Potential Selection Bias Research Articles

Representativeness of race, ethnicity and social determinants of health in patients with advanced non-small cell lung cancer via linkage of real-world electronic health records, administrative claims, and consumer financial data.

e13559 Background: Social determinants of health (SDOH) are both drivers of health disparities and barriers to clinical research participation, particularly among historically underserved or marginalized populations. Using real-world data (RWD), diversity plans in cancer clinical trials frequently aim to reduce disparities and improve representation. Our aim was to describe the representativeness of patients with advanced non-small cell lung cancer (aNSCLC) with respect to race, ethnicity and person-level SDOH in a curated electronic health record (EHR) database. Methods: This was a retrospective cohort study of individuals diagnosed with aNSCLC between 2016–2022 in a US-based oncology EHR database (ConcertAI). Information on person-level SDOH was derived from linkage of curated EHR data to administrative claims and consumer financial data. These data were also compared to a sample of patients diagnosed with first primary NSCLC from the Surveillance, Epidemiology, and End Results (SEER) Program and American Community Survey (ACS), where possible. The Kaplan-Meier product limit estimator was used to compare time from advanced diagnosis to treatment initiation. Results: From an overall sample of 17,772 patients with aNSCLC, a total of 10,390 patients had 1 or more SDOH characteristics of interest documented. Compared with patients without linked SDOH data, a higher proportion of patients with linked person-level SDOH data were non-Hispanic (NH) White patients (79% vs 71%) and lower proportions were NH Black (10% vs 13%), NH Asian/Pacific Islander (2% vs 4%) and Hispanic patients (2% vs 4%). Patients with linked SDOH were also more likely to have aNSCLC progressed from an earlier stage and received biomarker testing for targetable alterations. Overall, 54% of patients were married, 38% completed a bachelor’s degree or higher, 14% worked in a blue-collar occupation, and 61% had an individual income of ≤$35,000. All 4 of these SDOH characteristics differed significantly by race/ethnicity. Differences in time-to-treatment initiation were statistically significant by marital status (median of 50 [married] vs 55 [not married] days; P=0.02) and individual income (median of 50 [>$60,000] vs 55 [≤$30,000] days; P=0.04). Patients with aNSCLC in these data differed from patients in SEER and ACS estimates with respect to greater representation of patients who are NH White, have lower levels of education, and lower individual income. Conclusions: This analysis demonstrated the feasibility of measuring person-level SDOH using EHR from patients with aNSCLC treated at oncology clinics across the US. RWD with linked SDOH characteristics should be used cautiously to address the representativeness gap in evidence from oncology trials given their potential inherent selection biases.

Relationship between dietary knowledge, food preference, and long-short term health status among Chinese adults.

In recent years, with the improvement of people's living standards and changes in dietary patterns, dietary knowledge and food preference have been playing an increasingly crucial role in health. The aim of our study was to examine the relationship between dietary knowledge, food preference, and long-short term health status among Chinese adults aged 18-70. This study employed cross-sectional data from the 2015 China Health and Nutrition Survey obtained from 4822 adults. We utilized self-assessed health status as an indicator of long-term health status and utilized sickness in the last four weeks as a measure of short-term health status. Taking advantage of ordered probit regression, long-term health status was regressed on all predictors, while the binary logistic regression was used to analyze the factors influencing short-term health status. The propensity score matching is employed to account for potential selection bias in analysis, thereby increasing the robustness and credibility of results. The analysis revealed that dietary knowledge and food preference can improve an individual's long-term health status significantly. However, there is no evidence to show that short-term health status is affected by food preference. Furthermore, dietary knowledge is negatively associated with short-term health status. These findings highlight the importance of dietary education and healthy eating habits in improving the long-term health status of Chinese adults. The study suggests implications for public health strategies aimed at enhancing the health and well-being of Chinese adults.

Short-term Outcomes of Laparoscopic Versus Open Liver Resection in the Elderly: A Propensity Score-matched Analysis.

With the aging of the population, there is a rising proportion of elderly patients undergoing liver resection. However, the safety and efficacy of laparoscopic liver resection (LLR) in the elderly have not yet been established. In this study, we compared the short-term results of LLR and open liver resection (OLR) in elderly patients using propensity score matched (PSM) analysis. The study comprised 237 elderly patients aged 65 years and older who had undergone liver resection between 2015 to 2021, excluding biliary and vascular reconstruction and simultaneous surgeries other than liver resection. We conducted PSM analysis for baseline characteristics (age, sex, BMI, ASA-PS, disease, procedure, tumor size, and number of tumors) to eliminate potential selection bias. We then compared short-term postoperative outcomes between LLR and OLR groups in patients selected by PSM analysis. Applying PSM analysis, 90 cases each were selected for the LLR and OLR groups. The LLR group had a significantly lower complication rate (Clavien-Dindo: CD ≥II) (19% vs. 33%, p=0.03), especially bile leakage (CD ≥II) (0% vs. 6.7%, p=0.03) compared with those in the OLR group. In addition, a shorter operation time (244 min vs. 351 min, p<0.01), less blood loss (150 ml vs. 335 ml, p<0.01), and shorter hospital stay (8 days vs. 12 days, p<0.01) were observed in the LLR group. No operative or in-hospital deaths were observed in both groups. LLR can be safely performed in elderly patients and offers better short-term outcomes.

Election proximity and the effectiveness of economic sanctions

Do elections matter for sanction effectiveness? Scholars have long highlighted the importance of domestic political factors in target (i.e. sanctioned) states in explaining when economic sanctions work. This line of research, however, has primarily focused on political regime characteristics and interest groups that are relatively low time-variant during sanction episodes. Building on this literature, we explore the effect of temporal proximity to elections. While the impact of elections have been examined in the context of military conflicts, their possible effects on sanction effectiveness have not been subject to systematic scrutiny. We argue that target governments are more likely to comply with sender demands as elections loom near in order to avoid the likely political costs of sanctions. The effect of elections, however, is likely to vary across different election characteristics and political regime types. We assess the empirical merits of our claims using data on over 1,000 sanction cases between 1950 and 2020. The results from a battery of empirical tests, including those that account for potential selection bias, support our hypotheses. We find that elections have a positive effect on sanction success, and this effect is more prominent in less democratic states that hold competitive elections. This suggests that even if sanctions have a relatively low success rate against non-democratic polities, elections may provide a window of opportunity for senders to extract concessions from target states.

Infertility and pregnancy outcomes among adults with primary ciliary dyskinesia.

What is the prevalence of infertility and ectopic pregnancies among individuals with primary ciliary dyskinesia (PCD)? We found that 39 of 50 men (78%) and 72 of 118 women (61%) with PCD were infertile and that women with PCD had an increased risk of ectopic pregnancies (7.6 per 100 pregnancies, 95% CI 4.7-12.2). PCD is a heterogeneous multiorgan disease caused by mutations in genes required for the function and structure of motile cilia. Previous studies identified a link between PCD and infertility, but original data on prevalence of infertility and risk of ectopic pregnancies, the use and efficacy of medically assisted reproduction (MAR), and the association of fertility with PCD genotype are extremely limited. We performed a cross-sectional survey about fertility within the Living with PCD study (formerly COVID-PCD). Living with PCD is an international, online, participatory study that collects information directly from people with PCD. People with PCD of any age from anywhere in the world can participate in the study. At the time of the survey, 482 adults with PCD were registered within the Living with PCD study. We sent a questionnaire on fertility on 12 July 2022, to all participants older than 18 years enrolled in the Living with PCD study. Responses were collected until 8 March 2023. The fertility questionnaire covered topics related to pregnancy attempts, use of MAR, and pregnancy outcomes. Data were collected via the Research Electronic Data Capture (REDCap) platform. We defined infertility as failure to achieve a clinical pregnancy after 12 months or use of MAR for at least one pregnancy. In total, 265 of 482 adult participants (55%) completed the fertility questionnaire. Among 168 adults who had tried to conceive, 39 of 50 men (78%) and 72 of 118 women (61%) were infertile. Of the infertile men, 28 had tried MAR, and 17 of them (61%) fathered a child with the help of MAR. Among infertile women, 59 had used MAR, and 41 of them (69%) became pregnant with the help of MAR. In our population, women with PCD showed a relatively high risk of ectopic pregnancies: 1 in 10 women who became pregnant had at least one ectopic pregnancy and 7.6% of pregnancies were ectopic (95% CI 4.7-12.2). We evaluated the association between fertility and affected PCD genes in 46 individuals (11 men, 35 women) with available genetic and fertility information, and found differences between genotypes, e.g. all five women with a mutation in CCDC40 were infertile and all five with DNAH11 were fertile. The study has limitations, including potential selection bias as people experiencing problems with fertility might be more likely to fill in the questionnaire, which may have influenced our prevalence estimates. We were unable to validate clinical data obtained from participant self-reports owing to the anonymous study design, which is likely to lead to recall bias. The study underlines the need for addressing infertility in routine PCD care, with a focus on informing individuals with PCD about their increased risk. It emphasizes the utility and efficacy of MAR in PCD-related infertility. Additionally, women attempting conception should be made aware of the increased risk of ectopic pregnancies and seek systematic early consultation to confirm an intrauterine pregnancy. Fertility, efficacy of MAR, and risk for adverse pregnancy outcomes differ between people with PCD-depending on genotypes-and close monitoring and support might be needed from fertility specialists to increase chances of successful conception. Our research was funded by the Swiss National Science Foundation, Switzerland (SNSF 320030B_192804), the Swiss Lung Association, Switzerland (2021-08_Pedersen), and we also received support from the PCD Foundation, USA; the Verein Kartagener Syndrom und Primäre Ciliäre Dyskinesie, Germany; the PCD Support UK, UK; and PCD Australia, Australia. M. Goutaki received funding from the Swiss National Science Foundation, Switzerland (PZ00P3_185923). B. Maitre participates in the RaDiCo-DCP funded by INSERM France. The study authors participate in the BEAT-PCD Clinical Research Collaboration supported by the European Respiratory Society. All authors declare no conflict of interest. ClinicalTrials.gov ID NCT04602481.

Effects of the Coronavirus disease 2019 pandemic on mortality in patients with lung cancer: A multiple mediation analysis in Japan.

COVID-19 pandemic has had a substantial effect on healthcare systems worldwide, including the care of patients with lung cancer. The impact of healthcare disruptions and behavioral changes on lung cancer mortality is unclear. Patients newly diagnosed with lung cancer during the pandemic period 2020-2021 were compared with those diagnosed in the pre-pandemic 2018-2019. The primary outcome was all-cause mortality within 1 year. Cox proportional hazards regression analyses were conducted to estimate the changes in mortality between pandemic and pre-pandemic. Multiple mediation analyses were performed to determine the factors that accounted for the changes in mortality. In total, 5785 patients with lung cancer were included in this study. The overall mortality rate was significantly higher during the pandemic compared with the pre-pandemic (crude hazard ratio [HR]: 1.19, 95% confidence interval [CI]: 1.05, 1.29). Mediation analyses showed that not receiving tumor-directed treatment, diagnosis at an older age, and decreased diagnosis through cancer screening significantly accounted for 17.5% (95%CI: 4.2, 30.7), 13.9% (95%CI: 0.8, 27.0), and 12.4% (95%CI: 3.0, 21.8) of the increased mortality, respectively. This study revealed a significant increase in mortality risk in patients with lung cancer who have not received tumor-directed treatment or cancer screening, despite potential selection bias for follow-up status. Efforts should be focused on ensuring timely access to healthcare services, optimizing treatment delivery, and addressing the unique challenges faced by patients with lung cancer during the pandemic to mitigate the impact of the pandemic on lung cancer outcomes and provide clinical care to vulnerable populations.

A time-dependent analysis of sacubitril/valsartan and gliflozins benefits in patients receiving cardiac resynchronization therapy

Abstract Background While sacubitril/valsartan (ARNi), gliflozins (or SGLT2i) and cardiac resynchronization therapy (CRT) are firmly recognized as cornerstones of therapy for heart failure with reduced ejection fraction (HFrEF), robust evidence validating the long-term efficacy of their combination remains elusive. The few data suggesting a synergistic advantage of these drugs alongside CRT have not rigorously considered their time-varying administration, leading to potential selection bias, since only patients with longer initial survival could commence these treatments. As a result, the literature to date lacks a comprehensive and persuasive demonstration of the additional survival benefits conferred by ARNi and gliflozins over CRT alone in HFrEF. Purpose To evaluate the impact of ARNi and gliflozins on reducing cardiovascular and overall mortality among HFrEF patients undergoing CRT. Methods Patients with heart failure and an ejection fraction ≤ 35%, who were referred for CRT-D implantation from 2015 to 2023, were retrospectively recruited for the study. These patients were grouped into two cohorts: those not receiving drugs (no drugs group) and those treated with ARNi and/or SGLT2i (ARNi/SGLT2i group). Importantly, ARNi and SGLT2i treatments were considered as time-dependent covariates in order to account for patients who initiated or discontinued therapy during follow-up. Results The cohort included 183 ischemic and non-ischemic HFrEF patients (148 male [80.9 %], 113 ischemic [61.7 %], median [IQR] age 73 [65-80] years). 117 (74 %) patients started ARNi (61, 52.1 %), gliflozins (7, 6 %) or both drugs (49, 41.9 %) and were assigned to ARNi/SGLT2i group. During a median follow-up of 5.67 (CI 95 %, 5 – 6.5) years, 63 (34.4 %) patients died, of whom 47 (74.6 %) died of cardiovascular HF-related death. Specifically, 44 (of whom 35 (79 %) due to HF-related death) died in the no drugs group vs 19 (12 (63 %) due to HF-related death) in ARNi/SGLT2i patients. At univariable analysis (Panel A in the Figure), ARNi and/or SGLT2i treatments reduced all-cause (HR 0.59 [0.34-1.02], p = 0.056) and cardiovascular (HR 0.47 [0.24-0.92], p = 0.029) mortality. However, after multivariable adjustment for key covariates (1-year CRT response, age, atrial fibrillation, baseline LVEF, chronic obstructive pulmonary disease, glomerular filtration rate), the survival benefits of ARNi and SGLT2i use diminished, and the only factor strongly associated with reduced mortality risk remained 1-year positive response to CRT (Panel B). Conclusions Despite their recognized therapeutic benefits, ARNi and SGLT2i have not demonstrated additional survival benefit compared to CRT alone in patients with HFrEF. A 1-year positive response to CRT remains the most significant prognostic factor. Further studies with larger sample sizes and extended follow-up periods are needed to confirm this hypothesis, also evaluating whether the timing of introduction of these medications may impact survival.

Does tax avoidance affect productivity in SMEs?

PurposeThe present paper examines whether tax avoidance practices affect productivity in small and medium-sized enterprises (SMEs). This study also analyses whether this association is moderated by firm size, firm financial constraints, management control of cash flows, or information risk.Design/methodology/approachThis study used a sample of Spanish SMEs for the period 2006–2020. Tax avoidance was measured as the difference between the statutory tax rate and the effective tax rate, and three proxies for productivity were used: overall productivity, capital productivity and labour productivity. Firm fixed effects regressions, propensity score matching and change regressions were used to address the potential sample selection bias and endogeneity between tax avoidance and productivity.FindingsThe results of the empirical analysis suggest that tax avoidance increases productivity in SMEs. This beneficial effect of tax avoidance was found to be higher in small firms than in medium-sized firms, but smaller in firms that faced financial constraints. Furthermore, the findings showed that the tax avoidance effect on productivity was stronger in firms where managers had less control over the cash flow –i.e. dividend-paying firms–, and weaker in firms with lower quality of financial information – i.e. firms with qualified audit reports.Research limitations/implicationsThis study contributes to the research on the economic consequences of tax avoidance by examining its impact on firm-level productivity in SMEs. From additional analyses, the findings of the study suggest that the positive effect of tax avoidance on firm productivity depends on firm size, the financial slack of the firm, and the costs of agency conflicts and information problems associated with tax avoidance.Practical implicationsThe results of this study have implications for SMEs, suggesting that cash flows obtained through tax avoidance, if properly used, may increase firm productivity. In planning their tax avoidance practices, SME managers could take advantage of specific tax incentives designed for SMEs, which is particularly relevant given the low-productivity levels of these firms. The findings also highlight the importance of maintaining high-quality information and implementing mechanisms to mitigate the agency risks associated with tax avoidance to enhance the productivity of SMEs.Social implicationsThis study provides important insights to policymakers on SME tax policy, supporting the special tax rules for SMEs – in force in many OECD and EU countries – which aim to create an environment conducive to SME growth. The findings of the study also have macroeconomic implications, given the importance of firm productivity as a determinant of economic growth and the relevance of SMEs in most national economies.Originality/valueThis study provides novel empirical evidence on the effects of tax avoidance on firm-level productivity in SMEs. Despite the prevalence of SMEs as the predominant type of organization in most countries, no prior research has comprehensively examined this issue for this type of firm. This research question was addressed by considering proxies for overall, capital, and labour productivity and by examining how SME characteristics affect this relationship.

Invited commentary: mixing multiple imputation and bootstrapping for variance estimation.

Multiple imputation (MI) is commonly implemented to mitigate potential selection bias due to missing data. The accompanying article by Nguyen and Stuart (Am J Epidemiol. 2024;193(10):1470-1476) examines the statistical consistency of several ways of integrating MI with propensity scores. As Nguyen and Stuart noted, variance estimation for these different approaches remains to be developed. One common option is the nonparametric bootstrap, which can provide valid inference when closed-form variance estimators are not available. However, there is no consensus on how to implement MI and nonparametric bootstrapping in analyses. To complement Nguyen and Stuart's article on MI and propensity score analyses, we review some currently available approaches on variance estimation with MI and nonparametric bootstrapping.

Moderating effect of shift work on sleep and depression in individuals at high risk of bipolar disorder

BackgroundSocial Zeitgeber Theory posits that disruptions in social rhythms can increase susceptibility to bipolar disorder (BD). Shift work (SW) is one of the external factors that cause instability in social rhythms and the sleep-wake cycle. This study evaluated the moderating influences of SW on the risks of BD and sleep-related parameters and depressive symptoms. Furthermore, we evaluated the specific work schedules including daytime, nighttime, and regular and irregular rotating SW. MethodsAn online survey was administered to 6665 participants, with 3379 (50.7 %) classified as individuals with high scores of Mood Disorder Questionnaire (MDQ). The survey included the Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Scale (ISI), Epworth Sleepiness Scale (ESS), and Center for Epidemiologic Studies Depression Scale (CES-D). ResultsA multivariate regression model revealed significant interactive effects of MDQ positivity and SW on PSQI, ISI, and CES-D scores, but not ESS scores. In a secondary analysis of the high MDQ screen group, daytime workers had lower scores in sleep disturbances and depressive symptoms compared to those engaged in other forms of SW. LimitationsOnline surveys were accessible voluntarily, leading to potential selection bias. Cross-sectional data identified associations, not causal relationships. Only a self-reported questionnaire was used. ConclusionsOur findings emphasize the advantages of a daytime work schedule for individuals at high risk of BD. In accordance with the principles of social rhythm interpersonal therapy, sleep interventions for individuals at high risk of BD should include the maintenance of a consistent daytime schedule.

A Test Method for Identifying Selection Bias Risk in Prospective Controlled Clinical Therapy Trials Using the I2 Point Estimate.

A test method is proposed for identifying potential selection bias risk in single prospective controlled clinical therapy trials that can be applied by trial reviewers. The method is described in detail and was tested on eight randomised controlled trials (RCTs) with reported negative Berger-Exner test results as negative and on eight prospective, controlled cohort studies as positive controls. All 16 studies were identified by systematic literature search. The test method yielded negative results for all RCTs and positive results for six out of the eight cohortstudies. All test results remained within the expected limits for both study types, suggesting a reasonably high accuracy for correctly identifying selection bias risk. However, the method does not provide the possibility to establish whether such bias risk has actually altered trial outcomes. Instead, a positive test result may provide an empirical basis for rating a trial as of high selection bias risk during trial appraisal.

Efficiency of agricultural cooperative members in Indonesia

The food supply's stability is dependent on agricultural productivity, which, in turn, depends on the efficient allocation of production factors. This research analyzes the efficiency levels of rice farmers and compares them between cooperative members and non-members. This study quantifies efficiency using the stochastic frontier analysis (SFA) method and compares the results using the propensity score matching (PSM) method, which addresses potential selectivity bias resulting from the decision to join a cooperative. The study utilizes cross-sectional data from the Badan Pusat Statistik (BPS) of the Republic of Indonesia, encompassing a sample size of 68,204 farmers. The analysis reveals that the majority of farmers operate within an efficiency range of 70-90 percent. Cooperative members exhibit higher efficiency levels than non-members, with a 2.1 percent increase during the wet season and a 3.1 percent increase during the dry season. Researchers employ an alternative method, coarsened exact matching (CEM), to ensure robustness, yielding results similar to the PSM model. This research provides evidence that cooperatives have the potential to significantly enhance agricultural efficiency. The findings underscore the importance of developing and supporting cooperatives to enhance the overall welfare of farmers.

Psoriasis and mental health in adolescents: A cross-sectional study within the Danish National Birth Cohort

BackgroundPsoriasis is a chronic skin disease associated with lower quality of life and higher risk of anxiety and depression in adults. We investigate whether adolescents with psoriasis also experience poorer mental health than their peers. MethodsIn this cross-sectional study, we included questionnaire data on psoriasis and mental health from the 18-year follow-up of the Danish National Birth Cohort. We estimated odds ratios (OR) and 95 % confidence intervals (CI) using a logistic regression with inverse probability weighting to account for potential selection bias, adjusted for potential confounders identified a priori. We estimated associations between self-reported psoriasis and multiple aspects of mental health (self-rated health, life satisfaction, mental well-being, loneliness, overall and internalizing behavioral difficulties, depressive symptoms, and anxiety symptoms). In sensitivity analyses, we examined doctor-diagnosed psoriasis and psoriasis with and without joint pain. ResultsOf the 44,838 included in this study, 1147 (2.6 %) reported psoriasis. Adolescents with psoriasis had a higher risk of nearly all outcomes, including depressive symptoms (OR 1.38; 1.19–1.58) and panic/agoraphobia among both males (OR 1.72; 1.33–2.19) and females (OR 1.60; 1.33–1.92). Associations attenuated when restricted to doctor-diagnosed psoriasis. Associations with poor mental health were mainly observed for adolescents with psoriasis also reporting joint pain. LimitationsWe could not establish temporality and lacked data on joint pain in referents. ConclusionPsoriasis is associated with poor mental health in adolescents. This appears to be driven by adolescents with psoriasis also reporting joint pain and is less evident in those with a doctor-confirmed diagnosis.

Abstract PO5-26-07: Surgery for Invasive Lobular Carcinoma: A Patient Experience Survey from the Lobular Breast Cancer Alliance

Abstract The Lobular Breast Cancer Alliance (LBCA) is a nonprofit, patient advocacy organization committed to raising awareness and promoting research into invasive lobular carcinoma (ILC). While ILC accounts for 15% of breast cancers, knowledge about ILC remains limited. ILC’s hallmark is lack of E-cadherin, which results in non-cohesive formation and impacts accuracy of imaging tests and staging. Consequently, patients with ILC have higher rates of positive surgical margins, mastectomies, and axillary lymph node (LN) dissections. To understand the surgery experience of individuals with ILC, LBCA conducted an anonymous online survey from 6/21-7/2/23, distributed via the LBCA newsletter, social media, and partner organizations. Questions addressed pre-operative imaging, type of surgery, surgical margins, LN status, decision making about and patient experience with surgery. Analyses were limited to those respondents who had surgery. Study limitations include potential recall and selection bias. Results 1,482 individuals with a diagnosis of ILC completed the survey and 1,426 had undergone surgery. 76% were from North America, 11% from England, and 4% from Australia. Average age at diagnosis was 56 (range 31-86). At diagnosis, 38% were clinically stage 1; 37% stage 2; 17% stage 3; and 4% de novo metastatic. 75% had a mammogram that indicated dense breasts. Of 1,426 surgery respondents (SR), 95% reported that ILC was identified in only one breast at diagnosis. 80% had a pre-surgical MRI. MRI revealed larger tumors than seen on other imaging for 43% and revealed previously unseen contralateral ILC for 3%. 375 (26%) of SRs were diagnosed with ipsilateral disease and had a pre-surgical MRI that did not reveal new information about their ILC. Of these, post-surgical pathology reports indicated 16% had additional ipsilateral foci, 2% contralateral disease, and 40% had larger tumors than seen on pre-surgical imaging. 614 (43%) of SRs had one or more lumpectomy (L), 560 (39%) of SRs had a double mastectomy (DM), and 451 (32%) of SRs had a single mastectomy (SM). 123 (20%) of SRs who had one or more Ls, had a subsequent SM or DM. For those undergoing L (614), reasons for this choice included: recommendation from their care team (83%), wanted to keep their breast (25%), thought it was better for their overall survival (OS) (14%), and 13% indicated they wanted breasts but did not want reconstruction. Of the 560 women who had a DM, 60% indicated that they thought a DM would improve their OS, 50% were concerned about the risk of local recurrence, 47% doubted that imaging would detect future ILC tumors, and 45% noted concern that ILC is more likely to be bilateral. Of note, only 9% had ILC or ILC and another invasive breast cancer in both breasts at initial diagnosis and 31% who had a pre-surgical MRI changed their initial surgical treatment plan. Post surgery, pathology for DM group revealed larger tumors than seen on imaging (57%), and 6% had tumors found in a second breast that were not seen on imaging. For those 451 who had an SM, reasons for this choice included: 75% said it was what their care team recommended, 35% thought it would improve OS, 20% feared risk for local recurrence, and 15% doubted imaging would detect future ILC. Of 614 respondents who had L, 33% had positive margins at first surgery. Of those, 17% reported multiple Ls and M; and 24% reported clear margins were never achieved. Of the 1011 SM or DMs reported, 10% did not achieve clear margins after these surgeries. Conclusion The survey demonstrates the experience of a large cohort of women with ILC, reporting high rates of uncertainty about accuracy of imaging, high rates of repeat surgery, bilateral mastectomies, and positive margins. Patients are factoring concerns about potential extent of disease and future recurrence in their surgical decision making. These results support the need for improved pre-operative staging and imaging modalities specific to ILC. Citation Format: Laurie Hutcheson, Janice Axelrod, Tracy Cushing, Colleen Fitzwater, Rinath Jeselsohn, Gitte Joergensen, Maria Karsten, Miranda Kimm, Megan Kruse, Theresa Langdon, Julia Levine, Mason Mitchell-Daniels, Rita Mukhtar, Barbara Neilsen, Shani Paluch-Shimon, Therese Pross. Surgery for Invasive Lobular Carcinoma: A Patient Experience Survey from the Lobular Breast Cancer Alliance [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO5-26-07.

The impact of lobbying on managerial short-term resource adjustment decisions

This study examines the effect of political lobbying on firms' short-term resource adjustment decisions. Controlling for a wide range of known determinants of managerial cost behaviour, our results suggest that U.S. lobbying firms exhibit significantly less cost stickiness than non-lobbying firms. Lobbying reduces managers' "wait-and-see games" as they obtain preferential access to information on political and legislative processes. With early knowledge of impending (political and regulatory) threats and long-lasting downturns, managers can adjust unutilised capacity more swiftly. This effect is more pronounced for firms without alternative information channels like permanent exchange with regulators. Our findings hold for several robustness checks, for instance, controlling for potential sample selection bias or employing alternative measures of lobbying as well as (political) uncertainty and alternative samples.

Shared and Specific Neural Correlates of Attention Deficit Hyperactivity Disorder and Autism Spectrum Disorder: A Meta-Analysis of 243 Task-Based Functional MRI Studies.

To investigate shared and specific neural correlates of cognitive functions in attention deficit hyperactivity disorder (ADHD) and autism spectrum disorder (ASD), the authors performed a comprehensive meta-analysis and considered a balanced set of neuropsychological tasks across the two disorders. A broad set of electronic databases was searched up to December 4, 2022, for task-based functional MRI studies investigating differences between individuals with ADHD or ASD and typically developing control subjects. Spatial coordinates of brain loci differing significantly between case and control subjects were extracted. To avoid potential diagnosis-driven selection bias of cognitive tasks, the tasks were grouped according to the Research Domain Criteria framework, and stratified sampling was used to match cognitive component profiles. Activation likelihood estimation was used for the meta-analysis. After screening 20,756 potentially relevant references, a meta-analysis of 243 studies was performed, which included 3,084 participants with ADHD (676 females), 2,654 participants with ASD (292 females), and 6,795 control subjects (1,909 females). ASD and ADHD showed shared greater activations in the lingual and rectal gyri and shared lower activations in regions including the middle frontal gyrus, the parahippocampal gyrus, and the insula. By contrast, there were ASD-specific greater and lower activations in regions including the left middle temporal gyrus and the left middle frontal gyrus, respectively, and ADHD-specific greater and lower activations in the amygdala and the global pallidus, respectively. Although ASD and ADHD showed both shared and disorder-specific standardized neural activations, disorder-specific activations were more prominent than shared ones. Functional brain differences between ADHD and ASD are more likely to reflect diagnosis-related pathophysiology than bias from the selection of specific neuropsychological tasks.

The impact of rural living environment improvement programs on the subjective well-being of rural residents in China

Increasing people’s subjective well-being (SWB) remains a critical challenge for all countries. However, few studies have been dedicated to examining the influence of environmental governance programs on SWB, especially in developing and non-democratic societies. This paper aims to fill this void by taking the Rural Living Environment Improvement (RLEI) program in China—the largest rural living environment governance program in history, as an example to understand the role of environmental governance programs in SWB in the world’s biggest developing and non-democratic country. Based on 3747 individual samples from the China Labor-force Dynamics Survey database, we found that RLEI can significantly improve rural residents’ SWB. This effect remains significant after using the propensity score matching method and the instrumental variable approach to address potential selection bias and endogenous problems. The indirect analysis shows that RLEI can increase rural residents’ SWB mainly through improving their income, consumption expenditure, and health. Compared with rural sewage and livestock manure RLEI programs, rural waste RLEI program has a greater enhanced impact on rural residents’ SWB. The monetary value of RLEI based on the life satisfaction approach shows that the resulting improvement in rural residents’ SWB created by RLEI is almost equivalent to the effect of household income. While the monetary value of rural sewage, livestock manure, and rural waste RLEI program is equivalent to 1.2, 3.67, and 1.1 times the effect of household income. Heterogeneity analysis indicates that RLEI has a greater positive impact on SWB for junior and old-aged, low-educated, Midwestern and Northeastern, and working rural residents.

The impact of urbanization and economic development on health insurance performance: Evidence from China

Many previous studies find no significant effect of health insurance on health outcome in rural areas of China. Many researchers believe this could be because of the characteristics of health care provision in those areas. In this paper, we aim to examine if urbanization will change the situation. Our research question focuses on if urbanization will change the participation and performance of health insurance on health outcome in a positive direction. Using a longitudinal sample drawn from the China Health and Nutrition Survey (CHNS), we employed multiple estimation strategies for multiple waves to handle the potential selection bias. We find that urbanization factors such as population density, transportations and housing are associated with probability of insurance participation. That is, urbanization related factors tend to increase people’s willingness of insurance participation. We also conclude that urbanization improves the performance of insurance on self-reported health outcome. Results show that the health insurance has a significant positive impact on health production in urbanized areas. Health insurance in general increases the probability of health care utilization for all areas. However, it does not lead to a significant improvement in the health outcomes in under urbanized areas because of the health provision quality or characteristics of health insurance coverage in those areas.

Design and implementation of community consultation for research conducted under exception from informed consent regulations for the PreVent and the PreVent 2 trials: Changes over time and during the COVID-19 pandemic.

Emergency clinical research has played an important role in improving outcomes for acutely ill patients. This is due in part to regulatory measures that allow Exception From Informed Consent (EFIC) trials. The Food and Drug Administration (FDA) requires sponsor-investigators to engage in community consultation and public disclosure activities prior to initiating an Exception From Informed Consent trial. Various approaches to community consultation and public disclosure have been described and adapted to local contexts and Institutional Review Board (IRB) interpretations. The COVID-19 pandemic has precluded the ability to engage local communities through direct, in-person public venues, requiring research teams to find alternative ways to inform communities about emergency research. The PreVent and PreVent 2 studies were two Exception From Informed Consent trials of emergency endotracheal intubation, conducted in one geographic location for the PreVent Study and in two geographic locations for the PreVent 2 Study. During the period of the two studies, there was a substantial shift in the methodological approach spanning across the periods before and after the pandemic from telephone, to in-person, to virtual settings. During the 10 years of implementation of Exception From Informed Consent activities for the two PreVent trials, there was overall favorable public support for the concept of Exception From Informed Consent trials and for the importance of emergency clinical research. Community concerns were few and also did not differ much by method of contact. Attendance was higher with the implementation of virtual technology to reach members of the community, and overall feedback was more positive compared with telephone contacts or in-person events. However, the proportion of survey responses received after completion of the remote, live event was substantially lower, with a greater proportion of respondents having higher education levels. This suggests less active engagement after completion of the synchronous activity and potentially higher selection bias among respondents. Importantly, we found that engagement with local community leaders was a key component to develop appropriate plans to connect with the public. The PreVent experience illustrated operational advantages and disadvantages to community consultation conducted primarily by telephone, in-person events, or online activities. Approaches to enhance community acceptance included partnering with community leaders to optimize the communication strategies and trust building with the involvement of Institutional Review Board representatives during community meetings. Researchers might need to pivot from in-person planning to virtual techniques while maintaining the ability to engage with the public with two-way communication approaches. Due to less active engagement, and potential for selection bias in the responders, further research is needed to address the costs and benefits of virtual community consultation and public disclosure activities compared to in-person events.

Sustainable practices in cocoa production. The role of certification schemes and farmer cooperatives

In Côte d'Ivoire and Ghana, many small-scale cocoa producers cultivate cocoa in unshaded or low-shaded plots, leading to challenges such as reduced biodiversity, soil fertility depletion, and increased soil erosion. To assess the adoption of sustainable agricultural practices in the cocoa sector, we develop a scale that incorporates dimensions of agroforestry, soil conservation, pest and disease management and farm sanitation. Using data from >1700 cocoa producers, we examine farmer participation in cooperatives and three main certification schemes (incl. Fairtrade, Rainforest Alliance and Organic) to understand their roles in promoting sustainable practices. We apply a multinomial endogenous switching regression model to control for potential selection bias and estimate the impact of participating in certification schemes, farmer cooperatives or both. In Côte d'Ivoire, econometric results show that joint participation in both a certification scheme and a farmer cooperative is associated with a significantly higher sustainability score. In Ghana, certification scheme membership shows the highest effect.