Browsing by Subject "standards"

Now showing 1 - 10 of 19
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    Adapting ethical guidelines for adolescent health research to street-connected children and youth in low- and middle-income countries: a case study from western Kenya
    (Springer (Biomed Central Ltd.), 2015-12-18) Embleton, L.; Ott, Mary A.; Wachira, J.; Naanyu, V.; Kamanda, A.; Makori, D.; Ayuku, D.; Braitstein, P.; Department of Epidemiology, Richard M. Fairbanks School of Public Health
    BACKGROUND: Street-connected children and youth (SCCY) in low- and middle-income countries (LMIC) have multiple vulnerabilities in relation to participation in research. These require additional considerations that are responsive to their needs and the social, cultural, and economic context, while upholding core ethical principles of respect for persons, beneficence, and justice. The objective of this paper is to describe processes and outcomes of adapting ethical guidelines for SCCY's specific vulnerabilities in LMIC. METHODS: As part of three interrelated research projects in western Kenya, we created procedures to address SCCY's vulnerabilities related to research participation within the local context. These consisted of identifying ethical considerations and solutions in relation to community engagement, equitable recruitment, informed consent, vulnerability to coercion, and responsibility to report. RESULTS: Substantial community engagement provided input on SCCY's participation in research, recruitment, and consent processes. We designed an assent process to support SCCY to make an informed decision regarding their participation in the research that respected their autonomy and their right to dissent, while safeguarding them in situations where their capacity to make an informed decision was diminished. To address issues related to coercion and access to care, we worked to reduce the unequal power dynamic through street outreach, and provided access to care regardless of research participation. CONCLUSIONS: Although a vulnerable population, the specific vulnerabilities of SCCY can to some extent be managed using innovative procedures. Engaging SCCY in ethical research is a matter of justice and will assist in reducing inequities and advancing their health and human dignity.
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    ASN Presidential Address 2013: innovation and individualization--the path forward for nephrology
    (American Society for Nephrology, 2014-05) Molitoris, Bruce A.; Department of Medicine, IU School of Medicine
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    Computer-generated reminders and quality of pediatric HIV care in a resource-limited setting
    (American Academy of Pediatrics (AAP), 2013-03) Were, Martin C.; Nyandiko, Winstone M.; Huang, Kristin T. L.; Slaven, James E.; Shen, Changyu; Tierney, William M.; Vreeman, Rachel C.; Department of Medicine, IU School of Medicine
    OBJECTIVES: To evaluate the impact of clinician-targeted computer-generated reminders on compliance with HIV care guidelines in a resource-limited setting. METHODS: We conducted this randomized, controlled trial in an HIV referral clinic in Kenya caring for HIV-infected and HIV-exposed children (<14 years of age). For children randomly assigned to the intervention group, printed patient summaries containing computer-generated patient-specific reminders for overdue care recommendations were provided to the clinician at the time of the child's clinic visit. For children in the control group, clinicians received the summaries, but no computer-generated reminders. We compared differences between the intervention and control groups in completion of overdue tasks, including HIV testing, laboratory monitoring, initiating antiretroviral therapy, and making referrals. RESULTS: During the 5-month study period, 1611 patients (49% female, 70% HIV-infected) were eligible to receive at least 1 computer-generated reminder (ie, had an overdue clinical task). We observed a fourfold increase in the completion of overdue clinical tasks when reminders were availed to providers over the course of the study (68% intervention vs 18% control, P < .001). Orders also occurred earlier for the intervention group (77 days, SD 2.4 days) compared with the control group (104 days, SD 1.2 days) (P < .001). Response rates to reminders varied significantly by type of reminder and between clinicians. CONCLUSIONS: Clinician-targeted, computer-generated clinical reminders are associated with a significant increase in completion of overdue clinical tasks for HIV-infected and exposed children in a resource-limited setting.
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    Criteria for evaluating response and outcome in clinical trials for children with juvenile myelomonocytic leukemia
    (Ferrata Storti Foundation, 2015-01) Niemeyer, Charlotte M.; Loh, Mignon L.; Cseh, Annamaria; Cooper, Todd; Dvorak, Christopher C.; Chan, Rebecca; Xicoy, Blanca; Germing, Ulrich; Kojima, Seiji; Manabe, Atsushi; Dworzak, Michael; De Moerloose, Barbara; Starý, Jan; Smith, Owen P.; Masetti, Riccardo; Catala, Albert; Bergstraesser, Eva; Ussowicz, Marek; Fabri, Oskana; Baruchel, André; Cavé, Hélène; Zwaan, Michel; Locatelli, Franco; Hasle, Henrik; van den Heuvel-Eibrink, Marry M.; Flotho, Christian; Yoshimi, Ayami; Department of Pediatrics, IU School of Medicine
    Juvenile myelomonocytic leukemia is a rare myeloproliferative disease in young children. While hematopoietic stem cell transplantation remains the only curative therapeutic option for most patients, children with juvenile myelomonocytic leukemia increasingly receive novel agents in phase I-II clinical trials as pre-transplant therapy or therapy for relapse after transplantation. However, response criteria or definitions of outcome for standardized evaluation of treatment effect in patients with juvenile myelomonocytic leukemia are currently lacking. Here we propose criteria to evaluate the response to the non-transplant therapy and definitions of remission status after hematopoietic stem cell transplantation. For the evaluation of non-transplant therapy, we defined 6 clinical variables (white blood cell count, platelet count, hematopoietic precursors and blasts in peripheral blood, bone marrow blast percentage, spleen size and extramedullary disease) and 3 genetic variables (cytogenetic, molecular and chimerism response) which serve to describe the heterogeneous picture of response to therapy in each individual case. It is hoped that these criteria will facilitate the comparison of results between clinical trials in juvenile myelomonocytic leukemia.
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    Cultivating teacher professionalism in Chinese and U.S. settings: contexts, standards, and personhood
    (Taylor & Francis, 2021-07-12) Liu, Laura B.; Conner, J.M.; Li, Qiong; Education, IUPUC
    Our global era invites research on teacher reflection that is grounded in local contexts and enriched by cross-regional collaborations. Teacher professionalism is a shared global interest that is shaped by unique cultural factors in local settings. This study examines Chinese and U.S. undergraduate teacher education student views on the criteria for and standardised measures used to assess teacher professionalism. Data analyses of participant products, specifically group rubrics and individual reflections, involved constant comparative analyses to highlight convergent and divergent themes in student conceptions of teacher professionalism within and across the U.S. and Chinese university contexts. Findings demonstrate similarities and distinctions across participant views on the professional knowledge, skills, and dispositions involved in becoming a teacher, and reveals teacher professionalism as a dialectic among contexts, standards, and persons. Context distinguishes professional practice in ways that bring meaning and relevancy to local student needs. Standards provide a shared foundation for global discourse around key elements of a profession. Maintaining a person-centred view helps ensure assessment practices keep education’s broader civic goals central. Engaging in international dialogue on the meaning of teacher professionalism across regional cultures expanded understandings of professionalism, and how it may be fostered and evaluated more effectively in teacher education.
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    The experiences of family members in the nursing home to hospital transfer decision
    (Springer (Biomed Central Ltd.), 2016-11-15) Abrahamson, Kathleen; Bernard, Brittany; Magnabosco, Lara; Nazir, Arif; Unroe, Kathleen T.; Department of Medicine, School of Medicine
    BACKGROUND: The objective of this study was to better understand the experiences of family members in the nursing home to hospital transfer decision making process. Semi-structured interviews were conducted with 20 family members who had recently been involved in a nursing home to hospital transfer decision. RESULTS: Family members perceived themselves to play an advocacy role in their resident's care and interview themes clustered within three over-arching categories: Family perception of the nursing home's capacity to provide medical care: Resident and family choices; and issues at 'hand-off' and the hospital. Multiple sub-themes were also identified. CONCLUSIONS: Findings from this study contribute to knowledge surrounding the nursing home transfer decision by illuminating the experiences of family members in the transfer decision process.
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    Finding the elusive balance between reducing fatigue and enhancing education: perspectives from American residents
    (Springer (Biomed Central Ltd.), 2014) Hanna, John; Gutteridge, Daniel; Kudithipudi, Venu; Department of Medicine, IU School of Medicine
    Duty hour restrictions for residency training were implemented in the United States to improve residents' educational experience and quality of life, as well as to improve patient care and safety; however, these restrictions are by no means problem-free. In this paper, we discuss the positive and negative aspects of duty hour restrictions, briefly highlighting research on the impact of reduced duty hours and the experiences of American residents. We also consider whether certain specialties (e.g., Emergency Medicine, Radiology) may be more amenable than others (e.g., Surgery) to duty hour restrictions. We conclude that feedback from residents is a crucial element that must be considered in any future attempts to strike a balance between reducing fatigue and enhancing education.
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    GH safety workshop position paper: a critical appraisal of recombinant human GH therapy in children and adults
    (Bioscientifica, 2016-02) Allen, D. B.; Backeljauw, P.; Bidlingmaier, M.; Biller, B. M. K.; Boguszewski, M.; Burman, P.; Butler, G.; Chihara, K.; Christiansen, J.; Cianfarani, S.; Clayton, P.; Clemmons, D.; Cohen, P.; Darendeliler, F.; Deal, C.; Dunger, D.; Erfurth, E. M.; Fuqua, J. S.; Grimberg, A.; Haymond, M.; Higham, C.; Ho, K.; Hoffman, A. R.; Hokken-Koelega, A.; Johannsson, G.; Juul, A.; Kopchick, J.; Lee, P.; Pollak, M.; Radovick, S.; Robison, L.; Rosenfeld, R.; Ross, R. J.; Savendahl, L.; Saenger, P.; Toft Sorensen, H.; Stochholm, K.; Strasburger, C.; Swerdlow, A.; Thorner, M.; Department of Pediatrics, IU School of Medicine
    Recombinant human GH (rhGH) has been in use for 30 years, and over that time its safety and efficacy in children and adults has been subject to considerable scrutiny. In 2001, a statement from the GH Research Society (GRS) concluded that 'for approved indications, GH is safe'; however, the statement highlighted a number of areas for on-going surveillance of long-term safety, including cancer risk, impact on glucose homeostasis, and use of high dose pharmacological rhGH treatment. Over the intervening years, there have been a number of publications addressing the safety of rhGH with regard to mortality, cancer and cardiovascular risk, and the need for long-term surveillance of the increasing number of adults who were treated with rhGH in childhood. Against this backdrop of interest in safety, the European Society of Paediatric Endocrinology (ESPE), the GRS, and the Pediatric Endocrine Society (PES) convened a meeting to reappraise the safety of rhGH. The ouput of the meeting is a concise position statement.
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    The Healthy Aging Brain Care (HABC) Monitor: validation of the Patient Self-Report Version of the clinical tool designed to measure and monitor cognitive, functional, and psychological health
    (Dove Medical Press, 2014) Monahan, Patrick O.; Alder, Catherine A.; Khan, Babar A.; Stump, Timothy; Boustani, Malaz A.; Department of Medicine, IU School of Medicine
    BACKGROUND: Primary care providers need an inexpensive, simple, user-friendly, easily standardized, sensitive to change, and widely available multidomain instrument to measure the cognitive, functional, and psychological symptoms of patients suffering from multiple chronic conditions. We previously validated the Caregiver Report Version of the Healthy Aging Brain Care Monitor (HABC Monitor) for measuring and monitoring the severity of symptoms through caregiver reports. The purpose of this study was to assess the reliability and validity of the Patient Self-Report Version of the HABC Monitor (Self-Report HABC Monitor). DESIGN: Cross-sectional study. SETTING: Primary care clinics affiliated with a safety net urban health care system in Indianapolis, Indiana, USA. SUBJECTS: A total of 291 subjects aged ≥65 years with a mean age of 72.7 (standard deviation 6.2) years, 76% female, and 56% African Americans. ANALYSIS: Psychometric validity and reliability of the Self-Report HABC Monitor. RESULTS: Among 291 patients analyzed, the Self-Report HABC Monitor demonstrated excellent fit for the confirmatory factor analysis model (root mean square error of approximation =0.030, comparative fit index =0.974, weighted root mean square residual =0.837) and good internal consistency (0.78-0.92). Adequate convergent-divergent validity (differences between the Telephone Interview for Cognitive Status test-based cognitive function impairment versus nonimpairment groups) was demonstrated only when patients were removed from analysis if they had both cognitive function test impairment and suspiciously perfect self-report HABC Monitor cognitive floor scores of 0. CONCLUSION: The Self-Report HABC Monitor demonstrates good reliability and validity as a clinically practical multidimensional tool for measuring symptoms. The tool can be used along with its caregiver version to provide useful feedback (via monitoring of symptoms) for modifying care plans. Determining the validity of HABC Monitor scores from patients who self-report a perfect cognitive score of 0 requires cognitive function test results (eg, Telephone Interview for Cognitive Status or Mini Mental State Examination) or Caregiver Report HABC Monitor scores or further clinical examination to rule out the possibility that the patient is denying or unaware of their cognitive symptoms.