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Clinical uncertainty

A Tiwari, H Luo, X Chen, P Singh, I Bhattacharya, P Jasper, J E Tolsma, H M Jones, A Zutshi, A K Abraham
Understanding pharmacological target coverage is fundamental in drug discovery and development as it helps establish a sequence of research activities, from laboratory objectives to clinical doses. To this end, we evaluated the impact of tissue target concentration data on the level of confidence in tissue coverage predictions using a site of action (SoA) model for antibodies. By fitting the model to increasing amounts of synthetic tissue data and comparing the uncertainty in SoA coverage predictions, we confirmed that, in general, uncertainty decreases with longitudinal tissue data...
October 22, 2016: CPT: Pharmacometrics & Systems Pharmacology
Benjamin Kearns, Abdullah Pandor, Matt Stevenson, Jean Hamilton, Duncan Chambers, Mark Clowes, John Graham, M Satish Kumar
As part of its single technology appraisal (STA) process, the National Institute for Health and Care Excellence (NICE) invited the company that manufactures cabazitaxel (Jevtana(®), Sanofi, UK) to submit evidence for the clinical and cost effectiveness of cabazitaxel for treatment of patients with metastatic hormone-relapsed prostate cancer (mHRPC) previously treated with a docetaxel-containing regimen. The School of Health and Related Research Technology Appraisal Group at the University of Sheffield was commissioned to act as the independent Evidence Review Group (ERG)...
October 22, 2016: PharmacoEconomics
Alexander Romagna, Marcus Unterrainer, Christine Schmid-Tannwald, Matthias Brendel, Jörg-Christian Tonn, Silke Birgit Nachbichler, Alexander Muacevic, Peter Bartenstein, Friedrich-Wilhelm Kreth, Nathalie Lisa Albert
BACKGROUND: After focused high dose radiotherapy of brain metastases, differentiation between tumor recurrence and radiation-induced lesions by conventional MRI is challenging. This study investigates the usefulness of dynamic O-(2-(18)F-Fluoroethyl)-L-Tyrosine positron emission tomography ((18)F-FET PET) in patients with MRI-based suspicion of tumor recurrence after focused high dose radiotherapy of brain metastases. METHODS: Twenty-two patients with 34 brain metastases (median age 61...
October 21, 2016: Radiation Oncology
Stina Lou, Camilla P Nielsen, Lone Hvidman, Olav B Petersen, Mette B Risør
BACKGROUND: It is well documented that pregnant women experience increased worry and uncertainty following a high-risk prenatal screening result. While waiting for diagnostic results this worry continues to linger. It has been suggested that high-risk women put the pregnancy mentally 'on hold' during this period, however, not enough is known about how high-risk women and their partners cope while waiting for diagnostic results. The aim of this study was to identify the strategies employed to cope with worry and uncertainty...
October 21, 2016: BMC Pregnancy and Childbirth
Hardeep Singh, Mark L Graber, Timothy P Hofer
Timely and accurate diagnosis is foundational to good clinical practice and an essential first step to achieving optimal patient outcomes. However, a recent Institute of Medicine report concluded that most of us will experience at least one diagnostic error in our lifetime. The report argues for efforts to improve the reliability of the diagnostic process through better measurement of diagnostic performance. The diagnostic process is a dynamic team-based activity that involves uncertainty, plays out over time, and requires effective communication and collaboration among multiple clinicians, diagnostic services, and the patient...
October 20, 2016: Journal of Patient Safety
Margaret E Hunter, Robert M Dorazio, John S S Butterfield, Gaia Meigs-Friend, Leo G Nico, Jason A Ferrante
A set of universal guidelines is needed to determine the limit of detection (LOD) in PCR-based analyses of low concentration DNA. In particular, environmental DNA (eDNA) studies require sensitive and reliable methods to detect rare and cryptic species through shed genetic material in environmental samples. Current strategies for assessing detection limits of eDNA are either too stringent or subjective, possibly resulting in biased estimates of species' presence. Here, a conservative LOD analysis grounded in analytical chemistry is proposed to correct for overestimated DNA concentrations predominantly caused by the concentration plateau, a nonlinear relationship between expected and measured DNA concentrations...
October 21, 2016: Molecular Ecology Resources
U M Stamer, U Gundert-Remy, E Biermann, J Erlenwein, W Meiβner, S Wirz, T Stammschulte
BACKGROUND: Dipyrone (metamizole) is a non-opioid analgesic commonly used in Germany, which can, in very rare cases, cause life-threatening agranulocytosis. The prescribing information calls for regular monitoring of the differential blood count in cases of long-term treatment. However, there is uncertainty about how this testing should be handled in practice. OBJECTIVES: Which recommendations can be derived from the published literature for evaluating blood cell counts during treatment with metamizole and which other options for monitoring exist? METHODS: Data from recent epidemiological studies, reviews, and spontaneously reported cases were evaluated...
October 20, 2016: Der Schmerz
T A Tomsick, J Carrozzella, L Foster, M D Hill, R von Kummer, M Goyal, A M Demchuk, P Khatri, Y Palesch, J P Broderick, S D Yeatts, D S Liebeskind
BACKGROUND AND PURPOSE: Uncertainty persists regarding the safety and efficacy of endovascular therapy of M2 occlusions following IV tPA. We reviewed the impact of revascularization on clinical outcomes in 83 patients with M2 occlusions in the Interventional Management of Stroke III trial according to specific M1-M2 segment anatomic features. MATERIALS AND METHODS: Perfusion of any M2 branch distinguished M2-versus-M1 occlusion. Prespecified modified TICI and arterial occlusive lesion revascularization and clinical mRS 0-2 end points at 90 days for endovascular therapy-treated M2 occlusions were analyzed...
October 20, 2016: AJNR. American Journal of Neuroradiology
David R Holmes, Robert Califf, Andrew Farb, Dorothy Abel, Michael Mack, Tamara Syrek Jensen, Bram Zuckerman, Martin Leon, Jeff Shuren
Initial clinical studies of new medical technologies involve a complex balance of research participant benefits versus risks and costs of uncertainty when novel concepts are tested. The Food and Drug Administration Center for Devices and Radiological Health has recently introduced the Early Feasibility Study (EFS) Program for facilitating the conduct of these studies under the Investigational Device Exemption regulations. However, a systematic approach is needed to successfully implement this program while affording appropriate preservation of the rights and interests of patients...
October 25, 2016: Journal of the American College of Cardiology
Nicoletta Staropoli, Domenico Ciliberto, Silvia Chiellino, Francesca Caglioti, Teresa Del Giudice, Simona Gualtieri, Angela Salvino, Alessandra Strangio, Cirino Botta, Sandro Pignata, Pierfrancesco Tassone, Pierosandro Tagliaferri
OBJECTIVES: The current gold-standard for the first-line treatment in IIIb/IV stages of epithelial ovarian cancer (EOC) is the combination of carboplatin and paclitaxel plus bevacizumab in some countries. In the era of personalized medicine, there is still uncertainty on the impact of several molecularly targeted agents, which have been investigated for the management of this disease. To shed light on the actual role of targeted therapy in EOC, a systematic review and meta-analysis was performed...
October 13, 2016: Oncotarget
C Andres Benatti, Natalie A Afshari
PURPOSE OF REVIEW: The review updates the mechanisms, clinical presentation, diagnosis, and management of Descemet membrane detachment after cataract surgery, particularly during cataract surgery. RECENT FINDINGS: The advent of new imaging techniques like the anterior segment optical coherence tomography and a better comprehension of the clinical and pathological aspects of detachment, has improved the diagnosis and treatment of this complication to the extent that the first algorithms and protocols have been proposed...
October 19, 2016: Current Opinion in Ophthalmology
Elisa Bruno, Alessandra Nicoletti, Graziella Quattrocchi, Graziella Filippini, Carlo Colosimo, Mario Zappia
BACKGROUND: Essential tremor is one of the most common movement disorders. Treatment primarily consists of pharmacological agents. While primidone and propranolol are well-established treatments in clinical practice, they may be ineffective in 25% to 55% of patients and can produce serious adverse events in a large percentage of them. For these reasons, it is worth evaluating the treatment alternatives for essential tremor. Some specialists have suggested that pregabalin could be a potentially useful agent, but there is uncertainty about its efficacy and safety...
October 20, 2016: Cochrane Database of Systematic Reviews
Hamid Abbasi, Laura Bennet, Alistair J Gunn, Charles P Unsworth
Currently, there are no developed methods to detect sharp wave transients that exist in the latent phase after hypoxia-ischemia (HI) in the electroencephalogram (EEG) in order to determine if these micro-scale transients are potential biomarkers of HI. A major issue with sharp waves in the HI-EEG is that they possess a large variability in their sharp wave profile making it difficult to build a compact 'footprint of uncertainty' (FOU) required for ideal performance of a Type-2 fuzzy logic system (FLS) classifier...
August 18, 2016: International Journal of Neural Systems
Aline Iannone, Antonio Pedro de Mello Cruz, Joaquim Pereira Brasil-Neto, Raphael Boechat-Barros
Transcranial magnetic stimulation (TMS) has recently been investigated as a possible adjuvant treatment for many neuropsychiatric disorders, and has already been approved for the treatment of drug-resistant depression in the United States and in Brazil, among other countries. Although its use in other neuropsychiatric disorders is still largely experimental, many physicians have been using it as an off-label add-on therapy for various disorders. More recently, another technique, transcranial direct current stimulation (tDCS), has also become available as a much cheaper and portable alternative to TMS, although its mechanisms of action are different from those of TMS...
October 2016: Arquivos de Neuro-psiquiatria
Wolfgang G Kunz, M G Myriam Hunink, Wieland H Sommer, Sebastian E Beyer, Felix G Meinel, Franziska Dorn, Stefan Wirth, Maximilian F Reiser, Birgit Ertl-Wagner, Kolja M Thierfelder
BACKGROUND AND PURPOSE: Endovascular therapy in addition to standard care (EVT+SC) has been demonstrated to be more effective than SC in acute ischemic large vessel occlusion stroke. Our aim was to determine the cost-effectiveness of EVT+SC depending on patients' initial National Institutes of Health Stroke Scale (NIHSS) score, time from symptom onset, Alberta Stroke Program Early CT Score (ASPECTS), and occlusion location. METHODS: A decision model based on Markov simulations estimated lifetime costs and quality-adjusted life years (QALYs) associated with both strategies applied in a US setting...
October 6, 2016: Stroke; a Journal of Cerebral Circulation
Andrew Keller, Christian Gericke, Jennifer A Whitty, John Yaxley, Boon Kua, Geoff Coughlin, Troy Gianduzzo
BACKGROUND AND OBJECTIVES: The Göteborg randomised population-based prostate cancer screening trial demonstrated that prostate-specific antigen (PSA)-based screening reduces prostate cancer deaths compared with an age-matched control group. Utilising the prostate cancer detection rates from this study, we investigated the clinical and cost effectiveness of a similar PSA-based screening strategy for an Australian population of men aged 50-69 years. METHODS: A decision model that incorporated Markov processes was developed from a health system perspective...
October 18, 2016: Applied Health Economics and Health Policy
Leila Rooshenas, Daisy Elliott, Julia Wade, Marcus Jepson, Sangeetha Paramasivan, Sean Strong, Caroline Wilson, David Beard, Jane M Blazeby, Alison Birtle, Alison Halliday, Chris A Rogers, Rob Stein, Jenny L Donovan
BACKGROUND: Randomised controlled trials (RCTs) are essential for evidence-based medicine and increasingly rely on front-line clinicians to recruit eligible patients. Clinicians' difficulties with negotiating equipoise is assumed to undermine recruitment, although these issues have not yet been empirically investigated in the context of observable events. We aimed to investigate how clinicians conveyed equipoise during RCT recruitment appointments across six RCTs, with a view to (i) identifying practices that supported or hindered equipoise communication and (ii) exploring how clinicians' reported intentions compared with their actual practices...
October 2016: PLoS Medicine
Bharatendu Chandra, Joy Vijayan, Nobuhiro Yuki, Aravind Therimadasamy, Einar Wilder-Smith
No abstract text is available yet for this article.
October 18, 2016: Neurology
Martin O'Donnell
Salt (sodium chloride) is the primary source of sodium in the diet. Sodium is an essential nutrient, required for normal human physiology. Excess sodium intake is a risk factor for hypertension and cardiovascular disease. Observational studies have reported a curvilinear increase in blood pressure with increasing sodium intake, more marked in people with high sodium intakes and hypertension. Interventional clinical trials have demonstrated the efficacy of reduced sodium intake on reducing blood pressure, although the interventions employed in these trials are not generalizable to most settings (intensive dietary counselling or feeding trials)...
September 2016: Journal of Hypertension
Craig Anderson, Doug McEvoy, Jiguang Wang
OBJECTIVE: There is uncertainty over whether treatment of obstructive sleep apnea (OSA) can prevent serious cardiovascular (CV) events. DESIGN AND METHOD: SAVE (NCT00738179; ACTRN12608000409370) was designed to determine whether treatment of OSA with CPAP reduces the risk of serious CV events in patients with established CV disease. Participants were centrally randomised to CPAP treatment or usual care between 2008 and 2013,with follow-up completed late 2015 and the results will be announced in August 2016...
September 2016: Journal of Hypertension
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