**4. Discussion**

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; and eye contact.

The results of supplemental analyses demonstrate that there are statistically significant relationships between all but one of the subscales of the instrument (including all of the verbal communication measures) and years of experience. This may indicate that as research professionals gain experience, they acquire knowledge about effective strategies to communicate about complex medical and scientific concepts. In fact, the fact that the measure of nonverbal communication (behaviors which are often described as something akin to "instinctual" or innate in the published studies of Morgan and colleagues) has a correlation of nearly zero may indicate that many individuals who are drawn to this type of research position may naturally be "people-people" who may nonetheless benefit from training programs with an emphasis on verbal communication techniques when recruiting and consenting potential research participants. Tentative validity testing of several items and subscales of the instrument described here was performed in early 2017. The results of this early pilot testing demonstrated that items contained in the Clinical Trial Communication Inventory can be used to assess the pre- to post-test impact of a clinical trial communication training (see Ref. [17] for full results of the evaluation).

testing needs to be conducted to more thoroughly establish convergent and predictive validity with multiple professional groups, we believe that this instrument will help advance the

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The authors wish to thank the participants who completed the survey. A special thank goes to

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

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

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

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

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

I believe that members of some minority/ethnic populations have specific preferences for

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

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

When going through a consent form with a patient, I often say something like, 'so this

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

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

**Translation of medical and technical information**

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

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

Patricia Avissar and Robert Kolb for their help with the recruitment process.

development of clinical trial communication training programs.

**Acknowledgements**

**Use of eye contact**

**Maintaining patient privacy**

will still consent the patient.

I find ways of using lay language.

words or research-related terminology.

means…' followed by a lay explanation.

discussing a study.

groups.

which they belong.

contact.

While the CTCI is likely to prove useful to evaluate efforts in clinical trial communication training, it should be noted that with a relatively small sample, the validity of factor analytic strategies used to construct some of the initial scales may be limited, although the scales we created based on these results showed strong reliability. Future research should further develop this instrument by testing its robustness with a larger sample of research coordinators and validate it with other types of medical professionals who recruit for clinical trials, including physicians and study nurses. Additionally, it is vitally important for this instrument to be evaluated through convergent validity testing. The question remains whether the Clinical Trial Communication Inventory reflects real-world communication practice and indeed, whether these communication behaviors predict increased informed decision making or improved rates of clinical trial accrual. Convergent validity can be established through a variety of strategies, including checklists of exhibited communication behaviors during role plays and video recordings of actual recruitment and consent behaviors with patients. Predictive validity could be established by demonstrating that communication training results in changed scores on the CTCI from pre- to post-test, and more importantly, that scores post-training reflect improvements to informed consent with patients, which can be evaluated through patient "teach-backs" and an increased number of accurate responses to a set of study-related knowledge questions.
