Browsing by Author "Lin, Li"

Now showing 1 - 8 of 8
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    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 M
    BACKGROUND: 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.
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    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 P
    BACKGROUND: 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.
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    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 E
    Certificates 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.
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    Lower likelihood of cardiac procedures after acute coronary syndrome in patients with human immunodeficiency virus/acquired immunodeficiency syndrome.
    (Medicine, 2018-02) Clement, Meredith E; Lin, Li; Navar, Ann Marie; Okeke, Nwora Lance; Naggie, Susanna; Douglas, Pamela S
    Cardiovascular disease (CVD) is an increasing cause of morbidity and mortality in human immunodeficiency virus (HIV)-infected adults; however, this population may be less likely to receive interventions during hospitalization for acute coronary syndrome (ACS). The degree to which this disparity can be attributed to poorly controlled HIV infection is unknown.In this large cohort study, we used the National Inpatient Sample (NIS) to compare rates of cardiac procedures among patients with asymptomatic HIV-infection, symptomatic acquired immunodeficiency syndrome (AIDS), and uninfected adults hospitalized with ACS from 2009 to 2012. Multivariable analysis was used to compare procedure rates by HIV status, with appropriate weighting to account for NIS sampling design including stratification and hospital clustering.The dataset included 1,091,759 ACS hospitalizations, 0.35% of which (n = 3783) were in HIV-infected patients. Patients with symptomatic AIDS, asymptomatic HIV, and uninfected patients differed by sex, race, and income status. Overall rates of cardiac catheterization and revascularization were 53.3% and 37.4%, respectively. In multivariable regression, we found that relative to uninfected patients, those with symptomatic AIDS were less likely to undergo catheterization (odds ratio [OR] 0.48, confidence interval [CI] 0.43-0.55), percutaneous coronary intervention (OR 0.69, CI 0.59-0.79), and coronary artery bypass grafting (0.75, CI 0.61-0.93). No difference was seen for those with asymptomatic HIV relative to uninfected patients (OR 0.93, CI 0.81-1.07; OR 1.06, CI 0.93-1.21; OR 0.88, CI 0.72-1.06, respectively).We found that lower rates of cardiovascular procedures in HIV-infected patients were primarily driven by less frequent procedures in those with AIDS.
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    Novel loci and pathways significantly associated with longevity.
    (Sci Rep, 2016-02-25) Zeng, Yi; Nie, Chao; Min, Junxia; Liu, Xiaomin; Li, Mengmeng; Chen, Huashuai; Xu, Hanshi; Wang, Mingbang; Ni, Ting; Li, Yang; Yan, Han; Zhang, Jin-Pei; Song, Chun; Chi, Li-Qing; Wang, Han-Ming; Dong, Jie; Zheng, Gu-Yan; Lin, Li; Qian, Feng; Qi, Yanwei; Liu, Xiao; Cao, Hongzhi; Wang, Yinghao; Zhang, Lijuan; Li, Zhaochun; Zhou, Yufeng; Wang, Yan; Lu, Jiehua; Li, Jianxin; Qi, Ming; Bolund, Lars; Yashin, Anatoliy; Land, Kenneth C; Gregory, Simon; Yang, Ze; Gottschalk, William; Tao, Wei; Wang, Jian; Wang, Jun; Xu, Xun; Bae, Harold; Nygaard, Marianne; Christiansen, Lene; Christensen, Kaare; Franceschi, Claudio; Lutz, Michael W; Gu, Jun; Tan, Qihua; Perls, Thomas; Sebastiani, Paola; Deelen, Joris; Slagboom, Eline; Hauser, Elizabeth; Xu, Huji; Tian, Xiao-Li; Yang, Huanming; Vaupel, James W
    Only two genome-wide significant loci associated with longevity have been identified so far, probably because of insufficient sample sizes of centenarians, whose genomes may harbor genetic variants associated with health and longevity. Here we report a genome-wide association study (GWAS) of Han Chinese with a sample size 2.7 times the largest previously published GWAS on centenarians. We identified 11 independent loci associated with longevity replicated in Southern-Northern regions of China, including two novel loci (rs2069837-IL6; rs2440012-ANKRD20A9P) with genome-wide significance and the rest with suggestive significance (P < 3.65 × 10(-5)). Eight independent SNPs overlapped across Han Chinese, European and U.S. populations, and APOE and 5q33.3 were replicated as longevity loci. Integrated analysis indicates four pathways (starch, sucrose and xenobiotic metabolism; immune response and inflammation; MAPK; calcium signaling) highly associated with longevity (P ≤ 0.006) in Han Chinese. The association with longevity of three of these four pathways (MAPK; immunity; calcium signaling) is supported by findings in other human cohorts. Our novel finding on the association of starch, sucrose and xenobiotic metabolism pathway with longevity is consistent with the previous results from Drosophilia. This study suggests protective mechanisms including immunity and nutrient metabolism and their interactions with environmental stress play key roles in human longevity.
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    Sexual function and satisfaction among heterosexual and sexual minority U.S. adults: A cross-sectional survey.
    (PLoS One, 2017) Flynn, Kathryn E; Lin, Li; Weinfurt, Kevin P
    BACKGROUND: Despite known health disparities for sexual minorities, few studies have described sexual function by sexual orientation using a robust approach to measurement of sexual function. We compared recent sexual function and satisfaction by sexual orientation among English-speaking US adults. METHODS AND FINDINGS: Cross-sectional surveys were administered by KnowledgePanel® (GfK), an online panel that uses address-based probability sampling and is representative of the civilian, noninstitutionalized US population. Data were collected in 2013 from the general population (n = 3314, 35% response rate) and in 2014 from self-identified lesbian, gay, and bisexual adults (n = 1011, 50% response rate). Sexual function and satisfaction were measured using the Patient-Reported Outcomes Measurement Information System® Sexual Function and Satisfaction measure version 2.0 (PROMIS SexFS v2). The PROMIS SexFS v2 is a comprehensive, customizable measurement system with evidence for validity in diverse populations. A score of 50 (SD 10) on each domain corresponds to the average for US adults sexually active in the past 30 days. We adjusted all statistics for the complex sample designs and report differences within each sex where the 95% CIs do not overlap, corresponding to p<0.01. Among US men who reported any sexual activity in the past 30 days, there were no differences in erectile function or orgasm-ability. Compared to heterosexual men, sexual minority men reported higher oral dryness and lower orgasm-pleasure and satisfaction. Compared to heterosexual men, gay men reported lower interest, higher anal discomfort and higher oral discomfort. Among sexually active women, there were no differences in the domains of vulvar discomfort-clitoral, orgasm-pleasure, or satisfaction. Compared to heterosexual women, sexual minority women reported higher oral dryness. Lesbian women reported lower vaginal discomfort than other women; lesbian women reported higher lubrication and orgasm-ability than heterosexual women. Bisexual women reported higher interest, higher vulvar discomfort-labial and higher anal discomfort than other women, as well as higher oral discomfort compared to heterosexual women. CONCLUSIONS: Recent sexual function and satisfaction differed by sexual orientation among US adults. Sexual minority men and women had decrements in domains of sexual function that have not traditionally been included in multi-dimensional self-report measures. Clinicians should make themselves aware of their patients' sexual concerns and recognize that sexual minority patients may be more vulnerable to certain sexual difficulties than heterosexual patients.
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    Terminal ileum intubation is not associated with colonoscopy quality measures.
    (Journal of gastroenterology and hepatology, 2020-09) Leiman, David A; Jawitz, Nicole G; Lin, Li; Wood, Richard K; Gellad, Ziad F
    BACKGROUND AND AIM:Intubation of the terminal ileum (TI) demonstrates a complete colonoscopy, but its clinical value during screening exams is unknown. We aimed to determine whether TI intubation during screening colonoscopy is associated with colonoscopy quality measures or identifies subclinical pathology. METHODS:We performed a retrospective cohort study examining average-risk screening colonoscopies performed at an academic health system between July 2016 and October 2017. Data were extracted from an internal colonoscopy quality registry and the electronic health record. Appropriate statistical tests were used for group comparisons, to correlate TI intubation rate (TIIR) with measures of colonoscopy quality and to examine factors associated with the likelihood of TI intubation. RESULTS:There were 7799 colonoscopies performed with adequate prep quality by 28 gastroenterologists. Most patients were female (56.4%) with a median age of 58. The median TIIR was 37.0%, with significant variability among physicians (2-93%). The detection rates for all polyps, adenomas, and sessile serrated polyps were 62.1%, 45.5%, and 7.2%, respectively, and none correlated with TIIR. Intubation of the TI was associated with significantly longer withdrawal times. In a random 10% sample of cases with TI intubation, no clinically significant pathology was found. CONCLUSIONS:There is wide variability in TIIR among endoscopists. Except to provide photodocumentation of exam extent when other images may be difficult to obtain, the lack of correlation between TI intubation and meaningful clinical outcomes together with the associated time costs suggest routine TI intubation during screening colonoscopy may not be warranted.
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    Validation of the Observer-Reported Communication Ability (ORCA) Measure for Individuals With Angelman Syndrome.
    (American journal on intellectual and developmental disabilities, 2023-05) Zigler, Christina K; Lin, Li; McFatrich, Molly; Lucas, Nicole; Gordon, Kelly L; Jones, Harrison N; Berent, Allyson; Panagoulias, Jennifer; Evans, Paula; Reeve, Bryce B
    There is a critical need for high-quality clinical outcome assessments to capture the important aspects of communication ability of individuals with Angelman syndrome (AS). To center the perspective of caregivers, our team developed the novel Observer-Reported Communication Ability (ORCA) measure using best practice guidelines, with the goal of developing a measure that could be administered to caregivers directly without the need for a certified administrator for use in clinical trials. To refine the draft measure, we conducted two rounds of cognitive interviews with 24 caregivers and a quantitative study including 249 caregivers. The results from both studies support the overall content validity, construct validity, and the reliability of the ORCA measure for individuals with AS > 2 years old for use in research contexts. Future work should explore the responsiveness of ORCA measures to changes over time in a diverse sample.