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Compassionate use

V Cox, G Brigden, R H Crespo, E Lessem, S Lynch, M L Rich, B Waning, J Furin
SETTING: The World Health Organization recommended two new drugs, bedaquiline (BDQ) and delamanid (DLM), for the treatment of multidrug-resistant tuberculosis (MDR-TB) in 2013 and 2014, respectively. An estimated one third of patients with MDR-TB would benefit from the inclusion of these drugs in their treatment regimens. DESIGN: A convenience sample of 36 countries voluntarily reported monthly data on cumulative programmatic use of new drugs to the Drug-Resistant TB Scale-Up Treatment Action Team between 1 July 2015 and 31 June 2017...
April 1, 2018: International Journal of Tuberculosis and Lung Disease
Jessica Alber, Kelly McGarry, Richard B Noto, Peter J Snyder
Background: Recent genome-wide association screening (GWAS) studies have linked Alzheimer's disease (AD) neuropathology to gene networks that regulate immune function. Kan et al. recently reported that Arg1 (an anti-inflammatory gene that codes for arginase-1) is expressed in parts of the brain associated with amyloidosis prior to the onset of neuronal loss, suggesting that chronic brain arginine deprivation promotes AD-related neuropathology. They blocked arginine catabolism in their mouse AD model by administration of eflornithine (DFMO) to juvenile animals, effectively blocking the expression of AD-related amyloid pathology as the mice aged...
2018: Frontiers in Aging Neuroscience
Angela Grocott, Wilfred McSherry
(1) Background: There is limited empirical knowledge concerning aspects of healthcare that contribute to a good patient experience from the patient's perspective and how patient feedback informs service development. (2) Aim: To examine the issues that influence the effectiveness of communication on patient satisfaction, experience and engagement, in an acute National Health Service (NHS) setting, through identification of the patient's requirements and expectations. (3) Method: Data was gathered from a large teaching hospital using a Friends and Family Test (FFT) and a communication specific survey...
March 20, 2018: Healthcare (Basel, Switzerland)
Francesca Forti, Dwayne R Roach, Marco Cafora, Maria E Pasini, David S Horner, Ersilia V Fiscarelli, Martina Rossitto, Lisa Cariani, Federica Briani, Laurent Debarbieux, Daniela Ghisotti
The alarming diffusion of multidrug resistant (MDR) bacterial strains requires investigations on non-antibiotic therapies. Amongst them, the use of bacteriophages (phages) as antimicrobial agents, namely phage therapy, is a promising treatment strategy with support by recent successful compassionate treatments in Europe and the U.S.A. In this work, we combined host range and genomic information to design a 6-phage cocktail killing several clinical strains of P. aeruginosa , including those collected from Italian cystic fibrosis (CF) patients, and analyzed the cocktail performance...
March 19, 2018: Antimicrobial Agents and Chemotherapy
C Ranieri, S Di Tommaso, D C Loconte, V Grossi, P Sanese, R Bagnulo, F C Susca, G Forte, A Peserico, A De Luisi, A Bartuli, A Selicorni, D Melis, M Lerone, A D Praticò, G Abbadessa, Y Yu, B Schwartz, Martino Ruggieri, Cristiano Simone, Nicoletta Resta
Postzygotic mutations of the PIK3CA [phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha] gene constitutively activate the PI3K/AKT/mTOR pathway in PIK3CA-related overgrowth spectrum (PROS) patients, causing congenital mosaic tissue overgrowth that even multiple surgeries cannot solve. mTOR inhibitors are empirically tested and given for compassionate use in these patients. PROS patients could be ideal candidates for enrolment in trials with PI3K/AKT pathway inhibitors, considering the "clean" cellular setting in which a unique driver, a PIK3CA mutation, is present...
March 16, 2018: Neurogenetics
Debora de Souza Santos, Silvana Martins Mishima, Emerson Elias Merhy
This is a study with a qualitative approach that aims to analyze the subjective dimension of the Family Health teams' practices conducted in order to reconfigure the care model, using the work process in health as the fundamental analytical category from the Marxist standpoint. The data gathering tool used was the focus group, applied in 13 Family Health teams in Maceió, Alagoas. Thematic analysis combined with principles of hermeneutics and dialectics was used for treatment and interpretation of the data...
March 2018: Ciência & Saúde Coletiva
Ludovica De Panfilis, Roberto Satolli, Massimo Costantini
BACKGROUND: This article proposes a retrospective analysis of a compassionate use (CU), using a case study of request for Avelumab for a patient suffering from Merkel Cell Carcinoma. The study is the result of a discussion within a Provincial Ethics Committee (EC) following the finding of a high number of requests for CU program. The primary objective of the study is to illustrate the specific ethical and clinical profiles that emerge from the compassionate use program (CUP) issue. The secondary goals are: a) to promote a moral reflection among physicians who require approval for the CUP and b) provide the basis for recommendations on how to request CUP...
March 9, 2018: BMC Medical Ethics
Jerome Soquet, Roberto Chiletti, Stephen Horton, Igor E Konstantinov, Johann Brink, Christian P Brizard, Warwick Butt, Yves d'Udekem
BACKGROUND: In 2011 we reported unfavourable outcomes of second-run extracorporeal life support (ECLS) in children. We wanted to investigate whether this previous report affected our strategy and modified our long-term outcomes. METHODS: Between 1988 and 2015, 31 patients underwent a second-run ECLS. Median age at the time of first support was 9days (0-16 years). Median length of support for the first and second runs were 4.7days (0.1-10) and 3.6days (0.5-8.7) respectively, with an interval of 1...
February 13, 2018: Heart, Lung & Circulation
Vinayak Dev, Antonio T Fernando, Anecita Gigi Lim, Nathan S Consedine
BACKGROUND: Burnout has numerous negative consequences for nurses, potentially impairing their ability to deliver compassionate patient care. However, the association between burnout and compassion and, more specifically, barriers to compassion in medicine is unclear. This article evaluates the associations between burnout and barriers to compassion and examines whether dispositional self-compassion might mitigate this association. HYPOTHESIS: Consistent with prior work, the authors expected greater burnout to predict greater barriers to compassion...
February 21, 2018: International Journal of Nursing Studies
Rebecca Feo, Alison Kitson, Tiffany Conroy
AIMS AND OBJECTIVES: To investigate how fundamental aspects of nursing care have been defined in the literature from 2010-2016. BACKGROUND: A 2010 narrative review of nursing texts identified little consensus on what constitutes the fundamental aspects of nursing care. Since then there has been a proliferation of policies, strategic frameworks and research teams dedicated to investigating such care. It is unclear whether this increased activity has led to greater conceptual clarity...
March 7, 2018: Journal of Clinical Nursing
Leonard M Fleck
Meeting healthcare needs is a matter of social justice. Healthcare needs are virtually limitless; however, resources, such as money, for meeting those needs, are limited. How then should we (just and caring citizens and policymakers in such a society) decide which needs must be met as a matter of justice with those limited resources? One reasonable response would be that we should use cost effectiveness as our primary criterion for making those choices. This article argues instead that cost-effectiveness considerations must be constrained by considerations of healthcare justice...
April 2018: Cambridge Quarterly of Healthcare Ethics: CQ: the International Journal of Healthcare Ethics Committees
Victor H F Lee
A 65-year-old female with diabetes mellitus but otherwise good health in the past suffered from cough with occasional blood-stained sputum during initial presentation. The patient was diagnosed with pulmonary poorly differentiated adenocarcinoma with an epidermal growth factor receptor (EGFR) exon 19 deletion and hence received afatinib therapy for 25 months without obvious adverse events except for a grade 1-2 acneiform rash. The disease was stabilized after subsequent cycles of chemotherapy with pemetrexed and carboplatin followed by maintenance pemetrexed...
March 2018: Asia-Pacific Journal of Clinical Oncology
Sarah McAnaw, Carly A Rodriguez, Abbe Muller, Carole Mitnick, C Robert Horsburgh
No abstract text is available yet for this article.
February 1, 2018: International Journal of Tuberculosis and Lung Disease
Allison M Cummins, Raechel Wight, Nicole Watts, Christine Catling
OBJECTIVE: first year midwifery students learn early in semester about situations in midwifery where a high level of emotion is expressed, such as taking a sexual history, being faced with the body image changes of pregnancy and working with women in the extreme pain of labour. Commencing students usually have not had exposure to the realities of studying and working in midwifery, and often have an idealised view of midwifery that may lead to attrition from the course. We aimed to equip students with personal and professional tools to discuss sensitive issues in midwifery and promote self-care through the development of two workshops...
February 15, 2018: Midwifery
Amy L Haycraft
Opioid use disorder (OUD) in pregnancy is increasing, which often results in poor maternal and neonatal outcomes including neonatal abstinence syndrome (NAS) as a result of lack of prenatal care and inadequate substance use disorder management. Practice guidelines have been developed to manage OUD during and after pregnancy for mother and baby, but barriers exist, limiting comprehensive implementation. To reduce the impact of OUD in pregnancy and associated maternal and neonatal sequela, implementing compassionate evidence-based care and a non-punitive response is needed...
March 1, 2018: Journal of Psychosocial Nursing and Mental Health Services
François Huchet, Jean Christian Roussel, Vincent Letocart, Thibaut Manigold
AIMS: TAVR implantation in unicuspid aortic valve has rarely been reported previously, due to the rareness of this morphology. This case tries to bring answers to some challenges we may have to face in TAVR current practice. METHODS AND RESULTS: We describe the case of a cardiogenic shock complicating a pure native regurgitating and non-calcified unicuspid aortic valve, in a 40 years old woman without medical follow up. Conventional treatment options such as valve surgery or heart transplantation were denied due to extreme operative risk and multiple allo-immunizations...
February 27, 2018: EuroIntervention
Christian Maurer, Arlindo R Ferreira, Samuel Martel, Matteo Lambertini, Noam Pondé, Philippe Aftimos, Evandro de Azambuja, Martine Piccart
This is a single center retrospective analysis of patients with hormone receptor-positive, HER2-negative metastatic breast cancer progressing after ≥ 4 treatment lines treated with palbociclib in combination with endocrine therapy within a compassionate use program. Thirty-four patients were included between 10/2015 and 02/2017, the majority (82.4%) being previously treated with mTOR inhibitors. Disease control rate was 52.9% and 24.4% at week 12 and 24. Overall progression-free survival was 3.1 months with no difference between mTOR inhibitor-pretreated (3...
February 20, 2018: Breast: Official Journal of the European Society of Mastology
Alex R Kelman, Benjamin S Evare, Alinne Z Barrera, Ricardo F Muñoz, Paul Gilbert
OBJECTIVE: Depression is a prevalent and costly mental health problem that affects women as well as their larger communities, with substantial impacts on mother and infant during childbearing years. Face-to-face care has not adequately addressed this global concern due to difficulties in scaling these resources. Internet interventions, which can provide psychological tools to those lacking adequate access, show promise in filling this void. METHOD: We conducted a 2-condition proof-of-concept pilot randomized trial comparing brief Internet-based cognitive behavioural therapy (CBT) and brief Internet-based compassionate mind training (CMT) for women who are currently pregnant, became pregnant within the last year, and intend to become pregnant in the future...
February 23, 2018: Clinical Psychology & Psychotherapy
Jacques Young, Jerome Bertherat, Marie Christine Vantyghem, Olivier Chabre, Salima Senoussi, Rita Chadarevian, Frédéric Castinetti
OBJECTIVE: Ketoconazole (KTZ) is one of few available treatments for Cushing's syndrome (CS). Although KTZ has been associated with severe hepatotoxicity, little information is available about hepatic safety in CS. The aim of this study was to document changes in liver function in patients with CS treated with KTZ. DESIGN: An observational prospective French cohort study (compassionate use programme). METHODS: Enrolled patients were stratified into a KTZ-naive cohort and a cohort already treated by another formulation of ketoconazole (KTZ-switch cohort)...
February 22, 2018: European Journal of Endocrinology
Lisa Jane Gould, Peter Griffiths, Hannah Ruth Barker, Paula Libberton, Ines Mesa-Eguiagaray, Ruth M Pickering, Lisa Jane Shipway, Jackie Bridges
OBJECTIVE: Compassionate care continues to be a focus for national and international attention, but the existing evidence base lacks the experimental methodology necessary to guide the selection of effective interventions for practice. This study aimed to evaluate the Creating Learning Environments for Compassionate Care (CLECC) intervention in improving compassionate care. SETTING: Ward nursing teams (clusters) in two English National Health Service hospitals randomised to intervention (n=4) or control (n=2)...
February 22, 2018: BMJ Open
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