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Item Open Access A Differentially Private Bayesian Approach to Replication Analysis(2022) Yang, ChengxinReplication analysis is widely used in many fields of study. Once a research is published, other researchers will conduct analysis to assess the reliability of the published research. However, what if the data are confidential? In particular, if the data sets used for the studies are confidential, we cannot release the results of replication analyses to any entity without the permission to access the data sets, otherwise it may result in privacy leakage especially when the published study and replication studies are using similar or common data sets. In this paper, we present two methods for replication analysis. We illustrate the properties of our methods by a combination of theoretical analysis and simulation.
Item Open Access An Empirical Examination of the Commitment to Increased Disclosure(2008-06-04) Evans, MarkI examine the relation between a corporate commitment to increased disclosure and measures of liquidity, information asymmetry, and cost of equity capital. Relative to prior research on voluntary disclosure, I use a composite, ex ante measure of commitment based in social psychology and measure commitment using characteristics of earnings announcement disclosures. Prior to Regulation Fair Disclosure (Reg FD) I find that commitment to increased disclosure is negatively related to bid-ask spreads, probability of informed trade (PIN) scores, and implied cost of capital estimates. Further analysis reveals that the disclosure of balance sheet information in earnings releases is significantly related to spreads and PINs, regardless of firms' conference call behavior, while the combination of consistent open calls and disclosure of balance sheet information in earnings releases yields the most significant results for cost of capital. After the effective date of Reg FD I find that commitment is negatively related to PIN scores and implied cost of capital estimates, but not related to bid-ask spreads. Further analysis reveals that the disclosure of balance sheet information in earnings releases is significantly related to PINs and cost of capital, regardless of firms' conference call behavior.
Item Open Access Analysis of educational materials and destruction/opt-out initiatives for storage and use of residual newborn screening samples.(Genet Test Mol Biomarkers, 2010-10) Haga, Susanne BIn recent years, the storage and use of residual newborn screening (NBS) samples has gained attention. To inform ongoing policy discussions, this article provides an update of previous work on new policies, educational materials, and parental options regarding the storage and use of residual NBS samples. A review of state NBS Web sites was conducted for information related to the storage and use of residual NBS samples in January 2010. In addition, a review of current statutes and bills introduced between 2005 and 2009 regarding storage and/or use of residual NBS samples was conducted. Fourteen states currently provide information about the storage and/or use of residual NBS samples. Nine states provide parents the option to request destruction of the residual NBS sample after the required storage period or the option to exclude the sample for research uses. In the coming years, it is anticipated that more states will consider policies to address parental concerns about the storage and use of residual NBS samples. Development of new policies regarding storage and use of residual NBS samples will require careful consideration of impact on NBS programs, parent and provider educational materials, and respect for parents among other issues.Item Open Access Association Between Hospital Monopoly Status, Patient Socioeconomic Disadvantage, and Total Joint Arthroplasty Price Disclosure.(The Journal of the American Academy of Orthopaedic Surgeons, 2023-10) Peairs, Emily M; Zhang, Gloria X; Kerr, David; Erickson, Melissa M; Zhang, Yuqi; Cerullo, MarceloIntroduction
In recent years, healthcare institutions and regulatory bodies have enacted cost transparency mandates for routine interventions such as total hip arthroplasty and total knee arthroplasty. However, disclosure rates remain low. This study examined the effect of financial characteristics of hospitals and the socioeconomic status of patients on price disclosure.Methods
Hospitals conducting total hip arthroplasty/total knee arthroplasty, their quality ratings, and procedural volumes were identified using the Leapfrog Hospital Survey and linked to procedure-specific prices. Financial performance and the Area Deprivation Index (ADI) were used to correlate disclosure rates with hospital and patient characteristics. Hospital financial, operational, and patient summary statistics were compared by price-disclosure status using two-sample t -tests for continuous variables and Pearson chi-square test for categorical variables. The association between total joint arthroplasty price disclosure and hospital ADI was further evaluated using modified Poisson regression.Results
A total of 1,425 hospitals certified by the Centers for Medicare & Medicaid Services were identified in the United States. 50.5% (n = 721) of hospitals had no published payer-specific price information. Hospitals in an area of higher socioeconomic disadvantage were more likely to disclose prices of total joint arthroplasty (incidence rate ratio = 0.966, 95% CI: 0.937 to 0.995, P = 0.024). Hospitals that were considered monopolies or were for-profit were less likely to disclose prices (IRR = 1.15, 95% CI: 1.030 to 1.280, P = 0.01; IRR = 1.256, 95% CI: 0.986 to 1.526, P = 0.038, respectively). When accounting for both ADI and monopoly status, hospitals with patients who had a higher ADI were more likely to disclose costs for a total joint arthroplasty, whereas for-profit hospitals or hospitals considered monopolies in their HSA were less likely to disclose prices.Discussion
For nonmonopoly hospitals, a higher ADI correlated with a higher likelihood of price disclosure. However, for monopoly hospitals, there was no significant association between ADI and price disclosure.Level of evidence
II.Item Open Access Challenges and Opportunities in Supply Chain Environmental Sustainability Disclosure: Navigating the Request-Response Process between Stakeholders and Suppliers(2013-04-26) Jiang, Lin; Lab, Jessica; Lai, Phillip; Qian, Yifei; Rau, PeterEnvironmental sustainability is growing in importance to organizations in many different sectors. The need to account for suppliers’ environmental performance through sustainability surveys is taking up a greater portion of the daily job responsibilities of sustainability professionals. This report incorporates insights from interviews with 15 organizations across multiple industries that address the current challenges and opportunities confronting those in the sustainability supply chain disclosure process. In addition, we analyze 31 collected sustainability surveys based on four survey-level characteristics (survey level, type, purpose and industry) and on four question-level characteristics (question format, nature, topic and subtopic). The resulting data show that, while it would be difficult to establish a single common survey or set of questions, opportunities exist for the standardization of question wording and format, which would constitute a step towards reducing the amount of time that organizations spend on responding to surveys. This report provides a roadmap for taking this project forward based on these results, centering on the creation of a web-based platform containing a repository of standard-worded and formatted questions covering a broad range of environmental topics. Using this platform, organizations could select questions to send to their suppliers based on their own preferences, while suppliers could reduce the amount of time spent on responding to survey requests. This establishes a path forward in supply chain sustainability disclosure, with the potential to reduce systemic inefficiencies and redundancies in this process.Item Open Access Compliance with results reporting at ClinicalTrials.gov.(N Engl J Med, 2015-03-12) Anderson, Monique L; Chiswell, Karen; Peterson, Eric D; Tasneem, Asba; Topping, James; Califf, Robert MBACKGROUND: The Food and Drug Administration Amendments Act (FDAAA) mandates timely reporting of results of applicable clinical trials to ClinicalTrials.gov. We characterized the proportion of applicable clinical trials with publicly available results and determined independent factors associated with the reporting of results. METHODS: Using an algorithm based on input from the National Library of Medicine, we identified trials that were likely to be subject to FDAAA provisions (highly likely applicable clinical trials, or HLACTs) from 2008 through 2013. We determined the proportion of HLACTs that reported results within the 12-month interval mandated by the FDAAA or at any time during the 5-year study period. We used regression models to examine characteristics associated with reporting at 12 months and throughout the 5-year study period. RESULTS: From all the trials at ClinicalTrials.gov, we identified 13,327 HLACTs that were terminated or completed from January 1, 2008, through August 31, 2012. Of these trials, 77.4% were classified as drug trials. A total of 36.9% of the trials were phase 2 studies, and 23.4% were phase 3 studies; 65.6% were funded by industry. Only 13.4% of trials reported summary results within 12 months after trial completion, whereas 38.3% reported results at any time up to September 27, 2013. Timely reporting was independently associated with factors such as FDA oversight, a later trial phase, and industry funding. A sample review suggested that 45% of industry-funded trials were not required to report results, as compared with 6% of trials funded by the National Institutes of Health (NIH) and 9% of trials that were funded by other government or academic institutions. CONCLUSIONS: Despite ethical and legal obligations to disclose findings promptly, most HLACTs did not report results to ClinicalTrials.gov in a timely fashion during the study period. Industry-funded trials adhered to legal obligations more often than did trials funded by the NIH or other government or academic institutions. (Funded by the Clinical Trials Transformation Initiative and the NIH.).Item Open Access Concordance of financial disclosures among faculty at the 2018-2020 SAGES annual meetings.(Surgical endoscopy, 2023-06) Lois, Alex; Schwarz, Erin; Shadduck, Phillip; Denk, Peter; Sinha, Prashant; Lima, Diego L; Scarritt, Thomas; Sylla, Patricia A; Reinke, CarolineBackground
Financial relationships with industry may bias educational content delivered by physicians. SAGES strives to mitigate potential bias, relying on physician self-reporting. Retrospective review of relationships is possible using the Open Payments Database (OPD), a public record of industry-reported payments to US physicians. We aimed to evaluate the effectiveness of the SAGES disclosure process by comparing faculty disclosures to SAGES, faculty disclosures within presentations, and OPD records among speakers at the 2018-2020 SAGES meetings.Methods
We reviewed all presentations from the SAGES 2018-2020 Annual Meetings. For each invited presentation, all slide-disclosed relationships were recorded. For US physicians, we queried the OPD and recorded relationships ≥ $500 USD in the calendar year prior to presentation. We compared the slide-disclosed relationships with OPD-reported relationships and with those provided to SAGES during the faculty disclosure process. We surveyed a sample of the 2020 annual meeting speakers to analyze potential reasons for discordance.Results
From 2018 to 2020, there were 1,355 invited presentations, of which 1,234 (91%) were available for review. Disclosure slides were present in 1,098 (89%), increasing from 86% in 2018 to 93% in 2020. The proportion of speakers with OPD-reported relationships ≥ $500 increased from 54% in 2018 to 66% in 2020. The total value of OPD relationships decreased from $5.9 million (2018) to $3.3 million (2020) with a concomitant decrease in the proportion with high discordance from 9% in 2018 to 5% in 2020. Among the 2020 speakers with high discordance, the most common explanations for discordance were being unaware of payment or payment outside the 12-month timeframe (55%).Conclusions
Discordance between financial disclosures reported to SAGES and OPD highlight the need for improvements in the faculty disclosure process. SAGES will continue to streamline this process by incorporating faculty review of their OPD disclosures to ensure all educational programs remain free of commercial bias.Item Open Access Consistency of financial interest disclosures in the biomedical literature: the case of coronary stents.(PLoS One, 2008-05-07) Weinfurt, Kevin P; Seils, Damon M; Tzeng, Janice P; Lin, Li; Schulman, Kevin A; Califf, Robert MBACKGROUND: Disclosure of authors' financial interests has been proposed as a strategy for protecting the integrity of the biomedical literature. We examined whether authors' financial interests were disclosed consistently in articles on coronary stents published in 2006. METHODOLOGY/PRINCIPAL FINDINGS: We searched PubMed for English-language articles published in 2006 that provided evidence or guidance regarding the use of coronary artery stents. We recorded article characteristics, including information about authors' financial disclosures. The main outcome measures were the prevalence, nature, and consistency of financial disclosures. There were 746 articles, 2985 authors, and 135 journals in the database. Eighty-three percent of the articles did not contain disclosure statements for any author (including declarations of no interests). Only 6% of authors had an article with a disclosure statement. In comparisons between articles by the same author, the types of disagreement were as follows: no disclosure statements vs declarations of no interests (64%); specific disclosures vs no disclosure statements (34%); and specific disclosures vs declarations of no interests (2%). Among the 75 authors who disclosed at least 1 relationship with an organization, there were 2 cases (3%) in which the organization was disclosed in every article the author wrote. CONCLUSIONS/SIGNIFICANCE: In the rare instances when financial interests were disclosed, they were not disclosed consistently, suggesting that there are problems with transparency in an area of the literature that has important implications for patient care. Our findings suggest that the inconsistencies we observed are due to both the policies of journals and the behavior of some authors.Item Open Access Dirichlet Process Mixture Models for Nested Categorical Data(2015) Hu, JingchenThis thesis develops Bayesian latent class models for nested categorical data, e.g., people nested in households. The applications focus on generating synthetic microdata for public release and imputing missing data for household surveys, such as the 2010 U.S. Decennial Census.
The first contribution is methods for evaluating disclosure risks in fully synthetic categorical data. I quantify disclosure risks by computing Bayesian posterior probabilities that intruders can learn confidential values given the released data and assumptions about their prior knowledge. I demonstrate the methodology on a subset of data from the American Community Survey (ACS). The methods can be adapted to synthesizers for nested data, as demonstrated in later chapters of the thesis.
The second contribution is a novel two-level latent class model for nested categorical data. Here, I assume that all configurations of groups and units are theoretically possible. I use a nested Dirichlet Process prior distribution for the class membership probabilities. The nested structure facilitates simultaneous modeling of variables at both group and unit levels. I illustrate the modeling by generating synthetic data and imputing missing data for a subset of data from the 2012 ACS household data. I show that the model can capture within group relationships more effectively than standard one-level latent class models.
The third contribution is a version of the nested latent class model adapted for theoretically impossible combinations, e.g. a household with two household heads or a child older than her biological father. This version assigns zero probability to those impossible groups and units. I present a proof that the Markov Chain Monte Carlo (MCMC) sampling strategy estimates the desired target distribution. I illustrate this model by generating synthetic data and imputing missing data for a subset of data from the 2011 ACS household data. The results indicate that this version can estimate the joint distribution more effectively than the previous version.
Item Open Access Effects of Recognition versus Disclosure on the Structure and Financial Reporting of Share Based Payments(2008-04-21) Choudhary, PreetiI examine whether financial statement preparers (managers and auditors) treat recognized versus disclosed fair value of option compensation differently. Recognition refers to items that appear on the face of financial statements and that are included in subtotal figures that appear in the summary accounts; disclosure refers to items that appear in words and amounts in only the financial statement footnotes. I find that fair value recognition of option compensation is likely to have a significant impact on net income. Firms in my sample granted options amounting to a median fair value of 7% of profits in 1996 and 11% of profits in 2004. I compare the terms of option grants and the properties of fair value estimation under a disclosure reporting regime to terms and properties under a recognition regime. Under a fair value recognition regime, I find firms reduce/eliminate option grants across all levels of employees, reduce the statutory length of options, and substitute restricted stock and bonuses for option compensation. The fair value reduction in option grants is on average 9% (0.4%) of absolute net income. In contrast, under a fair value disclosure regime, option compensation was not reduced. I also find that firms increase the bias in three inputs to fair value option estimation: volatility, dividend, and interest. This increase amounts to 4%, 2%, and 0.3% of fair value cost. Mandatory recognition firms also display increased dividend and interest input accuracy. Combined, these results suggest that financial statements reflect differences in behavior between recognition and disclosure reporting regimes, such that both real actions and fair value estimation are used to reduce recognized values.
Item Open Access Improving Financial Statement Footnotes: Evidence from Derivative and Hedging Disclosures(2015) Steffen, ThomasI investigate whether changes in derivative and hedging footnote disclosures required by SFAS 161 affect investor and analyst uncertainty. My study is motivated by accounting standard setters' and researchers' interest in disclosure effectiveness, and by prior research linking investors' interpretations of public information to measures of uncertainty. For a broad sample of firms, I use textual analysis to measure changes in the amount and salience of derivative and hedging information caused by SFAS 161. Using a difference-in-differences design to study the effects of these changes, I find that investor uncertainty is reduced for firms adopting SFAS 161. In addition, I find that for some uncertainty proxies this reduction is greater for firms whose disclosures were more affected by SFAS 161, consistent with the new disclosures improving investor understanding. I also find evidence of a decreased association between bid-ask spread and movements in risk factors, indicating that SFAS 161 reduced uncertainty stemming from these movements.
Item Embargo Information Transparency and Risk Sharing in Commodity Futures Markets(2023) Wang, ShuyanA central function of commodity futures markets is to help firms in the real sector insure against commodity price fluctuations. I examine how greater availability of information about commodity fundamentals (henceforth, information transparency) affects the capacity of these markets to accommodate firms’ hedging needs. Theory suggests that while greater availability of information can reduce adverse selection and increase traders’ willingness to absorb risk, it can also accelerate the realization of risk and hinder the transfer of risk via the markets. Using both cross-sectional variation in information transparency across 26 commodity markets over 20 years and information shocks induced by the launch of the Agricultural Market Information System (AMIS) and the SEC’s revision of firms’ 10-K oil and gas reserve disclosures, I document that information transparency (i) makes it costlier to use commodity futures to hedge commodity price risk and (ii) reduces traders’ propensity to trade futures. Evidence suggests that these findings are consistent with theories positing that information disclosure impairs risk-sharing opportunities. This study contributes new evidence on how information influences the efficient allocation of commodity price risk across the real and financial sectors.
Item Open Access Institutional review boards' use and understanding of certificates of confidentiality.(PloS one, 2012-01) Beskow, Laura M; Check, Devon K; Namey, Emily E; Dame, Lauren A; Lin, Li; Cooper, Alexandra; Weinfurt, Kevin P; Wolf, Leslie ECertificates of Confidentiality, issued by agencies of the U.S. government, are regarded as an important tool for meeting ethical and legal obligations to safeguard research participants' privacy and confidentiality. By shielding against forced disclosure of identifying data, Certificates are intended to facilitate research on sensitive topics critical to the public's health. Although Certificates are potentially applicable to an extensive array of research, their full legal effect is unclear, and little is known about stakeholders' views of the protections they provide. To begin addressing this challenge, we conducted a national survey of institutional review board (IRB) chairs, followed by telephone interviews with selected chairs, to learn more about their familiarity with and opinions about Certificates; their institutions' use of Certificates; policies and practices concerning when Certificates are required or recommended; and the role Certificates play in assessments of research risk. Overall, our results suggest uncertainty about Certificates among IRB chairs. On most objective knowledge questions, most respondents chose the incorrect answer or 'unsure'. Among chairs who reported more familiarity with Certificates, composite opinion scores calculated based on five survey questions were evenly distributed among positive, neutral/middle, and negative views. Further, respondents expressed a variety of ideas about the appropriate use of Certificates, what they are intended to protect, and their effect on research risk. Nevertheless, chairs who participated in our study commonly viewed Certificates as a potentially valuable tool, frequently describing them as an 'extra layer' of protection. These findings lead to several practical observations concerning the need for more stakeholder education about Certificates, consideration of Certificates for a broader range of studies, the importance of remaining vigilant and using all tools available to protect participants' confidentiality, and the need for further empirical investigation of Certificates' effect on researchers and research participants.Item Open Access “Let the Sunshine In”: The Impact of Industry Payment Disclosure on Physician Prescription Behavior(Marketing Science, 2020-01-01) Guo, T; Sriram, S; Manchanda, PU.S. pharmaceutical companies frequently pay doctors to promote their drugs. This has raised concerns about conflict of interest, which policy makers have attempted to address by introducing payment disclosure laws. However, it is unclear if such disclosure has an effect on physician prescription behavior. We use individual-level claims data from a major provider of health insurance in the United States and employ a difference-indifferences research design to study the effect of the payment disclosure law introduced in Massachusetts in June 2009. The research design exploits the fact that, although physicians operating in Massachusetts were impacted by the legislation, their counterparts in the neighboring states of Connecticut, New York, New Hampshire, and Rhode Island were not. In order to keep the groups of physicians comparable, we restrict our analysis to physicians in the counties that are on the border of these states. We find that the Massachusetts disclosure law resulted in a decline in prescriptions in all three drug classes studied: statins, antidepressants, and antipsychotics. Our findings are robust to alternative control groups, time periods and estimation methods. We also show that the effect is highly heterogeneous across physician groups. Finally, we explore potential mechanisms driving these results.Item Open Access Patterns of HIV Serostatus Disclosure Among HIV-Positive Young Adults in Haiti: a Mixed Methods Investigation(2014) Philogene, JohaneBackground: By facilitating access to prevention and care services, HIV serostatus disclosure has been associated with improved physical health, psychological well-being, and improved health behaviors for people living with HIV/AIDS (PLWHA). Disclosure to sexual partners, in particular, can help prevent the forward transmission of HIV. Disclosure can increase social support but can also lead to negative social outcomes including stigma and discrimination. Thus, disclosing HIV status to friends, family, and sexual partners is a complex psychosocial challenge that PLWHA face, particularly adolescents and youth who have an increased lifespan due to current effective treatment protocols.
Objectives: This study had three objectives: 1) to determine gender-related differences in the rate and patterns of HIV serostatus disclosure to family, friends and sexual partners among HIV-positive youth in Haiti; 2) to identify gender-specific relational and psychosocial predictors of HIV disclosure to sexual partner; and 3) to qualitatively explore and describe motivations and experiences related to HIV disclosure in this population.
Methods: A cross-sectional study was conducted in a random sample of 680 sexually active HIV-positive young adults (18-29 years) from six clinics in Port-au-Prince, Haiti. Socio-demographic, health, sexual and reproductive history, sexual behavior, psychosocial and disclosure data were collected using a pre-tested interviewer-administered structured questionnaire. Rates and patterns of HIV serostatus were described, and factors associated with disclosure to all sexual partners in the past 3 months were analyzed using hierarchical logistic regression models, separately by gender. Qualitative data was collected through individual in-depth interviews with a purposefully selected sample of 12 young adult participants to explore whom they chose to disclose to, how they disclosed to these individuals, and how these individuals reacted. Content analysis allowed for the description of motivations and experiences related to HIV disclosure in this population.
Results: Slightly over half (56%) of participants had told at least one person about their HIV status. Female respondents were more likely than male respondents to have disclosed to family or friends. Male youth were more likely to disclose their status for the first time to sexual partners (35%), while female youth were more likely to choose their mother as their first confidant (51%). Overall, 33% of participants reported having disclosed their HIV status to all their sexual partners from the last 3 months, with no significant difference across genders. For both genders, older age and being unaware of partners' HIV status were significantly associated with lower odds of HIV serostatus disclosure. Additionally for young males, disclosure stigma was negatively associated with disclosure while HIV acceptance and personalized stigma were significant predictors of disclosure. Female youth who were single, had casual or multiple partners, and experienced greater personalized stigma were less likely to disclose, whereas the availability of social support was positively associated with disclosure to all sexual partners. While disclosure to sexual partners was motivated primarily by a desire to encourage partners to test for HIV and increase condom use, or by a sense of moral responsibility, important contextual differences emerged in qualitative analysis with regards to barriers to disclosure, particularly fear of stigma and fear of partner's reaction.
Conclusion: Rates of HIV serostatus disclosure to family, friends and sexual partners were low among this population of HIV-positive youth in Port-au-Prince. Context-specific gender-sensitive interventions are needed to increase social support, reduce HIV-related stigma, and assist youth living with HIV in making effective decisions on disclosure that will ultimately improve their well-being and quality of life. Further research is necessary to better understand the process and outcomes of HIV serostatus disclosure to sexual partners, as well as the relationship between HIV serostatus disclosure and sexual risk behaviors in this young HIV-positive population.
Item Open Access Population-based biobank participants' preferences for receiving genetic test results.(Journal of human genetics, 2017-12) Yamamoto, Kayono; Hachiya, Tsuyoshi; Fukushima, Akimune; Nakaya, Naoki; Okayama, Akira; Tanno, Kozo; Aizawa, Fumie; Tokutomi, Tomoharu; Hozawa, Atsushi; Shimizu, AtsushiThere are ongoing debates on issues relating to returning individual research results (IRRs) and incidental findings (IFs) generated by genetic research in population-based biobanks. To understand how to appropriately return genetic results from biobank studies, we surveyed preferences for returning IRRs and IFs among participants of the Tohoku Medical Megabank Project (TMM). We mailed a questionnaire to individuals enrolled in the TMM cohort study (Group 1; n=1031) and a group of Tohoku region residents (Group 2; n=2314). The respondents were required to be over 20 years of age. Nearly 90% of Group 1 participants and over 80% of Group 2 participants expressed a preference for receiving their genetic test results. Furthermore, over 60% of both groups preferred to receive their genetic results 'from a genetic specialist.' A logistic regression analysis revealed that engaging in 'health-conscious behaviors' (such as regular physical activity, having a healthy diet, intentionally reducing alcohol intake and/or smoking and so on) was significant, positively associated with preferring to receive their genetic test results (odds ratio=2.397 (Group 1) and 1.897 (Group 2)). Our findings provided useful information and predictors regarding the return of IRRs and IFs in a population-based biobank.Item Open Access SAGES perspective: professional medical associations, commercial interests, and conflicts of interest.(Surgical endoscopy, 2023-04) Shadduck, Phillip; Sylla, Patricia; Schwarz, Erin; Reinke, Caroline; Denk, Peter; Ginsberg, Shelley; Asbun, Horacio; Pryor, AuroraBackground
Professional medical associations (PMAs) have an essential role in advancing medical care and health. PMAs promote skills training, clinical standards, and other important educational activities. Most often, PMAs are not-for-profit entities that rely upon funding from industry to help cover the costs of these valuable activities. Equally important, innovation and progress in surgery require physician collaboration with industry throughout the product development process. SAGES has opined that, with appropriate Conflict of Interest (COI) disclosure and management processes, PMA educational activities can be both scientifically and ethically sound.Methods
SAGES has developed and implemented comprehensive and stringent processes for managing potential COI within the organization, at the annual meeting, and in developing educational offerings. This document reviews the SAGES COI processes and results 2009-2021.Results
Implementation of the SAGES COI disclosure and management processes reduced the reported perceived incidence of bias at the annual meeting from 4.4-6.2% (2008-2010) to 1.2-2.2% (2011-2013). Recent comparison of reported disclosures revealed a rise in number of speakers with financial relationships and an increase in reporting of disclosures in presentations without an associated increase in need for conflict resolution by the COI committee. Despite good overall adherence to COI policies, SAGES was recently cited for non-compliance with ACCME standards related to inclusion of faculty with ownership interest. This experience highlighted the potential for discordance in the interpretation of whether disclosures relate to specific CME content. SAGES COI processes have since been updated to reflect the more stringent 2020 ACCME Standards that exclude speakers and planners with ownership interest from any CME activity.Conclusions
The SAGES experience with disclosure and mitigation of financial relationships highlights the challenges of validating the accuracy of physician disclosures and establishing the relevance of financial relationships to the content of accredited educational activities. SAGES will continue to streamline its COI disclosure process with specific focus on aligning all financial disclosures among the various reporting platforms.Item Open Access Validation of the TAPS-1: A Four-Item Screening Tool to Identify Unhealthy Substance Use in Primary Care.(Journal of general internal medicine, 2017-09) Gryczynski, Jan; McNeely, Jennifer; Wu, Li-Tzy; Subramaniam, Geetha A; Svikis, Dace S; Cathers, Lauretta A; Sharma, Gaurav; King, Jacqueline; Jelstrom, Eve; Nordeck, Courtney D; Sharma, Anjalee; Mitchell, Shannon G; O'Grady, Kevin E; Schwartz, Robert PBACKGROUND:The Tobacco, Alcohol, Prescription Medication, and Other Substance use (TAPS) tool is a combined two-part screening and brief assessment developed for adult primary care patients. The tool's first-stage screening component (TAPS-1) consists of four items asking about past 12-month use for four substance categories, with response options of never, less than monthly, monthly, weekly, and daily or almost daily. OBJECTIVE:To validate the TAPS-1 in primary care patients. DESIGN:Participants completed the TAPS tool in self- and interviewer-administered formats, in random order. In this secondary analysis, the TAPS-1 was evaluated against DSM-5 substance use disorder (SUD) criteria to determine optimal cut-points for identifying unhealthy substance use at three severity levels (problem use, mild SUD, and moderate-to-severe SUD). PARTICIPANTS:Two thousand adult patients at five primary care sites. MAIN MEASURES:DSM-5 SUD criteria were determined via the modified Composite International Diagnostic Interview. Oral fluid was used as a biomarker of recent drug use. KEY RESULTS:Optimal frequency-of-use cut-points on the self-administered TAPS-1 for identifying SUDs were ≥ monthly use for tobacco and alcohol (sensitivity = 0.92 and 0.71, specificity = 0.80 and 0.85, AUC = 0.86 and 0.78, respectively) and any reported use for illicit drugs and prescription medication misuse (sensitivity = 0.93 and 0.89, specificity = 0.85 and 0.91, AUC = 0.89 and 0.90, respectively). The performance of the interviewer-administered format was similar. When administered first, the self-administered format yielded higher disclosure rates for past 12-month alcohol use, illicit drug use, and prescription medication misuse. Frequency of use alone did not provide sufficient information to discriminate between gradations of substance use problem severity. Among those who denied drug use on the TAPS-1, less than 4% had a drug-positive biomarker. CONCLUSIONS:The TAPS-1 can identify unhealthy substance use in primary care patients with a high level of accuracy, and may have utility in primary care for rapid triage.