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Risk management in clinical trials

Claire M Keene, Arjen Dondorp, Jane Crawley, Eric O Ohuma, Mavuto Mukaka
Background: Malaria burdens global health systems, and management with limited resources requires robust treatment guidelines and comprehensive planning. Expected length of stay (LOS) is useful in health-system planning, and factors influencing it can be targeted to reduce admission time and optimise service delivery. Methods: A secondary survival analysis of 1217 adult severe malaria patients from the South-East Asia Quinine Artesunate Malaria Trial, using a competing-risk approach...
March 19, 2018: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
Wei An, Aisaiti Ainiwaer, Patiguli Wusiman, Gulibusitan Ali, Adili Moming
PURPOSE: The study proposed to determine the superiority between different fixation methods in the mandibular angle fractures (MAFs) and to evaluate best option for surgeon and patient. METHODS: A systematic review was conducted according to PRISMA guidelines, examining Medline-Ovid, Embase, and Pubmed databases. The quality of studies was assessed, and the odds risk (OR) with its corresponding 95% confidence interval (CI) was assessed to measure the effect size...
March 20, 2018: Journal of Craniofacial Surgery
Roberta Venturella, Paola Quaresima, Mariella Micieli, Erika Rania, Annarita Palumbo, Federica Visconti, Fulvio Zullo, Costantino Di Carlo
PURPOSE: To propose an evidence-based review on the most frequent indications for Cesarean section (CS) given by specialists in disciplines other than Obstetrics and Gynecology, with the aim of increasing consciousness about the available data in the literature and the guidelines recommendations about topics that are not frequently managed by obstetricians and gynecologists. METHODS: We analyzed hospital discharge data regarding deliveries occurred in a 10-year study period in our department to obtain the prevalence and the list of the most recurrent non-obstetrical indications for CS...
March 20, 2018: Archives of Gynecology and Obstetrics
(no author information available yet)
BACKGROUND: Bilastine is an H1-antihistamine approved for symptomatic treatment of patients with allergic rhinoconjunctivitis or urticaria. The safety profile of bilastine in clinical trials of allergic rhinoconjunctivitis or urticaria, assessed by type and frequency of adverse events (AE), was similar to that of placebo. OBJECTIVE: As part of the risk management plan for bilastine, the safety profile of bilastine in the elderly was assessed. METHODS: A prospective, multicenter, observational, open-label, 3-month follow-up study was performed to assess the safetyprofile of bilastine 20 mg in patients aged greater than or equal to 65 years with allergic rhinoconjunctivitis and/or urticaria...
March 20, 2018: Allergy and Asthma Proceedings:
Teppei Okamoto, Shingo Hatakeyama, Hirotake Kodama, Hirotaka Horiguchi, Yuka Kubota, Koichi Kido, Masaki Momota, Shogo Hosogoe, Yoshimi Tanaka, Tooru Takashima, Fumitada Saitoh, Tadashi Suzuki, Chikara Ohyama
BACKGROUND: Although aortic calcification has a significant negative impact on prognosis in patients on hemodialysis (HD), risk factors for aortic calcification progression remain unclear. The aim of this study was to investigate the relationship between malnutrition and aortic calcification progression in patients on HD. METHODS: Between April 2015 and October 2016, we treated 232 patients on HD. Of those, we retrospectively evaluated data from 184 patients who had had regular blood tests and computed tomography (CT) scans...
March 20, 2018: BMC Nephrology
Hui Yin Lim, Harshal Nandurkar, Prahlad Ho
The advent of direct oral anticoagulants (DOACs) has revolutionized anticoagulation management in both stroke prevention and venous thromboembolism (VTE) treatment/prevention. Clinical trials and secondary real-world data have shown that DOACs have similar efficacy and, in some cases, improved bleeding safety profiles compared with vitamin K antagonists. Together with benefits of patient convenience, this has shifted the risk-benefit ratio toward long-term anticoagulation. However, current VTE risk assessment models are based on vitamin K antagonists and do not take into account the new paradigm of DOACs...
March 20, 2018: Seminars in Thrombosis and Hemostasis
Emily S Mohn, Hua J Kern, Edward Saltzman, Susan H Mitmesser, Diane L McKay
The long-term use of prescription and over-the-counter drugs can induce subclinical and clinically relevant micronutrient deficiencies, which may develop gradually over months or even years. Given the large number of medications currently available, the number of research studies examining potential drug-nutrient interactions is quite limited. A comprehensive, updated review of the potential drug-nutrient interactions with chronic use of the most often prescribed medications for commonly diagnosed conditions among the general U...
March 20, 2018: Pharmaceutics
Chun-De Liao, Jau-Yih Tsauo, Hung-Chou Chen, Tsan-Hon Liou
OBJECTIVE: Extracorporeal shock wave therapy (ESWT), including radial shock wave (RaSW) and focused shock wave (FoSW) types, is widely used for managing tendinopathies. The difference in efficacy between the 2 shock wave characteristics with different dosage levels remains controversial, and the purpose of this meta-analysis was to examine it for patients with lower extremity (LE) tendinopathy. DESIGN: A comprehensive search of online databases and search engines was performed...
March 19, 2018: American Journal of Physical Medicine & Rehabilitation
Samuel James Alexander Dobson, Kanna Mannadiar Jayaprakasan
We conducted a retrospective review into the role of commonly prescribed conventional adjuvant treatments in improving live birth rates after recurrent miscarriage (RM). Data from 301 couples attending the RM clinic in two Tertiary teaching hospitals were analysed with their live birth rate following a further pregnancy and a prevalence of conditions investigated in RM being the main outcomes measured. We found that 26% of women had explained RM and 74% had unexplained RM. Adjuvant versus conservative management did not improve the live birth rates in those with unexplained RM (68...
March 20, 2018: Journal of Obstetrics and Gynaecology: the Journal of the Institute of Obstetrics and Gynaecology
David Warr
For patients with cancer, the threat of chemotherapy-induced nausea and vomiting (CINV) can greatly influence treatment decisions and overall quality of life. Clinicians now have numerous effective antiemetic therapies to offer to patients, but selecting the optimal strategy can be complicated. Integration of current CINV guidelines, emerging data from recent clinical trials, and patient-specific risk factors can greatly improve antiemetic prophylaxis. Two challenging clinical scenarios are presented and discussed to provide insight on how to best approach these types of treatment decisions and apply recent advances in CINV prevention and management to patient care...
March 19, 2018: Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer
Mark Clemons
Numerous groups have published guidelines for the prevention and management of chemotherapy-induced nausea and vomiting (CINV). The current management of CINV, however, remains suboptimal, due in part to poor adherence to existing antiemetic guidelines. Challenges in clinical trial design have also slowed progress and complicated the selection of optimal antiemetic therapy. In addition, patient-specific characteristics and factors are not included in current CINV guidelines and are an important contributor to an individual's risk for nausea and vomiting...
March 19, 2018: Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer
Frédérique Rodieux, Laszlo Vutskits, Klara M Posfay-Barbe, Walid Habre, Valérie Piguet, Jules A Desmeules, Caroline F Samer
Children represent a vulnerable population in which management of nociceptive pain is complex. Drug responses in children differ from adults due to age-related differences. Moreover, therapeutic choices are limited by the lack of indication for a number of analgesic drugs due to the challenge of conducting clinical trials in children. Furthermore the assessment of efficacy as well as tolerance may be complicated by children's inability to communicate properly. According to the World Health Organization, weak opioids such as tramadol and codeine, may be used in addition to paracetamol and ibuprofen for moderate nociceptive pain in both children and adults...
2018: Frontiers in Pharmacology
Elizabeth Prout Parks, Reneé H Moore, Ziyi Li, Chanelle T Bishop-Gilyard, Andrew R Garrett, Douglas L Hill, Yasmeen P Bruton, David B Sarwer
BACKGROUND: Severe obesity in adolescents has deleterious physical and psychological complications necessitating frequent multi-disciplinary clinic visits. Greater treatment engagement has been equated with weight-loss. However, traditional medical weight-loss programs for adolescents have high attrition rates. Social media is widely used by adolescents and may enhance medical weight management engagement and success. OBJECTIVE: The first objective was to examine the acceptability and feasibility of using a private social media group as an adjunct to medical weight management in youth ages 14 to 20 years with severe obesity [body mass index (BMI) ≥ 35 kg/m2]...
March 19, 2018: JMIR Research Protocols
Sharon E Culliton, Dianne M Bryant, Steven J MacDonald, Kathy M Hibbert, Bert M Chesworth
BACKGROUND: Orthopedic surgeons recognize patient expectations of total knee arthroplasty (TKA) can be managed through education. E-learning is the application of educational technology. The objective of this study was to evaluate whether an e-learning tool could affect whether patients' expectations were met and they were satisfied 1 year following TKA. METHODS: Patients with osteoarthritis from the London Health Sciences Centre, Canada, were randomly assigned to either a control group (n = 207) receiving standard patient education or an intervention group (n = 209) using the e-learning tool in addition to the standard...
February 17, 2018: Journal of Arthroplasty
Chih-Hsing Wu, Shih-Te Tu, Yin-Fan Chang, Ding-Cheng Chan, Jui-Teng Chien, Chih-Hsueh Lin, Sonal Singh, Manikanta Dasari, Jung-Fu Chen, Keh-Sung Tsai
OBJECTIVES: This systematic review and meta-analysis evaluated the outcomes of patients with osteoporosis-related fractures managed through fracture liaison services (FLS) programs. METHODS: Medline, PubMed, EMBASE, and the Cochrane Library were searched (January 2000-February 2017 inclusive) using the keywords 'osteoporosis,' 'fractures,' 'liaison,' and 'service' to identify randomised controlled trials and observational studies of patients aged ≥50 years with osteoporosis-related fractures in hospital, clinic, community, or home-based settings who were managed using FLS...
March 16, 2018: Bone
Chinonso N Igwesi-Chidobe, Andre P Kengne, Isaac O Sorinola, Emma L Godfrey
Background: Physical activity improves physiological, cognitive and psychosocial functioning in chronic non-communicable diseases (NCDs). This study reviewed papers on the effects and patients' experiences of physical activity interventions for chronic NCDs in Africa. Methods: We conducted a systematic review of clinical and qualitative studies by searching eight bibliographic databases and grey literature until 19 April 2017. The mixed-methods appraisal and Cochrane Collaboration's tools were used for quality and risk of bias assessments...
March 15, 2018: International Health
Diana M Sobieraj, Erin R Weeda, Elaine Nguyen, Craig I Coleman, C Michael White, Stephen C Lazarus, Kathryn V Blake, Jason E Lang, William L Baker
Importance: Combined use of inhaled corticosteroids and long-acting β-agonists (LABAs) as the controller and the quick relief therapy termed single maintenance and reliever therapy (SMART) is a potential therapeutic regimen for the management of persistent asthma. Objective: To conduct a systematic review and meta-analysis of the effects of SMART in patients with persistent asthma. Data Sources and Study Selection: The databases of MEDLINE via OVID, EMBASE, the Cochrane Central Register of Controlled Trials, and the Cochrane Database of Systematic Reviews were searched from database inception through August 2016 and updated through November 28, 2017...
March 19, 2018: JAMA: the Journal of the American Medical Association
Diana M Sobieraj, William L Baker, Elaine Nguyen, Erin R Weeda, Craig I Coleman, C Michael White, Stephen C Lazarus, Kathryn V Blake, Jason E Lang
Importance: Long-acting muscarinic antagonists (LAMAs) are a potential adjunct therapy to inhaled corticosteroids in the management of persistent asthma. Objective: To conduct a systematic review and meta-analysis of the effects associated with LAMA vs placebo or vs other controllers as an add-on therapy to inhaled corticosteroids and the use of a LAMA as add-on therapy to inhaled corticosteroids and long-acting β-agonists (LABAs; hereafter referred to as triple therapy) vs inhaled corticosteroids and LABA in patients with uncontrolled, persistent asthma...
March 19, 2018: JAMA: the Journal of the American Medical Association
Güldane Cengiz Seval, Pervin Topçuoğlu, Taner Demirer
Hematopoietic stem cell transplantation is an established treatment for patients with a wide range of malignant and nonmalignant conditions. Noninfectious pulmonary complications still remain a leading cause of morbidity and mortality in these patients. Treating hematopoietic stem cell transplantation recipients with noninfectious pulmonary complications is still challenging, and the current treatment armamentarium and strategies are not adequate for patients receiving hematopoietic stem cell transplantation...
March 15, 2018: Balkan Medical Journal
Yasuhiro Fujisawa, Koji Yoshino, Taku Fujimura, Yoshiyuki Nakamura, Naoko Okiyama, Yosuke Ishitsuka, Rei Watanabe, Manabu Fujimoto
The most widely accepted treatment for cutaneous angiosarcoma (CAS) is wide local excision and postoperative radiation to decrease the risk of recurrence. Positive surgical margins and large tumors (T2, >5 cm) are known to be associated with poor prognosis. Moreover, T2 tumors are known to be associated with positive surgical margins. According to previous reports, the majority of CAS patients in Japan had T2 tumors, whereas less than half of the patients in the studies from western countries did so. Consequently, the reported 5-year overall survival of Japanese CAS patients without distant metastasis was only 9%, lower than that for stage-IV melanoma...
2018: Frontiers in Oncology
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