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generics AND quality

Adam C Fisher, Sau L Lee, Daniel P Harris, Lucinda Buhse, Steven Kozlowski, Lawrence Yu, Michael Kopcha, Janet Woodcock
Failures surrounding pharmaceutical quality, particularly with respect to product manufacturing issues and facility remediation, account for the majority of drug shortages and product recalls in the United States. Major scientific advancements pressure established regulatory paradigms, especially in the areas of biosimilars, precision medicine, combination products, emerging manufacturing technologies, and the use of real-world data. Pharmaceutical manufacturing is increasingly globalized, prompting the need for more efficient surveillance systems for monitoring product quality...
October 20, 2016: International Journal of Pharmaceutics
R Turck
Complaints about cancer drug costs are manifold. While there is excess in some cases and a significant financial burden for patients it appears that the outrage is not always well informed. In recent years innovative cancer drugs have improved patient' survival while better maintaining quality of life. Cancer drug costs represent less than 1% of overall healthcare costs, yet it is estimated that 83% of increased cancer survival can be attributed to new treatments. The challenge is to provide those cancer drugs that best address a patient's needs in the most cost-effective manner...
October 22, 2016: Annals of Oncology: Official Journal of the European Society for Medical Oncology
Julia Quitmann, Anja Rohenkohl, Rachel Sommer, Monika Bullinger, Neuza Silva
BACKGROUND: In the context of health-related quality of life (HrQoL) assessment in pediatric short stature, the present study aimed to examine the levels of agreement/disagreement between parents' and children's reports of generic and condition-specific HrQoL, and to identify socio-demographic, clinical and psychosocial variables associated with the extent and direction of parent-child discrepancies. METHODS: This study was part of the retest phase of the QoLISSY project, which was a multicenter study conducted simultaneously in France, Germany, Spain, Sweden and UK...
October 21, 2016: Health and Quality of Life Outcomes
K L Haywood, J Brett, E Tutton, S Staniszewska
PURPOSE: Hip fracture is the most common serious injury of older people, often resulting in reduced mobility and loss of independence. However, guidance for the use of patient-reported outcome measures (PROMs) does not exist: we describe the first review to apply internationally endorsed criteria in support of PROM quality and acceptability in this group, and make recommendations for future applications. METHODS: Systematic literature searches of major databases (1980-2015) to identify published evidence of the application and quality of clearly defined measures...
October 20, 2016: Quality of Life Research
Radu Prejbeanu, Dan V Poenaru, Andrei Dan Balanescu, Mihail-Lazar Mioc
PURPOSE: The medial plica (MP) is a normal anatomic structure consisting of a fold in the synovial layer of the joint. Arthroscopic resection is currently used as a gold standard procedure in patients with medial plica syndrome (MPS), but there are few prospective studies that analyze the long-term functional outcomes of plica resection. METHODS: The purpose of this prospective study was to evaluate the long-term results of arthroscopic resection of the medial plicae of the knee...
October 20, 2016: International Orthopaedics
Massimo Del Fabbro, Stefano Corbella, Patrick Sequeira-Byron, Igor Tsesis, Eyal Rosen, Alessandra Lolato, Silvio Taschieri
BACKGROUND: When primary root canal therapy fails, periapical lesions can be retreated with or without surgery. Root canal retreatment is a non-surgical procedure that involves removal of root canal filling materials from the tooth, followed by cleaning, shaping and obturating of the canals. Root-end resection is a surgical procedure that involves exposure of the periapical lesion through an osteotomy, surgical removal of the lesion, removal of part of the root-end tip, disinfection and, commonly, retrograde sealing or filling of the apical portion of the remaining root canal...
October 19, 2016: Cochrane Database of Systematic Reviews
Billingsley Kaambwa, Christine Mpundu-Kaambwa, Robert Adams, Sarah Appleton, Sean Martin, Gary Wittert
OBJECTIVE: To assess the suitability for use within economic evaluation of a widely used sleep-related instrument (the Epworth Sleepiness Scale [ESS]) by examining its convergent and discriminant validity with two widely used generic preference-based instruments (Short-Form 36 [SF-36] and the Assessment of Quality of Life 4 dimensions [AQoL-4D]). METHODS: Data from a cross-section of 2,236 community-dwelling Australian men were analyzed. Convergent validity was investigated using Spearman's correlation, intraclass correlation, and modified Bland-Altman plots, while discriminant validity was examined using Kruskal Wallis tests...
October 18, 2016: Behavioral Sleep Medicine
Albertino Damasceno
Hypertension is the main risk factor for morbidity and mortality in the world. In Sub-Saharan Africa, hypertension, previously almost unknown, is now a major risk factor. A paper recently published showed that mean systolic blood pressure is higher in all regions of Africa compared with other parts of the world, and, most important and contrary to what is happening in the rest of the world, it is increasing in the last years. Another important issue that characterises hypertension in Africa is its extremely low level of awareness and consequently low level of control...
September 2016: Journal of Hypertension
B Krishnan, G Arun Prasad, B Madhan
AIM: Proper and adequate documentation in operation notes is a basic tool of clinical practice with medical and legal implications. An audit was done to ascertain if oral and maxillofacial surgery operative notes in an Indian public sector hospital adhered to the guidelines published by the Royal College of Surgeons England. METHODS: Fifty randomly selected operative notes were evaluated against the guidelines by RCS England with regards to the essential generic components of an operation note...
September 2016: Journal of Maxillofacial and Oral Surgery
James W Varni, Robert J Shulman, Mariella M Self, Shehzad A Saeed, Ashish S Patel, Samuel Nurko, Deborah A Neigut, Miguel Saps, James P Franciosi, Jolanda M Denham, George M Zacur, Chelsea Vaughan Dark, Cristiane B Bendo, John F Pohl
OBJECTIVES: To investigate the multidimensional gastrointestinal symptoms predictors of generic health-related quality of life (HRQOL) in pediatric patients with inflammatory bowel disease (IBD) from the perspectives of pediatric patients and parents. METHODS: The Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptoms Scales and PedsQL 4.0 Generic Core Scales were completed in a 9-site study by 260 families of patients with IBD. Gastrointestinal Symptoms Scales measuring stomach pain, food and drink limits, gas and bloating, constipation, blood in stool, and diarrhea were identified as clinically important symptom differentiators from healthy controls based on prior findings, and subsequently tested for bivariate and multivariate linear associations with overall HRQOL (Generic Core Scales)...
October 5, 2016: Journal of Pediatric Gastroenterology and Nutrition
Bashir Mohamed Elmahi Yousif, Siripen Supakankunti
BACKGROUND: The appropriate use of medicines is essential for the provision of quality health services, patient safety, and the rational use of health resources. In Sudan, general practitioners (GPs) provide 80 % of insured patients' health services. Pharmaceutical service costs have been increasing since 2010. OBJECTIVES: We aimed to use the World Health Organization (WHO) and International Network for the Rational Use of Drugs prescribing indicators to assess prescription quality among GPs in different types of primary healthcare centers (PHCCs) within the National Health Insurance Fund (NHIF) in Gezira State, Sudan...
September 2016: Drugs—Real World Outcomes
Johanne Jeppesen Lomholt, Elisabeth Brammer Jacobsen, Mikael Thastum, Hans Pilegaard
BACKGROUND: The impact of correction of pectus excavatum (PE) on adolescents' health-related quality of life (HRQL) has only been investigated in prospective designs using disease-specific measures and without controls. The aim of this prospective study was to evaluate the HRQL before and after surgical correction of PE using a generic HRQL measure, and to compare the reported level of HRQL before surgery with an age-comparable control group. METHODS: Patients (n=107) and one of their parents (n=106) completed the generic HRQL measure: the Child Health Questionnaire before, 3 months, and 6 months after correction for PE...
September 2016: Annals of Cardiothoracic Surgery
Carl Brunius, Lin Shi, Rikard Landberg
INTRODUCTION: Liquid chromatography-mass spectrometry (LC-MS) is a commonly used technique in untargeted metabolomics owing to broad coverage of metabolites, high sensitivity and simple sample preparation. However, data generated from multiple batches are affected by measurement errors inherent to alterations in signal intensity, drift in mass accuracy and retention times between samples both within and between batches. These measurement errors reduce repeatability and reproducibility and may thus decrease the power to detect biological responses and obscure interpretation...
2016: Metabolomics: Official Journal of the Metabolomic Society
James W Varni, Robert J Shulman, Mariella M Self, Samuel Nurko, Miguel Saps, Shehzad A Saeed, Ashish S Patel, Chelsea Vaughan Dark, Cristiane B Bendo, John F Pohl
OBJECTIVES: To investigate the patient-reported multidimensional gastrointestinal symptoms predictors of generic health-related quality of life (HRQOL) in pediatric patients with functional gastrointestinal disorders (FGIDs). METHODS: The Pediatric Quality of Life Inventory™ (PedsQL™) Gastrointestinal Symptoms Scales and PedsQL™ 4.0 Generic Core Scales were completed in a 9-site study by 259 pediatric patients with functional constipation, functional abdominal pain (FAP), or irritable bowel syndrome (IBS)...
October 14, 2016: Quality of Life Research
Thomas Ebenhan, Isabel Schoeman, Daniel D Rossouw, Anne Grobler, Biljana Marjanovic-Painter, Judith Wagener, Hendrik G Kruger, Mike M Sathekge, Jan Rijn Zeevaart
PURPOSE: Radiopharmaceuticals containing the motive tripeptide arginyl-glycyl-asparatic acid (RGD) are known to target ανβ3 integrins during tumor angiogenesis. A more generic kit radiolabeling procedure accommodating Ga-68 from different generators was developed for NOTA-RGD and evaluated for its versatile use and safety in subsequent in vivo applications. The [(68)Ga]NOTA-RGD kit was further verified for its expected biodistribution and pharmacokinetics in nonhuman primates and its clinical sensitivity to detect solitary pulmonary nodules (SPN) in cancer patients...
October 14, 2016: Molecular Imaging and Biology: MIB: the Official Publication of the Academy of Molecular Imaging
O P Geerse, K Wynia, M Kruijer, M J Schotsman, T J N Hiltermann, A J Berendsen
PURPOSE: Improved survival rates from cancer have increased the need to understand the health-related problems of cancer treatment. We aimed to develop and validate the "Cancer Survivor Core Set" representing the most relevant health-related problems in adult cancer survivors using the International Classification of Functioning, Disability, and Health (ICF). METHODS: First, a Delphi study was conducted to select ICF categories representing the most relevant health-related problems...
October 14, 2016: Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer
Mervi Flinkman, Helena Leino-Kilpi, Olivia Numminen, Yunsuk Jeon, Liisa Kuokkanen, Riitta Meretoja
AIM: To report a systematic and psychometric review. BACKGROUND: The Nurse Competence Scale is currently the most widely used generic instrument to measure registered nurses' competence in different phases of their careers. Based on a decade of research, this review provides a summary of the existing evidence. DESIGN: A systematic literature review of research evidence and psychometric properties. DATA SOURCES: Nine databases from 2004 - October 2015...
October 12, 2016: Journal of Advanced Nursing
Wanda G Wright, Avron Spiro, Judith A Jones, Sharron E Rich, Raul I Garcia
OBJECTIVE: The aim of this study was to develop the Teen Oral Health-Related Quality of Life instrument (TOQOL) and demonstrate its validity and reliability in a diverse sample of 13-18-year-old adolescents. METHODS: A total of 363 adolescents aged 13-18 years participated in this cross sectional study. Oral screening examinations were conducted to collect oral health status data. Adolescents completed the TOQOL and a generic measure of health-related quality of life, the PedsQL...
October 12, 2016: Journal of Public Health Dentistry
Douglas P Sladen, Matthew L Carlson, Brittany P Dowling, Amy P Olund, Kathryn Teece, Melissa D DeJong, Alyce Breneman, Ann Peterson, Charles W Beatty, Brian A Neff, Colin L Driscoll
OBJECTIVES/HYPOTHESIS: This study was designed to examine speech recognition and self-perceived health-related quality of life (HRQoL) received from cochlear implantation among a cohort of adults and children with a short duration of unilateral hearing loss greater than 6 months, but less than 2 years. STUDY DESIGN: Single-subject repeated measures prospective study. METHODS: This study assessed changes in speech recognition and self-perceived quality of life by prospectively analyzing data at the preoperative evaluation and at the 3-month and 6-month postactivation intervals...
October 12, 2016: Laryngoscope
Hoang V T Ho, John L Sievenpiper, Andreea Zurbau, Sonia Blanco Mejia, Elena Jovanovski, Fei Au-Yeung, Alexandra L Jenkins, Vladimir Vuksan
Oats are a rich source of β-glucan, a viscous, soluble fibre recognised for its cholesterol-lowering properties, and are associated with reduced risk of CVD. Our objective was to conduct a systematic review and meta-analysis of randomised-controlled trials (RCT) investigating the cholesterol-lowering potential of oat β-glucan on LDL-cholesterol, non-HDL-cholesterol and apoB for the risk reduction of CVD. MEDLINE, Embase, CINAHL and Cochrane CENTRAL were searched. We included RCT of ≥3 weeks of follow-up, assessing the effect of diets enriched with oat β-glucan compared with controlled diets on LDL-cholesterol, non-HDL-cholesterol or apoB...
October 2016: British Journal of Nutrition
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