The MOSAIC Study: A Mixed-Methods Study of the Clinical, Emotional, and Financial Burden of Geographic Atrophy Among Patients and Caregivers in the US.

Purpose: Geographic atrophy (GA) impacts both patients and caregivers, yet little is understood about their respective burdens. The MOSAIC study aimed to identify the clinical, emotional, and financial burden among patients with GA and caregivers. Methods: A total of 28 patients with GA and 17 caregivers from the United States (US), the United Kingdom, and Australia participated in individualized qualitative interviews followed by a cross-sectional quantitative survey of 102 patients and 102 caregivers in the US. Interview transcripts were analyzed to develop conceptual models, which were then used to guide the design of quantitative surveys. Data were described at the item level and score level when appropriate (National Eye Institute Visual Function Questionnaire [NEI VFQ]-39 and Zarit Burden Interview [ZBI]). For the patient/caregiver dyad sample, the association between the NEI VFQ-39 scores and ZBI score was explored through correlation coefficients and scatterplots. Results: GA had a substantial impact on patients' vision-related quality of life, activities of daily living, and instrumental activities of daily living. There was considerable overlap between perspectives and key concerns identified by patients and caregivers. Eighty-three percent of caregivers reported having to drive patients to appointments due to limited patient mobility, for example, and 41% reported a change in their employment status after becoming a caregiver, with 50% of them unable to work due to caregiving. The burden of patients and caregivers had a correlation ranging from -0.63 to -0.21 between NEI VFQ-39 subscale and composite scores and ZBI score. Conclusion: This study confirms the paucity of support for both patients with GA and caregivers. Both groups require expanded access to financial, social, and mental health resources.

What is this summary about? People with geographic atrophy, also called GA, can lose their eyesight and have a hard time driving, reading, and recognizing faces. This can worsen their quality of life. Often, people with GA need someone to care for them. The MOSAIC study was done to find out how GA affects health, happiness, and finances of people with GA and their caregivers. What were the results? One hundred and two people with GA and 102 caregivers in the United States were interviewed. The average age of people with GA was 68 years and of caregivers was 46 years. The findings showed that most people with GA did not drive because of their poor eyesight and instead counted on their caregivers to drive them to doctor appointments and other places. They also had a reading and doing things around their home because of their worsened eyesight. Both people with GA and caregivers said they felt stressed. They both worried about spending money on things they need to make living with GA easier. They also felt stressed about their finances because they could not work as much. People with GA worried most about losing their independence and caregivers worried most about the future of their loved one with GA. What do the results mean? This study showed that GA has a serious effect on people's health and quality of life while also having a major impact on their caregivers.

Development of a Conceptual Model of the Patient Experience in Small Cell Lung Cancer: A Qualitative Interview Study.

INTRODUCTION: Small cell lung cancer (SCLC) is a subtype of lung cancer, the second most common cancer diagnosis worldwide. Currently, there is little published qualitative research that provides insight into the disease-related symptoms and impacts that are relevant to patients living with SCLC as directly reported by patients themselves. METHODS: This qualitative, cross-sectional, noninterventional, descriptive study included concept elicitation interviews with participants diagnosed with SCLC and the development of a conceptual model of clinical treatment benefit. RESULTS: Concept elicitation interview data from 26 participants with SCLC were used to develop a conceptual model of clinical treatment benefit that organized 28 patient-reported concepts into two domains: disease-related symptoms (organ-specific and systemic) and impacts. Organ-specific symptoms included cough, chest pain, and difficulty breathing. Systemic symptoms included pain, fatigue, appetite loss, and dizziness. Impacts included physical functioning, role functioning, reduced movement, impact on sleep, and weight loss. CONCLUSION: As evidenced by this study, people with SCLC experience considerable and significant symptoms and impacts, including physical and role functioning challenges, that affect their quality of life. This conceptual model will inform the design of a patient-reported outcome (PRO) questionnaire for a future SCLC clinical trial, helping to establish the content validity of the items and questionnaires used in the trial and ensuring that the questionnaires and items selected are appropriately targeted to the population. This conceptual model could also be used to inform future SCLC clinical trials.

Emotional Distress, Anxiety, and General Health Status in Patients With Newly Identified Small Pulmonary Nodules: Results From the Watch the Spot Trial.

BACKGROUND: Anxiety and emotional distress have not been studied in large, diverse samples of patients with pulmonary nodules. RESEARCH QUESTION: How common are anxiety and distress in patients with newly identified pulmonary nodules, and what factors are associated with these outcomes? STUDY DESIGN AND METHODS: This study surveyed participants in the Watch the Spot Trial, a large, pragmatic clinical trial of more vs less intensive strategies for radiographic surveillance of patients with small pulmonary nodules. The survey included validated instruments to measure patient-centered outcomes such as nodule-related emotional distress (Impact of Event Scale-Revised) and anxiety (Six-Item State Anxiety Inventory) 6 to 8 weeks following nodule identification. Mixed-effects models were used to compare outcomes between study arms following adjustment for potential confounders and clustering within enrollment site, while also examining a limited number of prespecified explanatory factors, including nodule size, mode of detection, type of ordering clinician, and lack of timely notification prior to contact by the study team. RESULTS: The trial enrolled 34,699 patients; 2,049 individuals completed the baseline survey (5.9%). Respondents and nonrespondents had similar demographic and nodule characteristics, although more respondents were non-Hispanic and White. Impact of Event Scale-Revised scores indicated mild, moderate, or severe distress in 32.2%, 9.4%, and 7.2% of respondents, respectively, with no difference in scores between study arms. Following adjustment, greater emotional distress was associated with larger nodule size and lack of timely notification by a clinician; distress was also associated with younger age, female sex, ever smoking, Black race, and Hispanic ethnicity. Anxiety was associated with lack of timely notification, ever smoking, and female sex. INTERPRETATION: Almost one-half of respondents experienced emotional distress 6 to 8 weeks following pulmonary nodule identification. Strategies are needed to mitigate the burden of distress, especially in younger, female, ever smoking, and minoritized patients, and those with larger nodules. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov; No.: NCT02623712; URL: www. CLINICALTRIALS: gov.

Factors Affecting Compliance with Diabetic Retinopathy Screening: A Qualitative Study Comparing English and Spanish Speakers.

Purpose: The purpose of this study was to understand individual-, social-, and system-level factors that affect compliance with recommended diabetic retinopathy (DR)-evaluations, and how these factors vary between English and Spanish speakers. Patients and Methods: We conducted a qualitative study using semi-structured interviews. Study subjects included Kaiser Permanente Southern California members with type II diabetes mellitus at least aged 26 years who spoke English or Spanish. Patients were divided into groups based on their adherence with DR evaluations. Our main outcome measure was the major themes expressed by patients that explained their compliance with DR evaluation. Results: Fifty-one participants were enrolled: 30 English speakers (11 nonadherent, 19 adherent) and 21 Spanish speakers (8 nonadherent, 13 adherent). Adherent patients were more likely to have had experience with diabetes and identify as being responsible for their own care. Substantially more non-adherent patients suggested that beliefs and attitudes were the reasons people missed retinopathy appointments. More English-speaking participants tended to be self-directed in managing their healthcare, whereas more Spanish speakers relied on others for help. English speakers also noted better relationships with their physicians. Spanish speakers outlined problems with insurance coverage and costs as barriers. Conclusion: These data suggest two specific intervention strategies that eye care providers could implement to improve adherence with diabetic retinopathy screening and follow up: incorporating a person with DR-related visual loss into the team of staff delivering diabetes support programs and communication campaigns including specific messaging to address fears related to vision loss.

De-implementation and substitution of clinical care processes: stakeholder perspectives on the transition to primary human papillomavirus (HPV) testing for cervical cancer screening.

BACKGROUND: New cervical cancer screening guidelines recommend primary human papillomavirus (HPV) testing for women age 30-65 years. Healthcare organizations are preparing to de-implement the previous recommended strategies of Pap testing or co-testing (Pap plus HPV test) and substitute primary HPV testing. However, there may be significant challenges to the replacement of this entrenched clinical practice, even with an evidence-based substitution. We sought to identify stakeholder-perceived barriers and facilitators to this substitution within a large healthcare system, Kaiser Permanente Southern California. METHODS: We conducted semi-structured qualitative interviews with clinician, administrative, and patient stakeholders regarding (a) acceptability and feasibility of the planned substitution; (b) perceptions of barriers and facilitators, with an emphasis on those related to the de-implementation/implementation cycle of substitution; and (c) perceived readiness to change. Our interview guide was informed by the Consolidated Framework for Implementation Research (CFIR). Using a team coding approach, we developed an initial coding structure refined during iterative analysis; the data were subsequently organized thematically into domains, key themes, and sub-themes using thematic analysis, followed by framework analysis informed by CFIR. RESULTS: We conducted 23 interviews: 5 patient and 18 clinical/administrative. Clinicians perceived that patients feel more tests equals better care, and clinicians and patients expressed fear of missed cancers ("…it'll be more challenging convincing the patient that only one test is…good enough to detect cancer."). Patients perceived practice changes resulting in "less care" are driven by the desire to cut costs. In contrast, clinicians/administrators viewed changing from two tests to one as acceptable and a workflow efficiency ("…It's very easy and half the work."). Stakeholder-recommended strategies included focusing on the increased efficacy of primary HPV testing and developing clinician talking points incorporating national guidelines to assuage "cost-cutting" fears. CONCLUSIONS: Substitution to replace an entrenched clinical practice is complex. Leveraging available facilitators is key to ease the process for clinical and administrative stakeholders-e.g., emphasizing the efficiency of going from two tests to one. Identifying and addressing clinician and patient fears regarding cost-cutting and perceived poorer quality of care is critical for substitution. Multicomponent and multilevel strategies for engagement and education will be required. TRIAL REGISTRATION: ClinicalTrials.gov, # NCT04371887.

Guidelines for the Evaluation of Pulmonary Nodules Detected Incidentally or by Screening: A Survey of Radiologist Awareness, Agreement, and Adherence From the Watch the Spot Trial.

PURPOSE: The aim of this study was to examine radiologists' beliefs about existing guidelines for pulmonary nodule evaluation. METHODS: A self-administered survey was developed to ascertain awareness of, agreement with, and adherence to published guidelines, including those from the Fleischner Society and the Lung CT Screening Reporting and Data System (Lung-RADS™). Surveys were distributed to 514 radiologists at 13 health care systems that are participating in a large, pragmatic trial of pulmonary nodule evaluation. Prespecified comparisons were made among groups defined by type of health system, years of experience, reader volume, and study arm. RESULTS: The response rate was 26.3%. Respondents were most familiar with guidelines from Fleischner (94%) and Lung-RADS (71%). For both incidental and screening-detected nodules, self-reported adherence to preferred guidelines was very high (97% and 94%, respectively), and most respondents believed that the benefits of adherence outweigh the harms (81% and 74%, respectively). Underlying evidence was thought to be high in quality by 68% of respondents for screening-detected nodules and 41% for incidental nodules. Approximately 70% of respondents believed that the frequency of recommended follow-up was "just right" for both guidelines. Radiologists who practice in nonintegrated health care systems were more likely to believe that the evidence was high in quality (79.5% versus 57.1%) and that the benefits of adherence outweigh the harms (85.1% versus 67.5%). Low-volume readers had lower awareness and self-reported adherence than higher volume readers. CONCLUSIONS: Radiologists reported high levels of familiarity and agreement with and adherence to guidelines for pulmonary nodule evaluation, but many overestimated the quality of evidence in support of the recommendations.

Impact of Physician-Patient Language Concordance on Patient Outcomes and Adherence to Clinical Chest Pain Recommendations.

OBJECTIVES: The objective was to evaluate if there is an association between patient-physician language concordance and adverse patient outcomes or physician adherence to clinical recommendations for emergency department (ED) patients with chest pain. METHODS: We conducted a retrospective observational study of adult ED chest pain encounters with a troponin order from May 2016 to September 2017 across 15 community EDs. Outcomes were 30-day acute myocardial infarction or all-cause mortality, hospital admission/observation, or noninvasive cardiac testing. To assess patient outcomes, we used the overall cohort. To assess adherence to clinical recommendations, we used a subgroup of patients with a low-risk HEART score. A mixed-effects logistic regression model was used to compare the odds of the outcomes between language concordant and discordant patient-physician pairs, controlling for patient characteristics. RESULTS: Overall, 52,014 ED encounters were included (10,791 low-risk HEART encounters). Of those 6,452 (12.4%) encounters were language discordant and 1.7% in each group had an adverse outcome. Adjusted models demonstrated no increased risk for language discordant ED encounters when comparing adverse outcomes (odds ratio [OR] = 0.96, 95% confidence interval [CI] = 0.6 to 1.5) for all patients or recommended care (OR = 1.02, 95% CI = 0.87 to 1.2) for low-risk patients. CONCLUSIONS: No associations were found between patient-physician language concordance and outcomes or physician adherence to clinical recommendations for ED patients with chest pain. Accessible and effective interpretation services, combined with a decision support tool with standard clinical recommendations, may have contributed to equitable care.

Methods for the Watch the Spot Trial. A Pragmatic Trial of More- versus Less-Intensive Strategies for Active Surveillance of Small Pulmonary Nodules.

Small pulmonary nodules are most often managed by surveillance imaging with computed tomography (CT) of the chest, but the optimal frequency and duration of surveillance are unknown. The Watch the Spot Trial is a multicenter, pragmatic, comparative-effectiveness trial with cluster randomization by hospital or health system that compares more- versus less-intensive strategies for active surveillance of small pulmonary nodules. The study plans to enroll approximately 35,200 patients with a small pulmonary nodule that is newly detected on chest CT imaging, either incidentally or by screening. Study protocols for more- and less-intensive surveillance were adapted from published guidelines. The primary outcome is the percentage of cancerous nodules that progress beyond American Joint Committee on Cancer seventh edition stage T1a. Secondary outcomes include patient-reported anxiety and emotional distress, nodule-related health care use, radiation exposure, and adherence with the assigned surveillance protocol. Distinctive aspects of the trial include: 1) the pragmatic integration of study procedures into existing clinical workflow; 2) the use of cluster randomization by hospital or health system; 3) the implementation and evaluation of a system-level intervention for protocol-based care; 4) the use of highly efficient, technology-enabled methods to identify and (passively) enroll participants; 5) reliance on data collected as part of routine clinical care, including data from electronic health records and state cancer registries; 6) linkage with state cancer registries for complete ascertainment of the primary study outcome; and 7) intensive engagement with a diverse group of patient and nonpatient stakeholders in the design and execution of the study.