Lung Cancer Screening Decision Aid Designed for a Primary Care Setting: A Randomized Clinical Trial.

Importance: Guidelines recommend shared decision-making prior to initiating lung cancer screening (LCS). However, evidence is lacking on how to best implement shared decision-making in clinical practice. Objective: To evaluate the impact of an LCS Decision Tool (LCSDecTool) on the quality of decision-making and LCS uptake. Design, Setting, and Participants: This randomized clinical trial enrolled participants at Veteran Affairs Medical Centers in Philadelphia, Pennsylvania; Milwaukee, Wisconsin; and West Haven, Connecticut, from March 18, 2019, to September 29, 2021, with follow-up through July 18, 2022. Individuals aged 55 to 80 years with a smoking history of at least 30 pack-years who were current smokers or had quit within the past 15 years were eligible to participate. Individuals with LCS within 15 months were excluded. Of 1047 individuals who were sent a recruitment letter or had referred themselves, 140 were enrolled. Intervention: A web-based patient- and clinician-facing LCS decision support tool vs an attention control intervention. Main Outcome and Measures: The primary outcome was decisional conflict at 1 month. Secondary outcomes included decisional conflict immediately after intervention and 3 months after intervention, knowledge, decisional regret, and anxiety immediately after intervention and 1 and 3 months after intervention and LCS by 6 months. Results: Of 140 enrolled participants (median age, 64.0 [IQR, 61.0-69.0] years), 129 (92.1%) were men and 11 (7.9%) were women. Of 137 participants with data available, 75 (53.6%) were African American or Black and 62 (44.3%) were White; 4 participants (2.9%) also reported Hispanic or Latino ethnicity. Mean decisional conflict score at 1 month did not differ between the LCSDecTool and control groups (25.7 [95% CI, 21.4-30.1] vs 29.9 [95% CI, 25.6-34.2], respectively; P = .18). Mean LCS knowledge score was greater in the LCSDecTool group immediately after intervention (7.0 [95% CI, 6.3-7.7] vs 4.9 [95% CI, 4.3-5.5]; P < .001) and remained higher at 1 month (6.3 [95% CI, 5.7-6.8] vs 5.2 [95% CI, 4.5-5.8]; P = .03) and 3 months (6.2 [95% CI, 5.6-6.8] vs 5.1 [95% CI, 4.4-5.8]; P = .01). Uptake of LCS was greater in the LCSDecTool group at 6 months (26 of 69 [37.7%] vs 15 of 71 [21.1%]; P = .04). Conclusions and Relevance: In this randomized clinical trial of an LCSDecTool compared with attention control, no effect on decisional conflict occurred at 1 month. The LCSDecTool used in the primary care setting did not yield a significant difference in decisional conflict. The intervention led to greater knowledge and LCS uptake. These findings can inform future implementation strategies and research in LCS shared decision-making. Trial Registration: ClinicalTrials.gov Identifier: NCT02899754.

Gender Differences in Emergency Medicine Attending Physician Comments to Residents: A Qualitative Analysis.

Importance: Prior studies have revealed gender differences in the milestone and clinical competency committee assessment of emergency medicine (EM) residents. Objective: To explore gender disparities and the reasons for such disparities in the narrative comments from EM attending physicians to EM residents. Design, Setting, and Participants: This multicenter qualitative analysis examined 10 488 narrative comments among EM faculty and EM residents between 2015 to 2018 in 5 EM training programs in the US. Data were analyzed from 2019 to 2021. Main Outcomes and Measures: Differences in narrative comments by gender and study site. Qualitative analysis included deidentification and iterative coding of the data set using an axial coding approach, with double coding of 20% of the comments at random to assess intercoder reliability (κ, 0.84). The authors reviewed the unmasked coded data set to identify emerging themes. Summary statistics were calculated for the number of narrative comments and their coded themes by gender and study site. χ2 tests were used to determine differences in the proportion of narrative comments by gender of faculty and resident. Results: In this study of 283 EM residents, of whom 113 (40%) identified as women, and 277 EM attending physicians, of whom 95 (34%) identified as women, there were notable gender differences in the content of the narrative comments from faculty to residents. Men faculty, compared with women faculty, were more likely to provide either nonspecific comments (115 of 182 [63.2%] vs 40 of 95 [42.1%]), or no comments (3387 of 10 496 [32.3%] vs 1169 of 4548 [25.7%]; P < .001) to men and women residents. Compared with men residents, more women residents were told that they were performing below level by men and women faculty (36 of 113 [31.9%] vs 43 of 170 [25.3%]), with the most common theme including lack of confidence with procedural skills. Conclusions and Relevance: In this qualitative study of narrative comments provided by EM attending physicians to residents, multiple modifiable contributors to gender disparities in assessment were identified, including the presence, content, and specificity of comments. Among women residents, procedural competency was associated with being conflated with procedural confidence. These findings can inform interventions to improve parity in assessment across graduate medical education.

A Veteran-Centric Web-Based Decision Aid for Lung Cancer Screening: Usability Analysis.

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.

Adapting the design of a Web-based decision support clinical trial during the COVID-19 pandemic.

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.

When Is a Harm a Harm? Discordance between Patient and Medical Experts' Evaluation of Lung Cancer Screening Attributes.

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.

Patient involvement in medical research: what patients and physicians learn from each other.

BACKGROUND: There is increasing interest in actively involving patients in the process of medical research to help ensure research is relevant and important to both researchers and people affected by the disease under study. This project examined the recently formed Vasculitis Patient-Powered Research Network (VPPRN), a rare disease research network, to better understand what investigators and patients learned from working on research teams together. METHODS: Qualitative interviews were conducted by phone with patients, physician/PhD-investigators, and study managers/staff who participated in the network. The question guiding the interviews and observational analysis was: "What have investigators and patients learned about working together while working on VPPRN teams?" Interview transcripts were analyzed in combination with observations from multiple in-person and telephone meetings. RESULTS: Transcripts and notes were reviewed and coded from 22 interviews conducted among 13 patient-partners, 5 study managers/staff, and 4 MD or PhD-investigators, and 6 in-person and 42 telephone/web-conference meetings. Patient-partners and investigators characterized their working relationships with one another, what they learned from their collaborations, and provided recommendations for future teams of patient-partners and investigators. Major themes included the great benefits of communicating about activities, being open to listening to each group member, and the importance of setting reasonable expectations. CONCLUSIONS: Direct engagement in research design and development by patient-partners and co-learning between investigators and patient-partners can result in a positive and productive working relationship for all members of a medical research team. This bi-directional engagement directly benefits and impacts research design, participant recruitment to studies, and study subject retention.