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https://www.readbyqxmd.com/read/29214573/post-approval-studies-for-rare-disease-treatments-and-orphan-drugs
#1
William C Maier, Ronald A Christensen, Patricia Anderson
Drug development involves a multi-stage process of drug discovery, animal studies and human clinical trials to assess the safety and efficacy of new medications. Rare disease drug development involves a much smaller number of affected patients, a predominance of pediatric patients and more complicated disease presentation. Post-approval studies are designed to address several limitations associated with the rare disease clinical trials.National and international regulatory agencies in the US and Europe have adopted similar approaches to requirements post-approval data for rare diseases and orphan drug indications...
2017: Advances in Experimental Medicine and Biology
https://www.readbyqxmd.com/read/29214395/pharmacological-management-of-hereditary-angioedema-with-c1-inhibitor-deficiency-in-pediatric-patients
#2
REVIEW
Henriette Farkas
Hereditary angioedema with C1-inhibitor deficiency (C1-INH-HAE) is a form of bradykinin-mediated angioedema. It is a rare disorder with an onset during childhood in most instances. Therefore, familiarity with the options for the management of pediatric cases is indispensable. The recurrent angioedematous episodes do not respond to conventional treatments and may evolve into a life-threatening condition. In view of the recommendations adopted by international consensus in 2016, patient management and follow-up should be guided by an individualized strategy...
December 7, 2017: Paediatric Drugs
https://www.readbyqxmd.com/read/29183026/late-effects-and-long-term-follow-up-after-cancer-in-childhood
#3
Thorsten Langer, Desiree Grabow, Diana Steinmann, Bernhard Wörmann, Gabriele Calaminus
Today, 80% of children and adolescents with cancer survive their disease. From the results of aftercare research arises the question: Are the survivors also healthy? Many late effects depend on the type of cancer and its treatment. Patients with brain tumors and with malignant sarcomas are very often affected by secondary diseases. Data from the USA report that around 2/3 of all patients still living 30 years after their cancer treatment in childhood suffer from late complications. Equivalent figures for Germany were previously unavailable...
2017: Oncology Research and Treatment
https://www.readbyqxmd.com/read/29182495/platelet-transfusion-for-patients-with-cancer-american-society-of-clinical-oncology-clinical-practice-guideline-update
#4
Charles A Schiffer, Kari Bohlke, Meghan Delaney, Heather Hume, Anthony J Magdalinski, Jeffrey J McCullough, James L Omel, John M Rainey, Paolo Rebulla, Scott D Rowley, Michael B Troner, Kenneth C Anderson
Purpose To provide evidence-based guidance on the use of platelet transfusion in people with cancer. This guideline updates and replaces the previous ASCO platelet transfusion guideline published initially in 2001. Methods ASCO convened an Expert Panel and conducted a systematic review of the medical literature published from September 1, 2014, through October 26, 2016. This review builds on two 2015 systematic reviews that were conducted by the AABB and the International Collaboration for Transfusion Medicine Guidelines...
November 28, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/29181500/perinatal-diagnosis-management-and-follow-up-of-cystic-renal-diseases-a-clinical-practice-recommendation-with-systematic-literature-reviews
#5
Charlotte Gimpel, Fred E Avni, Carsten Bergmann, Metin Cetiner, Sandra Habbig, Dieter Haffner, Jens König, Martin Konrad, Max C Liebau, Lars Pape, Georg Rellensmann, Andrea Titieni, Constantin von Kaisenberg, Stefanie Weber, Paul J D Winyard, Franz Schaefer
Importance: Prenatal and neonatal cystic kidney diseases are a group of rare disorders manifesting as single, multiple unilateral, or bilateral cysts or with increased echogenicity of the renal cortex without macroscopic cysts. They may be accompanied by grossly enlarged kidneys, renal oligohydramnios, pulmonary hypoplasia, extrarenal abnormalities, and neonatal kidney failure. The prognosis is extremely variable from trivial to very severe or even uniformly fatal, which poses significant challenges to prenatal counseling and management...
November 27, 2017: JAMA Pediatrics
https://www.readbyqxmd.com/read/29153021/-adult-phenylketonuria
#6
Csaba Sumánszki, András Gellért Barta, Péter Reismann
Starting from 1975 phenylketonuria is part of the newborn screening program in Hungary. Since then a generation, treated with special diet and medical foods right after neonatal diagnosis has reached adulthood. Thanks to early treatment initiation, children with phenylketonuria are able to lead life to the full. Consequently, phenylketonuria is no longer considered a pediatric disease. Follow up of adult patients with phenylketonuria is performed in internal medicine centers specialized in metabolic diseases...
November 2017: Orvosi Hetilap
https://www.readbyqxmd.com/read/29147468/use-of-dictation-as-a-tool-to-decrease-documentation-errors-in-electronic-health-records
#7
Samer Al Hadidi, Sunil Upadhaya, Rupal Shastri, Zain Alamarat
Background: Use of Electronic Health Records is increasing. Copy-and-paste function is frequently used with higher rates of documentation errors. Studies to determine the nature of such errors are needed.Objectives: Determination of the effect of implementing a dictation system for completing notes on the quality of clinical documentation. We hypothesized that implementation of the dictation system for note writing would decrease the rate of errors in the progress notes as well as decrease the rate of copying and pasting...
2017: Journal of Community Hospital Internal Medicine Perspectives
https://www.readbyqxmd.com/read/29146149/recent-patterns-in-antibiotic-use-for-children-with-group-a-streptococcal-infections
#8
Yusuke Okubo, Nobuaki Michihata, Naho Morisaki, Noriko Kinoshita, Isao Miyairi, Kevin Y Urayama, Hideo Yasunaga
BACKGROUND: Antibiotics are the most frequently prescribed medications for children, but inappropriate prescribing of antibiotics is prevalent. This study investigated recent trends in antibiotic use and factors associated with appropriate antibiotic selection among children with group A streptococcal infections. METHODS: We obtained records of outpatients aged under 18 years with diagnoses of group A streptococcal infections, using the Japan Medical Data Center database...
November 13, 2017: Journal of Global Antimicrobial Resistance
https://www.readbyqxmd.com/read/29143331/implicit-review-instrument-to-evaluate-quality-of-care-delivered-by-physicians-to-children-in-emergency-departments
#9
James P Marcin, Patrick S Romano, Madan Dharmar, James M Chamberlain, Nanette Dudley, Charles G Macias, Lise E Nigrovic, Elizabeth C Powell, Alexander J Rogers, Meridith Sonnett, Leah Tzimenatos, Elizabeth R Alpern, Rebecca Andrews-Dickert, Dominic A Borgialli, Erika Sidney, Charlie Casper, Jonathan Michael Dean, Nathan Kuppermann
OBJECTIVE: To evaluate the consistency, reliability, and validity of an implicit review instrument that measures the quality of care provided to children in the emergency department (ED). DATA SOURCES/STUDY SETTING: Medical records of randomly selected children from 12 EDs in the Pediatric Emergency Care Applied Research Network (PECARN). STUDY DESIGN: Eight pediatric emergency medicine physicians applied the instrument to 620 medical records...
November 16, 2017: Health Services Research
https://www.readbyqxmd.com/read/29140495/traditional-and-complementary-medicine-in-pediatric-oncology-and-low-middle-income-countries-recommendations-from-the-international-society-of-pediatric-oncology-siop-t-cm-collaborative
#10
Elena J Ladas, Stacey Marjerrison, Brijesh Arora, Peter B Hesseling, Roberta Ortiz, Federico Antillon, Shalini Jatia, Glenn M Afungchwi
Significant strides have been made in the treatment of childhood cancer. Improvements in survival have led to increased attention toward supportive care indications; including the use of traditional and complementary medicine (T&CM). The use of T&CM among children and adolescents with cancer is well documented in both high-income countries (HICs) and low-middle income countries (LMICs). A higher incidence of the use of T&CM has been reported among children undergoing treatment in LMICs, which has elevated concerns related to drug interactions, adherence to therapy, and treatment-related toxicities...
November 1, 2017: Journal of the National Cancer Institute. Monographs
https://www.readbyqxmd.com/read/29139249/-clinical-features-analysis-of-qingkailing-injection-for-adolescent-patients-based-on-real-world-his
#11
Li-Zhen Chen, Yan-Ming Xie, Lian-Xin Wang, Yin Zhang, Qun Wang, Ping-Ping Jia, Bo Feng
To explore the clinical application features of Qingkailing injection for adolescent patients. This study was based on the information from the hospitalized patients in 1998-2011 in HIS (hospital information system) of 16 tertiary hospitals in China. 615 adolescent patients with Qingkailing injection were used to investigate the clinical characteristics of Qingkailing injection. Apriori algorithm was adopted to establish the model, and Clementine 12.0 was used for correlation analysis. The results showed that male patients (355 cases) were more than female patients (243 cases); the age of the most patients was under 14 years old, with an average age of 9...
August 2017: Zhongguo Zhong Yao za Zhi, Zhongguo Zhongyao Zazhi, China Journal of Chinese Materia Medica
https://www.readbyqxmd.com/read/29128883/a-systematic-review-and-meta-analysis-of-the-effect-of-low-level-laser-therapy-lllt-on-chemotherapy-induced-oral-mucositis-in-pediatric-and-young-patients
#12
REVIEW
Mengxue He, Binghua Zhang, Nanping Shen, Na Wu, Jiwen Sun
Oral mucositis is one of the most frequent complications after chemotherapy, occurring in approximately 52 to 80% of children receiving treatment for cancer. Recently, it has been suggested that the use of low-energy laser could reduce the grade of oral mucositis and alleviate the symptoms. In 2014, Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology has recommended low-level laser therapy in prevention of mucositis for hematopoietic stem cell transplantation patients because of its beneficial effects in majority of recent studies...
November 11, 2017: European Journal of Pediatrics
https://www.readbyqxmd.com/read/29126406/perceptions-of-the-2011-acgme-duty-hour-requirements-among-residents-in-all-core-programs-at-a-large-academic-medical-center
#13
Benjamin J Sandefur, Diana M Shewmaker, Christine M Lohse, Steven H Rose, James E Colletti
BACKGROUND: The Accreditation Council for Graduate Medical Education (ACGME) implemented revisions to resident duty hour requirements (DHRs) in 2011 to improve patient safety and resident well-being. Perceptions of DHRs have been reported to vary by training stage and specialty among internal medicine and general surgery residents. The authors explored perceptions of DHRs among all residents at a large academic medical center. METHODS: The authors administered an anonymous cross-sectional survey about DHRs to residents enrolled in all ACGME-accredited core residency programs at their institution...
November 10, 2017: BMC Medical Education
https://www.readbyqxmd.com/read/29117934/uses-of-mobile-device-digital-photography-of-dermatologic-conditions-in-primary-care
#14
Jennifer L Pecina, Kirk D Wyatt, Nneka I Comfere, Matthew E Bernard, Frederick North
BACKGROUND: PhotoExam is a mobile app that incorporates digital photographs into the electronic health record (EHR) using iPhone operating system (iOS, Apple Inc)-based mobile devices. OBJECTIVE: The aim of this study was to describe usage patterns of PhotoExam in primary care and to assess clinician-level factors that influence the use of the PhotoExam app for teledermatology (TD) purposes. METHODS: Retrospective record review of primary care patients who had one or more photos taken with the PhotoExam app between February 16, 2015 to February 29, 2016 were reviewed for 30-day outcomes for rates of dermatology consult request, mode of dermatology consultation (curbside phone consult, eConsult, and in-person consult), specialty and training level of clinician using the app, performance of skin biopsy, and final pathological diagnosis (benign vs malignant)...
November 8, 2017: JMIR MHealth and UHealth
https://www.readbyqxmd.com/read/29117092/the-development-and-validation-of-a-concise-instrument-for-formative-assessment-of-team-leader-performance-during-simulated-pediatric-resuscitations
#15
Lindsay D Nadkarni, Cindy G Roskind, Marc A Auerbach, Aaron W Calhoun, Mark D Adler, David O Kessler
AIM: The aim of this study was to assess the validity of a formative feedback instrument for leaders of simulated resuscitations. METHODS: This is a prospective validation study with a fully crossed (person × scenario × rater) study design. The Concise Assessment of Leader Management (CALM) instrument was designed by pediatric emergency medicine and graduate medical education experts to be used off the shelf to evaluate and provide formative feedback to resuscitation leaders...
November 8, 2017: Simulation in Healthcare: Journal of the Society for Simulation in Healthcare
https://www.readbyqxmd.com/read/29091976/what-s-the-purpose-of-rounds-a-qualitative-study-examining-the-perceptions-of-faculty-and-students
#16
Oliver Hulland, Jeanne Farnan, Raphael Rabinowitz, Lisa Kearns, Michele Long, Bradley Monash, Priti Bhansali, H Barrett Fromme
BACKGROUND: Rounds are a critical activity on any inpatient service, but there is little literature describing the purpose of rounds from the perspective of faculty and trainees in teaching hospitals. OBJECTIVE: To evaluate and compare the perceptions of pediatric and internal medicine attendings and medical students regarding the purpose of inpatient attending rounds. METHODS: The authors conducted 10 semistructured focus groups with attendings and medical students in the spring of 2014 at 4 teaching hospitals...
November 2017: Journal of Hospital Medicine: An Official Publication of the Society of Hospital Medicine
https://www.readbyqxmd.com/read/29072006/-rule-of-clinical-application-of-auricular-acupuncture-based-on-data-mining
#17
Na Bao, Qiong Wang, Yan-Hui Sun, Jing Shi, Xiao-Feng Li, Jing Xu, Hai-Jiao Xing, Xuan-Ping Zhang, Xin Zhang, Yu-Zhu Du, Jun-Lei Li, Qing-Qing Yang, Xin-Xin Feng, Chun-Sheng Jia, Jian-Ling Wang
OBJECTIVE: To explore the rule of clinical application of auricular acupuncture therapy by data mining in order to guide clinical practice. METHODS: The data base about single auricular acupuncture therapy for different clinical diseases was established by collection, sorting, screening, recording, collation, data extraction, statistic analysis on data samples from journals, academic theses dissertations published in near 60 years. The application rules of auricular therapy including its predominant diseases, stimulus modality, therapeutic effect, and angle of needling were summarized by data mining technique...
February 25, 2017: Zhen Ci Yan Jiu, Acupuncture Research
https://www.readbyqxmd.com/read/29056858/innovative-partnerships-to-advance-public-health-training-in-community-based-academic-residency-programs
#18
Joan C Lo, Thomas E Baudendistel, Abhay Dandekar, Phuoc V Le, Stanton Siu, Bruce Blumberg
Collaborative partnerships between community-based academic residency training programs and schools of public health, represent an innovative approach to training future physician leaders in population management and public health. In Kaiser Permanente Northern California, development of residency-Masters in Public Health (MPH) tracks in the Internal Medicine Residency and the Pediatrics Residency programs, with MPH graduate studies completed at the University of California Berkeley School of Public Health, enables physicians to integrate clinical training with formal education in epidemiology, biostatistics, health policy, and disease prevention...
2017: Advances in Medical Education and Practice
https://www.readbyqxmd.com/read/29045276/impact-of-required-versus-self-directed-use-of-virtual-patient-cases-on-clerkship-performance-a-mixed-methods-study
#19
Sarang Kim, Laura R Willett, Wilbur J Pan, Joyce Afran, John A Walker, Judy A Shea
PURPOSE: To explore how students use and benefit from virtual patient cases (VPCs). METHOD: In academic years 2013-2014 and 2014-2015, cohorts of students in pediatrics (Peds), family medicine (FM), and internal medicine (IM) clerkships were allocated to either core required use (CRU) or self-directed use (SU) of MedU VPCs. Outcomes included number and time of case review, student perception of learning from VPCs, National Board of Medical Examiners (NBME) subject examination scores, and summative clinical ratings for medical knowledge and differential diagnoses/problem solving...
October 17, 2017: Academic Medicine: Journal of the Association of American Medical Colleges
https://www.readbyqxmd.com/read/29035190/brain-tumor-epidemiology-in-the-era-of-precision-medicine-the-2017-brain-tumor-epidemiology-consortium-meeting-report
#20
Kimberly J Johnson, Judith Schwartzbaum, Carol Kruchko, Michael E Scheurer, Ching C Lau, Adelheid Woehrer, Johannes A Hainfellner, Joseph Wiemels
The Brain Tumor Epidemiology Consortium (BTEC) is an international consortium that aims to advance the development of multicenter and interdisciplinary collaborations that focus on research related to the etiology, outcomes, and prevention of brain tumors. The 18th annual BTEC meeting was held in Banff, AB, Canada, on June 27 - 29, 2017. The meeting focused on the intersection between epidemiology and precision medicine, that is, the use of molecular indicators of risk, early disease and prognosis or precision epidemiology...
October 16, 2017: Clinical Neuropathology
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