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Clinical outcome research initiative

Martin Geoffrey Thomas, Carrie Bayliss, Simon Bond, Francis Dowling, James Galea, Vipul Jairath, Christopher Lamb, Christopher Probert, Elizabeth Timperley-Preece, Alastair Watson, Lynne Whitehead, John G Williams, Miles Parkes, Arthur Kaser, Tim Raine
INTRODUCTION: Acute severe ulcerative colitis (ASUC) is a severe manifestation of ulcerative colitis (UC) that warrants hospitalisation. Despite significant advances in therapeutic options for UC and in the medical management of steroid-refractory ASUC, the initial treatment paradigm has not changed since 1955 and is based on the use of intravenous corticosteroids. This treatment is successful in approximately 50% of patients but failure of this and subsequent medical therapy still occurs, with colectomy rates of up to 40% reported...
February 15, 2019: BMJ Open
Shinjini Bhatnagar, Partha P Majumder, Dinakar M Salunke
Globally, preterm birth is a major public health problem. In India, 3.6 million of the 27 million infants born annually are preterm. Risk stratification of women based on multidimensional risk factors assessed during pregnancy is critical for prevention of preterm birth. A cohort study of pregnant women was initiated in May 2015 at the civil hospital in Gurugram, Haryana, India. Women are enrolled within 20 weeks of gestation and are followed until delivery and once postpartum. The objectives are to identify clinical, epidemiologic, genomic, epigenomic, proteomic, and microbial correlates; discover molecular-risk markers by using an integrative -omics approach; and generate a risk-prediction algorithm for preterm birth...
February 16, 2019: American Journal of Epidemiology
Lisa Van de Wijer, Deborah N Mchaile, Quirijn de Mast, Blandina T Mmbaga, Nanda N J Rommelse, Ashanti Duinmaijer, André J A M van der Ven, Arnt F A Schellekens, Grace D Kinabo
BACKGROUND: Efavirenz is commonly prescribed for children with HIV infection, yet little is known about risks of neuropsychiatric side-effects. We aimed to compare competence (social involvement, activities, and school performance) and psychopathology (internalising and externalising problems), cognitive performance (intelligence and working memory), and adherence in Tanzanian children on an efavirenz-based versus a non-efavirenz-based regimen. METHODS: In this multicentre, cross-sectional, observational study, we included consecutive children (aged 6-12 years) with HIV infection, on combination antiretroviral therapy (cART) for at least 6 months, and with viral loads of less than 1000 copies per mL from HIV care clinics of three primary health facilities and three referral hospitals in Moshi, Kilimanjaro, Tanzania...
February 12, 2019: Lancet HIV
Katriona Brooksbank, Joanne O'Donnell, Vicky Corbett, Sarah Shield, Rachel Ainsworth, Ross Shearer, Susan Montgomery, Andrew Gallagher, Hannah Duncan, Lorna Hamilton, Valerie Laszlo, Rhonda Noone, Anna Baxendale, David Blane, Jennifer Logue
BACKGROUND: Guidelines for the management of type 2 diabetes universally recommend that adults with type 2 diabetes and obesity be offered individualized interventions to encourage weight loss. Yet despite the existing recommendations, provision of weight management services is currently patchy around the United Kingdom and where services are available, high attrition rates are often reported. In addition, individuals often fail to take up services, that is, after discussion with a general practitioner or practice nurse, individuals are referred to the service but do not attend for an appointment...
February 15, 2019: JMIR Research Protocols
Mehtap Ezel Çelakil, Zelal Ekinci, Burcu Bozkaya Yücel, Nazım Mutlu, Ayla Günlemez, Kenan Bek
BACKGROUND: Posterior urethral valve (PUV) is the most serious form of congenital anomalies of kidney and urinary tract (CAKUT) in boys with significant risk of progression to chronic kidney disease (CKD). We present our long term results in children with PUV. METHODS: Retrospective chart review of 113 children with PUV followed within the years of 1996-2018 was performed. Clinical, laboratory and epidemiologic parameters were analyzed for their impact on renal outcome...
February 14, 2019: Minerva Urologica e Nefrologica, the Italian Journal of Urology and Nephrology
Mathieu Marx, Nadège Costa, Benoit Lepage, Soumia Taoui, Laurent Molinier, Olivier Deguine, Bernard Fraysse
Background: Single-sided deafness (SSD) and asymmetric hearing loss (AHL) have recently been proposed as a new indication for cochlear implantation. There is still no recommended treatment for these hearing deficits, and most options considered rely on the transfer of sound from the poor ear to the better ear, using Contralateral Routing of the Signal (CROS) hearing aids or bone conduction (BC) devices. In contrast, cochlear implantation allows the poor ear to be stimulated and binaural hearing abilities to be partially restored...
2019: BMC Ear, Nose, and Throat Disorders
Meera R Nariadhara, Hendry R Sawe, Michael S Runyon, Victor Mwafongo, Brittany L Murray
Background: Modified systemic inflammatory response syndrome (mSIRS) criteria for the pediatric population together with the provider gestalt have the potential to predict clinical outcomes. However, this has not been studied in low-income countries. We investigated the ability of mSIRS and provider gestalt to predict mortality and morbidity among children presenting to the ED of a tertiary level hospital in Tanzania. Methods: This prospective observational study enrolled a convenience sample of children under 5 years old, presenting to the Emergency Medicine Department of Muhimbili National Hospital from September 2015 to April 2016...
2019: Tropical Medicine and Health
Christopher R Flud, Andres Duarte-Rojo
Minimal or Covert Hepatic Encephalopathy (MHE/CHE), the preclinical phase of Hepatic Encephalopathy (HE), is strongly associated with poorer Quality of Life (QOL), Overt HE (OHE), and death. Several diagnostic tests have been developed that have prognostic value in predicting clinical outcomes such as OHE, cirrhosis progression, and death. However, dispute among clinicians and HE researchers have kept its application largely underutilized. Current issues contributing to the confusion include: lack of a formal definition for CHE, uncertainty of which diagnostic tools to use, and whether one or two abnormal tests are required for a diagnosis...
January 2019: Journal of Clinical and Experimental Hepatology
Hai Lu, Menghan Li, Bo Zhang, Xuesong Ren, Lina Meng, Weijing Bai, Li Wang, Zhenzhen Wang, Shaojie Ding, Yuanyuan Gan, Zhilong Zhang, Peifang Li, Linpeng Wang, Zhihong Meng, Hong Zhao, Fei Wang, Chunhong Zhang
INTRODUCTION: Poststroke depression is a serious and common complication of stroke, especially the ischemic poststroke depression. Antidepressants are used in poststroke depression, and acupuncture may be an alternative approach. However, the efficacy and mechanism of acupuncture for poststroke depression has not been confirmed. METHODS/DESIGN: This is a multicenter, central-randomized, single-blind, sham-controlled clinical trial. We will allocate 208 subjects aged between 40 and 80 years old, diagnosed with initial poststroke depression (PSD) within 6 months to 2 groups randomly in a ratio of 1:1...
February 2019: Medicine (Baltimore)
Muhammad I Husain, Imran B Chaudhry, Ameer B Khoso, Mohammad Omair Husain, Raza R Rahman, Munir M Hamirani, John Hodsoll, Andre F Carvalho, Nusrat Husain, Allan H Young
BACKGROUND: A third of patients diagnosed with major depressive disorder (MDD) experience treatment-resistant depression (TRD). Relatively few pharmacological agents have established efficacy for TRD. Therefore, the evaluation of novel treatments for TRD is a pressing priority. Statins are pleiotropic agents and preclinical studies as well as preliminary clinical trials have suggested that these drugs may have antidepressant properties.AimsTo report on a protocol for a 12-week, randomised, double-blind, placebo-controlled trial of add-on treatment with simvastatin for patients meeting DSM-5 criteria for MDD who have failed to respond to at least two adequate trials with approved antidepressants...
January 2019: BJPsych Open
Joshua D Clapp, Shira M Kern, Ryan M Kozina, Adam J Ripley, Mary K Lear
The reliability and validity of reported exposure to significant trauma is critical to research evaluating outcomes following serious and distressing life events. The current study examined the reliability of reported exposure to disaster, fire, transportation accidents, physical assault, and sexual assault across 5- (N = 251), 12- (N = 223), and 24-month (N = 109) intervals in undergraduates completing a screening measure of probable trauma (N = 3,045). Concordance with later responses to an alternate checklist and events assessed via clinical interview was examined in a subset of participants (N = 274)...
February 14, 2019: Psychological Assessment
Jonathan P Evans, Boleslaw K Winiarski, Paul A Sutton, Lorenzo Ressel, Carrie A Duckworth, D Mark Pritchard, Daniel H Palmer, Christopher E Goldring, Neil R Kitteringham
Improving outcomes in colorectal cancer requires more accurate in vivo modelling of the disease in humans, allowing more reliable pre-clinical assessment of potential therapies. Novel imaging techniques are necessary to improve the longitudinal assessment of disease burden in these models, reducing the number of animals required for translational studies. This report describes the development of an immune-competent syngeneic orthotopic murine model of colorectal cancer, utilising caecal implantation of CT26 cells stably transfected with the luciferase gene into immune-competent BALB/c mice, allowing serial bioluminescent imaging of cancer progression...
February 13, 2019: Laboratory Animals
Brittany R Lapin, Nicolas R Thompson, Andrew Schuster, Irene L Katzan
PURPOSE: Assessment of outcomes from a proxy is often substituted for the patient's self-report when the patient is unable or unwilling to report their status. Research has indicated that proxies over-report symptoms on the patient's behalf. This study aimed to quantify the extent of proxy-introduced bias on the Patient-Reported Outcomes Measurement Information System Global Health (PROMIS GH) scale for mental (GMH) and physical (GPH) scores. METHODS: This retrospective cohort study included incident stroke patients seen in a cerebrovascular clinic who completed PROMIS GH between 10/12/15 and 6/6/18...
February 13, 2019: Quality of Life Research
Per Ertzgaard, Anand Nene, Carlotte Kiekens, Anthony S Burns
CONTEXT: Patient-reported outcome measures (PROMs) are valuable for capturing the impact of spasticity on health-related quality of life (HRQoL) in persons with spinal cord damage (SCD) and evaluating the efficacy of interventions. OBJECTIVE: To provide practical guidance for measuring HRQoL in persons with spasticity following SCD. METHODS: Literature reviews identified measures of HRQoL and caregiver burden, utilized in studies addressing spasticity in SCD...
February 13, 2019: Journal of Spinal Cord Medicine
Lisandro D Colantonio, Keri L Monda, Robert S Rosenson, Todd M Brown, Katherine E Mues, George Howard, Monika M Safford, Larisa Yedigarova, Michael E Farkouh, Paul Muntner
PURPOSE: Determine the risk for cardiovascular disease (CVD) events among adults with clinically evident CVD who meet the inclusion criteria for the FOURIER clinical trial on PCSK9 inhibition in a real-world database. METHODS: We analyzed data from 2072 African American and 2972 white REasons for Geographic And Racial Differences in Stroke (REGARDS) study participants 45-85 years of age with clinically evident CVD. Study participants meeting the FOURIER inclusion criteria (one major or two minor cardiovascular risk factors, fasting LDL cholesterol ≥ 70 mg/dL or non-HDL cholesterol ≥ 100 mg/dL, triglycerides ≤ 400 mg/dL, and taking statin) were followed for CVD events (myocardial infarction, stroke, coronary revascularization, and CVD death) from baseline in 2003-2007 through 2014...
February 11, 2019: Cardiovascular Drugs and Therapy
Bo-Lin Ho, Ya-Ju Lin, Sheng-Feng Lin, Ping-Song Chou, Chien-Fu Chen, Ruey-Tay Lin, Han-Hwa Hu, A-Ching Chao
OBJECTIVES: Dabigatran etexilate is a direct thrombin inhibitor that clinicians increasingly prescribe to prevent stroke in patients with nonvalvular atrial fibrillation (NVAF). Clinicians also commonly prescribe statins for primary and secondary prevention of cardiovascular diseases. Little is known about the bleeding risk in patients taking a statin and dabigatran together. The aim of this study was to evaluate the safety and persistence of dabigatran after co-medication with statins...
February 11, 2019: Acta Neurologica Scandinavica
Chiara Jongerius, Selena Russo, Ketti Mazzocco, Gabriella Pravettoni
BACKGROUND: The use of mobile health (mHealth) apps in clinical settings is increasing widely. mHealth has been used to promote prevention, improve early detection, manage care, and support survivors and chronic patients. However, data on the efficacy and utility of mHealth apps are limited. OBJECTIVE: The main objective of this review was to provide an overview of the available research-tested interventions using mHealth apps and their impact on breast cancer care...
February 11, 2019: JMIR MHealth and UHealth
Gaetano Gallo, Giuseppe Sena, Giuseppina Vescio, Matteo Papandrea, Rosario Sacco, Mario Trompetto, Giuseppe Sammarco
BACKGROUND: Colorectal cancer (CRC) is one of the leading cause of cancer deaths worldwide. The aetiology of CRC is complex and involves interaction on environmental and genetic factors. The two most important pathways are the EGFR (Epidermal Grow Factor Receptor) signaling pathway, with the involvement of KRAS and BRAF, and the DNA mismatch repair (MMR). Generally, KRAS and BRAF mutations are mutually exclusive. They are both able to cause RAS/RAF/MAPK signaling pathway upregulation and are necessary for CRC development...
February 4, 2019: Annali Italiani di Chirurgia
Tikun Shan, Tiejun Zhang, Weiqiang Qian, Lu Ma, Hao Li, Chao You, Xiaoqi Xie
BACKGROUND: Delayed cerebral ischemia seriously affects the prognosis of patients surviving the initial aneurysmal subarachnoid hemorrhage. Application of cilostazol was reported to ameliorate vasospasm and improve outcomes in series and clinical trials. But the effectiveness and feasibility of cilostazol on aneurysmal subarachnoid hemorrhage remained controversial. We performed a systematic review to clarify this issue. METHODS: PubMed, Ovid and Cochrane library database were systematically searched up to May 2018 for eligible publications in English...
February 9, 2019: Journal of Neurology
Kelly Claire Simon, Richard Munson, Archie Ong, Fulvio R Gil, Franco Campanella, Laura Hillman, Rebekah Lai, Richard Chesis, Samuel Tideman, Rosa Maria Vazquez, Steven Meyers, Roberta Frigerio, Demetrius Maraganore
BACKGROUND AND PURPOSE: Standardized electronic medical record tools provide an opportunity to efficiently provide care that conforms to Best Practices and supports quality improvement and practice-based research initiatives. METHODS: We describe the development of a customized structured clinical documentation "toolkit" that standardizes patient data collection to conform to Best Practices for treating patients with stroke. The toolkit collects patients' demographic information, relevant score test measures, and captures information on disability, treatment, and outcomes...
February 5, 2019: Journal of Stroke and Cerebrovascular Diseases: the Official Journal of National Stroke Association
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