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  1. The school system has been identified as an ideal setting for the implementation of prevention and early intervention programs for suicide. However, in Australia, suicide-prevention programs that are routinely...

    Authors: Alison L. Calear, Jacqueline L. Brewer, Philip J. Batterham, Andrew Mackinnon, Peter A. Wyman, Mark LoMurray, Fiona Shand, Dominique Kazan and Helen Christensen
    Citation: Trials 2016 17:349
  2. Obesity is an increasingly prevalent chronic condition that is associated with serious morbidity and mortality. Excess body weight is a risk factor contributing to diseases such as hypertension, heart disease,...

    Authors: Linda L. D. Zhong, Wai Kun, Tsz Fung Lam, Shi Ping Zhang, Jun Jun Yang, Tat Chi Ziea, Bacon Ng and Zhao Xiang Bian
    Citation: Trials 2016 17:346
  3. Subcutaneous administration of Ig (SCIg) has gained popularity as an alternative route of administration but has never been rigorously examined in chronic inflammatory demyelinating polyneuropathy (CIDP).

    Authors: Ivo N. van Schaik, Nan van Geloven, Vera Bril, Hans-Peter Hartung, Richard A. Lewis, Gen Sobue, John-Philip Lawo, Orell Mielke, David R. Cornblath and Ingemar S. J. Merkies
    Citation: Trials 2016 17:345
  4. Trials are robust sources of data for clinical practice; however, trial outcomes may not reflect what is important to communicate for decision-making. The study compared clinicians’ views of outcomes to includ...

    Authors: Angus G. K. McNair, Sara T. Brookes, Robert N. Whistance, Rachael O. Forsythe, Rhiannon Macefield, Jonathan Rees, James Jones, George Smith, Anne M. Pullyblank, Kerry N. L. Avery, Michael G. Thomas, Paul A. Sylvester, Anne Russell, Alfred Oliver, Dion Morton, Robin Kennedy…
    Citation: Trials 2016 17:344
  5. Increasing access to health and social services through service-integration approaches may provide a direct and sustainable way to improve health and social outcomes in low-income families.

    Authors: Jane Drummond, Natasha Wiebe, Sylvia So, Laurie Schnirner, Jeffrey Bisanz, Deanna L. Williamson, Maria Mayan, Laura Templeton and Konrad Fassbender
    Citation: Trials 2016 17:343
  6. Although much has evolved in our understanding of the pathogenesis and factors affecting outcome of patients with acute respiratory distress syndrome (ARDS), still there is no specific pharmacologic treatment ...

    Authors: Jesús Villar, Javier Belda, José Manuel Añón, Jesús Blanco, Lina Pérez-Méndez, Carlos Ferrando, Domingo Martínez, Juan Alfonso Soler, Alfonso Ambrós, Tomás Muñoz, Rosana Rivas, Ruth Corpas, Francisco J. Díaz-Dominguez, Marina Soro, Miguel Angel García-Bello, Rosa Lidia Fernández…
    Citation: Trials 2016 17:342
  7. Missing outcomes can seriously impair the ability to make correct inferences from randomized controlled trials (RCTs). Complete case (CC) analysis is commonly used, but it reduces sample size and is perceived ...

    Authors: Mavuto Mukaka, Sarah A. White, Dianne J. Terlouw, Victor Mwapasa, Linda Kalilani-Phiri and E. Brian Faragher
    Citation: Trials 2016 17:341
  8. The development of probiotics as therapies to cure or prevent disease lags far behind that of other investigational medications. Rigorously designed phase I clinical trials are nearly non-existent in the field...

    Authors: Smita Awasthi, Reason Wilken, Forum Patel, J. Bruce German, David A. Mills, Carlito B. Lebrilla, Kyoungmi Kim, Samara L. Freeman, Jennifer T. Smilowitz, April W. Armstrong and Emanual Maverakis
    Citation: Trials 2016 17:340
  9. Eyes sustaining open globe trauma are at high risk of severe visual impairment. Ocular injuries which result in visual loss invariably affect the posterior segment of the eye, and prevention of visual loss inv...

    Authors: Philip J. Banerjee, Victoria R. Cornelius, Rachel Phillips, Jessica W. Lo, Catey Bunce, Joanna Kelly, Caroline Murphy, Rhiannon Tudor Edwards, Elizabeth L. Robertson and David G. Charteris
    Citation: Trials 2016 17:339
  10. The ANCA-associated vasculitides (AAV) are systemic autoimmune inflammatory disorders characterised by necrotising inflammation affecting small to medium-sized blood vessels. Despite improvements in survival, ...

    Authors: Dimitrios Chanouzas, Lovesh Dyall, Peter Nightingale, Charles Ferro, Paul Moss, Matthew David Morgan and Lorraine Harper
    Citation: Trials 2016 17:338
  11. Ankylosing spondylitis (AS) is a chronic inflammatory autoimmune disease. Kunxian capsule, a Chinese patent medicine which has been used in the treatment of immunologic diseases for many years in China, has an...

    Authors: Qiuxia Li, Li Li, Liqi Bi, Changhong Xiao, Zhiming Lin, Shuangyan Cao, Zetao Liao and Jieruo Gu
    Citation: Trials 2016 17:337
  12. Subject recruitment for medical research is challenging. Slow patient accrual leads to increased costs and delays in treatment advances. Researchers need reliable tools to manage and predict the accrual rate. ...

    Authors: Yu Jiang, Peter Guarino, Shuangge Ma, Steve Simon, Matthew S. Mayo, Rama Raghavan and Byron J. Gajewski
    Citation: Trials 2016 17:336
  13. Decisions to stop randomized trials are often based on traditional P value thresholds and are often unconvincing to clinicians. To familiarize clinical investigators with the application and advantages of Bayesia...

    Authors: Claudia Pedroza, Jon E. Tyson, Abhik Das, Abbot Laptook, Edward F. Bell and Seetha Shankaran
    Citation: Trials 2016 17:335
  14. This project proposes a pilot study to investigate the positive healing effects of cognitive training with simple arithmetic and reading aloud on elderly postsurgical patients. Elderly patients undergoing surg...

    Authors: Kay Kulason, Rui Nouchi, Yasushi Hoshikawa, Masafumi Noda, Yoshinori Okada and Ryuta Kawashima
    Citation: Trials 2016 17:334
  15. Authors: Sadie Wickwar, Hayley McBain, Stanton P. Newman, Shashivadan P. Hirani, Catherine Hurt, Nicola Dunlop, Chris Flood and Daniel G. Ezra
    Citation: Trials 2016 17:333

    The original article was published in Trials 2016 17:129

  16. Approximately 180 million people worldwide, (3 % of the world’s population) are infected with hepatitis C (HCV). Insulin resistance (IR) and type 2 diabetes (T2DM) are common extrahepatic manifestations of chr...

    Authors: Mary-Anne Doyle, Joel Singer, Terry Lee, Miriam Muir and Curtis Cooper
    Citation: Trials 2016 17:331
  17. Small fiber neuropathy is the most common cause of neuropathic pain in peripheral neuropathies, with a minimum prevalence of 53/100,000. Patients experience excruciating pain, and currently available anti-neur...

    Authors: Bianca T. A. de Greef, Margot Geerts, Janneke G. J. Hoeijmakers, Catharina G. Faber and Ingemar S. J. Merkies
    Citation: Trials 2016 17:330
  18. Few studies have explored in depth the experiences of patients with advanced cancer who are participating in clinical investigational medicinal product trials. However, integrated qualitative studies in such t...

    Authors: Emily Harrop, Simon Noble, Michelle Edwards, Stephanie Sivell, Barbara Moore and Annmarie Nelson
    Citation: Trials 2016 17:329
  19. An estimated one billion children experience child abuse each year, with the highest rates in low- and middle-income countries. The Sinovuyo Teen programme is part of Parenting for Lifelong Health, a WHO/UNICE...

    Authors: Lucie Cluver, Franziska Meinck, Yulia Shenderovich, Catherine L. Ward, Rocio Herrero Romero, Alice Redfern, Carl Lombard, Jenny Doubt, Janina Steinert, Ricardo Catanho, Camille Wittesaele, Sachin De Stone, Nasteha Salah, Phelisa Mpimpilashe, Jamie Lachman, Heidi Loening…
    Citation: Trials 2016 17:328
  20. Haemorrhage remains a leading cause of morbidity and mortality in trauma patients. Fibrinogen is an essential endogenous component of haemostasis and the plasma level is associated with bleeding, transfusion a...

    Authors: Jacob Steinmetz, Hanne Hee Henriksen, Anne Marie Sørensen, Theis Lange, Claus Falck Larsen, Pär I. Johansson and Jakob Stensballe
    Citation: Trials 2016 17:327
  21. Parkinson’s disease (PD) results from a loss of dopamine in the brain, leading to movement dysfunctions such as bradykinesia, postural instability, resting tremor and muscle rigidity. Furthermore, dopamine def...

    Authors: Ashlee M. Hendy, Alex Tillman, Timo Rantalainen, Makii Muthalib, Liam Johnson, Dawson J. Kidgell, Daniel Wundersitz, Peter G. Enticott and Wei-Peng Teo
    Citation: Trials 2016 17:326
  22. People struggling with chronic pain may benefit from different types of non-pharmacological interventions such as self-management courses. Self-management courses aim to increase participants’ skills and knowl...

    Authors: Torunn Hatlen Nøst, Aslak Steinsbekk, Ola Bratås and Kjersti Grønning
    Citation: Trials 2016 17:325
  23. Vascular dementia is the second most common cause of dementia affecting over seven million people worldwide, yet there are no licensed treatments. There is an urgent need for a clinical trial in this patient g...

    Authors: Caroline Greenan, Lynn Murphy, Ly-Mee Yu, Patrick G. Kehoe, Elizabeth Coulthard, Philip Bath, Robert Stewart, Rob Jones, Anne Corbett, Alan Thomas, Peter Connelly, Frank Arrojo, Rachel Canning, Sylvia Wallach, Catherine Henderson, Bernadette McGuinness…
    Citation: Trials 2016 17:324
  24. Overweight and obesity are considered to be serious public health problems. In pediatric populations, insulin resistance, dyslipidemia, and hypertension associated with obesity occur with increased frequencies...

    Authors: Belén Pastor-Villaescusa, Javier Caballero-Villarraso, M. Dolores Cañete, Raúl Hoyos, José Maldonado, Gloria Bueno, Rosaura Leis, Ángel Gil, Ramón Cañete and Concepción M. Aguilera
    Citation: Trials 2016 17:323
  25. Before antiretroviral therapy (ART) became widely available in sub-Saharan Africa, several studies demonstrated that daily trimethoprim-sulfamethoxazole (TS) prophylaxis reduced morbidity and mortality among H...

    Authors: Matthew B. Laurens, Randy G. Mungwira, Osward M. Nyirenda, Titus H. Divala, Maxwell Kanjala, Francis Muwalo, Felix A. Mkandawire, Lufina Tsirizani, Wongani Nyangulu, Edson Mwinjiwa, Terrie E. Taylor, Jane Mallewa, William C. Blackwelder, Christopher V. Plowe, Miriam K. Laufer and Joep J. van Oosterhout
    Citation: Trials 2016 17:322
  26. I1 Introduction

    Authors: Mona Kanaan, Noreen Dadirai Mdege, Ada Keding, RA Parker, N. Mills, A. Shah, F. Strachan, C. Keerie, C. J. Weir, Andrew Forbes, Karla Hemming, Sarah A. Lawton, Emma Healey, Martyn Lewis, Elaine Nicholls, Clare Jinks…
    Citation: Trials 2016 17(Suppl 1):311

    This article is part of a Supplement: Volume 17 Supplement 1

  27. During clinical trials, researchers rarely question nominal doses specified on labels of investigational products, overlooking the potential for inaccuracies that may result when calculating pharmacokinetic an...

    Authors: Nancy Perrottet, Françoise Brunner-Ferber, Eric Grouzmann, François Spertini, Jérôme Biollaz, Thierry Buclin and Nicolas Widmer
    Citation: Trials 2016 17:321
  28. When subgroup analyses are not correctly analyzed and reported, incorrect conclusions may be drawn, and inappropriate treatments provided. Despite the increased recognition of the importance of subgroup analys...

    Authors: Nicole B. Gabler, Naihua Duan, Eli Raneses, Leah Suttner, Michael Ciarametaro, Elizabeth Cooney, Robert W. Dubois, Scott D. Halpern and Richard L. Kravitz
    Citation: Trials 2016 17:320
  29. Benign prostatic hyperplasia (BPH) and its associated lower urinary tract symptoms (LUTS) occur very commonly in older men. BPH and LUTS cause substantial physical and psychological impairment that could serio...

    Authors: XiangYun Liu, Guoyuan Huang, Peijie Chen, Yong Li, JiuLin Xiang, Ting Chen and Ru Wang
    Citation: Trials 2016 17:319
  30. Ventilator-acquired pneumonia (VAP) is a common reason for antimicrobial therapy in the intensive care unit (ICU). Biomarker-based diagnostics could improve antimicrobial stewardship through rapid exclusion of...

    Authors: Thomas P. Hellyer, Niall H. Anderson, Jennie Parker, Paul Dark, Tina Van Den Broeck, Suveer Singh, Ronan McMullan, Ashley M. Agus, Lydia M. Emerson, Bronagh Blackwood, Savita Gossain, Tim S. Walsh, Gavin D. Perkins, Andrew Conway Morris, Daniel F. McAuley and A. John Simpson
    Citation: Trials 2016 17:318

    The Erratum to this article has been published in Trials 2016 17:465

  31. It is estimated that up to 50 % of motor vehicle crash survivors develop significant psychological distress, such as depressive mood and anxiety, within 6 months of the crash. Associated impacts include loss o...

    Authors: Rebecca Guest, Yvonne Tran, Bamini Gopinath, Ian D. Cameron and Ashley Craig
    Citation: Trials 2016 17:317
  32. Many glaucoma patients do not adhere to their medication regimens because they fail to internalize the (health) costs of non-adherence, which may not occur until years or decades later. Behavioural economic th...

    Authors: Marcel Bilger, Tina T. Wong, Kaye L. Howard, Jia Yi Lee, Ai Nee Toh, Geraldine John, Ecosse L. Lamoureux and Eric A. Finkelstein
    Citation: Trials 2016 17:316
  33. With the development of computed tomography (CT) technology, coronary CT angiography can be acquired with low doses of radiation and contrast agent without a loss of diagnostic performance. The primary objecti...

    Authors: Dong Jin Im, Yun-Hyeon Kim, Ki Seok Choo, Joon-Won Kang, Jung Im Jung, Yoodong Won, Hyo Rim Kim, Myung Hee Chung, Kyunghwa Han and Byoung Wook Choi
    Citation: Trials 2016 17:315
  34. Evidence-based outpatient psychotherapeutic programs are first-line treatment of borderline personality disorder (BPD). Early and effective treatment of BPD is crucial to the prevention of its individual, psyc...

    Authors: Emma Beck, Sune Bo, Matthias Gondan, Stig Poulsen, Liselotte Pedersen, Jesper Pedersen and Erik Simonsen
    Citation: Trials 2016 17:314
  35. In this paper, we respond to a paper by Jamal and colleagues published in Trials in October 2015 and take an opportunity to continue the much-needed debate about what applied scientific realism is. The paper by J...

    Authors: Sara Van Belle, Geoff Wong, Gill Westhorp, Mark Pearson, Nick Emmel, Ana Manzano and Bruno Marchal
    Citation: Trials 2016 17:313
  36. Anthracycline-based treatment remains the backbone of chemotherapy for nonresectable soft tissue sarcomas (STS). More than 30 % of patients with STS are aged 60 years or older, limiting the choice of treatment...

    Authors: Annika Karch, Armin Koch and Viktor Grünwald
    Citation: Trials 2016 17:312
  37. The Pessary for the Prevention of Preterm Birth Study (PS3) is an international, multicenter, randomized clinical trial designed to examine the effectiveness of the Arabin pessary in preventing preterm birth i...

    Authors: Andrew R. Willan
    Citation: Trials 2016 17:310
  38. The multi-arm multi-stage (MAMS) design described by Royston et al. [Stat Med. 2003;22(14):2239–56 and Trials. 2011;12:81] can accelerate treatment evaluation by comparing multiple treatments with a control in...

    Authors: Daniel J. Bratton, Mahesh K. B. Parmar, Patrick P. J. Phillips and Babak Choodari-Oskooei
    Citation: Trials 2016 17:309
  39. Metabolic syndrome (MetS) and diabetes confer a high risk for developing subsequent cardiovascular disease (CVD). Persons with MetS constitute 24–34 % of the employee population at Baptist Health South Florida...

    Authors: Janisse M. Post, Shozab S. Ali, Lara L. Roberson, Ehimen C. Aneni, Sameer Shaharyar, Adnan Younus, Omar Jamal, Rameez Ahmad, Muhammad A. Aziz, Rehan Malik, Erica S. Spatz, Theodore Feldman, Jonathan Fialkow, Emir Veledar, Ricardo C. Cury, Arthur S. Agatston…
    Citation: Trials 2016 17:308
  40. Clinical trials oversight by a Trial Steering Committee (TSC) is mandated by Good Clinical Practice. This study used qualitative methods to explore the role and valued attributes of the TSC to inform planned u...

    Authors: Anne Daykin, Lucy E. Selman, Helen Cramer, Sharon McCann, Gillian W. Shorter, Matthew R. Sydes, Carrol Gamble, Rhiannon Macefield, J. Athene Lane and Alison Shaw
    Citation: Trials 2016 17:307
  41. Small fiber neuropathy generally leads to considerable pain and autonomic symptoms. Gain-of-function mutations in the SCN9A- gene, which codes for the Nav1.7 voltage-gated sodium channel, have been reported in sm...

    Authors: Bianca T. A. de Greef, Ingemar S. J. Merkies, Margot Geerts, Catharina G. Faber and Janneke G. J. Hoeijmakers
    Citation: Trials 2016 17:306
  42. Many previous studies have shown the potential therapeutic effect of acupuncture for allergic rhinitis. Most of these studies, however, were limited by the short duration of observations and lack of sham acupu...

    Authors: Yuxiu Sun, Hong Zhao, Yongming Ye, Wenbin Nie, Wenjing Bai, Jia Liu, Sinuo Li, Fang Wang, Mingjuan Han and Liyun He
    Citation: Trials 2016 17:305
  43. Attenuating the neurological damage occurring after out-of-hospital cardiac arrest is an ongoing research effort. This dual-centre study investigates the neuroprotective effects of the glucagon-like-peptide-1 ...

    Authors: Sebastian Wiberg, Christian Hassager, Jakob Hartvig Thomsen, Martin Frydland, Dan Eik Høfsten, Thomas Engstrøm, Lars Køber, Henrik Schmidt, Jacob Eifer Møller and Jesper Kjaergaard
    Citation: Trials 2016 17:304
  44. Physical activity interventions that are targeted at individuals can be effective in encouraging people to be more physically active. However, most such interventions are too long or complex and not scalable t...

    Authors: Joanna Mitchell, Wendy Hardeman, Sally Pears, Joana C. Vasconcelos, A. Toby Prevost, Ed Wilson and Stephen Sutton
    Citation: Trials 2016 17:303
  45. The self-expandable COMPLETE™ stent (Medtronic) has greater elasticity, allowing it to regain its shape after the compression force reduces, and has higher trackability, thus is easier to maneuver through tort...

    Authors: Woong Gil Choi, Seung Woon Rha, Cheol Ung Choi, Eung Ju Kim, Dong Joo Oh, Yoon Hyung Cho, Sang Ho Park, Seung Jin Lee, Ae Yong Hur, Young Guk Ko, Sang Min Park, Ki Chang Kim, Joo Han Kim, Min Woong Kim, Sang Min Kim, Jang Ho Bae…
    Citation: Trials 2016 17:302
  46. The CONsolidated Standards Of Reporting Trials (CONSORT) Statement provides a minimum standard set of items to be reported in published clinical trials; it has received widespread recognition within the biomed...

    Authors: Larissa Shamseer, Sally Hopewell, Douglas G. Altman, David Moher and Kenneth F. Schulz
    Citation: Trials 2016 17:301
  47. Up to 90 % of people living with dementia in care homes experience one or more behaviours that staff may describe as challenging to support (BSC). Of these agitation is the most common and difficult to manage....

    Authors: Claire A. Surr, Rebecca E. A. Walwyn, Amanda Lilley-Kelly, Robert Cicero, David Meads, Clive Ballard, Kayleigh Burton, Lynn Chenoweth, Anne Corbett, Byron Creese, Murna Downs, Amanda J. Farrin, Jane Fossey, Lucy Garrod, Elizabeth H. Graham, Alys Griffiths…
    Citation: Trials 2016 17:300
  48. Although evidence shows the positive health effects of physical activity, most of the adult population in Colombia are sedentary. It is, therefore, important to implement strategies that generate changes in li...

    Authors: Robinson Ramírez-Vélez, Alejandra Hernandez, Karem Castro, Alejandra Tordecilla-Sanders, Katherine González-Ruíz, Jorge Enrique Correa-Bautista, Mikel Izquierdo and Antonio García-Hermoso
    Citation: Trials 2016 17:298
  49. In adults with intellectual disability (ID) and epilepsy there are suggestions that improvements in management may follow introduction of epilepsy nurse-led care. However, this has not been tested in a definit...

    Authors: Howard Ring, Nakita Gilbert, Roxanne Hook, Adam Platt, Christopher Smith, Fiona Irvine, Cam Donaldson, Elizabeth Jones, Joanna Kelly, Adrian Mander, Caroline Murphy, Mark Pennington, Angela Pullen, Marcus Redley, Simon Rowe and James Wason
    Citation: Trials 2016 17:297

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