Artykuły w czasopismach na temat „Enrollment intention”
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Bager, Torben Eli, Kent Wickstrøm Jensen, Pia Schou Nielsen i Tue Avbæk Larsen. "Enrollment of SME managers to growth-oriented training programs". International Journal of Entrepreneurial Behavior & Research 21, nr 4 (1.06.2015): 578–99. http://dx.doi.org/10.1108/ijebr-12-2014-0224.
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Purpose – Entrepreneurial learning through formal growth-oriented training programs for SME managers promises to enhance the growth competences and growth intentions of the enrolled managers. The impact of such programs, however, depends on who enrolls since initial competence and growth-intention levels vary significantly. Potential participants may suffer from limited ability to transform new knowledge into practice, absence of growth intention and too high or too low a prior competence level to be able to benefit substantially. Selection and self-selection processes therefore have a bearing on the extent to which such programs result in additionality, i.e. improved growth performance compared to non-intervention. The paper aims to discuss these issues. Design/methodology/approach – Selection and self-selection processes are explored through a study of a large-scale training program for growth-oriented managers of small Danish firms. This program has, from 2012 to 2015, trained about 700 SME managers. Data are currently available for 366 of these participants. This evidence is compared with survey results from a randomly selected control group of 292 growth-oriented SME managers in the same firm-size group. The data were analyzed through descriptive statistics and logistic regression analysis. Findings – A number of selection and self-selection biases were identified in the analysis. While some of the identified biases did not seem to conflict with the ambitions of this growth program, others potentially have consequences for the additionality of the program. Originality/value – The paper is the first systematic study of the importance of who enrolls in training programs for SME managers.
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Kirby, Dale, i Dennis Sharpe. "Intention, Transition, Retention". International Journal of Information and Communication Technology Education 7, nr 1 (styczeń 2011): 21–32. http://dx.doi.org/10.4018/jicte.2011010103.
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Studies of student transition to post-secondary education have not examined the transition experiences of students who complete on-line courses as part of their high school curriculum. To address this area of deficit in on-line learning research, in this paper, the authors discuss a multi-year study that examined high school on-line learners’ plans to participate in post-secondary education, their enrollment in post-secondary education, and their persistence in a post-secondary program. Data for these analyses were collected from student surveys as well as high school and university academic records. The results suggest that participation in on-line courses in high school is not a significant factor in the post-secondary education transition process while student academic achievement is consistently influential.
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Estrada-Danell, Rafael Isaac, Roman Alberto Zamarripa-Franco, Pilar Giselle Zúñiga-Garay i Isaías Martínez-Trejo. "Aportaciones desde la minería de datos al proceso de captación de matrícula en Instituciones de Educación Superior particulares." Revista Electrónica Educare 20, nr 3 (1.09.2016): 1. http://dx.doi.org/10.15359/ree.20-3.11.
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This article aims to analyze how data mining (DM) optimizes the enrollment process, with the intention of designing a predictive model to manage private enrollment for higher education institutions of Mexico. It analyzes the current status of the higher education institutions in relation to its enrollment process and the application of the DM. With a correlational method, a dataset (DS) was used to model an entropy decision tree with the help of Rapid Miner software. The results show that it is possible to build and test a predictive model management of private enrollment for higher education institutions of Mexico as the ZAM&EST model proposed by the authors.
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Okun, Morris A., i Erin S. Sloane. "APPLICATION OF PLANNED BEHAVIOR THEORY TO PREDICTING VOLUNTEER ENROLLMENT BY COLLEGE STUDENTS IN A CAMPUS-BASED PROGRAM". Social Behavior and Personality: an international journal 30, nr 3 (1.01.2002): 243–49. http://dx.doi.org/10.2224/sbp.2002.30.3.243.
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The present study tested two hypotheses derived from the theory of planned behavior regarding volunteer enrollment by college students in a campus-based program. Undergraduates (N = 647) enrolled in eight sections of Introduction to Psychology received a recruitment message for volunteering through a campus-based program. Following exposure to the recruitment message, students completed a questionnaire and two months later the enrollment records of the campus-based program were checked. Consistent with the theory of planned behavior, attitude, subjective norm and perceived behavioral control predicted intent – and intent, in turn, predicted volunteer enrollment in the campus-based program. However, less than 33% of the students with the maximum possible intention score of six subsequently enrolled to volunteer in the campus-based program.
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Geist, C., B. G. Everett, R. G. Simmons, J. N. Sanders, L. M. Gawron, K. Myers i D. K. Turok. "Changing lives, dynamic plans: Prospective assessment of 12-month changes in pregnancy timing intentions and personal circumstances using data from HER Salt Lake". PLOS ONE 16, nr 9 (20.09.2021): e0257411. http://dx.doi.org/10.1371/journal.pone.0257411.
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Objectives To explore the association between changes in personal circumstances and shifts in pregnancy intentions. Study design New start contraceptive clients, who desired to prevent pregnancy for at least one year enrolled in the survey arm of the HER Salt Lake Contraceptive Initiative (September 2015 –March 2017) and responded to the question “What are your future pregnancy plans?” at enrollment and 12-month follow-up. We estimated multivariable binary logistic fixed-effects regressions to examine the association between changes in personal circumstances and a change from never desiring a pregnancy at enrollment to considering one in the future at 12-month follow-up. Results The majority of the 2825 participants (2246, 79%) maintained their pregnancy timing intention over the 12-month study period. Multivariable analyses of the 208 participants who changed from never desiring a pregnancy to considering pregnancy in the future at 12-month follow-up indicated that entering cohabitation (aOR 3.14, 95% CI 1.30–7.58), increased household income (aOR 1.06, 95% CI 1.00–1.13), and changes from unemployment to full-time employment (aOR 5.94, 95% CI 1.29–27.36) are associated with increased the odds of desiring a future pregnancy after never wanting one a year prior. Conclusions Pregnancy intentions are dynamic over twelve months and covary with partner status, household income, and employment status. Pregnancy intentions are linked to changes in life circumstances. Health care providers need to frequently assess pregnancy intentions and resulting contraceptive or preconception needs.
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Kweon, Goo-Chang. "The Relationship between Service Quality, Member Satisfaction and Re-enrollment Intention in Taekwondo Gym". World Society of Taekwondo Culture 1, nr 10 (30.06.2015): 1–18. http://dx.doi.org/10.18789/jwstc.2015.10.1.
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Beronja, Terry A., i Richard H. Bee. "AN ANALYSIS OF AN ENROLLMENT CONTROL PROGRAM AT AN OPEN ADMISSION UNIVERSITY". NACADA Journal 9, nr 1 (1.03.1989): 16–24. http://dx.doi.org/10.12930/0271-9517-9.1.16.
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University officials at many institutions of higher learning have initiated enrollment control programs (ECPs) in over-subscribed majors. Although the qualifying academic barriers determining program admission associated with these ECPs establish hardships for some students, the gewal intention of such programs is to prepare students for a particular curriculum as well as to select individuals deemed most qualified when limited enrollment opportunities exist. At universities where collegiate admission is a selection process, these ECPs fit into the framework of normal operation. At institutions (such as Youngstown State University) where “open admission” to the university is the policy, however, the establishment of ECPs has caused inadvertent conflicts for academic advisors.
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Henning, Marcus A. "Students' Motivation to Access Academic Advising Services". NACADA Journal 29, nr 1 (1.03.2009): 22–30. http://dx.doi.org/10.12930/0271-9517-29.1.22.
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The interrelationships between motivation for choosing a program of study, intention to access academic advisors, academic difficulty, and actual appointments with academic advisors were based on student self-reports of motivation and intentions. In addition, academic achievement measures and data on student access to academic advisors were obtained. Motivation level at the beginning of enrollment and academic difficulty at the end of the semester were not significantly related to intended or actual appointments with academic advisors. However, subtle trends indicate that students with higher levels of motivation, including those in academic difficulty, saw academic advisors more than did their less motivated peers. Notions of expectancy value, self-worth, goal orientation, and self-concept were the theoretical frameworks used in the analysis. Relative Emphasis: research, theory, practice
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Oday, Akile, Ali Ozturen, Mustafa Ilkan i A. Mohammed Abubakar. "Do eReferral, eWOM, familiarity and cultural distance predict enrollment intention? An application of an artificial intelligence technique". Journal of Hospitality and Tourism Technology 12, nr 3 (12.07.2021): 471–88. http://dx.doi.org/10.1108/jhtt-01-2020-0007.
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Purpose Little empirical attention has been paid to the effects of electronic word-of-mouth (eWOM), electronic referral (eReferral), familiarity and cultural distance on behavioral outcomes, especially within the context of educational tourism. Based on the social network theory, this paper aims to explore the effects of eReferral, eWOM, familiarity and cultural distance on enrollment intention. Design/methodology/approach Survey data (n = 931) were obtained from educational tourists using a judgmental sampling technique. Linear modeling and artificial intelligence (i.e. artificial neural network [ANN]) techniques were used for training and testing the proposed associations. Findings The results suggest that eReferral, eWOM, familiarity and cultural distance predict intention to enroll both symmetrically (linear modeling) and asymmetrically (ANN). The asymmetric modeling possesses greater predictive validity and relevance. Originality/value This study contributes theoretically and methodologically to the management literature by validating the proposed relationships and deploying contemporary methods such as the ANN. Implications for practice and theory are discussed.
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박정서 i 이원일. "The Effects of Service Quality for Children Physical Education on Parents’ Satisfaction and Re-enrollment Intention". Asian Journal of Physical Education and Sport Science 6, nr 2 (sierpień 2018): 43–52. http://dx.doi.org/10.24007/ajpess.2018.6.2.005.
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민재기, 최종균, Dongyun Roh i 원형진. "The Effects of Taekwondo Training Centers Service Fairness on the Trainees' Satisfaction and Re-enrollment Intention". Journal of Korean Alliance of Martial Arts. 13, nr 3 (grudzień 2011): 47–58. http://dx.doi.org/10.35277/kama.2011.13.3.47.
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Grau-Valldosera, Josep, Julià Minguillón i Anabel Blasco-Moreno. "Returning after taking a break in online distance higher education: from intention to effective re-enrollment". Interactive Learning Environments 27, nr 3 (7.05.2018): 307–23. http://dx.doi.org/10.1080/10494820.2018.1470986.
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Strekalova, Yulia A. "When Trust Is Not Enough: A Serial Mediation Model Explaining the Effect of Race Identity, eHealth Information Efficacy, and Information Behavior on Intention to Participate in Clinical Research". Health Education & Behavior 45, nr 6 (24.02.2018): 1036–42. http://dx.doi.org/10.1177/1090198118757822.
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Black participants remain significantly underrepresented in clinical research. Mistrust in medical researchers has been named a key barrier to the successful enrollment of minority study participants. However, trust is a social–interactional construct, and its effects on behavior are complex. This study hypothesized that intention to participate in clinical research is mediated by trust in medical researchers, eHealth literacy, and information seeking behavior. The data were collected through an online survey ( N = 340) and analyzed to identify serial mediation. The model showed insignificant direct effect of race identity on behavioral intention, c′ = −0.19, t(335) = −1.22, p = .22, but a significant total effect, c = −0.44, t(335) = −2.59, p < .01. The indirect effect of race identity on behavioral intention was also significant. The positive effect of trust in medical researchers on decisions to participate in clinical research can be amplified by stronger eHealth literacy and active information seeking, which can be supported through focused strategic health education and communication interventions. A focus on the development of information literacy that could provide prospective minority research volunteers with skills for informed decision making should be explored as an option for increasing mindful, informed participation in clinical research among currently underrepresented racial and ethnic groups.
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Cohen, Craig R., Su-Chun Cheng, Stephen Shiboski, Tsungai Chipato, Martin Matu, James Mwangi, Monalisa E. S. Mutimutema i in. "Diaphragm Used with Replens Gel and Risk of Bacterial Vaginosis: Results from a Randomized Controlled Trial". Infectious Diseases in Obstetrics and Gynecology 2012 (2012): 1–8. http://dx.doi.org/10.1155/2012/921519.
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Background. Bacterial vaginosis (BV) has been linked to female HIV acquisition and transmission. We investigated the effect of providing a latex diaphragm with Replens and condoms compared to condom only on BV prevalence among participants enrolled in an HIV prevention trial.Methods. We enrolled HIV-seronegative women and obtained a vaginal swab for diagnosis of BV using Nugent’s criteria; women with BV (score 7–10) were compared to those with intermediate (score 4–6) and normal flora (score 0–3). During quarterly follow-up visits over 12–24 months a vaginal Gram stain was obtained. The primary outcome was serial point prevalence of BV during followup.Results. 528 participants were enrolled; 213 (40%) had BV at enrollment. Overall, BV prevalence declined after enrollment in women with BV at baseline (OR=0.4, 95% CI 0.29–.56) but did not differ by intervention group. In the intention-to-treat analysis BV prevalence did not differ between the intervention and control groups for women who had BV (OR=1.01, 95% CI 0.52–1.94) or for those who did not have BV (OR=1.21, 95% CI 0.65–2.27) at enrollment. Only 2.1% of participants were treated for symptomatic BV and few women (5–16%) were reported using anything else but water to cleanse the vagina over the course of the trial.Conclusions. Provision of the diaphragm, Replens, and condoms did not change the risk of BV in comparison to the provision of condoms alone.
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Lin, Chung-Ying, Mike K. T. Cheung, Anchor T. F. Hung, Peter K. K. Poon, Sam C. C. Chan i Chetwyn C. H. Chan. "Can a modified theory of planned behavior explain the effects of empowerment education for people with type 2 diabetes?" Therapeutic Advances in Endocrinology and Metabolism 11 (styczeń 2020): 204201881989752. http://dx.doi.org/10.1177/2042018819897522.
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Background: The effectiveness of the Patient Empowerment Program (PEP) has been demonstrated in people with diabetes mellitus (DM); however, the underlying reasons for its effectiveness remain unclear. To improve effectiveness, we need to study the psychological mechanism(s) of PEP to understand why it is effective. This study hypothesized that the Theory of Planned Behavior (TPB), modified specifically for people with DM, could describe the mechanism explaining PEP effects. Methods: A longitudinal design was used. Patients with type 2 DM ( n = 365; 151 males; mean age = 62.9 ± 9.6 years) received two education sessions (i.e. seminars delivered by registered nurses to provide disease-specific knowledge), and some ( n = 210) further enrolled afterwards in five empowerment sessions (i.e. small-group interactive workshops conducted by social workers to practice action planning, problem solving, and experience sharing). Validated questionnaires were used to measure risk perception, health literacy, attitude, subjective norm, perceived behavioral control and behavioral intention on diabetes self-care behaviors, and four diabetes self-care behaviors (diet control, exercise, blood glucose monitoring, and foot care) at baseline. Three months later (i.e. at the end of PEP), all participants completed the behavioral intention and diabetes self-care behaviors measures again. Attitude, subjective norm, perceived behavioral control, behavioral intention, and diabetes self-care behaviors were assessed to represent the TPB constructs. Risk perception and health literacy elements relevant to people with DM were assessed and added to modify the TPB. Results: The behavioral intention was associated with three diabetes self-care behaviors: exercise, blood glucose monitoring, and foot care. The behavioral intention was found to be a significant mediator in the following relationships: empowerment session participation and exercise (β = 0.045, p = 0.04), and empowerment session participation and foot care (β = 0.099, p < 0.001). Conclusions: The effects of enrollment of empowerment sessions in PEP on exercise and foot care were likely to be mediated through behavioral intention.
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Chow, Stephanie, Audrey Chun, Lizette Munoz, Shamsi Fani, Rolfe Sean Morrison, Blair MacKenzie, Susana Lavayen i William Hung. "Building a Framework for Care of Older Patients in an Academic Setting: High Risk Geriatrics Ambulatory Care Program". Innovation in Aging 4, Supplement_1 (1.12.2020): 522. http://dx.doi.org/10.1093/geroni/igaa057.1684.
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Abstract BACKGROUND: Traditional models of geriatric medicine and health system reimbursement structure often force ambulatory care teams to function as high-volume delivery programs, thereby dis-servicing our most vulnerable and frail older patients. This “high cost and high needs” labeled demographic requires uniquely adapted plans from medical and social work providers. METHODS: To better examine opportunities for improved framework for geriatric ambulatory care, the Acute Life Interventions, Goals & Needs (ALIGN) Program has launched several inter-professional pilot programs, each with intention to explore components of health care service to older patients, and feasibility of implementation in other health care systems. Three current models include the ALIGN Program itself, a telemedicine community paramedicine program, and a geriatric surgery co-management program. RESULTS: Preliminary results are forthcoming, with initial promising findings. For the first 126 patients enrolled, mean emergency room (ED) visits 6 months prior to ALIGN enrollment were 1.7 visits per person, reduced to 0.7 ED visits/person 6 months post-graduation from the program, and 126 fewer ED visits. Mean hospitalization 6 months prior to enrollment was 0.32 per person, whereas 6 months post-graduation was 0.2 hospitalizations/person, totaling 40.32 hospitalizations saved. Mean length of stay in the hospital 6 months prior to ALIGN enrollment for the 22 patients admitted was 7.7 days, reduced to 7.3 days post-graduation, and 32 fewer hospital days in the small subset of patients requiring hospitalization despite program interventions. CONCLUSION: The ALIGN Program’s multi-professional and flexible modularity highlights promising innovative frameworks for ambulatory geriatrics care, warranting further exploration and collaboration.
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Aqeel, Samawiya, i Danish Ahmed Siddiqui. "The Effect of Social Media Following on Recruitment in Service Industries of Pakistan". Business Management and Strategy 10, nr 1 (18.04.2019): 41. http://dx.doi.org/10.5296/bms.v10i1.14633.
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Social technologies are progressively utilized in a few hierarchical capacities, as well as human resource management. The focal point of this research is by social media based reception in recruitment of employees in service industries in Pakistan. More specifically, the focal point of this study is the Use and Acceptance of Technology which is through social media by HR experts in the recruitment procedure and selecting representatives. Results acquired utilizing cross-sectional information gathered from 80 enrollment specialists through close ended Likert scale questionnaire. It was later analyzed using Descriptive analysis, CFA and Structured Equation Modeling. The results demonstrated that the center theories of the Acceptance and Use of Technology in recruitment through social media by HR experts were upheld. There was a positive effect of performance expectancy, effort expectancy and social impact on recruiter’s intention to use these technologies recruitment. Moreover, facilitating or encouraging conditions and social goal impactful affect the enrollment (Recruitment) specialist's usage behavior or conduct. There is an impulse effect of different moderators like gender, age, education, and managerial position such as the effect is robust for male, younger and high positioned recruiters while most of the experienced recruiters still emphasize on traditional approaches but beside all these social media seem to have an important impact in the process of recruitment.
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Dombrowski, Julia C., Michael R. Wierzbicki, Lori M. Newman, Jonathan A. Powell, Ashley Miller, Dwyn Dithmer, Olusegun O. Soge i Kenneth H. Mayer. "Doxycycline Versus Azithromycin for the Treatment of Rectal Chlamydia in Men Who Have Sex With Men: A Randomized Controlled Trial". Clinical Infectious Diseases 73, nr 5 (19.02.2021): 824–31. http://dx.doi.org/10.1093/cid/ciab153.
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Abstract Background Azithromycin and doxycycline are both recommended treatments for rectal Chlamydia trachomatis (CT) infection, but observational studies suggest that doxycycline may be more effective. Methods This randomized, double-blind, placebo-controlled trial compared azithromycin (single 1-g dose) versus doxycycline (100 mg twice daily for 7 days) for the treatment of rectal CT in men who have sex with men (MSM) in Seattle and Boston. Participants were enrolled after a diagnosis of rectal CT in clinical care and underwent repeated collection of rectal swabs for nucleic acid amplification testing (NAAT) at study enrollment and 2 weeks and 4 weeks postenrollment. The primary outcome was microbiologic cure (CT-negative NAAT) at 4 weeks. The complete case (CC) population included participants with a CT-positive NAAT at enrollment and a follow-up NAAT result; the intention-to-treat (ITT) population included all randomized participants. Results Among 177 participants enrolled, 135 (76%) met CC population criteria for the 4-week follow-up visit. Thirty-three participants (19%) were excluded because the CT NAAT repeated at enrollment was negative. Microbiologic cure was higher with doxycycline than azithromycin in both the CC population (100% [70 of 70] vs 74% [48 of 65]; absolute difference, 26%; 95% confidence interval [CI], 16–36%; P < .001) and the ITT population (91% [80 of 88] vs 71% [63 of 89]; absolute difference, 20%; 95% CI, 9–31%; P < .001). Conclusions A 1-week course of doxycycline was significantly more effective than a single dose of azithromycin for the treatment of rectal CT in MSM. Clinical Trials Registration NCT03608774.
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Reeves, M., Q. Zhao, J. Peipert i G. Secura. "Risk of subsequent pregnancy based on contraceptive method choice at enrollment: an intention-to-treat analysis of the choice project data". Contraception 90, nr 3 (wrzesień 2014): 330. http://dx.doi.org/10.1016/j.contraception.2014.05.130.
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Rouibah, Kamel. "Factors in the Choice of MIS as a Major". Journal of Global Information Management 24, nr 3 (lipiec 2016): 21–44. http://dx.doi.org/10.4018/jgim.2016070102.
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Decline of student enrollment in MIS major is still an issue. In order to reverse the trend, this study highlights the drivers toward the management information system (MIS) major in an Arab country based on the Theory of Reasoned Action (TRA) and the Network Externalities Theory. This is the first study that integrates the perceived number of enrolled students (PNES) with TRA in addition to other variables (reputation of the instructor, job availability, financial considerations, computer self-efficacy, easiness of the major, and IT anxiety) with intention to enroll in MIS. The model was tested with 499 undergraduate students and analyzed with LISREL. Results indicate that, unlike western culture, the subjective norms and PNES (and not attitude) are important drivers toward the major. This study is relevant for practitioners who can learn strategies to attract more students to the MIS major.
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Taehwan Kim. "The Effect of the E-Learning System to the Perception of the System Productivity and the Re-enrollment Intention to the College Students". Productivity Review 23, nr 3 (wrzesień 2009): 5–18. http://dx.doi.org/10.15843/kpapr.23.3.200909.5.
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Loveday, Benjamin, Jennifer J. Knox, Laura A. Dawson, Gary May, Ur Metser, Anthony M. Brade, Anne M. Horgan i in. "Intention to treat analysis of neoadjuvant chemoradiation and liver transplantation for perihilar cholangiocarcinoma." Journal of Clinical Oncology 34, nr 4_suppl (1.02.2016): 394. http://dx.doi.org/10.1200/jco.2016.34.4_suppl.394.
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394 Background: Neoadjuvant chemoradiation and liver transplantation is an option for selected unresectable patients with early stage perihilar cholangiocarcinoma (pCCA). This study aimed to determine the dropout rate, morbidity and survival of patients who entered a modified tri-modality protocol at Princess Margaret Cancer Centre. Methods: All patients enrolled into the protocol (Jan 2009 – Aug 2015) were included in the analysis. Enrollment criteria: ≤ 65 years old with brush biopsy-proven, unresectable pCCA proximal to the cystic duct, < 3.5 cm in diameter. Neoadjuvant protocol consisted of conformal radiation therapy (54-75 Gy, 1.5 Gy BID) concurrent with Capecitabine 800 mg/m2 BID until radiation completion. Following surgical staging patients received maintenance chemotherapy (Cisplatin 25 mg/m2 and Gemcitabine 1000 mg/m2, day 1 and 8 of 21 day cycle), until transplant or progression. Intention to treat analyses were performed on prospectively collected data to determine time to progression (TTP), dropout rate, overall survival (OS), and number of biliary procedures. Results: Seventeen patients were enrolled, with a median age of 53.9 (26.7-62.8) years, and tumour diameter of 2.7 (2.0-3.4) cm. Five patients had primary sclerosing cholangitis. Median follow up was 14 (6-41) months. The cohort required a median of 3 (0-8) biliary stents, and percutaneous transhepatic biliary drainage in 11/17. Median TTP was 6 (2-16) months. Protocol dropout occurred in 10/17 due to metastatic disease identified during chemoradiation (2), surgical staging (6), or maintenance chemotherapy (2). No dropouts were due to neoadjuvant toxicity. Four patients underwent transplantation (two living donor, two deceased donor), and three are on the transplant waiting list. Median survival from first consultation and start of chemoradiation was 18.2 and 17 months, respectively. Conclusions: Neoadjuvant chemoradiation and liver transplantation for unresectable early stage pCCA is feasible, although dropout during the protocol is high. Less than half of patients who began the treatment protocol remained eligible for transplantation due to cancer progression or upstaging after surgical staging.
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Janowski, Roselinde K., Inge Wessels, Samuel Bojo, Felix Monday, Kaitlyn Maloney, Victoria Achut, Daniel Oliver, Jamie M. Lachman, Lucie Cluver i Catherine L. Ward. "Transferability of Evidence-Based Parenting Programs to Routine Implementation in Postconflict South Sudan". Research on Social Work Practice 30, nr 8 (17.06.2020): 858–69. http://dx.doi.org/10.1177/1049731520932986.
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Purpose: This study investigated process and outcomes of the Parenting for Lifelong Health (PLH) for Young Children and for Adolescents programs implemented as part of routine service delivery in postconflict settings. Methods: These group-based programs were delivered by trained facilitators to 97 caregivers (PLH for Young Children) and 108 caregiver–adolescent dyads (PLH for Adolescents) over 12 or 14 (respectively) weekly sessions. Routine monitoring data were collected by the implementing partners using standardized self-report measures. Reducing harsh discipline was specified as the primary outcome, with secondary outcomes including improvements in positive parenting and reductions in poor parental supervision and parental inefficacy. Results: Analyses were intention to treat. Both PLH programs retained effectiveness in routine conditions in a postwar setting, with moderate to large effect sizes. The programs also had high enrollment and attendance rates, indicating high acceptability. Conclusions: Findings suggest promising viability for the implementation of evidence-based parenting programs in challenging postconflict contexts.
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Stults, Cheryl D., Sayeh Fattahi, Amy Meehan, M. Kate Bundorf, Albert S. Chan, Ting Pun i Ming Tai-Seale. "Comparative Usability Study of a Newly Created Patient-Centered Tool and Medicare.gov Plan Finder to Help Medicare Beneficiaries Choose Prescription Drug Plans". Journal of Patient Experience 6, nr 1 (6.06.2018): 81–86. http://dx.doi.org/10.1177/2374373518778343.
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Introduction: In response to reported difficulties in selecting a Medicare Part D prescription drug plan, we designed a patient-centered online Part D plan selection tool (CHOICE1.0) to simplify the selection process and to provide personalized, expert recommendations. Methods: This ethnographic comparative usability study observed 44 patients using the first version of the tool during Medicare 2016 Open Enrollment. Participants were observed as they chose their drug plan using Medicare.gov and 1 of 3 versions of CHOICE1.0 that varied in amount of expert guidance. Descriptive statistics were used to analyze exit survey data. The observations were video-recorded, and field notes were analyzed thematically. Results: Participants were significantly more satisfied with CHOICE1.0 for choosing a plan, understanding information, and ease of use compared to Medicare.gov . Those using expert versions of CHOICE1.0 were more likely to indicate their intention to switch plans than those using Medicare.gov , though they wanted to know the source and content. Conclusion: The more patient-centered prescription drug choice tool improved user experience and enabled users to choose plans more consistent with expert recommendations.
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Cheng, Matthew P., Alexander Lawandi, Guillaume Butler-Laporte, Samuel De L’Etoile-Morel, Katryn Paquette i Todd C. Lee. "117. Adjunctive Daptomycin in the Treatment of staphylococcus Aureus Bacteremia". Open Forum Infectious Diseases 7, Supplement_1 (1.10.2020): S187. http://dx.doi.org/10.1093/ofid/ofaa439.427.
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Abstract Background Bloodstream infections (BSI) caused by methicillin-susceptible Staphylococcus aureus (MSSA) are associated with significant morbidity and mortality. The objective of our study was to determine whether daptomycin given in combination with an anti-staphylococcal beta-lactam improved outcomes in MSSA BSI. Methods A randomized, double blind, placebo-controlled trial was performed at two academic hospitals in Montreal, Canada. Patients ≥ 18 years of age with MSSA BSI receiving either cefazolin or cloxacillin monotherapy were considered for inclusion. In addition to the standard of care treatment, participants received a 5-day course of adjunctive daptomycin or placebo. The primary outcome was the duration of MSSA BSI in days. Results Of 318 participants screened, 115 were enrolled and 104 were included in the intention to treat analysis (median age 67 years; 34.5% female). The median duration of bacteremia was 2.04 days among patients who received daptomycin versus 1.65 days in those who received placebo (absolute difference 0.39 days, p=0.40). A modified intention to treat analysis involving participants who remained bacteremic at the time of enrollment found a median duration of bacteremia of 3.06 days among patients who received daptomycin versus 3.0 days in those who received placebo (absolute difference 0.06 days, p=0.77). Ninety-day mortality in the daptomycin arm was 18.9% vs. 17.7% in the placebo arm (p=1.0). There were no significant differences in the proportion of patients who developed renal failure, hepatotoxicity, or rhabdomyolysis between groups. Conclusion Among patients with MSSA BSI, the administration of adjunctive daptomycin therapy to standard of care treatment did not shorten the duration of bacteremia. Disclosures All Authors: No reported disclosures
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Brubaker, Linda, J. Eric Jelovsek, Emily S. Lukacz, Sunil Balgobin, Alicia Ballard, Alison C. Weidner, Marie G. Gantz, Ryan Whitworth i Donna Mazloomdoost. "Recruitment and retention: A randomized controlled trial of video-enhanced versus standard consent processes within the E-OPTIMAL study". Clinical Trials 16, nr 5 (26.07.2019): 481–89. http://dx.doi.org/10.1177/1740774519865541.
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Background/aims: In this study, we compared two research consent techniques: a standardized video plus usual consent and usual consent alone. Methods: Individuals who completed 24-month outcomes (completers) in the Operations and Pelvic Muscle Training in the Management of Apical Support Loss study were invited to participate in an extended, longitudinal follow-up study (extended Operations and Pelvic Muscle Training in the Management of Apical Support Loss). Potential participants who were (1) able to provide consent and (2) not in long-term care facilities were randomized 1:1 to a standardized video detailing the importance of long-term follow-up studies of pelvic floor disorders followed by the usual institutional consent process versus the usual consent process alone. Randomization, stratified by site, used randomly permuted blocks. The primary outcome was the proportion of participants who enrolled in the extended study and completed data collection events 5 years after surgery. Secondary outcomes included the proportion enrolled in the extended study, completion of follow-up at each study year, completion of data collection points, completion of in-person visits, and completion of quality of life calls. Motivation and barriers to enrollment (study-level and personal-level) and satisfaction with the study consent process were measured by questionnaire prior to recruitment into extended Operations and Pelvic Muscle Training in the Management of Apical Support Loss. Groups were compared using an intention-to-treat principle, using unadjusted Student’s t-test (continuous) and chi-square or Fisher’s exact (categorical) test. A sample size of 340 (170/group) was estimated to detect a 15% difference in enrollment and study completion between groups with p < 0.05. Results: Of the 327 Operations and Pelvic Muscle Training in the Management of Apical Support Loss completers, 305 were randomized to the consent process study (153 video vs 152 no video). Groups were similar in demographics, surgical treatment, and outcomes. The overall rate of extended study enrollment was high, without significant differences between groups (video 92.8% vs no video 94.1%, p = 0.65). There were no significant differences in the primary outcome (video 79.1% vs no video 75.7%, p = 0.47) or in any secondary outcomes. Being “very satisfied” overall with study information (97.7% vs 88.5%, p = 0.01); “strong agreement” for feeling informed about the study (81.3% vs 70.8%, p = 0.06), understanding the study purpose (83.6% vs 71.0%, p = 0.02), nature and extent (82.8% vs 70.2%, p = 0.02), and potential societal benefits (82.8% vs 67.9%, p = 0.01); and research coordinator/study nurse relationship being “very important” (72.7% vs 63.4%, p = 0.03) were better in the video compared to the no video consent group. Conclusion: The extended study had high enrollment; most participants completed most study tasks during the 3-year observational extension, regardless of the use of video to augment research consent. The video was associated with a higher proportion of participants reporting improved study understanding and relationship with study personnel.
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Peralta, Carmen A., Martin Frigaard, Leticia Rolon, Karen Seal, Delphine Tuot, Josh Senyak, Lowell Lo i in. "Screening for CKD To Improve Processes of Care among Nondiabetic Veterans with Hypertension". Clinical Journal of the American Society of Nephrology 15, nr 2 (7.02.2020): 174–81. http://dx.doi.org/10.2215/cjn.05050419.
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Background and objectivesWe conducted a pilot, pragmatic, cluster-randomized trial to evaluate feasibility and preliminary effectiveness of screening for CKD using a triple-marker approach (creatinine, cystatin C, and albumin/creatinine ratio), followed by education and guidance, to improve care of hypertensive veterans in primary care. We used the electronic health record for identification, enrollment, intervention delivery, and outcome ascertainment.Design, setting, participants, & measurementsWe randomized 1819 veterans without diabetes but with hypertension (41 clusters) into three arms: (1) CKD screening followed by patient and provider education; (2) screening, education, plus pharmacist comanagement; or (3) usual care. The primary clinical outcome was BP change over 1 year. Implementation and process measures included proportion screened; CKD detection rate; and total and new use of renin-angiotensin system inhibitors, nonsteroidal anti-inflammatory drugs, and diuretics.ResultsMedian age was 68 years, 55% were white, 1658 (91%) had a prior creatinine measure, but only 172 (9%) had prior urine albumin/creatinine ratio, and 83 (5%) had a prior cystatin C measure. Among those in the intervention, 527 of 1215 (43%) were identified with upcoming appointments to have CKD screening. Of these, 367 (69%) completed testing. Among those tested, 77 (21%) persons had newly diagnosed CKD. After 1 year, change in systolic BP was −1 mm Hg (interquartile range, −11 to 11) in usual care, −2 mm Hg (−11 to 11) in the screen-educate arm, and −2 mm Hg (−13 to 10) in the screen-educate plus pharmacist arm; P=0.49. There were no significant differences in secondary outcomes in intention-to-treat analyses. In as-treated analyses, higher proportions of participants in the intervention arms initiated a renin-angiotensin system inhibitor (15% and 12% versus 7% in usual care, P=0.01) or diuretic (9% and 12% versus 4%, P=0.03).ConclusionsThe pragmatic design made identification, enrollment, and intervention delivery highly efficient. The limited ability to identify appointments resulted in inadequate between-arm differences in CKD testing rates to determine whether screening improves clinical outcomes.
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Kabue, Mark M., Lindsay Grenier, Stephanie Suhowatsky, Jaiyeola Oyetunji, Emmanuel Ugwa, Brenda Onguti, Eunice Omanga i in. "Group versus individual antenatal and first year postpartum care: Study protocol for a multi-country cluster randomized controlled trial in Kenya and Nigeria". Gates Open Research 2 (5.11.2018): 56. http://dx.doi.org/10.12688/gatesopenres.12867.1.
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Background: Antenatal care (ANC) in many low- and middle-income countries is under-utilized and of sub-optimal quality. Group ANC (G-ANC) is an intervention designed to improve the experience and provision of ANC for groups of women (cohorts) at similar stages of pregnancy. Methods: A two-arm, two-phase, cluster randomized controlled trial (cRCT) (non-blinded) is being conducted in Kenya and Nigeria. Public health facilities were matched and randomized to either standard individual ANC (control) or G-ANC (intervention) prior to enrollment. Participants include pregnant women attending first ANC at gestational age <24 weeks, health care providers, and sub-national health managers. Enrollment ended in June 2017 for both countries. In the intervention arm, pregnant women are assigned to cohorts at first ANC visit and receive subsequent care together during five meetings facilitated by a health care provider (Phase 1). After birth, the same cohorts meet four times over 12 months with their babies (Phase 2). Data collection was performed through surveys, clinical data extraction, focus group discussions, and in-depth interviews. Phase 1 data collection ended in January 2018 and Phase 2 concludes in November 2018. Intention-to-treat analysis will be used to evaluate primary outcomes for Phases 1 and 2: health facility delivery and use of a modern method of family planning at 12 months postpartum, respectively. Data analysis and reporting of results will be consistent with norms for cRCTs. General estimating equation models that account for clustering will be employed for primary outcome analyzes. Results: Overall 1,075 and 1,013 pregnant women were enrolled in Nigeria and Kenya, respectively. Final study results will be available in February 2019. Conclusions: This is the first cRCT on G-ANC in Africa. It is among the first to examine the effects of continuing group care through the first year postpartum. Registration: Pan African Clinical Trials Registry PACTR201706002254227 May 02, 2017
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Kabue, Mark M., Lindsay Grenier, Stephanie Suhowatsky, Jaiyeola Oyetunji, Emmanuel Ugwa, Brenda Onguti, Eunice Omanga i in. "Group versus individual antenatal and first year postpartum care: Study protocol for a multi-country cluster randomized controlled trial in Kenya and Nigeria". Gates Open Research 2 (4.07.2019): 56. http://dx.doi.org/10.12688/gatesopenres.12867.2.
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Background: Antenatal care (ANC) in many low- and middle-income countries is under-utilized and of sub-optimal quality. Group ANC (G-ANC) is an intervention designed to improve the experience and provision of ANC for groups of women (cohorts) at similar stages of pregnancy. Methods: A two-arm, two-phase, cluster randomized controlled trial (cRCT) (non-blinded) is being conducted in Kenya and Nigeria. Public health facilities were matched and randomized to either standard individual ANC (control) or G-ANC (intervention) prior to enrollment. Participants include pregnant women attending first ANC at gestational age <24 weeks, health care providers, and sub-national health managers. Enrollment ended in June 2017 for both countries. In the intervention arm, pregnant women are assigned to cohorts at first ANC visit and receive subsequent care together during five meetings facilitated by a health care provider (Phase 1). After birth, the same cohorts meet four times over 12 months with their babies (Phase 2). Data collection was performed through surveys, clinical data extraction, focus group discussions, and in-depth interviews. Phase 1 data collection ended in January 2018 and Phase 2 concludes in November 2018. Intention-to-treat analysis will be used to evaluate primary outcomes for Phases 1 and 2: health facility delivery and use of a modern method of family planning at 12 months postpartum, respectively. Data analysis and reporting of results will be consistent with norms for cRCTs. General estimating equation models that account for clustering will be employed for primary outcome analyzes. Results: Overall 1,075 and 1,013 pregnant women were enrolled in Nigeria and Kenya, respectively. Final study results will be available in February 2019. Conclusions: This is the first cRCT on G-ANC in Africa. It is among the first to examine the effects of continuing group care through the first year postpartum. Registration: Pan African Clinical Trials Registry PACTR201706002254227 May 02, 2017
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Siyoto, Sandu, i Albert Ronald Tule. "Treatment Interest of Badan Penyelenggara Jaminan Sosial (Social Security Organizing Agency) Patients in Balowerti Public Health Center Kediri City". Global Journal of Health Science 11, nr 11 (19.09.2019): 149. http://dx.doi.org/10.5539/gjhs.v11n11p149.
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The Social Security Organizing Agency (BPJS) which was established in 2014, implements the National Health Insurance Program (JKN). While JKN positively affects national health and increases the financial flow of private hospitals, there is a significant financial deficit, which can be covered by the involvement of informal private-sector workers, whose loyalty to the hospital is mainly influenced by hospital’s environment, communication with staff, and service quality. Previous studies indicate that in Indonesia loyalty to the public hospitals can have no relationships with service quality, to test this assumption, a sample of 126 subjects was recruited at the Balowerti City Health Center, Kediri City. All participants of the study received premium assistance beneficiaries (PBI) of BPJS insurance, which is fully subsidized by the government. Despite this, the main part of the sample evaluated their perception of the Balowerti City Health Center and the quality of its service as average or poor. Ordinal regression confirmed the existence of the influence of service quality and perception of the hospital on the behavioral intention of patients. Refers to perception of low service quality is the main reason for insufficient involvement if JKN. According to the previous studies, a lack of time for communication with the patient, long time of waiting, and a lack of information of BPJS are main reasons of patient dissatisfaction and low enrollment in JKN.
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Costello, B. A., J. R. Hecht i A. Grothey. "Progression-free survival in intention to treat populations versus total KRAS populations in patients treated for metastatic colorectal cancer: A pooled review". Journal of Clinical Oncology 27, nr 15_suppl (20.05.2009): 4054. http://dx.doi.org/10.1200/jco.2009.27.15_suppl.4054.
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4054 Background: In treatment trials of patients with metastatic colorectal cancer (mCRC), KRAS mutation status of tumor samples has been retrospectively demonstrated to be predictive of treatment benefit. Historically, clinical trials have not required tissue samples to be tested for KRAS mutation status as a condition of enrollment. Therefore, KRAS analyses have been based on available tissue samples representing only a portion of patients retrospectively analyzed for KRAS status and correlated with treatment end- points. Methods: A weighted analysis of pooled data was performed using six recently presented or published clinical trials of targeted therapy in mCRC which tested for the association of KRAS status with Progression Free Survival (PFS). The goal of the analysis was to determine whether there is a significant difference in PFS between the intention to treat (ITT) population and KRAS population in both the treatment and control arms. Results: The total ITT population of the pooled studies is 3864, and for the total KRAS population, 2295; a 59.4% retrieval rate (range 28–92%) for tissue samples available for KRAS analysis. The weighted Δ PFS across all arms between the ITT population and the KRAS population was 0.2 months with a range of 0–0.7 months. Of the 12 subgroups (6 control and 6 treatment arms), five had no difference in PFS between ITT and KRAS evaluable populations at all, and two additional subgroups demonstrated a difference PFS of only 0.1 months. The two studies with the lowest tissue retrieval rates (28% and 45%) had the largest Δ PFS. Conclusions: There is no meaningful difference in the PFS between the ITT and KRAS populations based on our analysis of pooled data. The difference in PFS was greatest in the two studies with the lowest rate of retrieval of tissue samples for KRAS testing. As such, subgroup analysis is better able to estimate and reflect the ITT population if a higher percentage of samples is able to be obtained. Further, our results suggest that there is not an inherent systemic bias influencing any potentially observed differences in PFS. Tissue samples should be required for all patients entering a clinical trial to avoid this issue and to make retrospective analysis more valid. [Table: see text]
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Drekonja, Dimitri, James R. Johnson, Amundson Carla, Michael Kuskowski i Barbara Trautner. "184. Seven vs. 14 Days Treatment Duration for Afebrile Men with Urinary Tract Infections; A Randomized Clinical Trial". Open Forum Infectious Diseases 7, Supplement_1 (1.10.2020): S220—S221. http://dx.doi.org/10.1093/ofid/ofaa439.494.
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Abstract Background Trials show that shorter-duration therapy is effective for many infectious diseases, but the optimal duration for UTI in men is unknown. Observational data suggests shorter-duration performs as well as longer-duration therapy, but trial data shows men with febrile UTI (a small but important subset of patients) do worse with 7 vs. 14 days of therapy. We performed a randomized controlled trial of afebrile men with UTI to determine whether 7 days of treatment was non-inferior to 14 days. Methods Men with symptomatic UTI at 2 VA hospitals were enrolled. Inclusion criteria included male gender, outpatient treatment, prescribed 7 to 14 days of ciprofloxacin or trimethoprim/sulfamethoxazole, and new onset of at least 1 of: dysuria, frequency, urgency, hematuria, costovertebral angle tenderness, and perineal, flank, or suprapubic pain. Exclusion criteria included UTI treatment in the past 14 days, symptoms due to a non-UTI diagnosis, and inadequate empiric treatment. Enrolled subjects took their clinically-prescribed medications days 1–7, then study medication days 8–14. Study medications were placebo or the originally prescribed antimicrobial, different in appearance from the original medication. The primary outcome was percentage of subjects with symptom resolution 14 days after completion of active therapy. Secondary outcomes included recurrence of UTI and adverse events. A pre-specified minimally clinically significant difference of 10% was selected, with a P value of 0.05 considered to be significant. Primary analysis was per-protocol; intention-to-treat performed as secondary analysis. Results Enrollment totaled 273, with 272 randomized to 7 (n = 136) vs. 14 (n = 136) days of antimicrobials. Mean age was 67.8 (SD 11.6), with a mean Charlson comorbidity index of 1.3 (SD 1.6). Overall, 254 subjects were in the per-protocol analysis. Symptom resolution occurred in 122 of 131 (93.1%) subjects receiving 7 days treatment, and 111 of 123 (90.2%) receiving 14 days (difference 2.9%, 95% CI -4.7 to 10.5% P = .50), confirming non-inferiority. Intention-to-treat analysis (n = 272) showed similar results. Conclusion Treatment with 7 days of antimicrobials was non-inferior to 14 days for symptom resolution. Afebrile men with UTI should not be treated beyond 7 days. Disclosures All Authors: No reported disclosures
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Pokharel, Achyut, C. Yaptinchay i A. E. Thaebtharm. "Comparison of clotrimazole 1% cream with 50% tea tree oil extract in a cream base for the treatment of tinea corporis/cruris: A randomized controlled trial". Nepal Journal of Dermatology, Venereology & Leprology 13, nr 1 (12.01.2016): 24–30. http://dx.doi.org/10.3126/njdvl.v13i1.14301.
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Background: Tinea cruris and corporis are common diseases and can be widespread. Estimated lifetime probability of contracting the disease is as high as 10-20%. Dermatophytic infections are one of the three most frequently observed skin diseases among poor communities in tropical countries. Tea tree oil exerts its antifungal activity by altering membrane properties and compromising membrane associated function resulting in clinical improvement and mycological cure of superficial dermatophytes. Objectives: The aim of this study is to determine the efficacy and safety of tea tree oil 50% in a cream base compared with clotrimazole 1% cream for the treatment of tinea corporis or cruris. Material and Methods: Sixty patients were enrolled in the study and randomized into tea tree oil and clotrimazole groups with 30 patients in each group. Both groups were instructed to apply cream two times a day after cleaning with soap for 4 weeks. The patients were asked to follow-up every 2 weeks for photography, microscopic and clinical assessment. Before enrollment, patient signed a written consent form. Results: Using intention to treat analysis, the assessment of mycological cure, clinical cure, global physician assessments and overall patient perception were done. There were no statistical difference of all the parameters between tea tree oil group and clotrimazole group. Conclusion: Tea tree oil 50% cream is safe and as effective as clotrimazole 1% cream for the treatment of tinea corporis or cruris.NJDVL Vol. 13, No. 1, 2015 Page: 24-30
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Fontenot, Holly B., Bradley Patrick White, Joshua G. Rosenberger, Hailee Lacasse, Chokdee Rutirasiri, Kenneth H. Mayer i Gregory Zimet. "Mobile App Strategy to Facilitate Human Papillomavirus Vaccination Among Young Men Who Have Sex With Men: Pilot Intervention Study". Journal of Medical Internet Research 22, nr 11 (4.11.2020): e22878. http://dx.doi.org/10.2196/22878.
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Background Mobile app-based interventions have been identified as potential facilitators for vaccination among young men who have sex with men (MSM). Objective This pilot study aimed to test the feasibility of a theoretically informed mobile health (mHealth) tool designed to reduce health disparities and facilitate human papillomavirus (HPV) vaccination among a sample of young MSM. Methods The development of the mHealth tool was guided by previous research, implementation intention theory, and design thinking. We recruited MSM aged 18-26 years through a popular online dating app and linked participants to our mHealth tool, which provided HPV vaccine information and fostered access to care. Results A total of 42 young MSM participated in this pilot study in Boston, Massachusetts. Participants reported variable HPV knowledge (ie, high knowledge of HPV risk factors and low knowledge of HPV-related cancer risks for men) and positive vaccine beliefs and attitudes. Of those who were either unvaccinated, not up to date, or did not report vaccine status, 23% (8/35) utilized the mHealth tool to obtain HPV vaccination. Participants primarily utilized the tool’s (1) educational components and (2) capabilities facilitating concrete vaccine action plans. Conclusions We recruited an underserved at-risk population of youth via an online dating app for our mHealth intervention that resulted in in-person health care delivery. This study was limited by enrollment challenges, including low willingness to download the mHealth tool to mobile devices.
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Kittelsrud, Julie M., Erik A. Ehli, Vikki Petersen, Tammy Jung, Jeffrey J. Beck, Noah Kallsen, Patricia Huizenga, Brittany Holm i Gareth E. Davies. "Avera Twin Register Growing Through Online Consenting and Survey Collection". Twin Research and Human Genetics 22, nr 6 (14.10.2019): 686–90. http://dx.doi.org/10.1017/thg.2019.73.
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AbstractThe aim of the Avera Twin Register (ATR) is to establish a prospective longitudinal repository of twins, multiples, siblings and family members’ biological samples to study environmental and genetic influences on health and disease. Also, it is our intention to contribute to international genome-wide association study (GWAS) twin consortia when appropriate sample size is achieved within the ATR. The ATR is young compared with existing registers and continues to collect a longitudinal repository of biological specimens, survey data and health information. Data and biological specimens were originally collected via face-to-face appointments or the postal department and consisted of paper-informed consents and questionnaires. Enrollment of the ATR began on May 18, 2016 and is located in Sioux Falls, South Dakota, a rural and frontier area in the Central United States with a regional population of approximately 880,000. The original target area for the ATR was South Dakota and the four surrounding states: Minnesota, Iowa, North Dakota and Nebraska. The ATR has found a need to expand that area based on twin and multiple siblings who live in various areas surrounding these states. A description of the state of the ATR today and its transition to online data collection and informed consent will be presented. The ATR collects longitudinal data on lifestyle, including diet and activity levels, aging, plus complex traits and diseases. All twins and multiples participating in the ATR are genotyped on the Illumina Global Screening Array and receive zygosity results.
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Terasaki, Mizuhiko, Soichiro Shibui, Yoshitaka Narita, Takamitsu Fujimaki, Tomokazu Aoki, Koji Kajiwara, Yutaka Sawamura i in. "Phase I Trial of a Personalized Peptide Vaccine for Patients Positive for Human Leukocyte Antigen–A24 With Recurrent or Progressive Glioblastoma Multiforme". Journal of Clinical Oncology 29, nr 3 (20.01.2011): 337–44. http://dx.doi.org/10.1200/jco.2010.29.7499.
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Purpose Personalized selection of suitable peptides for patients could offer a novel approach to developing cancer vaccines that boost anticancer immunity. We present the results of a phase I trial of 14 kinds of vaccine candidates (ITK-1) in patients with recurrent or progressive glioblastoma multiforme (GBM). Patients and Methods From January 2006 to January 2008, 12 patients from eight Japanese hospitals who were positive for human leukocyte antigen–A24, including 10 patients refractory to temozolomide (TMZ), were enrolled. The dose escalation trial included three dose groups (1, 3, and 5 mg) to determine the safety and tolerability of ITK-1 peptides. Immunologic response was monitored by measuring levels of cytotoxic T-lymphocyte precursors and peptide-specific immunoglobulin G. In another ITK-1 phase I trial for advanced prostate cancer, the vaccination schedule was skipped or discontinued in all three patients receiving the highest dose (5 mg/peptide) because of injection site reactions. This trial was therefore ended without enrollment for the highest dose, and data were analyzed by intention to treat. Results No serious adverse drug reactions were encountered, and treatment was well tolerated. The vaccine induced dose-dependent immune boosting. The recommended dose of ITK-1 peptides is 3 mg/peptide. Conclusion Personalized vaccination with ITK-1 peptides could be recommended in further stages of clinical trials. The safety and increased frequency of immune boosting offers potential clinical benefits in cases of recurrent or progressive GBM, even in TMZ-refractory settings.
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Morgensztern, Daniel, Michal G. Rose, John Charles Morris, Patrick C. Ma, Christina E. Brzezniak, Karen Grace Zeman, Arvinda Padmanabhan i in. "Multicenter phase II trial of RRx-001 in previously treated SCLC." Journal of Clinical Oncology 37, nr 15_suppl (20.05.2019): e20104-e20104. http://dx.doi.org/10.1200/jco.2019.37.15_suppl.e20104.
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e20104 Background: This exploratory single arm phase II study evaluated the efficacy and safety of RRx-001 followed by reintroduction of platinum plus etoposide in patients with previously treated small cell lung cancer (SCLC). Methods: Patients with SCLC that was platinum-resistant or received at least 2 prior lines were treated with RRx-001 4 mg IV on day 1 of each week of a 21-day cycle followed at progression by re-challenge with etoposide and cisplatin or carboplatin. The primary endpoints were overall survival (OS) and overall response rate to platinum therapy. Results: Between December 2016 and March 2018, 26 patients were enrolled and received at least one dose of RRx-001. The median number of prior lines of therapy was 2 (range 1-9) and 19 (73.1%) patients had platinum-resistant disease. In the intention-to-treat population, 1 (3.8%) achieved partial response (PR) and 7 (26.9%) had stable disease (SD) during treatment with RRx-001, whereas 1 patient (3.8%) had complete response and 6 (23.1%) had partial response on platinum plus etoposide. The estimated median and 12-month OS from enrollment were 8.6 months and 44.1%, respectively. The most common treatment-emergent adverse events from RRx-001 was mild discomfort at the infusion site (23%) and decreased appetite (15.3%). Conclusions: RRx-001 followed by re-challenge with platinum plus etoposide chemotherapy is feasible and associated with promising results. Clinical trial information: NCT02489903.
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Chernick, Lauren S., Jonathan Y. Siden, David L. Bell i Peter S. Dayan. "A Qualitative Assessment to Understand the Barriers and Enablers Affecting Contraceptive Use Among Adolescent Male Emergency Department Patients". American Journal of Men's Health 13, nr 1 (styczeń 2019): 155798831982591. http://dx.doi.org/10.1177/1557988319825919.
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Early fatherhood is common in the United States (U.S.). The emergency department (ED) plays a disproportionate role in serving patients with unmet reproductive and sexual health needs. With 8 million adolescent males visiting U.S. EDs annually, the ED is a potential site to implement interventions to minimize early fatherhood and unintended teenage pregnancy. Little is known about how adolescent male ED patients perceive and behave in sexual relationships and how they influence contraceptive decision making. The objective of this study was to identify the barriers and enablers affecting contraceptive and condom use among adolescent male ED patients. Semistructured interviews were conducted with males aged 14–19 in one urban ED. Enrollment continued until saturation of key themes. Interviews were recorded, transcribed, and coded based on thematic analysis using NVivo 10. The Social Ecological Model was used to organize and understand themes. Participants ( n = 24) were predominantly 18–19 years (63%) and Hispanic (92%). Most (71%) had sex ≤3 months prior but infrequently used a condom at last intercourse (42%). The primary barrier influencing contraceptive use was lack of knowledge of effective contraceptives. Other barriers consisted of perceived gender roles, poor partner communication, and little relationship with a primary provider. Enablers included intention not to get a partner pregnant, school-based sexual health education, normalcy to use condoms, and a trustworthy confidante. The identified barriers and enablers influencing adolescent males’ perspectives toward contraceptives should be addressed if designing future ED-based pregnancy prevention interventions targeting teen males.
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Katz, Sophie, Jennifer Crook, Jessica Gillon, Andras Szeles, J. Eric Stanford, Li Wang, Jennifer Colby, Ritu Banerjee i Ritu Banerjee. "2239. Randomized Controlled Trial of a PROcalcitonin-Guided Antibiotic Treatment Algorithm Plus Antibiotic Stewardship the Pediatric Intensive Care Unit (ProPICU)". Open Forum Infectious Diseases 6, Supplement_2 (październik 2019): S765—S766. http://dx.doi.org/10.1093/ofid/ofz360.1917.
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Abstract Background Procalcitonin (PCT) testing enables earlier antibiotic (abx) de-escalation in adult intensive care units (ICUs); similar data in children are lacking. Methods Single-center pragmatic randomized controlled trial of children admitted to the pediatric ICU and started on intravenous (IV) abx February 2018–April 2019 to evaluate whether a PCT-guided testing and treatment algorithm implemented through antibiotic stewardship (AS) audit and feedback promotes abx de-escalation in the pediatric ICU. Patients were randomized by month to either control or PCT arm. Exclusion criteria were receipt of IV abx within 7 days prior to enrollment, immune compromise, neonates < 34 weeks gestation, or receipt of abx for an infection requiring prolonged abx. All subjects had baseline AS review. Subjects in the PCT arm had PCT testing on days 0, 1, 2, and 4 and AS guidance. Some subjects in the control arm had baseline PCT testing that was not available to providers. Abx de-escalation = stopping or narrowing spectrum of abx; Abx escalation = broadening spectrum or starting an additional abx. The primary outcome was abx days of therapy (DOT) per patient in the first 14 days after enrollment. Kruskal–Wallis, Chi-square, and ANOVA tests were used. Results The modified intention to treat analysis included 270 patients: 133 control and 137 PCT. Significantly more males and febrile patients were in the PCT-guided arm (Table 1). Overall, abx DOT did not differ between arms (Table 2). In 85 patients with pneumonia, median DOT per patient was shorter in the PCT than control arm (8.0 vs. 9.3 days, P = 0.04). Among patients in the PCT arm, those with initial PCT level > 0.5 mg/L (n = 93) (4.3 vs. 7.1 days, P = 0.006). More AS recommendations (recs) were made in the PCT arm (53 PCT vs. 35 control, P = 0.03). Compliance with AS recs was similar (70%) between arms. Conclusion In the pediatric ICU, the use of a PCT testing and treatment algorithm with AS audit and feedback resulted in shorter abx DOT for patients with pneumonia and more AS recs compared with no PCT testing. PCT testing implemented with AS can reduce abx duration in select populations of critically ill children. Disclosures Ritu Banerjee, MD, PhD, Accelerate Diagnostics: Grant/Research Support; BioFire: Research Grant; Biomerieux: Research Grant; Roche: Research Grant.
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Klerk, Clara P. W., Susanne M. Smorenburg, Hans-Martin Otten, Anthonie W. A. Lensing, Martin H. Prins, Franco Piovella, Paolo Prandoni i in. "The Effect of Low Molecular Weight Heparin on Survival in Patients With Advanced Malignancy". Journal of Clinical Oncology 23, nr 10 (1.04.2005): 2130–35. http://dx.doi.org/10.1200/jco.2005.03.134.
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Purpose Studies in cancer patients with venous thromboembolism suggested that low molecular weight heparin may prolong survival. In a double-blind study, we evaluated the effect of low molecular weight heparin on survival in patients with advanced malignancy without venous thromboembolism. Methods Patients with metastasized or locally advanced solid tumors were randomly assigned to receive a 6-week course of subcutaneous nadroparin or placebo. The primary efficacy analysis was based on time from random assignment to death. The primary safety outcome was major bleeding. Results In total, 148 patients were allocated to nadroparin and 154 patients were allocated to placebo. Mean follow-up was 1 year. In the intention-to-treat analysis the overall hazard ratio of mortality was 0.75 (95% CI, 0.59 to 0.96) with a median survival of 8.0 months in the nadroparin recipients versus 6.6 months in the placebo group. After adjustment for potential confounders, the treatment effect remained statistically significant. Major bleeding occurred in five (3%) of nadroparin-treated patients and in one (1%) of the placebo recipients (P = .12). In the a priori specified subgroup of patients with a life expectancy of 6 months or more at enrollment, the hazard ratio was 0.64 (95% CI, 0.45 to 0.90) with a median survival of 15.4 and 9.4 months, respectively. For patients with a shorter life expectancy, the hazard ratio was 0.88 (95% CI, 0.62 to 1.25). Conclusion A brief course of subcutaneous low molecular weight heparin favorably influences the survival in patients with advanced malignancy and deserves additional clinical evaluation.
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Rao, Suchitra, Molly Lamb, Angela Moss, Rakesh Mistry i Samuel Dominguez. "150. the RAPID trial: randomized Controlled Trial assessing point-of-care influenza and Other Respiratory Virus diagnostics in the Pediatric ED Setting". Open Forum Infectious Diseases 7, Supplement_1 (1.10.2020): S205. http://dx.doi.org/10.1093/ofid/ofaa439.460.
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Abstract Background Respiratory illnesses represent one of the commonest reasons for pediatric visits to the ED, and over 50% of these children are prescribed antibiotics despite a viral etiology in most cases. Our objectives were to determine whether rapid respiratory pathogen (RRP) testing decreases antibiotic and health care utilization among children evaluated in the ED with a respiratory illness. Methods We conducted a randomized controlled trial among children 1 mo-18 yrs of age attending an ED with influenza like illness (ILI). All children received a nasopharyngeal swab for RRP testing, and were randomized to the intervention group (result given to providers and parents) or control group (result not given, routine clinical care). Families were interviewed on enrollment, 1 and 10 days later. The primary outcome was antibiotic use. Secondary outcomes included antiviral use, hospitalization and recurrent medical visits. Intention to treat (ITT) (assigned group) and pragmatic (provider knows test results) analyses were conducted using SAS v 9.4. Pragmatic analyses were adjusted using multivariable Poisson regression. Results Among 920 visits (890 children) with ILI, 795 (85%) were RRP positive. Sociodemographic characteristics between groups were similar; 37% of children in the intervention group were discharged before results were available and 12% of children in the control group underwent clinical testing. The median age was 2.1 yrs (IQR 0.88–5.6); 35% had high-risk comorbidities. In the ITT intervention group, children were more likely to receive antibiotics (RR 1.3, 95% CI 1.0–1.7) (Table 1). In adjusted pragmatic analyses, children with known results were more likely to receive antivirals (RR 2.6 95% CI 1.5–4.3) and be hospitalized (RR 2.0, 95% CI 1.5–2.7); antibiotic use was not significant (Table 2). Children testing negative for a virus were more likely to receive antibiotics than those with a virus (35% vs 23%, p = 0.01). Table 1. Clinical Outcomes by Study Arm, Intention to Treat Analyses Table 2. Clinical Outcomes by Study Arm, Pragmatic Analyses Conclusion Knowledge of testing led to a paradoxical increase in antibiotic prescribing, as well as an increase in appropriate antiviral prescribing, ED length of stay and hospitalization. Further studies are needed to assess whether RRP testing with faster turn around times or coupled with stewardship interventions may impact outcomes. Disclosures Suchitra Rao, MD, BioFire (Grant/Research Support) Molly Lamb, PhD, BioFire (Grant/Research Support) Rakesh Mistry, MD, MSCE, BioFire (Grant/Research Support) Samuel Dominguez, MD, PhD, BioFire (Consultant, Research Grant or Support)
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Fauble, Veena, Robyn M. Emanuel, Holly Lynn Geyer, Amylou Constance Dueck, Nicolaus Kroeger, Bart L. Scott, Aaron T. Gerds i in. "Myeloproliferative Neoplasm Quality Of Life (MPN-QOL) Study Group: Observational Study Of Quality Of Life and Symptomatic Response In Myelofibrosis Patients Receiving Undergoing Treatment With Conventional Therapy, The Measures Trial and Allogeneic Stem Cell Transplant, The Symptoms Trial". Blood 122, nr 21 (15.11.2013): 4090. http://dx.doi.org/10.1182/blood.v122.21.4090.4090.
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Abstract Introduction Myelofibrosis (MF) and Post PV/ET MF represents a group of debilitating hematological disorders in which quality of life (QOL) is severely compromised in most patients as a result of persistent constitutional symptoms, progressive cytopenias, and splenomegaly. Conventional therapeutic modalities have largely focused on symptoms palliation rather than cure. Allogeneic stem cell transplantion (ASCT) remains the only potential curative option for intermediate and high risk disease. Till now, outcome data for MF have historically focused on survival benefit. Until now, few studies have evaluated the QOL, financial burden, and symptom response in MF patients undergoing treatment including ASCT. The development of the Myeloproliferative Symptom Assessment Form Total Symptom (MPN-SAF TSS) score in 2012 allows us to objectively quantify with a standardized tool these crucial aspects of patients care. The Myeloproliferative Neoplasm Quality of Life (MPN-QOL) Study Group aims to objectively quantify symptomatic response to standard available treatments by utilizing the MPN-SAF TSS. We introduce two MPN-QOL prospective trials currently in active enrollment: The MPN Experimental Assessment of Symptoms by Utilizing Repetitive Evaluation (MEASURE) Trial and the Symptoms Yielded in Myelofibrosis Patients after Transplant as Objectified by MPN-SAF TSS (SYMPTOMS) Trial. Our intention with these studies is to quantify the QOL and symptom burden of PMF and post PV/ET MF patients undergoing treatment including ASCT. Methods The MEASURES trial is a prospective questionnaire based study evaluating the responsiveness of the MPN-SAF TSS in detecting symptomatic changes in target symptoms for an anticipated 180 ET, PV and MF (including primary MF, post-ET and post PV MF) patients receiving non-experimental medical therapy (aspirin, hydroxyurea, anagrelide, interferon, busulfan, melphalan, cladribine, thalidomide, lenalidomide, prednisone, danazol, ruxolitinib) and/or phlebotomy. Patients complete the MPN-SAF for seven consecutive days at the time of enrollment and repeat the survey for an additional seven consecutive days between 90 days and six months. Patients also complete the MDASI, EORTC and Global Impression of Change Items on the first day of the second assessment. Physicians acquire demographic, laboratory, physical examination and radiographic data, along with serial response assessments. In parallel, the SYMPTOMS trial is prospective questionnaire based study evaluating the QOL of patients undergoing ASCT utilizing MPN-SAF TSS, the FACT-BMT, Global Impression of Change, and a financial questionnaire. Patients will be evaluated at various time points pre-transplant, day 30, day 100 and 1 year post-transplant. Participants (N=110) will be prospectively enrolled from Mayo Clinic Arizona (MCA) with other centers to soon join. To date we have enrolled 5 patients from MCA on the SYMPTOMS trial and 32 patients on the MEASURES trial. Results Both trials began open enrollment in the summer of 2012 and remain in recruitment phase. Our updated preliminary data will be presented at the ASH 2013 meeting Conclusion Myeloproliferative Neoplasms have been associated with debilitating symptom profile that can significantly impair the QOL. We recognize the burden of this disease and treatment and have therefore initiated two ongoing parallel prospective trials with goals to quantify the QOL and symptom burden of MPN patients. By quantifying degree of burden and impairment in QOL in a standardized format in MPN patients undergoing a range of treatments, we will in the future be better able to inform our patients of the likely benefits and toxicities of the available treatment options. Disclosures: Birgegard: Vifor Pharma: Honoraria.
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Brown, M. Christopher. "Good Intentions: Collegiate Desegregation and Transdemographic Enrollments". Review of Higher Education 25, nr 3 (2002): 263–80. http://dx.doi.org/10.1353/rhe.2002.0009.
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Brousseau, David C., J. Paul Scott, Oluwakemi Badaki, Deepika S. Darbari, Corrie Chumpitazi, Gladstone E. Airewele, Angela M. Ellison i in. "A Multi-Center Randomized Controlled Trial of Intravenous Magnesium for Sickle Cell Pain Crisis in Children". Blood 124, nr 21 (6.12.2014): 88. http://dx.doi.org/10.1182/blood.v124.21.88.88.
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Abstract Introduction: There are approximately 18,000 hospitalizations and 75,000 hospitalization days annually in the United States for children experiencing sickle cell vasoocclusive crises. Despite advances in the management of other comorbidities of sickle cell disease, little has changed in the management of sickle cell pain crises. Magnesium, a known vasodilator, anti-inflammatory and pain reliever, has the potential to alter the pathophysiology of pain crises, shortening length of stay and decreasing opioid use. A previous pilot study showed IV magnesium shortened length of stay compared to historical controls. A randomized trial conducted in Canada showed no decrease in length of stay with the use of intravenous magnesium. In the MAGiC (MAGnesium for children in Crisis) study, we hypothesized that the addition of intravenous (IV) magnesium to standard therapy would shorten hospital length of stay, result in decreased opioid use and improve quality of life for pediatric patients hospitalized with sickle cell pain crises. Methods: The MAGiC study was a multi-center, randomized, double-blind, placebo-controlled trial of IV magnesium versus normal saline for the treatment of pediatric sickle cell pain crisis conducted at 8 sites. Participating sites were members of the Pediatric Emergency Care Applied Research Network (PECARN), and collaborations between Pediatric Emergency Medicine physicians and Pediatric sickle cell experts facilitated enrollment. Children aged 4 to 21 years, with hemoglobin SS or hemoglobin SB° thalassemia were eligible if they required inpatient hospitalization after failing emergency department (ED) management for pain. Enrollment occurred at 8 sites between December 2010 and December 2013, with a total of 217 eligible site enrollment months. Children received 40 mg/kg of IV magnesium every eight hours for a total of 6 doses or normal saline placebo of equivalent volume (1 ml/kg). Randomization was stratified by site, age and hydroxyurea use. The primary outcome was length of stay from the time of first drug infusion until 12 hours after the last IV opioid dose or time of discharge, whichever occurred first. Secondary outcomes included opioid use, recorded as morphine equivalents, and quality of life, as measured using the PedsQL Sickle cell disease specific module, fatigue module and generic module. Side effects, specifically hypotension, weakness, warmth on infusion, or the development of acute chest syndrome (ACS) were documented. Using an intention-to-treat analysis, we compared length of stay using a Van Elteren test, stratified by the same factors used to stratify randomization. Results: 208 children were enrolled. Four children were excluded prior to receipt of any study drug, resulting in 101 children receiving magnesium and 103 receiving placebo. The 2 groups were similar with respect to age, sex ,genotype, weight, history of ACS or asthma, previous hospitalizations within the past three years and days of pain prior to arrival. The median time from first ED opioid to first study drug infusion was 7.4 hours, similar between the two groups. The median (interquartile range) length of stay was 56.0 (27.0 - 109.0) hours in the magnesium group compared to 47.0 (24.0 - 99.0) hours in the placebo group, p = 0.264. Patients who received magnesium received 1.46 mg/kg of morphine equivalents compared to 1.28 mg/kg in the placebo group (p=0.11). Quality of life scores were similar between the two groups after 48 hours on study drug and one week after discharge (p > 0.10 at both time points). Safety analysis revealed no differences in hypotension (3% for magnesium versus 1% for placebo) or weakness (7% versus 4%) between the 2 groups. Of those who received magnesium, 26% reported warmth on infusion compared to 2% of children who received placebo, p < .0001. Other adverse events, serious adverse events, and rehospitalizations within 7 days were similar between the groups. Conclusion: Intravenous magnesium does not shorten length of stay, lessen opioid use or improve quality of life in children who require hospitalization for sickle cell pain crisis. Close collaboration between Pediatric Emergency Medicine physicians and Pediatric Hematologists allows for the successful enrollment of large numbers of children in an acute intervention trial for children with sickle cell disease. Disclosures Off Label Use: magnesium for sickle cell pain crisis.
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Lee, Stephanie J., Jennifer Le Rademacher, Heather Jim, Karen L. Syrjala, John R. Wingard, Brent R. Logan, Juan Wu i in. "Exercise and Stress Management Training For Patients Undergoing Autologous Or Allogeneic Hematopoietic Cell Transplantation. Results From Blood and Marrow Transplant Clinical Trials Network (BMT CTN) 0902". Blood 122, nr 21 (15.11.2013): 699. http://dx.doi.org/10.1182/blood.v122.21.699.699.
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Abstract Following up on single institution studies suggesting that engaging patients in exercise and/or stress reduction techniques during hematopoietic cell transplantation (HCT) improves functional status and quality of life, we conducted a randomized study through the Blood and Marrow Transplant Clinical Trials Network (BMT CTN). METHODS: Patients (n=711) at 21 US centers provided symptom and quality of life data at enrollment. They were randomized to 1 of 4 groups using a 2x2 factorial design, stratified by center and transplant type. Prior to HCT, each group received a 15 minute stress management training session or a 15 minute exercise training session, both, or neither, with trained personnel to discuss the importance of managing stress and/or keeping active during HCT. The 3 intervention groups were also given a DVD, pamphlet and diary to track participation in exercise and/or stress management. The trainer reviewed the goals of practicing the intervention, proper technique, identification of barriers and plans to overcome them. Exercise training also included calculation of target heart rate. The exercise goal was walking 3-5 times a week for at least 20-30 minutes at 50-75% of estimated heart rate reserve. The stress management goal was to use paced abdominal breathing, progressive muscle relaxation with guided imagery, and coping self-statements to decrease stress. The interventionists re-contacted patients at 30 and 60 days after HCT to review the training goals, discuss barriers and provide encouragement. The fourth group was a usual care control group. All groups received a DVD of general information about HCT. Participants provided self-reported assessments at 30, 60, 100 and 180 days after transplant. The primary endpoints were the physical (PCS) and mental (MCS) component subscales of the SF36 at day 100. The study was designed to have 85% power to detect a difference of 0.5 STD in the exercise or stress management groups on each of the two endpoints, maintaining an overall type I error rate of 0.05. Primary analysis was on an intention to treat (ITT) basis with values assigned to patients who died or otherwise did not provide information. Enrollment occurred from January 2011-June 2012. Results The groups were well-balanced for baseline characteristics. There were no differences in the primary endpoints of PCS and MCS at day +100 among any of the groups based on the ITT analysis (Table). Results were similar using other conditional and imputed methods. Higher PCS at day +100 was associated with higher PCS at enrollment (p<0.0001), being employed (coefficient 1.85, p=0.01), and having an autologous transplant rather than a myeloablative allogeneic HCT (coefficient 4.47, p<0.0001) or reduced intensity/non-myeloablative allogeneic HCT (coefficient 3.10, p=0.0003). There was no difference between the two types of allogeneic conditioning intensities (p=0.12). Higher MCS at day +100 was associated with higher enrollment MCS (p<0.0001) and higher income (greater than $50,000, coefficient 3.3, p<0.0001). Patients assigned to stress management training reported using these techniques more than those who did not get stress management training. Patients assigned to exercise training did not report greater exercise up to day 100 but this group did report greater activity at day +180 (p=0.04) and better PCS scores at day +180 (coefficient 1.84, p=0.02), although the effect was not significant (p=0.20) in a model including multiple imputation. There were no differences observed in overall survival, hospitalization days until day +100 or in other patient-reported outcomes, including treatment-related distress, sleep quality, pain, and nausea. Conclusions No improvements in functional status as measured by PCS and MCS at day +100 were evident between the groups. Functional status was highly associated with pre-transplant functioning and type of transplant but not with conditioning regimen intensity.TableDay 100 SF36 scoresExercise (n=358) Median (25th-75th)No Exercise (n=353) Median (25th-75th)p-valuePCS37.5 (19.7-46.7)39.7 (27.1-47.7)0.14MCS49.4 (27.3-57.7)50.1 (34.2-57.8)0.33Stress Management (n=356) Median (25th-75th)No Stress Management (n=355) Median (25th-75th)PCS37.8 (22.1-46.6)39.7 (25.7-47.9)0.21MCS50.7 (31.0-58.2)49.1 (30.5-56.8)0.30 Disclosures: No relevant conflicts of interest to declare.
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Davis, Thomas, Venkatesh Ramaiah, Khusrow Niazi, Hans Martin Gissler i Tami Crabtree. "Safety and effectiveness of the Phoenix Atherectomy System in lower extremity arteries: Early and midterm outcomes from the prospective multicenter EASE study". Vascular 25, nr 6 (27.09.2017): 563–75. http://dx.doi.org/10.1177/1708538117712383.
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Objectives To evaluate the novel Phoenix Atherectomy System as percutaneous treatment of de novo and restenotic infrainguinal arterial lesions. Methods This prospective, multicenter, nonrandomized investigational device exemption trial was conducted across 16 US and German centers between August 2010 and April 2013. Intention-to-treat enrollment was 128 patients (mean age: 71.8 years, 59% male) with 149 lesions (mean length: 34 mm, mean diameter stenosis: 89.5%), and the primary analysis per-protocol population consisted of 105 patients with 123 lesions. The primary efficacy endpoint, technical success, was the achievement of acute debulking with a post-atherectomy residual diameter stenosis ≤50% (before adjunctive therapy). The primary safety endpoint was the major adverse event (MAE) rate through 30 days. Results For the primary analysis per-protocol population, the rate of lesion technical success was 95.1% (117/123), with the lower limit of the 95% CI 90.6%, meeting the prospectively established target performance goal of ≥86%. After post-atherectomy adjunctive therapy, residual stenosis was ≤30% for 99.2% (122/123) of lesions (mean final diameter stenosis 10.5%). Improvement of ≥1 Rutherford class occurred for 74.5% of patients through 30 days and for 80% through six months. MAEs were experienced by 5.7% (6/105) of patients through 30 days (with the upper limit of the 95% CI 11.0%, meeting the target performance goal of <20%), and 16.8% through six months. Six-month freedom from TLR and TVR was 88.0% and 86.1%, respectively. Conclusions Based on the high rate of technical success and the low rates of MAEs through six months, the Phoenix Atherectomy System is safe and effective for the debulking of lower-extremity arterial lesions. ClinicalTrials.gov identifier NCT01541774
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Sarfo, Fred Stephen, Frank Treiber, Mulugeta Gebregziabher, Sheila Adamu, Michelle Nichols, Arti Singh, Vida Obese i in. "Phone-based intervention for blood pressure control among Ghanaian stroke survivors: A pilot randomized controlled trial". International Journal of Stroke 14, nr 6 (22.11.2018): 630–38. http://dx.doi.org/10.1177/1747493018816423.
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Background The potential of mobile-health (mHealth) technology for the management of hypertension among stroke survivors in Africa remains unexplored. We assessed whether an mHealth technology-enabled, nurse-guided intervention initiated among stroke patients within one month of symptom onset is effective in improving their blood pressure (BP) control. Methods A two-arm pilot cluster randomized controlled trial involving 60 stroke survivors, ≥18 years, with BP ≥140/90 mmHg at screening/enrollment visit at a medical center in Ghana. Participants in the intervention arm (n = 30) received a Blue-toothed BP device and smartphone with an App for monitoring BP measurements and medication intake under nurse guidance for three months after which intervention was withdrawn. Control arm (n = 30) received usual care. Primary outcome measure was proportion with clinic BP < 140/90 mmHg at month 9; secondary outcomes included medication adherence. Findings Mean ± SD age was 55 ± 13 years, 65% males. Two participants on intervention and three in control group were lost to follow-up. At month 9, proportion on the intervention versus controls with BP < 140/90 mmHg was 14/30 (46.7%) versus 12/30 (40.0%), p = 0.79 by intention-to-treat; systolic BP < 140 mmHg was 22/30 (73.3%) versus 13/30 (43.3%), p = 0.035. Mean ± SD medication possession ratio was 0.95 ± 0.16 on intervention versus 0.98 ± 0.24 in the control arm, p = 0.56. Interpretation We demonstrate feasibility and signal of improvement in BP control among stroke survivors in a resource-limited setting via an mHealth intervention. Larger scale studies are warranted. Trial registration NCT02568137. Registered on 13 July 2015 at ClinicalTrials.gov.
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Gornick, Michele Caroline, Erin Frances Cobain, Lan Q. Le, Elena Martinez Stoffel, Arul M. Chinnaiyan i J. Scott Roberts. "Oncologists’ use of tumor sequencing findings and patient derived benefit." Journal of Clinical Oncology 35, nr 15_suppl (20.05.2017): e13016-e13016. http://dx.doi.org/10.1200/jco.2017.35.15_suppl.e13016.
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e13016 Background: Despite increasing use of tumor genomic sequencing in clinical oncology, there is currently limited understanding of how oncologists interpret and apply this information to a patient’s clinical management. Methods: We surveyed oncologists who referred patients with refractory cancers to the Michigan Oncology Sequencing (MI-ONCOSEQ) program which uses integrative clinical sequencing to detect multiple classes of somatic and germline molecular aberrations including point mutations, amplifications, insertions/deletions, gene fusions, and outlier gene expression from June 2014-February 2015. Patients were also surveyed approximately 2 weeks after notification of completion of sequencing. In addition, we conducted chart reviews to ascertain how many patients’ clinical management was changed or derived clinical benefit as a result of sequencing. Results: Forty-three oncologists (37% female, 98% academic medical center practice), referring 112 patients ( M = 2, range: 1-9) completed the survey (response rate = 93%). Oncologists reported an intention to change 22% of patients’ treatment plans on the basis of sequencing results, with referral to a clinical trial (N = 12; 50%) as the most frequently endorsed intended change. However, few patients (N = 9, 38%) had an actual change in clinical management. Barriers identified included patient factors, ineligibility for identified treatment, and loss to follow-up/deceased. Of the 57 patients who completed post-sequencing surveys, 34 (60%) reported that results of sequencing had not been disclosed. However, patient records had documentation that results disclosure had indeed taken place in 41% of cases. Conclusions: Although expectation of enrollment in clinical trials is frequently proposed as the indication for genomic sequencing, practice barriers remain. These include lack of access to studies, severity of patient illness and challenges to effective communication of results.
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Klepin, Heidi D., Janet A. Tooze, Ann M. Geiger, Timothy S. Pardee, Leslie R. Ellis, Dianna Howard, Wendy Demark-Wahnefried i in. "A symptom-adapted physical activity intervention during induction chemotherapy for older adults with acute myeloid leukemia (AML) to maintain physical function." Journal of Clinical Oncology 39, nr 15_suppl (20.05.2021): 12009. http://dx.doi.org/10.1200/jco.2021.39.15_suppl.12009.
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12009 Background: Older adults are at risk for physical function decline during therapy for AML. Impaired physical function after induction therapy is associated with shorter survival Interventions designed to maintain function may improve treatment outcomes. We piloted a physical activity (PA) intervention among older adults receiving intensive chemotherapy for AML designed to prevent functional decline. Methods: Single institution randomized pilot study of PA vs. usual care. Eligibility included age ≥60 years, newly-diagnosed AML, ambulatory, planned intensive induction chemotherapy. Intervention participants were offered a PA session five days/week tailored daily to symptoms and conditions during the induction hospitalization. Session options were: 1) Standard (ward-based), walking + balance trahining + resistance exercises; 2) Intermediate (room-based), upper-body ergometer + balance training + resistance exercises; 3) Low-intensity (bed-based), upper-body ergometer + resistance exercises. Behavioral counseling sessions to establish PA goals and overcome barriers were conducted weekly during hospitalization and continued monthly by phone for 6 months. Assessment of physical function occurred at baseline, weekly during hospitalization (approximately 4-6 weeks), 3 months, and 6 months. The primary functional outcome of interest was the Short Physical Performance Battery (SPPB; 5 repeat chair stands, gait speed, balance tests; score 0-12 higher indicates better function). Clinically significant change in physical function was defined as ≥1.0 on the SPPB. Proportions of those that declined, remained stable, or improved on the SPPB were compared by group using an exact test for trend. Results: Among 96 eligible patients 70 enrolled (recruitment rate 73%, average participation 3 sessions/week). The mean age was 72.1±6.3 years, 70% were male. Mean baseline SPPB score was 7.0±3.8. In the surviving intention to treat population (N = 66), more intervention participants, compared to controls, maintained or improved their SPPB score (38% vs. 25%) during induction hospitalization (p = 0.278). Among those who achieved remission (N = 42), function was maintained or improved in a greater proportion of intervention participants (55%) compared to controls (23%), p = 0.047. Maintenance or improvement in SPPB from baseline to last follow-up (3 or 6 months post enrollment) was 62% vs 54% for intervention versus control among the intention to treat cohort (N = 50) and 67% vs. 55% among those who achieved remission (N = 40). Conclusions: A symptom adapted PA intervention with behavioral counseling during induction chemotherapy shows promise in preventing clinically meaningful decline in physical function among older adults with AML who achieve remission. Continued maintenance intervention may sustain benefits. Clinical trial information: NCT01519596.
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Guo, Weijian, Xinxiang Li, Mingzhu Huang, Ya'nan Yang, Qingguo Li, Chenchen Wang, Lei Liang i in. "XELOX or mFOLFOX6 chemotherapy combined with resection of primary lesion versus chemotherapy alone for colon cancer with unresectable metastases: A randomized clinical trial." Journal of Clinical Oncology 39, nr 15_suppl (20.05.2021): 3590. http://dx.doi.org/10.1200/jco.2021.39.15_suppl.3590.
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3590 Background: It is still controversial for colon cancer patients with unresectable metastases whether to resect the primary tumor when there are no symptoms of primary lesion. Methods: This is an open-label, single-center, prospective, randomized, controlled phase II trial. Colon cancer patients aged 18-80 years with unresectable metastases at enrollment will be randomly allocated to either resection group (group A) or chemotherapy group (group B), and stratified by tumor response and number of organ metastases, after receiving induction chemotherapy with 4 cycles of XELOX or 6 cycles of mFOLFOX6, excluding those with disease progression, lesions radically resectable, or primary lesion unresectable. Patients in group A received resection of primary lesion and then continued chemotherapy, and patients in group B just continued chemotherapy, both up to 4 cycles of XELOX or 6 cycles of mFOLFOX6, and capecitabine maintenance afterwards. If progression occurs 3 months after discontinuation of oxaliplatin and toxicity has recovered to grade I, the original regimen can be applied again. The primary endpoint was TFS (time to failure of strategy, defined as the time from randomization to secondary progression in patients received re-introduce of the induction chemotherapy regimen, or to first progression in patients without re-introduce of the original regimen). The secondary endpoints included progression-free survival (PFS, the time from randomization to first progression), overall survival (OS, the time from enrollment to death), and adverse events (AEs). Efficacy data were analyzed on an intention-to-treat (ITT) basis. This study is registered with ClinicalTrials.gov, number NCT02291744. Results: Between April, 2015, and July, 2020, 140 patients were enrolled, and 54 patients withdrew due to colon obstruction (16), perforation (1), disease progression (22), death (1), radical resection (3), or other reasons (11). Finally, 86 patients were randomized into group A (n = 42) or group B (n = 44). The median TFS was 143 days (95%CI: 104.9-181.1) in group A, and 196 days (95%CI: 96.5-295.5) in group B (HR:0.930 95%CI:0.589-1.468, p = 0.755). The median PFS was 147 days (95%CI: 105.7-188.3) in group A, and 206 days(95%CI:180.9-231.1) in group B (HR:0.831, 95%CI:0.522-1.323, p = 0.436). The median OS was 530 days (95%CI: 308.9-751.1) in group A, and 779 days (95%CI:626.3-931.7) in group B (HR:0.948 95%CI:0.554-1.622, p = 0.845). The incidence of treatment-related AEs was similar between two groups. Conclusions: Resection of primary tumor after induction chemotherapy could not bring survival benefits. It’s not recommended for patients without symptoms of primary lesion to receive primary tumor resection, but it also requires individualized treatment as colon obstruction or perforation occurred in some patients. Clinical trial information: NCT02291744.