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  1. Stepped wedge cluster randomised trials introduce interventions to groups of clusters in a random order and have been used to evaluate interventions for health and wellbeing. Standardised guidance for reportin...

    Authors: Calum Davey, James Hargreaves, Jennifer A Thompson, Andrew J Copas, Emma Beard, James J Lewis and Katherine L Fielding
    Citation: Trials 2015 16:358
  2. Stepped wedge trials (SWTs) can be considered as a variant of a clustered randomised trial, although in many ways they embed additional complications from the point of view of statistical design and analysis. ...

    Authors: Gianluca Baio, Andrew Copas, Gareth Ambler, James Hargreaves, Emma Beard and Rumana Z Omar
    Citation: Trials 2015 16:354
  3. In a stepped wedge, cluster randomised trial, clusters receive the intervention at different time points, and the order in which they received it is randomised. Previous systematic reviews of stepped wedge tri...

    Authors: Emma Beard, James J. Lewis, Andrew Copas, Calum Davey, David Osrin, Gianluca Baio, Jennifer A. Thompson, Katherine L. Fielding, Rumana Z. Omar, Sam Ononge, James Hargreaves and Audrey Prost
    Citation: Trials 2015 16:353
  4. There is limited guidance on the design of stepped wedge cluster randomised trials. Current methodological literature focuses mainly on trials with cross-sectional data collection at discrete times, yet many r...

    Authors: Andrew J. Copas, James J. Lewis, Jennifer A. Thompson, Calum Davey, Gianluca Baio and James R. Hargreaves
    Citation: Trials 2015 16:352
  5. Three arguments are usually invoked in favour of stepped wedge cluster randomised controlled trials: the logistic convenience of implementing an intervention in phases, the ethical benefit of providing the int...

    Authors: Audrey Prost, Ariella Binik, Ibrahim Abubakar, Anjana Roy, Manuela De Allegri, Christelle Mouchoux, Tobias Dreischulte, Helen Ayles, James J. Lewis and David Osrin
    Citation: Trials 2015 16:351
  6. In cluster randomised trials, randomisation increases internal study validity. If enough clusters are randomised, an unadjusted analysis should be unbiased. If a smaller number of clusters are included, strati...

    Authors: James R Hargreaves, Audrey Prost, Katherine L. Fielding and Andrew J. Copas
    Citation: Trials 2015 16:359
  7. Inflammatory response is one of the key components of pain perception. Continuous infusion (CWI) of local anesthetics has been shown to be effective in controlling pain and reducing postoperative morphine cons...

    Authors: Dario Bugada, Manuela De Gregori, Christian Compagnone, Carolina Muscoli, Ferdinando Raimondi, Silvia Bettinelli, Maria Antonietta Avanzini, Lorenzo Cobianchi, Andrea Peloso, Marco Baciarello, Concetta Dagostino, Luigino A. Giancotti, Sara Ilari, Filomena Lauro, Stefania Grimaldi, Ennio Tasciotti…
    Citation: Trials 2015 16:357
  8. Women with pregnancy complicated by pregestational diabetes experience increased rates of adverse pregnancy outcomes. Prepregnancy care is the targeted support and additional care offered to those women who ar...

    Authors: Aoife M. Egan, Valerie Smith, Declan Devane and Fidelma P. Dunne
    Citation: Trials 2015 16:356
  9. Pneumonia is responsible for a large proportion of hospital admissions and antibiotic utilization. Physician adherence to evidence-based pneumonia management guidelines is poor. Antimicrobial stewardship progr...

    Authors: Giulio DiDiodato, Leslie McArthur, Joseph Beyene, Marek Smieja and Lehana Thabane
    Citation: Trials 2015 16:355
  10. Psychological interventions which adopt an explicitly interpersonal approach are a recent development in the treatment of distressing voices. AVATAR therapy is one such approach which creates a direct dialogue...

    Authors: Tom K.J Craig, Mar Rus-Calafell, Thomas Ward, Miriam Fornells-Ambrojo, Paul McCrone, Richard Emsley and Philippa Garety
    Citation: Trials 2015 16:349
  11. Involving service users in planning their care is at the centre of policy initiatives to improve mental health care quality in England. Whilst users value care planning and want to be more involved in their ow...

    Authors: Peter Bower, Chris Roberts, Neil O’Leary, Patrick Callaghan, Penny Bee, Claire Fraser, Chris Gibbons, Nicola Olleveant, Anne Rogers, Linda Davies, Richard Drake, Caroline Sanders, Oonagh Meade, Andrew Grundy, Lauren Walker, Lindsey Cree…
    Citation: Trials 2015 16:348
  12. Mass drug administration (MDA) and focal MDA (fMDA) using dihydroartemisinin plus piperaquine (DHAp), represent two strategies to maximize the use of existing information to achieve greater clearance of human ...

    Authors: Thomas P. Eisele, Kafula Silumbe, Timothy Finn, Victor Chalwe, Mukalwa Kamuliwo, Busiku Hamainza, Hawela Moonga, Adam Bennett, Josh Yukich, Joseph Keating, Richard W. Steketee and John M. Miller
    Citation: Trials 2015 16:347
  13. Individuals with chronic lung disease are more susceptible to present reduction in exercise tolerance and muscles strength not only due to pulmonary limitations but also due systemic repercussions of the pulmo...

    Authors: Mariana Mazzuca Reimberg, Rejane Agnelo Silva Castro, Jessyca Pachi Rodrigues Selman, Aline Santos Meneses, Fabiano Politti, Márcia Carvalho Mallozi, Gustavo Falbo Wandalsen, Dirceu Solé, Kátia De Angelis, Simone Dal Corso and Fernanda Cordoba Lanza
    Citation: Trials 2015 16:346
  14. Since technique modifications of laparoscopic donor nephrectomy, e.g. retroperitoneoscopic donor nephrectomy or hand-assistance, have not shown significant benefit regarding safety or improvement of recovery, ...

    Authors: Denise M. D. Özdemir-van Brunschot, Gert J. Scheffer, Albert Dahan, Janneke E. E. A. Mulder, Simone A. A. Willems, Luuk B. Hilbrands, Frank C. H. d’Ancona, Rogier A. R. T. Donders, Kees J. H. M. van Laarhoven and Michiel C. Warlé
    Citation: Trials 2015 16:345
  15. Cognitive behavioural therapy is an effective treatment for depression. However, one third of the patients do not respond satisfactorily, and relapse rates of around 30 % within the first post-treatment year w...

    Authors: Morten Hvenegaard, Ed R. Watkins, Stig Poulsen, Nicole K. Rosenberg, Matthias Gondan, Ben Grafton, Stephen F. Austin, Henriette Howard and Stine B. Moeller
    Citation: Trials 2015 16:344
  16. Evidence that home telemonitoring for patients with chronic heart failure (CHF) offers clinical benefit over usual care is controversial as is evidence of a health economic advantage.

    Authors: Reiner Hofmann, Heinz Völler, Klaus Nagels, Dominik Bindl, Eik Vettorazzi, Ronny Dittmar, Walter Wohlgemuth, Till Neumann, Stefan Störk, Oliver Bruder, Karl Wegscheider, Eckhard Nagel and Eckart Fleck
    Citation: Trials 2015 16:343
  17. Individuals with a learning disability (LD) are at higher risk of developing type 2 diabetes, but LD is not straightforward to define or identify, especially at the milder end of the spectrum, which makes case...

    Authors: Rebecca E. A. Walwyn, Amy M. Russell, Louise D. Bryant, Amanda J. Farrin, Alexandra M. Wright-Hughes, Elizabeth H. Graham, Claire Hulme, John L. O’Dwyer, Gary J. Latchford, Alison J. Stansfield, Dinesh Nagi, Ramzi A. Ajjan and Allan O. House
    Citation: Trials 2015 16:342
  18. Manuscript abstracts represent a critical source of information for oncology practitioners. Practitioners may utilize the information contained in abstracts as a basis for treatment decisions particularly when...

    Authors: Shanthi Sivendran, Kristina Newport, Michael Horst, Adam Albert and Matthew D. Galsky
    Citation: Trials 2015 16:341
  19. Delirium is the most frequent complication among older people following hospitalisation. Delirium may be prevented in about one-third of patients using a multicomponent intervention. However, in the United Kin...

    Authors: John Young, Francine Cheater, Michelle Collinson, Marie Fletcher, Anne Forster, Mary Godfrey, John Green, Shamaila Anwar, Suzanne Hartley, Claire Hulme, Sharon K Inouye, David Meads, Gillian Santorelli, Najma Siddiqi, Jane Smith, Elizabeth Teale…
    Citation: Trials 2015 16:340
  20. Age-related muscle wasting has been strongly implicated with falls and fractures in the elderly, but it has also been associated with cognitive decline and dementia. Progressive resistance training (PRT) and a...

    Authors: Robin M. Daly, Jenny Gianoudis, Melissa Prosser, Dawson Kidgell, Kathryn A. Ellis, Stella O’Connell and Caryl A. Nowson
    Citation: Trials 2015 16:339
  21. Glaucoma involves progressive optic nerve fibre loss, subsequently leading to irreversible and disabling visual field defects. In Europe, the prevalence of glaucoma is approximately 2.2 % of all people aged ov...

    Authors: Marina Forbes, Helen Fairlamb and Leon Jonker
    Citation: Trials 2015 16:337
  22. Previous studies regarding rhythm control in patients with atrial fibrillation (AF) could not sufficiently demonstrate the efficacy of available anti-arrhythmic drugs. ‘Upstream therapy’ has emerged as a poten...

    Authors: Wen-Wei Qi, Tong Liu, Gang Xu, Li-Feng Li, Ying-Zi Liang, Lan Ye and Guang-Ping Li
    Citation: Trials 2015 16:336
  23. Despite Australia’s sunny climate, low vitamin D levels are increasingly prevalent. Sun exposure is limited by long working hours, an increase in time spent indoors, and sun protection practices, and there is ...

    Authors: Barbora de Courten, Aya Mousa, Negar Naderpoor, Helena Teede, Maximilian P J de Courten and Robert Scragg
    Citation: Trials 2015 16:335
  24. Authors: Roger Olofsson Bagge, Lars Ny, Charlotta All-Ericsson, Malin Sternby Eilard, Magnus Rizell, Christian Cahlin, Ulrika Stierner, Ulf Lönn, Johan Hansson, Ingrid Ljuslinder, Lotta Lundgren, Gustav Ullenhag, Jens Folke Kiilgaard, Jonas Nilsson and Per Lindnér
    Citation: Trials 2015 16:334

    The original article was published in Trials 2014 15:317

  25. It is increasingly acknowledged that clinical interventions for young persons with mental disorders need to optimize social, vocational and physical functioning, and take into account developmental needs, rath...

    Authors: Lillian Jean Gehue, Elizabeth Scott, Daniel Francis Hermens, Jan Scott and Ian Hickie
    Citation: Trials 2015 16:333
  26. Impaired glucose tolerance is present in one third of patients with a TIA or ischemic stroke and is associated with a two-fold risk of recurrent stroke. Metformin improves glucose tolerance, but often leads to...

    Authors: Elizabeth Osei, Susanne Fonville, Adrienne A. M. Zandbergen, Paul J. A. M. Brouwers, Laus J. M. M. Mulder, Hester F. Lingsma, Diederik W. J. Dippel, Peter J. Koudstaal and Heleen M. den Hertog
    Citation: Trials 2015 16:332
  27. Deep muscle relaxation has been shown to facilitate operating conditions during laparoscopic surgery. Minimally invasive esophageal surgery is a high-risk procedure in which the use of deep neuromuscular block...

    Authors: Denise P. Veelo, Suzanne S. Gisbertz, Rebekka A. Hannivoort, Susan van Dieren, Bart F. Geerts, Mark I. van Berge Henegouwen and Markus W. Hollmann
    Citation: Trials 2015 16:331
  28. This update describes changes to procedures for our randomised controlled trial of ‘On Your Feet to Earn Your Seat’, a habit-based intervention to reduce sedentary behaviour in older adults. Some of the amendm...

    Authors: Benjamin Gardner, Lee Smith, Daniel Aggio, Steve Iliffe, Kenneth R. Fox, Barbara J. Jefferis and Mark Hamer
    Citation: Trials 2015 16:330
  29. The pain of a severe burn injury is often characterised by intense background pain, coupled with severe exacerbations associated with essential procedures such as dressing changes. The experience of pain is af...

    Authors: Charlotte Small, Robert Stone, Jane Pilsbury, Michael Bowden and Julian Bion
    Citation: Trials 2015 16:329
  30. Beyond its classical role in calcium homoeostasis and bone metabolism, vitamin D deficiency has been found to be associated with several diseases, including diabetes, non-alcoholic fatty liver disease, and eve...

    Authors: Maria Luger, Renate Kruschitz, Rodrig Marculescu, Helmuth Haslacher, Friedrich Hoppichler, Enikö Kallay, Christian Kienbacher, Carmen Klammer, Melanie Kral, Felix Langer, Eva Luger, Gerhard Prager, Michael Trauner, Stefan Traussnigg, Tanja Würger, Karin Schindler…
    Citation: Trials 2015 16:328
  31. Complex metabolic changes cause obesity, making weight loss difficult. For this reason, understanding metabolism is important, and considering the shortcomings of conventional treatment options for obesity, ac...

    Authors: Koh-Woon Kim, Hye Hyun Yoo, Jae-Heung Cho, Yo-Chan Yang, Je-In Kim, Song-Yi Kim, Ji-Yeun Park, Hi-Joon Park and Mi-Yeon Song
    Citation: Trials 2015 16:327
  32. Metabolic acidosis is more common with advancing chronic kidney disease, and has been associated with impaired physical function, impaired bone health, accelerated decline in kidney function and increased vasc...

    Authors: Miles D. Witham, Margaret M. Band, Roberta C. Littleford, Alison Avenell, Roy L. Soiza, Marion E. T. McMurdo, Deepa Sumukadas, Simon A. Ogston, Edmund J. Lamb, Geeta Hampson and Paul McNamee
    Citation: Trials 2015 16:326
  33. The power of the randomised controlled trial depends upon its capacity to operate in a closed system whereby the intervention is the only causal force acting upon the experimental group and absent in the contr...

    Authors: Bronagh Blackwood and Lyvonne Tume
    Citation: Trials 2015 16:325
  34. Nowadays, short dental implants are being increasingly applied in extremely resorbed posterior regions. The recent studies have indicated that short implants present a similar success rate to conventional impl...

    Authors: Jun-Yu Shi, Ying-Xin Gu, Shi-Chong Qiao, Long-Fei Zhuang, Xiao-Meng Zhang and Hong-Chang Lai
    Citation: Trials 2015 16:324
  35. Obesity is a leading preventable cause of death and disability and is associated with a lower health-related quality of life. We evaluated the impact of telecoaching conducted by a counselor trained in motivat...

    Authors: Jill M. Huber, Joshua S. Shapiro, Mark L. Wieland, Ivana T. Croghan, Kristen S. Vickers Douglas, Darrell R. Schroeder, Julie C. Hathaway and Jon O. Ebbert
    Citation: Trials 2015 16:323
  36. Surgical site infections (SSIs) are the second most common form of nosocomial infection. Colorectal resections have high rates of SSIs secondary to the inherently contaminated intraluminal environment. Negativ...

    Authors: Sami A. Chadi, Kelly N. Vogt, Sarah Knowles, Patrick B. Murphy, Julie Ann Van Koughnett, Muriel Brackstone and Michael C. Ott
    Citation: Trials 2015 16:322
  37. Severe traumatic injury and haemorrhagic shock are frequently associated with disruptions of coagulation function (such as trauma-induced coagulopathy TIC) and activation of inflammatory cascades. These pathol...

    Authors: Penny S. Reynolds, Mary Jane Michael, Emily D. Cochran, Jacob A. Wegelin and Bruce D. Spiess
    Citation: Trials 2015 16:321
  38. Previous studies have indicated that acupuncture can alleviate the symptoms of Tourette syndrome (TS), but the evidence is insufficient. So far, there have been no reports on plum-blossom needle therapy for TS...

    Authors: Jinna Yu, Yongming Ye, Shanshan Li, Jun Liu, Yanbing Zhai, Min Zhang and Zhishun Liu
    Citation: Trials 2015 16:320
  39. Psychodynamic and cognitive-behavioral group therapies are frequently applied in day hospitals for the treatment of anxiety disorders and comorbid depressive or personality disorders in Poland and other Easter...

    Authors: Hubert Suszek, Paweł Holas, Tomasz Wyrzykowski, Steinar Lorentzen and Andrzej Kokoszka
    Citation: Trials 2015 16:319
  40. Growing use of cloud computing in clinical trials prompted the European Clinical Research Infrastructures Network, a European non-profit organisation established to support multinational clinical research, to ...

    Authors: Christian Ohmann, Steve Canham, Edgar Danielyan, Steve Robertshaw, Yannick Legré, Luca Clivio and Jacques Demotes
    Citation: Trials 2015 16:318
  41. Although vocational rehabilitation is a widely advocated intervention for workers on sick leave due to subacute or chronic nonspecific musculoskeletal pain, the optimal dosage of effective and cost-effective v...

    Authors: Timo T. Beemster, Judith M. van Velzen, Coen A.M. van Bennekom, Monique H.W. Frings-Dresen and Michiel F. Reneman
    Citation: Trials 2015 16:317
  42. The use of a laryngeal mask airway (LMA) in appropriate patients supports fast-track anesthesia with a lower incidence of postoperative airway-connected adverse events. Data on the most favorable anesthetic in...

    Authors: Ana Stevanovic, Rolf Rossaint, András P. Keszei, Harald Fritz, Gebhard Fröba, Friedrich Pühringer and Mark Coburn
    Citation: Trials 2015 16:316
  43. Bacterial vaginosis is associated with increased transmission of sexually transmitted infections, preterm labor, post-surgical infections, and endometritis. Current treatment for symptomatic bacterial vaginosi...

    Authors: Melinda Zeron Mullins and Konia M. Trouton
    Citation: Trials 2015 16:315
  44. The causes of chronic fatigue syndrome (CFS) and idiopathic chronic fatigue (ICF) are not clearly known, and there are no definitive treatments for them. Therefore, patients with CFS and ICF are interested in ...

    Authors: Jung-Eun Kim, Byung-Kwan Seo, Jin-Bong Choi, Hyeong-Jun Kim, Tae-Hun Kim, Min-Hee Lee, Kyung-Won Kang, Joo-Hee Kim, Kyung-Min Shin, Seunghoon Lee, So-Young Jung, Ae-Ran Kim, Mi-Suk Shin, Hee-Jung Jung, Hyo-Ju Park, Sung-Phil Kim…
    Citation: Trials 2015 16:314
  45. The management of dizziness in older patients is primarily diagnosis-oriented. However, in 40 % of older patients with dizziness, GPs are not able to identify an underlying cause, and a number of common underl...

    Authors: Hanneke Stam, Johannes C. van der Wouden, Henriëtte E. van der Horst and Otto R. Maarsingh
    Citation: Trials 2015 16:313
  46. Depression is a common and disabling condition. Since 2001, Chile has had a national program for depression in primary care and universal access to treatment for depressed people over the age of 15. There are ...

    Authors: Graciela Rojas, Pablo Martínez, Paul A. Vöhringer, Vania Martínez, Ariel Castro-Lara and Rosemarie Fritsch
    Citation: Trials 2015 16:311
  47. Critically ill patients rapidly loose much of their muscle mass and strength. This can be attributed to prolonged admission, prolonged mechanical ventilation and increased mortality, and it can have a negative...

    Authors: Helene Korvenius Nedergaard, Hanne Irene Jensen, Jørgen T. Lauridsen, Gisela Sjøgaard and Palle Toft
    Citation: Trials 2015 16:310
  48. Patient understanding of study information is fundamental to gaining informed consent to take part in a randomised controlled trial. In order to meet the requirements of research ethics committees, patient inf...

    Authors: Mei-See Man, Jo Rick and Peter Bower
    Citation: Trials 2015 16:309

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