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  1. The hypothesis of the proposed intervention is that Granulocyte-macrophage colony-stimulating factor (GM-CSF) has profound effects on antiviral immunity, and can provide the stimulus to restore immune homeosta...

    Authors: Cedric Bosteels, Bastiaan Maes, Karel Van Damme, Elisabeth De Leeuw, Jozefien Declercq, Anja Delporte, Bénédicte Demeyere, Stéfanie Vermeersch, Marnik Vuylsteke, Joren Willaert, Laura Bollé, Yuri Vanbiervliet, Jana Decuypere, Frederick Libeer, Stefaan Vandecasteele, Isabelle Peene…

    Citation: Trials 2020 21:491

    Content type: Letter

    Published on:

    The Correction to this article has been published in Trials 2020 21:554

  2. After the birth of a child, many mothers and fathers experience postpartum mental disorders like depression, anxiety, obsessive-compulsive disorder, stress or other illnesses. This endangers the establishment ...

    Authors: J. Mattheß, M. Eckert, K. Richter, G. Koch, T. Reinhold, P. Vienhues, A. Berghöfer, S. Roll, T. Keil, F. Schlensog-Schuster, K. von Klitzing, C. Ludwig-Körner and L. Kuchinke

    Citation: Trials 2020 21:490

    Content type: Study protocol

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  3. Colchicine is a well-known drug, which has been used for years to treat a wide range of rheumatic and inflammatory disorders. It helps break the cycle of inflammation through diverse mechanisms including reduc...

    Authors: Nooshin Dalili, Alireza Kashefizadeh, Mohsen Nafar, Fatemeh Poorrezagholi, Ahmad Firouzan, Fariba Samadian, Shiva Samavat, Shadi Ziaie and Somayeh Fatemizadeh

    Citation: Trials 2020 21:489

    Content type: Letter

    Published on:

  4. A variety of possible mechanisms can make the nucleic acid test of patients who meet the discharge conditions positive again, including reinfection, reactivation of the original virus, lack of strict discharge...

    Authors: Jiawen Li, Chi Zhang, Zhao Wu, Guiqiang Wang and Hong Zhao

    Citation: Trials 2020 21:488

    Content type: Letter

    Published on:

  5. Recent studies have indicated that a ketogenic diet can be used as an adjuvant therapy to enhance sensitivity to chemotherapy and radiotherapy in cancer patients. However, there are no sufficient data and no c...

    Authors: Yan Wang, Ming-Xi Jing, Lei Jiang, Yu-Feng Jia, E. Ying, Hui Cao, Xiang-Yu Guo and Tao Sun

    Citation: Trials 2020 21:487

    Content type: Study protocol

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  6. An impactful clinical trial will have real-life benefits for patients and society beyond the academic environment. This study analyses case studies of cancer trials to understand how impact is evidenced for ca...

    Authors: Catherine R. Hanna, Lauren P. Gatting, Kathleen Anne Boyd, Kathryn A. Robb and Rob J. Jones

    Citation: Trials 2020 21:486

    Content type: Research

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  7. The hypothesis of the study is that treatment with hydroxychloroquine sulphate in hospitalised patients with coronavirus disease 2019 (Covid-19) is safe and will accelerate the virological clearance rate for p...

    Authors: Magnus Nakrem Lyngbakken, Jan-Erik Berdal, Arne Eskesen, Dag Kvale, Inge Christoffer Olsen, Anbjørg Rangberg, Christine Monceyron Jonassen, Torbjørn Omland, Helge Røsjø and Olav Dalgard

    Citation: Trials 2020 21:485

    Content type: Letter

    Published on:

  8. Around 30% of post-menopausal breast cancer is related to excess body fat, alcohol intake and low levels of physical activity. Current estimates suggest that there is a 12% increased risk in post-menopausal br...

    Authors: Annie S. Anderson, Angela M. Craigie, Stephanie Gallant, Chloe McAdam, E. Jane Macaskill, Jennifer McKell, Nanette Mutrie, Ronan E. O’Carroll, Naveed Sattar, Martine Stead and Shaun Treweek

    Citation: Trials 2020 21:484

    Content type: Research

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  9. The objective of this study was to investigate the effects of Anethum graveolens (dill) powder supplementation on glycemic control, lipid profile, some antioxidants and inflammatory markers, and gastrointestinal ...

    Authors: Fatemeh Haidari, Mehrnoosh Zakerkish, Fatemeh Borazjani, Kambiz Ahmadi Angali and Golnaz Amoochi Foroushani

    Citation: Trials 2020 21:483

    Content type: Research

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  10. Chronic hepatitis B (CHB) is a global public health problem. Antiviral therapy is the primary treatment. Studies have shown that a combined therapy of traditional Chinese medicine (TCM) and conventional antivi...

    Authors: Qing-Juan Wu, Wen-Liang Lv, Juan-Mei Li, Ting-Ting Zhang, Wen-hui Zhou, Qiang Zhang, Jiu-Chong Wang, Qing-Nan Wang, Ruo-Xuan Zhang, Xin Zhao, Si-Tong Chen, Shuang Liu, Gao-Hui Li, Zheng-Min Cao, Lei Xu and Jing Chen

    Citation: Trials 2020 21:482

    Content type: Study protocol

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  11. The objectives of these two separate trials are: (1) to reduce health care workers (HCWs) absenteeism; and (2) to reduce hospital admission among the elderly during the COVID-19 pandemic through BCG vaccination.

    Authors: Thijs ten Doesschate, Simone J. C. F. M. Moorlag, Thomas W. van der Vaart, Esther Taks, Priya Debisarun, Jaap ten Oever, Chantal P. Bleeker-Rovers, Patricia Bruijning Verhagen, Arief Lalmohamed, Rob ter Heine, Reinout van Crevel, Janneke van de Wijgert, Axel B. Janssen, Marc J. Bonten, Cornelis H. van Werkhoven and Mihai G. Netea

    Citation: Trials 2020 21:481

    Content type: Letter

    Published on:

    The Correction to this article has been published in Trials 2020 21:555

  12. The prevalence of inadequate symptom control among cancer patients is quite high despite the availability of definitive care guidelines and accurate and efficient assessment tools.

    Authors: Lila J. Finney Rutten, Kathryn J. Ruddy, Linda L. Chlan, Joan M. Griffin, Jeph Herrin, Aaron L. Leppin, Deirdre R. Pachman, Jennifer L. Ridgeway, Parvez A. Rahman, Curtis B. Storlie, Patrick M. Wilson and Andrea L. Cheville

    Citation: Trials 2020 21:480

    Content type: Study protocol

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  13. Recruiting and retaining participants in randomised controlled trials (RCTs) is challenging. Digital tools, such as social media, data mining, email or text-messaging, could improve recruitment or retention, b...

    Authors: Geoff K. Frampton, Jonathan Shepherd, Karen Pickett, Gareth Griffiths and Jeremy C. Wyatt

    Citation: Trials 2020 21:478

    Content type: Review

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    The Editorial to this article has been published in Trials 2020 21:476

  14. For most chronic medical conditions, multiple medications are available and prescribers often have limited evidence about which therapy is likely to be the most effective and safe for an individual patient. As...

    Authors: Amy Rogers, Gillian Craig, Angela Flynn, Isla Mackenzie, Thomas MacDonald and Alexander Doney

    Citation: Trials 2020 21:477

    Content type: Commentary

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  15. Renal stones are common, with a lifetime prevalence of 10% in adults. Global incidence is increasing due to increases in obesity and diabetes, with these patient populations being more likely to suffer renal s...

    Authors: Sam McClinton, Kathryn Starr, Ruth Thomas, Graeme MacLennan, Thomas Lam, Rodolfo Hernandez, Robert Pickard, Ken Anson, Terry Clark, Steven MacLennan, David Thomas, Daron Smith, Ben Turney, Alison McDonald, Sarah Cameron and Oliver Wiseman

    Citation: Trials 2020 21:479

    Content type: Study protocol

    Published on:

  16. Objective: To undertake a pilot, feasibility RCT of umbilical cord blood derived cell therapy for treatment of adult patients infected with SARS-CoV-2 virus related moderate-to-severe pneumonia to prevent prog...

    Authors: Atul Malhotra, David Ernest, Benjamin A. Rogers, David Haylock, Ashalyn Watt, Guy Moeneclaey and Graham Jenkin

    Citation: Trials 2020 21:474

    Content type: Letter

    Published on:

  17. Citation: Trials 2020 21:475

    Content type: Letter

    Published on:

  18. We will investigate the effectiveness of Interferon Beta 1a, compared to Interferon Beta 1b and the usual therapeutic regimen in COVID-19 in patients that have tested positive and are moderately to severely ill.

    Authors: Seyed Sina Naghibi Irvani, Maryam Golmohammadi, Mohamad Amin Pourhoseingholi, Shervin Shokouhi and Ilad Alavi Darazam

    Citation: Trials 2020 21:473

    Content type: Letter

    Published on:

  19. SARS-CoV-2 infection presents a high transmission in the group of health professionals in Spain (12-15% infected). Currently there is no accepted chemoprophylaxis but hydroxychloroquine (HDQ) is known to inhib...

    Authors: Antonio Cuadrado-Lavín, José Manuel Olmos, José Manuel Cifrian, Teresa Gimenez, Marco Antonio Gandarillas, Mar García-Saiz, Maria Henar Rebollo, Victor Martínez-Taboada, Marcos López-Hoyos, María Carmen Fariñas and Javier Crespo

    Citation: Trials 2020 21:472

    Content type: Letter

    Published on:

  20. An amendment to this paper has been published and can be accessed via the original article.

    Authors: B. Joseph Elmunzer, Jose Serrano, Amitabh Chak, Steven A. Edmundowicz, Georgios I. Papachristou, James M. Scheiman, Vikesh K. Singh, Shyam Varadarajulu, John J. Vargo, Field F. Willingham, Todd H. Baron, Gregory A. Coté, Joseph Romagnuolo, April Wood-Williams, Emily K. Depue, Rebecca L. Spitzer…

    Citation: Trials 2020 21:471

    Content type: Correction

    Published on:

    The original article was published in Trials 2016 17:120

  21. SARS-CoV2 infection leads to a concomitant pulmonary inflammation. This inflammation is supposed to be the main driver in the pathogenesis of lung failure (Acute Respiratory Distress Syndrome) in COVID-19. Obj...

    Authors: Jonathan Rilinger, Winfried V. Kern, Daniel Duerschmied, Alexander Supady, Christoph Bode, Dawid L. Staudacher and Tobias Wengenmayer

    Citation: Trials 2020 21:470

    Content type: Letter

    Published on:

  22. Entertainment-education (E-E) media can improve behavioral intent toward health-related practices. In the era of COVID-19, millions of people can be reached by E-E media without requiring any physical contact....

    Authors: Alain Vandormael, Maya Adam, Merlin Greuel and Till Bärnighausen

    Citation: Trials 2020 21:469

    Content type: Letter

    Published on:

  23. The purpose of this study is to test the safety and effectiveness of individually or simultaneously blocking IL-6, IL-6 receptor and IL-1 versus standard of care on blood oxygenation and systemic cytokine rele...

    Authors: Bastiaan Maes, Cedric Bosteels, Elisabeth De Leeuw, Jozefien Declercq, Karel Van Damme, Anja Delporte, Bénédicte Demeyere, Stéfanie Vermeersch, Marnik Vuylsteke, Joren Willaert, Laura Bollé, Yuri Vanbiervliet, Jana Decuypere, Frederick Libeer, Stefaan Vandecasteele, Isabelle Peene…

    Citation: Trials 2020 21:468

    Content type: Letter

    Published on:

    The Correction to this article has been published in Trials 2020 21:556

  24. Comparison of the effect of hydroxychloroquine with placebo to prevent infection from the COVID -19 virus among healthcare professionals

    Authors: Reihaneh Pirjani, Tahereh Soori, Ahmad Reza Dehpour, Mahdi Sepidarkish, Ashraf Moini, Arshia Shizarpour and Razieh Mohammad Jafari

    Citation: Trials 2020 21:467

    Content type: Letter

    Published on:

  25. Primary objective: to evaluate the efficacy of melatonin as a prophylactic treatment on prevention of symptomatic SARS-CoV-2 infection among healthcare workers at high risk of SARS-CoV-2 exposure.

    Authors: Irene García García, Miguel Rodriguez-Rubio, Amelia Rodríguez Mariblanca, Lucía Martínez de Soto, Lucía Díaz García, Jaime Monserrat Villatoro, Javier Queiruga Parada, Enrique Seco Meseguer, María J. Rosales, Juan González, José R. Arribas, Antonio J. Carcas, Pedro de la Oliva and Alberto M. Borobia

    Citation: Trials 2020 21:466

    Content type: Letter

    Published on:

  26. Osteoporosis is becoming more prevalent in aging societies worldwide, and the economic burden attributable to osteoporotic fractures is substantial. The medications presently available to treat osteoporosis have

    Authors: Z. Q. Ren, Y. F. Wang, G. F. Ao, H. X. Chen, M. Huang, M. X. Lai, H. D. Zhao and R. Zhao

    Citation: Trials 2020 21:465

    Content type: Study protocol

    Published on:

  27. Dentin hypersensitivity (DH) is a condition characterized by short and sharp episodes of pain which will arise in response to tactile, chemical, thermal, evaporative or osmotic stimuli. The painful symptoms ca...

    Authors: Takashi Matsuura, Megumi Mae, Masayuki Ohira, Yasunori Yamashita, Ayako Nakazono, Kouji Sugimoto, Kajiro Yanagiguchi and Shizuka Yamada

    Citation: Trials 2020 21:464

    Content type: Study protocol

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  28. Acute otitis media (AOM) is a common painful infection in children, with around 2.8 million cases presenting to primary care in England and Wales annually. Nearly all children who present to their general prac...

    Authors: Kathryn Curtis, Michael Moore, Christie Cabral, Vasa Curcin, Jeremey Horwood, Richard Morris, Vibhore Prasad, Anne Schilder, Nicholas Turner, Scott Wilkes, Alastair D. Hay and Jodi Taylor

    Citation: Trials 2020 21:463

    Content type: Study protocol

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  29. The primary objective of the study is to assess the safety of a single intravenous infusion of Mesenchymal Stromal Cells (MSCs) in patients with Acute Respiratory Distress Syndrome (ARDS) due to COVID-19. Seco...

    Authors: Ellen Gorman, Manu Shankar-Hari, Phil Hopkins, William S. Tunnicliffe, Gavin D. Perkins, Jonathan Silversides, Peter McGuigan, Colette Jackson, Roisin Boyle, Jamie McFerran, Cliona McDowell, Christina Campbell, Margaret McFarland, Jon Smythe, Jacqui Thompson, Barry Williams…

    Citation: Trials 2020 21:462

    Content type: Letter

    Published on:

  30. Transcranial direct current stimulation (tDCS) is promising for improving motor and cognitive performance. Nevertheless, its mechanisms of action are unclear and need to be better characterised according to th...

    Authors: Yohan Grandperrin, Sidney Grosprêtre, Magali Nicolier, Philippe Gimenez, Chrystelle Vidal, Emmanuel Haffen and Djamila Bennabi

    Citation: Trials 2020 21:461

    Content type: Study protocol

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  31. Several modalities are used for the treatment of varicose veins. Open surgical treatment with ligation and stripping of the saphenous vein has been the standard of care for many years. Endovenous thermal ablat...

    Authors: Sungsin Cho, Hyung Sub Park, Taeseung Lee, Seung Jae Byun, Woo-Sung Yun, Shin-Seok Yang, Hyangkyoung Kim, Woo-Shik Kim, Jin Hyun Joh and In Mok Jung

    Citation: Trials 2020 21:460

    Content type: Study protocol

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  32. The investigational medicinal product GKT137831 is a selective inhibitor of NOX 1 and 4 isoforms of the nicotinamide adenine dinucleotide phosphate (NADPH) oxidase family of enzymes, which has the potential to...

    Authors: Alysha M. De Livera, Anne Reutens, Mark Cooper, Merlin Thomas, Karin Jandeleit-Dahm, Jonathan E. Shaw and Agus Salim

    Citation: Trials 2020 21:459

    Content type: Update

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  33. In the work-up strategy for pulmonary embolism (PE) in the ED, the recently introduced YEARS rule allows the raising of the D-dimer threshold to 1000 ng/ml in patients with no signs of deep venous thrombosis a...

    Authors: Anne-Laure Philippon, Margaux Dumont, Sonia Jimenez, Sarah Salhi, Marine Cachanado, Isabelle Durand-Zaleski, Tabassome Simon and Yonathan Freund

    Citation: Trials 2020 21:458

    Content type: Study protocol

    Published on:

  34. Hypertension is the most important modifiable risk factor for cardiovascular disease, the leading cause of mortality in the United States. The Emergency Department represents an underutilized opportunity to im...

    Authors: William J. Meurer, Mackenzie Dinh, Kelley M. Kidwell, Adam Flood, Emily Champoux, Candace Whitfield, Deborah Trimble, Joan Cowdery, Dominic Borgialli, Sacha Montas, Rebecca Cunningham, Lorraine R. Buis, Devin Brown and Lesli Skolarus

    Citation: Trials 2020 21:456

    Content type: Study protocol

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  35. Almost 15% of patients with ulcerative colitis (UC) will require a proctocolectomy with ileal pouch–anal anastomosis (IPAA) as a result of fulminant colitis, dysplasia, cancer, or medical refractory diseases. ...

    Authors: Caroline Trang-Poisson, Elise Kerdreux, Alexandra Poinas, Lucie Planche, Harry Sokol, Pascale Bemer, Karine Cabanas, Eliane Hivernaud, Laetitia Biron, Laurent Flet, Emmanuel Montassier, Ghislaine Le Garcasson, Anne Chiffoleau, Alexandra Jobert, Didier Lepelletier, Jocelyne Caillon…

    Citation: Trials 2020 21:455

    Content type: Study protocol

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  36. Postoperative upper gastrointestinal fistula (PUGIF) is a devastating complication, leading to high mortality (reaching up to 80%), increased length of hospital stay, reduced health-related quality of life and...

    Authors: Caroline Gronnier, Cécile Chambrier, Alain Duhamel, Benoît Dervaux, Denis Collet, Delphine Vaudoyer, Jean-Marc Régimbeau, Jacques Jougon, Jérémie Théréaux, Gil Lebreton, Julie Veziant, Alain Valverde, Pablo Ortega-Deballon, François Pattou, Muriel Mathonnet, Julie Perinel…

    Citation: Trials 2020 21:448

    Content type: Study protocol

    Published on:

  37. In rural Ethiopia, 72% of women are exposed to lifetime intimate partner violence (IPV); IPV is most prevalent during pregnancy. As well as adversely affecting women’s physical and mental health, IPV also incr...

    Authors: Roxanne C. Keynejad, Tesera Bitew, Katherine Sorsdahl, Bronwyn Myers, Simone Honikman, Girmay Medhin, Negussie Deyessa, Nick Sevdalis, Wietse A. Tol, Louise Howard and Charlotte Hanlon

    Citation: Trials 2020 21:454

    Content type: Study protocol

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  38. Patients taking opioids are known to develop opioid-induced constipation (OIC), which reduces their quality of life. The aim of this study is to compare magnesium oxide with naldemedine and determine which is ...

    Authors: Anna Ozaki, Takaomi Kessoku, Michihiro Iwaki, Takashi Kobayashi, Tsutomu Yoshihara, Takayuki Kato, Yasushi Honda, Yuji Ogawa, Kento Imajo, Takuma Higurashi, Masato Yoneda, Masataka Taguri, Takeharu Yamanaka, Hiroto Ishiki, Noritoshi Kobayashi, Satoru Saito…

    Citation: Trials 2020 21:453

    Content type: Study protocol

    Published on:

  39. Functional food ingredients and natural health products have been demonstrated to reduce disease risk and thereby help to lower health care costs across populations at risk for chronic or degenerative diseases...

    Authors: Maryam Shamloo, Matthew J. Granger, Elke A. Trautwein, James D. House and Dylan MacKay

    Citation: Trials 2020 21:452

    Content type: Study protocol

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  40. Approximately 30% of appendectomies are for complicated acute appendicitis (CAA). With laparoscopy, the main post-operative complication is deep abscesses (12% of cases of CAA, versus 4% for open surgery). A r...

    Authors: C. Sabbagh, N. Siembida, H. Dupont, M. Diouf, J. L. Schmit, S. Boddaert and J. M. Regimbeau

    Citation: Trials 2020 21:451

    Content type: Study protocol

    Published on:

  41. Rhizarthrosis (trapeziometacarpal osteoarthritis) is the second most common site of osteoarthritis in the hand affecting 10–30% of adults over the age of 50. Up to four times as many women as men have rhizarth...

    Authors: Markus Bock, Andreas Eisenschenk, Heiko Lorenzen and Martin Lautenbach

    Citation: Trials 2020 21:450

    Content type: Study protocol

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  42. Smartphone-based support can reach thousands of smokers and help those who would otherwise try to quit smoking by themselves with little chance of success. Nicotine medications double the chances of quitting s...

    Authors: Jean-François Etter and Yasser Khazaal

    Citation: Trials 2020 21:449

    Content type: Study protocol

    Published on:

  43. Coronary artery diseases (CAD) remains a severe socio-economic burden in the Western world. Coronary obstruction and subsequent myocardial ischemia result in progressive replacement of contractile myocardium w...

    Authors: Leo Pölzl, Felix Nägele, Michael Graber, Jakob Hirsch, Daniela Lobenwein, Martina Mitrovic, Agnes Mayr, Markus Theurl, Michael Schreinlechner, Matthias Pamminger, Christian Dorfmüller, Michael Grimm, Can Gollmann-Tepeköylü and Johannes Holfeld

    Citation: Trials 2020 21:447

    Content type: Study protocol

    Published on:

  44. Patients affected by hepatic cirrhosis show reductions in muscle mass and function, with poor quality of life and functional performance. As such, resistance training with blood flow restriction (BFR-RT) could...

    Authors: Sanmy Rocha Nóbrega, Silvana Gama Florencio Chachá and Cleiton Augusto Libardi

    Citation: Trials 2020 21:446

    Content type: Study protocol

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  45. There is increasing international recognition that populations included in trials should adequately represent the population treated in clinical practice; however, adults who lack the capacity to provide infor...

    Authors: Victoria Shepherd

    Citation: Trials 2020 21:445

    Content type: Commentary

    Published on:

  46. Endoscopic retrograde cholangiopancreatography (ERCP) is an increasingly common intervention in the treatment of pancreaticobiliary disorders. Patients are often elderly with complex co-morbidities. While moni...

    Authors: Venkatesan Thiruvenkatarajan, Ashok Dharmalingam, Gilberto Arenas, Medhat Wahba, Reinhard Steiner, Vasanth Rao Kadam, Andre Tran, John Currie, Roelof Van Wijk, Anthony Quail and Guy Ludbrook

    Citation: Trials 2020 21:444

    Content type: Study protocol

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  47. Benefits to patients from reduced depression have been shown from monitoring progress with patient-reported outcome measures (PROMs) in psychological therapy and mental health settings. This approach has not y...

    Authors: Tony Kendrick, Michael Moore, Geraldine Leydon, Beth Stuart, Adam W. A. Geraghty, Guiqing Yao, Glyn Lewis, Gareth Griffiths, Carl May, Rachel Dewar-Haggart, Samantha Williams, Shihua Zhu and Christopher Dowrick

    Citation: Trials 2020 21:441

    Content type: Study protocol

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  48. Prescribing, monitoring and administration of medicines in care homes could be improved. A cluster randomised controlled trial (RCT) is ongoing to evaluate the effectiveness of an independent prescribing pharm...

    Authors: Christine M. Bond, Richard Holland, David P. Alldred, Antony Arthur, Garry Barton, Linda Birt, Annie Blyth, James Desborough, Joanna Ford, Christine Handford, Helen Hill, Carmel M. Hughes, Vivienne Maskrey, Kate Massey, Phyo K. Myint, Nigel Norris…

    Citation: Trials 2020 21:439

    Content type: Study protocol

    Published on:

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