Background Web-based tools developed to facilitate a shared decision-making (SDM) process may facilitate the implementation of lung cancer screening (LCS), an evidence-based intervention to improve cancer outcomes. Veterans have specific risk factors and shared experiences that affect the benefits and potential harms of LCS and thus may value a veteran-centric LCS decision tool (LCSDecTool). Objective This study aims to conduct usability testing of an LCSDecTool designed for veterans receiving care at a Veteran Affairs medical center. Methods Usability testing of the LCSDecTool was conducted in a prototype version (phase 1) and a high-fidelity version (phase 2). A total of 18 veterans and 8 clinicians participated in phase 1, and 43 veterans participated in phase 2. Quantitative outcomes from the users included the System Usability Scale (SUS) and the End User Computing Satisfaction (EUCS) in phase 1 and the SUS, EUCS, and Patient Engagement scale in phase 2. Qualitative data were obtained from observations of user sessions and brief interviews. The results of phase 1 informed the modifications of the prototype for the high-fidelity version. Phase 2 usability testing took place in the context of a pilot hybrid type 1 effectiveness-implementation trial. Results In the phase 1 prototype usability testing, the mean SUS score (potential range: 0-100) was 81.90 (SD 9.80), corresponding to an excellent level of usability. The mean EUCS score (potential range: 1-5) was 4.30 (SD 0.71). In the phase 2 high-fidelity usability testing, the mean SUS score was 65.76 (SD 15.23), corresponding to a good level of usability. The mean EUCS score was 3.91 (SD 0.95); and the mean Patient Engagement scale score (potential range 1 [low] to 5 [high]) was 4.62 (SD 0.67). The median time to completion in minutes was 13 (IQR 10-16). A thematic analysis of user statements documented during phase 2 high-fidelity usability testing identified the following themes: a low baseline level of awareness and knowledge about LCS increased after use of the LCSDecTool; users sought more detailed descriptions about the LCS process; the LCSDecTool was generally easy to use, but specific navigation challenges remained; some users noted difficulty understanding medical terms used in the LCSDecTool; and use of the tool evoked veterans’ struggles with prior attempts at smoking cessation. Conclusions Our findings support the development and use of this eHealth technology in the primary care clinical setting as a way to engage veterans, inform them about a new cancer control screening test, and prepare them to participate in an SDM discussion with their provider.

Background The public health crises that emerged in the COVID-19 pandemic significantly impacted the provision of medical care and placed sudden restrictions on ongoing clinical research. Patient-facing clinical research confronted unique challenges in which recruitment and study protocols were halted and then adapted to meet safety procedures during the pandemic. Our study protocol included the use of a Lung Cancer Screening Decision Tool (LCSDecTool) in the context of a primary care visit and was considerably impacted by the pandemic. We describe our experience adapting a multi-site clinical trial of the LCSDecTool within the Department of Veterans Affairs Health Care System. We conducted a randomized controlled trial (RCT) comparing the LCSDecTool to a control intervention. Outcomes included lung cancer screening (LCS) knowledge, shared decision-making, and uptake and adherence to LCS protocol. We identified three strategies that led to the successful adaptation of the study design during the pandemic: (1) multi-level coordination and communication across the organization and study sites, (2) flexibility and adaptability in research during a time of uncertainty and changes in regulation, and (3) leveraging technology to deliver the intervention and conduct study visits, which raised issues concerning equity and internal and external validity. Conclusion Our experience highlights strategies successfully employed to adapt an intervention and behavioral research study protocol during the COVID-19 pandemic. This experience will inform clinical research moving forward both during and subsequent to the constraints placed on research and clinical care during the COVID-19 pandemic.

Background A shared decision-making (SDM) process for lung cancer screening (LCS) includes a discussion between clinicians and patients about benefits and potential harms. Expert-driven taxonomies consider mortality reduction a benefit and consider false-positives, incidental findings, overdiagnosis, overtreatment, radiation exposure, and direct and indirect costs of LCS as potential harms. Objective To explore whether patients conceptualize the attributes of LCS differently from expert-driven taxonomies. Design Cross-sectional study with semistructured interviews and a card-sort activity. Participants Twenty-three Veterans receiving primary care at a Veterans Affairs Medical Center, 55 to 73 y of age with 30 or more pack-years of smoking. Sixty-one percent were non-Hispanic African American or Black, 35% were non-Hispanic White, 4% were Hispanic, and 9% were female. Approach Semistructured interviews with thematic coding. Main Measures The proportion of participants categorizing each attribute as a benefit or harm and emergent themes that informed this categorization. Key Results In addition to categorizing reduced lung cancer deaths as a benefit (22/23), most also categorized the following as benefits: routine annual screening (8/9), significant incidental findings (20/23), follow-up in a nodule clinic (20/23), and invasive procedures (16/23). Four attributes were classified by most participants as a harm: false-positive (13/22), overdiagnosis (13/23), overtreatment (6/9), and radiation exposure (20/22). Themes regarding the evaluation of LCS outcomes were 1) the value of knowledge about body and health, 2) anticipated positive and negative emotions, 3) lack of clarity in terminology, 4) underlying beliefs about cancer, and 5) risk assessment and tolerance for uncertainty. Conclusions Anticipating discordance between patient- and expert-driven taxonomies of the benefits and harms of LCS can inform the development and interpretation of value elicitation and SDM discussions.

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BACKGROUND Web based tools developed to facilitate a Shared Decision Making (SDM) process may facilitate implementation of lung cancer screening (LCS), an evidence based intervention to improve cancer outcomes. Veterans have specific risk factors and shared experiences that impact the benefit and potential harms of LCS, so may value a Veteran centric LCS SDM too OBJECTIVE To develop and conduct usability testing of a LCS Decision Tool (LCSDecTool) designed for Veterans receiving care at a Veteran Affairs Medical Center (VAMC). METHODS A user-centered design approach was undertaken to develop the LCSDecTool. Usability of a prototype was assessed among 18 Veterans from two VA sites. Usability of a high fidelity version was assessed among 43 Veterans as part of a clinical trial. Outcomes included the System Usability Scale (SUS), the End User Computer Satisfaction (EUCS), and the Patient Engagement (PE) scale. Qualitative data from observations and short interviews with users were analyzed and themes pertaining to usability identified. RESULTS The mean (SD) in the pilot clinical trial (n=43) for the SUS (potential range 0 [low] to 100 [high] was 65.76 [15.23]); EUCS (potential range 1 [low] to 5 [high] was 3.91 [0.95]); and PE (potential range 1[low) to 5 [high] was 4.62 [0.67]). Time to completion of the LCSDecTool in minutes (median, intra-quartile range) was (13, 10-16). Emerging themes included: 1) a baseline gap in awareness of LCS with knowledge gained from using the LCSDecTool, 2) an interest in details about the LCS process, 3) the LCSDecTool was easy to use overall but specific navigation challenges identified, and 4) difficulty in understanding medical terminology. CONCLUSIONS The LCSDecTool demonstrates a good level of usability among Veterans when testing in the context of clinical care. Study findings will inform further modifications of the tool, including shortening the length and simplifying language. CLINICALTRIAL ClinicalTrials.gov Identifier: NCT02899754