Last data update: Jan 27, 2025. (Total: 48650 publications since 2009)
Records 1-11 (of 11 Records) |
Query Trace: Sadowski C[original query] |
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Using a medication event monitoring system to evaluate self-report and pill count for determining treatment completion with self-administered, once-weekly isoniazid and rifapentine
Scott AA , Sadowski C , Vernon A , Arevalo B , Beer K , Borisov A , Cayla JA , Chen M , Feng PJ , Moro RN , Holland DP , Martinson N , Millet JP , Miro JM , Belknap R . Contemp Clin Trials 2023 129 107173 BACKGROUND: Treatment completion is essential for the effectiveness of any latent tuberculosis infection (LTBI) regimen. The Tuberculosis Trials Consortium (TBTC) Study 33 (iAdhere) combined self-report and pill counts - standard of care (SOC) with a medication event monitoring system (MEMS) to determine treatment completion for 12-dose once-weekly isoniazid and rifapentine (3HP). Understanding the performance of SOC relative to MEMS can inform providers and suggest when interventions may be applied to optimize LTBI treatment completion. METHOD: iAdhere randomized participants to directly observed therapy (DOT), SAT, or SAT with text reminders in Hong Kong, South Africa, Spain and the United States (U.S.). This post-hoc secondary analysis evaluated treatment completion in both SAT arms, and compared completion based on SOC with MEMS to completion based on SOC only. Treatment completion proportions were compared. Characteristics associated with discordance between SOC and SOC with MEMS were identified. RESULTS: Overall 80.8% of 665 participants completed treatment per SOC, compared to 74.7% per SOC with MEMS, a difference of 6.1% (95%CI: 4.2%, 7.8%). Among U.S. participants only, this difference was 3.3% (95% CI: 1.8%, 4.9%). Differences in completion was 3.1% (95% CI: -1.1%, 7.3%) in Spain, and 36.8% (95% CI: 24.3%, 49.4%) in South Africa. There was no difference in Hong Kong. CONCLUSION: When used for monitoring 3HP, SOC significantly overestimated treatment completion in U.S. and South Africa. However, SOC still provides a reasonable estimate of treatment completion of the 3HP regimen, in U.S., Spain, and Hong Kong. |
Symptoms and systemic drug reactions in persons receiving weekly rifapentine plus isoniazid (3HP) treatment for latent tuberculosis infection
Sadowski C , Belknap R , Holland DP , Moro RN , Chen MP , Wright A , Millet JP , Cayla JA , Scott NA , Borisov A , Gandhi NR . Clin Infect Dis 2023 76 (12) 2090-2097 BACKGROUND: Three months of weekly rifapentine plus isoniazid (3HP) therapy for latent tuberculosis infections (LTBI) is recommended worldwide. The development of symptoms and systemic drug reactions (SDR) on 3HP have not been fully characterized. We aimed to determine the patterns of symptom development and identify SDR and associated factors in patients on 3HP. METHODS: We analyzed symptoms data in participants undergoing 3HP in Tuberculosis Trials Consortium's (TBTC) iAdhere study (Study 33). We examined the patterns of symptom reporting across participants from baseline and four monthly visits. Bivariate analyses and multivariable regression models were used to identify factors associated with SDR. Risk ratios and 95% confidence intervals (CI) were calculated. RESULTS: Among 1,002 participants receiving 3HP, 768 (77%) reported at least one symptom; 97% of these symptoms were grade 1 (79%) or grade 2 (18%). Most symptoms developed in the first month and resolved. 111 (11%) participants had symptoms that met criteria for SDR; however, 53 (48%) of these participants completed therapy. Factors associated with SDR and discontinuation included female sex (RR 2.05, CI: 1.19-3.54), age ≥45 years (RR 1.99, CI: 1.19-3.31), and use of concomitant medications (RR 2.26, CI: 1.15-4.42). CONCLUSIONS: Although most patients receiving 3HP reported symptoms, most were mild, occurred early, and resolved without stopping treatment. Among patients experiencing SDR, nearly half were able to complete therapy. Patient and provider education should focus on differentiating severe reactions where 3HP should be stopped from minor symptoms that will resolve. |
Expanding Reach of Occupational Health Knowledge: Contributing Subject-Matter Expertise to Wikipedia as a Class Assignment
Ceballos DM , Herrick RF , Carreón T , Nguyen VT , Chu MT , Sadowski JP , Blumenthal H , Morata TC . Inquiry 2021 58 469580211035735 The National Institute for Occupational Safety and Health (NIOSH) and several university programs have collaborated on a large effort to expand and improve occupational safety and health content in Wikipedia using a platform developed by Wiki Education. This article describes the initiative, student contributions, and evaluations of this effort by instructors from two universities between 2016 and 2020. The Wiki Education platform allowed instructors to set timelines and track students' progress throughout the semester while students accessed training to best expand health content in Wikipedia. Students chose topics in occupational health based on their interests and by a set of topics deemed as a priority by the "WikiProject Occupational Safety and Health." Students' contributions were peer-reviewed by instructors, NIOSH Wikipedians-in-Residence, and traditional Wikipedians. Students presented their projects in class at the end of the semester. Students from both schools expanded 55 articles, created 8 new articles, and translated 2 articles to Spanish, adding 1270 references; these articles were viewed over 8 million times by May 2020. Feedback received from the implementation suggested that students learned about science communication and digital literacy-providing valuable content on occupational health while reducing misinformation in the public domain. The process of identifying and addressing gaps in occupational health in Wikipedia requires participation and engagement toward improving access to information that otherwise would be restricted to the scientific literature, often behind a paywall. The Wikipedia assignment proved to be an engaging approach for instruction and information literacy. It helped students improve their science communication skills and digital literacy, tools that are likely to be critical for successful communication of science in their future careers. |
Developing a scalable framework for partnerships between health agencies and the Wikimedia ecosystem
Mietchen D , Rasberry L , Morata T , Sadowski JP , Novakovich J , Heilman JM . Res Ideas Outcomes 2021 7 e68121 In this era of information overload and misinformation, it is a challenge to rapidly translate evidence-based health information to the public. Wikipedia is a prominent global source of health information with high traffic, multilingual coverage, and acceptable quality control practices. Viewership data following the Ebola crisis and during the COVID-19 pandemic reveals that a significant number of web users located health guidance through Wikipedia and related projects, including its media repository Wikimedia Commons and structured data complement, Wikidata. The basic idea discussed in this paper is to increase and expedite health institutions' global reach to the general public, by developing a specific strategy to maximize the availability of focused content into Wikimedia's public digital knowledge archives. It was conceptualized from the experiences of leading health organizations such as Cochrane, the World Health Organization (WHO) and other United Nations Organizations, Cancer Research UK, National Network of Libraries of Medicine, and Centers for Disease Control and Prevention (CDC)'s National Institute for Occupational Safety and Health (NIOSH). Each has customized strategies to integrate content in Wikipedia and evaluate responses. We propose the development of an interactive guide on the Wikipedia and Wikidata platforms to support health agencies, health professionals and communicators in quickly distributing key messages during crisis situations. The guide aims to cover basic features of Wikipedia, including adding key health messages to Wikipedia articles, citing expert sources to facilitate fact-checking, staging text for translation into multiple languages; automating metrics reporting; sharing non-text media; anticipating offline reuse of Wikipedia content in apps or virtual assistants; structuring data for querying and reuse through Wikidata, and profiling other flagship projects from major health organizations. In the first phase, we propose the development of a curriculum for the guide using information from prior case studies. In the second phase, the guide would be tested on select health-related topics as new case studies. In its third phase, the guide would be finalized and disseminated. |
Optimizing drug inventory management with a web-based information system: The TBTC study 31/ACTG A5349 experience
Scott NA , Lee KK , Sadowski C , Kurbatova E , Goldberg SV , Nsubuga P , Kitshoff R , Whitelaw C , Thuy HN , Batra K , Allen-Blige C , Davis H , Kim J , Phan M , Fedrick P , Chiu KW , Heilig CM , Sizemore E . Contemp Clin Trials 2021 105 106377 INTRODUCTION: Efficient management of study drug inventory shipments is critical to keep research sites enrolling into multisite clinical treatment trials. A standard manual drug-management process used by the Tuberculosis Trials Consortium (TBTC), did not accommodate import permit approval timelines, shipment transit-times and time-zone differences. We compared a new web-based solution with the manual process, during an international 34-site clinical trial conducted by the TBTC and the AIDS Clinical Trials Group (ACTG); TBTC Study 31/ACTG A5349. MATERIAL AND METHODS: We developed and implemented a technological solution by integrating logistical and regulatory requirements for drug importation with statistical simulations that estimated stock-out times in an online Drug Management Module (DMM). We measured the average shipment-related drug stock-outs and time to drug availability, to assess the efficiency of the DMM compared to the manual approach. RESULTS: An Interrupted Time-Series (ITS) analysis showed a 15% [p-value = 0.03; 95% C.I. (-28.8%, -2.0%)] reduction in average shipment-related study drug stock-out after DMM implementation. The DMM streamlined the restocking process at study sites, reducing median transit-time for sites associated with a depot by 2 days [95% C.I. (-3.0, -1.0)]. Under the DMM, study drugs were available for treatment assignment on the day received, compared to one day after receipt under the manual process. DISCUSSION: The DMM provided TBTC's Data and Coordinating Center and site staff with more efficient procedures to manage and consistently maintain study drug inventory at enrolling sites. This DMM framework can improve efficiency in future multicenter clinical trials. TRIAL REGISTRATION: This trial was registered with ClinicalTrials.gov (Identifier: NCT02410772) on April 8, 2015. |
COVID-19 Among American Indian and Alaska Native Persons - 23 States, January 31-July 3, 2020.
Hatcher SM , Agnew-Brune C , Anderson M , Zambrano LD , Rose CE , Jim MA , Baugher A , Liu GS , Patel SV , Evans ME , Pindyck T , Dubray CL , Rainey JJ , Chen J , Sadowski C , Winglee K , Penman-Aguilar A , Dixit A , Claw E , Parshall C , Provost E , Ayala A , Gonzalez G , Ritchey J , Davis J , Warren-Mears V , Joshi S , Weiser T , Echo-Hawk A , Dominguez A , Poel A , Duke C , Ransby I , Apostolou A , McCollum J . MMWR Morb Mortal Wkly Rep 2020 69 (34) 1166-1169 Although non-Hispanic American Indian and Alaska Native (AI/AN) persons account for 0.7% of the U.S. population,* a recent analysis reported that 1.3% of coronavirus disease 2019 (COVID-19) cases reported to CDC with known race and ethnicity were among AI/AN persons (1). To assess the impact of COVID-19 among the AI/AN population, reports of laboratory-confirmed COVID-19 cases during January 22(†)-July 3, 2020 were analyzed. The analysis was limited to 23 states(§) with >70% complete race/ethnicity information and five or more laboratory-confirmed COVID-19 cases among both AI/AN persons (alone or in combination with other races and ethnicities) and non-Hispanic white (white) persons. Among 424,899 COVID-19 cases reported by these states, 340,059 (80%) had complete race/ethnicity information; among these 340,059 cases, 9,072 (2.7%) occurred among AI/AN persons, and 138,960 (40.9%) among white persons. Among 340,059 cases with complete patient race/ethnicity data, the cumulative incidence among AI/AN persons in these 23 states was 594 per 100,000 AI/AN population (95% confidence interval [CI] = 203-1,740), compared with 169 per 100,000 white population (95% CI = 137-209) (rate ratio [RR] = 3.5; 95% CI = 1.2-10.1). AI/AN persons with COVID-19 were younger (median age = 40 years; interquartile range [IQR] = 26-56 years) than were white persons (median age = 51 years; IQR = 32-67 years). More complete case report data and timely, culturally responsive, and evidence-based public health efforts that leverage the strengths of AI/AN communities are needed to decrease COVID-19 transmission and improve patient outcomes. |
Does screening or providing information on resources for intimate partner violence increase women's knowledge? Findings from a randomized controlled trial
Klevens J , Sadowski LS , Kee R , Garcia D . J Womens Health Issues Care 2015 4 (2) BACKGROUND: Screening for IPV in health care settings might increase women's knowledge or awareness around its frequency and its impact on health. When IPV is disclosed, assuring women it is not their fault should improve their knowledge that IPV is the perpetrator's responsibility. Providing information about IPV resources may also increase women's knowledge about the availability of solutions. METHODS: Women (n=2708) were randomly assigned to one of three groups: (1) partner violence screen plus video referral and list of local partner violence resources if screening was positive (n=909); (2) partner violence resource list only without screen (n=893); and (3) a no-screen, no-partner violence resource list control group (n=898). One year later, 2364 women (87%) were re-contacted and asked questions assessing their knowledge of the frequency of partner violence, its impact on physical and mental health, the availability of resources to help women experiencing partner violence, and that it is the perpetrator's fault. RESULTS: There were no differences between women screened and provided with a partner violence resource list compared to a control group as to women's knowledge of the frequency of IPV, its impact on physical or mental health, or the availability of IPV services in their community. However, among women who experienced IPV in the year before or year after enrolling in the trial, those who were provided a list of IPV resources without screening were significantly less likely to know that IPV is not the victim's fault than those in the control or list plus screening conditions. CONCLUSIONS: The results of this study suggest that providing information on partner violence resources, with or without asking questions about partner violence, did not result in improved knowledge. |
Effect of screening for partner violence on use of health services at 3-year follow-up of a randomized clinical trial
Klevens J , Sadowski LS , Kee R , Garcia D , Lokey C . JAMA 2015 314 (5) 515-6 The US Preventive Services Task Force recommends women of reproductive age be screened for partner violence.1 However, others, such as the World Health Organization2 and the Cochrane Collaborative,3 conclude there is insufficient evidence for this recommendation. | Our randomized clinical trial allocated women seeking care in outpatient clinics to 1 of 3 study groups: computerized partner violence screening and provision of a local resource list, universal provision of a partner violence resource list without screening, or a no screen/no resource list control group. No differences were found in women’s quality of life, days lost from work or housework, use of health care and partner violence services, or the recurrence of partner violence after 1 year.4 | We report women’s use of health services over 3 years, which we hypothesized would be lower in the intervention groups, as delayed effects of acting on the referral information could result from deteriorating health. |
Effect of screening for partner violence on women's quality of life: a randomized controlled trial
Klevens J , Kee R , Trick W , Garcia D , Angulo FR , Jones R , Sadowski LS . JAMA 2012 308 (7) 681-9 CONTEXT: Although partner violence screening has been endorsed by many health organizations, there is insufficient evidence that it has beneficial health outcomes. OBJECTIVE: To determine the effect of computerized screening for partner violence plus provision of a partner violence resource list vs provision of a partner violence list only on women's health in primary care settings, compared with a control group. DESIGN, SETTING, AND PARTICIPANTS: A 3-group blinded randomized controlled trial at 10 primary health care centers in Cook County, Illinois. Participants were enrolled from May 2009-April 2010 and reinterviewed 1 year (range, 48-56 weeks) later. Participants were English- or Spanish-speaking women meeting specific inclusion criteria and seeking clinical services at study sites. Of 3537 women approached, 2727 were eligible, 2708 were randomized (99%), and 2364 (87%) were recontacted 1 year later. Mean age of participants was 39 years. Participants were predominantly non-Latina African American (55%) or Latina (37%), had a high school education or less (57%), and were uninsured (57%). INTERVENTION: Randomization into 3 intervention groups: (1) partner violence screen (using the Partner Violence Screen instrument) plus a list of local partner violence resources if screening was positive (n = 909); (2) partner violence resource list only without screen (n = 893); and (3) no-screen, no-partner violence list control group (n=898). MAIN OUTCOME MEASURES: Quality of life (QOL, physical and mental health components) was the primary outcome, measured on the 12-item Short Form (scale range 0-100, mean of 50 for US population). RESULTS: At 1-year follow-up, there were no significant differences in the QOL physical health component between the screen plus partner violence resource list group (n = 801; mean score, 46.8; 95% CI, 46.1-47.4), the partner violence resource list only group (n = 772; mean score, 46.4; 95% CI, 45.8-47.1), and the control group (n = 791; mean score, 47.2; 95% CI, 46.5-47.8), or in the mental health component (screen plus partner violence resource list group [mean score, 48.3; 95% CI, 47.5-49.1], the partner violence resource list only group [mean score, 48.0; 95% CI, 47.2-48.9], and the control group [mean score, 47.8; 95% CI, 47.0-48.6]). There were also no differences between groups in days unable to work or complete housework; number of hospitalizations, emergency department, or ambulatory care visits; proportion who contacted a partner violence agency; or recurrence of partner violence. CONCLUSIONS: Among women receiving care in primary care clinics, providing a partner violence resource list with or without screening did not result in improved health. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00526994. |
Comparison of screening and referral strategies for exposure to partner violence
Klevens J , Sadowski L , Kee R , Trick W , Garcia D . Womens Health Issues 2011 22 (1) e45-52 BACKGROUND: Although under debate, routine screening for intimate partner violence (IPV) is recommended in health care settings. This study explored the utility of different screening and referral strategies for women exposed to IPV in primary health care. METHODS: Using a randomized controlled trial design we compared two screening strategies (health care providers [HCP] versus audio computer-assisted self-interviews [A-CASI]) and three referral strategies (HCP alone, A-CASI referral with HCP endorsement, and A-CASI alone). English-speaking women who were 18 years and older and were attending women's health clinics at a public hospital were eligible to participate. Participants were randomly assigned to one of three study groups (HCP screen and referral, A-CASI screen and referral with HCP referral endorsement, and A-CASI screen and referral). Women were reinterviewed by telephone 1 week later. The primary outcome was rate of IPV disclosure; secondary outcomes were screening mode preference, reactions to IPV screening, and use of referral resources. RESULTS: Of the 129 eligible women, 126 women were enrolled (98%); 102 women (81% of those enrolled) completed the follow-up telephone interview. Disclosure rates were higher for women screened with A-CASI compared with HCP-screened women (21% vs. 9%; p = .07). Screening mode preference, impact of screening (positive and negative reactions), and rates of use of referral resources were similar between study groups. CONCLUSION: A-CASI tended to yield higher rates of IPV disclosure and similar rates of use of referral resources. A-CASI technology may be a practical way to screen for IPV. |
Concordance in the measurement of quality of life and health indicators between two methods of computer-assisted interviews: self-administered and by telephone
Klevens J , Trick WE , Kee R , Angulo F , Garcia D , Sadowski LS . Qual Life Res 2011 20 (8) 1179-86 PURPOSE: The aim of this study was to establish the concordance for quality of life (QOL), disability, and use of health service indicators between two modes of computer-assisted interviews: audio-computer-assisted self-interview (A-CASI) and computer-assisted telephone interview (CATI). High concordance between these modes of data collection would allow comparisons and interchangeable use in cross-sectional or longitudinal assessments. METHODS: Adult English-speaking women (n = 126) were enrolled from women's health clinics at a public hospital. QOL using the short form 12 version 2, disability (days missed from work, inability to do household activities), and utilization of health services (number of emergency room visits and hospitalizations) were assessed first with A-CASI at the time of enrollment and again (n = 102) with CATI 1 week later. Participants assessed with both modes were 38 years old on average, predominantly African-American, 41% had a high school education or less, and 61% were uninsured. Lin's concordance correlation coefficient or Cohen's kappa was calculated to establish concordance between paired A-CASI and CATI assessments. RESULTS: Concordance between the two interview methods ranged from fair to substantial for the QOL components, (concordance correlation coefficient [CCC] of .76 and .87, respectively), the QOL subscales, and disability indices (CCC range; .53-.91). For health services utilization, there was moderate concordance for emergency room visits (CCC = .70) but only slight concordance for the number of hospitalizations in the past year (CCC = .37). CONCLUSIONS: Administering surveys through a telephone or self-administered computer-assisted interview resulted in moderate to substantial agreement for the short form QOL components and fair to substantial for the QOL subscales and disability measures. These findings suggest A-CASI and CATI can be used interchangeably for some QOL scales. |
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