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  1. Content type: Study protocol

    Due to an ageing population in Australia there has been an increase in the number of older adults with subjective cognitive impairment (SCI), a self-reported decline in cognitive function associated with an in...

    Authors: Adele E. Cave, Dennis H. Chang, Gerald W. Münch and Genevieve Z. Steiner

    Citation: Trials 2019 20:345

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  2. Content type: Study protocol

    Spleen qi deficiency (SQD), a syndrome based on traditional Chinese medicine (TCM) theory, is common in patients after radical gastrectomy. SQD manifests with chronic gastrointestinal disorders and systemic sy...

    Authors: Xu Zhou, Dong-mei Yan, Wei-feng Zhu, Wen-jun Liu, He-yun Nie, Sheng Xu, Yi-ping Jiang, Kun-he Zhang, Ying Fu, Yi-ye Wan, Xin-yu Yu, Hong Li, Xin Sun and Xiao-fan Chen

    Citation: Trials 2019 20:343

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  3. Content type: Study protocol

    Individuals with two copies of the apolipoprotein-1 (APOL1) gene risk variants are at high risk (HR) for non-diabetic kidney disease. The presence of these risk variants is highest in West Africa, specifically in...

    Authors: Muktar H. Aliyu, Usman J. Wudil, Donna J. Ingles, Bryan E. Shepherd, Wu Gong, Baba M. Musa, Hamza Muhammad, Mahmoud U. Sani, Aliyu Abdu, Aisha M. Nalado, Akinfenwa Atanda, Aima A. Ahonkhai, Talat A. Ikizler, Cheryl A. Winkler, Jeffrey B. Kopp, Paul L. Kimmel…

    Citation: Trials 2019 20:341

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  4. Content type: Study protocol

    Sufficient physical activity and a limited amount of sedentary behaviour can prevent a range of chronic diseases. However, most adults do not meet the recommendations for physical activity and sedentary behavi...

    Authors: Helene Schroé, Celien Van der Mispel, Ilse De Bourdeaudhuij, Maïté Verloigne, Louise Poppe and Geert Crombez

    Citation: Trials 2019 20:340

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  5. Content type: Study protocol

    The benefit of pulmonary rehabilitation (PR) in symptomatic chronic obstructive pulmonary disease (COPD) is well known. However, advanced patients with chronic respiratory failure (CRF), a category excluded fr...

    Authors: Michele Vitacca, Irene Pietta, Marta Lazzeri and Mara Paneroni

    Citation: Trials 2019 20:336

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  6. Content type: Study protocol

    Earlier vascular healing after drug-eluting stent (DES) implantation may reduce the incidence of late stent thrombosis and provide theoretical evidence to shorten dual antiplatelet therapy duration in patients...

    Authors: Bo Li, Qin Hua Jin, Yun Dai Chen, Chang Qian Wang, Bei Shi, Xi Su, Guo Sheng Fu, Yan Qing Wu, Xu Chen Zhou and Zu Yi Yuan

    Citation: Trials 2019 20:335

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  7. Content type: Research

    ‘Conditional trial design’ is a framework for efficiently planning new clinical trials based on a network of relevant existing trials. The framework considers whether new trials are required and how the existi...

    Authors: Adriani Nikolakopoulou, Sven Trelle, Alex J. Sutton, Matthias Egger and Georgia Salanti

    Citation: Trials 2019 20:334

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  8. Content type: Study protocol

    Virtual reality training (VRT) uses computer software to track a user’s movements and allow him or her to interact with a game presented on a television screen. VRT is increasingly being used for the rehabilit...

    Authors: Lisa Sheehy, Anne Taillon-Hobson, Heidi Sveistrup, Martin Bilodeau, Christine Yang, Vivian Welch, Alomgir Hossain and Hillel Finestone

    Citation: Trials 2019 20:333

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  9. Content type: Study protocol

    The placement of prophylactic intra-abdominal drains has been common practice in abdominal operations including pancreatic surgery. The PANDRA trial showed that the omission of drains following pancreatic head...

    Authors: Joerg Kaiser, Willem Niesen, Pascal Probst, Thomas Bruckner, Colette Doerr-Harim, Oliver Strobel, Phillip Knebel, Markus K. Diener, André L. Mihaljevic, Markus W. Büchler and Thilo Hackert

    Citation: Trials 2019 20:332

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  10. Content type: Study protocol

    Evidence is conflicting about a causal role of inflammation in psychosis and, specifically, regarding antibodies binding to neuronal membrane targets, especially N-methyl-D-aspartate receptors. NMDAR, LGI1 and...

    Authors: Belinda Lennox, Ksenija Yeeles, Peter B. Jones, Michael Zandi, Eileen Joyce, Ly-Mee Yu, Giuliano Tomei, Rebecca Pollard, Sally-Anne Vincent, Mio Shimazaki, Iona Cairns, Francis Dowling, Thomas Kabir, Thomas R. E. Barnes, Anne Lingford Hughes, Akram A. Hosseini…

    Citation: Trials 2019 20:331

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  11. Content type: Study protocol

    Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection with a hospital mortality in excess of 40%. Along with insufficient and delayed empirical antimicrobial therap...

    Authors: Stefan Hagel, Sandra Fiedler, Andreas Hohn, Alexander Brinkmann, Otto R. Frey, Heike Hoyer, Peter Schlattmann, Michael Kiehntopf, Jason A. Roberts and Mathias W. Pletz

    Citation: Trials 2019 20:330

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  12. Content type: Methodology

    Randomised controlled trials (RCTs) are widely used for establishing evidence of the effectiveness of interventions, yet public health interventions are often complex, posing specific challenges for RCTs. Alth...

    Authors: Katy Davis, Nicole Minckas, Virginia Bond, Cari Jo Clark, Tim Colbourn, Sarah J. Drabble, Therese Hesketh, Zelee Hill, Joanna Morrison, Oliver Mweemba, David Osrin, Audrey Prost, Janet Seeley, Maryam Shahmanesh, Esther J. Spindler, Erin Stern…

    Citation: Trials 2019 20:329

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  13. Content type: Study protocol

    Shoulder pain is a highly prevalent complaint and disorders of the rotator cuff, including tears, are thought to be the most common cause. The number of operations to repair the torn rotator cuff has risen sig...

    Authors: Chris Littlewood, Marcus Bateman, Kendra Cooke, Susie Hennnings, Tina Cookson, Kieran Bromley, Martyn Lewis, Lennard Funk, Jean Denton, Maria Moffatt, Rachel Winstanley, Saurabh Mehta, Gareth Stephens, Lisa Dikomitis, Linda Chesterton and Nadine E. Foster

    Citation: Trials 2019 20:328

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  14. Content type: Study protocol

    Inflammatory bowel disease (IBD) is a chronic condition characterized by recurrent episodes of intestinal inflammation and is thought to be related to an autoimmune reaction to genetic and environmental factor...

    Authors: Eleonora Scaioli, Andrea Belluzzi, Luigi Ricciardiello, Daniele Del Rio, Enrica Rotondo, Pedro Mena, Eleonora Derlindati and Francesca Danesi

    Citation: Trials 2019 20:327

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  15. Content type: Study protocol

    Chronic urticaria (CU) is a refractory skin disease with long duration and a high recurrence rate. Acupuncture has been widely used for the treatment of CU in clinical practice in China. However, until now, th...

    Authors: Yunzhou Shi, Hui Zheng, Siyuan Zhou, Qianhua Zheng, Leixiao Zhang, Xianjun Xiao, Wei Cao, Ying Liu and Ying Li

    Citation: Trials 2019 20:326

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  16. Content type: Study protocol

    There are currently no approved pharmacotherapies for managing methamphetamine dependence. N-acetylcysteine (NAC) has been found to reduce the craving for methamphetamine and other drugs, but its effect on metham...

    Authors: Rebecca McKetin, Olivia M. Dean, Alyna Turner, Peter J. Kelly, Brendan Quinn, Dan I. Lubman, Paul Dietze, Gregory Carter, Peter Higgs, Amanda L. Baker, Barbara Sinclair, David Reid, Victoria Manning, Nina te Pas, Wenbin Liang, Tamsin Thomas…

    Citation: Trials 2019 20:325

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  17. Content type: Study protocol

    There are no standardized therapy guidelines for rehabilitation of calcaneus fractures. While there is consensus on non or partial weight-bearing, the use of supporting devices such as specific foot ankle orth...

    Authors: Hagen Schmal, Anders Holsgaard Larsen, Lonnie Froberg, Julie Ladeby Erichsen, Carsten Fladmose Madsen and Lasse Pedersen

    Citation: Trials 2019 20:324

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  18. Content type: Study protocol

    Process evaluation is increasingly common alongside complex randomised controlled trials (RCTs). This evaluation helps in understanding the mechanisms of impact and how the study processes were executed, and i...

    Authors: Vivien P. Nichols, David R. Ellard, Frances E. Griffiths, Martin Underwood, Stephanie J. C. Taylor and Shilpa Patel

    Citation: Trials 2019 20:323

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  19. Content type: Correction

    After publication of the original article [1], the authors have notified us of an error in language used in the text:

    Authors: Clifton O. Bingham III, Carol L. Gaich, Amy M. DeLozier, Kathryn D. Engstrom, April N. Naegeli, Stephanie de Bono, Pixy Banerjee and Peter C. Taylor

    Citation: Trials 2019 20:322

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    The original article was published in Trials 2019 20:182

  20. Content type: Study protocol

    Long-lasting insecticidal nets (LLINs) are a key malaria control intervention, but their effectiveness is threatened by resistance to pyrethroid insecticides. Some new LLINs combine pyrethroids with piperonyl ...

    Authors: Sarah G. Staedke, Moses R. Kamya, Grant Dorsey, Catherine Maiteki-Sebuguzi, Samuel Gonahasa, Adoke Yeka, Amy Lynd, Jimmy Opigo, Janet Hemingway and Martin J. Donnelly

    Citation: Trials 2019 20:321

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  21. Content type: Study protocol

    Both-bone forearm fractures are a common fracture, accounting for 3.4% of all paediatric fractures. For now, elastic stable intramedullary nailing (ESIN) and open reduction and internal fixation (ORIF) are the...

    Authors: Chunhui Chen, Linzhen Xie, Wenhao Zheng, Hua Chen and Leyi Cai

    Citation: Trials 2019 20:320

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  22. Content type: Study protocol

    Antidepressants are used both for treating acute episodes and for prophylaxis to prevent future episodes of depression, also called maintenance treatment. This article describes the protocol for a randomised c...

    Authors: Larisa Duffy, Faye Bacon, Caroline S. Clarke, Yvonne Donkor, Nick Freemantle, Simon Gilbody, Rachael Hunter, Tony Kendrick, David Kessler, Michael King, Paul Lanham, Gemma Lewis, Dee Mangin, Louise Marston, Michael Moore, Irwin Nazareth…

    Citation: Trials 2019 20:319

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  23. Content type: Study protocol

    Melanoma is common; 15,906 people in the UK were diagnosed with melanoma in 2015 and incidence has increased fivefold in 30 years. Melanoma affects old and young people, with poor prognosis once metastatic. UK...

    Authors: P. Murchie, J. Masthoff, F. M. Walter, K. Rahman, J. L. Allan, N. Burrows, C. Proby, A. J. Lee, M. Johnston, A. Durrani, I. Depasquale, B. Brant, A. Neilson, F. Meredith, S. Treweek, S. Hall…

    Citation: Trials 2019 20:318

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  24. Content type: Study protocol

    The risk of falling is significantly higher in people with chronic stroke and it is, therefore, important to design interventions to improve mobility and decrease falls risk. Minimum toe clearance (MTC) is the...

    Authors: Rezaul Begg, Mary P. Galea, Lisa James, W. A. Tony Sparrow, Pazit Levinger, Fary Khan and Catherine M. Said

    Citation: Trials 2019 20:317

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  25. Content type: Commentary

    A malaria vaccine as part of the integrated malaria control and elimination efforts will have a major impact on public health in sub-Sahara Africa. The first malaria vaccine, RTS,S, now enters pilot implementa...

    Authors: Machteld van den Berg, Bernhards Ogutu, Nelson K. Sewankambo, Nikola Biller-Andorno and Marcel Tanner

    Citation: Trials 2019 20:316

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  26. Content type: Study protocol

    Taurine (Tau) is involved in many biochemical functions such as regulation of glucose and lipid metabolism, enhancement of energy expenditure, anti-inflammatory effects and appetite control. The most important...

    Authors: Fatemeh Haidari, Maryam Asadi, Javad mohammadi-asl and Kambiz Ahmadi-Angali

    Citation: Trials 2019 20:315

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  27. Content type: Study protocol

    Fabry disease (FD) is a genetic disorder caused by a deficiency in the enzyme alpha-galactosidase A, leading to an accumulation of glycosphingolipids in tissues across the body. Cardiac disease is the leading ...

    Authors: Ravi Vijapurapu, Rebecca Kozor, Derralynn A. Hughes, Peter Woolfson, Ana Jovanovic, Patrick Deegan, Rosemary Rusk, Gemma A. Figtree, Michel Tchan, David Whalley, Dipak Kotecha, Francisco Leyva, James Moon, Tarekegn Geberhiwot and Richard P. Steeds

    Citation: Trials 2019 20:314

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  28. Content type: Research

    Successful stroke trials require adequate recruitment. In this observational study, we assessed reasons for refusal to provide informed consent in eligible patients approached for clinical trial participation ...

    Authors: Zoe R. O’Neill, Halina M. Deptuck, Lauren Quong, Genoveva Maclean, Karina Villaluna, Princess King-Azote, Mukul Sharma, Ken Butcher, Robert G. Hart and Thalia S. Field

    Citation: Trials 2019 20:313

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  29. Content type: Study protocol

    Patients undergoing cardiac surgery with cardiopulmonary bypass are at an increased risk of developing postoperative pulmonary complications, potentially leading to excess morbidity and mortality. It is likely...

    Authors: Brian O’Gara, Balachundhar Subramaniam, Shahzad Shaefi, Ariel Mueller, Valerie Banner-Goodspeed and Daniel Talmor

    Citation: Trials 2019 20:312

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  30. Content type: Update

    The incidence of Achilles tendon rupture in the UK is increasing and the best rehabilitation strategy for patients treated non-operatively remains unclear. We describe a statistical analysis plan (SAP) for the...

    Authors: Ioana R. Marian, Matthew L. Costa and Susan J. Dutton

    Citation: Trials 2019 20:311

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  31. Content type: Study protocol

    Mild cognitive impairment (MCI) is defined as a decline in cognitive state with preservation of activities of daily living. Medications such as donepezil and rivastigmine have been commonly prescribed for MCI,...

    Authors: Hyo-Weon Suh, Jieun Kim, Ojin Kwon, Seung-Hun Cho, Jong Woo Kim, Hui-Yong Kwak, Yunna Kim, Kyung Mi Lee, Sun-Yong Chung and Jun-Hwan Lee

    Citation: Trials 2019 20:310

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  32. Content type: Commentary

    An international workshop on population health intervention research (PHIR) was organized to foster exchanges between experts from different disciplines and different fields.

    Authors: Lehana Thabane, Linda Cambon, Louise Potvin, Jeanine Pommier, Joëlle Kivits, Laetitia Minary, Kareen Nour, Pierre Blaise, Julie Charlesworth and François Alla

    Citation: Trials 2019 20:309

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    The original article was published in Trials 2019 20:285

  33. Content type: Study protocol

    The National Institutes of Health estimates the prevalence of insomnia in menopausal women at 40–50%. Some studies have shown that acupuncture might be effective in treating primary insomnia and insomnia relat...

    Authors: Shanshan Li, Ping Yin, Xuan Yin, Anna Bogachko, Tingting Liang, Lixing Lao and Shifen Xu

    Citation: Trials 2019 20:308

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  34. Content type: Research

    Improving efficiencies in clinical research is crucial to translation of findings into practice and delivery of effective, patient-centered health care. This paper describes a project that monitored pragmatic ...

    Authors: Paula Darby Lipman, Leanora Dluzak and Catherine M. Stoney

    Citation: Trials 2019 20:307

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  35. Content type: Study protocol

    Total knee arthroplasty (TKA) is an optimal option for patients with middle-to-end-stage knee osteoarthritis. However, the management of postoperative acute pain remains inefficient. Transcutaneous electrical ...

    Authors: Yulin Li, Lixi Chu, Xiangming Li, Weitao Zhai, Yinghui Ma, Yong He, Yuelin Xu, Sheng Ding, Huali Gao, Jing Zhang, Bowen Ye, Jingchao Wang, Jie Yao, Chonggui Wu and Lianbo Xiao

    Citation: Trials 2019 20:306

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  36. Content type: Study protocol

    Nursing home residents are frequently affected by joint contractures, which impacts their participation and daily activities. A complex intervention, the Participation Enabling Care in Nursing (PECAN), was pre...

    Authors: Natalie Nguyen, Regina Thalhammer, Katrin Beutner, Susanne Saal, Ricarda Servaty, Hanna Klingshirn, Andrea Icks, Kristina Freyberg, Markus Vomhof, Ulrich Mansmann, Lien Le, Martin Müller and Gabriele Meyer

    Citation: Trials 2019 20:305

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  37. Content type: Study protocol

    There are increasing studies showing that the use of a lung-protective ventilation strategy has a lung protection effect in patients undergoing abdominal surgery; however, the appropriate positive end-expirato...

    Authors: Zhen-feng Zhou, Jun-biao Fang, Long Chen, Hong-fa Wang, Yong-jian Yu, Wen-yuan Wang, Jia-bao Chen, Miao-zun Zhang and Shuang-fei Hu

    Citation: Trials 2019 20:304

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  38. Content type: Study protocol

    Caring for people with dementia (PWD) is stressful and poses many life challenges for the family caregivers. Interventions targeting the stress and psychological well-being of the caregivers have been proposed...

    Authors: Patrick Pui Kin Kor, Justina Yat-Wa Liu and Wai Tong Chien

    Citation: Trials 2019 20:303

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  39. Content type: Study protocol

    Aged long-term care receivers are affected by various adverse skin conditions like pressure ulcers, incontinence-associated dermatitis, dryness, intertrigo, and many more. Prevention of these skin problems and...

    Authors: Jan Kottner, Elisabeth Hahnel, Monira El Genedy, Konrad Neumann and Katrin Balzer

    Citation: Trials 2019 20:302

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  40. Content type: Research

    Informed consent is a prerequisite for patients included in clinical trials. Trial design, inclusion criteria and legal requirements are increasingly complex. This complexity challenges design and delivery of ...

    Authors: Pia Dellson, Christina Carlsson, Mef Nilbert and Helena Jernström

    Citation: Trials 2019 20:301

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  41. Content type: Commentary

    Trials have become bigger and more complicated due to the complexity introduced by biomarker stratification, and the advent of multi-arm multi-stage trials, and umbrella and basket platform designs. The trials...

    Authors: Liz Morrell, Joshua Hordern, Louise Brown, Matthew R. Sydes, Claire L. Amos, Richard S. Kaplan, Mahesh K. B. Parmar and Timothy S. Maughan

    Citation: Trials 2019 20:297

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  42. Content type: Methodology

    There is limited research and literature on the data management challenges encountered in multi-arm, multi-stage platform and umbrella protocols. These trial designs allow both (1) seamless addition of new res...

    Authors: Dominic Hague, Stephen Townsend, Lindsey Masters, Mary Rauchenberger, Nadine Van Looy, Carlos Diaz-Montana, Melissa Gannon, Nicholas James, Tim Maughan, Mahesh K. B. Parmar, Louise Brown and Matthew R. Sydes

    Citation: Trials 2019 20:294

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    The Methodology to this article has been published in Trials 2019 20:264

  43. Content type: Methodology

    There are limited research and literature on the trial management challenges encountered in running adaptive platform trials. This trial design allows both (1) the seamless addition of new research comparisons...

    Authors: Francesca Schiavone, Riya Bathia, Krishna Letchemanan, Lindsey Masters, Claire Amos, Anna Bara, Louise Brown, Clare Gilson, Cheryl Pugh, Nafisah Atako, Fleur Hudson, Mahesh Parmar, Ruth Langley, Richard S. Kaplan, Chris Parker, Gert Attard…

    Citation: Trials 2019 20:264

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    The Methodology to this article has been published in Trials 2019 20:294

  44. Content type: Study protocol

    Obesity is associated with a chronic systemic inflammatory process. Volatile or intravenous anesthetic agents may modulate immune function, and may do so differentially in obesity. However, no study has evalua...

    Authors: Giselle Carvalho de Sousa, Fernanda Ferreira Cruz, Luciana Boavista Heil, Carlos José Saboya Sobrinho, Felipe Saddy, Frederico Paranhos Knibel, Joana Barreto Pereira, Marcus J. Schultz, Paolo Pelosi, Marcelo Gama de Abreu, Pedro Leme Silva and Patricia Rieken Macedo Rocco

    Citation: Trials 2019 20:300

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  45. Content type: Study protocol

    Three-dimensional (3D) stereoscopic vision is crucial to perform any kind of manual task. The reduction from real life 3D to virtual two-dimensional (2D) sight is a major challenge in minimally invasive surger...

    Authors: Roger Wahba, Rabi Raj Datta, Andrea Hedergott, Jana Bußhoff, Thomas Bruns, Robert Kleinert, Georg Dieplinger, Hans Fuchs, Caroline Giezelt, Desdemona Möller, Martin Hellmich, Christiane J. Bruns and Dirk L. Stippel

    Citation: Trials 2019 20:299

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  46. Content type: Study protocol

    Cardiovascular rehabilitation is one of the treatment options for post-stroke individuals in order to improve functional independence in activities of daily life and reduce energy expenditure. The aim of this ...

    Authors: Josiela Cristina da Silva Rodrigues, Gustavo José Luvizutto, Rafael Dalle Molle da Costa, Robson Aparecido Prudente, Taís Regina da Silva, Juli Thomaz de Souza, Caroline Ferreira da Silva Mazeto Pupo da Silveira, Daniele Andreza Antonelli Rossi, Fernanda Cristina Winckler, Gabriel Pinheiro Modolo, Tainá Fabri Carneiro Valadão, Letícia Cláudia de Oliveira Antunes, Luis Cuadrado Martin, Rodrigo Bazan and Silméia Garcia Zanati Bazan

    Citation: Trials 2019 20:298

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  47. Content type: Study protocol

    Arterial stiffness is closely related to the process of atherosclerosis, an independent cardiovascular risk factor, and predictive of future cardiovascular events and mortality. Recently, we showed that magnes...

    Authors: Joëlle C. Schutten, Peter J. Joris, Ronald P. Mensink, Richard M. Danel, Frans Goorman, M. Rebecca Heiner-Fokkema, Rinse K. Weersma, Charlotte A. Keyzer, Martin H. de Borst and Stephan J. L. Bakker

    Citation: Trials 2019 20:295

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  48. Content type: Methodology

    In cluster-randomized controlled trials (C-RCTs), covariate-constrained randomization (CCR) methods efficiently control imbalance in multiple baseline cluster-level variables, but the choice of imbalance metri...

    Authors: Jody D. Ciolino, Alicia Diebold, Jessica K. Jensen, Gerald W. Rouleau, Kimberly K. Koloms and Darius Tandon

    Citation: Trials 2019 20:293

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  49. Content type: Study protocol

    An inappropriate anastomosis method during laparoscopic anterior rectal resection can increase the risk of anastomotic complications and affect surgical, economic, and oncological outcomes. The aim of this stu...

    Authors: Xiaolan You, Jian Wu, Yuanjie Wang, Qinghong Liu, Dehu Chen, Xiaojun Zhao, Yan Zhou, Xiaoqing Wu and Daorong Wang

    Citation: Trials 2019 20:292

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  50. Content type: Study protocol

    The number of women of childbearing age with chronic diseases is rising. Evidence has shown that obstetric complications and poor psychological well-being are more prevalent among this group, in addition to th...

    Authors: Mie Gaarskjaer de Wolff, Marianne Johansen, Anne S. Ersbøll, Susanne Rosthøj, Anne Brunsgaard, Julie Midtgaard, Ann Tabor and Hanne Kristine Hegaard

    Citation: Trials 2019 20:291

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