' communication, their state of mind, and preferences, mirroring behaviors;

**Mean SD Cronbach's alpha**

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207

3.55 .60 .86

Assessing Communication Practice during Clinical Trial Recruitment and Consent: The Clinical...

3.12 .57 .90

Eye contact (3 items) 4.10 .55 .69 Maintaining patient privacy (4 items) 3.34 .72 .76

Reframing medical and technical information (7 items) 3.50 .71 .86 Fostering understanding of research (9 items) 4.29 .59 .86 Explaining specific research concepts (3 items) 3.96 1.13 .88

Question answering (3 items) 3.25 .54 .83

**Table 6.** Means, standard deviations, and reliabilities of Clinical Trial Communication Inventory subscales.

**1 2 3 4 5 6 7**

Translation of medical and technical information (7

Nonverbal communication (reading, adapting,

items)

mirroring) (8 items)

1. Eye contact –

2. Privacy .53\*\*\* (70) –

3. Translation .51\*\*\* (64) .60\*\*\* (64) –

4. Reframing .53\*\*\* (59) .41\*\* (59) .70\*\*\* (58) –

5. Understanding .11 (50) .13 (57) .23 (56) .23 (54) –

**Table 7.** Pearson correlations of Clinical Trial Communication Inventory subscales.

6. Explaining .19 (60) .01 (60) .14 (58) .26 (55) .46\*\*\* (56) –

7. Nonverbal .59\*\*\* (61) .56\*\*\* (61) .56\*\*\* (59) .41\*\* (54) .04 (52) .13 (54) – 8. Questions .37\*\* (62) .41\*\* (62) .53\*\*\* (61) .50\*\*\* (.59) .36\*\* (56) .08 (58) .17 (57)

**Table 5.** Fostering understanding of medical research factor loadings for exploratory factor analysis with oblimin rotation.


**Table 6.** Means, standard deviations, and reliabilities of Clinical Trial Communication Inventory subscales.


\*\*\*p < .001.

**Item 1 2 3**

I frequently use examples as a way to explain technical information about a study **.78** .30 .19 I often use metaphors and analogies to explain randomization or other study concepts **.76** −.29 −.24 I use analogies to explain potentially scary tests or concepts **.76** −.41 −.31

I often give specific examples of what will happen to a patient if they join a study **.69** .09 .37 I find that I often use analogies (that aren't part of the consent form) when explaining a study **.66** .14 −.21 Patients like to hear stories about other patient's experiences with research participation .51 .51 −.10 I make sure that patients know that the consent form is not a contract .42 .42 −.30 I often use predetermined and rehearsed stories to clarify difficult concepts .44 .32 .60 I find it difficult to explain how randomization works in the context of the trial being offered .31 −.57 .54

**Table 4.** Reframing medical information factor loadings for exploratory factor analysis with oblimin rotation.

**Item 1 2** I always begin a discussion with a patient by explaining the purpose of our conversation **.51** −.24

I offer patients the option of delaying their decision about study participation **.59** .19

I explain the general rationale for a randomized clinical trial (when appropriate) **.60** −.50

**Table 5.** Fostering understanding of medical research factor loadings for exploratory factor analysis with oblimin

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

knowledge about a particular disease, condition, or treatment

that all trials have to receive approval from ethics committees

significant additional benefit from the experimental treatment)

researchers' motivations for conducting the study

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

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

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

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

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)

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

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

understanding of the study information

before they consent to being in a study

the uncertainty of treatment benefits

practice standard treatment)

rotation.

**.84** −.04 −.02

**.71** −.32 .30

**.69** −.44

**.68** −.26

**.75** −.15

**.70** −.38

**.75** −.08

**.73** .16

.62 .49

.58 .60

.68 .71

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

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

to patients

206 Clinical Trials in Vulnerable Populations

them

**Table 7.** Pearson correlations of Clinical Trial Communication Inventory subscales.
