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Treatment outcome package

Gilberto Ayala, Julio Garay, Miguel Aragon, Tom Decroo, Rony Zachariah
Objective To describe trends in tuberculosis (TB) notification and treatment outcomes in 25 prisons in El Salvador from 2009-2014 and to determine if a set of interventions introduced in 2011 affected TB case finding and management. Methods This was operational research that utilized a retrospective cohort study of program data from 2009-2014. The package of interventions introduced in 2011 provides staff training, engages inmates in TB case finding, and offers diagnosis through mobile X-ray and Xpert® MTB/RIF...
January 2016: Revista Panamericana de Salud Pública, Pan American Journal of Public Health
Peter Rijnbeek
Massive numbers of electronic health records are currently being collected globally, including structured data in the form of diagnoses, medications, laboratory test results, and unstructured data contained in clinical narratives. This opens unprecedented possibilities for research and ultimately patient care. However, actual use of these databases in a multi-center study is severely hampered by a variety of challenges, e.g., each database has a different database structure and uses different terminology systems...
September 2016: Journal of Hypertension
Arivudainambi Kayal, Viswanathan Mohan, Belma Malanda, Ranjit Mohan Anjana, Balaji Bhavadharini, Manni Mohanraj Mahalakshmi, Kumar Maheswari, Ram Uma, Ranjit Unnikrishnan, Gunasekaran Kalaiyarasi, Lyudmil Ninov, Anne Belton
AIM: The Women In India with GDM Strategy (WINGS) project was conducted with the aim of developing a model of care (MOC) suitable for women with gestational diabetes mellitus (GDM) in low- and middle-income countries. METHODOLOGY: The WINGS project was carried out in Chennai, Southern India, in two phases. In Phase I, a situational analysis was conducted to understand the practice patterns of health-care professionals and to determine the best screening criteria through a pilot screening study...
September 2016: Indian Journal of Endocrinology and Metabolism
Nefyn H Williams, Jessica L Roberts, Nafees Ud Din, Nicola Totton, Joanna M Charles, Claire A Hawkes, Val Morrison, Zoe Hoare, Michelle Williams, Aaron W Pritchard, Swapna Alexander, Andrew Lemmey, Robert T Woods, Catherine Sackley, Pip Logan, Rhiannon T Edwards, Clare Wilkinson
OBJECTIVE: To conduct a rigorous feasibility study for a future definitive parallel-group randomised controlled trial (RCT) and economic evaluation of an enhanced rehabilitation package for hip fracture. SETTING: Recruitment from 3 acute hospitals in North Wales. Intervention delivery in the community. PARTICIPANTS: Older adults (aged ≥65) who received surgical treatment for hip fracture, lived independently prior to fracture, had mental capacity (assessed by clinical team) and received rehabilitation in the North Wales area...
October 5, 2016: BMJ Open
Paul R Rosenbaum, Dylan S Small
In a sensitivity analysis in an observational study with a binary outcome, is it better to use all of the data or to focus on subgroups that are expected to experience the largest treatment effects? The answer depends on features of the data that may be difficult to anticipate, a trade-off between unknown effect-sizes and known sample sizes. We propose a sensitivity analysis for an adaptive test similar to the Mantel-Haenszel test. The adaptive test performs two highly correlated analyses, one focused analysis using a subgroup, one combined analysis using all of the data, correcting for multiple testing using the joint distribution of the two test statistics...
October 4, 2016: Biometrics
Sophia Taylor, Weyinmi Demeyin, Ann Muls, Catherine Ferguson, Damian J J Farnell, David Cohen, Jervoise Andreyev, John Green, Lesley Smith, Sam Ahmedzai, Sara Pickett, Annmarie Nelson, John Staffurth
INTRODUCTION: Radiotherapy treatment for prostate cancer can cause bowel problems, which may lead to severe difficulties for cancer survivors including limiting travel, work or socialising. These symptoms can appear at any time following radiotherapy. This study focuses on the early identification and protocol-based management of effects known to cause long-term, or even permanent, changes to the well-being of prostate cancer survivors. The rationale of this study is to improve the care offered to men and their families following pelvic radiotherapy for prostate cancer...
October 3, 2016: BMJ Open
Mehmet Akif Sargin, Murat Yassa, Bilge Dogan Taymur, Ayhan Çelik, Sibel Aydin, Emrah Orhan, Niyazi Tug
INTRODUCTION: Extra-uterine pregnancy or Ectopic Pregnancy (EP) is a major health problem for pregnant women, presenting as a potentially life-threatening emergency in the first trimester. There are three major options for the treatment of EP: expectant management, surgical treatment and medical management. The presence of free intraperitoneal fluid in EP-diagnosed patients is crucial for treatment planning and evaluation. AIM: To compare the outcomes of both the expectant man-agement and medical treatment with methotrexate (MTX) in ectopic pregnancies with free intraperitoneal fluid...
August 2016: Journal of Clinical and Diagnostic Research: JCDR
Yin-E Hu, Shu-Fang Dai, Bin Wang, Wei Qu, Jun-Ling Gao
OBJECTIVE: To evaluate the therapeutic effects of combined 5-aminolevulinic acid (ALA) and photodynamic therapy (PDT) on genital warts and the safety. METHODS: One hundred ten patients with genital warts who were treated in our hospital from June 2013 to October 2014 were selected. The warts and affected parts were disinfected with benzalkonium bromide solution, and the warts were covered with absorbent cotton that had already been added freshly prepared 20% ALA solution, packaged and fixed...
July 2016: Pakistan Journal of Medical Sciences Quarterly
Charles Ibiene Tobin-West, Anastasia Isodje
INTRODUCTION: Nigeria ranks among countries with the highest burden of tuberculosis. Yet evidence continues to indicate poor treatment outcomes which have been attributed to poor quality of care. This study aims to identify some of the systemic problems in order to inform policy decisions for improved quality of services and treatment outcomes in Nigeria. METHODS: A comparative assessment of the quality of TB care in rural and urban health facilities was carried out between May and June 2013, employing the Donabedian model of quality assessment...
2016: Pan African Medical Journal
Danjie Zhang, Ming-Hui Chen, Joseph G Ibrahim, Mark E Boye, Wei Shen
Joint models for longitudinal and survival data now have a long history of being used in clinical trials or other studies in which the goal is to assess a treatment effect while accounting for a longitudinal biomarker such as patient-reported outcomes or immune responses. Although software has been developed for fitting the joint model, no software packages are currently available for simultaneously fitting the joint model and assessing the fit of the longitudinal component and the survival component of the model separately as well as the contribution of the longitudinal data to the fit of the survival model...
July 2016: Journal of Statistical Software
Anna Gamell, Tracy R Glass, Lameck B Luwanda, Herry Mapesi, Leila Samson, Tom Mtoi, Angelo Nyamtema, Lukas Muri, Alex Ntamatungiro, Marcel Tanner, Christoph Hatz, Manuel Battegay, Emilio Letang
BACKGROUND: Strategies to improve HIV diagnosis and linkage into care, antiretroviral treatment coverage and treatment outcomes of mothers and children are urgently needed in sub-Saharan Africa. METHODS: From 12/2012, we implemented an intervention package to improve Prevention of Mother-To-Child Transmission (PMTCT) and pediatric HIV care in our rural Tanzanian clinic, consisting of: a) creation of a PMTCT and pediatric unit integrated within the reproductive and child health clinic; b) implementation of electronic medical records; c) provider-initiated HIV testing and counseling in the hospital wards; and d) early infant diagnosis test performed locally...
September 1, 2016: Journal of Acquired Immune Deficiency Syndromes: JAIDS
Patrick Lugenbiel, Patrick A Schweizer, Hugo A Katus, Dierk Thomas
The clinical management of heart rhythm disorders still constitutes a major challenge. The development of alternatives to current approaches is of significant interest in order to establish more effective therapies that increase quality of life and reduce symptoms and hospitalizations. Over the past two decades the mechanistic understanding of pathophysiological pathways underlying cardiac arrhythmias has advanced profoundly, opening up novel avenues for mechanism-based therapeutic approaches. In particular, gene therapy offers greater selectivity than small molecule-based or interventional treatment...
September 2, 2016: European Journal of Pharmacology
Alexander Pate, Jane Candlish, Matthew Sperrin, Tjeerd Pieter Van Staa
BACKGROUND: The Cohort Multiple Randomised Controlled Trial (cmRCT) is a newly proposed pragmatic trial design; recently several cmRCT have been initiated. This study tests the unresolved question of whether differential refusal in the intervention arm leads to bias or loss of statistical power and how to deal with this. METHODS: We conduct simulations evaluating a hypothetical cluster cmRCT in patients at risk of cardiovascular disease (CVD). To deal with refusal, we compare the analysis methods intention to treat (ITT), per protocol (PP) and two instrumental variable (IV) methods: two stage predictor substitution (2SPS) and two stage residual inclusion (2SRI) with respect to their bias and power...
2016: BMC Medical Research Methodology
Lars-Gunnar Lundh, Terese Petersson, Martin Wolgast
BACKGROUND: Randomized controlled trials (RCTs) are considered the best methodology for studying the efficacy of psychotherapy. Optimally an RCT design makes it possible to conclude that if one treatment has a better outcome than another, this is due to the treatment package (TP) as it was implemented in this particular context, rather than other factors beyond the treatment (= high internal validity). Strong internal validity does not, however, provide evidence for the treatment model (TM) that provides the theoretical basis of the TP, because the TP that is tested may differ from the comparison condition in a number of other ways that suggest alternative explanations for the effects...
2016: BMC Psychology
Björn Nashan, Mario Abbud-Filho, Franco Citterio
Delayed graft function (DGF) remains a major barrier to improved outcomes after kidney transplantation. High-risk transplant recipients can be identified, but no definitive prediction model exists. Novel biomarkers to predict DGF in the first hours post-transplant, such as neutrophil gelatinase-associated lipocalin (NGAL), are under investigation. Donor management to minimize the profound physiological consequences of brain death is highly complex. A hormonal resuscitation package to manage the catecholamine "storm" that follows brain death is recommended...
October 2016: Clinical Transplantation
Yousef Mortazavi, Fatemeh Sheikhsaran, Gholamreza Khamisipour Khamisipour, Masoud Soleimani, Ali Teimuri, Somayeh Shokri
OBJECTIVE: Treatment and repair of neurodegenerative diseases such as brain tumors, spinal cord injuries, and functional disorders, including Alzheimer's disease, are challenging problems. A common treatment approach for such disorders involves the use of mesenchymal stem cells (MSCs) as an alternative cell source to replace injured cells. However, use of these cells in hosts may potentially cause adverse outcomes such as tumorigenesis and uncontrolled differentiation. In attempt to generate mesenchymal derived neural cells, we have infected MSCs with recombinant lentiviruses that expressed nerve growth factor (NGF) and assessed their neural lineage genes...
July 2016: Cell Journal
Patrick Ingiliz, Stefan Christensen, Torben Kimhofer, Dietrich Hueppe, Thomas Lutz, Knud Schewe, Heiner Busch, Günther Schmutz, Malte H Wehmeyer, Christoph Boesecke, Karl-Georg Simon, Florian Berger, Jürgen K Rockstroh, Julian Schulze Zur Wiesch, Axel Baumgarten, Stefan Mauss
BACKGROUND:  Shortening the duration of treatment with HCV direct-acting antivirals (HCV-DAAs) leads to substantial cost reductions. According to the label, sofosbuvir and ledipasvir can be prescribed for 8 weeks (SL8) in non-cirrhotic, HCV genotype-1 women or men with low viral load. However, real-world data about the efficacy and safety of SL8 are largely missing. METHODS:  Interim results from an ongoing prospective, multicenter cohort of nine treatment centers in Germany (GECCO)...
August 17, 2016: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
Nimer Ortuno-Gutierrez, Rony Zachariah, Desalegn Woldeyohannes, Adama Bangoura, Gba-Foromo Chérif, Francis Loua, Veerle Hermans, Katie Tayler-Smith, Welile Sikhondze, Lansana-Mady Camara
SETTING: Ten targeted health facilities supported by Damien Foundation (a Belgian Non Governmental Organization) and the National Tuberculosis (TB) Program in Conakry, Guinea. OBJECTIVES: To uphold TB program performance during the Ebola outbreak in the presence of a package of pre-emptive additional measures geared at reinforcing the routine TB program, and ensuring Ebola infection control, health-workers safety and motivation. DESIGN: A retrospective comparative cohort study of a TB program assessing the performance before (2013) and during the (2014) Ebola outbreak...
2016: PloS One
William Hope, George L Drusano, John H Rex
The treatment of invasive fungal diseases constitutes a significant unmet medical need. There are relatively few antifungal agents in clinical development and a paucity of novel targets. Morbidity and mortality remain high and clinical outcomes are compromised by submaximal efficacy, emergence of drug resistance and drug-related toxicity. Thus, new antifungal agents are urgently required. A deep understanding of exposure-response relationships underpins the development of safe and effective clinical regimens of any therapeutic agent...
August 5, 2016: Journal of Antimicrobial Chemotherapy
Xiaoqun Liu, Xiangdong Liu, Tiankui Qiao, Wei Chen, Sujuan Yuan
BACKGROUND: The combined therapy of bevacizumab (BEV) with taxane (paclitaxel or docetaxel) has shown an improvement on progression-free survival (PFS) and objective remission in Her2-negative patients with locally recurrent or metastatic breast cancer (LR/MBC). However, there was no benefit in overall survival (OS). The aim of this study was to evaluate the efficacy and safety of adding an agent to the BEV/taxane regimens for the treatment of Her2-negative patients with LR/MBC in a first-line setting...
2016: OncoTargets and Therapy
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