Conflicts of Interest in Bronchoscopy Research - Is Self-Reporting Sufficient?

BACKGROUND: Robotic assisted bronchoscopy has been enthusiastically adopted in the U.S. and transformed the management of patients with indeterminate pulmonary nodules. Unprecedented industry investments in research, development, and marketing have profoundly affected the bronchoscopy landscape, leading to concerns that conflicts of interest could influence the validity of bronchoscopy studies. Disclosures of conflicts of interest in research are predicated on open and transparent self-reporting. RESEARCH QUESTION: Are self-reported relevant conflicts of interest in articles pertaining to robotic assisted bronchoscopy accurate when compared to publicly available payments on the Centers of Medicare & Medicaid Services' Open Payments Database? STUDY DESIGN AND METHODS: All articles pertaining to robotic assisted bronchoscopy indexed on PubMed between 2016 and 2022 were screened for relevance. Articles appearing in the five journals with the most relevant publications were selected. General, research, and associated research payments reported in the Open Payments Database were recorded for each US physician-author with available data. "Relevant payments" refer to transactions made to authors by bronchoscopy-related companies. Documentation of all payments involving these companies during the three years prior to an article's submission date was obtained. These payments were compared to the self-reported conflicts of interest for each author, per article, and the number and value of payments were categorized and totaled. RESULTS: Twenty-seven articles were included, accounting for 75 U.S. physicians with data reported in the Open Payments Database. Of the $17 million in relevant payments reported, $9.9 million were not disclosed (57%). Sixty-eight of 75 (91%) of authors had incomplete physician disclosures. Excluding food and beverage payments, sixty authors had incomplete disclosures (80%). INTERPRETATION: Relevant conflicts of interest appear to be inconsistently disclosed in publications on robotic assisted bronchoscopy, suggesting self-reporting may be an insufficient strategy. A centralized disclosure process that is automated or easier to use should be considered.

Patient Perspectives on Evolving Diverticulitis Treatment: An Assessment of Patient Willingness to Enroll in a Randomized Controlled Trial.

Objective: The objective of the study was to assess patients' attitudes regarding participation in a randomized trial of antibiotics versus placebo for acute diverticulitis. Background: Despite evidence that antibiotics may not be necessary to treat acute uncomplicated diverticulitis, they remain the mainstay of treatment in the United States. A randomized trial in the United States evaluating antibiotic effectiveness could accelerate the implementation of antibiotic-free treatment, but providers maintain concerns that patients may be unwilling to participate. Methods: This mixed-methods study conducted semi-structured interviews of patients presenting to a quaternary care emergency department with acute diverticulitis and a web-based survey of a larger cohort. The interviews assessed patients' experiences with diverticulitis and perceptions of participation in a trial comparing antibiotics versus placebo. The survey quantified patients' willingness to participate in such a study and the relative importance of factors influencing the process. Results: Thirteen patients completed an interview. Reasons to participate included a desire to help others or contribute to scientific knowledge. Doubts about the efficacy of observation as a treatment method were the main barrier to participation. In a survey of 218 subjects, 62% of respondents reported willingness to participate in a randomized clinical trial. "What my doctor thinks," followed by "What I have experienced in the past" were the most important decision-making factors. Conclusion: Patients with acute uncomplicated diverticulitis maintain complex and varying perceptions of antibiotic use. Most surveyed patients would be willing to participate in a trial of antibiotics versus placebo. Our findings support the trial's feasibility and may facilitate an informed approach to recruitment and consent.

Decision Aid for Colectomy in Recurrent Diverticulitis: Development and Usability Study.

BACKGROUND: Diverticular disease is a common gastrointestinal diagnosis with over 2.7 million clinic visits yearly. National guidelines from the American Society of Colon and Rectal Surgeons state that "the decision to recommend elective sigmoid colectomy after recovery from uncomplicated acute diverticulitis should be individualized." However, tools to individualize this decision are lacking. OBJECTIVE: This study aimed to develop an online educational decision aid (DA) to facilitate effective surgeon and patient communication about treatment options for recurrent left-sided diverticulitis. METHODS: We used a modified design sprint methodology to create a prototype DA. We engaged a multidisciplinary team and adapted elements from the Ottawa Personal Decision Guide. We then iteratively refined the prototype by conducting a mixed methods assessment of content and usability testing, involving cognitive interviews with patients and surgeons. The findings informed the refinement of the DA. Further testing included an in-clinic feasibility review. RESULTS: Over a 4-day in-person rapid design sprint, including patients, surgeons, and health communication experts, we developed a prototype of a diverticulitis DA, comprising an interactive website and handout with 3 discrete sections. The first section contains education about diverticulitis and treatment options. The second section clarifies the potential risks and benefits of both clinical treatment options (medical management vs colectomy). The third section invites patients to participate in a value clarification exercise. After navigating the DA, the patient prints a synopsis that they bring to their clinic appointment, which serves as a guide for shared decision-making. CONCLUSIONS: Design sprint methodology, emphasizing stakeholder co-design and complemented by extensive user testing, is an effective and efficient strategy to create a DA for patients living with recurrent diverticulitis facing critical treatment decisions.

A Delphi Panel Study for Public Education about Vascularized Composite Allograft Donation in the United States.

Introduction: Improving public awareness about the opportunity to become a vascularized composite allograft (VCA) donor is crucial to increasing access to organs. Prior research identified a need for comprehensive and comprehensible public education materials. A 2-round Delphi panel was conducted to garner US expert consensus on the topics and language to include in public education materials via an organ procurement organization-hosted website. Methods: The round 1 survey assessed the importance of educational topics and statements (n = 19) using 5-point Likert scales. The round 2 survey asked experts to rate new and repeated educational topics (n = 27). Open-ended comment boxes elicited experts' feedback and language revisions for educational statements. Responses were analyzed using descriptive statistics and rapid qualitative analysis. Findings: Eighteen experts responded to the round 1 survey and 15 to round 2. After round 2, 20 topics had mean (M) importance greater than neutral (M > 3.00) and were retained in the educational materials. The 5 most important topics by mean Likert ratings were: consent process for donation (M = 4.73), potential recipients (M = 4.73), most common vascularized composite organs transplanted (M = 4.47), purpose (M = 4.47), and definition (M = 4.47). Seven themes emerged from experts' open-ended comments about the importance and language of educational statements. Conclusions: Delphi panel findings identified expert-endorsed topics and educational statements for public education about vascularized composite organ donation via an educational website. Future research should assess the website's impact on public knowledge of VCA donation.

Co-design and usability of an interactive web-based fertility decision aid for transgender youth and young adults.

OBJECTIVE: To develop a patient- and family-centered Aid For Fertility-Related Medical Decisions (AFFRMED) interactive website targeted for transgender and nonbinary (TNB) youth/young adults and their parents to facilitate shared decision-making about fertility preservation interventions through user-centered participatory design. METHOD: TNB youth/young adults interested in or currently receiving pubertal suppression or gender-affirming hormone treatment and parents of eligible TNB youth/young adults were recruited to participate in a series of iterative human-centered co-design sessions to develop an initial AFFRMED prototype. Subsequently, TNB youth/young adults and parents of TNB youth/young adults were recruited for usability testing interviews, involving measures of usability (i.e., After Scenario Questionnaire, Net Promotor Score, System Usability Scale). RESULTS: Twenty-seven participants completed 18 iterative co-design sessions and provided feedback on 10 versions of AFFRMED (16 TNB youth/young adults and 11 parents). Nine TNB youth/young adults and six parents completed individual usability testing interviews. Overall, participants rated AFFRMED highly on measures of acceptability, appropriateness, usability, and satisfaction. However, scores varied by treatment cohort, with TNB youth interested in or currently receiving pubertal suppression treatment reporting the lowest usability scores. CONCLUSIONS: We co-created a youth- and family-centered fertility decision aid prototype that provides education and decision support in an online, interactive format. Future directions include testing the efficacy of the decision aid in improving fertility and fertility preservation knowledge, decisional self-efficacy, and decision satisfaction.

Knowledge gaps in heart and lung donation after the circulatory determination of death: Report of a workshop of the National Heart, Lung, and Blood Institute.

In a workshop sponsored by the U.S. National Heart, Lung, and Blood Institute, experts identified current knowledge gaps and research opportunities in the scientific, conceptual, and ethical understanding of organ donation after the circulatory determination of death and its technologies. To minimize organ injury from warm ischemia and produce better recipient outcomes, innovative techniques to perfuse and oxygenate organs postmortem in situ, such as thoracoabdominal normothermic regional perfusion, are being implemented in several medical centers in the US and elsewhere. These technologies have improved organ outcomes but have raised ethical and legal questions. Re-establishing donor circulation postmortem can be viewed as invalidating the condition of permanent cessation of circulation on which the earlier death determination was made and clamping arch vessels to exclude brain circulation can be viewed as inducing brain death. Alternatively, TA-NRP can be viewed as localized in-situ organ perfusion, not whole-body resuscitation, that does not invalidate death determination. Further scientific, conceptual, and ethical studies, such as those identified in this workshop, can inform and help resolve controversies raised by this practice.

Disparities Persist Among Hispanic Patients: Completing Evaluation, Waitlisting, and Receiving a Kidney Transplant.

Background: Hispanic patients receive disproportionately fewer kidney transplants (KT) than non-Hispanic White (NHW) patients. In this observational study, we evaluated disparities in completing evaluation steps to KT among Hispanic patients. Methods: Using medical records of Hispanic and NHW patients initiating evaluation at 4 transplant centers from January 2011 to March 2020, we performed sequential Cox models to compare Hispanic versus NHW patients reaching each step of the evaluation process until receiving a KT. Results: Among all 5197 patients (Hispanic n = 2473; NHW n = 2724) initiating evaluation, Hispanic patients had 8% lower risk to be approved by the kidney pancreas (KP) committee than NHW patients (adjusted hazard ratio [aHR], 0.92; 95% confidence intervals (CI), 0.86-0.98; P = 0.015). Among 3492 patients approved by the KP committee, Hispanic patients had 13% lower risk to be waitlisted than NHW patients (aHR, 0.87; 95% CI, 0.81-0.94; P = 0.004). Among 3382 patients who were waitlisted, Hispanic patients had 11% lower risk than NHW patients to receive KT (aHR, 0.89; 95% CI, 0.81-0.97; P = 0.011). Among all patients initiating evaluation, Hispanic patients had a 16% lower risk than NHW patients to reach KT (aHR, 0.84; 95% CI, 0.76-0.92; P = 0.0002). Conclusions: Our study found that disproportionately fewer Hispanic patients were approved by the KP committee, were waitlisted, and received a KT, particularly a living donor kidney transplant, than NHW patients. Closer oversight of the evaluation process may help patients overcome challenges in access to KT.

Development of a culturally targeted chatbot to inform living kidney donor candidates of African ancestry about APOL1 genetic testing: a mixed methods study.

Clinical chatbots are increasingly used to help integrate genetic testing into clinical contexts, but no chatbot exists for Apolipoprotein L1 (APOL1) genetic testing of living kidney donor (LKD) candidates of African ancestry. Our study aimed to culturally adapt and assess perceptions of the Gia® chatbot to help integrate APOL1 testing into LKD evaluation. Ten focus groups and post-focus group surveys were conducted with 54 LKDs, community members, and kidney transplant recipients of African ancestry. Data were analyzed through thematic analysis and descriptive statistics. Key themes about making Gia culturally targeted included ensuring: (1) transparency by providing Black LKDs' testimonials, explaining patient privacy and confidentiality protections, and explaining how genetic testing can help LKD evaluation; (2) content is informative by educating Black LKDs about APOL1 testing instead of aiming to convince them to undergo testing, presenting statistics, and describing how genetic discrimination is legally prevented; and (3) content avoids stigma about living donation in the Black community. Most agreed Gia was neutral and unbiased (82%), trustworthy (82%), and words, phrases, and expressions were familiar to the intended audience (85%). Our culturally adapted APOL1 Gia chatbot was well regarded. Future research should assess how this chatbot could supplement provider discussion prior to genetic testing to scale APOL1 counseling and testing for LKD candidate clinical evaluation.

Improving Health Equity in Living Donor Kidney Transplant: Application of an Implementation Science Framework.

BACKGROUND: Interventions to improve racial equity in access to living donor kidney transplants (LDKT) have focused primarily on patients, ignoring the contributions of clinicians, transplant centers, and health system factors. Obtaining access to LDKT is a complex, multi-step process involving patients, their families, clinicians, and health system functions. An implementation science framework can help elucidate multi-level barriers to achieving racial equity in LDKT and guide the implementation of interventions targeted at all levels. METHODS: We adopted the Pragmatic Robust Implementation and Sustainability Model (PRISM), an implementation science framework for racial equity in LDKT. The purpose was to provide a guide for assessment, inform intervention design, and support planning for the implementation of interventions. RESULTS: We applied 4 main PRISM domains to racial equity in LDKT: Organizational Characteristics, Program Components, External Environment, and Patient Characteristics. We specified elements within each domain that consider perspectives of the health system, transplant center, clinical staff, and patients. CONCLUSION: The applied PRISM framework provides a foundation for the examination of multi-level influences across the entirety of LDKT care. Researchers, quality improvement staff, and clinicians can use the applied PRISM framework to guide the assessment of inequities, support collaborative intervention development, monitor intervention implementation, and inform resource allocation to improve equity in access to LDKT.

Development and Validation of the Rating of CKD Knowledge Among Older Adults (Know-CKD) With Kidney Failure.

RATIONALE & OBJECTIVE: Few older adults with kidney failure engage in shared decision making (SDM) for kidney replacement therapy. The lack of instruments to assess SDM-relevant knowledge domains may contribute to this. We assessed the reliability and validity of a new instrument, the Rating of CKD Knowledge Older Adults (Know-CKD). STUDY DESIGN: Multistage process, including a stakeholder-engaged development phase, pilot testing, and validation of a knowledge instrument using a cross-sectional survey of older adults with CKD. SETTING & PARTICIPANTS: 363 patients aged 70+years with nondialysis advanced chronic kidney disease (CKD) (estimated glomerular filtration rate [eGFR]<30mL/min/1.73m2) in Boston, Chicago, Portland, ME, and San Diego from June 2018 and January 2020. EXPOSURE: Educational level, higher literacy (Single Item Literacy Screener [SILS]) and numeracy (Subjective Numeracy Scale [SNS]), having participated in clinic-sponsored dialysis education, and self-reported "feeling informed" about options for treatment. OUTCOME: Validity and reliability of the Know-CKD instrument. ANALYTICAL APPROACH: Reliability was assessed with the Kuder-Richardson-20 coefficient. Construct validity was demonstrated by testing a priori hypotheses using t test, analysis of variance (ANOVA) tests, and linear regression analyses. RESULTS: The mean (± SD) participant age was 77.6±5.9 years, and mean eGFR was 22.7±7.2mL/min/1.73m2; 281 participants (78%) self-reported as White. The 12-item Know-CKD assessment had good reliability (Kuder-Richardson-20 reliability coefficient=0.75), and a mean score of 58.2% ± 22.3 SD. The subscales did not attain acceptable reliability. The proportion answering correctly on each item ranged from 20.1% to 91.7%. In examining construct validity, the hypothesized associations held; Know-CKD significantly associated with higher education (ß=6.98 [95% CI, 1.34-12.61], P=0.02), health literacy (ß = -12.67 [95% CI, -19.49 to-5.86], P≤0.001), numeracy per 10% higher (ß=1.85 [95% CI, 1.02-2.69], P≤0.001), and attendance at dialysis class (ß=18.28 [95% CI, 13.30-23.27], P≤0.001). These associations were also observed for the subscales except for prognosis (not associated with literacy or numeracy). LIMITATIONS: Know-CKD is only available in English and has been used only in research settings. CONCLUSIONS: For older adults facing dialysis initiation decisions, Know-CKD is a valid, reliable, and easy to administer measure of knowledge. Further research should examine the relationship of kidney disease knowledge and SDM, patient satisfaction, and clinical outcomes. PLAIN-LANGUAGE SUMMARY: The Rating of CKD Knowledge Among Older Adults (Know-CKD) study measures knowledge of chronic kidney disease (CKD) and is designed for older adults. Most existing knowledge measures for CKD focus on people of all ages and all CKD stages. This measure is useful because it will allow researchers to assess how well patient education efforts are working. Patient education is a way to help patients make decisions about their care. We describe how the measure was developed by a team of doctors, researchers, and patients, and how the measure performed among persons with advanced CKD aged 70 years and older. Know-CKD can inform efforts to improve shared decision-making research and practice for older patients with kidney disease.

Defining the Need for Causal Inference to Understand the Impact of Social Determinants of Health: A Primer on Behalf of the Consortium for the Holistic Assessment of Risk in Transplantation (CHART).

Objective: This study aims to introduce key concepts and methods that inform the design of studies that seek to quantify the causal effect of social determinants of health (SDOH) on access to and outcomes following organ transplant. Background: The causal pathways between SDOH and transplant outcomes are poorly understood. This is partially due to the unstandardized and incomplete capture of the complex interactions between patients, their neighborhood environments, the tertiary care system, and structural factors that impact access and outcomes. Designing studies to quantify the causal impact of these factors on transplant access and outcomes requires an understanding of the fundamental concepts of causal inference. Methods: We present an overview of fundamental concepts in causal inference, including the potential outcomes framework and direct acyclic graphs. We discuss how to conceptualize SDOH in a causal framework and provide applied examples to illustrate how bias is introduced. Results: There is a need for direct measures of SDOH, increased measurement of latent and mediating variables, and multi-level frameworks for research that examine health inequities across multiple health systems to generalize results. We illustrate that biases can arise due to socioeconomic status, race/ethnicity, and incongruencies in language between the patient and clinician. Conclusions: Progress towards an equitable transplant system requires establishing causal pathways between psychosocial risk factors, access, and outcomes. This is predicated on accurate and precise quantification of social risk, best facilitated by improved organization of health system data and multicenter efforts to collect and learn from it in ways relevant to specialties and service lines.

Direct and Indirect Effects of a Web-Based Educational and Communication Skills Intervention "Promotoras de Donación" to Increase Donor Designation in Latinx Communities: Evaluation Study.

BACKGROUND: Latinx populations are severely underrepresented among organ donors compared with the non-Hispanic White population. The Promotoras de Donación e-learning module was developed to train Latinx lay health educators (ie, promotoras) to discuss deceased organ donation and promote donor designation within their communities. OBJECTIVE: This paper described the results of 2 studies designed to assess the direct and indirect effects of the module on promotoras' and mature Latinas' organ donation and donor designation knowledge, attitudes, and behaviors. METHODS: In partnership with 4 community-based promotoras organizations, we designed 2 nonrandomized, quasiexperimental pragmatic studies to evaluate the Promotoras de Donación e-learning module, with participating promotoras and mature Latinas serving as their own controls. Brief surveys were administered to participating promotoras before and after module completion to assess changes in organ donation knowledge and support and communication confidence (study 1). Promotoras participating in the first study were asked to hold at least 2 group conversations about organ donation and donor designation with mature Latinas (study 2); paper-pencil surveys were completed by all participants before and after the group conversations. Descriptive statistics, means and SDs, and counts and percentages were used as appropriate to categorize the samples. Paired sample 2-tailed t test was used to assess changes in knowledge of and support for organ donation and confidence in discussing donation and promoting donor designation from pre- to posttest. RESULTS: Overall, 40 promotoras completed this module (study 1). Increases in organ donation knowledge (mean 6.0, SD 1.9 to mean 6.2, SD 2.9) and support (mean 3.4, SD 0.9 to mean 3.6, SD 0.9) were observed from pre- to posttest; however, these changes did not reach statistical significance. A statistically significant increase in communication confidence was found (mean 692.1, SD 232.4 to mean 852.3, SD 139.7; P=.01). The module was well received, with most participants deeming it well organized, presenting new information, and providing realistic and helpful portrayals of donation conversations. A total of 52 group discussions with 375 attendees were led by 25 promotoras (study 2). The trained promotora-led group discussions about organ donation resulted in increased support for organ donation in promotoras and mature Latinas from pre- to posttest. Knowledge of the steps to become an organ donor and belief that the process is easy to perform increased in mature Latinas from pre- to posttest by 30.7% and 15.2%, respectively. In total, 5.6% (21/375) of attendees submitted completed organ donation registration forms. CONCLUSIONS: This evaluation provides preliminary support for the module's direct and indirect effects on organ donation knowledge, attitudes, and behaviors. The need for additional modifications to and future evaluations of the module are discussed.

Patient definitions of transplant success in upper extremity vascularized composite allotransplantation: A mixed-methods study.

Objective: Upper extremity vascularized composite allotransplantation is an innovative treatment option for people with upper extremity amputations. Limited patient-relevant long-term outcomes data about transplant success may impede patients' informed treatment decision-making. We assessed perceptions of what constitutes upper extremity vascularized composite allotransplantation success among individuals with upper extremity amputations. Methods: This multisite study entailed interviews and focus groups with individuals with upper extremity amputations and upper extremity vascularized composite allotransplantation candidates, participants, and recipients. We examined perceptions of transplant success and preferences for five upper extremity vascularized composite allotransplantation outcomes. Qualitative data were analyzed using thematic analysis; and quantitative data were analyzed using descriptive statistics. Results: In all, 50 individuals participated in interviews (61.7% participation rate), and 37 participated in nine focus groups (75.5% participation rate). Most were White (72%, 73%), had a mean age of 45 and 48 years, and had a unilateral amputation (84%, 59%), respectively. Participants conceptualized upper extremity vascularized composite allotransplantation success as transplant outcomes: (1) restoring function and sensation to enable new activities; (2) accepting the transplanted limb into one's identity and appearance; (3) not having transplant rejection; (4) attaining greater quality of life compared to prosthetics; and (5) ensuring benefits outweigh risks. Participants rated their most important upper extremity vascularized composite allotransplantation outcomes as follows: not having transplant rejection, not developing health complications, grasping objects, feeling touch and temperature, and accepting the upper extremity vascularized composite allotransplantation into your identity. Conclusion: Individuals with upper extremity amputations maintain several conceptions of vascularized composite allotransplantation success, spanning functional, psychosocial, clinical, and quality of life outcomes. Providers should address patients' conceptions of success to improve informed consent discussions and outcomes reporting for upper extremity vascularized composite allotransplantation.

Complex Patient Perspectives on Evolving Diverticulitis Treatment Patient Perspectives on Diverticulitis.

Background: Despite evidence that antibiotics may not be necessary to treat acute uncomplicated diverticulitis, they remain the mainstay of treatment in the United States. A randomized controlled trial evaluating antibiotic effectiveness could accelerate implementation of an antibiotic-free treatment strategy, but patients may be unwilling to participate. Objective: This study aims to assess patients' attitudes regarding participation in a randomized trial of antibiotics versus placebo for acute diverticulitis, including willingness to participate. Design: This is a mixed-methods study with qualitative and descriptive methods. Settings: Interviews were conducted in a quaternary care emergency department and surveys were administered virtually through a web-based portal. Patients: Patients with either current or previous acute uncomplicated diverticulitis participated. Interventions: Patients underwent semi-structured interviews or completed a web-based survey. Main Outcome measures: Rates of willingness to participate in a randomized controlled trial was measured. Salient factors related to healthcare decision-making were also identified and analyzed. Results: Thirteen patients completed an interview. Reasons to participate included a desire to help others or contribute to scientific knowledge. Doubts about the efficacy of observation as a treatment method were the main barrier to participation. In a survey of 218 subjects, 62% of respondents reported willingness to participate in a randomized clinical trial. "What my doctor thinks," followed by "What I've experienced in the past" were the most important decision-making factors. Limitations: There is possible selection bias inherent to using a study to evaluate willingness to participate in a study. Also, the population sampled was disproportionately White compared to the population affected by diverticulitis. Conclusions: Patients with acute uncomplicated diverticulitis maintain complex and varying perceptions of the use of antibiotics. Most surveyed patients would be willing to participate in a trial of antibiotics versus placebo. Our findings support a trial's feasibility and facilitate an informed approach to recruitment and consent.