Browsing by Subject "Confidentiality"
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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 Access to patient-level data from GlaxoSmithKline clinical trials.(N Engl J Med, 2013-08-01) Nisen, Perry; Rockhold, FrankItem Open Access Building a Group-Based Opioid Treatment (GBOT) blueprint: a qualitative study delineating GBOT implementation.(Addiction science & clinical practice, 2019-12-27) Sokol, Randi; Albanese, Mark; Chew, Aaronson; Early, Jessica; Grossman, Ellie; Roll, David; Sawin, Greg; Wu, Dominic J; Schuman-Olivier, ZevBACKGROUND:Group-Based Opioid Treatment (GBOT) has recently emerged as a mechanism for treating patients with opioid use disorder (OUD) in the outpatient setting. However, the more practical "how to" components of successfully delivering GBOT has received little attention in the medical literature, potentially limiting its widespread implementation and utilization. Building on a previous case series, this paper delineates the key components to implementing GBOT by asking: (a) What are the core components to GBOT implementation, and how are they defined? (b) What are the malleable components to GBOT implementation, and what conceptual framework should providers use in determining how to apply these components for effective delivery in their unique clinical environment? METHODS:To create a blueprint delineating GBOT implementation, we integrated findings from a previously conducted and separately published systematic review of existing GBOT studies, conducted additional literature review, reviewed best practice recommendations and policies related to GBOT and organizational frameworks for implementing health systems change. We triangulated this data with a qualitative thematic analysis from 5 individual interviews and 2 focus groups representing leaders from 5 different GBOT programs across our institution to identify the key components to GBOT implementation, distinguish "core" and "malleable" components, and provide a conceptual framework for considering various options for implementing the malleable components. RESULTS:We identified 6 core components to GBOT implementation that optimize clinical outcomes, comply with mandatory policies and regulations, ensure patient and staff safety, and promote sustainability in delivery. These included consistent group expectations, team-based approach to care, safe and confidential space, billing compliance, regular monitoring, and regular patient participation. We identified 14 malleable components and developed a novel conceptual framework that providers can apply when deciding how to employ each malleable component that considers empirical, theoretical and practical dimensions. CONCLUSION:While further research on the effectiveness of GBOT and its individual implementation components is needed, the blueprint outlined here provides an initial framework to help office-based opioid treatment sites implement a successful GBOT approach and hence potentially serve as future study sites to establish efficacy of the model. This blueprint can also be used to continuously monitor how components of GBOT influence treatment outcomes, providing an empirical framework for the ongoing process of refining implementation strategies.Item Open Access Bumps and bridges on the road to responsible sharing of clinical trial data.(Clin Trials, 2014-02) Berlin, Jesse A; Morris, Sandra; Rockhold, Frank; Askie, Lisa; Ghersi, Davina; Waldstreicher, JoanneBACKGROUND: Sharing data from clinical trials could assist with the advancement of science and medicine, potentially providing a better understanding of both the benefits and risks of medicines and other treatments. Sharing data also allows for questions to be addressed at the meta-analysis level that cannot be addressed within individual studies. PURPOSE: In this article, we offer some practical recommendations that will allow researchers to readily combine datasets from different studies and sources, thereby enabling meta-analyses that could have significant impact on advancing medicine. METHODS: The authors relied on their collective experience in the conduct and reporting of clinical trials to define the areas of potential concern related to responsible sharing of clinical trial data. We conducted a review of the literature and engaged in an iterative consensus-building process. RESULTS: To further the goal of responsible sharing of clinical trial data, collaboration on a consistent set of data standards and methods across both industry and academia is sorely needed. Protection of participant privacy is a paramount principle. The additional questions of who maintains, funds, and oversees databases of participant-level data will be important to resolve. Requiring researchers to register their requests for participant-level data and to provide details of their intended research would allow others to evaluate the proposed research plan, consistent with the principles of science and transparency. LIMITATIONS: The recommendations represent the views of the individual authors. We recognize that other approaches to data sharing that have been advocated are also based on sound ethical and scientific principles.Item Open Access Changes in HIV risk behavior and seroincidence among clients presenting for repeat HIV counseling and testing in Moshi, Tanzania.(AIDS Care, 2012) Fiorillo, Suzanne P; Landman, Keren Z; Tribble, Alison C; Mtalo, Antipas; Itemba, Dafrosa K; Ostermann, Jan; Thielman, Nathan M; Crump, John AWhile HIV counseling and testing (HCT) has been considered an HIV preventive measure in Africa, data are limited describing behavior changes following HCT. This study evaluated behavior changes and estimated HIV seroincidence rate among returning HCT clients. Repeat and one-time testing clients receiving HCT services in Moshi, Tanzania were identified. Information about sociodemographic characteristics, HIV-related behaviors and testing reasons were collected, along with HIV serostatus. Six thousand seven hundred and twenty-seven clients presented at least once for HCT; 1235 (18.4%) were HIV seropositive, median age was 29.7 years and 3712 (55.3%) were women. 1382 repeat and 4272 one-time testers were identified. Repeat testers were more likely to be male, older, married, or widowed, and testing because of unfaithful partner or new sexual partner. One-time testers were more likely to be students and testing due to illness. At second test, repeat testers were more likely to report that partners had received HIV testing, not have concurrent partners, not suspect partners have HIV, and have partners who did not have other partners. Clients who intended to change behaviors after the first test were more likely to report having changed behaviors by remaining abstinent (OR 2.58; p<0.0001) or using condoms (OR 2.00; p=0.006) at the second test. HIV seroincidence rate was 1.49 cases/100 person-years (PY). Clients presenting for repeat HCT reported some reduction of risky behavior and improved knowledge of sexual practices and HIV serostatus of their partners. Promoting behavior change through HCT should continue to be a focus of HIV prevention efforts in sub-Saharan Africa.Item Open Access Developing a simplified consent form for biobanking.(PLoS One, 2010-10-08) Beskow, Laura M; Friedman, Joëlle Y; Hardy, N Chantelle; Lin, Li; Weinfurt, Kevin PBACKGROUND: Consent forms have lengthened over time and become harder for participants to understand. We sought to demonstrate the feasibility of creating a simplified consent form for biobanking that comprises the minimum information necessary to meet ethical and regulatory requirements. We then gathered preliminary data concerning its content from hypothetical biobank participants. METHODOLOGY/PRINCIPAL FINDINGS: We followed basic principles of plain-language writing and incorporated into a 2-page form (not including the signature page) those elements of information required by federal regulations and recommended by best practice guidelines for biobanking. We then recruited diabetes patients from community-based practices and randomized half (n = 56) to read the 2-page form, first on paper and then a second time on a tablet computer. Participants were encouraged to use "More information" buttons on the electronic version whenever they had questions or desired further information. These buttons led to a series of "Frequently Asked Questions" (FAQs) that contained additional detailed information. Participants were asked to identify specific sentences in the FAQs they thought would be important if they were considering taking part in a biorepository. On average, participants identified 7 FAQ sentences as important (mean 6.6, SD 14.7, range: 0-71). No one sentence was highlighted by a majority of participants; further, 34 (60.7%) participants did not highlight any FAQ sentences. CONCLUSIONS: Our preliminary findings suggest that our 2-page form contains the information that most prospective participants identify as important. Combining simplified forms with supplemental material for those participants who desire more information could help minimize consent form length and complexity, allowing the most substantively material information to be better highlighted and enabling potential participants to read the form and ask questions more effectively.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 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 Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation.(The New England journal of medicine, 2019-11) Perez, Marco V; Mahaffey, Kenneth W; Hedlin, Haley; Rumsfeld, John S; Garcia, Ariadna; Ferris, Todd; Balasubramanian, Vidhya; Russo, Andrea M; Rajmane, Amol; Cheung, Lauren; Hung, Grace; Lee, Justin; Kowey, Peter; Talati, Nisha; Nag, Divya; Gummidipundi, Santosh E; Beatty, Alexis; Hills, Mellanie True; Desai, Sumbul; Granger, Christopher B; Desai, Manisha; Turakhia, Mintu P; Apple Heart Study InvestigatorsBACKGROUND:Optical sensors on wearable devices can detect irregular pulses. The ability of a smartwatch application (app) to identify atrial fibrillation during typical use is unknown. METHODS:Participants without atrial fibrillation (as reported by the participants themselves) used a smartphone (Apple iPhone) app to consent to monitoring. If a smartwatch-based irregular pulse notification algorithm identified possible atrial fibrillation, a telemedicine visit was initiated and an electrocardiography (ECG) patch was mailed to the participant, to be worn for up to 7 days. Surveys were administered 90 days after notification of the irregular pulse and at the end of the study. The main objectives were to estimate the proportion of notified participants with atrial fibrillation shown on an ECG patch and the positive predictive value of irregular pulse intervals with a targeted confidence interval width of 0.10. RESULTS:We recruited 419,297 participants over 8 months. Over a median of 117 days of monitoring, 2161 participants (0.52%) received notifications of irregular pulse. Among the 450 participants who returned ECG patches containing data that could be analyzed - which had been applied, on average, 13 days after notification - atrial fibrillation was present in 34% (97.5% confidence interval [CI], 29 to 39) overall and in 35% (97.5% CI, 27 to 43) of participants 65 years of age or older. Among participants who were notified of an irregular pulse, the positive predictive value was 0.84 (95% CI, 0.76 to 0.92) for observing atrial fibrillation on the ECG simultaneously with a subsequent irregular pulse notification and 0.71 (97.5% CI, 0.69 to 0.74) for observing atrial fibrillation on the ECG simultaneously with a subsequent irregular tachogram. Of 1376 notified participants who returned a 90-day survey, 57% contacted health care providers outside the study. There were no reports of serious app-related adverse events. CONCLUSIONS:The probability of receiving an irregular pulse notification was low. Among participants who received notification of an irregular pulse, 34% had atrial fibrillation on subsequent ECG patch readings and 84% of notifications were concordant with atrial fibrillation. This siteless (no on-site visits were required for the participants), pragmatic study design provides a foundation for large-scale pragmatic studies in which outcomes or adherence can be reliably assessed with user-owned devices. (Funded by Apple; Apple Heart Study ClinicalTrials.gov number, NCT03335800.).