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Lucy Doos, Derek Ward, Andrew Stevens, Claire Packer
OBJECTIVES: To determine the accuracy of pharmaceutical companies' predictions of drug licensing timeframes for their products in late stage clinical development. METHODS: We compared predicted licensing dates provided to the National Institute for Health Research Horizon Scanning Research and Intelligence Centre by pharmaceutical companies against actual marketing authorisation application (MAA) and marketing authorisation (MA) dates published by the European Medicines Agency for drugs granted authorisation between 2009 and 2013...
June 2016: Journal of Pharmaceutical Health Services Research
Clara Crunkhorn, Mieke van Driel, Van Nguyen, Treasure McGuire
AIM: This study explored consumer knowledge gaps and concerns regarding medication use in children. METHODS: Calls concerning or made by people under 18 to the pharmacist-operated, national consumer medicines call centre National Prescribing Service Medicines Line (2002 to June 2010) were analysed. Calls were classified and narratively explored by age group: <1, 1-4, 5-14 and 15-17 years. Consumer Medication Information (CMI) and evidence-based resources were examined to determine information concordance for common questions...
September 23, 2016: Journal of Paediatrics and Child Health
Eva L Pijpers, Sanne Kreijkamp-Kaspers, Treasure M McGuire, Laura Deckx, Wendy Brodribb, Mieke L van Driel
BACKGROUND: For many medicines, safe use during pregnancy is not established and adherence is often poor due to safety concerns. Therefore, it is important to identify consumers' medicines information needs during pregnancy. MATERIALS AND METHODS: A retrospective, mixed methods analysis was conducted on eight years of pregnancy-related calls to an Australian national medicines call centre. The call profile of pregnancy and non-pregnancy-related questions were compared...
September 14, 2016: Australian & New Zealand Journal of Obstetrics & Gynaecology
Marie Westwood, Bram Ramaekers, Shona Lang, Nigel Armstrong, Caro Noake, Shelley de Kock, Manuela Joore, Johan Severens, Jos Kleijnen
BACKGROUND: Allergy is a form of immune-mediated exaggerated sensitivity (hypersensitivity) to a substance that is either inhaled, swallowed, injected or comes into contact with the skin. Foreign substances that provoke allergies are called allergens. It has been claimed that multiplex allergen testing may help in diagnosing the cause of symptoms in patients with an unclear cause of allergy or who are allergic to more than one substance. OBJECTIVES: To evaluate multiplex allergen testing [devices that can measure the presence of multiple immunoglobulin E (IgE) antibodies in a patient's blood at the same time], by assessing (1) clinical effectiveness (allergy symptoms, incidence of acute exacerbations, mortality, adverse events of testing and treatment, health-care presentations or admissions, health-related quality of life); (2) effects on treatment (diet, immunotherapy medications, other potential testing); (3) any additional diagnostic information provided by multiplex allergen testing; and (4) cost-effectiveness (cost of different assessment strategies)...
September 2016: Health Technology Assessment: HTA
Leàn Rolfes, Judith Kolfschoten, Florence van Hunsel, Michel Kooijman, Eugène van Puijenbroek
BACKGROUND: There is limited information on actions taken in response to drug safety signals originating from a spontaneous reporting system (SRS) in pharmacovigilance. In The Netherlands the Pharmacovigilance Centre Lareb is an independent organization that works in close collaboration with the Dutch regulatory agency, the Medicines Evaluation Board (MEB). OBJECTIVE: The objective of this study is to gain insight in steps undertaken on signals originating from the SRS and disseminated by Lareb from 2008-2012...
August 22, 2016: International Journal of Risk & Safety in Medicine
Kamel Mohammedi, Louis Potier, Maud François, Dured Dardari, Marilyne Feron, Estelle Nobecourt-Dupuy, Manuel Dolz, Roxane Ducloux, Abdelkader Chibani, Dominique-François Eveno, Teresa Crea Avila, Ariane Sultan, Laurence Baillet-Blanco, Vincent Rigalleau, Gilberto Velho, Florence Tubach, Ronan Roussel, Jean-Claude Dupré, Dominique Malgrange, Michel Marre
BACKGROUND: Off-loading is essential for diabetic foot management, but remains understudied. The evaluation of Off-loading using a new removable oRTHOsis in DIABetic foot (ORTHODIAB) trial aims to evaluate the efficacy of a new removable device "Orthèse Diabète" in the healing of diabetic foot. METHODS/DESIGN: ORTHODIAB is a French multi-centre randomized, open label trial, with a blinded end points evaluation by an adjudication committee according to the Prospective Randomized Open Blinded End-point...
2016: Journal of Foot and Ankle Research
Nanna Christiansen, Zinab Kehk, Susan Keeling, Bryony Dean
AIM: The use of displacement values (DVs) when preparing intravenous (IV) medication for children enables accurate doses to be given1 and is assumed to be common paediatric practice. This survey aimed to assess views of UK paediatric pharmacists on DVs in practice to explore:▸ How prevalent is DV use in the paediatric hospital setting▸ Which type of IV administration guidelines were being used▸ Which form of DV presentation is perceived to be most practical▸ Which method of calculation is preferred METHOD: A national cross-sectional survey study was undertaken...
September 2016: Archives of Disease in Childhood
Stacey A Page, Kiran Pohar Manhas, Daniel A Muruve
BACKGROUND: Personal health information and biospecimens are valuable research resources essential for the advancement of medicine and protected by national standards and provincial statutes. Research ethics and privacy standards attempt to balance individual interests with societal interests. However these standards may not reflect public opinion or preferences. The purpose of this study was to assess the opinions and preferences of patients with kidney disease about the use of their health information and biospecimens for medical research...
2016: BMC Medical Ethics
Don Chalmers, Dianne Nicol, Jane Kaye, Jessica Bell, Alastair V Campbell, Calvin W L Ho, Kazuto Kato, Jusaku Minari, Chih-Hsing Ho, Colin Mitchell, Fruzsina Molnár-Gábor, Margaret Otlowski, Daniel Thiel, Stephanie M Fullerton, Tess Whitton
Biobanks have been heralded as essential tools for translating biomedical research into practice, driving precision medicine to improve pathways for global healthcare treatment and services. Many nations have established specific governance systems to facilitate research and to address the complex ethical, legal and social challenges that they present, but this has not lead to uniformity across the world. Despite significant progress in responding to the ethical, legal and social implications of biobanking, operational, sustainability and funding challenges continue to emerge...
2016: BMC Medical Ethics
Kun Hyung Kim, Myeong Soo Lee, Tae-Hun Kim, Jung Won Kang, Tae-Young Choi, Jae Dong Lee
BACKGROUND: People living with chronic kidney disease (CKD) experience a range of symptoms and often have complex comorbidities. Many pharmacological interventions for people with CKD have known risks of adverse events. Acupuncture is widely used for symptom management in patients with chronic diseases and in other palliative care settings. However, the safety and efficacy of acupuncture for people with CKD remains largely unknown. OBJECTIVES: We aimed to evaluate the benefits and harms of acupuncture, electro-acupuncture, acupressure, moxibustion and other acupuncture-related interventions (alone or combined with other acupuncture-related interventions) for symptoms of CKD...
2016: Cochrane Database of Systematic Reviews
Janet Heaton, Nicky Britten, Janet Krska, Joanne Reeve
: Aim To examine how patient perspectives and person-centred care values have been represented in documents on medicines optimisation policy in England. BACKGROUND: There has been growing support in England for a policy of medicines optimisation as a response to the rise of problematic polypharmacy. Conceptually, medicines optimisation differs from the medicines management model of prescribing in being based around the patient rather than processes and systems. This critical examination of current official and independent policy documents questions how central the patient is in them and whether relevant evidence has been utilised in their development...
June 16, 2016: Primary Health Care Research & Development
Stephanie M Lau, Treasure M McGuire, Mieke L van Driel
OBJECTIVES: To identify consumer information needs about paracetamol, the most commonly used analgesic and antipyretic worldwide. DESIGN: Retrospective analysis of medicines questions from the public. SETTING: Australian consumer medicines call centre. PARTICIPANTS: Callers to National Prescribing Service Medicines Line between September 2002 and June 2010 (n=123 217). MAIN OUTCOME MEASURES: Enquiry profile: demographics, enquiry type and concurrent medicines included in paracetamol calls; question themes derived from subset of call narratives...
2016: BMJ Open
Alexis Llewellyn, Rita Faria, Beth Woods, Mark Simmonds, James Lomas, Nerys Woolacott, Susan Griffin
The National Institute for Health and Care Excellence (NICE) invited the manufacturer of daclatasvir (Bristol-Myers Squibb) to submit clinical and cost-effectiveness evidence for daclatasvir in combination with other medicinal products within its licensed indication for the treatment of chronic hepatitis C, as part of the Institute's single technology appraisal process. The Centre for Reviews and Dissemination and Centre for Health Economics at the University of York were commissioned to act as the independent Evidence Review Group (ERG)...
October 2016: PharmacoEconomics
John K Field, Stephen W Duffy, David R Baldwin, Kate E Brain, Anand Devaraj, Tim Eisen, Beverley A Green, John A Holemans, Terry Kavanagh, Keith M Kerr, Martin Ledson, Kate J Lifford, Fiona E McRonald, Arjun Nair, Richard D Page, Mahesh Kb Parmar, Robert C Rintoul, Nicholas Screaton, Nicholas J Wald, David Weller, David K Whynes, Paula R Williamson, Ghasem Yadegarfar, David M Hansell
BACKGROUND: Lung cancer kills more people than any other cancer in the UK (5-year survival < 13%). Early diagnosis can save lives. The USA-based National Lung Cancer Screening Trial reported a 20% relative reduction in lung cancer mortality and 6.7% all-cause mortality in low-dose computed tomography (LDCT)-screened subjects. OBJECTIVES: To (1) analyse LDCT lung cancer screening in a high-risk UK population, determine optimum recruitment, screening, reading and care pathway strategies; and (2) assess the psychological consequences and the health-economic implications of screening...
May 2016: Health Technology Assessment: HTA
Qin Wang, Taixiang Wu, Xiao Y Chen, Xin Duan, Jie Zheng, Jieqi Qiao, Likun Zhou, Jiafu Wei, Juan Ni
No abstract text is available yet for this article.
2016: Cochrane Database of Systematic Reviews
Kennedy Obebi Cliff-Eribo, Helen Sammons, Kristina Star, I Ralph Edwards, Adeline Osakwe, Imti Choonara
BACKGROUND: Adverse drug reactions (ADRs) in children recorded in national pharmacovigilance databases in high-income countries have been analysed. Nigeria has a population of 31 million children and became a member of the WHO Programme for International Drug Monitoring in 2004 since when it has been submitting reports of suspected ADRs to the WHO Global Individual Case Safety Report database, VigiBase. OBJECTIVE: To gain information on reported ADRs in Nigerian children aged 0-17 years in VigiBase from 2005 to 2012...
January 29, 2016: Paediatrics and International Child Health
Olga P Nyssen, Stephanie J C Taylor, Geoff Wong, Elizabeth Steed, Liam Bourke, Joanne Lord, Carol A Ross, Sheila Hayman, Victoria Field, Ailish Higgins, Trisha Greenhalgh, Catherine Meads
BACKGROUND: Writing therapy to improve physical or mental health can take many forms. The most researched model of therapeutic writing (TW) is unfacilitated, individual expressive writing (written emotional disclosure). Facilitated writing activities are less widely researched. DATA SOURCES: Databases, including MEDLINE, EMBASE, PsycINFO, Linguistics and Language Behaviour Abstracts, Allied and Complementary Medicine Database and Cumulative Index to Nursing and Allied Health Literature, were searched from inception to March 2013 (updated January 2015)...
April 2016: Health Technology Assessment: HTA
Kathleen Anne Holloway, Laura Rosella, David Henry
BACKGROUND: Inappropriate overuse of antibiotics contributes to antimicrobial resistance (AMR), yet policy implementation to reduce inappropriate antibiotic use is poor in low and middle-income countries. AIMS: To determine whether public sector inappropriate antibiotic use is lower in countries reporting implementation of selected essential medicines policies. MATERIALS AND METHODS: Results from independently conducted antibiotic use surveys in countries that did, and did not report implementation of policies to reduce inappropriate antibiotic prescribing, were compared...
2016: PloS One
Prabhoo Dayal, Yatan Pal Singh Balhara
BACKGROUND & OBJECTIVES: There has been a limited focus on prescription drug abuse among women in the country. Choice of psychoactive substance, reasons for initiation and co-occurring disorders have been found to be different among men and women. The current study was aimed at studying the profile of female patients seeking in-patient treatment for prescription drug use over a period of five years at a tertiary care drug dependence treatment centre in India. METHODS: Case records of all female patients admitted with substance use disorder at a national level drug dependence treatment centre in north India across five years (between January 2008 and December 2012) were reviewed retrospectively to study their socio-demographic and clinical profile...
January 2016: Indian Journal of Medical Research
Anna Janicka, Robert Z Spaczyńiski, Rafał Kurzawa
OBJECTIVES: The aim of this report is to present data concerning results and complications related to infertility treatment using assisted reproductive technology (ART) and insemination (IUI) in Poland in 2012. MATERIAL AND METHODS: The report was prepared by the Fertility and Sterility Special Interest Group of the Polish Gynaecological Society (SPiN PTG), based on individual data provided by fertility clinics. Reporting was voluntary data were not subject to external verification...
December 2015: Ginekologia Polska
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